US (United States) Code. Title 42. Chapter 6A: Public Health Service

Codificación normativa de EEUU (Estados Unidos). Legislación federal estadounidense # The Public Health and Welfare

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-CITE-

42 USC Sec. 254i 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart ii - national health service corps program

-HEAD-

Sec. 254i. Annual report to Congress; contents

-STATUTE-

The Secretary shall submit an annual report to Congress, and

shall include in such report with respect to the previous calendar

year -

(1) the number, identity, and priority of all health

professional shortage areas designated in such year and the

number of health professional shortage areas which the Secretary

estimates will be designated in the subsequent year;

(2) the number of applications filed under section 254f of this

title in such year for assignment of Corps members and the action

taken on each such application;

(3) the number and types of Corps members assigned in such year

to health professional shortage areas, the number and types of

additional Corps members which the Secretary estimates will be

assigned to such areas in the subsequent year, and the need for

additional members for the Corps;

(4) the recruitment efforts engaged in for the Corps in such

year and the number of qualified individuals who applied for

service in the Corps in such year;

(5) the number of patients seen and the number of patient

visits recorded during such year with respect to each health

professional shortage area to which a Corps member was assigned

during such year;

(6) the number of Corps members who elected, and the number of

Corps members who did not elect, to continue to provide health

services in health professional shortage areas after termination

of their service in the Corps and the reasons (as reported to the

Secretary) of members who did not elect for not making such

election;

(7) the results of evaluations and determinations made under

section 254f(a)(1)(D) of this title during such year; and

(8) the amount charged during such year for health services

provided by Corps members, the amount which was collected in such

year by entities in accordance with section 254g of this title,

and the amount which was paid to the Secretary in such year under

such agreements.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 336A, formerly Sec. 336, as

added Pub. L. 94-484, title IV, Sec. 407(b)(3), Oct. 12, 1976, 90

Stat. 2277, renumbered Sec. 336A, Pub. L. 97-35, title XXVII, Sec.

2706(a), Aug. 13, 1981, 95 Stat. 907; amended Pub. L. 97-375, title

II, Sec. 206(a), Dec. 21, 1982, 96 Stat. 1823; Pub. L. 101-597,

title IV, Sec. 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3035; Pub. L.

107-251, title III, Sec. 307(b), Oct. 26, 2002, 116 Stat. 1649.)

-MISC1-

AMENDMENTS

2002 - Par. (8). Pub. L. 107-251 struck out "agreements under"

after "in accordance with".

1990 - Pars. (1), (3), (5), (6). Pub. L. 101-597 substituted

reference to health professional shortage area for reference to

health manpower shortage area wherever appearing.

1982 - Pub. L. 97-375 struck out "on May 1 of each year" after

"report to Congress".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254k, 11709 of this

title.

-End-

-CITE-

42 USC Sec. 254j 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart ii - national health service corps program

-HEAD-

Sec. 254j. National Advisory Council on National Health Service

Corps

-STATUTE-

(a) Establishment; appointment of members

There is established a council to be known as the National

Advisory Council on the National Health Service Corps (hereinafter

in this section referred to as the "Council"). The Council shall be

composed of not more than 15 members appointed by the Secretary.

The Council shall consult with, advise, and make recommendations

to, the Secretary with respect to his responsibilities in carrying

out this subpart (other than section 254r (!1) of this title), and

shall review and comment upon regulations promulgated by the

Secretary under this subpart.

(b) Term of members; compensation; expenses

(1) Members of the Council shall be appointed for a term of three

years, except that any member appointed to fill a vacancy occurring

prior to the expiration of the term for which the member's

predecessor was appointed shall be appointed for the remainder of

such term. No member shall be removed, except for cause. Members

may not be reappointed to the Council.

(2) Members of the Council (other than members who are officers

or employees of the United States), while attending meetings or

conferences thereof or otherwise serving on the business of the

Council, shall be entitled to receive for each day (including

traveltime) in which they are so serving compensation at a rate

fixed by the Secretary (but not to exceed the daily equivalent of

the annual rate of basic pay in effect for grade GS-18 of the

General Schedule); and while so serving away from their homes or

regular places of business all members may be allowed travel

expenses, including per diem in lieu of subsistence, as authorized

by section 5703 of title 5 for persons in the Government Service

employed intermittently.

(c) Termination

Section 14 of the Federal Advisory Committee Act shall not apply

with respect to the Council.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 337, as added Pub. L.

94-484, title IV, Sec. 407(b)(3), Oct. 12, 1976, 90 Stat. 2277;

amended Pub. L. 96-32, Sec. 7(g), July 10, 1979, 93 Stat. 84; Pub.

L. 97-35, title XXVII, Sec. 2707, Aug. 13, 1981, 95 Stat. 907; Pub.

L. 97-414, Sec. 8(f), Jan. 4, 1983, 96 Stat. 2061; Pub. L. 103-183,

title VII, Sec. 706(b), Dec. 14, 1993, 107 Stat. 2241.)

-REFTEXT-

REFERENCES IN TEXT

Section 254r of this title, referred to in subsec. (a), was in

the original a reference to section 338G of act July 1, 1944, which

was renumbered section 338I by Pub. L. 100-177, title II, Sec.

201(1), Dec. 1, 1987, 101 Stat. 992, and repealed by Pub. L.

100-713, title I, Sec. 104(b)(1), Nov. 23, 1988, 102 Stat. 4787.

Section 14 of the Federal Advisory Committee Act, referred to in

subsec. (c), is section 14 of Pub. L. 92-463, which is set out in

the Appendix to Title 5, Government Organization and Employees.

-MISC1-

AMENDMENTS

1993 - Subsec. (b)(2). Pub. L. 103-183 inserted "compensation at

a rate fixed by the Secretary (but not to exceed" before "the daily

equivalent" and substituted "Schedule);" for "Schedule;".

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

254r of this title)" after "carrying out this subpart".

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2707(a), amended subsec.

(a) generally, striking out pars. (1) to (5) respecting required

status and background of members appointed by the Secretary.

Subsec. (b)(1). Pub. L. 97-35, Sec. 2707(b), inserted "not"

before "be reappointed".

1979 - Subsec. (b)(2). Pub. L. 96-32 substituted "section 5703 of

title 5" for "section 5703(b) of title 5".

TERMINATION OF ADVISORY COMMITTEES

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 sections 254k, 254l, 254l-1, 254m,

254q-1, 11709 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254k 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart ii - national health service corps program

-HEAD-

Sec. 254k. Authorization of appropriations

-STATUTE-

(a) For the purpose of carrying out this subpart, there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 2002 through 2006.

(b) An appropriation under an authorization under subsection (a)

of this section for any fiscal year may be made at any time before

that fiscal year and may be included in an Act making an

appropriation under an authorization under subsection (a) of this

section for another fiscal year; but no funds may be made available

from any appropriation under such authorization for obligation

under sections 254d through 254h, section 254i, and section 254j of

this title before the fiscal year for which such appropriation is

authorized.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338, as added Pub. L.

94-484, title IV, Sec. 407(b)(3), Oct. 12, 1976, 90 Stat. 2278;

amended Pub. L. 95-626, title I, Sec. 122, Nov. 10, 1978, 92 Stat.

3570; Pub. L. 96-76, title II, Sec. 202(c), Sept. 29, 1979, 93

Stat. 582; Pub. L. 97-35, title XXVII, Sec. 2708, Aug. 13, 1981, 95

Stat. 908; Pub. L. 100-177, title III, Sec. 305, Dec. 1, 1987, 101

Stat. 1004; Pub. L. 101-597, title I, Sec. 108, Nov. 16, 1990, 104

Stat. 3021; Pub. L. 107-251, title III, Sec. 308, Oct. 26, 2002,

116 Stat. 1649.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-251 struck out par. (1)

designation before "For the purpose", substituted "2002 through

2006" for "1991 through 2000", and struck out par. (2) which read

as follows: "In the case of individuals who serve in the Corps

other than pursuant to obligated service under the Scholarship or

Loan Repayment Program, the Secretary each fiscal year shall, to

the extent practicable, make assignments under section 254f of this

title of such individuals who are certified nurse midwives,

certified nurse practitioners, or physician assistants."

1990 - Subsec. (a). Pub. L. 101-597 added subsec. (a) and struck

out former subsec. (a) which read as follows: "To carry out this

subpart, there are authorized to be appropriated $65,000,000 for

fiscal year 1988, $65,000,000 for fiscal year 1989, and $65,000,000

for fiscal year 1990."

1987 - Subsec. (a). Pub. L. 100-177 amended subsec. (a)

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

carry out the purposes of this subpart, there are authorized to be

appropriated $47,000,000 for the fiscal year ending September 30,

1978; $64,000,000 for the fiscal year ending September 30, 1979;

$82,000,000 for the fiscal year ending September 30, 1980;

$110,000,000 for the fiscal year ending September 30, 1982;

$120,000,000 for the fiscal year ending September 30, 1983; and

$130,000,000 for the fiscal year ending September 30, 1984."

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2708(a), inserted

provisions authorizing appropriations for fiscal years ending Sept.

30, 1982, 1983, and 1984.

Subsec. (b). Pub. L. 97-35, Sec. 2708(b), substituted reference

to sections 254d to 254h, 254i, and 254j of this title for

reference to this subpart.

1979 - Subsec. (a). Pub. L. 96-76 substituted "$82,000,000" for

"$70,000,000".

1978 - Subsec. (a). Pub. L. 95-626 substituted "$64,000,000" for

"$57,000,000" as amount authorized to be appropriated for fiscal

year ending Sept. 30, 1979.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254g, 254h-1, 254l,

254l-1, 254m, 254n, 254p, 11709 of this title.

-End-

-CITE-

42 USC subpart iii - scholarship program and loan

repayment program 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

SUBPART III - SCHOLARSHIP PROGRAM AND LOAN REPAYMENT PROGRAM

-MISC1-

AMENDMENTS

1987 - Pub. L. 100-177, title II, Sec. 202(f), Dec. 1, 1987, 101

Stat. 999, inserted subpart III heading and redesignated former

subpart III as IV.

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in sections 247b-7, 254d, 287c-33,

288-1, 288-2, 288-3, 288-5a, 288-6, 293b, 297n of this title; title

21 section 395.

-End-

-CITE-

42 USC Sec. 254l 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254l. National Health Service Corps Scholarship Program

-STATUTE-

(a) Establishment

The Secretary shall establish the National Health Service Corps

Scholarship Program to assure, with respect to the provision of

primary health services pursuant to section 254d(a)(2) of this

title -

(1) an adequate supply of physicians, dentists, behavioral and

mental health professionals, certified nurse midwives, certified

nurse practitioners, and physician assistants; and

(2) if needed by the Corps, an adequate supply of other health

professionals.

(b) Eligibility; application; written contract

To be eligible to participate in the Scholarship Program, an

individual must -

(1) be accepted for enrollment, or be enrolled, as a full-time

student (A) in an accredited (as determined by the Secretary)

educational institution in a State and (B) in a course of study

or program, offered by such institution and approved by the

Secretary, leading to a degree in medicine, osteopathic medicine,

dentistry, or other health profession, or an appropriate degree

from a graduate program of behavioral and mental health;

(2) be eligible for, or hold, an appointment as a commissioned

officer in the Regular or Reserve Corps of the Service or be

eligible for selection for civilian service in the Corps;

(3) submit an application to participate in the Scholarship

Program; and

(4) sign and submit to the Secretary, at the time of submittal

of such application, a written contract (described in subsection

(f) of this section) to accept payment of a scholarship and to

serve (in accordance with this subpart) for the applicable period

of obligated service in a health professional shortage area.

(c) Review and evaluation of information and forms by prospective

applicant

(1) In disseminating application forms and contract forms to

individuals desiring to participate in the Scholarship Program, the

Secretary shall include with such forms -

(A) a fair summary of the rights and liabilities of an

individual whose application is approved (and whose contract is

accepted) by the Secretary, including in the summary a clear

explanation of the damages to which the United States is entitled

under section 254o of this title in the case of the individual's

breach of the contract; and

(B) information respecting meeting a service obligation through

private practice under an agreement under section 254n of this

title and such other information as may be necessary for the

individual to understand the individual's prospective

participation in the Scholarship Program and service in the

Corps, including a statement of all factors considered in

approving applications for participation in the Program and in

making assignments for participants in the Program.

(2) The application form, contract form, and all other

information furnished by the Secretary under this subpart shall be

written in a manner calculated to be understood by the average

individual applying to participate in the Scholarship Program. The

Secretary shall make such application forms, contract forms, and

other information available to individuals desiring to participate

in the Scholarship Program on a date sufficiently early to insure

that such individuals have adequate time to carefully review and

evaluate such forms and information.

(3)(A) The Secretary shall distribute to health professions

schools materials providing information on the Scholarship Program

and shall encourage the schools to disseminate the materials to the

students of the schools.

(B)(i) In the case of any health professional whose period of

obligated service under the Scholarship Program is nearing

completion, the Secretary shall encourage the individual to remain

in a health professional shortage area and to continue providing

primary health services.

(ii) During the period in which a health professional is planning

and making the transition to private practice from obligated

service under the Scholarship Program, the Secretary may provide

assistance to the professional regarding such transition if the

professional is remaining in a health professional shortage area

and is continuing to provide primary health services.

(C) In the case of entities to which participants in the

Scholarship Program are assigned under section 254f of this title,

the Secretary shall encourage the entities to provide options with

respect to assisting the participants in remaining in the health

professional shortage areas involved, and in continuing to provide

primary health services, after the period of obligated service

under the Scholarship Program is completed. The options with

respect to which the Secretary provides such encouragement may

include options regarding the sharing of a single employment

position in the health professions by 2 or more health

professionals, and options regarding the recruitment of couples

where both of the individuals are health professionals.

(d) Factors considered in providing contracts; priorities

(1) Subject to section 254f-1 of this title, in providing

contracts under the Scholarship Program -

(A) the Secretary shall consider the extent of the demonstrated

interest of the applicants for the contracts in providing primary

health services;

(B) the Secretary, in considering applications from individuals

accepted for enrollment or enrolled in dental school, shall

consider applications from all individuals accepted for

enrollment or enrolled in any accredited dental school in a

State; and

(C) may (!1) consider such other factors regarding the

applicants as the Secretary determines to be relevant to

selecting qualified individuals to participate in such Program.

(2) In providing contracts under the Scholarship Program, the

Secretary shall give priority -

(A) first, to any application for such a contract submitted by

an individual who has previously received a scholarship under

this section or under section 294z (!1) of this title;

(B) second, to any application for such a contract submitted by

an individual who has characteristics that increase the

probability that the individual will continue to serve in a

health professional shortage area after the period of obligated

service pursuant to subsection (f) of this section is completed;

and

(C) third, subject to subparagraph (B), to any application for

such a contract submitted by an individual who is from a

disadvantaged background.

(e) Commencement of participation in Scholarship Program; notice

(1) An individual becomes a participant in the Scholarship

Program only upon the Secretary's approval of the individual's

application submitted under subsection (b)(3) of this section and

the Secretary's acceptance of the contract submitted by the

individual under subsection (b)(4) of this section.

(2) The Secretary shall provide written notice to an individual

promptly upon the Secretary's approving, under paragraph (1), of

the individual's participation in the Scholarship Program.

(f) Written contract; contents

The written contract (referred to in this subpart) between the

Secretary and an individual shall contain -

(1) an agreement that -

(A) subject to paragraph (2), the Secretary agrees (i) to

provide the individual with a scholarship (described in

subsection (g) of this section) in each such school year or

years for a period of years (not to exceed four school years)

determined by the individual, during which period the

individual is pursuing a course of study described in

subsection (b)(1)(B) of this section, and (ii) to accept

(subject to the availability of appropriated funds for carrying

out sections 254d through 254h and section 254j of this title)

the individual into the Corps (or for equivalent service as

otherwise provided in this subpart); and

(B) subject to paragraph (2), the individual agrees -

(i) to accept provision of such a scholarship to the

individual;

(ii) to maintain enrollment in a course of study described

in subsection (b)(1)(B) of this section until the individual

completes the course of study;

(iii) while enrolled in such course of study, to maintain

an acceptable level of academic standing (as determined under

regulations of the Secretary by the educational institution

offering such course of study);

(iv) if pursuing a degree from a school of medicine or

osteopathic medicine, to complete a residency in a specialty

that the Secretary determines is consistent with the needs of

the Corps; and

(v) to serve for a time period (hereinafter in the subpart

referred to as the "period of obligated service") equal to -

(I) one year for each school year for which the

individual was provided a scholarship under the Scholarship

Program, or

(II) two years,

whichever is greater, as a provider of primary health

services in a health professional shortage area (designated

under section 254e of this title) to which he is assigned by

the Secretary as a member of the Corps, or as otherwise

provided in this subpart;

(2) a provision that any financial obligation of the United

States arising out of a contract entered into under this subpart

and any obligation of the individual which is conditioned

thereon, is contingent upon funds being appropriated for

scholarships under this subpart and to carry out the purposes of

sections 254d through 254h and sections 254j and 254k of this

title;

(3) a statement of the damages to which the United States is

entitled, under section 254o of this title, for the individual's

breach of the contract; and

(4) such other statements of the rights and liabilities of the

Secretary and of the individual, not inconsistent with the

provisions of this subpart.

(g) Scholarship provisions; contract with educational institution;

increase in monthly stipend

(1) A scholarship provided to a student for a school year under a

written contract under the Scholarship Program shall consist of -

(A) payment to, or (in accordance with paragraph (2)) on behalf

of, the student of the amount (except as provided in section 292k

(!2) of this title) of -

(i) the tuition of the student in such school year; and

(ii) all other reasonable educational expenses, including

fees, books, and laboratory expenses, incurred by the student

in such school year; and

(B) payment to the student of a stipend of $400 per month

(adjusted in accordance with paragraph (3)) for each of the 12

consecutive months beginning with the first month of such school

year.

(2) The Secretary may contract with an educational institution,

in which a participant in the Scholarship Program is enrolled, for

the payment to the educational institution of the amounts of

tuition and other reasonable educational expenses described in

paragraph (1)(A). Payment to such an educational institution may be

made without regard to section 3324(a) and (b) of title 31.

(3) The amount of the monthly stipend, specified in paragraph

(1)(B) and as previously adjusted (if at all) in accordance with

this paragraph, shall be increased by the Secretary for each school

year ending in a fiscal year beginning after September 30, 1978, by

an amount (rounded to the next highest multiple of $1) equal to the

amount of such stipend multiplied by the overall percentage (under

section 5303 of title 5) of the adjustment (if such adjustment is

an increase) in the rates of pay under the General Schedule made

effective in the fiscal year in which such school year ends.

(h) Employment ceiling of Department unaffected

Notwithstanding any other provision of law, individuals who have

entered into written contracts with the Secretary under this

section, while undergoing academic training, shall not be counted

against any employment ceiling affecting the Department.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338A, formerly title VII,

Sec. 751, as added Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct.

12, 1976, 90 Stat. 2281; amended Pub. L. 95-215, Sec. 5, Dec. 19,

1977, 91 Stat. 1506; Pub. L. 95-623, Sec. 12(c), Nov. 9, 1978, 92

Stat. 3457; Pub. L. 95-626, title I, Sec. 113(b), Nov. 10, 1978, 92

Stat. 3563; Pub. L. 96-32, Sec. 7(i), July 10, 1979, 93 Stat. 84;

renumbered Sec. 338A and amended Pub. L. 97-35, title XXVII, Sec.

2709(a), (b), Aug. 13, 1981, 95 Stat. 908; Pub. L. 99-129, title

II, Sec. 210(b), Oct. 22, 1985, 99 Stat. 537; Pub. L. 100-607,

title VI, Sec. 629(a)(2), Nov. 4, 1988, 102 Stat. 3146; Pub. L.

101-509, title V, Sec. 529 [title I, Sec. 101(b)(4)(K)], Nov. 5,

1990, 104 Stat. 1427, 1440; Pub. L. 101-597, title II, Sec. 201,

title IV, Sec. 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3021, 3035;

Pub. L. 107-251, title III, Sec. 309, Oct. 26, 2002, 116 Stat.

1649.)

-REFTEXT-

REFERENCES IN TEXT

Section 294z of this title, referred to in subsec. (d)(2)(A), 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.

Section 292k of this title, referred to in subsec. (g)(1)(A), was

in the original a reference to section 711 of act July 1, 1944.

Section 711 of that Act was renumbered as section 710 by Pub. L.

97-35, title XXVII, Sec. 2720(b), Aug. 13, 1981, 95 Stat. 915, and

subsequently 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 710 of act

July 1, 1944, relating to insurance accounts, a new section 711,

relating to powers and responsibilities of the Secretary, and a new

section 712, relating to participation by Federal credit unions,

which are classified to sections 292i, 292j, and 292k,

respectively, of this title.

-COD-

CODIFICATION

In subsec. (g)(2), "section 3324(a) and (b) of title 31"

substituted for "section 3648 of the Revised Statutes (31 U.S.C.

529)" 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.

Section was formerly classified to section 294t of this title

prior to its renumbering by Pub. L. 97-35.

-MISC1-

AMENDMENTS

2002 - Subsec. (a)(1). Pub. L. 107-251, Sec. 309(1), inserted

"behavioral and mental health professionals," after "dentists,".

Subsec. (b)(1)(B). Pub. L. 107-251, Sec. 309(2), inserted ", or

an appropriate degree from a graduate program of behavioral and

mental health" after "other health profession".

Subsec. (c)(1). Pub. L. 107-251, Sec. 309(3), made technical

amendment to references in original act which appear in subpar. (A)

as reference to section 254o of this title and in subpar. (B) as

reference to section 254n of this title.

Subsec. (d)(1)(B), (C). Pub. L. 107-251, Sec. 309(4), added

subpar. (B) and redesignated former subpar. (B) as (C).

Subsec. (f)(1)(B)(iv), (v). Pub. L. 107-251, Sec. 309(5)(A),

added cl. (iv) and redesignated former cl. (iv) as (v).

Subsec. (f)(3). Pub. L. 107-251, Sec. 309(5)(B), made technical

amendment to reference in original act which appears in text as

reference to section 254o of this title.

Subsec. (i). Pub. L. 107-251, Sec. 309(6), struck out subsec.

(i), which required an annual report to Congress on the Scholarship

Program.

1990 - Subsec. (a). Pub. L. 101-597, Sec. 201(a)(1), substituted

"Corps Scholarship Program to assure, with respect to the provision

of primary health services pursuant to section 254d(a)(2) of this

title - " and pars. (1) and (2) for "Corps Scholarship Program

(hereinafter in this subpart referred to as the 'Scholarship

Program') to assure an adequate supply of trained physicians,

dentists, and nurses for the National Health Service Corps

(hereinafter in this subpart referred to as the 'Corps') and, if

needed by the Corps, podiatrists, optometrists, pharmacists,

clinical psychologists, graduates of schools of veterinary

medicine, graduates of schools of public health, graduates of

programs in health administration, graduates of programs for the

training of physician assistants, expanded function dental

auxiliaries, and nurse practitioners (as defined in section 296m of

this title), and other health professionals."

Subsec. (b)(4). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area.

Subsec. (c). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in par. (3)(B), (C).

Pub. L. 101-597, Sec. 201(b), inserted par. (1) designation,

redesignated former pars. (1) and (2) as subpars. (A) and (B),

inserted before period at end of subpar. (B) ", including a

statement of all factors considered in approving applications for

participation in the Program and in making assignments for

participants in the Program", inserted par. (2) designation, and

added par. (3).

Subsec. (d). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in par. (2)(B).

Pub. L. 101-597, Sec. 201(c), amended subsec. (d) generally.

Prior to amendment, subsec. (d) read as follows: "In determining

which applications under the Scholarship Program to approve (and

which contracts to accept), the Secretary shall give priority -

"(1) first, to applications made (and contracts submitted) by

individuals who have previously received scholarships under the

Scholarship Program or under section 294z of this title; and

"(2) second, to applications made (and contracts submitted) -

"(A) for the school year beginning in calendar year 1978, by

individuals who are entering their first, second, or third year

of study in a course of study or program described in

subsection (b)(1)(B) of this section in such school year;

"(B) for the school year beginning in calendar year 1979, by

individuals who are entering their first or second year of

study in a course of study or program described in subsection

(b)(1)(B) of this section in such school year; and

"(C) for each school year thereafter, by individuals who are

entering their first year of study in a course of study or

program described in subsection (b)(1)(B) of this section in

such school year."

Subsec. (f)(1)(B)(iv). Pub. L. 101-597, Sec. 401(b)[(a)],

substituted reference to health professional shortage area for

reference to health manpower shortage area in closing provisions.

Pub. L. 101-597, Sec. 201(a)(2), substituted "as a provider of

primary health services" after "whichever is greater,".

Subsec. (g)(3). Pub. L. 101-509 substituted "(under section 5303

of title 5)" for "(as set forth in the report transmitted to the

Congress under section 5305 of title 5)".

Subsec. (i). Pub. L. 101-597, Sec. 201(d)(1), amended

introductory provisions generally. Prior to amendment, introductory

provisions read as follows: "The Secretary shall report to Congress

on March 1 of each year - ".

Subsec. (i)(4), (5). Pub. L. 101-597, Sec. 201(d)(2), added pars.

(4) and (5) and struck out former par. (4) which read as follows:

"the amount of tuition paid in the aggregate and at each

educational institution for the school year beginning in such year

and for prior school years."

Subsec. (i)(6). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area.

Pub. L. 101-597, Sec. 201(d)(2)(C), added par. (6).

1988 - Subsec. (b)(1). Pub. L. 100-607 substituted "osteopathic

medicine" for "osteopathy".

1985 - Subsec. (g)(1). Pub. L. 99-129 struck out "or under

section 294z of this title (relating to scholarships for first-year

students of exceptional financial need)," after "Scholarship

Program".

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2709(b)(1), inserted

reference to clinical psychologists.

Subsec. (c). Pub. L. 97-35, Sec. 2709(b)(2), (3), substituted

"254o" for "294w" in par. (1), and inserted provisions relating to

information concerning meeting the service obligation in par. (2).

Subsec. (f). Pub. L. 97-35, Sec. 2709(b)(4)-(6), in par. (1)

substituted reference to sections 254d to 254h and 254j of this

title, for reference to subpart II of part D of subchapter II of

this chapter, in par. (2) substituted reference to sections 254d to

254h, 254j and 254k of this title, for reference to subpart II of

part D of subchapter II of this chapter, and in par. (3)

substituted "254o" for "294w".

Subsec. (j). Pub. L. 97-35, Sec. 2709(b)(7), struck out subsec.

(j) which related to consultation and participation of schools.

1979 - Subsec. (g)(3). Pub. L. 96-32 substituted "section 5305 of

title 5" for "section 5303 of title 5".

1978 - Subsec. (f). Pub. L. 95-626 substituted "subpart II of

part D" for "subpart II of part C" in pars. (1)(A) and (2).

Subsec. (i). Pub. L. 95-623 substituted March 1 for December 1 as

the date for Secretary's annual report to Congress.

1977 - Subsec. (d)(2). Pub. L. 95-215 substituted provisions

relating to the school years beginning in calendar years 1978 and

1979 for provisions relating to the school year ending in the

fiscal year beginning Oct. 1, 1977.

EFFECTIVE DATE OF 1990 AMENDMENT

Amendment by Pub. L. 101-509 effective on such date as the

President shall determine, but not earlier than 90 days, and not

later than 180 days, after Nov. 5, 1990, see section 529 [title

III, Sec. 305] of Pub. L. 101-509, set out as a note under section

5301 of Title 5, Government Organization and Employees.

EFFECTIVE DATE OF 1985 AMENDMENT

Section 228 of Pub. L. 99-129 provided that:

"(a) Except as provided in subsection (b), this Act and the

amendments and repeals made by this Act [enacting sections 294q-1

to 294q-3 of this title, amending this section and sections 292a,

292b, 292h, 292j, 293c, 294a, 294b, 294d, 294e, 294g, 294j, 294m to

294p, 294z, 295f to 295f-2, 295g, 295g-1, 295g-3, 295g-4, 295g-6 to

295g-8, 295g-8b, 295h, 295h-1a to 295h-1c, 296k, 296l, 296m, 297a,

298b-5, and 300aa-14 of this title, repealing sections 292c, 295 to

295e-5, 295g-2, 295g-5, 295g-8a, and 295g-9 of this title, enacting

provisions set out as notes under sections 201, 292h, 293c, 294d,

294n, and 300aa-14 of this title and section 462 of the Appendix to

Title 50, War and National Defense, and amending provisions set out

as a note under section 298b-5 of this title] shall take effect on

the date of enactment of this Act [Oct. 22, 1985].

"(b)(1) The amendments made by section 101(a) of this Act

[amending section 294a of this title] shall take effect as of

October 1, 1985.

"(2) The amendments made by section 208(e) of this Act [amending

section 294e of this title] shall take effect nine months after the

date of enactment of this Act [Oct. 22, 1985].

"(3) The amendment made by section 208(h) of this Act [amending

section 294a of this title] shall take effect as of October 1,

1983.

"(4) The provisions of section 746 of the Public Health Service

Act (as added by the amendment made by section 209(h)(2) of this

Act) [section 294g-2 of this title] shall take effect as of June

30, 1984.

"(5) The amendments made by section 209(j) of this Act [amending

sections 294m and 297a of this title] shall take effect as of June

30, 1984.

"(6) The amendments made by section 213(a) of this Act [amending

section 295g-1 of this title] shall take effect as of October 1,

1985."

EFFECTIVE DATE OF 1977 AMENDMENT

Section 5 of Pub. L. 95-215 provided that the amendment made by

that section is effective Oct. 1, 1977.

EFFECTIVE DATE

Section 408(b)(1) of Pub. L. 94-484 provided that the enactment

of sections 254l to 254r of this title and repeal of section 234 of

this title by Pub. L. 94-484 is effective Oct. 1, 1977.

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP

OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

Section 408(b)(2) of Pub. L. 94-484, as amended, eff. Oct. 12,

1976, by Pub. L. 95-83, title III, Sec. 307(p), Aug. 1, 1977, 91

Stat. 394, provided that:

"(A) Except as provided in subparagraphs (B) and (C), the

amendment made by paragraph (1) of this subsection [enacting this

section and sections 254l-1 to 254r of this title and repealing

section 234 of this title] shall apply with respect to scholarships

awarded under the National Health Service Corps Scholarship Program

from appropriations for such Program for fiscal years beginning

after September 30, 1977.

"(B) The provisions of section 225(f)(1) of the Public Health

Service Act (as in effect on September 30, 1977) [former section

234(f)(1) of this title] prescribing the financial obligation of a

participant in the Public Health and National Health Service Corps

Scholarship Program who fails to complete an active duty service

obligation incurred under that Program shall apply to any

individual who received a scholarship under such Program from

appropriations for such Program for any fiscal year ending before

October 1, 1977.

"(C) If an individual received a scholarship under the Public

Health and National Health Service Corps Scholarship Program for

any school year beginning before the date of the enactment of this

Act [Oct. 12, 1976], periods of internship or residency served by

such individual in a facility of the National Health Service Corps

or other facility of the Public Health Service shall be creditable

in satisfying such individual's service obligation incurred under

that Program for such scholarship or for any scholarship received

under the National Health Service Corps Scholarship Program for any

subsequent school year. If an individual received a scholarship

under the Public Health and National Health Service Corps Program

for the first time from appropriations for such Program for the

fiscal year ending September 30, 1977, periods of internship or

residency served by such individual in such a facility shall be

creditable in satisfying such individual's service obligation

incurred under that Program for such scholarship."

SCHOLARSHIP AND LOAN REPAYMENT PROGRAMS

Pub. L. 107-251, title III, Sec. 302(c), Oct. 26, 2002, 116 Stat.

1644, provided that: "The Secretary of Health and Human Services,

in consultation with organizations representing individuals in the

dental field and organizations representing publicly funded health

care providers, shall develop and implement a plan for increasing

the participation of dentists and dental hygienists in the National

Health Service Corps Scholarship Program under section 338A of the

Public Health Service Act (42 U.S.C. 254l) and the Loan Repayment

Program under section 338B of such Act (42 U.S.C. 254l-1)."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254d, 254h-1, 254m, 254n,

254o, 254o-1, 254q, 254q-1, 254s, 11709 of this title; title 25

sections 1613a, 1616m; title 26 section 117.

-FOOTNOTE-

(!1) So in original.

(!2) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254l-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254l-1. National Health Service Corps Loan Repayment Program

-STATUTE-

(a) Establishment

The Secretary shall establish a program to be known as the

National Health Service Corps Loan Repayment Program to assure,

with respect to the provision of primary health services pursuant

to section 254d(a)(2) of this title -

(1) an adequate supply of physicians, dentists, behavioral and

mental health professionals, certified nurse midwives, certified

nurse practitioners, and physician assistants; and

(2) if needed by the Corps, an adequate supply of other health

professionals.

(b) Eligibility

To be eligible to participate in the Loan Repayment Program, an

individual must -

(1)(A) have a degree in medicine, osteopathic medicine,

dentistry, or another health profession, or an appropriate degree

from a graduate program of behavioral and mental health, or be

certified as a nurse midwife, nurse practitioner, or physician

assistant;

(B) be enrolled in an approved graduate training program in

medicine, osteopathic medicine, dentistry, behavioral and mental

health, or other health profession; or

(C) be enrolled as a full-time student -

(i) in an accredited (as determined by the Secretary)

educational institution in a State; and

(ii) in the final year of a course of a study or program,

offered by such institution and approved by the Secretary,

leading to a degree in medicine, osteopathic medicine,

dentistry, or other health profession;

(2) be eligible for, or hold, an appointment as a commissioned

officer in the Regular or Reserve Corps of the Service or be

eligible for selection for civilian service in the Corps; and

(3) submit to the Secretary an application for a contract

described in subsection (f) of this section (relating to the

payment by the Secretary of the educational loans of the

individual in consideration of the individual serving for a

period of obligated service).

(c) Information to be included with application and contract forms;

understandability; availability

(1) Summary and information

In disseminating application forms and contract forms to

individuals desiring to participate in the Loan Repayment

Program, the Secretary shall include with such forms -

(A) a fair summary of the rights and liabilities of an

individual whose application is approved (and whose contract is

accepted) by the Secretary, including in the summary a clear

explanation of the damages to which the United States is

entitled under section 254o of this title in the case of the

individual's breach of the contract; and

(B) information respecting meeting a service obligation

through private practice under an agreement under section 254n

of this title and such other information as may be necessary

for the individual to understand the individual's prospective

participation in the Loan Repayment Program and service in the

Corps.

(2) Understandability

The application form, contract form, and all other information

furnished by the Secretary under this subpart shall be written in

a manner calculated to be understood by the average individual

applying to participate in the Loan Repayment Program.

(3) Availability

The Secretary shall make such application forms, contract

forms, and other information available to individuals desiring to

participate in the Loan Repayment Program on a date sufficiently

early to ensure that such individuals have adequate time to

carefully review and evaluate such forms and information.

(4) Recruitment and retention

(A) The Secretary shall distribute to health professions

schools materials providing information on the Loan Repayment

Program and shall encourage the schools to disseminate the

materials to the students of the schools.

(B)(i) In the case of any health professional whose period of

obligated service under the Loan Repayment Program is nearing

completion, the Secretary shall encourage the individual to

remain in a health professional shortage area and to continue

providing primary health services.

(ii) During the period in which a health professional is

planning and making the transition to private practice from

obligated service under the Loan Repayment Program, the Secretary

may provide assistance to the professional regarding such

transition if the professional is remaining in a health

professional shortage area and is continuing to provide primary

health services.

(C) In the case of entities to which participants in the Loan

Repayment Program are assigned under section 254f of this title,

the Secretary shall encourage the entities to provide options

with respect to assisting the participants in remaining in the

health professional shortage areas involved, and in continuing to

provide primary health services, after the period of obligated

service under the Loan Repayment Program is completed. The

options with respect to which the Secretary provides such

encouragement may include options regarding the sharing of a

single employment position in the health professions by 2 or more

health professionals, and options regarding the recruitment of

couples where both of the individuals are health professionals.

(d) Factors considered in providing contracts; priorities

(1) Subject to section 254f-1 of this title, in providing

contracts under the Loan Repayment Program -

(A) the Secretary shall consider the extent of the demonstrated

interest of the applicants for the contracts in providing primary

health services; and

(B) may consider such other factors regarding the applicants as

the Secretary determines to be relevant to selecting qualified

individuals to participate in such Program.

(2) In providing contracts under the Loan Repayment Program, the

Secretary shall give priority -

(A) to any application for such a contract submitted by an

individual whose training is in a health profession or specialty

determined by the Secretary to be needed by the Corps;

(B) to any application for such a contract submitted by an

individual who has (and whose spouse, if any, has)

characteristics that increase the probability that the individual

will continue to serve in a health professional shortage area

after the period of obligated service pursuant to subsection (f)

of this section is completed; and

(C) subject to subparagraph (B), to any application for such a

contract submitted by an individual who is from a disadvantaged

background.

(e) Approval required for participation

An individual becomes a participant in the Loan Repayment Program

only upon the Secretary and the individual entering into a written

contract described in subsection (f) of this section.

