-CITE-

42 USC Sec. 300u-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XV - HEALTH INFORMATION AND HEALTH PROMOTION

-HEAD-

Sec. 300u-6. Office of Minority Health

-STATUTE-

(a) In general

There is established an Office of Minority Health within the

Office of Public Health and Science. There shall be in the

Department of Health and Human Services a Deputy Assistant

Secretary for Minority Health, who shall be the head of the Office

of Minority Health. The Secretary, acting through such Deputy

Assistant Secretary, shall carry out this section.

(b) Duties

With respect to improving the health of racial and ethnic

minority groups, the Secretary, acting through the Deputy Assistant

Secretary for Minority Health (in this section referred to as the

"Deputy Assistant Secretary"), shall carry out the following:

(1) Establish short-range and long-range goals and objectives

and coordinate all other activities within the Public Health

Service that relate to disease prevention, health promotion,

service delivery, and research concerning such individuals. The

heads of each of the agencies of the Service shall consult with

the Deputy Assistant Secretary to ensure the coordination of such

activities.

(2) Enter into interagency agreements with other agencies of

the Public Health Service.

(3) Support research, demonstrations and evaluations to test

new and innovative models.

(4) Increase knowledge and understanding of health risk

factors.

(5) Develop mechanisms that support better information

dissemination, education, prevention, and service delivery to

individuals from disadvantaged backgrounds, including individuals

who are members of racial or ethnic minority groups.

(6) Ensure that the National Center for Health Statistics

collects data on the health status of each minority group.

(7) With respect to individuals who lack proficiency in

speaking the English language, enter into contracts with public

and nonprofit private providers of primary health services for

the purpose of increasing the access of the individuals to such

services by developing and carrying out programs to provide

bilingual or interpretive services.

(8) Support a national minority health resource center to carry

out the following:

(A) Facilitate the exchange of information regarding matters

relating to health information and health promotion, preventive

health services, and education in the appropriate use of health

care.

(B) Facilitate access to such information.

(C) Assist in the analysis of issues and problems relating to

such matters.

(D) Provide technical assistance with respect to the exchange

of such information (including facilitating the development of

materials for such technical assistance).

(9) Carry out programs to improve access to health care

services for individuals with limited proficiency in speaking the

English language. Activities under the preceding sentence shall

include developing and evaluating model projects.

(10) Advise in matters related to the development,

implementation, and evaluation of health professions education in

decreasing disparities in health care outcomes, including

cultural competency as a method of eliminating health

disparities.

(c) Advisory Committee

(1) In general

The Secretary shall establish an advisory committee to be known

as the Advisory Committee on Minority Health (in this subsection

referred to as the "Committee").

(2) Duties

The Committee shall provide advice to the Deputy Assistant

Secretary carrying out this section, including advice on the

development of goals and specific program activities under

paragraphs (1) through (10) of subsection (b) of this section for

each racial and ethnic minority group.

(3) Chair

The chairperson of the Committee shall be selected by the

Secretary from among the members of the voting members of the

Committee. The term of office of the chairperson shall be 2

years.

(4) Composition

(A) The Committee shall be composed of 12 voting members

appointed in accordance with subparagraph (B), and nonvoting, ex

officio members designated in subparagraph (C).

(B) The voting members of the Committee shall be appointed by

the Secretary from among individuals who are not officers or

employees of the Federal Government and who have expertise

regarding issues of minority health. The racial and ethnic

minority groups shall be equally represented among such members.

(C) The nonvoting, ex officio members of the Committee shall be

such officials of the Department of Health and Human Services as

the Secretary determines to be appropriate.

(5) Terms

Each member of the Committee shall serve for a term of 4 years,

except that the Secretary shall initially appoint a portion of

the members to terms of 1 year, 2 years, and 3 years.

(6) Vacancies

If a vacancy occurs on the Committee, a new member shall be

appointed by the Secretary within 90 days from the date that the

vacancy occurs, and serve for the remainder of the term for which

the predecessor of such member was appointed. The vacancy shall

not affect the power of the remaining members to execute the

duties of the Committee.

(7) Compensation

Members of the Committee who are officers or employees of the

United States shall serve without compensation. Members of the

Committee who are not officers or employees of the United States

shall receive compensation, for each day (including travel time)

they are engaged in the performance of the functions of the

Committee. Such compensation may not be in an amount in excess of

the daily equivalent of the annual maximum rate of basic pay

payable under the General Schedule (under title 5) for positions

above GS-15.

(d) Certain requirements regarding duties

(1) Recommendations regarding language

(A) Proficiency in speaking English

The Deputy Assistant Secretary shall consult with the

Director of the Office of International and Refugee Health, the

Director of the Office of Civil Rights, and the Directors of

other appropriate departmental entities regarding

recommendations for carrying out activities under subsection

(b)(9) of this section.

(B) Health professions education regarding health disparities

The Deputy Assistant Secretary shall carry out the duties

under subsection (b)(10) of this section in collaboration with

appropriate personnel of the Department of Health and Human

Services, other Federal agencies, and other offices, centers,

and institutions, as appropriate, that have responsibilities

under the Minority Health and Health Disparities Research and

Education Act of 2000.

(2) Equitable allocation regarding activities

In carrying out subsection (b) of this section, the Secretary

shall ensure that services provided under such subsection are

equitably allocated among all groups served under this section by

the Secretary.

(3) Cultural competency of services

The Secretary shall ensure that information and services

provided pursuant to subsection (b) of this section are provided

in the language, educational, and cultural context that is most

appropriate for the individuals for whom the information and

services are intended.

(e) Grants and contracts regarding duties

(1) In general

In carrying out subsection (b) of this section, the Secretary

acting through the Deputy Assistant Secretary may make awards of

grants, cooperative agreements, and contracts to public and

nonprofit private entities.

(2) Process for making awards

The Deputy Assistant Secretary shall ensure that awards under

paragraph (1) are made, to the extent practical, only on a

competitive basis, and that a grant is awarded for a proposal

only if the proposal has been recommended for such an award

through a process of peer review.

(3) Evaluation and dissemination

The Deputy Assistant Secretary, directly or through contracts

with public and private entities, shall provide for evaluations

of projects carried out with awards made under paragraph (1)

during the preceding 2 fiscal years. The report shall be included

in the report required under subsection (f) of this section for

the fiscal year involved.

(f) Reports

(1) In general

Not later than February 1 of fiscal year 1999 and of each

second year thereafter, the Secretary shall submit to the

Committee on Energy and Commerce of the House of Representatives,

and to the Committee on Labor and Human Resources of the Senate,

a report describing the activities carried out under this section

during the preceding 2 fiscal years and evaluating the extent to

which such activities have been effective in improving the health

of racial and ethnic minority groups. Each such report shall

include the biennial reports submitted under subsections (e)(3)

and (f)(2) (!1) of this section for such years by the heads of

the Public Health Service agencies.

(2) Agency reports

Not later than February 1, 1999, and biennially thereafter, the

heads of the Public Health Service agencies shall submit to the

Deputy Assistant Secretary a report summarizing the minority

health activities of each of the respective agencies.

(g) Definitions

For purposes of this section:

(1) The term "racial and ethnic minority group" means American

Indians (including Alaska Natives, Eskimos, and Aleuts); Asian

Americans; Native Hawaiians and other Pacific Islanders; Blacks;

and Hispanics.

(2) The term "Hispanic" means individuals whose origin is

Mexican, Puerto Rican, Cuban, Central or South American, or any

other Spanish-speaking country.

(h) Funding

(1) (!2) Authorization of appropriations. - For the purpose of

carrying out this section, there are authorized to be appropriated

$30,000,000 for fiscal year 1998, and such sums as may be necessary

for each of the fiscal years 1999 through 2002.

-SOURCE-

(July 1, 1944, ch. 373, title XVII, Sec. 1707, as added Pub. L.

101-527, Sec. 2, Nov. 6, 1990, 104 Stat. 2312; amended Pub. L.

101-557, title IV, Sec. 401(a)(1), Nov. 15, 1990, 104 Stat. 2770;

Pub. L. 105-392, title II, Sec. 201(a), (c), Nov. 13, 1998, 112

Stat. 3582, 3585; Pub. L. 106-525, title IV, Sec. 403, title VI,

Sec. 601, Nov. 22, 2000, 114 Stat. 2509, 2511.)

-REFTEXT-

REFERENCES IN TEXT

The General Schedule, referred to in subsec. (c)(7), is set out

under section 5332 of Title 5, Government Organization and

Employees.

The Minority Health and Health Disparities Research and Education

Act of 2000, referred to in subsec. (d)(1)(B), is Pub. L. 106-525,

Nov. 22, 2000, 114 Stat. 2495. For complete classification of this

Act to the Code, see Short Title of 2000 Amendments note set out

under section 201 of this title and Tables.

Subsections (e)(3) and (f)(2) of this section, referred to in

subsec. (f)(1), was in the original "sections 201(e)(3) and

201(f)(2)", and was translated to reflect the probable intent of

Congress, because section 201 of act July 1, 1944, which is

classified to section 202 of this title, does not contain

subsections, and subsections (e)(3) and (f)(2) of this section

require biennial reporting.

-MISC1-

PRIOR PROVISIONS

A prior section 300u-6, act July 1, 1944, ch. 373, title XVII,

Sec. 1707, as added Nov. 10, 1978, Pub. L. 95-626, title V, Sec.

502, 92 Stat. 3593; amended July 10, 1979, Pub. L. 96-32, Sec.

6(k), 93 Stat. 84, related to project grants to State Councils on

Physical Fitness for physical fitness improvement, prior to repeal

by Pub. L. 98-551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816.

AMENDMENTS

2000 - Subsec. (b)(10). Pub. L. 106-525, Sec. 403(1), added par.

(10).

Subsec. (c)(2). Pub. L. 106-525, Sec. 403(2), substituted

"paragraphs (1) through (10)" for "paragraphs (1) through (9)".

Subsec. (d)(1). Pub. L. 106-525, Sec. 403(3), amended heading and

text of par. (1) generally. Prior to amendment, text read as

follows: "The Deputy Assistant Secretary for Minority Health shall

consult with the Director of the Office of International and

Refugee Health, the Director of the Office of Civil Rights, and the

Directors of other appropriate departmental entities regarding

recommendations for carrying out activities under subsection (b)(9)

of this section."

Subsec. (g)(1). Pub. L. 106-525, Sec. 601, substituted "Asian

Americans;" for "Asian Americans and" and inserted "Native

Hawaiians and other" before "Pacific Islanders;".

1998 - Pub. L. 105-392, Sec. 201(c)(1), struck out "Establishment

of" before "Office" in section catchline.

Subsec. (a). Pub. L. 105-392, Sec. 201(c)(2), substituted "Public

Health and Science" for "the Assistant Secretary for Health".

Subsecs. (b) to (h). Pub. L. 105-392, Sec. 201(a), added subsecs.

(b) to (h) and struck out former subsecs. (b) to (f), which

related, respectively, to duties of Secretary, certain requirements

regarding duties, grants and contracts regarding duties, reports,

and funding.

1990 - Subsec. (b)(8). Pub. L. 101-557 added par. (8).

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

Representatives by section 1(a) of Pub. L. 104-14, set out as a

note preceding section 21 of Title 2, The Congress. Committee on

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

of Representatives by House Resolution No. 5, One Hundred Seventh

Congress, Jan. 3, 2001.

-MISC2-

EFFECTIVE DATE OF 1990 AMENDMENT

Section 401(a)(2) of Pub. L. 101-557 provided that: "The

amendments made by paragraph (1) [amending this section] shall take

effect on the date of the enactment of the Disadvantaged Minority

Health Improvement Act of 1990 [Nov. 6, 1990]."

TERMINATION OF ADVISORY COMMITTEES

Advisory committees established after Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period beginning on the

date of their establishment, unless, in the case of a committee

established by the President or an officer of the Federal

Government, such committee is renewed by appropriate action prior

to the expiration of such 2-year period, or in the case of a

committee established by the Congress, its duration is otherwise

provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 776, set out in the Appendix to Title 5, Government

Organization and Employees.

Pub. L. 93-641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a

note under section 217a of this title, provided that an advisory

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

an Act of Congress enacted after Jan. 4, 1975.

CONGRESSIONAL FINDINGS

Section 1(b) of Pub. L. 101-527 provided that: "The Congress

finds that -

"(1) racial and ethnic minorities are disproportionately

represented among individuals from disadvantaged backgrounds;

"(2) the health status of individuals from disadvantaged

backgrounds, including racial and ethnic minorities, in the

United States is significantly lower than the health status of

the general population of the United States;

"(3) minorities suffer disproportionately high rates of cancer,

stroke, heart diseases, diabetes, substance abuse, acquired

immune deficiency syndrome, and other diseases and disorders;

"(4) the incidence of infant mortality among minorities is

almost double that for the general population;

"(5) Blacks, Hispanics, and Native Americans constitute

approximately 12 percent, 7.9 percent, and 0.01 percent,

respectively, of the population of the United States;

"(6) Blacks, Hispanics, and Native Americans in the United

States constitute approximately 3 percent, 4 percent, and less

than 0.01 percent, respectively, of physicians, 2.7 percent, 1.7

percent, and less than 0.01 percent, respectively, of dentists,

and 4.5 percent, 1.6 percent, and less than 0.01 percent,

respectively, of nurses;

"(7) the number of individuals who are from disadvantaged

backgrounds in health professions should be increased for the

purpose of improving the access of other such individuals to

health services;

"(8) minority health professionals have historically tended to

practice in low-income areas and to serve minorities;

"(9) minority health professionals have historically tended to

engage in the general practice of medicine and specialties

providing primary care;

"(10) reports published in leading medical journals indicate

that access to health care among minorities can be substantially

improved by increasing the number of minority health

professionals;

"(11) increasing the number of minorities serving on the

faculties of health professions schools can be an important

factor in attracting minorities to pursue a career in the health

professions;

"(12) diversity in the faculty and student body of health

professions schools enhances the quality of education for all

students attending the schools;

"(13) the Report of the Secretary's Task Force on Black and

Minority Health (prepared for the Secretary of Health and Human

Services and issued in 1985) described the health status problems

of minorities, and made recommendations concerning measures that

should be implemented by the Secretary with respect to improving

the health status of minorities through programs for providing

health information and education; and

"(14) the Office of Minority Health, created in 1985 by the

Secretary of Health and Human Services, should be authorized

pursuant to statute and should receive increased funding to

support efforts to improve the health of individuals from

disadvantaged backgrounds, including minorities, including the

implementation of the recommendations made by the Secretary's

Task Force on Black and Minority Health."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 287c-31, 299a-1 of this

title.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. No par. (2) has been enacted.

-End-

-CITE-

42 USC Sec. 300u-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XV - HEALTH INFORMATION AND HEALTH PROMOTION

-HEAD-

Sec. 300u-7. Office of Adolescent Health

-STATUTE-

(a) In general

There is established an Office of Adolescent Health within the

Office of the Assistant Secretary for Health, which office (!1)

shall be headed by a director (!1) appointed by the Secretary. The

Secretary shall carry out this section acting through the Director

of such Office.

(b) Duties

With respect to adolescent health, the Secretary shall -

(1) coordinate all activities within the Department of Health

and Human Services that relate to disease prevention, health

promotion, preventive health services, and health information and

education with respect to the appropriate use of health care,

including coordinating -

(A) the design of programs, support for programs, and the

evaluation of programs;

(B) the monitoring of trends;

(C) projects of research (including multidisciplinary

projects) on adolescent health; and

(D) the training of health providers who work with

adolescents, particularly nurse practitioners, physician

assistants, and social workers;

(2) coordinate the activities described in paragraph (1) with

similar activities in the private sector; and

(3) support projects, conduct research, and disseminate

information relating to preventive medicine, health promotion,

and physical fitness and sports medicine.

(c) Certain demonstration projects

(1) In general

In carrying out subsection (b)(3) of this section, the

Secretary may make grants to carry out demonstration projects for

the purpose of improving adolescent health, including projects to

train health care providers in providing services to adolescents

and projects to reduce the incidence of violence among

adolescents, particularly among minority males.

(2) Authorization of appropriations

For the purpose of carrying out paragraph (1), there are

authorized to be appropriated $5,000,000 for fiscal year 1993,

and such sums as may be necessary for each of the fiscal years

1994 through 1997.

(d) Information clearinghouse

In carrying out subsection (b) of this section, the Secretary

shall establish and maintain a National Information Clearinghouse

on Adolescent Health to collect and disseminate to health

professionals and the general public information on adolescent

health.

(e) National plan

In carrying out subsection (b) of this section, the Secretary

shall develop a national plan for improving adolescent health. The

plan shall be consistent with the applicable objectives established

by the Secretary for the health status of the people of the United

States for the year 2000, and shall be periodically reviewed, and

as appropriate, revised. The plan, and any revisions in the plan,

shall be submitted to the Committee on Energy and Commerce of the

House of Representatives and the Committee on Labor and Human

Resources of the Senate.

(f) Adolescent health

For purposes of this section, the term "adolescent health", with

respect to adolescents of all ethnic and racial groups, means all

diseases, disorders, and conditions (including with respect to

mental health) -

(1) unique to adolescents, or more serious or more prevalent in

adolescents;

(2) for which the factors of medical risk or types of medical

intervention are different for adolescents, or for which it is

unknown whether such factors or types are different for

adolescents; or

(3) with respect to which there has been insufficient clinical

research involving adolescents as subjects or insufficient

clinical data on adolescents.

-SOURCE-

(July 1, 1944, ch. 373, title XVII, Sec. 1708, as added Pub. L.

102-531, title III, Sec. 302, Oct. 27, 1992, 106 Stat. 3483.)

-MISC1-

PRIOR PROVISIONS

A prior section 300u-7, act July 1, 1944, ch. 373, title XVII,

Sec. 1708, as added Nov. 10, 1978, Pub. L. 95-626, title V, Sec.

502, 92 Stat. 3594; amended July 10, 1979, Pub. L. 96-32, Sec.

6(l), 93 Stat. 84, related to project grants for physical fitness

improvement and research projects, prior to repeal by Pub. L.

98-551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816.

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

Representatives by section 1(a) of Pub. L. 104-14, set out as a

note preceding section 21 of Title 2, The Congress. Committee on

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

of Representatives by House Resolution No. 5, One Hundred Seventh

Congress, Jan. 3, 2001.

-FOOTNOTE-

(!1) So in original. Probably should be capitalized.

-End-

-CITE-

42 USC Sec. 300u-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XV - HEALTH INFORMATION AND HEALTH PROMOTION

-HEAD-

Sec. 300u-8. Biennial report regarding nutrition and health

-STATUTE-

(a) Biennial report

The Secretary shall require the Surgeon General of the Public

Health Service to prepare biennial reports on the relationship

between nutrition and health. Such reports may, with respect to

such relationship, include any recommendations of the Secretary and

the Surgeon General.

(b) Submission to Congress

The Secretary shall ensure that, not later than February 1 of

1995 and of every second year thereafter, a report under subsection

(a) of this section is submitted to the Committee on Energy and

Commerce of the House of Representatives and the Committee on Labor

and Human Resources of the Senate.

-SOURCE-

(July 1, 1944, ch. 373, title XVII, Sec. 1709, as added Pub. L.

103-183, title VII, Sec. 704, Dec. 14, 1993, 107 Stat. 2240.)

-MISC1-

PRIOR PROVISIONS

A prior section 300u-8, act July 1, 1944, ch. 373, title XVII,

Sec. 1709, as added Nov. 10, 1978, Pub. L. 95-626, title V, Sec.

502, 92 Stat. 3594, related to establishment of national program on

sports medicine research, prior to repeal by Pub. L. 98-551, Sec.

2(c), Oct. 30, 1984, 98 Stat. 2816.

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

Representatives by section 1(a) of Pub. L. 104-14, set out as a

note preceding section 21 of Title 2, The Congress. Committee on

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

of Representatives by House Resolution No. 5, One Hundred Seventh

Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 300u-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XV - HEALTH INFORMATION AND HEALTH PROMOTION

-HEAD-

Sec. 300u-9. Education regarding DES

-STATUTE-

(a) In general

The Secretary, acting through the heads of the appropriate

agencies of the Public Health Service, shall carry out a national

program for the education of health professionals and the public

with respect to the drug diethylstilbestrol (commonly known as

DES). To the extent appropriate, such national program shall use

methodologies developed through the education demonstration program

carried out under section 283a of this title. In developing and

carrying out the national program, the Secretary shall consult

closely with representatives of nonprofit private entities that

represent individuals who have been exposed to DES and that have

expertise in community-based information campaigns for the public

and for health care providers. The implementation of the national

program shall begin during fiscal year 1999.

(b) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 1999 through 2003. The authorization of

appropriations established in the preceding sentence is in addition

to any other authorization of appropriation that is available for

such purpose.

-SOURCE-

(July 1, 1944, ch. 373, title XVII, Sec. 1710, as added Pub. L.

105-340, title I, Sec. 101(b), Oct. 31, 1998, 112 Stat. 3191.)

-MISC1-

PRIOR PROVISIONS

A prior section 300u-9, act July 1, 1944, ch. 373, title XVII,

Sec. 1710, as added Nov. 10, 1978, Pub. L. 95-626, title V, Sec.

502, 92 Stat. 3594; amended Oct. 17, 1979, Pub. L. 96-88, title

III, Sec. 301(b)(2), title V, Sec. 507, 93 Stat. 678, 692, related

to Conference on Education in Lifetime Sports, prior to repeal by

Pub. L. 98-551, Sec. 2(c), Oct. 30, 1984, 98 Stat. 2816.

-End-

-CITE-

42 USC SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE

STUDY OF ETHICAL PROBLEMS IN MEDICINE AND

BIOMEDICAL AND BEHAVIOR RESEARCH 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR

RESEARCH

-HEAD-

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR RESEARCH

-End-

-CITE-

42 USC Sec. 300v 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR

RESEARCH

-HEAD-

Sec. 300v. Commission

-STATUTE-

(a) Establishment; composition; appointment of members; vacancies

(1) There is established the President's Commission for the Study

of Ethical Problems in Medicine and Biomedical and Behavioral

Research (hereinafter in this subchapter referred to as the

"Commission") which shall be composed of eleven members appointed

by the President. The members of the Commission shall be appointed

as follows:

(A) Three of the members shall be appointed from individuals

who are distinguished in biomedical or behavioral research.

(B) Three of the members shall be appointed from individuals

who are distinguished in the practice of medicine or otherwise

distinguished in the provision of health care.

(C) Five of the members shall be appointed from individuals who

are distinguished in one or more of the fields of ethics,

theology, law, the natural sciences (other than a biomedical or

behavioral science), the social sciences, the humanities, health

administration, government, and public affairs.

(2) No individual who is a full-time officer or employee of the

United States may be appointed as a member of the Commission. The

Secretary of Health and Human Services, the Secretary of Defense,

the Director of Central Intelligence, the Director of the Office of

Science and Technology Policy, the Secretary of Veterans Affairs,

and the Director of the National Science Foundation shall each

designate an individual to provide liaison with the Commission.

(3) No individual may be appointed to serve as a member of the

Commission if the individual has served for two terms of four years

each as such a member.

(4) A vacancy in the Commission shall be filled in the manner in

which the original appointment was made.

(b) Terms of members

(1) Except as provided in paragraphs (2) and (3), members shall

be appointed for terms of four years.

(2) Of the members first appointed -

(A) four shall be appointed for terms of three years, and

(B) three shall be appointed for terms of two years,

as designated by the President at the time of appointment.

(3) Any member appointed to fill a vacancy occurring before the

expiration of the term for which his predecessor was appointed

shall be appointed only for the remainder of such term. A member

may serve after the expiration of his term until his successor has

taken office.

(c) Chairman

The Chairman of the Commission shall be appointed by the

President, by and with the advice and consent of the Senate, from

members of the Commission.

(d) Meetings

(1) Seven members of the Commission shall constitute a quorum for

business, but a lesser number may conduct hearings.

(2) The Commission shall meet at the call of the Chairman or at

the call of a majority of its members.

(e) Compensation; travel expenses, etc.

(1) Members of the Commission shall each be entitled to receive

the daily equivalent of the annual rate of basic pay in effect for

grade GS-18 of the General Schedule for each day (including travel

time) during which they are engaged in the actual performance of

duties vested in the Commission.

(2) While away from their homes or regular places of business in

the performance of services for the Commission, members of the

Commission shall be allowed travel expenses, including per diem in

lieu of subsistence, in the same manner as persons employed

intermittently in the Government service are allowed expenses under

section 5703 of title 5.

-SOURCE-

(July 1, 1944, ch. 373, title XVIII, Sec. 1801, as added Pub. L.

95-622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3437; amended

Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695;

Pub. L. 100-527, Sec. 10(1), Oct. 25, 1988, 102 Stat. 2640.)

-MISC1-

AMENDMENTS

1988 - Subsec. (a)(2). Pub. L. 100-527 substituted "Secretary of

Veterans Affairs" for "Administrator of Veterans' Affairs".

-CHANGE-

CHANGE OF NAME

"Secretary of Health and Human Services" substituted for

"Secretary of Health, Education, and Welfare" in subsec. (a)(2)

pursuant to section 509(b) of Pub. L. 96-88, which is classified to

section 3508(b) of Title 20, Education.

-MISC2-

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-527 effective Mar. 15, 1989, see section

18(a) of Pub. L. 100-527, set out as a Department of Veterans

Affairs Act note under section 301 of Title 38, Veterans' Benefits.

REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES

References in laws to the rates of pay for GS-16, 17, or 18, or

to maximum rates of pay under the General Schedule, to be

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note

under section 5376 of Title 5.

APPOINTMENT OF INITIAL MEMBERS

Section 302(a) of Pub. L. 95-622 directed President to initially

appoint members to President's Commission for the Study of Ethical

Problems in Medicine and Biomedical and Behavioral Research

(established under the amendment made by section 301) [enacting

this subchapter] not later than 90 days after Nov. 9, 1978.

-EXEC-

EXECUTIVE ORDER NO. 12184

Ex. Ord. No. 12184, Dec. 17, 1979, 44 F.R. 75091, which

established the President's Special Commission for the Study of

Ethical Problems in Medicine and Biomedical and Behavioral

Research, was revoked by Ex. Ord. No. 12553, Feb. 25, 1986, 51 F.R.

7237.

-End-

-CITE-

42 USC Sec. 300v-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR

RESEARCH

-HEAD-

Sec. 300v-1. Duties of Commission

-STATUTE-

(a) Studies and investigations; priority and order; report to

President and Congress

(1) The Commission shall undertake studies of the ethical and

legal implications of -

(A) the requirements for informed consent to participation in

research projects and to otherwise undergo medical procedures;

(B) the matter of defining death, including the advisability of

developing a uniform definition of death;

(C) voluntary testing, counseling, and information and

education programs with respect to genetic diseases and

conditions, taking into account the essential equality of all

human beings, born and unborn;

(D) the differences in the availability of health services as

determined by the income or residence of the persons receiving

the services;

(E) current procedures and mechanisms designed (i) to safeguard

the privacy of human subjects of behavioral and biomedical

research, (ii) to ensure the confidentiality of individually

identifiable patient records, and (iii) to ensure appropriate

access of patients to information continued (!1) in such

records,(!2) and

(F) such other matters relating to medicine or biomedical or

behavioral research as the President may designate for study by

the Commission.

The Commission shall determine the priority and order of the

studies required under this paragraph.

(2) The Commission may undertake an investigation or study of any

other appropriate matter which relates to medicine or biomedical or

behavioral research (including the protection of human subjects of

biomedical or behavioral research) and which is consistent with the

purposes of this subchapter on its own initiative or at the request

of the head of a Federal agency.

(3) In order to avoid duplication of effort, the Commission may,

in lieu of, or as part of, any study or investigation required or

otherwise conducted under this subsection, use a study or

investigation conducted by another entity if the Commission sets

forth its reasons for such use.

(4) Upon the completion of each investigation or study undertaken

by the Commission under this subsection (including a study or

investigation which merely uses another study or investigation), it

shall report its findings (including any recommendations for

legislation or administrative action) to the President and the

Congress and to each Federal agency to which a recommendation in

the report applies.

(b) Recommendations to agencies; subsequent administrative

requirements

(1) Within 60 days of the date a Federal agency receives a

recommendation from the Commission that the agency take any action

with respect to its rules, policies, guidelines, or regulations,

the agency shall publish such recommendation in the Federal

Register and shall provide opportunity for interested persons to

submit written data, views, and arguments with respect to adoption

of the recommendation.

(2) Within the 180-day period beginning on the date of such

publication, the agency shall determine whether the action proposed

by such recommendation is appropriate, and, to the extent that it

determines that -

(A) such action is not appropriate, the agency shall, within

such time period, provide the Commission with, and publish in the

Federal Register, a notice of such determination (including an

adequate statement of the reasons for the determination), or

(B) such action is appropriate, the agency shall undertake such

action as expeditiously as feasible and shall notify the

Commission of the determination and the action undertaken.

(c) Report on protection of human subjects; scope; submission to

President, etc.

The Commission shall biennially report to the President, the

Congress, and appropriate Federal agencies on the protection of

human subjects of biomedical and behavioral research. Each such

report shall include a review of the adequacy and uniformity (1) of

the rules, policies, guidelines, and regulations of all Federal

agencies regarding the protection of human subjects of biomedical

or behavioral research which such agencies conduct or support, and

(2) of the implementation of such rules, policies, guidelines, and

regulations by such agencies, and may include such recommendations

for legislation and administrative action as the Commission deems

appropriate.

(d) Annual report; scope; submission to President, etc.

Not later than December 15 of each year (beginning with 1979) the

Commission shall report to the President, the Congress, and

appropriate Federal agencies on the activities of the Commission

during the fiscal year ending in such year. Each such report shall

include a complete list of all recommendations described in

subsection (b)(1) of this section made to Federal agencies by the

Commission during the fiscal year and the actions taken, pursant

(!3) to subsection (b)(2) of this section, by the agencies upon

such recommendations, and may include such recommendations for

legislation and administrative action as the Commission deems

appropriate.

(e) Publication and dissemination of reports

The Commission may at any time publish and disseminate to the

public reports respecting its activities.

(f) Definitions

For purposes of this section:

(1) The term "Federal agency" means an authority of the

government of the United States, but does not include (A) the

Congress, (B) the courts of the United States, and (C) the

government of the Commonwealth of Puerto Rico, the government of

the District of Columbia, or the government of any territory or

possession of the United States.

(2) The term "protection of human subjects" includes the

protection of the health, safety, and privacy of individuals.

-SOURCE-

(July 1, 1944, ch. 373, title XVIII, Sec. 1802, as added Pub. L.

95-622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3439; amended

Pub. L. 96-32, Sec. 4, July 10, 1979, 93 Stat. 82.)

-MISC1-

AMENDMENTS

1979 - Subsec. (f). Pub. L. 96-32 redesignated definitions

subsection following subsec. (e) as (f), which in original was

designated as "(b)".

-FOOTNOTE-

(!1) So in original. Probably should be "contained".

(!2) So in original. The comma probably should be a semicolon.

(!3) So in original. Probably should be "pursuant".

-End-

-CITE-

42 USC Sec. 300v-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR

RESEARCH

-HEAD-

Sec. 300v-2. Administrative provisions

-STATUTE-

(a) Hearings

The Commission may for the purpose of carrying out this

subchapter hold such hearings, sit and act at such times and

places, take such testimony, and receive such evidence, as the

Commission may deem advisable.

(b) Appointment and compensation of staff personnel; procurement

and compensation of temporary and intermittent services; detail

of personnel from other Federal agencies

(1) The Commission may appoint and fix the pay of such staff

personnel as it deems desirable. Such personnel shall be appointed

subject to the provisions of title 5 governing appointments in the

competitive service, and shall be paid in accordance with the

provisions of chapter 51 and subchapter III of chapter 53 of such

title relating to classification and General Schedule pay rates.

(2) The Commission may procure temporary and intermittent

services to the same extent as is authorized by section 3109(b) of

title 5, but at rates for individuals not to exceed the daily

equivalent of the annual rate of basic pay in effect for grade

GS-18 of the General Schedule.

(3) Upon request of the Commission, the head of any Federal

agency is authorized to detail, on a reimbursable basis, any of the

personnel of such agency to the Commission to assist it in carrying

out its duties under this subchapter.

(c) Contracting authority

The Commission, in performing its duties and functions under this

subchapter, may enter into contracts with appropriate public or

nonprofit private entities. The authority of the Commission to

enter into such contracts is effective for any fiscal year only to

such extent or in such amounts as are provided in advance in

appropriation Acts.

(d) Informational requirements and prohibitions

(1) The Commission may secure directly from any Federal agency

information necessary to enable it to carry out this subchapter.

Upon request of the Chairman of the Commission, the head of such

agency shall furnish such information to the Commission.

(2) The Commission shall promptly arrange for such security

clearances for its members and appropriate staff as are necessary

to obtain access to classified information needed to carry out its

duties under this subchapter.

(3) The Commission shall not disclose any information reported to

or otherwise obtained by the Commission which is exempt from

disclosure under subsection (a) of section 552 of title 5 by reason

of paragraphs (4) and (6) of subsection (b) of such section.

(e) Support services from Administrator of General Services

The Administrator of General Services shall provide to the

Commission on a reimbursable basis such administrative support

services as the Commission may request.

-SOURCE-

(July 1, 1944, ch. 373, title XVIII, Sec. 1803, as added Pub. L.

95-622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3440.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 governing appointments in the

competitive service, referred to in subsec. (b)(1), are classified

to section 3301 et seq. of Title 5, Government Organization and

Employees.

-MISC1-

REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES

References in laws to the rates of pay for GS-16, 17, or 18, or

to maximum rates of pay under the General Schedule, to be

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note

under section 5376 of Title 5.

-End-

-CITE-

42 USC Sec. 300v-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVI - PRESIDENT'S COMMISSION FOR THE STUDY OF ETHICAL

PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOR

RESEARCH

-HEAD-

Sec. 300v-3. Authorization of appropriations; termination of

Commission

-STATUTE-

(a) To carry out this subchapter there are authorized to be

appropriated $5,000,000 for the fiscal year ending September 30,

1979, $5,000,000 for the fiscal year ending September 30, 1980,

$5,000,000 for the fiscal year ending September 30, 1981, and

$5,000,000 for the fiscal year ending September 30, 1982.

(b) The Commission shall be subject to the Federal Advisory

Committee Act, except that, under section 14(a)(1)(B) of such Act,

the Commission shall terminate on December 31, 1982.

-SOURCE-

(July 1, 1944, ch. 373, title XVIII, Sec. 1804, as added Pub. L.

95-622, title III, Sec. 301, Nov. 9, 1978, 92 Stat. 3441.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Advisory Committee Act, referred to in subsec. (b),

is Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is

set out in the Appendix to Title 5, Government Organization and

Employees.

-End-

-CITE-

42 USC SUBCHAPTER XVII - BLOCK GRANTS 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

-HEAD-

SUBCHAPTER XVII - BLOCK GRANTS

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in sections 247b-6, 256d, 3013 of

this title; title 31 section 6703.

-End-

-CITE-

42 USC Part A - Preventive Health and Health Services

Block Grants 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

PART A - PREVENTIVE HEALTH AND HEALTH SERVICES BLOCK GRANTS

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in section 9875 of this title; title 25

section 1680h.

-End-

-CITE-

42 USC Sec. 300w 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w. Authorization of appropriations

-STATUTE-

(a) For the purpose of allotments under section 300w-1 of this

title, there are authorized to be appropriated $205,000,000 for

fiscal year 1993, and such sums as may be necessary for each of the

fiscal years 1994 through 1998.

(b) Of the amount appropriated for any fiscal year under

subsection (a) of this section, at least $7,000,000 shall be made

available for allotments under section 300w-1(b) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1901, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 535; amended

Pub. L. 98-555, Sec. 4, Oct. 30, 1984, 98 Stat. 2855; Pub. L.

100-607, title III, Sec. 301(a), Nov. 4, 1988, 102 Stat. 3111; Pub.

L. 102-531, title I, Sec. 101, Oct. 27, 1992, 106 Stat. 3469; Pub.

L. 103-183, title VII, Sec. 705(e), Dec. 14, 1993, 107 Stat. 2241.)

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-183 substituted "through 1998"

for "through 1997".

1992 - Subsec. (a). Pub. L. 102-531, Sec. 101(a), amended subsec.

(a) generally. Prior to amendment, subsec. (a) read as follows:

"For the purpose of allotments under section 300w-1 of this title,

there is authorized to be appropriated $95,000,000 for fiscal year

1982, $96,500,000 for fiscal year 1983, $98,500,000 for fiscal year

1984, $98,500,000 for the fiscal year ending September 30, 1985,

$98,500,000 for the fiscal year ending September 30, 1986,

$98,500,000 for the fiscal year ending September 30, 1987,

$110,000,000 for fiscal year 1989, and such sums as may be

necessary for each of the fiscal years 1990 and 1991."

Subsec. (b). Pub. L. 102-531, Sec. 101(b), substituted

"$7,000,000" for "$3,500,000".

1988 - Subsec. (a). Pub. L. 100-607 struck out "and" after

"1986," and inserted ", $110,000,000 for fiscal year 1989, and such

sums as may be necessary for each of the fiscal years 1990 and

1991" before period at end.

1984 - Subsec. (a). Pub. L. 98-555, Sec. 4(a), inserted

provisions authorizing appropriations for fiscal years ending Sept.

30, 1985, 1986, and 1987.

Subsec. (b). Pub. L. 98-555, Sec. 4(b), substituted "$3,500,000"

for "$3,000,000".

EFFECTIVE DATE

Section 901 of Pub. L. 97-35 provided in part that this

subchapter is effective Oct. 1, 1981.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300w-1 of this title.

-End-

-CITE-

42 USC Sec. 300w-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-1. Allotments

-STATUTE-

(a) Availability based upon prior year distributions

(1) From the amounts appropriated under section 300w of this

title for any fiscal year and available for allotment under this

subsection, the Secretary shall allot to each State an amount which

bears the same ratio to the available amounts for that fiscal year

as the amounts provided by the Secretary under the provisions of

law listed in paragraph (2) to the State and entities in the State

for fiscal year 1981 bore to the total amount appropriated for such

provisions of law for fiscal year 1981.

(2) The provisions of law referred to in paragraph (1) are the

following provisions of law as in effect on September 30, 1981:

(A) The authority for grants under section 247b of this title

for preventive health service programs for the control of

rodents.

(B) The authority for grants under section 247b of this title

for establishing and maintaining community and school-based

fluoridation programs.

(C) The authority for grants under section 247b of this title

for preventive health service programs for hypertension.

(D) Sections 247b-1 (!1) and 247b-2 of this title.

(E) Section 246(d) (!1) of this title.

(F) Section 255(a) (!1) of this title.

(G) Sections 300d-1,(!1) 300d-2,(!1) and 300d-3 (!1) of this

title.

(b) Population

From the amount required to be made available under section

300w(b) of this title for allotments under this subsection for any

fiscal year, the Secretary shall make allotments to each State on

the basis of the population of the State.

(c) Distribution of appropriated funds not allotted

To the extent that all the funds appropriated under section 300w

of this title for a fiscal year and available for allotment in such

fiscal year are not otherwise allotted to States because -

(1) one or more States have not submitted an application or

description of activities in accordance with section 300w-4 of

this title for the fiscal year;

(2) one or more States have notified the Secretary that they do

not intend to use the full amount of their allotment; or

(3) some State allotments are offset or repaid under section

300w-5(b)(3) of this title;

such excess shall be allotted among each of the remaining States in

proportion to the amount otherwise allotted to such States for the

fiscal year without regard to this subsection.

(d) Distributions to Indian tribes

(1) If the Secretary -

(A) receives a request from the governing body of an Indian

tribe or tribal organization within any State that funds under

this part be provided directly by the Secretary to such tribe or

organization, and

(B) determines that the members of such tribe or tribal

organization would be better served by means of grants made

directly by the Secretary under this part,

the Secretary shall reserve from amounts which would otherwise be

allotted to such State under subsection (a) of this section for the

fiscal year the amount determined under paragraph (2).

(2) The Secretary shall reserve for the purpose of paragraph (1)

from amounts that would otherwise be allotted to such State under

subsection (a) of this section an amount equal to the amount which

bears the same ratio to the State's allotment for the fiscal year

involved as the total amount provided or allotted for fiscal year

1981 by the Secretary to such tribe or tribal organization under

the provisions of law referred to in subsection (a) of this section

bore to the total amount provided or allotted for such fiscal year

by the Secretary to the State and entities (including Indian tribes

and tribal organizations) in the State under such provisions of

law.

(3) The amount reserved by the Secretary on the basis of a

determination under this subsection shall be granted to the Indian

tribe or tribal organization serving the individuals for whom such

a determination has been made.

(4) In order for an Indian tribe or tribal organization to be

eligible for a grant for a fiscal year under this subsection, it

shall submit to the Secretary a plan for such fiscal year which

meets such criteria as the Secretary may prescribe.

(5) The terms "Indian tribe" and "tribal organization" have the

same meaning given such terms in section 450b(b) and (c) (!2) of

title 25.

(e) Report on equitable distribution of available funds

The Secretary shall conduct a study for the purpose of devising a

formula for the equitable distribution of funds available for

allotment to the States under this section. In conducting the

study, the Secretary shall take into account -

(1) the financial resources of the various States,

(2) the populations of the States, and

(3) any other factor which the Secretary may consider

appropriate.

Before June 30, 1982, the Secretary shall submit a report to the

Congress respecting the development of a formula and make such

recommendations as the Secretary may deem appropriate in order to

ensure the most equitable distribution of funds under allotments

under this section.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1902, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 535.)

-REFTEXT-

REFERENCES IN TEXT

Section 247b-1 of this title, referred to in subsec. (a)(2)(D),

was in the original a reference to section 401 of the Health

Services and Centers Amendments of 1978, Pub. L. 95-626, which was

repealed effective Oct. 1, 1981, by Pub. L. 97-35, title IX, Sec.

902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561. Pub. L. 100-572,

Sec. 3, Oct. 31, 1988, 102 Stat. 2887, enacted section 317A of act

July 1, 1944, which is classified to section 247b-1 of this title.

Section 247b-2 of this title, referred to in subsec. (a)(2)(D),

was repealed effective Oct. 1, 1981, by Pub. L. 97-35, title IX,

Sec. 902(a), (h), Aug. 13, 1981, 95 Stat. 559, 561.

Section 246(d) of this title, referred to in subsec. (a)(2)(E),

was repealed effective Oct. 1, 1981, by Pub. L. 97-35, title IX,

Sec. 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561.

Section 255 of this title, referred to in subsec. (a)(2)(F), was

in the original a reference to section 339 of act July 1, 1944,

which was repealed effective Oct. 1, 1981, by Pub. L. 97-35, title

IX, Sec. 902(b), (h), Aug. 13, 1981, 95 Stat. 559, 561. Pub. L.

97-414, Sec. 6(a), Jan. 4, 1983, 96 Stat. 2057, added a new section

339 of act July 1, 1944, which is classified to section 255 of this

title.

Sections 300d-1, 300d-2, and 300d-3 of this title, referred to in

subsec. (a)(2)(G), were in the original references to sections

1202, 1203, and 1204, respectively, of act July 1, 1944, which were

repealed effective Oct. 1, 1981, by Pub. L. 97-35, title IX, Sec.

902(d)(1), (h), Aug. 13, 1981, 95 Stat. 560, 561. Pub. L. 101-590,

Sec. 3, Nov. 16, 1990, 104 Stat. 2916-2918, enacted new sections

1202, 1203, and 1204 of act July 1, 1944, which were classified to

sections 300d-1, 300d-2, and 300d-3, respectively, of this title.

Pub. L. 103-183, title VI, Sec. 601(b), Dec. 14, 1983, 107 Stat.

2238, repealed section 1202 and renumbered sections 1203 and 1204

as 1202 and 1203, respectively.

Section 450b of title 25, referred to in subsec. (d)(5), has been

amended, and subsecs. (b) and (c) of section 450b no longer define

the terms "Indian tribe" and "tribal organization". However, such

terms are defined elsewhere in that section.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w, 300w-2, 300w-3,

300w-4, 300w-7 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300w-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-2. Payments under allotments to States

-STATUTE-

(a)(1) For each fiscal year, the Secretary shall make payments,

as provided by section 6503(a) of title 31, to each State from its

allotment under section 300w-1 of this title (other than any amount

reserved under section 300w-1(d) of this title) from amounts

appropriated for that fiscal year.

(2) Any amount paid to a State for a fiscal year and remaining

unobligated at the end of such year shall remain available for the

next fiscal year to such State for the purposes for which it was

made.

(b) The Secretary, at the request of a State, may reduce the

amount of payments under subsection (a) of this section by -

(1) the fair market value of any supplies or equipment

furnished the State, and

(2) the amount of the pay, allowances, and travel expenses of

any officer or employee of the Government when detailed to the

State and the amount of any other costs incurred in connection

with the detail of such officer or employee,

when the furnishing of supplies or equipment or the detail of an

officer or employee is for the convenience of and at the request of

the State and for the purpose of conducting activities described in

section 300w-3 of this title. The amount by which any payment is so

reduced shall be available for payment by the Secretary of the

costs incurred in furnishing the supplies or equipment or in

detailing the personnel, on which the reduction of the payment is

based, and the amount shall be deemed to be part of the payment and

shall be deemed to have been paid to the State.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1903, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 537.)

-COD-

CODIFICATION

In subsec. (a)(1), "section 6503(a) of title 31" substituted for

"section 203 of the Intergovernmental Cooperation Act of 1968 (42

U.S.C. 4213)" on authority of Pub. L. 97-258, Sec. 4(b), Sept. 13,

1982, 96 Stat. 1067, the first section of which enacted Title 31,

Money and Finance.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w-3, 300w-4, 300w-5,

9875 of this title.

-End-

-CITE-

42 USC Sec. 300w-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-3. Use of allotments

-STATUTE-

(a) Preventive health services, comprehensive public health

services, emergency medical services, etc.

(1) Except as provided in subsections (b) and (c) of this

section, payments made to a State under section 300w-2 of this

title may be used for the following:

(A) Activities consistent with making progress toward achieving

the objectives established by the Secretary for the health status

of the population of the United States for the year 2000 (in this

part referred to as "year 2000 health objectives").

(B) Preventive health service programs for the control of

rodents and for community and school-based fluoridation programs.

(C) Feasibility studies and planning for emergency medical

services systems and the establishment, expansion, and

improvement of such systems. Amounts for such systems may not be

used for the costs of the operation of the systems or the

purchase of equipment for the systems, except that such amounts

may be used for the payment of not more than 50 percent of the

costs of purchasing communications equipment for the systems.

Amounts may be expended for feasibility studies or planning for

the trauma-care components of such systems only if the studies or

planning, respectively, is consistent with the requirements of

section 300d-13(a) of this title.

(D) Providing services to victims of sex offenses and for

prevention of sex offenses.

(E) The establishment, operation, and coordination of effective

and cost-efficient systems to reduce the prevalence of illness

due to asthma and asthma-related illnesses, especially among

children, by reducing the level of exposure to cockroach allergen

or other known asthma triggers through the use of integrated pest

management, as applied to cockroaches or other known allergens.

Amounts expended for such systems may include the costs of

building maintenance and the costs of programs to promote

community participation in the carrying out at such sites of

integrated pest management, as applied to cockroaches or other

known allergens. For purposes of this subparagraph, the term

"integrated pest management" means an approach to the management

of pests in public facilities that combines biological, cultural,

physical, and chemical tools in a way that minimizes economic,

health, and environmental risks.

(F) With respect to activities described in any of

subparagraphs (A) through (E), related planning, administration,

and educational activities.

(G) Monitoring and evaluation of activities carried out under

any of subparagraphs (A) through (F).

(2) Except as provided in subsection (b) of this section, amounts

paid to a State under section 300w-2 of this title from its

allotment under section 300w-1(b) of this title may only be used

for providing services to rape victims and for rape prevention.

(3) The Secretary may provide technical assistance to States in

planning and operating activities to be carried out under this

part.

(b) Prohibited uses

A State may not use amounts paid to it under section 300w-2 of

this title to -

(1) provide inpatient services,

(2) make cash payments to intended recipients of health

services,

(3) purchase or improve land, purchase, construct, or

permanently improve (other than minor remodeling) any building or

other facility, or purchase major medical equipment,

(4) satisfy any requirement for the expenditure of non-Federal

funds as a condition for the receipt of Federal funds, or

(5) provide financial assistance to any entity other than a

public or nonprofit private entity.

Except as provided in subsection (a)(1)(E) of this section, the

Secretary may waive the limitation contained in paragraph (3) upon

the request of a State if the Secretary finds that there are

extraordinary circumstances to justify the waiver and that granting

the waiver will assist in carrying out this part.

(c) Transfer of funds

A State may transfer not more than 7 percent of the amount

allotted to the State under section 300w-1(a) of this title for any

fiscal year for use by the State under part B of this subchapter

and title V of the Social Security Act [42 U.S.C. 701 et seq.] in

such fiscal year as follows: At any time in the first three

quarters of the fiscal year a State may transfer not more than 3

percent of the allotment of the State for the fiscal year for such

use, and in the last quarter of a fiscal year a State may transfer

for such use not more than the remainder of the amount of its

allotment which may be transferred.

(d) Limitation on administrative costs

Of the amount paid to any State under section 300w-2 of this

title, not more than 10 percent paid from each of its allotments

under subsections (a) and (b) of section 300w-1 of this title may

be used for administering the funds made available under section

300w-2 of this title. The State will pay from non-Federal sources

the remaining costs of administering such funds.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1904, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 537; amended

Pub. L. 97-414, Sec. 8(s), Jan. 4, 1983, 96 Stat. 2062; Pub. L.

99-646, Sec. 87(d)(1)(A), Nov. 10, 1986, 100 Stat. 3623; Pub. L.

99-654, Sec. 3(b)(1)(A), Nov. 14, 1986, 100 Stat. 3663; Pub. L.

100-607, title III, Sec. 301(b), Nov. 4, 1988, 102 Stat. 3111; Pub.

L. 102-531, title I, Sec. 102, Oct. 27, 1992, 106 Stat. 3470; Pub.

L. 106-310, div. A, title V, Sec. 511, Oct. 17, 2000, 114 Stat.

1116.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsec. (c), is act Aug.

14, 1935, ch. 531, 49 Stat. 620, as amended. Title V of the Social

Security Act is classified generally to subchapter V (Sec. 701 et

seq.) of chapter 7 of this title. For complete classification of

this Act to the Code, see section 1305 of this title and Tables.

-MISC1-

AMENDMENTS

2000 - Subsec. (a)(1)(E). Pub. L. 106-310, Sec. 511(3), added

subpar. (E). Former subpar. (E) redesignated (F).

Subsec. (a)(1)(F). Pub. L. 106-310, Sec. 511(1), (4),

redesignated subpar. (E) as (F) and substituted "subparagraphs (A)

through (E)" for "subparagraphs (A) through (D)". Former subpar.

(F) redesignated (G).

Subsec. (a)(1)(G). Pub. L. 106-310, Sec. 511(1), (2), (5),

redesignated subpar. (F) as (G) and substituted "subparagraphs (A)

through (F)." for "subparagraphs (A) through (E)".

1992 - Subsec. (a)(1). Pub. L. 102-531, Sec. 102(a), amended par.

(1) generally, substituting present provisions for provisions

authorizing, except as provided in subsecs. (b) and (c), use of the

amounts paid to a State under section 300w-2 of this title from its

allotment under section 300w-1(a) of this title and amounts

transferred by the State, for use in preventive health service

programs, including hypertension and high cholesterol services,

health-risk reduction programs, immunization services, home health

agencies, emergency medical services, services to victims of sex

offenses, and uterine cancer and breast cancer services.

Subsec. (c). Pub. L. 102-531, Sec. 102(b), substituted "part B"

for "parts B and C".

1988 - Subsec. (a)(1)(B). Pub. L. 100-607, Sec. 301(b)(1),

inserted "and elevated serum cholesterol" before period at end.

Subsec. (a)(1)(C). Pub. L. 100-607, Sec. 301(b)(2), inserted ",

including programs designed to reduce the incidence of chronic

diseases" before period at end.

Subsec. (a)(1)(D). Pub. L. 100-607, Sec. 301(b)(3), inserted ",

including immunization services" before period at end.

Subsec. (a)(1)(F). Pub. L. 100-607, Sec. 301(b)(4), substituted

"systems, except that such amounts may be used for the payment of

not more than 50 percent of the costs of purchasing communications

equipment for the systems" for "systems (other than systems with

respect to which grants were made as prescribed by section

300w-4(c)(2) of this title)".

Subsec. (a)(1)(H). Pub. L. 100-607, Sec. 301(b)(5), added subpar.

(H).

1986 - Subsec. (a)(1)(G). Pub. L. 99-646 and Pub. L. 99-654

amended subpar. (G) identically, substituting "victims of sex

offenses and for prevention of sex offenses" for "rape victims and

for rape prevention".

1983 - Subsec. (a)(1)(F). Pub. L. 97-414 inserted "(other than

systems with respect to which grants were made as prescribed by

section 300w-4(c)(2) of this title)" after "equipment for the

systems".

EFFECTIVE DATE OF 1986 AMENDMENTS

Amendments by Pub. L. 99-646 and Pub. L. 99-654 effective 30 days

after Nov. 10, 1986, and 30 days after Nov. 14, 1986, respectively,

see section 87(e) of Pub. L. 99-646 and section 4 of Pub. L.

99-654, set out as an Effective Date note under section 2241 of

Title 18, Crimes and Criminal Procedure.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w-2, 300w-4, 300w-5,

300w-9 of this title.

-End-

-CITE-

42 USC Sec. 300w-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-4. Application for payments; State plan

-STATUTE-

(a) In general

The Secretary may make payments under section 300w-2 of this

title to a State for a fiscal year only if -

(1) the State submits to the Secretary an application for the

payments;

(2) the application contains a State plan in accordance with

subsection (b) of this section;

(3) the application contains the certification described in

subsection (c) of this section;

(4) the application contains such assurances as the Secretary

may require regarding the compliance of the State with the

requirements of this part (including assurances regarding

compliance with the agreements described in subsection (c) of

this section); and

(5) the application is in such form and is submitted by such

date as the Secretary may require.

(b) State plan

A State plan required in subsection (a)(2) of this section for a

fiscal year is in accordance with this subsection if the plan meets

the following conditions:

(1) The plan is developed by the State agency with principal

responsibility for public health programs, in consultation with

the advisory committee established pursuant to subsection (c)(2)

of this section.

(2) The plan specifies the activities authorized in section

300w-3 of this title that are to be carried out with payments

made to the State under section 300w-2 of this title, including a

specification of the year 2000 health objectives for which the

State will expend the payments.

(3) The plan specifies the populations in the State for which

such activities are to be carried out.

(4) The plan specifies any populations in the State that have a

disparate need for such activities.

(5) With respect to each population specified under paragraph

(3), the plan contains a strategy for expending such payments to

carry out such activities to make progress toward improving the

health status of the population, which strategy includes -

(A) a description of the programs and projects to be carried

out;

(B) an estimate of the number of individuals to be served by

the programs and projects; and

(C) an estimate of the number of public health personnel

needed to carry out the strategy.

(6) The plan specifies the amount of such payments to be

expended for each of such activities and, with respect to the

activity involved -

(A) the amount to be expended for each population specified

under paragraph (3); and

(B) the amount to be expended for each population specified

under paragraph (4).

(c) State certification

The certification referred to in subsection (a)(3) of this

section for a fiscal year is a certification to the Secretary by

the chief executive officer of the State involved as follows:

(1)(A) In the development of the State plan required in

subsection (a)(2) of this section -

(i) the chief health officer of the State held public

hearings on the plan; and

(ii) proposals for the plan were made public in a manner that

facilitated comments from public and private entities

(including Federal and other public agencies).

(B) The State agrees that, if any revisions are made in such

plan during the fiscal year, the State will, with respect to the

revisions, hold hearings and make proposals public in accordance

with subparagraph (A), and will submit to the Secretary a

description of the revisions.

(2) The State has established an advisory committee in

accordance with subsection (d) of this section.

(3) The State agrees to expend payments under section 300w-2 of

this title only for the activities authorized in section 300w-3

of this title.

(4) The State agrees to expend such payments in accordance with

the State plan submitted under subsection (a)(2) of this section

(with any revisions submitted to the Secretary under paragraph

(1)(B)), including making expenditures to carry out the strategy

contained in the plan pursuant to subsection (b)(5) of this

section.

(5)(A) The State agrees that, in the case of each population

for which such strategy is carried out, the State will measure

the extent of progress being made toward improving the health

status of the population.

(B) The State agrees that -

(i) the State will collect and report data in accordance with

section 300w-5(a) of this title; and

(ii) for purposes of subparagraph (A), progress will be

measured through use of each of the applicable uniform data

items developed by the Secretary under paragraph (2) of such

section, or if no such items are applicable, through use of the

uniform criteria developed by the Secretary under paragraph (3)

of such section.

(6) With respect to the activities authorized in section 300w-3

of this title, the State agrees to maintain State expenditures

for such activities at a level that is not less than the average

level of such expenditures maintained by the State for the 2-year

period preceding the fiscal year for which the State is applying

to receive payments under section 300w-2 of this title.

(7) The State agrees to establish reasonable criteria to

evaluate the effective performance of entities that receive funds

from such payments and procedures for procedural and substantive

independent State review of the failure by the State to provide

funds for any such entity.

(8) The State agrees to permit and cooperate with Federal

investigations undertaken in accordance with section 300w-6 of

this title.

(9) The State has in effect a system to protect from

inappropriate disclosure patient and sex offense victim records

maintained by the State in connection with an activity funded

under this part or by any entity which is receiving payments from

the allotment of the State under this part.

(10) The State agrees to provide the officer of the State

government responsible for the administration of the State

highway safety program with an opportunity to -

(A) participate in the development of any plan by the State

relating to emergency medical services, as such plan relates to

highway safety; and

(B) review and comment on any proposal by any State agency to

use any Federal grant or Federal payment received by the State

for the provision of emergency medical services as such

proposal relates to highway safety.

(d) State Advisory Committee

(1) In general

For purposes of subsection (c)(2) of this section, an advisory

committee is in accordance with this subsection if such committee

is known as the State Preventive Health Advisory Committee (in

this subsection referred to as the "Committee") and the Committee

meets the conditions described in the subsequent paragraphs of

this subsection.

(2) Duties

A condition under paragraph (1) for a State is that the duties

of the Committee are -

(A) to hold public hearings on the State plan required in

subsection (a)(2) of this section; and

(B) to make recommendations pursuant to subsection (b)(1) of

this section regarding the development and implementation of

such plan, including recommendations on -

(i) the conduct of assessments of the public health;

(ii) which of the activities authorized in section 300w-3

of this title should be carried out in the State;

(iii) the allocation of payments made to the State under

section 300w-2 of this title;

(iv) the coordination of activities carried out under such

plan with relevant programs of other entities; and

(v) the collection and reporting of data in accordance with

section 300w-5(a) of this title.

