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. 274 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. 274. Organ procurement and transplantation network

-STATUTE-

(a) Contract authority of Secretary; limitation; available

appropriations

The Secretary shall by contract provide for the establishment and

operation of an Organ Procurement and Transplantation Network which

meets the requirements of subsection (b) of this section. The

amount provided under such contract in any fiscal year may not

exceed $2,000,000. Funds for such contracts shall be made available

from funds available to the Public Health Service from

appropriations for fiscal years beginning after fiscal year 1984.

(b) Functions

(1) The Organ Procurement and Transplantation Network shall carry

out the functions described in paragraph (2) and shall -

(A) be a private nonprofit entity that has an expertise in

organ procurement and transplantation, and

(B) have a board of directors -

(i) that includes representatives of organ procurement

organizations (including organizations that have received

grants under section 273 of this title), transplant centers,

voluntary health associations, and the general public; and

(ii) that shall establish an executive committee and other

committees, whose chairpersons shall be selected to ensure

continuity of leadership for the board.

(2) The Organ Procurement and Transplantation Network shall -

(A) establish in one location or through regional centers -

(i) a national list of individuals who need organs, and

(ii) a national system, through the use of computers and in

accordance with established medical criteria, to match organs

and individuals included in the list, especially individuals

whose immune system makes it difficult for them to receive

organs,

(B) establish membership criteria and medical criteria for

allocating organs and provide to members of the public an

opportunity to comment with respect to such criteria,

(C) maintain a twenty-four-hour telephone service to facilitate

matching organs with individuals included in the list,

(D) assist organ procurement organizations in the nationwide

distribution of organs equitably among transplant patients,

(E) adopt and use standards of quality for the acquisition and

transportation of donated organs, including standards for

preventing the acquisition of organs that are infected with the

etiologic agent for acquired immune deficiency syndrome,

(F) prepare and distribute, on a regionalized basis (and, to

the extent practicable, among regions or on a national basis),

samples of blood sera from individuals who are included on the

list and whose immune system makes it difficult for them to

receive organs, in order to facilitate matching the compatibility

of such individuals with organ donors,

(G) coordinate, as appropriate, the transportation of organs

from organ procurement organizations to transplant centers,

(H) provide information to physicians and other health

professionals regarding organ donation,

(I) collect, analyze, and publish data concerning organ

donation and transplants,

(J) carry out studies and demonstration projects for the

purpose of improving procedures for organ procurement and

allocation,

(K) work actively to increase the supply of donated organs,

(L) submit to the Secretary an annual report containing

information on the comparative costs and patient outcomes at each

transplant center affiliated with the organ procurement and

transplantation network,

(M) recognize the differences in health and in organ

transplantation issues between children and adults throughout the

system and adopt criteria, polices, and procedures that address

the unique health care needs of children,

(N) carry out studies and demonstration projects for the

purpose of improving procedures for organ donation procurement

and allocation, including but not limited to projects to examine

and attempt to increase transplantation among populations with

special needs, including children and individuals who are members

of racial or ethnic minority groups, and among populations with

limited access to transportation, and

(O) provide that for purposes of this paragraph, the term

"children" refers to individuals who are under the age of 18.

(c) Consideration of critical comments

The Secretary shall establish procedures for -

(1) receiving from interested persons critical comments

relating to the manner in which the Organ Procurement and

Transplantation Network is carrying out the duties of the Network

under subsection (b) of this section; and

(2) the consideration by the Secretary of such critical

comments.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 372, as added Pub. L.

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2344; amended

Pub. L. 100-607, title IV, Sec. 403, Nov. 4, 1988, 102 Stat. 3115;

Pub. L. 101-616, title II, Sec. 202(a)-(c), Nov. 16, 1990, 104

Stat. 3283, 3284; Pub. L. 106-310, div. A, title XXI, Sec. 2101(a),

Oct. 17, 2000, 114 Stat. 1156.)

-MISC1-

PRIOR PROVISIONS

A prior section 274, act July 1, 1944, ch. 373, title III, Sec.

372, as added July 28, 1956, ch. 772, title II, Sec. 201, 70 Stat.

710; amended June 25, 1959, Pub. L. 86-70, Sec. 31(b)(2)-(4), 73

Stat. 148, related to grants to Alaska for a mental health program

and payment for construction of hospital facilities, prior to the

general revision of this part by section 201 of Pub. L. 98-507.

Another section 372 of act July 1, 1944, added by act Aug. 3,

1956, ch. 941, Sec. 1, 70 Stat. 960, which related to functions of

National Library of Medicine, was renumbered section 382 and

classified to section 276 of this title, prior to repeal by Pub. L.

99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

2000 - Subsec. (b)(2)(M) to(O). Pub. L. 106-310 added subpars.

(M) to (O).

1990 - Subsec. (b)(1)(A). Pub. L. 101-616, Sec. 202(a)(1),

substituted "that has an expertise in organ procurement and

transplantation" for "which is not engaged in any activity

unrelated to organ procurement".

Subsec. (b)(1)(B). Pub. L. 101-616, Sec. 202(a)(2), amended

subpar. (B) generally. Prior to amendment, subpar. (B) read as

follows: "have a board of directors which includes representatives

of organ procurement organizations (including organizations which

have received grants under section 273 of this title), transplant

centers, voluntary health associations, and the general public."

Subsec. (b)(2)(D). Pub. L. 101-616, Sec. 202(b)(1), inserted

"nationwide" after "organizations in the" and "equitably among

transplant patients" after "organs".

Subsec. (b)(2)(F). Pub. L. 101-616, Sec. 202(c), substituted

"compatibility" for "compatability".

Subsec. (b)(2)(K), (L). Pub. L. 101-616, Sec. 202(b)(2)-(4),

added subpars. (K) and (L).

1988 - Subsec. (b)(2)(B), (C). Pub. L. 100-607, Sec. 403(a)(1),

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

(C) and (D), respectively.

Subsec. (b)(2)(D). Pub. L. 100-607, Sec. 403(a)(1), (2),

redesignated former subpar. (C) as (D) and substituted "organs" for

"organs which cannot be placed within the service areas of the

organizations". Former subpar. (D) redesignated (E).

Subsec. (b)(2)(E). Pub. L. 100-607, Sec. 403(a)(1), (3),

redesignated former subpar. (D) as (E) and inserted "including

standards for preventing the acquisition of organs that are

infected with the etiologic agent for acquired immune deficiency

syndrome," after "organs,". Former subpar. (E) redesignated (F).

Subsec. (b)(2)(F). Pub. L. 100-607, Sec. 403(a)(1), (4),

redesignated former subpar. (E) as (F) and inserted "(and, to the

extent practicable, among regions or on a national basis)" after

"basis". Former subpar. (F) redesignated (G).

Subsec. (b)(2)(G) to (I). Pub. L. 100-607, Sec. 403(a)(1),

redesignated former subpars. (F) to (H) as (G) to (I),

respectively.

Subsec. (b)(2)(J). Pub. L. 100-607, Sec. 403(a)(5), added subpar.

(J).

Subsec. (c). Pub. L. 100-607, Sec. 403(b), added subsec. (c).

EFFECTIVE DATE OF 1990 AMENDMENT

Section 202(d) of Pub. L. 101-616 provided that: "The amendments

made by subsection (a) [amending this section] shall become

effective on December 31, 1990."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 273, 274b, 274c, 1320b-8

of this title.

-End-

-CITE-

42 USC Sec. 274a 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. 274a. Scientific registry

-STATUTE-

The Secretary shall, by grant or contract, develop and maintain a

scientific registry of the recipients of organ transplants. The

registry shall include such information respecting patients and

transplant procedures as the Secretary deems necessary to an

ongoing evaluation of the scientific and clinical status of organ

transplantation. The Secretary shall prepare for inclusion in the

report under section 274d of this title an analysis of information

derived from the registry.

-SOURCE-

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

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2345; amended

Pub. L. 100-607, title IV, Sec. 404, Nov. 4, 1988, 102 Stat. 3116;

Pub. L. 101-616, title I, Sec. 101(b), Nov. 16, 1990, 104 Stat.

3282.)

-MISC1-

PRIOR PROVISIONS

A prior section 373 of act July 1, 1944, added by act Aug. 3,

1956, ch. 907, Sec. 1, 70 Stat. 960, which related to a Board of

Regents of National Library of Medicine, was renumbered section 383

and classified to section 277 of this title, prior to repeal by

Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1990 - Pub. L. 101-616 struck out "and bone marrow registry"

after "Scientific registry" in section catchline and struck out

subsec. (a) designation and subsec. (b) which directed

establishment of bone marrow registry and authorized appropriations

for fiscal years 1989 and 1990 for such purpose.

1988 - Pub. L. 100-607 inserted "and bone marrow registry" in

section catchline, designated existing text as subsec. (a), and

added subsec. (b).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 274b of this title.

-End-

-CITE-

42 USC Sec. 274b 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. 274b. General provisions respecting grants and contracts

-STATUTE-

(a) Application requirement

No grant may be made under this part or contract entered into

under section 274 or 274a of this title unless an application

therefor has been submitted to, and approved by, the Secretary.

Such an application shall be in such form and shall be submitted in

such manner as the Secretary shall by regulation prescribe.

(b) Special considerations and priority; planning and establishment

grants

(1) A grant for planning under section 273(a)(1) of this title

may be made for one year with respect to any organ procurement

organization and may not exceed $100,000.

(2) Grants under section 273(a)(2) of this title may be made for

two years. No such grant may exceed $500,000 for any year and no

organ procurement organization may receive more than $800,000 for

initial operation or expansion.

(3) Grants or contracts under section 273(a)(3) of this title may

be made for not more than 3 years.

(c) Determination of grant amount; terms of payment; recordkeeping;

access for purposes of audits and examination of records

(1) The Secretary shall determine the amount of a grant or

contract made under section 273 or 274a of this title. Payments

under such grants and contracts may be made in advance on the basis

of estimates or by the way of reimbursement, with necessary

adjustments on account of underpayments or overpayments, and in

such installments and on such terms and conditions as the Secretary

finds necessary to carry out the purposes of such grants and

contracts.

(2)(A) Each recipient of a grant or contract under section 273 or

274a of this title shall keep such records as the Secretary shall

prescribe, including records which fully disclose the amount and

disposition by such recipient of the proceeds of such grant or

contract, the total cost of the undertaking in connection with

which such grant or contract was made, and the amount of that

portion of the cost of the undertaking supplied by other sources,

and such other records as will facilitate an effective audit.

(B) The Secretary and the Comptroller General of the United

States, or any of their duly authorized representatives, shall have

access for the purpose of audit and examination to any books,

documents, papers, and records of the recipient of a grant or

contract under section 273 or 274a of this title that are pertinent

to such grant or contract.

(d) "Transplant center" and "organ" defined

For purposes of this part:

(1) The term "transplant center" means a health care facility

in which transplants of organs are performed.

(2) The term "organ" means the human kidney, liver, heart,

lung, pancreas, and any other human organ (other than corneas and

eyes) specified by the Secretary by regulation and for purposes

of section 274a of this title, such term includes bone marrow.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 374, as added Pub. L.

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2345; amended

Pub. L. 100-607, title IV, Sec. 402(b), Nov. 4, 1988, 102 Stat.

3114; Pub. L. 101-616, title II, Sec. 203, Nov. 16, 1990, 104 Stat.

3284.)

-MISC1-

PRIOR PROVISIONS

A prior section 374 of act July 1, 1944, added by act Aug. 3,

1956, ch. 907, Sec. 1, 70 Stat. 961, which related to acceptance

and administration of gifts to National Library of Medicine and to

establishment of memorials to donors, was renumbered section 384

and classified to section 278 of this title, prior to repeal by

Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1990 - Subsec. (a). Pub. L. 101-616, Sec. 203(1), substituted "No

grant may be made under this part" for "No grant may be made under

section 273 or 274a of this title".

Subsec. (b). Pub. L. 101-616, Sec. 203(2), redesignated par. (2)

as (1) and substituted "section 273(a)(1)" for "section 273",

struck out former par. (1) which set forth factors in considering

applications for section 273 grants, redesignated par. (3) as (2)

and substituted "section 273(a)(2)" for "paragraphs (2) and (3) of

section 273(a)", and added par. (3).

Subsec. (c). Pub. L. 101-616, Sec. 203(3), inserted "or contract"

after "grant" wherever appearing and "and contracts" after "grants"

wherever appearing.

1988 - Subsec. (b)(3). Pub. L. 100-607 substituted "paragraphs

(2) and (3) of section 273(a) of this title" for "section 273 of

this title for the establishment, initial operation, or expansion

of organ procurement organizations".

-End-

-CITE-

42 USC Sec. 274c 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. 274c. Administration

-STATUTE-

The Secretary shall designate and maintain an identifiable

administrative unit in the Public Health Service to -

(1) administer this part and coordinate with the organ

procurement activities under title XVIII of the Social Security

Act [42 U.S.C. 1395 et seq.],

(2) conduct a program of public information to inform the

public of the need for organ donations,

(3) provide technical assistance to organ procurement

organizations, the Organ Procurement and Transplantation Network

established under section 274 of this title, and other entities

in the health care system involved in organ donations,

procurement, and transplants, and

(4) provide information -

(i) to patients, their families, and their physicians about

transplantation; and

(ii) to patients and their families about the resources

available nationally and in each State, and the comparative

costs and patient outcomes at each transplant center affiliated

with the organ procurement and transplantation network, in

order to assist the patients and families with the costs

associated with transplantation.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 375, as added Pub. L.

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2346; amended

Pub. L. 100-607, title IV, Sec. 405, Nov. 4, 1988, 102 Stat. 3116;

Pub. L. 101-616, title II, Sec. 204, Nov. 16, 1990, 104 Stat.

3285.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in par. (1), 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.

-MISC1-

PRIOR PROVISIONS

A prior section 375 of act July 1, 1944, added by act Aug. 3,

1956, ch. 907, Sec. 1, 70 Stat. 962, which related to definitions,

was renumbered section 385 and classified to section 279 of this

title, prior to repeal by Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985,

99 Stat. 879.

AMENDMENTS

1990 - Pub. L. 101-616, Sec. 204(a), struck out ", during fiscal

years 1985 through 1990," after "The Secretary shall".

Par. (3). Pub. L. 101-616, Sec. 204(b)(1), struck out "receiving

funds under section 273 of this title" after "organ procurement

organizations".

Par. (4). Pub. L. 101-616, Sec. 204(b)(2), amended par. (4)

generally. Prior to amendment, par. (4) read as follows: "not later

than April 1 of each of the years 1989 and 1990, submit to the

Congress a report on the status of organ donation and coordination

services and include in the report an analysis of the efficiency

and effectiveness of the procurement and allocation of organs and a

description of problems encountered in the procurement and

allocation of organs."

1988 - Pub. L. 100-607, in introductory provisions, substituted

"1985 through 1990" for "1985, 1986, 1987, and 1988" and, in par.

(4), substituted "not later than April 1 of each of the years 1989

and 1990, submit to the Congress a report" for "one year after the

date on which the Task Force on Organ Transplantation transmits its

final report under section 104(c) of the National Organ Transplant

Act, and annually thereafter through fiscal year 1988, submit to

Congress an annual report".

-End-

-CITE-

42 USC Sec. 274d 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. 274d. Report

-STATUTE-

Not later than February 10 of 1991 and of each second year

thereafter, the Secretary shall publish, and submit to the

Committee on Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of the Senate.(!1) a

report on the scientific and clinical status of organ

transplantation. The Secretary shall consult with the Director of

the National Institutes of Health and the Commissioner of the Food

and Drug Administration in the preparation of the report.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 376, as added Pub. L.

98-507, title II, Sec. 201, Oct. 19, 1984, 98 Stat. 2346; amended

Pub. L. 100-607, title IV, Sec. 406, Nov. 4, 1988, 102 Stat. 3116;

Pub. L. 101-616, title II, Sec. 205, Nov. 16, 1990, 104 Stat.

3285.)

-MISC1-

PRIOR PROVISIONS

A prior section 376 of act July 1, 1944, added by act Aug. 3,

1956, ch. 907, Sec. 1, 70 Stat. 962, which related to Library

facilities, was renumbered section 386 and classified to section

280 of this title, prior to repeal by Pub. L. 99-158, Sec. 3(b),

Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1990 - Pub. L. 101-616 substituted "Not later than February 10 of

1991 and of each second year thereafter, the Secretary shall

publish, and submit to the Committee on Energy and Commerce of the

House of Representatives and the Committee on Labor and Human

Resources of the Senate." for "The Secretary shall, not later than

October 1 of each year, publish".

1988 - Pub. L. 100-607 substituted "shall, not later than October

1 of each year," for "shall annually".

-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.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 274a of this title.

-FOOTNOTE-

(!1) So in original. The period probably should be a comma.

-End-

-CITE-

42 USC Sec. 274e 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. 274e. Prohibition of organ purchases

-STATUTE-

(a) Prohibition

It shall be unlawful for any person to knowingly acquire,

receive, or otherwise transfer any human organ for valuable

consideration for use in human transplantation if the transfer

affects interstate commerce.

(b) Penalties

Any person who violates subsection (a) of this section shall be

fined not more than $50,000 or imprisoned not more than five years,

or both. (c) Definitions

For purposes of subsection (a) of this section:

(1) The term "human organ" means the human (including fetal)

kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye,

bone, and skin or any subpart thereof and any other human organ

(or any subpart thereof, including that derived from a fetus)

specified by the Secretary of Health and Human Services by

regulation.

(2) The term "valuable consideration" does not include the

reasonable payments associated with the removal, transportation,

implantation, processing, preservation, quality control, and

storage of a human organ or the expenses of travel, housing, and

lost wages incurred by the donor of a human organ in connection

with the donation of the organ.

(3) The term "interstate commerce" has the meaning prescribed

for it by section 321(b) of title 21.

-SOURCE-

(Pub. L. 98-507, title III, Sec. 301, Oct. 19, 1984, 98 Stat. 2346;

Pub. L. 100-607, title IV, Sec. 407, Nov. 4, 1988, 102 Stat. 3116.)

-COD-

CODIFICATION

Section was enacted as part of the National Organ Transplant Act,

and not as part of the Public Health Service Act which comprises

this chapter.

-MISC1-

AMENDMENTS

1988 - Subsec. (c)(1). Pub. L. 100-607 amended par. (1)

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

'human organ' means the human kidney, liver, heart, lung, pancreas,

bone marrow, cornea, eye, bone, and skin, and any other human organ

specified by the Secretary of Health and Human Services by

regulation."

-End-

-CITE-

42 USC Sec. 274f 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. 274f. Study by General Accounting Office

-STATUTE-

(a) In general

The Comptroller General of the United States shall conduct a

study for the purpose of determining -

(1) the extent to which the procurement and allocation of

organs have been equitable, efficient, and effective;

(2) the problems encountered in the procurement and allocation;

and

(3) the effect of State required-request laws.

(b) Report

Not later than January 7, 1992, the Comptroller General of the

United States shall complete the study required in subsection (a)

of this section and submit to the Committee on Energy and Commerce

of the House of Representatives, and to the Committee on Labor and

Human Resources of the Senate, a report describing the findings

made as a result of the study.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 377, as added Pub. L.

101-616, title II, Sec. 206(a), Nov. 16, 1990, 104 Stat. 3285.)

-CHANGE-

CHANGE OF NAMECommittee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

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

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

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

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

Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 274g 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. 274g. Authorization of appropriations

-STATUTE-

For the purpose of carrying out this part, there are authorized

to be appropriated $8,000,000 for fiscal year 1991, and such sums

as may be necessary for each of the fiscal years 1992 and 1993. -SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 378, as added Pub. L.

101-616, title II, Sec. 206(a), Nov. 16, 1990, 104 Stat. 3285;

amended Pub. L. 105-196, Sec. 4(1), July 16, 1998, 112 Stat. 636.)

-MISC1-

AMENDMENTS

1998 - Pub. L. 105-196 made technical amendment relating to

placement of section within part H of this subchapter.

-End-

-CITE-

42 USC Part I - National Bone Marrow Donor Registry 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

PART I - NATIONAL BONE MARROW DONOR REGISTRY

-MISC1-

AMENDMENTS

1990 - Pub. L. 101-616, title I, Sec. 101(a)(2), Nov. 16, 1990,

104 Stat. 3279, added part I "National Bone Marrow Donor Registry"

and redesignated former part I "Biomedical Ethics" as J.

1985 - Pub. L. 99-158, Secs. 3(b), 11, Nov. 20, 1985, 99 Stat.

879, 883, added part I "Biomedical Ethics", and repealed former

part I "National Library of Medicine".

1970 - Pub. L. 91-212, Sec. 10(a)(2), Mar. 13, 1970, 84 Stat. 66,

redesignated part H "National Library of Medicine", as part I

"National Library of Medicine".

-End-

-CITE-

42 USC Sec. 274k 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

Sec. 274k. National Registry

STATUTE-

(a) Establishment

The Secretary shall by contract establish and maintain a National

Bone Marrow Donor Registry (referred to in this part as the

"Registry") that has the purpose of increasing the number of

transplants for recipients suitably matched to biologically

unrelated donors of bone marrow, and that meets the requirements of

this section. The Registry shall be under the general supervision

of the Secretary, and under the direction of a board of directors

meeting the following requirements:

(1) Each member of the board shall serve for a term of 2 years,

and each such member may serve as many as 3 consecutive 2-year

terms, except that such limitations shall not apply to the Chair

of the board (or the Chair-elect) or to the member of the board

who most recently served as the Chair.

(2) A member of the board may continue to serve after the

expiration of the term of such member until a successor is

appointed.

(3) In order to ensure the continuity of the board, the board

shall be appointed so that each year the terms of approximately

one-third of the members of the board expire.

(4) The membership of the board shall include representatives

of marrow donor centers and marrow transplant centers; recipients

of a bone marrow transplant; persons who require or have required

such a transplant; family members of such a recipient or family

members of a patient who has requested the assistance of the

Registry in searching for an unrelated donor of bone marrow;

persons with expertise in the social sciences; and members of the

general public; and in addition nonvoting representatives from

the Naval Medical Research and Development Command and from the

Division of Organ Transplantation of the Health Resources and

Services Administration.

(b) Functions

The Registry shall -

(1) establish a system for finding marrow donors suitably

matched to unrelated recipients for bone marrow transplantation;

(2) carry out a program for the recruitment of bone marrow

donors in accordance with subsection (c) of this section,

including with respect to increasing the representation of racial

and ethnic minority groups (including persons of mixed ancestry)

in the enrollment of the Registry;

(3) carry out informational and educational activities in

accordance with subsection (c) of this section;

(4) annually update information to account for changes in the

status of individuals as potential donors of bone marrow;

(5) provide for a system of patient advocacy through the office

established under subsection (d) of this section;

(6) provide case management services for any potential donor of

bone marrow to whom the Registry has provided a notice that the

potential donor may be suitably matched to a particular patient

(which services shall be provided through a mechanism other than

the system of patient advocacy under subsection (d) of this

section), and conduct surveys of donors and potential donors to

determine the extent of satisfaction with such services and to

identify ways in which the services can be improved;

(7) with respect to searches for unrelated donors of bone

marrow that are conducted through the system under paragraph (1),

collect and analyze and publish data on the number and percentage

of patients at each of the various stages of the search process,

including data regarding the furthest stage reached; the number

and percentage of patients who are unable to complete the search

process, and the reasons underlying such circumstances; and

comparisons of transplant centers regarding search and other

costs that prior to transplantation are charged to patients by

transplant centers; and

(8) support studies and demonstration projects for the purpose

of increasing the number of individuals, especially minorities,

who are willing to be marrow donors.

(c) Recruitment; priorities; information and education

(1) Recruitment; priorities

The Registry shall carry out a program for the recruitment of

bone marrow donors. Such program shall identify populations that

are underrepresented among potential donors enrolled with the

Registry. In the case of populations that are identified under

the preceding sentence:

(A) The Registry shall give priority to carrying out

activities under this part to increase representation for such

populations in order to enable a member of such a population,

to the extent practicable, to have a probability of finding a

suitable unrelated donor that is comparable to the probability

that an individual who is not a member of an underrepresented

population would have.

(B) The Registry shall consider racial and ethnic minority

groups (including persons of mixed ancestry) to be populations

that have been identified for purposes of this paragraph, and

shall carry out subparagraph (A) with respect to such

populations.

(2) Information and education regarding recruitment; testing and

enrollment

(A) In general

In carrying out the program under paragraph (1), the Registry

shall carry out informational and educational activities for

purposes of recruiting individuals to serve as donors of bone

marrow, and shall test and enroll with the Registry potential

donors. Such information and educational activities shall

include the following:

(i) Making information available to the general public,

including information describing the needs of patients with

respect to donors of bone marrow.

(ii) Educating and providing information to individuals who

are willing to serve as potential donors, including providing

updates.

(iii) Training individuals in requesting individuals to

serve as potential donors.

(B) Priorities

In carrying out informational and educational activities

under subparagraph (A), the Registry shall give priority to

recruiting individuals to serve as donors of bone marrow for

populations that are identified under paragraph (1).

(3) Transplantation as treatment option

In addition to activities regarding recruitment, the program

under paragraph (1) shall provide information to physicians,

other health care professionals, and the public regarding the

availability, as a potential treatment option, of receiving a

transplant of bone marrow from an unrelated donor.

(d) Patient advocacy; case management

(1) In general

The Registry shall establish and maintain an office of patient

advocacy (in this subsection referred to as the "Office").

(2) General functions

The Office shall meet the following requirements:

(A) The Office shall be headed by a director.

(B) The Office shall operate a system for patient advocacy,

which shall be separate from mechanisms for donor advocacy, and

which shall serve patients for whom the Registry is conducting,

or has been requested to conduct, a search for an unrelated

donor of bone marrow.

(C) In the case of such a patient, the Office shall serve as

an advocate for the patient by directly providing to the

patient (or family members, physicians, or other individuals

acting on behalf of the patient) individualized services with

respect to efficiently utilizing the system under subsection

(b)(1) of this section to conduct an ongoing search for a

donor.

(D) In carrying out subparagraph (C), the Office shall

monitor the system under subsection (b)(1) of this section to

determine whether the search needs of the patient involved are

being met, including with respect to the following:

(i) Periodically providing to the patient (or an individual

acting on behalf of the patient) information regarding donors

who are suitability matched to the patient, and other

information regarding the progress being made in the search.

(ii) Informing the patient (or such other individual) if

the search has been interrupted or discontinued.

(iii) Identifying and resolving problems in the search, to

the extent practicable.

(E) In carrying out subparagraph (C), the Office shall

monitor the system under subsection (b)(1) of this section to

determine whether the Registry, donor centers, transplant

centers, and other entities participating in the Registry

program are complying with standards issued under subsection

(e)(4) of this section for the system for patient advocacy

under this subsection.

(F) The Office shall ensure that the following data are made

available to patients:

(i) The resources available through the Registry.

(ii) A comparison of transplant centers regarding search

and other costs that prior to transplantation are charged to

patients by transplant centers.

(iii) A list of donor registries, transplant centers, and

other entities that meet the applicable standards, criteria,

and procedures under subsection (e) of this section.

(iv) The posttransplant outcomes for individual transplant

centers.

(v) Such other information as the Registry determines to be

appropriate.

(G) The Office shall conduct surveys of patients (or family

members, physicians, or other individuals acting on behalf of

patients) to determine the extent of satisfaction with the

system for patient advocacy under this subsection, and to

identify ways in which the system can be improved.

(3) Case management

(A) In general

In serving as an advocate for a patient under paragraph (2),

the Office shall provide individualized case management

services directly to the patient (or family members,

physicians, or other individuals acting on behalf of the

patient), including -

(i) individualized case assessment; and

(ii) the functions described in paragraph (2)(D) (relating

to progress in the search process).

(B) Postsearch functions

In addition to the case management services described in

paragraph (1) for patients, the Office may, on behalf of

patients who have completed the search for an unrelated donor,

provide information and education on the process of receiving a

transplant of bone marrow, including the posttransplant

process.

(e) Criteria, standards, and procedures

Not later than 180 days after November 16, 1990, the Secretary

shall establish and enforce, for entities participating in the

program, including the Registry, individual marrow donor centers,

marrow donor registries, marrow collection centers, and marrow

transplant centers -

(1) quality standards and standards for tissue typing,

obtaining the informed consent of donors, and providing patient

advocacy;

(2) donor selection criteria, based on established medical

criteria, to protect both the donor and the recipient and to

prevent the transmission of potentially harmful infectious

diseases such as the viruses that cause hepatitis and the

etiologic agent for Acquired Immune Deficiency Syndrome;

(3) procedures to ensure the proper collection and

transportation of the marrow;

(4) standards for the system for patient advocacy operated

under subsection (d) of this section, including standards

requiring the provision of appropriate information (at the start

of the search process and throughout the process) to patients and

their families and physicians;

(5) standards that -

(A) require the establishment of a system of strict

confidentiality of records relating to the identity, address,

HLA type, and managing marrow donor center for marrow donors

and potential marrow donors; and

(B) prescribe the purposes for which the records described in

subparagraph (A) may be disclosed, and the circumstances and

extent of the disclosure; and

(6) in the case of a marrow donor center or marrow donor

registry participating in the program, procedures to ensure the

establishment of a method for integrating donor files, searches,

and general procedures of the center or registry with the

Registry.

(f) Comment procedures

The Secretary shall establish and provide information to the

public on procedures, which may include establishment of a policy

advisory committee, under which the Secretary shall receive and

consider comments from interested persons relating to the manner in

which the Registry is carrying out the duties of the Registry under

subsection (b) of this section and complying with the criteria,

standards, and procedures described in subsection (e) of this

section.

(g) Consultation

The Secretary shall consult with the board of directors of the

Registry and the bone marrow donor program of the Department of the

Navy in developing policies affecting the Registry.

(h) Application

To be eligible to enter into a contract under this section, an

entity shall submit to the Secretary and obtain approval of an

application at such time, in such manner, and containing such

information as the Secretary shall by regulation prescribe.

(i) Eligibility

Entities eligible to receive a contract under this section shall

include private nonprofit entities.

(j) Records

(1) Recordkeeping

Each recipient of a contract or subcontract under subsection

(a) of this section shall keep such records as the Secretary

shall prescribe, including records that fully disclose the amount

and disposition by the recipient of the proceeds of the contract,

the total cost of the undertaking in connection with which the

contract was made, and the amount of the portion of the cost of

the undertaking supplied by other sources, and such other records

as will facilitate an effective audit.

(2) Examination of records

The Secretary and the Comptroller General of the United States

shall have access to any books, documents, papers, and records of

the recipient of a contract or subcontract entered into under

this section that are pertinent to the contract, for the purpose

of conducting audits and examinations.

(k) Penalties for disclosure

Any person who discloses the content of any record referred to in

subsection (e)(5)(A) of this section without the prior written

consent of the donor or potential donor with respect to whom the

record is maintained, or in violation of the standards described in

subsection (e)(5)(B) of this section, shall be imprisoned for not

more than 2 years or fined in accordance with title 18, or both.

(l) Annual report regarding pretransplant costs

The Registry shall annually submit to the Secretary the data

collected under subsection (b)(7) of this section on comparisons of

transplant centers regarding search and other costs that prior to

transplantation are charged to patients by transplant centers. The

data shall be submitted to the Secretary through inclusion in the

annual report required in section 274l(c) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 379, as added Pub. L.

101-616, title I, Sec. 101(a)(2), Nov. 16, 1990, 104 Stat. 3279;

amended Pub. L. 105-196, Sec. 2(a), (b)(1), (c)-(g), July 16, 1998,

112 Stat. 631-635.)

-MISC1-

AMENDMENTS

1998 - Subsec. (a). Pub. L. 105-196, Sec. 2(a), substituted

"(referred to in this part as the 'Registry') that has the purpose

of increasing the number of transplants for recipients suitably

matched to biologically unrelated donors of bone marrow, and that

meets" for "(referred to in this part as the 'Registry') that

meets" and substituted "under the direction of a board of directors

meeting the following requirements:" and pars. (1) to (4) for

"under the direction of a board of directors that shall include

representatives of marrow donor centers, marrow transplant centers,

persons with expertise in the social science, and the general

public."

Subsec. (b)(2) to (8). Pub. L. 105-196, Sec. 2(b)(1), added pars.

(2) to (7), redesignated former par. (7) as (8), and struck out

former pars. (2) to (6) which read as follows:

"(2) establish a system for patient advocacy, separate from

mechanisms for donor advocacy, that directly assists patients,

their families, and their physicians in the search for an unrelated

marrow donor;

"(3) increase the representation of individuals from racial and

ethnic minority groups in the pool of potential donors for the

Registry in order to enable an individual in a minority group, to

the extent practicable, to have a comparable chance of finding a

suitable unrelated donor as would an individual not in a minority

group;

"(4) provide information to physicians, other health care

professionals, and the public regarding bone marrow

transplantation;

"(5) recruit potential bone marrow donors;

"(6) collect, analyze, and publish data concerning bone marrow

donation and transplantation; and".

Subsecs. (c), (d). Pub. L. 105-196, Sec. 2(c), (d), added

subsecs. (c) and (d). Former subsecs. (c) and (d) redesignated (e)

and (f), respectively.

Subsec. (e). Pub. L. 105-196, Sec. 2(c), redesignated subsec. (c)

as (e). Former subsec. (e) redesignated (g).

Subsec. (e)(4). Pub. L. 105-196, Sec. 2(e), added par. (4) and

struck out former par. (4) which read as follows: "standards that

require the provision of information to patients, their families,

and their physicians at the start of the search process concerning

-

"(A) the resources available through the Registry;

"(B) all other marrow donor registries meeting the standards

described in this paragraph; and

"(C) in the case of the Registry -

"(i) the comparative costs of all charges by marrow

transplant centers incurred by patients prior to

transplantation; and

"(ii) the success rates of individual marrow transplant

centers;".

Subsec. (f). Pub. L. 105-196, Sec. 2(c), (g)(1), redesignated

subsec. (d) as (f) and substituted "subsection (e)" for "subsection

(c)". Former subsec. (f) redesignated (h).

Subsecs. (g) to (i). Pub. L. 105-196, Sec. 2(c), redesignated

subsecs. (e) to (g) as (g) to (i), respectively. Former subsecs.

(h) and (i) redesignated (j) and (k), respectively.

Subsec. (j). Pub. L. 105-196, Sec. 2(c), redesignated subsec. (h)

as (j) and struck out heading and text of former subsec. (j). Text

read as follows: "There are authorized to be appropriated to carry

out this section $15,000,000 for fiscal year 1991 and such sums as

may be necessary for each of fiscal years 1992 and 1993."

Subsec. (k). Pub. L. 105-196, Sec. 2(c), (g)(2), redesignated

subsec. (i) as (k) and substituted "subsection (e)(5)(A)" for

"subsection (c)(5)(A)" and "subsection (e)(5)(B)" for "subsection

(c)(5)(B)".

Subsec. (l). Pub. L. 105-196, Sec. 2(f), added subsec. (l).

EFFECTIVE DATE OF 1998 AMENDMENT

Pub. L. 105-196, Sec. 7, July 16, 1998, 112 Stat. 637, provided

that: "This Act [see Short Title of 1998 Amendment note set out

under section 201 of this title] takes effect October 1, 1998, or

upon the date of the enactment of this Act [July 16, 1998],

whichever occurs later."

SAVINGS PROVISION

Section 102 of title I of Pub. L. 101-616 provided that:

"(a) In General. - This title [enacting this section and section

274l of this title and amending section 274a of this title], and

the amendments made by this title, shall not affect any legal

document, including any order, regulation, grant, or contract, in

effect on the date of enactment of this Act [Nov. 16, 1990], or any

administrative proceeding or lawsuit pending on the date, that

relates to the bone marrow registry established under section

373(b) of the Public Health Service Act [section 274a(b) of this

title] (as it existed before the amendment made by section 101(b)

of this Act).