(f) Contents of contracts

The written contract (referred to in this subpart) between the

Secretary and an individual shall contain -

(1) an agreement that -

(A) subject to paragraph (3), the Secretary agrees -

(i) to pay on behalf of the individual loans in accordance

with subsection (g) of this section; and

(ii) to accept (subject to the availability of appropriated

funds for carrying out sections 254d through 254h of this

title and section 254j of this title) the individual into the

Corps (or for equivalent service as otherwise provided in

this subpart); and

(B) subject to paragraph (3), the individual agrees -

(i) to accept loan payments on behalf of the individual;

(ii) in the case of an individual described in subsection

(b)(1)(C) of this section, to maintain enrollment in a course

of study or training described in such subsection until the

individual completes the course of study or training;

(iii) in the case of an individual described in subsection

(b)(1)(C) of this section, while enrolled in such course of

study or training, to maintain an acceptable level of

academic standing (as determined under regulations of the

Secretary by the educational institution offering such course

of study or training); and

(iv) to serve for a time period (hereinafter in this

subpart referred to as the "period of obligated service")

equal to 2 years or such longer period as the individual may

agree to, as a provider of primary health services in a

health professional shortage area (designated under section

254e of this title) to which such individual is assigned by

the Secretary as a member of the Corps or released under

section 254n of this title;

(2) a provision permitting the Secretary to extend for such

longer additional periods, as the individual may agree to, the

period of obligated service agreed to by the individual under

paragraph (1)(B)(iv), including extensions resulting in an

aggregate period of obligated service in excess of 4 years;

(3) a provision that any financial obligation of the United

States arising out of a contract entered into under this subpart

and any obligation of the individual that is conditioned thereon,

is contingent on funds being appropriated for loan repayments

under this subpart and to carry out the purposes of sections 254d

through 254h of this title and sections 254j and 254k of this

title;

(4) a statement of the damages to which the United States is

entitled, under section 254o of this title for the individual's

breach of the contract; and

(5) such other statements of the rights and liabilities of the

Secretary and of the individual, not inconsistent with this

subpart.

(g) Payments

(1) In general

A loan repayment provided for an individual under a written

contract under the Loan Repayment Program shall consist of

payment, in accordance with paragraph (2), on behalf of the

individual of the principal, interest, and related expenses on

government and commercial loans received by the individual

regarding the undergraduate or graduate education of the

individual (or both), which loans were made for -

(A) tuition expenses;

(B) all other reasonable educational expenses, including

fees, books, and laboratory expenses, incurred by the

individual; or

(C) reasonable living expenses as determined by the

Secretary.

(2) Payments for years served

(A) In general

For each year of obligated service that an individual

contracts to serve under subsection (f) of this section the

Secretary may pay up to $35,000 on behalf of the individual for

loans described in paragraph (1). In making a determination of

the amount to pay for a year of such service by an individual,

the Secretary shall consider the extent to which each such

determination -

(i) affects the ability of the Secretary to maximize the

number of contracts that can be provided under the Loan

Repayment Program from the amounts appropriated for such

contracts;

(ii) provides an incentive to serve in health professional

shortage areas with the greatest such shortages; and

(iii) provides an incentive with respect to the health

professional involved remaining in a health professional

shortage area, and continuing to provide primary health

services, after the completion of the period of obligated

service under the Loan Repayment Program.

(B) Repayment schedule

Any arrangement made by the Secretary for the making of loan

repayments in accordance with this subsection shall provide

that any repayments for a year of obligated service shall be

made no later than the end of the fiscal year in which the

individual completes such year of service.

(3) Tax liability

For the purpose of providing reimbursements for tax liability

resulting from payments under paragraph (2) on behalf of an

individual -

(A) the Secretary shall, in addition to such payments, make

payments to the individual in an amount equal to 39 percent of

the total amount of loan repayments made for the taxable year

involved; and

(B) may make such additional payments as the Secretary

determines to be appropriate with respect to such purpose.

(4) Payment schedule

The Secretary may enter into an agreement with the holder of

any loan for which payments are made under the Loan Repayment

Program to establish a schedule for the making of such payments.

(h) Employment ceiling

Notwithstanding any other provision of law, individuals who have

entered into written contracts with the Secretary under this

section, while undergoing academic or other training, shall not be

counted against any employment ceiling affecting the Department.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338B, as added Pub. L.

100-177, title II, Sec. 201(3), Dec. 1, 1987, 101 Stat. 992;

amended Pub. L. 100-607, title VI, Sec. 629(a)(2), Nov. 4, 1988,

102 Stat. 3146; Pub. L. 101-597, title II, Sec. 202(a)-(g)(1), (h),

title IV, Sec. 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3023-3026,

3035; Pub. L. 105-392, title I, Sec. 109, Nov. 13, 1998, 112 Stat.

3562; Pub. L. 107-251, title III, Sec. 310, Oct. 26, 2002, 116

Stat. 1650.)

-MISC1-

PRIOR PROVISIONS

A prior section 338B of act July 1, 1944, was renumbered section

338C by section 201(2) of Pub. L. 100-177 and is classified to

section 254m of this title.

AMENDMENTS

2002 - Subsec. (a)(1). Pub. L. 107-251, Sec. 310(1)(A), inserted

"behavioral and mental health professionals," after "dentists,".

Subsec. (a)(2). Pub. L. 107-251, Sec. 310(1)(B), struck out

"(including mental health professionals)" before period at end.

Subsec. (b)(1)(A). Pub. L. 107-251, Sec. 310(2), added subpar.

(A) and struck out former subpar. (A) which read as follows: "must

have a degree in medicine, osteopathic medicine, dentistry, or

other health profession, or be certified as a nurse midwife, nurse

practioner, or physician assistant;".

Subsec. (e)(1). Pub. L. 107-251, Sec. 310(3), struck out par. (1)

designation and heading.

Subsec. (i). Pub. L. 107-251, Sec. 310(4), struck out subsec.

(i), which required an annual report to Congress about the Loan

Repayment Program.

1998 - Subsec. (b)(1)(B). Pub. L. 105-392 substituted "behavioral

and mental health, or other health profession" for "or other health

profession".

1990 - Subsec. (a). Pub. L. 101-597, Sec. 202(a)(1), substituted

"Corps Loan Repayment Program to assure, with respect to the

provision of primary health services pursuant to section 254d(a)(2)

of this title - " and pars. (1) and (2) for "Corps Loan Repayment

Program (hereinafter in this subpart referred to as the 'Loan

Repayment Program') in order to assure -

"(1) an adequate supply of trained physicians, dentists, and

nurses for the Corps; and

"(2) if needed by the Corps, an adequate supply of podiatrists,

optometrists, pharmacists, clinical psychologists, graduates of

schools of veterinary medicine, graduates of schools of public

health, graduates of programs in health administration, graduates

of programs for the training of physician assistants, expanded

function dental auxiliaries, and nurse practitioners (as defined

in section 296m of this title), and other health professionals."

Subsec. (b)(1). Pub. L. 101-597, Sec. 202(b)(1)(A), amended par.

(1) generally. Prior to amendment, par. (1) read as follows:

"(A) be enrolled -

"(i) as a full-time student -

"(I) in an accredited (as determined by the Secretary)

educational institution in a State; and

"(II) in the final year of a course of study or program,

offered by such institution and approved by the Secretary,

leading to a degree in medicine, osteopathic medicine,

dentistry, or other health profession; or

"(ii) in an approved graduate training program in medicine,

osteopathic medicine, dentistry, or other health profession; or

"(B) have -

"(i) a degree in medicine, osteopathic medicine, dentistry, or

other health profession;

"(ii) completed an approved graduate training program in

medicine, osteopathic medicine, dentistry, or other health

profession in a State, except that the Secretary may waive the

completion requirement of this clause for good cause; and

"(iii) a license to practice medicine, osteopathic medicine,

dentistry, or other health profession in a State;".

Subsec. (b)(2) to (4). Pub. L. 101-597, Sec. 202(b)(2)(A),

inserted "and" at end of par. (2), added par. (3), and struck out

former pars. (3) and (4) which read as follows:

"(3) submit an application to participate in the Loan Repayment

Program; and

"(4) sign and submit to the Secretary, at the time of the

submission of such application, a written contract (described in

subsection (f) of this section) to accept repayment of educational

loans and to serve (in accordance with this subpart) for the

applicable period of obligated service in a health manpower

shortage area."

Subsec. (c)(4). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in subpars. (B) and (C).

Pub. L. 101-597, Sec. 202(c), added par. (4).

Subsec. (d). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in par. (2)(B).

Pub. L. 101-597, Sec. 202(d), amended subsec. (d) generally.

Prior to amendment, subsec. (d) read as follows: "In determining

which applications under the Loan Repayment Program to approve (and

which contracts to accept), the Secretary shall give priority to

applications made by -

"(1) individuals whose training is in a health profession or

specialty determined by the Secretary to be needed by the Corps;

and

"(2) individuals who are committed to service in medically

underserved areas."

Subsec. (e). Pub. L. 101-597, Sec. 202(b)(2)(B), substituted

"only upon the Secretary and the individual entering into a written

contract described in subsection (f) of this section." for "only on

the Secretary's approval of the individual's application submitted

under subsection (b)(3) of this section and the Secretary's

acceptance of the contract submitted by the individual under

subsection (b)(4) of this section." in par. (1) and struck out par.

(2) which read as follows: "The Secretary shall provide written

notice to an individual promptly on -

"(A) the Secretary's approving, under paragraph (1), of the

individual's participation in the Loan Repayment Program; or

"(B) the Secretary's disapproving an individual's participation

in such Program."

Subsec. (f)(1)(B)(ii), (iii). Pub. L. 101-597, Sec. 202(b)(1)(B),

substituted "subsection (b)(1)(C)" for "subsection (b)(1)(A)".

Subsec. (f)(1)(B)(iv). Pub. L. 101-597, Sec. 401(b)[(a)],

substituted reference to health professional shortage area for

reference to health manpower shortage area.

Pub. L. 101-597, Sec. 202(a)(2), inserted "as a provider of

primary health services" before "in a health".

Subsec. (f)(2). Pub. L. 101-597, Sec. 202(e), inserted before

semicolon at end ", including extensions resulting in an aggregate

period of obligated service in excess of 4 years".

Subsec. (g)(1). Pub. L. 101-597, Sec. 202(f)(1), inserted

"regarding the undergraduate or graduate education of the

individual (or both), which loans were made" after "loans received

by the individual".

Subsec. (g)(2)(A). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in cls. (ii) and (iii).

Pub. L. 101-597, Sec. 202(f)(2)(A), substituted "For each year"

for "Except as provided in subparagraph (B) and paragraph (3), for

each year" and "$35,000" for "$20,000", inserted at end "In making

a determination of the amount to pay for a year of such service by

an individual, the Secretary shall consider the extent to which

each such determination - ", and added immediately thereafter cls.

(i) to (iii).

Subsec. (g)(2)(B), (C). Pub. L. 101-597, Sec. 202(f)(2)(B),

redesignated subpar. (C) as (B) and struck out former subpar. (B)

which read as follows: "For each year of obligated service that an

individual contracts under subsection (f) of this section to serve

in the Indian Health Service, or to serve in a health program or

facility operated by a tribe or tribal organization under the

Indian Self-Determination Act (25 U.S.C. 450f et seq.), the

Secretary may pay up to $25,000 on behalf of the individual for

loans described in paragraph (1)."

Subsec. (g)(3). Pub. L. 101-597, Sec. 202(g)(1), amended par. (3)

generally. Prior to amendment, par. (3) read as follows: "In

addition to payments made under paragraph (2), in any case in which

payments on behalf of an individual under the Loan Repayment

Program result in an increase in Federal, State, or local income

tax liability for such individual, the Secretary may, on the

request of such individual, make payments to such individual in a

reasonable amount, as determined by the Secretary, to reimburse

such individual for all or part of the increased tax liability of

the individual."

Subsec. (i). Pub. L. 101-597, Sec. 401(b)[(a)], substituted

reference to health professional shortage area for reference to

health manpower shortage area in par. (8).

Pub. L. 101-597, Sec. 202(h), amended subsec. (i) generally.

Prior to amendment, subsec. (i) read as follows: "The Secretary

shall, not later than March 1 of each year, submit to the Congress

a report specifying -

"(1) the number, and type of health profession training, of

individuals receiving loan payments under the Loan Repayment

Program;

"(2) the educational institution at which such individuals are

receiving their training;

"(3) the number of applications filed under this section in the

school year beginning in such year and in prior school years; and

"(4) the amount of loan payments made in the year reported on."

1988 - Subsec. (b)(1). Pub. L. 100-607 substituted "osteopathic

medicine" for "osteopathy" wherever appearing.

EFFECTIVE DATE OF 1990 AMENDMENT

Section 202(g)(2) of Pub. L. 101-597 provided that: "The

amendment made by paragraph (1) [amending this section] shall apply

only with respect to contracts under section 338B of the Public

Health Service Act [this section] (relating to service in the

National Health Service Corps) that are entered into on or after

the effective date of this Act [Nov. 16, 1990]."

REGULATIONS

Section 205 of title II of Pub. L. 100-177 provided that: "Not

later than 180 days after the effective date of the amendments made

by this title [Dec. 21, 1987], the Secretary of Health and Human

Services shall issue regulations for the loan repayment programs

established by the amendments [enacting this section and sections

254q and 254q-1 of this title, amending sections 242a, 254d, 254g,

254h-1, and 254o of this title, and repealing former section 254q

of this title]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254d, 254h-1, 254m, 254n,

254o, 254o-1, 254q, 254q-1, 254t, 287c-33, 288-2, 288-4, 288-5,

288-5a, 288-6 of this title; title 25 section 1616a; title 37

section 303a.

-End-

-CITE-

42 USC Sec. 254m 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254m. Obligated service under contract

-STATUTE-

(a) Service in full-time clinical practice

Except as provided in section 254n of this title, each individual

who has entered into a written contract with the Secretary under

section 254l or 254l-1 of this title shall provide service in the

full-time clinical practice of such individual's profession as a

member of the Corps for the period of obligated service provided in

such contract.

(b) Notice to individual; information for informed decision;

eligibility; notice to Secretary; qualification and appointment

as commissioned officer; appointment as civilian member;

designation of non-United States employee as member; deferment of

obligated service

(1) If an individual is required under subsection (a) of this

section to provide service as specified in section 254l(f)(1)(B)(v)

or 254l-1(f)(1)(B)(iv) of this title (hereinafter in this

subsection referred to as "obligated service"), the Secretary

shall, not later than ninety days before the date described in

paragraph (5), determine if the individual shall provide such

service -

(A) as a member of the Corps who is a commissioned officer in

the Regular or Reserve Corps of the Service or who is a civilian

employee of the United States, or

(B) as a member of the Corps who is not such an officer or

employee,

and shall notify such individual of such determination.

(2) If the Secretary determines that an individual shall provide

obligated service as a member of the Corps who is a commissioned

officer in the Service or a civilian employee of the United States,

the Secretary shall, not later than sixty days before the date

described in paragraph (5), provide such individual with sufficient

information regarding the advantages and disadvantages of service

as such a commissioned officer or civilian employee to enable the

individual to make a decision on an informed basis. To be eligible

to provide obligated service as a commissioned officer in the

Service, an individual shall notify the Secretary, not later than

thirty days before the date described in paragraph (5), of the

individual's desire to provide such service as such an officer. If

an individual qualifies for an appointment as such an officer, the

Secretary shall, as soon as possible after the date described in

paragraph (5), appoint the individual as a commissioned officer of

the Regular or Reserve Corps of the Service and shall designate the

individual as a member of the Corps.

(3) If an individual provided notice by the Secretary under

paragraph (2) does not qualify for appointment as a commissioned

officer in the Service, the Secretary shall, as soon as possible

after the date described in paragraph (5), appoint such individual

as a civilian employee of the United States and designate the

individual as a member of the Corps.

(4) If the Secretary determines that an individual shall provide

obligated service as a member of the Corps who is not an employee

of the United States, the Secretary shall, as soon as possible

after the date described in paragraph (5), designate such

individual as a member of the Corps to provide such service.

(5)(A) In the case of the Scholarship Program, the date referred

to in paragraphs (1) through (4) shall be the date on which the

individual completes the training required for the degree for which

the individual receives the scholarship, except that -

(i) for an individual receiving such a degree after September

30, 2000, from a school of medicine or osteopathic medicine, such

date shall be the date the individual completes a residency in a

specialty that the Secretary determines is consistent with the

needs of the Corps; and

(ii) at the request of an individual, the Secretary may,

consistent with the needs of the Corps, defer such date until the

end of a period of time required for the individual to complete

advanced training (including an internship or residency).

(B) No period of internship, residency, or other advanced

clinical training shall be counted toward satisfying a period of

obligated service under this subpart.

(C) In the case of the Loan Repayment Program, if an individual

is required to provide obligated service under such Program, the

date referred to in paragraphs (1) through (4) -

(i) shall be the date determined under subparagraph (A) in the

case of an individual who is enrolled in the final year of a

course of study;

(ii) shall, in the case of an individual who is enrolled in an

approved graduate training program in medicine, osteopathic

medicine, dentistry, or other health profession, be the date the

individual completes such training program; and

(iii) shall, in the case of an individual who has a degree in

medicine, osteopathic medicine, dentistry, or other health

profession and who has completed graduate training, be the date

the individual enters into an agreement with the Secretary under

section 254l-1 of this title.

(c) Obligated service period; commencement

An individual shall be considered to have begun serving a period

of obligated service -

(1) on the date such individual is appointed as an officer in a

Regular or Reserve Corps of the Service or is designated as a

member of the Corps under subsection (b)(3) or (b)(4) of this

section, or

(2) in the case of an individual who has entered into an

agreement with the Secretary under section 254n of this title, on

the date specified in such agreement,

whichever is earlier.

(d) Assignment of personnel

The Secretary shall assign individuals performing obligated

service in accordance with a written contract under the Scholarship

Program to health professional shortage areas in accordance with

sections 254d through 254h and sections 254j and 254k of this

title. If the Secretary determines that there is no need in a

health professional shortage area (designated under section 254e of

this title) for a member of the profession in which an individual

is obligated to provide service under a written contract and if

such individual is an officer in the Service or a civilian employee

of the United States, the Secretary may detail such individual to

serve his period of obligated service as a full-time member of such

profession in such unit of the Department as the Secretary may

determine.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338C, formerly title VII,

Sec. 752, as added Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct.

12, 1976, 90 Stat. 2284; amended Pub. L. 95-626, title I, Sec.

113(b), Nov. 10, 1978, 92 Stat. 3563; Pub. L. 96-76, title II, Sec.

202(a), (b), Sept. 29, 1979, 93 Stat. 582; renumbered Sec. 338B and

amended Pub. L. 97-35, title XXVII, Sec. 2709(a), (c), Aug. 13,

1981, 95 Stat. 908, 909; Pub. L. 97-414, Sec. 8(g)(1), Jan. 4,

1983, 96 Stat. 2061; renumbered Sec. 338C and amended Pub. L.

100-177, title II, Sec. 201(2), title III, Sec. 306, Dec. 1, 1987,

101 Stat. 992, 1004; Pub. L. 100-607, title VI, Sec. 629(a)(2),

Nov. 4, 1988, 102 Stat. 3146; Pub. L. 101-597, title IV, Sec.

401(b)[(a)], Nov. 16, 1990, 104 Stat. 3035; Pub. L. 107-251, title

III, Sec. 311, Oct. 26, 2002, 116 Stat. 1650.)

-COD-

CODIFICATION

Section was formerly classified to section 294u of this title

prior to its renumbering by Pub. L. 97-35.

-MISC1-

PRIOR PROVISIONS

A prior section 338C of act July 1, 1944, was renumbered section

338D by section 201(2) of Pub. L. 100-177 and is classified to

section 254n of this title.

AMENDMENTS

2002 - Subsec. (b)(1). Pub. L. 107-251, Sec. 311(1)(A),

substituted "section 254l(f)(1)(B)(v)" for "254l(f)(1)(B)(iv)" in

introductory provisions.

Subsec. (b)(5)(A). Pub. L. 107-251, Sec. 311(1)(B)(i), added

subpar. (A) and struck out former subpar. (A) which read as

follows: "In the case of the Scholarship Program, with respect to

an individual receiving a degree from a school of medicine,

osteopathic medicine, dentistry, veterinary medicine, optometry,

podiatry, or pharmacy, the date referred to in paragraphs (1)

through (4) shall be the date on which the individual completes the

training required for such degree, except that -

"(i) at the request of such an individual with whom the

Secretary has entered into a contract under section 254l of this

title prior to October 1, 1985, the Secretary shall defer such

date until the end of the period of time (not to exceed the

number of years specified in subparagraph (B) or such greater

period as the Secretary, consistent with the needs of the Corps,

may authorize) required for the individual to complete an

internship, residency, or other advanced clinical training; and

"(ii) at the request of such an individual with whom the

Secretary has entered into a contract under section 254l of this

title on or after October 1, 1985, the Secretary may defer such

date in accordance with clause (i)."

Subsec. (b)(5)(B). Pub. L. 107-251, Sec. 311(1)(B)(i), (iii),

redesignated subpar. (C) as (B) and struck out former subpar. (B)

which read as follows:

"(B)(i) In the case of the Scholarship Program, with respect to

an individual receiving a degree from a school of medicine,

osteopathic medicine, or dentistry, the number of years referred to

in subparagraph (A)(i) shall be 3 years.

"(ii) In the case of the Scholarship Program, with respect to an

individual receiving a degree from a school of veterinary medicine,

optometry, podiatry, or pharmacy, the number of years referred to

in subparagraph (A)(i) shall be 1 year."

Subsec. (b)(5)(C). Pub. L. 107-251, Sec. 311(1)(B)(iii),

redesignated subpar. (E) as (C). Former subpar. (C) redesignated

(B).

Subsec. (b)(5)(C)(i). Pub. L. 107-251, Sec. 311(1)(B)(iv),

substituted "subparagraph (A)" for "subparagraph (A), (B), or (D)".

Subsec. (b)(5)(D). Pub. L. 107-251, Sec. 311(1)(B)(ii), struck

out subpar. (D) which read as follows: "In the case of the

Scholarship Program, with respect to an individual receiving a

degree from an institution other than a school referred to in

subparagraph (A), the date referred to in paragraphs (1) through

(4) shall be the date on which the individual completes the

academic training of the individual leading to such degree."

Subsec. (b)(5)(E). Pub. L. 107-251, Sec. 311(1)(B)(iii),

redesignated subpar. (E) as (C).

Subsec. (e). Pub. L. 107-251, Sec. 311(2), struck out subsec. (e)

which related to service under National Research Service Award

program as credit against obligated service time.

1990 - Subsec. (d). Pub. L. 101-597 substituted reference to

health professional shortage area for reference to health manpower

shortage area wherever appearing.

1988 - Subsec. (b)(5). Pub. L. 100-607 substituted "osteopathic

medicine" for "osteopathy" wherever appearing.

1987 - Subsec. (a). Pub. L. 100-177, Sec. 306(1), inserted "or

254l-1", and made technical amendment to reference to section 254n

of this title to reflect renumbering of corresponding section of

original act.

Subsec. (b)(1). Pub. L. 100-177, Sec. 306(2), inserted reference

to section 254l-l(f)(1)(B)(iv).

Subsec. (b)(5). Pub. L. 100-177, Sec. 306(3), substituted par.

(5) consisting of subpars. (A) to (E) for former par. (5)

consisting of subpars. (A) and (B).

Subsec. (c)(2). Pub. L. 100-177, Sec. 306(4), made technical

amendment to reference to section 254n of this title to reflect

renumbering of corresponding section of original act.

1983 - Subsec. (e). Pub. L. 97-414 inserted "or under section 234

of this title as in effect on September 30, 1977" after

"Scholarship Program".

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2709(c)(1), substituted

"254n" for "294v" and "254l" for "294t".

Subsec. (b). Pub. L. 97-35, Sec. 2709(c)(2), substituted

provisions relating to notice, information, etc., for individuals

required to give obligated service, for provisions relating to

notice, information, etc., for individuals required to provide

service under the Scholarship Program.

Subsec. (c). Pub. L. 97-35, Sec. 2709(c)(3), (4), in par. (1)

inserted reference to designation under subsec. (b)(3) or (4) of

this section, and in par. (2) substituted "254n" for "294v".

Subsec. (d). Pub. L. 97-35, Sec. 2709(c)(5), inserted provision

relating to individuals who are officers in the Service or civilian

employees of the United States, and substituted reference to

sections 254d to 254h, 254j, and 254k of this title, for reference

to subpart II of part D of subchapter II of this chapter.

Subsec. (e). Pub. L. 97-35, Sec. 2709(c)(6), substituted

provisions respecting mandatory determination of service

requirement, for provisions respecting discretionary determination

of service requirement.

1979 - Subsec. (b)(5)(A). Pub. L. 96-76, Sec. 202(a), (b)(1),

(2), inserted provisions authorizing a greater period than three

years for individuals receiving degrees from schools of medicine,

osteopathy, and dentistry, and provisions respecting individuals

receiving degrees from schools of veterinary medicine, optometry,

podiatry, and pharmacy, and substituted "No period" for "No such

period".

Subsec. (b)(5)(B). Pub. L. 96-76, Sec. 202(b)(3), substituted

"referred to in subparagraph (A)" for "of medicine, osteopathy, or

dentistry".

1978 - Subsec. (d). Pub. L. 95-626 substituted "subpart II of

part D" for "subpart II of part C".

EFFECTIVE DATE OF 1981 AMENDMENT

Section 2709(h) of Pub. L. 97-35 provided that: "The amendments

made by paragraphs (2), (3), and (5)(B) of subsection (c) [amending

this section] shall apply with respect to contracts entered into

under the National Health Service Corps scholarship program under

subpart III of part C of title VII of the Public Health Service Act

[section 294r et seq. of this title] after the date of the

enactment of this Act [Aug. 13, 1981]. An individual who before

such date has entered into such a contract and who has not begun

the period of obligated service required under such contract shall

be given the opportunity to revise such contract to permit the

individual to serve such period as a member of the National Health

Service Corps who is not an employee of the United States."

EFFECTIVE DATE

Section effective Oct. 1, 1977, see section 408(b)(1) of Pub. L.

94-484, set out in part as a note under section 254l of this title.

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP

OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

See section 408(b)(2) of Pub. L. 94-484, set out as a note under

section 254l of this title.

SPECIAL RETENTION PAY FOR REGULAR OR RESERVE OFFICERS FOR PERIOD

OFFICER IS OBLIGATED UNDER THIS SECTION

Pub. L. 100-446, title II, Sept. 27, 1988, 102 Stat. 1816,

provided that: "the Secretary of Health and Human Services may

authorize special retention pay under paragraph (4) of 37 U.S.C.

302(a) to any regular or reserve officer for the period during

which the officer is obligated under section 338B [now 338C] of the

Public Health Service Act [this section] and assigned and providing

direct health services or serving the officer's obligation as a

specialist".

Similar provisions were contained in the following prior

appropriation acts:

Pub. L. 100-202, Sec. 101(g) [title II], Dec. 22, 1987, 101 Stat.

1329-213, 1329-246.

Pub. L. 99-500, Sec. 101(h) [title II], Oct. 18, 1986, 100 Stat.

1783-242, 1783-277, and Pub. L. 99-591, Sec. 101(h) [title II],

Oct. 30, 1986, 100 Stat. 3341-242, 3341-277.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254d, 254f-1, 254n, 254o,

254t, 287c-33, 288-2, 288-5, 288-5a, 288-6, 293b, 11709 of this

title; title 25 sections 1613a, 1616e, 1621p.

-End-

-CITE-

42 USC Sec. 254n 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254n. Private practice

-STATUTE-

(a) Application for release of obligations; conditions

The Secretary shall, to the extent permitted by, and consistent

with, the requirements of applicable State law, release an

individual from all or part of his service obligation under section

254m(a) of this title or under section 234 (!1) of this title (as

in effect on September 30, 1977) if the individual applies for such

a release under this section and enters into a written agreement

with the Secretary under which the individual agrees to engage for

a period equal to the remaining period of his service obligation in

the full-time private clinical practice (including service as a

salaried employee in an entity directly providing health services)

of his health profession -

(1) in the case of an individual who received a scholarship

under the Scholarship Program or a loan repayment under the Loan

Repayment Program and who is performing obligated service as a

member of the Corps in a health professional shortage area on the

date of his application for such a release, in the health

professional shortage area in which such individual is serving on

such date or in the case of an individual for whom a loan payment

was made under the Loan Repayment Program and who is performing

obligated service as a member of the Corps in a health

professional shortage area on the date of the application of the

individual for such a release, in the health professional

shortage area selected by the Secretary; or

(2) in the case of any other individual, in a health

professional shortage area (designated under section 254e of this

title) selected by the Secretary.

(b) Written agreement; actions to ensure compliance

(1) The written agreement described in subsection (a) of this

section shall -

(A) provide that, during the period of private practice by an

individual pursuant to the agreement, the individual shall comply

with the requirements of section 254g of this title that apply to

entities; and

(B) contain such additional provisions as the Secretary may

require to carry out the objectives of this section.

(2) The Secretary shall take such action as may be appropriate to

ensure that the conditions of the written agreement prescribed by

this subsection are adhered to.

(c) Breach of service contract

If an individual breaches the contract entered into under section

254l or 254l-1 of this title by failing (for any reason) to begin

his service obligation in accordance with an agreement entered into

under subsection (a) of this section or to complete such service

obligation, the Secretary may permit such individual to perform

such service obligation as a member of the Corps.

(d) Travel expenses

The Secretary may pay an individual who has entered into an

agreement with the Secretary under subsection (a) of this section

an amount to cover all or part of the individual's expenses

reasonably incurred in transporting himself, his family, and his

possessions to the location of his private clinical practice.

(e) Sale of equipment and supplies

Upon the expiration of the written agreement under subsection (a)

of this section, the Secretary may (notwithstanding any other

provision of law) sell to the individual who has entered into an

agreement with the Secretary under subsection (a) of this section,

equipment and other property of the United States utilized by such

individual in providing health services. Sales made under this

subsection shall be made at the fair market value (as determined by

the Secretary) of the equipment or such other property, except that

the Secretary may make such sales for a lesser value to the

individual if he determines that the individual is financially

unable to pay the full market value.

(f) Malpractice insurance

The Secretary may, out of appropriations authorized under section

254k of this title, pay to individuals participating in private

practice under this section the cost of such individual's

malpractice insurance and the lesser of -

(1)(A) $10,000 in the first year of obligated service;

(B) $7,500 in the second year of obligated service;

(C) $5,000 in the third year of obligated service; and

(D) $2,500 in the fourth year of obligated service; or

(2) an amount determined by subtracting such individual's net

income before taxes from the income the individual would have

received as a member of the Corps for each such year of obligated

service.

(g) Technical assistance

The Secretary shall, upon request, provide to each individual

released from service obligation under this section technical

assistance to assist such individual in fulfilling his or her

agreement under this section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338D, formerly title VII,

Sec. 753, as added Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct.

12, 1976, 90 Stat. 2285; amended Pub. L. 96-538, title IV, Sec.

403, Dec. 17, 1980, 94 Stat. 3192; renumbered Sec. 338C and amended

Pub. L. 97-35, title XXVII, Sec. 2709(a), (d), Aug. 13, 1981, 95

Stat. 908, 910; renumbered Sec. 338D and amended Pub. L. 100-177,

title II, Sec. 201(2), title III, Sec. 307, Dec. 1, 1987, 101 Stat.

992, 1005; Pub. L. 101-597, title IV, Sec. 401(b)[(a)], Nov. 16,

1990, 104 Stat. 3035; Pub. L. 107-251, title III, Sec. 312, Oct.

26, 2002, 116 Stat. 1650.)

-REFTEXT-

REFERENCES IN TEXT

Section 234 of this title, referred to in subsec. (a), was

repealed by Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct. 12,

1976, 90 Stat. 2281, effective Oct. 1, 1977.

-COD-

CODIFICATION

Section was formerly classified to section 294v of this title

prior to its renumbering by Pub. L. 97-35.

-MISC1-

PRIOR PROVISIONS

A prior section 338D of act July 1, 1944, was renumbered section

338E by section 201(2) of Pub. L. 100-177 and is classified to

section 254o of this title.

AMENDMENTS

2002 - Subsec. (b). Pub. L. 107-251 added subsec. (b) and struck

out former subsec. (b) which related to written agreements,

regulations, and actions to ensure compliance.

1990 - Subsec. (a)(1), (2). Pub. L. 101-597 substituted reference

to health professional shortage area for reference to health

manpower shortage area wherever appearing.

1987 - Subsec. (a). Pub. L. 100-177, Sec. 307(1)-(3), made

technical amendment to reference to section 254m of this title to

reflect renumbering of corresponding section of original act, in

introductory provisions, in par. (1) inserted "who received a

scholarship under the Scholarship Program or a loan repayment under

the Loan Repayment Program and" after "individual" the first time

it appeared as the probable intent of Congress, and inserted "or in

the case of an individual for whom a loan payment was made under

the Loan Repayment Program and who is performing obligated service

as a member of the Corps in a health manpower shortage area on the

date of the application of the individual for such a release, in

the health manpower shortage area selected by the Secretary", and

in par. (2) inserted "selected by the Secretary".

Subsec. (b). Pub. L. 100-177, Sec. 307(4), inserted at end "The

Secretary shall take such action as may be appropriate to ensure

that the conditions of the written agreement prescribed by this

subsection are adhered to."

Subsec. (c). Pub. L. 100-177, Sec. 307(5), inserted reference to

section 254l-1.

Subsec. (e). Pub. L. 100-177, Sec. 307(b), designated par. (2) as

entire subsection and struck out par. (1) which read as follows:

"The Secretary may make such arrangements as he determines are

necessary for the individual for the use of equipment and supplies

and for the lease or acquisition of other equipment and supplies."

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2709(d)(1), inserted

provision respecting requirements of applicable State law,

substituted references to sections 254m(a) and 234 of this title,

for reference to section 294u(a) of this title, and in cl. (2)

struck out priority requirement under section 254f(c) of this

title.

Subsec. (b)(1)(B). Pub. L. 97-35, Sec. 2709(d)(2), inserted "(i)"

before "shall not" and added cl. (ii).

Subsecs. (c) to (g). Pub. L. 97-35, Sec. 2709(d)(3), added

subsecs. (c) to (g).

1980 - Subsec. (a). Pub. L. 96-538 substituted in par. (2) "which

has" for "which (A) has" and struck out subpar. (B) which referred

to a health manpower shortage area which has a sufficient financial

base to substain private practice and provide the individual with

income of not less than the income of members of the Corps, and

struck out provision following par. (2) which provided that in the

case of an individual described in par. (1), the Secretary release

the individual from his service obligation under this subsection

only if the Secretary determines that the area in which the

individual is serving met the requirements of cl. (B) of par. (2).

EFFECTIVE DATE

Section effective Oct. 1, 1977, see section 408(b)(1) of Pub. L.

94-484, set out in part as a note under section 254l of this title.

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP

OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

See section 408(b)(2) of Pub. L. 94-484, set out as a note under

section 254l of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254d, 254l, 254l-1, 254m,

254o, 254p, 254t, 294cc, 11709 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254o 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254o. Breach of scholarship contract or loan repayment

contract

-STATUTE-

(a) Failure to maintain academic standing; dismissal from

institution; voluntary termination; liability; failure to accept

payment

(1) An individual who has entered into a written contract with

the Secretary under section 254l of this title and who -

(A) fails to maintain an acceptable level of academic standing

in the educational institution in which he is enrolled (such

level determined by the educational institution under regulations

of the Secretary);

(B) is dismissed from such educational institution for

disciplinary reasons; or

(C) voluntarily terminates the training in such an educational

institution for which he is provided a scholarship under such

contract, before the completion of such training,

in lieu of any service obligation arising under such contract,

shall be liable to the United States for the amount which has been

paid to him, or on his behalf, under the contract.

(2) An individual who has entered into a written contract with

the Secretary under section 254l-1 of this title and who -

(A) in the case of an individual who is enrolled in the final

year of a course of study, fails to maintain an acceptable level

of academic standing in the educational institution in which such

individual is enrolled (such level determined by the educational

institution under regulations of the Secretary) or voluntarily

terminates such enrollment or is dismissed from such educational

institution before completion of such course of study; or

(B) in the case of an individual who is enrolled in a graduate

training program, fails to complete such training program and

does not receive a waiver from the Secretary under section

254l-1(b)(1)(B)(ii) of this title,

in lieu of any service obligation arising under such contract shall

be liable to the United States for the amount that has been paid on

behalf of the individual under the contract.

(b) Failure to commence or complete service obligations; formula to

determine liability; payment to United States; recovery of

delinquent damages; disclosure to credit reporting agencies

(1)(A) Except as provided in paragraph (2), if an individual

breaches his written contract by failing (for any reason not

specified in subsection (a) of this section or section 254p(d) of

this title) to begin such individual's service obligation under

section 254l of this title in accordance with section 254m or 254n

of this title, to complete such service obligation, or to complete

a required residency as specified in section 254l(f)(1)(B)(iv) of

this title, the United States shall be entitled to recover from the

individual an amount determined in accordance with the formula

T-S

A=3G6F G7A - - G7B

T

in which "A" is the amount the United States is entitled to

recover, "G6f" is the sum of the amounts paid under this subpart

to or on behalf of the individual and the interest on such amounts

which would be payable if at the time the amounts were paid they

were loans bearing interest at the maximum legal prevailing rate,

as determined by the Treasurer of the United States; "t" is the

total number of months in the individual's period of obligated

service; and "s" is the number of months of such period served by

him in accordance with section 254m of this title or a written

agreement under section 254n of this title.

(B)(i) Any amount of damages that the United States is entitled

to recover under this subsection or under subsection (c) of this

section shall, within the 1-year period beginning on the date of

the breach of the written contract (or such longer period beginning

on such date as specified by the Secretary), be paid to the United

States. Amounts not paid within such period shall be subject to

collection through deductions in Medicare payments pursuant to

section 1395ccc of this title.

(ii) If damages described in clause (i) are delinquent for 3

months, the Secretary shall, for the purpose of recovering such

damages -

(I) utilize collection agencies contracted with by the

Administrator of the General Services Administration; or

(II) enter into contracts for the recovery of such damages with

collection agencies selected by the Secretary.

(iii) Each contract for recovering damages pursuant to this

subsection shall provide that the contractor will, not less than

once each 6 months, submit to the Secretary a status report on the

success of the contractor in collecting such damages. Section 3718

of title 31 shall apply to any such contract to the extent not

inconsistent with this subsection.

(iv) To the extent not otherwise prohibited by law, the Secretary

shall disclose to all appropriate credit reporting agencies

information relating to damages of more than $100 that are entitled

to be recovered by the United States under this subsection and that

are delinquent by more than 60 days or such longer period as is

determined by the Secretary.