(3) Composition

(A) A condition under paragraph (1) for a State is that the

Committee is composed of such members of the general public, and

such officials of the health departments of political

subdivisions of the State, as may be necessary to provide

adequate representation of the general public and of such health

departments.

(B) With respect to compliance with subparagraph (A), the

membership of advisory committees established pursuant to

subsection (c)(2) of this section may include representatives of

community-based organizations (including minority community-based

organizations), schools of public health, and entities to which

the State involved awards grants or contracts to carry out

activities authorized in section 300w-3 of this title.

(4) Chair; meetings

A condition under paragraph (1) for a State is that the State

public health officer serves as the chair of the Committee, and

that the Committee meets not less than twice each fiscal year.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1905, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 538; amended

Pub. L. 98-555, Sec. 5(a), (d), Oct. 30, 1984, 98 Stat. 2855, 2856;

Pub. L. 99-646, Sec. 87(d)(1)(B), Nov. 10, 1986, 100 Stat. 3624;

Pub. L. 99-654, Sec. 3(b)(1)(B), Nov. 14, 1986, 100 Stat. 3663;

Pub. L. 100-607, title III, Sec. 301(c), Nov. 4, 1988, 102 Stat.

3112; Pub. L. 101-590, Sec. 4, Nov. 16, 1990, 104 Stat. 2928; Pub.

L. 102-531, title I, Sec. 103(a), Oct. 27, 1992, 106 Stat. 3470.)

-MISC1-

AMENDMENTS

1992 - Pub. L. 102-531 amended section generally, substituting

present provisions for provisions relating to submission and form

of application for assistance under this part as well as required

assurances, public hearings on proposed use and distribution of

funds, certifications by chief executive officer of State, and a

description of intended use of funds as well as public access to

and revision of such description.

1990 - Subsec. (c). Pub. L. 101-590, which directed amendment of

subsec. (c) by adding at the end thereof a new par. (7), was

executed by adding par. (7) after par. (6) and before the last

sentence to reflect the probable intent of Congress.

1988 - Subsec. (d). Pub. L. 100-607 inserted at end "The

description shall include a statement of the public health

objectives expected to be achieved by the State through the use of

the payments the State will receive under section 300w-2 of this

title."

1986 - Subsec. (c)(6). Pub. L. 99-646 and Pub. L. 99-654 amended

par. (6) identically, substituting "sex offense" for "rape".

1984 - Subsec. (c)(2). Pub. L. 98-555, Sec. 5(a), redesignated

par. (3) as (2). Former par. (2), which related to grants for

fiscal year 1982, was struck out.

Subsec. (c)(3). Pub. L. 98-555, Sec. 5(a), redesignated par. (5)

as (3). Former par. (3) redesignated (2).

Subsec. (c)(4). Pub. L. 98-555, Sec. 5(a), redesignated par. (6)

as (4). Former par. (4), which related to grants for preventive

health service programs for hypertension, was struck out.

Subsec. (c)(5) to (8). Pub. L. 98-555, Sec. 5(a), redesignated

pars. (7) and (8) as (5) and (6), respectively. Former pars. (5)

and (6) redesignated (3) and (4), respectively.

Subsec. (e). Pub. L. 98-555, Sec. 5(d), struck out subsec. (e)

which related to grants by States.

EFFECTIVE DATE OF 1986 AMENDMENTS

Amendments by Pub. L. 99-646 and Pub. L. 99-654 effective 30 days

after Nov. 10, 1986, and 30 days after Nov. 14, 1986, respectively,

see section 87(e) of Pub. L. 99-646 and section 4 of Pub. L.

99-654, set out as an Effective Date note under section 2241 of

Title 18, Crimes and Criminal Procedure.

DELAYED APPLICABILITY OF REQUIREMENT REGARDING ADVISORY COMMITTEES

Section 103(b) of Pub. L. 102-531 provided that: "With respect to

compliance with the requirement established in subsection (c)(2) of

section 1905 of the Public Health Service Act [subsec. (c)(2) of

this section] (as amended by subsection (a) of this section), a

State is deemed, notwithstanding such section, to be in compliance

with such requirement if the State establishes an advisory

committee in accordance with subsection (d) of such section not

later than 180 days after the date of the enactment of this Act

[Oct. 27, 1992]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w-1, 300w-5, 300w-6 of

this title.

-End-

-CITE-

42 USC Sec. 300w-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-5. Reports, data, and audits

-STATUTE-

(a) Annual reports; contents; data collection; copies

(1) For purposes of section 300w-4(c)(5)(B)(i) of this title, a

State is collecting and reporting data for a fiscal year in

accordance with this subsection if the State submits to the

Secretary, not later than February 1 of the succeeding fiscal year,

a report that -

(A) describes the purposes for which the State expended

payments made to the State under section 300w-2 of this title;

(B) pursuant to section 300w-4(c)(5)(A) of this title,

describes the extent of progress made by the State for purposes

of such section;

(C) meets the conditions described in the subsequent paragraphs

of this subsection; and

(D) contains such additional information regarding activities

authorized in section 300w-3 of this title, and is submitted in

such form, as the Secretary may require.

(2)(A) The Secretary, in consultation with the States, shall

develop sets of data for uniformly defining health status for

purposes of the year 2000 health objectives (which sets are in this

subsection referred to as "uniform data sets"). Each of such sets

shall consist of one or more categories of information (in this

subsection individually referred to as a "uniform data item"). The

Secretary shall develop formats for the uniform collecting and

reporting of information on such items.

(B) A condition under paragraph (1)(C) for a fiscal year is that

the State involved will, in accordance with the applicable format

under subparagraph (A), collect during such year, and include in

the report under paragraph (1), the necessary information for one

uniform data item from each of the uniform data sets, which items

are selected for the State by the Secretary.

(C) In the case of fiscal year 1995 and each subsequent fiscal

year, a condition under paragraph (1) for a State is that the State

will, in accordance with the applicable format under subparagraph

(A), collect during such year, and include in the report under

paragraph (1), the necessary information for each of the uniform

data sets appropriate to the year 2000 health objectives that the

State has, in the State plan submitted under section 300w-4 of this

title for the fiscal year, specified as a purpose for which

payments under section 300w-2 of this title are to be expended.

(3) The Secretary, in consultation with the States, shall

establish criteria for the uniform collection and reporting of data

on activities authorized in section 300w-3 of this title with

respect to which no uniform data items exist.

(4) A condition under paragraph (1) for a fiscal year is that the

State involved will make copies of the report submitted under such

paragraph for the fiscal year available for public inspection, and

will upon request provide a copy of the report to any individual

for a charge not exceeding the cost of providing the copy.

(b) Fiscal control; accounting procedures; annual audits;

repayments and offsets; public inspection; Comptroller General

evaluations; report to Congress

(1) Each State shall establish fiscal control and fund accounting

procedures as may be necessary to assure the proper disbursal of

and accounting for Federal funds paid to the State under section

300w-2 of this title and funds transferred under section 300w-3(c)

of this title for use under this part.

(2) Each State shall annually audit its expenditures from

payments received under section 300w-2 of this title. Such State

audits shall be conducted by an entity independent of any agency

administering a program funded under this part and, in so far as

practical, in accordance with the Comptroller General's standards

for auditing governmental organizations, programs, activities, and

functions. Within 30 days following the date each audit is

completed, the chief executive officer of the State shall transmit

a copy of that audit to the Secretary.

(3) Each State shall, after being provided by the Secretary with

adequate notice and opportunity for a hearing within the State,

repay to the United States amounts found not to have been expended

in accordance with the requirements of this part or the

certification provided by the State under section 300w-4 of this

title. If such repayment is not made, the Secretary shall, after

providing the State with adequate notice and opportunity for a

hearing within the State, offset such amounts against the amount of

any allotment to which the State is or may become entitled under

this part.

(4) The State shall make copies of the reports and audits

required by this section available for public inspection within the

State.

(5) The Comptroller General of the United States shall, from time

to time, evaluate the expenditures by States of grants under this

part in order to assure that expenditures are consistent with the

provisions of this part and the certification provided by the State

under section 300w-4 of this title.

(6) Not later than October 1, 1990, the Secretary shall report to

the Congress on the activities of the States that have received

funds under this part and may include in the report any

recommendations for appropriate changes in legislation.

(c) Inapplicability of title XVII of Omnibus Budget Reconciliation

Act of 1981

Title XVII of the Omnibus Budget Reconciliation Act of 1981 shall

not apply with respect to audits of funds allotted under this part.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1906, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 540; amended

Pub. L. 98-555, Sec. 5(b), (c), Oct. 30, 1984, 98 Stat. 2855, 2856;

Pub. L. 100-607, title III, Sec. 301(d), Nov. 4, 1988, 102 Stat.

3112; Pub. L. 102-531, title I, Sec. 104, Oct. 27, 1992, 106 Stat.

3473.)

-REFTEXT-

REFERENCES IN TEXT

The Omnibus Budget Reconciliation Act of 1981, referred to in

subsec. (c), is Pub. L. 97-35, Aug. 13, 1981, 95 Stat. 357, as

amended. Title XVII of the Omnibus Budget Reconciliation Act of

1981 enacted sections 3595, and 4511 to 4514 of Title 5, Government

Organization and Employees, amended sections 3393, 3593, 3596,

4501, 4502, 4505, 4506, 7542, 7543, 8340, and 8345 of Title 5, and

sections 2003 and 2401 of Title 39, Postal Service, and enacted

provisions set out as notes under sections 3595, 4501, 5303, 5343,

8340, and 8345 of Title 5, section 1243 of former Title 31, Money

and Finance, and sections 403, 2003, 2004, and 2401 of Title 39.

For complete classification of this Act to the Code, see Tables.

-MISC1-

AMENDMENTS

1992 - Pub. L. 102-531, Sec. 104(b)(1), substituted "Reports,

data, and audits" for "Reports and audits" in section catchline.

Subsec. (a). Pub. L. 102-531, Sec. 104(a), amended subsec. (a)

generally, substituting present provisions for provisions requiring

an annual report by each State of its activities under this part,

outlining the contents of such report, and for providing copies of

the report to interested persons.

Subsec. (d). Pub. L. 102-531, Sec. 104(b)(2), struck out subsec.

(d) which provided for development of model criteria and forms for

collection of data and information on services provided under this

part.

1988 - Subsec. (a)(3). Pub. L. 100-607, Sec. 301(d)(1), added

par. (3).

Subsec. (b)(6). Pub. L. 100-607, Sec. 301(d)(2), substituted

"1990" for "1983".

1984 - Subsec. (a)(1)(B). Pub. L. 98-555, Sec. 5(b), substituted

"preventive health and preventive health services programs in the

State assisted by funds from allotments under this part, including

a summary of the services which were provided, the providers of

such services, and the individuals who received such services" for

"activities of the State under this part".

Subsec. (d). Pub. L. 98-555, Sec. 5(c), added subsec. (d).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w-1, 300w-4, 9875 of

this title.

-End-

-CITE-

42 USC Sec. 300w-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-6. Withholding of funds

-STATUTE-

(a) Prerequisites

(1) The Secretary shall, after adequate notice and an opportunity

for a hearing conducted within the affected State, withhold funds

from any State which does not use its allotment in accordance with

the requirements of this part or the certification provided under

section 300w-4 of this title. The Secretary shall withhold such

funds until the Secretary finds that the reason for the withholding

has been removed and there is reasonable assurance that it will not

recur.

(2) The Secretary may not institute proceedings to withhold funds

under paragraph (1) unless the Secretary has conducted an

investigation concerning whether the State has used its allotment

in accordance with the requirements of this part or the

certification provided under section 300w-4 of this title.

Investigations required by this paragraph shall be conducted within

the affected State by qualified investigators.

(3) The Secretary shall respond in an expeditious manner to

complaints of a substantial or serious nature that a State has

failed to use funds in accordance with the requirements of this

part or certifications provided under section 300w-4 of this title.

(4) The Secretary may not withhold funds under paragraph (1) from

a State for a minor failure to comply with the requirements of this

part or certifications provided under section 300w-4 of this title.

(b) Investigations

(1) The Secretary shall conduct in several States in each fiscal

year investigations of the use of funds received by the States

under this part in order to evaluate compliance with the

requirements of this part and certifications provided under section

300w-4 of this title.

(2) The Comptroller General of the United States may conduct

investigations of the use of funds received under this part by a

State in order to insure compliance with the requirements of this

part and certifications provided under section 300w-4 of this

title.

(c) Availability of books, documents, papers, and records

Each State, and each entity which has received funds from an

allotment made to a State under this part, shall make appropriate

books, documents, papers, and records available to the Secretary or

the Comptroller General of the United States, or any of their duly

authorized representatives, for examination, copying, or mechanical

reproduction on or off the premises of the appropriate entity upon

a reasonable request therefor.

(d) Information not readily available

(1) In conducting any investigation in a State, the Secretary or

the Comptroller General of the United States may not make a request

for any information not readily available to such State or an

entity which has received funds from an allotment made to the State

under this part or make an unreasonable request for information to

be compiled, collected, or transmitted in any form not readily

available.

(2) Paragraph (1) does not apply to the collection, compilation,

or transmittal of data in the course of a judicial proceeding.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1907, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 541.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300w-4, 9875 of this

title.

-End-

-CITE-

42 USC Sec. 300w-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-7. Nondiscrimination provisions

-STATUTE-

(a) Programs and activities receiving Federal financial assistance

(1) For the purpose of applying the prohibitions against

discrimination on the basis of age under the Age Discrimination Act

of 1975 [42 U.S.C. 6101 et seq.], on the basis of handicap under

section 504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], on

the basis of sex under title IX of the Education Amendments of 1972

[20 U.S.C. 1681 et seq.], or on the basis of race, color, or

national origin under title VI of the Civil Rights Act of 1964 [42

U.S.C. 2000d et seq.], programs and activities funded in whole or

in part with funds made available under this part are considered to

be programs and activities receiving Federal financial assistance.

(2) No person shall on the ground of sex or religion be excluded

from participation in, be denied the benefits of, or be subjected

to discrimination under, any program or activity funded in whole or

in part with funds made available under this part.

(b) Failure to comply

Whenever the Secretary finds that a State, or an entity that has

received a payment from an allotment to a State under section

300w-1 of this title, has failed to comply with a provision of law

referred to in subsection (a)(1) of this section, with subsection

(a)(2) of this section, or with an applicable regulation (including

one prescribed to carry out subsection (a)(2) of this section), the

Secretary shall notify the chief executive officer of the State and

shall request him to secure compliance. If within a reasonable

period of time, not to exceed sixty days, the chief executive

officer fails or refuses to secure compliance, the Secretary may -

(1) refer the matter to the Attorney General with a

recommendation that an appropriate civil action be instituted,

(2) exercise the powers and functions provided by title VI of

the Civil Rights Act of 1964 [42 U.S.C. 2000d et seq.], the Age

Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], or section

504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], as may be

applicable, or

(3) take such other action as may be provided by law.

(c) Civil actions by Attorney General

When a matter is referred to the Attorney General pursuant to

subsection (b)(1) of this section, or whenever he has reason to

believe that a State or an entity is engaged in a pattern or

practice in violation of a provision of law referred to in

subsection (a)(1) of this section or in violation of subsection

(a)(2) of this section, the Attorney General may bring a civil

action in any appropriate district court of the United States for

such relief as may be appropriate, including injunctive relief.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1908, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 542.)

-REFTEXT-

REFERENCES IN TEXT

The Age Discrimination Act of 1975, referred to in subsecs.

(a)(1) and (b)(2), is title III of Pub. L. 94-135, Nov. 28, 1975,

89 Stat. 728, as amended, which is classified generally to chapter

76 (Sec. 6101 et seq.) of this title. For complete classification

of this Act to the Code, see Short Title note set out under section

6101 of this title and Tables.

The Education Amendments of 1972, referred to in subsec. (a)(1),

is Pub. L. 92-318, June 23, 1972, 86 Stat. 235, as amended. Title

IX of the Act, known as the Patsy Takemoto Mink Equal Opportunity

in Education Act, is classified principally to chapter 38 (Sec.

1681 et seq.) of Title 20, Education. For complete classification

of title IX to the Code, see Short Title note set out under section

1681 of Title 20 and Tables.

The Civil Rights Act of 1964, referred to in subsecs. (a)(1) and

(b)(2), is Pub. L. 88-352, July 2, 1964, 78 Stat. 241, as amended.

Title VI of the Civil Rights Act of 1964 is classified generally to

subchapter V (Sec. 2000d et seq.) of chapter 21 of this title. For

complete classification of this Act to the Code, see Short Title

note set out under section 2000a of this title and Tables.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 9875 of this title.

-End-

-CITE-

42 USC Sec. 300w-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-8. Criminal penalty for false statements

-STATUTE-

Whoever -

(1) knowingly and willfully makes or causes to be made any

false statement or representation of a material fact in

connection with the furnishing of items or services for which

payment may be made by a State from funds allotted to the State

under this part, or

(2) having knowledge of the occurrence of any event affecting

his initial or continued right to any such payment conceals or

fails to disclose such event with an intent fraudulently to

secure such payment either in a greater amount than is due or

when no such payment is authorized,

shall be fined not more than $25,000 or imprisoned for not more

than five years, or both.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1909, as added Pub. L.

97-35, title IX, Sec. 901, Aug. 13, 1981, 95 Stat. 542.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 9875 of this title.

-End-

-CITE-

42 USC Sec. 300w-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-9. Emergency medical services for children

-STATUTE-

(a) Grant authority

For activities in addition to the activities which may be carried

out by States under section 300w-3(a)(1)(F) (!1) of this title, the

Secretary may make grants to States or accredited schools of

medicine in States to support a program of demonstration projects

for the expansion and improvement of emergency medical services for

children who need treatment for trauma or critical care. Any grant

made under this subsection shall be for not more than a 3-year

period (with an optional 4th year based on performance), subject to

annual evaluation by the Secretary. Only 3 grants under this

subsection may be made in a State (to a State or to a school of

medicine in such State) in any fiscal year.

(b) Renewals

The Secretary may renew a grant made under subsection (a) of this

section for one additional one-year period only if the Secretary

determines that renewal of such grant will provide significant

benefits through the collection, analysis, and dissemination of

information or data which will be useful to States in which grants

under such subsection have not been made.

(c) Definitions

For purposes of this section -

(1) the term "school of medicine" has the same meaning as in

section 292a(4) (!1) of this title; and

(2) the term "accredited" has the same meaning as in section

292a(5) (!1) of this title.

(d) Authorization of appropriations

To carry out this section, there are authorized to be

appropriated $2,000,000 for fiscal year 1985 and for each of the

two succeeding fiscal years, $3,000,000 for fiscal year 1989,

$4,000,000 for fiscal year 1990, $5,000,000 for each of the fiscal

years 1991 and 1992, and such sums as may be necessary for each of

the fiscal years 1993 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1910, as added Pub. L.

98-555, Sec. 7, Oct. 30, 1984, 98 Stat. 2856; amended Pub. L.

99-272, title XVII, Sec. 17004, Apr. 7, 1986, 100 Stat. 360; Pub.

L. 100-607, title III, Sec. 302, Nov. 4, 1988, 102 Stat. 3112; Pub.

L. 101-590, Sec. 5, Nov. 16, 1990, 104 Stat. 2928; Pub. L. 102-410,

Sec. 11, Oct. 13, 1992, 106 Stat. 2101; Pub. L. 105-392, title IV,

Sec. 415, Nov. 13, 1998, 112 Stat. 3590.)

-REFTEXT-

REFERENCES IN TEXT

Section 300w-3(a)(1) of this title, referred to in subsec. (a),

was amended generally by Pub. L. 102-531, title I, Sec. 102(a),

Oct. 27, 1992, 106 Stat. 3470, and, as so amended, provisions

formerly appearing in subpar. (F) are contained in subpar. (C).

Section 292a of this title, referred to in subsec. (c), was in

the original a reference to section 701 of act July 1, 1944.

Section 701 of that Act was omitted in the general revision of

subchapter V of this chapter by Pub. L. 102-408, title I, Sec. 102,

Oct. 13, 1992, 106 Stat. 1994. Pub. L. 102-408 enacted a new

section 701 of act July 1, 1944, relating to statement of purpose,

and a new section 702, relating to scope and duration of loan

insurance program, which are classified to sections 292 and 292a,

respectively, of this title. For provisions relating to

definitions, see section 295p of this title.

-MISC1-

AMENDMENTS

1998 - Subsec. (a). Pub. L. 105-392, Sec. 415(1), substituted

"3-year period (with an optional 4th year based on performance)"

for "two-year period" and "3 grants" for "one grant".

Subsec. (d). Pub. L. 105-392, Sec. 415(2), substituted "2005" for

"1997".

1992 - Subsec. (a). Pub. L. 102-410, Sec. 11(1), substituted

"grants" for "not more than four grants in any fiscal year" after

"Secretary may make" in first sentence.

Subsec. (d). Pub. L. 102-410, Sec. 11(2), substituted

"$5,000,000" for "and $5,000,000" and inserted before period ", and

such sums as may be necessary for each of the fiscal years 1993

through 1997".

1990 - Subsec. (a). Pub. L. 101-590, Sec. 5(1)(A), which directed

the substitution of "grants" for "not more that four grants in any

fiscal year" could not be executed because the language to be

stricken did not appear in text.

Pub. L. 101-590, Sec. 5(1)(B), struck out "in such States" after

"demonstration projects" in first sentence.

Subsec. (d). Pub. L. 101-590, Sec. 5(2), substituted "each of the

fiscal years 1991 and 1992" for "fiscal year 1991".

1988 - Subsec. (a). Pub. L. 100-607, Sec. 302(a), substituted

"shall be for not more than a two-year period, subject to annual

evaluation by the Secretary" for "shall be for a one-year period".

Subsec. (d). Pub. L. 100-607, Sec. 302(b), inserted ", $3,000,000

for fiscal year 1989, $4,000,000 for fiscal year 1990, and

$5,000,000 for fiscal year 1991" before period at end.

1986 - Subsec. (a). Pub. L. 99-272, Sec. 17004(1), which directed

substitution of "not more than four grants in any fiscal year to

States or accredited schools of medicine in States" for "grant to

not more than four States in any fiscal year" was made by

substituting former phrase for "grants to not more than four States

in any fiscal year", as the probable intent of Congress.

Pub. L. 99-272, Sec. 17004(2), inserted at end "Only one grant

under this subsection may be made in a State (to a State or to a

school of medicine in such State) in any fiscal year."

Subsec. (b). Pub. L. 99-272, Sec. 17004(3), substituted "States

in which grants under such subsection have not been made" for

"other States".

Subsecs. (c), (d). Pub. L. 99-272, Sec. 17004(4), (5), added

subsec. (c) and redesignated former subsec. (c) as (d).

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300w-10 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part A - Preventive Health and Health Services Block Grants

-HEAD-

Sec. 300w-10. Repealed. Pub. L. 106-386, div. B, title IV, Sec.

1401(b), Oct. 28, 2000, 114 Stat. 1513

-MISC1-

Section, act July 1, 1944, ch. 373, title XIX, Sec. 1910A, as

added Pub. L. 103-322, title IV, Sec. 40151, Sept. 13, 1994, 108

Stat. 1920, related to use of allotments for rape prevention

education. See section 280b-1c of this title.

A prior section 300w-10, act July 1, 1944, ch. 373, title XIX,

Sec. 1910A, as added Oct. 30, 1984, Pub. L. 98-555, Sec. 8, 98

Stat. 2856, related to State planning grants, prior to repeal by

Pub. L. 100-607, title III, Sec. 303, Nov. 4, 1988, 102 Stat. 3112.

-End-

-CITE-

42 USC Part B - Block Grants Regarding Mental Health and

Substance Abuse 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

-HEAD-

PART B - BLOCK GRANTS REGARDING MENTAL HEALTH AND SUBSTANCE ABUSE

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in sections 290ff, 300w-3, 15025 of this

title; title 7 section 2012.

-End-

-CITE-

42 USC subpart i - block grants for community mental

health services 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

SUBPART I - BLOCK GRANTS FOR COMMUNITY MENTAL HEALTH SERVICES

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in section 300x-59 of this title.

-End-

-CITE-

42 USC Sec. 300x 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x. Formula grants to States

-STATUTE-

(a) In general

For the purpose described in subsection (b) of this section, the

Secretary, acting through the Director of the Center for Mental

Health Services, shall make an allotment each fiscal year for each

State in an amount determined in accordance with section 300x-7 of

this title. The Secretary shall make a grant to the State of the

allotment made for the State for the fiscal year if the State

submits to the Secretary an application in accordance with section

300x-6 of this title.

(b) Purpose of grants

A funding agreement for a grant under subsection (a) of this

section is that, subject to section 300x-5 of this title, the State

involved will expend the grant only for the purpose of -

(1) carrying out the plan submitted under section 300x-1(a) of

this title by the State for the fiscal year involved;

(2) evaluating programs and services carried out under the

plan; and

(3) planning, administration, and educational activities

related to providing services under the plan.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1911, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378.)

-MISC1-

PRIOR PROVISIONS

A prior section 300x, act July 1, 1944, ch. 373, title XIX, Sec.

1911, as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95

Stat. 543; amended Oct. 19, 1984, Pub. L. 98-509, title I, Secs.

101, 106(a), 98 Stat. 2353, 2358; Nov. 18, 1988, Pub. L. 100-690,

title II, Sec. 2021, 102 Stat. 4194, authorized appropriations in

fiscal years 1990 and 1991 for purpose of carrying out this subpart

and section 290aa-11 of this title, prior to repeal by Pub. L.

102-321, Sec. 201(2).

EFFECTIVE DATE

Part effective July 10, 1992, with programs making awards

providing financial assistance in fiscal year 1993 and subsequent

years effective for awards made on or after Oct. 1, 1992, and with

provision that section 205(a) of Pub. L. 102-321, set out below,

regarding allotments made for fiscal year 1992 under this part as

in effect on the day before July 10, 1992, applies with respect to

the program established in this part, see section 801(b), (d) of

Pub. L. 102-321, set out as an Effective Date of 1992 Amendment

note under section 236 of this title.

TEMPORARY PROVISIONS REGARDING FUNDING

Section 205 of Pub. L. 102-321, as amended by Pub. L. 102-352,

Sec. 2(c), Aug. 26, 1992, 106 Stat. 939; Pub. L. 102-408, title

III, Sec. 312, Oct. 13, 1992, 106 Stat. 2091, provided that, with

respect to allotments made for fiscal year 1992 under this part, as

in effect on the day before July 10, 1992, any portion of the total

of such allotments that has not been paid to the States as of the

first day of the fourth quarter of such fiscal year be reallotted

with the result that the total allotment made for a State for

fiscal year 1992 be the amount indicated for the State in a

specified table, authorized Secretary of Health and Human Services

to make a grant to a State of the reallotment if the State agrees

that the grant be subject to all conditions upon which allotments

and payments under this part, as in effect on the day before July

10, 1992, are made for fiscal 1992, with specified exceptions,

permitted transfers of allotments made in fiscal years 1993 and

1994 between this part and subpart II, section 300x-21 of this

title, under certain circumstances, defined terms as used, and

directed funding, subject to a limitation, of a program for

pregnant and postpartum women for fiscal year 1993.

REPORT ON ALLOTMENT FORMULA

Section 707 of Pub. L. 102-321 directed Secretary of Health and

Human Services to enter into a contract with National Academy of

Sciences, or if such Academy declines, with another public or

nonprofit private agency, for purpose of conducting a study or

studies concerning statutory formulae under which funds made

available under this section and section 300x-21 of this title are

allocated among States and territories, specified findings to be

made by the study or studies, directed Secretary to ensure that not

later than 6 months after July 10, 1992, the study was completed

and a report submitted to Committee on Energy and Commerce of House

of Representatives and Committee on Labor and Human Resources of

Senate, and directed entity preparing the report to consult with

Comptroller General with Comptroller General to review the study

after its submittal and within three months make appropriate

recommendations concerning such report to such committees.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 290aa-2a, 290bb-31,

290ff, 300x-1, 300x-2, 300x-3, 300x-4, 300x-5, 300x-6, 300x-7,

300x-8, 300x-51, 300x-52, 300x-53, 300x-54, 300x-55, 300x-56,

300x-57, 300x-58, 300x-60, 300x-62, 300x-63, 300x-64, 300x-66 of

this title.

-End-

-CITE-

42 USC Sec. 300x-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-1. State plan for comprehensive community mental health

services for certain individuals

-STATUTE-

(a) In general

The Secretary may make a grant under section 300x of this title

only if -

(1) the State involved submits to the Secretary a plan for

providing comprehensive community mental health services to

adults with a serious mental illness and to children with a

serious emotional disturbance;

(2) the plan meets the criteria specified in subsection (b) of

this section; and

(3) the plan is approved by the Secretary.

(b) Criteria for plan

With respect to the provision of comprehensive community mental

health services to individuals who are either adults with a serious

mental illness or children with a serious emotional disturbance,

the criteria referred to in subsection (a) of this section

regarding a plan are as follows:

(1) Comprehensive community-based mental health systems

The plan provides for an organized community-based system of

care for individuals with mental illness and describes available

services and resources in a comprehensive system of care,

including services for dually diagnosed individuals. The

description of the system of care shall include health and mental

health services, rehabilitation services, employment services,

housing services, educational services, substance abuse services,

medical and dental care, and other support services to be

provided to individuals with Federal, State and local public and

private resources to enable such individuals to function outside

of inpatient or residential institutions to the maximum extent of

their capabilities, including services to be provided by local

school systems under the Individuals with Disabilities Education

Act [20 U.S.C. 1400 et seq.]. The plan shall include a separate

description of case management services and provide for

activities leading to reduction of hospitalization.

(2) Mental health system data and epidemiology

The plan contains an estimate of the incidence and prevalence

in the State of serious mental illness among adults and serious

emotional disturbance among children and presents quantitative

targets to be achieved in the implementation of the system

described in paragraph (1).

(3) Children's services

In the case of children with serious emotional disturbance, the

plan -

(A) subject to subparagraph (B), provides for a system of

integrated social services, educational services, juvenile

services, and substance abuse services that, together with

health and mental health services, will be provided in order

for such children to receive care appropriate for their

multiple needs (such system to include services provided under

the Individuals with Disabilities Education Act [20 U.S.C. 1400

et seq.]);

(B) provides that the grant under section 300x of this title

for the fiscal year involved will not be expended to provide

any service under such system other than comprehensive

community mental health services; and

(C) provides for the establishment of a defined geographic

area for the provision of the services of such system.

(4) Targeted services to rural and homeless populations

The plan describes the State's outreach to and services for

individuals who are homeless and how community-based services

will be provided to individuals residing in rural areas.

(5) Management systems

The plan describes the financial resources, staffing and

training for mental health providers that is necessary to

implement the plan, and provides for the training of providers of

emergency health services regarding mental health. The plan

further describes the manner in which the State intends to expend

the grant under section 300x of this title for the fiscal year

involved.

Except as provided for in paragraph (3), the State plan shall

contain the information required under this subsection with respect

to both adults with serious mental illness and children with

serious emotional disturbance.

(c) Definitions regarding mental illness and emotional disturbance;

methods for estimate of incidence and prevalence

(1) Establishment by Secretary of definitions; dissemination

For purposes of this subpart, the Secretary shall establish

definitions for the terms "adults with a serious mental illness"

and "children with a serious emotional disturbance". The

Secretary shall disseminate the definitions to the States.

(2) Standardized methods

The Secretary shall establish standardized methods for making

the estimates required in subsection (b)(11) (!1) of this section

with respect to a State. A funding agreement for a grant under

section 300x of this title for the State is that the State will

utilize such methods in making the estimates.

(3) Date certain for compliance by Secretary

Not later than 90 days after July 10, 1992, the Secretary shall

establish the definitions described in paragraph (1), shall begin

dissemination of the definitions to the States, and shall

establish the standardized methods described in paragraph (2).

(d) Requirement of implementation of plan

(1) Complete implementation

Except as provided in paragraph (2), in making a grant under

section 300x of this title to a State for a fiscal year, the

Secretary shall make a determination of the extent to which the

State has implemented the plan required in subsection (a) of this

section. If the Secretary determines that a State has not

completely implemented the plan, the Secretary shall reduce the

amount of the allotment under section 300x of this title for the

State for the fiscal year involved by an amount equal to 10

percent of the amount determined under section 300x-7 of this

title for the State for the fiscal year.

(2) Substantial implementation and good faith effort regarding

fiscal year 1993

(A) In making a grant under section 300x of this title to a

State for fiscal year 1993, the Secretary shall make a

determination of the extent to which the State has implemented

the plan required in subsection (a) of this section. If the

Secretary determines that the State has not substantially

implemented the plan, the Secretary shall, subject to

subparagraph (B), reduce the amount of the allotment under

section 300x of this title for the State for such fiscal year by

an amount equal to 10 percent of the amount determined under

section 300x-7 of this title for the State for the fiscal year.

(B) In carrying out subparagraph (A), if the Secretary

determines that the State is making a good faith effort to

implement the plan required in subsection (a) of this section,

the Secretary may make a reduction under such subparagraph in an

amount that is less than the amount specified in such

subparagraph, except that the reduction may not be made in an

amount that is less than 5 percent of the amount determined under

section 300x-7 of this title for the State for fiscal year 1993.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1912, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 379;

amended Pub. L. 106-310, div. B, title XXXII, Sec. 3204(a), Oct.

17, 2000, 114 Stat. 1192.)

-REFTEXT-

REFERENCES IN TEXT

The Individuals with Disabilities Education Act, referred to in

subsec. (b)(1), (3)(A), is title VI of Pub. L. 91-230, Apr. 13,

1970, 84 Stat. 175, as amended, which is classified generally to

chapter 33 (Sec. 1400 et seq.) of Title 20, Education. For complete

classification of this Act to the Code, see section 1400 of Title

20 and Tables.

Subsection (b)(11) of this section, referred to in subsec.

(c)(2), was repealed by Pub. L. 106-310, div. B, title XXXII, Sec.

3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions relating to

estimates formerly contained in subsec. (b)(11) are now contained

in subsec. (b)(2) of this section.

-MISC1-

PRIOR PROVISIONS

Prior sections 300x-1 to 300x-1b were repealed by Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378.

Section 300x-1, act July 1, 1944, ch. 373, title XIX, Sec. 1912,

as added Oct. 19, 1984, Pub. L. 98-509, title I, Sec. 102(a), 98

Stat. 2353, authorized grants for training of employees adversely

affected by changes in delivery of mental health services and for

providing assistance in securing employment.

Another prior section 300x-1, act July 1, 1944, ch. 373, title

XIX, Sec. 1912, as added Aug. 13, 1981, Pub. L. 97-35, title IX,

Sec. 901, 95 Stat. 543; amended Jan. 4, 1983, Pub. L. 97-414, Sec.

8(t), 96 Stat. 2062; Oct. 19, 1984, Pub. L. 98-509, title I, Sec.

106(e), 98 Stat. 2358, contained provisions relating to grants and

allotment of grants for alcohol, drug abuse, and mental health

services, prior to repeal by section 102(a) of Pub. L. 98-509.

Section 300x-1a, act July 1, 1944, ch. 373, title XIX, Sec.

1912A, as added and amended Nov. 18, 1988, Pub. L. 100-690, title

II, Secs. 2022(a)-(c), 2023, 102 Stat. 4194, 4196, 4197; Aug. 16,

1989, Pub. L. 101-93, Sec. 2(a), 103 Stat. 603, related to

allotments of grants for alcohol, drug abuse, and mental health

services.

Another prior section 300x-1a, act July 1, 1944, ch. 373, title

XIX, Sec. 1913, as added Oct. 19, 1984, Pub. L. 98-509, title I,

Sec. 102(a), 98 Stat. 2353, was transferred to section 300x-1b of

this title.

Section 300x-1b, act July 1, 1944, ch. 373, title XIX, Sec. 1913,

as added Oct. 19, 1984, Pub. L. 98-509, title I, Sec. 102(a), 98

Stat. 2353; amended Nov. 18, 1988, Pub. L. 100-690, title II, Sec.

2022(d), 102 Stat. 4197; Aug. 16, 1989, Pub. L. 101-93, Sec. 2(b),

103 Stat. 605, related to allotments to States and Indian tribes or

tribal organizations for alcohol, drug abuse, and mental health

services.

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310 added pars. (1) to (5) and

concluding provisions and struck out former pars. (1) to (12)

relating to criteria for plan.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x, 300x-2, 300x-4,

300x-6, 300x-8, 300x-51, 300x-54, 300x-55 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-2. Certain agreements

-STATUTE-

(a) Allocation for systems of integrated services for children

(1) In general

With respect to children with a serious emotional disturbance,

a funding agreement for a grant under section 300x of this title

is that -

(A) in the case of a grant for fiscal year 1993, the State

involved will expend not less than 10 percent of the grant to

increase (relative to fiscal year 1992) funding for the system

of integrated services described in section 300x-1(b)(9) (!1)

of this title;

(B) in the case of a grant for fiscal year 1994, the State

will expend not less than 10 percent of the grant to increase

(relative to fiscal year 1993) funding for such system; and

(C) in the case of a grant for any subsequent fiscal year,

the State will expend for such system not less than an amount

equal to the amount expended by the State for fiscal year 1994.

(2) Waiver

(A) Upon the request of a State, the Secretary may provide to

the State a waiver of all or part of the requirement established

in paragraph (1) if the Secretary determines that the State is

providing an adequate level of comprehensive community mental

health services for children with a serious emotional

distrubance,(!2) as indicated by a comparison of the number of

such children for which such services are sought with the

availability in the State of the services.

(B) The Secretary shall approve or deny a request for a waiver

under subparagraph (A) not later than 120 days after the date on

which the request is made.

(C) Any waiver provided by the Secretary under subparagraph (A)

shall be applicable only to the fiscal year involved.

(b) Providers of services

A funding agreement for a grant under section 300x of this title

for a State is that, with respect to the plan submitted under

section 300x-1(a) of this title for the fiscal year involved -

(1) services under the plan will be provided only through

appropriate, qualified community programs (which may include

community mental health centers, child mental-health programs,

psychosocial rehabilitation programs, mental health peer-support

programs, and mental-health primary consumer-directed programs);

and

(2) services under the plan will be provided through community

mental health centers only if the centers meet the criteria

specified in subsection (c) of this section.

(c) Criteria for mental health centers

The criteria referred to in subsection (b)(2) of this section

regarding community mental health centers are as follows:

(1) With respect to mental health services, the centers provide

services as follows:

(A) Services principally to individuals residing in a defined

geographic area (hereafter in this subsection referred to as a

"service area").

(B) Outpatient services, including specialized outpatient

services for children, the elderly, individuals with a serious

mental illness, and residents of the service areas of the

centers who have been discharged from inpatient treatment at a

mental health facility.

(C) 24-hour-a-day emergency care services.

(D) Day treatment or other partial hospitalization services,

or psychosocial rehabilitation services.

(E) Screening for patients being considered for admission to

State mental health facilities to determine the appropriateness

of such admission.

(2) The mental health services of the centers are provided,

within the limits of the capacities of the centers, to any

individual residing or employed in the service area of the center

regardless of ability to pay for such services.

(3) The mental health services of the centers are available and

accessible promptly, as appropriate and in a manner which

preserves human dignity and assures continuity and high quality

care.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1913, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 381.)

-REFTEXT-

REFERENCES IN TEXT

Section 300x-1(b)(9) of this title, referred to in subsec.

(a)(1)(A), was repealed by Pub. L. 106-310, div. B, title XXXII,

Sec. 3204(a), Oct. 17, 2000, 114 Stat. 1192. Provisions relating to

a system of integrated social services formerly contained in

section 300x-1(b)(9) are now contained in section 300x-1(b)(3) of

this title.

-MISC1-

PRIOR PROVISIONS

A prior section 300x-2, act July 1, 1944, ch. 373, title XIX,

Sec. 1914, formerly Sec. 1913, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 545; renumbered Sec. 1914 and

amended Oct. 19, 1984, Pub. L. 98-509, title I, Sec. 106(a),

(c)-(e), (g), 98 Stat. 2358, 2359; Nov. 18, 1988, Pub. L. 100-690,

title II, Sec. 2022(e), 102 Stat. 4197; Aug. 16, 1989, Pub. L.

101-93, Sec. 2(c)(1), 103 Stat. 605, related to payment to States

of allotments of grants for alcohol, drug abuse, and mental health

services, prior to repeal by Pub. L. 102-321, Sec. 201(2).

A prior section 1913 of act July 1, 1944, was classified to

section 300x-1b of this title and repealed by Pub. L. 102-321.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 1395x of this title.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) So in original. Probably should be "disturbance,".

-End-

-CITE-

42 USC Sec. 300x-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-3. State mental health planning council

-STATUTE-

(a) In general

A funding agreement for a grant under section 300x of this title

is that the State involved will establish and maintain a State

mental health planning council in accordance with the conditions

described in this section.

(b) Duties

A condition under subsection (a) of this section for a Council is

that the duties of the Council are -

(1) to review plans provided to the Council pursuant to section

300x-4(a) of this title by the State involved and to submit to

the State any recommendations of the Council for modifications to

the plans;

(2) to serve as an advocate for adults with a serious mental

illness, children with a severe emotional disturbance, and other

individuals with mental illnesses or emotional problems; and

(3) to monitor, review, and evaluate, not less than once each

year, the allocation and adequacy of mental health services

within the State.

(c) Membership

(1) In general

A condition under subsection (a) of this section for a Council

is that the Council be composed of residents of the State,

including representatives of -

(A) the principal State agencies with respect to -

(i) mental health, education, vocational rehabilitation,

criminal justice, housing, and social services; and

(ii) the development of the plan submitted pursuant to

title XIX of the Social Security Act [42 U.S.C. 1396 et

seq.];

(B) public and private entities concerned with the need,

planning, operation, funding, and use of mental health services

and related support services;

(C) adults with serious mental illnesses who are receiving

(or have received) mental health services; and

(D) the families of such adults or families of children with

emotional disturbance.

(2) Certain requirements

A condition under subsection (a) of this section for a Council

is that -

(A) with respect to the membership of the Council, the ratio

of parents of children with a serious emotional disturbance to

other members of the Council is sufficient to provide adequate

representation of such children in the deliberations of the

Council; and

(B) not less than 50 percent of the members of the Council

are individuals who are not State employees or providers of

mental health services.

(d) "Council" defined

For purposes of this section, the term "Council" means a State

mental health planning council.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1914, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 382.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsec. (c)(1)(A)(ii), is

act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of

the Act is classified generally to subchapter XIX (Sec. 1396 et

seq.) of chapter 7 of this title. For complete classification of

this Act to the Code, see section 1305 of this title and Tables.

-MISC1-

PRIOR PROVISIONS

A prior section 300x-3, act July 1, 1944, ch. 373, title XIX,

Sec. 1915, formerly Sec. 1914, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 545; renumbered Sec. 1915 and

amended Oct. 19, 1984, Pub. L. 98-509, title I, Secs. 105(b),

106(a), (b), (d), (g), 98 Stat. 2358, 2359; Nov. 18, 1988, Pub. L.

100-690, title II, Secs. 2024-2026, 102 Stat. 4198, 4199; Aug. 16,

1989, Pub. L. 101-93, Sec. 2(d), 103 Stat. 606; Nov. 28, 1990, Pub.

L. 101-639, Sec. 3(a)(2), 104 Stat. 4601, related to the use of

grant allotments for alcohol, drug abuse, and mental health

services, prior to repeal by Pub. L. 102-321, Sec. 201(2).

A prior section 1914 of act July 1, 1944, was classified to

section 300x-2 of this title prior to repeal by Pub. L. 102-321.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-4 of this title;

title 29 section 725.

-End-

-CITE-

42 USC Sec. 300x-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-4. Additional provisions

-STATUTE-

(a) Review of State plan by mental health planning council

The Secretary may make a grant under section 300x of this title

to a State only if -

(1) the plan submitted under section 300x-1(a) of this title

with respect to the grant and the report of the State under

section 300x-52(a) of this title concerning the preceding fiscal

year has been reviewed by the State mental health planning

council under section 300x-3 of this title; and

(2) the State submits to the Secretary any recommendations

received by the State from such council for modifications to the

plan (without regard to whether the State has made the

recommended modifications) and any comments concerning the annual

report.

(b) Maintenance of effort regarding State expenditures for mental

health

(1) In general

A funding agreement for a grant under section 300x of this

title is that the State involved will maintain State expenditures

for community mental health services at a level that is not less

than the average level of such expenditures maintained by the

State for the 2-year period preceding the fiscal year for which

the State is applying for the grant.

(2) Exclusion of certain funds

The Secretary may exclude from the aggregate State expenditures

under subsection (a) of this section, funds appropriated to the

principle agency for authorized activities which are of a

non-recurring nature and for a specific purpose.

(3) Waiver

The Secretary may, upon the request of a State, waive the

requirement established in paragraph (1) if the Secretary

determines that extraordinary economic conditions in the State

justify the waiver.

(4) Noncompliance by State

(A) In making a grant under section 300x of this title to a

State for a fiscal year, the Secretary shall make a determination

of whether, for the previous fiscal year, the State maintained

material compliance with the agreement made under paragraph (1).

If the Secretary determines that a State has failed to maintain

such compliance, the Secretary shall reduce the amount of the

allotment under section 300x of this title for the State for the

fiscal year for which the grant is being made by an amount equal

to the amount constituting such failure for the previous fiscal

year.

(B) The Secretary may make a grant under section 300x of this

title for a fiscal year only if the State involved submits to the

Secretary information sufficient for the Secretary to make the

determination required in subparagraph (A).

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1915, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 383;

amended Pub. L. 106-310, div. B, title XXXII, Sec. 3204(b), (c),

Oct. 17, 2000, 114 Stat. 1193.)

-MISC1-

PRIOR PROVISIONS

Prior sections 300x-4 and 300x-4a were repealed by Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378.

Section 300x-4, act July 1, 1944, ch. 373, title XIX, Sec. 1916,

formerly Sec. 1915, as added Aug. 13, 1981, Pub. L. 97-35, title

IX, Sec. 901, 95 Stat. 546; amended Jan. 4, 1983, Pub. L. 97-414,

Sec. 8(u), 96 Stat. 2063; renumbered Sec. 1916 and amended Oct. 19,

1984, Pub. L. 98-509, title I, Secs. 103, 106(a)-(c), (f), (g), 98

Stat. 2355, 2358, 2359; Oct. 7, 1985, Pub. L. 99-117, Sec. 7(a), 99

Stat. 492; Nov. 14, 1986, Pub. L. 99-660, title V, Sec. 503, 100

Stat. 3797; Nov. 18, 1988, Pub. L. 100-690, title II, Secs.

2027-2035, 2037(a)(2), 102 Stat. 4199-4201, 4203; Aug. 16, 1989,

Pub. L. 101-93, Sec. 2(e)-(l), (p)(1), (q)(1), 103 Stat. 606-609;

Aug. 15, 1990, Pub. L. 101-374, Sec. 4(b), 104 Stat. 459, required

States to make application and describe their activities in

relation to allotments for grants for alcohol, drug abuse, and

mental health services.

A prior section 1915 of act July 1, 1944, was classified to

section 300x-3 of this title prior to repeal by Pub. L. 102-321.

Section 300x-4a, act July 1, 1944, ch. 373, title XIX, Sec.

1916A, as added Nov. 18, 1988, Pub. L. 100-690, title II, Sec.

2036, 102 Stat. 4202; amended Aug. 16, 1989, Pub. L. 101-93, Sec.

2(m), 103 Stat. 608, related to group homes for recovering

substance abusers.

AMENDMENTS

2000 - Subsec. (a)(1). Pub. L. 106-310, Sec. 3204(b)(1), inserted

"and the report of the State under section 300x-52(a) of this title

concerning the preceding fiscal year" after "to the grant".

Subsec. (a)(2). Pub. L. 106-310, Sec. 3204(b)(2), inserted "and

any comments concerning the annual report" before period at end.

Subsec. (b)(2) to (4). Pub. L. 106-310, Sec. 3204(c), added par.

(2) and redesignated former pars. (2) and (3) as (3) and (4),

respectively.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-3, 300x-6, 300x-24,

300x-54, 300x-55 of this title.

-End-

-CITE-

42 USC Sec. 300x-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-5. Restrictions on use of payments

-STATUTE-

(a) In general

A funding agreement for a grant under section 300x of this title

is that the State involved will not expend the grant -

(1) to provide inpatient services;

(2) to make cash payments to intended recipients of health

services;

(3) to purchase or improve land, purchase, construct, or

permanently improve (other than minor remodeling) any building or

other facility, or purchase major medical equipment;

(4) to satisfy any requirement for the expenditure of

non-Federal funds as a condition for the receipt of Federal

funds; or

(5) to provide financial assistance to any entity other than a

public or nonprofit private entity.

(b) Limitation on administrative expenses

A funding agreement for a grant under section 300x of this title

is that the State involved will not expend more than 5 percent of

the grant for administrative expenses with respect to the grant.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1916, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 384.)

-MISC1-

PRIOR PROVISIONS

A prior section 300x-5, act July 1, 1944, ch. 373, title XIX,

Sec. 1917, formerly Sec. 1916, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 549; renumbered Sec. 1917 and

amended Oct. 19, 1984, Pub. L. 98-509, title I, Secs. 104, 106(a),

(b), (d), (g), 98 Stat. 2357-2359; Oct. 7, 1985, Pub. L. 99-117,

Sec. 7(b), 99 Stat. 493; Nov. 18, 1988, Pub. L. 100-690, title II,

Secs. 2037(a)(1), (b), 2052(b), 102 Stat. 4203, 4208; Aug. 16,

1989, Pub. L. 101-93, Sec. 2(p)(2), 103 Stat. 609, related to

reports and audits relative to grants for alcohol, drug abuse, and

mental health services, prior to repeal by Pub. L. 102-321, Sec.

201(2).

A prior section 1916 of act July 1, 1944, was classified to

section 300x-4 of this title prior to repeal by Pub. L. 102-321.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x, 300x-6 of this

title.

-End-

-CITE-

42 USC Sec. 300x-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-6. Application for grant

-STATUTE-

(a) In general

For purposes of section 300x of this title, an application for a

grant under such section for a fiscal year in accordance with this

section if, subject to subsection (b) of this section -

(1) the plan is received by the Secretary not later than

September 1 of the fiscal year prior to the fiscal year for which

a State is seeking funds, and the report from the previous fiscal

year as required under section 300x-51 of this title is received

by December 1 of the fiscal year of the grant;

(2) the application contains each funding agreement that is

described in this subpart or subpart III for such a grant (other

than any such agreement that is not applicable to the State);

(3) the agreements are made through certification from the

chief executive officer of the State;

(4) with respect to such agreements, the application provides

assurances of compliance satisfactory to the Secretary;

(5) the application contains the plan required in section

300x-1(a) of this title, the information required in section

300x-4(b)(3)(B) (!1) of this title, and the report required in

section 300x-52(a) of this title;

(6) the application contains recommendations in compliance with

section 300x-4(a) of this title, or if no such recommendations

are received by the State, the application otherwise demonstrates

compliance with such section; and

(7) the application (including the plan under section 300x-1(a)

of this title) is otherwise in such form, is made in such manner,

and contains such agreements, assurances, and information as the

Secretary determines to be necessary to carry out this subpart.

(b) Waivers regarding certain territories

In the case of any territory of the United States except Puerto

Rico, the Secretary may waive such provisions of this subpart and

subpart III as the Secretary determines to be appropriate, other

than the provisions of section 300x-5 of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1917, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 384;

amended Pub. L. 106-310, div. B, title XXXII, Sec. 3204(d), (e),

Oct. 17, 2000, 114 Stat. 1193.)

-REFTEXT-

REFERENCES IN TEXT

Section 300x-4(b)(3)(B) of this title, referred to in subsec.

(a)(5), was redesignated section 300x-4(b)(4)(B) by Pub. L.

106-310, div. B, title XXXII, Sec. 3204(c)(1), Oct. 17, 2000, 114

Stat. 1193.

-MISC1-

PRIOR PROVISIONS

A prior section 300x-6, act July 1, 1944, ch. 373, title XIX,

Sec. 1918, formerly Sec. 1917, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 550; renumbered Sec. 1918 and

amended Oct. 19, 1984, Pub. L. 98-509, title I, Sec. 106(d), (g),

98 Stat. 2358, 2359, authorized withholding funds from States which

did not use allotments of grants for alcohol, drug abuse, and

mental health services in accordance with requirements, prior to

repeal by Pub. L. 102-321, Sec. 201(2).

A prior section 1917 of act July 1, 1944, was classified to

section 300x-5 of this title prior to repeal by Pub. L. 102-321.

AMENDMENTS

2000 - Subsec. (a)(1). Pub. L. 106-310, Sec. 3204(d), amended

par. (1) generally. Prior to amendment, par. (1) read as follows:

"the State involved submits the application not later than the date

specified by the Secretary as being the date after which

applications for such a grant will not be considered (in any case

in which the Secretary specifies such a date);".

Subsec. (b). Pub. L. 106-310, Sec. 3204(e), substituted "except

Puerto Rico" for "whose allotment under section 300x of this title

for the fiscal year is the amount specified in section

300x-7(c)(2)(B) of this title".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-7. Determination of amount of allotment

-STATUTE-

(a) States

(1) Determination under formula

Subject to subsection (b) of this section, the Secretary shall

determine the amount of the allotment required in section 300x of

this title for a State for a fiscal year in accordance with the

following formula:

G7 X G7

A B

U

--------------------------------------------------------------------

--------------------------------------------------------------------

(2) Determination of term "A"

For purposes of paragraph (1), the term "A" means the

difference between -

(A) the amount appropriated under section 300x-9(a) of this

title for allotments under section 300x of this title for the

fiscal year involved; and

(B) an amount equal to 1.5 percent of the amount referred to

in subparagraph (A).

(3) Determination of term "U"

For purposes of paragraph (1), the term "U" means the sum of

the respective terms "X" determined for the States under

paragraph (4).

(4) Determination of term "X"

For purposes of paragraph (1), the term "X" means the product

of -

(A) an amount equal to the product of -

(i) the term "P", as determined for the State involved

under paragraph (5); and

(ii) the factor determined under paragraph (8) for the

State; and

(B) the greater of -

(i) 0.4; and

(ii) an amount equal to an amount determined for the State

in accordance with the following formula:

G7A R% G7B

P%

--------------------------------------------------------------------

--------------------------------------------------------------------

(5) Determination of term "P"

(A) For purposes of paragraph (4), the term "P" means the sum

of -

(i) an amount equal to the product of 0.107 and the number of

individuals in the State who are between 18 and 24 years of age

(inclusive);

(ii) an amount equal to the product of 0.166 and the number

of individuals in the State who are between 25 and 44 years of

age (inclusive);

(iii) an amount equal to the product of 0.099 and the number

of individuals in the State who are between 45 and 64 years of

age (inclusive); and

(iv) an amount equal to the product of 0.082 and the number

of individuals in the State who are 65 years of age or older.

(B) With respect to data on population that is necessary for

purposes of making a determination under subparagraph (A), the

Secretary shall use the most recent data that is available from

the Secretary of Commerce pursuant to the decennial census and

pursuant to reasonable estimates by such Secretary of changes

occurring in the data in the ensuing period.

(6) Determination of term "R%"

(A) For purposes of paragraph (4), the term "R%", except as

provided in subparagraph (D), means the percentage constituted by

the ratio of the amount determined under subparagraph (B) for the

State involved to the amount determined under subparagraph (C).

(B) The amount determined under this subparagraph for the State

involved is the quotient of -

(i) the most recent 3-year arithmetic mean of the total

taxable resources of the State, as determined by the Secretary

of the Treasury; divided by

(ii) the factor determined under paragraph (8) for the State.

(C) The amount determined under this subparagraph is the sum of

the respective amounts determined for the States under

subparagraph (B) (including the District of Columbia).

(D)(i) In the case of the District of Columbia, for purposes of

paragraph (4), the term "R%" means the percentage constituted by

the ratio of the amount determined under clause (ii) for such

District to the amount determined under clause (iii).

(ii) The amount determined under this clause for the District

of Columbia is the quotient of -

(I) the most recent 3-year arithmetic mean of total personal

income in such District, as determined by the Secretary of

Commerce; divided by

(II) the factor determined under paragraph (8) for the

District.

(iii) The amount determined under this clause is the sum of the

respective amounts determined for the States (including the

District of Columbia) by making, for each State, the same

determination as is described in clause (ii) for the District of

Columbia.

(7) Determination of term "P%"

For purposes of paragraph (4), the term "P%" means the

percentage constituted by the ratio of the term "P" determined

under paragraph (5) for the State involved to the sum of the

respective terms "P" determined for the States.

(8) Determination of certain factor

(A) The factor determined under this paragraph for the State

involved is a factor whose purpose is to adjust the amount

determined under clause (i) of paragraph (4)(A), and the amounts

determined under each of subparagraphs (B)(i) and (D)(ii)(I) of

paragraph (6), to reflect the differences that exist between the

State and other States in the costs of providing comprehensive

community mental health services to adults with a serious mental

illness and to children with a serious emotional disturbance.

(B) Subject to subparagraph (C), the factor determined under

this paragraph and in effect for the fiscal year involved shall

be determined according to the methodology described in the

report entitled "Adjusting the Alcohol, Drug Abuse and Mental

Health Services Block Grant Allocations for Poverty Populations

and Cost of Service", dated March 30, 1990, and prepared by

Health Economics Research, a corporation, pursuant to a contract

with the National Institute on Drug Abuse.

(C) The factor determined under this paragraph for the State

involved may not for any fiscal year be greater than 1.1 or less

than 0.9.

(D)(i) Not later than October 1, 1992, the Secretary, after

consultation with the Comptroller General, shall in accordance

with this section make a determination for each State of the

factor that is to be in effect for the State under this

paragraph. The factor so determined shall remain in effect

through fiscal year 1994, and shall be recalculated every third

fiscal year thereafter.

(ii) After consultation with the Comptroller General, the

Secretary shall, through publication in the Federal Register,

periodically make such refinements in the methodology referred to

in subparagraph (B) as are consistent with the purpose described

in subparagraph (A).

(b) Minimum allotments for States

With respect to fiscal year 2000, and subsequent fiscal years,

the amount of the allotment of a State under section 300x of this

title shall not be less than the amount the State received under

such section for fiscal year 1998.

(c) Territories

(1) Determination under formula

Subject to paragraphs (2) and (4), the amount of an allotment

under section 300x of this title for a territory of the United

States for a fiscal year shall be the product of -

(A) an amount equal to the amounts reserved under paragraph

(3) for the fiscal year; and

(B) a percentage equal to the quotient of -

(i) the civilian population of the territory, as indicated

by the most recently available data; divided by

(ii) the aggregate civilian population of the territories

of the United States, as indicated by such data.