"(b) Continued Effect. - A legal document described in subsection

(a) or an order issued in a lawsuit described in subsection (a)

shall continue in effect until modified, terminated, or revoked.

"(c) Proceedings. - In any administrative proceeding or lawsuit

described in subsection (a), parties shall take appeals, and

officials shall hold proceedings and render judgments, in the same

manner and with the same effect as if this title had not been

enacted."

REPORT OF INSPECTOR GENERAL; PLAN REGARDING RELATIONSHIP BETWEEN

REGISTRY AND DONOR CENTERS

Pub. L. 105-196, Sec. 2(b)(2), July 16, 1998, 112 Stat. 632,

provided that: "The Secretary of Health and Human Services shall

ensure that, not later than 1 year after the date of the enactment

of this Act [July 16, 1998], the National Bone Marrow Donor

Registry (under section 379 of the Public Health Service Act [this

section]) develops, evaluates, and implements a plan to effectuate

efficiencies in the relationship between such Registry and donor

centers. The plan shall incorporate, to the extent practicable, the

findings and recommendations made in the inspection conducted by

the Office of the Inspector General (Department of Health and Human

Services) as of January 1997 and known as the Bone Marrow Program

Inspection."

STUDY BY GENERAL ACCOUNTING OFFICE

Pub. L. 105-196, Sec. 5, July 16, 1998, 112 Stat. 636, provided

that:

"(a) In General. - During the period indicated pursuant to

subsection (b), the Comptroller General of the United States shall

conduct a study of the National Bone Marrow Donor Registry under

section 379 of the Public Health Service Act [this section] for

purposes of making determinations of the following:

"(1) The extent to which, relative to the effective date of

this Act [Oct. 1, 1998], such Registry has increased the

representation of racial and ethnic minority groups (including

persons of mixed ancestry) among potential donors of bone marrow

who are enrolled with the Registry, and whether the extent of

increase results in a level of representation that meets the

standard established in subsection (c)(1)(A) of such section 379

[subsec. (c)(1)(A) of this section] (as added by section 2(c) of

this Act).

"(2) The extent to which patients in need of a transplant of

bone marrow from a biologically unrelated donor, and the

physicians of such patients, have been utilizing the Registry in

the search for such a donor.

"(3) The number of such patients for whom the Registry began a

preliminary search but for whom the full search process was not

completed, and the reasons underlying such circumstances.

"(4) The extent to which the plan required in section 2(b)(2)

of this Act [set out as a note above] (relating to the

relationship between the Registry and donor centers) has been

implemented.

"(5) The extent to which the Registry, donor centers, donor

registries, collection centers, transplant centers, and other

appropriate entities have been complying with the standards,

criteria, and procedures under subsection (e) of such section 379

[subsec. (e) of this section] (as redesignated by section 2(c) of

this Act).

"(b) Report. - A report describing the findings of the study

under subsection (a) shall be submitted to the Congress not later

than October 1, 2001. The report may not be submitted before

January 1, 2001."

COMPLIANCE WITH NEW REQUIREMENTS FOR OFFICE OF PATIENT ADVOCACY

Pub. L. 105-196, Sec. 6, July 16, 1998, 112 Stat. 636, provided

that: "With respect to requirements for the office of patient

advocacy under section 379(d) of the Public Health Service Act

[subsec. (d) of this section], the Secretary of Health and Human

Services shall ensure that, not later than 180 days after the

effective date of this Act [Oct. 1, 1998], such office is in

compliance with all requirements (established pursuant to the

amendment made by section 2(d) [amending this section]) that are

additional to the requirements that under section 379 of such Act

[this section] were in effect with respect to patient advocacy on

the day before the date of the enactment of this Act [July 16,

1998]."

-SECREF- SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 274l of this title.

-End-

-CITE-

42 USC Sec. 274l 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

Sec. 274l. Bone marrow scientific registry

-STATUTE-

(a) Establishment of recipient registry

The Secretary, acting through the Registry under section 274k of

this title (in this section referred to as the "Registry"), shall

establish and maintain a scientific registry of information

relating to patients who have been recipients of a transplant of

bone marrow from a biologically unrelated donor.

(b) Information

The scientific registry under subsection (a) of this section

shall include information with respect to patients described in

subsection (a) of this section, transplant procedures, and such

other information as the Secretary determines to be appropriate to

conduct an ongoing evaluation of the scientific and clinical status

of transplantation involving recipients of bone marrow from

biologically unrelated donors.

(c) Annual report on patient outcomes

The Registry shall annually submit to the Secretary a report

concerning patient outcomes with respect to each transplant center.

Each such report shall use data collected and maintained by the

scientific registry under subsection (a) of this section. Each such

report shall in addition include the data required in section

274k(l) of this title (relating to pretransplant costs).

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 379A, as added Pub. L.

105-196, Sec. 3, July 16, 1998, 112 Stat. 635.)

-MISC1-

PRIOR PROVISIONS

A prior section 274l, act July 1, 1944, ch. 373, title III, Sec.

379A, as added Pub. L. 101-616, title I, Sec. 101(a)(2), Nov. 16,

1990, 104 Stat. 3282, related to study by General Accounting

Office, prior to repeal by Pub. L. 105-196, Secs. 3, 7, July 16,

1998, 112 Stat. 635, 637, effective Oct. 1, 1998.

EFFECTIVE DATE

Section effective Oct. 1, 1998, see section 7 of Pub. L. 105-196,

set out as an Effective Date of 1998 Amendment note under section

274k of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 274k of this title.

-End-

-CITE-

42 USC Sec. 274m 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

Sec. 274m. Authorization of appropriations

-STATUTE-

For the purpose of carrying out this part, there are authorized

to be appropriated $18,000,000 for fiscal year 1999, and such sums

as may be necessary for each of the fiscal years 2000 through 2003.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 379B, as added Pub. L.

105-196, Sec. 4(2), July 16, 1998, 112 Stat. 636.)

-MISC1-

EFFECTIVE DATE

Section effective Oct. 1, 1998, see section 7 of Pub. L. 105-196,

set out as an Effective Date of 1998 Amendment note under section

274k of this title.

-End-

-CITE-

42 USC Sec. 275 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

Sec. 275. Repealed. Pub. L. 103-43, title I, Sec. 121(a), June 10,

1993, 107 Stat. 133

-MISC1-

Section, act July 1, 1944, ch. 373, title III, Sec. 381, as added

Nov. 20, 1985, Pub. L. 99-158, Sec. 11, 99 Stat. 883; amended Nov.

4, 1988, Pub. L. 100-607, title I, Sec. 157(a), 102 Stat. 3059,

established the Biomedical Ethics Board and provided for its

membership, functions, reports to Congress, etc., and provided for

appointment of a Biomedical Ethics Advisory Committee to assist the

Biomedical Ethics Board.

A prior section 275, act July 1, 1944, ch. 373, title III, Sec.

381, formerly Sec. 371, as added Aug. 3, 1956, ch. 907, Sec. 1, 70

Stat. 960; renumbered Sec. 381, Mar. 13, 1970, Pub. L. 91-212, Sec.

10(a)(3), 84 Stat. 66, established a National Library of Medicine

in the Public Health Service and stated the congressional purposes

for such establishment, prior to repeal by Pub. L. 99-158, Sec.

3(b), Nov. 20, 1985, 99 Stat. 879.

-End-

-CITE-

42 USC Secs. 276 to 280a-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part I - National Bone Marrow Donor Registry

-HEAD-

Secs. 276 to 280a-1. Repealed. Pub. L. 99-158, Sec. 3(b), Nov. 20,

1985, 99 Stat. 879

-MISC1-

Section 276, act July 1, 1944, ch. 373, title III, Sec. 382,

formerly Sec. 372, as added Aug. 3, 1956, ch. 907, Sec. 1, 70 Stat.

960; renumbered Sec. 382 and amended Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(a)(3), (b)(1), (d)(1), 84 Stat. 66, 67; Nov. 18, 1971, Pub.

L. 92-157, title III, Sec. 301(d)(1), 85 Stat. 463, related to

functions of Secretary with regard to acquisition, etc., of

materials and rules for public access to materials.

Section 277, act July 1, 1944, ch. 373, title III, Sec. 383,

formerly Sec. 373, as added Aug. 3, 1956, ch. 907, Sec. 1, 70 Stat.

960; amended Oct. 22, 1965, Pub. L. 89-291, Sec. 4, 79 Stat. 1067;

renumbered Sec. 383 and amended Mar. 13, 1970, Pub. L. 91-212, Sec.

10(a)(3), (d)(1), 84 Stat. 66, 67; Oct. 30, 1970, Pub. L. 91-515,

title VI, Sec. 601(b)(2), 84 Stat. 1311; Nov. 18, 1971, Pub. L.

92-157, title III, Sec. 301(d)(2), 85 Stat. 464; Nov. 9, 1978, Pub.

L. 95-622, title II, Sec. 212, 92 Stat. 3421, related to

establishment, etc., of Board of Regents.

Section 278, act July 1, 1944, ch. 373, title III, Sec. 384,

formerly Sec. 374, as added Aug. 3, 1956, ch. 907, Sec. 1, 70 Stat.

961; renumbered Sec. 384 and amended Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(a)(3), (d)(1), 84 Stat. 66, 67; Oct. 17, 1979, Pub. L.

96-88, title V, Sec. 509(b), 93 Stat. 695; Apr. 26, 1983, Pub. L.

98-24, Sec. 2(a)(2), 97 Stat. 176, related to acceptance and

administration of gifts and establishment of memorials to donors.

Section 279, act July 1, 1944, ch. 373, title III, Sec. 385,

formerly Sec. 375, as added Aug. 3, 1956, ch. 907 Sec. 1, 70 Stat.

962; renumbered Sec. 385 and amended Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(a)(3), (b)(2), 84 Stat. 66, defined "medicine" and

"medical".

Section 280, act July 1, 1944, ch. 373, title III, Sec. 386,

formerly Sec. 376, as added Aug. 3, 1956, ch. 907, Sec. 1, 70 Stat.

962; renumbered Sec. 386 and amended Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(a)(3), (d)(1), 84 Stat. 66, 67; Nov. 18, 1971, Pub. L.

92-157, title III, Sec. 301(d)(3), 85 Stat. 464, authorized

appropriations for erection and equipment of Library.

Section 280a, act July 1, 1944, ch. 373, title III, Sec. 387,

formerly Sec. 377, as added Aug. 3, 1956, ch. 907, Sec. 1, 70 Stat.

962; amended 1970 Reorg. Plan No. 2 Sec. 102, eff. July 1, 1970, 35

F.R. 7959, 84 Stat. 2085; renumbered Sec. 387, Mar. 13, 1970, Pub.

L. 91-212, Sec. 10(a)(3), 84 Stat. 66, related to transfer of Armed

Forces Medical Library to Public Health Service for use in

administration of part I.

Section 280a-1, act July 1, 1944, ch. 373, title III, Sec. 388,

formerly Sec. 378, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 3,

79 Stat. 1067; renumbered Sec. 388 and amended Mar. 13, 1970, Pub.

L. 91-212, Sec. 10(a)(3), (d)(1), 84 Stat. 66, 67; Nov. 18, 1971,

Pub. L. 92-157, title III, Sec. 301(d)(4), 85 Stat. 464, related to

establishment of regional branches.

-End-

-CITE-

42 USC Part J - Prevention and Control of Injuries 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

PART J - PREVENTION AND CONTROL OF INJURIES MISC1-

AMENDMENTS

1993 - Pub. L. 103-183, title II, Sec. 203(a)(1), Dec. 14, 1993,

107 Stat. 2232, substituted "Prevention and Control of Injuries"

for "Injury Control" in part heading.

Pub. L. 103-43, title XX, Sec. 2008(i)(2)(B)(i), June 10, 1993,

107 Stat. 213, redesignated part K "Injury Control" as J. Former

part J "Biomedical Ethics", consisting of section 275, was repealed

by Pub. L. 103-43, title I, Sec. 121(a), June 10, 1993, 107 Stat.

133.

1990 - Pub. L. 101-616, title I, Sec. 101(a)(1), Nov. 16, 1990,

104 Stat. 3279, redesignated part I "Biomedical Ethics" as J.

Former part J "Injury Control" redesignated K.

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in section 3796gg of this title.

-End-

-CITE-

42 USC Sec. 280b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b. Research

-STATUTE-

(a) The Secretary, through the Director of the Centers for

Disease Control and Prevention, shall -

(1) conduct, and give assistance to public and nonprofit

private entities, scientific institutions, and individuals

engaged in the conduct of, research relating to the causes,

mechanisms, prevention, diagnosis, treatment of injuries, and

rehabilitation from injuries;

(2) make grants to, or enter into cooperative agreements or

contracts with, public and nonprofit private entities (including

academic institutions, hospitals, and laboratories) and

individuals for the conduct of such research; and

(3) make grants to, or enter into cooperative agreements or

contracts with, academic institutions for the purpose of

providing training on the causes, mechanisms, prevention,

diagnosis, treatment of injuries, and rehabilitation from

injuries.

(b) The Secretary, through the Director of the Centers for

Disease Control and Prevention, shall collect and disseminate,

through publications and other appropriate means, information

concerning the practical applications of research conducted or

assisted under subsection (a) of this section. In carrying out the

preceding sentence, the Secretary shall disseminate such

information to the public, including through elementary and

secondary schools.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 391, as added Pub. L.

99-649, Sec. 3, Nov. 10, 1986, 100 Stat. 3633; amended Pub. L.

101-558, Sec. 2(a), Nov. 15, 1990, 104 Stat. 2772; Pub. L. 102-531,

title III, Sec. 312(d)(3), Oct. 27, 1992, 106 Stat. 3504; Pub. L.

103-183, title II, Sec. 203(b)(2), Dec. 14, 1993, 107 Stat. 2232.)

-MISC1-

PRIOR PROVISIONS

A prior section 280b, act July 1, 1944, ch. 373, title III, Sec.

390, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat. 1059;

amended Mar. 13, 1970, Pub. L. 91-212, Secs. 4(b), 5(b), 6(b), 84

Stat. 64, 65; July 23, 1974, Pub. L. 93-353, title II, Secs.

201(a), (b), 202(a), 88 Stat. 371, 372; Aug. 1, 1977, Pub. L.

95-83, title II, Sec. 202, 91 Stat. 386; Nov. 9, 1978, Pub. L.

95-622, title II, Sec. 211, 92 Stat. 3420; Aug. 13, 1981, Pub. L.

97-35, title IX, Sec. 925(a), 95 Stat. 569, set forth findings and

declaration of policy and authorized appropriations with regard to

assistance to medical libraries, prior to repeal by Pub. L. 99-158,

Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

A prior section 391 of act July 1, 1944, ch. 373, title III, as

added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat. 1059; amended

Mar. 13, 1970, Pub. L. 91-212, Sec. 10(b)(3), 84 Stat. 66; July 23,

1974, Pub. L. 93-353, title II, Sec. 202(b), 88 Stat. 372, which

defined "sciences related to health", "National Medical Libraries

Assistance Advisory Board", "Board", and "medical library", was

classified to section 280b-1 of this title, prior to repeal by Pub.

L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1993 - Subsec. (b). Pub. L. 103-183 inserted at end "In carrying

out the preceding sentence, the Secretary shall disseminate such

information to the public, including through elementary and

secondary schools."

1992 - Pub. L. 102-531 substituted "Centers for Disease Control

and Prevention" for "Centers for Disease Control" in subsecs. (a)

and (b).

1990 - Subsec. (a)(2). Pub. L. 101-558, Sec. 2(a)(1), inserted ",

or enter into cooperative agreements or contracts with," after

"grants to".

Subsec. (a)(3). Pub. L. 101-558, Sec. 2(a)(2), added par. (3).

FINDINGS AND PURPOSES

Section 2 of Pub. L. 99-649 provided that:

"(a) The Congress finds and declares that:

"(1) Injury is one of the principal public health problems in

America, and causes over 140,000 deaths per year.

"(2) Injury rates are particularly high for children and the

elderly.

"(3) Injury causes 50 percent of all deaths for children over

the age of one year and two-thirds of all deaths for children

over the age of 15 years, and is the leading cause of death for

individuals under the age of 44 years. Individuals over the age

of 65 years have the highest fatality rates for many injuries.

"(4) Injury control has not been given high priority in the

United States, and the research being conducted on injury control

and the number of personnel involved in injury control activities

are not adequate.

"(b) The purposes of this Act [enacting this part] are -

"(1) to promote research into the causes, diagnosis, treatment,

prevention, and control of injuries and rehabilitation from

injuries;

"(2) to promote cooperation between specialists in fields

involved in injury research; and

"(3) to promote coordination between Federal, State, and local

governments and public and private entities in order to achieve a

reduction in deaths from injuries."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 280b-1a of this title.

-End-

-CITE-

42 USC Sec. 280b-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-1. Prevention and control activities

-STATUTE-

(a) The Secretary, through the Director of the Centers for

Disease Control and Prevention, shall -

(1) assist States and political subdivisions of States in

activities for the prevention and control of injuries; and

(2) encourage regional activities between States designed to

reduce injury rates.

(b) The Secretary, through the Director of the Centers for

Disease Control and Prevention, may -

(1) enter into agreements between the Service and public and

private community health agencies which provide for cooperative

planning of activities to deal with problems relating to the

prevention and control of injuries;

(2) work in cooperation with other Federal agencies, and with

public and nonprofit private entities, to promote activities

regarding the prevention and control of injuries; and

(3) make grants to States and, after consultation with State

health agencies, to other public or nonprofit private entities

for the purpose of carrying out demonstration projects for the

prevention and control of injuries at sites that are not subject

to the Occupational Safety and Health Act of 1970 [29 U.S.C. 651

et seq.], including homes, elementary and secondary schools, and

public buildings.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 392, as added Pub. L.

99-649, Sec. 3, Nov. 10, 1986, 100 Stat. 3634; amended Pub. L.

101-558, Sec. 2(b), Nov. 15, 1990, 104 Stat. 2772; Pub. L. 102-531,

title III, Secs. 301, 312(d)(4), Oct. 27, 1992, 106 Stat. 3482,

3504; Pub. L. 103-183, title II, Sec. 203(a)(2), (b)(1), Dec. 14,

1993, 107 Stat. 2232.)

-REFTEXT-REFERENCES IN TEXT

The Occupational Safety and Health Act of 1970, referred to in

subsec. (b)(3), is Pub. L. 91-596, Dec. 29, 1970, 84 Stat. 1590, as

amended, which is classified principally to chapter 15 (Sec. 651 et

seq.) of Title 29, Labor. For complete classification of this Act

to the Code, see Short Title note set out under section 651 of

Title 29 and Tables.

-MISC1-

PRIOR PROVISIONS

A prior section 280b-1, act July 1, 1944, ch. 373, title III,

Sec. 391, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat.

1059; amended Mar. 13, 1970, Pub. L. 91-212, Sec. 10(b)(3), 84

Stat. 66; July 23, 1974, Pub. L. 93-353, title II, Sec. 202(b), 88

Stat. 372, defined "sciences related to health", "National Medical

Libraries Assistance Advisory Board", "Board", and "medical

library", prior to repeal by Pub. L. 99-158, Sec. 3(b), Nov. 20,

1985, 99 Stat. 879.

A prior section 392 of act July 1, 1944, ch. 373, title III, as

added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat. 1060; amended

Mar. 13, 1970, Pub. L. 91-212, Sec. 10(b)(4), (d)(2)(A), 84 Stat.

66, 67; July 23, 1974, Pub. L. 93-353, title II, Sec. 202(c), 88

Stat. 372, which related to composition, functions, etc., of the

National Medical Libraries Assistance Advisory Board, was

classified to section 280b-2 of this title, prior to repeal by Pub.

L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1993 - Pub. L. 103-183, Sec. 203(a)(2)(A), substituted

"Prevention and control activities" for "Control activities" in

section catchline.

Subsec. (a)(1). Pub. L. 103-183, Sec. 203(a)(2)(B), inserted "and

control" after "prevention".

Subsec. (b)(1). Pub. L. 103-183, Sec. 203(a)(2)(C), substituted

"the prevention and control of injuries" for "injuries and injury

control".

Subsec. (b)(2). Pub. L. 103-183, Sec. 203(b)(1), substituted "to

promote activities regarding the prevention and control of

injuries; and" for "to promote injury control. In carrying out the

preceding sentence, the Secretary shall disseminate such

information to the public, including through elementary and

secondary schools; and".

1992 - Pub. L. 102-531, Sec. 312(d)(4), substituted "Centers for

Disease Control and Prevention" for "Centers for Disease Control"

in introductory provisions of subsecs. (a) and (b).

Subsec. (b)(1). Pub. L. 102-531, Sec. 301(1), struck out "and"

after semicolon at end.

Subsec. (b)(2). Pub. L. 102-531, Sec. 301(2), inserted sentence

requiring Secretary to disseminate information on injury control to

the public, including through elementary and secondary schools and

substituted "; and" for period at end.

Subsec. (b)(3). Pub. L. 102-531, Sec. 301(3), added par. (3).

1990 - Subsec. (b)(2). Pub. L. 101-558 amended par. (2)

generally. Prior to amendment, par. (2) read as follows: "work in

cooperation with Federal, State, and local agencies to promote

injury control."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 280b-1a of this title.

-End-

-CITE-

42 USC Sec. 280b-1a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-1a. Interpersonal violence within families and among

acquaintances

-STATUTE-

(a) With respect to activities that are authorized in sections

280b and 280b-1 of this title, the Secretary, acting through the

Director of the Centers for Disease Control and Prevention, shall

carry out such activities with respect to interpersonal violence

within families and among acquaintances. Activities authorized in

the preceding sentence include the following:

(1) Collecting data relating to the incidence of such violence.

(2) Making grants to public and nonprofit private entities for

the evaluation of programs whose purpose is to prevent such

violence, including the evaluation of demonstration projects

under paragraph (6).

(3) Making grants to public and nonprofit private entities for

the conduct of research on identifying effective strategies for

preventing such violence.

(4) Providing to the public information and education on such

violence, including information and education to increase

awareness of the public health consequences of such violence.

(5) Training health care providers as follows:

(A) To identify individuals whose medical conditions or

statements indicate that the individuals are victims of such

violence.

(B) To routinely determine, in examining patients, whether

the medical conditions or statements of the patients so

indicate.

(C) To refer individuals so identified to entities that

provide services regarding such violence, including referrals

for counseling, housing, legal services, and services of

community organizations.

(6) Making grants to public and nonprofit private entities for

demonstration projects with respect to such violence, including

with respect to prevention.

(b) For purposes of this part, the term "interpersonal violence

within families and among acquaintances" includes behavior commonly

referred to as domestic violence, sexual assault, spousal abuse,

woman battering, partner abuse, elder abuse, and acquaintance rape.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 393, as added Pub. L.

103-183, title II, Sec. 201(2), Dec. 14, 1993, 107 Stat. 2231.)

-MISC1-

PRIOR PROVISIONS

A prior section 393 of act July 1, 1944, was renumbered section

394 and is classified to section 280b-2 of this title.

Another prior section 393 of act July 1, 1944, was renumbered

section 394 and was classified to section 280b-4 of this title.

-End-

-CITE-

42 USC Sec. 280b-1b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-1b. Prevention of traumatic brain injury

-STATUTE-

(a) In general

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, may carry out projects to reduce

the incidence of traumatic brain injury. Such projects may be

carried out by the Secretary directly or through awards of grants

or contracts to public or nonprofit private entities. The Secretary

may directly or through such awards provide technical assistance

with respect to the planning, development, and operation of such

projects.

(b) Certain activities

Activities under subsection (a) of this section may include -

(1) the conduct of research into identifying effective

strategies for the prevention of traumatic brain injury;

(2) the implementation of public information and education

programs for the prevention of such injury and for broadening the

awareness of the public concerning the public health consequences

of such injury; and

(3) the implementation of a national education and awareness

campaign regarding such injury (in conjunction with the program

of the Secretary regarding health-status goals for 2010, commonly

referred to as Healthy People 2010), including -

(A) the national dissemination of information on -

(i) incidence and prevalence; and

(ii) information relating to traumatic brain injury and the

sequelae of secondary conditions arising from traumatic brain

injury upon discharge from hospitals and trauma centers; and

(B) the provision of information in primary care settings,

including emergency rooms and trauma centers, concerning the

availability of State level services and resources.

(c) Coordination of activities

The Secretary shall ensure that activities under this section are

coordinated as appropriate with other agencies of the Public Health

Service that carry out activities regarding traumatic brain injury.

(d) "Traumatic brain injury" defined

For purposes of this section, the term "traumatic brain injury"

means an acquired injury to the brain. Such term does not include

brain dysfunction caused by congenital or degenerative disorders,

nor birth trauma, but may include brain injuries caused by anoxia

due to trauma. The Secretary may revise the definition of such term

as the Secretary determines necessary, after consultation with

States and other appropriate public or nonprofit private entities.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 393A, as added Pub. L.

104-166, Sec. 1, July 29, 1996, 110 Stat. 1445; amended Pub. L.

106-310, div. A, title XIII, Sec. 1301(a), Oct. 17, 2000, 114 Stat.

1137.)

-MISC1-

AMENDMENTS

2000 - Subsec. (b)(3). Pub. L. 106-310, Sec. 1301(a)(1), added

par. (3).

Subsec. (d). Pub. L. 106-310, Sec. 1301(a)(2), substituted

"anoxia due to trauma" for "anoxia due to near drowning" and

inserted ", after consultation with States and other appropriate

public or nonprofit private entities" after "Secretary determines

necessary".

-End-

-CITE-

42 USC Sec. 280b-1c 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-1c. Use of allotments for rape prevention education

-STATUTE-

(a) Permitted use

The Secretary, acting through the National Center for Injury

Prevention and Control at the Centers for Disease Control and

Prevention, shall award targeted grants to States to be used for

rape prevention and education programs conducted by rape crisis

centers, State sexual assault coalitions, and other public and

private nonprofit entities for -

(1) educational seminars;

(2) the operation of hotlines;

(3) training programs for professionals;

(4) the preparation of informational material;

(5) education and training programs for students and campus

personnel designed to reduce the incidence of sexual assault at

colleges and universities;

(6) education to increase awareness about drugs used to

facilitate rapes or sexual assaults; and

(7) other efforts to increase awareness of the facts about, or

to help prevent, sexual assault, including efforts to increase

awareness in underserved communities and awareness among

individuals with disabilities (as defined in section 12102 of

this title).

(b) Collection and dissemination of information on sexual assault

The Secretary shall, through the National Resource Center on

Sexual Assault established under the National Center for Injury

Prevention and Control at the Centers for Disease Control and

Prevention, provide resource information, policy, training, and

technical assistance to Federal, State, local, and Indian tribal

agencies, as well as to State sexual assault coalitions and local

sexual assault programs and to other professionals and interested

parties on issues relating to sexual assault, including maintenance

of a central resource library in order to collect, prepare,

analyze, and disseminate information and statistics and analyses

thereof relating to the incidence and prevention of sexual assault.

(c) Authorization of appropriations

(1) In general

There is authorized to be appropriated to carry out this

section $80,000,000 for each of fiscal years 2001 through 2005.

(2) National resource center allotment

Of the total amount made available under this subsection in

each fiscal year, not more than the greater of $1,000,000 or 2

percent of such amount shall be available for allotment under

subsection (b) of this section.

(d) Limitations

(1) Supplement not supplant

Amounts provided to States under this section shall be used to

supplement and not supplant other Federal, State, and local

public funds expended to provide services of the type described

in subsection (a) of this section.

(2) Studies

A State may not use more than 2 percent of the amount received

by the State under this section for each fiscal year for

surveillance studies or prevalence studies.

(3) Administration

A State may not use more than 5 percent of the amount received

by the State under this section for each fiscal year for

administrative expenses.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 393B, as added Pub. L.

106-386, div. B, title IV, Sec. 1401(a), Oct. 28, 2000, 114 Stat.

1512.)

-COD-

CODIFICATION

Another section 393B of act July 1, 1944, is classified to

section 280b-1d of this title.

-End-

-CITE-

42 USC Sec. 280b-1d 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-1d. National program for traumatic brain injury

registries

-STATUTE-

(a) (!1) In general

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, may make grants to States or their

designees to operate the State's traumatic brain injury registry,

and to academic institutions to conduct applied research that will

support the development of such registries, to collect data

concerning -

(1) demographic information about each traumatic brain injury;

(2) information about the circumstances surrounding the injury

event associated with each traumatic brain injury;

(3) administrative information about the source of the

collected information, dates of hospitalization and treatment,

and the date of injury; and

(4) information characterizing the clinical aspects of the

traumatic brain injury, including the severity of the injury,

outcomes of the injury, the types of treatments received, and the

types of services utilized.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 393B, as added Pub. L.

106-310, div. A, title XIII, Sec. 1301(b), Oct. 17, 2000, 114 Stat.

1137.)

-COD-

CODIFICATION

Another section 393B of act July 1, 1944, is classified to

section 280b-1c of this title.

-FOOTNOTE-

(!1) So in original. No subsec. (b) has been enacted.

-End-

-CITE-

42 USC Sec. 280b-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-2. General provisions

-STATUTE-

(a) Advisory committee

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, shall establish an advisory

committee to advise the Secretary and such Director with respect to

the prevention and control of injuries.

(b) Technical assistance

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, may provide technical assistance to

public and nonprofit private entities with respect to the planning,

development, and operation of any program or service carried out

pursuant to this part. The Secretary may provide such technical

assistance directly or through grants or contracts.

(c) Biennial report

Not later than February 1 of 1995 and of every second year

thereafter, the Secretary, acting through the Director of the

Centers for Disease Control and Prevention, shall submit to the

Committee on Energy and Commerce of the House of Representatives,

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

report describing the activities carried out under this part during

the preceding 2 fiscal years. Such report shall include a

description of such activities that were carried out with respect

to interpersonal violence within families and among acquaintances

and with respect to rural areas.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 394, formerly Sec. 393, as

added Pub. L. 99-649, Sec. 3, Nov. 10, 1986, 100 Stat. 3634;

amended Pub. L. 101-558, Sec. 2(c), Nov. 15, 1990, 104 Stat. 2772;

Pub. L. 102-531, title III, Sec. 312(d)(5), Oct. 27, 1992, 106

Stat. 3504; renumbered Sec. 394 and amended Pub. L. 103-183, title

II, Secs. 201(1), 202, Dec. 14, 1993, 107 Stat. 2231, 2232.)

-MISC1-

PRIOR PROVISIONS

A prior section 280b-2, act July 1, 1944, ch. 373, title III,

Sec. 392, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat.

1060; amended Mar. 13, 1970, Pub. L. 91-212, Sec. 10(b)(4),

(d)(2)(A), 84 Stat. 66, 67; July 23, 1974, Pub. L. 93-353, title

II, Sec. 202(c), 88 Stat. 372, related to composition, functions,

etc., of National Medical Libraries Assistance Advisory Board,

prior to repeal by Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99

Stat. 879.

A prior section 394 of act July 1, 1944, was renumbered section

394A and is classified to section 280b-3 of this title.

AMENDMENTS

1993 - Pub. L. 103-183, Sec. 202, amended section generally.

Prior to amendment, section read as follows: "By not later than

September 30, 1992, the Secretary, through the Director of the

Centers for Disease Control and Prevention, shall prepare and

submit to the Committee on Energy and Commerce of the House of

Representatives, and to the Committee on Labor and Human Resources

of the Senate, a report describing the activities conducted or

supported under this part. The report shall include -

"(1) information regarding the practical applications of

research conducted pursuant to subsection (a) of section 280b of

this title, including information that has not been disseminated

under subsection (b) of such section; and

"(2) information on such activities regarding the prevention

and control of injuries in rural areas, including information

regarding injuries that are particular to rural areas."

1992 - Pub. L. 102-531 substituted "Centers for Disease Control

and Prevention" for "Centers for Disease Control" in introductory

provisions.

1990 - Pub. L. 101-558 amended section generally. Prior to

amendment, section read as follows: "By January 1, 1989, the

Secretary, through the Director of the Centers for Disease Control,

shall prepare and transmit to the Congress a report analyzing the

incidence and causes of childhood injuries in the United States and

containing recommendations for such legislation with respect to

injury control as the Secretary considers appropriate."

-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 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.

-End-

-CITE-

42 USC Sec. 280b-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part J - Prevention and Control of Injuries

-HEAD-

Sec. 280b-3. Authorization of appropriations

-STATUTE-

For the purpose of carrying out this part, there are authorized

to be appropriated $50,000,000 for fiscal year 1994, such sums as

may be necessary for each of the fiscal years 1995 through 1998,

and such sums as may be necessary for each of the fiscal years 2001

through 2005..(!1)

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 394A, formerly Sec. 394, as

added Pub. L. 99-649, Sec. 3, Nov. 10, 1986, 100 Stat. 3634;

amended Pub. L. 101-558, Sec. 2(d), Nov. 15, 1990, 104 Stat. 2773;

renumbered Sec. 394A and amended Pub. L. 103-183, title II, Secs.

201(1), 204, Dec. 14, 1993, 107 Stat. 2231, 2233; Pub. L. 106-310,

div. A, title XIII, Sec. 1306, Oct. 17, 2000, 114 Stat. 1143.)

-MISC1-

PRIOR PROVISIONS

A prior section 280b-3, act July 1, 1944, ch. 373, title III,

Sec. 393, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat.

1060; amended Mar. 13, 1970, Pub. L. 91-212, Secs. 2(a), 3,

10(d)(2), 84 Stat. 63, 64, 67, related to grants for construction

of medical library facilities, prior to repeal by Pub. L. 93-353,

title II, Sec. 202(d), July 23, 1974, 88 Stat. 372.

Prior sections 280b-4 to 280b-11 were repealed by Pub. L. 99-158,

Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

Section 280b-4, act July 1, 1944, ch. 373, title III, Sec. 393,

formerly Sec. 394, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1062; amended Mar. 13, 1970, Pub. L. 91-212, Secs. 2(b),

10(d)(2)(A), 84 Stat. 63, 67; June 18, 1973, Pub. L. 93-45, title

I, Sec. 107(a), 87 Stat. 92; renumbered Sec. 393 and amended July

23, 1974, Pub. L. 93-353, title II, Secs. 203(a), 204, 88 Stat.

372, 373, related to grants for training in medical library

sciences.

Section 280b-5, act July 1, 1944, ch. 373, title III, Sec. 394,

formerly Sec. 395, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1062; amended Mar. 13, 1970, Pub. L. 91-212, Secs. 2(c),

(d), 4(a), 5(a), 10(c)(1)(A), (B), (2)(A)-(C), (d)(2)(A), 84 Stat.

63, 64, 66, 67; June 18, 1973, Pub. L. 93-45, title I, Sec. 107(b),

(c), 87 Stat. 92; renumbered Sec. 394 and amended July 23, 1974,

Pub. L. 93-353, title II, Secs. 203(b), 204, 88 Stat. 372, 373,

related to assistance for special scientific projects; research and

development in medical library science and related fields.

Section 280b-6, act July 1, 1944, ch. 373, title III, Sec. 396,

as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2, 79 Stat. 1063, was

redesignated as subsecs. (b) and (c) of section 280b-5 of this

title by Pub. L. 91-212, Sec. 10(c)(2), Mar. 13, 1970, 84 Stat. 66.

Section 280b-7, act July 1, 1944, ch. 373, title III, Sec. 395,

formerly Sec. 397, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1063; renumbered Sec. 396 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(e), 6(a)(1), (2), 10(c)(3), (d)(2)(A), 84 Stat.