(2) If an individual is released under section 254n (!1) of this

title from a service obligation under section 234 (!1) of this

title (as in effect on September 30, 1977) and if the individual

does not meet the service obligation incurred under section 254n

(!1) of this title, subsection (f) of such section 234 (!1) of this

title shall apply to such individual in lieu of paragraph (1) of

this subsection.

(3) The Secretary may terminate a contract with an individual

under section 254l of this title if, not later than 30 days before

the end of the school year to which the contract pertains, the

individual -

(A) submits a written request for such termination; and

(B) repays all amounts paid to, or on behalf of, the individual

under section 254l(g) of this title.

(c) Failure to commence or complete service obligations for other

reasons; determination of liability; payment to United States;

waiver of recovery for extreme hardship or good cause shown

(1) If (for any reason not specified in subsection (a) of this

section or section 254p(d) of this title) an individual breaches

the written contract of the individual under section 254l-1 of this

title by failing either to begin such individual's service

obligation in accordance with section 254m or 254n of this title or

to complete such service obligation, the United States shall be

entitled to recover from the individual an amount equal to the sum

of -

(A) the total of the amounts paid by the United States under

section 254l-1(g) of this title on behalf of the individual for

any period of obligated service not served;

(B) an amount equal to the product of the number of months of

obligated service that were not completed by the individual,

multiplied by $7,500; and

(C) the interest on the amounts described in subparagraphs (A)

and (B), at the maximum legal prevailing rate, as determined by

the Treasurer of the United States, from the date of the breach;

except that the amount the United States is entitled to recover

under this paragraph shall not be less than $31,000.

(2) The Secretary may terminate a contract with an individual

under section 254l-1 of this title if, not later than 45 days

before the end of the fiscal year in which the contract was entered

into, the individual -

(A) submits a written request for such termination; and

(B) repays all amounts paid on behalf of the individual under

section 254l-1(g) of this title.

(3) Damages that the United States is entitled to recover shall

be paid in accordance with subsection (b)(1)(B) of this section.

(d) Cancellation of obligation upon death of individual; waiver or

suspension of obligation for impossibility, hardship, or

unconscionability; release of debt by discharge in bankruptcy,

time limitations

(1) Any obligation of an individual under the Scholarship Program

(or a contract thereunder) or the Loan Repayment Program (or a

contract thereunder) for service or payment of damages shall be

canceled upon the death of the individual.

(2) The Secretary shall by regulation provide for the partial or

total waiver or suspension of any obligation of service or payment

by an individual under the Scholarship Program (or a contract

thereunder) or the Loan Repayment Program (or a contract

thereunder) whenever compliance by the individual is impossible or

would involve extreme hardship to the individual and if enforcement

of such obligation with respect to any individual would be

unconscionable.

(3)(A) Any obligation of an individual under the Scholarship

Program (or a contract thereunder) or the Loan Repayment Program

(or a contract thereunder) for payment of damages may be released

by a discharge in bankruptcy under title 11 only if such discharge

is granted after the expiration of the 7-year period beginning on

the first date that payment of such damages is required, and only

if the bankruptcy court finds that nondischarge of the obligation

would be unconscionable.

(B)(i) Subparagraph (A) shall apply to any financial obligation

of an individual under the provision of law specified in clause

(ii) to the same extent and in the same manner as such subparagraph

applies to any obligation of an individual under the Scholarship or

Loan Repayment Program (or contract thereunder) for payment of

damages.

(ii) The provision of law referred to in clause (i) is subsection

(f) of section 234 (!2) of this title, as in effect prior to the

repeal of such section by section 408(b)(1) of Public Law 94-484.

(e) Inapplicability of Federal and State statute of limitations on

actions for collection

Notwithstanding any other provision of Federal or State law,

there shall be no limitation on the period within which suit may be

filed, a judgment may be enforced, or an action relating to an

offset or garnishment, or other action, may be initiated or taken

by the Secretary, the Attorney General, or the head of another

Federal agency, as the case may be, for the repayment of the amount

due from an individual under this section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338E, formerly title VII,

Sec. 754, as added Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct.

12, 1976, 90 Stat. 2286; amended Pub. L. 95-83, title III, Sec.

307(g), Aug. 1, 1977, 91 Stat. 391; renumbered Sec. 338D and

amended Pub. L. 97-35, title XXVII, Sec. 2709(a), (e)(1)-(4)(A),

Aug. 13, 1981, 95 Stat. 908, 911; Pub. L. 97-414, Sec. 8(g)(2),

Jan. 4, 1983, 96 Stat. 2061; renumbered Sec. 338E and amended Pub.

L. 100-177, title II, Secs. 201(2), 202(e), title III, Sec. 308(a),

Dec. 1, 1987, 101 Stat. 992, 997, 1006; Pub. L. 100-203, title IV,

Sec. 4052(b), Dec. 22, 1987, 101 Stat. 1330-97; Pub. L. 100-360,

title IV, Sec. 411(f)(10)(B), July 1, 1988, 102 Stat. 780; Pub. L.

101-597, title II, Sec. 203(a), Nov. 16, 1990, 104 Stat. 3027; Pub.

L. 107-251, title III, Sec. 313(a), Oct. 26, 2002, 116 Stat. 1651.)

-REFTEXT-

REFERENCES IN TEXT

Section 234 of this title, referred to in subsecs. (b)(2) and

(d)(3)(B)(ii), was repealed by Pub. L. 94-484, title IV, Sec.

408(b)(1), Oct. 12, 1976, 90 Stat. 2281, effective Oct. 1, 1977.

Section 254n of this title, referred to in subsec. (b)(2), in the

original referred to section 753, meaning section 753 of the Public

Health Service Act, which was classified to section 294v of this

title. Section 753 was redesignated section 338C of the Public

Health Service Act by Pub. L. 97-35, title XXVII, Sec. 2709(a),

Aug. 13, 1981, 95 Stat. 908, and was transferred to section 254n of

this title. Section 338C of the Public Health Service Act was

renumbered section 338D by Pub. L. 100-177, title II, Sec. 201(2),

Dec. 1, 1987, 101 Stat. 992.

-COD-

CODIFICATION

Section was formerly classified to section 294w of this title

prior to its renumbering by Pub. L. 97-35.

-MISC1-

PRIOR PROVISIONS

A prior section 338E of act July 1, 1944, was renumbered section

338F by Pub. L. 100-177 and classified to section 254p of this

title, and subsequently renumbered 338G by Pub. L. 101-597.

AMENDMENTS

2002 - Subsec. (a)(1). Pub. L. 107-251, Sec. 313(a)(1),

substituted semicolon for comma at end of subpar. (A) and "; or"

for comma at end of subpar. (B), struck out "or" at end of subpar.

(C), and struck out subpar. (D) which read as follows: "fails to

accept payment, or instructs the educational institution in which

he is enrolled not to accept payment, in whole or in part, of a

scholarship under such contract,".

Subsec. (b)(1)(A). Pub. L. 107-251, Sec. 313(a)(2)(A)(ii)-(iv),

struck out "either" before "to begin", substituted "254n of this

title," for "254n of this title or", and inserted "or to complete a

required residency as specified in section 254l(f)(1)(B)(iv) of

this title," before "the United States" the first time appearing.

Pub. L. 107-251, Sec. 313(a)(2)(A)(i), made technical amendment

to reference in original act which appears in text as reference to

section 254p of this title.

Subsec. (b)(3). Pub. L. 107-251, Sec. 313(a)(2)(B), added par.

(3).

Subsec. (c)(1). Pub. L. 107-251, Sec. 313(a)(3)(A)(ii), added

subpars. (A) to (C) and concluding provisions and struck out former

subpars. (A) to (C) which related, respectively, to amounts to be

recovered in the case of a contract for a 2-year period of

obligated service, in the case of a contract for a period of

obligated service of greater than 2 years where the breach occurred

before the end of the first 2 years of such period, and in the case

of a contract for a period of obligated service of greater than 2

years, where the breach occurred after the first 2 years of such

period.

Pub. L. 107-251, Sec. 313(a)(3)(A)(i), in introductory

provisions, made technical amendment to reference in original act

which appears in text as reference to section 254p(d) of this

title.

Subsec. (c)(2). Pub. L. 107-251, Sec. 313(a)(3)(B), added par.

(2) and struck out former par. (2) which read as follows: "For

purposes of paragraph (1), the term 'unserved obligation penalty'

means the amount equal to the product of the number of months of

obligated service that were not completed by an individual,

multiplied by $1,000, except that in any case in which the

individual fails to serve 1 year, the unserved obligation penalty

shall be equal to the full period of obligated service multiplied

by $1,000."

Subsec. (c)(3), (4). Pub. L. 107-251, Sec. 313(a)(3)(B), (C),

redesignated par. (4) as (3) and struck out former par. (3) which

read as follows: "The Secretary may waive, in whole or in part, the

rights of the United States to recover amounts under this section

in any case of extreme hardship or other good cause shown, as

determined by the Secretary."

Subsec. (d)(3)(A). Pub. L. 107-251, Sec. 313(a)(4), substituted

"7-year period" for "five-year period".

Subsec. (e). Pub. L. 107-251, Sec. 313(a)(5), added subsec. (e).

1990 - Subsec. (d)(3). Pub. L. 101-597 designated existing

provision as subpar. (A) and added subpar. (B).

1988 - Subsec. (b)(1)(B)(i). Pub. L. 100-360 made technical

amendment to directory language of Pub. L. 100-203, see 1987

Amendment note below.

1987 - Pub. L. 100-177, Sec. 202(e)(6), inserted "or loan

repayment contract" in section catchline.

Subsec. (a). Pub. L. 100-177, Sec. 202(e)(1), designated existing

provisions as par. (1), and former pars. (1) to (4) as subpars. (A)

to (D), respectively, and added par. (2).

Subsec. (b)(1). Pub. L. 100-177, Sec. 202(e)(2), designated

existing provisions as subpar. (A), made technical amendments to

references to sections 254m, 254n, and 254p of this title wherever

appearing to reflect renumbering of corresponding sections of

original act, inserted "under section 254l of this title" after

first reference to "service obligation" as the probable intent of

Congress, struck out at end "Any amount of damages which the United

States is entitled to recover under this subsection shall, within

the one year period beginning on the date of the breach of the

written contract (or such longer period beginning on such date as

specified by the Secretary for good cause shown), be paid to the

United States.", and added subpar. (B).

Subsec. (b)(1)(B)(i). Pub. L. 100-203, as amended by Pub. L.

100-360, inserted at end "Amounts not paid within such period shall

be subject to collection through deductions in Medicare payments

pursuant to section 1395ccc of this title."

Subsec. (c). Pub. L. 100-177, Sec. 202(e)(4), added subsec. (c).

Former subsec. (c) redesignated (d).

Subsec. (d). Pub. L. 100-177, Secs. 202(e)(3), (5), 308(a),

redesignated subsec. (c) as (d), in pars. (1), (2), and (3),

inserted "or the Loan Repayment Program (or a contract thereunder",

and in par. (3) inserted ", and only if the bankruptcy court finds

that nondischarge of the obligation would be unconscionable".

1983 - Subsec. (b)(1). Pub. L. 97-414 substituted "section

254p(d)" for "section 254q(b)".

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2709(e)(1), (2),

redesignated subsec. (b) as (a) and, as so redesignated, in

introductory text substituted "254l" for "294t" and added par. (4).

Former subsec. (a), which related to liability of individual upon

failure to accept payment, was struck out.

Subsec. (b). Pub. L. 97-35, Sec. 2709(e)(1), (3), redesignated

subsec. (c) as (b) and, as so redesignated, designated existing

provisions as par. (1) and made numerous changes to reflect

renumbering of subpart sections, and added par. (2). Former subsec.

(b) redesignated (a).

Subsecs. (c), (d). Pub. L. 97-35, Sec. 2709(e)(1), (4)(A),

redesignated subsec. (d) as (c) and, as so redesignated, in par.

(2) inserted reference to partial or total waiver. Former subsec.

(c) redesignated (b).

1977 - Subsec. (c). Pub. L. 95-83 substituted " 'G6f' is the sum

of the amounts paid under this subpart to or on behalf of the

individual and the interest on such amounts which would be payable

if at the time the amounts were paid they were loans" for " 'G6f'

is the sum of the amount paid under this subpart to or on behalf of

the individual and the interest on such amount which would be

payable if at the time it was paid it was a loan".

EFFECTIVE DATE OF 2002 AMENDMENT

Pub. L. 107-251, title III, Sec. 313(b), Oct. 26, 2002, 116 Stat.

1652, provided that: "The amendment made by subsection (a)(4)

[amending this section] shall apply to any obligation for which a

discharge in bankruptcy has not been granted before the date that

is 31 days after the date of enactment of this Act [Oct. 26,

2002]."

EFFECTIVE DATE OF 1990 AMENDMENT

Section 203(b) of Pub. L. 101-597 provided that: "With respect to

any financial obligation of an individual under subsection (f) of

section 225 of the Public Health Service Act [former section 234 of

this title], as in effect prior to the repeal of such section by

section 408(b)(1) of Public Law 94-484, the amendment made by

subsection (a) of this section [amending this section] applies to

any backruptcy [sic] proceeding in which discharge of such an

obligation has not been granted before the date that is 31 days

after the date of the enactment of this Act [Nov. 16, 1990]."

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

Section effective Oct. 1, 1977, see section 408(b)(1) of Pub. L.

94-484, set out in part as a note under section 254l of this title.

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP

OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

See section 408(b)(2) of Pub. L. 94-484, set out as a note under

section 254l of this title.

SPECIAL REPAYMENT PROVISIONS

Section 204 of Pub. L. 100-177 provided that an individual who

breached a written contract entered into under section 254l of this

title by failing either to begin such individual's service

obligation in accordance with section 254m of this title or to

complete such service obligation; or otherwise breached such a

contract; and, as of Nov. 1, 1987, was liable to United States

under subsec. (b) of this section was to be relieved of liability

to United States under such section if the individual provided

notice to Secretary and service in accordance with a written

contract with the Secretary that obligated the individual to

provide service in accordance with section and authorized Secretary

to exclude an individual from relief from liability under this

section for reasons related to the individual's professional

competence or conduct.

EXISTING PROCEEDINGS

Section 308(b) of Pub. L. 100-177 provided that: "The amendment

made by subsection (a) [amending this section] applies to any

bankruptcy proceeding in which discharge of an obligation under

section 338E(d)(3) of the Public Health Service Act [subsec. (d)(3)

of this section] (as redesignated by sections 201(2) and 202(e)(3)

of this Act) has not been granted before the date that is 31 days

after the date of enactment of this Act [Dec. 1, 1987]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254d, 254l, 254l-1,

254o-1, 254p, 287c-33, 288-2, 288-4, 288-5, 288-5a, 288-6, 1395ccc

of this title.

-FOOTNOTE-

(!1) See References in Text note below.

(!2) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254o-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254o-1. Fund regarding use of amounts recovered for contract

breach to replace services lost as result of breach

-STATUTE-

(a) Establishment of Fund

There is established in the Treasury of the United States a fund

to be known as the National Health Service Corps Member Replacement

Fund (hereafter in this section referred to as the "Fund"). The

Fund shall consist of such amounts as may be appropriated under

subsection (b) of this section to the Fund. Amounts appropriated

for the Fund shall remain available until expended.

(b) Authorization of appropriations to Fund

For each fiscal year, there is authorized to be appropriated to

the Fund an amount equal to the sum of -

(1) the amount collected during the preceding fiscal year by

the Federal Government pursuant to the liability of individuals

under section 254o of this title for the breach of contracts

entered into under section 254l or 254l-1 of this title;

(2) the amount by which grants under section 254q-1 of this

title have, for such preceding fiscal year, been reduced under

subsection (g)(2)(B) of such section; and

(3) the aggregate of the amount of interest accruing during the

preceding fiscal year on obligations held in the Fund pursuant to

subsection (d) of this section and the amount of proceeds from

the sale or redemption of such obligations during such fiscal

year.

(c) Use of Fund

(1) Payments to certain health facilities

Amounts in the Fund and available pursuant to appropriations

Act may, subject to paragraph (2), be expended by the Secretary

to make payments to any entity -

(A) to which a Corps member has been assigned under section

254f of this title; and

(B) that has a need for a health professional to provide

primary health services as a result of the Corps member having

breached the contract entered into under section 254l or 254l-1

of this title by the individual.

(2) Purpose of payments

An entity receiving payments pursuant to paragraph (1) may

expend the payments to recruit and employ a health professional

to provide primary health services to patients of the entity, or

to enter into a contract with such a professional to provide the

services to the patients.

(d) Investment

(1) In general

The Secretary of the Treasury shall invest such amounts of the

Fund as such Secretary determines are not required to meet

current withdrawals from the Fund. Such investments may be made

only in interest-bearing obligations of the United States. For

such purpose, such obligations may be acquired on original issue

at the issue price, or by purchase of outstanding obligations at

the market price.

(2) Sale of obligations

Any obligation acquired by the Fund may be sold by the

Secretary of the Treasury at the market price.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338F, as added Pub. L.

101-597, title II, Sec. 204, Nov. 16, 1990, 104 Stat. 3027.)

-MISC1-

PRIOR PROVISIONS

A prior section 338F of act July 1, 1944, was renumbered section

338G by Pub. L. 101-597 and is classified to section 254p of this

title.

Another prior section 338F of act July 1, 1944, was renumbered

section 338G by section 201(2) of Pub. L. 100-177 and classified to

section 254q of this title, prior to repeal by Pub. L. 100-177,

title II, Sec. 203, Dec. 1, 1987, 101 Stat. 999.

-End-

-CITE-

42 USC Sec. 254p 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254p. Special loans for former Corps members to enter private

practice

-STATUTE-

(a) Persons entitled; conditions

The Secretary may, out of appropriations authorized under section

254k of this title, make one loan to a Corps member who has agreed

in writing -

(1) to engage in the private full-time clinical practice of the

profession of the member in a health professional shortage area

(designated under section 254e of this title) for a period of not

less than 2 years which -

(A) in the case of a Corps member who is required to complete

a period of obligated service under this subpart, begins not

later than 1 year after the date on which such individual

completes such period of obligated service; and

(B) in the case of an individual who is not required to

complete a period of obligated service under this subpart,

begins at such time as the Secretary considers appropriate;

(2) to conduct such practice in accordance with section

254n(b)(1) of this title; and

(3) to such additional conditions as the Secretary may require

to carry out this section.

Such a loan shall be used to assist such individual in meeting the

costs of beginning the practice of such individual's profession in

accordance with such agreement, including the costs of acquiring

equipment and renovating facilities for use in providing health

services, and of hiring nurses and other personnel to assist in

providing health services. Such loan may not be used for the

purchase or construction of any building.

(b) Amount of loan; maximum interest rate

(1) The amount of a loan under subsection (a) of this section to

an individual shall not exceed $25,000.

(2) The interest rate for any such loan shall not exceed an

annual rate of 5 percent.

(c) Application for loan; submission and approval; interest rates

and repayment terms

The Secretary may not make a loan under this section unless an

application therefor has been submitted to, and approved by, the

Secretary. The Secretary shall, by regulation, set interest rates

and repayment terms for loans under this section.

(d) Breach of agreement; notice; determination of liability

If the Secretary determines that an individual has breached a

written agreement entered into under subsection (a) of this

section, he shall, as soon as practicable after making such

determination, notify the individual of such determination. If

within 60 days after the date of giving such notice, such

individual is not practicing his profession in accordance with the

agreement under such subsection and has not provided assurances

satisfactory to the Secretary that he will not knowingly violate

such agreement again, the United States shall be entitled to

recover from such individual -

(1) in the case of an individual who has received a grant under

this section (as in effect prior to October 1, 1984), an amount

determined under section 254o(b) of this title, except that in

applying the formula contained in such section "G6f" shall be

the sum of the amount of the grant made under subsection (a) of

this section to such individual and the interest on such amount

which would be payable if at the time it was paid it was a loan

bearing interest at the maximum legal prevailing rate, "t" shall

be the number of months that such individual agreed to practice

his profession under such agreement, and "s" shall be the number

of months that such individual practices his profession in

accordance with such agreement; and

(2) in the case of an individual who has received a loan under

this section, the full amount of the principal and interest owed

by such individual under this section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338G, formerly title VII,

Sec. 755, as added Pub. L. 94-484, title IV, Sec. 408(b)(1), Oct.

12, 1976, 90 Stat. 2287; renumbered Sec. 338E and amended Pub. L.

97-35, title XXVII, Sec. 2709(a), (f), Aug. 13, 1981, 95 Stat. 908,

911; Pub. L. 97-414, Sec. 8(g)(3), Jan. 4, 1983, 96 Stat. 2061;

renumbered Sec. 338F and amended Pub. L. 100-177, title II, Sec.

201(2), title III, Sec. 309, Dec. 1, 1987, 101 Stat. 992, 1006;

renumbered Sec. 338G and amended Pub. L. 101-597, title II, Sec.

204, title IV, Sec. 401(b)[(a)], Nov. 16, 1990, 104 Stat. 3027,

3035.)

-COD-

CODIFICATION

Section was formerly classified to section 294x of this title

prior to renumbering by Pub. L. 97-35.

-MISC1-

PRIOR PROVISIONS

A prior section 338G of act July 1, 1944, was renumbered section

338H by Pub. L. 101-597 and is classified to section 254q of this

title.

Another prior section 338G of act July 1, 1944, was renumbered

section 338I by section 201(1) of Pub. L. 100-177 and classified to

section 254r of this title, prior to repeal by Pub. L. 100-713,

title I, Sec. 104(b)(1), Nov. 23, 1988, 102 Stat. 4787.

Another prior section 338G of act July 1, 1944, was classified to

section 254q of this title prior to repeal by Pub. L. 100-177,

title II, Sec. 203, Dec. 1, 1987, 101 Stat. 999.

AMENDMENTS

1990 - Subsec. (a)(1). Pub. L. 101-597, Sec. 401(b)[(a)],

substituted reference to health professional shortage area for

reference to health manpower shortage area.

1987 - Subsec. (a). Pub. L. 100-177, Sec. 309(1), substituted

subsec. (a) consisting of pars. (1) to (3) for former subsec. (a)

consisting of pars. (1) and (2).

Subsec. (b). Pub. L. 100-177, Sec. 309(1), added subsec. (b) and

struck out former subsec. (b) which read as follows: "The amount of

the grant or loan under subsection (a) of this section to an

individual shall be -

"(1) $12,500 if the individual agrees to practice his

profession in accordance with the agreement for a period of at

least one year, but less than two years; or

"(2) $25,000 if the individual agrees to practice his

profession in accordance with the agreement for a period of at

least two years."

Subsec. (c). Pub. L. 100-177, Sec. 309(2), struck out "grant or"

before "loan" in first sentence.

Subsec. (d)(1). Pub. L. 100-177, Sec. 309(3), substituted "under

this section (as in effect prior to October 1, 1984)" for "under

this section", and made technical amendment to reference to section

254o(b) of this title to reflect renumbering of corresponding

section of original act.

1983 - Subsec. (d)(1). Pub. L. 97-414 substituted "section

254o(b)" for "section 254o(c)".

1981 - Subsec. (a). Pub. L. 97-35, Sec. 2709(f)(2)-(4), made

numerous changes to reflect renumbering of subpart sections, among

them inserting references to section 254k of this title and

striking out references to section 294v of this title, and added

applicability to loans.

Subsec. (b). Pub. L. 97-35, Sec. 2709(f)(5), inserted

applicability to loans.

Subsec. (c). Pub. L. 97-35, Sec. 2709(f)(6), inserted provisions

relating to loans and interest rates, etc.

Subsec. (d). Pub. L. 97-35, Sec. 2709(f)(7), restructured and

revised criteria determining amount of liability of individual

within 60 days after the date of notice instead of within 120 days

after the date of notice.

EFFECTIVE DATE

Section effective Oct. 1, 1977, see section 408(b)(1) of Pub. L.

94-484, set out in part as a note under section 254l of this title.

EFFECTIVE DATE; SAVINGS PROVISION; CREDIT FOR PERIOD OF INTERNSHIP

OR RESIDENCY BEFORE SEPTEMBER 30, 1977, TOWARDS SERVICE OBLIGATION

See section 408(b)(2) of Pub. L. 94-484, set out as a note under

section 254l of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254o, 293b of this title.

-End-

-CITE-

42 USC Sec. 254q 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254q. Authorization of appropriations

-STATUTE-

(a) Authorization of appropriations

For the purposes of carrying out this subpart, there are

authorized to be appropriated $146,250,000 for fiscal year 2002,

and such sums as may be necessary for each of fiscal years 2003

through 2006.

(b) Scholarships for new participants

Of the amounts appropriated under subsection (a) of this section

for a fiscal year, the Secretary shall obligate not less than 10

percent for the purpose of providing contracts for -

(1) scholarships under this subpart to individuals who have not

previously received such scholarships; or

(2) scholarships or loan repayments under the Loan Repayment

Program under section 254l-1 of this title to individuals from

disadvantaged backgrounds.

(c) Scholarships and loan repayments

With respect to certification as a nurse practitioner, nurse

midwife, or physician assistant, the Secretary shall, from amounts

appropriated under subsection (a) of this section for a fiscal

year, obligate not less than a total of 10 percent for contracts

for both scholarships under the Scholarship Program under section

254l of this title and loan repayments under the Loan Repayment

Program under section 254l-1 of this title to individuals who are

entering the first year of a course of study or program described

in section 254l(b)(1)(B) of this title that leads to such a

certification or individuals who are eligible for the loan

repayment program as specified in section 254l-1(b) of this title

for a loan related to such certification.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338H, formerly Sec. 338G,

as added Pub. L. 100-177, title II, Sec. 203, Dec. 1, 1987, 101

Stat. 999; renumbered Sec. 338H and amended Pub. L. 101-597, title

II, Secs. 204, 205, Nov. 16, 1990, 104 Stat. 3027, 3028; Pub. L.

107-251, title III, Sec. 314, Oct. 26, 2002, 116 Stat. 1652.)

-MISC1-

PRIOR PROVISIONS

A prior section 254q, act July 1, 1944, ch. 373, title III, Sec.

338G, formerly title VII, Sec. 756, as added Oct. 12, 1976, Pub. L.

94-484, title IV, Sec. 408(b)(1), 90 Stat. 2288; renumbered Sec.

338F and amended Aug. 13, 1981, Pub. L. 97-35, title XXVII, Sec.

2709(a), (g), 95 Stat. 908, 912; renumbered Sec. 338G, Dec. 1,

1987, Pub. L. 100-177, title II, Sec. 201(2), 101 Stat. 992,

authorized appropriations for fiscal years 1978 to 1987, prior to

repeal by Pub. L. 100-177, Sec. 203.

A prior section 338H of act July 1, 1944, was renumbered section

338I by Pub. L. 101-597 and is classified to section 254q-1 of this

title.

AMENDMENTS

2002 - Pub. L. 107-251 amended section generally. Prior to

amendment, section related to annual report to Congress,

authorization of appropriations for fiscal years 1991 through 2000,

and reservation of percentage of appropriated amounts for

scholarships for new participants and for first-year study in

certain fields.

1990 - Subsec. (a). Pub. L. 101-597, Sec. 205(a), substituted

"March 1" for "January 20" and "5 fiscal years" for "3 fiscal

years" wherever appearing.

Subsec. (b). Pub. L. 101-597, Sec. 205(b), amended subsec. (b)

generally. Prior to amendment, subsec. (b) read as follows: "There

are authorized to be appropriated such sums as may be necessary for

scholarships and loan repayments under this subpart."

-End-

-CITE-

42 USC Sec. 254q-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254q-1. Grants to States for loan repayment programs

-STATUTE-

(a) In general

(1) Authority for grants

The Secretary, acting through the Administrator of the Health

Resources and Services Administration, may make grants to States

for the purpose of assisting the States in operating programs

described in paragraph (2) in order to provide for the increased

availability of primary health care services in health

professional shortage areas. The National Advisory Council

established under section 254j of this title shall advise the

Administrator regarding the program under this section.

(2) Loan repayment programs

The programs referred to in paragraph (1) are, subject to

subsection (c) of this section, programs of entering into

contracts under which the State involved agrees to pay all or

part of the principal, interest, and related expenses of the

educational loans of health professionals in consideration of the

professionals agreeing to provide primary health services in

health professional shortage areas.

(3) Direct administration by State agency

The Secretary may not make a grant under paragraph (1) unless

the State involved agrees that the program operated with the

grant will be administered directly by a State agency.

(b) Requirement of matching funds

(1) In general

The Secretary may not make a grant under subsection (a) of this

section unless the State agrees that, with respect to the costs

of making payments on behalf of individuals under contracts made

pursuant to paragraph (2) of such subsection, the State will make

available (directly or through donations from public or private

entities) non-Federal contributions in cash toward such costs in

an amount equal to not less than $1 for each $1 of Federal funds

provided in the grant.

(2) Determination of amount of non-Federal contribution

In determining the amount of non-Federal contributions in cash

that a State has provided pursuant to paragraph (1), the

Secretary may not include any amounts provided to the State by

the Federal Government.

(c) Coordination with Federal program

(1) Assignments for health professional shortage areas under

Federal program

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that, in carrying out

the program operated with the grant, the State will assign health

professionals participating in the program only to public and

nonprofit private entities located in and providing health

services in health professional shortage areas.

(2) Remedies for breach of contracts

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that the contracts

provided by the State pursuant to paragraph (2) of such

subsection will provide remedies for any breach of the contracts

by the health professionals involved.

(3) Limitation regarding contract inducements

(A) Except as provided in subparagraph (B), the Secretary may

not make a grant under subsection (a) of this section unless the

State involved agrees that the contracts provided by the State

pursuant to paragraph (2) of such subsection will not be provided

on terms that are more favorable to health professionals than the

most favorable terms that the Secretary is authorized to provide

for contracts under the Loan Repayment Program under section

254l-1 of this title, including terms regarding -

(i) the annual amount of payments provided on behalf of the

professionals regarding educational loans; and

(ii) the availability of remedies for any breach of the

contracts by the health professionals involved.

(B) With respect to the limitation established in subparagraph

(A) regarding the annual amount of payments that may be provided

to a health professional under a contract provided by a State

pursuant to subsection (a)(2) of this section, such limitation

shall not apply with respect to a contract if -

(i) the excess of such annual payments above the maximum

amount authorized in section 254l-1(g)(2)(A) of this title for

annual payments regarding contracts is paid solely from

non-Federal contributions under subsection (b) of this section;

and

(ii) the contract provides that the health professional

involved will satisfy the requirement of obligated service

under the contract solely through the provision of primary

health services in a health professional shortage area that is

receiving priority for purposes of section 254f-1(a)(1) of this

title and that is authorized to receive assignments under

section 254f of this title of individuals who are participating

in the Scholarship Program under section 254l of this title.

(d) Restrictions on use of funds

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that the grant will not be

expended -

(1) to conduct activities for which Federal funds are expended

-

(A) within the State to provide technical or other

nonfinancial assistance under subsection (f) of section 254c

(!1) of this title;

(B) under a memorandum of agreement entered into with the

State under subsection (h) of such section; or

(C) under a grant under section 254r of this title; or

(2) for any purpose other than making payments on behalf of

health professionals under contracts entered into pursuant to

subsection (a)(2) of this section.

(e) Reports

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees -

(1) to submit to the Secretary such reports regarding the

States loan repayment program, as are determined to be

appropriate by the Secretary; and

(2) to submit such a report not later than January 10 of each

fiscal year immediately following any fiscal year for which the

State has received such a grant.

(f) Requirement of application

The Secretary may not make a grant under subsection (a) of this

section unless an application for the grant is submitted to the

Secretary and the application is 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 such

subsection.

(g) Noncompliance

(1) In general

The Secretary may not make payments under subsection (a) of

this section to a State for any fiscal year subsequent to the

first fiscal year of such payments unless the Secretary

determines that, for the immediately preceding fiscal year, the

State has complied with each of the agreements made by the State

under this section.

(2) Reduction in grant relative to number of breached contracts

(A) Before making a grant under subsection (a) of this section

to a State for a fiscal year, the Secretary shall determine the

number of contracts provided by the State under paragraph (2) of

such subsection with respect to which there has been an initial

breach by the health professionals involved during the fiscal

year preceding the fiscal year for which the State is applying to

receive the grant.

(B) Subject to paragraph (3), in the case of a State with 1 or

more initial breaches for purposes of subparagraph (A), the

Secretary shall reduce the amount of a grant under subsection (a)

of this section to the State for the fiscal year involved by an

amount equal to the sum of the expenditures of Federal funds made

regarding the contracts involved and an amount representing

interest on the amount of such expenditures, determined with

respect to each contract on the basis of the maximum legal rate

prevailing for loans made during the time amounts were paid under

the contract, as determined by the Treasurer of the United

States.

(3) Waiver regarding reduction in grant

The Secretary may waive the requirement established in

paragraph (2)(B) with respect to the initial breach of a contract

if the Secretary determines that such breach by the health

professional involved was attributable solely to the professional

having a serious illness.

(h) "State" defined

For purposes of this section, the term "State" means each of the

several States.

(i) Authorization of appropriations

(1) In general

For the purpose of making grants under subsection (a) of this

section, there are authorized to be appropriated $12,000,000 for

fiscal year 2002 and such sums as may be necessary for each of

fiscal years 2003 through 2006.

(2) Availability

Amounts appropriated under paragraph (1) shall remain available

until expended.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338I, formerly Sec. 338H,

as added Pub. L. 100-177, title II, Sec. 203, Dec. 1, 1987, 101

Stat. 999; renumbered Sec. 338I and amended Pub. L. 101-597, title

II, Sec. 204, title III, Sec. 301, title IV, Sec. 401(b)[(a)], Nov.

16, 1990, 104 Stat. 3027, 3029, 3035; Pub. L. 105-392, title IV,

Sec. 408, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107-251, title

III, Sec. 315, Oct. 26, 2002, 116 Stat. 1653.)

-REFTEXT-

REFERENCES IN TEXT

Section 254c of this title, referred to in subsec. (d)(1)(A), was

in the original a reference to section 330, meaning section 330 of

act July 1, 1944, which was omitted in the general amendment of

subpart I (Sec. 254b et seq.) of this part by Pub. L. 104-299, Sec.

2, Oct. 11, 1996, 110 Stat. 3626. Sections 2 and 3(a) of Pub. L.

104-299 enacted new sections 330 and 330A of act July 1, 1944,

which are classified, respectively, to sections 254b and 254c of

this title.

-MISC1-

PRIOR PROVISIONS

A prior section 338I of act July 1, 1944, was classified to

section 254r of this title prior to repeal by Pub. L. 100-713,

title I, Sec. 104(b)(1), Nov. 23, 1988, 102 Stat. 4787.

AMENDMENTS

2002 - Subsec. (a)(1). Pub. L. 107-251, Sec. 315(1), added par.

(1) and struck out heading and text of former par. (1). Text read

as follows: "The Secretary, acting through the Administrator of the

Health Resources and Services Administration, may make grants to

States for the purpose of assisting the States in operating

programs described in paragraph (2) in order to provide for the

increased availability of primary health services in health

professional shortage areas."

Subsec. (e)(1). Pub. L. 107-251, Sec. 315(2), added par. (1) and

struck out former par. (1) which read as follows: "to submit to the

Secretary reports providing the same types of information regarding

the program operated pursuant to such subsection as reports

submitted pursuant to subsection (i) of section 254l-1 of this

title provide regarding the Loan Repayment Program under such

section; and".

Subsec. (i)(1). Pub. L. 107-251, Sec. 315(3), added par. (1) and

struck out heading and text of former par. (1). Text read as

follows: "For the purpose of making grants under subsection (a) of

this section, there is authorized to be appropriated $10,000,000

for each of the fiscal years 1991 through 1995, and such sums as

may be necessary for each of the fiscal years 1998 through 2002."

1998 - Subsec. (i)(1). Pub. L. 105-392 inserted ", and such sums

as may be necessary for each of the fiscal years 1998 through 2002"

before period at end.

1990 - Pub. L. 101-597, Sec. 401(b)[(a)], substituted reference

to health professional shortage area for reference to health

manpower shortage area wherever appearing in subsecs. (a)(1), (2)

and (c)(1), (3)(B)(ii).

Pub. L. 101-597, Sec. 301, amended section generally,

substituting present provisions for provisions which related to: in

subsec. (a), grants; in subsec. (b), applications; in subsec. (c),

Federal share; and in subsec. (d), authorization of appropriations.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 254o-1, 254r, 293b of

this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254r 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254r. Grants to States for operation of offices of rural

health

-STATUTE-

(a) In general

The Secretary, acting through the Director of the Office of Rural

Health Policy (established in section 912 of this title), may make

grants to States for the purpose of improving health care in rural

areas through the operation of State offices of rural health.

(b) Requirement of matching funds

(1) In general

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees, with respect to the

costs to be incurred by the State in carrying out the purpose

described in such subsection, to provide non-Federal

contributions toward such costs in an amount equal to -

(A) for the first fiscal year of payments under the grant,

not less than $1 for each $3 of Federal funds provided in the

grant;

(B) for any second fiscal year of such payments, not less

than $1 for each $1 of Federal funds provided in the grant; and

(C) for any third fiscal year of such payments, not less than

$3 for each $1 of Federal funds provided in the grant.

(2) Determination of amount of non-Federal contribution

(A) Subject to subparagraph (B), non-Federal contributions

required in 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 non-Federal

contributions.

(B) The Secretary may not make a grant under subsection (a) of

this section unless the State involved agrees that -

(i) for the first fiscal year of payments under the grant,

100 percent or less of the non-Federal contributions required

in paragraph (1) will be provided in the form of in-kind

contributions;

(ii) for any second fiscal year of such payments, not more

than 50 percent of such non-Federal contributions will be

provided in the form of in-kind contributions; and

(iii) for any third fiscal year of such payments, such

non-Federal contributions will be provided solely in the form

of cash.