(2) Minimum allotment for territories

The amount of an allotment under section 300x of this title for

a territory of the United States for a fiscal year shall be the

greater of -

(A) the amount determined under paragraph (1) for the

territory for the fiscal year;

(B) $50,000; and

(C) with respect to fiscal years 1993 and 1994, an amount

equal to 20.6 percent of the amount received by the territory

from allotments made pursuant to this part for fiscal year

1992.

(3) Reservation of amounts

The Secretary shall each fiscal year reserve for the

territories of the United States 1.5 percent of the amounts

appropriated under section 300x-9(a) of this title for allotments

under section 300x of this title for the fiscal year.

(4) Availability of data on population

With respect to data on the civilian population of the

territories of the United States, if the Secretary determines for

a fiscal year that recent such data for purposes of paragraph

(1)(B) do not exist regarding a territory, the Secretary shall

for such purposes estimate the civilian population of the

territory by modifying the data on the territory to reflect the

average extent of change occurring during the ensuing period in

the population of all territories with respect to which recent

such data do exist.

(5) Applicability of certain provisions

For purposes of subsection (a) of this section, the term

"State" does not include the territories of the United States.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1918, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 385;

amended Pub. L. 102-352, Sec. 2(a)(8), (9), Aug. 26, 1992, 106

Stat. 938; Pub. L. 105-277, div. A, Sec. 101(f) [title II, Sec.

218(a)], Oct. 21, 1998, 112 Stat. 2681-337, 2681-362; Pub. L.

106-113, div. B, Sec. 1000(a)(4) [title II, Sec. 212(a)], Nov. 29,

1999, 113 Stat. 1535, 1501A-239; Pub. L. 106-310, div. B, title

XXXII, Sec. 3205, Oct. 17, 2000, 114 Stat. 1193.)

-MISC1-

PRIOR PROVISIONS

A prior section 300x-7, act July 1, 1944, ch. 373, title XIX,

Sec. 1919, formerly Sec. 1918, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 551; renumbered Sec. 1919 and

amended Oct. 19, 1984, Pub. L. 98-509, title I, Sec. 106(a), (g),

98 Stat. 2358, 2359, related to nondiscrimination provisions with

respect to alcohol, drug abuse, and mental health programs, prior

to repeal by Pub. L. 102-321, Sec. 201(2).

A prior section 1918 of act July 1, 1944, was classified to

section 300x-6 of this title prior to repeal by Pub. L. 102-321.

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310 reenacted heading without

change and amended text generally. Prior to amendment, text read as

follows: "With respect to fiscal year 2000, the amount of the

allotment of a State under section 300x of this title shall not be

less than the amount the State received under section 300x of this

title for fiscal year 1998."

1999 - Subsec. (b). Pub. L. 106-113 amended heading and text of

subsec. (b) generally. Prior to amendment, text read as follows:

"For each of the fiscal years 1993 and 1994, the amount of the

allotment required in section 300x of this title for a State for

the fiscal year involved shall be the greater of -

"(1) the amount determined under subsection (a) of this section

for the State for the fiscal year; and

"(2) an amount equal to 20.6 percent of the amount received by

the State from allotments made pursuant to this part for fiscal

year 1992 (including reallotments under section 205(a) of the

ADAMHA Reorganization Act)."

1998 - Subsec. (b). Pub. L. 105-277, temporarily amended subsec.

(b) to read as follows: "(b) Minimum allotments for States. -

"(1) In general. - With respect to fiscal year 1999, the amount

of the allotment of a State under section 300x of this title

shall not be less than the amount the State received under

section 300x of this title for fiscal year 1998."

See Effective and Termination Dates of 1998 Amendment note below.

1992 - Subsec. (a)(5)(A)(iii). Pub. L. 102-352, Sec. 2(a)(8),

substituted "45" for "25".

Subsec. (c)(2)(C). Pub. L. 102-352, Sec. 2(a)(9), added subpar.

(C).

EFFECTIVE AND TERMINATION DATES OF 1998 AMENDMENT

Pub. L. 105-277, div. A, Sec. 101(f) [title II, Sec. 218(c)],

Oct. 21, 1998, 112 Stat. 2681-337, 2681-363, provided that:

"(1) In general. - The amendments made by subsections (a) and (b)

[amending this section and section 300x-33 of this title] shall

become effective as if enacted on October 1, 1998 and shall only

apply during fiscal year 1999.

"(2) Application. - Upon the expiration of the fiscal year

described in paragraph (1), the provisions of sections 1918(b) and

1933(b) of the Public Health Service Act (42 U.S.C. 300x-7(b) and

300x-33(b)), as in effect on September 30, 1998, shall be applied

as if the amendments made by this section had not been enacted."

EFFECTIVE DATE OF 1992 AMENDMENTS

Amendment by Pub. L. 102-352 effective immediately upon

effectuation of amendment made by Pub. L. 102-321, see section 3(1)

of Pub. L. 102-352, set out as a note under section 285n of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x, 300x-1, 300x-33,

300x-64 of this title.

-End-

-CITE-

42 USC Sec. 300x-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-8. Definitions

-STATUTE-

For purposes of this subpart:

(1) The terms "adults with a serious mental illness" and

"children with a serious emotional disturbance" have the meanings

given such terms under section 300x-1(c)(1) of this title.

(2) The term "funding agreement", with respect to a grant under

section 300x of this title to a State, means that the Secretary

may make such a grant only if the State makes the agreement

involved.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1919, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 388.)

-MISC1-

PRIOR PROVISIONS

A prior section 300x-8, act July 1, 1944, ch. 373, title XIX,

Sec. 1920, formerly Sec. 1919, as added Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 901, 95 Stat. 552; renumbered Sec. 1920, Oct.

19, 1984, Pub. L. 98-509, title I, Sec. 106(g), 98 Stat. 2359,

authorized criminal penalty for false statements in connection with

services furnished relative to alcohol, drug abuse, and mental

health services block grant, prior to repeal by Pub. L. 102-321,

Sec. 201(2).

A prior section 1919 of act July 1, 1944, was classified to

section 300x-7 of this title prior to repeal by Pub. L. 102-321.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-64 of this title.

-End-

-CITE-

42 USC Sec. 300x-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart i - block grants for community mental health services

-HEAD-

Sec. 300x-9. Funding

-STATUTE-

(a) Authorization of appropriations

For the purpose of carrying out this subpart, and subpart III and

section 290aa-4 of this title with respect to mental health, there

are authorized to be appropriated $450,000,000 for fiscal year

2001, and such sums as may be necessary for each of the fiscal

years 2002 and 2003.

(b) Allocations for technical assistance, data collection, and

program evaluation

(1) In general

For the purpose of carrying out section 300x-58(a) of this

title with respect to mental health and the purposes specified in

paragraphs (2) and (3), the Secretary shall obligate 5 percent of

the amounts appropriated under subsection (a) of this section for

a fiscal year.

(2) Data collection

The purpose specified in this paragraph is carrying out

sections 290aa-4 and 300y of this title with respect to mental

health.

(3) Program evaluation

The purpose specified in this paragraph is the conduct of

evaluations of prevention and treatment programs and services

with respect to mental health to determine methods for improving

the availability and quality of such programs and services.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1920, as added Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 388;

amended Pub. L. 106-310, div. B, title XXXII, Sec. 3204(f), Oct.

17, 2000, 114 Stat. 1193.)

-MISC1-

PRIOR PROVISIONS

Prior sections 300x-9 to 300x-13 were repealed by Pub. L.

102-321, title II, Sec. 201(2), July 10, 1992, 106 Stat. 378.

Section 300x-9, act July 1, 1944, ch. 373, title XIX, Sec. 1921,

formerly Sec. 1920, as added Aug. 13, 1981, Pub. L. 97-35, title

IX, Sec. 901, 95 Stat. 552; renumbered Sec. 1920A and amended Oct.

19, 1984, Pub. L. 98-509, title I, Secs. 105(a), 106(g), 98 Stat.

2358, 2359; Oct. 7, 1985, Pub. L. 99-117, Sec. 7(c), 99 Stat. 493;

renumbered Sec. 1921 and amended Nov. 18, 1988, Pub. L. 100-690,

title II, Sec. 2038(2), (6), 102 Stat. 4203, authorized technical

assistance with respect to development of services under alcohol,

drug abuse, and mental health services block grants.

A prior section 1920 of act July 1, 1944, was classified to

section 300x-8 of this title and repealed by Pub. L. 102-321.

Section 300x-9a, act July 1, 1944, ch. 373, title XIX, Sec. 1922,

as added Nov. 18, 1988, Pub. L. 100-690, title II, Sec. 2039(a),

102 Stat. 4204; amended Aug. 16, 1989, Pub. L. 101-93, Sec.

2(n)(1), 103 Stat. 608, related to service research on

community-based alcohol and drug abuse treatment programs.

Section 300x-9b, act July 1, 1944, ch. 373, title XIX, Sec. 1923,

as added Nov. 18, 1988, Pub. L. 100-690, title II, Sec. 2040, 102

Stat. 4204; amended Aug. 16, 1989, Pub. L. 101-93, Sec. 2(q)(2),

103 Stat. 609, related to service research on community-based

mental health treatment programs.

Section 300x-10, act July 1, 1944, ch. 373, title XIX, Sec. 1924,

formerly Sec. 1920B, as added Nov. 14, 1986, Pub. L. 99-660, title

V, Sec. 502(2), 100 Stat. 3795; renumbered Sec. 1924 and amended

Nov. 18, 1988, Pub. L. 100-690, title II, Sec. 2038(3), (4), 102

Stat. 4203; Nov. 28, 1990, Pub. L. 101-639, Sec. 3(a)(1), 104 Stat.

4601, related to development grants for State comprehensive mental

health services plans.

Section 300x-11, act July 1, 1944, ch. 373, title XIX, Sec. 1925,

formerly Sec. 1920C, as added Nov. 14, 1986, Pub. L. 99-660, title

V, Sec. 502(2), 100 Stat. 3795; renumbered Sec. 1925 and amended

Nov. 18, 1988, Pub. L. 100-690, title II, Secs. 2038(3), 2041(a),

102 Stat. 4203, 4205; Aug. 16, 1989, Pub. L. 101-93, Sec. 2(o)(1),

103 Stat. 608; Nov. 28, 1990, Pub. L. 101-639, Sec. 3(b), 104 Stat.

4601, related to State comprehensive mental health services plans.

Section 300x-12, act July 1, 1944, ch. 373, title XIX, Sec. 1926,

formerly Sec. 1920D, as added Nov. 14, 1986, Pub. L. 99-660, title

V, Sec. 502(2), 100 Stat. 3796; renumbered Sec. 1926 and amended

Nov. 18, 1988, Pub. L. 100-690, title II, Sec. 2038(3), (5), 102

Stat. 4203; Aug. 16, 1989, Pub. L. 101-93, Sec. 2(o)(2), 103 Stat.

609; Nov. 28, 1990, Pub. L. 101-639, Sec. 3(c), 104 Stat. 4602,

related to enforcement of requirement of developing State

comprehensive mental health services plans.

Section 300x-13, act July 1, 1944, ch. 373, title XIX, Sec. 1927,

formerly Sec. 1920E, as added Nov. 14, 1986, Pub. L. 99-660, title

V, Sec. 502(2), 100 Stat. 3797; renumbered Sec. 1927, Nov. 18,

1988, Pub. L. 100-690, title II, Sec. 2038(3), 102 Stat. 4203,

related to development of model standards for provision of care to

chronically mentally ill persons.

AMENDMENTS

2000 - Subsec. (a). Pub. L. 106-310, Sec. 3204(f)(1), substituted

"$450,000,000 for fiscal year 2001, and such sums as may be

necessary for each of the fiscal years 2002 and 2003" for

"$450,000,000 for fiscal year 1993, and such sums as may be

necessary for fiscal year 1994".

Subsec. (b)(2). Pub. L. 106-310, Sec. 3204(f)(2), substituted

"sections 290aa-4 and 300y of this title" for "section 290aa-4 of

this title".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-7 of this title.

-End-

-CITE-

42 USC subpart ii - block grants for prevention and

treatment of substance abuse 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

SUBPART II - BLOCK GRANTS FOR PREVENTION AND TREATMENT OF SUBSTANCE

ABUSE

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in sections 290kk, 300x-59, 422,

1383e of this title.

-End-

-CITE-

42 USC Sec. 300x-21 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-21. Formula grants to States

-STATUTE-

(a) In general

For the purpose described in subsection (b) of this section, the

Secretary, acting through the Center for Substance Abuse Treatment,

shall make an allotment each fiscal year for each State in an

amount determined in accordance with section 300x-33 of this title.

The Secretary shall make a grant to the State of the allotment made

for the State for the fiscal year if the State submits to the

Secretary an application in accordance with section 300x-32 of this

title.

(b) Authorized activities

A funding agreement for a grant under subsection (a) of this

section is that, subject to section 300x-31 of this title, the

State involved will expend the grant only for the purpose of

planning, carrying out, and evaluating activities to prevent and

treat substance abuse and for related activities authorized in

section 300x-24 of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1921, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 388.)

-MISC1-

PRIOR PROVISIONS

A prior section 1921 of act July 1, 1944, was classified to

section 300x-9 of this title prior to repeal by Pub. L. 102-321.

Another prior section 1921 of act July 1, 1944, was classified to

section 300y of this title prior to repeal by Pub. L. 100-690.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 290aa-2a, 290bb, 300x-22,

300x-23, 300x-24, 300x-25, 300x-26, 300x-27, 300x-28, 300x-29,

300x-30, 300x-31, 300x-32, 300x-33, 300x-34, 300x-51, 300x-52,

300x-53, 300x-54, 300x-55, 300x-56, 300x-57, 300x-58, 300x-60,

300x-62, 300x-63, 300x-64, 300x-66, 1395x of this title.

-End-

-CITE-

42 USC Sec. 300x-22 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-22. Certain allocations

-STATUTE-

(a) Allocation regarding primary prevention programs

A funding agreement for a grant under section 300x-21 of this

title is that, in expending the grant, the State involved -

(1) will expend not less than 20 percent for programs for

individuals who do not require treatment for substance abuse,

which programs -

(A) educate and counsel the individuals on such abuse; and

(B) provide for activities to reduce the risk of such abuse

by the individuals;

(2) will, in carrying out paragraph (1) -

(A) give priority to programs for populations that are at

risk of developing a pattern of such abuse; and

(B) ensure that programs receiving priority under

subparagraph (A) develop community-based strategies for the

prevention of such abuse, including strategies to discourage

the use of alcoholic beverages and tobacco products by

individuals to whom it is unlawful to sell or distribute such

beverages or products.

(b) Allocations regarding women

(1) In general

Subject to paragraph (2), a funding agreement for a grant under

section 300x-21 of this title for a fiscal year is that -

(A) in the case of a grant for fiscal year 1993, the State

involved will expend not less than 5 percent of the grant to

increase (relative to fiscal year 1992) the availability of

treatment services designed for pregnant women and women with

dependent children (either by establishing new programs or

expanding the capacity of existing programs);

(B) in the case of a grant for fiscal year 1994, the State

will expend not less than 5 percent of the grant to so increase

(relative to fiscal year 1993) the availability of such

services for such women; and

(C) in the case of a grant for any subsequent fiscal year,

the State will expend for such services for such women not less

than an amount equal to the amount expended by the State for

fiscal year 1994.

(2) Waiver

(A) Upon the request of a State, the Secretary may provide to

the State a waiver of all or part of the requirement established

in paragraph (1) if the Secretary determines that the State is

providing an adequate level of treatments services for women

described in such paragraph, as indicated by a comparison of the

number of such women seeking the services with the availability

in the State of the services.

(B) The Secretary shall approve or deny a request for a waiver

under subparagraph (A) not later than 120 days after the date on

which the request is made.

(C) Any waiver provided by the Secretary under subparagraph (A)

shall be applicable only to the fiscal year involved.

(3) Childcare and prenatal care

A funding agreement for a grant under section 300x-21 of this

title for a State is that each entity providing treatment

services with amounts reserved under paragraph (1) by the State

will, directly or through arrangements with other public or

nonprofit private entities, make available prenatal care to women

receiving such services and, while the women are receiving the

services, childcare.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1922, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 389; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(a), (f)(2)(A),

Oct. 17, 2000, 114 Stat. 1210, 1211.)

-STATAMEND-

AMENDMENT OF SUBSECTION (B)(2), (3)

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17,

2000, 114 Stat. 1211, provided that, effective upon publication of

regulations developed in accordance with section 300x-32(e)(1) of

this title, subsection (c) of this section [now subsection (b)] is

amended by striking out paragraph (2) and redesignating paragraph

(3) as paragraph (2).

-MISC1-

PRIOR PROVISIONS

A prior section 1922 of act July 1, 1944, was classified to

section 300x-9a of this title prior to repeal by Pub. L. 102-321.

Another prior section 1922 of act July 1, 1944, was classified to

section 300y-1 of this title prior to repeal by Pub. L. 100-690.

AMENDMENTS

2000 - Subsec. (a). Pub. L. 106-310, Sec. 3303(a), redesignated

subsec. (b) as (a) and struck out heading and text of former

subsec. (a). Text read as follows: "A funding agreement for a grant

under section 300x-21 of this title is that, in expending the

grant, the State involved will expend -

"(1) not less than 35 percent for prevention and treatment

activities regarding alcohol; and

"(2) not less than 35 percent for prevention and treatment

activities regarding other drugs."

Subsec. (b). Pub. L. 106-310, Sec. 3303(a)(2), redesignated

subsec. (c) as (b). Former subsec. (b) redesignated (a).

Subsec. (c). Pub. L. 106-310, Sec. 3303(a)(2), redesignated

subsec. (c) as (b).

EFFECTIVE DATE OF 2000 AMENDMENT

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17,

2000, 114 Stat. 1211, provided that the amendment made by section

3303(f)(2) is effective upon the publication of the regulations

developed in accordance with section 300x-32(e)(1) of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-32 of this title.

-End-

-CITE-

42 USC Sec. 300x-23 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-23. Intravenous substance abuse

-STATUTE-

(a) Capacity of treatment programs

(1) Notification of reaching capacity

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will, in the case of programs of

treatment for intravenous drug abuse, require that any such

program receiving amounts from the grant, upon reaching 90

percent of its capacity to admit individuals to the program,

provide to the State a notification of such fact.

(2) Provision of treatment

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will, with respect to

notifications under paragraph (1), ensure that each individual

who requests and is in need of treatment for intravenous drug

abuse is admitted to a program of such treatment not later than -

(A) 14 days after making the request for admission to such a

program; or

(B) 120 days after the date of such request, if no such

program has the capacity to admit the individual on the date of

such request and if interim services are made available to the

individual not later than 48 hours after such request.

(b) Outreach regarding intravenous substance abuse

A funding agreement for a grant under section 300x-21 of this

title is that the State involved, in providing amounts from the

grant to any entity for treatment services for intravenous drug

abuse, will require the entity to carry out activities to encourage

individuals in need of such treatment to undergo treatment.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1923, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 390.)

-MISC1-

PRIOR PROVISIONS

A prior section 1923 of act July 1, 1944, was classified to

section 300x-9b of this title prior to repeal by Pub. L. 102-321.

Another prior section 1923 of act July 1, 1944, was classified to

section 300y-2 of this title prior to repeal by Pub. L. 100-690.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-29, 300x-32 of this

title.

-End-

-CITE-

42 USC Sec. 300x-24 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-24. Requirements regarding tuberculosis and human

immunodeficiency virus

-STATUTE-

(a) Tuberculosis

(1) In general

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will require that any entity

receiving amounts from the grant for operating a program of

treatment for substance abuse -

(A) will, directly or through arrangements with other public

or nonprofit private entities, routinely make available

tuberculosis services to each individual receiving treatment

for such abuse; and

(B) in the case of an individual in need of such treatment

who is denied admission to the program on the basis of the lack

of the capacity of the program to admit the individual, will

refer the individual to another provider of tuberculosis

services.

(2) Tuberculosis services

For purposes of paragraph (1), the term "tuberculosis

services", with respect to an individual, means -

(A) counseling the individual with respect to tuberculosis;

(B) testing to determine whether the individual has

contracted such disease and testing to determine the form of

treatment for the disease that is appropriate for the

individual; and

(C) providing such treatment to the individual.

(b) Human immunodeficiency virus

(1) Requirement for certain States

In the case of a State described in paragraph (2), a funding

agreement for a grant under section 300x-21 of this title is that

-

(A) with respect to individuals undergoing treatment for

substance abuse, the State will, subject to paragraph (3),

carry out 1 or more projects to make available to the

individuals early intervention services for HIV disease at the

sites at which the individuals are undergoing such treatment;

(B) for the purpose of providing such early intervention

services through such projects, the State will make available

from the grant the percentage that is applicable for the State

under paragraph (4); and

(C) the State will, subject to paragraph (5), carry out such

projects only in geographic areas of the State that have the

greatest need for the projects.

(2) Designated States

For purposes of this subsection, a State described in this

paragraph is any State whose rate of cases of acquired immune

deficiency syndrome is 10 or more such cases per 100,000

individuals (as indicated by the number of such cases reported to

and confirmed by the Director of the Centers for Disease Control

for the most recent calendar year for which such data are

available).

(3) Use of existing programs regarding substance abuse

With respect to programs that provide treatment services for

substance abuse, a funding agreement for a grant under section

300x-21 of this title for a designated State is that each such

program participating in a project under paragraph (1) will be a

program that began operation prior to the fiscal year for which

the State is applying to receive the grant. A program that so

began operation may participate in a project under paragraph (1)

without regard to whether the program has been providing early

intervention services for HIV disease.

(4) Applicable percentage regarding expenditures for services

(A)(i) For purposes of paragraph (1)(B), the percentage that is

applicable under this paragraph for a designated State is,

subject to subparagraph (B), the percentage by which the amount

of the grant under section 300x-21 of this title for the State

for the fiscal year involved is an increase over the amount

specified in clause (ii).

(ii) The amount specified in this clause is the amount that was

reserved by the designated State involved from the allotment of

the State under section 300x-1a (!1) of this title for fiscal

year 1991 in compliance with section 300x-4(c)(6)(A)(ii) (!1) of

this title (as such sections were in effect for such fiscal

year).

(B) If the percentage determined under subparagraph (A) for a

designated State for a fiscal year is less than 2 percent

(including a negative percentage, in the case of a State for

which there is no increase for purposes of such subparagraph),

the percentage applicable under this paragraph for the State is 2

percent. If the percentage so determined is 2 percent or more,

the percentage applicable under this paragraph for the State is

the percentage determined under subparagraph (A), subject to not

exceeding 5 percent.

(5) Requirement regarding rural areas

(A) A funding agreement for a grant under section 300x-21 of

this title for a designated State is that, if the State will

carry out 2 or more projects under paragraph (1), the State will

carry out 1 such project in a rural area of the State, subject to

subparagraph (B).

(B) The Secretary shall waive the requirement established in

subparagraph (A) if the State involved certifies to the Secretary

that -

(i) there is insufficient demand in the State to carry out a

project under paragraph (1) in any rural area of the State; or

(ii) there are no rural areas in the State.

(6) Manner of providing services

With respect to the provision of early intervention services

for HIV disease to an individual, a funding agreement for a grant

under section 300x-21 of this title for a designated State is

that -

(A) such services will be undertaken voluntarily by, and with

the informed consent of, the individual; and

(B) undergoing such services will not be required as a

condition of receiving treatment services for substance abuse

or any other services.

(7) Definitions

For purposes of this subsection:

(A) The term "designated State" means a State described in

paragraph (2).

(B) The term "early intervention services", with respect to

HIV disease, means -

(i) appropriate pretest counseling;

(ii) testing individuals with respect to such disease,

including tests to confirm the presence of the disease, tests

to diagnose the extent of the deficiency in the immune

system, and tests to provide information on appropriate

therapeutic measures for preventing and treating the

deterioration of the immune system and for preventing and

treating conditions arising from the disease;

(iii) appropriate post-test counseling; and

(iv) providing the therapeutic measures described in clause

(ii).

(C) The term "HIV disease" means infection with the etiologic

agent for acquired immune deficiency syndrome.

(c) Expenditure of grant for compliance with agreements

(1) In general

A grant under section 300x-21 of this title may be expended for

purposes of compliance with the agreements required in this

section, subject to paragraph (2).

(2) Limitation

A funding agreement for a grant under section 300x-21 of this

title for a State is that the grant will not be expended to make

payment for any service provided for purposes of compliance with

this section to the extent that payment has been made, or can

reasonably be expected to be made, with respect to such service -

(A) under any State compensation program, under any insurance

policy, or under any Federal or State health benefits program

(including the program established in title XVIII of the Social

Security Act [42 U.S.C. 1395 et seq.] and the program

established in title XIX of such Act [42 U.S.C. 1396 et seq.]);

or

(B) by an entity that provides health services on a prepaid

basis.

(d) Maintenance of effort

With respect to services provided for by a State for purposes of

compliance with this section, a funding agreement for a grant under

section 300x-21 of this title is that the State will maintain

expenditures of non-Federal amounts for such services at a level

that is not less than average level of such expenditures maintained

by the State for 2-year period preceding the first fiscal year for

which the State receives such a grant.

(e) Applicability of certain provision

Section 300x-31 of this title applies to this section (and to

each other provision of this subpart).

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1924, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 391.)

-REFTEXT-

REFERENCES IN TEXT

Section 300x-1a of this title, referred to in subsec.

(b)(4)(A)(ii), was repealed by Pub. L. 102-321, title II, Sec.

201(2), July 10, 1992, 106 Stat. 378.

Section 300x-4 of this title, referred to in subsec.

(b)(4)(A)(ii), was in the original a reference to section 1916 of

act July 1, 1944, which was repealed by Pub. L. 102-321, title II,

Sec. 201(2), July 10, 1992, 106 Stat. 378. Section 201(2) of Pub.

L. 102-321 enacted new sections 1915 and 1916 of act July 1, 1944,

which are classified to sections 300x-4 and 300x-5, respectively,

of this title.

The Social Security Act, referred to in subsec. (c)(2)(A), is act

Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles XVIII and

XIX of the Act are classified generally to subchapters XVIII (Sec.

1395 et seq.) and XIX (Sec. 1396 et seq.) of chapter 7 of this

title. For complete classification of this Act to the Code, see

section 1305 of this title and Tables.

-MISC1-

PRIOR PROVISIONS

A prior section 1924 of act July 1, 1944, was classified to

section 300x-10 of this title prior to repeal by Pub. L. 102-321.

Another prior section 1924 of act July 1, 1944, was classified to

section 300y-3 of this title prior to repeal by Pub. L. 99-280.

-CHANGE-

CHANGE OF NAME

Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-21, 300x-32 of this

title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-25 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-25. Group homes for recovering substance abusers

-STATUTE-

(a) State revolving funds for establishment of homes

A State, using funds available under section 300x-21 of this

title, may establish and maintain the ongoing operation of a

revolving fund in accordance with this section to support group

homes for recovering substance abusers as follows:

(1) The purpose of the fund is to make loans for the costs of

establishing programs for the provision of housing in which

individuals recovering from alcohol or drug abuse may reside in

groups of not less than 6 individuals. The fund is established

directly by the State or through the provision of a grant or

contract to a nonprofit private entity.

(2) The programs are carried out in accordance with guidelines

issued under subsection (b) of this section.

(3) Not less than $100,000 is available for the fund.

(4) Loans made from the revolving fund do not exceed $4,000 and

each such loan is repaid to the revolving fund by the residents

of the housing involved not later than 2 years after the date on

which the loan is made.

(5) Each such loan is repaid by such residents through monthly

installments, and a reasonable penalty is assessed for each

failure to pay such periodic installments by the date specified

in the loan agreement involved.

(6) Such loans are made only to nonprofit private entities

agreeing that, in the operation of the program established

pursuant to the loan -

(A) the use of alcohol or any illegal drug in the housing

provided by the program will be prohibited;

(B) any resident of the housing who violates such prohibition

will be expelled from the housing;

(C) the costs of the housing, including fees for rent and

utilities, will be paid by the residents of the housing; and

(D) the residents of the housing will, through a majority

vote of the residents, otherwise establish policies governing

residence in the housing, including the manner in which

applications for residence in the housing are approved.

(b) Issuance by Secretary of guidelines

The Secretary shall ensure that there are in effect guidelines

under this subpart for the operation of programs described in

subsection (a) of this section.

(c) Applicability to territories

The requirements established in subsection (a) of this section

shall not apply to any territory of the United States other than

the Commonwealth of Puerto Rico.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1925, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 393; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(b), Oct. 17, 2000,

114 Stat. 1210.)

-MISC1-

PRIOR PROVISIONS

A prior section 1925 of act July 1, 1944, was classified to

section 300x-11 of this title prior to repeal by Pub. L. 102-321.

Another prior section 1925 of act July 1, 1944, was classified to

section 300y-4 of this title prior to repeal by Pub. L. 99-280.

AMENDMENTS

2000 - Subsec. (a). Pub. L. 106-310, in introductory provisions,

substituted "A State, using funds available under section 300x-21

of this title, may establish and maintain the ongoing operation of

a revolving fund in accordance with this section to support group

homes for recovering substance abusers as follows:" for "For fiscal

year 1993 and subsequent fiscal years, the Secretary may make a

grant under section 300x-21 of this title only if the State

involved has established, and is providing for the ongoing

operation of, a revolving fund as follows:".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 290bb of this title.

-End-

-CITE-

42 USC Sec. 300x-26 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-26. State law regarding sale of tobacco products to

individuals under age of 18

-STATUTE-

(a) Relevant law

(1) In general

Subject to paragraph (2), for fiscal year 1994 and subsequent

fiscal years, the Secretary may make a grant under section

300x-21 of this title only if the State involved has in effect a

law providing that it is unlawful for any manufacturer, retailer,

or distributor of tobacco products to sell or distribute any such

product to any individual under the age of 18.

(2) Delayed applicability for certain States

In the case of a State whose legislature does not convene a

regular session in fiscal year 1993, and in the case of a State

whose legislature does not convene a regular session in fiscal

year 1994, the requirement described in paragraph (1) as a

condition of a receipt of a grant under section 300x-21 of this

title shall apply only for fiscal year 1995 and subsequent fiscal

years.

(b) Enforcement

(1) In general

For the first applicable fiscal year and for subsequent fiscal

years, a funding agreement for a grant under section 300x-21 of

this title is that the State involved will enforce the law

described in subsection (a) of this section in a manner that can

reasonably be expected to reduce the extent to which tobacco

products are available to individuals under the age of 18.

(2) Activities and reports regarding enforcement

For the first applicable fiscal year and for subsequent fiscal

years, a funding agreement for a grant under section 300x-21 of

this title is that the State involved will -

(A) annually conduct random, unannounced inspections to

ensure compliance with the law described in subsection (a) of

this section; and

(B) annually submit to the Secretary a report describing -

(i) the activities carried out by the State to enforce such

law during the fiscal year preceding the fiscal year for

which the State is seeking the grant;

(ii) the extent of success the State has achieved in

reducing the availability of tobacco products to individuals

under the age of 18; and

(iii) the strategies to be utilized by the State for

enforcing such law during the fiscal year for which the grant

is sought.

(c) Noncompliance of State

Before making a grant under section 300x-21 of this title to a

State for the first applicable fiscal year or any subsequent fiscal

year, the Secretary shall make a determination of whether the State

has maintained compliance with subsections (a) and (b) of this

section. If, after notice to the State and an opportunity for a

hearing, the Secretary determines that the State is not in

compliance with such subsections, the Secretary shall reduce the

amount of the allotment under such section for the State for the

fiscal year involved by an amount equal to -

(1) in the case of the first applicable fiscal year, 10 percent

of the amount determined under section 300x-33 of this title for

the State for the fiscal year;

(2) in the case of the first fiscal year following such

applicable fiscal year, 20 percent of the amount determined under

section 300x-33 of this title for the State for the fiscal year;

(3) in the case of the second such fiscal year, 30 percent of

the amount determined under section 300x-33 of this title for the

State for the fiscal year; and

(4) in the case of the third such fiscal year or any subsequent

fiscal year, 40 percent of the amount determined under section

300x-33 of this title for the State for the fiscal year.

(d) "First applicable fiscal year" defined

For purposes of this section, the term "first applicable fiscal

year" means -

(1) fiscal year 1995, in the case of any State described in

subsection (a)(2) of this section; and

(2) fiscal year 1994, in the case of any other State.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1926, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 394.)

-MISC1-

PRIOR PROVISIONS

A prior section 1926 of act July 1, 1944, was classified to

section 300x-12 of this title prior to repeal by Pub. L. 102-321.

Another prior section 1926 of act July 1, 1944, was classified to

section 300y-5 of this title prior to repeal by Pub. L. 99-280.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-54, 300x-55 of this

title.

-End-

-CITE-

42 USC Sec. 300x-27 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-27. Treatment services for pregnant women

-STATUTE-

(a) In general

A funding agreement for a grant under section 300x-21 of this

title is that the State involved -

(1) will ensure that each pregnant woman in the State who seeks

or is referred for and would benefit from such services is given

preference in admissions to treatment facilities receiving funds

pursuant to the grant; and

(2) will, in carrying out paragraph (1), publicize the

availability to such women of services from the facilities and

the fact that the women receive such preference.

(b) Referrals regarding States

A funding agreement for a grant under section 300x-21 of this

title is that, in carrying out subsection (a)(1) of this section -

(1) the State involved will require that, in the event that a

treatment facility has insufficient capacity to provide treatment

services to any woman described in such subsection who seeks the

services from the facility, the facility refer the woman to the

State; and

(2) the State, in the case of each woman for whom a referral

under paragraph (1) is made to the State -

(A) will refer the woman to a treatment facility that has the

capacity to provide treatment services to the woman; or

(B) will, if no treatment facility has the capacity to admit

the woman, make interim services available to the woman not

later than 48 hours after the women (!1) seeks the treatment

services.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1927, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 395; amended

Pub. L. 102-352, Sec. 2(a)(10), Aug. 26, 1992, 106 Stat. 938.)

-MISC1-

PRIOR PROVISIONS

A prior section 1927 of act July 1, 1944, was classified to

section 300x-12 of this title prior to repeal by Pub. L. 102-321.

Another prior section 1927 of act July 1, 1944, was classified to

section 300y-6 of this title prior to repeal by Pub. L. 99-280.

AMENDMENTS

1992 - Subsec. (b)(2)(B). Pub. L. 102-352 struck out "available"

before "interim services available".

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-352 effective immediately upon

effectuation of amendment made by Pub. L. 102-321, see section 3(1)

of Pub. L. 102-352, set out as a note under section 285n of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-29 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be "woman".

-End-

-CITE-

42 USC Sec. 300x-28 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-28. Additional agreements

-STATUTE-

(a) Improvement of process for appropriate referrals for treatment

With respect to individuals seeking treatment services, a funding

agreement for a grant under section 300x-21 of this title is that

the State involved will improve (relative to fiscal year 1992) the

process in the State for referring the individuals to treatment

facilities that can provide to the individuals the treatment

modality that is most appropriate for the individuals.

(b) Continuing education

With respect to any facility for treatment services or prevention

actitivities (!1) that is receiving amounts from a grant under

section 300x-21 of this title, a funding agreement for a State for

a grant under such section is that continuing education in such

services or activities (or both, as the case may be) will be made

available to employees of the facility who provide the services or

activities.

(c) Coordination of various activities and services

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will coordinate prevention and

treatment activities with the provision of other appropriate

services (including health, social, correctional and criminal

justice, educational, vocational rehabilitation, and employment

services).

(d) Waiver of requirement

(1) In general

Upon the request of a State, the Secretary may provide to a

State a waiver of any or all of the requirements established in

this section if the Secretary determines that, with respect to

services for the prevention and treatment of substance abuse, the

requirement involved is unnecessary for maintaining quality in

the provision of such services in the State.

(2) Date certain for acting upon request

The Secretary shall approve or deny a request for a waiver

under paragraph (1) not later than 120 days after the date on

which the request is made.

(3) Applicability of waiver

Any waiver provided by the Secretary under paragraph (1) shall

be applicable only to the fiscal year involved.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1928, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 396; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(f)(2)(B), Oct. 17,

2000, 114 Stat. 1211.)

-STATAMEND-

REPEAL OF SUBSECTION (D)

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17,

2000, 114 Stat. 1211, provided that, effective upon publication of

regulations developed in accordance with section 300x-32(e)(1) of

this title, subsection (d) of this section is repealed.

-MISC1-

PRIOR PROVISIONS

A prior section 1928 of act July 1, 1944, was classified to

section 300y-7 of this title prior to repeal by Pub. L. 99-280.

EFFECTIVE DATE OF 2000 AMENDMENT

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(f)(2), Oct. 17,

2000, 114 Stat. 1211, provided that the amendment made by section

3303(f)(2) is effective upon the publication of the regulations

developed in accordance with section 300x-32(e)(1) of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-32 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be "activities".

-End-

-CITE-

42 USC Sec. 300x-29 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-29. Submission to Secretary of statewide assessment of

needs

-STATUTE-

The Secretary may make a grant under section 300x-21 of this

title only if the State submits to the Secretary an assessment of

the need in the State for authorized activities (which assessment

is conducted in accordance with criteria issued by the Secretary),

both by locality and by the State in general, which assessment

includes a description of -

(1) the incidence and prevalence in the State of drug abuse and

the incidence and prevalence in the State of alcohol abuse and

alcoholism;

(2) current prevention and treatment activities in the State;

(3) the need of the State for technical assistance to carry out

such activities;

(4) efforts by the State to improve such activities; and

(5) the extent to which the availability of such activities is

insufficient to meet the need for the activities, the interim

services to be made available under sections 300x-23(a) and

300x-27(b) of this title, and the manner in which such services

are to be so available.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1929, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 396.)

-MISC1-

PRIOR PROVISIONS

A prior section 1929 of act July 1, 1944, was classified to

section 300y-8 of this title prior to repeal by Pub. L. 99-280.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-32 of this title.

-End-

-CITE-

42 USC Sec. 300x-30 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-30. Maintenance of effort regarding State expenditures

-STATUTE-

(a) In general

With respect to the principal agency of a State for carrying out

authorized activities, a funding agreement for a grant under

section 300x-21 of this title for the State for a fiscal year is

that such agency will for such year maintain aggregate State

expenditures for authorized activities at a level that is not less

than the average level of such expenditures maintained by the State

for the 2-year period preceding the fiscal year for which the State

is applying for the grant.

(b) Exclusion of certain funds

The Secretary may exclude from the aggregate State expenditures

under subsection (a) of this section, funds appropriated to the

principle agency for authorized activities which are of a

non-recurring nature and for a specific purpose.

(c) Waiver

(1) In general

Upon the request of a State, the Secretary may waive all or

part of the requirement established in subsection (a) of this

section if the Secretary determines that extraordinary economic

conditions in the State justify the waiver.

(2) Date certain for acting upon request

The Secretary shall approve or deny a request for a waiver

under paragraph (1) not later than 120 days after the date on

which the request is made.

(3) Applicability of waiver

Any waiver provided by the Secretary under paragraph (1) shall

be applicable only to the fiscal year involved.

(d) Noncompliance by State

(1) In general

In making a grant under section 300x-21 of this title to a

State for a fiscal year, the Secretary shall make a determination

of whether, for the previous fiscal year, the State maintained

material compliance with any agreement made under subsection (a)

of this section. If the Secretary determines that a State has

failed to maintain such compliance, the Secretary shall reduce

the amount of the allotment under section 300x-21 of this title

for the State for the fiscal year for which the grant is being

made by an amount equal to the amount constituting such failure

for the previous fiscal year.

(2) Submission of information to Secretary

The Secretary may make a grant under section 300x-21 of this

title for a fiscal year only if the State involved submits to the

Secretary information sufficient for the Secretary to make the

determination required in paragraph (1).

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1930, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 397; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(c), Oct. 17, 2000,

114 Stat. 1210.)

-MISC1-

PRIOR PROVISIONS

A prior section 1930 of act July 1, 1944, was classified to

section 300y-9 of this title prior to repeal by Pub. L. 99-280.

AMENDMENTS

2000 - Subsecs. (b) to (d). Pub. L. 106-310 added subsec. (b) and

redesignated former subsecs. (b) and (c) as (c) and (d),

respectively.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-32, 300x-54, 300x-55

of this title.

-End-

-CITE-

42 USC Sec. 300x-31 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-31. Restrictions on expenditure of grant

-STATUTE-

(a) In general

(1) Certain restrictions

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will not expend the grant -

(A) to provide inpatient hospital services, except as

provided in subsection (b) of this section;

(B) to make cash payments to intended recipients of health

services;

(C) to purchase or improve land, purchase, construct, or

permanently improve (other than minor remodeling) any building

or other facility, or purchase major medical equipment;

(D) to satisfy any requirement for the expenditure of

non-Federal funds as a condition for the receipt of Federal

funds;

(E) to provide financial assistance to any entity other than

a public or nonprofit private entity; or

(F) to carry out any program prohibited by section 300ee-5 of

this title.

(2) Limitation on administrative expenses

A funding agreement for a grant under section 300x-21 of this

title is that the State involved will not expend more than 5

percent of the grant to pay the costs of administering the grant.

(3) Limitation regarding penal and correctional institutions

A funding agreement for a State for a grant under section

300x-21 of this title is that, in expending the grant for the

purpose of providing treatment services in penal or correctional

institutions of the State, the State will not expend more than an

amount equal to the amount expended for such purpose by the State

from the grant made under section 300x-1a (!1) of this title to

the State for fiscal year 1991 (as section 300x-1a (!1) of this

title was in effect for such fiscal year).

(b) Exception regarding inpatient hospital services

(1) Medical necessity as precondition

With respect to compliance with the agreement made under

subsection (a) of this section, a State may expend a grant under

section 300x-21 of this title to provide inpatient hospital

services as treatment for substance abuse only if it has been

determined, in accordance with guidelines issued by the

Secretary, that such treatment is a medical necessity for the

individual involved, and that the individual cannot be

effectively treated in a community-based, nonhospital,

residential program of treatment.

(2) Rate of payment

In the case of an individual for whom a grant under section

300x-21 of this title is expended to provide inpatient hospital

services described in paragraph (1), a funding agreement for the

grant for the State involved is that the daily rate of payment

provided to the hospital for providing the services to the

individual will not exceed the comparable daily rate provided for

community-based, nonhospital, residential programs of treatment

for substance abuse.

(c) Waiver regarding construction of facilities

(1) In general

The Secretary may provide to any State a waiver of the

restriction established in subsection (a)(1)(C) of this section

for the purpose of authorizing the State to expend a grant under

section 300x-21 of this title for the construction of a new

facility or rehabilitation of an existing facility, but not for

land acquisition.

(2) Standard regarding need for waiver

The Secretary may approve a waiver under paragraph (1) only if

the State demonstrates to the Secretary that adequate treatment

cannot be provided through the use of existing facilities and

that alternative facilities in existing suitable buildings are

not available.

(3) Amount

In granting a waiver under paragraph (1), the Secretary shall

allow the use of a specified amount of funds to construct or

rehabilitate a specified number of beds for residential treatment

and a specified number of slots for outpatient treatment, based

on reasonable estimates by the State of the costs of construction

or rehabilitation. In considering waiver applications, the

Secretary shall ensure that the State has carefully designed a

program that will minimize the costs of additional beds.

(4) Matching funds

The Secretary may grant a waiver under paragraph (1) only if

the State agrees, with respect to the costs to be incurred by the

State in carrying out the purpose of the waiver, to make

available non-Federal contributions in cash toward such costs in

an amount equal to not less than $1 for each $1 of Federal funds

provided under section 300x-21 of this title.

(5) Date certain for acting upon request

The Secretary shall act upon a request for a waiver under

paragraph (1) not later than 120 days after the date on which the

request is made.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1931, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 397.)

-REFTEXT-

REFERENCES IN TEXT

Section 300x-1a of this title, referred to in subsec. (a)(3), was

repealed by Pub. L. 102-321, title II, Sec. 201(2), July 10, 1992,

106 Stat. 378.

-MISC1-

PRIOR PROVISIONS

A prior section 1931 of act July 1, 1944, was classified to

section 300y-21 of this title and subsequently omitted from the

Code.

Another prior section 1931 of act July 1, 1944, was classified to

section 300y-10 of this title prior to repeal by Pub. L. 99-280.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-21, 300x-24,

300x-32, 300x-34, 1395x of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-32 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-32. Application for grant; approval of State plan

-STATUTE-

(a) In general

For purposes of section 300x-21 of this title, an application for

a grant under such section for a fiscal year is in accordance with

this section if, subject to subsections (c) and (d)(2) of this

section -

(1) the application is received by the Secretary not later than

October 1 of the fiscal year for which the State is seeking

funds;

(2) the application contains each funding agreement that is

described in this subpart or subpart III for such a grant (other

than any such agreement that is not applicable to the State);

(3) the agreements are made through certification from the

chief executive officer of the State;

(4) with respect to such agreements, the application provides

assurances of compliance satisfactory to the Secretary;

(5) the application contains the information required in

section 300x-29 of this title, the information required in

section 300x-30(c)(2) (!1) of this title, and the report required

in section 300x-52(a) of this title;

(6)(A) the application contains a plan in accordance with

subsection (b) of this section and the plan is approved by the

Secretary; and

(B) the State provides assurances satisfactory to the Secretary

that the State complied with the provisions of the plan under

subparagraph (A) that was approved by the Secretary for the most

recent fiscal year for which the State received a grant under

section 300x-21 of this title; and

(7) the application (including the plan under paragraph (6)) is

otherwise in such form, is made in such manner, and contains such

agreements, assurances, and information as the Secretary

determines to be necessary to carry out this subpart.

(b) State plan

(1) In general

A plan submitted by a State under subsection (a)(6) of this

section is in accordance with this subsection if the plan

contains detailed provisions for complying with each funding

agreement for a grant under section 300x-21 of this title that is

applicable to the State, including a description of the manner in

which the State intends to expend the grant.

(2) Authority of Secretary regarding modifications

As a condition of making a grant under section 300x-21 of this

title to a State for a fiscal year, the Secretary may require

that the State modify any provision of the plan submitted by the

State under subsection (a)(6) of this section (including

provisions on priorities in carrying out authorized activities).

If the Secretary approves the plan and makes the grant to the

State for the fiscal year, the Secretary may not during such year

require the State to modify the plan.

(3) Authority of Center for Substance Abuse Prevention

With respect to plans submitted by the States under subsection

(a)(6) of this section, the Secretary, acting through the

Director of the Center for Substance Abuse Prevention, shall

review and approve or disapprove the provisions of the plans that

relate to prevention activities.

(c) Waivers regarding certain territories

In the case of any territory of the United States except Puerto

Rico, the Secretary may waive such provisions of this subpart and

subpart III as the Secretary determines to be appropriate, other

than the provisions of section 300x-31 of this title.

(d) Issuance of regulations; precondition to making grants

(1) Regulations

Not later than August 25, 1992, the Secretary, acting as

appropriate through the Director of the Center for Treatment

Improvement or the Director of the Center for Substance Abuse

Prevention, shall by regulation establish standards specifying

the circumstances in which the Secretary will consider an

application for a grant under section 300x-21 of this title to be

in accordance with this section.

(2) Issuance as precondition to making grants

The Secretary may not make payments under any grant under

section 300x-21 of this title for fiscal year 1993 on or after

January 1, 1993, unless the Secretary has issued standards under

paragraph (1).

(e) Waiver authority for certain requirements

(1) In general

Upon the request of a State, the Secretary may waive the

requirements of all or part of the sections described in

paragraph (2) using objective criteria established by the

Secretary by regulation after consultation with the States and

other interested parties including consumers and providers.

(2) Sections

The sections described in paragraph (1) are sections 300x-22(c)

(!1), 300x-23, 300x-24 and 300x-28 of this title.

(3) Date certain for acting upon request

The Secretary shall approve or deny a request for a waiver

under paragraph (1) and inform the State of that decision not

later than 120 days after the date on which the request and all

the information needed to support the request are submitted.

(4) Annual reporting requirement

The Secretary shall annually report to the general public on

the States that receive a waiver under this subsection.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1932, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 399; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(d)-(f)(1), Oct.

17, 2000, 114 Stat. 1211.)

-REFTEXT-

REFERENCES IN TEXT

Section 300x-30(c) of this title, referred to in subsec. (a)(5),

was redesignated section 300x-30(d) of this title by Pub. L.

106-310, div. B, title XXXIII, Sec. 3303(c)(1), Oct. 17, 2000, 114

Stat. 1211.

Section 300x-22(c) of this title, referred to in subsec. (e)(2),

was redesignated section 300x-22(b) of this title by Pub. L.

106-310, div. B, title XXXIII, Sec. 3303(a)(2), Oct. 17, 2000, 114

Stat. 1210.

-MISC1-

PRIOR PROVISIONS

A prior section 1932 of act July 1, 1944, was classified to

section 300y-22 of this title and subsequently omitted from the

Code.

Another prior section 1932 of act July 1, 1944, was classified to

section 300y-11 of this title prior to repeal by Pub. L. 99-280.

AMENDMENTS

2000 - Subsec. (a)(1). Pub. L. 106-310, Sec. 3303(d), amended

par. (1) generally. Prior to amendment, par. (1) read as follows:

"the State involved submits the application not later than the date

specified by the Secretary;".

Subsec. (c). Pub. L. 106-310, Sec. 3303(e), substituted "except

Puerto Rico" for "whose allotment under section 300x-21 of this

title for the fiscal year is the amount specified in section

300x-33(c)(2)(B) of this title".

Subsec. (e). Pub. L. 106-310, Sec. 3303(f)(1), added subsec. (e).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 290bb, 300x-21, 300x-51

of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-33 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-33. Determination of amount of allotment

-STATUTE-

(a) States

(1) In general

Subject to subsection (b) of this section, the Secretary shall

determine the amount of the allotment required in section 300x-21

of this title for a State for a fiscal year as follows:

(A) The formula established in paragraph (1) of section

300x-7(a) of this title shall apply to this subsection to the

same extent and in the same manner as the formula applies for

purposes of section 300x-7(a) of this title, except that, in

the application of such formula for purposes of this

subsection, the modifications described in subparagraph (B)

shall apply.

(B) For purposes of subparagraph (A), the modifications

described in this subparagraph are as follows:

(i) The amount specified in paragraph (2)(A) of section

300x-7(a) of this title is deemed to be the amount

appropriated under section 300x-35(a) of this title for

allotments under section 300x-21 of this title for the fiscal

year involved.

(ii) The term "P" is deemed to have the meaning given in

paragraph (2) of this subsection. Section 300x-7(a)(5)(B) of

this title applies to the data used in determining such term

for the States.

(iii) The factor determined under paragraph (8) of section

300x-7(a) of this title is deemed to have the purpose of

reflecting the differences that exist between the State

involved and other States in the costs of providing

authorized services.

(2) Determination of term "P"

For purposes of this subsection, the term "P" means the

percentage that is the arithmetic mean of the percentage

determined under subparagraph (A) and the percentage determined

under subparagraph (B), as follows:

(A) The percentage constituted by the ratio of -

(i) an amount equal to the sum of the total number of

individuals who reside in the State involved and are between

18 and 24 years of age (inclusive) and the number of

individuals in the State who reside in urbanized areas of the

State and are between such years of age; to

(ii) an amount equal to the total of the respective sums

determined for the States under clause (i).

(B) The percentage constituted by the ratio of -

(i) the total number of individuals in the State who are

between 25 and 64 years of age (inclusive); to

(ii) an amount equal to the sum of the respective amounts

determined for the States under clause (i).

(b) Minimum allotments for States

(1) In general

With respect to fiscal year 2000, and each subsequent fiscal

year, the amount of the allotment of a State under section

300x-21 of this title shall not be less than the amount the State

received under such section for the previous fiscal year

increased by an amount equal to 30.65 percent of the percentage

by which the aggregate amount allotted to all States for such

fiscal year exceeds the aggregate amount allotted to all States

for the previous fiscal year.

(2) Limitations

(A) In general

Except as provided in subparagraph (B), a State shall not

receive an allotment under section 300x-21 of this title for a

fiscal year in an amount that is less than an amount equal to

0.375 percent of the amount appropriated under section

300x-35(a) of this title for such fiscal year.

(B) Exception

In applying subparagraph (A), the Secretary shall ensure that

no State receives an increase in its allotment under section

300x-21 of this title for a fiscal year (as compared to the

amount allotted to the State in the prior fiscal year) that is

in excess of an amount equal to 300 percent of the percentage

by which the amount appropriated under section 300x-35(a) of

this title for such fiscal year exceeds the amount appropriated

for the prior fiscal year.

(3) Decrease in or equal appropriations

If the amount appropriated under section 300x-35(a) of this

title for a fiscal year is equal to or less than the amount

appropriated under such section for the prior fiscal year, the

amount of the State allotment under section 300x-21 of this title

shall be equal to the amount that the State received under

section 300x-21 of this title in the prior fiscal year decreased

by the percentage by which the amount appropriated for such

fiscal year is less than the amount appropriated or (!1) such

section for the prior fiscal year.

(c) Territories

(1) Determination under formula

Subject to paragraphs (2) and (4), the amount of an allotment

under section 300x-21 of this title for a territory of the United

States for a fiscal year shall be the product of -

(A) an amount equal to the amounts reserved under paragraph

(3) for the fiscal year; and

(B) a percentage equal to the quotient of -

(i) the civilian population of the territory, as indicated

by the most recently available data; divided by

(ii) the aggregate civilian population of the territories

of the United States, as indicated by such data.

(2) Minimum allotment for territories

The amount of an allotment under section 300x-21 of this title

for a territory of the United States for a fiscal year shall be

the greater of -

(A) the amount determined under paragraph (1) for the

territory for the fiscal year;

(B) $50,000; and

(C) with respect to fiscal years 1993 and 1994, an amount

equal to 79.4 percent of the amount received by the territory

from allotments made pursuant to this part for fiscal year

1992.

(3) Reservation of amounts

The Secretary shall each fiscal year reserve for the

territories of the United States 1.5 percent of the amounts

appropriated under section 300x-35(a) of this title for

allotments under section 300x-21 of this title for the fiscal

year.

(4) Availability of data on population

With respect to data on the civilian population of the

territories of the United States, if the Secretary determines for

a fiscal year that recent such data for purposes of paragraph

(1)(B) do not exist regarding a territory, the Secretary shall

for such purposes estimate the civilian population of the

territory by modifying the data on the territory to reflect the

average extent of change occurring during the ensuing period in

the population of all territories with respect to which recent

such data do exist.

(5) Applicability of certain provisions

For purposes of subsections (a) and (b) of this section, the

term "State" does not include the territories of the United

States.

(d) Indian tribes and tribal organizations

(1) In general

If the Secretary -

(A) receives a request from the governing body of an Indian

tribe or tribal organization within any State that funds under

this subpart be provided directly by the Secretary to such

tribe or organization; and

(B) makes a determination that the members of such tribe or

tribal organization would be better served by means of grants

made directly by the Secretary under this; (!2)

the Secretary shall reserve from the allotment under section

300x-21 of this title for the State for the fiscal year involved

an amount that bears the same ratio to the allotment as the

amount provided under this subpart to the tribe or tribal

organization for fiscal year 1991 for activities relating to the

prevention and treatment of the abuse of alcohol and other drugs

bore to the amount of the portion of the allotment under this

subpart for the State for such fiscal year that was expended for

such activities.

(2) Tribe or tribal organization as grantee

The amount reserved by the Secretary on the basis of a

determination under this paragraph (!3) shall be granted to the

Indian tribe or tribal organization serving the individuals for

whom such a determination has been made.

(3) Application

In order for an Indian tribe or tribal organization to be

eligible for a grant for a fiscal year under this paragraph,(!3)

it shall submit to the Secretary a plan for such fiscal year that

meets such criteria as the Secretary may prescribe.

(4) Definitions

The terms "Indian tribe" and "tribal organization" have the

same meaning given such terms in subsections (b) and (c) (!4) of

section 450b of title 25.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1933, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 400; amended

Pub. L. 102-352, Sec. 2(a)(11), Aug. 26, 1992, 106 Stat. 938; Pub.

L. 105-277, div. A, Sec. 101(f) [title II, Sec. 218(b)], Oct. 21,

1998, 112 Stat. 2681-337, 2681-362; Pub. L. 106-113, div. B, Sec.

1000(a)(4) [title II, Sec. 212(b)], Nov. 29, 1999, 113 Stat. 1535,

1501A-239; Pub. L. 106-310, div. B, title XXXIII, Sec. 3304, Oct.

17, 2000, 114 Stat. 1212.)

-REFTEXT-

REFERENCES IN TEXT

Section 450b of title 25, referred to in subsec. (d)(4), was

amended, and subsecs. (b) and (c) of section 450 no longer define

the terms "Indian tribe" and "tribal organization". However, such

terms are defined elsewhere in that section.

-MISC1-

PRIOR PROVISIONS

A prior section 1933 of act July 1, 1944, was classified to

section 300y-23 of this title and subsequently omitted from the

Code.

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310 reenacted heading without

change and amended text generally. Prior to amendment, text read as

follows: "Each State's allotment for fiscal year 2000 for programs

under this subpart shall be equal to such State's allotment for

such programs for fiscal year 1999, except that, if the amount

appropriated in fiscal year 2000 is less than the amount

appropriated in fiscal year 1999, then the amount of a State's

allotment under section 300x-21 of this title shall be equal to the

amount that the State received under section 300x-21 of this title

in fiscal year 1999 decreased by the percentage by which the amount

appropriated for fiscal year 2000 is less than the amount

appropriated for such section for fiscal year 1999."

1999 - Subsec. (b). Pub. L. 106-113 amended heading and text of

subsec. (b) generally. Prior to amendment, text read as follows:

"For each of the fiscal years 1993 and 1994, the amount of the

allotment required in section 300x-21 of this title for a State for

the fiscal year involved shall be the greater of -

"(1) the amount determined under subsection (a) of this section

for the State for the fiscal year; and

"(2) an amount equal to 79.4 percent of the amount received by

the State from allotments made pursuant to this part for fiscal

year 1992 (including reallotments under section 205(a) of the

ADAMHA Reorganization Act)."

1998 - Subsec. (b). Pub. L. 105-277, temporarily amended subsec.

(b) to read as follows: "(b) Minimum allotments for States. -

"(1) In general. - With respect to fiscal year 1999, the amount

of the allotment of a State under section 300x-21 of this title

shall not be less than the amount the State received under

section 300x-21 of this title for fiscal year 1998 increased by

30.65 percent of the percentage by which the amount allotted to

the States for fiscal year 1999 exceeds the amount allotted to

the States for fiscal year 1998.