63, 64, 67; June 18, 1973, Pub. L. 93-45, title I, Sec. 107(d), 87

Stat. 92; renumbered Sec. 395 and amended July 23, 1974, Pub. L.

93-353, title II, Secs. 203(c), 204, 88 Stat. 372, 373, related to

grants for establishing, expanding, and improving basic medical

library or related resources.

Section 280b-8, act July 1, 1944, ch. 373, title III, Sec. 396,

formerly Sec. 398, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1065; renumbered Sec. 397 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(f), 7, 10(c)(3), (d)(2)(A), 84 Stat. 63, 65, 67;

June 18, 1973, Pub. L. 93-45, title I, Sec. 107(e), 87 Stat. 92;

renumbered Sec. 396 and amended July 23, 1974, Pub. L. 93-353,

title II, Secs. 202(e), (f), 203(d), 204, 88 Stat. 372, 373,

related to grants for establishment of regional medical libraries.

Section 280b-9, act July 1, 1944, ch. 373, title III, Sec. 397,

formerly Sec. 399, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1066; renumbered Sec. 398 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(g), 8, 10(c)(3), (d)(2)(A), 84 Stat. 63, 65, 67;

June 18, 1973, Pub. L. 93-45, title I, Sec. 107(f), 87 Stat. 92;

renumbered Sec. 397 and amended July 23, 1974, Pub. L. 93-353,

title II, Secs. 203(e), 204, 88 Stat. 372, 373, related to grants

to provide support for biomedical scientific publications.

Section 280b-10, act July 1, 1944, ch. 373, title III, Sec. 398,

formerly Sec. 399a, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1066; renumbered Sec. 399, Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(c)(3), 84 Stat. 67; renumbered Sec. 398, July 23, 1974,

Pub. L. 93-353, title II, Sec. 204, 88 Stat. 373, related to the

continuing availability of appropriated funds.

Section 280b-11, act July 1, 1944, ch. 373, title III, Sec. 399,

formerly Sec. 399b, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1066; renumbered Sec. 399a and amended Mar. 13, 1970, Pub.

L. 91-212, Sec. 10(c)(3), (d)(2)(A), 84 Stat. 67; renumbered Sec.

399, July 23, 1974, Pub. L. 93-353, title II, Sec. 204, 88 Stat.

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

695, related to the maintenance of records by recipients of grants

and audits thereof by the Secretary of Health and Human Services

and the Comptroller General of the United States.

A prior section 280b-12, act July 1, 1944, ch. 373, title III,

Sec. 399b, as added Mar. 13, 1970, Pub. L. 91-212, Sec. 9, 84 Stat.

65, related to transfer of funds, prior to repeal by Pub. L.

93-353, title II, Sec. 204, July 23, 1974, 88 Stat. 373, applicable

with respect to fiscal years beginning after June 30, 1974.

AMENDMENTS

2000 - Pub. L. 106-310, which directed the amendment of this

section by striking out "and" after "1994", was executed by

striking "and" after "1994," to reflect the probable intent of

Congress.

Pub. L. 106-310 inserted before period at end ", and such sums as

may be necessary for each of the fiscal years 2001 through 2005."

1993 - Pub. L. 103-183, Sec. 204, amended section generally.

Prior to amendment, section read as follows: "To carry out sections

280b and 280b-1 of this title, there are authorized to be

appropriated $10,000,000 for each of the fiscal years 1988, 1989,

and 1990, $30,000,000 for fiscal year 1991, and such sums as may be

necessary for each of the fiscal years 1992 and 1993."

1990 - Pub. L. 101-558 struck out subsec. (a) designation,

inserted before period at end of first sentence ", $30,000,000 for

fiscal year 1991, and such sums as may be necessary for each of the

fiscal years 1992 and 1993", and struck out at end "Of the amounts

appropriated under this section for any fiscal year, not more than

20 percent may be used for Federal administrative expenses to carry

out such section for such fiscal year."

-FOOTNOTE-

(!1) So in original.

-End-

-CITE-

42 USC Part K - Health Care Services in the Home 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

-HEAD-

PART K - HEALTH CARE SERVICES IN THE HOME

-MISC1-

AMENDMENTS

1993 - Pub. L. 103-43, title XX, Sec. 2008(i)(2)(B)(i), June 10,

1993, 107 Stat. 213, redesignated part L "Health Care Services in

the Home" as K. Former part K "Injury Control" redesignated J.

1990 - Pub. L. 101-616, title I, Sec. 101(a)(1), Nov. 16, 1990,

104 Stat. 3279, redesignated part J "Injury Control" as K. Former

part K "Health Care Services in the Home" redesignated L.

PRIOR PROVISIONS

A prior part K, added Pub. L. 93-222, Sec. 3, Dec. 29, 1973, 87

Stat. 934, related to quality assurance, prior to repeal by Pub. L.

95-623, Sec. 11(b), Nov. 9, 1978, 92 Stat. 3455.

-End-

-CITE-

42 USC subpart i - grants for demonstration projects 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart i - grants for demonstration projects

-HEAD-

SUBPART I - GRANTS FOR DEMONSTRATION PROJECTS

-End-

-CITE-

42 USC Sec. 280c 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart i - grants for demonstration projects

-HEAD-

Sec. 280c. Establishment of program

-STATUTE-

(a) In general

The Secretary, acting through the Administrator of the Health

Resources and Services Administration, shall make not less than 5,

and not more than 20, grants to States for the purpose of assisting

grantees in carrying out demonstration projects -

(1) to identify low-income individuals who can avoid

institutionalization or prolonged hospitalization if skilled

medical services, skilled nursing care services, homemaker or

home health aide services, or personal care services are provided

in the homes of the individuals;

(2) to pay the costs of the provision of such services in the

homes of such individuals; and

(3) to coordinate the provision by public and private entities

of such services, and other long-term care services, in the homes

of such individuals.

(b) Requirement with respect to age of recipients of services

The Secretary may not make a grant under subsection (a) of this

section to a State unless the State agrees to ensure that -

(1) not less than 25 percent of the grant is expended to

provide services under such subsection to individuals who are not

less than 65 years of age; and

(2) of the portion of the grant reserved by the State for

purposes of complying with paragraph (1), not less than 10

percent is expended to provide such services to individuals who

are not less than 85 years of age.

(c) Relationship to items and services under other programs

A State may not make payments from a grant under subsection (a)

of this section for any item or service to the extent that payment

has been made, or can reasonably be expected to be made, with

respect to such item or service -

(1) under any State compensation program, under an insurance

policy, or under any Federal or State health benefits program; or

(2) by an entity that provides health services on a prepaid

basis.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 395, as added Pub. L.

100-175, title VI, Sec. 602, Nov. 29, 1987, 101 Stat. 979; amended

Pub. L. 101-557, title I, Sec. 101(a)-(c), Nov. 15, 1990, 104 Stat.

2766; Pub. L. 102-108, Sec. 2(f), Aug. 17, 1991, 105 Stat. 550.)

-MISC1-

PRIOR PROVISIONS

A prior section 280C, act July 1, 1944, ch. 373, title III, Sec.

399A, formerly Sec. 399c, as added Dec. 29, 1973, Pub. L. 93-222,

Sec. 3, 87 Stat. 934; renumbered Sec. 399A, July 29, 1975, Pub. L.

94-63, title VI, Sec. 607(a), (c), 89 Stat. 351, provided for

programs designed to assure the quality of health care, prior to

repeal by Pub. L. 95-623, Sec. 11(b), Nov. 9, 1978, 92 Stat. 3455.

A prior section 395 of act July 1, 1944, ch. 373, title III,

formerly Sec. 397, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1063; renumbered Sec. 396 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(e), 6(a)(1), (2), 10(c)(3), (d)(2)(A), 84 Stat.

63, 64, 67; June 18, 1973, Pub. L. 93-45, title I, Sec. 107(d), 87

Stat. 92; renumbered Sec. 395 and amended July 23, 1974, Pub. L.

93-353, title II, Secs. 203(c), 204, 88 Stat. 372, 373, which

related to grants for establishing, expanding, and improving basic

medical library or related resources, was classified to section

280b-7 of this title, prior to repeal by Pub. L. 99-158, Sec. 3(b),

Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1991 - Subsec. (a)(1). Pub. L. 102-108 inserted "skilled medical

services," after "if".

1990 - Subsec. (a). Pub. L. 101-557, Sec. 101(a), substituted

"shall make not less than 5, and not more than 20, grants" for

"shall make not less than 3, and not more than 5, grants".

Subsec. (a)(1). Pub. L. 101-557, Sec. 101(b), substituted

"skilled nursing care services, homemaker or home health aide

services, or personal care services are provided in the homes of

the individuals" for "skilled medical services or related health

services (or both) are provided in the homes of the individuals".

Subsec. (b). Pub. L. 101-557, Sec. 101(c), substituted "to ensure

that - " and pars. (1) and (2) for "to ensure that not less than 25

percent of individuals receiving services pursuant to subsection

(a) of this section are individuals who are not less than 65 years

of age".

EFFECTIVE DATE

Part effective Oct. 1, 1987, see section 701(a) of Pub. L.

100-175, set out as an Effective Date of 1987 Amendment note under

section 3001 of this title.

SHORT TITLE

For short title of title VI of Pub. L. 100-175, which enacted

this part as the "Health Care Services in the Home Act of 1987",

see section 601 of Pub. L. 100-175, set out as a Short Title of

1987 Amendments note under section 201 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 280c-1, 280c-2 of this

title.

-End-

-CITE-

42 USC Sec. 280c-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart i - grants for demonstration projects

-HEAD-

Sec. 280c-1. Limitation on duration of grant and requirement of

matching funds

-STATUTE-

(a) Limitation on duration of grant

The period during which payments are made to a State from a grant

under section 280c(a) of this title may not exceed 3 years. Such

payments shall be subject to annual evaluation by the Secretary.

(b) Requirement of matching funds

(1)(A) For the first year of payments to a State from a grant

under section 280c(a) of this title, the Secretary may not make

such payments in an amount exceeding 75 percent of the costs of

services to be provided by the State pursuant to such section.

(B) For the second year of such payments to a State, the

Secretary may not make such payments in an amount exceeding 65

percent of the costs of such services.

(C) For the third year of such payments to a State, the Secretary

may not make such payments in an amount exceeding 55 percent of the

costs of such services.

(2) The Secretary may not make a grant under section 280c(a) of

this title to a State unless the State agrees to make available,

directly or through donations from public or private entities,

non-Federal contributions toward the costs of services to be

provided pursuant to such section in an amount equal to -

(A) for the first year of payments to the State from the grant,

not less than $25 (in cash or in kind under subsection (c) of

this section) for each $75 of Federal funds provided in the

grant;

(B) for the second year of such payments to the State, not less

than $35 (in cash or in kind under subsection (c) of this

section) for each $65 of such Federal funds; and

(C) for the third year of such payments to the State, not less

than $45 (in cash or in kind under subsection (c) of this

section) for each $55 of such Federal funds.

(c) Determination of amount of non-Federal contribution

Non-Federal contributions required in subsection (b) of this

section 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.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 396, as added Pub. L.

100-175, title VI, Sec. 602, Nov. 29, 1987, 101 Stat. 979.)

-MISC1-

PRIOR PROVISIONS

A prior section 396 of act July 1, 1944, ch. 373, title III,

formerly Sec. 398, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1065; renumbered Sec. 397 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(f), 7, 10(c)(3), (d)(2)(A), 84 Stat. 63, 65, 67;

June 18, 1973, Pub. L. 93-45, title I, Sec. 107(e), 87 Stat. 92;

renumbered Sec. 396 and amended July 23, 1974, Pub. L. 93-353,

title II, Secs. 202(e), (f), 203(d), 204, 88 Stat. 372, 373, which

related to grants for establishment of regional medical libraries,

was classified to section 280b-8 of this title, prior to repeal by

Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

-End-

-CITE-

42 USC Sec. 280c-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart i - grants for demonstration projects

-HEAD-

Sec. 280c-2. General provisions

-STATUTE-

(a) Limitation on administrative expenses

The Secretary may not make a grant under section 280c(a) of this

title to a State unless the State agrees that not more than 10

percent of the grant will be expended for administrative expenses

with respect to the grant.

(b) Description of intended use of grant

The Secretary may not make a grant under section 280c(a) of this

title to a State unless -

(1) the State submits to the Secretary a description of the

purposes for which the State intends to expend the grant; and

(2) such description provides information relating to the

programs and activities to be supported and services to be

provided, including -

(A) the number of individuals who will receive services

pursuant to section 280c(a) of this title and the average costs

of providing such services to each such individual; and

(B) a description of the manner in which such programs and

activities will be coordinated with any similar programs and

activities of public and private entities.

(c) Requirement of application

The Secretary may not make a grant under section 280c(a) of this

title to a State unless the State has submitted to the Secretary an

application for the grant. The application shall -

(1) contain the description of intended expenditures required

in subsection (b) of this section;

(2) with respect to carrying out the purpose for which the

grant is to be made, provide assurances of compliance

satisfactory to the Secretary; and

(3) otherwise be in such form, be made in such manner, and

contain such information and agreements as the Secretary

determines to be necessary to carry out this subpart.

(d) Evaluations and report by Secretary

The Secretary shall -

(1) provide for an evaluation of each demonstration project for

which a grant is made under section 280c(a) of this title; and

(2) not later than 6 months after the completion of such

evaluations, submit to the Congress a report describing the

findings made as a result of the evaluations.

(e) Authorizations of appropriations

For the purpose of carrying out this subpart, there are

authorized to be appropriated $5,000,000 for each of the fiscal

years 1988 through 1990, $7,500,000 for fiscal year 1991, and such

sums as may be necessary for each of the fiscal years 1992 and

1993.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 397, as added Pub. L.

100-175, title VI, Sec. 602, Nov. 29, 1987, 101 Stat. 980; amended

Pub. L. 101-557, title I, Sec. 101(d), Nov. 15, 1990, 104 Stat.

2766.)

-MISC1-

PRIOR PROVISIONS

A prior section 397 of act July 1, 1944, ch. 373, title III,

formerly Sec. 399, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1066; renumbered Sec. 398 and amended Mar. 13, 1970, Pub.

L. 91-212, Secs. 2(g), 8, 10(c)(3), (d)(2)(A), 84 Stat. 63, 65, 67;

June 18, 1973, Pub. L. 93-45, title I, Sec. 107(f), 87 Stat. 92;

renumbered Sec. 397 and amended July 23, 1974, Pub. L. 93-353,

title II, Secs. 203(e), 204, 88 Stat. 372, 373, which related to

grants to provide support for biomedical scientific publications,

was classified to section 280b-9 of this title, prior to repeal by

Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1990 - Subsec. (e). Pub. L. 101-557 substituted "there are" for

"there is" and inserted before period at end ", $7,500,000 for

fiscal year 1991, and such sums as may be necessary for each of the

fiscal years 1992 and 1993".

-End-

-CITE-

42 USC subpart ii - grants for demonstration projects

with respect to alzheimer's disease 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart ii - grants for demonstration projects with respect to

alzheimer's disease

-HEAD-

SUBPART II - GRANTS FOR DEMONSTRATION PROJECTS WITH RESPECT TO

ALZHEIMER'S DISEASE

-End-

-CITE-

42 USC Sec. 280c-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart ii - grants for demonstration projects with respect to

alzheimer's disease

-HEAD-

Sec. 280c-3. Establishment of program

-STATUTE-

(a) In general

The Secretary shall make grants to States for the purpose of

assisting grantees in carrying out demonstration projects for

planning, establishing, and operating programs -

(1) to coordinate the development and operation with public and

private organizations of diagnostic, treatment, care management,

respite care, legal counseling, and education services provided

within the State to individuals with Alzheimer's disease or

related disorders and to the families and care providers of such

individuals;

(2) to provide home health care, personal care, day care,

companion services, short-term care in health facilities, and

other respite care to individuals with Alzheimer's disease or

related disorders who are living in single family homes or in

congregate settings;

(3) to improve the access of such individuals to home-based or

community-based long-term care services (subject to the services

being provided by entities that were providing such services in

the State involved as of October 1, 1995), particularly such

individuals who are members of racial or ethnic minority groups,

who have limited proficiency in speaking the English language, or

who live in rural areas; and

(4) to provide to health care providers, to individuals with

Alzheimer's disease or related disorders, to the families of such

individuals, to organizations established for such individuals

and such families, and to the general public, information with

respect to -

(A) diagnostic services, treatment services, and related

services available to such individuals and to the families of

such individuals;

(B) sources of assistance in obtaining such services,

including assistance under entitlement programs; and

(C) the legal rights of such individuals and such families.

(b) Requirement with respect to certain expenditures

The Secretary may not make a grant under subsection (a) of this

section to a State unless the State agrees to expend not less than

50 percent of the grant for the provision of services described in

subsection (a)(2) of this section.

(c) Relationship to items and services under other programs

A State may not make payments from a grant under subsection (a)

of this section for any item or service to the extent that payment

has been made, or can reasonably be expected to be made, with

respect to such item or service -

(1) under any State compensation program, under an insurance

policy, or under any Federal or State health benefits program; or

(2) by an entity that provides health services on a prepaid

basis.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 398, as added Pub. L.

100-175, title VI, Sec. 602, Nov. 29, 1987, 101 Stat. 981; amended

Pub. L. 101-557, title I, Sec. 102(a), (b), Nov. 15, 1990, 104

Stat. 2767; Pub. L. 105-392, title III, Sec. 302(a), Nov. 13, 1998,

112 Stat. 3586.)

-MISC1-

PRIOR PROVISIONS

A prior section 398 of act July 1, 1944, ch. 373, title III,

formerly Sec. 399a, as added Oct. 22, 1965, Pub. L. 89-291, Sec. 2,

79 Stat. 1066; renumbered Sec. 399, Mar. 13, 1970, Pub. L. 91-212,

Sec. 10(c)(3), 84 Stat. 67; renumbered Sec. 398, July 23, 1974,

Pub. L. 93-353, title II, Sec. 204, 88 Stat. 373, which related to

the continuing availability of appropriated funds, was classified

to section 280b-10 of this title, prior to repeal by Pub. L.

99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1998 - Subsec. (a). Pub. L. 105-392, Sec. 302(a)(1), struck out

"not less than 5, and not more than 15," after "shall make" in

introductory provisions.

Subsec. (a)(2). Pub. L. 105-392, Sec. 302(a)(2), inserted "who

are living in single family homes or in congregate settings" after

"disorders" and struck out "and" at end.

Subsec. (a)(3), (4). Pub. L. 105-392, Sec. 302(a)(3), (4), added

par. (3) and redesignated former par. (3) as (4).

1990 - Subsec. (a). Pub. L. 101-557, Sec. 102(a), substituted

"shall make not less than 5, and not more than 15, grants" for

"shall make not less than 3, and not more than 5, grants".

Subsec. (a)(1). Pub. L. 101-557, Sec. 102(b), substituted "with

public and private organizations" for "by public and private

organizations".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 280c-4, 280c-5 of this

title.

-End-

-CITE-

42 USC Sec. 280c-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart ii - grants for demonstration projects with respect to

alzheimer's disease

-HEAD-

Sec. 280c-4. Requirement of matching funds

-STATUTE-

(a) Requirement of matching funds

(1)(A) For the first year of payments to a State from a grant

under section 280c-3(a) of this title, the Secretary may not make

such payments in an amount exceeding 75 percent of the costs of

services to be provided by the State pursuant to such section.

(B) For the second year of such payments to a State, the

Secretary may not make such payments in an amount exceeding 65

percent of the costs of such services.

(C) For the third or subsequent year of such payments to a State,

the Secretary may not make such payments in an amount exceeding 55

percent of the costs of such services.

(2) The Secretary may not make a grant under section 280c-3(a) of

this title to a State unless the State agrees to make available,

directly or through donations from public or private entities,

non-Federal contributions toward the costs of services to be

provided pursuant to such section in an amount equal to -

(A) for the first year of payments to the State from the grant,

not less than $25 (in cash or in kind under subsection (c) of

this section) for each $75 of Federal funds provided in the

grant;

(B) for the second year of such payments to the State, not less

than $35 (in cash or in kind under subsection (c) of this

section) for each $65 of such Federal funds; and

(C) for the third or subsequent year of such payments to the

State, not less than $45 (in cash or in kind under subsection (c)

of this section) for each $55 of such Federal funds.

(b) Determination of amount of non-Federal contribution

Non-Federal contributions required in subsection (b) of this

section 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.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 398A, formerly Sec. 399, as

added Pub. L. 100-175, title VI, Sec. 602, Nov. 29, 1987, 101 Stat.

982; renumbered Sec. 398A, Pub. L. 102-321, title V, Sec. 502(1),

July 10, 1992, 106 Stat. 427; amended Pub. L. 105-392, title III,

Sec. 302(b), Nov. 13, 1998, 112 Stat. 3586.)

-MISC1-

AMENDMENTS

1998 - Pub. L. 105-392, Sec. 302(b)(1), substituted "Requirement

of matching funds" for "Limitation on duration of grant and

requirement of matching funds" in section catchline.

Subsec. (a). Pub. L. 105-392, Sec. 302(b)(2)-(4), redesignated

subsec. (b) as (a), substituted "third or subsequent year" for

"third year" in pars. (1)(C) and (2)(C), and struck out heading and

text of former subsec. (a). Text read as follows: "The period

during which payments are made to a State from a grant under

section 280c-3(a) of this title may not exceed 3 years. Such

payments shall be subject to annual evaluation by the Secretary."

Subsecs. (b), (c). Pub. L. 105-392, Sec. 302(b)(3), redesignated

subsecs. (b) and (c) as (a) and (b), respectively.

-End-

-CITE-

42 USC Sec. 280c-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart ii - grants for demonstration projects with respect to

alzheimer's disease

-HEAD-

Sec. 280c-5. General provisions

-STATUTE-

(a) Limitation on administrative expenses

The Secretary may not make a grant under section 280c-3(a) of

this title to a State unless the State agrees that not more than 10

percent of the grant will be expended for administrative expenses

with respect to the grant.

(b) Description of intended use of grant

The Secretary may not make a grant under section 280c-3(a) of

this title to a State unless -

(1) the State submits to the Secretary a description of the

purposes for which the State intends to expend the grant; and

(2) such description provides information relating to the

programs and activities to be supported and services to be

provided, including -

(A) the number of individuals who will receive services

pursuant to section 280c-3(a) of this title and the average

costs of providing such services to each such individual; and

(B) a description of the manner in which such programs and

activities will be coordinated with any similar programs and

activities of public and private entities.

(c) Requirement of application

The Secretary may not make a grant under section 280c-3(a) of

this title to a State unless the State has submitted to the

Secretary an application for the grant. The application shall -

(1) contain the description of intended expenditures required

in subsection (b) of this section;

(2) with respect to carrying out the purpose for which the

grant is to be made, provide assurances of compliance

satisfactory to the Secretary; and

(3) otherwise be in such form, be made in such manner, and

contain such information and agreements as the Secretary

determines to be necessary to carry out this subpart.

(d) Evaluations and report by Secretary

The Secretary shall -

(1) provide for an evaluation of each demonstration project for

which a grant is made under section 280c-3(a) of this title; and

(2) not later than 6 months after the completion of such

evaluations, submit to the Congress a report describing the

findings made as a result of the evaluations.

(e) Authorizations of appropriations

For the purpose of carrying out this subpart, there are

authorized to be appropriated $5,000,000 for each of the fiscal

years 1988 through 1990, $7,500,000 for fiscal year 1991, such sums

as may be necessary for each of the fiscal years 1992 and 1993,

$8,000,000 for fiscal year 1998, and such sums as may be necessary

for each of the fiscal years 1999 through 2002.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 398B, formerly Sec. 399A,

as added Pub. L. 100-175, title VI, Sec. 602, Nov. 29, 1987, 101

Stat. 982; amended Pub. L. 101-557, title I, Sec. 102(c), Nov. 15,

1990, 104 Stat. 2767; renumbered Sec. 398B, Pub. L. 102-321, title

V, Sec. 502(1), July 10, 1992, 106 Stat. 427; Pub. L. 105-392,

title III, Sec. 302(c), Nov. 13, 1998, 112 Stat. 3586.)

-MISC1-

AMENDMENTS

1998 - Subsec. (e). Pub. L. 105-392 substituted "1991, such sums"

for "1991, and such sums" and inserted before period at end ",

$8,000,000 for fiscal year 1998, and such sums as may be necessary

for each of the fiscal years 1999 through 2002".

1990 - Subsec. (e). Pub. L. 101-557 substituted "there are" for

"there is" and inserted before period at end ", $7,500,000 for

fiscal year 1991, and such sums as may be necessary for each of the

fiscal years 1992 and 1993".

-End-

-CITE-

42 USC subpart iii - grants for home visiting services

for at-risk families 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart iii - grants for home visiting services for at-risk families

-HEAD-

SUBPART III - GRANTS FOR HOME VISITING SERVICES FOR AT-RISK

FAMILIES

-End-

-CITE-

42 USC Sec. 280c-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part K - Health Care Services in the Home

subpart iii - grants for home visiting services for at-risk families

-HEAD-

Sec. 280c-6. Projects to improve maternal, infant, and child health

-STATUTE-

(a) In general

(1) Establishment of program

The Secretary, acting through the Administrator of the Health

Resources and Services Administration, shall make grants to

eligible entities to pay the Federal share of the cost of

providing the services specified in subsection (b) of this

section to families in which a member is -

(A) a pregnant woman at risk of delivering an infant with a

health or developmental complication; or

(B) a child less than 3 years of age -

(i) who is experiencing or is at risk of a health or

developmental complication, or of child abuse or neglect; or

(ii) who has been prenatally exposed to maternal substance

abuse.

(2) Minimum period of awards; administrative consultations

(A) The Secretary shall award grants under paragraph (1) for

periods of at least three years.

(B) The Administrator of the Administration for Children,

Youth, and Families and the Director of the National Commission

to Prevent Infant Mortality shall be consulted regarding the

promulgation of program guidelines and funding priorities under

this section.

(3) Requirement of status as medicaid provider

(A) Subject to subparagraph (B), the Secretary may make a grant

under paragraph (1) only if, in the case of any service under

such paragraph that is covered in the State plan approved under

title XIX of the Social Security Act [42 U.S.C. 1396 et seq.] for

the State involved -

(i) the entity involved will provide the service directly,

and the entity has entered into a participation agreement under

the State plan and is qualified to receive payments under such

plan; or

(ii) the entity will enter into an agreement with an

organization under which the organization will provide the

service, and the organization has entered into such a

participation agreement and is qualified to receive such

payments.

(B)(i) In the case of an organization making an agreement under

subparagraph (A)(ii) regarding the provision of services under

paragraph (1), the requirement established in such subparagraph

regarding a participation agreement shall be waived by the

Secretary if the organization does not, in providing health or

mental health services, impose a charge or accept reimbursement

available from any third-party payor, including reimbursement

under any insurance policy or under any Federal or State health

benefits program.

(ii) A determination by the Secretary of whether an

organization referred to in clause (i) meets the criteria for a

waiver under such clause shall be made without regard to whether

the organization accepts voluntary donations regarding the

provision of services to the public.

(b) Home visiting services for eligible families

With respect to an eligible family, each of the following

services shall, directly or through arrangement with other public

or nonprofit private entities, be available (as applicable to the

family member involved) in each project operated with a grant under

subsection (a) of this section:

(1) Prenatal and postnatal health care.

(2) Primary health care for the children, including

developmental assessments.

(3) Education for the parents concerning infant care and child

development, including the development and utilization of parent

and teacher resource networks and other family resource and

support networks where such networks are available.

(4) Upon the request of a parent, providing the education

described in paragraph (3) to other individuals who have

responsibility for caring for the children.

(5) Education for the parents concerning behaviors that

adversely affect health.

(6) Assistance in obtaining necessary health, mental health,

developmental, social, housing, and nutrition services and other

assistance, including services and other assistance under

maternal and child health programs; the special supplemental

nutrition program for women, infants, and children; section 1786

of this title; title V of the Social Security Act [42 U.S.C. 701

et seq.]; title XIX of such Act [42 U.S.C. 1396 et seq.]

(including the program for early and periodic screening,

diagnostic, and treatment services described in section 1905(r)

of such Act [42 U.S.C. 1396d(r)]); titles IV and XIX of the

Social Security Act [42 U.S.C. 601 et seq., 1396 et seq.];

housing programs; other food assistance programs; and appropriate

alcohol and drug dependency treatment programs, according to

need.

(c) Considerations in making grants

In awarding grants under subsection (a) of this section, the

Secretary shall take into consideration -

(1) the ability of the entity involved to provide, either

directly or through linkages, a broad range of preventive and

primary health care services and related social, family support,

and developmental services;

(2) different combinations of professional and lay home

visitors utilized within programs that are reflective of the

identified service needs and characteristics of target

populations;

(3) the extent to which the population to be targeted has

limited access to health care, and related social, family

support, and developmental services; and

(4) whether such grants are equitably distributed among urban

and rural settings and whether entities serving Native American

communities are represented among the grantees.

(d) Federal share

With respect to the costs of carrying out a project under

subsection (a) of this section, a grant under such subsection for

the project may not exceed 90 percent of such costs. To be eligible

to receive such a grant, an applicant must provide assurances that

the applicant will obtain at least 10 percent of such costs from

non-Federal funds (and such contributions to such costs may be in

cash or in-kind, including facilities and personnel).

(e) Rule of construction regarding at-risk births

For purposes of subsection (a)(1) of this section, a pregnant

woman shall be considered to be at risk of delivering an infant

with a health or developmental complication if during the pregnancy

the woman -

(1) lacks appropriate access to, or information concerning,

early and routine prenatal care;

(2) lacks the transportation necessary to gain access to the

services described in subsection (b) of this section;

(3) lacks appropriate child care assistance, which results in

impeding the ability of such woman to utilize health and related

social services;

(4) is fearful of accessing substance abuse services or child

and family support services; or

(5) is a minor with a low income.

(f) Delivery of services and case management

(1) Case management model

Home visiting services provided under this section shall be

delivered according to a case management model, and a registered

nurse, licensed social worker, or other licensed health care

professional with experience and expertise in providing health

and related social services in home and community settings shall

be assigned as the case manager for individual cases under such

model.

(2) Case manager

A case manager assigned under paragraph (1) shall have primary

responsibility for coordinating and overseeing the development of

a plan for each family that is to receive home visiting services

under this section, and for coordinating the delivery of such

services provided through appropriate personnel.

(3) Appropriate personnel

In determining which personnel shall be utilized in the

delivery of services, the case manager shall consider -

(A) the stated objective of the project to be operated with

the grant, as determined after considering identified gaps in

the current service delivery system; and

(B) the nature of the needs of the family to be served, as

determined at the initial assessment of the family that is

conducted by the case manager, and through follow-up contacts

by other providers of home visiting services.

(4) Family service plan

A case manager, in consultation with a team established in

accordance with paragraph (5) for the family involved, shall

develop a plan for the family following the initial visit to the

home of the family. Such plan shall reflect -

(A) an assessment of the health and related social service

needs of the family;

(B) a structured plan for the delivery of home visiting

services to meet the identified needs of the family;

(C) the frequency with which such services are to be provided

to the family;

(D) ongoing revisions made as the needs of family members

change; and

(E) the continuing voluntary participation of the family in

the plan.

(5) Home visiting services team

The team to be consulted under paragraph (4) on behalf of a

family shall include, as appropriate, other nursing

professionals, physician assistants, social workers, child

welfare professionals, infant and early childhood specialists,

nutritionists, and laypersons trained as home visitors. The case

manager shall ensure that the plan is coordinated with those

physician services that may be required by the mother or child.

(g) Outreach

Each grantee under subsection (a) of this section shall provide

outreach and casefinding services to inform eligible families of

the availability of home visiting services from the project.

(h) Confidentiality

In accordance with applicable State law, an entity receiving a

grant under subsection (a) of this section shall maintain

confidentiality with respect to services provided to families under

this section.

(i) Certain assurances

The Secretary may award a grant under subsection (a) of this

section only if the entity involved provides assurances

satisfactory to the Secretary that -

(1) the entity will provide home visiting services with

reasonable frequency -

(A) to families with pregnant women, as early in the

pregnancy as is practicable, and until the infant reaches at

least 2 years of age; and

(B) to other eligible families, for at least 2 years; and

(2) the entity will coordinate with public health and related

social service agencies to prevent duplication of effort and

improve the delivery of comprehensive health and related social

services.

(j) Submission to Secretary of certain information

The Secretary may award a grant under subsection (a) of this

section only if the entity involved submits to the Secretary -

(1) a description of the population to be targeted for home

visiting services and methods of outreach and casefinding for

identifying eligible families, including the use of lay home

visitors where appropriate;

(2) a description of the types and qualifications of home

visitors used by the entity and the process by which the entity

will provide continuing training and sufficient support to the

home visitors; and

(3) such other information as the Secretary determines to be

appropriate.

(k) Limitation regarding administrative expenses

Not more than 10 percent of a grant under subsection (a) of this

section may be expended for administrative expenses with respect to

the grant. The costs of training individuals to serve in the

project involved are not subject to the preceding sentence.

(l) Restrictions on use of grant

To be eligible to receive a grant under this section, an entity

must agree that the grant will not be expended -

(1) to provide inpatient hospital services;

(2) to make cash payments to intended recipients of services;

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

permanently improve (other than minor remodeling) any building or

other facility, or purchase major medical equipment;

(4) to satisfy any requirement for the expenditure of

non-Federal funds as a condition for the receipt of Federal

funds; or

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

public or nonprofit private entity.

(m) Reports to Secretary

To be eligible to receive a grant under this section, an entity

must agree to submit an annual report on the services provided

under this section to the Secretary in such manner and containing

such information as the Secretary by regulation requires. At a

minimum, the entity shall report information concerning eligible

families, including -

(1) the characteristics of the families and children receiving

services under this section;

(2) the usage, nature, and location of the provider, of

preventive health services, including prenatal, primary infant,

and child health care;

(3) the incidence of low birthweight and premature infants;

(4) the length of hospital stays for pre- and post-partum women

and their children;

(5) the incidence of substantiated child abuse and neglect for

all children within participating families;

(6) the number of emergency room visits for routine health

care;

(7) the source of payment for health care services and the

extent to which the utilization of health care services, other

than routine screening and medical care, available to the

individuals under the program established under title XIX of the

Social Security Act [42 U.S.C. 1396 et seq.], and under other

Federal, State, and local programs, is reduced;

(8) the number and type of referrals made for health and

related social services, including alcohol and drug treatment

services, and the utilization of such services provided by the

grantee; and

(9) the incidence of developmental disabilities.

(n) Requirement of application

The Secretary may make a grant under subsection (a) of this

section only if -

(1) an application for the grant is submitted to the Secretary;

(2) the application contains the agreements and assurances

required in this section, and the information required in

subsection (j) of this section;

(3) the application contains evidence that the preparation of

the application has been coordinated with the State agencies

responsible for maternal and child health and child welfare, and

coordinated with services provided under part H (!1) of the

Individuals with Disabilities Education Act; and

(4) 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 this section.

(o) Peer review

(1) Requirement

In making determinations for awarding grants under subsection

(a) of this section, the Secretary shall rely on the

recommendations of the peer review panel established under

paragraph (2).

(2) Composition

The Secretary shall establish a review panel to make

recommendations under paragraph (1) that shall be composed of -

(A) national experts in the fields of maternal and child

health, child abuse and neglect, and the provision of

community-based primary health services; and

(B) representatives of relevant Federal agencies, including

the Health Resources and Services Administration, the Substance

Abuse and Mental Health Services Administration, the

Administration for Children, Youth, and Families, the U.S.