(c) Certain required activities

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that activities carried

out by an office operated pursuant to such subsection will include

-

(1) establishing and maintaining within the State a

clearinghouse for collecting and disseminating information on -

(A) rural health care issues;

(B) research findings relating to rural health care; and

(C) innovative approaches to the delivery of health care in

rural areas;

(2) coordinating the activities carried out in the State that

relate to rural health care, including providing coordination for

the purpose of avoiding redundancy in such activities; and

(3) identifying Federal and State programs regarding rural

health, and providing technical assistance to public and

nonprofit private entities regarding participation in such

programs.

(d) Requirement regarding annual budget for office

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that, for any fiscal year

for which the State receives such a grant, the office operated

pursuant to subsection (a) of this section will be provided with an

annual budget of not less than $50,000.

(e) Certain uses of funds

(1) Restrictions

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees that -

(A) if research with respect to rural health is conducted

pursuant to the grant, not more than 10 percent of the grant

will be expended for such research; and

(B) the grant will not be expended -

(i) to provide health care (including providing cash

payments regarding such care);

(ii) to conduct activities for which Federal funds are

expended -

(I) within the State to provide technical and other

nonfinancial assistance under subsection (f) of section

254c (!1) of this title;

(II) under a memorandum of agreement entered into with

the State under subsection (h) of such section; or

(III) under a grant under section 254q-1 of this title;

(iii) to purchase medical equipment, to purchase

ambulances, aircraft, or other vehicles, or to purchase major

communications equipment;

(iv) to purchase or improve real property; or

(v) to carry out any activity regarding a certificate of

need.

(2) Authorities

Activities for which a State may expend a grant under

subsection (a) of this section include -

(A) paying the costs of establishing an office of rural

health for purposes of subsection (a) of this section;

(B) subject to paragraph (1)(B)(ii)(III), paying the costs of

any activity carried out with respect to recruiting and

retaining health professionals to serve in rural areas of the

State; and

(C) providing grants and contracts to public and nonprofit

private entities to carry out activities authorized in this

section.

(f) Reports

The Secretary may not make a grant under subsection (a) of this

section unless the State involved agrees -

(1) to submit to the Secretary reports containing such

information as the Secretary may require regarding activities

carried out under this section by the State; and

(2) to submit such a report not later than January 10 of each

fiscal year immediately following any fiscal year for which the

State has received such a grant.

(g) Requirement of application

The Secretary may not make a grant under subsection (a) of this

section unless an application for the grant is submitted to the

Secretary and the application is 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 such

subsection.

(h) Noncompliance

The Secretary may not make payments under subsection (a) of this

section to a State for any fiscal year subsequent to the first

fiscal year of such payments unless the Secretary determines that,

for the immediately preceding fiscal year, the State has complied

with each of the agreements made by the State under this section.

(i) "State" defined

For purposes of this section, the term "State" means each of the

several States.

(j) Authorization of appropriations

(1) In general

For the purpose of making grants under subsection (a) of this

section, there are authorized to be appropriated $3,000,000 for

fiscal year 1991, $4,000,000 for fiscal year 1992, $3,000,000 for

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

the fiscal years 1998 through 2002.

(2) Availability

Amounts appropriated under paragraph (1) shall remain available

until expended.

(k) Termination of program

No grant may be made under this section after the aggregate

amounts appropriated under subsection (j)(1) of this section are

equal to $36,000,000.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338J, as added Pub. L.

101-597, title III, Sec. 302, Nov. 16, 1990, 104 Stat. 3032;

amended Pub. L. 105-392, title III, Sec. 301, Nov. 13, 1998, 112

Stat. 3585.)

-REFTEXT-

REFERENCES IN TEXT

Section 254c of this title, referred to in subsec.

(e)(1)(B)(ii)(I), was in the original a reference to section 330,

meaning section 330 of act July 1, 1944, which was omitted in the

general amendment of subpart I (Sec. 254b et seq.) of this part by

Pub. L. 104-299, Sec. 2, Oct. 11, 1996, 110 Stat. 3626. Sections 2

and 3(a) of Pub. L. 104-299 enacted new sections 330 and 330A of

act July 1, 1944, which are classified, respectively, to sections

254b and 254c of this title.

-MISC1-

PRIOR PROVISIONS

A prior section 254r, act July 1, 1944, ch. 373, title III, Sec.

338I, formerly title VII, Sec. 757, as added Aug. 1, 1977, Pub. L.

95-83, title III, Sec. 307(n)(1), 91 Stat. 392; amended Dec. 17,

1980, Pub. L. 96-537, Sec. 3(d), 94 Stat. 3174; renumbered Sec.

338G, Aug. 13, 1981, Pub. L. 97-35, title XXVII, Sec. 2709(a), 95

Stat. 908; Oct. 30, 1984, Pub. L. 98-551, Sec. 3, 98 Stat. 2817;

renumbered Sec. 338I, Dec. 1, 1987, Pub. L. 100-177, title II, Sec.

201(1), 101 Stat. 992; Nov. 4, 1988, Pub. L. 100-607, title VI,

Sec. 629(a)(3), 102 Stat. 3146, which related to Indian Health

Scholarships and was classified to section 294y-1 of this title

prior to renumbering by Pub. L. 97-35, was repealed by Pub. L.

100-713, title I, Sec. 104(b)(1), Nov. 23, 1988, 102 Stat. 4787.

For provisions continuing scholarships provided on or before Nov.

23, 1988, see section 104(b)(2) of Pub. L. 100-713.

A prior section 338J of act July 1, 1944, was renumbered section

338K by Pub. L. 101-597 and is classified to section 254s of this

title.

AMENDMENTS

1998 - Subsec. (b)(1). Pub. L. 105-392, Sec. 301(1), struck out

"in cash" after "contributions" in introductory provisions.

Subsec. (j)(1). Pub. L. 105-392, Sec. 301(2), struck out "and"

after "1992," and inserted before period at end ", and such sums as

may be necessary for each of the fiscal years 1998 through 2002".

Subsec. (k). Pub. L. 105-392, Sec. 301(3), substituted

"$36,000,000" for "$10,000,000".

COMMUNICATIONS FOR RURAL HEALTH PROVIDERS

Pub. L. 102-538, title I, Sec. 154, formerly Sec. 134, Oct. 27,

1992, 106 Stat. 3541, renumbered Sec. 154 by Pub. L. 103-66, title

VI, Sec. 6001(a)(2), Aug. 10, 1993, 107 Stat. 379, directed

Secretary of Commerce, in conjunction with Secretary of Health and

Human Services, to establish an advisory panel to develop

recommendations for the improvement of rural health care through

the collection of information needed by providers and the

improvement in the use of communications to disseminate such

information and, not later than 1 year after establishment of Panel

to prepare and submit to Congress a report summarizing the

recommendations made by the Panel.

Similar provisions were contained in Pub. L. 101-555, Sec. 3,

Nov. 15, 1990, 104 Stat. 2760.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 254q-1 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 254s 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254s. Native Hawaiian Health Scholarships

-STATUTE-

(a) Eligibility

Subject to the availability of funds appropriated under the

authority of subsection (d) of this section, the Secretary shall

provide funds to Papa Ola Lokahi for the purpose of providing

scholarship assistance to students who -

(1) meet the requirements of section 254l(b) of this title, and

(2) are Native Hawaiians.

(b) Terms and conditions

(1) The scholarship assistance provided under subsection (a) of

this section shall be provided under the same terms and subject to

the same conditions, regulations, and rules that apply to

scholarship assistance provided under section 254l of this title.

(2) The Native Hawaiian Health Scholarship program shall not be

administered by or through the Indian Health Service.

(c) "Native Hawaiian" defined

For purposes of this section, the term "Native Hawaiian" means

any individual who is -

(1) a citizen of the United States,

(2) a resident of the State of Hawaii, and

(3) a descendant of the aboriginal people, who prior to 1778,

occupied and exercised sovereignty in the area that now

constitutes the State of Hawaii, as evidenced by -

(A) genealogical records,

(B) Kupuna (elders) or Kama'aina (long-term community

residents) verification, or

(C) birth records of the State of Hawaii.

(d) Authorization of appropriations

There are authorized to be appropriated $1,800,000 for each of

the fiscal years 1990, 1991, and 1992 for the purpose of funding

the scholarship assistance provided under subsection (a) of this

section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338K, formerly Sec. 338J,

as added Pub. L. 100-713, title I, Sec. 106, Nov. 23, 1988, 102

Stat. 4787; renumbered Sec. 338K, Pub. L. 101-597, title III, Sec.

302, Nov. 16, 1990, 104 Stat. 3032; amended Pub. L. 101-644, title

IV, Sec. 401, Nov. 29, 1990, 104 Stat. 4668; Pub. L. 107-116, title

V, Sec. 514(b), Jan. 10, 2002, 115 Stat. 2220.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-116, which directed the amendment

of subsec. (a) by substituting "Papa Ola Lokahi" for "Kamehameha

School/Bishop Estate", was executed by making the substitution for

"Kamehameha Schools/Bishop Estate" to reflect the probable intent

of Congress.

1990 - Subsec. (a). Pub. L. 101-644, which directed the general

amendment of subsec. (a) of section 338J of the Public Health

Service Act, was executed to subsec. (a) of this section, to

reflect the probable intent of Congress and the intervening

renumbering of section 338J as 338K by Pub. L. 101-597. Prior to

amendment, subsec. (a) read as follows: "Subject to the

availability of funds appropriated under the authority of

subsection (d) of this section, the Secretary shall provide

scholarship assistance, pursuant to a contract with the Kamehameha

Schools/Bishop Estate, to students who -

"(1) meet the requirements of section 254l(b) of this title,

and

"(2) are Native Hawaiians."

-End-

-CITE-

42 USC Sec. 254t 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iii - scholarship program and loan repayment program

-HEAD-

Sec. 254t. Demonstration project

-STATUTE-

(a) Program authorized

The Secretary shall establish a demonstration project to provide

for the participation of individuals who are chiropractic doctors

or pharmacists in the Loan Repayment Program described in section

254l-1 of this title.

(b) Procedure

An individual that receives assistance under this section with

regard to the program described in section 254l-1 of this title

shall comply with all rules and requirements described in such

section (other than subparagraphs (A) and (B) of section

254l-1(b)(1) of this title) in order to receive assistance under

this section.

(c) Limitations

(1) In general

The demonstration project described in this section shall

provide for the participation of individuals who shall provide

services in rural and urban areas.

(2) Availability of other health professionals

The Secretary may not assign an individual receiving assistance

under this section to provide obligated service at a site unless

-

(A) the Secretary has assigned a physician (as defined in

section 1395x(r) of this title) or other health professional

licensed to prescribe drugs to provide obligated service at

such site under section 254m or 254n of this title; and

(B) such physician or other health professional will provide

obligated service at such site concurrently with the individual

receiving assistance under this section.

(3) Rules of construction

(A) Supervision of individuals

Nothing in this section shall be construed to require or

imply that a physician or other health professional licensed to

prescribe drugs must supervise an individual receiving

assistance under the demonstration project under this section,

with respect to such project.

(B) Licensure of health professionals

Nothing in this section shall be construed to supersede State

law regarding licensure of health professionals.

(d) Designations

The demonstration project described in this section, and any

providers who are selected to participate in such project, shall

not be considered by the Secretary in the designation of a health

professional shortage area under section 254e of this title during

fiscal years 2002 through 2004.

(e) Rule of construction

This section shall not be construed to require any State to

participate in the project described in this section.

(f) Report

(1) In general

The Secretary shall evaluate the participation of individuals

in the demonstration projects under this section and prepare and

submit a report containing the information described in paragraph

(2) to -

(A) the Committee on Health, Education, Labor, and Pensions

of the Senate;

(B) the Subcommittee on Labor, Health and Human Services, and

Education of the Committee on Appropriations of the Senate;

(C) the Committee on Energy and Commerce of the House of

Representatives; and

(D) the Subcommittee on Labor, Health and Human Services, and

Education of the Committee on Appropriations of the House of

Representatives.

(2) Content

The report described in paragraph (1) shall detail -

(A) the manner in which the demonstration project described

in this section has affected access to primary care services,

patient satisfaction, quality of care, and health care services

provided for traditionally underserved populations;

(B) how the participation of chiropractic doctors and

pharmacists in the Loan Repayment Program might affect the

designation of health professional shortage areas; and

(C) whether adding chiropractic doctors and pharmacists as

permanent members of the National Health Service Corps would be

feasible and would enhance the effectiveness of the National

Health Service Corps.

(g) Authorization of appropriations

(1) In general

There are authorized to be appropriated to carry out this

section, such sums as may be necessary for fiscal years 2002

through 2004.

(2) Fiscal year 2005

If the Secretary determines and certifies to Congress by not

later than September 30, 2004, that the number of individuals

participating in the demonstration project established under this

section is insufficient for purposes of performing the evaluation

described in subsection (f)(1) of this section, the authorization

of appropriations under paragraph (1) shall be extended to

include fiscal year 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 338L, as added Pub. L.

107-251, title III, Sec. 317, Oct. 26, 2002, 116 Stat. 1653.)

-MISC1-

PRIOR PROVISIONS

A prior section 254t, act July 1, 1944, ch. 373, title III, Sec.

338L, as added Pub. L. 101-527, Sec. 8, Nov. 6, 1990, 104 Stat.

2328, related to demonstration grants to States for community

scholarship programs, prior to repeal by Pub. L. 107-251, title

III, Sec. 316, Oct. 26, 2002, 116 Stat. 1653.

-End-

-CITE-

42 USC subpart iv - home health services 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part D - Primary Health Care

subpart iv - home health services

-HEAD-

SUBPART IV - HOME HEALTH SERVICES

-MISC1-

AMENDMENTS

1987 - Pub. L. 100-177, title II, Sec. 202(f)(1), Dec. 1, 1987,

101 Stat. 999, substituted "IV" for "III" as subpart designation.

1983 - Pub. L. 97-414, Sec. 6(a), Jan. 4, 1983, 96 Stat. 2057,

added heading "Subpart III - Home Health Services".

1978 - Pub. L. 95-626, title I, Sec. 105(b), title II, Sec.

207(a), Nov. 10, 1978, 92 Stat. 3560, 3585, struck out heading

"Part D - Lepers" and added heading "Subpart III - Home Health

Services".

-End-

-End-

-CITE-

42 USC Sec. 262a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 1 - biological products

-HEAD-

Sec. 262a. Enhanced control of dangerous biological agents and

toxins

-STATUTE-

(a) Regulatory control of certain biological agents and toxins

(1) List of biological agents and toxins

(A) In general

The Secretary shall by regulation establish and maintain a

list of each biological agent and each toxin that has the

potential to pose a severe threat to public health and safety.

(B) Criteria

In determining whether to include an agent or toxin on the

list under subparagraph (A), the Secretary shall -

(i) consider -

(I) the effect on human health of exposure to the agent

or toxin;

(II) the degree of contagiousness of the agent or toxin

and the methods by which the agent or toxin is transferred

to humans;

(III) the availability and effectiveness of

pharmacotherapies and immunizations to treat and prevent

any illness resulting from infection by the agent or toxin;

and

(IV) any other criteria, including the needs of children

and other vulnerable populations, that the Secretary

considers appropriate; and

(ii) consult with appropriate Federal departments and

agencies and with scientific experts representing appropriate

professional groups, including groups with pediatric

expertise.

(2) Biennial review

The Secretary shall review and republish the list under

paragraph (1) biennially, or more often as needed, and shall by

regulation revise the list as necessary in accordance with such

paragraph.

(b) Regulation of transfers of listed agents and toxins

The Secretary shall by regulation provide for -

(1) the establishment and enforcement of safety procedures for

the transfer of listed agents and toxins, including measures to

ensure -

(A) proper training and appropriate skills to handle such

agents and toxins; and

(B) proper laboratory facilities to contain and dispose of

such agents and toxins;

(2) the establishment and enforcement of safeguard and security

measures to prevent access to such agents and toxins for use in

domestic or international terrorism or for any other criminal

purpose;

(3) the establishment of procedures to protect the public

safety in the event of a transfer or potential transfer of such

an agent or toxin in violation of the safety procedures

established under paragraph (1) or the safeguard and security

measures established under paragraph (2); and

(4) appropriate availability of biological agents and toxins

for research, education, and other legitimate purposes.

(c) Possession and use of listed agents and toxins

The Secretary shall by regulation provide for the establishment

and enforcement of standards and procedures governing the

possession and use of listed agents and toxins, including the

provisions described in paragraphs (1) through (4) of subsection

(b) of this section, in order to protect the public health and

safety.

(d) Registration; identification; database(1) Registration

Regulations under subsections (b) and (c) of this section shall

require registration with the Secretary of the possession, use,

and transfer of listed agents and toxins, and shall include

provisions to ensure that persons seeking to register under such

regulations have a lawful purpose to possess, use, or transfer

such agents and toxins, including provisions in accordance with

subsection (e)(6) of this section.

(2) Identification; database

Regulations under subsections (b) and (c) of this section shall

require that registration include (if available to the person

registering) information regarding the characterization of listed

agents and toxins to facilitate their identification, including

their source. The Secretary shall maintain a national database

that includes the names and locations of registered persons, the

listed agents and toxins such persons are possessing, using, or

transferring, and information regarding the characterization of

such agents and toxins.

(e) Safeguard and security requirements for registered persons

(1) In general

Regulations under subsections (b) and (c) of this section shall

include appropriate safeguard and security requirements for

persons possessing, using, or transferring a listed agent or

toxin commensurate with the risk such agent or toxin poses to

public health and safety (including the risk of use in domestic

or international terrorism). The Secretary shall establish such

requirements in collaboration with the Secretary of Homeland

Security and the Attorney General, and shall ensure compliance

with such requirements as part of the registration system under

such regulations.

(2) Limiting access to listed agents and toxins

Requirements under paragraph (1) shall include provisions to

ensure that registered persons -

(A) provide access to listed agents and toxins to only those

individuals whom the registered person involved determines have

a legitimate need to handle or use such agents and toxins;

(B) submit the names and other identifying information for

such individuals to the Secretary and the Attorney General,

promptly after first determining that the individuals need

access under subparagraph (A), and periodically thereafter

while the individuals have such access, not less frequently

than once every five years;

(C) deny access to such agents and toxins by individuals whom

the Attorney General has identified as restricted persons; and

(D) limit or deny access to such agents and toxins by

individuals whom the Attorney General has identified as within

any category under paragraph (3)(B)(ii), if limiting or denying

such access by the individuals involved is determined

appropriate by the Secretary, in consultation with the Attorney

General.

(3) Submitted names; use of databases by attorney general

(A) In general

Upon the receipt of names and other identifying information

under paragraph (2)(B), the Attorney General shall, for the

sole purpose of identifying whether the individuals involved

are within any of the categories specified in subparagraph (B),

promptly use criminal, immigration, national security, and

other electronic databases that are available to the Federal

Government and are appropriate for such purpose.

(B) Certain individuals

For purposes of subparagraph (A), the categories specified in

this subparagraph regarding an individual are that -

(i) the individual is a restricted person; or

(ii) the individual is reasonably suspected by any Federal

law enforcement or intelligence agency of -

(I) committing a crime set forth in section 2332b(g)(5)

of title 18;

(II) knowing involvement with an organization that

engages in domestic or international terrorism (as defined

in section 2331 of such title 18) or with any other

organization that engages in intentional crimes of

violence; or

(III) being an agent of a foreign power (as defined in

section 1801 of title 50).

(C) Notification by Attorney General regarding submitted names

After the receipt of a name and other identifying information

under paragraph (2)(B), the Attorney General shall promptly

notify the Secretary whether the individual is within any of

the categories specified in subparagraph (B).

(4) Notifications by Secretary

The Secretary, after receiving notice under paragraph (3)

regarding an individual, shall promptly notify the registered

person involved of whether the individual is granted or denied

access under paragraph (2). If the individual is denied such

access, the Secretary shall promptly notify the individual of the

denial.

(5) Expedited review

Regulations under subsections (b) and (c) of this section shall

provide for a procedure through which, upon request to the

Secretary by a registered person who submits names and other

identifying information under paragraph (2)(B) and who

demonstrates good cause, the Secretary may, as determined

appropriate by the Secretary -

(A) request the Attorney General to expedite the process of

identification under paragraph (3)(A) and notification of the

Secretary under paragraph (3)(C); and

(B) expedite the notification of the registered person by the

Secretary under paragraph (4).

(6) Process regarding persons seeking to register

(A) Individuals

Regulations under subsections (b) and (c) of this section

shall provide that an individual who seeks to register under

either of such subsections is subject to the same processes

described in paragraphs (2) through (4) as apply to names and

other identifying information submitted to the Attorney General

under paragraph (2)(B). Paragraph (5) does not apply for

purposes of this subparagraph.

(B) Other persons

Regulations under subsections (b) and (c) of this section

shall provide that, in determining whether to deny or revoke

registration by a person other than an individual, the

Secretary shall submit the name of such person to the Attorney

General, who shall use criminal, immigration, national

security, and other electronic databases available to the

Federal Government, as appropriate for the purpose of promptly

notifying the Secretary whether the person, or, where relevant,

the individual who owns or controls such person, is a

restricted person or is reasonably suspected by any Federal law

enforcement or intelligence agency of being within any category

specified in paragraph (3)(B)(ii) (as applied to persons,

including individuals). Such regulations shall provide that a

person who seeks to register under either of such subsections

is subject to the same processes described in paragraphs (2)

and (4) as apply to names and other identifying information

submitted to the Attorney General under paragraph (2)(B).

Paragraph (5) does not apply for purposes of this subparagraph.

The Secretary may exempt Federal, State, or local governmental

agencies from the requirements of this subparagraph.

(7) Review

(A) Administrative review

(i) In general

Regulations under subsections (b) and (c) of this section

shall provide for an opportunity for a review by the

Secretary -

(I) when requested by the individual involved, of a

determination under paragraph (2) to deny the individual

access to listed agents and toxins; and

(II) when requested by the person involved, of a

determination under paragraph (6) to deny or revoke

registration for such person.

(ii) Ex parte review

During a review under clause (i), the Secretary may

consider information relevant to the review ex parte to the

extent that disclosure of the information could compromise

national security or an investigation by any law enforcement

agency.

(iii) Final agency action

The decision of the Secretary in a review under clause (i)

constitutes final agency action for purposes of section 702

of title 5.

(B) Certain procedures

(i) Submission of ex parte materials in judicial proceedings

When reviewing a decision of the Secretary under

subparagraph (A), and upon request made ex parte and in

writing by the United States, a court, upon a sufficient

showing, may review and consider ex parte documents

containing information the disclosure of which could

compromise national security or an investigation by any law

enforcement agency. If the court determines that portions of

the documents considered ex parte should be disclosed to the

person involved to allow a response, the court shall

authorize the United States to delete from such documents

specified items of information the disclosure of which could

compromise national security or an investigation by any law

enforcement agency, or to substitute a summary of the

information to which the person may respond. Any order by the

court authorizing the disclosure of information that the

United States believes could compromise national security or

an investigation by any law enforcement agency shall be

subject to the processes set forth in subparagraphs (A) and

(B)(i) of section 2339B(f)(5) of title 18 (relating to

interlocutory appeal and expedited consideration).

(ii) Disclosure of information

In a review under subparagraph (A), and in any judical (!1)

proceeding conducted pursuant to such review, neither the

Secretary nor the Attorney General may be required to

disclose to the public any information that under subsection

(h) of this section shall not be disclosed under section 552

of title 5.

(8) Notifications regarding theft or loss of agents

Requirements under paragraph (1) shall include the prompt

notification of the Secretary, and appropriate Federal, State,

and local law enforcement agencies, of the theft or loss of

listed agents and toxins.

(9) Technical assistance for registered persons

The Secretary, in consultation with the Attorney General, may

provide technical assistance to registered persons to improve

security of the facilities of such persons.

(f) Inspections

The Secretary shall have the authority to inspect persons subject

to regulations under subsection (b) or (c) of this section to

ensure their compliance with such regulations, including

prohibitions on restricted persons and other provisions of

subsection (e) of this section.

(g) Exemptions

(1) Clinical or diagnostic laboratories

Regulations under subsections (b) and (c) of this section shall

exempt clinical or diagnostic laboratories and other persons who

possess, use, or transfer listed agents or toxins that are

contained in specimens presented for diagnosis, verification, or

proficiency testing, provided that -

(A) the identification of such agents or toxins is reported

to the Secretary, and when required under Federal, State, or

local law, to other appropriate authorities; and

(B) such agents or toxins are transferred or destroyed in a

manner set forth by the Secretary by regulation.

(2) Products

(A) In general

Regulations under subsections (b) and (c) of this section

shall exempt products that are, bear, or contain listed agents

or toxins and are cleared, approved, licensed, or registered

under any of the Acts specified in subparagraph (B), unless the

Secretary by order determines that applying additional

regulation under subsection (b) or (c) of this section to a

specific product is necessary to protect public health and

safety.

(B) Relevant laws

For purposes of subparagraph (A), the Acts specified in this

subparagraph are the following:

(i) The Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301

et seq.].

(ii) Section 262 of this title.

(iii) The Act commonly known as the Virus-Serum-Toxin Act

(the eighth paragraph under the heading "Bureau of Animal

Industry" in the Act of March 4, 1913; 21 U.S.C. 151-159).

(iv) The Federal Insecticide, Fungicide, and Rodenticide

Act [7 U.S.C. 136 et seq.].

(C) Investigational use

(i) In general

The Secretary may exempt an investigational product that

is, bears, or contains a listed agent or toxin from the

applicability of provisions of regulations under subsection

(b) or (c) of this section when such product is being used in

an investigation authorized under any Federal Act and the

Secretary determines that applying additional regulation

under subsection (b) or (c) of this section to such product

is not necessary to protect public health and safety.

(ii) Certain processes

Regulations under subsections (b) and (c) of this section

shall set forth the procedures for applying for an exemption

under clause (i). In the case of investigational products

authorized under any of the Acts specified in subparagraph

(B), the Secretary shall make a determination regarding a

request for an exemption not later than 14 days after the

first date on which both of the following conditions have

been met by the person requesting the exemption:

(I) The person has submitted to the Secretary an

application for the exemption meeting the requirements

established by the Secretary.

(II) The person has notified the Secretary that the

investigation has been authorized under such an Act.

(3) Public health emergencies

The Secretary may temporarily exempt a person from the

applicability of the requirements of this section, in whole or in

part, if the Secretary determines that such exemption is

necessary to provide for the timely participation of the person

in a response to a domestic or foreign public health emergency

(whether determined under section 247d(a) of this title or

otherwise) that involves a listed agent or toxin. With respect to

the emergency involved, such exemption for a person may not

exceed 30 days, except that the Secretary, after review of

whether such exemption remains necessary, may provide one

extension of an additional 30 days.

(4) Agricultural emergencies

Upon request of the Secretary of Agriculture, after the

granting by such Secretary of an exemption under section

8401(g)(1)(D) of title 7 pursuant to a finding that there is an

agricultural emergency, the Secretary of Health and Human

Services may temporarily exempt a person from the applicability

of the requirements of this section, in whole or in part, to

provide for the timely participation of the person in a response

to the agricultural emergency. With respect to the emergency

involved, the exemption under this paragraph for a person may not

exceed 30 days, except that upon request of the Secretary of

Agriculture, the Secretary of Health and Human Services may,

after review of whether such exemption remains necessary, provide

one extension of an additional 30 days.

(h) Disclosure of information

(1) Nondisclosure of certain information

No Federal agency specified in paragraph (2) shall disclose

under section 552 of title 5 any of the following:

(A) Any registration or transfer documentation submitted

under subsections (b) and (c) of this section for the

possession, use, or transfer of a listed agent or toxin; or

information derived therefrom to the extent that it identifies

the listed agent or toxin possessed, used, or transferred by a

specific registered person or discloses the identity or

location of a specific registered person.

(B) The national database developed pursuant to subsection

(d) of this section, or any other compilation of the

registration or transfer information submitted under

subsections (b) and (c) of this section to the extent that such

compilation discloses site-specific registration or transfer

information.

(C) Any portion of a record that discloses the site-specific

or transfer-specific safeguard and security measures used by a

registered person to prevent unauthorized access to listed

agents and toxins.

(D) Any notification of a release of a listed agent or toxin

submitted under subsections (b) and (c) of this section, or any

notification of theft or loss submitted under such subsections.

(E) Any portion of an evaluation or report of an inspection

of a specific registered person conducted under subsection (f)

of this section that identifies the listed agent or toxin

possessed by a specific registered person or that discloses the

identity or location of a specific registered person if the

agency determines that public disclosure of the information

would endanger public health or safety.

(2) Covered agencies

For purposes of paragraph (1) only, the Federal agencies

specified in this paragraph are the following:

(A) The Department of Health and Human Services, the

Department of Justice, the Department of Agriculture, and the

Department of Transportation.

(B) Any Federal agency to which information specified in

paragraph (1) is transferred by any agency specified in

subparagraph (A) of this paragraph.

(C) Any Federal agency that is a registered person, or has a

sub-agency component that is a registered person.

(D) Any Federal agency that awards grants or enters into

contracts or cooperative agreements involving listed agents and

toxins to or with a registered person, and to which information

specified in paragraph (1) is transferred by any such

registered person.

(3) Other exemptions

This subsection may not be construed as altering the

application of any exemptions to public disclosure under section

552 of title 5, except as to subsection (!2) 552(b)(3) of such

title, to any of the information specified in paragraph (1).

(4) Rule of construction

Except as specifically provided in paragraph (1), this

subsection may not be construed as altering the authority of any

Federal agency to withhold under section 552 of title 5, or the

obligation of any Federal agency to disclose under section 552 of

title 5, any information, including information relating to -

(A) listed agents and toxins, or individuals seeking access

to such agents and toxins;

(B) registered persons, or persons seeking to register their

possession, use, or transfer of such agents and toxins;

(C) general safeguard and security policies and requirements

under regulations under subsections (b) and (c) of this

section; or

(D) summary or statistical information concerning

registrations, registrants, denials or revocations of

registrations, listed agents and toxins, inspection evaluations

and reports, or individuals seeking access to such agents and

toxins.

(5) Disclosures to Congress; other disclosures

This subsection may not be construed as providing any authority

-

(A) to withhold information from the Congress or any

committee or subcommittee thereof; or

(B) to withhold information from any person under any other

Federal law or treaty.

(i) Civil money penalty

(1) In general

In addition to any other penalties that may apply under law,

any person who violates any provision of regulations under

subsection (b) or (c) of this section shall be subject to the

United States for a civil money penalty in an amount not

exceeding $250,000 in the case of an individual and $500,000 in

the case of any other person.

(2) Applicability of certain provisions

The provisions of section 1320a-7a of this title (other than

subsections (a), (b), (h), and (i), the first sentence of

subsection (c), and paragraphs (1) and (2) of subsection (f))

shall apply to a civil money penalty under paragraph (1) in the

same manner as such provisions apply to a penalty or proceeding

under section 1320a-7a(a) of this title. The Secretary may

delegate authority under this subsection in the same manner as

provided in section 1320a-7a(j)(2) of this title, and such

authority shall include all powers as contained in section 6 of

the Inspector General Act of 1978 (5 U.S.C. App.).

(j) Notification in event of release

Regulations under subsections (b) and (c) of this section shall

require the prompt notification of the Secretary by a registered

person whenever a release, meeting criteria established by the

Secretary, of a listed agent or toxin has occurred outside of the

biocontainment area of a facility of the registered person. Upon

receipt of such notification and a finding by the Secretary that

the release poses a threat to public health or safety, the

Secretary shall take appropriate action to notify relevant State

and local public health authorities, other relevant Federal

authorities, and, if necessary, other appropriate persons

(including the public). If the released listed agent or toxin is an

overlap agent or toxin (as defined in subsection (l) of this

section), the Secretary shall promptly notify the Secretary of

Agriculture upon notification by the registered person.

(k) Reports

The Secretary shall report to the Congress annually on the number

and nature of notifications received under subsection (e)(8) of

this section (relating to theft or loss) and subsection (j) of this

section (relating to releases).

(l) Definitions

For purposes of this section:

(1) The terms "biological agent" and "toxin" have the meanings

given such terms in section 178 of title 18.

(2) The term "listed agents and toxins" means biological agents

and toxins listed pursuant to subsection (a)(1) of this section.

(3) The term "listed agents or toxins" means biological agents

or toxins listed pursuant to subsection (a)(1) of this section.

(4) The term "overlap agents and toxins" means biological

agents and toxins that -

(A) are listed pursuant to subsection (a)(1) of this section;

and

(B) are listed pursuant to section 8401(a)(1) of title 7.

(5) The term "overlap agent or toxin" means a biological agent

or toxin that -

(A) is listed pursuant to subsection (a)(1) of this section;

and

(B) is listed pursuant to section 8401(a)(1) of title 7.

(6) The term "person" includes Federal, State, and local

governmental entities.

(7) The term "registered person" means a person registered

under regulations under subsection (b) or (c) of this section.

(8) The term "restricted person" has the meaning given such

term in section 175b of title 18.

(m) 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 2002 through 2007.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 351A, as added Pub. L.

107-188, title II, Sec. 201(a), June 12, 2002, 116 Stat. 637;

amended Pub. L. 107-296, title XVII, Sec. 1709(a), Nov. 25, 2002,

116 Stat. 2318.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in

subsec.(g)(2)(B)(i), 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 section 301 of Title 21 and Tables.

The Act commonly known as the Virus-Serum-Toxin Act, referred to

in subsec. (g)(2)(B)(iii), is the eighth paragraph under the

heading "Bureau of Animal Industry" of act Mar. 4, 1913, ch. 145,

37 Stat. 832, as amended, which is classified generally to chapter

5 (Sec. 151 et seq.) of Title 21, Food and Drugs. For complete

classification of this Act to the Code, see Short Title note set

out under section 151 of Title 21 and Tables.

The Federal Insecticide, Fungicide, and Rodenticide Act, referred

to in subsec. (g)(2)(B)(iv), is act June 25, 1947, ch. 125, as

amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973,

which is classified generally to subchapter II (Sec. 136 et seq.)

of chapter 6 of Title 7, Agriculture. For complete classification

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

136 of Title 7 and Tables.

Section 6 of the Inspector General Act of 1978, referred to in

subsec. (i)(2), is section 6 of Pub. L. 95-452, which is set out in

the Appendix to Title 5, Government Organization and Employees.

-MISC1-

AMENDMENTS

2002 - Subsec. (e)(1). Pub. L. 107-296 substituted "collaboration

with the Secretary of Homeland Security and" for "consultation

with".

EFFECTIVE DATE OF 2002 AMENDMENT

Amendment by Pub. L. 107-296 effective 60 days after Nov. 25,

2002, see section 4 of Pub. L. 107-296, set out as an Effective

Date note under section 101 of Title 6, Domestic Security.

EFFECTIVE DATE

Pub. L. 107-188, title II, Sec. 203(b), June 12, 2002, 116 Stat.

647, provided that: "Subsection (h) of section 351A of the Public

Health Service Act [subsec. (h) of this section], as added by

section 201 of this Act, is deemed to have taken effect on the

effective date of the Antiterrorism and Effective Death Penalty Act

of 1996 [Pub. L. 104-132, Apr. 24, 1996, 110 Stat. 1214]."

REGULATIONS

Pub. L. 107-188, title II, Sec. 203(a), June 12, 2002, 116 Stat.

647, provided that:"Regulations promulgated by the Secretary of

Health and Human Services under section 511 of the Antiterrorism

and Effective Death Penalty Act of 1996 [Pub. L. 104-132, set out

as a note under section 262 of this title] are deemed to have been

promulgated under section 351A of the Public Health Service Act

[this section], as added by section 201 of this Act. Such regulations,

including the list under [former] subsection (d)(1) of such section

511, that were in effect on the day before the date of the enactment

of this Act [June 12, 2002] remain in effect until modified by the

Secretary in accordance with such section 351A and with section 202

of this Act [set out as a note below]."

REPORT TO CONGRESS

Pub. L. 107-188, title II, Sec. 201(b), June 12, 2002, 116 Stat.

646, provided that: "Not later than one year after the date of the

enactment of this Act [June 12, 2002], the Secretary of Health and

Human Services, after consultation with other appropriate Federal

agencies, shall submit to the Congress a report that -

"(1) describes the extent to which there has been compliance by

governmental and private entities with applicable regulations

under section 351A of the Public Health Service Act [this

section] (as added by subsection (a) of this section), including

the extent of compliance before the date of the enactment of this

Act [June 12, 2002], and including the extent of compliance with

regulations promulgated after such date of enactment;

"(2) describes the actions to date and future plans of the

Secretary for updating the list of biological agents and toxins

under such section 351A;

"(3) describes the actions to date and future plans of the

Secretary for determining compliance with regulations under such

section 351A and for taking appropriate enforcement actions;

"(4) evaluates the impact of such section 351A on research on

biological agents and toxins listed pursuant to such section; and

"(5) provides any recommendations of the Secretary for

administrative or legislative initiatives regarding such section

351A."

IMPLEMENTATION BY DEPARTMENT OF HEALTH AND HUMAN SERVICES

Pub. L. 107-188, title II, Sec. 202, June 12, 2002, 116 Stat.

646, provided that:

"(a) Date Certain for Notice of Possession. - Not later than 90

days after the date of the enactment of this Act [June 12, 2002],

all persons (unless exempt under subsection (g) of section 351A of

the Public Health Service Act [subsec. (g) of this section], as

added by section 201 of this Act) in possession of biological

agents or toxins listed under such section 351A of the Public

Health Service Act [this section] shall notify the Secretary of

Health and Human Services of such possession. Not later than 30

days after such date of enactment, the Secretary shall provide

written guidance on how such notice is to be provided to the

Secretary.