"(2) Limitation

"(A) In general. - Except as provided in subparagraph (B), a

State shall not receive an allotment under section 300x-21 of

this title for fiscal year 1999 in an amount that is less than

an amount equal to 0.375 percent of the amount appropriated

under section 300x-35(a) of this title for such fiscal year.

"(B) Exception. - In applying subparagraph (A), the Secretary

shall ensure that no State receives an increase in its

allotment under section 300x-21 of this title for fiscal year

1999 (as compared to the amount allotted to the State in the

fiscal year 1998) that is in excess of an amount equal to 300

percent of the percentage by which the amount appropriated

under section 300x-35(a) of this title for fiscal year 1999

exceeds the amount appropriated for the prior fiscal year.

"(3) Only for the purposes of calculating minimum allotments

under this subsection, any reference to the amount appropriated

under section 300x-35(a) of this title for fiscal year 1998,

allotments to States under section 300x-21 of this title and any

references to amounts received by States in fiscal year 1998

shall include amounts appropriated or received under the

amendments made by section 105 of the Contract with America

Advancement Act of 1996 (Public Law 104-121)."

See Effective and Termination Dates of 1998 Amendment note below.

1992 - Subsec. (c)(2)(C). Pub. L. 102-352 added subpar. (C).

EFFECTIVE AND TERMINATION DATES OF 1998 AMENDMENT

Amendment by Pub. L. 105-277 effective as if enacted on Oct. 1,

1998, and applicable only during fiscal year 1999, and upon

expiration of fiscal year 1999, subsec. (b) of this section, as in

effect on Sept. 30, 1998, to be applied as if such amendment had

not been enacted, see section 101(f) [title II, Sec. 218(c)] of

Pub. L. 105-277, set out as a note under section 300x-7 of this

title.

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-352 effective immediately upon

effectuation of amendment made by Pub. L. 102-321, see section 3(1)

of Pub. L. 102-352, set out as a note under section 285n of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-21, 300x-26, 300x-64

of this title.

-FOOTNOTE-

(!1) So in original. Probably should be "for".

(!2) So in original. Probably should be "this subpart;".

(!3) So in original. Probably should be "subsection".

(!4) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300x-34 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-34. Definitions

-STATUTE-

For purposes of this subpart:

(1) The term "authorized activities", subject to section

300x-31 of this title, means the activities described in section

300x-21(b) of this title.

(2) The term "funding agreement", with respect to a grant under

section 300x-21 of this title to a State, means that the

Secretary may make such a grant only if the State makes the

agreement involved.

(3) The term "prevention activities", subject to section

300x-31 of this title, means activities to prevent substance

abuse.

(4) The term "substance abuse" means the abuse of alcohol or

other drugs.

(5) The term "treatment activities" means treatment services

and, subject to section 300x-31 of this title, authorized

activities that are related to treatment services.

(6) The term "treatment facility" means an entity that provides

treatment services.

(7) The term "treatment services", subject to section 300x-31

of this title, means treatment for substance abuse.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1934, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 402.)

-MISC1-

PRIOR PROVISIONS

A prior section 1934 of act July 1, 1944, was classified to

section 300y-24 of this title and subsequently omitted from the

Code.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-64 of this title.

-End-

-CITE-

42 USC Sec. 300x-35 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart ii - block grants for prevention and treatment of substance

abuse

-HEAD-

Sec. 300x-35. Funding

-STATUTE-

(a) Authorization of appropriations

For the purpose of carrying out this subpart, subpart III and

section 290aa-4 of this title with respect to substance abuse, and

section 290bb-21(d) of this title, there are authorized to be

appropriated $2,000,000,000 for fiscal year 2001, and such sums as

may be necessary for each of the fiscal years 2002 and 2003.

(b) Allocations for technical assistance, national data base, data

collection, and program evaluations

(1) In general

(A) For the purpose of carrying out section 300x-58(a) of this

title with respect to substance abuse, section 290bb-21(d) of

this title, and the purposes specified in subparagraphs (B) and

(C), the Secretary shall obligate 5 percent of the amounts

appropriated under subsection (a) of this section each fiscal

year.

(B) The purpose specified in this subparagraph is the

collection of data in this paragraph (!1) is carrying out

sections 290aa-4 and 300y of this title with respect to substance

abuse.

(C) The purpose specified in this subparagraph is the conduct

of evaluations of authorized activities to determine methods for

improving the availability and quality of such activities.

(2) Activities of Center for Substance Abuse Prevention

Of the amounts reserved under paragraph (1) for a fiscal year,

the Secretary, acting through the Director of the Center for

Substance Abuse Prevention, shall obligate 20 percent for

carrying out paragraph (1)(C), section 300x-58(a) of this title

with respect to prevention activities, and section 290bb-21(d) of

this title.

(3) Core data set

A State that receives a new grant, contract, or cooperative

agreement from amounts available to the Secretary under paragraph

(1), for the purposes of improving the data collection, analysis

and reporting capabilities of the State, shall be required, as a

condition of receipt of funds, to collect, analyze, and report to

the Secretary for each fiscal year subsequent to receiving such

funds a core data set to be determined by the Secretary in

conjunction with the States.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1935, as added Pub. L.

102-321, title II, Sec. 202, July 10, 1992, 106 Stat. 403; amended

Pub. L. 106-310, div. B, title XXXIII, Sec. 3303(g), Oct. 17, 2000,

114 Stat. 1211.)

-MISC1-

PRIOR PROVISIONS

A prior section 1935 of act July 1, 1944, was classified to

section 300y-25 of this title and subsequently omitted from the

Code.

AMENDMENTS

2000 - Subsec. (a). Pub. L. 106-310, Sec. 3303(g)(1), substituted

"$2,000,000,000 for fiscal year 2001, and such sums as may be

necessary for each of the fiscal years 2002 and 2003" for

"$1,500,000,000 for fiscal year 1993, and such sums as may be

necessary for fiscal year 1994".

Subsec. (b)(1)(B). Pub. L. 106-310, Sec. 3303(g)(2), substituted

"sections 290aa-4 and 300y of this title" for "section 290aa-4 of

this title".

Subsec. (b)(2). Pub. L. 106-310, Sec. 3303(g)(3), made technical

amendment to reference in original act which appears in text as

reference to section 300x-58(a) of this title.

Subsec. (b)(3). Pub. L. 106-310, Sec. 3303(g)(4), added par. (3).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-33 of this title.

-FOOTNOTE-

(!1) So in original. The words "is the collection of data in this

paragraph" probably should not appear.

-End-

-CITE-

42 USC subpart iii - general provisions 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

SUBPART III - GENERAL PROVISIONS

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in sections 300x-6, 300x-9, 300x-32,

300x-35 of this title.

-End-

-CITE-

42 USC Sec. 300x-51 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-51. Opportunity for public comment on State plans

-STATUTE-

A funding agreement for a grant under section 300x or 300x-21 of

this title is that the State involved will make the plan required

in section 300x-1 of this title, and the plan required in section

300x-32 of this title, respectively, public within the State in

such manner as to facilitate comment from any person (including any

Federal or other public agency) during the development of the plan

(including any revisions) and after the submission of the plan to

the Secretary.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1941, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 403.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300x-6 of this title.

-End-

-CITE-

42 USC Sec. 300x-52 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-52. Requirement of reports and audits by States

-STATUTE-

(a) Report

A funding agreement for a grant under section 300x or 300x-21 of

this title is that the State involved will submit to the Secretary

a report in such form and containing such information as the

Secretary determines (after consultation with the States) to be

necessary for securing a record and a description of -

(1) the purposes for which the grant received by the State for

the preceding fiscal year under the program involved were

expended and a description of the activities of the State under

the program; and

(2) the recipients of amounts provided in the grant.

(b) Audits

A funding agreement for a grant under section 300x or 300x-21 of

this title is that the State will, with respect to the grant,

comply with chapter 75 of title 31.

(c) Availability to public

A funding agreement for a grant under section 300x or 300x-21 of

this title is that the State involved will -

(1) make copies of the reports and audits described in this

section available for public inspection within the State; and

(2) provide copies of the report under subsection (a) of this

section, upon request, to any interested person (including any

public agency).

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1942, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 403;

amended Pub. L. 104-316, title I, Sec. 122(e), Oct. 19, 1996, 110

Stat. 3837.)

-MISC1-

AMENDMENTS

1996 - Subsec. (a). Pub. L. 104-316 struck out "and the

Comptroller General" after "with the States" in introductory

provisions.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-4, 300x-6, 300x-32

of this title.

-End-

-CITE-

42 USC Sec. 300x-53 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-53. Additional requirements

-STATUTE-

(a) In general

A funding agreement for a grant under section 300x or 300x-21 of

this title is that the State involved will -

(1)(A) for the fiscal year for which the grant involved is

provided, provide for independent peer review to assess the

quality, appropriateness, and efficacy of treatment services

provided in the State to individuals under the program involved;

and

(B) ensure that, in the conduct of such peer review, not fewer

than 5 percent of the entities providing services in the State

under such program are reviewed (which 5 percent is

representative of the total population of such entities);

(2) permit and cooperate with Federal investigations undertaken

in accordance with section 300x-55 of this title; and

(3) provide to the Secretary any data required by the Secretary

pursuant to section 290aa-4 of this title and will cooperate with

the Secretary in the development of uniform criteria for the

collection of data pursuant to such section.

(b) Patient records

The Secretary may make a grant under section 300x or 300x-21 of

this title only if the State involved has in effect a system to

protect from inappropriate disclosure patient records maintained by

the State in connection with an activity funded under the program

involved or by any entity which is receiving amounts from the

grant.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1943, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 404;

amended Pub. L. 102-352, Sec. 2(a)(12), Aug. 26, 1992, 106 Stat.

939.)

-MISC1-

AMENDMENTS

1992 - Subsec. (a)(3). Pub. L. 102-352 substituted "section

290aa-4 of this title" for "section 290bb-21 of this title".

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-352 effective immediately upon

effectuation of amendment made by Pub. L. 102-321, see section 3(1)

of Pub. L. 102-352, set out as a note under section 285n of this

title.

-End-

-CITE-

42 USC Sec. 300x-54 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-54. Disposition of certain funds appropriated for

allotments

-STATUTE-

(a) In general

Amounts described in subsection (b) of this section and available

for a fiscal year pursuant to section 300x or 300x-21 of this

title, as the case may be, shall be allotted by the Secretary and

paid to the States receiving a grant under the program involved,

other than any State referred to in subsection (b) of this section

with respect to such program. Such amounts shall be allotted in a

manner equivalent to the manner in which the allotment under the

program involved was determined.

(b) Specification of amounts

The amounts referred to in subsection (a) of this section are any

amounts that -

(1) are not paid to States under the program involved as a

result of -

(A) the failure of any State to submit an application in

accordance with the program;

(B) the failure of any State to prepare such application in

compliance with the program; or

(C) any State informing the Secretary that the State does not

intend to expend the full amount of the allotment made to the

State under the program;

(2) are terminated, repaid, or offset under section 300x-55 of

this title;

(3) in the case of the program established in section 300x of

this title, are available as a result of reductions in allotments

under such section pursuant to section 300x-1(d) or 300x-4(b) of

this title; or

(4) in the case of the program established in section 300x-21

of this title, are available as a result of reductions in

allotments under such section pursuant to section 300x-26 or

300x-30 of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1944, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 404.)

-End-

-CITE-

42 USC Sec. 300x-55 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-55. Failure to comply with agreements

-STATUTE-

(a) Suspension or termination of payments

Subject to subsection (e) of this section, if the Secretary

determines that a State has materially failed to comply with the

agreements or other conditions required for the receipt of a grant

under the program involved, the Secretary may in whole or in part

suspend payments under the grant, terminate the grant for cause, or

employ such other remedies (including the remedies provided for in

subsections (b) and (c) of this section) as may be legally

available and appropriate in the circumstances involved.

(b) Repayment of payments

(1) In general

Subject to subsection (e) of this section, the Secretary may

require a State to repay with interest any payments received by

the State under section 300x or 300x-21 of this title that the

Secretary determines were not expended by the State in accordance

with the agreements required under the program involved.

(2) Offset against payments

If a State fails to make a repayment required in paragraph (1),

the Secretary may offset the amount of the repayment against the

amount of any payment due to be paid to the State under the

program involved.

(c) Withholding of payments

(1) In general

Subject to subsections (e) and (g)(3) of this section, the

Secretary may withhold payments due under section 300x or 300x-21

of this title if the Secretary determines that the State involved

is not expending amounts received under the program involved in

accordance with the agreements required under the program.

(2) Termination of withholding

The Secretary shall cease withholding payments from a State

under paragraph (1) if the Secretary determines that there are

reasonable assurances that the State will expend amounts received

under the program involved in accordance with the agreements

required under the program.

(d) Applicability of remedies to certain violations

(1) In general

With respect to agreements or other conditions for receiving a

grant under the program involved, in the case of the failure of a

State to maintain material compliance with a condition referred

to in paragraph (2), the provisions for noncompliance with the

condition that are provided in the section establishing the

condition shall apply in lieu of subsections (a) through (c) of

this section.

(2) Relevant conditions

For purposes of paragraph (1):

(A) In the case of the program established in section 300x of

this title, a condition referred to in this paragraph is the

condition established in section 300x-1(d) of this title and

the condition established in section 300x-4(b) of this title.

(B) In the case of the program established in section 300x-21

of this title, a condition referred to in this paragraph is the

condition established in section 300x-26 of this title and the

condition established in section 300x-30 of this title.

(e) Opportunity for hearing

Before taking action against a State under any of subsections (a)

through (c) of this section (or under a section referred to in

subsection (d)(2) of this section, as the case may be), the

Secretary shall provide to the State involved adequate notice and

an opportunity for a hearing.

(f) Requirement of hearing in certain circumstances

(1) In general

If the Secretary receives a complaint that a State has failed

to maintain material compliance with the agreements or other

conditions required for receiving a grant under the program

involved (including any condition referred to for purposes of

subsection (d) of this section), and there appears to be

reasonable evidence to support the complaint, the Secretary shall

promptly conduct a hearing with respect to the complaint.

(2) Finding of material noncompliance

If in a hearing under paragraph (1) the Secretary finds that

the State involved has failed to maintain material compliance

with the agreement or other condition involved, the Secretary

shall take such action under this section as may be appropriate

to ensure that material compliance is so maintained, or such

action as may be required in a section referred to in subsection

(d)(2) of this section, as the case may be.

(g) Certain investigations

(1) Requirement regarding Secretary

The Secretary shall in fiscal year 1994 and each subsequent

fiscal year conduct in not less than 10 States investigations of

the expenditure of grants received by the States under section

300x or 300x-21 of this title in order to evaluate compliance

with the agreements required under the program involved.

(2) Provision of records, etc., upon request

Each State receiving a grant under section 300x or 300x-21 of

this title, and each entity receiving funds from the grant, shall

make appropriate books, documents, papers, and records available

to the Secretary or the Comptroller General, or any of their duly

authorized representatives, for examination, copying, or

mechanical reproduction on or off the premises of the appropriate

entity upon a reasonable request therefor.

(3) Limitations on authority

The Secretary may not institute proceedings under subsection

(c) of this section unless the Secretary has conducted an

investigation concerning whether the State has expended payments

under the program involved in accordance with the agreements

required under the program. Any such investigation shall be

conducted within the State by qualified investigators.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1945, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 405.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-53, 300x-54 of this

title.

-End-

-CITE-

42 USC Sec. 300x-56 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-56. Prohibitions regarding receipt of funds

-STATUTE-

(a) Establishment

(1) Certain false statements and representations

A person shall not knowingly and willfully make or cause to be

made any false statement or representation of a material fact in

connection with the furnishing of items or services for which

payments may be made by a State from a grant made to the State

under section 300x or 300x-21 of this title.

(2) Concealing or failing to disclose certain events

A person with knowledge of the occurrence of any event

affecting the initial or continued right of the person to receive

any payments from a grant made to a State under section 300x or

300x-21 of this title shall not conceal or fail to disclose any

such event with an intent fraudulently to secure such payment

either in a greater amount than is due or when no such amount is

due.

(b) Criminal penalty for violation of prohibition

Any person who violates any prohibition established in subsection

(a) of this section shall for each violation be fined in accordance

with title 18 or imprisoned for not more than 5 years, or both.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1946, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 406.)

-End-

-CITE-

42 USC Sec. 300x-57 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-57. Nondiscrimination

-STATUTE-

(a) In general

(1) Rule of construction regarding certain civil rights laws

For the purpose of applying the prohibitions against

discrimination on the basis of age under the Age Discrimination

Act of 1975 [42 U.S.C. 6101 et seq.], on the basis of handicap

under section 504 of the Rehabilitation Act of 1973 [29 U.S.C.

794], on the basis of sex under title IX of the Education

Amendments of 1972 [20 U.S.C. 1681 et seq.], or on the basis of

race, color, or national origin under title VI of the Civil

Rights Act of 1964 [42 U.S.C. 2000d et seq.], programs and

activities funded in whole or in part with funds made available

under section 300x or 300x-21 of this title shall be considered

to be programs and activities receiving Federal financial

assistance.

(2) Prohibition

No person shall on the ground of sex (including, in the case of

a woman, on the ground that the woman is pregnant), or on the

ground of religion, be excluded from participation in, be denied

the benefits of, or be subjected to discrimination under, any

program or activity funded in whole or in part with funds made

available under section 300x or 300x-21 of this title.

(b) Enforcement

(1) Referrals to Attorney General after notice

Whenever the Secretary finds that a State, or an entity that

has received a payment pursuant to section 300x or 300x-21 of

this title, has failed to comply with a provision of law referred

to in subsection (a)(1) of this section, with subsection (a)(2)

of this section, or with an applicable regulation (including one

prescribed to carry out subsection (a)(2) of this section), the

Secretary shall notify the chief executive officer of the State

and shall request the chief executive officer to secure

compliance. If within a reasonable period of time, not to exceed

60 days, the chief executive officer fails or refuses to secure

compliance, the Secretary may -

(A) refer the matter to the Attorney General with a

recommendation that an appropriate civil action be instituted;

(B) exercise the powers and functions provided by the Age

Discrimination Act of 1975 [42 U.S.C. 6101 et seq.], section

504 of the Rehabilitation Act of 1973 [29 U.S.C. 794], title IX

of the Education Amendments of 1972 [20 U.S.C. 1681 et seq.],

or title VI of the Civil Rights Act of 1964 [42 U.S.C. 2000d et

seq.], as may be applicable; or

(C) take such other actions as may be authorized by law.

(2) Authority of Attorney General

When a matter is referred to the Attorney General pursuant to

paragraph (1)(A), or whenever the Attorney General has reason to

believe that a State or an entity is engaged in a pattern or

practice in violation of a provision of law referred to in

subsection (a)(1) of this section or in violation of subsection

(a)(2) of this section, the Attorney General may bring a civil

action in any appropriate district court of the United States for

such relief as may be appropriate, including injunctive relief.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1947, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 407.)

-REFTEXT-

REFERENCES IN TEXT

The Age Discrimination Act of 1975, referred to in subsecs.

(a)(1) and (b)(1)(B), is title III of Pub. L. 94-135, Nov. 28,

1975, 89 Stat. 728, as amended, which is classified generally to

chapter 76 (Sec. 6101 et seq.) of this title. For complete

classification of this Act to the Code, see Short Title note set

out under section 6101 of this title and Tables.

The Education Amendments of 1972, referred to in subsecs. (a)(1)

and (b)(1)(B), is Pub. L. 92-318, June 23, 1972, 86 Stat. 235, as

amended. Title IX of the Act, known as the Patsy Takemoto Mink

Equal Opportunity in Education Act, is classified principally to

chapter 38 (Sec. 1681 et seq.) of Title 20, Education. For complete

classification of title IX to the Code, see Short Title note set

out under section 1681 of Title 20 and Tables.

The Civil Rights Act of 1964, referred to in subsecs. (a)(1) and

(b)(1)(B), is Pub. L. 88-352, July 2, 1964, 78 Stat. 241, as

amended. Title VI of the Act is classified generally to subchapter

V (Sec. 2000d et seq.) of chapter 21 of this title. For complete

classification of this Act to the Code, see Short Title note set

out under section 2000a of this title and Tables.

-End-

-CITE-

42 USC Sec. 300x-58 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-58. Technical assistance and provision of supplies and

services in lieu of grant funds

-STATUTE-

(a) Technical assistance

The Secretary shall, without charge to a State receiving a grant

under section 300x or 300x-21 of this title, provide to the State

(or to any public or nonprofit private entity within the State)

technical assistance with respect to the planning, development, and

operation of any program or service carried out pursuant to the

program involved. The Secretary may provide such technical

assistance directly, through contract, or through grants.

(b) Provision of supplies and services in lieu of grant funds

(1) In general

Upon the request of a State receiving a grant under section

300x or 300x-21 of this title, the Secretary may, subject to

paragraph (2), provide supplies, equipment, and services for the

purpose of aiding the State in carrying out the program involved

and, for such purpose, may detail to the State any officer or

employee of the Department of Health and Human Services.

(2) Corresponding reduction in payments

With respect to a request described in paragraph (1), the

Secretary shall reduce the amount of payments under the program

involved to the State by an amount equal to the costs of

detailing personnel and the fair market value of any supplies,

equipment, or services provided by the Secretary. The Secretary

shall, for the payment of expenses incurred in complying with

such request, expend the amounts withheld.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1948, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300x-9, 300x-35 of this

title.

-End-

-CITE-

42 USC Sec. 300x-59 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-59. Plans for performance partnerships

-STATUTE-

(a) Development

The Secretary in conjunction with States and other interested

groups shall develop separate plans for the programs authorized

under subparts I and II for creating more flexibility for States

and accountability based on outcome and other performance measures.

The plans shall each include -

(1) a description of the flexibility that would be given to the

States under the plan;

(2) the common set of performance measures that would be used

for accountability, including measures that would be used for the

program under subpart II for pregnant addicts, HIV transmission,

tuberculosis, and those with a co-occurring substance abuse and

mental disorders, and for programs under subpart I for children

with serious emotional disturbance and adults with serious mental

illness and for individuals with co-occurring mental health and

substance abuse disorders;

(3) the definitions for the data elements to be used under the

plan;

(4) the obstacles to implementation of the plan and the manner

in which such obstacles would be resolved;

(5) the resources needed to implement the performance

partnerships under the plan; and

(6) an implementation strategy complete with recommendations

for any necessary legislation.

(b) Submission

Not later than 2 years after October 17, 2000, the plans

developed under subsection (a) of this section shall be submitted

to the Committee on Health, Education, Labor, and Pensions of the

Senate and the Committee on Commerce of the House of

Representatives.

(c) Information

As the elements of the plans described in subsection (a) of this

section are developed, States are encouraged to provide information

to the Secretary on a voluntary basis.

(d) Participants

The Secretary shall include among those interested groups that

participate in the development of the plan consumers of mental

health or substance abuse services, providers, representatives of

political divisions of States, and representatives of racial and

ethnic groups including Native Americans.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1949, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408;

amended Pub. L. 106-310, div. B, title XXXIV, Sec. 3403(a), Oct.

17, 2000, 114 Stat. 1219.)

-COD-

CODIFICATION

October 17, 2000, referred to in subsec. (b), was in the original

"the date of the enactment of this Act", which was translated as

meaning the date of enactment of Pub. L. 106-310, which amended

this section generally, to reflect the probable intent of Congress.

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-310 amended section catchline and text

generally. Prior to amendment, text read as follows: "Not later

than January 24, 1994, the Secretary shall submit to the Committee

on Energy and Commerce of the House of Representatives, and to the

Committee on Labor and Human Resources of the Senate, a report on

the activities of the States carried out pursuant to the programs

established in sections 300x and 300x-21 of this title. Such report

may include any recommendations of the Secretary for appropriate

changes in legislation."

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

of House of Representatives by House Resolution No. 5, One Hundred

Seventh Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 300x-60 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-60. Rule of construction regarding delegation of

authority to States

-STATUTE-

With respect to States receiving grants under section 300x or

300x-21 of this title, this part may not be construed to authorize

the Secretary to delegate to the States the primary responsibility

for interpreting the governing provisions of this part.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1950, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.)

-End-

-CITE-

42 USC Sec. 300x-61 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-61. Solicitation of views of certain entities

-STATUTE-

In carrying out this part, the Secretary, as appropriate, shall

solicit the views of the States and other appropriate entities.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1951, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 408.)

-End-

-CITE-

42 USC Sec. 300x-62 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-62. Availability to States of grant payments

-STATUTE-

Any amounts paid to a State for a fiscal year under section 300x

or 300x-21 of this title shall be available for obligation and

expenditure until the end of the fiscal year following the fiscal

year for which the amounts were paid.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1952, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409;

amended Pub. L. 106-310, div. B, title XXXIV, Sec. 3403(b), Oct.

17, 2000, 114 Stat. 1220.)

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-310 reenacted section catchline without change

and amended text generally. Prior to amendment, text read as

follows:

"(a) In General. - Subject to subsection (b) of this section, any

amounts paid to a State under the program involved shall be

available for obligation until the end of the fiscal year for which

the amounts were paid, and if obligated by the end of such year,

shall remain available for expenditure until the end of the

succeeding fiscal year.

"(b) Exception Regarding Noncompliance of Subgrantees. - If a

State has in accordance with subsection (a) of this section

obligated amounts paid to the State under the program involved, in

any case in which the Secretary determines that the obligation

consists of a grant or contract awarded by the State, and that the

State has terminated or reduced the amount of such financial

assistance on the basis of the failure of the recipient of the

assistance to comply with the terms upon which the assistance was

conditioned -

"(1) the amounts involved shall be available for reobligation

by the State through September 30 of the fiscal year following

the fiscal year for which the amounts were paid to the State; and

"(2) any of such amounts that are obligated by the State in

accordance with paragraph (1) shall be available for expenditure

through such date."

-End-

-CITE-

42 USC Sec. 300x-63 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-63. Continuation of certain programs

-STATUTE-

(a) In general

Of the amount allotted to the State of Hawaii under section 300x

of this title, and the amount allotted to such State under section

300x-21 of this title, an amount equal to the proportion of Native

Hawaiians residing in the State to the total population of the

State shall be available, respectively, for carrying out the

program involved for Native Hawaiians.

(b) Expenditure of amounts

The amount made available under subsection (a) of this section

may be expended only through contracts entered into by the State of

Hawaii with public and private nonprofit organizations to enable

such organizations to plan, conduct, and administer comprehensive

substance abuse and treatment programs for the benefit of Native

Hawaiians. In entering into contracts under this section, the State

of Hawaii shall give preference to Native Hawaiian organizations

and Native Hawaiian health centers.

(c) Definitions

For the purposes of this subsection,(!1) the terms "Native

Hawaiian", "Native Hawaiian organization", and "Native Hawaiian

health center" have the meaning given such terms in section 11707

of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1953, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409.)

-FOOTNOTE-

(!1) So in original. Probably should be "section,".

-End-

-CITE-

42 USC Sec. 300x-64 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-64. Definitions

-STATUTE-

(a) Definitions for this subpart

For purposes of this subpart:

(1) The term "program involved" means the program of grants

established in section 300x or 300x-21 of this title, or both, as

indicated by whether the State involved is receiving or is

applying to receive a grant under section 300x or 300x-21 of this

title, or both.

(2)(A) The term "funding agreement", with respect to a grant

under section 300x of this title, has the meaning given such term

in section 300x-8 of this title.

(B) The term "funding agreement", with respect to a grant under

section 300x-21 of this title, has the meaning given such term in

section 300x-34 of this title.

(b) Definitions for this part

For purposes of this part:

(1) The term "Comptroller General" means the Comptroller

General of the United States.

(2) The term "State", except as provided in sections

300x-7(c)(5) of this title and 300x-33(c)(5) of this title, means

each of the several States, the District of Columbia, and each of

the territories of the United States.

(3) The term "territories of the United States" means each of

the Commonwealth of Puerto Rico, American Samoa, Guam, the

Commonwealth of the Northern Mariana Islands, the Virgin Islands,

Palau, the Marshall Islands, and Micronesia.

(4) The term "interim services", in the case of an individual

in need of treatment for substance abuse who has been denied

admission to a program of such treatment on the basis of the lack

of the capacity of the program to admit the individual, means

services for reducing the adverse health effects of such abuse,

for promoting the health of the individual, and for reducing the

risk of transmission of disease, which services are provided

until the individual is admitted to such a program.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1954, as added Pub. L.

102-321, title II, Sec. 203(a), July 10, 1992, 106 Stat. 409.)

-End-

-CITE-

42 USC Sec. 300x-65 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-65. Services provided by nongovernmental organizations

-STATUTE-

(a) Purposes

The purposes of this section are -

(1) to prohibit discrimination against nongovernmental

organizations and certain individuals on the basis of religion in

the distribution of government funds to provide substance abuse

services under this subchapter and subchapter III-A of this

chapter, and the receipt of services under such subchapters; and

(2) to allow the organizations to accept the funds to provide

the services to the individuals without impairing the religious

character of the organizations or the religious freedom of the

individuals.

(b) Religious organizations included as nongovernmental providers

(1) In general

A State may administer and provide substance abuse services

under any program under this subchapter or subchapter III-A of

this chapter through grants, contracts, or cooperative agreements

to provide assistance to beneficiaries under such subchapters

with nongovernmental organizations.

(2) Requirement

A State that elects to utilize nongovernmental organizations as

provided for under paragraph (1) shall consider, on the same

basis as other nongovernmental organizations, religious

organizations to provide services under substance abuse programs

under this subchapter or subchapter III-A of this chapter, so

long as the programs under such subchapters are implemented in a

manner consistent with the Establishment Clause of the first

amendment to the Constitution. Neither the Federal Government nor

a State or local government receiving funds under such programs

shall discriminate against an organization that provides services

under, or applies to provide services under, such programs, on

the basis that the organization has a religious character.

(c) Religious character and independence

(1) In general

A religious organization that provides services under any

substance abuse program under this subchapter or subchapter III-A

of this chapter shall retain its independence from Federal,

State, and local governments, including such organization's

control over the definition, development, practice, and

expression of its religious beliefs.

(2) Additional safeguards

Neither the Federal Government nor a State or local government

shall require a religious organization -

(A) to alter its form of internal governance; or

(B) to remove religious art, icons, scripture, or other

symbols,

in order to be eligible to provide services under any substance

abuse program under this subchapter or subchapter III-A of this

chapter.

(d) Employment practices

(1) Substance abuse

A religious organization that provides services under any

substance abuse program under this subchapter or subchapter III-A

of this chapter may require that its employees providing services

under such program adhere to rules forbidding the use of drugs or

alcohol.

(2) Title VII exemption

The exemption of a religious organization provided under

section 702 or 703(e)(2) of the Civil Rights Act of 1964 (42

U.S.C. 2000e-1, 2000e-2(e)(2)) regarding employment practices

shall not be affected by the religious organization's provision

of services under, or receipt of funds from, any substance abuse

program under this subchapter or subchapter III-A of this

chapter.

(e) Rights of beneficiaries of assistance

(1) In general

If an individual described in paragraph (3) has an objection to

the religious character of the organization from which the

individual receives, or would receive, services funded under any

substance abuse program under this subchapter or subchapter III-A

of this chapter, the appropriate Federal, State, or local

governmental entity shall provide to such individual (if

otherwise eligible for such services) within a reasonable period

of time after the date of such objection, services that -

(A) are from an alternative provider that is accessible to

the individual; and

(B) have a value that is not less than the value of the

services that the individual would have received from such

organization.

(2) Notice

The appropriate Federal, State, or local governmental entity

shall ensure that notice is provided to individuals described in

paragraph (3) of the rights of such individuals under this

section.

(3) Individual described

An individual described in this paragraph is an individual who

receives or applies for services under any substance abuse

program under this subchapter or subchapter III-A of this

chapter.

(f) Nondiscrimination against beneficiaries

A religious organization providing services through a grant,

contract, or cooperative agreement under any substance abuse

program under this subchapter or subchapter III-A of this chapter

shall not discriminate, in carrying out such program, against an

individual described in subsection (e)(3) of this section on the

basis of religion, a religious belief, a refusal to hold a

religious belief, or a refusal to actively participate in a

religious practice.

(g) Fiscal accountability

(1) In general

Except as provided in paragraph (2), any religious organization

providing services under any substance abuse program under this

subchapter or subchapter III-A of this chapter shall be subject

to the same regulations as other nongovernmental organizations to

account in accord with generally accepted accounting principles

for the use of such funds provided under such program.

(2) Limited audit

Such organization shall segregate government funds provided

under such substance abuse program into a separate account. Only

the government funds shall be subject to audit by the government.

(h) Compliance

Any party that seeks to enforce such party's rights under this

section may assert a civil action for injunctive relief exclusively

in an appropriate Federal or State court against the entity, agency

or official that allegedly commits such violation.

(i) Limitations on use of funds for certain purposes

No funds provided through a grant or contract to a religious

organization to provide services under any substance abuse program

under this subchapter or subchapter III-A of this chapter shall be

expended for sectarian worship, instruction, or proselytization.

(j) Effect on State and local funds

If a State or local government contributes State or local funds

to carry out any substance abuse program under this subchapter or

subchapter III-A of this chapter, the State or local government may

segregate the State or local funds from the Federal funds provided

to carry out the program or may commingle the State or local funds

with the Federal funds. If the State or local government commingles

the State or local funds, the provisions of this section shall

apply to the commingled funds in the same manner, and to the same

extent, as the provisions apply to the Federal funds.

(k) Treatment of intermediate contractors

If a nongovernmental organization (referred to in this subsection

as an "intermediate organization"), acting under a contract or

other agreement with the Federal Government or a State or local

government, is given the authority under the contract or agreement

to select nongovernmental organizations to provide services under

any substance abuse program under this subchapter or subchapter

III-A of this chapter, the intermediate organization shall have the

same duties under this section as the government but shall retain

all other rights of a nongovernmental organization under this

section.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1955, as added Pub. L.

106-310, div. B, title XXXIII, Sec. 3305, Oct. 17, 2000, 114 Stat.

1212.)

-End-

-CITE-

42 USC Sec. 300x-66 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part B - Block Grants Regarding Mental Health and Substance Abuse

subpart iii - general provisions

-HEAD-

Sec. 300x-66. Services for individuals with co-occurring disorders

-STATUTE-

States may use funds available for treatment under sections 300x

and 300x-21 of this title to treat persons with co-occurring

substance abuse and mental disorders as long as funds available

under such sections are used for the purposes for which they were

authorized by law and can be tracked for accounting purposes.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1956, as added Pub. L.

106-310, div. B, title XXXIV, Sec. 3407, Oct. 17, 2000, 114 Stat.

1222.)

-End-

-CITE-

42 USC Part C - Certain Programs Regarding Mental Health

and Substance Abuse 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part C - Certain Programs Regarding Mental Health and Substance

Abuse

-HEAD-

PART C - CERTAIN PROGRAMS REGARDING MENTAL HEALTH AND SUBSTANCE

ABUSE

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-310, div. B, title XXXIV, Sec. 3404(1), Oct.

17, 2000, 114 Stat. 1220, added part C heading and struck out

former part C heading "Certain Programs Regarding Substance Abuse".

-End-

-CITE-

42 USC subpart i - data infrastructure development 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part C - Certain Programs Regarding Mental Health and Substance

Abuse

subpart i - data infrastructure development

-HEAD-

SUBPART I - DATA INFRASTRUCTURE DEVELOPMENT

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-310, div. B, title XXXIV, Sec. 3404(1), Oct.

17, 2000, 114 Stat. 1220, added subpart I heading and struck out

former subpart I heading "Expansion of Capacity for Providing

Treatment".

-End-

-CITE-

42 USC Sec. 300y 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part C - Certain Programs Regarding Mental Health and Substance

Abuse

subpart i - data infrastructure development

-HEAD-

Sec. 300y. Data infrastructure development

-STATUTE-

(a) In general

The Secretary may make grants to, and enter into contracts or

cooperative agreements with States for the purpose of developing

and operating mental health or substance abuse data collection,

analysis, and reporting systems with regard to performance measures

including capacity, process, and outcomes measures.

(b) Projects

The Secretary shall establish criteria to ensure that services

will be available under this section to States that have a

fundamental basis for the collection, analysis, and reporting of

mental health and substance abuse performance measures and States

that do not have such basis. The Secretary will establish criteria

for determining whether a State has a fundamental basis for the

collection, analysis, and reporting of data.

(c) Condition of receipt of funds

As a condition of the receipt of an award under this section a

State shall agree to collect, analyze, and report to the Secretary

within 2 years of the date of the award on a core set of

performance measures to be determined by the Secretary in

conjunction with the States.

(d) Matching requirement

(1) In general

With respect to the costs of the program to be carried out

under subsection (a) of this section by a State, the Secretary

may make an award under such subsection only if the applicant

agrees to make available (directly or through donations from

public or private entities) non-Federal contributions toward such

costs in an amount that is not less than 50 percent of such

costs.

(2) Determination of amount contributed

Non-Federal contributions under paragraph (1) may be in cash or

in kind, fairly evaluated, including plant, equipment, or

services. Amounts provided by the Federal Government, or services

assisted or subsidized to any significant extent by the Federal

Government, may not be included in determining the amount of such

contributions.

(e) Duration of support

The period during which payments may be made for a project under

subsection (a) of this section may be not less than 3 years nor

more than 5 years.

(f) Authorization of appropriation

(1) In general

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 2001, 2002 and 2003.

(2) Allocation

Of the amounts appropriated under paragraph (1) for a fiscal

year, 50 percent shall be expended to support data infrastructure

development for mental health and 50 percent shall be expended to

support data infrastructure development for substance abuse.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1971, as added Pub. L.

106-310, div. B, title XXXIV, Sec. 3404(2), Oct. 17, 2000, 114

Stat. 1220.)

-MISC1-

PRIOR PROVISIONS

A prior section 300y, act July 1, 1944, ch. 373, title XIX, Sec.

1971, as added Pub. L. 102-321, title II, Sec. 204, July 10, 1992,

106 Stat. 410; amended Pub. L. 102-352, Sec. 2(a)(13), Aug. 26,

1992, 106 Stat. 939, related to categorical grants to States for

programs regarding substance abuse, prior to repeal by Pub. L.

106-310, div. B, title XXXIV, Sec. 3404(2), Oct. 17, 2000, 114

Stat. 1220.

Another prior section 300y, act July 1, 1944, ch. 373, title XIX,

Sec. 1921, as added Oct. 27, 1986, Pub. L. 99-570, title IV, Sec.

4002, 100 Stat. 3207-103, related to establishment of special

alcohol abuse and drug abuse programs, prior to repeal by Pub. L.

100-690, title II, Sec. 2038(1), Nov. 18, 1988, 102 Stat. 4203.

Another prior section 300y, act July 1, 1944, ch. 373, title XIX,

Sec. 1921, as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec.

901, 95 Stat. 552, related to planning grants, prior to repeal by

Pub. L. 99-280, Sec. 5, Apr. 24, 1986, 100 Stat. 400.

Prior sections 300y-1 and 300y-2 were repealed by Pub. L.

100-690, title II, Sec. 2038(1), Nov. 18, 1988, 102 Stat. 4203.

Section 300y-1, act July 1, 1944, ch. 373, title XIX, Sec. 1922,

as added Oct. 27, 1986, Pub. L. 99-570, title IV, Sec. 4002, 100

Stat. 3207-106, related to transfer of funds to Administrator of

Veterans' Affairs.

Another prior section 300y-1, act July 1, 1944, ch. 373, title

XIX, Sec. 1922, as added Aug. 13, 1981, Pub. L. 97-35, title IX,

Sec. 901, 95 Stat. 552, authorized appropriations, prior to repeal

by Pub. L. 99-280, Sec. 5, Apr. 24, 1986, 100 Stat. 400.

Section 300y-2, act July 1, 1944, ch. 373, title XIX, Sec. 1923,

as added Oct. 27, 1986, Pub. L. 99-570, title IV, Sec. 4002, 100

Stat. 3207-106, related to evaluation of treatment programs.

Another prior section 300y-2, act July 1, 1944, ch. 373, title

XIX, Sec. 1923, as added Aug. 13, 1981, Pub. L. 97-35, title IX,

Sec. 901, 95 Stat. 552, provided for grants under section 254c of

this title, prior to repeal by Pub. L. 99-280, Sec. 5, Apr. 24,

1986, 100 Stat. 400.

Prior sections 300y-3 to 300y-10 were repealed by Pub. L. 99-280,

Sec. 5, Apr. 24, 1986, 100 Stat. 400.

Section 300y-3, act July 1, 1944, ch. 373, title XIX, Sec. 1924,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

553, provided that allotments be based upon prior year

distributions and provided for direct distributions to Indian

tribes.

Section 300y-4, act July 1, 1944, ch. 373, title XIX, Sec. 1925,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

553, related to payments under allotments to States.

Section 300y-5, act July 1, 1944, ch. 373, title XIX, Sec. 1926,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

554, related to State grants to community health centers from

allotments.

Section 300y-6, act July 1, 1944, ch. 373, title XIX, Sec. 1927,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

556, related to application requirements and submittal,

availability for public comment, and revision of a description of

intended use of funds.

Section 300y-7, act July 1, 1944, ch. 373, title XIX, Sec. 1928,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

557, related to reporting and auditing requirements.

Section 300y-8, act July 1, 1944, ch. 373, title XIX, Sec. 1929,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

558, related to withholding of funds from a State not in

compliance.

Section 300y-9, act July 1, 1944, ch. 373, title XIX, Sec. 1930,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

558, related to nondiscrimination requirements.

Section 300y-10, act July 1, 1944, ch. 373, title XIX, Sec. 1931,

as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

559, provided criminal penalty for false statements.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 290bb-32, 300x-9, 300x-35

of this title.

-End-

-CITE-

42 USC subpart ii - interim maintenance treatment of

narcotics dependence 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part C - Certain Programs Regarding Mental Health and Substance

Abuse

subpart ii - interim maintenance treatment of narcotics dependence

-HEAD-

SUBPART II - INTERIM MAINTENANCE TREATMENT OF NARCOTICS DEPENDENCE

-End-

-CITE-

42 USC Sec. 300y-11 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVII - BLOCK GRANTS

Part C - Certain Programs Regarding Mental Health and Substance

Abuse

subpart ii - interim maintenance treatment of narcotics dependence

-HEAD-

Sec. 300y-11. Interim maintenance treatment

-STATUTE-

(a) Requirement regarding Secretary

Subject to the following subsections of this section, for the

purpose of reducing the incidence of the transmission of HIV

disease pursuant to the intravenous abuse of heroin or other

morphine-like drugs, the Secretary, in establishing conditions for

the use of methadone in public or nonprofit private programs of

treatment for dependence on such drugs, shall authorize such

programs -

(1) to dispense methadone for treatment purposes to individuals

who -

(A) meet the conditions for admission to such programs that

dispense methadone as part of comprehensive treatment for such

dependence; and

(B) are seeking admission to such programs that so dispense

methadone, but as a result of the limited capacity of the

programs, will not gain such admission until 14 or more days

after seeking admission to the programs; and

(2) in dispensing methadone to such individuals, to provide

only minimum ancillary services during the period in which the

individuals are waiting for admission to programs of

comprehensive treatment.

(b) Inapplicability of requirement in certain circumstances

(1) In general

The requirement established in subsection (a) of this section

for the Secretary does not apply if any or all of the following

conditions are met:

(A) The preponderance of scientific research indicates that

the risk of the transmission of HIV disease pursuant to the

intravenous abuse of drugs is minimal.

(B) The preponderance of scientific research indicates that

the medically supervised dispensing of methadone is not an

effective method of reducing the extent of dependence on heroin

and other morphine-like drugs.

(C) The preponderance of available data indicates that, of

treatment programs that dispense methadone as part of

comprehensive treatment, a substantial majority admit all

individuals seeking services to the programs not later than 14

days after the individuals seek admission to the programs.

(2) Evaluation by Secretary

In evaluating whether any or all of the conditions described in

paragraph (1) have been met, the Secretary shall consult with the

National Commission on Acquired Immune Deficiency Syndrome.

(c) Conditions for obtaining authorization from Secretary

(1) In general

In carrying out the requirement established in subsection (a)

of this section, the Secretary shall, after consultation with the

National Commission on Acquired Immune Deficiency Syndrome, by

regulation issue such conditions for treatment programs to obtain

authorization from the Secretary to provide interim maintenance

treatment as may be necessary to carry out the purpose described

in such subsection. Such conditions shall include conditions for

preventing the unauthorized use of methadone.

(2) Counseling on HIV disease

The regulations issued under paragraph (1) shall provide that

an authorization described in such paragraph may not be issued to

a treatment program unless the program provides to recipients of

the treatment counseling on preventing exposure to and the

transmission of HIV disease.

(3) Permission of relevant State as condition of authorization

The regulations issued under paragraph (1) shall provide that

the Secretary may not provide an authorization described in such

paragraph to any treatment program in a State unless the chief

public health officer of the State has certified to the Secretary

that -

(A) such officer does not object to the provision of such

authorizations to treatment programs in the State; and

(B) the provision of interim maintenance services in the

State will not reduce the capacity of comprehensive treatment

programs in the State to admit individuals to the programs

(relative to the date on which such officer so certifies).

(4) Date certain for issuance of regulations; failure of

Secretary

The Secretary shall issue the final rule for purposes of the

regulations required in paragraph (1), and such rule shall be

effective, not later than the expiration of the 180-day period

beginning on July 10, 1992. If the Secretary fails to meet the

requirement of the preceding sentence, the proposed rule issued

on March 2, 1989, with respect to part 291 of title 21, Code of

Federal Regulations (docket numbered 88N-0444; 54 Fed. Reg. 8973

et seq.) is deemed to take effect as a final rule upon the

expiration of such period, and the provisions of paragraph (3) of

this subsection are deemed to be incorporated into such rule.

(d) Definitions

For purposes of this section:

(1) The term "interim maintenance services" means the provision

of methadone in a treatment program under the circumstances

described in paragraphs (1) and (2) of subsection (a) of this

section.

(2) The term "HIV disease" means infection with the etiologic

agent for acquired immune deficiency syndrome.

(3) The term "treatment program" means a public or nonprofit

private program of treatment for dependence on heroin or other

morphine-like drugs.

-SOURCE-

(July 1, 1944, ch. 373, title XIX, Sec. 1976, as added Pub. L.

102-321, title II, Sec. 204, July 10, 1992, 106 Stat. 412.)

-MISC1-

PRIOR PROVISIONS

A prior section 300y-11, act July 1, 1944, ch. 373, title XIX,

Sec. 1932, as added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec.

901, 95 Stat. 559; amended Jan. 4, 1983, Pub. L. 97-414, Sec. 8(v),

96 Stat. 2063, related to applicability of other provisions and

promulgation of regulations, prior to repeal by Pub. L. 99-280,

Sec. 5, Apr. 24, 1986, 100 Stat. 400.

Sections 300y-21 to 300y-27 terminated Jan. 1, 1991, pursuant to

section 300y-27 and were omitted from the Code.

Section 300y-21, act July 1, 1944, ch. 373, title XIX, Sec. 1931,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3117, provided definitions for this part.

A prior section 1931 of act July 1, 1944, ch. 373, title XIX, as

added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

559, provided criminal penalty for false statements and was

classified to former section 300y-10 of this title, prior to repeal

by Pub. L. 99-280, Sec. 5, Apr. 24, 1986, 100 Stat. 400.

Section 300y-22, act July 1, 1944, ch. 373, title XIX, Sec. 1932,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3117, authorized appropriations for this part.

A prior section 1932 of act July 1, 1944, ch. 373, title XIX, as

added Aug. 13, 1981, Pub. L. 97-35, title IX, Sec. 901, 95 Stat.

559; amended Jan. 4, 1983, Pub. L. 97-414, Sec. 8(v), 96 Stat.

2063, related to applicability of other provisions and promulgation

of regulations and was classified to former section 300y-11 of this

title, prior to repeal by Pub. L. 99-280, Sec. 5, Apr. 24, 1986,

100 Stat. 400.

Section 300y-23, act July 1, 1944, ch. 373, title XIX, Sec. 1933,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3117, provided for allotments under this part.

Section 300y-24, act July 1, 1944, ch. 373, title XIX, Sec. 1934,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3118, provided for payments under allotments to States.

Section 300y-25, act July 1, 1944, ch. 373, title XIX, Sec. 1935,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3118, specified use of allotments.

Section 300y-26, act July 1, 1944, ch. 373, title XIX, Sec. 1936,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3119, provided for applications, requirements of the

application, and description of activities.

Section 300y-27, act July 1, 1944, ch. 373, title XIX, Sec. 1937,

as added Nov. 4, 1988, Pub. L. 100-607, title IV, Sec. 408(a), 102

Stat. 3120; amended Aug. 16, 1989, Pub. L. 101-93, Sec. 5(f)(1)(B),

103 Stat. 612, provided for termination of this part effective Jan.

1, 1991.

EFFECTIVE DATE

Section effective July 10, 1992, with programs making awards

providing financial assistance in fiscal year 1993 and subsequent

years effective for awards made on or after Oct. 1, 1992, see

section 801(b), (d)(1) of Pub. L. 102-321, set out as an Effective

Date of 1992 Amendment note under section 236 of this title.

-End-

-CITE-

42 USC SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE

DEMONSTRATION PROJECTS 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-End-

-CITE-

42 USC Sec. 300z 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z. Findings and purposes

-STATUTE-

(a) The Congress finds that -

(1) in 1978, an estimated one million one hundred thousand

teenagers became pregnant, more than five hundred thousand

teenagers carried their babies to term, and over one-half of the

babies born to such teenagers were born out of wedlock;

(2) adolescents aged seventeen and younger accounted for more

than one-half of the out of wedlock births to teenagers;

(3) in a high proportion of cases, the pregnant adolescent is

herself the product of an unmarried parenthood during adolescence

and is continuing the pattern in her own lifestyle;

(4) it is estimated that approximately 80 per centum of

unmarried teenagers who carry their pregnancies to term live with

their families before and during their pregnancy and remain with

their families after the birth of the child;

(5) pregnancy and childbirth among unmarried adolescents,

particularly young adolescents, often results in severe adverse

health, social, and economic consequences including: a higher

percentage of pregnancy and childbirth complications; a higher

incidence of low birth weight babies; a higher infant mortality

and morbidity; a greater likelihood that an adolescent marriage

will end in divorce; a decreased likelihood of completing

schooling; and higher risks of unemployment and welfare

dependency; and therefore, education, training, and job research

services are important for adolescent parents;

(6)(A) adoption is a positive option for unmarried pregnant

adolescents who are unwilling or unable to care for their

children since adoption is a means of providing permanent

families for such children from available approved couples who

are unable or have difficulty in conceiving or carrying children

of their own to term; and

(B) at present, only 4 per centum of unmarried pregnant

adolescents who carry their babies to term enter into an adoption

plan or arrange for their babies to be cared for by relatives or

friends;

(7) an unmarried adolescent who becomes pregnant once is likely

to experience recurrent pregnancies and childbearing, with

increased risks;

(8)(A) the problems of adolescent premarital sexual relations,

pregnancy, and parenthood are multiple and complex and are

frequently associated with or are a cause of other troublesome

situations in the family; and

(B) such problems are best approached through a variety of

integrated and essential services provided to adolescents and

their families by other family members, religious and charitable

organizations, voluntary associations, and other groups in the

private sector as well as services provided by publicly sponsored

initiatives;

(9) a wide array of educational, health, and supportive

services are not available to adolescents with such problems or

to their families, or when available frequently are fragmented

and thus are of limited effectiveness in discouraging adolescent

premarital sexual relations and the consequences of such

relations;

(10)(A) prevention of adolescent sexual activity and adolescent

pregnancy depends primarily upon developing strong family values

and close family ties, and since the family is the basic social

unit in which the values and attitudes of adolescents concerning

sexuality and pregnancy are formed, programs designed to deal

with issues of sexuality and pregnancy will be successful to the

extent that such programs encourage and sustain the role of the

family in dealing with adolescent sexual activity and adolescent

pregnancy;

(B) Federal policy therefore should encourage the development

of appropriate health, educational, and social services where

such services are now lacking or inadequate, and the better

coordination of existing services where they are available; and

(C) services encouraged by the Federal Government should

promote the involvement of parents with their adolescent

children, and should emphasize the provision of support by other

family members, religious and charitable organizations, voluntary

associations, and other groups in the private sector in order to

help adolescents and their families deal with complex issues of

adolescent premarital sexual relations and the consequences of

such relations; and

(11)(A) there has been limited research concerning the societal

causes and consequences of adolescent pregnancy;

(B) there is limited knowledge concerning which means of

intervention are effective in mediating or eliminating adolescent

premarital sexual relations and adolescent pregnancy; and

(C) it is necessary to expand and strengthen such knowledge in

order to develop an array of approaches to solving the problems

of adolescent premarital sexual relations and adolescent

pregnancy in both urban and rural settings.

(b) Therefore, the purposes of this subchapter are -

(1) to find effective means, within the context of the family,

of reaching adolescents before they become sexually active in

order to maximize the guidance and support available to

adolescents from parents and other family members, and to promote

self discipline and other prudent approaches to the problem of

adolescent premarital sexual relations, including adolescent

pregnancy;

(2) to promote adoption as an alternative for adolescent

parents;

(3) to establish innovative, comprehensive, and integrated

approaches to the delivery of care services both for pregnant

adolescents, with primary emphasis on unmarried adolescents who

are seventeen years of age or under, and for adolescent parents,

which shall be based upon an assessment of existing programs and,

where appropriate, upon efforts to establish better coordination,

integration, and linkages among such existing programs in order

to -

(A) enable pregnant adolescents to obtain proper care and

assist pregnant adolescents and adolescent parents to become

productive independent contributors to family and community

life; and

(B) assist families of adolescents to understand and resolve

the societal causes which are associated with adolescent

pregnancy;

(4) to encourage and support research projects and

demonstration projects concerning the societal causes and

consequences of adolescent premarital sexual relations,

contraceptive use, pregnancy, and child rearing;

(5) to support evaluative research to identify effective

services which alleviate, eliminate, or resolve any negative

consequences of adolescent premarital sexual relations and

adolescent childbearing for the parents, the child, and their

families; and

(6) to encourage and provide for the dissemination of results,

findings, and information from programs and research projects

relating to adolescent premarital sexual relations, pregnancy,

and parenthood.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2001, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 578; amended

Pub. L. 98-512, Sec. 2(b), (c), Oct. 19, 1984, 98 Stat. 2409.)

-MISC1-

AMENDMENTS

1984 - Subsec. (a)(5). Pub. L. 98-512, Sec. 2(b), struck out

reference relating to developmental disabilities and inserted

provision relating to importance of education, training, and job

research services for adolescent parents.

Subsec. (b)(3). Pub. L. 98-512, Sec. 2(c), inserted "both" before

"for pregnant adolescents".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300z-7 of this title.

-End-

-CITE-

42 USC Sec. 300z-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-1. Definitions; regulations applicable

-STATUTE-

(a) For the purposes of this subchapter, the term -

(1) "Secretary" means the Secretary of Health and Human

Services;

(2) "eligible person" means -

(A) with regard to the provision of care services, a pregnant

adolescent, an adolescent parent, or the family of a pregnant

adolescent or an adolescent parent; or

(B) with regard to the provision of prevention services and

referral to such other services which may be appropriate, a

nonpregnant adolescent;

(3) "eligible grant recipient" means a public or nonprofit

private organization or agency which demonstrates, to the

satisfaction of the Secretary -

(A) in the case of an organization which will provide care

services, the capability of providing all core services in a

single setting or the capability of creating a network through

which all core services would be provided; or

(B) in the case of an organization which will provide

prevention services, the capability of providing such services;

(4) "necessary services" means services which may be provided

by grantees which are -

(A) pregnancy testing and maternity counseling;

(B) adoption counseling and referral services which present

adoption as an option for pregnant adolescents, including

referral to licensed adoption agencies in the community if the

eligible grant recipient is not a licensed adoption agency;

(C) primary and preventive health services including prenatal

and postnatal care;

(D) nutrition information and counseling;

(E) referral for screening and treatment of venereal disease;

(F) referral to appropriate pediatric care;

(G) educational services relating to family life and problems

associated with adolescent premarital sexual relations,

including -

(i) information about adoption;

(ii) education on the responsibilities of sexuality and

parenting;

(iii) the development of material to support the role of

parents as the provider of sex education; and

(iv) assistance to parents, schools, youth agencies, and

health providers to educate adolescents and preadolescents

concerning self-discipline and responsibility in human

sexuality;

(H) appropriate educational and vocational services;

(I) referral to licensed residential care or maternity home

services; and

(J) mental health services and referral to mental health

services and to other appropriate physical health services;

(K) child care sufficient to enable the adolescent parent to

continue education or to enter into employment;

(L) consumer education and homemaking;

(M) counseling for the immediate and extended family members

of the eligible person;

(N) transportation;

(O) outreach services to families of adolescents to

discourage sexual relations among unemancipated minors;

(P) family planning services; and

(Q) such other services consistent with the purposes of this

subchapter as the Secretary may approve in accordance with

regulations promulgated by the Secretary;

(5) "core services" means those services which shall be

provided by a grantee, as determined by the Secretary by

regulation;

(6) "supplemental services" means those services which may be

provided by a grantee, as determined by the Secretary by

regulation;

(7) "care services" means necessary services for the provision

of care to pregnant adolescents and adolescent parents and

includes all core services with respect to the provision of such

care prescribed by the Secretary by regulation;

(8) "prevention services" means necessary services to prevent

adolescent sexual relations, including the services described in

subparagraphs (A), (D), (E), (G), (H), (M), (N), (O), and (Q) of

paragraph (4);

(9) "adolescent" means an individual under the age of nineteen;

and

(10) "unemancipated minor" means a minor who is subject to the

control, authority, and supervision of his or her parents or

guardians, as determined under State law.

(b) Until such time as the Secretary promulgates regulations

pursuant to the second sentence of this subsection, the Secretary

shall use the regulations promulgated under title VI of the Health

Services and Centers Amendments of 1978 [42 U.S.C. 300a-21 et seq.]

which were in effect on August 13, 1981, to determine which

necessary services are core services for purposes of this

subchapter. The Secretary may promulgate regulations to determine

which necessary services are core services for purposes of this

subchapter based upon an evaluation of and information concerning

which necessary services are essential to carry out the purposes of

this subchapter and taking into account (1) factors such as whether

services are to be provided in urban or rural areas, the ethnic

groups to be served, and the nature of the populations to be

served, and (2) the results of the evaluations required under

section 300z-5(b) of this title. The Secretary may from time to

time revise such regulations.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2002, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 580; amended

Pub. L. 98-512, Sec. 2(d), Oct. 19, 1984, 98 Stat. 2409.)