Advisory Board on Child Abuse and Neglect, and the National

Commission to Prevent Infant Mortality.

(p) Evaluations

(1) In general

The Secretary shall, directly or through contracts with public

or private entities -

(A) conduct evaluations to determine the effectiveness of

projects under subsection (a) of this section in reducing the

incidence of children born with health or developmental

complications, the incidence among children less than 3 years

of age of such complications, and the incidence of child abuse

and neglect; and

(B) not less than once during each 3-year period, prepare and

submit to the appropriate committees of Congress a report

concerning the results of such evaluations.

(2) Contents

The evaluations conducted under paragraph (1) shall -

(A) include a summary of the data contained in the annual

reports submitted under subsection (m) of this section;

(B) assess the relative effectiveness of projects under

subsection (a) of this section in urban and rural areas, and

among programs utilizing differing combinations of

professionals and trained home visitors recruited from the

community to meet the needs of defined target service

populations; and

(C) make further recommendations necessary or desirable to

increase the effectiveness of such projects.

(q) Definitions

For purposes of this section:

(1) The term "eligible entity" includes public and nonprofit

private entities that provide health or related social services,

including community-based organizations, visiting nurse

organizations, hospitals, local health departments, community

health centers, Native Hawaiian health centers, nurse managed

clinics, family service agencies, child welfare agencies,

developmental service providers, family resource and support

programs, and resource mothers projects.

(2) The term "eligible family" means a family described in

subsection (a) of this section.

(3) The term "health or developmental complication", with

respect to a child, means -

(A) being born in an unhealthy or potentially unhealthy

condition, including premature birth, low birthweight, and

prenatal exposure to maternal substance abuse;

(B) a condition arising from a condition described in

subparagraph (A);

(C) a physical disability or delay; and

(D) a developmental disability or delay.

(4) The term "home visiting services" means the services

specified in subsection (b) of this section, provided at the

residence of the eligible family involved or provided pursuant to

arrangements made for the family (including arrangements for

services in community settings).

(5) The term "home visitors" means providers of home visiting

services.

(r) Authorization of appropriations

For the purpose of carrying out this section, there is authorized

to be appropriated $30,000,000 for each of the fiscal years 1993

and 1994.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399, as added Pub. L.

102-321, title V, Sec. 502(2), July 10, 1992, 106 Stat. 427;

amended Pub. L. 103-448, title II, Sec. 204(w)(2)(D), Nov. 2, 1994,

108 Stat. 4746.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsecs. (a)(3)(A),

(b)(6), and (m)(7), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as

amended. Titles IV, V, and XIX of the Act are classified generally

to subchapters IV (Sec. 601 et seq.), V (Sec. 701 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.

The Individuals with Disabilities Education Act, referred to in

subsec. (n)(3), is title VI of Pub. L. 91-230, Apr. 13, 1970, 84

Stat. 175, as amended. Part H of the Act was classified generally

to subchapter VIII (Sec. 1471 et seq.) of chapter 33 of Title 20,

Education, prior to repeal by Pub. L. 105-17, title II, Sec.

203(b), June 4, 1997, 111 Stat. 157, effective July 1, 1998. For

complete classification of this Act to the Code, see section 1400

of Title 20 and Tables.

-MISC1-

PRIOR PROVISIONS

A prior section 399 of act July 1, 1944, was renumbered section

398A by section 502(1) of Pub. L. 102-321 and is classified to

section 280c-4 of this title.

Another prior section 399 of act July 1, 1944, ch. 373, title

III, formerly Sec. 399b, as added Oct. 22, 1965, Pub. L. 89-291,

Sec. 2, 79 Stat. 1066; renumbered Sec. 399a and amended Mar. 13,

1970, Pub. L. 91-212, Sec. 10(c)(3), (d)(2)(A), 84 Stat. 67;

renumbered Sec. 399, July 23, 1974, Pub. L. 93-353, title II, Sec.

204, 88 Stat. 373; Oct. 17, 1979, Pub. L. 96-88, title V, Sec.

509(b), 93 Stat. 695, which related to the maintenance of records

by recipients of grants and audits thereof by the Secretary of

Health and Human Services and the Comptroller General of the United

States, was classified to section 280b-11 of this title, prior to

repeal by Pub. L. 99-158, Sec. 3(b), Nov. 20, 1985, 99 Stat. 879.

AMENDMENTS

1994 - Subsec. (b)(6). Pub. L. 103-448 substituted "special

supplemental nutrition program" for "special supplemental food

program".

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-448 effective Oct. 1, 1994, see section

401 of Pub. L. 103-448, set out as a note under section 1755 of

this title.

EFFECTIVE DATE

Section effective July 10, 1992, with programsmaking awards

providing financial assistance in fiscal year 1993 and subsequent

years effective for awards made on or after Oct. 1, 1992, see

section 801(b), (d)(1) of Pub. L. 102-321, set out as an Effective

Date of 1992 Amendment note under section 236 of this title.

REFERENCE TO COMMUNITY, MIGRANT, PUBLIC HOUSING, OR HOMELESS HEALTH

CENTER CONSIDERED REFERENCE TO HEALTH CENTER

Reference to community health center, migrant health center,

public housing health center, or homeless health center considered

reference to health center, see section 4(c) of Pub. L. 104-299,

set out as a note under section 254b of this title.

PURPOSE

Section 501 of title V of Pub. L. 102-321 provided that: "The

purpose of this title [enacting this section] is -

"(1) to increase the use of, and to provide information on the

availability of early, continuous and comprehensive prenatal

care;

"(2) to reduce the incidence of infant mortality and of infants

born prematurely, with low birthweight, or with other impairments

including those associated with maternal substance abuse;

"(3) for pregnant women and mothers of children below the age

of 3 whose children have experienced or are at risk of

experiencing a health or developmental complication, to provide

assistance in obtaining health and related social services

necessary to meet the special needs of the women and their

children;

"(4) to assist, when requested, women who are pregnant and

at-risk for poor birth outcomes, or who have young children and

are abusing alcohol or other drugs, in obtaining appropriate

treatment; and

"(5) to reduce the incidence of child abuse and neglect."

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Part L - [Repealed] 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part L - [Repealed]

-HEAD-

PART L - [REPEALED]

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-310, div. B, title XXXI, Sec. 3106(n), Oct.

17, 2000, 114 Stat. 1179, struck out heading for part L "Services

for Children of Substance Abusers".

1993 - Pub. L. 103-43, title XX, Sec. 2008(i)(2)(B)(ii), June 10,

1993, 107 Stat. 213, redesignated part M "Services for Children of

Substance Abusers" as L. Former part L "Health Care Services in the

Home" redesignated K.

1990 - Pub. L. 101-616, title I, Sec. 101(a)(1), Nov. 16, 1990,

104 Stat. 3279, redesignated part K "Health Care Services in the

Home" as L.

-End-

-CITE-

42 USC Sec. 280d 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part L - [Repealed]

-HEAD-

Sec. 280d. Transferred

-COD-

CODIFICATION

Section, act July 1, 1944, ch. 373, title III, Sec. 399D, as

added Pub. L. 102-321, title IV, Sec. 401(a), July 10, 1992, 106

Stat. 419, and amended, which related to grants for services for

children of substance abusers, was renumbered section 399A of title

III of act July 1, 1944 by Pub. L. 106-310, div. A, title V, Sec.

502(1), Oct. 17, 2000, 114 Stat. 1115. Subsequently, section 399D

was renumbered section 519 of title V of act July 1, 1944, without

reference to its prior renumbering as 399A, by Pub. L. 106-310,

div. B, title XXXI, Sec. 3106(m), Oct. 17, 2000, 114 Stat. 1179.

Section was transferred to section 290bb-25 of this title.

-End-

-CITE-

42 USC Sec. 280d-11 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part L - [Repealed]

-HEAD-

Sec. 280d-11. Transferred

-COD-

CODIFICATION

Section, act July 1, 1944, ch. 373, title III, Sec. 399F, as

added Pub. L. 102-531, title II, Sec. 201, Oct. 27, 1992, 106 Stat.

3474, which comprised part N in its entirety and which related to

establishment and duties of National Foundation for the Centers for

Disease Control and Prevention, was renumbered section 399G of act

July 1, 1944, by Pub. L. 106-310, div. A, title V, Sec. 502(3),

Oct. 17, 2000, 114 Stat. 1115, and transferred to section 280e-11

of this title.

-End-

-CITE-

42 USC Part M - National Program of Cancer Registries 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

PART M - NATIONAL PROGRAM OF CANCER REGISTRIES

-End-

-CITE-

42 USC Sec. 280e 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

Sec. 280e. National program of cancer registries

-STATUTE-

(a) In general

(1) Statewide cancer registries

The Secretary, acting through the Director of the Centers for

Disease Control, may make grants to States, or may make grants or

enter into contracts with academic or nonprofit organizations

designated by the State to operate the State's cancer registry in

lieu of making a grant directly to the State, to support the

operation of population-based, statewide registries to collect,

for each condition specified in paragraph (2)(A), data concerning

-

(A) demographic information about each case of cancer;

(B) information on the industrial or occupational history of

the individuals with the cancers, to the extent such

information is available from the same record;

(C) administrative information, including date of diagnosis

and source of information;

(D) pathological data characterizing the cancer, including

the cancer site, stage of disease (pursuant to Staging Guide),

incidence, and type of treatment; and

(E) other elements determined appropriate by the Secretary.

(2) Cancer; benign brain-related tumors

(A) In general

For purposes of paragraph (1), the conditions referred to in

this paragraph are the following:

(i) Each form of in-situ and invasive cancer (with the

exception of basal cell and squamous cell carcinoma of the

skin), including malignant brain-related tumors.

(ii) Benign brain-related tumors.

(B) Brain-related tumor

For purposes of subparagraph (A):

(i) The term "brain-related tumor" means a listed primary

tumor (whether malignant or benign) occurring in any of the

following sites:

(I) The brain, meninges, spinal cord, cauda equina, a

cranial nerve or nerves, or any other part of the central

nervous system.

(II) The pituitary gland, pineal gland, or

craniopharyngeal duct.

(ii) The term "listed", with respect to a primary tumor,

means a primary tumor that is listed in the International

Classification of Diseases for Oncology (commonly referred to

as the ICD-O).

(iii) The term "International Classification of Diseases

for Oncology" means a classification system that includes

topography (site) information and histology (cell type

information) developed by the World Health Organization, in

collaboration with international centers, to promote

international comparability in the collection,

classification, processing, and presentation of cancer

statistics. The ICD-O system is a supplement to the

International Statistical Classification of Diseases and

Related Health Problems (commonly known as the ICD) and is

the standard coding system used by cancer registries

worldwide. Such term includes any modification made to such

system for purposes of the United States. Such term further

includes any published classification system that is

internationally recognized as a successor to the

classification system referred to in the first sentence of

this clause.

(C) Statewide cancer registry

References in this section to cancer registries shall be

considered to be references to registries described in this

subsection.

(b) Matching funds

(1) In general

The Secretary may make a grant under subsection (a) of this

section only if the State, or the academic or nonprofit private

organization designated by the State to operate the cancer

registry of the State, involved agrees, with respect to the costs

of the program, to make available (directly or through donations

from public or private entities) non-Federal contributions toward

such costs in an amount that is not less than 25 percent of such

costs or $1 for every $3 of Federal funds provided in the grant.

(2) Determination of amount of non-Federal contribution;

maintenance of effort

(A) 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) With respect to a State in which the purpose described in

subsection (a) of this section is to be carried out, the

Secretary, in making a determination of the amount of non-Federal

contributions provided under paragraph (1), may include only such

contributions as are in excess of the amount of such

contributions made by the State toward the collection of data on

cancer for the fiscal year preceding the first year for which a

grant under subsection (a) of this section is made with respect

to the State. The Secretary may decrease the amount of

non-Federal contributions that otherwise would have been required

by this subsection in those cases in which the State can

demonstrate that decreasing such amount is appropriate because of

financial hardship.

(c) Eligibility for grants

(1) In general

No grant shall be made by the Secretary under subsection (a) of

this section unless an application has been submitted to, and

approved by, the Secretary. Such application shall be in such

form, submitted in such a manner, and be accompanied by such

information, as the Secretary may specify. No such application

may be approved unless it contains assurances that the applicant

will use the funds provided only for the purposes specified in

the approved application and in accordance with the requirements

of this section, that the application will establish such fiscal

control and fund accounting procedures as may be necessary to

assure proper disbursement and accounting of Federal funds paid

to the applicant under subsection (a) of this section, and that

the applicant will comply with the peer review requirements under

sections 289 and 289a of this title.

(2) Assurances

Each applicant, prior to receiving Federal funds under

subsection (a) of this section, shall provide assurances

satisfactory to the Secretary that the applicant will -

(A) provide for the establishment of a registry in accordance

with subsection (a) of this section;

(B) comply with appropriate standards of completeness,

timeliness, and quality of population-based cancer registry

data;

(C) provide for the annual publication of reports of cancer

data under subsection (a) of this section; and

(D) provide for the authorization under State law of the

statewide cancer registry, including promulgation of

regulations providing -

(i) a means to assure complete reporting of cancer cases

(as described in subsection (a) of this section) to the

statewide cancer registry by hospitals or other facilities

providing screening, diagnostic or therapeutic services to

patients with respect to cancer;

(ii) a means to assure the complete reporting of cancer

cases (as defined in subsection (a) of this section) to the

statewide cancer registry by physicians, surgeons, and all

other health care practitioners diagnosing or providing

treatment for cancer patients, except for cases directly

referred to or previously admitted to a hospital or other

facility providing screening, diagnostic or therapeutic

services to patients in that State and reported by those

facilities;

(iii) a means for the statewide cancer registry to access

all records of physicians and surgeons, hospitals, outpatient

clinics, nursing homes, and all other facilities,

individuals, or agencies providing such services to patients

which would identify cases of cancer or would establish

characteristics of the cancer, treatment of the cancer, or

medical status of any identified patient;

(iv) for the reporting of cancer case data to the statewide

cancer registry in such a format, with such data elements,

and in accordance with such standards of quality timeliness

and completeness, as may be established by the Secretary;

(v) for the protection of the confidentiality of all cancer

case data reported to the statewide cancer registry,

including a prohibition on disclosure to any person of

information reported to the statewide cancer registry that

identifies, or could lead to the identification of, an

individual cancer patient, except for disclosure to other

State cancer registries and local and State health officers;

(vi) for a means by which confidential case data may in

accordance with State law be disclosed to cancer researchers

for the purposes of cancer prevention, control and research;

(vii) for the authorization or the conduct, by the

statewide cancer registry or other persons and organizations,

of studies utilizing statewide cancer registry data,

including studies of the sources and causes of cancer,

evaluations of the cost, quality, efficacy, and

appropriateness of diagnostic, therapeutic, rehabilitative,

and preventative services and programs relating to cancer,

and any other clinical, epidemiological, or other cancer

research; and

(viii) for protection for individuals complying with the

law, including provisions specifying that no person shall be

held liable in any civil action with respect to a cancer case

report provided to the statewide cancer registry, or with

respect to access to cancer case information provided to the

statewide cancer registry.

(d) Relationship to certain programs

(1) In general

This section may not be construed to act as a replacement for

or diminishment of the program carried out by the Director of the

National Cancer Institute and designated by such Director as the

Surveillance, Epidemiology, and End Results Program (SEER).

(2) Supplanting of activities

In areas where both such programs exist, the Secretary shall

ensure that SEER support is not supplanted and that any

additional activities are consistent with the guidelines provided

for in subsection (c)(2)(C) and (D) of this section and are

appropriately coordinated with the existing SEER program.

(3) Transfer of responsibility

The Secretary may not transfer administration responsibility

for such SEER program from such Director.

(4) Coordination

To encourage the greatest possible efficiency and effectiveness

of Federally supported efforts with respect to the activities

described in this subsection, the Secretary shall take steps to

assure the appropriate coordination of programs supported under

this part with existing Federally supported cancer registry

programs.

(e) Requirement regarding certain study on breast cancer

In the case of a grant under subsection (a) of this section to

any State specified in subsection (b) of section 280e-3 of this

title, the Secretary may establish such conditions regarding the

receipt of the grant as the Secretary determines are necessary to

facilitate the collection of data for the study carried out under

such section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399B, formerly Sec. 399H,

as added Pub. L. 102-515, Sec. 3, Oct. 24, 1992, 106 Stat. 3372;

renumbered Sec. 399B and amended Pub. L. 106-310, div. A, title V,

Sec. 502(2)(A), (B), Oct. 17, 2000, 114 Stat. 1115; Pub. L.

107-260, Sec. 2(a), Oct. 29, 2002, 116 Stat. 1743.)

-MISC1-

AMENDMENTS

2002 - Subsec. (a). Pub. L. 107-260 designated existing

provisions as par. (1), inserted par. (1) heading, substituted

"population-based, statewide registries to collect, for each

condition specified in paragraph (2)(A), data" for

"population-based, statewide cancer registries in order to collect,

for each form of in-situ and invasive cancer (with the exception of

basal cell and squamous cell carcinoma of the skin), data",

redesignated former pars. (1) to (5) as subpars. (A) to (E) of par.

(1), respectively, and added par. (2).

2000 - Subsec. (e). Pub. L. 106-310, Sec. 502(2)(B), substituted

"subsection (b) of section 280e-3 of this title" for "section

280e-3(b) of this title" and "such section" for "section 399C".

-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.

-MISC2-

EFFECTIVE DATE OF 2002 AMENDMENT

Pub. L. 107-260, Sec. 2(b), Oct. 29, 2002, 116 Stat. 1744,

provided that: "The amendments made by subsection (a) [amending

this section] apply to grants under section 399B of the Public

Health Service Act [this section] for fiscal year 2002 and

subsequent fiscal years, except that, in the case of a State that

received such a grant for fiscal year 2000, the Secretary of Health

and Human Services may delay the applicability of such amendments

to the State for not more than 12 months if the Secretary

determines that compliance with such amendments requires the

enactment of a statute by the State or the issuance of State

regulations."

CONGRESSIONAL FINDINGS AND PURPOSE

Section 2 of Pub. L. 102-515 provided that:

"(a) Findings. - Congress finds that -

"(1) cancer control efforts, including prevention and early

detection, are best addressed locally by State health departments

that can identify unique needs;

"(2) cancer control programs and existing statewide

population-based cancer registries have identified cancer

incidence and cancer mortality rates that indicate the burden of

cancer for Americans is substantial and varies widely by

geographic location and by ethnicity;

"(3) statewide cancer incidence and cancer mortality data, can

be used to identify cancer trends, patterns, and variation for

directing cancer control intervention;

"(4) the American Association of Central Cancer Registries

(AACCR) cites that of the 50 States, approximately 38 have

established cancer registries, many are not statewide and 10 have

no cancer registry; and

"(5) AACCR also cites that of the 50 States, 39 collect data on

less than 100 percent of their population, and less than half

have adequate resources for insuring minimum standards for

quality and for completeness of case information.

"(b) Purpose. - It is the purpose of this Act [enacting this part

and provisions set out as a note under section 201 of this title]

to establish a national program of cancer registries."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 280e-1, 280e-3 of this

title.

-End-

-CITE-

42 USC Sec. 280e-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

Sec. 280e-1. Planning grants regarding registries

-STATUTE-

(a) In general

(1) States

The Secretary, acting through the Director of the Centers for

Disease Control, may make grants to States for the purpose of

developing plans that meet the assurances required by the

Secretary under section 280e(c)(2) of this title.

(2) Other entities

For the purpose described in paragraph (1), the Secretary may

make grants to public entities other than States and to nonprofit

private entities. Such a grant may be made to an entity only if

the State in which the purpose is to be carried out has certified

that the State approves the entity as qualified to carry out the

purpose.

(b) Application

The Secretary may make a grant under subsection (a) of this

section only if an application for the grant is submitted to the

Secretary, the application contains the certification required in

subsection (a)(2) of this section (if the application is for a

grant under such subsection), 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 this section.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399C, formerly Sec. 399I,

as added Pub. L. 102-515, Sec. 3, Oct. 24, 1992, 106 Stat. 3375;

renumbered Sec. 399C, Pub. L. 106-310, div. A, title V, Sec.

502(2)(A), Oct. 17, 2000, 114 Stat. 1115.)

-CHANGE-

CHANGE OF NAME

Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 280e-4 of this title.

-End-

-CITE-

42 USC Sec. 280e-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

Sec. 280e-2. Technical assistance in operations of statewide cancer

registries

-STATUTE-

The Secretary, acting through the Director of the Centers for

Disease Control, may, directly or through grants and contracts, or

both, provide technical assistance to the States in the

establishment and operation of statewide registries, including

assistance in the development of model legislation for statewide

cancer registries and assistance in establishing a computerized

reporting and data processing system.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399D, formerly Sec. 399J,

as added Pub. L. 102-515, Sec. 3, Oct. 24, 1992, 106 Stat. 3376;

renumbered Sec. 399D, Pub. L. 106-310, div. A, title V, Sec.

502(2)(A), Oct. 17, 2000, 114 Stat. 1115.)

-MISC1-

PRIOR PROVISIONS

A prior section 399D of act July 1, 1944, was renumbered section

519, and is classified to section 290bb-25 of this title.

-CHANGE-

CHANGE OF NAME

Centers for Disease Control changed to Centers for Disease

Control and Prevention by Pub. L. 102-531, title III, Sec. 312,

Oct. 27, 1992, 106 Stat. 3504.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 280e-4 of this title.

-End-

-CITE-

42 USC Sec. 280e-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

Sec. 280e-3. Study in certain States to determine factors

contributing to elevated breast cancer mortality rates

-STATUTE-

(a) In general

Subject to subsections (c) and (d) of this section, the

Secretary, acting through the Director of the National Cancer

Institute, shall conduct a study for the purpose of determining the

factors contributing to the fact that breast cancer mortality rates

in the States specified in subsection (b) of this section are

elevated compared to rates in other States.

(b) Relevant States

The States referred to in subsection (a) of this section are

Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New

Jersey, New York, Rhode Island, Vermont, and the District of

Columbia.

(c) Cooperation of State

The Secretary may conduct the study required in subsection (a) of

this section in a State only if the State agrees to cooperate with

the Secretary in the conduct of the study, including providing

information from any registry operated by the State pursuant to

section 280e(a) of this title.

(d) Planning, commencement, and duration

The Secretary shall, during each of the fiscal years 1993 and

1994, develop a plan for conducting the study required in

subsection (a) of this section. The study shall be initiated by the

Secretary not later than fiscal year 1994, and the collection of

data under the study may continue through fiscal year 1998.

(e) Report

Not later than September 30, 1999, the Secretary shall complete

the study required in subsection (a) of this section and submit to

the Committee on Energy and Commerce of the House of

Representatives, and to the Committee on Labor and Human Resources

of the Senate, a report describing the findings and recommendations

made as a result of the study.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399E, formerly Sec. 399K,

as added Pub. L. 102-515, Sec. 3, Oct. 24, 1992, 106 Stat. 3376;

renumbered Sec. 399E and amended Pub. L. 106-310, div. A, title V,

Sec. 502(2)(A), (C), Oct. 17, 2000, 114 Stat. 1115.)

-MISC1-

AMENDMENTS

2000 - Subsec. (c). Pub. L. 106-310, Sec. 502(2)(C), made

technical amendment to reference in original act which appears in

text as reference to section 280e(a) of this title.

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

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

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

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

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

Congress, Jan. 3, 2001.

-MISC2-

POTENTIAL ENVIRONMENTAL AND OTHER RISKS CONTRIBUTING TO INCIDENCE

OF BREAST CANCER

Pub. L. 103-43, title XIX, Sec. 1911, June 10, 1993, 107 Stat.

205, provided that Director of the National Cancer Institute, in

collaboration with Director of the National Institute of

Environmental Health Sciences, was to conduct case-control study to

assess biological markers of environmental and other potential risk

factors contributing to incidence of breast cancer in specified

counties in State of New York and northeastern United States that

had highest age-adjusted mortality rate of such cancer, and to

report results of such study to Congress not later than 30 months

after June 10, 1993.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 280e, 280e-4 of this

title.

-End-

-CITE-

42 USC Sec. 280e-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part M - National Program of Cancer Registries

-HEAD-

Sec. 280e-4. Authorization of appropriations

-STATUTE-

(a) Registries

For the purpose of carrying out this part, there are authorized

to be appropriated $30,000,000 for fiscal year 1994, and such sums

as may be necessary for each of the fiscal years 1995 through 2003.

Of the amounts appropriated under the preceding sentence for any

such fiscal year, the Secretary may obligate not more than 25

percent for carrying out section 280e-1 of this title, and not more

than 10 percent may be expended for assessing the accuracy,

completeness and quality of data collected, and not more than 10

percent of which is to be expended under section 280e-2 of this

title.

(b) Breast cancer study

Of the amounts appropriated for the National Cancer Institute

under subpart 1 of part C of subchapter III of this chapter for any

fiscal year in which the study required in section 280e-3 of this

title is being carried out, the Secretary shall expend not less

than $1,000,000 for the study.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399F, formerly Sec. 399L,

as added Pub. L. 102-515, Sec. 3, Oct. 24, 1992, 106 Stat. 3376;

amended Pub. L. 103-43, title XX, Sec. 2003, June 10, 1993, 107

Stat. 208; Pub. L. 103-183, title VII, Sec. 705(c), Dec. 14, 1993,

107 Stat. 2241; Pub. L. 105-340, title II, Sec. 202, Oct. 31, 1998,

112 Stat. 3194; renumbered Sec. 399F and amended Pub. L. 106-310,

div. A, title V, Sec. 502(2)(A), (D), Oct. 17, 2000, 114 Stat.

1115.)

-MISC1-

PRIOR PROVISIONS

A prior section 399F of act July 1, 1944, was renumbered section

399G and is classified to section 280e-11 of this title.

AMENDMENTS

2000 - Subsec. (a). Pub. L. 106-310, Sec. 502(2)(D)(ii),

substituted "section 280e-2 of this title" for "subsection 280e-2

of this title".

Pub. L. 106-310, Sec. 502(2)(D)(i), made technical amendment to

reference in original act which appears in text as reference to

section 280e-1 of this title.

Subsec. (b). Pub. L. 106-310, Sec. 502(2)(D)(iii), made technical

amendment to reference in original act which appears in text as

reference to section 280e-3 of this title.

1998 - Subsec. (a). Pub. L. 105-340 substituted "2003" for

"1998".

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

for "through 1996".

Pub. L. 103-43 substituted "there are authorized to be

appropriated $30,000,000 for fiscal year 1994, and such sums as may

be necessary for each of the fiscal years 1995 through 1996" for

"the Secretary may use $30,000,000 for each of the fiscal years

1993 through 1997" in first sentence and "Of the amounts

appropriated under the preceding sentence" for "Out of any amounts

used" in second sentence.

-End-

-CITE-

42 USC Part N - National Foundation for the Centers for

Disease Control and Prevention 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part N - National Foundation for the Centers for Disease Control and

Prevention

-HEAD-

PART N - NATIONAL FOUNDATION FOR THE CENTERS FOR DISEASE CONTROL

AND PREVENTION

-COD-

CODIFICATION

This part was formerly set out preceding part M of this

subchapter.

-End-

-CITE-

42 USC Sec. 280e-11 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part N - National Foundation for the Centers for Disease Control and

Prevention

-HEAD-

Sec. 280e-11. Establishment and duties of Foundation

-STATUTE-

(a) In general

There shall be established in accordance with this section a

nonprofit private corporation to be known as the National

Foundation for the Centers for Disease Control and Prevention (in

this part referred to as the "Foundation"). The Foundation shall

not be an agency or instrumentality of the Federal Government, and

officers, employees, and members of the board of the Foundation

shall not be officers or employees of the Federal Government.

(b) Purpose of Foundation

The purpose of the Foundation shall be to support and carry out

activities for the prevention and control of diseases, disorders,

injuries, and disabilities, and for promotion of public health.

(c) Endowment fund

(1) In general

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

shall establish a fund for providing endowments for positions

that are associated with the Centers for Disease Control and

Prevention and dedicated to the purpose described in such

subsection. Subject to subsection (f)(1)(B) of this section, the

fund shall consist of such donations as may be provided by

non-Federal entities and such non-Federal assets of the

Foundation (including earnings of the Foundation and the fund) as

the Foundation may elect to transfer to the fund.

(2) Authorized expenditures of fund

The provision of endowments under paragraph (1) shall be the

exclusive function of the fund established under such paragraph.

Such endowments may be expended only for the compensation of

individuals holding the positions, for staff, equipment,

quarters, travel, and other expenditures that are appropriate in

supporting the positions, and for recruiting individuals to hold

the positions endowed by the fund.

(d) Certain activities of Foundation

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

may provide for the following with respect to the purpose described

in such subsection:

(1) Programs of fellowships for State and local public health

officials to work and study in association with the Centers for

Disease Control and Prevention.

(2) Programs of international arrangements to provide

opportunities for public health officials of other countries to

serve in public health capacities in the United States in

association with the Centers for Disease Control and Prevention

or elsewhere, or opportunities for employees of such Centers (or

other public health officials in the United States) to serve in

such capacities in other countries, or both.

(3) Studies, projects, and research (which may include applied

research on the effectiveness of prevention activities,

demonstration projects, and programs and projects involving

international, Federal, State, and local governments).

(4) Forums for government officials and appropriate private

entities to exchange information. Participants in such forums may

include institutions of higher education and appropriate

international organizations.

(5) Meetings, conferences, courses, and training workshops.

(6) Programs to improve the collection and analysis of data on

the health status of various populations.

(7) Programs for writing, editing, printing, and publishing of

books and other materials.

(8) Other activities to carry out the purpose described in

subsection (b) of this section.

(e) General structure of Foundation; nonprofit status

(1) Board of directors

The Foundation shall have a board of directors (in this part

referred to as the "Board"), which shall be established and

conducted in accordance with subsection (f) of this section. The

Board shall establish the general policies of the Foundation for

carrying out subsection (b) of this section, including the

establishment of the bylaws of the Foundation.

(2) Executive director

The Foundation shall have an executive director (in this part

referred to as the "Director"), who shall be appointed by the

Board, who shall serve at the pleasure of the Board, and for whom

the Board shall establish the rate of compensation. Subject to

compliance with the policies and bylaws established by the Board

pursuant to paragraph (1), the Director shall be responsible for

the daily operations of the Foundation in carrying out subsection

(b) of this section.

(3) Nonprofit status

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

establish such policies and bylaws under paragraph (1), and the

Director shall carry out such activities under paragraph (2), as

may be necessary to ensure that the Foundation maintains status

as an organization that -

(A) is described in subsection (c)(3) of section 501 of title

26; and

(B) is, under subsection (a) of such section, exempt from

taxation.

(f) Board of directors

(1) Certain bylaws

(A) In establishing bylaws under subsection (e)(1) of this

section, the Board shall ensure that the bylaws of the Foundation

include bylaws for the following:

(i) Policies for the selection of the officers, employees,

agents, and contractors of the Foundation.

(ii) Policies, including ethical standards, for the

acceptance and disposition of donations to the Foundation and

for the disposition of the assets of the Foundation.

(iii) Policies for the conduct of the general operations of

the Foundation.

(iv) Policies for writing, editing, printing, and publishing

of books and other materials, and the acquisition of patents

and licenses for devices and procedures developed by the

Foundation.

(B) In establishing bylaws under subsection (e)(1) of this

section, the Board shall ensure that the bylaws of the Foundation

(and activities carried out under the bylaws) do not -

(i) reflect unfavorably upon the ability of the Foundation,

or the Centers for Disease Control and Prevention, to carry out

its responsibilities or official duties in a fair and objective

manner; or

(ii) compromise, or appear to compromise, the integrity of

any governmental program or any officer or employee involved in

such program.

(2) Composition

(A) Subject to subparagraph (B), the Board shall be composed of

7 individuals, appointed in accordance with paragraph (4), who

collectively possess education or experience appropriate for

representing the general field of public health, the general

field of international health, and the general public. Each such

individual shall be a voting member of the Board.

(B) The Board may, through amendments to the bylaws of the

Foundation, provide that the number of members of the Board shall

be a greater number than the number specified in subparagraph

(A).

(3) Chair

The Board shall, from among the members of the Board, designate

an individual to serve as the chair of the Board (in this

subsection referred to as the "Chair").

(4) Appointments, vacancies, and terms

Subject to subsection (j) of this section (regarding the

initial membership of the Board), the following shall apply to

the Board:

(A) Any vacancy in the membership of the Board shall be

filled by appointment by the Board, after consideration of

suggestions made by the Chair and the Director regarding the

appointments. Any such vacancy shall be filled not later than

the expiration of the 180-day period beginning on the date on

which the vacancy occurs.

(B) The term of office of each member of the Board appointed

under subparagraph (A) shall be 5 years. A member of the Board

may continue to serve after the expiration of the term of the

member until the expiration of the 180-day period beginning on

the date on which the term of the member expires.

(C) A vacancy in the membership of the Board shall not affect

the power of the Board to carry out the duties of the Board. If

a member of the Board does not serve the full term applicable

under subparagraph (B), the individual appointed to fill the

resulting vacancy shall be appointed for the remainder of the

term of the predecessor of the individual.

(5) Compensation

Members of the Board may not receive compensation for service

on the Board. The members may be reimbursed for travel,

subsistence, and other necessary expenses incurred in carrying

out the duties of the Board.

(g) Certain responsibilities of executive director

In carrying out subsection (e)(2) of this section, the Director

shall carry out the following functions:

(1) Hire, promote, compensate, and discharge officers and

employees of the Foundation, and define the duties of the

officers and employees.

(2) Accept and administer donations to the Foundation, and

administer the assets of the Foundation.

(3) Establish a process for the selection of candidates for

holding endowed positions under subsection (c) of this section.

(4) Enter into such financial agreements as are appropriate in

carrying out the activities of the Foundation.

(5) Take such action as may be necessary to acquire patents and

licenses for devices and procedures developed by the Foundation

and the employees of the Foundation.

(6) Adopt, alter, and use a corporate seal, which shall be

judicially noticed.

(7) Commence and respond to judicial proceedings in the name of

the Foundation.

(8) Other functions that are appropriate in the determination

of the Director.

(h) General provisions

(1) Authority for accepting funds

The Director of the Centers for Disease Control and Prevention

may accept and utilize, on behalf of the Federal Government, any

gift, donation, bequest, or devise of real or personal property

from the Foundation for the purpose of aiding or facilitating the

work of such Centers. Funds may be accepted and utilized by such

Director under the preceding sentence without regard to whether

the funds are designated as general-purpose funds or

special-purpose funds.

(2) Authority for acceptance of voluntary services

(A) The Director of the Centers for Disease Control and

Prevention may accept, on behalf of the Federal Government, any

voluntary services provided to such Centers by the Foundation for

the purpose of aiding or facilitating the work of such Centers.

In the case of an individual, such Director may accept the

services provided under the preceding sentence by the individual

for not more than 2 years.

(B) The limitation established in subparagraph (A) regarding

the period of time in which services may be accepted applies to

each individual who is not an employee of the Federal Government

and who serves in association with the Centers for Disease

Control and Prevention pursuant to financial support from the

Foundation.

(3) Administrative control

No officer, employee, or member of the Board of the Foundation

may exercise any administrative or managerial control over any

Federal employee.