"(b) Date Certain for Promulgation; Effective Date Regarding

Criminal and Civil Penalties. - Not later than 180 days after the

date of the enactment of this Act [June 12, 2002], the Secretary of

Health and Human Services shall promulgate an interim final rule

for carrying out section 351A of the Public Health Service Act

[this section], subject to subsection (c). Such interim final rule

shall take effect 60 days after the date on which such rule is

promulgated, including for purposes of -

"(1) section 175b(c) of title 18, United States Code (relating

to criminal penalties), as added by section 231(a)(5) of this

Act; and

"(2) section 351A(i) of the Public Health Service Act [subsec.

(i) of this section] (relating to civil penalties).

"(c) Transitional Provision Regarding Current Research and

Education. - The interim final rule under subsection (b) shall

include time frames for the applicability of the rule that minimize

disruption of research or educational projects that involve

biological agents and toxins listed pursuant to section 351A(a)(1)

of the Public Health Service Act [subsec. (a)(1) of this section]

and that were underway as of the effective date of such rule."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 247d-6 of this title;

title 6 section 182; title 7 sections 8401, 8411; title 18 section

175b.

-FOOTNOTE-

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

(!2) So in original. Probably should be "section".

-End--CITE-

42 USC Sec. 263 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 1 - biological products

-HEAD-

Sec. 263. Preparation of biological products by Service

-STATUTE-

(a) The Service may prepare for its own use any product described

in section 262 of this title and any product necessary to carrying

out any of the purposes of section 241 of this title.

(b) The Service may prepare any product described in section 262

of this title for the use of other Federal departments or agencies,

and public or private agencies and individuals engaged in work in

the field of medicine when such product is not available from

establishments licensed under such section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 352, 58 Stat. 703.)

-TRANS-

TRANSFER OF FUNCTIONS

Functions of Public Health Service, Surgeon General of Public

Health Service, and all other officers and employees of Public

Health Service, and functions of all agencies of or in Public

Health Service transferred to Secretary of Health, Education, and

Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R.

8855, 80 Stat. 1610, set out as a note under section 202 of this

title. Secretary of Health, Education, and Welfare redesignated

Secretary of Health and Human Services by section 509(b) of Pub. L.

96-88 which is classified to section 3508(b) of Title 20,

Education.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 201 of this title.

-End-

-CITE-

42 USC subpart 2 - clinical laboratories 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

SUBPART 2 - CLINICAL LABORATORIES

-End-

-CITE-

42 USC Sec. 263a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a. Certification of laboratories

-STATUTE-

(a) "Laboratory" or "clinical laboratory" defined

As used in this section, the term "laboratory" or "clinical

laboratory" means a facility for the biological, microbiological,

serological, chemical, immuno-hematological, hematological,

biophysical, cytological, pathological, or other examination of

materials derived from the human body for the purpose of providing

information for the diagnosis, prevention, or treatment of any

disease or impairment of, or the assessment of the health of, human

beings.

(b) Certificate requirement

No person may solicit or accept materials derived from the human

body for laboratory examination or other procedure unless there is

in effect for the laboratory a certificate issued by the Secretary

under this section applicable to the category of examinations or

procedures which includes such examination or procedure.

(c) Issuance and renewal of certificates

(1) In general

The Secretary may issue or renew a certificate for a laboratory

only if the laboratory meets the requirements of subsection (d)

of this section.

(2) Term

A certificate issued under this section shall be valid for a

period of 2 years or such shorter period as the Secretary may

establish.

(d) Requirements for certificates

(1) In general

A laboratory may be issued a certificate or have its

certificate renewed if -

(A) the laboratory submits (or if the laboratory is

accredited under subsection (e) of this section, the

accreditation body which accredited the laboratory submits), an

application -

(i) in such form and manner as the Secretary shall

prescribe,

(ii) that describes the characteristics of the laboratory

examinations and other procedures performed by the laboratory

including -

(I) the number and types of laboratory examinations and

other procedures performed,

(II) the methodologies for laboratory examinations and

other procedures employed, and

(III) the qualifications (educational background,

training, and experience) of the personnel directing and

supervising the laboratory and performing the laboratory

examinations and other procedures, and

(iii) that contains such other information as the Secretary

may require to determine compliance with this section, and

the laboratory agrees to provide to the Secretary (or if the

laboratory is accredited, to the accreditation body which

accredited it) a description of any change in the information

submitted under clause (ii) not later than 6 months after the

change was put into effect,

(B) the laboratory provides the Secretary -

(i) with satisfactory assurances that the laboratory will

be operated in accordance with standards issued by the

Secretary under subsection (f) of this section, or

(ii) with proof of accreditation under subsection (e) of

this section,

(C) the laboratory agrees to permit inspections by the

Secretary under subsection (g) of this section,

(D) the laboratory agrees to make records available and

submit reports to the Secretary as the Secretary may reasonably

require, and

(E) the laboratory agrees to treat proficiency testing

samples in the same manner as it treats materials derived from

the human body referred to it for laboratory examinations or

other procedures in the ordinary course of business.

(2) Requirements for certificates of waiver

(A) In general

A laboratory which only performs laboratory examinations and

procedures described in paragraph (3) shall be issued a

certificate of waiver or have its certificate of waiver renewed

if -

(i) the laboratory submits an application -

(I) in such form and manner as the Secretary shall

prescribe,

(II) that describes the characteristics of the laboratory

examinations and other procedures performed by the

laboratory, including the number and types of laboratory

examinations and other procedures performed, the

methodologies for laboratory examinations and other

procedures employed, and the qualifications (educational

background, training, and experience) of the personnel

directing and supervising the laboratory and performing the

laboratory examinations and other procedures, and

(III) that contains such other information as the

Secretary may reasonably require to determine compliance

with this section, and

(ii) the laboratory agrees to make records available and

submit reports to the Secretary as the Secretary may require.

(B) Changes

If a laboratory makes changes in the examinations and other

procedures performed by it only with respect to examinations

and procedures which are described in paragraph (3), the

laboratory shall report such changes to the Secretary not later

than 6 months after the change has been put into effect. If a

laboratory proposes to make changes in the examinations and

procedures performed by it such that the laboratory will

perform an examination or procedure not described in paragraph

(3), the laboratory shall report such change to the Secretary

before the change takes effect.

(C) Effect

Subsections (f) and (g) of this section shall not apply to a

laboratory to which has been issued a certificate of waiver.

(3) Examinations and procedures

The examinations and procedures identified in paragraph (2) are

laboratory examinations and procedures that have been approved by

the Food and Drug Administration for home use or that, as

determined by the Secretary, are simple laboratory examinations

and procedures that have an insignificant risk of an erroneous

result, including those that -

(A) employ methodologies that are so simple and accurate as

to render the likelihood of erroneous results by the user

negligible, or

(B) the Secretary has determined pose no unreasonable risk of

harm to the patient if performed incorrectly.

(4) "Certificate" defined

As used in this section, the term "certificate" includes a

certificate of waiver issued under paragraph (2).

(e) Accreditation (C) Approved proficiency testing programs

For the purpose of administering proficiency testing programs

which meet the standards established under subparagraph (A),

the Secretary shall approve a proficiency testing program

offered by a private nonprofit organization or a State if the

program meets the standards established under subparagraph (A)

and the organization or State provides technical assistance to

laboratories seeking to qualify under the program. The

Secretary shall evaluate each program approved under this

subparagraph annually to determine if the program continues to

meet the standards established under subparagraph (A) and shall

withdraw the approval of any program that no longer meets such

standards.

(D) Onsite testing

The Secretary shall perform, or shall direct a program

approved under subparagraph (C) to perform, onsite proficiency

testing to assure compliance with the requirements of

subsection (d)(5) of this section. The Secretary shall perform,

on an onsite or other basis, proficiency testing to evaluate

the performance of a proficiency testing program approved under

subparagraph (C) and to assure quality performance by a

laboratory.

(E) Training, technical assistance, and enhanced proficiency

testing

The Secretary may, in lieu of or in addition to actions

authorized under subsection (h), (i), or (j) of this section,

require any laboratory which fails to perform acceptably on an

individual examination and procedure or a category of

examination and procedures -

(i) to undertake training and to obtain the necessary

technical assistance to meet the requirements of the

proficency (!2) testing program,

(ii) to enroll in a program of enhanced proficiency

testing, or

(iii) to undertake any combination of the training,

technical assistance, or testing described in clauses (i) and

(ii).

(F) Testing results

The Secretary shall establish a system to make the results of

the proficiency testing programs subject to the standards

established by the Secretary under subparagraph (A) available,

on a reasonable basis, upon request of any person. The

Secretary shall include with results made available under this

subparagraph such explanatory information as may be appropriate

to assist in the interpretation of such results.

(4) National standards for quality assurance in cytology services

(A) Establishment

The Secretary shall establish national standards for quality

assurance in cytology services designed to assure consistent

performance by laboratories of valid and reliable cytological

services.

(B) Standards

The standards established under subparagraph (A) shall

include -

(i) the maximum number of cytology slides that any

individual may screen in a 24-hour period,

(ii) requirements that a clinical laboratory maintain a

record of (I) the number of cytology slides screened during

each 24-hour period by each individual who examines cytology

slides for the laboratory, and (II) the number of hours

devoted during each 24-hour period to screening cytology

slides by such individual,

(iii) criteria for requiring rescreening of cytological

preparations, such as (I) random rescreening of cytology

specimens determined to be in the benign category, (II)

focused rescreening of such preparations in high risk groups,

and (III) for each abnormal cytological result, rescreening

of all prior cytological specimens for the patient, if

available,

(iv) periodic confirmation and evaluation of the

proficiency of individuals involved in screening or

interpreting cytological preparations, including announced

and unannounced on-site proficiency testing of such

individuals, with such testing to take place, to the extent

practicable, under normal working conditions,

(v) procedures for detecting inadequately prepared slides,

for assuring that no cytological diagnosis is rendered on

such slides, and for notifying referring physicians of such

slides,

(vi) requirements that all cytological screening be done on

the premises of a laboratory that is certified under this

section,

(vii) requirements for the retention of cytology slides by

laboratories for such periods of time as the Secretary

considers appropriate, and

(viii) standards requiring periodic inspection of cytology

services by persons capable of evaluating the quality of

cytology services.

(g) Inspections

(1) In general

The Secretary may, on an announced or unannounced basis, enter

and inspect, during regular hours of operation, laboratories

which have been issued a certificate under this section. In

conducting such inspections the Secretary shall have access to

all facilities, equipment, materials, records, and information

that the Secretary determines have a bearing on whether the

laboratory is being operated in accordance with this section. As

part of such an inspection the Secretary may copy any such

material or require to it (!3) be submitted to the Secretary. An

inspection under this paragraph may be made only upon presenting

identification to the owner, operator, or agent in charge of the

laboratory being inspected.

(2) Compliance with requirements and standards

The Secretary shall conduct inspections of laboratories under

paragraph (1) to determine their compliance with the requirements

of subsection (d) of this section and the standards issued under

subsection (f) of this section. Inspections of laboratories not

accredited under subsection (e) of this section shall be

conducted on a biennial basis or with such other frequency as the

Secretary determines to be necessary to assure compliance with

such requirements and standards. Inspections of laboratories

accredited under subsection (e) of this section shall be

conducted on such basis as the Secretary determines is necessary

to assure compliance with such requirements and standards.

(h) Intermediate sanctions

(1) In general

If the Secretary determines that a laboratory which has been

issued a certificate under this section no longer substantially

meets the requirements for the issuance of a certificate, the

Secretary may impose intermediate sanctions in lieu of the

actions authorized by subsection (i) of this section.

(2) Types of sanctions

The intermediate sanctions which may be imposed under paragraph

(1) shall consist of -

(A) directed plans of correction,

(B) civil money penalties in an amount not to exceed $10,000

for each violation listed in subsection (i)(1) of this section

or for each day of substantial noncompliance with the

requirements of this section,

(C) payment for the costs of onsite monitoring, or

(D) any combination of the actions described in subparagraphs

(A), (B), and (C).

(3) Procedures

The Secretary shall develop and implement procedures with

respect to when and how each of the intermediate sanctions is to

be imposed under paragraph (1). Such procedures shall provide for

notice to the laboratory and a reasonable opportunity to respond

to the proposed sanction and appropriate procedures for appealing

determinations relating to the imposition of intermediate

sanctions (!4)

(i) Suspension, revocation, and limitation

(1) In general

Except as provided in paragraph (2), the certificate of a

laboratory issued under this section may be suspended, revoked,

or limited if the Secretary finds, after reasonable notice and

opportunity for hearing to the owner or operator of the

laboratory, that such owner or operator or any employee of the

laboratory -

(A) has been guilty of misrepresentation in obtaining the

certificate,

(B) has performed or represented the laboratory as entitled

to perform a laboratory examination or other procedure which is

not within a category of laboratory examinations or other

procedures authorized in the certificate,

(C) has failed to comply with the requirements of subsection

(d) of this section or the standards prescribed by the

Secretary under subsection (f) of this section,

(D) has failed to comply with reasonable requests of the

Secretary for -

(i) any information or materials, or

(ii) work on materials,

that the Secretary concludes is necessary to determine the

laboratory's continued eligibility for its certificate or

continued compliance with the Secretary's standards under

subsection (f) of this section,

(E) has refused a reasonable request of the Secretary, or any

Federal officer or employee duly designated by the Secretary,

for permission to inspect the laboratory and its operations and

pertinent records during the hours the laboratory is in

operation,

(F) has violated or aided and abetted in the violation of any

provisions of this section or of any regulation promulgated

thereunder, or

(G) has not complied with an intermediate sanction imposed

under subsection (h) of this section.

(2) Action before a hearing

If the Secretary determines that -

(A) the failure of a laboratory to comply with the standards

of the Secretary under subsection (f) of this section presents

an imminent and serious risk to human health, or

(B) a laboratory has engaged in an action described in

subparagraph (D) or (E) of paragraph (1),

the Secretary may suspend or limit the certificate of the

laboratory before holding a hearing under paragraph (1) regarding

such failure or refusal. The opportunity for a hearing shall be

provided no later than 60 days from the effective date of the

suspension or limitation. A suspension or limitation under this

paragraph shall stay in effect until the decision of the

Secretary made after the hearing under paragraph (1).

(3) Ineligibility to own or operate laboratories after revocation

No person who has owned or operated a laboratory which has had

its certificate revoked may, within 2 years of the revocation of

the certificate, own or operate a laboratory for which a

certificate has been issued under this section. The certificate

of a laboratory which has been excluded from participation under

the medicare program under title XVIII of the Social Security Act

[42 U.S.C. 1395 et seq.] because of actions relating to the

quality of the laboratory shall be suspended for the period the

laboratory is so excluded.

(4) Improper referrals

Any laboratory that the Secretary determines intentionally

refers its proficiency testing samples to another laboratory for

analysis shall have its certificate revoked for at least one year

and shall be subject to appropriate fines and penalties as

provided for in subsection (h) of this section.

(j) Injunctions

Whenever the Secretary has reason to believe that continuation of

any activity by a laboratory would constitute a significant hazard

to the public health the Secretary may bring suit in the district

court of the United States for the district in which such

laboratory is situated to enjoin continuation of such activity.

Upon proper showing, a temporary injunction or restraining order

against continuation of such activity pending issuance of a final

order under this subsection shall be granted without bond by such

court.

(k) Judicial review

(1) Petition

Any laboratory which has had an intermediate sanction imposed

under subsection (h) of this section or has had its certificate

suspended, revoked, or limited under subsection (i) of this

section may, at any time within 60 days after the date the action

of the Secretary under subsection (i) or (h) of this section

becomes final, file a petition with the United States court of

appeals for the circuit wherein the laboratory has its principal

place of business for judicial review of such action. As soon as

practicable after receipt of the petition, the clerk of the court

shall transmit a copy of the petition to the Secretary or other

officer designated by the Secretary for that purpose. As soon as

practicable after receipt of the copy, the Secretary shall file

in the court the record on which the action of the Secretary is

based, as provided in section 2112 of title 28.

(2) Additional evidence

If the petitioner applies to the court for leave to adduce

additional evidence, and shows to the satisfaction of the court

that such additional evidence is material and that there were

reasonable grounds for the failure to adduce such evidence in the

proceeding before the Secretary, the court may order such

additional evidence (and evidence in rebuttal of such additional

evidence) to be taken before the Secretary, and to be adduced

upon the hearing in such manner and upon such terms and

conditions as the court may deem proper. The Secretary may modify

the findings of the Secretary as to the facts, or make new

findings, by reason of the additional evidence so taken, and the

Secretary shall file such modified or new findings, and the

recommendations of the Secretary, if any, for the modification or

setting aside of his original action, with the return of such

additional evidence.

(3) Judgment of court

Upon the filing of the petition referred to in paragraph (1),

the court shall have jurisdiction to affirm the action, or to set

it aside in whole or in part, temporarily or permanently. The

findings of the Secretary as to the facts, if supported by

substantial evidence, shall be conclusive.

(4) Finality of judgment

The judgment of the court affirming or setting aside, in whole

or in part, any such action of the Secretary shall be final,

subject to review by the Supreme Court of the United States upon

certiorari or certification as provided in section 1254 of title

28.

(l) Sanctions

Any person who intentionally violates any requirement of this

section or any regulation promulgated thereunder shall be

imprisoned for not more than one year or fined under title 18, or

both, except that if the conviction is for a second or subsequent

violation of such a requirement such person shall be imprisoned for

not more than 3 years or fined in accordance with title 18, or

both.

(m) Fees

(1) Certificate fees

The Secretary shall require payment of fees for the issuance

and renewal of certificates, except that the Secretary shall only

require a nominal fee for the issuance and renewal of

certificates of waiver.

(2) Additional fees

The Secretary shall require the payment of fees for inspections

of laboratories which are not accredited and for the cost of

performing proficiency testing on laboratories which do not

participate in proficiency testing programs approved under

subsection (f)(3)(C) of this section.

(3) Criteria

(A) Fees under paragraph (1)

Fees imposed under paragraph (1) shall be sufficient to cover

the general costs of administering this section, including

evaluating and monitoring proficiency testing programs approved

under subsection (f) of this section and accrediting bodies and

implementing and monitoring compliance with the requirements of

this section.

(B) Fees under paragraph (2)

Fees imposed under paragraph (2) shall be sufficient to cover

the cost of the Secretary in carrying out the inspections and

proficiency testing described in paragraph (2).

(C) Fees imposed under paragraphs (1) and (2)

Fees imposed under paragraphs (1) and (2) shall vary by group

or classification of laboratory, based on such considerations

as the Secretary determines are relevant, which may include the

dollar volume and scope of the testing being performed by the

laboratories.

(n) Information

On April 1, 1990 and annually thereafter, the Secretary shall

compile and make available to physicians and the general public

information, based on the previous calendar year, which the

Secretary determines is useful in evaluating the performance of a

laboratory, including -

(1) a list of laboratories which have been convicted under

Federal or State laws relating to fraud and abuse, false

billings, or kickbacks,

(2) a list of laboratories -

(A) which have had their certificates revoked, suspended, or

limited under subsection (i) of this section, or

(B) which have been the subject of a sanction under

subsection (l) of this section,

together with a statement of the reasons for the revocation,

suspension, limitation, or sanction,

(3) a list of laboratories subject to intermediate sanctions

under subsection (h) of this section together with a statement of

the reasons for the sanctions,

(4) a list of laboratories whose accreditation has been

withdrawn or revoked together with a statement of the reasons for

the withdrawal or revocation,

(5) a list of laboratories against which the Secretary has

taken action under subsection (j) of this section together with a

statement of the reasons for such action, and

(6) a list of laboratories which have been excluded from

participation under title XVIII or XIX of the Social Security Act

[42 U.S.C. 1395 et seq., 1396 et seq.].

The information to be compiled under paragraphs (1) through (6)

shall be information for the calendar year preceding the date the

information is to be made available to the public and shall be

accompanied by such explanatory information as may be appropriate

to assist in the interpretation of the information compiled under

such paragraphs.

(o) Delegation

In carrying out this section, the Secretary may, pursuant to

agreement, use the services or facilities of any Federal or State

or local public agency or nonprofit private organization, and may

pay therefor in advance or by way of reimbursement, and in such

installments, as the Secretary may determine.

(p) State laws

(1) Except as provided in paragraph (2), nothing in this section

shall be construed as affecting the power of any State to enact and

enforce laws relating to the matters covered by this section to the

extent that such laws are not inconsistent with this section or

with the regulations issued under this section.

(2) If a State enacts laws relating to matters covered by this

section which provide for requirements equal to or more stringent

than the requirements of this section or than the regulations

issued under this section, the Secretary may exempt clinical

laboratories in that State from compliance with this section.

(q) Consultations

In carrying out this section, the Secretary shall consult with

appropriate private organizations and public agencies.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 353, as added Pub. L.

90-174, Sec. 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L.

100-578, Sec. 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105-115,

title I, Sec. 123(h), Nov. 21, 1997, 111 Stat. 2324.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsecs. (i)(3) and

(n)(6), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.

Titles XVIII and XIX of the Social Security Act are classified

generally to subchapters XVIII (Sec. 1395 et seq.) and XIX (Sec.

1396 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.

-COD-

CODIFICATION

Subsec. (e)(3) of this section, which required the Secretary to

annually prepare and submit to certain committees of Congress a

report describing the results of the evaluation conducted under

subsec. (e)(2)(D) of this section, terminated, effective May 15,

2000, pursuant to section 3003 of Pub. L. 104-66, as amended, set

out as a note under section 1113 of Title 31, Money and Finance.

See, also, page 96 of House Document No. 103-7.

-MISC1-

AMENDMENTS

1997 - Subsec. (d)(3). Pub. L. 105-115 amended heading and text

of par. (3) generally. Prior to amendment, text read as follows:

"The examinations and procedures identified in paragraph (2) are

simple laboratory examinations and procedures which, as determined

by the Secretary, have an insignificant risk of an erroneous

result, including those which -

"(A) have been approved by the Food and Drug Administration for

home use,

"(B) employ methodologies that are so simple and accurate as to

render the likelihood of erroneous results negligible, or

"(C) the Secretary has determined pose no reasonable risk of

harm to the patient if performed incorrectly."

1988 - Pub. L. 100-578 substituted "Certification of

laboratories" for "Licensing of laboratories" in section catchline,

and amended text generally, revising and restating as subsecs. (a)

to (q) provisions of former subsecs. (a) to (l).

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of Title 21, Food and

Drugs.

EFFECTIVE DATE OF 1988 AMENDMENT; EXCEPTIONS; CONTINUING

APPLICABILITY

Section 3 of Pub. L. 100-578 provided that: "Subsections (g)(1),

(h), (i), (j), (k), (l), and (m) of section 353 of the Public

Health Service Act [this section], as amended by section 101

[probably means section 2 of Pub. L. 100-578], shall take effect

January 1, 1989, except that any reference in such subsections to

the standards established under subsection (f) shall be considered

a reference to the standards established under subsection (d) of

such section 353, as in effect on December 31, 1988. During the

period beginning January 1, 1989, and ending December 31, 1989,

subsections (a) through (d) and subsection (i) through (l) of such

section 353 as in effect on December 31, 1988, shall continue to

apply to clinical laboratories. The remaining subsections of such

section 353, as so amended, shall take effect January 1, 1990,

except that subsections (f)(1)(C) and (g)(2) shall take effect July

1, 1991, with respect to laboratories which were not subject to the

requirements of such section 353 as in effect on December 31,

1988."

EFFECTIVE DATE

Section 5(b) of Pub. L. 90-174 provided that: "The amendment made

by subsection (a) [enacting this section] shall become effective on

the first day of the thirteenth month after the month [December

1967] in which it is enacted, except that the Secretary of Health,

Education, and Welfare may postpone such effective date for such

additional period as he finds necessary, but not beyond the first

day of the 19th month after such month [December 1967] in which the

amendment is enacted."

STUDIES

Section 4 of Pub. L. 100-578 directed Secretary to conduct

studies and submit report to Congress, not later than May 1, 1990,

relating to the reliability and quality control procedures of

clinical laboratory testing programs and the effect of errors in

the testing procedures and results on the diagnosis and treatment

of patients.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-2, 300aa-2, 1395x,

1395aa of this title; title 35 section 287.

-FOOTNOTE-

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

(!2) So in original. Probably should be "proficiency".

(!3) So in original. Probably should be "require it to".

(!4) So in original. Probably should be followed by a period.

-End-

-CITE-

42 USC Sec. 263a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a. Certification of laboratories

-STATUTE-

(a) "Laboratory" or "clinical laboratory" defined

As used in this section, the term "laboratory" or "clinical

laboratory" means a facility for the biological, microbiological,

serological, chemical, immuno-hematological, hematological,

biophysical, cytological, pathological, or other examination of

materials derived from the human body for the purpose of providing

information for the diagnosis, prevention, or treatment of any

disease or impairment of, or the assessment of the health of, human

beings.

(b) Certificate requirement

No person may solicit or accept materials derived from the human

body for laboratory examination or other procedure unless there is

in effect for the laboratory a certificate issued by the Secretary

under this section applicable to the category of examinations or

procedures which includes such examination or procedure.

(c) Issuance and renewal of certificates

(1) In general

The Secretary may issue or renew a certificate for a laboratory

only if the laboratory meets the requirements of subsection (d)

of this section.

(2) Term

A certificate issued under this section shall be valid for a

period of 2 years or such shorter period as the Secretary may

establish.

(d) Requirements for certificates

(1) In general

A laboratory may be issued a certificate or have its

certificate renewed if -

(A) the laboratory submits (or if the laboratory is

accredited under subsection (e) of this section, the

accreditation body which accredited the laboratory submits), an

application -

(i) in such form and manner as the Secretary shall

prescribe,

(ii) that describes the characteristics of the laboratory

examinations and other procedures performed by the laboratory

including -

(I) the number and types of laboratory examinations and

other procedures performed,

(II) the methodologies for laboratory examinations and

other procedures employed, and

(III) the qualifications (educational background,

training, and experience) of the personnel directing and

supervising the laboratory and performing the laboratory

examinations and other procedures, and

(iii) that contains such other information as the Secretary

may require to determine compliance with this section, and

the laboratory agrees to provide to the Secretary (or if the

laboratory is accredited, to the accreditation body which

accredited it) a description of any change in the information

submitted under clause (ii) not later than 6 months after the

change was put into effect,

(B) the laboratory provides the Secretary -

(i) with satisfactory assurances that the laboratory will

be operated in accordance with standards issued by the

Secretary under subsection (f) of this section, or

(ii) with proof of accreditation under subsection (e) of

this section,

(C) the laboratory agrees to permit inspections by the

Secretary under subsection (g) of this section,

(D) the laboratory agrees to make records available and

submit reports to the Secretary as the Secretary may reasonably

require, and

(E) the laboratory agrees to treat proficiency testing

samples in the same manner as it treats materials derived from

the human body referred to it for laboratory examinations or

other procedures in the ordinary course of business.

(2) Requirements for certificates of waiver

(A) In general

A laboratory which only performs laboratory examinations and

procedures described in paragraph (3) shall be issued a

certificate of waiver or have its certificate of waiver renewed

if -

(i) the laboratory submits an application -

(I) in such form and manner as the Secretary shall

prescribe,

(II) that describes the characteristics of the laboratory

examinations and other procedures performed by the

laboratory, including the number and types of laboratory

examinations and other procedures performed, the

methodologies for laboratory examinations and other

procedures employed, and the qualifications (educational

background, training, and experience) of the personnel

directing and supervising the laboratory and performing the

laboratory examinations and other procedures, and

(III) that contains such other information as the

Secretary may reasonably require to determine compliance

with this section, and

(ii) the laboratory agrees to make records available and

submit reports to the Secretary as the Secretary may require.

(B) Changes

If a laboratory makes changes in the examinations and other

procedures performed by it only with respect to examinations

and procedures which are described in paragraph (3), the

laboratory shall report such changes to the Secretary not later

than 6 months after the change has been put into effect. If a

laboratory proposes to make changes in the examinations and

procedures performed by it such that the laboratory will

perform an examination or procedure not described in paragraph

(3), the laboratory shall report such change to the Secretary

before the change takes effect.

(C) Effect

Subsections (f) and (g) of this section shall not apply to a

laboratory to which has been issued a certificate of waiver.

(3) Examinations and procedures

The examinations and procedures identified in paragraph (2) are

laboratory examinations and procedures that have been approved by

the Food and Drug Administration for home use or that, as

determined by the Secretary, are simple laboratory examinations

and procedures that have an insignificant risk of an erroneous

result, including those that -

(A) employ methodologies that are so simple and accurate as

to render the likelihood of erroneous results by the user

negligible, or

(B) the Secretary has determined pose no unreasonable risk of

harm to the patient if performed incorrectly.

(4) "Certificate" defined

As used in this section, the term "certificate" includes a

certificate of waiver issued under paragraph (2).

(e) Accreditation

(1) In general

A laboratory may be accredited for purposes of obtaining a

certificate if the laboratory -

(A) meets the standards of an approved accreditation body,

and

(B) authorizes the accreditation body to submit to the

Secretary (or such State agency as the Secretary may designate)

such records or other information as the Secretary may require.

(2) Approval of accreditation bodies

(A) In general

The Secretary may approve a private nonprofit organization to

be an accreditation body for the accreditation of laboratories

if -

(i) using inspectors qualified to evaluate the

methodologies used by the laboratories in performing

laboratory examinations and other procedures, the

accreditation body agrees to inspect a laboratory for

purposes of accreditation with such frequency as determined

by (!1) Secretary,

(ii) the standards applied by the body in determining

whether or not to accredit a laboratory are equal to or more

stringent than the standards issued by the Secretary under

subsection (f) of this section,

(iii) there is adequate provision for assuring that the

standards of the accreditation body continue to be met by the

laboratory,

(iv) in the case of any laboratory accredited by the body

which has had its accreditation denied, suspended, withdrawn,

or revoked or which has had any other action taken against it

by the accrediting body, the accrediting body agrees to

submit to the Secretary the name of such laboratory within 30

days of the action taken,

(v) the accreditation body agrees to notify the Secretary

at least 30 days before it changes its standards, and

(vi) if the accreditation body has its approval withdrawn

by the Secretary, the body agrees to notify each laboratory

accredited by the body of the withdrawal within 10 days of

the withdrawal.

(B) Criteria and procedures

The Secretary shall promulgate criteria and procedures for

approving an accreditation body and for withdrawing such

approval if the Secretary determines that the accreditation

body does not meet the requirements of subparagraph (A).

(C) Effect of withdrawal of approval

If the Secretary withdraws the approval of an accreditation

body under subparagraph (B), the certificate of any laboratory

accredited by the body shall continue in effect for 60 days

after the laboratory receives notification of the withdrawal of

the approval, except that the Secretary may extend such period

for a laboratory if it determines that the laboratory submitted

an application for accreditation or a certificate in a timely

manner after receipt of the notification of the withdrawal of

approval. If an accreditation body withdraws or revokes the

accreditation of a laboratory, the certificate of the

laboratory shall continue in effect -

(i) for 45 days after the laboratory receives notice of the

withdrawal or revocation of the accreditation, or

(ii) until the effective date of any action taken by the

Secretary under subsection (i) of this section.

(D) Evaluations

The Secretary shall evaluate annually the performance of each

approved accreditation body by -

(i) inspecting under subsection (g) of this section a

sufficient number of the laboratories accredited by such body

to allow a reasonable estimate of the performance of such

body, and

(ii) such other means as the Secretary determines

appropriate.

(3) Omitted

(f) Standards

(1) In general

The Secretary shall issue standards to assure consistent

performance by laboratories issued a certificate under this

section of valid and reliable laboratory examinations and other

procedures. Such standards shall require each laboratory issued a

certificate under this section -

(A) to maintain a quality assurance and quality control

program adequate and appropriate for the validity and

reliability of the laboratory examinations and other procedures

of the laboratory and to meet requirements relating to the

proper collection, transportation, and storage of specimens and

the reporting of results,

(B) to maintain records, equipment, and facilities necessary

for the proper and effective operation of the laboratory,

(C) in performing and carrying out its laboratory

examinations and other procedures, to use only personnel

meeting such qualifications as the Secretary may establish for

the direction, supervision, and performance of examinations and

procedures within the laboratory, which qualifications shall

take into consideration competency, training, experience, job

performance, and education and which qualifications shall, as

appropriate, be different on the basis of the type of

examinations and procedures being performed by the laboratory

and the risks and consequences of erroneous results associated

with such examinations and procedures,

(D) to qualify under a proficiency testing program meeting

the standards established by the Secretary under paragraph (3),

and

(E) to meet such other requirements as the Secretary

determines necessary to assure consistent performance by such

laboratories of accurate and reliable laboratory examinations

and procedures.

(2) Considerations

In developing the standards to be issued under paragraph (1),

the Secretary shall, within the flexibility provided under

subparagraphs (A) through (E) of paragraph (1), take into

consideration -

(A) the examinations and procedures performed and the

methodologies employed,

(B) the degree of independent judgment involved,

(C) the amount of interpretation involved,

(D) the difficulty of the calculations involved,

(E) the calibration and quality control requirements of the

instruments used,

(F) the type of training required to operate the instruments

used in the methodology, and

(G) such other factors as the Secretary considers relevant.

(3) Proficiency testing program

(A) In general

The Secretary shall establish standards for the proficiency

testing programs for laboratories issued a certificate under

this section which are conducted by the Secretary, conducted by

an organization approved under subparagraph (C), or conducted

by an approved accrediting body. The standards shall require

that a laboratory issued a certificate under this section be

tested for each examination and procedure conducted within a

category of examinations or procedures for which it has

received a certificate, except for examinations and procedures

for which the Secretary has determined that a proficiency test

cannot reasonably be developed. The testing shall be conducted

on a quarterly basis, except where the Secretary determines for

technical and scientific reasons that a particular examination

or procedure may be tested less frequently (but not less often

than twice per year).

(B) Criteria

The standards established under subparagraph (A) shall

include uniform criteria for acceptable performance under a

proficiency testing program, based on the available technology

and the clinical relevance of the laboratory examination or

other procedure subject to such program. The criteria shall be

established for all examinations and procedures and shall be

uniform for each examination and procedure. The standards shall

also include a system for grading proficiency testing

performance to determine whether a laboratory has performed

acceptably for a particular quarter and acceptably for a

particular examination or procedure or category of examination

or procedure over a period of successive quarters.

(C) Approved proficiency testing programs

For the purpose of administering proficiency testing programs

which meet the standards established under subparagraph (A),

the Secretary shall approve a proficiency testing program

offered by a private nonprofit organization or a State if the

program meets the standards established under subparagraph (A)

and the organization or State provides technical assistance to

laboratories seeking to qualify under the program. The

Secretary shall evaluate each program approved under this

subparagraph annually to determine if the program continues to

meet the standards established under subparagraph (A) and shall

withdraw the approval of any program that no longer meets such

standards.

(D) Onsite testing

The Secretary shall perform, or shall direct a program

approved under subparagraph (C) to perform, onsite proficiency

testing to assure compliance with the requirements of

subsection (d)(5) of this section. The Secretary shall perform,

on an onsite or other basis, proficiency testing to evaluate

the performance of a proficiency testing program approved under

subparagraph (C) and to assure quality performance by a

laboratory.

(E) Training, technical assistance, and enhanced proficiency

testing

The Secretary may, in lieu of or in addition to actions

authorized under subsection (h), (i), or (j) of this section,

require any laboratory which fails to perform acceptably on an

individual examination and procedure or a category of

examination and procedures -

(i) to undertake training and to obtain the necessary

technical assistance to meet the requirements of the

proficency (!2) testing program,

(ii) to enroll in a program of enhanced proficiency

testing, or

(iii) to undertake any combination of the training,

technical assistance, or testing described in clauses (i) and

(ii).

(F) Testing results

The Secretary shall establish a system to make the results of

the proficiency testing programs subject to the standards

established by the Secretary under subparagraph (A) available,

on a reasonable basis, upon request of any person. The

Secretary shall include with results made available under this

subparagraph such explanatory information as may be appropriate

to assist in the interpretation of such results.

(4) National standards for quality assurance in cytology services

(A) Establishment

The Secretary shall establish national standards for quality

assurance in cytology services designed to assure consistent

performance by laboratories of valid and reliable cytological

services.

(B) Standards

The standards established under subparagraph (A) shall

include -

(i) the maximum number of cytology slides that any

individual may screen in a 24-hour period,

(ii) requirements that a clinical laboratory maintain a

record of (I) the number of cytology slides screened during

each 24-hour period by each individual who examines cytology

slides for the laboratory, and (II) the number of hours

devoted during each 24-hour period to screening cytology

slides by such individual,

(iii) criteria for requiring rescreening of cytological

preparations, such as (I) random rescreening of cytology

specimens determined to be in the benign category, (II)

focused rescreening of such preparations in high risk groups,

and (III) for each abnormal cytological result, rescreening

of all prior cytological specimens for the patient, if

available,

(iv) periodic confirmation and evaluation of the

proficiency of individuals involved in screening or

interpreting cytological preparations, including announced

and unannounced on-site proficiency testing of such

individuals, with such testing to take place, to the extent

practicable, under normal working conditions,

(v) procedures for detecting inadequately prepared slides,

for assuring that no cytological diagnosis is rendered on

such slides, and for notifying referring physicians of such

slides,

(vi) requirements that all cytological screening be done on

the premises of a laboratory that is certified under this

section,

(vii) requirements for the retention of cytology slides by

laboratories for such periods of time as the Secretary

considers appropriate, and

(viii) standards requiring periodic inspection of cytology

services by persons capable of evaluating the quality of

cytology services.

(g) Inspections

(1) In general

The Secretary may, on an announced or unannounced basis, enter

and inspect, during regular hours of operation, laboratories

which have been issued a certificate under this section. In

conducting such inspections the Secretary shall have access to

all facilities, equipment, materials, records, and information

that the Secretary determines have a bearing on whether the

laboratory is being operated in accordance with this section. As

part of such an inspection the Secretary may copy any such

material or require to it (!3) be submitted to the Secretary. An

inspection under this paragraph may be made only upon presenting

identification to the owner, operator, or agent in charge of the

laboratory being inspected.