-REFTEXT-

REFERENCES IN TEXT

The Health Services and Centers Amendments of 1978, referred to

in subsec. (b), is Pub. L. 95-626, Nov. 10, 1978, 92 Stat. 3551, as

amended. Title VI of the Health Services and Centers Amendments of

1978 was classified generally to part A (Sec. 300a-21 et seq.) of

subchapter VIII-A of this chapter prior to its repeal by Pub. L.

97-35, title IX, Sec. 955(b), title XXI, Sec. 2193(f), Aug. 13,

1981, 95 Stat. 592, 828. For complete classification of this Act to

the Code, see Short Title of 1978 Amendments note set out under

section 201 of this title and Tables.

-MISC1-

AMENDMENTS

1984 - Subsec. (a)(4)(H). Pub. L. 98-512 struck out "and referral

to such services" after "vocational services".

-End-

-CITE-

42 USC Sec. 300z-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-2. Demonstration projects; grant authorization, etc.

-STATUTE-

(a) The Secretary may make grants to further the purposes of this

subchapter to eligible grant recipients which have submitted an

application which the Secretary finds meets the requirements of

section 300z-5 of this title for demonstration projects which the

Secretary determines will help communities provide appropriate care

and prevention services in easily accessible locations.

Demonstration projects shall, as appropriate, provide, supplement,

or improve the quality of such services. Demonstration projects

shall use such methods as will strengthen the capacity of families

to deal with the sexual behavior, pregnancy, or parenthood of

adolescents and to make use of support systems such as other family

members, friends, religious and charitable organizations, and

voluntary associations.

(b) Grants under this subchapter for demonstration projects may

be for the provision of -

(1) care services;

(2) prevention services; or

(3) a combination of care services and prevention services.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2003, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 582.)

-End-

-CITE-

42 USC Sec. 300z-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-3. Uses of grants for demonstration projects for services

-STATUTE-

(a) Covered projects

Except as provided in subsection (b) of this section, funds

provided for demonstration projects for services under this

subchapter may be used by grantees only to -

(1) provide to eligible persons -

(A) care services;

(B) prevention services; or

(C) care and prevention services (in the case of a grantee

who is providing a combination of care and prevention

services);

(2) coordinate, integrate, and provide linkages among providers

of care, prevention, and other services for eligible persons in

furtherance of the purposes of this subchapter;

(3) provide supplemental services where such services are not

adequate or not available to eligible persons in the community

and which are essential to the care of pregnant adolescents and

to the prevention of adolescent premarital sexual relations and

adolescent pregnancy;

(4) plan for the administration and coordination of pregnancy

prevention services and programs of care for pregnant adolescents

and adolescent parents which will further the objectives of this

subchapter; and

(5) fulfill assurances required for grant approval by section

300z-5 of this title.

(b) Family planning services; availability in community

(1) No funds provided for a demonstration project for services

under this subchapter may be used for the provision of family

planning services (other than counseling and referral services) to

adolescents unless appropriate family planning services are not

otherwise available in the community.

(2) Any grantee who receives funds for a demonstration project

for services under this subchapter and who, after determining under

paragraph (1) that appropriate family planning services are not

otherwise available in the community, provides family planning

services (other than counseling and referral services) to

adolescents may only use funds provided under this subchapter for

such family planning services if all funds received by such grantee

from all other sources to support such family planning services are

insufficient to support such family planning services.

(c) Fees for services: criteria

Grantees who receive funds for a demonstration project for

services under this subchapter shall charge fees for services

pursuant to a fee schedule approved by the Secretary as a part of

the application described in section 300z-5 of this title which

bases fees charged by the grantee on the income of the eligible

person or the parents or legal guardians of the eligible person and

takes into account the difficulty adolescents face in obtaining

resources to pay for services. A grantee who receives funds for a

demonstration project for services under this subchapter may not,

in any case, discriminate with regard to the provision of services

to any individual because of that individual's inability to provide

payment for such services, except that in determining the ability

of an unemancipated minor to provide payment for services, the

income of the family of an unemancipated minor shall be considered

in determining the ability of such minor to make such payments

unless the parents or guardians of the unemancipated minor refuse

to make such payments.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2004, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 583.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300z-5 of this title.

-End-

-CITE-

42 USC Sec. 300z-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-4. Grants for demonstration projects for services

-STATUTE-

(a) Priorities

In approving applications for grants for demonstration projects

for services under this subchapter, the Secretary shall give

priority to applicants who -

(1) serve an area where there is a high incidence of adolescent

pregnancy;

(2) serve an area with a high proportion of low-income families

and where the availability of programs of care for pregnant

adolescents and adolescent parents is low;

(3) show evidence -

(A) in the case of an applicant who will provide care

services, of having the ability to bring together a wide range

of needed core services and, as appropriate, supplemental

services in comprehensive single-site projects, or to establish

a well-integrated network of such services (appropriate for the

target population and geographic area to be served including

the special needs of rural areas) for pregnant adolescents or

adolescent parents; or

(B) in the case of an applicant who will provide prevention

services, of having the ability to provide prevention services

for adolescents and their families which are appropriate for

the target population and the geographic area to be served,

including the special needs of rural areas;

(4) will utilize to the maximum extent feasible existing

available programs and facilities such as neighborhood and

primary health care centers, maternity homes which provide or can

be equipped to provide services to pregnant adolescents, agencies

serving families, youth, and children with established programs

of service to pregnant adolescents and vulnerable families,

licensed adoption agencies, children and youth centers, maternal

and infant health centers, regional rural health facilities,

school and other educational programs, mental health programs,

nutrition programs, recreation programs, and other ongoing

pregnancy prevention services and programs of care for pregnant

adolescents and adolescent parents;

(5) make use, to the maximum extent feasible, of other Federal,

State, and local funds, programs, contributions, and other

third-party reimbursements;

(6) can demonstrate a community commitment to the program by

making available to the demonstration project non-Federal funds,

personnel, and facilities;

(7) have involved the community to be served, including public

and private agencies, adolescents, and families, in the planning

and implementation of the demonstration project; and

(8) will demonstrate innovative and effective approaches in

addressing the problems of adolescent premarital sexual

relations, pregnancy, or parenthood, including approaches to

provide pregnant adolescents with adequate information about

adoption.

(b) Factors to be considered in making grants; special needs of

rural areas

(1) The amount of a grant for a demonstration project for

services under this subchapter shall be determined by the

Secretary, based on factors such as the incidence of adolescent

pregnancy in the geographic area to be served, and the adequacy of

pregnancy prevention services and programs of care for pregnant

adolescents and adolescent parents in such area.

(2) In making grants for demonstration projects for services

under this subchapter, the Secretary shall consider the special

needs of rural areas and, to the maximum extent practicable, shall

distribute funds taking into consideration the relative number of

adolescents in such areas in need of such services.

(c) Duration; Federal share

(1) A grantee may not receive funds for a demonstration project

for services under this subchapter for a period in excess of 5

years.

(2)(A) Subject to paragraph (3), a grant for a demonstration

project for services under this subchapter may not exceed -

(i) 70 per centum of the costs of the project for the first and

second years of the project;

(ii) 60 per centum of such costs for the third year of the

project;

(iii) 50 per centum of such costs for the fourth year of the

project; and

(iv) 40 per centum of such costs for the fifth year of the

project.

(B) Non-Federal contributions required by subparagraph (A) may be

in cash or in kind, fairly evaluated, including plant, equipment,

or services.

(3) The Secretary may waive the limitation specified in paragraph

(2)(A) for any year in accordance with criteria established by

regulation.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2005, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 584.)

-End-

-CITE-

42 USC Sec. 300z-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-5. Requirements for applications

-STATUTE-

(a) Form, content, and assurances

An application for a grant for a demonstration project for

services under this subchapter shall be in such form and contain

such information as the Secretary may require, and shall include -

(1) an identification of the incidence of adolescent pregnancy

and related problems;

(2) a description of the economic conditions and income levels

in the geographic area to be served;

(3) a description of existing pregnancy prevention services and

programs of care for pregnant adolescents and adolescent parents

(including adoption services), and including where, how, by whom,

and to which population groups such services are provided, and

the extent to which they are coordinated in the geographic area

to be served;

(4) a description of the major unmet needs for services for

adolescents at risk of initial or recurrent pregnancies and an

estimate of the number of adolescents not being served in the

area;

(5)(A) in the case of an applicant who will provide care

services, a description of how all core services will be provided

in the demonstration project using funds under this subchapter or

will otherwise be provided by the grantee in the area to be

served, the population to which such services will be provided,

how such services will be coordinated, integrated, and linked

with other related programs and services and the source or

sources of funding of such core services in the public and

private sectors; or

(B) in the case of an applicant who will provide prevention

services, a description of the necessary services to be provided

and how the applicant will provide such services;

(6) a description of the manner in which adolescents needing

services other than the services provided directly by the

applicant will be identified and how access and appropriate

referral to such other services (such as medicaid; licensed

adoption agencies; maternity home services; public assistance;

employment services; child care services for adolescent parents;

and other city, county, and State programs related to adolescent

pregnancy) will be provided, including a description of a plan to

coordinate such other services with the services supported under

this subchapter;

(7) a description of the applicant's capacity to continue

services as Federal funds decrease and in the absence of Federal

assistance;

(8) a description of the results expected from the provision of

services, and the procedures to be used for evaluating those

results;

(9) a summary of the views of public agencies, providers of

services, and the general public in the geographic area to be

served, concerning the proposed use of funds provided for a

demonstration project for services under this subchapter and a

description of procedures used to obtain those views, and, in the

case of applicants who propose to coordinate services

administered by a State, the written comments of the appropriate

State officials responsible for such services;

(10) assurances that the applicant will have an ongoing quality

assurance program;

(11) assurances that, where appropriate, the applicant shall

have a system for maintaining the confidentiality of patient

records in accordance with regulations promulgated by the

Secretary;

(12) assurances that the applicant will demonstrate its

financial responsibility by the use of such accounting procedures

and other requirements as may be prescribed by the Secretary;

(13) assurances that the applicant (A) has or will have a

contractual or other arrangement with the agency of the State (in

which the applicant provides services) that administers or

supervises the administration of a State plan approved under

title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for

the payment of all or a part of the applicant's costs in

providing health services to persons who are eligible for medical

assistance under such a State plan, or (B) has made or will make

every reasonable effort to enter into such an arrangement;

(14) assurances that the applicant has made or will make and

will continue to make every reasonable effort to collect

appropriate reimbursement for its costs in providing health

services to persons who are entitled to benefits under title V of

the Social Security Act [42 U.S.C. 701 et seq.], to medical

assistance under a State plan approved under title XIX of such

Act [42 U.S.C. 1396 et seq.], or to assistance for medical

expenses under any other public assistance program or private

health insurance program;

(15) assurances that the applicant has or will make and will

continue to make every reasonable effort to collect appropriate

reimbursement for its costs in providing services to persons

entitled to services under parts B and E of title IV [42 U.S.C.

620 et seq., 670 et seq.] and title XX of the Social Security Act

[42 U.S.C. 1397 et seq.];

(16)(A) a description of -

(i) the schedule of fees to be used in the provision of

services, which shall comply with section 300z-3(c) of this

title and which shall be designed to cover all reasonable

direct and indirect costs incurred by the applicant in

providing services; and

(ii) a corresponding schedule of discounts to be applied to

the payment of such fees, which shall comply with section

300z-3(c) of this title and which shall be adjusted on the

basis of the ability of the eligible person to pay;

(B) assurances that the applicant has made and will continue to

make every reasonable effort -

(i) to secure from eligible persons payment for services in

accordance with such schedules;

(ii) to collect reimbursement for health or other services

provided to persons who are entitled to have payment made on

their behalf for such services under any Federal or other

government program or private insurance program; and

(iii) to seek such reimbursement on the basis of the full

amount of fees for services without application of any

discount; and

(C) assurances that the applicant has submitted or will submit

to the Secretary such reports as the Secretary may require to

determine compliance with this paragraph;

(17) assurances that the applicant will make maximum use of

funds available under subchapter VIII of this chapter;

(18) assurances that the acceptance by any individual of family

planning services or family planning information (including

educational materials) provided through financial assistance

under this subchapter shall be voluntary and shall not be a

prerequisite to eligibility for or receipt of any other service

furnished by the applicant;

(19) assurances that fees collected by the applicant for

services rendered in accordance with this subchapter shall be

used by the applicant to further the purposes of this subchapter;

(20) assurances that the applicant, if providing both

prevention and care services will not exclude or discriminate

against any adolescent who receives prevention services and

subsequently requires care services as a pregnant adolescent;

(21) a description of how the applicant will, as appropriate in

the provision of services -

(A) involve families of adolescents in a manner which will

maximize the role of the family in the solution of problems

relating to the parenthood or pregnancy of the adolescent;

(B) involve religious and charitable organizations, voluntary

associations, and other groups in the private sector as well as

services provided by publicly sponsored initiatives;

(22)(A) assurances that -

(i) except as provided in subparagraph (B) and subject to

clause (ii), the applicant will notify the parents or guardians

of any unemancipated minor requesting services from the

applicant and, except as provided in subparagraph (C), will

obtain the permission of such parents or guardians with respect

to the provision of such services; and

(ii) in the case of a pregnant unemancipated minor requesting

services from the applicant, the applicant will notify the

parents or guardians of such minor under clause (i) within a

reasonable period of time;

(B) assurances that the applicant will not notify or request

the permission of the parents or guardian of any unemancipated

minor without the consent of the minor -

(i) who solely is requesting from the applicant pregnancy

testing or testing or treatment for venereal disease;

(ii) who is the victim of incest involving a parent; or

(iii) if an adult sibling of the minor or an adult aunt,

uncle, or grandparent who is related to the minor by blood

certifies to the grantee that notification of the parents or

guardians of such minor would result in physical injury to such

minor; and

(C) assurances that the applicant will not require, with

respect to the provision of services, the permission of the

parents or guardians of any pregnant unemancipated minor if such

parents or guardians are attempting to compel such minor to have

an abortion;

(23) assurances that primary emphasis for services supported

under this subchapter shall be given to adolescents seventeen and

under who are not able to obtain needed assistance through other

means;

(24) assurances that funds received under this subchapter shall

supplement and not supplant funds received from any other

Federal, State, or local program or any private sources of funds;

and

(25) a plan for the conduct of, and assurances that the

applicant will conduct, evaluations of the effectiveness of the

services supported under this subchapter in accordance with

subsection (b) of this section.

(b) Evaluations: amount, conduct, and technical assistance

(1) Each grantee which receives funds for a demonstration project

for services under this subchapter shall expend at least 1 per

centum but not in excess of 5 per centum of the amounts received

under this subchapter for the conduct of evaluations of the

services supported under this subchapter. The Secretary may, for a

particular grantee upon good cause shown, waive the provisions of

the preceding sentence with respect to the amounts to be expended

on evaluations, but may not waive the requirement that such

evaluations be conducted.

(2) Evaluations required by paragraph (1) shall be conducted by

an organization or entity which is independent of the grantee

providing services supported under this subchapter. To assist in

conducting the evaluations required by paragraph (1), each grantee

shall develop a working relationship with a college or university

located in the grantee's State which will provide or assist in

providing monitoring and evaluation of services supported under

this subchapter unless no college or university in the grantee's

State is willing or has the capacity to provide or assist in

providing such monitoring and assistance.

(3) The Secretary may provide technical assistance with respect

to the conduct of evaluations required under this subsection to any

grantee which is unable to develop a working relationship with a

college or university in the applicant's State for the reasons

described in paragraph (2).

(c) Reports

Each grantee which receives funds for a demonstration project for

services under this subchapter shall make such reports concerning

its use of Federal funds as the Secretary may require. Reports

shall include, at such times as are considered appropriate by the

Secretary, the results of the evaluations of the services supported

under this subchapter.

(d) Notification of parents; "adult" defined

(1) A grantee shall periodically notify the Secretary of the

exact number of instances in which a grantee does not notify the

parents or guardians of a pregnant unemancipated minor under

subsection (a)(22)(B)(iii) of this section.

(2) For purposes of subsection (a)(22)(B)(iii) of this section,

the term "adult" means an adult as defined by State law.

(e) Submission of applications to Governor; comments by Governor

Each applicant shall provide the Governor of the State in which

the applicant is located a copy of each application submitted to

the Secretary for a grant for a demonstration project for services

under this subchapter. The Governor shall submit to the applicant

comments on any such application within the period of sixty days

beginning on the day when the Governor receives such copy. The

applicant shall include the comments of the Governor with such

application.

(f) Availability of core services

No application submitted for a grant for a demonstration project

for care services under this subchapter may be approved unless the

Secretary is satisfied that core services shall be available

through the applicant within a reasonable time after such grant is

received.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2006, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 585.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsec. (a)(13) to (15),

is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Parts B

and E of title IV of the Social Security Act are classified

generally to part B (Sec. 620 et seq.) and part E (Sec. 670 et

seq.) of subchapter IV of chapter 7 of this title. Titles V, XIX,

and XX of the Social Security Act are classified generally to

subchapters V (Sec. 701 et seq.), XIX (Sec. 1396 et seq.), and XX

(Sec. 1397 et seq.), respectively, of chapter 7 of this title. For

complete classification of this Act to the Code, see section 1305

of this title and Tables.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300z-1, 300z-2, 300z-3 of

this title.

-End-

-CITE-

42 USC Sec. 300z-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-6. Coordination of programs

-STATUTE-

(a) The Secretary shall coordinate Federal policies and programs

providing services relating to the prevention of adolescent sexual

relations and initial and recurrent adolescent pregnancies and

providing care services for pregnant adolescents. In achieving such

coordination, the Secretary shall -

(1) require grantees who receive funds for demonstration

projects for services under this subchapter to report

periodically to the Secretary concerning Federal, State, and

local policies and programs that interfere with the delivery of

and coordination of pregnancy prevention services and other

programs of care for pregnant adolescents and adolescent parents;

(2) provide technical assistance to facilitate coordination by

State and local recipients of Federal assistance;

(3) review all programs administered by the Department of

Health and Human Services which provide prevention services or

care services to determine if the policies of such programs are

consistent with the policies of this subchapter, consult with

other departments and agencies of the Federal Government who

administer programs that provide such services, and encourage

such other departments and agencies to make recommendations, as

appropriate, for legislation to modify such programs in order to

facilitate the use of all Government programs which provide such

services as a basis for delivery of more comprehensive prevention

services and more comprehensive programs of care for pregnant

adolescents and adolescent parents;

(4) give priority in the provision of funds, where appropriate,

to applicants using single or coordinated grant applications for

multiple programs; and

(5) give priority, where appropriate, to the provision of funds

under Federal programs administered by the Secretary (other than

the program established by this subchapter) to projects providing

comprehensive prevention services and comprehensive programs of

care for pregnant adolescents and adolescent parents.

(b) Any recipient of a grant for a demonstration project for

services under this subchapter shall coordinate its activities with

any other recipient of such a grant which is located in the same

locality.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2007, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 589.)

-End-

-CITE-

42 USC Sec. 300z-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-7. Research

-STATUTE-

(a) Grants and contracts; duration; renewal; amount

(1) The Secretary may make grants and enter into contracts with

public agencies or private organizations or institutions of higher

education to support the research and dissemination activities

described in paragraphs (4), (5), and (6) of section 300z(b) of

this title.

(2) The Secretary may make grants or enter into contracts under

this section for a period of one year. A grant or contract under

this section for a project may be renewed for four additional

one-year periods, which need not be consecutive.

(3) A grant or contract for any one-year period under this

section may not exceed $100,000 for the direct costs of conducting

research or disemination (!1) activities under this section and may

include such additional amounts for the indirect costs of

conducting such activities as the Secretary determines appropriate.

The Secretary may waive the preceding sentence with respect to a

specific project if he determines that -

(A) exceptional circumstances warrant such waiver and that the

project will have national impact; or

(B) additional amounts are necessary for the direct costs of

conducting limited demonstration projects for the provision of

necessary services in order to provide data for research carried

out under this subchapter.

(4) The amount of any grant or contract made under this section

may remain available for obligation or expenditure after the close

of the one-year period for which such grant or contract is made in

order to assist the recipient in preparing the report required by

subsection (f)(1) of this section.

(b) Scope of permissible activities

(1) Funds provided for research under this section may be used

for descriptive or explanatory surveys, longitudinal studies, or

limited demonstration projects for services that are for the

purpose of increasing knowledge and understanding of the matters

described in paragraphs (4) and (5) of section 300z(b) of this

title.

(2) Funds provided under this section may not be used for the

purchase or improvement of land, or the purchase, construction, or

permanent improvement (other than minor remodeling) of any building

or facility.

(c) Applications

The Secretary may not make any grant or enter into any contract

to support research or dissemination activities under this section

unless -

(1) the Secretary has received an application for such grant or

contract which is in such form and which contains such

information as the Secretary may by regulation require;

(2) the applicant has demonstrated that the applicant is

capable of conducting one or more of the types of research or

dissemination activities described in paragraph (4), (5), or (6)

of section 300z(b) of this title; and

(3) in the case of an application for a research project, the

panel established by subsection (e)(2) of this section has

determined that the project is of scientific merit.

(d) Coordination with National Institutes of Health

The Secretary shall, where appropriate, coordinate research and

dissemination activities carried out under this section with

research and dissemination activities carried out by the National

Institutes of Health.

(e) Review of applications for grants and contracts; establishment

of review panel

(1) The Secretary shall establish a system for the review of

applications for grants and contracts under this section. Such

system shall be substantially similar to the system for scientific

peer review of the National Institutes of Health and shall meet the

requirements of paragraphs (2) and (3).

(2) In establishing the system required by paragraph (1), the

Secretary shall establish a panel to review applications under this

section. Not more than 25 per centum of the members of the panel

shall be physicians. The panel shall meet as often as may be

necessary to facilitate the expeditious review of applications

under this section, but not less than once each year. The panel

shall review each project for which an application is made under

this section, evaluate the scientific merit of the project,

determine whether the project is of scientific merit, and make

recommendations to the Secretary concerning whether the application

for the project should be approved.

(3) The Secretary shall make grants under this section from among

the projects which the panel established by paragraph (2) has

determined to be of scientific merit and may only approve an

application for a project if the panel has made such determination

with respect to such a project. The Secretary shall make a

determination with respect to an application within one month after

receiving the determinations and recommendations of such panel with

respect to the application.

(f) Reports

(1)(A) The recipient of a grant or contract for a research

project under this section shall prepare and transmit to the

Secretary a report describing the results and conclusions of such

research. Except as provided in subparagraph (B), such report shall

be transmitted to the Secretary not later than eighteen months

after the end of the year for which funds are provided under this

section. The recipient may utilize reprints of articles published

or accepted for publication in professional journals to supplement

or replace such report if the research contained in such articles

was supported under this section during the year for which the

report is required.

(B) In the case of any research project for which assistance is

provided under this section for two or more consecutive one-year

periods, the recipient of such assistance shall prepare and

transmit the report required by subparagraph (A) to the Secretary

not later than twelve months after the end of each one-year period

for which such funding is provided.

(2) Recipients of grants and contracts for dissemination under

this section shall submit to the Secretary such reports as the

Secretary determines appropriate.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2008, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 589; amended

Pub. L. 98-512, Sec. 2(e), Oct. 19, 1984, 98 Stat. 2409.)

-MISC1-

AMENDMENTS

1984 - Subsec. (g). Pub. L. 98-512 struck out subsec. (g) which

provided for collection of survey data used primarily for

generation of national population estimates.

-FOOTNOTE-

(!1) So in original. Probably should be "dissemination".

-End-

-CITE-

42 USC Sec. 300z-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-8. Evaluation and administration

-STATUTE-

(a) Of the funds appropriated under this subchapter, the

Secretary shall reserve not less than 1 per centum and not more

than 3 per centum for the evaluation of activities carried out

under this subchapter. The Secretary shall submit to the

appropriate committees of the Congress a summary of each evaluation

conducted under this section.

(b) The officer or employee of the Department of Health and Human

Services designated by the Secretary to carry out the provisions of

this subchapter shall report directly to the Assistant Secretary

for Health with respect to the activities of such officer or

employee in carrying out such provisions.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2009, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 591.)

-End-

-CITE-

42 USC Sec. 300z-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-9. Authorization of appropriations

-STATUTE-

(a) For the purpose of carrying out this subchapter, there are

authorized to be appropriated $30,000,000 for the fiscal year

ending September 30, 1982, $30,000,000 for the fiscal year ending

September 30, 1983, $30,000,000 for the fiscal year ending

September 30, 1984, and $30,000,000 for the fiscal year ending

September 30, 1985.

(b) At least two-thirds of the amounts appropriated to carry out

this subchapter shall be used to make grants for demonstration

projects for services.

(c) Not more than one-third of the amounts specified under

subsection (b) of this section for use for grants for demonstration

projects for services shall be used for grants for demonstration

projects for prevention services.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2010, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 591; amended

Pub. L. 98-512, Sec. 2(a), Oct. 19, 1984, 98 Stat. 2409.)

-MISC1-

AMENDMENTS

1984 - Subsec. (a). Pub. L. 98-509 inserted provisions

authorizing appropriations for fiscal year ending Sept. 30, 1985.

-End-

-CITE-

42 USC Sec. 300z-10 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XVIII - ADOLESCENT FAMILY LIFE DEMONSTRATION PROJECTS

-HEAD-

Sec. 300z-10. Restrictions

-STATUTE-

(a) Grants or payments may be made only to programs or projects

which do not provide abortions or abortion counseling or referral,

or which do not subcontract with or make any payment to any person

who provides abortions or abortion counseling or referral, except

that any such program or project may provide referral for abortion

counseling to a pregnant adolescent if such adolescent and the

parents or guardians of such adolescent request such referral; and

grants may be made only to projects or programs which do not

advocate, promote, or encourage abortion.

(b) The Secretary shall ascertain whether programs or projects

comply with subsection (a) of this section and take appropriate

action if programs or projects do not comply with such subsection,

including withholding of funds.

-SOURCE-

(July 1, 1944, ch. 373, title XX, Sec. 2011, as added Pub. L.

97-35, title IX, Sec. 955(a), Aug. 13, 1981, 95 Stat. 592.)

-End-

-CITE-

42 USC SUBCHAPTER XIX - VACCINES 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

-HEAD-

SUBCHAPTER XIX - VACCINES

-MISC1-

PRIOR PROVISIONS

A prior subchapter XIX (Sec. 300aa et seq.), comprised of title

XXI of the Public Health Service Act, act July 1, 1944, ch. 373,

Secs. 2101 to 2116, was renumbered title XXIII, Secs. 2301 to 2316,

of the Public Health Service Act, and transferred to subchapter XXI

(Sec. 300cc et seq.) of this chapter, renumbered title XXV, Secs.

2501 to 2514, of the Public Health Service Act, and transferred to

subchapter XXV (Sec. 300aaa et seq.) of this chapter, renumbered

title XXVI, Secs. 2601 to 2614, of the Public Health Service Act,

renumbered title XXVII, Secs. 2701 to 2714, of the Public Health

Service Act, and renumbered title II, part B, Secs. 231 to 244, of

the Public Health Service Act, and transferred to part B (Sec. 238

et seq.) of subchapter I of this chapter.

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in section 283d of this title;

title 26 section 9510.

-End-

-CITE-

42 USC Part 1 - National Vaccine Program 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

PART 1 - NATIONAL VACCINE PROGRAM

-End-

-CITE-

42 USC Sec. 300aa-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-1. Establishment

-STATUTE-

The Secretary shall establish in the Department of Health and

Human Services a National Vaccine Program to achieve optimal

prevention of human infectious diseases through immunization and to

achieve optimal prevention against adverse reactions to vaccines.

The Program shall be administered by a Director selected by the

Secretary.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2101, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-1, act July 1, 1944, Sec. 2102, was

successively renumbered by subsequent acts and transferred, see

section 238a of this title.

A prior section 2101 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238 of

this title.

EFFECTIVE DATE

Section 323 of title III of Pub. L. 99-660, as amended by Pub. L.

100-203, title IV, Sec. 4302(a), Dec. 22, 1987, 101 Stat. 1330-221;

Pub. L. 102-168, title II, Sec. 201(a), Nov. 26, 1991, 105 Stat.

1102, provided that: "Subtitle 1 of title XXI of the Public Health

Service Act [part 1 of this subchapter (42 U.S.C. 300aa-1 to

300aa-6)] shall take effect on the date of the enactment of this

Act [Nov. 14, 1986] and parts A and B of subtitle 2 of such title

[subparts A and B of part 2 of this subchapter (42 U.S.C. 300aa-10

to 300aa-23)] shall take effect on October 1, 1988 and parts C and

D of such title [subparts C and D of part 2 of this subchapter (42

U.S.C. 300aa-25 to 300aa-33)] and this title [probably means

provisions of title III of Pub. L. 99-660 other than those that

enacted this subchapter and redesignated former sections 300aa to

300aa-15 of this title as sections 300cc to 300cc-15 of this title;

these other provisions amended sections 218, 242c, 262, 286, and

289f of this title and enacted provisions set out as notes under

sections 201, 300aa-1, and 300aa-4 of this title] shall take effect

on the date of the enactment of the Vaccine Compensation Amendments

of 1987 [Dec. 22, 1987]."

SEVERABILITY

Section 322 of title III of Pub. L. 99-660, as amended by Pub. L.

101-239, title VI, Sec. 6602, Dec. 19, 1989, 103 Stat. 2293; Pub.

L. 101-502, Sec. 5(g)(1), Nov. 3, 1990, 104 Stat. 1288, provided

that:

"(a) In General. - Except as provided in subsection (b), if any

provision [of] part A or B of subtitle 2 of title XXI of the Public

Health Service Act [subparts A and B of part 2 of this subchapter],

as added by section 311(a), or the application of such a provision

to any person or circumstance is held invalid by reason of a

violation of the Constitution, both such parts shall be considered

invalid.

"(b) Special Rule. - If any amendment made by section 6601 of the

Omnibus Budget Reconciliation Act of 1989 [Pub. L. 101-239,

amending sections 300aa-10 to 300aa-17, 300aa-21, 300aa-23,

300aa-26, and 300aa-27 of this title] to title XXI of the Public

Health Service Act [this subchapter] or the application of such a

provision to any person or circumstance is held invalid by reason

of the Constitution, subsection (a) shall not apply and such title

XXI of the Public Health Service Act without such amendment shall

continue in effect."

[Amendment by section 5(g)(1) of Pub. L. 101-502 to section

322(a) of Pub. L. 99-660, set out above, effective Nov. 14, 1986,

see section 5(h) of Pub. L. 101-502, set out as an Effective Date

of 1990 Amendment note under section 300aa-11 of this title.]

EVALUATION OF PROGRAM; STUDY AND REPORT TO CONGRESS

Pub. L. 101-239, title VI, Sec. 6601(t), Dec. 19, 1989, 103 Stat.

2293, as amended by Pub. L. 102-168, title II, Sec. 201(b), Nov.

26, 1991, 105 Stat. 1103, directed the Secretary of Health and

Human Services to evaluate the National Vaccine Injury Compensation

Program under this subchapter and report results of such study to

Committee on Energy and Commerce of House of Representatives and

Committee on Labor and Human Resources of Senate not later than

Jan. 1, 1993.

RELATED STUDIES

Section 312 of title III of Pub. L. 99-660 directed Secretary of

Health and Human Services, not later than 3 years after the

effective date of this title (see Effective Date note above), to

conduct, through studies by the Institute of Medicine of the

National Academy of Sciences or other appropriate nonprofit private

groups or associations, a review of pertussis vaccines and related

illnesses and conditions and MMR vaccines, vaccines containing

material intended to prevent or confer immunity against measles,

mumps, and rubella disease, and related illnesses and conditions,

make specific findings and report these findings in the Federal

Register not later than 3 years after the effective date of this

title, and at the same time these findings are published in the

Federal Register, propose regulations as a result of such findings,

and not later than 42 months after the effective date of this

title, promulgate such proposed regulations with such modifications

as may be necessary after opportunity for public hearing.

STUDY OF OTHER VACCINE RISKS

Section 313 of title III of Pub. L. 99-660 provided that:

"(a) Study. -

"(1) Not later than 3 years after the effective date of this

title [see Effective Date note above], the Secretary shall, after

consultation with the Advisory Commission on Childhood Vaccines

established under section 2119 of the Public Health Service Act

[section 300aa-19 of this title] -

"(A) arrange for a broad study of the risks (other than the

risks considered under section 102 [21 U.S.C. 382]) to children

associated with each vaccine set forth in the Vaccine Injury

Table under section 2114 of such Act [section 300aa-14 of this

title], and

"(B) establish guidelines, after notice and opportunity for

public hearing and consideration of all relevant medical and

scientific information, respecting the administration of such

vaccines which shall include -

"(i) the circumstances under which any such vaccine should

not be administered,

"(ii) the circumstances under which administration of any

such vaccine should be delayed beyond its usual time of

administration, and

"(iii) the groups, categories, or characteristics of

potential recipients of such vaccine who may be at

significantly higher risk of major adverse reactions to such

vaccine than the general population of potential recipients.

"(2)(A) The Secretary shall request the Institute of Medicine

of the National Academy of Sciences to conduct the study required

by paragraph (1) under an arrangement by which the actual

expenses incurred by such Academy in conducting such study will

be paid by the Secretary.

"(B) If the Institute of Medicine is unwilling to conduct such

study under such an arrangement, the Secretary shall enter into a

similar arrangement with other appropriate nonprofit private

groups or associations under which such groups or associations

will conduct such study.

"(C) The Institute of Medicine or other group or association

conducting the study required by paragraph (1) shall conduct such

studies in consultation with the Advisory Commission on Childhood

Vaccines established under section 2119 of the Public Health

Service Act [section 300aa-19 of this title].

"(b) Revision of Guidelines. - The Secretary shall periodically,

but at least every 3 years after establishing guidelines under

subsection (a), review and revise such guidelines after notice and

opportunity for public hearing and consideration of all relevant

medical and scientific information, unless the Secretary finds that

on the basis of all relevant information no revision of such

guidelines is warranted and publishes such finding in the Federal

Register.

"(c) Factors Affecting Guidelines. - Guidelines under subsection

(a) shall take into account -

"(1) the risk to potential recipients of the vaccines with

respect to which the guidelines are established,

"(2) the medical and other characteristics of such potential

recipients, and

"(3) the risks to the public of not having such vaccines

administered.

"(d) Dissemination. - The Secretary shall widely disseminate the

guidelines established under subsection (a) to -

"(1) physicians and other health care providers,

"(2) professional health associations,

"(3) State and local governments and agencies, and

"(4) other relevant entities."

REVIEW OF WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION

Section 314 of title III of Pub. L. 99-660 directed Secretary of

Health and Human Services, not later than 1 year after the

effective date of this title (see Effective Date note above) and

after consultation with Advisory Commission on Childhood Vaccines

and with other appropriate entities, to review the warnings, use

instructions, and precautionary information presently issued by

manufacturers of vaccines set forth in the Vaccine Injury Table set

out in section 300aa-14 of this title and by rule determine whether

such warnings, instructions, and information adequately warn health

care providers of the nature and extent of dangers posed by such

vaccines, and, if any such warning, instruction, or information is

determined to be inadequate for such purpose in any respect,

require at the same time that the manufacturers revise and reissue

such warning, instruction, or information as expeditiously as

practical, but not later than 18 months after the effective date of

this title.

STUDY OF IMPACT ON SUPPLY OF VACCINES

Section 316 of title III of Pub. L. 99-660 provided that: "On

June 30, 1987, and on June 30 of each second year thereafter, the

Secretary of Health and Human Services shall submit to the

Committee on Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of the Senate -

"(1) an assessment of the impact of the amendments made by this

title [enacting this subchapter, amending sections 218, 242c,

262, 286, and 289f of this title, redesignating former sections

300aa to 300aa-15 of this title as sections 300cc to 300cc-15 of

this title, and enacting provisions set out as notes under this

section and sections 201 and 300aa-1 of this title] on the supply

of vaccines listed in the Vaccine Injury Table under section 2114

of the Public Health Service Act [section 300aa-14 of this

title], and

"(2) an assessment of the ability of the administrators of

vaccines (including public clinics and private administrators) to

provide such vaccines to children."

WAIVER OF PAPERWORK REDUCTION

Section 321 of title III of Pub. L. 99-660 provided that:

"Chapter 35 of title 44, United States Code, shall not apply to

information required for purposes of carrying out this title and

implementing the amendments made by this title [enacting this

subchapter, amending sections 218, 242c, 262, 286, and 289f of this

title, redesignating former sections 300aa to 300aa-15 of this

title as sections 300cc to 300cc-15 of this title, and enacting

provisions set out as notes under sections 201, 300aa-1, and

300aa-4 of this title]."

-End-

-CITE-

42 USC Sec. 300aa-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-2. Program responsibilities

-STATUTE-

(a) The Director of the Program shall have the following

responsibilities:

(1) Vaccine research

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction for research carried out in or through the National

Institutes of Health, the Centers for Disease Control and

Prevention, the Office of Biologics Research and Review of the

Food and Drug Administration, the Department of Defense, and the

Agency for International Development on means to induce human

immunity against naturally occurring infectious diseases and to

prevent adverse reactions to vaccines.

(2) Vaccine development

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction for activities carried out in or through the National

Institutes of Health, the Office of Biologics Research and Review

of the Food and Drug Administration, the Department of Defense,

and the Agency for International Development to develop the

techniques needed to produce safe and effective vaccines.

(3) Safety and efficacy testing of vaccines

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction for safety and efficacy testing of vaccines carried out

in or through the National Institutes of Health, the Centers for

Disease Control and Prevention, the Office of Biologics Research

and Review of the Food and Drug Administration, the Department of

Defense, and the Agency for International Development.

(4) Licensing of vaccine manufacturers and vaccines

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction for the allocation of resources in the implementation

of the licensing program under section 263a of this title.

(5) Production and procurement of vaccines

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, ensure that the governmental

and non-governmental production and procurement of safe and

effective vaccines by the Public Health Service, the Department

of Defense, and the Agency for International Development meet the

needs of the United States population and fulfill commitments of

the United States to prevent human infectious diseases in other

countries.

(6) Distribution and use of vaccines

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction to the Centers for Disease Control and Prevention and

assistance to States, localities, and health practitioners in the

distribution and use of vaccines, including efforts to encourage

public acceptance of immunizations and to make health

practitioners and the public aware of potential adverse reactions

and contraindications to vaccines.

(7) Evaluating the need for and the effectiveness and adverse

effects of vaccines and immunization activities

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, coordinate and provide

direction to the National Institutes of Health, the Centers for

Disease Control and Prevention, the Office of Biologics Research

and Review of the Food and Drug Administration, the National

Center for Health Statistics, the National Center for Health

Services Research and Health Care Technology Assessment, and the

Health Care Financing Administration in monitoring the need for

and the effectiveness and adverse effects of vaccines and

immunization activities.

(8) Coordinating governmental and non-governmental activities

The Director of the Program shall, through the plan issued

under section 300aa-3 of this title, provide for the exchange of

information between Federal agencies involved in the

implementation of the Program and non-governmental entities

engaged in the development and production of vaccines and in

vaccine research and encourage the investment of non-governmental

resources complementary to the governmental activities under the

Program.

(9) Funding of Federal agencies

The Director of the Program shall make available to Federal

agencies involved in the implementation of the plan issued under

section 300aa-3 of this title funds appropriated under section

300aa-6 of this title to supplement the funds otherwise available

to such agencies for activities under the plan.

(b) In carrying out subsection (a) of this section and in

preparing the plan under section 300aa-3 of this title, the

Director shall consult with all Federal agencies involved in

research on and development, testing, licensing, production,

procurement, distribution, and use of vaccines.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2102, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3756;

amended Pub. L. 102-531, title III, Sec. 312(d)(13), Oct. 27, 1992,

106 Stat. 3505.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-2, act July 1, 1944, Sec. 2103, was

successively renumbered by subsequent acts and transferred, see

section 238b of this title.

A prior section 2102 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238a of

this title.

AMENDMENTS

1992 - Subsec. (a)(1), (3), (6), (7). Pub. L. 102-531 substituted

"Centers for Disease Control and Prevention" for "Centers for

Disease Control".

DEMONSTRATION PROJECTS FOR OUTREACH PROGRAMS

Pub. L. 101-502, Sec. 2(b), Nov. 3, 1990, 104 Stat. 1285,

provided that:

"(1) In general. - The Secretary of Health and Human Services,

acting through the Director of the Centers for Disease Control, may

make grants to public and nonprofit private entities for the

purpose of carrying out demonstration projects -

"(A) to provide, without charge, immunizations against

vaccine-preventable diseases to children not more than 2 years of

age who reside in communities whose population includes a

significant number of low-income individuals; and

"(B) to provide outreach services to identify such children and

to inform the parents (or other guardians) of the children of the

availability from the entities of the immunizations specified in

subparagraph (A).

"(2) Authorization of appropriations. - For the purpose of

carrying out paragraph (1), there are authorized to be appropriated

such sums as may be necessary for each of the fiscal years 1991

through 1993."

[Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.]

SUPPLY OF VACCINES

Pub. L. 101-502, Sec. 3, Nov. 3, 1990, 104 Stat. 1285, provided

that:

"(a) In General. - The Secretary of Health and Human Services,

acting through the Director of the Centers for Disease Control,

shall acquire and maintain a supply of vaccines sufficient to

provide vaccinations throughout a 6-month period. Any proceeds

received by the Secretary from the sale of vaccines from such

supply shall be available to the Secretary for the purpose of

purchasing vaccines for the supply. Such proceeds shall remain

available for such purpose until expended.

"(b) Authorization of Appropriations. - For the purpose of

carrying out subsection (a), there are authorized to be

appropriated $5,000,000 for fiscal year 1991, and such sums as may

be necessary for each of the fiscal years 1992 through 1995."

[Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.]

Pub. L. 100-177, title I, Sec. 110(b), Dec. 1, 1987, 101 Stat.

991, provided that:

"(1) In general. - The Secretary of Health and Human Services,

acting through the Director of the Centers for Disease Control,

shall acquire and maintain a supply of vaccines sufficient to

provide vaccinations throughout a 6-month period.

"(2) Authorization of Appropriations. - There are authorized to

be appropriated to carry out paragraph (1) $5,000,000 for fiscal

year 1988, and such sums as may be necessary for each of the fiscal

years 1989 and 1990."

[Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.]

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-3, 300aa-5, 300aa-6

of this title.

-End-

-CITE-

42 USC Sec. 300aa-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-3. Plan

-STATUTE-

The Director of the Program shall prepare and issue a plan for

the implementation of the responsibilities of the Director under

section 300aa-2 of this title. The plan shall establish priorities

in research and the development, testing, licensing, production,

procurement, distribution, and effective use of vaccines, describe

an optimal use of resources to carry out such priorities, and

describe how each of the various departments and agencies will

carry out their vaccine functions in consultation and coordination

with the Program and in conformity with such priorities. The first

plan under this section shall be prepared not later than January 1,

1987, and shall be revised not later than January 1 of each

succeeding year.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2103, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3757.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-3, act July 1, 1944, Sec. 2104, which was

renumbered section 2304 by Pub. L. 99-660, was transferred to

section 300cc-3 of this title, prior to repeal by Pub. L. 98-621,

Sec. 10(s), Nov. 8, 1984, 98 Stat. 3381.

A prior section 2103 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238b of

this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-2, 300aa-5 of this

title.

-End-

-CITE-

42 USC Sec. 300aa-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-4. Repealed. Pub. L. 105-362, title VI, Sec.

601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285

-MISC1-

Section, act July 1, 1944, ch. 373, title XXI, Sec. 2104, as

added Pub. L. 99-660, title III, Sec. 311(a), Nov. 14, 1986, 100

Stat. 3757, related to national vaccine program report.

A prior section 300aa-4, act July 1, 1944, Sec. 2105, was

repealed by Pub. L. 99-117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495.

See section 300cc-4 of this title.

A prior section 2104 of act July 1, 1944, was renumbered section

2304 by Pub. L. 99-660 and classified to section 300cc-3 of this

title, and was repealed by Pub. L. 98-621, Sec. 10(s), Nov. 8,

1984, 98 Stat. 3381.

-End-

-CITE-

42 USC Sec. 300aa-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-5. National Vaccine Advisory Committee

-STATUTE-

(a) There is established the National Vaccine Advisory Committee.

The members of the Committee shall be appointed by the Director of

the Program, in consultation with the National Academy of Sciences,

from among individuals who are engaged in vaccine research or the

manufacture of vaccines or who are physicians, members of parent

organizations concerned with immunizations, or representatives of

State or local health agencies or public health organizations.

(b) The Committee shall -

(1) study and recommend ways to encourage the availability of

an adequate supply of safe and effective vaccination products in

the States,

(2) recommend research priorities and other measures the

Director of the Program should take to enhance the safety and

efficacy of vaccines,

(3) advise the Director of the Program in the implementation of

sections 300aa-2, 300aa-3, and 300aa-4 (!1) of this title, and

(4) identify annually for the Director of the Program the most

important areas of government and non-government cooperation that

should be considered in implementing sections 300aa-2, 300aa-3,

and 300aa-4 (!1) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2105, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758.)

-REFTEXT-

REFERENCES IN TEXT

Section 300aa-4 of this title, referred to in subsec. (b)(3),

(4), was repealed by Pub. L. 105-362, title VI, Sec. 601(a)(1)(H),

Nov. 10, 1998, 112 Stat. 3285.

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-5, act July 1, 1944, Sec. 2106, was

successively renumbered by subsequent acts and transferred, see

section 238c of this title.

A prior section 2105 of act July 1, 1944, was repealed by Pub. L.

99-117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495. See section 300cc-4

of this title.

TERMINATION OF ADVISORY COMMITTEES

Advisory committees established after Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period beginning on the

date of their establishment, unless, in the case of a committee

established by the President or an officer of the Federal

Government, such committee is renewed by appropriate action prior

to the expiration of such 2-year period, or in the case of a

committee established by the Congress, its duration is otherwise

provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 776, set out in the Appendix to Title 5, Government

Organization and Employees.

Pub. L. 93-641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a

note under section 217a of this title, provided that an advisory

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

an Act of Congress enacted after Jan. 4, 1975.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 300aa-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 1 - National Vaccine Program

-HEAD-

Sec. 300aa-6. Authorization of appropriations

-STATUTE-

(a) To carry out this part other than section 300aa-2(9) of this

title there are authorized to be appropriated $4,000,000 for fiscal

year 1991, and such sums as may be necessary for each of the fiscal

years 1992 through 1995.

(b) To carry out section 300aa-2(9) of this title there are

authorized to be appropriated $30,000,000 for fiscal year 1991, and

such sums as may be necessary for each of the fiscal years 1992

through 1995.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2106, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758;

amended Pub. L. 101-502, Sec. 4, Nov. 3, 1990, 104 Stat. 1286.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-6, act July 1, 1944, Sec. 2107, was

successively renumbered by subsequent acts and transferred, see

section 238d of this title.

A prior section 2106 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238c of

this title.

Prior sections 300aa-7 to 300aa-9, act July 1, 1944, Secs.

2108-2110, respectively, were successively renumbered by subsequent

acts and transferred, see sections 238e to 238g, respectively, of

this title.

AMENDMENTS

1990 - Pub. L. 101-502 substituted provisions authorizing

appropriations for fiscal years 1991 through 1995 for provisions

authorizing appropriations for fiscal years 1987 through 1991 in

subsecs. (a) and (b).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-2 of this title.

-End-

-CITE-

42 USC Part 2 - National Vaccine Injury Compensation

Program 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

-HEAD-

PART 2 - NATIONAL VACCINE INJURY COMPENSATION PROGRAM

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in title 26 section 9510.

-End-

-CITE-

42 USC subpart a - program requirements 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

SUBPART A - PROGRAM REQUIREMENTS

-End-

-CITE-

42 USC Sec. 300aa-10 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-10. Establishment of program

-STATUTE-

(a) Program established

There is established the National Vaccine Injury Compensation

Program to be administered by the Secretary under which

compensation may be paid for a vaccine-related injury or death.

(b) Attorney's obligation

It shall be the ethical obligation of any attorney who is

consulted by an individual with respect to a vaccine-related injury

or death to advise such individual that compensation may be

available under the program (!1) for such injury or death.

(c) Publicity

The Secretary shall undertake reasonable efforts to inform the

public of the availability of the Program.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2110, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758;

amended Pub. L. 101-239, title VI, Sec. 6601(b), Dec. 19, 1989, 103

Stat. 2285.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-10, act July 1, 1944, Sec. 2111, was

successively renumbered by subsequent acts and transferred, see

section 238h of this title.

A prior section 2110 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238g of

this title.

AMENDMENTS

1989 - Subsec. (c). Pub. L. 101-239 added subsec. (c).

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6601(s) of Pub. L. 101-239, as amended by Pub. L.

102-572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516,

provided that:

"(1) Except as provided in paragraph (2), the amendments made by

this section [amending this section and sections 300aa-11 to

300aa-17, 300aa-21, 300aa-23, 300aa-26, and 300aa-27 of this title]

shall apply as follows:

"(A) Petitions filed after the date of enactment of this

section [Dec. 19, 1989] shall proceed under the National Vaccine

Injury Compensation Program under title XXI of the Public Health

Service Act [this subchapter] as amended by this section.

"(B) Petitions currently pending in which the evidentiary

record is closed shall continue to proceed under the Program in

accordance with the law in effect before the date of the

enactment of this section, except that if the United States Court

of Federal Claims is to review the findings of fact and

conclusions of law of a special master on such a petition, the

court may receive further evidence in conducting such review.

"(C) Petitions currently pending in which the evidentiary

record is not closed shall proceed under the Program in

accordance with the law as amended by this section.

All pending cases which will proceed under the Program as amended

by this section shall be immediately suspended for 30 days to

enable the special masters and parties to prepare for proceeding

under the Program as amended by this section. In determining the

240-day period prescribed by section 2112(d) of the Public Health

Service Act [42 U.S.C. 300aa-12(d)], as amended by this section, or

the 420-day period prescribed by section 2121(b) of such Act [42

U.S.C. 300aa-21(b)], as so amended, any period of suspension under

the preceding sentence shall be excluded.

"(2) The amendments to section 2115 of the Public Health Service

Act [42 U.S.C. 300aa-15] shall apply to all pending and

subsequently filed petitions."

EFFECTIVE DATE

Subpart effective Oct. 1, 1988, see section 323 of Pub. L.

99-660, as amended, set out as a note under section 300aa-1 of this

title.

-FOOTNOTE-

(!1) So in original. Probably should be capitalized.

-End-

-CITE-

42 USC Sec. 300aa-11 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-11. Petitions for compensation

-STATUTE-

(a) General rule

(1) A proceeding for compensation under the Program for a

vaccine-related injury or death shall be initiated by service upon

the Secretary and the filing of a petition containing the matter

prescribed by subsection (c) of this section with the United States

Court of Federal Claims. The clerk of the United States Court of

Federal Claims shall immediately forward the filed petition to the

chief special master for assignment to a special master under

section 300aa-12(d)(1) of this title.

(2)(A) No person may bring a civil action for damages in an

amount greater than $1,000 or in an unspecified amount against a

vaccine administrator or manufacturer in a State or Federal court

for damages arising from a vaccine-related injury or death

associated with the administration of a vaccine after October 1,

1988, and no such court may award damages in an amount greater than

$1,000 in a civil action for damages for such a vaccine-related

injury or death, unless a petition has been filed, in accordance

with section 300aa-16 of this title, for compensation under the

Program for such injury or death and -

(i)(I) the United States Court of Federal Claims has issued a

judgment under section 300aa-12 of this title on such petition,

and

(II) such person elects under section 300aa-21(a) of this title

to file such an action, or

(ii) such person elects to withdraw such petition under section

300aa-21(b) of this title or such petition is considered

withdrawn under such section.

(B) If a civil action which is barred under subparagraph (A) is

filed in a State or Federal court, the court shall dismiss the

action. If a petition is filed under this section with respect to

the injury or death for which such civil action was brought, the

date such dismissed action was filed shall, for purposes of the

limitations of actions prescribed by section 300aa-16 of this

title, be considered the date the petition was filed if the

petition was filed within one year of the date of the dismissal of

the civil action.

(3) No vaccine administrator or manufacturer may be made a party

to a civil action (other than a civil action which may be brought

under paragraph (2)) for damages for a vaccine-related injury or

death associated with the administration of a vaccine after October

1, 1988.

(4) If in a civil action brought against a vaccine administrator

or manufacturer before October 1, 1988, damages were denied for a

vaccine-related injury or death or if such civil action was

dismissed with prejudice, the person who brought such action may

file a petition under subsection (b) of this section for such

injury or death.

(5)(A) A plaintiff who on October 1, 1988, has pending a civil

action for damages for a vaccine-related injury or death may, at

any time within 2 years after October 1, 1988, or before judgment,

whichever occurs first, petition to have such action dismissed

without prejudice or costs and file a petition under subsection (b)

of this section for such injury or death.

(B) If a plaintiff has pending a civil action for damages for a

vaccine-related injury or death, such person may not file a

petition under subsection (b) of this section for such injury or

death.

(6) If a person brings a civil action after November 15, 1988

(!1) for damages for a vaccine-related injury or death associated

with the administration of a vaccine before November 15, 1988, such

person may not file a petition under subsection (b) of this section

for such injury or death.

(7) If in a civil action brought against a vaccine administrator

or manufacturer for a vaccine-related injury or death damages are

awarded under a judgment of a court or a settlement of such action,

the person who brought such action may not file a petition under

subsection (b) of this section for such injury or death.

(8) If on October 1, 1988, there was pending an appeal or

rehearing with respect to a civil action brought against a vaccine

administrator or manufacturer and if the outcome of the last

appellate review of such action or the last rehearing of such

action is the denial of damages for a vaccine-related injury or

death, the person who brought such action may file a petition under

subsection (b) of this section for such injury or death.

(9) This subsection applies only to a person who has sustained a

vaccine-related injury or death and who is qualified to file a

petition for compensation under the Program.

(10) The Clerk of the United States Claims Court (!2) is

authorized to continue to receive, and forward, petitions for

compensation for a vaccine-related injury or death associated with

the administration of a vaccine on or after October 1, 1992.

(b) Petitioners

(1)(A) Except as provided in subparagraph (B), any person who has

sustained a vaccine-related injury, the legal representative of

such person if such person is a minor or is disabled, or the legal

representative of any person who died as the result of the

administration of a vaccine set forth in the Vaccine Injury Table

may, if the person meets the requirements of subsection (c)(1) of

this section, file a petition for compensation under the Program.

(B) No person may file a petition for a vaccine-related injury or

death associated with a vaccine administered before October 1,

1988, if compensation has been paid under this part for 3500

petitions for such injuries or deaths.

(2) Only one petition may be filed with respect to each

administration of a vaccine.

(c) Petition content

A petition for compensation under the Program for a

vaccine-related injury or death shall contain -

(1) except as provided in paragraph (3), an affidavit, and

supporting documentation, demonstrating that the person who

suffered such injury or who died -

(A) received a vaccine set forth in the Vaccine Injury Table

or, if such person did not receive such a vaccine, contracted

polio, directly or indirectly, from another person who received

an oral polio vaccine,

(B)(i) if such person received a vaccine set forth in the

Vaccine Injury Table -

(I) received the vaccine in the United States or in its

trust territories,

(II) received the vaccine outside the United States or a

trust territory and at the time of the vaccination such

person was a citizen of the United States serving abroad as a

member of the Armed Forces or otherwise as an employee of the

United States or a dependent of such a citizen, or

(III) received the vaccine outside the United States or a

trust territory and the vaccine was manufactured by a vaccine

manufacturer located in the United States and such person

returned to the United States not later than 6 months after

the date of the vaccination,

(ii) if such person did not receive such a vaccine but

contracted polio from another person who received an oral polio

vaccine, was a citizen of the United States or a dependent of

such a citizen,

(C)(i) sustained, or had significantly aggravated, any

illness, disability, injury, or condition set forth in the

Vaccine Injury Table in association with the vaccine referred

to in subparagraph (A) or died from the administration of such

vaccine, and the first symptom or manifestation of the onset or

of the significant aggravation of any such illness, disability,

injury, or condition or the death occurred within the time

period after vaccine administration set forth in the Vaccine

Injury Table, or

(ii)(I) sustained, or had significantly aggravated, any

illness, disability, injury, or condition not set forth in the

Vaccine Injury Table but which was caused by a vaccine referred

to in subparagraph (A), or

(II) sustained, or had significantly aggravated, any illness,

disability, injury, or condition set forth in the Vaccine

Injury Table the first symptom or manifestation of the onset or

significant aggravation of which did not occur within the time

period set forth in the Table but which was caused by a vaccine

referred to in subparagraph (A),

(D)(i) suffered the residual effects or complications of such

illness, disability, injury, or condition for more than 6

months after the administration of the vaccine, or (ii) died

from the administration of the vaccine, or (iii) suffered such

illness, disability, injury, or condition from the vaccine

which resulted in inpatient hospitalization and surgical

intervention, and

(E) has not previously collected an award or settlement of a

civil action for damages for such vaccine-related injury or

death,

(2) except as provided in paragraph (3), maternal prenatal and

delivery records, newborn hospital records (including all

physicians' and nurses' notes and test results), vaccination

records associated with the vaccine allegedly causing the injury,

pre- and post-injury physician or clinic records (including all

relevant growth charts and test results), all post-injury

inpatient and outpatient records (including all provider notes,

test results, and medication records), if applicable, a death

certificate, and if applicable, autopsy results, and

(3) an identification of any records of the type described in

paragraph (1) or (2) which are unavailable to the petitioner and

the reasons for their unavailability.

(d) Additional information

A petition may also include other available relevant medical

records relating to the person who suffered such injury or who died

from the administration of the vaccine.

(e) Schedule

The petitioner shall submit in accordance with a schedule set by

the special master assigned to the petition assessments,

evaluations, and prognoses and such other records and documents as

are reasonably necessary for the determination of the amount of

compensation to be paid to, or on behalf of, the person who

suffered such injury or who died from the administration of the

vaccine.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2111, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3758;

amended Pub. L. 100-203, title IV, Secs. 4302(b), 4304(a), (b),

4306, 4307(1), (2), Dec. 22, 1987, 101 Stat. 1330-221, 1330-223,

1330-224; Pub. L. 101-239, title VI, Sec. 6601(c)(1)-(7), Dec. 19,

1989, 103 Stat. 2285, 2286; Pub. L. 101-502, Sec. 5(a), Nov. 3,

1990, 104 Stat. 1286; Pub. L. 102-168, title II, Sec. 201(h)(1),

Nov. 26, 1991, 105 Stat. 1104; Pub. L. 102-572, title IX, Sec.

902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103-43, title XX,

Sec. 2012, June 10, 1993, 107 Stat. 214; Pub. L. 105-277, div. C,

title XV, Sec. 1502, Oct. 21, 1998, 112 Stat. 2681-741; Pub. L.