(4) Applicability of certain standards to non-Federal employees

In the case of any individual who is not an employee of the

Federal Government and who serves in association with the Centers

for Disease Control and Prevention pursuant to financial support

from the Foundation, the Foundation shall negotiate a memorandum

of understanding with the individual and the Director of the

Centers for Disease Control and Prevention specifying that the

individual -

(A) shall be subject to the ethical and procedural standards

regulating Federal employment, scientific investigation, and

research findings (including publications and patents) that are

required of individuals employed by the Centers for Disease

Control and Prevention, including standards under this chapter,

the Ethics in Government Act, and the Technology Transfer Act;

(!1) and

(B) shall be subject to such ethical and procedural standards

under chapter 11 of title 18 (relating to conflicts of

interest), as the Director of such Centers determines is

appropriate, except such memorandum may not provide that the

individual shall be subject to the standards of section 209 of

title 18.

(5) Financial conflicts of interest

Any individual who is an officer, employee, or member of the

Board of the Foundation may not directly or indirectly

participate in the consideration or determination by the

Foundation of any question affecting -

(A) any direct or indirect financial interest of the

individual; or

(B) any direct or indirect financial interest of any business

organization or other entity of which the individual is an

officer or employee or in which the individual has a direct or

indirect financial interest.

(6) Audits; availability of records

The Foundation shall -

(A) provide for biennial audits of the financial condition of

the Foundation; and

(B) make such audits, and all other records, documents, and

other papers of the Foundation, available to the Secretary and

the Comptroller General of the United States for examination or

audit.

(7) Reports

(A) Not later than February 1 of each fiscal year, the

Foundation shall publish a report describing the activities of

the Foundation during the preceding fiscal year. Each such report

shall include for the fiscal year involved a comprehensive

statement of the operations, activities, financial condition, and

accomplishments of the Foundation.

(B) With respect to the financial condition of the Foundation,

each report under subparagraph (A) shall include the source, and

a description of, all gifts to the Foundation of real or personal

property, and the source and amount of all gifts to the

Foundation of money. Each such report shall include a

specification of any restrictions on the purposes for which gifts

to the Foundation may be used.

(C) The Foundation shall make copies of each report submitted

under subparagraph (A) available for public inspection, and shall

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

charge not exceeding the cost of providing the copy.

(8) Liaison from Centers for Disease Control and Prevention

The Director of the Centers for Disease Control and Prevention

shall serve as the liaison representative of such Centers to the

Board and the Foundation.

(i) Federal funding

(1) Authority for annual grants

(A) The Secretary, acting through the Director of the Centers

for Disease Control and Prevention, shall -

(i) for fiscal year 1993, make a grant to an entity described

in subsection (j)(9) of this section (relating to the

establishment of a committee to establish the Foundation);

(ii) for fiscal year 1994, make a grant to the committee

established under such subsection, or if the Foundation has

been established, to the Foundation; and

(iii) for fiscal year 1995 and each subsequent fiscal year,

make a grant to the Foundation.

(B) A grant under subparagraph (A) may be expended -

(i) in the case of an entity receiving the grant under

subparagraph (A)(i), only for the purpose of carrying out the

duties established in subsection (j)(9) of this section for the

entity;

(ii) in the case of the committee established under such

subsection, only for the purpose of carrying out the duties

established in subsection (j) of this section for the

committee; and

(iii) in the case of the Foundation, only for the purpose of

the administrative expenses of the Foundation.

(C) A grant under subparagraph (A) may not be expended to

provide amounts for the fund established under subsection (c) of

this section.

(D) For the purposes described in subparagraph (B) -

(i) any portion of the grant made under subparagraph (A)(i)

for fiscal year 1993 that remains unobligated after the entity

receiving the grant completes the duties established in

subsection (j)(9) of this section for the entity shall be

available to the committee established under such subsection;

and

(ii) any portion of a grant under subparagraph (A) made for

fiscal year 1993 or 1994 that remains unobligated after such

committee completes the duties established in such subsection

for the committee shall be available to the Foundation.

(2) Funding for grants

(A) For the purpose of grants under paragraph (1), there is

authorized to be appropriated $500,000 for each fiscal year.

(B) For the purpose of grants under paragraph (1), the

Secretary may for each fiscal year make available not more than

$500,000 from the amounts appropriated for the fiscal year for

the programs of the Department of Health and Human Services. Such

amounts may be made available without regard to whether amounts

have been appropriated under subparagraph (A).

(3) Certain restriction

If the Foundation receives Federal funds for the purpose of

serving as a fiscal intermediary between Federal agencies, the

Foundation may not receive such funds for the indirect costs of

carrying out such purpose in an amount exceeding 10 percent of

the direct costs of carrying out such purpose. The preceding

sentence may not be construed as authorizing the expenditure of

any grant under paragraph (1) for such purpose.

(j) Committee for establishment of Foundation

(1) In general

There shall be established in accordance with this subsection a

committee to carry out the functions described in paragraph (2)

(which committee is referred to in this subsection as the

"Committee").

(2) Functions

The functions referred to in paragraph (1) for the Committee

are as follows:

(A) To carry out such activities as may be necessary to

incorporate the Foundation under the laws of the State

involved, including serving as incorporators for the

Foundation. Such activities shall include ensuring that the

articles of incorporation for the Foundation require that the

Foundation be established and operated in accordance with the

applicable provisions of this part (or any successor to this

part), including such provisions as may be in effect pursuant

to amendments enacted after October 27, 1992.

(B) To ensure that the Foundation qualifies for and maintains

the status described in subsection (e)(3) of this section

(regarding taxation).

(C) To establish the general policies and initial bylaws of

the Foundation, which bylaws shall include the bylaws described

in subsections (e)(3) and (f)(1) of this section.

(D) To provide for the initial operation of the Foundation,

including providing for quarters, equipment, and staff.

(E) To appoint the initial members of the Board in accordance

with the requirements established in subsection (f)(2)(A) of

this section for the composition of the Board, and in

accordance with such other qualifications as the Committee may

determine to be appropriate regarding such composition. Of the

members so appointed -

(i) 2 shall be appointed to serve for a term of 3 years;

(ii) 2 shall be appointed to serve for a term of 4 years;

and

(iii) 3 shall be appointed to serve for a term of 5 years.

(3) Completion of functions of Committee; initial meeting of

Board

(A) The Committee shall complete the functions required in

paragraph (1) not later than September 30, 1994. The Committee

shall terminate upon the expiration of the 30-day period

beginning on the date on which the Secretary determines that the

functions have been completed.

(B) The initial meeting of the Board shall be held not later

than November 1, 1994.

(4) Composition

The Committee shall be composed of 5 members, each of whom

shall be a voting member. Of the members of the Committee -

(A) no fewer than 2 shall have broad, general experience in

public health; and

(B) no fewer than 2 shall have broad, general experience in

nonprofit private organizations (without regard to whether the

individuals have experience in public health).

(5) Chair

The Committee shall, from among the members of the Committee,

designate an individual to serve as the chair of the Committee.

(6) Terms; vacancies

The term of members of the Committee shall be for the duration

of the Committee. A vacancy in the membership of the Committee

shall not affect the power of the Committee to carry out the

duties of the Committee. If a member of the Committee does not

serve the full term, the individual appointed to fill the

resulting vacancy shall be appointed for the remainder of the

term of the predecessor of the individual.

(7) Compensation

Members of the Committee may not receive compensation for

service on the Committee. Members of the Committee may be

reimbursed for travel, subsistence, and other necessary expenses

incurred in carrying out the duties of the Committee.

(8) Committee support

The Director of the Centers for Disease Control and Prevention

may, from amounts available to the Director for the general

administration of such Centers, provide staff and financial

support to assist the Committee with carrying out the functions

described in paragraph (2). In providing such staff and support,

the Director may both detail employees and contract for

assistance.

(9) Grant for establishment of Committee

(A) With respect to a grant under paragraph (1)(A)(i) of

subsection (i) of this section for fiscal year 1993, an entity

described in this paragraph is a private nonprofit entity with

significant experience in domestic and international issues of

public health. Not later than 180 days after October 27, 1992,

the Secretary shall make the grant to such an entity (subject to

the availability of funds under paragraph (2) of such

subsection).

(B) The grant referred to in subparagraph (A) may be made to an

entity only if the entity agrees that -

(i) the entity will establish a committee that is composed in

accordance with paragraph (4); and

(ii) the entity will not select an individual for membership

on the Committee unless the individual agrees that the

Committee will operate in accordance with each of the

provisions of this subsection that relate to the operation of

the Committee.

(C) The Secretary may make a grant referred to in subparagraph

(A) only if the applicant for the grant makes an agreement that

the grant will not be expended for any purpose other than

carrying out subparagraph (B). Such a grant may be made only if

an application for the grant is submitted to the Secretary

containing such agreement, and the application is in such form,

is made in such manner, and contains such other agreements and

such assurances and information as the Secretary determines to be

necessary to carry out this paragraph.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399G, formerly Sec. 399F,

as added Pub. L. 102-531, title II, Sec. 201, Oct. 27, 1992, 106

Stat. 3474; renumbered Sec. 399G, Pub. L. 106-310, div. A, title V,

Sec. 502(3), Oct. 17, 2000, 114 Stat. 1115.)

-REFTEXT-

REFERENCES IN TEXT

The Ethics in Government Act, referred to in subsec. (h)(4)(A),

probably means the Ethics in Government Act of 1978, Pub. L.

95-521, Oct. 26, 1978, 92 Stat. 1824, as amended. For complete

classification of this Act to the Code, see Short Title note set

out under section 101 of Pub. L. 95-521 in the Appendix to Title 5,

Government Organization and Employees, and Tables.

The Technology Transfer Act, referred to in subsec. (h)(4)(A),

may mean the Federal Technology Transfer Act of 1986, Pub. L.

99-502, Oct. 20, 1986, 100 Stat. 1785, as amended, or the National

Competitiveness Technology Transfer Act of 1989, part C (Secs.

3131-3133) of title XXXI of div. C of Pub. L. 101-189, Nov. 29,

1989, 103 Stat. 1674. For complete classification of these Acts to

the Code, see Short Title of 1986 Amendment note and Short Title of

1989 Amendment note both set out under section 3701 of Title 15,

Commerce and Trade, and Tables.

-COD-

CODIFICATION

Section was formerly classified to section 280d-11 of this title

prior to renumbering by Pub. L. 106-310.

-MISC1-

PRIOR PROVISIONS

A prior section 399G of act July 1, 1944, was renumbered section

399H and is classified to section 280f of this title.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Part O - Fetal Alcohol Syndrome Prevention and

Services Program 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part O - Fetal Alcohol Syndrome Prevention and Services Program

-HEAD-

PART O - FETAL ALCOHOL SYNDROME PREVENTION AND SERVICES PROGRAM

-End-

-CITE-

42 USC Sec. 280f 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part O - Fetal Alcohol Syndrome Prevention and Services Program

-HEAD-

Sec. 280f. Establishment of Fetal Alcohol Syndrome prevention and

services program

-STATUTE-

(a) Fetal Alcohol Syndrome prevention, intervention and services

delivery program

The Secretary shall establish a comprehensive Fetal Alcohol

Syndrome and Fetal Alcohol Effect prevention, intervention and

services delivery program that shall include -

(1) an education and public awareness program to support,

conduct, and evaluate the effectiveness of -

(A) educational programs targeting medical schools, social

and other supportive services, educators and counselors and

other service providers in all phases of childhood development,

and other relevant service providers, concerning the

prevention, identification, and provision of services for

children, adolescents and adults with Fetal Alcohol Syndrome

and Fetal Alcohol Effect;

(B) strategies to educate school-age children, including

pregnant and high risk youth, concerning Fetal Alcohol Syndrome

and Fetal Alcohol Effect;

(C) public and community awareness programs concerning Fetal

Alcohol Syndrome and Fetal Alcohol Effect; and

(D) strategies to coordinate information and services across

affected community agencies, including agencies providing

social services such as foster care, adoption, and social work,

medical and mental health services, and agencies involved in

education, vocational training and civil and criminal justice;

(2) a prevention and diagnosis program to support clinical

studies, demonstrations and other research as appropriate to -

(A) develop appropriate medical diagnostic methods for

identifying Fetal Alcohol Syndrome and Fetal Alcohol Effect;

and

(B) develop effective prevention services and interventions

for pregnant, alcohol-dependent women; and

(3) an applied research program concerning intervention and

prevention to support and conduct service demonstration projects,

clinical studies and other research models providing advocacy,

educational and vocational training, counseling, medical and

mental health, and other supportive services, as well as models

that integrate and coordinate such services, that are aimed at

the unique challenges facing individuals with Fetal Alcohol

Syndrome or Fetal Alcohol Effect and their families.

(b) Grants and technical assistance

The Secretary may award grants, cooperative agreements and

contracts and provide technical assistance to eligible entities

described in section 280f-1 of this title to carry out subsection

(a) of this section.

(c) Dissemination of criteria

In carrying out this section, the Secretary shall develop a

procedure for disseminating the Fetal Alcohol Syndrome and Fetal

Alcohol Effect diagnostic criteria developed pursuant to section

705 of the ADAMHA Reorganization Act to health care providers,

educators, social workers, child welfare workers, and other

individuals.

(d) National Task Force

(1) In general

The Secretary shall establish a task force to be known as the

National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol

Effect (referred to in this subsection as the "Task Force") to

foster coordination among all governmental agencies, academic

bodies and community groups that conduct or support Fetal Alcohol

Syndrome and Fetal Alcohol Effect research, programs, and

surveillance, and otherwise meet the general needs of populations

actually or potentially impacted by Fetal Alcohol Syndrome and

Fetal Alcohol Effect.

(2) Membership

The Task Force established pursuant to paragraph (1) shall -

(A) be chaired by an individual to be appointed by the

Secretary and staffed by the Administration; and

(B) include the Chairperson of the Interagency Coordinating

Committee on Fetal Alcohol Syndrome of the Department of Health

and Human Services, individuals with Fetal Alcohol Syndrome and

Fetal Alcohol Effect, and representatives from advocacy and

research organizations such as the Research Society on

Alcoholism, the FAS Family Resource Institute, the National

Organization of Fetal Alcohol Syndrome, the Arc, the academic

community, and Federal, State and local government agencies and

offices.

(3) Functions

The Task Force shall -

(A) advise Federal, State and local programs and research

concerning Fetal Alcohol Syndrome and Fetal Alcohol Effect,

including programs and research concerning education and public

awareness for relevant service providers, school-age children,

women at-risk, and the general public, medical diagnosis,

interventions for women at-risk of giving birth to children

with Fetal Alcohol Syndrome and Fetal Alcohol Effect, and

beneficial services for individuals with Fetal Alcohol Syndrome

and Fetal Alcohol Effect and their families;

(B) coordinate its efforts with the Interagency Coordinating

Committee on Fetal Alcohol Syndrome of the Department of Health

and Human Services; and

(C) report on a biennial basis to the Secretary and relevant

committees of Congress on the current and planned activities of

the participating agencies.

(4) Time for appointment

The members of the Task Force shall be appointed by the

Secretary not later than 6 months after November 13, 1998.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399H, formerly Sec. 399G,

as added Pub. L. 105-392, title IV, Sec. 419(d), Nov. 13, 1998, 112

Stat. 3593; renumbered Sec. 399H and amended Pub. L. 106-310, div.

A, title V, Sec. 502(4)(A), (B), Oct. 17, 2000, 114 Stat. 1115.)

-REFTEXT-

REFERENCES IN TEXT

Section 705 of the ADAMHA Reorganization Act, referred to in

subsec. (c), is section 705 of Pub. L. 102-321, title VII, July 10,

1992, 106 Stat. 438, which was formerly set out as a note under

section 285n of this title.

-MISC1-

PRIOR PROVISIONS

A prior section 399H of act July 1, 1944, was renumbered section

399B and is classified to section 280e of this title.

Another prior section 399H of act July 1, 1944, was renumbered

section 399I and is classified to section 280f-1 of this title.

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310, Sec. 502(4)(B), made

technical amendment to reference in original act which appears in

text as reference to section 280f-1 of this title.

CONGRESSIONAL FINDINGS AND PURPOSE

Pub. L. 105-392, title IV, Sec. 419(b), (c), Nov. 13, 1998, 112

Stat. 3591, 3592, provided that:

"(b) Findings. - Congress finds that -

"(1) Fetal Alcohol Syndrome is the leading preventable cause of

mental retardation, and it is 100 percent preventable;

"(2) estimates on the number of children each year vary, but

according to some researchers, up to 12,000 infants are born in

the United States with Fetal Alcohol Syndrome, suffering

irreversible physical and mental damage;

"(3) thousands more infants are born each year with Fetal

Alcohol Effect, also known as Alcohol Related Neurobehavioral

Disorder (ARND), a related and equally tragic syndrome;

"(4) children of women who use alcohol while pregnant have a

significantly higher infant mortality rate (13.3 per 1,000) than

children of those women who do not use alcohol (8.6 per 1,000);

"(5) Fetal Alcohol Syndrome and Fetal Alcohol Effect are

national problems which can impact any child, family, or

community, but their threat to American Indians and Alaska

Natives is especially alarming;

"(6) in some American Indian communities, where alcohol

dependency rates reach 50 percent and above, the chances of a

newborn suffering Fetal Alcohol Syndrome or Fetal Alcohol Effect

are up to 30 times greater than national averages;

"(7) in addition to the immeasurable toll on children and their

families, Fetal Alcohol Syndrome and Fetal Alcohol Effect pose

extraordinary financial costs to the Nation, including the costs

of health care, education, foster care, job training, and general

support services for affected individuals;

"(8) the total cost to the economy of Fetal Alcohol Syndrome

was approximately $2,500,000,000 in 1995, and over a lifetime,

health care costs for one Fetal Alcohol Syndrome child are

estimated to be at least $1,400,000;

"(9) researchers have determined that the possibility of giving

birth to a baby with Fetal Alcohol Syndrome or Fetal Alcohol

Effect increases in proportion to the amount and frequency of

alcohol consumed by a pregnant woman, and that stopping alcohol

consumption at any point in the pregnancy reduces the emotional,

physical, and mental consequences of alcohol exposure to the

baby; and

"(10) though approximately 1 out of every 5 pregnant women

drink alcohol during their pregnancy, we know of no safe dose of

alcohol during pregnancy, or of any safe time to drink during

pregnancy, thus, it is in the best interest of the Nation for the

Federal Government to take an active role in encouraging all

women to abstain from alcohol consumption during pregnancy.

"(c) Purpose. - It is the purpose of this section [enacting this

part and provisions set out as a note under section 201 of this

title] to establish, within the Department of Health and Human

Services, a comprehensive program to help prevent Fetal Alcohol

Syndrome and Fetal Alcohol Effect nationwide and to provide

effective intervention programs and services for children,

adolescents and adults already affected by these conditions. Such

program shall -

"(1) coordinate, support, and conduct national, State, and

community-based public awareness, prevention, and education

programs on Fetal Alcohol Syndrome and Fetal Alcohol Effect;

"(2) coordinate, support, and conduct prevention and

intervention studies as well as epidemiologic research concerning

Fetal Alcohol Syndrome and Fetal Alcohol Effect;

"(3) coordinate, support and conduct research and demonstration

projects to develop effective developmental and behavioral

interventions and programs that foster effective advocacy,

educational and vocational training, appropriate therapies,

counseling, medical and mental health, and other supportive

services, as well as models that integrate or coordinate such

services, aimed at the unique challenges facing individuals with

Fetal Alcohol Syndrome or Fetal Alcohol Effect and their

families; and

"(4) foster coordination among all Federal, State and local

agencies, and promote partnerships between research institutions

and communities that conduct or support Fetal Alcohol Syndrome

and Fetal Alcohol Effect research, programs, surveillance,

prevention, and interventions and otherwise meet the general

needs of populations already affected or at risk of being

impacted by Fetal Alcohol Syndrome and Fetal Alcohol Effect."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 280f-2, 280f-3 of this

title.

-End-

-CITE-

42 USC Sec. 280f-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part O - Fetal Alcohol Syndrome Prevention and Services Program

-HEAD-

Sec. 280f-1. Eligibility

-STATUTE-

To be eligible to receive a grant, or enter into a cooperative

agreement or contract under this part, an entity shall -

(1) be a State, Indian tribal government, local government,

scientific or academic institution, or nonprofit organization;

and

(2) prepare and submit to the Secretary an application at such

time, in such manner, and containing such information as the

Secretary may prescribe, including a description of the

activities that the entity intends to carry out using amounts

received under this part.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399I, formerly Sec. 399H,

as added Pub. L. 105-392, title IV, Sec. 419(d), Nov. 13, 1998, 112

Stat. 3594; renumbered Sec. 399I, Pub. L. 106-310, div. A, title V,

Sec. 502(4)(A), Oct. 17, 2000, 114 Stat. 1115.)

-MISC1-

PRIOR PROVISIONS

A prior section 399I of act July 1, 1944, was renumbered section

399C and is classified to section 280e-1 of this title.

Another prior section 399I of act July 1, 1944, was renumbered

section 399J and is classified to section 280f-2 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 280f of this title.

-End-

-CITE-

42 USC Sec. 280f-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part O - Fetal Alcohol Syndrome Prevention and Services Program

-HEAD-

Sec. 280f-2. Authorization of appropriations

-STATUTE-

(a) In general

There are authorized to be appropriated to carry out this part,

$27,000,000 for each of the fiscal years 1999 through 2003.

(b) Task Force

From amounts appropriated for a fiscal year under subsection (a)

of this section, the Secretary may use not to exceed $2,000,000 of

such amounts for the operations of the National Task Force under

section 280f(d) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399J, formerly Sec. 399I,

as added Pub. L. 105-392, title IV, Sec. 419(d), Nov. 13, 1998, 112

Stat. 3595; renumbered Sec. 399J and amended Pub. L. 106-310, div.

A, title V, Sec. 502(4)(A), (C), Oct. 17, 2000, 114 Stat. 1115.)

-MISC1-

PRIOR PROVISIONS

A prior section 399J of act July 1, 1944, was renumbered section

399D and is classified to section 280e-2 of this title.

Another prior section 399J of act July 1, 1944, was renumbered

section 399K and is classified to section 280f-3 of this title.

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310, Sec. 502(4)(C), made

technical amendment to reference in original act which appears in

text as reference to section 280f(d) of this title.

-End-

-CITE-

42 USC Sec. 280f-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part O - Fetal Alcohol Syndrome Prevention and Services Program

-HEAD-

Sec. 280f-3. Sunset provision

-STATUTE-

This part shall not apply on the date that is 7 years after the

date on which all members of the National Task Force have been

appointed under section 280f(d)(1) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399K, formerly Sec. 399J,

as added Pub. L. 105-392, title IV, Sec. 419(d), Nov. 13, 1998, 112

Stat. 3595; renumbered Sec. 399K and amended Pub. L. 106-310, div.

A, title V, Sec. 502(4)(A), (D), Oct. 17, 2000, 114 Stat. 1115.)

-MISC1-

PRIOR PROVISIONS

A prior section 399K of act July 1, 1944, was renumbered section

399E and is classified to section 280e-3 of this title.

AMENDMENTS

2000 - Pub. L. 106-310, Sec. 502(4)(D), made technical amendment

to reference in original act which appears in text as reference to

section 280f(d)(1) of this title.

-End-

-CITE-

42 USC Part P - Additional Programs 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part P - Additional Programs

-HEAD-

PART P - ADDITIONAL PROGRAMS

-End-

-CITE-

42 USC Sec. 280g 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part P - Additional Programs

-HEAD-

Sec. 280g. Children's asthma treatment grants program

-STATUTE-

(a) Authority to make grants

(1) In general

In addition to any other payments made under this chapter or

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

Secretary shall award grants to eligible entities to carry out

the following purposes:

(A) To provide access to quality medical care for children

who live in areas that have a high prevalence of asthma and who

lack access to medical care.

(B) To provide on-site education to parents, children, health

care providers, and medical teams to recognize the signs and

symptoms of asthma, and to train them in the use of medications

to treat asthma and prevent its exacerbations.

(C) To decrease preventable trips to the emergency room by

making medication available to individuals who have not

previously had access to treatment or education in the

management of asthma.

(D) To provide other services, such as smoking cessation

programs, home modification, and other direct and support

services that ameliorate conditions that exacerbate or induce

asthma.

(2) (!1) Certain projects

In making grants under paragraph (1), the Secretary may make

grants designed to develop and expand the following projects:

(A) Projects to provide comprehensive asthma services to

children in accordance with the guidelines of the National

Asthma Education and Prevention Program (through the National

Heart, Lung and Blood Institute), including access to care and

treatment for asthma in a community-based setting.

(B) Projects to fully equip mobile health care clinics that

provide preventive asthma care including diagnosis, physical

examinations, pharmacological therapy, skin testing, peak flow

meter testing, and other asthma-related health care services.

(C) Projects to conduct validated asthma management education

programs for patients with asthma and their families, including

patient education regarding asthma management, family education

on asthma management, and the distribution of materials,

including displays and videos, to reinforce concepts presented

by medical teams.

(2) (!1) Award of grants

(A) Application

(i) In general

An eligible entity shall submit an application to the

Secretary for a grant under this section in such form and

manner as the Secretary may require.

(ii) Required information

An application submitted under this subparagraph shall

include a plan for the use of funds awarded under the grant

and such other information as the Secretary may require.

(B) Requirement

In awarding grants under this section, the Secretary shall

give preference to eligible entities that demonstrate that the

activities to be carried out under this section shall be in

localities within areas of known or suspected high prevalence

of childhood asthma or high asthma-related mortality or high

rate of hospitalization or emergency room visits for asthma

(relative to the average asthma prevalence rates and associated

mortality rates in the United States). Acceptable data sets to

demonstrate a high prevalence of childhood asthma or high

asthma-related mortality may include data from Federal, State,

or local vital statistics, claims data under title XIX or XXI

of the Social Security Act [42 U.S.C. 1396 et seq., 1397aa et

seq.], other public health statistics or surveys, or other data

that the Secretary, in consultation with the Director of the

Centers for Disease Control and Prevention, deems appropriate.

(3) Definition of eligible entity

For purposes of this section, the term "eligible entity" means

a public or nonprofit private entity (including a State or

political subdivision of a State), or a consortium of any of such

entities.

(b) Coordination with other children's programs

An eligible entity shall identify in the plan submitted as part

of an application for a grant under this section how the entity

will coordinate operations and activities under the grant with -

(1) other programs operated in the State that serve children

with asthma, including any such programs operated under title V,

XIX, or XXI of the Social Security Act [42 U.S.C. 701 et seq.,

1396 et seq., 1397aa et seq.]; and

(2) one or more of the following -

(A) the child welfare and foster care and adoption assistance

programs under parts B and E of title IV of such Act [42 U.S.C.

620 et seq., 670 et seq.];

(B) the head start program established under the Head Start

Act (42 U.S.C. 9831 et seq.);

(C) the program of assistance under the special supplemental

nutrition program for women, infants and children (WIC) under

section 1786 of this title;

(D) local public and private elementary or secondary schools;

or

(E) public housing agencies, as defined in section 1437a of

this title.

(c) Evaluation

An eligible entity that receives a grant under this section shall

submit to the Secretary an evaluation of the operations and

activities carried out under the grant that includes -

(1) a description of the health status outcomes of children

assisted under the grant;

(2) an assessment of the utilization of asthma-related health

care services as a result of activities carried out under the

grant;

(3) the collection, analysis, and reporting of asthma data

according to guidelines prescribed by the Director of the Centers

for Disease Control and Prevention; and

(4) such other information as the Secretary may require.

(d) 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 2001 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399L, as added Pub. L.

106-310, div. A, title V, Sec. 501, Oct. 17, 2000, 114 Stat. 1113.)

-REFTEXT-

REFERENCES IN TEXT

The Social Security Act, referred to in subsecs. (a)(1), (2)(B)

and (b)(1), (2)(A), is act Aug. 14, 1935, ch. 531, 49 Stat. 620, as

amended. Parts B and E of title IV of the Act are classified

generally to parts B (Sec. 620 et seq.) and E (Sec. 670 et seq.),

respectively, of subchapter IV of chapter 7 of this title. Titles

V, XIX, and XXI of the Act are classified generally to subchapters

V (Sec. 701 et seq.), XIX (Sec. 1396 et seq.), and XXI (Sec. 1397aa

et seq.), respectively, of chapter 7 of this title. For complete

classification of this Act to the Code, see section 1305 of this

title and Tables.

The Head Start Act, referred to in subsec. (b)(2)(B), is

subchapter B (Secs. 635-657) of chapter 8 of subtitle A of title VI

of Pub. L. 97-35, Aug. 13, 1981, 95 Stat. 499, as amended, which is

classified generally to subchapter II (Sec. 9831 et seq.) of

chapter 105 of this title. For complete classification of this Act

to the Code, see Short Title note set out under section 9801 of

this title and Tables.

-MISC1-

PRIOR PROVISIONS

A prior section 399L of act July 1, 1944, was renumbered section

399F and is classified to section 280e-4 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 247b-10 of this title.

-FOOTNOTE-

(!1) So in original. Two pars. (2) have been enacted.

-End-

-CITE-

42 USC Sec. 280g-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part P - Additional Programs

-HEAD-

Sec. 280g-1. Early detection, diagnosis, and treatment regarding

hearing loss in infants

-STATUTE-

(a) Statewide newborn and infant hearing screening, evaluation and

intervention programs and systems

The Secretary, acting through the Administrator of the Health

Resources and Services Administration, shall make awards of grants

or cooperative agreements to develop statewide newborn and infant

hearing screening, evaluation and intervention programs and systems

for the following purposes:

(1) To develop and monitor the efficacy of state-wide newborn

and infant hearing screening, evaluation and intervention

programs and systems. Early intervention includes referral to

schools and agencies, including community, consumer, and

parent-based agencies and organizations and other programs

mandated by part C of the Individuals with Disabilities Education

Act [20 U.S.C. 1431 et seq.], which offer programs specifically

designed to meet the unique language and communication needs of

deaf and hard of hearing newborns, infants, toddlers, and

children.

(2) To collect data on statewide newborn and infant hearing

screening, evaluation and intervention programs and systems that

can be used for applied research, program evaluation and policy

development.

(b) Technical assistance, data management, and applied research

(1) Centers for Disease Control and Prevention

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, shall make awards of grants or

cooperative agreements to provide technical assistance to State

agencies to complement an intramural program and to conduct

applied research related to newborn and infant hearing screening,

evaluation and intervention programs and systems. The program

shall develop standardized procedures for data management and

program effectiveness and costs, such as -

(A) to ensure quality monitoring of newborn and infant

hearing loss screening, evaluation, and intervention programs

and systems;

(B) to provide technical assistance on data collection and

management;

(C) to study the costs and effectiveness of newborn and

infant hearing screening, evaluation and intervention programs

and systems conducted by State-based programs in order to

answer issues of importance to State and national policymakers;

(D) to identify the causes and risk factors for congenital

hearing loss;

(E) to study the effectiveness of newborn and infant hearing

screening, audiologic and medical evaluations and intervention

programs and systems by assessing the health, intellectual and

social developmental, cognitive, and language status of these

children at school age; and

(F) to promote the sharing of data regarding early hearing

loss with State-based birth defects and developmental

disabilities monitoring programs for the purpose of identifying

previously unknown causes of hearing loss.

(2) National Institutes of Health

The Director of the National Institutes of Health, acting

through the Director of the National Institute on Deafness and

Other Communication Disorders, shall for purposes of this

section, continue a program of research and development on the

efficacy of new screening techniques and technology, including

clinical studies of screening methods, studies on efficacy of

intervention, and related research.

(c) Coordination and collaboration

(1) In general

In carrying out programs under this section, the Administrator

of the Health Resources and Services Administration, the Director

of the Centers for Disease Control and Prevention, and the

Director of the National Institutes of Health shall collaborate

and consult with other Federal agencies; State and local

agencies, including those responsible for early intervention

services pursuant to title XIX of the Social Security Act [42

U.S.C. 1396 et seq.] (Medicaid Early and Periodic Screening,

Diagnosis and Treatment Program); title XXI of the Social

Security Act [42 U.S.C. 1397aa et seq.] (State Children's Health

Insurance Program); title V of the Social Security Act [42 U.S.C.

701 et seq.] (Maternal and Child Health Block Grant Program); and

part C of the Individuals with Disabilities Education Act [20

U.S.C. 1431 et seq.]; consumer groups of and that serve

individuals who are deaf and hard-of-hearing and their families;

appropriate national medical and other health and education

specialty organizations; persons who are deaf and hard-of-hearing

and their families; other qualified professional personnel who

are proficient in deaf or hard-of-hearing children's language and

who possess the specialized knowledge, skills, and attributes

needed to serve deaf and hard-of-hearing newborns, infants,

toddlers, children, and their families; third-party payers and

managed care organizations; and related commercial industries.

(2) Policy development

The Administrator of the Health Resources and Services

Administration, the Director of the Centers for Disease Control

and Prevention, and the Director of the National Institutes of

Health shall coordinate and collaborate on recommendations for

policy development at the Federal and State levels and with the

private sector, including consumer, medical and other health and

education professional-based organizations, with respect to

newborn and infant hearing screening, evaluation and intervention

programs and systems.

(3) State early detection, diagnosis, and intervention programs

and systems; data collection

The Administrator of the Health Resources and Services

Administration and the Director of the Centers for Disease

Control and Prevention shall coordinate and collaborate in

assisting States to establish newborn and infant hearing

screening, evaluation and intervention programs and systems under

subsection (a) of this section and to develop a data collection

system under subsection (b) of this section.

(d) Rule of construction; religious accommodation

Nothing in this section shall be construed to preempt or prohibit

any State law, including State laws which do not require the

screening for hearing loss of newborn infants or young children of

parents who object to the screening on the grounds that such

screening conflicts with the parents' religious beliefs.

(e) Definitions

For purposes of this section:

(1) The term "audiologic evaluation" refers to procedures to

assess the status of the auditory system; to establish the site

of the auditory disorder; the type and degree of hearing loss,

and the potential effects of hearing loss on communication; and

to identify appropriate treatment and referral options. Referral

options should include linkage to State coordinating agencies

under part C of the Individuals with Disabilities Education Act

[20 U.S.C. 1431 et seq.] or other appropriate agencies, medical

evaluation, hearing aid/sensory aid assessment, audiologic

rehabilitation treatment, national and local consumer, self-help,

parent, and education organizations, and other family-centered

services.

(2) The terms "audiologic rehabilitation" and "audiologic

intervention" refer to procedures, techniques, and technologies

to facilitate the receptive and expressive communication

abilities of a child with hearing loss.

(3) The term "early intervention" refers to providing

appropriate services for the child with hearing loss, including

nonmedical services, and ensuring that families of the child are

provided comprehensive, consumer-oriented information about the

full range of family support, training, information services,

communication options and are given the opportunity to consider

the full range of educational and program placements and options

for their child.

(4) The term "medical evaluation by a physician" refers to key

components including history, examination, and medical decision

making focused on symptomatic and related body systems for the

purpose of diagnosing the etiology of hearing loss and related

physical conditions, and for identifying appropriate treatment

and referral options.

(5) The term "medical intervention" refers to the process by

which a physician provides medical diagnosis and direction for

medical and/or surgical treatment options of hearing loss and/or

related medical disorder associated with hearing loss.

(6) The term "newborn and infant hearing screening" refers to

objective physiologic procedures to detect possible hearing loss

and to identify newborns and infants who, after rescreening,

require further audiologic and medical evaluations.

(f) Authorization of appropriations

(1) Statewide newborn and infant hearing screening, evaluation

and intervention programs and systems

For the purpose of carrying out subsection (a) of this section,

there are authorized to be appropriated to the Health Resources

and Services Administration such sums as may be necessary for

fiscal year 2002.

(2) Technical assistance, data management, and applied research;

Centers for Disease Control and Prevention

For the purpose of carrying out subsection (b)(1) of this

section, there are authorized to be appropriated to the Centers

for Disease Control and Prevention such sums as may be necessary

for fiscal year 2002.