(2) Compliance with requirements and standards

The Secretary shall conduct inspections of laboratories under

paragraph (1) to determine their compliance with the requirements

of subsection (d) of this section and the standards issued under

subsection (f) of this section. Inspections of laboratories not

accredited under subsection (e) of this section shall be

conducted on a biennial basis or with such other frequency as the

Secretary determines to be necessary to assure compliance with

such requirements and standards. Inspections of laboratories

accredited under subsection (e) of this section shall be

conducted on such basis as the Secretary determines is necessary

to assure compliance with such requirements and standards.

(h) Intermediate sanctions

(1) In general

If the Secretary determines that a laboratory which has been

issued a certificate under this section no longer substantially

meets the requirements for the issuance of a certificate, the

Secretary may impose intermediate sanctions in lieu of the

actions authorized by subsection (i) of this section.

(2) Types of sanctions

The intermediate sanctions which may be imposed under paragraph

(1) shall consist of -

(A) directed plans of correction,

(B) civil money penalties in an amount not to exceed $10,000

for each violation listed in subsection (i)(1) of this section

or for each day of substantial noncompliance with the

requirements of this section,

(C) payment for the costs of onsite monitoring, or

(D) any combination of the actions described in subparagraphs

(A), (B), and (C).

(3) Procedures

The Secretary shall develop and implement procedures with

respect to when and how each of the intermediate sanctions is to

be imposed under paragraph (1). Such procedures shall provide for

notice to the laboratory and a reasonable opportunity to respond

to the proposed sanction and appropriate procedures for appealing

determinations relating to the imposition of intermediate

sanctions (!4)

(i) Suspension, revocation, and limitation

(1) In general

Except as provided in paragraph (2), the certificate of a

laboratory issued under this section may be suspended, revoked,

or limited if the Secretary finds, after reasonable notice and

opportunity for hearing to the owner or operator of the

laboratory, that such owner or operator or any employee of the

laboratory -

(A) has been guilty of misrepresentation in obtaining the

certificate,

(B) has performed or represented the laboratory as entitled

to perform a laboratory examination or other procedure which is

not within a category of laboratory examinations or other

procedures authorized in the certificate,

(C) has failed to comply with the requirements of subsection

(d) of this section or the standards prescribed by the

Secretary under subsection (f) of this section,

(D) has failed to comply with reasonable requests of the

Secretary for -

(i) any information or materials, or

(ii) work on materials,

that the Secretary concludes is necessary to determine the

laboratory's continued eligibility for its certificate or

continued compliance with the Secretary's standards under

subsection (f) of this section,

(E) has refused a reasonable request of the Secretary, or any

Federal officer or employee duly designated by the Secretary,

for permission to inspect the laboratory and its operations and

pertinent records during the hours the laboratory is in

operation,

(F) has violated or aided and abetted in the violation of any

provisions of this section or of any regulation promulgated

thereunder, or

(G) has not complied with an intermediate sanction imposed

under subsection (h) of this section.

(2) Action before a hearing

If the Secretary determines that -

(A) the failure of a laboratory to comply with the standards

of the Secretary under subsection (f) of this section presents

an imminent and serious risk to human health, or

(B) a laboratory has engaged in an action described in

subparagraph (D) or (E) of paragraph (1),

the Secretary may suspend or limit the certificate of the

laboratory before holding a hearing under paragraph (1) regarding

such failure or refusal. The opportunity for a hearing shall be

provided no later than 60 days from the effective date of the

suspension or limitation. A suspension or limitation under this

paragraph shall stay in effect until the decision of the

Secretary made after the hearing under paragraph (1).

(3) Ineligibility to own or operate laboratories after revocation

No person who has owned or operated a laboratory which has had

its certificate revoked may, within 2 years of the revocation of

the certificate, own or operate a laboratory for which a

certificate has been issued under this section. The certificate

of a laboratory which has been excluded from participation under

the medicare program under title XVIII of the Social Security Act

[42 U.S.C. 1395 et seq.] because of actions relating to the

quality of the laboratory shall be suspended for the period the

laboratory is so excluded.

(4) Improper referrals

Any laboratory that the Secretary determines intentionally

refers its proficiency testing samples to another laboratory for

analysis shall have its certificate revoked for at least one year

and shall be subject to appropriate fines and penalties as

provided for in subsection (h) of this section.

(j) Injunctions

Whenever the Secretary has reason to believe that continuation of

any activity by a laboratory would constitute a significant hazard

to the public health the Secretary may bring suit in the district

court of the United States for the district in which such

laboratory is situated to enjoin continuation of such activity.

Upon proper showing, a temporary injunction or restraining order

against continuation of such activity pending issuance of a final

order under this subsection shall be granted without bond by such

court.

(k) Judicial review

(1) Petition

Any laboratory which has had an intermediate sanction imposed

under subsection (h) of this section or has had its certificate

suspended, revoked, or limited under subsection (i) of this

section may, at any time within 60 days after the date the action

of the Secretary under subsection (i) or (h) of this section

becomes final, file a petition with the United States court of

appeals for the circuit wherein the laboratory has its principal

place of business for judicial review of such action. As soon as

practicable after receipt of the petition, the clerk of the court

shall transmit a copy of the petition to the Secretary or other

officer designated by the Secretary for that purpose. As soon as

practicable after receipt of the copy, the Secretary shall file

in the court the record on which the action of the Secretary is

based, as provided in section 2112 of title 28.

(2) Additional evidence

If the petitioner applies to the court for leave to adduce

additional evidence, and shows to the satisfaction of the court

that such additional evidence is material and that there were

reasonable grounds for the failure to adduce such evidence in the

proceeding before the Secretary, the court may order such

additional evidence (and evidence in rebuttal of such additional

evidence) to be taken before the Secretary, and to be adduced

upon the hearing in such manner and upon such terms and

conditions as the court may deem proper. The Secretary may modify

the findings of the Secretary as to the facts, or make new

findings, by reason of the additional evidence so taken, and the

Secretary shall file such modified or new findings, and the

recommendations of the Secretary, if any, for the modification or

setting aside of his original action, with the return of such

additional evidence.

(3) Judgment of court

Upon the filing of the petition referred to in paragraph (1),

the court shall have jurisdiction to affirm the action, or to set

it aside in whole or in part, temporarily or permanently. The

findings of the Secretary as to the facts, if supported by

substantial evidence, shall be conclusive.

(4) Finality of judgment

The judgment of the court affirming or setting aside, in whole

or in part, any such action of the Secretary shall be final,

subject to review by the Supreme Court of the United States upon

certiorari or certification as provided in section 1254 of title

28.

(l) Sanctions

Any person who intentionally violates any requirement of this

section or any regulation promulgated thereunder shall be

imprisoned for not more than one year or fined under title 18, or

both, except that if the conviction is for a second or subsequent

violation of such a requirement such person shall be imprisoned for

not more than 3 years or fined in accordance with title 18, or

both.

(m) Fees

(1) Certificate fees

The Secretary shall require payment of fees for the issuance

and renewal of certificates, except that the Secretary shall only

require a nominal fee for the issuance and renewal of

certificates of waiver.

(2) Additional fees

The Secretary shall require the payment of fees for inspections

of laboratories which are not accredited and for the cost of

performing proficiency testing on laboratories which do not

participate in proficiency testing programs approved under

subsection (f)(3)(C) of this section.

(3) Criteria

(A) Fees under paragraph (1)

Fees imposed under paragraph (1) shall be sufficient to cover

the general costs of administering this section, including

evaluating and monitoring proficiency testing programs approved

under subsection (f) of this section and accrediting bodies and

implementing and monitoring compliance with the requirements of

this section.

(B) Fees under paragraph (2)

Fees imposed under paragraph (2) shall be sufficient to cover

the cost of the Secretary in carrying out the inspections and

proficiency testing described in paragraph (2).

(C) Fees imposed under paragraphs (1) and (2)

Fees imposed under paragraphs (1) and (2) shall vary by group

or classification of laboratory, based on such considerations

as the Secretary determines are relevant, which may include the

dollar volume and scope of the testing being performed by the

laboratories.

(n) Information

On April 1, 1990 and annually thereafter, the Secretary shall

compile and make available to physicians and the general public

information, based on the previous calendar year, which the

Secretary determines is useful in evaluating the performance of a

laboratory, including -

(1) a list of laboratories which have been convicted under

Federal or State laws relating to fraud and abuse, false

billings, or kickbacks,

(2) a list of laboratories -

(A) which have had their certificates revoked, suspended, or

limited under subsection (i) of this section, or

(B) which have been the subject of a sanction under

subsection (l) of this section,

together with a statement of the reasons for the revocation,

suspension, limitation, or sanction,

(3) a list of laboratories subject to intermediate sanctions

under subsection (h) of this section together with a statement of

the reasons for the sanctions,

(4) a list of laboratories whose accreditation has been

withdrawn or revoked together with a statement of the reasons for

the withdrawal or revocation,

(5) a list of laboratories against which the Secretary has

taken action under subsection (j) of this section together with a

statement of the reasons for such action, and

(6) a list of laboratories which have been excluded from

participation under title XVIII or XIX of the Social Security Act

[42 U.S.C. 1395 et seq., 1396 et seq.].

The information to be compiled under paragraphs (1) through (6)

shall be information for the calendar year preceding the date the

information is to be made available to the public and shall be

accompanied by such explanatory information as may be appropriate

to assist in the interpretation of the information compiled under

such paragraphs.

(o) Delegation

In carrying out this section, the Secretary may, pursuant to

agreement, use the services or facilities of any Federal or State

or local public agency or nonprofit private organization, and may

pay therefor in advance or by way of reimbursement, and in such

installments, as the Secretary may determine.

(p) State laws

(1) Except as provided in paragraph (2), nothing in this section

shall be construed as affecting the power of any State to enact and

enforce laws relating to the matters covered by this section to the

extent that such laws are not inconsistent with this section or

with the regulations issued under this section.

(2) If a State enacts laws relating to matters covered by this

section which provide for requirements equal to or more stringent

than the requirements of this section or than the regulations

issued under this section, the Secretary may exempt clinical

laboratories in that State from compliance with this section.

(q) Consultations

In carrying out this section, the Secretary shall consult with

appropriate private organizations and public agencies.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 353, as added Pub. L.

90-174, Sec. 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L.

100-578, Sec. 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105-115,

title I, Sec. 123(h), Nov. 21, 1997, 111 Stat. 2324.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsecs. (i)(3) and

(n)(6), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended.

Titles XVIII and XIX of the Social Security Act are classified

generally to subchapters XVIII (Sec. 1395 et seq.) and XIX (Sec.

1396 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.

-COD-

CODIFICATION

Subsec. (e)(3) of this section, which required the Secretary to

annually prepare and submit to certain committees of Congress a

report describing the results of the evaluation conducted under

subsec. (e)(2)(D) of this section, terminated, effective May 15,

2000, pursuant to section 3003 of Pub. L. 104-66, as amended, set

out as a note under section 1113 of Title 31, Money and Finance.

See, also, page 96 of House Document No. 103-7.

-MISC1-

AMENDMENTS

1997 - Subsec. (d)(3). Pub. L. 105-115 amended heading and text

of par. (3) generally. Prior to amendment, text read as follows:

"The examinations and procedures identified in paragraph (2) are

simple laboratory examinations and procedures which, as determined

by the Secretary, have an insignificant risk of an erroneous

result, including those which -

"(A) have been approved by the Food and Drug Administration for

home use,

"(B) employ methodologies that are so simple and accurate as to

render the likelihood of erroneous results negligible, or

"(C) the Secretary has determined pose no reasonable risk of

harm to the patient if performed incorrectly."

1988 - Pub. L. 100-578 substituted "Certification of

laboratories" for "Licensing of laboratories" in section catchline,

and amended text generally, revising and restating as subsecs. (a)

to (q) provisions of former subsecs. (a) to (l).

EFFECTIVE DATE OF 1997 AMENDMENT

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21,

1997, except as otherwise provided, see section 501 of Pub. L.

105-115, set out as a note under section 321 of Title 21, Food and

Drugs.

EFFECTIVE DATE OF 1988 AMENDMENT; EXCEPTIONS; CONTINUING

APPLICABILITY

Section 3 of Pub. L. 100-578 provided that: "Subsections (g)(1),

(h), (i), (j), (k), (l), and (m) of section 353 of the Public

Health Service Act [this section], as amended by section 101

[probably means section 2 of Pub. L. 100-578], shall take effect

January 1, 1989, except that any reference in such subsections to

the standards established under subsection (f) shall be considered

a reference to the standards established under subsection (d) of

such section 353, as in effect on December 31, 1988. During the

period beginning January 1, 1989, and ending December 31, 1989,

subsections (a) through (d) and subsection (i) through (l) of such

section 353 as in effect on December 31, 1988, shall continue to

apply to clinical laboratories. The remaining subsections of such

section 353, as so amended, shall take effect January 1, 1990,

except that subsections (f)(1)(C) and (g)(2) shall take effect July

1, 1991, with respect to laboratories which were not subject to the

requirements of such section 353 as in effect on December 31,

1988."

EFFECTIVE DATE

Section 5(b) of Pub. L. 90-174 provided that: "The amendment made

by subsection (a) [enacting this section] shall become effective on

the first day of the thirteenth month after the month [December

1967] in which it is enacted, except that the Secretary of Health,

Education, and Welfare may postpone such effective date for such

additional period as he finds necessary, but not beyond the first

day of the 19th month after such month [December 1967] in which the

amendment is enacted."

STUDIES

Section 4 of Pub. L. 100-578 directed Secretary to conduct

studies and submit report to Congress, not later than May 1, 1990,

relating to the reliability and quality control procedures of

clinical laboratory testing programs and the effect of errors in

the testing procedures and results on the diagnosis and treatment

of patients.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-2, 300aa-2, 1395x,

1395aa of this title; title 35 section 287.

-FOOTNOTE-

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

(!2) So in original. Probably should be "proficiency".

(!3) So in original. Probably should be "require it to".

(!4) So in original. Probably should be followed by a period.

-End-

-CITE-

42 USC Sec. 263a-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-1. Assisted reproductive technology programs

-STATUTE-

(a) In general

Effective 2 years after October 24, 1992, each assisted

reproductive technology (as defined in section 263a-7 (!1) of this

title) program shall annually report to the Secretary through the

Centers for Disease Control -

(1) pregnancy success rates achieved by such program through

each assisted reproductive technology, and

(2) the identity of each embryo laboratory (as defined in

section 263a-7 (!1) of this title) used by such program and

whether the laboratory is certified under section 263a-2 of this

title or has applied for such certification.

(b) Pregnancy success rates

(1) In general

For purposes of subsection (a)(1) of this section, the

Secretary shall, in consultation with the organizations

referenced in subsection (c) of this section, define pregnancy

success rates and shall make public any proposed definition in

such manner as to facilitate comment from any person (including

any Federal or other public agency) during its development.

(2) Definition

In developing the definition of pregnancy success rates, the

Secretary shall take into account the effect on success rates of

age, diagnosis, and other significant factors and shall include

in such rates -

(A) the basic live birth rate calculated for each assisted

reproductive technology performed by an assisted reproductive

technology program by dividing the number of pregnancies which

result in live births by the number of ovarian stimulation

procedures attempted by such program, and

(B) the live birth rate per successful oocyte retrieval

procedure calculated for each assisted reproductive technology

performed by an assisted reproductive technology program by

dividing the number of pregnancies which result in live births

by the number of successful oocyte retrieval procedures

performed by such program.

(c) Consultation

In developing the definition under subsection (b) of this

section, the Secretary shall consult with appropriate consumer and

professional organizations with expertise in using, providing, and

evaluating professional services and embryo laboratories associated

with assisted reproductive technologies.

-SOURCE-

(Pub. L. 102-493, Sec. 2, Oct. 24, 1992, 106 Stat. 3146.)

-REFTEXT-

REFERENCES IN TEXT

Section 263a-7 of this title, referred to in subsec. (a), was in

the original "section 7" meaning section 7 of Pub. L. 102-493,

which was translated as reading section 8 to reflect the probable

intent of Congress, because definitions are contained in section 8

instead of section 7.

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-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.

-MISC1-

EFFECTIVE DATE

Section 9 of Pub. L. 102-493 provided that: "This Act [enacting

this section, sections 263a-2 to 263a-7 of this title, and

provisions set out as a note under section 201 of this title] shall

take effect upon the expiration of 2 years after the date of the

enactment of this Act [Oct. 24, 1992]."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 263a-5, 263a-6, 263a-7 of

this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 263a-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-2. Certification of embryo laboratories

-STATUTE-

(a) In general

(1) Development

Not later than 2 years after October 24, 1992, the Secretary,

through the Centers for Disease Control, shall develop a model

program for the certification of embryo laboratories (referred to

in this section as a "certification program") to be carried out

by the States.

(2) Consultation

In developing the certification program under paragraph (1),

the Secretary shall consult with appropriate consumer and

professional organizations with expertise in using, providing,

and evaluating professional services and embryo laboratories

associated with the assisted reproductive technology programs.

(b) Distribution

The Secretary shall distribute a description of the certification

program to -

(1) the Governor of each State,

(2) the presiding officers of each State legislature,

(3) the public health official of each State, and

(4) the official responsible in each State for the operation of

the State's contract with the Secretary under section 1395aa of

this title,

and shall encourage such officials to assist in the State adopting

such program.

(c) Requirements

The certification program shall include the following

requirements:

(1) Administration

The certification program shall be administered by the State

and shall provide for the inspection and certification of embryo

laboratories in the State by the State or by approved

accreditation organizations.

(2) Application requirements

The certification program shall provide for the submission of

an application to a State by an embryo laboratory for

certification, in such form as may be specified by the State.

Such an application shall include -

(A) assurances satisfactory to the State that the embryo

laboratory will be operated in accordance with the standards

under subsection (d) of this section,

(B) a report to the State identifying the assisted

reproductive technology programs with which the laboratory is

associated, and

(C) such other information as the State finds necessary.

An embryo laboratory which meets the requirements of section 263a

of this title shall, for the purposes of subparagraph (A) be

considered in compliance with the standards referred to in such

subparagraph which are the same as the standards in effect under

section 263a of this title.

(d) Standards

The certification program shall include the following standards

developed by the Secretary:

(1) A standard to assure consistent performance of procedures

by each embryo laboratory certified under the certification

program or by an approved accreditation organization in a State

which has not adopted the certification program.

(2) A standard for a quality assurance and a quality control

program to assure valid, reliable, and reproduceable (!1)

procedures in the laboratory.

(3) A standard for the maintenance of records (on a program by

program basis) on laboratory tests and procedures performed,

including the scientific basis of, and the methodology used for,

the tests, procedures, and preparation of any standards or

controls, criteria for acceptable and unacceptable outcomes,

criteria for sample rejection, and procedures for safe sample

disposal.

(4) A standard for the maintenance of written records on

personnel and facilities necessary for proper and effective

operation of the laboratory, schedules of preventive maintenance,

function verification for equipment, and the release of such

records to the State upon demand.

(5) A standard for the use of such personnel who meet such

qualifications as the Secretary may develop.

(e) Certification under State programs

A State may qualify to adopt the certification program if the

State has submitted an application to the Secretary to adopt such

program and the Secretary has approved the application. Such an

application shall include -

(1) assurances by the State satisfactory to the Secretary that

the certification program within the State meets the requirements

of this section,

(2) an agreement to make such reports as the Secretary may

require, and

(3) information about any proposed use of accreditation

organizations under subsection (g) (!2) of this section.

(f) Use of accreditation organizations

A State which has adopted the certification program may use

accreditation organizations approved under section 263a-3 of this

title to inspect and certify embryo laboratories.

(g) Inspections

(1) In general

A State which qualifies to adopt the certification program

within the State shall conduct inspections in accordance with

paragraph (2) to determine if laboratories in the State meet the

requirements of such program. Such inspections shall be carried

out by the State or by accreditation organizations used by the

State under subsection (g) (!2) of this section.

(2) Requirements

Inspections carried out under paragraph (1) shall -

(A) be periodic and unannounced, or

(B) be announced in such circumstances as the Secretary

determines will not diminish the likelihood of discovering

deficiencies in the operations of a laboratory.

Before making a determination under subparagraph (B), the

Secretary shall make public, in such manner as to facilitate

comment from any person (including any Federal or other public

agency), a proposal indicating the circumstances under which

announced inspections would be permitted.

(3) Results

The specific findings, including deficiencies, identified in an

inspection carried out under paragraph (1) and any subsequent

corrections to those deficiencies shall be announced and made

available to the public upon request beginning no later than 60

days after the date of the inspection.

(h) Validation inspections

(1) In general

The Secretary may enter and inspect, during regular hours of

operation, embryo laboratories -

(A) which have been certified by a State under the

certification program, or

(B) which have been certified by an accreditation

organization approved by the Secretary under section 263a-3 of

this title,

for the purpose of determining whether the laboratory is being

operated in accordance with the standards in subsection (d) of

this section.

(2) Access to facilities and records

In conducting an inspection of an embryo laboratory under

paragraph (1), the Secretary shall have access to all facilities,

equipment, materials, records, and information which the

Secretary determines is necessary to determine if such laboratory

is being operated in accordance with the standards in subsection

(d) of this section. As part of such an inspection, the Secretary

may copy any material, record, or information inspected or

require it to be submitted to the Secretary. Such an inspection

may be made only upon the presentation of identification to the

owner, operator, or agent in charge of the laboratory being

inspected.

(3) Failure to comply

If the Secretary determines as a result of an inspection under

paragraph (1) that the embryo laboratory is not in compliance

with the standards in subsection (d) of this section, the

Secretary shall -

(A) notify the State in which the laboratory is located and,

if appropriate, the accreditation organization which certified

the laboratory,

(B) make available to the public the results of the

inspection,

(C) conduct additional inspections of other embryo

laboratories under paragraph (1) to determine if -

(i) such State in carrying out the certification program is

reliably identifying the deficiencies of such laboratory, or

(ii) the accreditation organization which certified such

laboratories is reliably identifying such deficencies,(!3)

and

(D) if the Secretary determines -

(i) that such State in carrying out the certification

program has not met the requirements applicable to such

program, or

(ii) the accreditation organization which certified such

laboratory has not met the requirements of section 263a-3 of

this title,

the Secretary may revoke the approval of the State certification

program or revoke the approval of such accreditation

organization.

(i) Limitation

(1) Secretary

In developing the certification program, the Secretary may not

establish any regulation, standard, or requirement which has the

effect of exercising supervision or control over the practice of

medicine in assisted reproductive technology programs.

(2) State

In adopting the certification program, a State may not

establish any regulation, standard, or requirement which has the

effect of exercising supervision or control over the practice of

medicine in assisted reproductive technology programs.

(j) Term

The term of a certification issued by a State or an accreditation

organization in a State shall be prescribed by the Secretary in the

certification program and shall be valid for a period of time to be

defined by the Secretary through the public comment process

described in subsection (h)(2) (!4) of this section. The Secretary

shall provide an application for recertification to be submitted at

the time of changes in the ownership of a certified laboratory or

changes in the administration of such a laboratory.

-SOURCE-

(Pub. L. 102-493, Sec. 3, Oct. 24, 1992, 106 Stat. 3146.)

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-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.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-1, 263a-3, 263a-4,

263a-5, 263a-6, 263a-7 of this title.

-FOOTNOTE-

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

(!2) So in original. Probably should be subsection "(f)".

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

(!4) So in original. Probably should be subsection "(g)(2)".

-End-

-CITE-

42 USC Sec. 263a-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-3. Accreditation organizations

-STATUTE-

(a) Approval of accreditation organizations

Not later than 2 years after October 24, 1992, the Secretary,

through the Centers for Disease Control, shall promulgate criteria

and procedures for the approval of accreditation organizations to

inspect and certify embryo laboratories. The procedures shall

require an application to the Secretary by an accreditation

organization for approval. An accreditation organization which has

received such an approval -

(1) may be used by States in the certification program under

section 263a-2 of this title to inspect and certify embryo

laboratories, or

(2) may certify embryo laboratories in States which have not

adopted such a certification program.

(b) Criteria and procedures

The criteria and procedures promulgated under subsection (a) of

this section shall include -

(1) requirements for submission of such reports and the

maintenance of such records as the Secretary or a State may

require, and

(2) requirements for the conduct of inspections under section

263a-2(h) (!1) of this title.

(c) Evaluations

The Secretary shall evaluate annually the performance of each

accreditation organization approved by the Secretary by -

(1) inspecting under section 263a-2(i) (!2) of this title a

sufficient number of embryo laboratories accredited by such an

organization to allow a reasonable estimate of the performance of

such organization, and

(2) such other means as the Secretary determines to be

appropriate.

(d) Transition

If the Secretary revokes approval under section 263a-2(i)(3)(D)

(!3) of this title of an accreditation organization after an

evaluation under subsection (c) of this section, the certification

of any embryo laboratory accredited by the organization shall

continue in effect for 60 days after the laboratory is notified by

the Secretary of the withdrawal of approval, except that the

Secretary may extend the period during which the certification

shall remain in effect if the Secretary determines that the

laboratory submitted an application to another approved

accreditation organization for certification after receipt of such

notice in a timely manner.

-SOURCE-

(Pub. L. 102-493, Sec. 4, Oct. 24, 1992, 106 Stat. 3150.)

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-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.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-2, 263a-5, 263a-6,

263a-7 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be section "263a-2(g)".

(!2) So in original. Probably should be section "263a-2(h)".

(!3) So in original. Probably should be section

"263a-2(h)(3)(D)".

-End-

-CITE-

42 USC Sec. 263a-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-4. Certification revocation and suspension

-STATUTE-

(a) In general

A certification issued by a State or an accreditation

organization for an embryo laboratory shall be revoked or suspended

if the State or organization finds, on the basis of inspections and

after reasonable notice and opportunity for hearing to the owner or

operator of the laboratory, that the owner or operator or any

employee of the laboratory -

(1) has been guilty of misrepresentation in obtaining the

certification,

(2) has failed to comply with any standards under section

263a-2 of this title applicable to the certification, or

(3) has refused a request of the State or accreditation

organization for permission to inspect the laboratory, its

operations, and records.

(b) Effect

If the certification of an embryo laboratory is revoked or

suspended, the certification of the laboratory shall continue in

effect for 60 days after the laboratory receives notice of the

revocation or suspension. If the certification of an embryo

laboratory is revoked or suspended, the laboratory may apply for

recertification after one year after the date of the revocation or

suspension.

-SOURCE-

(Pub. L. 102-493, Sec. 5, Oct. 24, 1992, 106 Stat. 3150.)

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-6, 263a-7 of this

title.

-End-

-CITE-

42 USC Sec. 263a-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-5. Publication

-STATUTE-

The Secretary, through the Centers for Disease Control, shall not

later than 3 years after October 24, 1992, and annually thereafter

publish and distribute to the States and the public -

(1)(A) (!1) pregnancy success rates reported to the Secretary

under section 263a-1(a)(1) of this title and, in the case of an

assisted reproductive technology program which failed to report

one or more success rates as required under such section, the

name of each such program and each pregnancy success rate which

the program failed to report, and

(B) from information reported under section 263a-1(a)(2) of

this title -

(i) the identity of each embryo laboratory in a State which

has adopted the certification program under such program and

whether such laboratory is certified under section 263a-2 of

this title,

(ii) the identity of each embryo laboratory in a State which

has not adopted such certification program and which has been

certified by an accreditation organization approved by the

Secretary under section 263a-3 of this title, and

(iii) in the case of an embryo laboratory which is not

certified under section 263a-2 of this title or certified by an

accreditation organization approved by the Secretary under

section 263a-3 of this title, whether the laboratory applied

for certification.

-SOURCE-

(Pub. L. 102-493, Sec. 6, Oct. 24, 1992, 106 Stat. 3151.)

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-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.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-6, 263a-7 of this

title.

-FOOTNOTE-

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

-End-

-CITE-

42 USC Sec. 263a-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-6. Fees

-STATUTE-

The Secretary may require the payment of fees for the purpose of,

and in an amount sufficient to cover the cost of, administering

sections 263a-1 to 263a-7 of this title. A State operating a

program under section 263a-2 of this title may require the payment

of fees for the purpose of, and in an amount sufficient to cover

the costs of, administering its program.

-SOURCE-

(Pub. L. 102-493, Sec. 7, Oct. 24, 1992, 106 Stat. 3151.)

-REFTEXT-

REFERENCES IN TEXT

Sections 263a-1 to 263a-7 of this title, referred to in text, was

in the original "this Act", meaning Pub. L. 102-493, Oct. 24, 1992,

106 Stat. 3146, known as the Fertility Clinic Success Rate and

Certification Act of 1992, which enacted sections 263a-1 to 263a-7

of this title and provisions set out as notes under sections 201

and 263a-1 of this title. For complete classification of this Act

to the Code, see Short Title note set out under section 201 of this

title and Tables.

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 263a-7 of this title.

-End-

-CITE-

42 USC Sec. 263a-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 2 - clinical laboratories

-HEAD-

Sec. 263a-7. Definitions

-STATUTE-

For purposes of sections 263a-1 to 263a-7 of this title:

(1) Assisted reproductive technology

The term "assisted reproductive technology" means all

treatments or procedures which include the handling of human

oocytes or embryos, including in vitro fertilization, gamete

intrafallopian transfer, zygote intrafallopian transfer, and such

other specific technologies as the Secretary may include in this

definition, after making public any proposed definition in such

manner as to facilitate comment from any person (including any

Federal or other public agency).

(2) Embryo laboratory

The term "embryo laboratory" means a facility in which human

oocytes are subject to assisted reproductive technology treatment

or procedures based on manipulation of oocytes or embryos which

are subject to implantation.

(3) Secretary

The term "Secretary" means the Secretary of Health and Human

Services.

-SOURCE-

(Pub. L. 102-493, Sec. 8, Oct. 24, 1992, 106 Stat. 3151.)

-REFTEXT-

REFERENCES IN TEXT

Sections 263a-1 to 263a-7 of this title, referred to in text, was

in the original "this Act", meaning Pub. L. 102-493, Oct. 24, 1992,

106 Stat. 3146, known as the Fertility Clinic Success Rate and

Certification Act of 1992, which enacted sections 263a-1 to 263a-7

of this title and provisions set out as notes under sections 201

and 263a-1 of this title. For complete classification of this Act

to the Code, see Short Title note set out under section 201 of this

title and Tables.

-COD-

CODIFICATION

Section was enacted as part of the Fertility Clinic Success Rate

and Certification Act of 1992, and not as part of the Public Health

Service Act which comprises this chapter.

-MISC1-

EFFECTIVE DATE

Section effective upon expiration of 2 years after Oct. 24, 1992,

see section 9 of Pub. L. 102-493, set out as a note under section

263a-1 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 263a-1, 263a-6 of this

title.

-End-

-CITE-

42 USC subpart 3 - mammography facilities 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 3 - mammography facilities

-HEAD-

SUBPART 3 - MAMMOGRAPHY FACILITIES

-MISC1-

PRIOR PROVISIONS

A prior subpart 3 of part F of title III of the Public Health

Service Act, comprising this subpart, was renumbered subchapter C

of chapter V of the Federal Food, Drug, and Cosmetic Act, by Pub.

L. 101-629, Sec. 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, as

amended by Pub. L. 103-80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat.

779, and is classified to part C (Sec. 360hh et seq.) of subchapter

V of chapter 9 of Title 21, Food and Drugs.

-End-

-CITE-

42 USC Sec. 263b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part F - Licensing of Biological Products and Clinical Laboratories

subpart 3 - mammography facilities

-HEAD-

Sec. 263b. Certification of mammography facilities

-STATUTE-

(a) Definitions

As used in this section:

(1) Accreditation body

The term "accreditation body" means a body that has been

approved by the Secretary under subsection (e)(1)(A) of this

section to accredit mammography facilities.

(2) Certificate

The term "certificate" means the certificate described in

subsection (b)(1) of this section.

(3) Facility

(A) In general

The term "facility" means a hospital, outpatient department,

clinic, radiology practice, or mobile unit, an office of a

physician, or other facility as determined by the Secretary,

that conducts breast cancer screening or diagnosis through

mammography activities. Such term does not include a facility

of the Department of Veterans Affairs.

(B) Activities

For the purposes of this section, the activities of a

facility include the operation of equipment to produce the

mammogram, the processing of the film, the initial

interpretation of the mammogram and the viewing conditions for

that interpretation. Where procedures such as the film

processing, or the interpretation of the mammogram are

performed in a location different from where the mammogram is

performed, the facility performing the mammogram shall be

responsible for meeting the quality standards described in

subsection (f) of this section.

(4) Inspection

The term "inspection" means an onsite evaluation of the

facility by the Secretary, or State or local agency on behalf of

the Secretary.

(5) Mammogram

The term "mammogram" means a radiographic image produced

through mammography.

(6) Mammography

The term "mammography" means radiography of the breast.

(7) Survey

The term "survey" means an onsite physics consultation and

evaluation performed by a medical physicist as described in

subsection (f)(1)(E) of this section.

(8) Review physician

The term "review physician" means a physician as prescribed by

the Secretary under subsection (f)(1)(D) of this section who

meets such additional requirements as may be established by an

accreditation body under subsection (e) of this section and

approved by the Secretary to review clinical images under

subsection (e)(1)(B)(i) of this section on behalf of the

accreditation body.

(b) Certificate requirement

(1) Certificate

No facility may conduct an examination or procedure described

in paragraph (2) involving mammography after October 1, 1994,

unless the facility obtains -

(A) a certificate -

(i) that is issued, and, if applicable, renewed, by the

Secretary in accordance with subsection (c)(1) of this

section;

(ii) that is applicable to the examination or procedure to

be conducted; and

(iii) that is displayed prominently in such facility; or

(B) a provisional certificate -

(i) that is issued by the Secretary in accordance with

subsection (c)(2) of this section;

(ii) that is applicable to the examination or procedure to

be conducted; and

(iii) that is displayed prominently in such facility.

The reference to a certificate in this section includes a

provisional certificate.

(2) Examination or procedure

A facility shall obtain a certificate in order to -

(A) operate radiological equipment that is used to image the

breast;

(B) provide for the interpretation of a mammogram produced by

such equipment at the facility or under arrangements with a

qualified individual at a facility different from where the

mammography examination is performed; and

(C) provide for the processing of film produced by such

equipment at the facility or under arrangements with a

qualified individual at a facility different from where the

mammography examination is performed.

(c) Issuance and renewal of certificates

(1) In general

The Secretary may issue or renew a certificate for a facility

if the person or agent described in subsection (d)(1)(A) of this

section meets the applicable requirements of subsection (d)(1) of

this section with respect to the facility. The Secretary may

issue or renew a certificate under this paragraph for not more

than 3 years.

(2) Provisional certificate

The Secretary may issue a provisional certificate for an entity

to enable the entity to qualify as a facility. The applicant for

a provisional certificate shall meet the requirements of

subsection (d)(1) of this section, except providing information

required by clauses (iii) and (iv) of subsection (d)(1)(A) of

this section. A provisional certificate may be in effect no

longer than 6 months from the date it is issued, except that it

may be extended once for a period of not more than 90 days if the

owner, lessor, or agent of the facility demonstrates to the

Secretary that without such extension access to mammography in

the geographic area served by the facility would be significantly

reduced and if the owner, lessor, or agent of the facility will

describe in a report to the Secretary steps that will be taken to

qualify the facility for certification under subsection (b)(1) of

this section.

(d) Application for certificate

(1) Submission

The Secretary may issue or renew a certificate for a facility

if -

(A) the person who owns or leases the facility or an

authorized agent of the person, submits to the Secretary, in

such form and manner as the Secretary shall prescribe, an

application that contains at a minimum -

(i) a description of the manufacturer, model, and type of

each x-ray machine, image receptor, and processor operated in

the performance of mammography by the facility;

(ii) a description of the procedures currently used to

provide mammography at the facility, including -

(I) the types of procedures performed and the number of

such procedures performed in the prior 12 months;

(II) the methodologies for mammography; and

(III) the names and qualifications (educational

background, training, and experience) of the personnel

performing mammography and the physicians reading and

interpreting the results from the procedures;

(iii) proof of on-site survey by a qualified medical

physicist as described in subsection (f)(1)(E) of this

section; and

(iv) proof of accreditation in such manner as the Secretary

shall prescribe; and

(B) the person or agent submits to the Secretary -

(i) a satisfactory assurance that the facility will be

operated in accordance with standards established by the

Secretary under subsection (f) of this section to assure the

safety and accuracy of mammography;

(ii) a satisfactory assurance that the facility will -

(I) permit inspections under subsection (g) of this

section;

(II) make such records and information available, and

submit such reports, to the Secretary as the Secretary may

require; and

(III) update the information submitted under subparagraph

(A) or assurances submitted under this subparagraph on a

timely basis as required by the Secretary; and

(iii) such other information as the Secretary may require.

An applicant shall not be required to provide in an application

under subparagraph (A) any information which the applicant has

supplied to the accreditation body which accredited the

applicant, except as required by the Secretary.

(2) Appeal

If the Secretary denies an application for the certification of

a facility submitted under paragraph (1)(A), the Secretary shall

provide the owner or lessor of the facility or the agent of the

owner or lessor who submitted such application -

(A) a statement of the grounds on which the denial is based,

and

(B) an opportunity for an appeal in accordance with the

procedures set forth in regulations of the Secretary published

at part 498 of title 42, Code of Federal Regulations.

(3) Effect of denial

If the application for the certification of a facility is

denied, the facility may not operate unless the denial of the

application is overturned at the conclusion of the administrative

appeals process provided in the regulations referred to in

paragraph (2)(B).

(e) Accreditation

(1) Approval of accreditation bodies

(A) In general

The Secretary may approve a private nonprofit organization or

State agency to accredit facilities for purposes of subsection

(d)(1)(A)(iv) of this section if the accreditation body meets

the standards for accreditation established by the Secretary as

described in subparagraph (B) and provides the assurances

required by subparagraph (C).