106-310, div. A, title XVII, Sec. 1701(a), Oct. 17, 2000, 114 Stat.

1151.)

-COD-

CODIFICATION

In subsecs. (a)(2)(A), (3), (4), (5)(A), (8), and (b)(1)(B),

"October 1, 1988" substituted for "the effective date of this

subpart" on authority of section 323 of Pub. L. 99-660, as amended,

set out as an Effective Date note under section 300aa-1 of this

title.

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-11, act July 1, 1944, Sec. 2112, was

successively renumbered by subsequent acts and transferred, see

section 238i of this title.

A prior section 2111 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238h of

this title.

AMENDMENTS

2000 - Subsec. (c)(1)(D)(iii). Pub. L. 106-310 added cl. (iii).

1998 - Subsec. (c)(1)(D)(i). Pub. L. 105-277 struck out "and

incurred unreimbursable expenses due in whole or in part to such

illness, disability, injury, or condition in an amount greater than

$1,000" before ", or (ii) died".

1993 - Subsec. (a)(10). Pub. L. 103-43 added par. (10).

1992 - Subsec. (a)(1), (2)(A)(i)(I). Pub. L. 102-572 substituted

"United States Court of Federal Claims" for "United States Claims

Court" wherever appearing.

1991 - Subsec. (a)(2)(A)(i), (ii). Pub. L. 102-168 realigned

margins of cls. (i) and (ii).

1990 - Subsec. (a)(2)(A). Pub. L. 101-502, Sec. 5(a)(1),

substituted "unless a petition has been filed, in accordance with

section 300aa-16 of this title, for compensation under the Program

for such injury or death and - " and cls. (i) and (ii) for "unless

-

"(i) a petition has been filed, in accordance with section

300aa-16 of this title, for compensation under the Program for

such injury or death,

"(ii) the United States Claims Court has issued a judgment

under section 300aa-12 of this title on such petition, and

"(iii) such person elects under section 300aa-21(a) of this

title to file such an action."

Subsec. (a)(5)(A). Pub. L. 101-502, Sec. 5(a)(2), struck out

"without prejudice" after "without prejudice or costs".

Subsec. (a)(5)(B). Pub. L. 101-502, Sec. 5(a)(3), substituted

"plaintiff" for "plaintiff who".

Subsec. (d). Pub. L. 101-502, Sec. 5(a)(4), struck out "(d)

except as provided in paragraph (3)," before "(d) Additional

information".

Subsec. (e). Pub. L. 101-502, Sec. 5(a)(5), substituted "(e)

Schedule" for "(e)(e) Schedule".

1989 - Subsec. (a)(1). Pub. L. 101-239, Sec. 6601(c)(1),

substituted "filing of a petition containing the matter prescribed

in subsection (c) of this section" for "filing of a petition" and

inserted at end "The clerk of the United States Claims Court shall

immediately forward the filed petition to the chief special master

for assignment to a special master under section 300aa-12(d)(1) of

this title."

Subsec. (a)(2)(A)(i). Pub. L. 101-239, Sec. 6601(c)(2), struck

out "under subsection (b) of this section" after "section 300aa-16

of this title,".

Subsec. (a)(5)(A). Pub. L. 101-239, Sec. 6601(c)(3)(A),

substituted "petition to have such action dismissed without

prejudice or costs" for "elect to withdraw such action".

Subsec. (a)(5)(B). Pub. L. 101-239, Sec. 6601(c)(3)(B),

substituted "has pending" for "on October 1, 1988, had pending" and

struck out "does not withdraw the action under subparagraph (A)"

after "vaccine-related injury or death".

Subsec. (a)(6). Pub. L. 101-239, Sec. 6601(c)(4), substituted

"November 15, 1988" for "the effective date of this subpart" in two

places.

Subsec. (a)(8). Pub. L. 101-239, Sec. 6601(c)(5), added par. (8).

Former par. (8) redesignated (9).

Subsec. (a)(9). Pub. L. 101-239, Sec. 6601(c)(5), (7),

redesignated par. (8) as (9) and realigned margin.

Subsec. (c)(1). Pub. L. 101-239, Sec. 6601(c)(6)(A), inserted

"except as provided in paragraph (3)," after "(1)" in introductory

provisions.

Subsec. (c)(2). Pub. L. 101-239, Sec. 6601(c)(6)(B), (C), added

par. (2) and redesignated former par. (2) as subsec. (d).

Pub. L. 101-239, Sec. 6601(c)(6)(A), inserted "except as provided

in paragraph (3)," after "(2)".

Subsec. (c)(3). Pub. L. 101-239, Sec. 6601(c)(6)(C), (D), added

par. (3). Former par. (3) redesignated subsec. (e).

Subsec. (d). Pub. L. 101-239, Sec. 6601(c)(6)(B), redesignated

former subsec. (c)(2) as subsec. (d), expanded margin to full

measure, inserted subsec. designation and heading, substituted "A

petition may also include other available" for "all available",

struck out "(including autopsy reports, if any)" after "relevant

medical records", and substituted "administration of the vaccine."

for "administration of the vaccine and an identification of any

unavailable records known to the petitioner and the reasons for

their unavailability, and".

Subsec. (e). Pub. L. 101-239, Sec. 6601(c)(6)(D), redesignated

former subsec. (c)(3) as subsec. (e), expanded margin to full

measure, inserted subsec. designation and heading, and substituted

"The petitioner shall submit in accordance with a schedule set by

the special master assigned to the petition" for "appropriate".

1987 - Subsec. (a)(1). Pub. L. 100-203, Sec. 4307(1), which

directed that par. (1) be amended by substituting "with the United

States Claims Court" for "with the United States district court for

the district in which the petitioner resides or the injury or death

occurred", was executed making the substitution for "with the

United States district court for the district in which the

petitioner resides or in which the injury or death occurred", as

the probable intent of Congress.

Subsec. (a)(2)(A). Pub. L. 100-203, Sec. 4306, substituted

"vaccine administrator or manufacturer" for "vaccine manufacturer".

Pub. L. 100-203, Sec. 4302(b)(1), substituted "effective date of

this subpart" for "effective date of this part".

Subsec. (a)(2)(A)(ii). Pub. L. 100-203, Sec. 4307(2), substituted

"the United States Claims Court" for "a district court of the

United States".

Subsec. (a)(3). Pub. L. 100-203, Sec. 4306, substituted "vaccine

administrator or manufacturer" for "vaccine manufacturer".

Pub. L. 100-203, Sec. 4302(b)(1), substituted "effective date of

this subpart" for "effective date of this part".

Subsec. (a)(4). Pub. L. 100-203, Sec. 4306, substituted "vaccine

administrator or manufacturer" for "vaccine manufacturer".

Pub. L. 100-203, Sec. 4302(b)(1), substituted "effective date of

this subpart" for "effective date of this part".

Subsec. (a)(5)(A). Pub. L. 100-203, Sec. 4302(b)(2), substituted

"after the effective date of this subpart" for "after the effective

date of this subchapter".

Pub. L. 100-203, Sec. 4302(b)(1), substituted "who on the

effective date of this subpart" for "who on the effective date of

this part".

Subsec. (a)(5)(B). Pub. L. 100-203, Sec. 4302(b)(1), substituted

"effective date of this subpart" for "effective date of this part".

Subsec. (a)(6). Pub. L. 100-203, Sec. 4302(b)(1), substituted

"effective date of this subpart" for "effective date of this part"

in two places.

Subsec. (a)(7). Pub. L. 100-203, Sec. 4306, substituted "vaccine

administrator or manufacturer" for "vaccine manufacturer".

Subsec. (a)(8). Pub. L. 100-203, Sec. 4304(a), added par. (8).

Subsec. (b)(1)(A). Pub. L. 100-203, Sec. 4304(b)(1), substituted

"may, if the person meets the requirements of subsection (c)(1) of

this section, file" for "may file".

Subsec. (b)(1)(B). Pub. L. 100-203, Sec. 4302(b)(1), substituted

"effective date of this subpart" for "effective date of this part".

Subsec. (c)(1)(D). Pub. L. 100-203, Sec. 4304(b)(2), substituted

"for more than 6 months" for "for more than 1 year", "and incurred"

for ", (ii) incurred", and "(ii)" for "(iii)".

-CHANGE-

CHANGE OF NAME

References to United States Claims Court deemed to refer to

United States Court of Federal Claims, see section 902(b) of Pub.

L. 102-572, set out as a note under section 171 of Title 28,

Judiciary and Judicial Procedure.

-MISC2-

EFFECTIVE DATE OF 2000 AMENDMENT

Pub. L. 106-310, div. A, title XVII, Sec. 1701(b), Oct. 17, 2000,

114 Stat. 1151, provided that: "The amendment made by subsection

(a) [amending this section] takes effect upon the date of the

enactment of this Act [Oct. 17, 2000], including with respect to

petitions under section 2111 of the Public Health Service Act [this

section] that are pending on such date."

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1991 AMENDMENT

Section 201(i) of Pub. L. 102-168 provided that:

"(1) Except as provided in paragraph (2), the amendments made by

this section [amending this section and sections 300aa-12,

300aa-15, 300aa-16, 300aa-19, and 300aa-21 of this title and

provisions set out as a note under section 300aa-1 of this title]

shall take effect on the date of the enactment of this Act [Nov.

26, 1991].

"(2) The amendments made by subsections (d) and (f) [amending

sections 300aa-12, 300aa-15, 300aa-16, and 300aa-21 of this title]

shall take effect as if the amendments had been in effect on and

after October 1, 1988."

EFFECTIVE DATE OF 1990 AMENDMENT

Section 5(h) of Pub. L. 101-502 provided that: "The amendments

made by subsections (f)(1) and (g) [amending section 300aa-21 of

this title and provisions set out as a note under section 300aa-1

of this title and enacting provisions set out as a note under

section 300aa-12 of this title] shall take effect as of November

14, 1986, and the amendments made by subsections (a) through (e)

and subsection (f)(2) [amending this section and sections 300aa-12,

300aa-13, 300aa-15, 300aa-16, and 300aa-21 of this title] shall

take effect as of September 30, 1990."

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-12, 300aa-13,

300aa-14, 300aa-15, 300aa-16, 300aa-21, 300aa-23, 300aa-34 of this

title.

-FOOTNOTE-

(!1) So in original. Probably should be followed by a comma.

(!2) See Change of Name note below.

-End-

-CITE-

42 USC Sec. 300aa-12 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-12. Court jurisdiction

-STATUTE-

(a) General rule

The United States Court of Federal Claims and the United States

Court of Federal Claims special masters shall, in accordance with

this section, have jurisdiction over proceedings to determine if a

petitioner under section 300aa-11 of this title is entitled to

compensation under the Program and the amount of such compensation.

The United States Court of Federal Claims may issue and enforce

such orders as the court deems necessary to assure the prompt

payment of any compensation awarded.

(b) Parties

(1) In all proceedings brought by the filing of a petition under

section 300aa-11(b) of this title, the Secretary shall be named as

the respondent, shall participate, and shall be represented in

accordance with section 518(a) of title 28.

(2) Within 30 days after the Secretary receives service of any

petition filed under section 300aa-11 of this title the Secretary

shall publish notice of such petition in the Federal Register. The

special master designated with respect to such petition under

subsection (c) of this section shall afford all interested persons

an opportunity to submit relevant, written information -

(A) relating to the existence of the evidence described in

section 300aa-13(a)(1)(B) of this title, or

(B) relating to any allegation in a petition with respect to

the matters described in section 300aa-11(c)(1)(C)(ii) of this

title.

(c) United States Court of Federal Claims special masters

(1) There is established within the United States Court of

Federal Claims an office of special masters which shall consist of

not more than 8 special masters. The judges of the United States

Court of Federal Claims shall appoint the special masters, 1 of

whom, by designation of the judges of the United States Court of

Federal Claims, shall serve as chief special master. The

appointment and reappointment of the special masters shall be by

the concurrence of a majority of the judges of the court.

(2) The chief special master and other special masters shall be

subject to removal by the judges of the United States Court of

Federal Claims for incompetency, misconduct, or neglect of duty or

for physical or mental disability or for other good cause shown.

(3) A special master's office shall be terminated if the judges

of the United States Court of Federal Claims determine, upon advice

of the chief special master, that the services performed by that

office are no longer needed.

(4) The appointment of any individual as a special master shall

be for a term of 4 years, subject to termination under paragraphs

(2) and (3). Individuals serving as special masters on December 19,

1989, shall serve for 4 years from the date of their original

appointment, subject to termination under paragraphs (2) and (3).

The chief special master in office on December 19, 1989, shall

continue to serve as chief special master for the balance of the

master's term, subject to termination under paragraphs (2) and (3).

(5) The compensation of the special masters shall be determined

by the judges of the United States Court of Federal Claims, upon

advice of the chief special master. The salary of the chief special

master shall be the annual rate of basic pay for level IV of the

Executive Schedule, as prescribed by section 5315, title 5. The

salaries of the other special masters shall not exceed the annual

rate of basic pay of level V of the Executive Schedule, as

prescribed by section 5316, title 5.

(6) The chief special master shall be responsible for the

following:

(A) Administering the office of special masters and their

staff, providing for the efficient, expeditious, and effective

handling of petitions, and performing such other duties related

to the Program as may be assigned to the chief special master by

a concurrence of a majority of the United States Claims Courts

(!1) judges.

(B) Appointing and fixing the salary and duties of such

administrative staff as are necessary. Such staff shall be

subject to removal for good cause by the chief special master.

(C) Managing and executing all aspects of budgetary and

administrative affairs affecting the special masters and their

staff, subject to the rules and regulations of the Judicial

Conference of the United States. The Conference rules and

regulations pertaining to United States magistrate judges shall

be applied to the special masters.

(D) Coordinating with the United States Court of Federal Claims

the use of services, equipment, personnel, information, and

facilities of the United States Court of Federal Claims without

reimbursement.

(E) Reporting annually to the Congress and the judges of the

United States Court of Federal Claims on the number of petitions

filed under section 300aa-11 of this title and their disposition,

the dates on which the vaccine-related injuries and deaths for

which the petitions were filed occurred, the types and amounts of

awards, the length of time for the disposition of petitions, the

cost of administering the Program, and recommendations for

changes in the Program.

(d) Special masters

(1) Following the receipt and filing of a petition under section

300aa-11 of this title, the clerk of the United States Court of

Federal Claims shall forward the petition to the chief special

master who shall designate a special master to carry out the

functions authorized by paragraph (3).

(2) The special masters shall recommend rules to the Court of

Federal Claims and, taking into account such recommended rules, the

Court of Federal Claims shall promulgate rules pursuant to section

2071 of title 28. Such rules shall -

(A) provide for a less-adversarial, expeditious, and informal

proceeding for the resolution of petitions,

(B) include flexible and informal standards of admissibility of

evidence,

(C) include the opportunity for summary judgment,

(D) include the opportunity for parties to submit arguments and

evidence on the record without requiring routine use of oral

presentations, cross examinations, or hearings, and

(E) provide for limitations on discovery and allow the special

masters to replace the usual rules of discovery in civil actions

in the United States Court of Federal Claims.

(3)(A) A special master to whom a petition has been assigned

shall issue a decision on such petition with respect to whether

compensation is to be provided under the Program and the amount of

such compensation. The decision of the special master shall -

(i) include findings of fact and conclusions of law, and

(ii) be issued as expeditiously as practicable but not later

than 240 days, exclusive of suspended time under subparagraph

(C), after the date the petition was filed.

The decision of the special master may be reviewed by the United

States Court of Federal Claims in accordance with subsection (e) of

this section.

(B) In conducting a proceeding on a petition a special master -

(i) may require such evidence as may be reasonable and

necessary,

(ii) may require the submission of such information as may be

reasonable and necessary,

(iii) may require the testimony of any person and the

production of any documents as may be reasonable and necessary,

(iv) shall afford all interested persons an opportunity to

submit relevant written information -

(I) relating to the existence of the evidence described in

section 300aa-13(a)(1)(B) of this title, or

(II) relating to any allegation in a petition with respect to

the matters described in section 300aa-11(c)(1)(C)(ii) of this

title, and

(v) may conduct such hearings as may be reasonable and

necessary.

There may be no discovery in a proceeding on a petition other than

the discovery required by the special master.

(C) In conducting a proceeding on a petition a special master

shall suspend the proceedings one time for 30 days on the motion of

either party. After a motion for suspension is granted, further

motions for suspension by either party may be granted by the

special master, if the special master determines the suspension is

reasonable and necessary, for an aggregate period not to exceed 150

days.

(D) If, in reviewing proceedings on petitions for vaccine-related

injuries or deaths associated with the administration of vaccines

before October 1, 1988, the chief special master determines that

the number of filings and resultant workload place an undue burden

on the parties or the special master involved in such proceedings,

the chief special master may, in the interest of justice, suspend

proceedings on any petition for up to 30 months (but for not more

than 6 months at a time) in addition to the suspension time under

subparagraph (C).

(4)(A) Except as provided in subparagraph (B), information

submitted to a special master or the court in a proceeding on a

petition may not be disclosed to a person who is not a party to the

proceeding without the express written consent of the person who

submitted the information.

(B) A decision of a special master or the court in a proceeding

shall be disclosed, except that if the decision is to include

information -

(i) which is trade secret or commercial or financial

information which is privileged and confidential, or

(ii) which are medical files and similar files the disclosure

of which would constitute a clearly unwarranted invasion of

privacy,

and if the person who submitted such information objects to the

inclusion of such information in the decision, the decision shall

be disclosed without such information.

(e) Action by United States Court of Federal Claims

(1) Upon issuance of the special master's decision, the parties

shall have 30 days to file with the clerk of the United States

Court of Federal Claims a motion to have the court review the

decision. If such a motion is filed, the other party shall file a

response with the clerk of the United States Court of Federal

Claims no later than 30 days after the filing of such motion.

(2) Upon the filing of a motion under paragraph (1) with respect

to a petition, the United States Court of Federal Claims shall have

jurisdiction to undertake a review of the record of the proceedings

and may thereafter -

(A) uphold the findings of fact and conclusions of law of the

special master and sustain the special master's decision,

(B) set aside any findings of fact or conclusion of law of the

special master found to be arbitrary, capricious, an abuse of

discretion, or otherwise not in accordance with law and issue its

own findings of fact and conclusions of law, or

(C) remand the petition to the special master for further

action in accordance with the court's direction.

The court shall complete its action on a petition within 120 days

of the filing of a response under paragraph (1) excluding any days

the petition is before a special master as a result of a remand

under subparagraph (C). The court may allow not more than 90 days

for remands under subparagraph (C).

(3) In the absence of a motion under paragraph (1) respecting the

special master's decision or if the United States Court of Federal

Claims takes the action described in paragraph (2)(A) with respect

to the special master's decision, the clerk of the United States

Court of Federal Claims shall immediately enter judgment in

accordance with the special master's decision.

(f) Appeals

The findings of fact and conclusions of law of the United States

Court of Federal Claims on a petition shall be final determinations

of the matters involved, except that the Secretary or any

petitioner aggrieved by the findings or conclusions of the court

may obtain review of the judgment of the court in the United States

court of appeals for the Federal Circuit upon petition filed within

60 days of the date of the judgment with such court of appeals

within 60 days of the date of entry of the United States Claims

Court's (!2) judgment with such court of appeals.

(g) Notice

If -

(1) a special master fails to make a decision on a petition

within the 240 days prescribed by subsection (d)(3)(A)(ii) of

this section (excluding (A) any period of suspension under

subsection (d)(3)(C) or (d)(3)(D) of this section, and (B) any

days the petition is before a special master as a result of a

remand under subsection (e)(2)(C) of this section), or

(2) the United States Court of Federal Claims fails to enter a

judgment under this section on a petition within 420 days

(excluding (A) any period of suspension under subsection

(d)(3)(C) or (d)(3)(D) of this section, and (B) any days the

petition is before a special master as a result of a remand under

subsection (e)(2)(C) of this section) after the date on which the

petition was filed,

the special master or court shall notify the petitioner under such

petition that the petitioner may withdraw the petition under

section 300aa-21(b) of this title or the petitioner may choose

under section 300aa-21(b) of this title to have the petition remain

before the special master or court, as the case may be.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2112, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3761;

amended Pub. L. 100-203, title IV, Secs. 4303(d)(2)(A), 4307(3),

4308(a), (b), Dec. 22, 1987, 101 Stat. 1330-222, 1330-224; Pub. L.

100-360, title IV, Sec. 411(o)(2), (3)(A), July 1, 1988, 102 Stat.

808; Pub. L. 101-239, title VI, Sec. 6601(d)-(i), Dec. 19, 1989,

103 Stat. 2286-2290; Pub. L. 101-502, Sec. 5(b), Nov. 3, 1990, 104

Stat. 1286; Pub. L. 101-650, title III, Sec. 321, Dec. 1, 1990, 104

Stat. 5117; Pub. L. 102-168, title II, Sec. 201(c), (d)(1), (h)(2),

(3), Nov. 26, 1991, 105 Stat. 1103, 1104; Pub. L. 102-572, title

IX, Sec. 902(b), Oct. 29, 1992, 106 Stat. 4516; Pub. L. 103-66,

title XIII, Sec. 13632(c), Aug. 10, 1993, 107 Stat. 646.)

-COD-

CODIFICATION

In subsec. (c)(4), "on December 19, 1989," substituted for "upon

the date of the enactment of this subsection" and "on the date of

the enactment of this subsection".

In subsec. (d)(3)(D), "October 1, 1988," substituted for "the

effective date of this part".

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-12, act July 1, 1944, Sec. 2113, was

successively renumbered by subsequent acts and transferred, see

section 238j of this title.

A prior section 2112 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238i of

this title.

AMENDMENTS

1993 - Subsec. (d)(3)(D). Pub. L. 103-66 substituted "30 months

(but for not more than 6 months at a time)" for "540 days".

1992 - Subsecs. (a), (c) to (g). Pub. L. 102-572 substituted

"United States Court of Federal Claims" for "United States Claims

Court" and "Court of Federal Claims" for "Claims Court", wherever

appearing.

1991 - Subsec. (d)(3)(D). Pub. L. 102-168, Sec. 201(c), (h)(2),

realigned margin and substituted "540 days" for "180 days".

Subsec. (g). Pub. L. 102-168, Sec. 201(h)(3), made technical

amendment to underlying provisions of original Act.

Pub. L. 102-168, Sec. 201(d)(1), substituted "or the petitioner

may choose under section 300aa-21(b) of this title to have the

petition remain before the special master or court, as the case may

be" for "and the petition will be considered withdrawn under such

section if the petitioner, the special master, or the court do not

take certain actions" before period at end.

1990 - Subsec. (d)(3)(D). Pub. L. 101-502, Sec. 5(b)(1), added

subpar. (D).

Subsec. (g). Pub. L. 101-502, Sec. 5(b)(2), added subsec. (g).

1989 - Subsec. (a). Pub. L. 101-239, Sec. 6601(d), substituted

"and the United States Claims Court special masters shall, in

accordance with this section, have jurisdiction" for "shall have

jurisdiction (1)", ". The United States Claims Court may issue" for

", and (2) to issue", and "deems" for "deem".

Subsec. (b)(1). Pub. L. 101-239, Sec. 6601(f), substituted "In

all proceedings brought by the filing of a petition under section

300aa-11(b) of this title, the Secretary shall be named as the

respondent, shall participate, and shall be represented in

accordance with section 518(a) of title 28." for "The Secretary

shall be named as the respondent in all proceedings brought by the

filing of a petition under section 300aa-11(b) of this title.

Except as provided in paragraph (2), no other person may intervene

in any such proceeding."

Subsec. (c). Pub. L. 101-239, Sec. 6601(e)(2), added subsec. (c).

Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 101-239, Sec. 6601(e)(1), redesignated

subsec. (c) as (d). Former subsec. (d) redesignated (e).

Subsec. (d)(1). Pub. L. 101-239, Sec. 6601(g)(1), amended par.

(1) generally. Prior to amendment, par. (1) read as follows:

"Following receipt of a petition under subsection (a) of this

section, the United States Claims Court shall designate a special

master to carry out the functions authorized by paragraph (2)."

Subsec. (d)(2) to (4). Pub. L. 101-239, Sec. 6601(g)(2), added

pars. (2) to (4) and struck out former par. (2) which prescribed

functions of special masters.

Subsec. (e). Pub. L. 101-239, Sec. 6601(h), substituted "Action

by United States Claims Court" for "Action by court" as heading and

amended text generally. Prior to amendment, text read as follows:

"(1) Upon objection by the petitioner or respondent to the

proposed findings of fact or conclusions of law prepared by the

special master or upon the court's own motion, the court shall

undertake a review of the record of the proceedings and may

thereafter make a de novo determination of any matter and issue its

judgment accordingly, including findings of fact and conclusions of

law, or remand for further proceedings.

"(2) If no objection is filed under paragraph (1) or if the court

does not choose to review the proceeding, the court shall adopt the

proposed findings of fact and conclusions of law of the special

master as its own and render judgment thereon.

"(3) The court shall render its judgment on any petition filed

under the Program as expeditiously as practicable but not later

than 365 days after the date on which the petition was filed."

Pub. L. 101-239, Sec. 6601(e)(1), redesignated subsec. (d) as

(e). Former subsec. (e) redesignated (f).

Subsec. (f). Pub. L. 101-239, Sec. 6601(i), inserted "within 60

days of the date of entry of the United States Claims Court's

judgment with such court of appeals" after "with such court of

appeals".

Pub. L. 101-239, Sec. 6601(e)(1), redesignated subsec. (e) as

(f).

1988 - Subsec. (c)(2). Pub. L. 100-360, Sec. 411(o)(3)(A), added

Pub. L. 100-203, Sec. 4308(a), see 1987 Amendment note below.

Subsec. (e). Pub. L. 100-360, Sec. 411(o)(2), made technical

amendment to directory language of Pub. L. 100-203, Sec.

4307(3)(C), see 1987 Amendment note below.

Pub. L. 100-360, Sec. 411(o)(3)(A), added Pub. L. 100-203, Sec.

4308(b), see 1987 Amendment note below.

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4307(3)(A), substituted

"United States Claims Court" for "district courts of the United

States" and "the court" for "the courts".

Subsec. (c)(1). Pub. L. 100-203, Sec. 4307(3)(B), substituted

"the United States Claims Court" for "the district court of the

United States in which the petition is filed".

Subsec. (c)(2). Pub. L. 100-203, Sec. 4308(a), as added by Pub.

L. 100-360, Sec. 411(o)(3)(A), inserted ", shall prepare and submit

to the court proposed findings of fact and conclusions of law," in

introductory provisions and struck out subpar. (E) which read as

follows: "prepare and submit to the court proposed findings of fact

and conclusions of law."

Subsec. (e). Pub. L. 100-203, Sec. 4308(b), as added by Pub. L.

100-360, Sec. 411(o)(3)(A), inserted "within 60 days of the date of

the judgment" after "petition filed".

Pub. L. 100-203, Sec. 4307(3)(C), as amended by Pub. L. 100-360,

Sec. 411(o)(2), substituted "the United States Claims Court" for "a

district court of the United States" and "for the Federal Circuit"

for "for the circuit in which the court is located".

Pub. L. 100-203, Sec. 4303(d)(2)(A), redesignated subsec. (g) as

(e) and struck out former subsec. (e) relating to administration of

an award.

Subsec. (f). Pub. L. 100-203, Sec. 4303(d)(2)(A), struck out

subsec. (f) which related to revision of an award.

Subsec. (g). Pub. L. 100-203, Sec. 4303(d)(2)(A), redesignated

subsec. (g) as (e).

-CHANGE-

CHANGE OF NAME

"United States magistrate judges" substituted for "United States

magistrates" in subsec. (c)(6)(C) pursuant to section 321 of Pub.

L. 101-650, set out as a note under section 631 of Title 28,

Judiciary and Judicial Procedure.

-MISC2-

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1991 AMENDMENT

Amendment by section 201(d)(1) of Pub. L. 102-168 effective as if

in effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub.

L. 102-168, set out as a note under section 300aa-11 of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-502 effective Sept. 30, 1990, see

section 5(h) of Pub. L. 101-502, set out as a note under section

300aa-11 of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, except that

such suspension be excluded in determining the 240-day period

prescribed in subsec. (d) of this section, see section 6601(s)(1)

of Pub. L. 101-239, set out as a note under section 300aa-10 of

this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by Pub. L. 100-360, as it relates to a provision

in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203,

effective as if included in the enactment of that provision in Pub.

L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a

Reference to OBRA; Effective Date note under section 106 of Title

1, General Provisions.

TERMINATION OF REPORTING REQUIREMENTS

For termination, effective May 15, 2000, of provisions in subsec.

(c)(6)(E) of this section relating to reporting annually to the

Congress, see section 3003 of Pub. L. 104-66, as amended, set out

as a note under section 1113 of Title 31, Money and Finance, and

page 13 of House Document No. 103-7.

REVIEW BY 3-JUDGE PANEL

Section 322(c) of Pub. L. 99-660, as added by Pub. L. 101-502,

Sec. 5(g)(2), Nov. 3, 1990, 104 Stat. 1288, and amended by Pub. L.

102-572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516,

provided that: "If the review authorized by section 2112(f)

[subsec. (f) of this section] is held invalid because the judgment

of the United States Court of Federal Claims being reviewed did not

arise from a case or controversy under Article III of the

Constitution, such judgment shall be reviewed by a 3-judge panel of

the United States Court of Federal Claims. Such panel shall not

include the judge who participated in such judgment."

[Enactment of section 322(c) of Pub. L. 99-660 by section 5(g)(2)

of Pub. L. 101-502, set out above, effective Nov. 14, 1986, see

section 5(h) of Pub. L. 101-502, set out as an Effective Date of

1990 Amendment note under section 300aa-11 of this title.]

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-11, 300aa-15,

300aa-21 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be a reference to the United

States Court of Federal Claims.

(!2) So in original. Probably should be a reference to the

United States Court of Federal Claims.

-End-

-CITE-

42 USC Sec. 300aa-13 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-13. Determination of eligibility and compensation

-STATUTE-

(a) General rule

(1) Compensation shall be awarded under the Program to a

petitioner if the special master or court finds on the record as a

whole -

(A) that the petitioner has demonstrated by a preponderance of

the evidence the matters required in the petition by section

300aa-11(c)(1) of this title, and

(B) that there is not a preponderance of the evidence that the

illness, disability, injury, condition, or death described in the

petition is due to factors unrelated to the administration of the

vaccine described in the petition.

The special master or court may not make such a finding based on

the claims of a petitioner alone, unsubstantiated by medical

records or by medical opinion.

(2) For purposes of paragraph (1), the term "factors unrelated to

the administration of the vaccine" -

(A) does not include any idiopathic, unexplained, unknown,

hypothetical, or undocumentable cause, factor, injury, illness,

or condition, and

(B) may, as documented by the petitioner's evidence or other

material in the record, include infection, toxins, trauma

(including birth trauma and related anoxia), or metabolic

disturbances which have no known relation to the vaccine

involved, but which in the particular case are shown to have been

the agent or agents principally responsible for causing the

petitioner's illness, disability, injury, condition, or death.

(b) Matters to be considered

(1) In determining whether to award compensation to a petitioner

under the Program, the special master or court shall consider, in

addition to all other relevant medical and scientific evidence

contained in the record -

(A) any diagnosis, conclusion, medical judgment, or autopsy or

coroner's report which is contained in the record regarding the

nature, causation, and aggravation of the petitioner's illness,

disability, injury, condition, or death, and

(B) the results of any diagnostic or evaluative test which are

contained in the record and the summaries and conclusions.

Any such diagnosis, conclusion, judgment, test result, report, or

summary shall not be binding on the special master or court. In

evaluating the weight to be afforded to any such diagnosis,

conclusion, judgment, test result, report, or summary, the special

master or court shall consider the entire record and the course of

the injury, disability, illness, or condition until the date of the

judgment of the special master or court.

(2) The special master or court may find the first symptom or

manifestation of onset or significant aggravation of an injury,

disability, illness, condition, or death described in a petition

occurred within the time period described in the Vaccine Injury

Table even though the occurrence of such symptom or manifestation

was not recorded or was incorrectly recorded as having occurred

outside such period. Such a finding may be made only upon

demonstration by a preponderance of the evidence that the onset or

significant aggravation of the injury, disability, illness,

condition, or death described in the petition did in fact occur

within the time period described in the Vaccine Injury Table.

(c) "Record" defined

For purposes of this section, the term "record" means the record

established by the special masters of the United States Court of

Federal Claims in a proceeding on a petition filed under section

300aa-11 of this title.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2113, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3763;

amended Pub. L. 100-203, title IV, Sec. 4307(4), Dec. 22, 1987, 101

Stat. 1330-224; Pub. L. 101-239, title VI, Sec. 6601(j), Dec. 19,

1989, 103 Stat. 2290; Pub. L. 101-502, Sec. 5(c), Nov. 3, 1990, 104

Stat. 1287; Pub. L. 102-572, title IX, Sec. 902(b)(1), Oct. 29,

1992, 106 Stat. 4516.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-13, act July 1, 1944, Sec. 2114, was

successively renumbered by subsequent acts and transferred, see

section 238k of this title.

A prior section 2113 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238j of

this title.

AMENDMENTS

1992 - Subsec. (c). Pub. L. 102-572 substituted "United States

Court of Federal Claims" for "United States Claims Court".

1990 - Subsec. (c). Pub. L. 101-502 inserted "the" after "special

masters of".

1989 - Subsecs. (a)(1), (b). Pub. L. 101-239, Sec. 6601(j)(1),

substituted "special master or court" for "court" wherever

appearing.

Subsec. (c). Pub. L. 101-239, Sec. 6601(j)(2), inserted "special

masters of" after "established by the".

1987 - Subsec. (c). Pub. L. 100-203 substituted "the United

States Claims Court" for "a district court of the United States".

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-502 effective Sept. 30, 1990, see

section 5(h) of Pub. L. 101-502, set out as a note under section

300aa-11 of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-12 of this title.

-End-

-CITE-

42 USC Sec. 300aa-14 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-14. Vaccine Injury Table

-STATUTE-

(a) Initial table

The following is a table of vaccines, the injuries, disabilities,

illnesses, conditions, and deaths resulting from the administration

of such vaccines, and the time period in which the first symptom or

manifestation of onset or of the significant aggravation of such

injuries, disabilities, illnesses, conditions, and deaths is to

occur after vaccine administration for purposes of receiving

compensation under the Program:

VACCINE INJURY TABLE

--------------------------------------------------------------------

I. DTP; P; DTP/Polio

Combination; or Any

Other Vaccine

Containing Whole Cell

Pertussis Bacteria,

Extracted or Partial

Cell Bacteria, or

Specific Pertussis

Antigen(s).

Illness, disability, Time period for first

injury, or condition symptom or

covered: manifestation of onset

or of significant

aggravation after

vaccine administration:

A. Anaphylaxis or 24 hours

anaphylactic shock

B. Encephalopathy (or 3 days

encephalitis)

C. Shock-collapse or 3 days

hypotonic-

hyporesponsive collapse

D. Residual seizure 3 days

disorder in accordance

with subsection (b)(2)

E. Any acute Not applicable

complication or sequela

(including death) of an

illness, disability,

injury, or condition

referred to above which

illness, disability,

injury, or condition

arose within the time

period prescribed

II. Measles, mumps,

rubella, or any vaccine

containing any of the

foregoing as a

component; DT; Td; or

Tetanus Toxoid.

A. Anaphylaxis or 24 hours

anaphylactic shock

B. Encephalopathy (or 15 days (for mumps,

encephalitis) rubella, measles, or

any vaccine containing

any of the foregoing as

a component). 3 days

(for DT, Td, or tetanus

toxoid).

C. Residual seizure 15 days (for mumps,

disorder in accordance rubella, measles, or

with subsection (b)(2) any vaccine containing

any of the foregoing as

a component). 3 days

(for DT, Td, or tetanus

toxoid).

D. Any acute Not applicable

complication or sequela

(including death) of an

illness, disability,

injury, or condition

referred to above which

illness, disability,

injury, or condition

arose within the time

period prescribed

III. Polio Vaccines (other

than Inactivated Polio

Vaccine).

A. Paralytic polio

- in a 30 days

non-immunodeficient

recipient

- in an 6 months

immunodeficient

recipient

- in a Not applicable

vaccine-associated

community case

B. Any acute Not applicable

complication or sequela

(including death) of an

illness, disability,

injury, or condition

referred to above which

illness, disability,

injury, or condition

arose within the time

period prescribed

IV. Inactivated Polio

Vaccine.

A. Anaphylaxis or 24 hours

anaphylactic shock

B. Any acute Not applicable

complication or sequela

(including death) of an

illness, disability,

injury, or condition

referred to above which

illness, disability,

injury, or condition

arose within the time

period prescribed

--------------------------------------------------------------------

(b) Qualifications and aids to interpretation

The following qualifications and aids to interpretation shall

apply to the Vaccine Injury Table in subsection (a) of this

section:

(1) A shock-collapse or a hypotonic-hyporesponsive collapse may

be evidenced by indicia or symptoms such as decrease or loss of

muscle tone, paralysis (partial or complete), hemiplegia or

hemiparesis, loss of color or turning pale white or blue,

unresponsiveness to environmental stimuli, depression of

consciousness, loss of consciousness, prolonged sleeping with

difficulty arousing, or cardiovascular or respiratory arrest.

(2) A petitioner may be considered to have suffered a residual

seizure disorder if the petitioner did not suffer a seizure or

convulsion unaccompanied by fever or accompanied by a fever of

less than 102 degrees Fahrenheit before the first seizure or

convulsion after the administration of the vaccine involved and

if -

(A) in the case of a measles, mumps, or rubella vaccine or

any combination of such vaccines, the first seizure or

convulsion occurred within 15 days after administration of the

vaccine and 2 or more seizures or convulsions occurred within 1

year after the administration of the vaccine which were

unaccompanied by fever or accompanied by a fever of less than

102 degrees Fahrenheit, and

(B) in the case of any other vaccine, the first seizure or

convulsion occurred within 3 days after administration of the

vaccine and 2 or more seizures or convulsions occurred within 1

year after the administration of the vaccine which were

unaccompanied by fever or accompanied by a fever of less than

102 degrees Fahrenheit.

(3)(A) The term "encephalopathy" means any significant acquired

abnormality of, or injury to, or impairment of function of the

brain. Among the frequent manifestations of encephalopathy are

focal and diffuse neurologic signs, increased intracranial

pressure, or changes lasting at least 6 hours in level of

consciousness, with or without convulsions. The neurological

signs and symptoms of encephalopathy may be temporary with

complete recovery, or may result in various degrees of permanent

impairment. Signs and symptoms such as high pitched and unusual

screaming, persistent unconsolable crying, and bulging fontanel

are compatible with an encephalopathy, but in and of themselves

are not conclusive evidence of encephalopathy. Encephalopathy

usually can be documented by slow wave activity on an

electroencephalogram.

(B) If in a proceeding on a petition it is shown by a

preponderance of the evidence that an encephalopathy was caused

by infection, toxins, trauma, or metabolic disturbances the

encephalopathy shall not be considered to be a condition set

forth in the table. If at the time a judgment is entered on a

petition filed under section 300aa-11 of this title for a

vaccine-related injury or death it is not possible to determine

the cause, by a preponderance of the evidence, of an

encephalopathy, the encephalopathy shall be considered to be a

condition set forth in the table. In determining whether or not

an encephalopathy is a condition set forth in the table, the

court shall consider the entire medical record.

(4) For purposes of paragraphs (2) and (3), the terms "seizure"

and "convulsion" include grand mal, petit mal, absence,

myoclonic, tonic-clonic, and focal motor seizures and signs. If a

provision of the table to which paragraph (1), (2), (3), or (4)

applies is revised under subsection (c) or (d) of this section,

such paragraph shall not apply to such provision after the

effective date of the revision unless the revision specifies that

such paragraph is to continue to apply.

(c) Administrative revision of table

(1) The Secretary may promulgate regulations to modify in

accordance with paragraph (3) the Vaccine Injury Table. In

promulgating such regulations, the Secretary shall provide for

notice and opportunity for a public hearing and at least 180 days

of public comment.

(2) Any person (including the Advisory Commission on Childhood

Vaccines) may petition the Secretary to propose regulations to

amend the Vaccine Injury Table. Unless clearly frivolous, or

initiated by the Commission, any such petition shall be referred to

the Commission for its recommendations. Following -

(A) receipt of any recommendation of the Commission, or

(B) 180 days after the date of the referral to the Commission,

whichever occurs first, the Secretary shall conduct a rulemaking

proceeding on the matters proposed in the petition or publish in

the Federal Register a statement of reasons for not conducting such

proceeding.

(3) A modification of the Vaccine Injury Table under paragraph

(1) may add to, or delete from, the list of injuries, disabilities,

illnesses, conditions, and deaths for which compensation may be

provided or may change the time periods for the first symptom or

manifestation of the onset or the significant aggravation of any

such injury, disability, illness, condition, or death.

(4) Any modification under paragraph (1) of the Vaccine Injury

Table shall apply only with respect to petitions for compensation

under the Program which are filed after the effective date of such

regulation.

(d) Role of Commission

Except with respect to a regulation recommended by the Advisory

Commission on Childhood Vaccines, the Secretary may not propose a

regulation under subsection (c) of this section or any revision

thereof, unless the Secretary has first provided to the Commission

a copy of the proposed regulation or revision, requested

recommendations and comments by the Commission, and afforded the

Commission at least 90 days to make such recommendations.

(e) Additional vaccines

(1) Vaccines recommended before August 1, 1993

By August 1, 1995, the Secretary shall revise the Vaccine

Injury Table included in subsection (a) of this section to

include -

(A) vaccines which are recommended to the Secretary by the

Centers for Disease Control and Prevention before August 1,

1993, for routine administration to children,

(B) the injuries, disabilities, illnesses, conditions, and

deaths associated with such vaccines, and

(C) the time period in which the first symptoms or

manifestations of onset or other significant aggravation of

such injuries, disabilities, illnesses, conditions, and deaths

associated with such vaccines may occur.

(2) Vaccines recommended after August 1, 1993

When after August 1, 1993, the Centers for Disease Control and

Prevention recommends a vaccine to the Secretary for routine

administration to children, the Secretary shall, within 2 years

of such recommendation, amend the Vaccine Injury Table included

in subsection (a) of this section to include -

(A) vaccines which were recommended for routine

administration to children,

(B) the injuries, disabilities, illnesses, conditions, and

deaths associated with such vaccines, and

(C) the time period in which the first symptoms or

manifestations of onset or other significant aggravation of

such injuries, disabilities, illnesses, conditions, and deaths

associated with such vaccines may occur.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2114, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3764;

amended Pub. L. 101-239, title VI, Sec. 6601(k), Dec. 19, 1989, 103

Stat. 2290; Pub. L. 103-66, title XIII, Sec. 13632(a)(2), Aug. 10,

1993, 107 Stat. 645.)

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-14, act July 1, 1944, Sec. 2115, was

successively renumbered by subsequent acts and transferred, see

section 238l of this title.

A prior section 2114 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238k of

this title.

AMENDMENTS

1993 - Subsec. (e). Pub. L. 103-66 amended heading and text of

subsec. (e) generally. Prior to amendment, text read as follows:

"The Secretary may recommend to Congress revisions of the table to

change the vaccines covered by the table."

1989 - Subsec. (a). Pub. L. 101-239, Sec. 6601(k)(1), substituted

"(b)(2)" for "(c)(2)" in items I.D. and II.C. in table.

Subsec. (b)(3)(B). Pub. L. 101-239, Sec. 6601(k)(2), substituted

"300aa-11 of this title" for "300aa-11(b) of this title".

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

REVISIONS OF VACCINE INJURY TABLE

The Vaccine Injury Table as modified by regulations promulgated

by the Secretary of Health and Human Services is set out at 42 CFR

100.3.

Section 13632(a)(3) of Pub. L. 103-66 provided that: "A revision

by the Secretary under section 2114(e) of the Public Health Service

Act (42 U.S.C. 300aa-14(e)) (as amended by paragraph (2)) shall

take effect upon the effective date of a tax enacted to provide

funds for compensation paid with respect to the vaccine to be added

to the vaccine injury table in section 2114(a) of the Public Health

Service Act (42 U.S.C. 300aa-14(a))."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-25, 300aa-33 of

this title.

-End-

-CITE-

42 USC Sec. 300aa-15 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-15. Compensation

-STATUTE-

(a) General rule

Compensation awarded under the Program to a petitioner under

section 300aa-11 of this title for a vaccine-related injury or

death associated with the administration of a vaccine after October

1, 1988, shall include the following:

(1)(A) Actual unreimbursable expenses incurred from the date of

the judgment awarding such expenses and reasonable projected

unreimbursable expenses which -

(i) result from the vaccine-related injury for which the

petitioner seeks compensation,

(ii) have been or will be incurred by or on behalf of the

person who suffered such injury, and

(iii)(I) have been or will be for diagnosis and medical or

other remedial care determined to be reasonably necessary, or

(II) have been or will be for rehabilitation, developmental

evaluation, special education, vocational training and

placement, case management services, counseling, emotional or

behavioral therapy, residential and custodial care and service

expenses, special equipment, related travel expenses, and

facilities determined to be reasonably necessary.

(B) Subject to section 300aa-16(a)(2) of this title, actual

unreimbursable expenses incurred before the date of the judgment

awarding such expenses which -

(i) resulted from the vaccine-related injury for which the

petitioner seeks compensation,

(ii) were incurred by or on behalf of the person who suffered

such injury, and

(iii) were for diagnosis, medical or other remedial care,

rehabilitation, developmental evaluation, special education,

vocational training and placement, case management services,

counseling, emotional or behavioral therapy, residential and

custodial care and service expenses, special equipment, related

travel expenses, and facilities determined to be reasonably

necessary.

(2) In the event of a vaccine-related death, an award of

$250,000 for the estate of the deceased.

(3)(A) In the case of any person who has sustained a

vaccine-related injury after attaining the age of 18 and whose

earning capacity is or has been impaired by reason of such

person's vaccine-related injury for which compensation is to be

awarded, compensation for actual and anticipated loss of earnings

determined in accordance with generally recognized actuarial

principles and projections.

(B) In the case of any person who has sustained a

vaccine-related injury before attaining the age of 18 and whose

earning capacity is or has been impaired by reason of such

person's vaccine-related injury for which compensation is to be

awarded and whose vaccine-related injury is of sufficient

severity to permit reasonable anticipation that such person is

likely to suffer impaired earning capacity at age 18 and beyond,

compensation after attaining the age of 18 for loss of earnings

determined on the basis of the average gross weekly earnings of

workers in the private, non-farm sector, less appropriate taxes

and the average cost of a health insurance policy, as determined

by the Secretary.

(4) For actual and projected pain and suffering and emotional

distress from the vaccine-related injury, an award not to exceed

$250,000.

(b) Vaccines administered before effective date

Compensation awarded under the Program to a petitioner under

section 300aa-11 of this title for a vaccine-related injury or

death associated with the administration of a vaccine before

October 1, 1988, may include the compensation described in

paragraphs (1)(A) and (2) of subsection (a) of this section and may

also include an amount, not to exceed a combined total of $30,000,

for -

(1) lost earnings (as provided in paragraph (3) of subsection

(a) of this section),

(2) pain and suffering (as provided in paragraph (4) of

subsection (a) of this section), and

(3) reasonable attorneys' fees and costs (as provided in

subsection (e) of this section.(!1)

(c) Residential and custodial care and service

The amount of any compensation for residential and custodial care

and service expenses under subsection (a)(1) of this section shall

be sufficient to enable the compensated person to remain living at

home.

(d) Types of compensation prohibited

Compensation awarded under the Program may not include the

following:

(1) Punitive or exemplary damages.

(2) Except with respect to compensation payments under

paragraphs (2) and (3) of subsection (a) of this section,

compensation for other than the health, education, or welfare of

the person who suffered the vaccine-related injury with respect

to which the compensation is paid.

(e) Attorneys' fees

(1) In awarding compensation on a petition filed under section

300aa-11 of this title the special master or court shall also award

as part of such compensation an amount to cover -

(A) reasonable attorneys' fees, and

(B) other costs,

incurred in any proceeding on such petition. If the judgment of the

United States Court of Federal Claims on such a petition does not

award compensation, the special master or court may award an amount

of compensation to cover petitioner's reasonable attorneys' fees

and other costs incurred in any proceeding on such petition if the

special master or court determines that the petition was brought in

good faith and there was a reasonable basis for the claim for which

the petition was brought.

(2) If the petitioner, before October 1, 1988, filed a civil

action for damages for any vaccine-related injury or death for

which compensation may be awarded under the Program, and petitioned

under section 300aa-11(a)(5) of this title to have such action

dismissed and to file a petition for compensation under the

Program, in awarding compensation on such petition the special

master or court may include an amount of compensation limited to

the costs and expenses incurred by the petitioner and the attorney

of the petitioner before October 1, 1988, in preparing, filing, and

prosecuting such civil action (including the reasonable value of

the attorney's time if the civil action was filed under contingent

fee arrangements).

(3) No attorney may charge any fee for services in connection

with a petition filed under section 300aa-11 of this title which is

in addition to any amount awarded as compensation by the special

master or court under paragraph (1).

(f) Payment of compensation

(1) Except as provided in paragraph (2), no compensation may be

paid until an election has been made, or has been deemed to have

been made, under section 300aa-21(a) of this title to receive

compensation.

(2) Compensation described in subsection (a)(1)(A)(iii) of this

section shall be paid from the date of the judgment of the United

States Court of Federal Claims under section 300aa-12 of this title

awarding the compensation. Such compensation may not be paid after

an election under section 300aa-21(a) of this title to file a civil

action for damages for the vaccine-related injury or death for

which such compensation was awarded.

(3) Payments of compensation under the Program and the costs of

carrying out the Program shall be exempt from reduction under any

order issued under part C of the Balanced Budget and Emergency

Deficit Control Act of 1985 [2 U.S.C. 900 et seq.].

(4)(A) Except as provided in subparagraph (B), payment of

compensation under the Program shall be determined on the basis of

the net present value of the elements of the compensation and shall

be paid from the Vaccine Injury Compensation Trust Fund established

under section 9510 of title 26 in a lump sum of which all or a

portion may be used as ordered by the special master to purchase an

annuity or otherwise be used, with the consent of the petitioner,

in a manner determined by the special master to be in the best

interests of the petitioner.

(B) In the case of a payment of compensation under the Program to

a petitioner for a vaccine-related injury or death associated with

the administration of a vaccine before October 1, 1988, the

compensation shall be determined on the basis of the net present

value of the elements of compensation and shall be paid from

appropriations made available under subsection (j) of this section

in a lump sum of which all or a portion may be used as ordered by

the special master to purchase an annuity or otherwise be used,

with the consent of the petitioner, in a manner determined by the

special master to be in the best interests of the petitioner. Any

reasonable attorneys' fees and costs shall be paid in a lump sum.

If the appropriations under subsection (j) of this section are

insufficient to make a payment of an annual installment, the

limitation on civil actions prescribed by section 300aa-21(a) of

this title shall not apply to a civil action for damages brought by

the petitioner entitled to the payment.

(C) In purchasing an annuity under subparagraph (A) or (B), the

Secretary may purchase a guarantee for the annuity, may enter into

agreements regarding the purchase price for and rate of return of

the annuity, and may take such other actions as may be necessary to

safeguard the financial interests of the United States regarding

the annuity. Any payment received by the Secretary pursuant to the

preceding sentence shall be paid to the Vaccine Injury Compensation

Trust Fund established under section 9510 of title 26, or to the

appropriations account from which the funds were derived to

purchase the annuity, whichever is appropriate.

(g) Program not primarily liable

Payment of compensation under the Program shall not be made for

any item or service to the extent that payment has been made, or

can reasonably be expected to be made, with respect to such item or

service (1) under any State compensation program, under an

insurance policy, or under any Federal or State health benefits

program (other than under title XIX of the Social Security Act [42

U.S.C. 1396 et seq.]), or (2) by an entity which provides health

services on a prepaid basis.

(h) Liability of health insurance carriers, prepaid health plans,

and benefit providers

No policy of health insurance may make payment of benefits under

the policy secondary to the payment of compensation under the

Program and -

(1) no State, and

(2) no entity which provides health services on a prepaid basis

or provides health benefits,

may make the provision of health services or health benefits

secondary to the payment of compensation under the Program, except

that this subsection shall not apply to the provision of services

or benefits under title XIX of the Social Security Act [42 U.S.C.

1396 et seq.].

(i) Source of compensation

(1) Payment of compensation under the Program to a petitioner for

a vaccine-related injury or death associated with the

administration of a vaccine before October 1, 1988, shall be made

by the Secretary from appropriations under subsection (j) of this

section.

(2) Payment of compensation under the Program to a petitioner for

a vaccine-related injury or death associated with the

administration of a vaccine on or after October 1, 1988, shall be

made from the Vaccine Injury Compensation Trust Fund established

under section 9510 of title 26.

(j) Authorization

For the payment of compensation under the Program to a petitioner

for a vaccine-related injury or death associated with the

administration of a vaccine before October 1, 1988, there are

authorized to be appropriated to the Department of Health and Human

Services $80,000,000 for fiscal year 1989, $80,000,000 for fiscal

year 1990, $80,000,000 for fiscal year 1991, $80,000,000 for fiscal

year 1992, $110,000,000 for fiscal year 1993, and $110,000,000 for

each succeeding fiscal year in which a payment of compensation is

required under subsection (f)(4)(B) of this section. Amounts

appropriated under this subsection shall remain available until

expended.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2115, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3767;

amended Pub. L. 100-203, title IV, Secs. 4302(b), 4303(a)-(d)(1),

(e), (g), 4307(5), (6), Dec. 22, 1987, 101 Stat. 1330-221 to

1330-223, 1330-225; Pub. L. 100-360, title IV, Sec. 411(o)(1), July

1, 1988, 102 Stat. 808; Pub. L. 101-239, title VI, Sec. 6601(c)(8),

(l), Dec. 19, 1989, 103 Stat. 2286, 2290; Pub. L. 101-502, Sec.

5(d), Nov. 3, 1990, 104 Stat. 1287; Pub. L. 102-168, title II, Sec.

201(e), (f), Nov. 26, 1991, 105 Stat. 1103; Pub. L. 102-531, title

III, Sec. 314, Oct. 27, 1992, 106 Stat. 3508; Pub. L. 102-572,

title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516; Pub. L.

103-66, title XIII, Sec. 13632(b), Aug. 10, 1993, 107 Stat. 646.)

-REFTEXT-

REFERENCES IN TEXT

The Balanced Budget and Emergency Deficit Control Act of 1985,

referred to in subsec. (f)(3), is title II of Pub. L. 99-177, Dec.

12, 1985, 99 Stat. 1038. Part C of the Act is classified generally

to subchapter I (Sec. 900 et seq.) of chapter 20 of Title 2, The

Congress. For complete classification of this Act to the Code, see

Short Title note set out under section 900 of Title 2 and Tables.

The Social Security Act, referred to in subsecs. (g) and (h), is

act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Title XIX of

the Social Security Act is classified generally to subchapter XIX

(Sec. 1396 et seq.) of chapter 7 of this title. For complete

classification of this Act to the Code, see section 1305 of this

title and Tables.

-COD-

CODIFICATION

In subsecs. (a), (b), (e)(2), (f)(4)(B), (i), and (j), "October

1, 1988" substituted for "the effective date of this subpart" on

authority of section 323 of Pub. L. 99-660, as amended, set out as

an Effective Date note under section 300aa-1 of this title.

-MISC1-

PRIOR PROVISIONS

A prior section 300aa-15, act July 1, 1944, Sec. 2116, was

successively renumbered by subsequent acts and transferred, see

section 238m of this title.

A prior section 2115 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238l of

this title.

AMENDMENTS

1993 - Subsec. (j). Pub. L. 103-66 substituted "$110,000,000 for

each succeeding fiscal year" for "$80,000,000 for each succeeding

fiscal year".

1992 - Subsecs. (e)(1), (f)(2). Pub. L. 102-572 substituted

"United States Court of Federal Claims" for "United States Claims

Court".

Subsec. (j). Pub. L. 102-531 increased authorization for fiscal

year 1993 from $80,000,000 to $110,000,000.

1991 - Subsec. (f)(4)(A). Pub. L. 102-168, Sec. 201(e)(1)(A),

(2), struck out "of the proceeds" after "portion" and substituted

"Vaccine Injury Compensation Trust Fund established under section

9510 of title 26" for "trust fund".

Subsec. (f)(4)(B). Pub. L. 102-168, Sec. 201(e)(1)(B), which

directed substitution of "shall be paid from appropriations made

available under subsection (j) of this section in a lump sum of

which all or a portion" for "paid in 4 equal installments of which

all or portion of the proceeds" was executed by making the

substitution for "paid in 4 equal annual installments of which all

or a portion of the proceeds" to reflect the probable intent of

Congress.

Subsec. (f)(4)(C). Pub. L. 102-168, Sec. 201(f), added subpar.

(C).

1990 - Subsec. (e)(2). Pub. L. 101-502, Sec. 5(d)(1), inserted

"of compensation" before "limited to the costs".

Subsec. (f)(2). Pub. L. 101-502, Sec. 5(d)(2)(A), substituted

"section 300aa-21(a)" for "section 300aa-21(b)".

Subsec. (f)(4)(B). Pub. L. 101-502, Sec. 5(d)(2)(B), substituted

"subsection (j)" for "subsection (i)" and "the limitation on civil

actions prescribed by section 300aa-21(a) of this title" for

"section 300aa-11(a) of this title".

Subsec. (j). Pub. L. 101-502, Sec. 5(d)(3), inserted before

period at end of first sentence ", and $80,000,000 for each

succeeding fiscal year in which a payment of compensation is

required under subsection (f)(4)(B) of this section".

1989 - Subsec. (b). Pub. L. 101-239, Sec. 6601(l)(1), substituted

"may include the compensation described in paragraphs (1)(A) and

(2) of subsection (a) of this section and may also include an

amount, not to exceed a combined total of $30,000, for - " and cls.

(1) to (3) for "may not include the compensation described in

paragraph (1)(B) of subsection (a) of this section and may include

attorneys' fees and other costs included in a judgment under

subsection (e) of this section, except that the total amount that

may be paid as compensation under paragraphs (3) and (4) of

subsection (a) of this section and included as attorneys' fees and

other costs under subsection (e) of this section may not exceed

$30,000."

Subsec. (e)(1). Pub. L. 101-239, Sec. 6601(l)(2)(A), substituted

"In awarding compensation on a petition filed under section

300aa-11 of this title the special master or court shall also award

as part of such compensation an amount to cover" for "The judgment

of the United States Claims Court on a petition filed under section

300aa-11 of this title awarding compensation shall include an

amount to cover".