(3) Technical assistance, data management, and applied research;

national institute on deafness and other communication

disorders

For the purpose of carrying out subsection (b)(2) of this

section, there are authorized to be appropriated to the National

Institute on Deafness and Other Communication Disorders such sums

as may be necessary for fiscal year 2002.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399M, as added Pub. L.

106-310, div. A, title VII, Sec. 702, Oct. 17, 2000, 114 Stat.

1121.)

-REFTEXT-

REFERENCES IN TEXT

The Individuals with Disabilities Education Act, referred to in

subsecs. (a)(1), (c)(1), and (e)(1), is title VI of Pub. L. 91-230,

Apr. 13, 1970, 84 Stat. 175, as amended. Part C of the Act is

classified generally to subchapter III (Sec. 1431 et seq.) of

chapter 33 of Title 20, Education. For complete classification of

this Act to the Code, see section 1400 of Title 20 and Tables.

The Social Security Act, referred to in subsec. (c)(1), is act

Aug. 14, 1935, ch. 531, 49 Stat. 620, as amended. Titles V, XIX,

and XXI of the Act are classified generally to subchapters V (Sec.

701 et seq.), XIX (Sec. 1396 et seq.), and XXI (Sec. 1397aa et

seq.), respectively, of chapter 7 of this title. For complete

classification of this Act to the Code, see section 1305 of this

title and Tables.

-MISC1-

PURPOSES

Pub. L. 106-310, div. A, title VII, Sec. 701, Oct. 17, 2000, 114

Stat. 1120, provided that: "The purposes of this title [enacting

this section] are to clarify the authority within the Public Health

Service Act [this chapter] to authorize statewide newborn and

infant hearing screening, evaluation and intervention programs and

systems, technical assistance, a national applied research program,

and interagency and private sector collaboration for policy

development, in order to assist the States in making progress

toward the following goals:

"(1) All babies born in hospitals in the United States and its

territories should have a hearing screening before leaving the

birthing facility. Babies born in other countries and residing in

the United States via immigration or adoption should have a

hearing screening as early as possible.

"(2) All babies who are not born in hospitals in the United

States and its territories should have a hearing screening within

the first 3 months of life.

"(3) Appropriate audiologic and medical evaluations should be

conducted by 3 months for all newborns and infants suspected of

having hearing loss to allow appropriate referral and provisions

for audiologic rehabilitation, medical and early intervention

before the age of 6 months.

"(4) All newborn and infant hearing screening programs and

systems should include a component for audiologic rehabilitation,

medical and early intervention options that ensures linkage to

any new and existing state-wide systems of intervention and

rehabilitative services for newborns and infants with hearing

loss.

"(5) Public policy in regard to newborn and infant hearing

screening and intervention should be based on applied research

and the recognition that newborns, infants, toddlers, and

children who are deaf or hard-of-hearing have unique language,

learning, and communication needs, and should be the result of

consultation with pertinent public and private sectors."

-End-

-CITE-

42 USC Sec. 280g-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part P - Additional Programs

-HEAD-

Sec. 280g-2. Childhood malignancies

-STATUTE-

(a) In general

The Secretary, acting as appropriate through the Director of the

Centers for Disease Control and Prevention and the Director of the

National Institutes of Health, shall study environmental and other

risk factors for childhood cancers (including skeletal

malignancies, leukemias, malignant tumors of the central nervous

system, lymphomas, soft tissue sarcomas, and other malignant

neoplasms) and carry out projects to improve outcomes among

children with childhood cancers and resultant secondary conditions,

including limb loss, anemia, rehabilitation, and palliative care.

Such projects shall be carried out by the Secretary directly and

through awards of grants or contracts.

(b) Certain activities

Activities under subsection (a) of this section include -

(1) the expansion of current demographic data collection and

population surveillance efforts to include childhood cancers

nationally;

(2) the development of a uniform reporting system under which

treating physicians, hospitals, clinics, and States report the

diagnosis of childhood cancers, including relevant associated

epidemiological data; and

(3) support for the National Limb Loss Information Center to

address, in part, the primary and secondary needs of persons who

experience childhood cancers in order to prevent or minimize the

disabling nature of these cancers.

(c) Coordination of activities

The Secretary shall assure that activities under this section are

coordinated as appropriate with other agencies of the Public Health

Service that carry out activities focused on childhood cancers and

limb loss.

(d) Definition

For purposes of this section, the term "childhood cancer" refers

to a spectrum of different malignancies that vary by histology,

site of disease, origin, race, sex, and age. The Secretary may for

purposes of this section revise the definition of such term to the

extent determined by the Secretary to be appropriate.

(e) 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 2001 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399N, as added Pub. L.

106-310, div. A, title XI, Sec. 1101, Oct. 17, 2000, 114 Stat.

1131.)

-End-

-CITE-

42 USC Part Q - Programs To Improve the Health of

Children 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part Q - Programs To Improve the Health of Children

-HEAD-

PART Q - PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN

-End-

-CITE-

42 USC Sec. 280h 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part Q - Programs To Improve the Health of Children

-HEAD-

Sec. 280h. Grants to promote childhood nutrition and physical

activity

-STATUTE-

(a) In general

The Secretary, acting though the Director of the Centers for

Disease Control and Prevention, shall award competitive grants to

States and political subdivisions of States for the development and

implementation of State and community-based intervention programs

to promote good nutrition and physical activity in children and

adolescents.

(b) Eligibility

To be eligible to receive a grant under this section a State or

political subdivision of a State shall prepare and submit to the

Secretary an application at such time, in such manner, and

containing such information as the Secretary may require, including

a plan that describes -

(1) how the applicant proposes to develop a comprehensive

program of school- and community-based approaches to encourage

and promote good nutrition and appropriate levels of physical

activity with respect to children or adolescents in local

communities;

(2) the manner in which the applicant shall coordinate with

appropriate State and local authorities, such as State and local

school departments, State departments of health, chronic disease

directors, State directors of programs under section 1786 of this

title, 5-a-day coordinators, governors councils for physical

activity and good nutrition, and State and local parks and

recreation departments; and

(3) the manner in which the applicant will evaluate the

effectiveness of the program carried out under this section.

(c) Use of funds

A State or political subdivision of a State shall use amount

received under a grant under this section to -

(1) develop, implement, disseminate, and evaluate school- and

community-based strategies in States to reduce inactivity and

improve dietary choices among children and adolescents;

(2) expand opportunities for physical activity programs in

school- and community-based settings; and

(3) develop, implement, and evaluate programs that promote good

eating habits and physical activity including opportunities for

children with cognitive and physical disabilities.

(d) Technical assistance

The Secretary may set-aside an amount not to exceed 10 percent of

the amount appropriated for a fiscal year under subsection (h) of

this section to permit the Director of the Centers for Disease

Control and Prevention to -

(1) provide States and political subdivisions of States with

technical support in the development and implementation of

programs under this section; and

(2) disseminate information about effective strategies and

interventions in preventing and treating obesity through the

promotion of good nutrition and physical activity.

(e) Limitation on administrative costs

Not to exceed 10 percent of the amount of a grant awarded to the

State or political subdivision under subsection (a) of this section

for a fiscal year may be used by the State or political subdivision

for administrative expenses.

(f) Term

A grant awarded under subsection (a) of this section shall be for

a term of 3 years.

(g) Definition

In this section, the term "children and adolescents" means

individuals who do not exceed 18 years of age.

(h) Authorization of appropriations

There are authorized to be appropriated to carry out this section

such sums as may be necessary for each of the fiscal years 2001

through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399W, as added Pub. L.

106-310, div. A, title XXIV, Sec. 2401, Oct. 17, 2000, 114 Stat.

1158.)

-End-

-CITE-

42 USC Sec. 280h-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part Q - Programs To Improve the Health of Children

-HEAD-

Sec. 280h-1. Applied research program

-STATUTE-

(a) In general

The Secretary, acting through the Centers for Disease Control and

Prevention and in consultation with the Director of the National

Institutes of Health, shall -

(1) conduct research to better understand the relationship

between physical activity, diet, and health and factors that

influence health-related behaviors;

(2) develop and evaluate strategies for the prevention and

treatment of obesity to be used in community-based interventions

and by health professionals;

(3) develop and evaluate strategies for the prevention and

treatment of eating disorders, such as anorexia and bulimia;

(4) conduct research to establish the prevalence, consequences,

and costs of childhood obesity and its effects in adulthood;

(5) identify behaviors and risk factors that contribute to

obesity;

(6) evaluate materials and programs to provide nutrition

education to parents and teachers of children in child care or

pre-school and the food service staff of such child care and

pre-school entities; and

(7) evaluate materials and programs that are designed to

educate and encourage physical activity in child care and

pre-school facilities.

(b) Authorization of appropriations

There are authorized to be appropriated to carry out this section

such sums as may be necessary for each of the fiscal years 2001

through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399X, as added Pub. L.

106-310, div. A, title XXIV, Sec. 2401, Oct. 17, 2000, 114 Stat.

1159.)

-End-

-CITE-

42 USC Sec. 280h-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part Q - Programs To Improve the Health of Children

-HEAD-

Sec. 280h-2. Education campaign

-STATUTE-

(a) In general

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, and in collaboration with national,

State, and local partners, physical activity organizations,

nutrition experts, and health professional organizations, shall

develop a national public campaign to promote and educate children

and their parents concerning -

(1) the health risks associated with obesity, inactivity, and

poor nutrition;

(2) ways in which to incorporate physical activity into daily

living; and

(3) the benefits of good nutrition and strategies to improve

eating habits.

(b) Authorization of appropriations

There are authorized to be appropriated to carry out this section

such sums as may be necessary for each of the fiscal years 2001

through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399Y, as added Pub. L.

106-310, div. A, title XXIV, Sec. 2401, Oct. 17, 2000, 114 Stat.

1160.)

-End-

-CITE-

42 USC Sec. 280h-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER II - GENERAL POWERS AND DUTIES

Part Q - Programs To Improve the Health of Children

-HEAD-

Sec. 280h-3. Health professional education and training

-STATUTE-

(a) In general

The Secretary, acting through the Director of the Centers for

Disease Control and Prevention, in collaboration with the

Administrator of the Health Resources and Services Administration

and the heads of other agencies, and in consultation with

appropriate health professional associations, shall develop and

carry out a program to educate and train health professionals in

effective strategies to -

(1) better identify and assess patients with obesity or an

eating disorder or patients at-risk of becoming obese or

developing an eating disorder;

(2) counsel, refer, or treat patients with obesity or an eating

disorder; and

(3) educate patients and their families about effective

strategies to improve dietary habits and establish appropriate

levels of physical activity.

(b) Authorization of appropriations

There are authorized to be appropriated to carry out this section

such sums as may be necessary for each of the fiscal years 2001

through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title III, Sec. 399Z, as added Pub. L.

106-310, div. A, title XXIV, Sec. 2401, Oct. 17, 2000, 114 Stat.

1160.)

-End-

-CITE-

42 USC SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

-HEAD-

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

-COD-

CODIFICATION

Title IV of the Public Health Service Act, comprising this

subchapter, was originally enacted by act July 1, 1944, ch. 373, 58

Stat. 707, at which time title IV related solely to the National

Cancer Institute. Because of the extensive amendments,

reorganization of the subject matter, and expansion of title IV by

the acts listed below, title IV is shown herein as having been

added by Pub. L. 99-158, without reference to intervening

amendments.

The provisions of title IV as originally enacted were

subsequently redesignated as part A of title IV and amended, and

parts B to I of title IV were added and amended by the following

acts: June 16, 1948, ch. 481, 62 Stat. 464; June 24, 1948, ch. 621,

62 Stat. 598; Aug. 15, 1950, ch. 714, 64 Stat. 443; Oct. 5, 1961,

Pub. L. 87-395, 75 Stat. 824; Oct. 17, 1962, Pub. L. 87-838, 76

Stat. 1072; Aug. 16, 1968, Pub. L. 90-489, 82 Stat. 771; Oct. 30,

1970, Pub. L. 91-515, 84 Stat. 1297; Dec. 23, 1971, Pub. L. 92-218,

85 Stat. 778; May 19, 1972, Pub. L. 92-305, 86 Stat. 162; Sept. 19,

1972, Pub. L. 92-423, 86 Stat. 679; Apr. 22, 1974, Pub. L. 93-270,

88 Stat. 90; May 14, 1974, Pub. L. 93-282, 88 Stat. 126; May 31,

1974, Pub. L. 93-296, 88 Stat. 184; July 12, 1974, Pub. L. 93-348,

88 Stat. 342; July 23, 1974, Pub. L. 93-352, 88 Stat. 358; July 23,

1974, Pub. L. 93-354, 88 Stat. 373; Jan. 4, 1975, Pub. L. 93-640,

88 Stat. 2217; July 29, 1975, Pub. L. 94-63, 89 Stat. 304; Nov. 28,

1975, Pub. L. 94-135, 89 Stat. 713; Apr. 21, 1976, Pub. L. 94-273,

90 Stat. 375; Apr. 22, 1976, Pub. L. 94-278, 90 Stat. 401; Oct. 19,

1976, Pub. L. 94-562, 90 Stat. 2645; Aug. 1, 1977, Pub. L. 95-83,

91 Stat. 383; Nov. 9, 1978, Pub. L. 95-622, 92 Stat. 3412; Nov. 9,

1978, Pub. L. 95-623, 92 Stat. 3443; July 10, 1979, Pub. L. 96-32,

93 Stat. 82; Oct. 7, 1980, Pub. L. 96-398, 94 Stat. 1564; Dec. 17,

1980, Pub. L. 96-538, 94 Stat. 3183; Aug. 13, 1981, Pub. L. 97-35,

95 Stat. 358; Apr. 26, 1984, Pub. L. 98-24, 97 Stat. 175.

Title IV was subsequently amended generally and completely

reorganized by Pub. L. 99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 822.

-SECREF-

SUBCHAPTER REFERRED TO IN OTHER SECTIONS

This subchapter is referred to in section 9660 of this title.

-End-

-CITE-

42 USC Part A - National Institutes of Health 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

PART A - NATIONAL INSTITUTES OF HEALTH

-End-

-CITE-

42 USC Sec. 281 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 281. Organization of National Institutes of Health

-STATUTE-

(a) Agency of Public Health Service

The National Institutes of Health is an agency of the Service.

(b) Agencies within

(1) The following national research institutes are agencies of

the National Institutes of Health:

(A) The National Cancer Institute.

(B) The National Heart, Lung, and Blood Institute.

(C) The National Institute of Diabetes and Digestive and Kidney

Diseases.

(D) The National Institute of Arthritis and Musculoskeletal and

Skin Diseases.

(E) The National Institute on Aging.

(F) The National Institute of Allergy and Infectious Diseases.

(G) The National Institute of Child Health and Human

Development.

(H) The National Institute of Dental and Craniofacial Research.

(I) The National Eye Institute.

(J) The National Institute of Neurological Disorders and

Stroke.

(K) The National Institute of General Medical Sciences.

(L) The National Institute of Environmental Health Sciences.

(M) The National Institute on Deafness and Other Communication

Disorders.

(N) The National Institute on Alcohol Abuse and Alcoholism.

(O) The National Institute on Drug Abuse.

(P) The National Institute of Mental Health.

(Q) The National Institute of Nursing Research.

(R) The National Institute of Biomedical Imaging and

Bioengineering.

(2) The following entities are agencies of the National

Institutes of Health:

(A) The National Library of Medicine.

(B) The National Center for Research Resources.

(C) The John E. Fogarty International Center for Advanced Study

in the Health Sciences.

(D) The National Center for Human Genome Research.

(E) The Office of Dietary Supplements.

(F) The National Center for Complementary and Alternative

Medicine.

(G) The National Center on Minority Health and Health

Disparities.

(c) Establishment of additional national research institutes;

reorganization or abolition of institutes

(1) The Secretary may establish in the National Institutes of

Health one or more additional national research institutes to

conduct and support research, training, health information, and

other programs with respect to any particular disease or groups of

diseases or any other aspect of human health if -

(A) the Secretary determines that an additional institute is

necessary to carry out such activities; and

(B) the additional institute is not established before the

expiration of 180 days after the Secretary has provided the

Committee on Energy and Commerce of the House of Representatives

and the Committee on Labor and Human Resources of the Senate

written notice of the determination made under subparagraph (A)

with respect to the institute.

(2) The Secretary may reorganize the functions of any national

research institute and may abolish any national research institute

if the Secretary determines that the institute is no longer

required. A reorganization or abolition may not take effect under

this paragraph before the expiration of 180 days after the

Secretary has provided the Committee on Energy and Commerce of the

House of Representatives and the Committee on Labor and Human

Resources of the Senate written notice of the reorganization or

abolition.

(d) "National research institute" defined

For purposes of this subchapter, the term "national research

institute" means a national research institute listed in subsection

(b) of this section or established under subsection (c) of this

section. A reference to the National Institutes of Health includes

its agencies.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 401, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 822; amended Pub. L.

100-553, Sec. 2(1), Oct. 28, 1988, 102 Stat. 2769; Pub. L. 100-607,

title I, Sec. 101(1), Nov. 4, 1988, 102 Stat. 3048; Pub. L.

100-690, title II, Sec. 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238;

Pub. L. 102-321, title I, Sec. 121(a), July 10, 1992, 106 Stat.

358; Pub. L. 103-43, title XV, Secs. 1501(1), 1511(b)(1), 1521(1),

June 10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103-417, Sec.

13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L. 105-277, div. A, Sec.

101(f) [title II, Sec. 212, title VI, Sec. 601(k)], Oct. 21, 1998,

112 Stat. 2681-337, 2681-359, 2681-388; Pub. L. 106-525, title I,

Sec. 101(b)(1), Nov. 22, 2000, 114 Stat. 2501; Pub. L. 106-580,

Sec. 3(e), Dec. 29, 2000, 114 Stat. 3091.)

-MISC1-

AMENDMENTS

2000 - Subsec. (b)(1)(R). Pub. L. 106-580 added subpar. (R).

Subsec. (b)(2)(F). Pub. L. 106-525, Sec. 101(b)(1)(A), realigned

margins.

Subsec. (b)(2)(G). Pub. L. 106-525, Sec. 101(b)(1)(B), added

subpar. (G).

1998 - Subsec. (b)(1)(H). Pub. L. 105-277, Sec. 101(f) [title II,

Sec. 212], substituted "National Institute of Dental and

Craniofacial Research" for "National Institute of Dental Research".

Subsec. (b)(2)(F). Pub. L. 105-277, Sec. 101(f) [title VI, Sec.

601(k)], added subpar. (F).

1994 - Subsec. (b)(2)(E). Pub. L. 103-417 added subpar. (E).

1993 - Subsec. (b)(1)(Q). Pub. L. 103-43, Sec. 1511(b)(1)(A),

added subpar. (Q).

Subsec. (b)(2)(B). Pub. L. 103-43, Sec. 1501(1), amended subpar.

(B) generally, substituting "National Center for Research

Resources" for "Division of Research Resources".

Subsec. (b)(2)(D). Pub. L. 103-43, Secs. 1511(b)(1)(B), 1521(1),

added subpar. (D) and struck out former subpar. (D) which read as

follows: "The National Center for Nursing Research."

1992 - Subsec. (b)(1)(N) to (P). Pub. L. 102-321 added subpars.

(N) to (P).

1988 - Subsec. (b)(1)(J), (M). Pub. L. 100-553 and Pub. L.

100-607 made identical amendments, striking out "and Communicative"

after "Neurological" in subpar. (J), and adding subpar. (M). Pub.

L. 100-690 amended subsec. (b)(1) to read as if the amendments by

Pub. L. 100-607 had not been enacted.

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

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

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

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

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

Congress, Jan. 3, 2001.

-MISC2-

EFFECTIVE DATE OF 2000 AMENDMENT

Pub. L. 106-525, title VI, Sec. 603, Nov. 22, 2000, 114 Stat.

2511, provided that: "This Act [enacting subpart 6 (Sec. 287c-31 et

seq.) of part E of this subchapter and sections 293e, 296e-1, and

299a-1 of this title, amending sections 281, 296f, 299a, 299c-6,

and 300u-6 of this title, repealing section 283b of this title, and

enacting provisions set out as notes under sections 201, 287c-31,

293e, and 3501 of this title] and the amendments made by this Act

take effect October 1, 2000, or upon the date of the enactment of

this Act [Nov. 22, 2000], whichever occurs later."

EFFECTIVE DATE OF 1992 AMENDMENT

Amendment by Pub. L. 102-321 effective Oct. 1, 1992, with

provision for programs providing financial assistance, see section

801(c), (d) of Pub. L. 102-321, set out as a note under section 236

of this title.

EFFECTIVE DATE OF 1988 AMENDMENT

For effective date of amendment by Pub. L. 100-690, see section

2613(b)(1) of Pub. L. 100-690, set out as an Effect of Enactment of

Similar Provisions note under section 285m of this title.

STUDY OF THE USE OF CENTERS OF EXCELLENCE AT THE NATIONAL

INSTITUTES OF HEALTH

Pub. L. 107-84, Sec. 7, Dec. 18, 2001, 115 Stat. 829, required

the Secretary of Health and Human Services to contract, not later

than 60 days after Dec. 18, 2001, with the Institute of Medicine to

conduct a study on the impact of, need for, and other issues

associated with Centers of Excellence at the National Institutes of

Health and complete the study and submit a report not later than

one year after the date of the contract.

REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN DEVELOPMENT OF

DEFENSES AGAINST BIOLOGICAL WARFARE

Section 1904 of Pub. L. 103-43 directed Secretary of Health and

Human Services, in consultation with Secretary of Defense and with

heads of other appropriate executive agencies, to report to

Congress, not later than 12 months after June 10, 1993, on the

appropriateness and impact of the National Institutes of Health

assuming responsibility for the conduct of all Federal research,

development, testing, and evaluation functions relating to medical

countermeasures against biowarfare threat agents.

RESEARCH ON LUPUS ERYTHEMATOSUS

Section 5 of Pub. L. 99-158, as amended by Pub. L. 102-531, title

III, Sec. 312(f), Oct. 27, 1992, 106 Stat. 3506, directed Secretary

of Health and Human Resources to establish a Lupus Erythematosus

Coordinating Committee to plan, develop, coordinate, and implement

comprehensive Federal initiatives in research on Lupus

Erythematosus, provided for composition of committee and meetings,

and directed Committee to prepare a report for Congress on its

activities, to be submitted not later than 18 months after Nov. 20,

1985, with Committee to terminate one month after the report was

submitted.

INTERAGENCY COMMITTEE ON LEARNING DISABILITIES

Section 9 of Pub. L. 99-158 directed Director of the National

Institutes of Health, not later than 90 days after Nov. 20, 1985,

to establish an Interagency Committee on Learning Disabilities to

review and assess Federal research priorities, activities, and

findings regarding learning disabilities (including central nervous

system dysfunction in children), provided for composition of the

Committee, directed Committee to report to Congress on its

activities not later than 18 months after Nov. 20, 1985, and

provided that the Committee terminate 90 days after submission of

the report.

-End-

-CITE-

42 USC Sec. 282 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 282. Director of National Institutes of Health

-STATUTE-

(a) Appointment

The National Institutes of Health shall be headed by the Director

of the National Institutes of Health (hereafter in this subchapter

referred to as the "Director of NIH") who shall be appointed by the

President by and with the advice and consent of the Senate. The

Director of NIH shall perform functions as provided under

subsection (b) of this section and as the Secretary may otherwise

prescribe.

(b) Duties and authority

In carrying out the purposes of section 241 of this title, the

Secretary, acting through the Director of NIH -

(1) shall be responsible for the overall direction of the

National Institutes of Health and for the establishment and

implementation of general policies respecting the management and

operation of programs and activities within the National

Institutes of Health;

(2) shall coordinate and oversee the operation of the national

research institutes and administrative entities within the

National Institutes of Health;

(3) shall assure that research at or supported by the National

Institutes of Health is subject to review in accordance with

section 289a of this title;

(4) for the national research institutes and administrative

entities within the National Institutes of Health -

(A) may acquire, construct, improve, repair, operate, and

maintain, at the site of such institutes and entities,

laboratories, and other research facilities, other facilities,

equipment, and other real or personal property, and

(B) may acquire, without regard to section 8141 of title 40,

by lease or otherwise through the Administrator of General

Services, buildings or parts of buildings in the District of

Columbia or communities located adjacent to the District of

Columbia for use for a period not to exceed ten years;

(5) may secure resources for research conducted by or through

the National Institutes of Health;

(6) may, without regard to the provisions of title 5 governing

appointments in the competitive service, and without regard to

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

such title relating to classification and General Schedule pay

rates, establish such technical and scientific peer review groups

and scientific program advisory committees as are needed to carry

out the requirements of this subchapter and appoint and pay the

members of such groups, except that officers and employees of the

United States shall not receive additional compensation for

service as members of such groups;

(7) may secure for the National Institutes of Health

consultation services and advice of persons from the United

States or abroad;

(8) may use, with their consent, the services, equipment,

personnel, information, and facilities of other Federal, State,

or local public agencies, with or without reimbursement therefor;

(9) may, for purposes of study, admit and treat at facilities

of the National Institutes of Health individuals not otherwise

eligible for such treatment;

(10) may accept voluntary and uncompensated services;

(11) may perform such other administrative functions as the

Secretary determines are needed to effectively carry out this

subchapter;

(12) after consultation with the Director of the Office of

Research on Women's Health, shall ensure that resources of the

National Institutes of Health are sufficiently allocated for

projects of research on women's health that are identified under

section 287d(b) of this title;

(13) may conduct and support research training -

(A) for which fellowship support is not provided under

section 288 of this title; and

(B) which does not consist of residency training of

physicians or other health professionals; and

(14) may appoint physicians, dentists, and other health care

professionals, subject to the provisions of title 5 relating to

appointments and classifications in the competitive service, and

may compensate such professionals subject to the provisions of

chapter 74 of title 38.

The Federal Advisory Committee Act shall not apply to the duration

of a peer review group appointed under paragraph (6). The members

of such a group shall be individuals who by virtue of their

training or experience are eminently qualified to perform the

review functions of such group. Not more than one-fourth of the

members of any such group shall be officers or employees of the

United States.

(c) Availability of substances and organisms for research

The Director of NIH may make available to individuals and

entities, for biomedical and behavioral research, substances and

living organisms. Such substances and organisms shall be made

available under such terms and conditions (including payment for

them) as the Secretary determines appropriate.

(d) Services of experts or consultants; number; payment of

expenses, conditions, recovery

(1) The Director of NIH may obtain (in accordance with section

3109 of title 5, but without regard to the limitation in such

section on the period of service) the services of not more than 220

experts or consultants, with scientific or other professional

qualifications, for the National Institutes of Health.

(2)(A) Except as provided in subparagraph (B), experts and

consultants whose services are obtained under paragraph (1) shall

be paid or reimbursed, in accordance with title 5, for their travel

to and from their place of service and for other expenses

associated with their assignment.

(B) Expenses specified in subparagraph (A) shall not be allowed

in connection with the assignment of an expert or consultant whose

services are obtained under paragraph (1) unless the expert or

consultant has agreed in writing to complete the entire period of

the assignment or one year of the assignment, whichever is shorter,

unless separated or reassigned for reasons which are beyond the

control of the expert or consultant and which are acceptable to the

Secretary. If the expert or consultant violates the agreement, the

money spent by the United States for such expenses is recoverable

from the expert or consultant as a debt due the United States. The

Secretary may waive in whole or in part a right of recovery under

this subparagraph.

(e) Dissemination of research information

The Director of NIH shall -

(1) advise the agencies of the National Institutes of Health on

medical applications of research;

(2) coordinate, review, and facilitate the systematic

identification and evaluation of, clinically relevant information

from research conducted by or through the national research

institutes;

(3) promote the effective transfer of the information described

in paragraph (2) to the health care community and to entities

that require such information;

(4) monitor the effectiveness of the activities described in

paragraph (3); and

(5) ensure that, after January 1, 1994, all new or revised

health education and promotion materials developed or funded by

the National Institutes of Health and intended for the general

public are in a form that does not exceed a level of functional

literacy, as defined in the National Literacy Act of 1991 (Public

Law 102-73).

(f) Associate Director for Prevention; functions

There shall be in the National Institutes of Health an Associate

Director for Prevention. The Director of NIH shall delegate to the

Associate Director for Prevention the functions of the Director

relating to the promotion of the disease prevention research

programs of the national research institutes and the coordination

of such programs among the national research institutes and between

the national research institutes and other public and private

entities, including elementary, secondary, and post-secondary

schools. The Associate Director shall -

(1) annually review the efficacy of existing policies and

techniques used by the national research institutes to

disseminate the results of disease prevention and behavioral

research programs; and

(2) recommend, coordinate, and oversee the modification or

reconstruction of such policies and techniques to ensure maximum

dissemination, using advanced technologies to the maximum extent

practicable, of research results to such entities.

(g) Enhancing competitiveness of certain entities in obtaining

research funds

(1)(A) In the case of entities described in subparagraph (B), the

Director of NIH, acting through the Director of the National Center

for Research Resources, shall establish a program to enhance the

competitiveness of such entities in obtaining funds from the

national research institutes for conducting biomedical and

behavioral research.

(B) The entities referred to in subparagraph (A) are entities

that conduct biomedical and behavioral research and are located in

a State in which the aggregate success rate for applications to the

national research institutes for assistance for such research by

the entities in the State has historically constituted a low

success rate of obtaining such funds, relative to such aggregate

rate for such entities in other States.

(C) With respect to enhancing competitiveness for purposes of

subparagraph (A), the Director of NIH, in carrying out the program

established under such subparagraph, may -

(i) provide technical assistance to the entities involved,

including technical assistance in the preparation of applications

for obtaining funds from the national research institutes;

(ii) assist the entities in developing a plan for biomedical or

behavioral research proposals; and

(iii) assist the entities in implementing such plan.

(2) The Director of NIH shall establish a program of supporting

projects of biomedical or behavioral research whose principal

researchers are individuals who have not previously served as the

principal researchers of such projects supported by the Director.

(h) Increased participation of women and disadvantaged individuals

in biomedical and behavioral research

The Secretary, acting through the Director of NIH and the

Directors of the agencies of the National Institutes of Health,

shall, in conducting and supporting programs for research, research

training, recruitment, and other activities, provide for an

increase in the number of women and individuals from disadvantaged

backgrounds (including racial and ethnic minorities) in the fields

of biomedical and behavioral research.

(i) Discretionary fund; uses; report to Congressional committees;

authorization of appropriations

(1) There is established a fund, consisting of amounts

appropriated under paragraph (3) and made available for the fund,

for use by the Director of NIH to carry out the activities

authorized in this chapter for the National Institutes of Health.

The purposes for which such fund may be expended include -

(A) providing for research on matters that have not received

significant funding relative to other matters, responding to new

issues and scientific emergencies, and acting on research

opportunities of high priority;

(B) supporting research that is not exclusively within the

authority of any single agency of such Institutes; and

(C) purchasing or renting equipment and quarters for activities

of such Institutes.

(2) Not later than February 10 of each fiscal year, the Secretary

shall submit to the Committee on Energy and Commerce of the House

of Representatives, and to the Committee on Labor and Human

Resources of the Senate, a report describing the activities

undertaken and expenditures made under this section during the

preceding fiscal year. The report may contain such comments of the

Secretary regarding this section as the Secretary determines to be

appropriate.

(3) For the purpose of carrying out this subsection, there are

authorized to be appropriated $25,000,000 for fiscal year 1994, and

such sums as may be necessary for each of the fiscal years 1995 and

1996.

(j) Data bank of information on clinical trials for drugs for

serious or life-threatening diseases and conditions

(1)(A) The Secretary, acting through the Director of NIH, shall

establish, maintain, and operate a data bank of information on

clinical trials for drugs for serious or life-threatening diseases

and conditions (in this subsection referred to as the "data bank").

The activities of the data bank shall be integrated and coordinated

with related activities of other agencies of the Department of

Health and Human Services, and to the extent practicable,

coordinated with other data banks containing similar information.

(B) The Secretary shall establish the data bank after

consultation with the Commissioner of Food and Drugs, the directors

of the appropriate agencies of the National Institutes of Health

(including the National Library of Medicine), and the Director of

the Centers for Disease Control and Prevention.

(2) In carrying out paragraph (1), the Secretary shall collect,

catalog, store, and disseminate the information described in such

paragraph. The Secretary shall disseminate such information through

information systems, which shall include toll-free telephone

communications, available to individuals with serious or

life-threatening diseases and conditions, to other members of the

public, to health care providers, and to researchers.

(3) The data bank shall include the following:

(A) A registry of clinical trials (whether federally or

privately funded) of experimental treatments for serious or

life-threatening diseases and conditions under regulations

promulgated pursuant to section 355(i) of title 21, which

provides a description of the purpose of each experimental drug,

either with the consent of the protocol sponsor, or when a trial

to test effectiveness begins. Information provided shall consist

of eligibility criteria for participation in the clinical trials,

a description of the location of trial sites, a point of contact

for those wanting to enroll in the trial, and a description of

whether, and through what procedure, the manufacturer or sponsor

of the investigation of a new drug will respond to requests for

protocol exception, with appropriate safeguards, for

single-patient and expanded protocol use of the new drug,

particularly in children, and shall be in a form that can be

readily understood by members of the public. Such information

shall be forwarded to the data bank by the sponsor of the trial

not later than 21 days after the approval of the protocol.

(B) Information pertaining to experimental treatments for

serious or life-threatening diseases and conditions that may be

available -

(i) under a treatment investigational new drug application

that has been submitted to the Secretary under section

360bbb(c) of title 21; or

(ii) as a Group C cancer drug (as defined by the National

Cancer Institute).

The data bank may also include information pertaining to the

results of clinical trials of such treatments, with the consent

of the sponsor, including information concerning potential

toxicities or adverse effects associated with the use or

administration of such experimental treatments.

(4) The data bank shall not include information relating to an

investigation if the sponsor has provided a detailed certification

to the Secretary that disclosure of such information would

substantially interfere with the timely enrollment of subjects in

the investigation, unless the Secretary, after the receipt of the

certification, provides the sponsor with a detailed written

determination that such disclosure would not substantially

interfere with such enrollment.

(5) For the purpose of carrying out this subsection, there are

authorized to be appropriated such sums as may be necessary. Fees

collected under section 379h of title 21 shall not be used in

carrying out this subsection.

(k) Day care for children of employees

(1) The Director of NIH may establish a program to provide day

care services for the employees of the National Institutes of

Health similar to those services provided by other Federal agencies

(including the availability of day care service on a 24-hour-a-day

basis).

(2) Any day care provider at the National Institutes of Health

shall establish a sliding scale of fees that takes into

consideration the income and needs of the employee.

(3) For purposes regarding the provision of day care services,

the Director of NIH may enter into rental or lease purchase

agreements.

(l) Interagency research on trauma

The Director of NIH shall carry out the program established in

part F of subchapter X of this chapter (relating to interagency

research on trauma).

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 402, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L.

100-607, title I, Sec. 111, Nov. 4, 1988, 102 Stat. 3052; Pub. L.

102-321, title I, Sec. 163(b)(3), July 10, 1992, 106 Stat. 376;

Pub. L. 103-43, title I, Sec. 141(b), title II, Secs. 201, 202,

206, 208, 210(b), (c), title III, Sec. 303(b), June 10, 1993, 107

Stat. 139, 144, 148-150, 153; Pub. L. 105-115, title I, Sec.

113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 105-362, title VI,

Sec. 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; Pub. L. 105-392,

title IV, Sec. 409, Nov. 13, 1998, 112 Stat. 3589; Pub. L. 107-109,

Sec. 15(c)(2), Jan. 4, 2002, 115 Stat. 1420.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 governing appointments in the

competitive service, referred to in subsec. (b)(6), (14), are

classified generally to section 3301 et seq. of Title 5, Government

Organization and Employees.