(B) Standards

The Secretary shall establish standards for accreditation

bodies, including -

(i) standards that require an accreditation body to perform

-

(I) a review of clinical images from each facility

accredited by such body not less often than every 3 years

which review will be made by qualified review physicians;

and

(II) a review of a random sample of clinical images from

such facilities in each 3-year period beginning October 1,

1994, which review will be made by qualified review

physicians;

(ii) standards that prohibit individuals conducting the

reviews described in clause (i) from maintaining any

relationship to the facility undergoing review which would

constitute a conflict of interest;

(iii) standards that limit the imposition of fees for

accreditation to reasonable amounts;

(iv) standards that require as a condition of accreditation

that each facility undergo a survey at least annually by a

medical physicist as described in subsection (f)(1)(E) of

this section to ensure that the facility meets the standards

described in subparagraphs (A) and (B) of subsection (f)(1)

of this section;

(v) standards that require monitoring and evaluation of

such survey, as prescribed by the Secretary;

(vi) standards that are equal to standards established

under subsection (f) of this section which are relevant to

accreditation as determined by the Secretary; and

(vii) such additional standards as the Secretary may

require.

(C) Assurances

The accrediting body shall provide the Secretary satisfactory

assurances that the body will -

(i) comply with the standards as described in subparagraph

(B);

(ii) comply with the requirements described in paragraph

(4);

(iii) submit to the Secretary the name of any facility for

which the accreditation body denies, suspends, or revokes

accreditation;

(iv) notify the Secretary in a timely manner before the

accreditation body changes the standards of the body;

(v) notify each facility accredited by the accreditation

body if the Secretary withdraws approval of the accreditation

body under paragraph (2) in a timely manner; and

(vi) provide such other additional information as the

Secretary may require.

(D) Regulations

Not later than 9 months after October 27, 1992, the Secretary

shall promulgate regulations under which the Secretary may

approve an accreditation body.

(2) Withdrawal of approval

(A) In general

The Secretary shall promulgate regulations under which the

Secretary may withdraw the approval of an accreditation body if

the Secretary determines that the accreditation body does not

meet the standards under subparagraph (B) of paragraph (1), the

requirements of clauses (i) through (vi) of subparagraph (C) of

paragraph (1), or the requirements of paragraph (4).

(B) Effect of withdrawal

If the Secretary withdraws the approval of an accreditation

body under subparagraph (A), the certificate of any facility

accredited by the body shall continue in effect until the

expiration of a reasonable period, as determined by the

Secretary, for such facility to obtain another accreditation.

(3) Accreditation

To be accredited by an approved accreditation body a facility

shall meet -

(A) the standards described in paragraph (1)(B) which the

Secretary determines are applicable to the facility, and

(B) such other standards which the accreditation body may

require.

(4) Compliance

To ensure that facilities accredited by an accreditation body

will continue to meet the standards of the accreditation body,

the accreditation body shall -

(A) make onsite visits on an annual basis of a sufficient

number of the facilities accredited by the body to allow a

reasonable estimate of the performance of the body; and

(B) take such additional measures as the Secretary determines

to be appropriate.

Visits made under subparagraph (A) shall be made after providing

such notice as the Secretary may require.

(5) Revocation of accreditation

If an accreditation body revokes the accreditation of a

facility, the certificate of the facility shall continue in

effect until such time as may be determined by the Secretary.

(6) Evaluation and report

(A) Evaluation

The Secretary shall evaluate annually the performance of each

approved accreditation body by -

(i) inspecting under subsection (g)(2) of this section a

sufficient number of the facilities accredited by the body to

allow a reasonable estimate of the performance of the body;

and

(ii) such additional means as the Secretary determines to

be appropriate.

(B) Report

The Secretary shall annually prepare and submit to the

Committee on Labor and Human Resources of the Senate and the

Committee on Energy and Commerce of the House of

Representatives a report that describes the results of the

evaluation conducted in accordance with subparagraph (A).

(f) Quality standards

(1) In general

The standards referred to in subsection (d)(1)(B)(i) of this

section are standards established by the Secretary which include

-

(A) standards that require establishment and maintenance of a

quality assurance and quality control program at each facility

that is adequate and appropriate to ensure the reliability,

clarity, and accuracy of interpretation of mammograms and

standards for appropriate radiation dose;

(B) standards that require use of radiological equipment

specifically designed for mammography, including radiologic

standards and standards for other equipment and materials used

in conjunction with such equipment;

(C) a requirement that personnel who perform mammography -

(i)(I) be licensed by a State to perform radiological

procedures; or

(II) be certified as qualified to perform radiological

procedures by an organization described in paragraph (2)(A);

and

(ii) during the 2-year period beginning October 1, 1994,

meet training standards for personnel who perform mammography

or meet experience requirements which shall at a minimum

include 1 year of experience in the performance of

mammography; and

(iii) upon the expiration of such 2-year period meet

minimum training standards for personnel who perform

mammograms;

(D) a requirement that mammograms be interpreted by a

physician who is certified as qualified to interpret

radiological procedures, including mammography -

(i)(I) by a board described in paragraph (2)(B); or

(II) by a program that complies with the standards

described in paragraph (2)(C); and

(ii) who meets training and continuing medical education

requirements as established by the Secretary;

(E) a requirement that individuals who survey mammography

facilities be medical physicists -

(i) licensed or approved by a State to perform such

surveys, reviews, or inspections for mammography facilities;

(ii) certified in diagnostic radiological physics or

certified as qualified to perform such surveys by a board as

described in paragraph (2)(D); or

(iii) in the first 5 years after October 27, 1992, who meet

other criteria established by the Secretary which are

comparable to the criteria described in clause (i) or (ii);

(F) a requirement that a medical physicist who is qualified

in mammography as described in subparagraph (E) survey

mammography equipment and oversee quality assurance practices

at each facility;

(G) a requirement that -

(i) a facility that performs any mammogram -

(I) except as provided in subclause (II), maintain the

mammogram in the permanent medical records of the patient

for a period of not less than 5 years, or not less than 10

years if no subsequent mammograms of such patient are

performed at the facility, or longer if mandated by State

law; and

(II) upon the request of or on behalf of the patient,

transfer the mammogram to a medical institution, to a

physician of the patient, or to the patient directly; and

(ii)(I) a facility must assure the preparation of a written

report of the results of any mammography examination signed

by the interpreting physician;

(II) such written report shall be provided to the patient's

physicians (if any);

(III) if such a physician is not available or if there is

no such physician, the written report shall be sent directly

to the patient; and

(IV) whether or not such a physician is available or there

is no such physician, a summary of the written report shall

be sent directly to the patient in terms easily understood by

a lay person; and

(H) standards relating to special techniques for mammography

of patients with breast implants.

Subparagraph (G) shall not be construed to limit a patient's

access to the patient's medical records.

(2) Certification of personnel

The Secretary shall by regulation -

(A) specify organizations eligible to certify individuals to

perform radiological procedures as required by paragraph

(1)(C);

(B) specify boards eligible to certify physicians to

interpret radiological procedures, including mammography, as

required by paragraph (1)(D);

(C) establish standards for a program to certify physicians

described in paragraph (1)(D); and

(D) specify boards eligible to certify medical physicists who

are qualified to survey mammography equipment and to oversee

quality assurance practices at mammography facilities.

(g) Inspections

(1) Annual inspections

(A) In general

The Secretary may enter and inspect facilities to determine

compliance with the certification requirements under subsection

(b) of this section and the standards established under

subsection (f) of this section. The Secretary shall, if

feasible, delegate to a State or local agency the authority to

make such inspections.

(B) Identification

The Secretary, or State or local agency acting on behalf of

the Secretary, may conduct inspections only on presenting

identification to the owner, operator, or agent in charge of

the facility to be inspected.

(C) Scope of inspection

In conducting inspections, the Secretary or State or local

agency acting on behalf of the Secretary -

(i) shall have access to all equipment, materials, records,

and information that the Secretary or State or local agency

considers necessary to determine whether the facility is

being operated in accordance with this section; and

(ii) may copy, or require the facility to submit to the

Secretary or the State or local agency, any of the materials,

records, or information.

(D) Qualifications of inspectors

Qualified individuals, as determined by the Secretary, shall

conduct all inspections. The Secretary may request that a State

or local agency acting on behalf of the Secretary designate a

qualified officer or employee to conduct the inspections, or

designate a qualified Federal officer or employee to conduct

inspections. The Secretary shall establish minimum

qualifications and appropriate training for inspectors and

criteria for certification of inspectors in order to inspect

facilities for compliance with subsection (f) of this section.

(E) Frequency

The Secretary or State or local agency acting on behalf of

the Secretary shall conduct inspections under this paragraph of

each facility not less often than annually, subject to

paragraph (6).

(F) Records and annual reports

The Secretary or a State or local agency acting on behalf of

the Secretary which is responsible for inspecting mammography

facilities shall maintain records of annual inspections

required under this paragraph for a period as prescribed by the

Secretary. Such a State or local agency shall annually prepare

and submit to the Secretary a report concerning the inspections

carried out under this paragraph. Such reports shall include a

description of the facilities inspected and the results of such

inspections.

(2) Inspection of accredited facilities

The Secretary shall inspect annually a sufficient number of the

facilities accredited by an accreditation body to provide the

Secretary with a reasonable estimate of the performance of such

body.

(3) Inspection of facilities inspected by State or local agencies

The Secretary shall inspect annually facilities inspected by

State or local agencies acting on behalf of the Secretary to

assure a reasonable performance by such State or local agencies.

(4) Timing

The Secretary, or State or local agency, may conduct

inspections under paragraphs (1), (2), and (3), during regular

business hours or at a mutually agreeable time and after

providing such notice as the Secretary may prescribe, except that

the Secretary may waive such requirements if the continued

performance of mammography at such facility threatens the public

health.

(5) Limited reinspection

Nothing in this section limits the authority of the Secretary

to conduct limited reinspections of facilities found not to be in

compliance with this section.

(6) Demonstration program

(A) In general

The Secretary may establish a demonstration program under

which inspections under paragraph (1) of selected facilities

are conducted less frequently by the Secretary (or as

applicable, by State or local agencies acting on behalf of the

Secretary) than the interval specified in subparagraph (E) of

such paragraph.

(B) Requirements

Any demonstration program under subparagraph (A) shall be

carried out in accordance with the following:

(i) The program may not be implemented before April 1,

2001. Preparations for the program may be carried out prior

to such date.

(ii) In carrying out the program, the Secretary may not

select a facility for inclusion in the program unless the

facility is substantially free of incidents of noncompliance

with the standards under subsection (f) of this section. The

Secretary may at any time provide that a facility will no

longer be included in the program.

(iii) The number of facilities selected for inclusion in

the program shall be sufficient to provide a statistically

significant sample, subject to compliance with clause (ii).

(iv) Facilities that are selected for inclusion in the

program shall be inspected at such intervals as the Secretary

determines will reasonably ensure that the facilities are

maintaining compliance with such standards.

(h) Sanctions

(1) In general

In order to promote voluntary compliance with this section, the

Secretary may, in lieu of taking the actions authorized by

subsection (i) of this section, impose one or more of the

following sanctions:

(A) Directed plans of correction which afford a facility an

opportunity to correct violations in a timely manner.

(B) Payment for the cost of onsite monitoring.

(2) Patient information

If the Secretary determines that the quality of mammography

performed by a facility (whether or not certified pursuant to

subsection (c) of this section) was so inconsistent with the

quality standards established pursuant to subsection (f) of this

section as to present a significant risk to individual or public

health, the Secretary may require such facility to notify

patients who received mammograms at such facility, and their

referring physicians, of the deficiencies presenting such risk,

the potential harm resulting, appropriate remedial measures, and

such other relevant information as the Secretary may require.

(3) Civil money penalties

The Secretary may assess civil money penalties in an amount not

to exceed $10,000 for -

(A) failure to obtain a certificate as required by subsection

(b) of this section,

(B) each failure by a facility to substantially comply with,

or each day on which a facility fails to substantially comply

with, the standards established under subsection (f) of this

section or the requirements described in subclauses (I) through

(III) of subsection (d)(1)(B)(ii) of this section,

(C) each failure to notify a patient of risk as required by

the Secretary pursuant to paragraph (2), and

(D) each violation, or for each aiding and abetting in a

violation of, any provision of, or regulation promulgated

under, this section by an owner, operator, or any employee of a

facility required to have a certificate.

(4) Procedures

The Secretary shall develop and implement procedures with

respect to when and how each of the sanctions is to be imposed

under paragraphs (1) through (3). Such procedures shall provide

for notice to the owner or operator of the facility and a

reasonable opportunity for the owner or operator to respond to

the proposed sanctions and appropriate procedures for appealing

determinations relating to the imposition of sanctions.

(i) Suspension and revocation

(1) In general

The certificate of a facility issued under subsection (c) of

this section may be suspended or revoked if the Secretary finds,

after providing, except as provided in paragraph (2), reasonable

notice and an opportunity for a hearing to the owner or operator

of the facility, that the owner, operator, or any employee of the

facility -

(A) has been guilty of misrepresentation in obtaining the

certificate;

(B) has failed to comply with the requirements of subsection

(d)(1)(B)(ii)(III) of this section or the standards established

by the Secretary under subsection (f) of this section;

(C) has failed to comply with reasonable requests of the

Secretary (or of an accreditation body approved pursuant to

subsection (e) of this section) for any record, information,

report, or material that the Secretary (or such accreditation

body or State carrying out certification program requirements

pursuant to subsection (q) of this section) concludes is

necessary to determine the continued eligibility of the

facility for a certificate or continued compliance with the

standards established under subsection (f) of this section;

(D) has refused a reasonable request of the Secretary, any

Federal officer or employee duly designated by the Secretary,

or any State or local officer or employee duly designated by

the State or local agency, for permission to inspect the

facility or the operations and pertinent records of the

facility in accordance with subsection (g) of this section;

(E) has violated or aided and abetted in the violation of any

provision of, or regulation promulgated under, this section; or

(F) has failed to comply with a sanction imposed under

subsection (h) of this section.

(2) Action before a hearing

(A) In general

The Secretary may suspend the certificate of the facility

before holding a hearing required by paragraph (1) if the

Secretary has reason to believe that the circumstance of the

case will support one or more of the findings described in

paragraph (1) and that -

(i) the failure or violation was intentional; or

(ii) the failure or violation presents a serious risk to

human health.

(B) Hearing

If the Secretary suspends a certificate under subparagraph

(A), the Secretary shall provide an opportunity for a hearing

to the owner or operator of the facility not later than 60 days

from the effective date of the suspension. The suspension shall

remain in effect until the decision of the Secretary made after

the hearing.

(3) Ineligibility to own or operate facilities after revocation

If the Secretary revokes the certificate of a facility on the

basis of an act described in paragraph (1), no person who owned

or operated the facility at the time of the act may, within 2

years of the revocation of the certificate, own or operate a

facility that requires a certificate under this section.

(j) Injunctions

If the Secretary determines that -

(1) continuation of any activity related to the provision of

mammography by a facility would constitute a serious risk to

human health, the Secretary may bring suit in the district court

of the United States for the district in which the facility is

situated to enjoin continuation of the activity; and

(2) a facility is operating without a certificate as required

by subsection (b) of this section, the Secretary may bring suit

in the district court of the United States for the district in

which the facility is situated to enjoin the operation of the

facility.

Upon a proper showing, the district court shall grant a temporary

injunction or restraining order against continuation of the

activity or against operation of a facility, as the case may be,

without requiring the Secretary to post a bond, pending issuance of

a final order under this subsection.

(k) Judicial review

(1) Petition

If the Secretary imposes a sanction on a facility under

subsection (h) of this section or suspends or revokes the

certificate of a facility under subsection (i) of this section,

the owner or operator of the facility may, not later than 60 days

after the date the action of the Secretary becomes final, file a

petition with the United States court of appeals for the circuit

in which the facility is situated for judicial review of the

action. As soon as practicable after receipt of the petition, the

clerk of the court shall transmit a copy of the petition to the

Secretary or other officer designated by the Secretary. As soon

as practicable after receipt of the copy, the Secretary shall

file in the court the record on which the action of the Secretary

is based, as provided in section 2112 of title 28.

(2) Additional evidence

If the petitioner applies to the court for leave to adduce

additional evidence, and shows to the satisfaction of the court

that the additional evidence is material and that there were

reasonable grounds for the failure to adduce such evidence in the

proceeding before the Secretary, the court may order the

additional evidence (and evidence in rebuttal of the additional

evidence) to be taken before the Secretary, and to be adduced

upon the hearing in such manner and upon such terms and

conditions as the court may determine to be proper. The Secretary

may modify the findings of the Secretary as to the facts, or make

new findings, by reason of the additional evidence so taken, and

the Secretary shall file the modified or new findings, and the

recommendations of the Secretary, if any, for the modification or

setting aside of the original action of the Secretary with the

return of the additional evidence.

(3) Judgment of court

Upon the filing of the petition referred to in paragraph (1),

the court shall have jurisdiction to affirm the action, or to set

the action aside in whole or in part, temporarily or permanently.

The findings of the Secretary as to the facts, if supported by

substantial evidence, shall be conclusive.

(4) Finality of judgment

The judgment of the court affirming or setting aside, in whole

or in part, any action of the Secretary shall be final, subject

to review by the Supreme Court of the United States upon

certiorari or certification, as provided in section 1254 of title

28.

(l) Information

(1) In general

Not later than October 1, 1996, and annually thereafter, the

Secretary shall compile and make available to physicians and the

general public information that the Secretary determines is

useful in evaluating the performance of facilities, including a

list of facilities -

(A) that have been convicted under Federal or State laws

relating to fraud and abuse, false billings, or kickbacks;

(B) that have been subject to sanctions under subsection (h)

of this section, together with a statement of the reasons for

the sanctions;

(C) that have had certificates revoked or suspended under

subsection (i) of this section, together with a statement of

the reasons for the revocation or suspension;

(D) against which the Secretary has taken action under

subsection (j) of this section, together with a statement of

the reasons for the action;

(E) whose accreditation has been revoked, together with a

statement of the reasons of the revocation;

(F) against which a State has taken adverse action; and

(G) that meets such other measures of performance as the

Secretary may develop.

(2) Date

The information to be compiled under paragraph (1) shall be

information for the calendar year preceding the date the

information is to be made available to the public.

(3) Explanatory information

The information to be compiled under paragraph (1) shall be

accompanied by such explanatory information as may be appropriate

to assist in the interpretation of the information compiled under

such paragraph.

(m) State laws

Nothing in this section shall be construed to limit the authority

of any State to enact and enforce laws relating to the matters

covered by this section that are at least as stringent as this

section or the regulations issued under this section.

(n) National Advisory Committee

(1) Establishment

In carrying out this section, the Secretary shall establish an

advisory committee to be known as the National Mammography

Quality Assurance Advisory Committee (hereafter in this

subsection referred to as the "Advisory Committee").

(2) Composition

The Advisory Committee shall be composed of not fewer than 13,

nor more than 19 individuals, who are not officers or employees

of the Federal Government. The Secretary shall make appointments

to the Advisory Committee from among -

(A) physicians,

(B) practitioners, and

(C) other health professionals,

whose clinical practice, research specialization, or professional

expertise include a significant focus on mammography. The

Secretary shall appoint at least 4 individuals from among

national breast cancer or consumer health organizations with

expertise in mammography and at least 2 practicing physicians who

provide mammography services.

(3) Functions and duties

The Advisory Committee shall -

(A) advise the Secretary on appropriate quality standards and

regulations for mammography facilities;

(B) advise the Secretary on appropriate standards and

regulations for accreditation bodies;

(C) advise the Secretary in the development of regulations

with respect to sanctions;

(D) assist in developing procedures for monitoring compliance

with standards under subsection (f) of this section;

(E) make recommendations and assist in the establishment of a

mechanism to investigate consumer complaints;

(F) report on new developments concerning breast imaging that

should be considered in the oversight of mammography

facilities;

(G) determine whether there exists a shortage of mammography

facilities in rural and health professional shortage areas and

determine the effects of personnel or other requirements of

subsection (f) of this section on access to the services of

such facilities in such areas;

(H) determine whether there will exist a sufficient number of

medical physicists after October 1, 1999, to assure compliance

with the requirements of subsection (f)(1)(E) of this section;

(I) determine the costs and benefits of compliance with the

requirements of this section (including the requirements of

regulations promulgated under this section); and

(J) perform other activities that the Secretary may require.

The Advisory Committee shall report the findings made under

subparagraphs (G) and (I) to the Secretary and the Congress no

later than October 1, 1993.

(4) Meetings

The Advisory Committee shall meet not less than quarterly for

the first 3 years of the program and thereafter, at least

biannually.

(5) Chairperson

The Secretary shall appoint a chairperson of the Advisory

Committee.

(o) Consultations

In carrying out this section, the Secretary shall consult with

appropriate Federal agencies within the Department of Health and

Human Services for the purposes of developing standards,

regulations, evaluations, and procedures for compliance and

oversight.

(p) Breast cancer screening surveillance research grants

(1) Research

(A) Grants

The Secretary shall award grants to such entities as the

Secretary may determine to be appropriate to establish

surveillance systems in selected geographic areas to provide

data to evaluate the functioning and effectiveness of breast

cancer screening programs in the United States, including

assessments of participation rates in screening mammography,

diagnostic procedures, incidence of breast cancer, mode of

detection (mammography screening or other methods), outcome and

follow up information, and such related epidemiologic analyses

that may improve early cancer detection and contribute to

reduction in breast cancer mortality. Grants may be awarded for

further research on breast cancer surveillance systems upon the

Secretary's review of the evaluation of the program.

(B) Use of funds

Grants awarded under subparagraph (A) may be used -

(i) to study -

(I) methods to link mammography and clinical breast

examination records with population-based cancer registry

data;

(II) methods to provide diagnostic outcome data, or

facilitate the communication of diagnostic outcome data, to

radiology facilities for purposes of evaluating patterns of

mammography interpretation; and

(III) mechanisms for limiting access and maintaining

confidentiality of all stored data; and

(ii) to conduct pilot testing of the methods and mechanisms

described in subclauses (I), (II), and (III) of clause (i) on

a limited basis.

(C) Grant application

To be eligible to receive funds under this paragraph, an

entity shall submit an application to the Secretary at such

time, in such manner, and containing such information as the

Secretary may require.

(D) Report

A recipient of a grant under this paragraph shall submit a

report to the Secretary containing the results of the study and

testing conducted under clauses (i) and (ii) of subparagraph

(B), along with recommendations for methods of establishing a

breast cancer screening surveillance system.

(2) Establishment

The Secretary shall establish a breast cancer screening

surveillance system based on the recommendations contained in the

report described in paragraph (1)(D).

(3) Standards and procedures

The Secretary shall establish standards and procedures for the

operation of the breast cancer screening surveillance system,

including procedures to maintain confidentiality of patient

records.

(4) Information

The Secretary shall recruit facilities to provide to the breast

cancer screening surveillance system relevant data that could

help in the research of the causes, characteristics, and

prevalence of, and potential treatments for, breast cancer and

benign breast conditions, if the information may be disclosed

under section 552 of title 5.

(q) State program

(1) In general

The Secretary may, upon application, authorize a State -

(A) to carry out, subject to paragraph (2), the certification

program requirements under subsections (b), (c), (d), (g)(1),

(h), (i), and (j) of this section (including the requirements

under regulations promulgated pursuant to such subsections),

and

(B) to implement the standards established by the Secretary

under subsection (f) of this section,

with respect to mammography facilities operating within the

State.

(2) Approval

The Secretary may approve an application under paragraph (1) if

the Secretary determines that -

(A) the State has enacted laws and issued regulations

relating to mammography facilities which are the requirements

of this section (including the requirements under regulations

promulgated pursuant to such subsections), and

(B) the State has provided satisfactory assurances that the

State -

(i) has the legal authority and qualified personnel

necessary to enforce the requirements of and the regulations

promulgated pursuant to this section (including the

requirements under regulations promulgated pursuant to such

subsections),

(ii) will devote adequate funds to the administration and

enforcement of such requirements, and

(iii) will provide the Secretary with such information and

reports as the Secretary may require.

(3) Authority of Secretary

In a State with an approved application -

(A) the Secretary shall carry out the Secretary's functions

under subsections (e) and (f) of this section;

(B) the Secretary may take action under subsections (h), (i),

and (j) of this section; and

(C) the Secretary shall conduct oversight functions under

subsections (g)(2) and (g)(3) of this section.

(4) Withdrawal of approval

(A) In general

The Secretary may, after providing notice and opportunity for

corrective action, withdraw the approval of a State's authority

under paragraph (1) if the Secretary determines that the State

does not meet the requirements of such paragraph. The Secretary

shall promulgate regulations for the implementation of this

subparagraph.

(B) Effect of withdrawal

If the Secretary withdraws the approval of a State under

subparagraph (A), the certificate of any facility certified by

the State shall continue in effect until the expiration of a

reasonable period, as determined by the Secretary, for such

facility to obtain certification by the Secretary.

(r) Funding

(1) Fees

(A) In general

The Secretary shall, in accordance with this paragraph assess

and collect fees from persons described in subsection (d)(1)(A)

of this section (other than persons who are governmental

entities, as determined by the Secretary) to cover the costs of

inspections conducted under subsection (g)(1) of this section

by the Secretary or a State acting under a delegation under

subparagraph (A) of such subsection. Fees may be assessed and

collected under this paragraph only in such manner as would

result in an aggregate amount of fees collected during any

fiscal year which equals the aggregate amount of costs for such

fiscal year for inspections of facilities of such persons under

subsection (g)(1) of this section. A person's liability for

fees shall be reasonably based on the proportion of the

inspection costs which relate to such person.

(B) Deposit and appropriations

(i) Deposit and availability

Fees collected under subparagraph (A) shall be deposited as

an offsetting collection to the appropriations for the

Department of Health and Human Services as provided in

appropriation Acts and shall remain available without fiscal

year limitation.

(ii) Appropriations

Fees collected under subparagraph (A) shall be collected

and available only to the extent provided in advance in

appropriation Acts.

(2) Authorization of appropriations

There are authorized to be appropriated to carry out this

section -

(A) to award research grants under subsection (p) of this

section, such sums as may be necessary for each of the fiscal

years 1993 through 2002; and

(B) for the Secretary to carry out other activities which are

not supported by fees authorized and collected under paragraph

(1), such sums as may be necessary for fiscal years 1993

through 2002.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 354, as added Pub. L.

102-539, Sec. 2, Oct. 27, 1992, 106 Stat. 3547; amended Pub. L.

105-248, Secs. 2-13, Oct. 9, 1998, 112 Stat. 1864-1867.)

-MISC1-

PRIOR PROVISIONS

A prior section 263b, act July 1, 1944, ch. 373, title III, Sec.

354, as added Oct. 18, 1968, Pub. L. 90-602, Sec. 2(3), 82 Stat.

1173; amended Nov. 28, 1990, Pub. L. 101-629, Sec. 19(a)(1)(B), 104

Stat. 4529; Aug. 13, 1993, Pub. L. 103-80, Sec. 4(a)(2), 107 Stat.

779, set forth Congressional declaration of purpose, prior to

repeal by Pub. L. 101-629, Sec. 19(a)(3), Nov. 28, 1990, 104 Stat.

4530.

Sections 263c to 263n, act July 1, 1944, ch. 373, title III,

Secs. 355-360F, as added Oct. 18, 1968, Pub. L. 90-602, Sec. 2(3),

82 Stat. 1174, and amended, which related to electronic product

radiation control, were renumbered sections 531 to 542,

respectively, of the Federal Food, Drug, and Cosmetic Act by Pub.

L. 101-629, Sec. 19(a)(4), Nov. 28, 1990, 104 Stat. 4530, and are

classified to sections 360hh to 360ss, respectively, of Title 21,

Food and Drugs.

AMENDMENTS

1998 - Subsec. (a)(4). Pub. L. 105-248, Sec. 9(1), inserted "or

local" after "State".

Subsec. (a)(8). Pub. L. 105-248, Sec. 4(b), added par. (8).

Subsec. (d)(2)(B). Pub. L. 105-248, Sec. 3, substituted "part 498

of title 42, Code of Federal Regulations" for "42 C.F.R. 498 and in

effect on October 27, 1992".

Subsec. (e)(1)(B)(i)(I), (II). Pub. L. 105-248, Sec. 4(a)(1),

substituted "review physicians" for "practicing physicians".

Subsec. (e)(1)(B)(ii). Pub. L. 105-248, Sec. 4(a)(2), substituted

"relationship" for "financial relationship".

Subsec. (f)(1)(G)(i). Pub. L. 105-248, Sec. 5, added cl. (i) and

struck out former cl. (i) which read as follows: "a facility that

performs any mammogram maintain the mammogram in the permanent

medical records of the patient -

"(I) for a period of not less than 5 years, or not less than 10

years if no additional mammograms of such patient are performed

at the facility, or longer if mandated by State law; or

"(II) until such time as the patient should request that the

patient's medical records be forwarded to a medical institution

or a physician of the patient;

whichever is longer; and".

Subsec. (f)(1)(G)(ii)(IV). Pub. L. 105-248, Sec. 6, added subcl.

(IV) and struck out former subcl. (IV) which read as follows: "if

such report is sent to the patient, the report shall include a

summary written in terms easily understood by a lay person; and".

Subsec. (g)(1). Pub. L. 105-248, Sec. 9(1), inserted "or local"

after "State" wherever appearing.

Subsec. (g)(1)(A). Pub. L. 105-248, Sec. 7, in first sentence,

struck out "certified" before "facilities" and inserted "the

certification requirements under subsection (b) of this section

and" after "compliance with".

Subsec. (g)(1)(E). Pub. L. 105-248, Sec. 8(1), inserted ",

subject to paragraph (6)" before period at end.

Subsec. (g)(3). Pub. L. 105-248, Sec. 9(1), (2), inserted "or

local" after "State" in heading and in two places in text.

Subsec. (g)(4). Pub. L. 105-248, Sec. 9(1), inserted "or local"

after "State".

Subsec. (g)(6). Pub. L. 105-248, Sec. 8(2), added par. (6).

Subsec. (h)(2). Pub. L. 105-248, Sec. 10(a), added par. (2) and

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

Subsec. (h)(3). Pub. L. 105-248, Sec. 10(a)(1), (b), redesignated

par. (2) as (3), added subpar. (C), and redesignated former subpar.

(C) as (D). Former par. (3) redesignated (4).

Subsec. (h)(4). Pub. L. 105-248, Sec. 10(a)(1), (c), redesignated

par. (3) as (4) and substituted "paragraphs (1) through (3)" for

"paragraphs (1) and (2)".

Subsec. (i)(1)(C). Pub. L. 105-248, Sec. 11, inserted "(or of an

accreditation body approved pursuant to subsection (e) of this

section)" after "of the Secretary" and inserted "(or such

accreditation body or State carrying out certification program

requirements pursuant to subsection (q) of this section)" after

"that the Secretary".

Subsec. (i)(1)(D). Pub. L. 105-248, Sec. 9(3), inserted "or

local" after "any State" and "or local agency" after "by the

State".

Subsec. (i)(2)(A). Pub. L. 105-248, Sec. 12, substituted "has

reason to believe that the circumstance of the case will support

one or more of the findings described in paragraph (1) and that - "

and cls. (i) and (ii) for "makes the finding described in paragraph

(1) and determines that -

"(i) the failure of a facility to comply with the standards

established by the Secretary under subsection (f) of this section

presents a serious risk to human health; or

"(ii) a facility has engaged in an action described in

subparagraph (D) or (E) of paragraph (1)."

Subsec. (q)(4)(B). Pub. L. 105-248, Sec. 13, substituted

"certified" for "accredited".

Subsec. (r)(2)(A). Pub. L. 105-248, Sec. 2, substituted

"subsection (p)" for "subsection (q)" and "2002" for "1997".

Subsec. (r)(2)(B). Pub. L. 105-248, Sec. 2, substituted "fiscal

years" for "fiscal year" and "2002" for "1997".

-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-

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 Congress, its duration is otherwise

provided for 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.

REGULATIONS

Pub. L. 103-183, title VII, Sec. 707, Dec. 14, 1993, 107 Stat.

2241, provided that: "The Secretary of Health and Human Services is

authorized to issue interim final regulations -

"(1) under which the Secretary may approve accreditation bodies

under section 354(e) of the Public Health Service Act (42 U.S.C.

263b(e)); and

"(2) establishing quality standards under section 354(f) of the

Public Health Service Act (42 U.S.C. 263b(f))."

STUDY

Section 3 of Pub. L. 102-539 directed Comptroller General of

United States to conduct a study of the certification program

authorized by this section to determine if the program has resulted

in improvement of quality and accessibility of mammography

services, and if the program has reduced the frequency of poor

quality mammography and improved early detection of breast cancer,

with Comptroller General, not later than 3 years from Oct. 27,

1992, submit to Congress an interim report of results of study and,

not later than 5 years from such date to submit a final report.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 1395m, 1395x of this

title; title 38 section 7319.

-End-

-CITE-

42 USC Part G - Quarantine and Inspection 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

PART G - QUARANTINE AND INSPECTION

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in section 300j-9 of this title.

-End-

-CITE-

42 USC Sec. 264 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 264. Regulations to control communicable diseases

-STATUTE-

(a) Promulgation and enforcement by Surgeon General

The Surgeon General, with the approval of the Secretary, is

authorized to make and enforce such regulations as in his judgment

are necessary to prevent the introduction, transmission, or spread

of communicable diseases from foreign countries into the States or

possessions, or from one State or possession into any other State

or possession. For purposes of carrying out and enforcing such

regulations, the Surgeon General may provide for such inspection,

fumigation, disinfection, sanitation, pest extermination,

destruction of animals or articles found to be so infected or

contaminated as to be sources of dangerous infection to human

beings, and other measures, as in his judgment may be necessary.

(b) Apprehension, detention, or conditional release of individuals

Regulations prescribed under this section shall not provide for

the apprehension, detention, or conditional release of individuals

except for the purpose of preventing the introduction,

transmission, or spread of such communicable diseases as may be

specified from time to time in Executive orders of the President

upon the recommendation of the Secretary, in consultation with the

Surgeon General,(!1).

(c) Application of regulations to persons entering from foreign

countries

Except as provided in subsection (d) of this section, regulations

prescribed under this section, insofar as they provide for the

apprehension, detention, examination, or conditional release of

individuals, shall be applicable only to individuals coming into a

State or possession from a foreign country or a possession.

(d) Apprehension and examination of persons reasonably believed to

be infected

(1) Regulations prescribed under this section may provide for the

apprehension and examination of any individual reasonably believed

to be infected with a communicable disease in a qualifying stage

and (A) to be moving or about to move from a State to another

State; or (B) to be a probable source of infection to individuals

who, while infected with such disease in a qualifying stage, will

be moving from a State to another State. Such regulations may

provide that if upon examination any such individual is found to be

infected, he may be detained for such time and in such manner as

may be reasonably necessary. For purposes of this subsection, the

term "State" includes, in addition to the several States, only the

District of Columbia.

(2) For purposes of this subsection, the term "qualifying stage",

with respect to a communicable disease, means that such disease -

(A) is in a communicable stage; or

(B) is in a precommunicable stage, if the disease would be

likely to cause a public health emergency if transmitted to other

individuals.

(e) Preemption

Nothing in this section or section 266 of this title, or the

regulations promulgated under such sections, may be construed as

superseding any provision under State law (including regulations

and including provisions established by political subdivisions of

States), except to the extent that such a provision conflicts with

an exercise of Federal authority under this section or section 266

of this title.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 361, 58 Stat. 703; 1953

Reorg. Plan No. 1, Secs. 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67

Stat. 631; Pub. L. 86-624, Sec. 29(c), July 12, 1960, 74 Stat. 419;

Pub. L. 94-317, title III, Sec. 301(b)(1), June 23, 1976, 90 Stat.

707; Pub. L. 107-188, title I, Sec. 142(a)(1), (2), (b)(1), (c),

June 12, 2002, 116 Stat. 626, 627.)

-MISC1-

AMENDMENTS

2002 - Pub. L. 107-188, Sec. 142(a)(1), (2), (b)(1), and (c),

which directed certain amendments to section 361 of the Public

Health Act, was executed by making the amendments to this section,

which is section 361 of the Public Health Service Act, to reflect

the probable intent of Congress. See below.

Subsec. (b). Pub. L. 107-188, Sec. 142(a)(1), substituted

"Executive orders of the President upon the recommendation of the

Secretary, in consultation with the Surgeon General," for

"Executive orders of the President upon the recommendation of the

National Advisory Health Council and the Surgeon General".

Subsec. (d). Pub. L. 107-188, Sec. 142(a)(2), (b)(1), substituted

in first sentence "Regulations" for "On recommendation of the

National Advisory Health Council, regulations", "in a qualifying

stage" for "in a communicable stage" in two places,designated

existing text as par. (1) and substituted "(A)" and "(B)" for

"(1)" and "(2)", respectively, and added par. (2).

Subsec. (e). Pub. L. 107-188, Sec. 142(c), added subsec. (e).

1976 - Subsec. (d). Pub. L. 94-317 inserted provision defining

"State" to include, in addition to the several States, only the

District of Columbia.

1960 - Subsec. (c). Pub. L. 86-624 struck out reference to

Territory of Hawaii.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment by Pub. L. 86-624 effective Aug. 21, 1959, see section

47(f) of Pub. L. 86-624, set out as a note under section 201 of

this title.

-TRANS-

TRANSFER OF FUNCTIONS

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

Functions of Federal Security Administrator transferred to

Secretary of Health, Education, and Welfare and all agencies of

Federal Security Agency transferred to Department of Health,

Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,

set out as a note under section 3501 of this title. Federal

Security Agency and office of Administrator abolished by section 8

of Reorg. Plan No. 1 of 1953. Secretary and Department of Health,

Education, and Welfare redesignated Secretary and Department of

Health and Human Services by section 509(b) of Pub. L. 96-88 which

is classified to section 3508(b) of Title 20.