Pub. L. 101-239, Sec. 6601(l)(2)(B), (C), substituted "the

special master or court may award an amount of compensation to

cover" for "the court may include in the judgment an amount to

cover" and "the special master or court determines that the

petition was brought in good faith and there was a reasonable basis

for the claim for which the petition" for "the court determines

that the civil action was brought in good faith and there was a

reasonable basis for the claim for which the civil action".

Subsec. (e)(2). Pub. L. 101-239, Sec. 6601(l)(2)(D), which

directed amendment of par. (2) by substituting "the special master

or court may also award an amount of compensation" for "the

judgment of the court on such petition may include an amount",

could not be executed because of the prior amendment by Pub. L.

101-239, Sec. 6601(c)(8)(B), see Amendment note below.

Pub. L. 101-239, Sec. 6601(c)(8), substituted "and petitioned

under section 300aa-11(a)(5) of this title to have such action

dismissed" for "and elected under section 300aa-11(a)(4) of this

title to withdraw such action" and "in awarding compensation on

such petition the special master or court may include" for "the

judgment of the court on such petition may include".

Subsec. (e)(3). Pub. L. 101-239, Sec. 6601(l)(2)(E), substituted

"awarded as compensation by the special master or court under

paragraph (1)" for "included under paragraph (1) in a judgment on

such petition".

Subsec. (f)(3). Pub. L. 101-239, Sec. 6601(l)(3)(A), inserted

"under the Program and the costs of carrying out the Program" after

"Payments of compensation".

Subsec. (f)(4)(A). Pub. L. 101-239, Sec. 6601(l)(3)(B), struck

out "made in a lump sum" after "the Program shall be" and inserted

"and shall be paid from the trust fund in a lump sum of which all

or a portion of the proceeds may be used as ordered by the special

master to purchase an annuity or otherwise be used, with the

consent of the petitioner, in a manner determined by the special

master to be in the best interests of the petitioner" after

"elements of the compensation".

Subsec. (f)(4)(B). Pub. L. 101-239, Sec. 6601(l)(3)(C),

substituted "determined on the basis of the net present value of

the elements of compensation and paid in 4 equal annual

installments of which all or a portion of the proceeds may be used

as ordered by the special master to purchase an annuity or

otherwise be used, with the consent of the petitioner, in a manner

determined by the special master to be in the best interests of the

petitioner. Any reasonable attorneys' fees and costs shall be paid

in a lump sum" for "paid in 4 equal annual installments".

Subsec. (g). Pub. L. 101-239, Sec. 6601(l)(4)(A), inserted

"(other than under title XIX of the Social Security Act)" after

"State health benefits program".

Subsec. (h). Pub. L. 101-239, Sec. 6601(l)(4)(B), inserted before

period at end ", except that this subsection shall not apply to the

provision of services or benefits under title XIX of the Social

Security Act".

Subsec. (i)(1). Pub. L. 101-239, Sec. 6601(l)(5), which directed

amendment of par. (1) by substituting "(j)" for "(i)", could not be

executed because "(i)" did not appear.

Subsec. (j). Pub. L. 101-239, Sec. 6601(l)(6), struck out "and"

after "fiscal year 1991," and inserted ", $80,000,000 for fiscal

year 1993" after "fiscal year 1992".

1988 - Subsec. (i)(1). Pub. L. 100-360, Sec. 411(o)(1)(A),

substituted "by the Secretary from appropriations under subsection

(j)" for "from appropriations under subsection (i)".

Subsec. (j). Pub. L. 100-360, Sec. 411(o)(1)(B), inserted "to the

Department of Health and Human Services".

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4302(b)(1), substituted

"effective date of this subpart" for "effective date of this part".

Pub. L. 100-203, Sec. 4303(d)(1)(A), struck out last two

sentences which read as follows: "Payments for projected expenses

shall be paid on a periodic basis (but no payment may be made for a

period in excess of 1 year). Payments for pain and suffering and

emotional distress and incurred expenses may be paid in a lump

sum."

Subsec. (a)(1). Pub. L. 100-203, Sec. 4303(c), struck out last

sentence of subpars. (A) and (B) each of which read as follows:

"The amount of unreimbursable expenses which may be recovered under

this subparagraph shall be limited to the amount in excess of the

amount set forth in section 300aa-11(c)(1)(D)(ii) of this title."

Subsec. (b). Pub. L. 100-203, Sec. 4303(e), substituted "may not

include the compensation described in paragraph (1)(B) of

subsection (a) of this section and may include attorneys' fees and

other costs included in a judgment under subsection (e) of this

section, except that the total amount that may be paid as

compensation under paragraphs (3) and (4) of subsection (a) of this

section and included as attorneys' fees and other costs under

subsection (e) of this section may not exceed $30,000" for "shall

only include the compensation described in paragraphs (1)(A) and

(2) of subsection (a) of this section".

Pub. L. 100-203, Sec. 4302(b)(1), substituted "effective date of

this subpart" for "effective date of this part".

Subsec. (e)(1). Pub. L. 100-203, Sec. 4307(5), substituted "of

the United States Claims Court" for "of a court" in two places.

Subsec. (e)(2). Pub. L. 100-203, Sec. 4302(b), substituted

"effective date of this subpart, filed a" for "effective date of

this subchapter, filed a" and "effective date of this subpart in

preparing" for "effective date of this part in preparing".

Subsec. (f). Pub. L. 100-203, Sec. 4303(d)(1)(B), (g), added par.

(4) and redesignated a second subsec. (f), relating to the Program

not being primarily liable, as subsec. (g).

Subsec. (f)(2). Pub. L. 100-203, Sec. 4307(6), substituted

"United States Claims Court" for "district court of the United

States".

Subsecs. (g), (h). Pub. L. 100-203, Sec. 4303(g), redesignated a

second subsec. (f), relating to the Program not being liable, as

(g) and redesignated former subsec. (g) as (h).

Subsecs. (i), (j). Pub. L. 100-203, Sec. 4303(a), (b), added

subsecs. (i) and (j).

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1991 AMENDMENT

Amendment by section 201(f) of Pub. L. 102-168 effective as if in

effect on and after Oct. 1, 1988, see section 201(i)(2) of Pub. L.

102-168, set out as a note under section 300aa-11 of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-502 effective Sept. 30, 1990, see

section 5(h) of Pub. L. 101-502, set out as a note under section

300aa-11 of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

Amendment by Pub. L. 101-239 applicable to all pending and

subsequently filed petitions, see section 6601(s)(2) of Pub. L.

101-239, set out as a note under section 300aa-10 of this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by Pub. L. 100-360, as it relates to a provision

in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203,

effective as if included in the enactment of that provision in Pub.

L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a

Reference to OBRA; Effective Date note under section 106 of Title

1, General Provisions.

-FOOTNOTE-

(!1) So in original. Probably should be preceded by a closing

parenthesis.

-End-

-CITE-

42 USC Sec. 300aa-16 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-16. Limitations of actions

-STATUTE-

(a) General rule

In the case of -

(1) a vaccine set forth in the Vaccine Injury Table which is

administered before October 1, 1988, if a vaccine-related injury

or death occurred as a result of the administration of such

vaccine, no petition may be filed for compensation under the

Program for such injury or death after the expiration of 28

months after October 1, 1988, and no such petition may be filed

if the first symptom or manifestation of onset or of the

significant aggravation of such injury occurred more than 36

months after the date of administration of the vaccine,

(2) a vaccine set forth in the Vaccine Injury Table which is

administered after October 1, 1988, if a vaccine-related injury

occurred as a result of the administration of such vaccine, no

petition may be filed for compensation under the Program for such

injury after the expiration of 36 months after the date of the

occurrence of the first symptom or manifestation of onset or of

the significant aggravation of such injury, and

(3) a vaccine set forth in the Vaccine Injury Table which is

administered after October 1, 1988, if a death occurred as a

result of the administration of such vaccine, no petition may be

filed for compensation under the Program for such death after the

expiration of 24 months from the date of the death and no such

petition may be filed more than 48 months after the date of the

occurrence of the first symptom or manifestation of onset or of

the significant aggravation of the injury from which the death

resulted.

(b) Effect of revised table

If at any time the Vaccine Injury Table is revised and the effect

of such revision is to permit an individual who was not, before

such revision, eligible to seek compensation under the Program, or

to significantly increase the likelihood of obtaining compensation,

such person may, notwithstanding section 300aa-11(b)(2) of this

title, file a petition for such compensation not later than 2 years

after the effective date of the revision, except that no

compensation may be provided under the Program with respect to a

vaccine-related injury or death covered under the revision of the

table if -

(1) the vaccine-related death occurred more than 8 years before

the date of the revision of the table, or

(2) the vaccine-related injury occurred more than 8 years

before the date of the revision of the table.

(c) State limitations of actions

If a petition is filed under section 300aa-11 of this title for a

vaccine-related injury or death, limitations of actions under State

law shall be stayed with respect to a civil action brought for such

injury or death for the period beginning on the date the petition

is filed and ending on the date (1) an election is made under

section 300aa-21(a) of this title to file the civil action or (2)

an election is made under section 300aa-21(b) of this title to

withdraw the petition.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2116, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3769;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(2), Dec. 22, 1987,

101 Stat. 1330-221; Pub. L. 101-239, title VI, Sec. 6601(m)(1),

Dec. 19, 1989, 103 Stat. 2291; Pub. L. 101-502, Sec. 5(e), Nov. 3,

1990, 104 Stat. 1287; Pub. L. 102-168, title II, Sec. 201(d)(2),

Nov. 26, 1991, 105 Stat. 1103; Pub. L. 103-66, title XIII, Sec.

13632(a)(1), Aug. 10, 1993, 107 Stat. 645.)

-COD-

CODIFICATION

In subsec. (a)(1) to (3), "October 1, 1988" and "October 1,

1988," substituted for "the effective date of this subpart" on

authority of section 323 of Pub. L. 99-660, as amended, set out as

an Effective Date note under section 300aa-1 of this title.

-MISC1-

PRIOR PROVISIONS

A prior section 2116 of act July 1, 1944, was successively

renumbered by subsequent acts and transferred, see section 238m of

this title.

AMENDMENTS

1993 - Subsec. (b). Pub. L. 103-66 substituted "or to

significantly increase the likelihood of obtaining compensation,

such person may, notwithstanding section 300aa-11(b)(2) of this

title, file" for "such person may file".

1991 - Subsec. (c). Pub. L. 102-168 substituted "or (2)" for ",

(2)" and struck out ", or (3) the petition is considered withdrawn

under section 300aa-21(b) of this title."

1990 - Subsec. (a)(1). Pub. L. 101-502, Sec. 5(e)(1), substituted

"28 months" for "24 months" and inserted before comma at end "and

no such petition may be filed if the first symptom or manifestation

of onset or of the significant aggravation of such injury occurred

more than 36 months after the date of administration of the

vaccine".

Subsec. (c). Pub. L. 101-502, Sec. 5(e)(2), substituted "and

ending on the date (1) an election is made under section

300aa-21(a) of this title to file the civil action, (2) an election

is made under section 300aa-21(b) of this title to withdraw the

petition, or (3) the petition is considered withdrawn under section

300aa-21(b) of this title" for "and ending on the date a final

judgment is entered on the petition".

1989 - Subsec. (c). Pub. L. 101-239 substituted "300aa-11 of this

title" for "300aa-11(b) of this title".

1987 - Subsec. (a). Pub. L. 100-203 substituted "effective date

of this subpart" for "effective date of this subchapter" in pars.

(1) to (3).

EFFECTIVE DATE OF 1991 AMENDMENT

Amendment by Pub. L. 102-168 effective as if in effect on and

after Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102-168, set

out as a note under section 300aa-11 of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-502 effective Sept. 30, 1990, see

section 5(h) of Pub. L. 101-502, set out as a note under section

300aa-11 of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-11, 300aa-15,

300aa-21 of this title.

-End-

-CITE-

42 USC Sec. 300aa-17 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-17. Subrogation

-STATUTE-

(a) General rule

Upon payment of compensation to any petitioner under the Program,

the trust fund which has been established to provide such

compensation shall be subrograted (!1) to all rights of the

petitioner with respect to the vaccine-related injury or death for

which compensation was paid, except that the trust fund may not

recover under such rights an amount greater than the amount of

compensation paid to the petitioner.

(b) Disposition of amounts recovered

Amounts recovered under subsection (a) of this section shall be

collected on behalf of, and deposited in, the Vaccine Injury

Compensation Trust Fund established under section 9510 of title 26.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2117, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3770;

amended Pub. L. 100-203, title IV, Sec. 4307(7), Dec. 22, 1987, 101

Stat. 1330-225; Pub. L. 101-239, title VI, Sec. 6601(m)(2), Dec.

19, 1989, 103 Stat. 2291.)

-MISC1-

AMENDMENTS

1989 - Subsec. (b). Pub. L. 101-239 substituted "the Vaccine

Injury Compensation Trust Fund established under section 9510 of

title 26" for "the trust fund which has been established to provide

compensation under the Program".

1987 - Subsec. (a). Pub. L. 100-203 struck out par. (1)

designation before "Upon" and struck out par. (2) which read as

follows: "In any case in which it deems such action appropriate, a

district court of the United States may, after entry of a final

judgment providing for compensation to be paid under section

300aa-15 of this title for a vaccine-related injury or death, refer

the record of such proceeding to the Secretary and the Attorney

General with such recommendation as the court deems appropriate

with respect to the investigation or commencement of a civil action

by the Secretary under paragraph (1)."

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be "subrogated".

-End-

-CITE-

42 USC Sec. 300aa-18 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-18. Repealed. Pub. L. 100-203, title IV, Sec.

4303(d)(2)(B), Dec. 22, 1987, 101 Stat. 1330-222

-MISC1-

Section, act July 1, 1944, ch. 373, title XXI, Sec. 2118, as

added Nov. 14, 1986, Pub. L. 99-660, title III, Sec. 311(a), 100

Stat. 3771, provided for annual increases for inflation of

compensation under subsections (a)(2) and (a)(4) of section

300aa-15 of this title and civil penalty under section 300aa-27(b)

of this title.

-End-

-CITE-

42 USC Sec. 300aa-19 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart a - program requirements

-HEAD-

Sec. 300aa-19. Advisory Commission on Childhood Vaccines

-STATUTE-

(a) Establishment

There is established the Advisory Commission on Childhood

Vaccines. The Commission shall be composed of:

(1) Nine members appointed by the Secretary as follows:

(A) Three members who are health professionals, who are not

employees of the United States, and who have expertise in the

health care of children, the epidemiology, etiology, and

prevention of childhood diseases, and the adverse reactions

associated with vaccines, of whom at least two shall be

pediatricians.

(B) Three members from the general public, of whom at least

two shall be legal representatives of children who have

suffered a vaccine-related injury or death.

(C) Three members who are attorneys, of whom at least one

shall be an attorney whose specialty includes representation of

persons who have suffered a vaccine-related injury or death and

of whom one shall be an attorney whose specialty includes

representation of vaccine manufacturers.

(2) The Director of the National Institutes of Health, the

Assistant Secretary for Health, the Director of the Centers for

Disease Control and Prevention, and the Commissioner of Food and

Drugs (or the designees of such officials), each of whom shall be

a nonvoting ex officio member.

The Secretary shall select members of the Commission within 90 days

of October 1, 1988. The members of the Commission shall select a

Chair from among the members.

(b) Term of office

Appointed members of the Commission shall be appointed for a term

of office of 3 years, except that of the members first appointed, 3

shall be appointed for a term of 1 year, 3 shall be appointed for a

term of 2 years, and 3 shall be appointed for a term of 3 years, as

determined by the Secretary.

(c) Meetings

The Commission shall first meet within 60 days after all members

of the Commission are appointed, and thereafter shall meet not less

often than four times per year and at the call of the chair. A

quorum for purposes of a meeting is 5. A decision at a meeting is

to be made by a ballot of a majority of the voting members of the

Commission present at the meeting.

(d) Compensation

Members of the Commission who are officers or employees of the

Federal Government shall serve as members of the Commission without

compensation in addition to that received in their regular public

employment. Members of the Commission who are not officers or

employees of the Federal Government shall be compensated at a rate

not to exceed the daily equivalent of the rate in effect for grade

GS-18 of the General Schedule for each day (including traveltime)

they are engaged in the performance of their duties as members of

the Commission. All members, while so serving away from their homes

or regular places of business, may be allowed travel expenses,

including per diem in lieu of subsistence, in the same manner as

such expenses are authorized by section 5703 of title 5 for

employees serving intermittently.

(e) Staff

The Secretary shall provide the Commission with such professional

and clerical staff, such information, and the services of such

consultants as may be necessary to assist the Commission in

carrying out effectively its functions under this section.

(f) Functions

The Commission shall -

(1) advise the Secretary on the implementation of the Program,

(2) on its own initiative or as the result of the filing of a

petition, recommend changes in the Vaccine Injury Table,

(3) advise the Secretary in implementing the Secretary's

responsibilities under section 300aa-27 of this title regarding

the need for childhood vaccination products that result in fewer

or no significant adverse reactions,

(4) survey Federal, State, and local programs and activities

relating to the gathering of information on injuries associated

with the administration of childhood vaccines, including the

adverse reaction reporting requirements of section 300aa-25(b) of

this title, and advise the Secretary on means to obtain, compile,

publish, and use credible data related to the frequency and

severity of adverse reactions associated with childhood vaccines,

and

(5) recommend to the Director of the National Vaccine Program

research related to vaccine injuries which should be conducted to

carry out this part.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2119, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3771;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221; Pub. L. 102-168, title II, Sec. 201(g), Nov.

26, 1991, 105 Stat. 1104; Pub. L. 102-531, title III, Sec.

312(d)(14), Oct. 27, 1992, 106 Stat. 3505.)

-COD-

CODIFICATION

In subsec. (a), "October 1, 1988" substituted for "the effective

date of this subpart" on authority of section 323 of Pub. L.

99-660, as amended, set out as an Effective Date note under section

300aa-1 of this title.

-MISC1-

AMENDMENTS

1992 - Subsec. (a)(2). Pub. L. 102-531 substituted "Centers for

Disease Control and Prevention" for "Centers for Disease Control".

1991 - Subsec. (c). Pub. L. 102-168 inserted "present at the

meeting" before period at end.

1987 - Subsec. (a). Pub. L. 100-203 substituted "effective date

of this subpart" for "effective date of this part" in last

sentence.

TERMINATION OF ADVISORY COMMISSIONS

Advisory commissions established after Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period beginning on the

date of their establishment, unless, in the case of a commission

established by the President or an officer of the Federal

Government, such commission is renewed by appropriate action prior

to the expiration of such 2-year period, or in the case of a

commission established by the Congress, its duration is otherwise

provided by law. See sections 3(2) and 14 of Pub. L. 92-463, Oct.

6, 1972, 86 Stat. 776, set out in the Appendix to Title 5,

Government Organization and Employees.

Pub. L. 93-641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a

note under section 217a of this title, provided that an advisory

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

an Act of Congress enacted after Jan. 4, 1975.

REFERENCES IN OTHER LAWS TO GS-16, 17, OR 18 PAY RATES

References in laws to the rates of pay for GS-16, 17, or 18, or

to maximum rates of pay under the General Schedule, to be

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

[title I, Sec. 101(c)(1)] of Pub. L. 101-509, set out in a note

under section 5376 of Title 5.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-33 of this title.

-End-

-CITE-

42 USC subpart b - additional remedies 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart b - additional remedies

-HEAD-

SUBPART B - ADDITIONAL REMEDIES

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in section 300aa-34 of this title.

-End-

-CITE-

42 USC Sec. 300aa-21 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart b - additional remedies

-HEAD-

Sec. 300aa-21. Authority to bring actions

-STATUTE-

(a) Election

After judgment has been entered by the United States Court of

Federal Claims or, if an appeal is taken under section 300aa-12(f)

of this title, after the appellate court's mandate is issued, the

petitioner who filed the petition under section 300aa-11 of this

title shall file with the clerk of the United States Court of

Federal Claims -

(1) if the judgment awarded compensation, an election in

writing to receive the compensation or to file a civil action for

damages for such injury or death, or

(2) if the judgment did not award compensation, an election in

writing to accept the judgment or to file a civil action for

damages for such injury or death.

An election shall be filed under this subsection not later than 90

days after the date of the court's final judgment with respect to

which the election is to be made. If a person required to file an

election with the court under this subsection does not file the

election within the time prescribed for filing the election, such

person shall be deemed to have filed an election to accept the

judgment of the court. If a person elects to receive compensation

under a judgment of the court in an action for a vaccine-related

injury or death associated with the administration of a vaccine

before October 1, 1988, or is deemed to have accepted the judgment

of the court in such an action, such person may not bring or

maintain a civil action for damages against a vaccine administrator

or manufacturer for the vaccine-related injury or death for which

the judgment was entered. For limitations on the bringing of civil

actions for vaccine-related injuries or deaths associated with the

administration of a vaccine after October 1, 1988, see section

300aa-11(a)(2) of this title.

(b) Continuance or withdrawal of petition

A petitioner under a petition filed under section 300aa-11 of

this title may submit to the United States Court of Federal Claims

a notice in writing choosing to continue or to withdraw the

petition if -

(1) a special master fails to make a decision on such petition

within the 240 days prescribed by section 300aa-12(d)(3)(A)(ii)

of this title (excluding (i) any period of suspension under

section 300aa-12(d)(3)(C) or 300aa-12(d)(3)(D) of this title, and

(ii) any days the petition is before a special master as a result

of a remand under section 300aa-12(e)(2)(C) of this title), or

(2) the court fails to enter a judgment under section 300aa-12

of this title on the petition within 420 days (excluding (i) any

period of suspension under section 300aa-12(d)(3)(C) or

300aa-12(d)(3)(D) of this title, and (ii) any days the petition

is before a special master as a result of a remand under section

300aa-12(e)(2)(C) of this title) after the date on which the

petition was filed.

Such a notice shall be filed within 30 days of the provision of the

notice required by section 300aa-12(g) of this title.

(c) Limitations of actions

A civil action for damages arising from a vaccine-related injury

or death for which a petition was filed under section 300aa-11 of

this title shall, except as provided in section 300aa-16(c) of this

title, be brought within the period prescribed by limitations of

actions under State law applicable to such civil action.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2121, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3772;

amended Pub. L. 100-203, title IV, Secs. 4304(c), 4307(8), 4308(c),

Dec. 22, 1987, 101 Stat. 1330-224, 1330-225; Pub. L. 100-360, title

IV, Sec. 411(o)(3)(A), July 1, 1988, 102 Stat. 808; Pub. L.

101-239, title VI, Sec. 6601(n), Dec. 19, 1989, 103 Stat. 2291;

Pub. L. 101-502, Sec. 5(f), Nov. 3, 1990, 104 Stat. 1287; Pub. L.

102-168, title II, Sec. 201(d)(3), Nov. 26, 1991, 105 Stat. 1103;

Pub. L. 102-572, title IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat.

4516.)

-COD-

CODIFICATION

In subsec. (a), "October 1, 1988," and "October 1, 1988"

substituted for "the effective date of this part".

-MISC1-

AMENDMENTS

1992 - Subsecs. (a), (b). Pub. L. 102-572 substituted "United

States Court of Federal Claims" for "United States Claims Court"

wherever appearing.

1991 - Subsec. (b). Pub. L. 102-168 substituted "Continuance or

withdrawal of petition" for "Withdrawal of petition" in heading,

redesignated introductory provisions of par. (1) as introductory

provisions of subsec. (b) and substituted "a notice in writing

choosing to continue or to withdraw the petition" for "a notice in

writing withdrawing the petition", redesignated subpars. (A) and

(B) of former par. (1) as pars. (1) and (2), respectively, and

realigned margins, struck out at end of former par. (1) "If such a

notice is not filed before the expiration of such 30 days, the

petition with respect to which the notice was to be filed shall be

considered withdrawn under this paragraph.", and struck out par.

(2) which read as follows: "If a special master or the court does

not enter a decision or make a judgment on a petition filed under

section 300aa-11 of this title within 30 days of the provision of

the notice in accordance with section 300aa-12(g) of this title,

the special master or court shall no longer have jurisdiction over

such petition and such petition shall be considered as withdrawn

under paragraph (1)."

1990 - Subsec. (a). Pub. L. 101-502, Sec. 5(f)(1), in closing

provisions, inserted after second sentence "If a person elects to

receive compensation under a judgment of the court in an action for

a vaccine-related injury or death associated with the

administration of a vaccine before October 1, 1988, or is deemed to

have accepted the judgment of the court in such an action, such

person may not bring or maintain a civil action for damages against

a vaccine administrator or manufacturer for the vaccine-related

injury or death for which the judgment was entered." and inserted

"for vaccine-related injuries or deaths associated with the

administration of a vaccine after October 1, 1988" after "actions"

in last sentence.

Subsec. (b). Pub. L. 101-502, Sec. 5(f)(2), amended subsec. (b)

generally. Prior to amendment, subsec. (b) read as follows: "If the

United States Claims Court fails to enter a judgment under section

300aa-12 of this title on a petition filed under section 300aa-11

of this title within 420 days (excluding any period of suspension

under section 300aa-12(d) of this title and excluding any days the

petition is before a special master as a result of a remand under

section 300aa-12(e)(2)(C) of this title) after the date on which

the petition was filed, the petitioner may submit to the court a

notice in writing withdrawing the petition. An election shall be

filed under this subsection not later than 90 days after the date

of the entry of the Claims Court's judgment or the appellate

court's mandate with respect to which the election is to be made. A

person who has submitted a notice under this subsection may,

notwithstanding section 300aa-11(a)(2) of this title, thereafter

maintain a civil action for damages in a State or Federal court

without regard to this subpart and consistent with otherwise

applicable law."

1989 - Subsec. (a). Pub. L. 101-239, Sec. 6601(n)(1)(A), amended

introductory provisions generally. Prior to amendment, introductory

provisions read as follows: "After the judgment of the United

States Claims Court under section 300aa-11 of this title on a

petition filed for compensation under the Program for a

vaccine-related injury or death has become final, the person who

filed the petition shall file with the court - ".

Pub. L. 101-239, Sec. 6601(n)(1)(B), amended last sentence

generally. Prior to amendment, last sentence read as follows: "If a

person elects to receive compensation under a judgment of the court

or is deemed to have accepted the judgment of the court, such

person may not bring or maintain a civil action for damages against

a vaccine manufacturer for the vaccine-related injury or death for

which the judgment was entered."

Subsec. (b). Pub. L. 101-239, Sec. 6601(n)(2), substituted

"within 420 days (excluding any period of suspension under section

300aa-12(d) of this title and excluding any days the petition is

before a special master as a result of a remand under section

300aa-12(e)(2)(C) of this title)" for "within 365 days" in first

sentence and amended second sentence generally. Prior to amendment,

second sentence read as follows: "Such a notice shall be filed not

later than 90 days after the expiration of such 365-day period."

1988 - Subsec. (a). Pub. L. 100-360 added Pub. L. 100-203, Sec.

4308(c), see 1987 Amendment note below.

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4308(c), as added by

Pub. L. 100-360, substituted "the court's final judgment" for "the

entry of the court's judgment" in concluding provisions.

Pub. L. 100-203, Sec. 4307(8), substituted "the United States

Claims Court" for "a district court of the United States" and "the

court" for "a court" in three places.

Subsecs. (b), (c). Pub. L. 100-203, Sec. 4304(c), added subsec.

(b) and redesignated former subsec. (b) as (c).

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1991 AMENDMENT

Amendment by Pub. L. 102-168 effective as in effect on and after

Oct. 1, 1988, see section 201(i)(2) of Pub. L. 102-168, set out as

a note under section 300aa-11 of this title.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by section 5(f)(1) of Pub. L. 101-502 effective Nov.

14, 1986, and amendment by section 5(f)(2) of Pub. L. 101-502

effective Sept. 30, 1990, see section 5(h) of Pub. L. 101-502, set

out as a note under section 300aa-11 of this title.

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, except that

such suspension be excluded in determining the 420-day period

prescribed in subsec. (b) of this section, see section 6601(s)(1)

of Pub. L. 101-239, set out as a note under section 300aa-10 of

this title.

EFFECTIVE DATE OF 1988 AMENDMENT

Except as specifically provided in section 411 of Pub. L.

100-360, amendment by Pub. L. 100-360, as it relates to a provision

in the Omnibus Budget Reconciliation Act of 1987, Pub. L. 100-203,

effective as if included in the enactment of that provision in Pub.

L. 100-203, see section 411(a) of Pub. L. 100-360, set out as a

Reference to OBRA; Effective Date note under section 106 of Title

1, General Provisions.

EFFECTIVE DATE

Subpart effective Oct. 1, 1988, see section 323 of Pub. L.

99-660, set out as a note under section 300aa-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300aa-11, 300aa-12,

300aa-15, 300aa-16, 300aa-34 of this title.

-End-

-CITE-

42 USC Sec. 300aa-22 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart b - additional remedies

-HEAD-

Sec. 300aa-22. Standards of responsibility

-STATUTE-

(a) General rule

Except as provided in subsections (b), (c), and (e) of this

section State law shall apply to a civil action brought for damages

for a vaccine-related injury or death.

(b) Unavoidable adverse side effects; warnings

(1) No vaccine manufacturer shall be liable in a civil action for

damages arising from a vaccine-related injury or death associated

with the administration of a vaccine after October 1, 1988, if the

injury or death resulted from side effects that were unavoidable

even though the vaccine was properly prepared and was accompanied

by proper directions and warnings.

(2) For purposes of paragraph (1), a vaccine shall be presumed to

be accompanied by proper directions and warnings if the vaccine

manufacturer shows that it complied in all material respects with

all requirements under the Federal Food, Drug, and Cosmetic Act [21

U.S.C. 301 et seq.] and section 262 of this title (including

regulations issued under such provisions) applicable to the vaccine

and related to vaccine-related injury or death for which the civil

action was brought unless the plaintiff shows -

(A) that the manufacturer engaged in the conduct set forth in

subparagraph (A) or (B) of section 300aa-23(d)(2) of this title,

or

(B) by clear and convincing evidence that the manufacturer

failed to exercise due care notwithstanding its compliance with

such Act and section (and regulations issued under such

provisions).

(c) Direct warnings

No vaccine manufacturer shall be liable in a civil action for

damages arising from a vaccine-related injury or death associated

with the administration of a vaccine after October 1, 1988, solely

due to the manufacturer's failure to provide direct warnings to the

injured party (or the injured party's legal representative) of the

potential dangers resulting from the administration of the vaccine

manufactured by the manufacturer.

(d) Construction

The standards of responsibility prescribed by this section are

not to be construed as authorizing a person who brought a civil

action for damages against a vaccine manufacturer for a

vaccine-related injury or death in which damages were denied or

which was dismissed with prejudice to bring a new civil action

against such manufacturer for such injury or death.

(e) Preemption

No State may establish or enforce a law which prohibits an

individual from bringing a civil action against a vaccine

manufacturer for damages for a vaccine-related injury or death if

such civil action is not barred by this part.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2122, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3773;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in subsec.

(b)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,

which is classified generally to chapter 9 (Sec. 301 et seq.) of

Title 21, Food and Drugs. For complete classification of this Act

to the Code, see Tables.

-COD-

CODIFICATION

In subsecs. (b)(1), (c), "October 1, 1988" was substituted for

"the effective date of this subpart" on authority of section 323 of

Pub. L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-MISC1-

AMENDMENTS

1987 - Subsecs. (b)(1), (c). Pub. L. 100-203 substituted

"effective date of this subpart" for "effective date of this part".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-23 of this title.

-End-

-CITE-

42 USC Sec. 300aa-23 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart b - additional remedies

-HEAD-

Sec. 300aa-23. Trial

-STATUTE-

(a) General rule

A civil action against a vaccine manufacturer for damages for a

vaccine-related injury or death associated with the administration

of a vaccine after October 1, 1988, which is not barred by section

300aa-11(a)(2) of this title shall be tried in three stages.

(b) Liability

The first stage of such a civil action shall be held to determine

if a vaccine manufacturer is liable under section 300aa-22 of this

title.

(c) General damages

The second stage of such a civil action shall be held to

determine the amount of damages (other than punitive damages) a

vaccine manufacturer found to be liable under section 300aa-22 of

this title shall be required to pay.

(d) Punitive damages

(1) If sought by the plaintiff, the third stage of such an action

shall be held to determine the amount of punitive damages a vaccine

manufacturer found to be liable under section 300aa-22 of this

title shall be required to pay.

(2) If in such an action the manufacturer shows that it complied,

in all material respects, with all requirements under the Federal

Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] and this

chapter applicable to the vaccine and related to the vaccine injury

or death with respect to which the action was brought, the

manufacturer shall not be held liable for punitive damages unless

the manufacturer engaged in -

(A) fraud or intentional and wrongful withholding of

information from the Secretary during any phase of a proceeding

for approval of the vaccine under section 262 of this title,

(B) intentional and wrongful withholding of information

relating to the safety or efficacy of the vaccine after its

approval, or

(C) other criminal or illegal activity relating to the safety

and effectiveness of vaccines,

which activity related to the vaccine-related injury or death for

which the civil action was brought.

(e) Evidence

In any stage of a civil action, the Vaccine Injury Table, any

finding of fact or conclusion of law of the United States Court of

Federal Claims or a special master in a proceeding on a petition

filed under section 300aa-11 of this title and the final judgment

of the United States Court of Federal Claims and subsequent

appellate review on such a petition shall not be admissible.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2123, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774;

amended Pub. L. 100-203, title IV, Secs. 4302(b)(1), 4307(9), Dec.

22, 1987, 101 Stat. 1330-221, 1330-225; Pub. L. 101-239, title VI,

Sec. 6601(o), Dec. 19, 1989, 103 Stat. 2292; Pub. L. 102-572, title

IX, Sec. 902(b)(1), Oct. 29, 1992, 106 Stat. 4516.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in subsec.

(d)(2), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended,

which is classified generally to chapter 9 (Sec. 301 et seq.) of

Title 21, Food and Drugs. For complete classification of this Act

to the Code, see Tables.

-COD-

CODIFICATION

In subsec. (a), "October 1, 1988" substituted for "the effective

date of this subpart" on authority of section 323 of Pub. L.

99-660, as amended, set out as an Effective Date note under section

300aa-1 of this title.

-MISC1-

AMENDMENTS

1992 - Subsec. (e). Pub. L. 102-572 substituted "United States

Court of Federal Claims" for "United States Claims Court" in two

places.

1989 - Subsec. (e). Pub. L. 101-239 substituted "finding of fact

or conclusion of law" for "finding", "special master" for "master

appointed by such court", and directed substitution of "the United

States Claims Court and subsequent appellate review" for "a

district court of the United States" which was executed by

inserting "and subsequent appellate review" after "the United

States Claims Court" the second place it appeared to reflect the

probable intent of Congress and the amendment by Pub. L. 100-203,

Sec. 4307(a), see 1987 Amendment note below.

1987 - Subsec. (a). Pub. L. 100-203, Sec. 4302(b)(1), substituted

"effective date of this subpart" for "effective date of this part".

Subsec. (e). Pub. L. 100-203, Sec. 4307(9), substituted "the

United States Claims Court" for "a district court of the United

States" in two places.

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-572 effective Oct. 29, 1992, see section

911 of Pub. L. 102-572, set out as a note under section 171 of

Title 28, Judiciary and Judicial Procedure.

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-22 of this title.

-End-

-CITE-

42 USC subpart c - assuring a safer childhood vaccination

program in united states 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart c - assuring a safer childhood vaccination program in united

states

-HEAD-

SUBPART C - ASSURING A SAFER CHILDHOOD VACCINATION PROGRAM IN

UNITED STATES

-End-

-CITE-

42 USC Sec. 300aa-25 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart c - assuring a safer childhood vaccination program in united

states

-HEAD-

Sec. 300aa-25. Recording and reporting of information

-STATUTE-

(a) General rule

Each health care provider who administers a vaccine set forth in

the Vaccine Injury Table to any person shall record, or ensure that

there is recorded, in such person's permanent medical record (or in

a permanent office log or file to which a legal representative

shall have access upon request) with respect to each such vaccine -

(1) the date of administration of the vaccine,

(2) the vaccine manufacturer and lot number of the vaccine,

(3) the name and address and, if appropriate, the title of the

health care provider administering the vaccine, and

(4) any other identifying information on the vaccine required

pursuant to regulations promulgated by the Secretary.

(b) Reporting

(1) Each health care provider and vaccine manufacturer shall

report to the Secretary -

(A) the occurrence of any event set forth in the Vaccine Injury

Table, including the events set forth in section 300aa-14(b) of

this title which occur within 7 days of the administration of any

vaccine set forth in the Table or within such longer period as is

specified in the Table or section,

(B) the occurrence of any contraindicating reaction to a

vaccine which is specified in the manufacturer's package insert,

and

(C) such other matters as the Secretary may by regulation

require.

Reports of the matters referred to in subparagraphs (A) and (B)

shall be made beginning 90 days after December 22, 1987. The

Secretary shall publish in the Federal Register as soon as

practicable after such date a notice of the reporting requirement.

(2) A report under paragraph (1) respecting a vaccine shall

include the time periods after the administration of such vaccine

within which vaccine-related illnesses, disabilities, injuries, or

conditions, the symptoms and manifestations of such illnesses,

disabilities, injuries, or conditions, or deaths occur, and the

manufacturer and lot number of the vaccine.

(3) The Secretary shall issue the regulations referred to in

paragraph (1)(C) within 180 days of December 22, 1987.

(c) Release of information

(1) Information which is in the possession of the Federal

Government and State and local governments under this section and

which may identify an individual shall not be made available under

section 552 of title 5, or otherwise, to any person except -

(A) the person who received the vaccine, or

(B) the legal representative of such person.

(2) For purposes of paragraph (1), the term "information which

may identify an individual" shall be limited to the name, street

address, and telephone number of the person who received the

vaccine and of that person's legal representative and the medical

records of such person relating to the administration of the

vaccine, and shall not include the locality and State of vaccine

administration, the name of the health care provider who

administered the vaccine, the date of the vaccination, or

information concerning any reported illness, disability, injury, or

condition resulting from the administration of the vaccine, any

symptom or manifestation of such illness, disability, injury, or

condition, or death resulting from the administration of the

vaccine.

(3) Except as provided in paragraph (1), all information reported

under this section shall be available to the public.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2125, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3774;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221.)

-COD-

CODIFICATION

In subsec. (b)(1), (3), "December 22, 1987" was substituted for

"the effective date of this subpart" on authority of section 323 of

Pub. L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-MISC1-

AMENDMENTS

1987 - Subsec. (b)(1), (3). Pub. L. 100-203 substituted

"effective date of this subpart" for "effective date of this part".

EFFECTIVE DATE

Subpart effective Dec. 22, 1987, see section 323 of Pub. L.

99-660, set out as a note under section 300aa-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-19 of this title.

-End-

-CITE-

42 USC Sec. 300aa-26 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart c - assuring a safer childhood vaccination program in united

states

-HEAD-

Sec. 300aa-26. Vaccine information

-STATUTE-

(a) General rule

Not later than 1 year after December 22, 1987, the Secretary

shall develop and disseminate vaccine information materials for

distribution by health care providers to the legal representatives

of any child or to any other individual receiving a vaccine set

forth in the Vaccine Injury Table. Such materials shall be

published in the Federal Register and may be revised.

(b) Development and revision of materials

Such materials shall be developed or revised -

(1) after notice to the public and 60 days of comment thereon,

and

(2) in consultation with the Advisory Commission on Childhood

Vaccines, appropriate health care providers and parent

organizations, the Centers for Disease Control and Prevention,

and the Food and Drug Administration.

(c) Information requirements

The information in such materials shall be based on available

data and information, shall be presented in understandable terms

and shall include -

(1) a concise description of the benefits of the vaccine,

(2) a concise description of the risks associated with the

vaccine,

(3) a statement of the availability of the National Vaccine

Injury Compensation Program, and

(4) such other relevant information as may be determined by the

Secretary.

(d) Health care provider duties

On and after a date determined by the Secretary which is -

(1) after the Secretary develops the information materials

required by subsection (a) of this section, and

(2) not later than 6 months after the date such materials are

published in the Federal Register,

each health care provider who administers a vaccine set forth in

the Vaccine Injury Table shall provide to the legal representatives

of any child or to any other individual to whom such provider

intends to administer such vaccine a copy of the information

materials developed pursuant to subsection (a) of this section,

supplemented with visual presentations or oral explanations, in

appropriate cases. Such materials shall be provided prior to the

administration of such vaccine.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2126, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3775;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221; Pub. L. 101-239, title VI, Sec. 6601(p), Dec.

19, 1989, 103 Stat. 2292; Pub. L. 102-531, title III, Sec.

312(d)(15), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103-183, title

VII, Sec. 708, Dec. 14, 1993, 107 Stat. 2242.)

-COD-

CODIFICATION

In subsec. (a), "December 22, 1987" substituted for "the

effective date of this subpart" on authority of section 323 of Pub.

L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-183, Sec. 708(c), inserted "or to

any other individual" after "to the legal representatives of any

child".

Subsec. (b). Pub. L. 103-183, Sec. 708(a), struck out "by rule"

after "revised" in introductory provisions and substituted "and 60"

for ", opportunity for a public hearing, and 90" in par. (1).

Subsec. (c). Pub. L. 103-183, Sec. 708(b), inserted in

introductory provisions "shall be based on available data and

information," after "such materials", added pars. (1) to (4), and

struck out former pars. (1) to (10) which read as follows:

"(1) the frequency, severity, and potential long-term effects of

the disease to be prevented by the vaccine,

"(2) the symptoms or reactions to the vaccine which, if they

occur, should be brought to the immediate attention of the health

care provider,

"(3) precautionary measures legal representatives should take to

reduce the risk of any major adverse reactions to the vaccine that

may occur,

"(4) early warning signs or symptoms to which legal

representatives should be alert as possible precursors to such

major adverse reactions,

"(5) a description of the manner in which legal representatives

should monitor such major adverse reactions, including a form on

which reactions can be recorded to assist legal representatives in

reporting information to appropriate authorities,

"(6) a specification of when, how, and to whom legal

representatives should report any major adverse reaction,

"(7) the contraindications to (and bases for delay of) the

administration of the vaccine,

"(8) an identification of the groups, categories, or

characteristics of potential recipients of the vaccine who may be

at significantly higher risk of major adverse reaction to the

vaccine than the general population,

"(9) a summary of -

"(A) relevant Federal recommendations concerning a complete

schedule of childhood immunizations, and

"(B) the availability of the Program, and

"(10) such other relevant information as may be determined by the

Secretary."

Subsec. (d). Pub. L. 103-183, Sec. 708(c), (d), in concluding

provisions, inserted "or to any other individual" after "to the

legal representatives of any child", substituted "supplemented with

visual presentations or oral explanations, in appropriate cases"

for "or other written information which meets the requirements of

this section", and struck out "or other information" after "Such

materials".

1992 - Subsec. (b)(2). Pub. L. 102-531 substituted "Centers for

Disease Control and Prevention" for "Centers for Disease Control".

1989 - Subsec. (c)(9). Pub. L. 101-239 amended par. (9)

generally. Prior to amendment, par. (9) read as follows: "a summary

of relevant State and Federal laws concerning the vaccine,

including information on -

"(A) the number of vaccinations required for school attendance

and the schedule recommended for such vaccinations, and

"(B) the availability of the Program, and".

1987 - Subsec. (a). Pub. L. 100-203 substituted "effective date

of this subpart" for "effective date of this part".

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-End-

-CITE-

42 USC Sec. 300aa-27 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart c - assuring a safer childhood vaccination program in united

states

-HEAD-

Sec. 300aa-27. Mandate for safer childhood vaccines

-STATUTE-

(a) General rule

In the administration of this part and other pertinent laws under

the jurisdiction of the Secretary, the Secretary shall -

(1) promote the development of childhood vaccines that result

in fewer and less serious adverse reactions than those vaccines

on the market on December 22, 1987, and promote the refinement of

such vaccines, and

(2) make or assure improvements in, and otherwise use the

authorities of the Secretary with respect to, the licensing,

manufacturing, processing, testing, labeling, warning, use

instructions, distribution, storage, administration, field

surveillance, adverse reaction reporting, and recall of

reactogenic lots or batches, of vaccines, and research on

vaccines, in order to reduce the risks of adverse reactions to

vaccines.

(b) Task force

(1) The Secretary shall establish a task force on safer childhood

vaccines which shall consist of the Director of the National

Institutes of Health, the Commissioner of the Food and Drug

Administration, and the Director of the Centers for Disease

Control.

(2) The Director of the National Institutes of Health shall serve

as chairman of the task force.

(3) In consultation with the Advisory Commission on Childhood

Vaccines, the task force shall prepare recommendations to the

Secretary concerning implementation of the requirements of

subsection (a) of this section.

(c) Report

Within 2 years after December 22, 1987, and periodically

thereafter, the Secretary shall prepare and transmit to the

Committee on Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of the Senate a

report describing the actions taken pursuant to subsection (a) of

this section during the preceding 2-year period.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2127, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3777;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221; Pub. L. 101-239, title VI, Sec. 6601(q), Dec.

19, 1989, 103 Stat. 2292.)

-COD-

CODIFICATION

In subsecs. (a)(1), (c), "December 22, 1987" substituted for "the

effective date of this subpart" on authority of section 323 of Pub.

L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-MISC1-

AMENDMENTS

1989 - Subsecs. (b), (c). Pub. L. 101-239 added subsec. (b) and

redesignated former subsec. (b) as (c).

1987 - Subsecs. (a)(1), (b). Pub. L. 100-203 substituted

"effective date of this subpart" for "effective date of this part".

-CHANGE-

CHANGE OF NAME

Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

Representatives by section 1(a) of Pub. L. 104-14, set out as a

note preceding section 21 of Title 2, The Congress. Committee on

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

of Representatives by House Resolution No. 5, One Hundred Seventh

Congress, Jan. 3, 2001.

-MISC2-

EFFECTIVE DATE OF 1989 AMENDMENT

For applicability of amendments by Pub. L. 101-239 to petitions

filed after Dec. 19, 1989, petitions currently pending in which the

evidentiary record is closed, and petitions currently pending in

which the evidentiary record is not closed, with provision for an

immediate suspension for 30 days of all pending cases, see section

6601(s)(1) of Pub. L. 101-239, set out as a note under section

300aa-10 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-19 of this title.

-End-

-CITE-

42 USC Sec. 300aa-28 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart c - assuring a safer childhood vaccination program in united

states

-HEAD-

Sec. 300aa-28. Manufacturer recordkeeping and reporting

-STATUTE-

(a) General rule

Each vaccine manufacturer of a vaccine set forth in the Vaccine

Injury Table or any other vaccine the administration of which is

mandated by the law or regulations of any State, shall, with

respect to each batch, lot, or other quantity manufactured or

licensed after December 22, 1987 -

(1) prepare and maintain records documenting the history of the

manufacturing, processing, testing, repooling, and reworking of

each batch, lot, or other quantity of such vaccine, including the

identification of any significant problems encountered in the

production, testing, or handling of such batch, lot, or other

quantity,

(2) if a safety test on such batch, lot, or other quantity

indicates a potential imminent or substantial public health

hazard is presented, report to the Secretary within 24 hours of

such safety test which the manufacturer (or manufacturer's

representative) conducted, including the date of the test, the

type of vaccine tested, the identity of the batch, lot, or other

quantity tested, whether the batch, lot, or other quantity tested

is the product of repooling or reworking of previous batches,

lots, or other quantities (and, if so, the identity of the

previous batches, lots, or other quantities which were repooled

or reworked), the complete test results, and the name and address

of the person responsible for conducting the test,

(3) include with each such report a certification signed by a

responsible corporate official that such report is true and

complete, and

(4) prepare, maintain, and upon request submit to the Secretary

product distribution records for each such vaccine by batch, lot,

or other quantity number.

(b) Sanction

Any vaccine manufacturer who intentionally destroys, alters,

falsifies, or conceals any record or report required under

paragraph (1) or (2) of subsection (a) of this section shall -

(1) be subject to a civil penalty of up to $100,000 per

occurrence, or

(2) be fined $50,000 or imprisoned for not more than 1 year, or

both.

Such penalty shall apply to the person who intentionally destroyed,

altered, falsified, or concealed such record or report, to the

person who directed that such record or report be destroyed,

altered, falsified, or concealed, and to the vaccine manufacturer

for which such person is an agent, employee, or representative.

Each act of destruction, alteration, falsification, or concealment

shall be treated as a separate occurrence.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2128, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3777;

amended Pub. L. 100-203, title IV, Sec. 4302(b)(1), Dec. 22, 1987,

101 Stat. 1330-221.)

-COD-

CODIFICATION

In subsec. (a), "December 22, 1987" substituted for "the

effective date of this subpart" on authority of section 323 of Pub.

L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-MISC1-

AMENDMENTS

1987 - Subsec. (a). Pub. L. 100-203 substituted "effective date

of this subpart" for "effective date of this part".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300aa-33 of this title.

-End-

-CITE-

42 USC subpart d - general provisions 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart d - general provisions

-HEAD-

SUBPART D - GENERAL PROVISIONS

-End-

-CITE-

42 USC Sec. 300aa-31 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart d - general provisions

-HEAD-

Sec. 300aa-31. Citizen's actions

-STATUTE-

(a) General rule

Except as provided in subsection (b) of this section, any person

may commence in a district court of the United States a civil

action on such person's own behalf against the Secretary where

there is alleged a failure of the Secretary to perform any act or

duty under this part.

(b) Notice

No action may be commenced under subsection (a) of this section

before the date which is 60 days after the person bringing the

action has given written notice of intent to commence such action

to the Secretary.

(c) Costs of litigation

The court, in issuing any final order in any action under this

section, may award costs of litigation (including reasonable

attorney and expert witness fees) to any plaintiff who

substantially prevails on one or more significant issues in the

action.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2131, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778;

amended Pub. L. 100-203, title IV, Sec. 4305, Dec. 22, 1987, 101

Stat. 1330-224.)

-MISC1-

AMENDMENTS

1987 - Subsec. (c). Pub. L. 100-203, which directed that subsec.

(c) be amended by substituting "to any plaintiff who substantially

prevails on one or more significant issues in the action" for "to

any party, whenever the court determines that such award is

appropriate", was executed by making the substitution for "to any

party, whenever the court determines such award is appropriate", to

reflect the probable intent of Congress.

EFFECTIVE DATE

Subpart effective Dec. 22, 1987, see section 323 of Pub. L.

99-660, set out as a note under section 300aa-1 of this title.

-End-

-CITE-

42 USC Sec. 300aa-32 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart d - general provisions

-HEAD-

Sec. 300aa-32. Judicial review

-STATUTE-

A petition for review of a regulation under this part may be

filed in a court of appeals of the United States within 60 days

from the date of the promulgation of the regulation or after such

date if such petition is based solely on grounds arising after such

60th day.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2132, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778.)

-End-

-CITE-

42 USC Sec. 300aa-33 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart d - general provisions

-HEAD-

Sec. 300aa-33. Definitions

-STATUTE-

For purposes of this part:

(1) The term "health care provider" means any licensed health

care professional, organization, or institution, whether public

or private (including Federal, State, and local departments,

agencies, and instrumentalities) under whose authority a vaccine

set forth in the Vaccine Injury Table is administered.

(2) The term "legal representative" means a parent or an

individual who qualifies as a legal guardian under State law.

(3) The term "manufacturer" means any corporation,

organization, or institution, whether public or private

(including Federal, State, and local departments, agencies, and

instrumentalities), which manufactures, imports, processes, or

distributes any vaccine set forth in the Vaccine Injury table,

including any component or ingredient of any such vaccine, except

that, for purposes of section 300aa-28 of this title, such term

shall include the manufacturer of any other vaccine covered by

that section. The term "manufacture" means to manufacture,

import, process, or distribute a vaccine including any component

or ingredient of any such vaccine.

(4) The term "significant aggravation" means any change for the

worse in a preexisting condition which results in markedly

greater disability, pain, or illness accompanied by substantial

deterioration of health.

(5) The term "vaccine-related injury or death" means an

illness, injury, condition, or death associated with one or more

of the vaccines set forth in the Vaccine Injury Table, except

that the term does not include an illness, injury, condition, or

death associated with an adulterant or contaminant intentionally

added to such a vaccine. For purposes of the preceding sentence,

an adulterant or contaminant shall not include any component or

ingredient listed in a vaccine's product license application or

product label.

(6)(A) The term "Advisory Commission on Childhood Vaccines"

means the Commission established under section 300aa-19 of this

title.

(B) The term "Vaccine Injury Table" means the table set out in

section 300aa-14 of this title.

(7) The term "vaccine" means any preparation or suspension,

including but not limited to a preparation or suspension

containing an attenuated or inactive microorganism or subunit

thereof or toxin, developed or administered to produce or enhance

the body's immune response to a disease or diseases and includes

all components and ingredients listed in the vaccines's product

license application and product label.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2133, as added Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3778;

amended Pub. L. 107-296, title XVII, Secs. 1714-1716, Nov. 25,

2002, 116 Stat. 2320, 2321.)

-MISC1-

AMENDMENTS

2002 - Par. (3). Pub. L. 107-296, Sec. 1714, in first sentence,

substituted "any vaccine set forth in the Vaccine Injury table,

including any component or ingredient of any such vaccine" for

"under its label any vaccine set forth in the Vaccine Injury Table"

and, in second sentence, inserted "including any component or

ingredient of any such vaccine" before period at end.

Par. (5). Pub. L. 107-296, Sec. 1715, inserted at end "For

purposes of the preceding sentence, an adulterant or contaminant

shall not include any component or ingredient listed in a vaccine's

product license application or product label."

Par. (7). Pub. L. 107-296, Sec. 1716, added par. (7).

EFFECTIVE DATE OF 2002 AMENDMENT

Pub. L. 107-296, title XVII, Sec. 1717, Nov. 25, 2002, 116 Stat.

2321, provided that: "The amendments made by sections 1714, 1715,

and 1716 [amending this section] shall apply to all actions or

proceedings pending on or after the date of enactment of this Act

[Nov. 25, 2002], unless a court of competent jurisdiction has

entered judgment (regardless of whether the time for appeal has

expired) in such action or proceeding disposing of the entire

action or proceeding."

-End-

-CITE-

42 USC Sec. 300aa-34 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XIX - VACCINES

Part 2 - National Vaccine Injury Compensation Program

subpart d - general provisions

-HEAD-

Sec. 300aa-34. Termination of program

-STATUTE-

(a) Reviews

The Secretary shall review the number of awards of compensation

made under the program to petitioners under section 300aa-11 of

this title for vaccine-related injuries and deaths associated with

the administration of vaccines on or after December 22, 1987, as

follows:

(1) The Secretary shall review the number of such awards made

in the 12-month period beginning on December 22, 1987.

(2) At the end of each 3-month period beginning after the

expiration of the 12-month period referred to in paragraph (1)

the Secretary shall review the number of such awards made in the

3-month period.

(b) Report

(1) If in conducting a review under subsection (a) of this

section the Secretary determines that at the end of the period

reviewed the total number of awards made by the end of that period

and accepted under section 300aa-21(a) of this title exceeds the

number of awards listed next to the period reviewed in the table in

paragraph (2) -

(A) the Secretary shall notify the Congress of such

determination, and

(B) beginning 180 days after the receipt by Congress of a

notification under paragraph (1), no petition for a

vaccine-related injury or death associated with the

administration of a vaccine on or after December 22, 1987, may be

filed under section 300aa-11 of this title.

Section 300aa-11(a) of this title and subpart B of this part shall

not apply to civil actions for damages for a vaccine-related injury

or death for which a petition may not be filed because of

subparagraph (B).

(2) The table referred to in paragraph (1) is as follows:

Total number of

awards

by the end of

the period

Period reviewed: reviewed

12 months after December 22, 1987 150

13th through the 15th month after December 22,

1987 188

16th through the 18th month after December 22,

1987 225

19th through the 21st month after December 22,

1987 263

22nd through the 24th month after December 22,

1987 300

25th through the 27th month after December 22,

1987 338

28th through the 30th month after December 22,

1987 375

31st through the 33rd month after December 22,

1987 413

34th through the 36th month after December 22,

1987 450

37th through the 39th month after December 22,

1987 488

40th through the 42nd month after December 22,

1987 525

43rd through the 45th month after December 22,

1987 563

46th through the 48th month after December 22,

1987 600.

-SOURCE-

(July 1, 1944, ch. 373, title XXI, Sec. 2134, as added Pub. L.

100-203, title IV, Sec. 4303(f), Dec. 22, 1987, 101 Stat.

1330-222.)

-COD-

CODIFICATION

In subsecs. (a) and (b), "December 22, 1987" substituted for "the

effective date of this subpart" on authority of section 323 of Pub.

L. 99-660, as amended, set out as an Effective Date note under

section 300aa-1 of this title.

-End-

-CITE-

42 USC SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP

HEALTH PLANS FOR CERTAIN STATE AND LOCAL

EMPLOYEES 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in sections 300gg-91, 1396a, 1396e

of this title; title 26 section 9832; title 29 section 1191b.

-End-

-CITE-

42 USC Sec. 300bb-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-1. State and local governmental group health plans must

provide continuation coverage to certain individuals

-STATUTE-

(a) In general

In accordance with regulations which the Secretary shall

prescribe, each group health plan that is maintained by any State

that receives funds under this chapter, by any political

subdivision of such a State, or by any agency or instrumentality of

such a State or political subdivision, shall provide, in accordance

with this subchapter, that each qualified beneficiary who would

lose coverage under the plan as a result of a qualifying event is

entitled, under the plan, to elect, within the election period,

continuation coverage under the plan.

(b) Exception for certain plans

Subsection (a) of this section shall not apply to -

(1) any group health plan for any calendar year if all

employers maintaining such plan normally employed fewer than 20

employees on a typical business day during the preceding calendar

year, or

(2) any group health plan maintained for employees by the

government of the District of Columbia or any territory or

possession of the United States or any agency or instrumentality.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2201, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 232;

amended Pub. L. 101-239, title VI, Sec. 6801(a)(1), Dec. 19, 1989,

103 Stat. 2296.)

-MISC1-

AMENDMENTS

1989 - Subsec. (b). Pub. L. 101-239 struck out at end "Under

regulations, rules similar to the rules of subsections (a) and (b)

of section 52 of title 26 (relating to employers under common

control) shall apply for purposes of paragraph (1)."

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6801(a)(2) of Pub. L. 101-239 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to years beginning after December 31, 1986."

EFFECTIVE DATE

Section 10003(b) of Pub. L. 99-272 provided that:

"(1) General rule. - The amendments made by this section

[enacting this subchapter] shall apply to plan years beginning on

or after July 1, 1986.

"(2) Special rule for collective bargaining agreements. - In the

case of a group health plan maintained pursuant to one or more

collective bargaining agreements between employee representatives

and one or more employers ratified before the date of the enactment

of this Act [Apr. 7, 1986], the amendments made by this section

shall not apply to plan years beginning before the later of -

"(A) the date on which the last of the collective bargaining

agreements relating to the plan terminates (determined without

regard to any extension thereof agreed to after the date of the

enactment of this Act), or

"(B) January 1, 1987.