The General Schedule, referred to in subsec. (b)(6), is set out

under section 5332 of Title 5, Government Organization and

Employees.

The provisions of title 5 relating to classifications, referred

to in subsec. (b)(14), are classified generally to chapter 51 (Sec.

5101 et seq.) and to subchapter III (Sec. 5331 et seq.) of chapter

53 of Title 5, Government Organization and Employees.

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

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

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

Employees.

The provisions of title 5 relating to reimbursement for travel

expenses, referred to in subsec. (d)(2)(A), are classified

generally to section 5701 et seq. of Title 5, Government

Organization and Employees.

The National Literacy Act of 1991, referred to in subsec. (e)(5),

is Pub. L. 102-73, July 25, 1991, 105 Stat. 333, as amended, which

was repealed by Pub. L. 105-220, title II, Sec. 251(a)(2), Aug. 7,

1998, 112 Stat. 1079. For complete classification of this Act to

the Code, see Tables.

-COD-

CODIFICATION

In subsec. (b)(4)(B),"section 8141 of title 40" substituted for

"the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L.

107-217, Sec. 5(c), Aug. 21, 2002, 116 Stat. 1303, the first

section of which enacted Title 40, Public Buildings, Property, and

Works.

-MISC1-

AMENDMENTS

2002 - Subsec. (j)(3)(A). Pub. L. 107-109, which directed the

amendment of the first sentence of subsec. (j)(3)(A) by

substituting "trial sites," for "trial sites, and" and "in the

trial, and a description of whether, and through what procedure,

the manufacturer or sponsor of the investigation of a new drug will

respond to requests for protocol exception, with appropriate

safeguards, for single-patient and expanded protocol use of the new

drug, particularly in children," for "in the trial,", was executed

by making the substitutions in the second sentence, to reflect the

probable intent of Congress.

1998 - Subsec. (b)(13), (14). Pub. L. 105-392 added pars. (13)

and (14).

Subsec. (f). Pub. L. 105-362 inserted "and" at end of par. (1),

substituted a period for "; and" at end of par. (2), and struck out

par. (3) which read as follows: "annually prepare and submit to the

Director of NIH a report concerning the prevention and

dissemination activities undertaken by the Associate Director,

including -

"(A) a summary of the Associate Director's review of existing

dissemination policies and techniques together with a detailed

statement concerning any modification or restructuring, or

recommendations for modification or restructuring, of such

policies and techniques; and

"(B) a detailed statement of the expenditures made for the

prevention and dissemination activities reported on and the

personnel used in connection with such activities."

1997 - Subsecs. (j) to (l). Pub. L. 105-115 added subsec. (j) and

redesignated former subsecs. (j) and (k) as (k) and (l),

respectively.

1993 - Subsec. (b)(12). Pub. L. 103-43, Sec. 141(b), added par.

(12).

Subsec. (e)(5). Pub. L. 103-43, Sec. 210(b), added par. (5).

Subsec. (f). Pub. L. 103-43, Sec. 201, substituted "other public

and private entities, including elementary, secondary, and

post-secondary schools. The Associate Director shall - " and pars.

(1) to (3) for "other public and private entities. The Associate

Director shall annually report to the Director of NIH on the

prevention activities undertaken by the Associate Director. The

report shall include a detailed statement of the expenditures made

for the activities reported on and the personnel used in connection

with such activities".

Subsec. (g). Pub. L. 103-43, Sec. 202, added subsec. (g).

Subsec. (h). Pub. L. 103-43, Sec. 206, added subsec. (h).

Subsec. (i). Pub. L. 103-43, Sec. 208, added subsec. (i).

Subsec. (j). Pub. L. 103-43, Sec. 210(c), added subsec. (j).

Subsec. (k). Pub. L. 103-43, Sec. 303(b), added subsec. (k).

1992 - Subsec. (d)(1). Pub. L. 102-321 substituted "220" for "two

hundred".

1988 - Subsec. (b)(6). Pub. L. 100-607 inserted "and scientific

program advisory committees" after "peer review groups".

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

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

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

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

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

Congress, Jan. 3, 2001.

-MISC2-

EFFECTIVE DATE OF 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 1992 AMENDMENT

Amendment by Pub. L. 102-321 effective Oct. 1, 1992, with

provision for programs providing financial assistance, see section

801(c), (d) of Pub. L. 102-321, set out as a note under section 236

of this title.

COLLABORATION AND REPORT

Section 113(b) of Pub. L. 105-115 provided that:

"(1) In general. - The Secretary of Health and Human Services,

the Director of the National Institutes of Health, and the

Commissioner of Food and Drugs shall collaborate to determine the

feasibility of including device investigations within the scope of

the data bank under section 402(j) of the Public Health Service Act

[subsec. (j) of this section].

"(2) Report. - Not later than two years after the date of

enactment of this section [Nov. 21, 1997], the Secretary of Health

and Human Services shall prepare and submit to the Committee on

Labor and Human Resources of the Senate and the Committee on

Commerce of the House of Representatives a report -

"(A) of the public health need, if any, for inclusion of device

investigations within the scope of the data bank under section

402(j) of the Public Health Service Act;

"(B) on the adverse impact, if any, on device innovation and

research in the United States if information relating to such

device investigations is required to be publicly disclosed; and

"(C) on such other issues relating to such section 402(j) as

the Secretary determines to be appropriate."

CHRONIC FATIGUE SYNDROME; EXPERTS AND RESEARCH REPRESENTATIVES ON

ADVISORY COMMITTEES AND BOARDS

Section 902(c) of Pub. L. 103-43 provided that: "The Secretary of

Health and Human Services, acting through the Director of the

National Institutes of Health, shall ensure that appropriate

individuals with expertise in chronic fatigue syndrome or

neuromuscular diseases and representative of a variety of

disciplines and fields within the research community are appointed

to appropriate National Institutes of Health advisory committees

and boards."

THIRD-PARTY PAYMENTS REGARDING CERTAIN CLINICAL TRIALS AND CERTAIN

LIFE-THREATENING ILLNESSES

Section 1901(a) of Pub. L. 103-43 provided that: "The Secretary

of Health and Human Services, acting through the Director of the

National Institutes of Health, shall conduct a study for the

purpose of -

"(1) determining the policies of third-party payors regarding

the payment of the costs of appropriate health services that are

provided incident to the participation of individuals as subjects

in clinical trials conducted in the development of drugs with

respect to acquired immune deficiency syndrome, cancer, and other

life-threatening illnesses; and

"(2) developing recommendations regarding such policies."

PERSONNEL STUDY OF RECRUITMENT, RETENTION AND TURNOVER

Section 1905 of Pub. L. 103-43 directed Secretary of Health and

Human Services, acting through Director of National Institutes of

Health, to conduct a study to review the retention, recruitment,

vacancy and turnover rates of support staff, including

firefighters, law enforcement, procurement officers, technicians,

nurses and clerical employees, to ensure that National Institutes

of Health is adequately supporting conduct of efficient, effective

and high quality research for the American public, and to submit a

report to Congress on results of such study not later than 1 year

after June 10, 1993.

CHRONIC PAIN CONDITIONS

Section 1907 of Pub. L. 103-43 directed Director of the National

Institutes of Health to submit to Congress, not later than 2 years

after June 10, 1993, a report and study on the incidence in the

United States of cases of chronic pain, including chronic pain

resulting from back injuries, reflex sympathetic dystrophy

syndrome, temporomandibular joint disorder, post-herpetic

neuropathy, painful diabetic neuropathy, phantom pain, and

post-stroke pain, and the effect of such cases on the costs of

health care in the United States.

SUPPORT FOR BIOENGINEERING RESEARCH

Section 1912 of Pub. L. 103-43 directed Secretary of Health and

Human Services, acting through Director of the National Institutes

of Health, to conduct a study for the purpose of determining the

sources and amounts of public and private funding devoted to basic

research in bioengineering, including biomaterials sciences,

cellular bioprocessing, tissue and rehabilitation engineering,

evaluating whether that commitment is sufficient to maintain the

innovative edge that the United States has in these technologies,

evaluating the role of the National Institutes of Health or any

other Federal agency to achieve a greater commitment to innovation

in bioengineering, and evaluating the need for better coordination

and collaboration among Federal agencies and between the public and

private sectors, and, not later than 1 year after June 10, 1993, to

prepare and submit to Committee on Labor and Human Resources of

Senate, and Committee on Energy and Commerce of House of

Representatives, a report containing the findings of the study

together with recommendations concerning the enactment of

legislation to implement the results of such study.

MASTER PLAN FOR PHYSICAL INFRASTRUCTURE FOR RESEARCH

Section 2002 of Pub. L. 103-43 directed Secretary of Health and

Human Services, acting through Director of the National Institutes

of Health, not later than June 1, 1994, to present to Congress a

master plan to provide for replacement or refurbishment of less

than adequate buildings, utility equipment and distribution systems

(including the resources that provide electrical and other

utilities, chilled water, air handling, and other services that the

Secretary, acting through the Director, deemed necessary), roads,

walkways, parking areas, and grounds that underpin the laboratory

and clinical facilities of the National Institutes of Health, and

provided that the plan could make recommendations for the

undertaking of new projects that are consistent with the objectives

of this section, such as encircling the National Institutes of

Health Federal enclave with an adequate chilled water conduit.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 283, 284, 285g-4, 289a of

this title; title 21 section 360bbb.

-End-

-CITE-

42 USC Sec. 283 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283. Biennial report of Director to President and Congress;

contents

-STATUTE-

The Secretary shall transmit to the President and to the Congress

a biennial report which shall be prepared by the Director of NIH

and which shall consist of -

(1) a description of the activities carried out by and through

the National Institutes of Health and the policies respecting the

programs of the National Institutes of Health and such

recommendations respecting such policies as the Secretary

considers appropriate;

(2) a description of the activities undertaken to improve

grants and contracting accountability and technical and

scientific peer review procedures of the National Institutes of

Health and the national research institutes;

(3) the reports made by the Associate Director for Prevention

under section 282(f) of this title during the period for which

the biennial report is prepared;

(4) a description of the health related behavioral research

that has been supported by the National Institutes of Health in

the preceding 2-year period, and a description of any plans for

future activity in such area; and

(5) the biennial reports of the Directors of each of the

national research institutes, the Director of the Division of

Research Resources, and the Director of the National Center for

Nursing Research.

The first report under this section shall be submitted not later

than July 1, 1986, and shall relate to the fiscal year ending

September 30, 1985. The next report shall be submitted not later

than December 30, 1988, and shall relate to the two-fiscal-year

period ending on the preceding September 30. Each subsequent report

shall be submitted not later than 90 days after the end of the

two-fiscal-year period for which the report is to be submitted.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 403, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L.

100-607, title I, Sec. 112, Nov. 4, 1988, 102 Stat. 3052.)

-MISC1-

AMENDMENTS

1988 - Pars. (4), (5). Pub. L. 100-607 added par. (4) and

redesignated former par. (4) as (5).

-CHANGE-

CHANGE OF NAME

Division of Research Resources changed to National Center for

Research Resources by Pub. L. 103-43, title XV, Sec. 1501, June 10,

1993, 107 Stat. 172.

National Center for Nursing Research changed to National

Institute of Nursing Research by Pub. L. 103-43, title XV, Sec.

1511, June 10, 1993, 107 Stat. 178.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 283e, 284b, 285g-4,

285q-3, 287a-1, 287d, 287d-2, 289a-2 of this title.

-End-

-CITE-

42 USC Sec. 283a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283a. Establishment of program regarding DES

-STATUTE-

(a) In general

The Director of NIH shall establish a program for the conduct and

support of research and training, the dissemination of health

information, and other programs with respect to the diagnosis and

treatment of conditions associated with exposure to the drug

diethylstilbestrol (in this section referred to as "DES").

(b) Education programs

In carrying out subsection (a) of this section, the Director of

NIH, after consultation with nonprofit private entities

representing individuals who have been exposed to DES, shall

conduct or support programs to educate health professionals and the

public on the drug, including the importance of identifying and

treating individuals who have been exposed to the drug.

(c) Longitudinal studies

After consultation with the Office of Research on Women's Health,

the Director of NIH, acting through the appropriate national

research institutes, shall in carrying out subsection (a) of this

section conduct or support one or more longitudinal studies to

determine the incidence of the following diseases or disorders in

the indicated populations and the relationship of DES to the

diseases or disorders:

(1) In the case of women to whom (on or after January 1, 1938)

DES was administered while the women were pregnant, the incidence

of all diseases and disorders (including breast cancer,

gynecological cancers, and impairments of the immune system,

including autoimmune disease).

(2) In the case of women exposed to DES in utero, the incidence

of clear cell cancer (including recurrences), the long-term

health effects of such cancer, and the effects of treatments for

such cancer.

(3) In the case of men and women exposed to DES in utero, the

incidence of all diseases and disorders (including impairments of

the reproductive and autoimmune systems).

(4) In the case of children of men or women exposed to DES in

utero, the incidence of all diseases and disorders.

(d) Exposure to DES in utero

For purposes of this section, an individual shall be considered

to have been exposed to DES in utero if, during the pregnancy that

resulted in the birth of such individual, DES was (on or after

January 1, 1938) administered to the biological mother of the

individual.

(e) Authorization of appropriations

In addition to any other authorization of appropriations

available for the purpose of carrying out this section, there are

authorized to be appropriated for such purpose such sums as may be

necessary for each of the fiscal years 1993 through 2003.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 403A, as added Pub. L.

102-409, Sec. 2, Oct. 13, 1992, 106 Stat. 2092; amended Pub. L.

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

-MISC1-

AMENDMENTS

1998 - Subsec. (e). Pub. L. 105-340 substituted "2003" for

"1996".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 300u-9 of this title.

-End-

-CITE-

42 USC Sec. 283b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283b. Repealed. Pub. L. 106-525, title I, Sec. 101(b)(2), Nov.

22, 2000, 114 Stat. 2501

-MISC1-

Section, act July 1, 1944, ch. 373, title IV, Sec. 404, as added

Pub. L. 103-43, title I, Sec. 151, June 10, 1993, 107 Stat. 139,

related to the establishment and purpose of the Office of Research

on Minority Health.

-End-

-CITE-

42 USC Sec. 283c 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283c. Office of Behavioral and Social Sciences Research

-STATUTE-

(a) There is established within the Office of the Director of NIH

an office to be known as the Office of Behavioral and Social

Sciences Research (in this section referred to as the "Office").

The Office shall be headed by a director, who shall be appointed by

the Director of NIH.

(b)(1) With respect to research on the relationship between human

behavior and the development, treatment, and prevention of medical

conditions, the Director of the Office shall -

(A) coordinate research conducted or supported by the agencies

of the National Institutes of Health; and

(B) identify projects of behavioral and social sciences

research that should be conducted or supported by the national

research institutes, and develop such projects in cooperation

with such institutes.

(2) Research authorized under paragraph (1) includes research on

teen pregnancy, infant mortality, violent behavior, suicide, and

homelessness. Such research does not include neurobiological

research, or research in which the behavior of an organism is

observed for the purpose of determining activity at the cellular or

molecular level.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404A, as added Pub. L.

103-43, title II, Sec. 203(a), June 10, 1993, 107 Stat. 145.)

-MISC1-

EFFECTIVE DATE

Section 203(c) of Pub. L. 103-43 provided that: "The amendment

described in subsection (a) [enacting this section] is made upon

the date of the enactment of this Act [June 10, 1993] and takes

effect July 1, 1993. Subsection (b) [107 Stat. 145] takes effect on

such date."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 287c-31 of this title.

-End-

-CITE-

42 USC Sec. 283d 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283d. Children's Vaccine Initiative

-STATUTE-

(a) Development of new vaccines

The Secretary, in consultation with the Director of the National

Vaccine Program under subchapter XIX of this chapter and acting

through the Directors of the National Institute for Allergy and

Infectious Diseases, the National Institute for Child Health and

Human Development, the National Institute for Aging, and other

public and private programs, shall carry out activities, which

shall be consistent with the global Children's Vaccine Initiative,

to develop affordable new and improved vaccines to be used in the

United States and in the developing world that will increase the

efficacy and efficiency of the prevention of infectious diseases.

In carrying out such activities, the Secretary shall, to the extent

practicable, develop and make available vaccines that require fewer

contacts to deliver, that can be given early in life, that provide

long lasting protection, that obviate refrigeration, needles and

syringes, and that protect against a larger number of diseases.

(b) Report

In the report required in section 300aa-4 (!1) of this title, the

Secretary, acting through the Director of the National Vaccine

Program under subchapter XIX of this chapter, shall include

information with respect to activities and the progress made in

implementing the provisions of this section and achieving its

goals.

(c) Authorization of appropriations

In addition to any other amounts authorized to be appropriated

for activities of the type described in this section, there are

authorized to be appropriated to carry out this section $20,000,000

for fiscal year 1994, and such sums as may be necessary for each of

the fiscal years 1995 and 1996.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404B, as added Pub. L.

103-43, title II, Sec. 204, June 10, 1993, 107 Stat. 146.)

-REFTEXT-

REFERENCES IN TEXT

Section 300aa-4 of this title, referred to in subsec. (b), was

repealed by Pub. L. 105-362, title VI, Sec. 601(a)(1)(H), Nov. 10,

1998, 112 Stat. 3285.

-FOOTNOTE-

(!1) See References in Text note below.

-End-

-CITE-

42 USC Sec. 283e 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283e. Plan for use of animals in research

-STATUTE-

(a) Preparation

The Director of NIH, after consultation with the committee

established under subsection (e) of this section, shall prepare a

plan -

(1) for the National Institutes of Health to conduct or support

research into -

(A) methods of biomedical research and experimentation that

do not require the use of animals;

(B) methods of such research and experimentation that reduce

the number of animals used in such research;

(C) methods of such research and experimentation that produce

less pain and distress in such animals; and

(D) methods of such research and experimentation that involve

the use of marine life (other than marine mammals);

(2) for establishing the validity and reliability of the

methods described in paragraph (1);

(3) for encouraging the acceptance by the scientific community

of such methods that have been found to be valid and reliable;

and

(4) for training scientists in the use of such methods that

have been found to be valid and reliable.

(b) Submission to Congressional committees

Not later than October 1, 1993, the Director of NIH shall submit

to the Committee on Energy and Commerce of the House of

Representatives, and to the Committee on Labor and Human Resources

of the Senate, the plan required in subsection (a) of this section

and shall begin implementation of the plan.

(c) Periodic review and revision

The Director of NIH shall periodically review, and as

appropriate, make revisions in the plan required under subsection

(a) of this section. A description of any revision made in the plan

shall be included in the first biennial report under section 283 of

this title that is submitted after the revision is made.

(d) Dissemination of information

The Director of NIH shall take such actions as may be appropriate

to convey to scientists and others who use animals in biomedical or

behavioral research or experimentation information respecting the

methods found to be valid and reliable under subsection (a)(2) of

this section.

(e) Interagency Coordinating Committee on the Use of Animals in

Research

(1) The Director of NIH shall establish within the National

Institutes of Health a committee to be known as the Interagency

Coordinating Committee on the Use of Animals in Research (in this

subsection referred to as the "Committee").

(2) The Committee shall provide advice to the Director of NIH on

the preparation of the plan required in subsection (a) of this

section.

(3) The Committee shall be composed of -

(A) the Directors of each of the national research institutes

and the Director of the Center for Research Resources (or the

designees of such Directors); and

(B) representatives of the Environmental Protection Agency, the

Food and Drug Administration, the Consumer Product Safety

Commission, the National Science Foundation, and such additional

agencies as the Director of NIH determines to be appropriate,

which representatives shall include not less than one

veterinarian with expertise in laboratory-animal medicine.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404C, as added Pub. L.

103-43, title II, Sec. 205(a), June 10, 1993, 107 Stat. 146.)

-CHANGE-

CHANGE OF NAME

Committee on Energy and Commerce of House of Representatives

treated as referring to Committee on Commerce of House of

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

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

Commerce of House of Representatives changed to Committee on Energy

and Commerce of House of Representatives, and jurisdiction over

matters relating to securities and exchanges and insurance

generally transferred to Committee on Financial Services of House

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

Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 283f 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283f. Requirements regarding surveys of sexual behavior

-STATUTE-

With respect to any survey of human sexual behavior proposed to

be conducted or supported through the National Institutes of

Health, the survey may not be carried out unless -

(1) the proposal has undergone review in accordance with any

applicable requirements of sections 289 and 289a of this title;

and

(2) the Secretary, in accordance with section 289a-1 of this

title, makes a determination that the information expected to be

obtained through the survey will assist -

(A) in reducing the incidence of sexually transmitted

diseases, the incidence of infection with the human

immunodeficiency virus, or the incidence of any other

infectious disease; or

(B) in improving reproductive health or other conditions of

health.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404D, as added Pub. L.

103-43, title II, Sec. 207, June 10, 1993, 107 Stat. 148.)

-MISC1-

PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND AMERICAN TEENAGE SEX

SURVEY

Section 2015 of Pub. L. 103-43 provided that: "The Secretary of

Health and Human Services may not during fiscal year 1993 or any

subsequent fiscal year conduct or support the SHARP survey of adult

sexual behavior or the American Teenage Study of adolescent sexual

behavior. This section becomes effective on the date of the

enactment of this Act [June 10, 1993]."

-End-

-CITE-

42 USC Sec. 283g 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283g. Muscular dystrophy; initiative through Director of

National Institutes of Health

-STATUTE-

(a) Expansion, intensification, and coordination of activities

(1) In general

The Director of NIH, in coordination with the Directors of the

National Institute of Neurological Disorders and Stroke, the

National Institute of Arthritis and Muscoskeletal and Skin

Diseases, the National Institute of Child Health and Human

Development, and the other national research institutes as

appropriate, shall expand and intensify programs of such

Institutes with respect to research and related activities

concerning various forms of muscular dystrophy, including

Duchenne, myotonic, facioscapulohumeral muscular dystrophy

(referred to in this section as "FSHD") and other forms of

muscular dystrophy.

(2) Coordination

The Directors referred to in paragraph (1) shall jointly

coordinate the programs referred to in such paragraph and consult

with the Muscular Dystrophy Interagency Coordinating Committee

established under section 6 of the MD-CARE Act.(!1)

(3) Allocations by Director of NIH

The Director of NIH shall allocate the amounts appropriated to

carry out this section for each fiscal year among the national

research institutes referred to in paragraph (1).

(b) Centers of excellence

(1) In general

The Director of NIH shall award grants and contracts under

subsection (a)(1) of this section to public or nonprofit private

entities to pay all or part of the cost of planning,

establishing, improving, and providing basic operating support

for centers of excellence regarding research on various forms of

muscular dystrophy.

(2) Research

Each center under paragraph (1) shall supplement but not

replace the establishment of a comprehensive research portfolio

in all the muscular dystrophies. As a whole, the centers shall

conduct basic and clinical research in all forms of muscular

dystrophy including early detection, diagnosis, prevention, and

treatment, including the fields of muscle biology, genetics,

noninvasive imaging, genetics, pharmacological and other

therapies.

(3) Coordination of centers; reports

The Director of NIH -

(A) shall, as appropriate, provide for the coordination of

information among centers under paragraph (1) and ensure

regular communication between such centers; and

(B) shall require the periodic preparation of reports on the

activities of the centers and the submission of the reports to

the Director.

(4) Organization of centers

Each center under paragraph (1) shall use the facilities of a

single institution, or be formed from a consortium of cooperating

institutions, meeting such requirements as may be prescribed by

the Director of NIH.

(5) Duration of support

Support for a center established under paragraph (1) may be

provided under this section for a period of not to exceed 5

years. Such period may be extended for 1 or more additional

periods not exceeding 5 years if the operations of such center

have been reviewed by an appropriate technical and scientific

peer review group established by the Director of NIH and if such

group has recommended to the Director that such period should be

extended.

(c) Facilitation of research

The Director of NIH shall provide for a program under subsection

(a)(1) of this section under which samples of tissues and genetic

materials that are of use in research on muscular dystrophy are

donated, collected, preserved, and made available for such

research. The program shall be carried out in accordance with

accepted scientific and medical standards for the donation,

collection, and preservation of such samples.

(d) Coordinating Committee

(1) In general

The Secretary shall establish the Muscular Dystrophy

Coordinating Committee (referred to in this section as the

"Coordinating Committee") to coordinate activities across the

National Institutes and with other Federal health programs and

activities relating to the various forms of muscular dystrophy.

(2) Composition

The Coordinating Committee shall consist of not more than 15

members to be appointed by the Secretary, of which -

(A) 2/3 of such members shall represent governmental

agencies, including the directors or their designees of each of

the national research institutes involved in research with

respect to muscular dystrophy and representatives of all other

Federal departments and agencies whose programs involve health

functions or responsibilities relevant to such diseases,

including the Centers for Disease Control and Prevention, the

Health Resources and Services Administration and the Food and

Drug Administration and representatives of other governmental

agencies that serve children with muscular dystrophy, such as

the Department of Education; and

(B) 1/3 of such members shall be public members, including

a broad cross section of persons affected with muscular

dystrophies including parents or legal guardians, affected

individuals, researchers, and clinicians.

Members appointed under subparagraph (B) shall serve for a term

of 3 years, and may serve for an unlimited number of terms if

reappointed.

(3) Chair

(A) In general

With respect to muscular dystrophy, the Chair of the

Coordinating Committee shall serve as the principal advisor to

the Secretary, the Assistant Secretary for Health, and the

Director of NIH, and shall provide advice to the Director of

the Centers for Disease Control and Prevention, the

Commissioner of Food and Drugs, and to the heads of other

relevant agencies. The Coordinating Committee shall select the

Chair for a term not to exceed 2 years.

(B) Appointment

The Chair of the Committee shall be appointed by and be

directly responsible to the Secretary.

(4) Administrative support; terms of service; other provisions

The following shall apply with respect to the Coordinating

Committee:

(A) The Coordinating Committee shall receive necessary and

appropriate administrative support from the Department of

Health and Human Services.

(B) The Coordinating Committee shall meet as appropriate as

determined by the Secretary, in consultation with the

chair.(!2)

(e) Plan for HHS activities

(1) In general

Not later than 1 year after December 18, 2001, the Coordinating

Committee shall develop a plan for conducting and supporting

research and education on muscular dystrophy through the national

research institutes and shall periodically review and revise the

plan. The plan shall -

(A) provide for a broad range of research and education

activities relating to biomedical, epidemiological,

psychosocial, and rehabilitative issues, including studies of

the impact of such diseases in rural and underserved

communities;

(B) identify priorities among the programs and activities of

the National Institutes of Health regarding such diseases; and

(C) reflect input from a broad range of scientists, patients,

and advocacy groups.

(2) Certain elements of plan

The plan under paragraph (1) shall, with respect to each form

of muscular dystrophy, provide for the following as appropriate:

(A) Research to determine the reasons underlying the

incidence and prevalence of various forms of muscular

dystrophy.

(B) Basic research concerning the etiology and genetic links

of the disease and potential causes of mutations.

(C) The development of improved screening techniques.

(D) Basic and clinical research for the development and

evaluation of new treatments, including new biological agents.

(E) Information and education programs for health care

professionals and the public.

(f) Reports to Congress

The Coordinating Committee shall biennially submit to the

Committee on Energy and Commerce of the House of Representatives,

and the Committee on Health, Education, Labor, and Pensions of the

Senate, a report that describes the research, education, and other

activities on muscular dystrophy being conducted or supported

through the Department of Health and Human Services. Each such

report shall include the following:

(1) The plan under subsection (e)(1) of this section (or

revisions to the plan, as the case may be).

(2) Provisions specifying the amounts expended by the

Department of Health and Human Services with respect to various

forms of muscular dystrophy, including Duchenne, myotonic, FSHD

and other forms of muscular dystrophy.

(3) Provisions identifying particular projects or types of

projects that should in the future be considered by the national

research institutes or other entities in the field of research on

all muscular dystrophies.

(g) Public input

The Secretary shall, under subsection (a)(1) of this section,

provide for a means through which the public can obtain information

on the existing and planned programs and activities of the

Department of Health and Human Services with respect to various

forms of muscular dystrophy and through which the Secretary can

receive comments from the public regarding such programs and

activities.

(h) 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 fiscal years 2002 through 2006. The authorization of

appropriations established in the preceding sentence is in addition

to any other authorization of appropriations that is available for

conducting or supporting through the National Institutes of Health

research and other activities with respect to muscular dystrophy.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404E, as added Pub. L.

107-84, Sec. 3, Dec. 18, 2001, 115 Stat. 824.)

-REFTEXT-

REFERENCES IN TEXT

Section 6 of the MD-CARE Act, referred to in subsec. (a)(2), is

section 6 of Pub. L. 107-84, which is set out as a note under

section 247b-18 of this title and does not relate to establishment

of a coordinating committee. However, subsec. (d) of this section

contains provisions relating to the establishment of the Muscular

Dystrophy Coordinating Committee.

-MISC1-

PRIOR PROVISIONS

A prior section 283g, act July 1, 1944, ch. 373, title IV, Sec.

404E, as added Pub. L. 103-43, title II, Sec. 209, June 10, 1993,

107 Stat. 149, related to Office of Alternative Medicine, prior to

repeal by Pub. L. 105-277, div. A, Sec. 101(f) [title VI, Sec.

601(1)], Oct. 21, 1998, 112 Stat. 2681-337, 2681-387.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 247b-18 of this title.

-FOOTNOTE-

(!1) See References in Text note below.

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

-End-

-CITE-

42 USC Sec. 283h 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283h. Office of Rare Diseases

-STATUTE-

(a) Establishment

There is established within the Office of the Director of NIH an

office to be known as the Office of Rare Diseases (in this section

referred to as the "Office"), which shall be headed by a Director

(in this section referred to as the "Director"), appointed by the

Director of NIH.

(b) Duties

(1) In general

The Director of the Office shall carry out the following:

(A) The Director shall recommend an agenda for conducting and

supporting research on rare diseases through the national

research institutes and centers. The agenda shall provide for a

broad range of research and education activities, including

scientific workshops and symposia to identify research

opportunities for rare diseases.

(B) The Director shall, with respect to rare diseases,

promote coordination and cooperation among the national

research institutes and centers and entities whose research is

supported by such institutes.

(C) The Director, in collaboration with the directors of the

other relevant institutes and centers of the National

Institutes of Health, may enter into cooperative agreements

with and make grants for regional centers of excellence on rare

diseases in accordance with section 283i of this title.

(D) The Director shall promote the sufficient allocation of

the resources of the National Institutes of Health for

conducting and supporting research on rare diseases.

(E) The Director shall promote and encourage the

establishment of a centralized clearinghouse for rare and

genetic disease information that will provide understandable

information about these diseases to the public, medical

professionals, patients and families.

(F) The Director shall biennially prepare a report that

describes the research and education activities on rare

diseases being conducted or supported through the national

research institutes and centers, and that identifies particular

projects or types of projects that should in the future be

conducted or supported by the national research institutes and

centers or other entities in the field of research on rare

diseases.

(G) The Director shall prepare the NIH Director's annual

report to Congress on rare disease research conducted by or

supported through the national research institutes and centers.

(2) Principal advisor regarding orphan diseases

With respect to rare diseases, the Director shall serve as the

principal advisor to the Director of NIH and shall provide advice

to other relevant agencies. The Director shall provide liaison

with national and international patient, health and scientific

organizations concerned with rare diseases.

(c) Definition

For purposes of this section, the term "rare disease" means any

disease or condition that affects less than 200,000 persons in the

United States.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as already have been

appropriated for fiscal year 2002, and $4,000,000 for each of the

fiscal years 2003 through 2006.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404F, as added Pub. L.

107-280, Sec. 3, Nov. 6, 2002, 116 Stat. 1989.)

-MISC1-

FINDINGS AND PURPOSES

Pub. L. 107-280, Sec. 2, Nov. 6, 2002, 116 Stat. 1988, provided

that:

"(a) Findings. - Congress makes the following findings:

"(1) Rare diseases and disorders are those which affect small

patient populations, typically populations smaller than 200,000

individuals in the United States. Such diseases and conditions

include Huntington's disease, amyotrophic lateral sclerosis (Lou

Gehrig's disease), Tourette syndrome, Crohn's disease, cystic

fibrosis, cystinosis, and Duchenne muscular dystrophy.

"(2) For many years, the 25,000,000 Americans suffering from

the over 6,000 rare diseases and disorders were denied access to

effective medicines because prescription drug manufacturers could

rarely make a profit from marketing drugs for such small groups

of patients. The prescription drug industry did not adequately

fund research into such treatments. Despite the urgent health

need for these medicines, they came to be known as 'orphan drugs'

because no companies would commercialize them.

"(3) During the 1970s, an organization called the National

Organization for Rare Disorders (NORD) was founded to provide

services and to lobby on behalf of patients with rare diseases

and disorders. NORD was instrumental in pressing Congress for

legislation to encourage the development of orphan drugs.

"(4) The Orphan Drug Act [Pub. L. 97-414, see Short Title of

1983 Amendments note set out under section 301 of Title 21, Food

and Drugs] created financial incentives for the research and

production of such orphan drugs. New Federal programs at the

National Institutes of Health and the Food and Drug

Administration encouraged clinical research and commercial

product development for products that target rare diseases. An

Orphan Products Board was established to promote the development

of drugs and devices for rare diseases or disorders.

"(5) Before 1983, some 38 orphan drugs had been developed.

Since the enactment of the Orphan Drug Act [Jan. 4, 1983], more

than 220 new orphan drugs have been approved and marketed in the

United States and more than 800 additional drugs are in the

research pipeline.

"(6) Despite the tremendous success of the Orphan Drug Act,

rare diseases and disorders deserve greater emphasis in the

national biomedical research enterprise. The Office of Rare

Diseases at the National Institutes of Health was created in

1993, but lacks a statutory authorization.

"(7) The National Institutes of Health has received a

substantial increase in research funding from Congress for the

purpose of expanding the national investment of the United States

in behavioral and biomedical research.

"(8) Notwithstanding such increases, funding for rare diseases

and disorders at the National Institutes of Health has not

increased appreciably.

"(9) To redress this oversight, the Department of Health and

Human Services has proposed the establishment of a network of

regional centers of excellence for research on rare diseases.

"(b) Purposes. - The purposes of this Act [see Short Title of

2002 Amendments note set out under section 201 of this title] are

to -

"(1) amend the Public Health Service Act [this chapter] to

establish an Office of Rare Diseases at the National Institutes

of Health; and

"(2) increase the national investment in the development of

diagnostics and treatments for patients with rare diseases and

disorders."

-End-

-CITE-

42 USC Sec. 283i 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part A - National Institutes of Health

-HEAD-

Sec. 283i. Rare disease regional centers of excellence

-STATUTE-

(a) Cooperative agreements and grants

(1) In general

The Director of the Office of Rare Diseases (in this section

referred to as the "Director"), in collaboration with the

directors of the other relevant institutes and centers of the

National Institutes of Health, may enter into cooperative

agreements with and make grants to public or private nonprofit

entities to pay all or part of the cost of planning,

establishing, or strengthening, and providing basic operating

support for regional centers of excellence for clinical research

into, training in, and demonstration of diagnostic, prevention,

control, and treatment methods for rare diseases.

(2) Policies

A cooperative agreement or grant under paragraph (1) shall be

entered into in accordance with policies established by the

Director of NIH.

(b) Coordination with other institutes

The Director shall coordinate the activities under this section

with similar activities conducted by other national research

institutes, centers and agencies of the National Institutes of

Health and by the Food and Drug Administration to the extent that

such institutes, centers and agencies have responsibilities that

are related to rare diseases.