-EXEC-

EX. ORD. NO. 12452. REVISED LIST OF QUARANTINABLE COMMUNICABLE

DISEASES

Ex. Ord. No. 12452, Dec. 22, 1983, 48 F.R. 56927, provided:

By the authority vested in me as President by the Constitution

and laws of the United States of America, including Section 264(b)

of Title 42 of the United States Code, it is hereby ordered as

follows:

Section 1. Based upon the recommendation of the National Advisory

Health Council and the Assistant Secretary for Health of the

Department of Health and Human Services, and for the purposes of

specifying certain communicable diseases for regulations providing

for the apprehension, detention, or conditional release of

individuals to prevent the introduction, transmission, or spread of

communicable diseases, the following named communicable diseases

are hereby specified pursuant to Section 264(b) of Title 42 of the

United States Code: Cholera or suspected Cholera, Diphtheria,

infectious Tuberculosis, Plague, suspected Smallpox, Yellow Fever,

and suspected Viral Hemorrhagic Fevers (Lassa, Marburg, Ebola,

Congo-Crimean, and others not yet isolated or named).

Sec. 2. Executive Order No. 9708 of March 26, 1946, Executive

Order No. 10532 of May 28, 1954, and Executive Order No. 11070 of

December 12, 1962, are hereby revoked.

Ronald Reagan.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 201, 266, 271 of this

title; title 21 section 381; title 49 section 24301.

-FOOTNOTE-

(!1) So in original. Comma probably should not appear.

-End-

-CITE-

42 USC Sec. 265 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 265. Suspension of entries and imports from designated places

to prevent spread of communicable diseases

-STATUTE-

Whenever the Surgeon General determines that by reason of the

existence of any communicable disease in a foreign country there is

serious danger of the introduction of such disease into the United

States, and that this danger is so increased by the introduction of

persons or property from such country that a suspension of the

right to introduce such persons and property is required in the

interest of the public health, the Surgeon General, in accordance

with regulations approved by the President, shall have the power to

prohibit, in whole or in part, the introduction of persons and

property from such countries or places as he shall designate in

order to avert such danger, and for such period of time as he may

deem necessary for such purpose.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 362, 58 Stat. 704.)

-TRANS-

TRANSFER OF FUNCTIONS

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 271 of this title.

-End-

-CITE-

42 USC Sec. 266 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 266. Special quarantine powers in time of war

-STATUTE-

To protect the military and naval forces and war workers of the

United States, in time of war, against any communicable disease

specified in Executive orders as provided in subsection (b) of

section 264 of this title, the Secretary, in consultation with the

Surgeon General, is authorized to provide by regulations for the

apprehension and examination, in time of war, of any individual

reasonably believed (1) to be infected with such disease and (2) to

be a probable source of infection to members of the armed forces of

the United States or to individuals engaged in the production or

transportation of arms, munitions, ships, food, clothing, or other

supplies for the armed forces. Such regulations may provide that if

upon examination any such individual is found to be so infected, he

may be detained for such time and in such manner as may be

reasonably necessary.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 363, 58 Stat. 704; Pub. L.

107-188, title I, Sec. 142(a)(3), (b)(2), June 12, 2002, 116 Stat.

626, 627.)

-MISC1-

AMENDMENTS

2002 - Pub. L. 107-188, which directed substitution of "the

Secretary, in consultation with the Surgeon General," for "the

Surgeon General, on recommendation of the National Advisory Health

Council," and striking out of "in a communicable stage" after "(1)

to be infected with such disease", in section 363 of the Public

Health Act, was executed to this section, which is section 363 of

the Public Health Service Act, to reflect the probable intent of

Congress.

-TRANS-

TRANSFER OF FUNCTIONS

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

-MISC2-

TERMINATION OF WAR AND EMERGENCIES

Joint Res. July 25, 1947, ch. 327, Sec. 3, 61 Stat. 451, provided

that in the interpretation of this section, the date July 25, 1947,

shall be deemed to be the date of termination of any state of war

theretofore declared by Congress and of the national emergencies

proclaimed by the President on Sept. 8, 1939, and May 27, 1941.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 264, 271 of this title.

-End-

-CITE-

42 USC Sec. 267 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 267. Quarantine stations, grounds, and anchorages

-STATUTE-

(a) Control and management

Except as provided in title II of the Act of June 15, 1917, as

amended [50 U.S.C. 191 et seq.], the Surgeon General shall control,

direct, and manage all United States quarantine stations, grounds,

and anchorages, designate their boundaries, and designate the

quarantine officers to be in charge thereof. With the approval of

the President he shall from time to time select suitable sites for

and establish such additional stations, grounds, and anchorages in

the States and possessions of the United States as in his judgment

are necessary to prevent the introduction of communicable diseases

into the States and possessions of the United States.

(b) Hours of inspection

The Surgeon General shall establish the hours during which

quarantine service shall be performed at each quarantine station,

and, upon application by any interested party, may establish

quarantine inspection during the twenty-four hours of the day, or

any fraction thereof, at such quarantine stations as, in his

opinion, require such extended service. He may restrict the

performance of quarantine inspection to hours of daylight for such

arriving vessels as cannot, in his opinion, be satisfactorily

inspected during hours of darkness. No vessel shall be required to

undergo quarantine inspection during the hours of darkness, unless

the quarantine officer at such quarantine station shall deem an

immediate inspection necessary to protect the public health.

Uniformity shall not be required in the hours during which

quarantine inspection may be obtained at the various ports of the

United States.

(c) Overtime pay for employees of Service

The Surgeon General shall fix a reasonable rate of extra

compensation for overtime services of employees of the United

States Public Health Service, Foreign Quarantine Division,

performing overtime duties including the operation of vessels, in

connection with the inspection or quarantine treatment of persons

(passengers and crews), conveyances, or goods arriving by land,

water, or air in the United States or any place subject to the

jurisdiction thereof, hereinafter referred to as "employees of the

Public Health Service", when required to be on duty between the

hours of 6 o'clock postmeridian and 6 o'clock antemeridian (or

between the hours of 7 o'clock postmeridian and 7 o'clock

antemeridian at stations which have a declared workday of from 7

o'clock antemeridian to 7 o'clock postmeridian), or on Sundays or

holidays, such rate, in lieu of compensation under any other

provision of law, to be fixed at two times the basic hourly rate

for each hour that the overtime extends beyond 6 o'clock (or 7

o'clock as the case may be) postmeridian, and two times the basic

hourly rate for each overtime hour worked on Sundays or holidays.

As used in this subsection, the term "basic hourly rate" shall mean

the regular basic rate of pay which is applicable to such employees

for work performed within their regular scheduled tour of duty.

(d) Payment of extra compensation to United States; bond or deposit

to assure payment; deposit of moneys to credit of appropriation

(1) The said extra compensation shall be paid to the United

States by the owner, agent, consignee, operator, or master or other

person in charge of any conveyance, for whom, at his request,

services as described in this subsection (hereinafter referred to

as overtime service) are performed. If such employees have been

ordered to report for duty and have so reported, and the requested

services are not performed by reason of circumstances beyond the

control of the employees concerned, such extra compensation shall

be paid on the same basis as though the overtime services had

actually been performed during the period between the time the

employees were ordered to report for duty and did so report, and

the time they were notified that their services would not be

required, and in any case as though their services had continued

for not less than one hour. The Surgeon General with the approval

of the Secretary of Health and Human Services may prescribe

regulations requiring the owner, agent, consignee, operator, or

master or other person for whom the overtime services are performed

to file a bond in such amounts and containing such conditions and

with such sureties, or in lieu of a bond, to deposit money or

obligations of the United States in such amount, as will assure the

payment of charges under this subsection, which bond or deposit may

cover one or more transactions or all transactions during a

specified period: Provided, That no charges shall be made for

services performed in connection with the inspection of (1) persons

arriving by international highways, ferries, bridges, or tunnels,

or the conveyances in which they arrive, or (2) persons arriving by

aircraft or railroad trains, the operations of which are covered by

published schedules, or the aircraft or trains in which they

arrive, or (3) persons arriving by vessels operated between

Canadian ports and ports on Puget Sound or operated on the Great

Lakes and connecting waterways, the operations of which are covered

by published schedules, or the vessels in which they arrive.

(2) Moneys collected under this subsection shall be deposited in

the Treasury of the United States to the credit of the

appropriation charged with the expense of the services, and the

appropriations so credited shall be available for the payment of

such compensation to the said employees for services so rendered.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 364, 58 Stat. 704; Pub. L.

85-58, ch. VII, Sec. 701, June 21, 1957, 71 Stat. 181; Pub. L.

85-580, title II, Sec. 201, Aug. 1, 1958, 72 Stat. 467; Pub. L.

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

-MISC1-

AMENDMENTS

1958 - Subsec. (c). Pub. L. 85-580 increased rate of pay for each

hour that overtime extends beyond 6 o'clock (or 7 o'clock as the

case may be) postmeridian from one and one-half times the basic

hourly rate to two times the basic hourly rate.

1957 - Subsecs. (c), (d). Pub. L. 85-58 added subsecs. (c) and

(d).

-TRANS-

TRANSFER OF FUNCTIONS

"Secretary of Health and Human Services" substituted for

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

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

section 3508(b) of Title 20, Education.

Functions of Public Health Service, Surgeon General of Public

Health Service, and all other officers and employees of Public

Health Service, and functions of all agencies of or in Public

Health Service transferred to Secretary of Health, Education, and

Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R.

8855, 80 Stat. 1610, set out as a note under section 202 of this

title. Secretary of Health, Education, and Welfare redesignated

Secretary of Health and Human Services by section 509(b) of Pub. L.

96-88 which is classified to section 3508(b) of Title 20.

DELEGATION OF FUNCTIONS

Functions of President delegated to Secretary of Health Health

and Human Services, see Ex. Ord. No. 11140, Jan. 30, 1964, 29 F.R.

1637, as amended, set out as a note under section 202 of this

title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 270, 271 of this title.

-End-

-CITE-

42 USC Sec. 268 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 268. Quarantine duties of consular and other officers

-STATUTE-

(a) Any consular or medical officer of the United States,

designated for such purpose by the Secretary, shall make reports to

the Surgeon General, on such forms and at such intervals as the

Surgeon General may prescribe, of the health conditions at the port

or place at which such officer is stationed.

(b) It shall be the duty of the customs officers and of Coast

Guard officers to aid in the enforcement of quarantine rules and

regulations; but no additional compensation, except actual and

necessary traveling expenses, shall be allowed any such officer by

reason of such services.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 365, 58 Stat. 705; 1953

Reorg. Plan No. 1, Secs. 5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67

Stat. 631.)

-TRANS-

TRANSFER OF FUNCTIONS

For transfer of authorities, functions, personnel, and assets of

the Coast Guard, including the authorities and functions of the

Secretary of Transportation relating thereto, to the Department of

Homeland Security, and for treatment of related references, see

sections 468(b), 551(d), 552(d), and 557 of Title 6, Domestic

Security, and the Department of Homeland Security Reorganization

Plan of November 25, 2002, as modified, set out as a note under

section 542 of Title 6.

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

Reference to Secretary of Health, Education, and Welfare

substituted for reference to Federal Security Administrator

pursuant to section 5 of Reorg. Plan No. 1, of 1953, set out as a

note under section 3501 of this title, which transferred functions

of Federal Security Administrator to Secretary of Health,

Education, and Welfare and all agencies of Federal Security Agency

to Department of Health, Education, and Welfare. Federal Security

Agency and office of Administrator abolished by section 8 of Reorg.

Plan No. 1 of 1953. Secretary and Department of Health, Education,

and Welfare redesignated Secretary and Department of Health and

Human Services by section 509(b) of Pub. L. 96-88 which is

classified to section 3508(b) of Title 20.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 270 of this title.

-End-

-CITE-

42 USC Sec. 269 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 269. Bills of health

-STATUTE-

(a) Detail of medical officer; conditions precedent to issuance;

consular officer to receive fees

Except as otherwise prescribed in regulations, any vessel at any

foreign port or place clearing or departing for any port or place

in a State or possession shall be required to obtain from the

consular officer of the United States or from the Public Health

Service officer, or other medical officer of the United States

designated by the Surgeon General, at the port or place of

departure, a bill of health in duplicate, in the form prescribed by

the Surgeon General. The President, from time to time, shall

specify the ports at which a medical officer shall be stationed for

this purpose. Such bill of health shall set forth the sanitary

history and condition of said vessel, and shall state that it has

in all respects complied with the regulations prescribed pursuant

to subsection (c) of this section. Before granting such duplicate

bill of health, such consular or medical officer shall be satisfied

that the matters and things therein stated are true. The consular

officer shall be entitled to demand and receive the fees for bills

of health and such fees shall be established by regulation.

(b) Collectors of customs to receive originals; duplicate copies as

part of ship's papers

Original bills of health shall be delivered to the collectors of

customs at the port of entry. Duplicate copies of such bills of

health shall be delivered at the time of inspection to quarantine

officers at such port. The bills of health herein prescribed shall

be considered as part of the ship's papers, and when duly certified

to by the proper consular or other officer of the United States,

over his official signature and seal, shall be accepted as evidence

of the statements therein contained in any court of the United

States.

(c) Regulations to secure sanitary conditions of vessels

The Surgeon General shall from time to time prescribe

regulations, applicable to vessels referred to in subsection (a) of

this section for the purpose of preventing the introduction into

the States or possessions of the United States of any communicable

disease by securing the best sanitary condition of such vessels,

their cargoes, passengers, and crews. Such regulations shall be

observed by such vessels prior to departure, during the course of

the voyage, and also during inspection, disinfection, or other

quarantine procedure upon arrival at any United States quarantine

station.

(d) Vessels from ports near frontier

The provisions of subsections (a) and (b) of this section shall

not apply to vessels plying between such foreign ports on or near

the frontiers of the United States and ports of the United States

as are designated by treaty.

(e) Compliance with regulations

It shall be unlawful for any vessel to enter any port in any

State or possession of the United States to discharge its cargo, or

land its passengers, except upon a certificate of the quarantine

officer that regulations prescribed under subsection (c) of this

section have in all respects been complied with by such officer,

the vessel, and its master. The master of every such vessel shall

deliver such certificate to the collector of customs at the port of

entry, together with the original bill of health and other papers

of the vessel. The certificate required by this subsection shall be

procurable from the quarantine officer, upon arrival of the vessel

at the quarantine station and satisfactory inspection thereof, at

any time within which quarantine services are performed at such

station.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 366, 58 Stat. 705.)

-TRANS-

TRANSFER OF FUNCTIONS

Functions of Public Health Service, Surgeon General of Public

Health Service, and all other officers and employees of Public

Health Service, and functions of all agencies of or in Public

Health Service transferred to Secretary of Health, Education, and

Welfare by Reorg. Plan No. 3 of 1966, eff. June 25, 1966, 31 F.R.

8855, 80 Stat. 1610, set out as a note under section 202 of this

title. Secretary of Health, Education, and Welfare redesignated

Secretary of Health and Human Services by section 509(b) of Pub. L.

96-88 which is classified to section 3508(b) of Title 20,

Education.

All offices of collector of customs, comptroller of customs,

surveyor of customs, and appraiser of merchandise of Bureau of

Customs of Department of the Treasury to which appointments were

required to be made by the President with the advice and consent of

the Senate ordered abolished, with such offices to be terminated

not later than December 31, 1966, by Reorg. Plan No. 1, of 1965,

eff. May 25, 1965, 30 F.R. 7035, 79 Stat. 1317, set out in the

Appendix to Title 5, Government Organization and Employees. All

functions of offices eliminated were already vested in Secretary of

the Treasury by Reorg. Plan No. 26 of 1950, eff. July 31, 1950, 15

F.R. 4935, 64 Stat. 1280, set out in the Appendix to Title 5.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 270, 271 of this title.

-End-

-CITE-

42 USC Sec. 270 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 270. Quarantine regulations governing civil air navigation and

civil aircraft

-STATUTE-

The Surgeon General is authorized to provide by regulations for

the application to air navigation and aircraft of any of the

provisions of sections 267 to 269 of this title and regulations

prescribed thereunder (including penalties and forfeitures for

violations of such sections and regulations), to such extent and

upon such conditions as he deems necessary for the safeguarding of

the public health.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 367, 58 Stat. 706.)

-TRANS-

ABOLITION OF OFFICE OF SURGEON GENERAL

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

-End-

-CITE-

42 USC Sec. 271 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 271. Penalties for violation of quarantine laws

-STATUTE-

(a) Penalties for persons violating quarantine laws

Any person who violates any regulation prescribed under sections

264 to 266 of this title, or any provision of section 269 of this

title or any regulation prescribed thereunder, or who enters or

departs from the limits of any quarantine station, ground, or

anchorage in disregard of quarantine rules and regulations or

without permission of the quarantine officer in charge, shall be

punished by a fine of not more than $1,000 or by imprisonment for

not more than one year, or both.

(b) Penalties for vessels violating quarantine laws

Any vessel which violates section 269 of this title, or any

regulations thereunder or under section 267 of this title, or which

enters within or departs from the limits of any quarantine station,

ground, or anchorage in disregard of the quarantine rules and

regulations or without permission of the officer in charge, shall

forfeit to the United States not more than $5,000, the amount to be

determined by the court, which shall be a lien on such vessel, to

be recovered by proceedings in the proper district court of the

United States. In all such proceedings the United States attorney

shall appear on behalf of the United States; and all such

proceedings shall be conducted in accordance with the rules and

laws governing cases of seizure of vessels for violation of the

revenue laws of the United States.

(c) Remittance or mitigation of forfeitures

With the approval of the Secretary, the Surgeon General may, upon

application therefor, remit or mitigate any forfeiture provided for

under subsection (b) of this section, and he shall have authority

to ascertain the facts upon all such applications.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 368, 58 Stat. 706; June 25,

1948, ch. 646, Sec. 1, 62 Stat. 909; 1953 Reorg. Plan No. 1, Secs.

5, 8, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631.)

-CHANGE-

CHANGE OF NAME

Act June 25, 1948, eff. Sept. 1, 1948, substituted "United States

attorney" for "United States district attorney". See section 541 of

Title 28, Judiciary and Judicial Procedure, and Historical and

Revision note thereunder.

-TRANS-

TRANSFER OF FUNCTIONS

Office of Surgeon General abolished by section 3 of Reorg. Plan

No. 3 of 1966, eff. June 25, 1966, 31 F.R. 8855, 80 Stat. 1610, and

functions thereof transferred to Secretary of Health, Education,

and Welfare by section 1 of Reorg. Plan No. 3 of 1966, set out as a

note under section 202 of this title. Secretary of Health,

Education, and Welfare redesignated Secretary of Health and Human

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

section 3508(b) of Title 20, Education.

Functions of Federal Security Administrator transferred to

Secretary of Health, Education, and Welfare and all agencies of

Federal Security Agency transferred to Department of Health,

Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953,

set out as a note under section 3501 of this title. Federal

Security Agency and office of Administrator abolished by section 8

of Reorg. Plan No. 1 of 1953. Secretary and Department of Health,

Education, and Welfare redesignated Secretary and Department of

Health and Human Services by section 509(b) of Pub. L. 96-88 which

is classified to section 3508(b) of Title 20.

-End-

-CITE-

42 USC Sec. 272 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part G - Quarantine and Inspection

-HEAD-

Sec. 272. Administration of oaths by quarantine officers

-STATUTE-

Medical officers of the United States, when performing duties as

quarantine officers at any port or place within the United States,

are authorized to take declarations and administer oaths in matters

pertaining to the administration of the quarantine laws and

regulations of the United States.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 369, 58 Stat. 706.)

-End-

-CITE-

42 USC Part H - Organ Transplants 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part H - Organ Transplants

-HEAD-

PART H - ORGAN TRANSPLANTS

-MISC1-

PRIOR PROVISIONS

A prior part H related to grants to Alaska for mental health,

prior to the general revision of part H by Pub. L. 98-507, title

II, Sec. 201, Oct. 19, 1984, 98 Stat. 2342.

Another prior part H, entitled "National Library of Medicine", as

added by act Aug. 3, 1956, ch. 907, 70 Stat. 960, was redesignated

part I and classified to section 275 et seq. of this title, prior

to repeal by Pub. L. 99-158.

-End-

-CITE-

42 USC Sec. 273 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part H - Organ Transplants

-HEAD-

Sec. 273. Organ procurement organizations

-STATUTE-

(a) Grant authority of Secretary

(1) The Secretary may make grants for the planning of qualified

organ procurement organizations described in subsection (b) of this

section.

(2) The Secretary may make grants for the establishment, initial

operation, consolidation, and expansion of qualified organ

procurement organizations described in subsection (b) of this

section.

(3) The Secretary may make grants to, and enter into contracts

with, qualified organ procurement organizations described in

subsection (b) of this section and other nonprofit private entities

for the purpose of carrying out special projects designed to

increase the number of organ donors.

(b) Qualified organizations

(1) A qualified organ procurement organization for which grants

may be made under subsection (a) of this section is an organization

which, as determined by the Secretary, will carry out the functions

described in paragraph (2) (!1) and -

(A) is a nonprofit entity,

(B) has accounting and other fiscal procedures (as specified by

the Secretary) necessary to assure the fiscal stability of the

organization,

(C) has an agreement with the Secretary to be reimbursed under

title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.]

for the procurement of kidneys,

(D) notwithstanding any other provision of law, has met the

other requirements of this section and has been certified or

recertified by the Secretary within the previous 4-year period as

meeting the performance standards to be a qualified organ

procurement organization through a process that either -

(i) granted certification or recertification within such

4-year period with such certification or recertification in

effect as of January 1, 2000, and remaining in effect through

the earlier of -

(I) January 1, 2002; or

(II) the completion of recertification under the

requirements of clause (ii); or

(ii) is defined through regulations that are promulgated by

the Secretary by not later than January 1, 2002, that -

(I) require recertifications of qualified organ procurement

organizations not more frequently than once every 4 years;

(II) rely on outcome and process performance measures that

are based on empirical evidence, obtained through reasonable

efforts, of organ donor potential and other related factors

in each service area of qualified organ procurement

organizations;

(III) use multiple outcome measures as part of the

certification process; and

(IV) provide for a qualified organ procurement organization

to appeal a decertification to the Secretary on substantive

and procedural grounds; (!2)

(E) has procedures to obtain payment for non-renal organs

provided to transplant centers,

(F) has a defined service area that is of sufficient size to

assure maximum effectiveness in the procurement and equitable

distribution of organs, and that either includes an entire

metropolitan statistical area (as specified by the Director of

the Office of Management and Budget) or does not include any part

of the area,

(G) has a director and such other staff, including the organ

donation coordinators and organ procurement specialists necessary

to effectively obtain organs from donors in its service area, and

(H) has a board of directors or an advisory board which -

(i) is composed of -

(I) members who represent hospital administrators,

intensive care or emergency room personnel, tissue banks, and

voluntary health associations in its service area,

(II) members who represent the public residing in such

area,

(III) a physician with knowledge, experience, or skill in

the field of histocompatability (!3) or an individual with a

doctorate degree in a biological science with knowledge,

experience, or skill in the field of histocompatibility,

(IV) a physician with knowledge or skill in the field of

neurology, and

(V) from each transplant center in its service area which

has arrangements described in paragraph (2)(G) (!1) with the

organization, a member who is a surgeon who has practicing

privileges in such center and who performs organ transplant

surgery,

(ii) has the authority to recommend policies for the

procurement of organs and the other functions described in

paragraph (2),(!1) and

(iii) has no authority over any other activity of the

organization.

(2)(A) Not later than 90 days after November 16, 1990, the

Secretary shall publish in the Federal Register a notice of

proposed rulemaking to establish criteria for determining whether

an entity meets the requirement established in paragraph

(1)(E).(!1)

(B) Not later than 1 year after November 16, 1990, the Secretary

shall publish in the Federal Register a final rule to establish the

criteria described in subparagraph (A).

(3) An organ procurement organization shall -

(A) have effective agreements, to identify potential organ

donors, with a substantial majority of the hospitals and other

health care entities in its service area which have facilities

for organ donations,

(B) conduct and participate in systematic efforts, including

professional education, to acquire all useable organs from

potential donors,

(C) arrange for the acquisition and preservation of donated

organs and provide quality standards for the acquisition of

organs which are consistent with the standards adopted by the

Organ Procurement and Transplantation Network under section

274(b)(2)(E) of this title, including arranging for testing with

respect to preventing the acquisition of organs that are infected

with the etiologic agent for acquired immune deficiency syndrome,

(D) arrange for the appropriate tissue typing of donated

organs,

(E) have a system to allocate donated organs equitably among

transplant patients according to established medical criteria,

(F) provide or arrange for the transportation of donated organs

to transplant centers,

(G) have arrangements to coordinate its activities with

transplant centers in its service area,

(H) participate in the Organ Procurement Transplantation

Network established under section 274 of this title,

(I) have arrangements to cooperate with tissue banks for the

retrieval, processing, preservation, storage, and distribution of

tissues as may be appropriate to assure that all useable tissues

are obtained from potential donors,

(J) evaluate annually the effectiveness of the organization in

acquiring potentially available organs, and

(K) assist hospitals in establishing and implementing protocols

for making routine inquiries about organ donations by potential

donors.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 371, as added Pub. L.

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2342; amended

Pub. L. 100-607, title IV, Sec. 402(a), (c)(1), (2), (d), Nov. 4,

1988, 102 Stat. 3114, 3115; Pub. L. 101-616, title II, Secs.

201(a)-(c)(1), (d), (e), 206(b), Nov. 16, 1990, 104 Stat. 3283,

3285; Pub. L. 106-505, title VII, Sec. 701(c), Nov. 13, 2000, 114

Stat. 2347; Pub. L. 106-554, Sec. 1(a)(1) [title II, Sec. 219(b)],

Dec. 21, 2000, 114 Stat. 2763, 2763A-29.)

-REFTEXT-

REFERENCES IN TEXT

Paragraph (2), referred to in subsec. (b)(1), meaning paragraph

(2) of subsec. (b) of this section, was redesignated paragraph (3)

by section 201(d)(1) of Pub. L. 101-616. See 1990 Amendment note

below.

The Social Security Act, referred to in subsec. (b)(1)(C), 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.

Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning

paragraph (1)(E) of subsec. (b) of this section, was redesignated

paragraph (1)(F) by section 701(c)(1) of Pub. L. 106-505 and

section 1(a)(1) [title II, Sec. 219(b)(1)] of Pub. L. 106-554. See

2000 Amendment note below.

-MISC1-

PRIOR PROVISIONS

A prior section 273, act July 1, 1944, ch. 373, title III, Sec.

371, as added July 28, 1956, ch. 772, title II, Sec. 201, 70 Stat.

709, authorized grants to the Territory of Alaska for an integrated

mental health program, prior to repeal by Pub. L. 86-70, Sec.

31(b)(1), June 25, 1959, 73 Stat. 148, effective July 1, 1959.

A prior section 371 of act July 1, 1944, added by act Aug. 3,

1956, ch. 907, Sec. 1, 70 Stat. 960, was renumbered section 381 and

classified to section 275 of this title, prior to repeal by Pub. L.

99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

2000 - Subsec. (b)(1)(D) to (H). Pub. L. 106-505 and Pub. L.

106-554 amended par. (1) identically, adding subpar. (D),

redesignating former subpars. (D) to (G) as (E) to (H),

respectively, and realigning margins of subpar. (F).

1990 - Pub. L. 101-616, Sec. 201(a), substituted "Organ

procurement organizations" for "Assistance for organ procurement

organizations" in section catchline.

Subsec. (a)(3). Pub. L. 101-616, Sec. 201(b)(1), substituted "may

make grants to, and enter into contracts with, qualified organ

procurement organizations described in subsection (b) of this

section and other nonprofit private entities for the purpose of

carrying out special projects" for "may make grants for special

projects".

Subsec. (a)(4). Pub. L. 101-616, Sec. 201(b)(2), struck out par.

(4) which set forth factors to consider in making grants.

Subsec. (b)(1)(E). Pub. L. 101-616, Sec. 201(c)(1), amended

subpar. (E) generally. Prior to amendment, subpar. (E) read as

follows: "has a defined service area which is a geographical area

of sufficient size such that (unless the service area comprises an

entire State) the organization can reasonably expect to procure

organs from not less than 50 donors each year and which either

includes an entire standard metropolitan statistical area (as

specified by the Office of Management and Budget) or does not

include any part of such an area,".

Subsec. (b)(1)(G)(i)(III). Pub. L. 101-616, Sec. 201(e), made

technical correction to Pub. L. 100-607, Sec. 402(c)(2). See 1988

Amendment note below.

Subsec. (b)(2), (3). Pub. L. 101-616, Sec. 201(d), added par. (2)

and redesignated former par. (2) as (3).

Subsec. (c). Pub. L. 101-616, Sec. 206(b), struck out subsec. (c)

which authorized appropriations for subsec. (a) grants for fiscal

years 1988 through 1990.

1988 - Subsec. (a)(2). Pub. L. 100-607, Sec. 402(a)(1), inserted

"consolidation," after "initial operation,".

Subsec. (a)(3). Pub. L. 100-607, Sec. 402(a)(2), added par. (3).

Former par. (3) redesignated (4).

Subsec. (a)(4). Pub. L. 100-607, Sec. 402(a)(2), redesignated

former par. (3) as (4).

Subsec. (a)(4)(C). Pub. L. 100-607, Sec. 402(a)(3), added subpar.

(C).

Subsec. (b)(1)(E). Pub. L. 100-607, Sec. 402(c)(1)(A),

substituted "size such that" for "size which", and "the

organization can reasonably expect to procure organs from not less

than 50 donors each year" for "will include at least fifty

potential organ donors each year".

Subsec. (b)(1)(G)(i)(III). Pub. L. 100-607, Sec. 402(c)(2), as

amended by Pub. L. 101-616, Sec. 201(e), inserted "or an individual

with a doctorate degree in a biological science with knowledge,

experience, or skill in the field of histocompatibility" before

comma at end.

Subsec. (b)(2)(C). Pub. L. 100-607, Sec. 402(c)(1)(B),

substituted "274(b)(2)(E) of this title, including arranging for

testing with respect to preventing the acquisition of organs that

are infected with the etiologic agent for acquired immune

deficiency syndrome," for "274(b)(2)(D) of this title,".

Subsec. (b)(2)(E). Pub. L. 100-607, Sec. 402(c)(1)(C),

substituted "organs equitably among transplant patients" for

"organs among transplant centers and patients".

Subsec. (b)(2)(K). Pub. L. 100-607, Sec. 402(c)(1)(D), added

subpar. (K).

Subsec. (c). Pub. L. 100-607, Sec. 402(d), amended subsec. (c)

generally. Prior to amendment, subsec. (c) read as follows: "For

grants under subsection (a) of this section there are authorized to

be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for

fiscal year 1986, and $12,000,000 for fiscal year 1987."

EFFECTIVE DATE OF 1990 AMENDMENT

Section 207 of title II of Pub. L. 101-616 provided that: "Except

as otherwise provided in this title, the amendments made by this

title [enacting sections 274f and 274g of this title, amending this

section and sections 274 and 274b to 274d of this title, and

repealing provisions set out as a note below] shall become

effective on October 1, 1990, or on the date of the enactment of

this Act [Nov. 16, 1990], whichever occurs later."

EFFECTIVE DATE OF 1988 AMENDMENT

Section 402(c)(3) of Pub. L. 100-607, as amended by Pub. L.

101-274, Apr. 23, 1990, 104 Stat. 139, which provided that the

amendment made by section 402(c)(1)(A) of Pub. L. 100-607, amending

this section, was not to apply to an organ procurement organization

designated under section 1320b-8(b) of this title until Jan. 1,

1992, was repealed by Pub. L. 101-616, title II, Sec. 201(c)(2),

Nov. 16, 1990, 104 Stat. 3283.

SHORT TITLE

For short title of Pub. L. 98-507, which enacted this part as the

"National Organ Transplant Act", see section 1 of Pub. L. 98-507,

set out as a Short Title of 1984 Amendments note under section 201

of this title.

SEVERABILITY

Section 301 of Pub. L. 101-616 provided that: "If any provision

of this Act [enacting sections 274f, 274g, 274k, and 274l of this

title, amending this section and sections 274 to 274d of this

title, enacting provisions set out as notes under this section and

sections 274 and 274k of this title, and repealing provisions set

out as a note above], amendment made by this Act, or application of

the provision or amendment to any person or circumstance is held to

be unconstitutional, the remainder of this Act, the amendments made

by this Act, and the application of the provisions or amendments to

any person or circumstance shall not be affected."

CERTIFICATION OF ORGAN PROCUREMENT ORGANIZATIONS

Pub. L. 106-505, title VII, Sec. 701(b), Nov. 13, 2000, 114 Stat.

2346, and Pub. L. 106-554, Sec. 1(a)(1) [title II, Sec. 219(a)],

Dec. 21, 2000, 114 Stat. 2763, 2763A-28, provided that: "Congress

makes the following findings:

"(1) Organ procurement organizations play an important role in

the effort to increase organ donation in the United States.

"(2) The current process for the certification and

recertification of organ procurement organizations conducted by

the Department of Health and Human Services has created a level

of uncertainty that is interfering with the effectiveness of

organ procurement organizations in raising the level of organ

donation.

"(3) The General Accounting Office, the Institute of Medicine,

and the Harvard School of Public Health have identified

substantial limitations in the organ procurement organization

certification and recertification process and have recommended

changes in that process.

"(4) The limitations in the recertification process include:

"(A) An exclusive reliance on population-based measures of

performance that do not account for the potential in the

population for organ donation and do not permit consideration

of other outcome and process standards that would more

accurately reflect the relative capability and performance of

each organ procurement organization.

"(B) A lack of due process to appeal to the Secretary of

Health and Human Services for recertification on either

substantive or procedural grounds.

"(5) The Secretary of Health and Human Services has the

authority under section 1138(b)(1)(A)(i) of the Social Security

Act (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the period for

recertification of an organ procurement organization from 2 to 4

years on the basis of its past practices in order to avoid the

inappropriate disruption of the nation's organ system.

"(6) The Secretary of Health and Human Services can use the

extended period described in paragraph (5) for recertification of

all organ procurement organizations to -

"(A) develop improved performance measures that would reflect

organ donor potential and interim outcomes, and to test these

measures to ensure that they accurately measure performance

differences among the organ procurement organizations; and

"(B) improve the overall certification process by

incorporating process as well as outcome performance measures,

and developing equitable processes for appeals."

STUDY REGARDING IMMUNOSUPPRESSIVE DRUGS

Pub. L. 106-310, div. A, title XXI, Sec. 2101(b), Oct. 17, 2000,

114 Stat. 1156, provided that:

"(1) In general. - The Secretary of Health and Human Services

(referred to in this subsection as the 'Secretary') shall provide

for a study to determine the costs of immunosuppressive drugs that

are provided to children pursuant to organ transplants and to

determine the extent to which health plans and health insurance

cover such costs. The Secretary may carry out the study directly or

through a grant to the Institute of Medicine (or other public or

nonprofit private entity).

"(2) Recommendations regarding certain issues. - The Secretary

shall ensure that, in addition to making determinations under

paragraph (1), the study under such paragraph makes recommendations

regarding the following issues:

"(A) The costs of immunosuppressive drugs that are provided to

children pursuant to organ transplants and to determine the

extent to which health plans, health insurance and government

programs cover such costs.

"(B) The extent of denial of organs to be released for

transplant by coroners and medical examiners.

"(C) The special growth and developmental issues that children

have pre- and post-organ transplantation.

"(D) Other issues that are particular to the special health and

transplantation needs of children.

"(3) Report. - The Secretary shall ensure that, not later than

December 31, 2001, the study under paragraph (1) is completed and a

report describing the findings of the study is submitted to the

Congress."

STUDY ON HOSPITAL AGREEMENTS WITH ORGAN PROCUREMENT AGENCIES

Pub. L. 103-432, title I, Sec. 155(b), Oct. 31, 1994, 108 Stat.

4439, directed Office of Technology Assessment to conduct study to

determine efficacy and fairness of requiring a hospital to enter

into agreement under subsec. (b)(3)(A) of this section with organ

procurement agency for service area in which such hospital is

located and impact of such requirement on efficacy and fairness of

organ procurement and distribution, and to submit to Congress, not

later than 2 years after Oct. 31, 1994, report containing findings

of such study and implications of such findings with respect to

policies affecting organ procurement and distribution.

TASK FORCE ON ORGAN PROCUREMENT AND TRANSPLANTATION

Pub. L. 98-507, title I, Secs. 101-105, Oct. 19, 1984, 98 Stat.

2339-2342, directed Secretary of Health and Human Services, not

later than 90 days after Oct. 19, 1984, to establish a Task Force

on Organ Transplantation to conduct comprehensive examinations,

prepare an assessment and report, and submit advice as to

regulation of the medical, legal, ethical, economic, and social

issues presented by human organ procurement and transplantation,

with the final report due not later than 12 months after the Task

Force is established and the Task Force to terminate 3 months

thereafter.

BONE MARROW REGISTRY DEMONSTRATION AND STUDY

Section 401 of Pub. L. 98-507 directed Secretary of Health and

Human Services to hold a conference on the feasibility of

establishing and the effectiveness of a national registry of

voluntary bone marrow donors not later than 9 months after Oct. 19,

1984, and if the conference found that it was feasible to establish

a national registry of voluntary donors of bone marrow and that

such a registry was likely to be effective in matching donors with

recipients, the Secretary was to establish a registry of voluntary

donors of bone marrow not later than six months after the

completion of the conference, and further directed the Secretary,

acting through the Assistant Secretary for Health, to study the

establishment and implementation of the registry to identify the

issues presented by the establishment of such a registry, to

evaluate participation of bone marrow donors, to assess the

implementation of the informed consent and confidentiality

requirements, and to determine if the establishment of a permanent

bone marrow registry was needed and appropriate, and to report the

results of the study to Congress not later than two years after the

date the registry was established.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 274, 274b, 1320b-8 of

this title.

-FOOTNOTE-

(!1) See References in Text note below.

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

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

-End-