For purposes of subparagraph (A), any plan amendment made pursuant

to a collective bargaining agreement relating to the plan which

amends the plan solely to conform to any requirement added by this

section shall not be treated as a termination of such collective

bargaining agreement."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300bb-2 of this title.

-End-

-CITE-

42 USC Sec. 300bb-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-2. Continuation coverage

-STATUTE-

For purposes of section 300bb-1 of this title, the term

"continuation coverage" means coverage under the plan which meets

the following requirements:

(1) Type of benefit coverage

The coverage must consist of coverage which, as of the time the

coverage is being provided, is identical to the coverage provided

under the plan to similarly situated beneficiaries under the plan

with respect to whom a qualifying event has not occurred. If

coverage is modified under the plan for any group of similarly

situated beneficiaries, such coverage shall also be modified in

the same manner for all individuals who are qualified

beneficiaries under the plan pursuant to this part (!1) in

connection with such group.

(2) Period of coverage

The coverage must extend for at least the period beginning on

the date of the qualifying event and ending not earlier than the

earliest of the following:

(A) Maximum required period

(i) General rule for terminations and reduced hours

In the case of a qualifying event described in section

300bb-3(2) of this title, except as provided in clause (ii),

the date which is 18 months after the date of the qualifying

event.

(ii) Special rule for multiple qualifying events

If a qualifying event occurs during the 18 months after the

date of a qualifying event described in section 300bb-3(2) of

this title, the date which is 36 months after the date of the

qualifying event described in section 300bb-3(2) of this

title.

(iii) General rule for other qualifying events

In the case of a qualifying event not described in section

300bb-3(2) of this title, the date which is 36 months after

the date of the qualifying event.

(iv) Medicare entitlement followed by qualifying event

In the case of a qualifying event described in section

300bb-3(2) of this title that occurs less than 18 months

after the date the covered employee became entitled to

benefits under title XVIII of the Social Security Act [42

U.S.C. 1395 et seq.], the period of coverage for qualified

beneficiaries other than the covered employee shall not

terminate under this subparagraph before the close of the

36-month period beginning on the date the covered employee

became so entitled.

In the case of a qualified beneficiary who is determined, under

title II or XVI of the Social Security Act [42 U.S.C. 401 et

seq., 1381 et seq.], to have been disabled at any time during

the first 60 days of continuation coverage under this

subchapter, any reference in clause (i) or (ii) to 18 months is

deemed a reference to 29 months (with respect to all qualified

beneficiaries), but only if the qualified beneficiary has

provided notice of such determination under section 300bb-6(3)

of this title before the end of such 18 months.

(B) End of plan

The date on which the employer ceases to provide any group

health plan to any employee.

(C) Failure to pay premium

The date on which coverage ceases under the plan by reason of

a failure to make timely payment of any premium required under

the plan with respect to the qualified beneficiary. The payment

of any premium (other than any payment referred to in the last

sentence of paragraph (3)) shall be considered to be timely if

made within 30 days after the date due or within such longer

period as applies to or under the plan.

(D) Group health plan coverage or medicare entitlement

The date on which the qualified beneficiary first becomes,

after the date of the election -

(i) covered under any other group health plan (as an

employee or otherwise) which does not contain any exclusion

or limitation with respect to any preexisting condition of

such beneficiary (other than such an exclusion or limitation

which does not apply to (or is satisfied by) such beneficiary

by reason of chapter 100 of title 26, part 7 of subtitle B of

title I of the Employee Retirement Income Security Act of

1974 [29 U.S.C. 1181 et seq.], or subchapter XXV of this

chapter), or

(ii) entitled to benefits under title XVIII of the Social

Security Act [42 U.S.C. 1395 et seq.].

(E) Termination of extended coverage for disability

In the case of a qualified beneficiary who is disabled at any

time during the first 60 days of continuation coverage under

this subchapter, the month that begins more than 30 days after

the date of the final determination under title II or XVI of

the Social Security Act [42 U.S.C. 401 et seq., 1381 et seq.]

that the qualified beneficiary is no longer disabled.

(3) Premium requirements

The plan may require payment of a premium for any period of

continuation coverage, except that such premium -

(A) shall not exceed 102 percent of the applicable premium

for such period, and

(B) may, at the election of the payor, be made in monthly

installments.

In no event may the plan require the payment of any premium

before the day which is 45 days after the day on which the

qualified beneficiary made the initial election for continuation

coverage.(!2) In the case of an individual described in the last

sentence of paragraph (2)(A), any reference in subparagraph (A)

of this paragraph to "102 percent" is deemed a reference to "150

percent" for any month after the 18th month of continuation

coverage described in clause (i) or (ii) of paragraph (2)(A).

(4) No requirement of insurability

The coverage may not be conditioned upon, or discriminate on

the basis of lack of, evidence of insurability.

(5) Conversion option

In the case of a qualified beneficiary whose period of

continuation coverage expires under paragraph (2)(A), the plan

must, during the 180-day period ending on such expiration date,

provide to the qualified beneficiary the option of enrollment

under a conversion health plan otherwise generally available

under the plan.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2202, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 233;

amended Pub. L. 99-514, title XVIII, Sec. 1895(d)(1)(C), (2)(C),

(3)(C), (4)(C), Oct. 22, 1986, 100 Stat. 2937-2939; Pub. L.

101-239, title VI, Secs. 6702(a), (b), 6801(b)(1)(A), (2)(A),

(3)(A), Dec. 19, 1989, 103 Stat. 2295, 2297; Pub. L. 104-188, title

I, Sec. 1704(g)(1)(C), Aug. 20, 1996, 110 Stat. 1880; Pub. L.

104-191, title IV, Sec. 421(a)(1), Aug. 21, 1996, 110 Stat. 2087.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in par. (2)(A), (D)(ii), and

(E), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.

Titles II, XVI, and XVIII of the Social Security Act are classified

generally to subchapters II (Sec. 401 et seq.), XVI (Sec. 1381 et

seq.), and XVIII (Sec. 1395 et seq.), respectively, of chapter 7 of

this title. For complete classification of this Act to the Code,

see section 1305 of this title and Tables.

The Employee Retirement Income Security Act of 1974, referred to

in par. (2)(D)(i), is Pub. L. 93-406, Sept. 2, 1974, 88 Stat. 829,

as amended. Part 7 of subtitle B of title I of the Act is

classified generally to part 7 (Sec. 1181 et seq.) of subtitle B of

subchapter I of chapter 18 of Title 29, Labor. For complete

classification of this Act to the Code, see Short Title note set

out under section 1001 of Title 29 and Tables.

-MISC1-

AMENDMENTS

1996 - Par. (2)(A). Pub. L. 104-191, Sec. 421(a)(1)(A)(ii)(IV),

inserted "(with respect to all qualified beneficiaries)" after "29

months" in concluding provisions.

Pub. L. 104-191, Sec. 421(a)(1)(A)(ii)(III), which directed

amendment of concluding provisions by striking "with respect to

such event,", was executed by striking that phrase, which did not

contain a comma at end, before "is deemed a reference" to reflect

the probable intent of Congress.

Pub. L. 104-191, Sec. 421(a)(1)(A)(ii)(I), (II), in concluding

provisions, substituted "a qualified beneficiary" for "an

individual" and "at any time during the first 60 days of

continuation coverage under this subchapter" for "at the time of a

qualifying event described in section 300bb-3(2) of this title".

Pub. L. 104-191, Sec. 421(a)(1)(A)(i), transferred sentence

following cl. (iii) to appear as concluding provisions following

cl. (iv).

Par. (2)(A)(iv). Pub. L. 104-188 amended heading and text of cl.

(iv) generally. Prior to amendment, text read as follows: "In the

case of an event described in section 300bb-3(4) of this title

(without regard to whether such event is a qualifying event), the

period of coverage for qualified beneficiaries other than the

covered employee for such event or any subsequent qualifying event

shall not terminate before the close of the 36-month period

beginning on the date the covered employee becomes entitled to

benefits under title XVIII of the Social Security Act."

Par. (2)(D)(i). Pub. L. 104-191, Sec. 421(a)(1)(B), inserted

"(other than such an exclusion or limitation which does not apply

to (or is satisfied by) such beneficiary by reason of chapter 100

of title 26, part 7 of subtitle B of title I of the Employee

Retirement Income Security Act of 1974, or subchapter XXV of this

chapter)" before ", or".

Par. (2)(E). Pub. L. 104-191, Sec. 421(a)(1)(C), substituted "at

any time during the first 60 days of continuation coverage under

this subchapter" for "at the time of a qualifying event described

in section 300bb-3(2) of this title".

1989 - Par. (2)(A). Pub. L. 101-239, Sec. 6702(a)(1), inserted

after cl. (iii) "In the case of an individual who is determined,

under title II or XVI of the Social Security Act, to have been

disabled at the time of a qualifying event described in section

300bb-3(2) of this title, any reference in clause (i) or (ii) to 18

months with respect to such event is deemed a reference to 29

months, but only if the qualified beneficiary has provided notice

of such determination under section 300bb-6(3) of this title before

the end of such 18 months."

Par. (2)(A)(iv). Pub. L. 101-239, Sec. 6801(b)(1)(A), added cl.

(iv).

Par. (2)(D). Pub. L. 101-239, Sec. 6801(b)(2)(A), substituted

"entitlement" for "eligibility" in heading and inserted "which does

not contain any exclusion or limitation with respect to any

preexisting condition of such beneficiary" after "or otherwise)" in

cl. (i).

Par. (2)(E). Pub. L. 101-239, Sec. 6702(a)(2), added subpar. (E).

Par. (3). Pub. L. 101-239, Sec. 6801(b)(3)(A), which directed the

general amendment of the concluding provision was executed by

amending the first sentence of the concluding provision generally

to reflect the probable intent of Congress and amendment of

concluding provision by Pub. L. 101-239, Sec. 6702(b). Prior to

amendment, first sentence of the concluding provision read as

follows: "If an election is made after the qualifying event, the

plan shall permit payment for continuation coverage during the

period preceding the election to be made within 45 days of the date

of the election."

Pub. L. 101-239, Sec. 6702(b), inserted at end of concluding

provision "In the case of an individual described in the last

sentence of paragraph (2)(A), any reference in subparagraph (A) of

this paragraph to '102 percent' is deemed a reference to '150

percent' for any month after the 18th month of continuation

coverage described in clause (i) or (ii) of paragraph (2)(A)." See

Amendment note above.

1986 - Par. (1). Pub. L. 99-514, Sec. 1895(d)(1)(C), inserted at

end "If coverage is modified under the plan for any group of

similarly situated beneficiaries, such coverage shall also be

modified in the same manner for all individuals who are qualified

beneficiaries under the plan pursuant to this part in connection

with such group."

Par. (2)(A). Pub. L. 99-514, Sec. 1895(d)(2)(C), amended subpar.

(A) generally. Prior to amendment, subpar. (A) read as follows:

"Maximum period. - In the case of -

"(i) a qualifying event described in section 300bb-3(2) of this

title (relating to terminations and reduced hours), the date

which is 18 months after the date of the qualifying event, and

"(ii) any qualifying event not described in clause (i), the

date which is 36 months after the date of the qualifying event."

Par. (2)(C). Pub. L. 99-514, Sec. 1895(d)(3)(C), inserted at end

"The payment of any premium (other than any payment referred to in

the last sentence of paragraph (3)) shall be considered to be

timely if made within 30 days after the date due or within such

longer period as applies to or under the plan."

Par. (2)(D). Pub. L. 99-514, Sec. 1895(d)(4)(C)(ii), (iii),

substituted "Group health plan coverage" for "Reemployment" in

heading, added cl. (i), and struck out former cl. (i) which read as

follows: "a covered employee under any other group health plan,

or".

Par. (2)(E). Pub. L. 99-514, Sec. 1895(d)(4)(C)(i), struck out

subpar. (E), remarriage of spouse, which read as follows: "In the

case of an individual who is a qualified beneficiary by reason of

being the spouse of a covered employee, the date on which the

beneficiary remarries and becomes covered under a group health

plan."

EFFECTIVE DATE OF 1996 AMENDMENTS

Amendment by Pub. L. 104-191 effective Jan. 1, 1997, regardless

of whether the qualifying event occurred before, on, or after such

date, see section 421(d) of Pub. L. 104-191, set out as a note

under section 4980B of Title 26, Internal Revenue Code.

Amendment by Pub. L. 104-188 applicable to plan years beginning

after Dec. 31, 1989, see section 1704(g)(2) of Pub. L. 104-188, set

out as a note under section 4980B of Title 26.

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6702(d) of Pub. L. 101-239 provided that: "The amendments

made by this section [amending this section and section 300bb-6 of

this title] shall apply to plan years beginning on or after the

date of the enactment of this Act [Dec. 19, 1989], regardless of

whether the qualifying event occurred before, on, or after such

date."

Section 6801(b)(1)(B) of Pub. L. 101-239 provided that: "The

amendments made by this paragraph [amending this section] shall

apply to plan years beginning after December 31, 1989."

Section 6801(b)(2)(B) of Pub. L. 101-239 provided that: "The

amendments made by subparagraph (A) [amending this section] shall

apply to -

"(i) qualifying events occurring after December 31, 1989, and

"(ii) in the case of qualified beneficiaries who elected

continuation coverage after December 31, 1988, the period for

which the required premium was paid (or was attempted to be paid

but was rejected as such)."

Section 6801(b)(3)(B) of Pub. L. 101-239 provided that: "The

amendment made by subparagraph (A) [amending this section] shall

apply to plan years beginning after December 31, 1989."

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by Pub. L. 99-514 effective, except as otherwise

provided, as if included in enactment of the Consolidated Omnibus

Budget Reconciliation Act of 1985, Pub. L. 99-272, see section

1895(e) of Pub. L. 99-514, set out as a note under section 162 of

Title 26, Internal Revenue Code.

PLAN AMENDMENTS NOT REQUIRED UNTIL JANUARY 1, 1989

For provisions directing that if any amendments made by subtitle

A or subtitle C of title XI [Secs. 1101-1147 and 1171-1177] or

title XVIII [Secs. 1800-1899A] of Pub. L. 99-514 require an

amendment to any plan, such plan amendment shall not be required to

be made before the first plan year beginning on or after Jan. 1,

1989, see section 1140 of Pub. L. 99-514, as amended, set out as a

note under section 401 of Title 26, Internal Revenue Code.

-FOOTNOTE-

(!1) So in original. This subchapter is not divided into parts.

(!2) See 1989 Amendment note below.

-End-

-CITE-

42 USC Sec. 300bb-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-3. Qualifying event

-STATUTE-

For purposes of this subchapter, the term "qualifying event"

means, with respect to any covered employee, any of the following

events which, but for the continuation coverage required under this

subchapter, would result in the loss of coverage of a qualified

beneficiary:

(1) The death of the covered employee.

(2) The termination (other than by reason of such employee's

gross misconduct), or reduction of hours, of the covered

employee's employment.

(3) The divorce or legal separation of the covered employee

from the employee's spouse.

(4) The covered employee becoming entitled to benefits under

title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].

(5) A dependent child ceasing to be a dependent child under the

generally applicable requirements of the plan.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2203, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 234.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in par. (4), is act Aug. 14,

1935, ch. 531, 49 Stat. 620, as amended. Title XVIII of the Social

Security Act is classified generally to subchapter XVIII (Sec. 1395

et seq.) of chapter 7 of this title. For complete classification of

this Act to the Code, see section 1305 of this title and Tables.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300bb-2, 300bb-6, 300bb-8

of this title.

-End-

-CITE-

42 USC Sec. 300bb-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-4. Applicable premium

-STATUTE-

For purposes of this subchapter -

(1) In general

The term "applicable premium" means, with respect to any period

of continuation coverage of qualified beneficiaries, the cost to

the plan for such period of the coverage for similarly situated

beneficiaries with respect to whom a qualifying event has not

occurred (without regard to whether such cost is paid by the

employer or employee).

(2) Special rule for self-insured plans

To the extent that a plan is a self-insured plan -

(A) In general

Except as provided in subparagraph (B), the applicable

premium for any period of continuation coverage of qualified

beneficiaries shall be equal to a reasonable estimate of the

cost of providing coverage for such period for similarly

situated beneficiaries which -

(i) is determined on an actuarial basis, and

(ii) takes into account such factors as the Secretary may

prescribe in regulations.

(B) Determination on basis of past cost

If a plan administrator elects to have this subparagraph

apply, the applicable premium for any period of continuation

coverage of qualified beneficiaries shall be equal to -

(i) the cost to the plan for similarly situated

beneficiaries for the same period occurring during the

preceding determination period under paragraph (3), adjusted

by

(ii) the percentage increase or decrease in the implicit

price deflator of the gross national product (calculated by

the Department of Commerce and published in the Survey of

Current Business) for the 12-month period ending on the last

day of the sixth month of such preceding determination

period.

(C) Subparagraph (B) not to apply where significant change

A plan administrator may not elect to have subparagraph (B)

apply in any case in which there is any significant difference,

between the determination period and the preceding

determination period, in coverage under, or in employees

covered by, the plan. The determination under the preceding

sentence for any determination period shall be made at the same

time as the determination under paragraph (3).

(3) Determination period

The determination of any applicable premium shall be made for a

period of 12 months and shall be made before the beginning of

such period.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2204, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 234.)

-End-

-CITE-

42 USC Sec. 300bb-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-5. Election

-STATUTE-

(a) In general

For purposes of this subchapter -

(1) Election period

The term "election period" means the period which -

(A) begins not later than the date on which coverage

terminates under the plan by reason of a qualifying event,

(B) is of at least 60 days' duration, and

(C) ends not earlier than 60 days after the later of -

(i) the date described in subparagraph (A), or

(ii) in the case of any qualified beneficiary who receives

notice under section 300bb-6(4) of this title, the date of

such notice.

(2) Effect of election on other beneficiaries

Except as otherwise specified in an election, any election of

continuation coverage by a qualified beneficiary described in

subparagraph (A)(i) or (B) of section 300bb-8(3) of this title

shall be deemed to include an election of continuation coverage

on behalf of any other qualified beneficiary who would lose

coverage under the plan by reason of the qualifying event. If

there is a choice among types of coverage under the plan, each

qualified beneficiary is entitled to make a separate selection

among such types of coverage.

(b) Temporary extension of COBRA election period for certain

individuals

(1) In general

In the case of a nonelecting TAA-eligible individual and

notwithstanding subsection (a) of this section, such individual

may elect continuation coverage under this subchapter during the

60-day period that begins on the first day of the month in which

the individual becomes a TAA-eligible individual, but only if

such election is made not later than 6 months after the date of

the TAA-related loss of coverage.

(2) Commencement of coverage; no reach-back

Any continuation coverage elected by a TAA-eligible individual

under paragraph (1) shall commence at the beginning of the 60-day

election period described in such paragraph and shall not include

any period prior to such 60-day election period.

(3) Preexisting conditions

With respect to an individual who elects continuation coverage

pursuant to paragraph (1), the period -

(A) beginning on the date of the TAA-related loss of

coverage, and

(B) ending on the first day of the 60-day election period

described in paragraph (1),

shall be disregarded for purposes of determining the 63-day

periods referred to in section 300gg(c)(2) of this title, section

1181(c)(2) of title 29, and section 9801(c)(2) of title 26.

(4) Definitions

For purposes of this subsection:

(A) Nonelecting TAA-eligible individual

The term "nonelecting TAA-eligible individual" means a

TAA-eligible individual who -

(i) has a TAA-related loss of coverage; and

(ii) did not elect continuation coverage under this part

(!1) during the TAA-related election period.

(B) TAA-eligible individual

The term "TAA-eligible individual" means -

(i) an eligible TAA recipient (as defined in paragraph (2)

of section 35(c) of title 26), and

(ii) an eligible alternative TAA recipient (as defined in

paragraph (3) of such section).

(C) TAA-related election period

The term "TAA-related election period" means, with respect to

a TAA-related loss of coverage, the 60-day election period

under this part (!1) which is a direct consequence of such

loss.

(D) TAA-related loss of coverage

The term "TAA-related loss of coverage" means, with respect

to an individual whose separation from employment gives rise to

being an TAA-eligible individual, the loss of health benefits

coverage associated with such separation.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2205, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 235;

amended Pub. L. 99-514, title XVIII, Sec. 1895(d)(5)(C), Oct. 22,

1986, 100 Stat. 2939; Pub. L. 107-210, div. A, title II, Sec.

203(e)(2), Aug. 6, 2002, 116 Stat. 970.)

-MISC1-

AMENDMENTS

2002 - Pub. L. 107-210 designated existing provisions as subsec.

(a), inserted subsec. heading, and added subsec. (b).

1986 - Par. (2). Pub. L. 99-514 inserted "of continuation

coverage" after "any election" and inserted at end "If there is a

choice among types of coverage under the plan, each qualified

beneficiary is entitled to make a separate selection among such

types of coverage.".

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by Pub. L. 99-514 effective, except as otherwise

provided, as if included in enactment of the Consolidated Omnibus

Budget Reconciliation Act of 1985, Pub. L. 99-272, see section

1895(e) of Pub. L. 99-514, set out as a note under section 162 of

Title 26, Internal Revenue Code.

CONSTRUCTION OF 2002 AMENDMENT

Nothing in amendment by Pub. L. 107-210, other than provisions

relating to COBRA continuation coverage and reporting requirements,

to be construed as creating new mandate on any party regarding

health insurance coverage, see section 203(f) of Pub. L. 107-210,

set out as a note under section 2918 of Title 29, Labor.

PLAN AMENDMENTS NOT REQUIRED UNTIL JANUARY 1, 1989

For provisions directing that if any amendments made by subtitle

A or subtitle C of title XI [Secs. 1101-1147 and 1171-1177] or

title XVIII [Secs. 1800-1899A] of Pub. L. 99-514 require an

amendment to any plan, such plan amendment shall not be required to

be made before the first plan year beginning on or after Jan. 1,

1989, see section 1140 of Pub. L. 99-514, as amended, set out as a

note under section 401 of Title 26, Internal Revenue Code.

-FOOTNOTE-

(!1) So in original. This subchapter is not divided into parts.

-End-

-CITE-

42 USC Sec. 300bb-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-6. Notice requirements

-STATUTE-

In accordance with regulations prescribed by the Secretary -

(1) the group health plan shall provide, at the time of

commencement of coverage under the plan, written notice to each

covered employee and spouse of the employee (if any) of the

rights provided under this subsection,(!1)

(2) the employer of an employee under a plan must notify the

plan administrator of a qualifying event described in paragraph

(1), (2), or (4) of section 300bb-3 of this title within 30 days

of the date of the qualifying event,

(3) each covered employee or qualified beneficiary is

responsible for notifying the plan administrator of the

occurrence of any qualifying event described in paragraph (3) or

(5) of section 300bb-3 of this title within 60 days after the

date of the qualifying event and each qualified beneficiary who

is determined, under title II or XVI of the Social Security Act

[42 U.S.C. 401 et seq., 1381 et seq.], to have been disabled at

any time during the first 60 days of continuation coverage under

this subchapter is responsible for notifying the plan

administrator of such determination within 60 days after the date

of the determination and for notifying the plan administrator

within 30 days after the date of any final determination under

such title or titles that the qualified beneficiary is no longer

disabled, and

(4) the plan administrator shall notify -

(A) in the case of a qualifying event described in paragraph

(1), (2), or (4) of section 300bb-3 of this title, any

qualified beneficiary with respect to such event, and

(B) in the case of a qualifying event described in paragraph

(3) or (5) of section 300bb-3 of this title where the covered

employee notifies the plan administrator under paragraph (3),

any qualified beneficiary with respect to such event,

of such beneficiary's rights under this subsection.(!1)

For purposes of paragraph (4), any notification shall be made

within 14 days of the date on which the plan administrator is

notified under paragraph (2) or (3), whichever is applicable, and

any such notification to an individual who is a qualified

beneficiary as the spouse of the covered employee shall be treated

as notification to all other qualified beneficiaries residing with

such spouse at the time such notification is made.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2206, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 235;

amended Pub. L. 99-514, title XVIII, Sec. 1895(d)(6)(C), Oct. 22,

1986, 100 Stat. 2939; Pub. L. 100-203, title IV, Sec. 4009(j)(8),

Dec. 22, 1987, 101 Stat. 1330-59; Pub. L. 101-239, title VI, Sec.

6702(c), Dec. 19, 1989, 103 Stat. 2295; Pub. L. 104-191, title IV,

Sec. 421(a)(2), Aug. 21, 1996, 110 Stat. 2088.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in par. (3), is act Aug. 14,

1935, ch. 531, 49 Stat. 620, as amended. Titles II and XVI of the

Social Security Act are classified generally to subchapters II

(Sec. 401 et seq.) and XVI (Sec. 1381 et seq.), respectively, of

chapter 7 of this title. For complete classification of this Act to

the Code, see section 1305 of this title and Tables.

-MISC1-

AMENDMENTS

1996 - Par. (3). Pub. L. 104-191 substituted "at any time during

the first 60 days of continuation coverage under this subchapter"

for "at the time of a qualifying event described in section

300bb-3(2) of this title".

1989 - Par. (3). Pub. L. 101-239 inserted "and each qualified

beneficiary who is determined, under title II or XVI of the Social

Security Act, to have been disabled at the time of a qualifying

event described in section 300bb-3(2) of this title is responsible

for notifying the plan administrator of such determination within

60 days after the date of the determination and for notifying the

plan administrator within 30 days after the date of any final

determination under such title or titles that the qualified

beneficiary is no longer disabled" after "date of the qualifying

event".

1987 - Par. (3). Pub. L. 100-203 amended directory language of

Pub. L. 99-514, see 1986 Amendment note below.

1986 - Par. (3). Pub. L. 99-514, as amended by Pub. L. 100-203,

inserted "within 60 days after the date of the qualifying event".

EFFECTIVE DATE OF 1996 AMENDMENT

Amendment by Pub. L. 104-191 effective Jan. 1, 1997, regardless

of whether the qualifying event occurred before, on, or after such

date, see section 421(d) of Pub. L. 104-191, set out as a note

under section 4980B of Title 26, Internal Revenue Code.

EFFECTIVE DATE OF 1989 AMENDMENT

Amendment by Pub. L. 101-239 applicable to plan years beginning

on or after Dec. 19, 1989, regardless of whether the qualifying

event occurred before, on, or after such date, see section 6702(d)

of Pub. L. 101-239, set out as a note under section 300bb-2 of this

title.

EFFECTIVE DATE OF 1987 AMENDMENT

Section 4009(j)(8) of Pub. L. 100-203 provided that the amendment

made by that section is effective as if included in Pub. L. 99-514.

EFFECTIVE DATE OF 1986 AMENDMENT

Amendment by Pub. L. 99-514 applicable only with respect to

qualifying events occurring after Oct. 22, 1986, see section

1895(d)(6)(D) of Pub. L. 99-514, set out as a note under section

162 of Title 26, Internal Revenue Code.

NOTIFICATION TO COVERED EMPLOYEES

Section 10003(c) of Pub. L. 99-272 provided that: "At the time

that the amendments made by this section [enacting this subchapter]

apply to a group health plan (covered under section 2201 of the

Public Health Service Act [section 300bb-1 of this title]), the

plan shall notify each covered employee, and spouse of the employee

(if any), who is covered under the plan at that time of the

continuation coverage required under title XXII of such Act [this

subchapter]. The notice furnished under this subsection is in lieu

of notice that may otherwise be required under section 2206(1) of

such Act [par. (1) of this section] with respect to such

individuals."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300bb-2, 300bb-5 of this

title.

-FOOTNOTE-

(!1) So in original. Probably should be "subchapter".

-End-

-CITE-

42 USC Sec. 300bb-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-7. Enforcement

-STATUTE-

Any individual who is aggrieved by the failure of a State,

political subdivision, or agency or instrumentality thereof, to

comply with the requirements of this subchapter may bring an action

for appropriate equitable relief.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2207, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 236.)

-MISC1-

CONTINUED COVERAGE OF COSTS OF PEDIATRIC VACCINE UNDER CERTAIN

GROUP HEALTH PLANS

Pub. L. 103-66, title XIII, Sec. 13631(d), Aug. 10, 1993, 107

Stat. 643, provided that:

"(1) Requirement. - The requirement of this paragraph, with

respect to a group health plan for plan years beginning after the

date of the enactment of this Act [Aug. 10, 1993], is that the

group health plan not reduce its coverage of the costs of pediatric

vaccines (as defined under section 1928(h)(6) of the Social

Security Act [section 1396s(h)(6) of this title]) below the

coverage it provided as of May 1, 1993.

"(2) Enforcement. - For purposes of section 2207 of the Public

Health Service Act [this section], the requirement of paragraph (1)

is deemed a requirement of title XXII of such Act [this

subchapter]."

-End-

-CITE-

42 USC Sec. 300bb-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XX - REQUIREMENTS FOR CERTAIN GROUP HEALTH PLANS FOR

CERTAIN STATE AND LOCAL EMPLOYEES

-HEAD-

Sec. 300bb-8. Definitions

-STATUTE-

For purposes of this subchapter -

(1) Group health plan

The term "group health plan" has the meaning given such term in

5000(b) (!1) of title 26. Such term shall not include any plan

substantially all of the coverage under which is for qualified

long-term care services (as defined in section 7702B(c) of title

26).

(2) Covered employee

The term "covered employee" means an individual who is (or was)

provided coverage under a group health plan by virtue of the

performance of services by the individual for 1 or more persons

maintaining the plan (including as an employee defined in section

401(c)(1) of title 26).

(3) Qualified beneficiary

(A) In general

The term "qualified beneficiary" means, with respect to a

covered employee under a group health plan, any other

individual who, on the day before the qualifying event for that

employee, is a beneficiary under the plan -

(i) as the spouse of the covered employee, or

(ii) as the dependent child of the employee.

Such term shall also include a child who is born to or placed

for adoption with the covered employee during the period of

continuation coverage under this subchapter.

(B) Special rule for terminations and reduced employment

In the case of a qualifying event described in section

300bb-3(2) of this title, the term "qualified beneficiary"

includes the covered employee.

(4) Plan administrator

The term "plan administrator" has the meaning given the term

"administrator" by section 1002(16)(A) of title 29.

-SOURCE-

(July 1, 1944, ch. 373, title XXII, Sec. 2208, as added Pub. L.

99-272, title X, Sec. 10003(a), Apr. 7, 1986, 100 Stat. 236;

amended Pub. L. 100-647, title III, Sec. 3011(b)(7), Nov. 10, 1988,

102 Stat. 3625; Pub. L. 101-239, title VI, Sec. 6801(c)(1), Dec.

19, 1989, 103 Stat. 2297; Pub. L. 104-191, title I, Sec. 102(d),

title III, Sec. 321(d)(3), title IV, Sec. 421(a)(3), Aug. 21, 1996,

110 Stat. 1978, 2059, 2088.)

-MISC1-

AMENDMENTS

1996 - Par. (1). Pub. L. 104-191, Sec. 321(d)(3), inserted at end

"Such term shall not include any plan substantially all of the

coverage under which is for qualified long-term care services (as

defined in section 7702B(c) of title 26)."

Pub. L. 104-191, Sec. 102(d), substituted "5000(b)" for "section

162(i)(2)".

Par. (3)(A). Pub. L. 104-191, Sec. 421(a)(3), inserted at end

"Such term shall also include a child who is born to or placed for

adoption with the covered employee during the period of

continuation coverage under this subchapter."

1989 - Par. (2). Pub. L. 101-239 substituted "the performance of

services by the individual for 1 or more persons maintaining the

plan (including as an employee defined in section 401(c)(1) of

title 26)" for "the individual's employment or previous employment

with an employer".

1988 - Par. (1). Pub. L. 100-647 substituted "section 162(i)(2)

of the Internal Revenue Code of 1986" for "section 162(i)(3) of the

Internal Revenue Code of 1954", which for purposes of codification

was translated as "section 162(i)(2) of title 26".

EFFECTIVE DATE OF 1996 AMENDMENT

Amendment by section 321(d)(3) of Pub. L. 104-191 applicable to

contracts issued after Dec. 31, 1996, see section 321(f) of Pub. L.

104-191, set out as an Effective Date note under section 7702B of

Title 26, Internal Revenue Code.

Amendment by section 421(a)(3) of Pub. L. 104-191 effective Jan.

1, 1997, regardless of whether the qualifying event occurred

before, on, or after such date, see section 421(d) of Pub. L.

104-191, set out as a note under section 4980B of Title 26.

EFFECTIVE DATE OF 1989 AMENDMENT

Section 6801(c)(2) of Pub. L. 101-239 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

to plan years beginning after December 31, 1989."

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-647 applicable to taxable years

beginning after Dec. 31, 1988, but not applicable to any plan for

any plan year to which section 162(k) of Title 26, Internal Revenue

Code (as in effect on the day before Nov. 10, 1988), did not apply

by reason of section 10001(e)(2) of Pub. L. 99-272, see section

3011(d) of Pub. L. 100-647, set out as a note under section 162 of

Title 26.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300bb-5 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be preceded by "section".

-End-

-CITE-

42 USC SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED

IMMUNE DEFICIENCY SYNDROME 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

-HEAD-

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE

DEFICIENCY SYNDROME

-MISC1-

PRIOR PROVISIONS

A prior subchapter XXI (Sec. 300cc et seq.), comprised of title

XXIII of the Public Health Service Act, act July 1, 1944, ch. 373,

2301-2316, was renumbered title XXV, Secs. 2501-2514, of the Public

Health Service Act, and transferred to subchapter XXV (Sec. 300aaa

et seq.) of this chapter, renumbered title XXVI, Secs. 2601-2614,

of the Public Health Service Act, renumbered title XXVII, Secs.

2701-2714, of the Public Health Service Act, and renumbered title

II, part B, Secs. 231-244, of the Public Health Service Act, and

transferred to part B (Sec. 238 et seq.) of subchapter I of this

chapter.

-End-

-CITE-

42 USC Part A - Administration of Research Programs 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part A - Administration of Research Programs

-HEAD-

PART A - ADMINISTRATION OF RESEARCH PROGRAMS

-End-

-CITE-

42 USC Sec. 300cc 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part A - Administration of Research Programs

-HEAD-

Sec. 300cc. Requirement of annual comprehensive report on all

expenditures by Secretary with respect to acquired immune

deficiency syndrome

-STATUTE-

(a) In general

Not later than December 1 of each fiscal year, the Secretary

shall prepare and submit to the Congress a report on the

expenditures by the Secretary of amounts appropriated for the

preceding fiscal year with respect to acquired immune deficiency

syndrome.

(b) Inclusion of certain information

The report required in subsection (a) of this section shall, with

respect to acquired immune deficiency syndrome, include -

(1) for each program, project, or activity with respect to such

syndrome, a specification of the amount obligated by each office

and agency of the Department of Health and Human Services;

(2) a summary description of each such program, project, or

activity;

(3) a list of such programs, projects, or activities that are

directed towards members of minority groups;

(4) a description of the extent to which programs, projects,

and activities described in paragraph (3) have been coordinated

between the Director of the Office of Minority Health and the

Director of the Centers for Disease Control and Prevention;

(5) a summary of the progress made by each such program,

project, or activity with respect to the prevention and control

of acquired immune deficiency syndrome;

(6) a summary of the evaluations conducted under this

subchapter; and

(7) any report required in this chapter to be submitted to the

Secretary for inclusion in the report required in subsection (a)

of this section.

-SOURCE-

(July 1, 1944, ch. 373, title XXIII, Sec. 2301, as added Pub. L.

100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3063;

amended Pub. L. 102-531, title III, Sec. 312(d)(16), Oct. 27, 1992,

106 Stat. 3505.)

-MISC1-

PRIOR PROVISIONS

A prior section 300cc, act July 1, 1944, Sec. 2301, was

successively renumbered by subsequent acts and transferred, see

section 238 of this title.

AMENDMENTS

1992 - Subsec. (b)(4). Pub. L. 102-531 substituted "Centers for

Disease Control and Prevention" for "Centers for Disease Control".

TERMINATION OF REPORTING REQUIREMENTS

For termination, effective May 15, 2000, of provisions of law

requiring submittal to Congress of any annual, semiannual, or other

regular periodic report listed in House Document No. 103-7 (in

which a report required under this section is listed on page 94),

see section 3003 of Pub. L. 104-66, as amended, and section 1(a)(4)

[div. A, Sec. 1402(1)] of Pub. L. 106-554, set out as notes under

section 1113 of Title 31, Money and Finance.

DEVELOPMENT OF RAPID HIV TEST

Pub. L. 106-345, title V, Sec. 502, Oct. 20, 2000, 114 Stat.

1353, provided that:

"(a) Expansion, Intensification, and Coordination of Research and

Other Activities. -

"(1) In general. - The Director of NIH shall expand, intensify,

and coordinate research and other activities of the National

Institutes of Health with respect to the development of reliable

and affordable tests for HIV disease that can rapidly be

administered and whose results can rapidly be obtained (in this

section referred to as 'rapid HIV test').

"(2) Report to congress. - The Director of NIH shall

periodically submit to the appropriate committees of Congress a

report describing the research and other activities conducted or

supported under paragraph (1).

"(3) Authorization of appropriations. - For the purpose of

carrying out this subsection, there are authorized to be

appropriated such sums as may be necessary for each of the fiscal

years 2001 through 2005.

"(b) Premarket Review of Rapid HIV Tests. -

"(1) In general. - Not later than 90 days after the date of the

enactment of this Act [Oct. 20, 2000], the Secretary, in

consultation with the Director of the Centers for Disease Control

and Prevention and the Commissioner of Food and Drugs, shall

submit to the appropriate committees of the Congress a report

describing the progress made towards, and barriers to, the

premarket review and commercial distribution of rapid HIV tests.

The report shall -

"(A) assess the public health need for and public health

benefits of rapid HIV tests, including the minimization of

false positive results through the availability of multiple

rapid HIV tests;

"(B) make recommendations regarding the need for the

expedited review of rapid HIV test applications submitted to

the Center for Biologics Evaluation and Research and, if such

recommendations are favorable, specify criteria and procedures

for such expedited review; and

"(C) specify whether the barriers to the premarket review of

rapid HIV tests include the unnecessary application of

requirements -

"(i) necessary to ensure the efficacy of devices for donor

screening to rapid HIV tests intended for use in other

screening situations; or

"(ii) for identifying antibodies to HIV subtypes of rare

incidence in the United States to rapid HIV tests intended

for use in screening situations other than donor screening.

"(c) Guidelines of Centers for Disease Control and Prevention. -

Promptly after commercial distribution of a rapid HIV test begins,

the Secretary, acting through the Director of the Centers for

Disease Control and Prevention, shall establish or update

guidelines that include recommendations for States, hospitals, and

other appropriate entities regarding the ready availability of such

tests for administration to pregnant women who are in labor or in

the late stage of pregnancy and whose HIV status is not known to

the attending obstetrician."

LIMITATION ON EXPENDITURES FOR AIDS AND HIV ACTIVITIES

Pub. L. 104-146, Sec. 11, May 20, 1996, 110 Stat. 1373, provided

that: "Notwithstanding any other provision of law, the total

amounts of Federal funds expended in any fiscal year for AIDS and

HIV activities may not exceed the total amounts expended in such

fiscal year for activities related to cancer."

VACCINES FOR HUMAN IMMUNODEFICIENCY VIRUS

Pub. L. 103-43, title XIX, Sec. 1901(b), June 10, 1993, 107 Stat.

200, provided that:

"(1) In general. - The Secretary of Health and Human Services,

acting through the National Institutes of Health, shall develop a

plan for the appropriate inclusion of HIV-infected women, including

pregnant women, HIV-infected infants, and HIV-infected children in

studies conducted by or through the National Institutes of Health

concerning the safety and efficacy of HIV vaccines for the

treatment and prevention of HIV infection. Such plan shall ensure

the full participation of other Federal agencies currently

conducting HIV vaccine studies and require that such studies

conform fully to the requirements of part 46 of title 45, Code of

Federal Regulations.

"(2) Report. - Not later than 180 days after the date of the

enactment of this Act [June 10, 1993], the Secretary of Health and

Human Services shall prepare and submit to the Committee on Energy

and Commerce of the House of Representatives, and the Committee on

Labor and Human Resources of the Senate, a report concerning the

plan developed under paragraph (1).

"(3) Implementation. - Not later than 12 months after the date of

the enactment of this Act, the Secretary of Health and Human

Services shall implement the plan developed under paragraph (1),

including measures for the full participation of other Federal

agencies currently conducting HIV vaccine studies.

"(4) Authorization of appropriations. - For the purpose of

carrying out this subsection, there are authorized to be

appropriated such sums as may be necessary for each of the fiscal

years 1994 through 1996."

REQUIREMENT OF CERTAIN RESEARCH STUDIES

Section 203 of Pub. L. 100-607 provided that after consultation

with Director of National Center for Health Services Research and

Health Care Technology Assessment, the Secretary of Health and

Human Services, acting through the Director of Centers for Disease

Control, was to conduct a study for purpose of determining

mortality rates with respect to acquired immune deficiency syndrome

among individuals of various groups at risk of such syndrome, among

various geographic areas, and among individuals with varying

financial resources for payment of health care services, with a

report to be submitted to Congress not later than 18 months after

Nov. 4, 1988, and further directed Secretary to request the

National Academy of Sciences and other similar appropriate

nonprofit institutions to report to the Secretary findings made by

such institutions with respect to the manner in which research on,

and the development of, vaccines and drugs for the prevention and

treatment of acquired immune deficiency syndrome and related

conditions can be enhanced by the establishment of consortia

designed to combine and share resources needed for such research

and development, consisting of businesses involved in such research

and development, of nonprofit research institutions, or of

combinations of such businesses and such institutions, and the

appropriate participation, if any, of the Federal Government in

such consortia, with a report to be submitted to Congress not later

than 1 year after Nov. 4, 1988.

NATIONAL COMMISSION ON ACQUIRED IMMUNE DEFICIENCY SYNDROME

Subtitle D (Secs. 241-249) of title II of Pub. L. 100-607, as

amended by Pub. L. 100-690, title II, Sec. 2602(a), Nov. 18, 1988,

102 Stat. 4233, established National Commission on Acquired Immune

Deficiency Syndrome for the purpose of promoting the development of

a national consensus on policy concerning acquired immune

deficiency syndrome and of studying and making recommendations for

a consistent national policy concerning such syndrome, including

financing of health care needs and research, dissemination of

information to prevent spread of such syndrome, behavioral changes

needed to combat such syndrome, and related civil rights issues,

provided for membership of Commission, reports, executive director

and staff of Commission, powers, and appropriations, and provided

for termination of Commission 30 days after submission of its final

report.

-EXEC-

EX. ORD. NO. 12963. PRESIDENTIAL ADVISORY COUNCIL ON HIV/AIDS

Ex. Ord. No. 12963, June 14, 1995, 60 F.R. 31905, as amended by

Ex. Ord. No. 13009, June 14, 1996, 61 F.R. 39799 [30799], provided:

By the authority vested in me as President by the Constitution

and the laws of the United States of America, I hereby direct the

Secretary of Health and Human Services to exercise her discretion

as follows:

Section 1. Establishment. (a) The Secretary of Health and Human

Services (the "Secretary") shall establish an HIV/AIDS Advisory

Council (the "Advisory Council" or the "Council"), to be known as

the Presidential Advisory Council on HIV/AIDS. The Advisory Council

shall be composed of not more than 35 members to be appointed or

designated by the Secretary. The Advisory Council shall comply with

the Federal Advisory Committee Act, as amended (5 U.S.C. App.).

(b) The Secretary shall designate a Chairperson from among the

members of the Advisory Council.

Sec. 2. Functions. The Advisory Council shall provide advice,

information, and recommendations to the Secretary regarding

programs and policies intended to (a) promote effective prevention

of HIV disease, (b) advance research on HIV and AIDS, and (c)

promote quality services to persons living with HIV disease and

AIDS. The functions of the Advisory Council shall be solely

advisory in nature. The Secretary shall provide the President with

copies of all written reports provided to the Secretary by the

Advisory Council.

Sec. 3. Administration. (a) The heads of executive departments

and agencies shall, to the extent permitted by law, provide the

Advisory Council with such information as it may require for

purposes of carrying out its functions.

(b) Any members of the Advisory Council that receive compensation

shall be compensated in accordance with Federal law. Committee

members may be allowed travel expenses, including per diem in lieu

of subsistence, to the extent permitted by law for persons serving

intermittently in the Government service (5 U.S.C. section

5701-5707).

(c) To the extent permitted by law, and subject to the

availability of appropriations, the Department of Health and Human

Services shall provide the Advisory Council with such funds and

support as may be necessary for the performance of its functions.

Sec. 4. General Provisions. (a) Notwithstanding the provisions of

any other Executive order, any functions of the President under the

Federal Advisory Committee Act that are applicable to the Advisory

Council, except that of reporting annually to the Congress, shall

be performed by the Department of Health and Human Services, in

accordance with the guidelines and procedures established by the

Administrator of General Services.

(b) This order is intended only to improve the internal

management of the executive branch, and it is not intended to

create any right, benefit, or trust responsibility, substantive or

procedural, enforceable at law or equity by a party against the

United States, its agencies, it officers, or any person.

William J. Clinton.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300cc-1, 300cc-41,

300ee-22 of this title.

-End-

-CITE-

42 USC Sec. 300cc-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part A - Administration of Research Programs

-HEAD-

Sec. 300cc-1. Requirement of expediting awards of grants and

contracts for research

-STATUTE-

(a) In general

The Secretary shall expedite the award of grants, contracts, and

cooperative agreements for research projects relating to acquired

immune deficiency syndrome (including such research projects

initiated independently of any solicitation by the Secretary for

proposals for such research projects).

(b) Time limitations with respect to certain applications

(1) With respect to programs of grants, contracts, and

cooperative agreements described in subsection (a) of this section,

any application submitted in response to a solicitation by the

Secretary for proposals pursuant to such a program -

(A) may not be approved if the application is submitted after

the expiration of the 3-month period beginning on the date on

which the solicitation is issued; and

(B) shall be awarded, or otherwise finally acted upon, not

later than the expiration of the 6-month period beginning on the

expiration of the period described in subparagraph (A).

(2) If the Secretary makes a determination that it is not

practicable to administer a program referred to in paragraph (1) in

accordance with the time limitations described in such paragraph,

the Secretary may adjust the time limitations accordingly.

(c) Requirements with respect to adjustments in time limitations

With respect to any program for which a determination described

in subsection (b)(2) of this section is made, the Secretary shall -

(1) if the determination is made before the Secretary issues a

solicitation for proposals pursuant to the program, ensure that

the solicitation describes the time limitations as adjusted by

the determination; and

(2) if the determination is made after the Secretary issues

such a solicitation for proposals, issue a statement describing

the time limitations as adjusted by the determination and

individually notify, with respect to the determination, each

applicant whose application is submitted before the expiration of

the 3-month period beginning on the date on which the

solicitation was issued.

(d) Annual reports to Congress

Except as provided in subsection (e) of this section, the

Secretary shall annually prepare, for inclusion in the

comprehensive report required in section 300cc of this title, a

report -

(A) summarizing programs for which the Secretary has made a

determination described in subsection (b)(2) of this section,

including a description of the time limitations as adjusted by

the determination and including a summary of the solicitation

issued by the Secretary for proposals pursuant to the program;

and

(B) summarizing applications that -

(i) were submitted pursuant to a program of grants,

contracts, or cooperative agreements referred to in paragraph

(1) of subsection (b) of this section for which a determination

described in paragraph (2) of such subsection has not been

made; and

(ii) were not processed in accordance with the time

limitations described in such paragraph (1).

(e) Quarterly reports for fiscal year 1989

For fiscal year 1989, the report required in subsection (d) of

this section shall, not less than quarterly, be prepared and

submitted to the Committee on Energy and Commerce of the House of

Representatives and the Committee on Labor and Human Resources of

the Senate.

-SOURCE-

(July 1, 1944, ch. 373, title XXIII, Sec. 2302, as added Pub. L.

100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3063.)

-MISC1-

PRIOR PROVISIONS

A prior section 300cc-1, act July 1, 1944, Sec. 2302, was

successively renumbered by subsequent acts and transferred, see

section 238a of this title.

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

Representatives by section 1(a) of Pub. L. 104-14, set out as a

note preceding section 21 of Title 2, The Congress. Committee on

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

of Representatives by House Resolution No. 5, One Hundred Seventh

Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 300cc-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part A - Administration of Research Programs

-HEAD-

Sec. 300cc-2. Requirements with respect to processing of requests

for personnel and administrative support

-STATUTE-

(a) In general

The Director of the Office of Personnel Management or the

Administrator of General Services, as the case may be, shall

respond to any priority request made by the Administrator of the

Substance Abuse and Mental Health Services Administration, the

Director of the Centers for Disease Control and Prevention, the

Commissioner of Food and Drugs, or the Director of the National

Institutes of Health, not later than 21 days after the date on

which such request is made. If the Director of the Office of

Personnel Management or the Administrator of General Services, as

the case may be, does not disapprove a priority request during the

21-day period, the request shall be deemed to be approved.

(b) Notice to Secretary and to Assistant Secretary for Health

The Administrator of the Substance Abuse and Mental Health

Services Administration, the Director of the Centers for Disease

Control and Prevention, the Commissioner of Food and Drugs, and the

Director of the National Institutes of Health, shall, respectively,

transmit to the Secretary and the Assistant Secretary for Health a

copy of each priority request made under this section by the agency

head involved. The copy shall be transmitted on the date on which

the priority request involved is made.

(c) "Priority request" defined

For purposes of this section, the term "priority request" means

any request that -

(1) is designated as a priority request by the Administrator of

the Substance Abuse and Mental Health Services Administration,

the Director of the Centers for Disease Control and Prevention,

the Commissioner of Food and Drugs, or the Director of the

National Institutes of Health; and

(2)(A) is made to the Director of the Office of Personnel

Management for the allocation of personnel to carry out

activities with respect to acquired immune deficiency syndrome;

or

(B) is made to the Administrator of General Services for

administrative support or space in carrying out such activities.

-SOURCE-

(July 1, 1944, ch. 373, title XXIII, Sec. 2303, as added Pub. L.

100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3064;

amended Pub. L. 102-321, title I, Secs. 161, 163(b)(7), July 10,

1992, 106 Stat. 375, 376; Pub. L. 102-531, title III, Sec.

312(d)(17), Oct. 27, 1992, 106 Stat. 3505.)

-MISC1-

PRIOR PROVISIONS

A prior section 300cc-2, act July 1, 1944, Sec. 2303, was

successively renumbered by subsequent acts and transferred, see

section 238b of this title.

AMENDMENTS

1992 - Subsec. (a). Pub. L. 102-531 substituted "Centers for

Disease Control and Prevention" for "Centers for Disease Control".

Pub. L. 102-321, Sec. 161, substituted "Administrator of the

Substance Abuse and Mental Health Services Administration" for

"Administrator of the Alcohol, Drug Abuse, and Mental Health

Administration".

Subsec. (b). Pub. L. 102-531 substituted "Centers for Disease

Control and Prevention" for "Centers for Disease Control".

Pub. L. 102-321, Sec. 163(b)(7)(A), substituted "Administrator of

the Substance Abuse and Mental Health Services Administration" for

"Administrator of the Alcohol, Drug Abuse, and Mental Health

Administration".

Subsec. (c)(1). Pub. L. 102-531 substituted "Centers for Disease

Control and Prevention" for "Centers for Disease Control".

Pub. L. 102-321, Sec. 163(b)(7)(B), substituted "Administrator of

the Substance Abuse and Mental Health Services Administration" for

"Administrator of the Alcohol, Drug Abuse, and Mental Health

Administration".

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-321 effective Oct. 1, 1992, see section

801(c) of Pub. L. 102-321, set out as a note under section 236 of

this title.

-End-

-CITE-

42 USC Sec. 300cc-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part A - Administration of Research Programs

-HEAD-

Sec. 300cc-3. Establishment of Research Advisory Committee

-STATUTE-

(a) In general

After consultation with the Commissioner of Food and Drugs, the

Secretary, acting through the Director of the National Institute of

Allergy and Infectious Diseases, shall establish within such

Institute an advisory committee to be known as the AIDS Research

Advisory Committee (hereafter in this section referred to as the

"Committee").

(b) Composition

The Committee shall be composed of physicians whose clinical

practice includes a significant number of patients with acquired

immune deficiency syndrome.

(c) Duties

The Committee shall -

(1) advise the Director of such Institute (and may provide

advice to the Directors of other agencies of the National

Institutes of Health, as appropriate) on appropriate research

activities to be undertaken with respect to clinical treatment of

such syndrome, including advice with respect to -

(A) research on drugs for preventing or minimizing the

development of symptoms or conditions arising from infection

with the etiologic agent for such syndrome, including

recommendations on the projects of research with respect to

diagnosing immune deficiency and with respect to predicting,

diagnosing, preventing, and treating opportunistic cancers and

infectious diseases; and

(B) research on the effectiveness of treating such symptoms

or conditions with drugs that -

(i) are not approved by the Commissioner of Food and Drugs

for the purpose of treating such symptoms or conditions; and

(ii) are being utilized for such purpose by individuals

infected with such etiologic agent;

(2)(A) review ongoing publicly and privately supported research

on clinical treatment for acquired immune deficiency syndrome,

including research on drugs described in paragraph (1); and

(B) periodically issue, and make available to health care

professionals, reports describing and evaluating such research;

(3) conduct studies and convene meetings for the purpose of

determining the recommendations among physicians in clinical

practice on clinical treatment of acquired immune deficiency

syndrome, including treatment with the drugs described in

paragraph (1); and

(4) conduct a study for the purpose of developing, with respect

to individuals infected with the etiologic agent for acquired

immune deficiency syndrome, a consensus among health care

professionals on clinical treatments for preventing or minimizing

the development of symptoms or conditions arising from infection

with such etiologic agent.

-SOURCE-

(July 1, 1944, ch. 373, title XXIII, Sec. 2304, as added Pub. L.

100-607, title II, Sec. 201(4), Nov. 4, 1988, 102 Stat. 3065;

amended Pub. L. 100-690, title II, Sec. 2617(a), Nov. 18, 1988, 102

Stat. 4240; Pub. L. 103-43, title XVIII, Sec. 1811(1), title XX,

Sec. 2008(d)(1), June 10, 1993, 107 Stat. 199, 212.)

-MISC1-

PRIOR PROVISIONS

A prior section 300cc-3, acts July 1, 1944, ch. 373, title XXIII,

Sec. 2304, formerly title V, Sec. 504, 58 Stat. 710; June 25, 1948,

ch. 654, Sec. 6, 62 Stat. 1018; 1953 Reorg. Plan No. 1, Secs. 5, 8,

eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; renumbered title

XXI, Sec. 2104, Apr. 26, 1983, Pub. L. 98-24, Sec. 2(a)(1), 97

Stat. 176; renumbered title XXIII, Sec. 2304, Nov. 14, 1986, Pub.

L. 99-660, title III, Sec. 311(a), 100 Stat. 3755, related to care

of Service patients at Saint Elizabeths Hospital, prior to repeal

by Pub. L. 98-621, Sec. 10(s), Nov. 8, 1984, 98 Stat. 3381,

effective Oct. 1, 1987. Subsequent to repeal, section 2104 of title

XXI of act July 1, 1944, was renumbered section 2304 of title XXIII

of that act by section 311(a) of Pub. L. 99-660.

A prior section 300cc-4, acts July 1, 1944, ch. 373, title XXI,

Sec. 2105, formerly title V, Sec. 505, 58 Stat. 710; 1953 Reorg.

Plan No. 1, Secs. 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat.

631; renumbered title XXI, Sec. 2105, Apr. 26, 1983, Pub. L. 98-24,

Sec. 2(a)(1), 97 Stat. 176, provided procedures under which the

Secretary could settle claims for damages from collisions or

incident to the operation of vessels within a year of the accrual

of such claims and not to exceed $3,000, prior to repeal by Pub. L.

99-117, Sec. 12(f), Oct. 7, 1985, 99 Stat. 495. Subsequent to

repeal, section 2105 of title XXI of act July 1, 1944, was

renumbered section 2305 of title XXIII of that act by Pub. L.

99-660, title III, Sec. 311(a), Nov. 14, 1986, 100 Stat. 3755.

Prior sections 300cc-5 to 300cc-10, act July 1, 1944, Secs. 2306

to 2311, respectively, were successively renumbered by subsequent

acts and transferred, see sections 238c to 238h of this title.

AMENDMENTS

1993 - Pub. L. 103-43, Sec. 2008(d)(1)(A), substituted "Research

Advisory Committee" for "Clinical Research Review Committee" in

section catchline.

Subsec. (a). Pub. L. 103-43, Sec. 2008(d)(1)(B), substituted

"AIDS Research Advisory Committee" for "AIDS Clinical Research

Review Committee".

Subsec. (c)(1). Pub. L. 103-43, Sec. 1811(1), in introductory

provisions inserted "(and may provide advice to the Directors of

other agencies of the National Institutes of Health, as

appropriate)" after "Director of such Institute" and in subpar. (A)

inserted before semicolon at end ", including recommendations on

the projects of research with respect to diagnosing immune

deficiency and with respect to predicting, diagnosing, preventing,

and treating opportunistic cancers and infectious diseases".

1988 - Subsec. (c)(2)(B). Pub. L. 100-690 substituted semicolon

for period.

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-690 effective immediately after

enactment of Pub. L. 100-607, which was approved Nov. 4, 1988, see

section 2600 of Pub. L. 100-690, set out as a note under section

242m of this title.

TERMINATION OF ADVISORY COMMITTEES

Advisory committees established after Jan. 5, 1973, to terminate

not later than the expiration of the 2-year period beginning on the

date of their establishment, unless, in the case of a committee

established by the President or an officer of the Federal

Government, such committee is renewed by appropriate action prior

to the expiration of such 2-year period, or in the case of a

committee established by the Congress, its duration is otherwise

provided by law. See section 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 776, set out in the Appendix to Title 5, Government

Organization and Employees.

Pub. L. 93-641, Sec. 6, Jan. 4, 1975, 88 Stat. 2275, set out as a

note under section 217a of this title, provided that an advisory

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

an Act of Congress enacted after Jan. 4, 1975.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 300cc-12, 300cc-14,

300cc-17, 300cc-18 of this title.

-End-

-CITE-

42 USC Part B - Research Authority 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER XXI - RESEARCH WITH RESPECT TO ACQUIRED IMMUNE DEFICIENCY

SYNDROME

Part B - Research Authority

-HEAD-

PART B - RESEARCH AUTHORITY

-End-

-CITE-

42 USC Sec. 300cc-11 01/06/03

-EXPCITE-