(c) Uses for Federal payments under cooperative agreements or

grants

Federal payments made under a cooperative agreement or grant

under subsection (a) of this section may be used for -

(1) staffing, administrative, and other basic operating costs,

including such patient care costs as are required for research;

(2) clinical training, including training for allied health

professionals, continuing education for health professionals and

allied health professions personnel, and information programs for

the public with respect to rare diseases; and

(3) clinical research and demonstration programs.

(d) Period of support; additional periods

Support of a center under subsection (a) of this section may be

for a period of not to exceed 5 years. Such period may be extended

by the Director for additional periods of not more than 5 years if

the operations of such center have been reviewed by an appropriate

technical and scientific peer review group established by the

Director and if such group has recommended to the Director that

such period should be extended.

(e) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as already have been

appropriated for fiscal year 2002, and $20,000,000 for each of the

fiscal years 2003 through 2006.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 404G, as added Pub. L.

107-280, Sec. 4, Nov. 6, 2002, 116 Stat. 1990.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 283h of this title.

-End-

-CITE-

42 USC Part B - General Provisions Respecting National

Research Institutes 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

PART B - GENERAL PROVISIONS RESPECTING NATIONAL RESEARCH INSTITUTES

-End-

-CITE-

42 USC Sec. 284 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284. Directors of national research institutes

-STATUTE-

(a) Appointment

The Director of the National Cancer Institute shall be appointed

by the President and the Directors of the other national research

institutes shall be appointed by the Secretary. Each Director of a

national research institute shall report directly to the Director

of NIH.

(b) Duties and authority; grants, contracts, and cooperative

agreements

(1) In carrying out the purposes of section 241 of this title

with respect to human diseases or disorders or other aspects of

human health for which the national research institutes were

established, the Secretary, acting through the Director of each

national research institute -

(A) shall encourage and support research, investigations,

experiments, demonstrations, and studies in the health sciences

related to -

(i) the maintenance of health,

(ii) the detection, diagnosis, treatment, and prevention of

human diseases and disorders,

(iii) the rehabilitation of individuals with human diseases,

disorders, and disabilities, and

(iv) the expansion of knowledge of the processes underlying

human diseases, disorders, and disabilities, the processes

underlying the normal and pathological functioning of the body

and its organ systems, and the processes underlying the

interactions between the human organism and the environment;

(B) may, subject to the peer review prescribed under section

289a(b) of this title and any advisory council review under

section 284a(a)(3)(A)(i) of this title, conduct the research,

investigations, experiments, demonstrations, and studies referred

to in subparagraph (A);

(C) may conduct and support research training (i) for which

fellowship support is not provided under section 288 of this

title, and (ii) which is not residency training of physicians or

other health professionals;

(D) may develop, implement, and support demonstrations and

programs for the application of the results of the activities of

the institute to clinical practice and disease prevention

activities;

(E) may develop, conduct, and support public and professional

education and information programs;

(F) may secure, develop and maintain, distribute, and support

the development and maintenance of resources needed for research;

(G) may make available the facilities of the institute to

appropriate entities and individuals engaged in research

activities and cooperate with and assist Federal and State

agencies charged with protecting the public health;

(H) may accept unconditional gifts made to the institute for

its activities, and, in the case of gifts of a value in excess of

$50,000, establish suitable memorials to the donor;

(I) may secure for the institute consultation services and

advice of persons from the United States or abroad;

(J) may use, with their consent, the services, equipment,

personnel, information, and facilities of other Federal, State,

or local public agencies, with or without reimbursement therefor;

(K) may accept voluntary and uncompensated services; and

(L) may perform such other functions as the Secretary

determines are needed to carry out effectively the purposes of

the institute.

The indemnification provisions of section 2354 of title 10 shall

apply with respect to contracts entered into under this subsection

and section 282(b) of this title.

(2) Support for an activity or program under this subsection may

be provided through grants, contracts, and cooperative agreements.

The Secretary, acting through the Director of each national

research institute -

(A) may enter into a contract for research, training, or

demonstrations only if the contract has been recommended after

technical and scientific peer review required by regulations

under section 289a of this title;

(B) may make grants and cooperative agreements under paragraph

(1) for research, training, or demonstrations, except that -

(i) if the direct cost of the grant or cooperative agreement

to be made does not exceed $50,000, such grant or cooperative

agreement may be made only if such grant or cooperative

agreement has been recommended after technical and scientific

peer review required by regulations under section 289a of this

title, and

(ii) if the direct cost of the grant or cooperative agreement

to be made exceeds $50,000, such grant or cooperative agreement

may be made only if such grant or cooperative agreement has

been recommended after technical and scientific peer review

required by regulations under section 289a of this title and is

recommended under section 284a(a)(3)(A)(ii) of this title by

the advisory council for the national research institute

involved; and

(C) shall, subject to section 300cc-40b(d)(2) of this title,

receive from the President and the Office of Management and

Budget directly all funds appropriated by the Congress for

obligation and expenditure by the Institute.

(c) Coordination with other public and private entities;

cooperation with other national research institutes; appointment

of additional peer review groups

In carrying out subsection (b) of this section, each Director of

a national research institute -

(1) shall coordinate, as appropriate, the activities of the

institute with similar programs of other public and private

entities;

(2) shall cooperate with the Directors of the other national

research institutes in the development and support of

multidisciplinary research and research that involves more than

one institute;

(3) may, in consultation with the advisory council for the

Institute and with the approval of the Director of NIH -

(A) establish technical and scientific peer review groups in

addition to those appointed under section 282(b)(6) of this

title; and

(B) appoint the members of peer review groups established

under subparagraph (A); and

(4) may publish, or arrange for the publication of, information

with respect to the purpose of the Institute without regard to

section 501 of title 44.

The Federal Advisory Committee Act shall not apply to the duration

of a peer review group appointed under paragraph (3).

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 405, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 826; amended Pub. L.

100-607, title I, Sec. 116, Nov. 4, 1988, 102 Stat. 3053; Pub. L.

100-690, title II, Sec. 2613(c), Nov. 18, 1988, 102 Stat. 4239;

Pub. L. 103-43, title III, Sec. 301(a)(1), (b), June 10, 1993, 107

Stat. 150.)

-REFTEXT-

REFERENCES IN TEXT

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

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

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

Employees.

-MISC1-

AMENDMENTS

1993 - Subsec. (b)(2)(C). Pub. L. 103-43, Sec. 301(a)(1), added

subpar. (C).

Subsec. (c). Pub. L. 103-43, Sec. 301(b)(2), inserted concluding

provisions relating to Federal Advisory Committee Act.

Subsec. (c)(3). Pub. L. 103-43, Sec. 301(b)(1), amended par. (3)

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

consultation with the advisory council for the Institute and the

approval of the Director of NIH, establish and appoint technical

and scientific peer review groups in addition to those established

and appointed under section 282(b)(6) of this title; and".

1988 - Subsec. (b)(1). Pub. L. 100-607, Sec. 116(1), struck out

"the" after "with respect to" in introductory provisions.

Subsec. (c)(3). Pub. L. 100-690 substituted "establish and

appoint" and "established and appointed" for "establish" and

"established", respectively.

Pub. L. 100-607, Sec. 116(2)(A), amended par. (3) generally.

Prior to amendment, par. (3) read as follows: "may, with the

approval of the advisory council for the institute and the Director

of NIH, appoint technical and scientific peer review groups in

addition to those appointed under section 282(b)(6) of this title."

Subsec. (c)(4). Pub. L. 100-607, Sec. 116(2)(C), added par. (4).

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-690 effective immediately after

enactment of Pub. L. 100-607, which was approved Nov. 4, 1988, see

section 2600 of Pub. L. 100-690, set out as a note under section

242m of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 284a, 285a-2, 285b-3,

289a, 300cc-41 of this title.

-End-

-CITE-

42 USC Sec. 284a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284a. Advisory councils

-STATUTE-

(a) Establishment; acceptance of conditional gifts; functions

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

Secretary shall appoint an advisory council for each national

research institute which (A) shall advise, assist, consult with,

and make recommendations to the Secretary and the Director of such

institute on matters related to the activities carried out by and

through the institute and the policies respecting such activities,

and (B) shall carry out the special functions prescribed by part C

of this subchapter.

(2) Each advisory council for a national research institute may

recommend to the Secretary acceptance, in accordance with section

238 of this title, of conditional gifts for study, investigation,

or research respecting the diseases, disorders, or other aspect of

human health with respect to which the institute was established,

for the acquisition of grounds, or for the construction, equipping,

or maintenance of facilities for the institute.

(3) Each advisory council for a national research institute -

(A)(i) may on the basis of the materials provided under section

289a(b)(2) of this title respecting research conducted at the

institute, make recommendations to the Director of the institute

respecting such research,

(ii) may review applications for grants and cooperative

agreements for research or training and for which advisory

council approval is required under section 284(b)(2) of this

title and recommend for approval applications for projects which

show promise of making valuable contributions to human knowledge,

and

(iii) may review any grant, contract, or cooperative agreement

proposed to be made or entered into by the institute;

(B) may collect, by correspondence or by personal

investigation, information as to studies which are being carried

on in the United States or any other country as to the diseases,

disorders, or other aspect of human health with respect to which

the institute was established and with the approval of the

Director of the institute make available such information through

appropriate publications for the benefit of public and private

health entities and health professions personnel and scientists

and for the information of the general public; and

(C) may appoint subcommittees and convene workshops and

conferences.

(b) Membership; compensation

(1) Each advisory council shall consist of ex officio members and

not more than eighteen members appointed by the Secretary. The ex

officio members shall be nonvoting members.

(2) The ex officio members of an advisory council shall consist

of -

(A) the Secretary, the Director of NIH, the Director of the

national research institute for which the council is established,

the Under Secretary for Health of the Department of Veterans

Affairs or the Chief Dental Director of the Department of

Veterans Affairs, and the Assistant Secretary of Defense for

Health Affairs (or the designees of such officers), and

(B) such additional officers or employees of the United States

as the Secretary determines necessary for the advisory council to

effectively carry out its functions.

(3) The members of an advisory council who are not ex officio

members shall be appointed as follows:

(A) Two-thirds of the members shall be appointed by the

Secretary from among the leading representatives of the health

and scientific disciplines (including not less than two

individuals who are leaders in the fields of public health and

the behavioral or social sciences) relevant to the activities of

the national research institute for which the advisory council is

established.

(B) One-third of the members shall be appointed by the

Secretary from the general public and shall include leaders in

fields of public policy, law, health policy, economics, and

management.

(4) Members of an advisory council who are officers or employees

of the United States shall not receive any compensation for service

on the advisory council. The other members of an advisory council

shall receive, for each day (including traveltime) they are engaged

in the performance of the functions of the advisory council,

compensation at rates not to exceed the daily equivalent of the

annual rate in effect for grade GS-18 of the General Schedule.

(c) Term of office; reappointment; vacancy

The term of office of an appointed member of an advisory council

is four years, except that any member appointed to fill a vacancy

for an unexpired term shall be appointed for the remainder of such

term and the Secretary shall make appointments to an advisory

council in such a manner as to ensure that the terms of the members

do not all expire in the same year. A member may serve after the

expiration of the member's term for 180 days after the date of such

expiration. A member who has been appointed for a term of four

years may not be reappointed to an advisory council before two

years from the date of expiration of such term of office. If a

vacancy occurs in the advisory council among the appointed members,

the Secretary shall make an appointment to fill the vacancy within

90 days from the date the vacancy occurs.

(d) Chairman; term of office

The chairman of an advisory council shall be selected by the

Secretary from among the appointed members, except that the

Secretary may select the Director of the national research

institute for which the advisory council is established to be the

chairman of the advisory council. The term of office of the

chairman shall be two years.

(e) Meetings

The advisory council shall meet at the call of the chairman or

upon the request of the Director of the national research institute

for which it was established, but at least three times each fiscal

year. The location of the meetings of each advisory council is

subject to the approval of the Director of the national research

institute for which the advisory council was established.

(f) Appointment of executive secretary; training and orientation

for new members

The Director of the national research institute for which an

advisory council is established shall designate a member of the

staff of the institute to serve as the executive secretary of the

advisory council. The Director of such institute shall make

available to the advisory council such staff, information, and

other assistance as it may require to carry out its functions. The

Director of such institute shall provide orientation and training

for new members of the advisory council to provide them with such

information and training as may be appropriate for their effective

participation in the functions of the advisory council.

(g) Comments and recommendations for inclusion in biennial report;

additional reports

Each advisory council may prepare, for inclusion in the biennial

report made under section 284b of this title, (1) comments

respecting the activities of the advisory council in the fiscal

years respecting which the report is prepared, (2) comments on the

progress of the national research institute for which it was

established in meeting its objectives, and (3) recommendations

respecting the future directions and program and policy emphasis of

the institute. Each advisory council may prepare such additional

reports as it may determine appropriate.

(h) Advisory councils in existence; application of section to

National Cancer Advisory Board and advisory council to National

Heart, Lung, and Blood Institute

(1) Except as provided in paragraph (2), this section does not

terminate the membership of any advisory council for a national

research institute which was in existence on November 20, 1985.

After November 20, 1985 -

(A) the Secretary shall make appointments to each such advisory

council in such a manner as to bring about as soon as practicable

the composition for such council prescribed by this section;

(B) each advisory council shall organize itself in accordance

with this section and exercise the functions prescribed by this

section; and

(C) the Director of each national research institute shall

perform for such advisory council the functions prescribed by

this section.

(2)(A) The National Cancer Advisory Board shall be the advisory

council for the National Cancer Institute. This section applies to

the National Cancer Advisory Board, except that -

(i) appointments to such Board shall be made by the President;

(ii) the term of office of an appointed member shall be 6

years;

(iii) of the members appointed to the Board not less than five

members shall be individuals knowledgeable in environmental

carcinogenesis (including carcinogenesis involving occupational

and dietary factors);

(iv) the chairman of the Board shall be selected by the

President from the appointed members and shall serve as chairman

for a term of two years;

(v) the ex officio members of the Board shall be nonvoting

members and shall be the Secretary, the Director of the Office of

Science and Technology Policy, the Director of NIH, the Under

Secretary for Health of the Department of Veterans Affairs, the

Director of the National Institute for Occupational Safety and

Health, the Director of the National Institute of Environmental

Health Sciences, the Secretary of Labor, the Commissioner of the

Food and Drug Administration, the Administrator of the

Environmental Protection Agency, the Chairman of the Consumer

Product Safety Commission, the Assistant Secretary of Defense for

Health Affairs, and the Director of the Office of Science of the

Department of Energy (or the designees of such officers); and

(vi) the Board shall meet at least four times each fiscal year.

(B) This section applies to the advisory council to the National

Heart, Lung, and Blood Institute, except that the advisory council

shall meet at least four times each fiscal year.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 406, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 828; amended Pub. L.

100-607, title I, Sec. 117, Nov. 4, 1988, 102 Stat. 3053; Pub. L.

101-381, title I, Sec. 102(1), Aug. 18, 1990, 104 Stat. 585; Pub.

L. 102-405, title III, Sec. 302(e)(1), Oct. 9, 1992, 106 Stat.

1985; Pub. L. 103-43, title II, Sec. 210(a), title XX, Secs.

2008(b)(1), 2010(b)(2), June 10, 1993, 107 Stat. 149, 210, 214;

Pub. L. 105-245, title III, Sec. 309(b)(2)(C), Oct. 7, 1998, 112

Stat. 1853.)

-MISC1-

AMENDMENTS

1998 - Subsec. (h)(2)(A)(v). Pub. L. 105-245 substituted "Science

of the Department of Energy" for "Energy Research of the Department

of Energy".

1993 - Subsec. (a)(2). Pub. L. 103-43, Sec. 2010(b)(2),

substituted "section 238" for "section 300aaa".

Subsec. (b)(2)(A). Pub. L. 103-43, Sec. 2008(b)(1)(A),

substituted "Department of Veterans Affairs" for "Veterans'

Administration" in two places.

Subsec. (c). Pub. L. 103-43, Sec. 210(a), substituted "for 180

days after the date of such expiration" for "until a successor has

taken office".

Subsec. (h)(2)(A)(v). Pub. L. 103-43, Sec. 2008(b)(1)(B),

substituted "Department of Veterans Affairs" for "Veterans'

Administration".

1992 - Subsecs. (b)(2)(A), (h)(2)(A)(v). Pub. L. 102-405

substituted "Under Secretary for Health" for "Chief Medical

Director".

1990 - Subsec. (a)(2). Pub. L. 101-381 made technical amendment

to reference to section 300aaa of this title to reflect renumbering

of corresponding section of original act.

1988 - Subsec. (b)(1). Pub. L. 100-607, Sec. 117(a), inserted at

end "The ex officio members shall be nonvoting members."

Subsec. (b)(3)(A). Pub. L. 100-607, Sec. 117(b), inserted "not

less than two individuals who are leaders in the fields of" after

"(including".

Subsec. (h)(2)(A)(v). Pub. L. 100-607, Sec. 117(c), inserted

"shall be nonvoting members and" after "Board" and substituted "the

Assistant Secretary of Defense for Health Affairs, and the Director

of the Office of Energy Research of the Department of Energy" for

"and the Assistant Secretary of Defense for Health Affairs".

TERMINATION OF ADVISORY COUNCILS

Advisory councils 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 council

established by the President or an officer of the Federal

Government, such council is renewed by appropriate action prior to

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

established by the Congress, its duration is otherwise provided by

law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

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

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

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

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

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

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

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

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

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

under section 5376 of Title 5.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 284, 284b, 285b-7,

285c-6, 285r, 287c-21, 287c-31, 289c, 300cc-40a of this title.

-End-

-CITE-

42 USC Sec. 284b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284b. Biennial report

-STATUTE-

The Director of each national research institute, after

consultation with the advisory council for the institute, shall

prepare for inclusion in the biennial report made under section 283

of this title a biennial report which shall consist of a

description of the activities of the institute and program policies

of the Director of the institute in the fiscal years respecting

which the report is prepared. The Director of each national

research institute may prepare such additional reports as the

Director determines appropriate. The Director of each national

research institute shall provide the advisory council for the

institute an opportunity for the submission of the written comments

referred to in section 284a(g) of this title.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 407, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 831.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 284a, 285a-2, 285a-5,

285a-6, 285b-6, 285c-7, 285g-4, 285n-1, 285o-1, 285p-1 of this

title.

-End-

-CITE-

42 USC Sec. 284c 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284c. Certain uses of funds

-STATUTE-

(a)(1) Except as provided in paragraph (2), the sum of the

amounts obligated in any fiscal year for administrative expenses of

the National Institutes of Health may not exceed an amount which is

5.5 percent of the total amount appropriated for such fiscal year

for the National Institutes of Health.

(2) Paragraph (1) does not apply to the National Library of

Medicine, the National Center for Nursing Research, the John E.

Fogarty International Center for Advanced Study in the Health

Sciences, the Warren G. Magnuson Clinical Center, and the Office of

Medical Applications of Research.

(3) For purposes of paragraph (1), the term "administrative

expenses" means expenses incurred for the support of activities

relevant to the award of grants, contracts, and cooperative

agreements and expenses incurred for general administration of the

scientific programs and activities of the National Institutes of

Health.

(b) For fiscal year 1989 and subsequent fiscal years, amounts

made available to the National Institutes of Health shall be

available for payment of nurses and allied health professionals in

accordance with payment authorities, scheduling options, benefits,

and other authorities provided under chapter 73 of title 38 for

nurses of the Department of Veterans Affairs.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 408, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 831; amended Pub. L.

100-607, title I, Sec. 118, Nov. 4, 1988, 102 Stat. 3053; Pub. L.

100-690, title II, Sec. 2613(d), Nov. 18, 1988, 102 Stat. 4239;

Pub. L. 103-43, title IV, Sec. 403(b)(1), title XX, Sec.

2008(b)(2), June 10, 1993, 107 Stat. 158, 211; Pub. L. 104-316,

title I, Sec. 122(a), Oct. 19, 1996, 110 Stat. 3836; Pub. L.

105-362, title VI, Sec. 601(a)(1)(B), Nov. 10, 1998, 112 Stat.

3285.)

-MISC1-

AMENDMENTS

1998 - Subsec. (a)(4). Pub. L. 105-362 struck out par. (4) which

read as follows: "Not later than December 31, 1987, and December 31

of each succeeding year, the Secretary shall report to the Congress

the amount obligated in the fiscal year preceding such date for

administrative expenses of the National Institutes of Health and

the total amount appropriated for the National Institutes of Health

for such fiscal year. The Secretary shall consult with the

Comptroller General of the United States in preparing each report."

1996 - Subsec. (a)(3). Pub. L. 104-316 struck out at end "In

identifying expenses incurred for such support and administration

the Secretary shall consult with the Comptroller General of the

United States."

1993 - Pub. L. 103-43 amended section catchline generally,

redesignated subsec. (b) as (a) and par. (5) of subsec. (a) as (b),

struck out former subsec. (a) which authorized appropriations in

addition to amounts otherwise appropriated under this subchapter

for the National Cancer Institute for programs other than under

section 285a-1 of this title and for its program under section

285a-1 of this title and for the National Heart, Lung, and Blood

Institute for programs other than under section 285b-1 of this

title and for its program under section 285b-1 of this title, and

substituted "Department of Veterans Affairs" for "Veterans'

Administration" in subsec. (b).

1988 - Subsec. (a)(1), (2). Pub. L. 100-607, Sec. 118(a), amended

pars. (1) and (2) generally. Prior to amendment, pars. (1) and (2)

read as follows:

"(1)(A) For the National Cancer Institute (other than its

programs under section 285a-1 of this title), there are authorized

to be appropriated $1,194,000,000 for fiscal year 1986,

$1,270,000,000 for fiscal year 1987, and $1,344,000,000 for fiscal

year 1988.

"(B) For the programs under section 285a-1 of this title, there

are authorized to be appropriated $68,000,000 for fiscal year 1986,

$74,000,000 for fiscal year 1987, and $80,000,000 for fiscal year

1988.

"(2)(A) For the National Heart, Lung, and Blood Institute (other

than its programs under section 285b-1 of this title), there are

authorized to be appropriated $809,000,000 for fiscal year 1986,

$871,000,000 for fiscal year 1987, and $927,000,000 for fiscal year

1988. Of the amount appropriated under this subsection for such

fiscal year, not less than 15 percent of such amount shall be

reserved for programs respecting diseases of the lung and not less

than 15 percent of such amount shall be reserved for programs

respecting blood diseases and blood resources.

"(B) For the programs under section 285b-1 of this title, there

are authorized to be appropriated $82,000,000 for fiscal year 1986,

$90,000,000 for fiscal year 1987, and $98,000,000 for fiscal year

1988."

Subsec. (a)(2)(B). Pub. L. 100-690 inserted a comma after

"section 285b-1 of this title".

Subsec. (b)(5). Pub. L. 100-607, Sec. 118(b), added par. (5).

-CHANGE-

CHANGE OF NAME

National Center for Nursing Research changed to National

Institute of Nursing Research by Pub. L. 103-43, title XV, Sec.

1511, June 10, 1993, 107 Stat. 178.

-MISC2-

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-690 effective immediately after

enactment of Pub. L. 100-607, which was approved Nov. 4, 1988, see

section 2600 of Pub. L. 100-690, set out as a note under section

242m of this title.

WARREN G. MAGNUSON CLINICAL CENTER; AVAILABILITY OF FUNDS FOR

PAYMENT OF NURSES; RATE OF PAY AND OPTIONS AND BENEFITS

Pub. L. 99-349, title I, July 2, 1986, 100 Stat. 738, provided

that: "Funds made available for fiscal year 1986 and hereafter to

the Warren G. Magnuson Clinical Center of the National Institutes

of Health shall be available for payment of nurses at the rates of

pay and with schedule options and benefits authorized for the

Veterans Administration pursuant to 38 U.S.C. 4107."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285m-6 of this title.

-End-

-CITE-

42 USC Sec. 284d 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284d. Definitions

-STATUTE-

(a) Health service research

For purposes of this subchapter, the term "health services

research" means research endeavors that study the impact of the

organization, financing and management of health services on the

quality, cost, access to and outcomes of care. Such term does not

include research on the efficacy of services to prevent, diagnose,

or treat medical conditions.

(b) Clinical research

As used in this subchapter, the term "clinical research" means

patient oriented clinical research conducted with human subjects,

or research on the causes and consequences of disease in human

populations involving material of human origin (such as tissue

specimens and cognitive phenomena) for which an investigator or

colleague directly interacts with human subjects in an outpatient

or inpatient setting to clarify a problem in human physiology,

pathophysiology or disease, or epidemiologic or behavioral studies,

outcomes research or health services research, or developing new

technologies, therapeutic interventions, or clinical trials.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409, as added Pub. L.

102-321, title I, Sec. 121(b), July 10, 1992, 106 Stat. 358;

amended Pub. L. 103-43, title XX, Sec. 2016(a), June 10, 1993, 107

Stat. 218; Pub. L. 106-505, title II, Sec. 206, Nov. 13, 2000, 114

Stat. 2329.)

-MISC1-

AMENDMENTS

2000 - Pub. L. 106-505 designated existing provisions as subsec.

(a), inserted heading, and added subsec. (b).

1993 - Pub. L. 103-43 inserted at end "Such term does not include

research on the efficacy of services to prevent, diagnose, or treat

medical conditions."

EFFECTIVE DATE

Section effective Oct. 1, 1992, with provision for programs

providing financial assistance, see section 801(c), (d) of Pub. L.

102-321, set out as an Effective Date of 1992 Amendment note under

section 236 of this title.

-End-

-CITE-

42 USC Sec. 284e 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284e. Research on osteoporosis, Paget's disease, and related

bone disorders

-STATUTE-

(a) Establishment

The Directors of the National Institute of Arthritis and

Musculoskeletal and Skin Diseases, the National Institute on Aging,

the National Institute of Dental Research, and the National

Institute of Diabetes and Digestive and Kidney Diseases, shall

expand and intensify the programs of such Institutes with respect

to research and related activities concerning osteoporosis, Paget's

disease, and related bone disorders.

(b) Coordination

The Directors referred to in subsection (a) of this section shall

jointly coordinate the programs referred to in such subsection and

consult with the Arthritis and Musculoskeletal Diseases Interagency

Coordinating Committee and the Interagency Task Force on Aging

Research.

(c) Information clearinghouse

(1) In general

In order to assist in carrying out the purpose described in

subsection (a) of this section, the Director of NIH shall provide

for the establishment of an information clearinghouse on

osteoporosis and related bone disorders to facilitate and enhance

knowledge and understanding on the part of health professionals,

patients, and the public through the effective dissemination of

information.

(2) Establishment through grant or contract

For the purpose of carrying out paragraph (1), the Director of

NIH shall enter into a grant, cooperative agreement, or contract

with a nonprofit private entity involved in activities regarding

the prevention and control of osteoporosis and related bone

disorders.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated $40,000,000 for fiscal year 1994, and

such sums as may be necessary for each of the fiscal years 1995

through 2003.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409A, as added Pub. L.

103-43, title III, Sec. 302, June 10, 1993, 107 Stat. 151; amended

Pub. L. 105-340, title I, Sec. 102, Oct. 31, 1998, 112 Stat. 3192.)

-MISC1-

AMENDMENTS

1998 - Subsec. (d). Pub. L. 105-340 substituted "through 2003"

for "and 1996".

-End-

-CITE-

42 USC Sec. 284f 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284f. Parkinson's disease

-STATUTE-

(a) In general

The Director of NIH shall establish a program for the conduct and

support of research and training with respect to Parkinson's

disease (subject to the extent of amounts appropriated under

subsection (e) of this section).

(b) Inter-institute coordination

(1) In general

The Director of NIH shall provide for the coordination of the

program established under subsection (a) of this section among

all of the national research institutes conducting Parkinson's

disease research.

(2) Conference

Coordination under paragraph (1) shall include the convening of

a research planning conference not less frequently than once

every 2 years. Each such conference shall prepare and submit to

the Committee on Appropriations and the Committee on Labor and

Human Resources of the Senate and the Committee on Appropriations

and the Committee on Commerce of the House of Representatives a

report concerning the conference.

(c) Morris K. Udall research centers

(1) In general

The Director of NIH is authorized to award Core Center Grants

to encourage the development of innovative multidisciplinary

research and provide training concerning Parkinson's disease. The

Director is authorized to award not more than 10 Core Center

Grants and designate each center funded under such grants as a

Morris K. Udall Center for Research on Parkinson's Disease.

(2) Requirements

(A) In general

With respect to Parkinson's disease, each center assisted

under this subsection shall -

(i) use the facilities of a single institution or a

consortium of cooperating institutions, and meet such

qualifications as may be prescribed by the Director of the

NIH; and

(ii) conduct basic and clinical research.

(B) Discretionary requirements

With respect to Parkinson's disease, each center assisted

under this subsection may -

(i) conduct training programs for scientists and health

professionals;

(ii) conduct programs to provide information and continuing

education to health professionals;

(iii) conduct programs for the dissemination of information

to the public;

(iv) separately or in collaboration with other centers,

establish a nationwide data system derived from patient

populations with Parkinson's disease, and where possible,

comparing relevant data involving general populations;

(v) separately or in collaboration with other centers,

establish a Parkinson's Disease Information Clearinghouse to

facilitate and enhance knowledge and understanding of

Parkinson's disease; and

(vi) separately or in collaboration with other centers,

establish a national education program that fosters a

national focus on Parkinson's disease and the care of those

with Parkinson's disease.

(3) Stipends regarding training programs

A center may use funds provided under paragraph (1) to provide

stipends for scientists and health professionals enrolled in

training programs under paragraph (2)(B).

(4) Duration of support

Support of a center under this subsection may be for a period

not exceeding five years. Such period may be extended by the

Director of NIH for one or more additional periods of not more

than five years if the operations of such center have been

reviewed by an appropriate technical and scientific peer review

group established by the Director and if such group has

recommended to the Director that such period should be extended.

(d) Morris K. Udall Awards for Excellence in Parkinson's Disease

Research

The Director of NIH is authorized to establish a grant program to

support investigators with a proven record of excellence and

innovation in Parkinson's disease research and who demonstrate

potential for significant future breakthroughs in the understanding

of the pathogensis,(!1) diagnosis, and treatment of Parkinson's

disease. Grants under this subsection shall be available for a

period of not to exceed 5 years.

(e) Authorization of appropriations

For the purpose of carrying out this section and section 241 of

this title and this subchapter with respect to research focused on

Parkinson's disease, there are authorized to be appropriated up to

$100,000,000 for fiscal year 1998, and such sums as may be

necessary for each of the fiscal years 1999 and 2000.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409B, as added Pub. L.

105-78, title VI, Sec. 603(c), Nov. 13, 1997, 111 Stat. 1520.)

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

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

Seventh Congress, Jan. 3, 2001.

-MISC1-

FINDING AND PURPOSE

Section 603(b) of Pub. L. 105-78 provided that:

"(1) Finding. - Congress finds that to take full advantage of the

tremendous potential for finding a cure or effective treatment, the

Federal investment in Parkinson's disease must be expanded, as well

as the coordination strengthened among the National Institutes of

Health research institutes.

"(2) Purpose. - It is the purpose of this section [enacting this

section] to provide for the expansion and coordination of research

regarding Parkinson's disease, and to improve care and assistance

for afflicted individuals and their family caregivers."

-FOOTNOTE-

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

-End-

-CITE-

42 USC Sec. 284g 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284g. Expansion, intensification, and coordination of

activities of National Institutes of Health with respect to

research on autism

-STATUTE-

(a) In general

(1) Expansion of activities

The Director of NIH (in this section referred to as the

"Director") shall expand, intensify, and coordinate the

activities of the National Institutes of Health with respect to

research on autism.

(2) Administration of program; collaboration among agencies

The Director shall carry out this section acting through the

Director of the National Institute of Mental Health and in

collaboration with any other agencies that the Director

determines appropriate.

(b) Centers of excellence

(1) In general

The Director shall under subsection (a)(1) of this section make

awards of grants and contracts to public or nonprofit private

entities to pay all or part of the cost of planning,

establishing, improving, and providing basic operating support

for centers of excellence regarding research on autism.

(2) Research

Each center under paragraph (1) shall conduct basic and

clinical research into autism. Such research should include

investigations into the cause, diagnosis, early detection,

prevention, control, and treatment of autism. The centers, as a

group, shall conduct research including the fields of

developmental neurobiology, genetics, and psychopharmacology.

(3) Services for patients

(A) In general

A center under paragraph (1) may expend amounts provided

under such paragraph to carry out a program to make individuals

aware of opportunities to participate as subjects in research

conducted by the centers.

(B) Referrals and costs

A program under subparagraph (A) may, in accordance with such

criteria as the Director may establish, provide to the subjects

described in such subparagraph, referrals for health and other

services, and such patient care costs as are required for

research.

(C) Availability and access

The extent to which a center can demonstrate availability and

access to clinical services shall be considered by the Director

in decisions about awarding grants to applicants which meet the

scientific criteria for funding under this section.

(4) Coordination of centers; reports

The Director shall, as appropriate, provide for the

coordination of information among centers under paragraph (1) and

ensure regular communication between such centers, and may

require the periodic preparation of reports on the activities of

the centers and the submission of the reports to the Director.

(5) Organization of centers

Each center under paragraph (1) shall use the facilities of a

single institution, or be formed from a consortium of cooperating

institutions, meeting such requirements as may be prescribed by

the Director.

(6) Number of centers; duration of support

(A) In general

The Director shall provide for the establishment of not less

than five centers under paragraph (1).

(B) Duration

Support for a center established under paragraph (1) may be

provided under this section for a period of not to exceed 5

years. Such period may be extended for one or more additional

periods not exceeding 5 years if the operations of such center

have been reviewed by an appropriate technical and scientific

peer review group established by the Director and if such group

has recommended to the Director that such period should be

extended.

(c) Facilitation of research

The Director shall under subsection (a)(1) of this section

provide for a program under which samples of tissues and genetic

materials that are of use in research on autism are donated,

collected, preserved, and made available for such research. The

program shall be carried out in accordance with accepted scientific

and medical standards for the donation, collection, and

preservation of such samples.

(d) Public input

The Director shall under subsection (a)(1) of this section

provide for means through which the public can obtain information

on the existing and planned programs and activities of the National

Institutes of Health with respect to autism and through which the

Director can receive comments from the public regarding such

programs and activities.

(e) Funding

There are authorized to be appropriated such sums as may be

necessary to carry out this section. Amounts appropriated under

this subsection are in addition to any other amounts appropriated

for such purpose.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409C, as added Pub. L.

106-310, div. A, title I, Sec. 101, Oct. 17, 2000, 114 Stat. 1105.)

-COD-

CODIFICATION

Another section 409C of act July 1, 1944, was renumbered section

409G and is classified to section 284k of this title.

-End-

-CITE-

42 USC Sec. 284h 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284h. Pediatric Research Initiative

-STATUTE-

(a) Establishment

The Secretary shall establish within the Office of the Director

of NIH a Pediatric Research Initiative (referred to in this section

as the "Initiative") to conduct and support research that is

directly related to diseases, disorders, and other conditions in

children. The Initiative shall be headed by the Director of NIH.

(b) Purpose

The purpose of the Initiative is to provide funds to enable the

Director of NIH -

(1) to increase support for pediatric biomedical research

within the National Institutes of Health to realize the expanding

opportunities for advancement in scientific investigations and

care for children;

(2) to enhance collaborative efforts among the Institutes to

conduct and support multidisciplinary research in the areas that

the Director deems most promising; and

(3) in coordination with the Food and Drug Administration, to

increase the development of adequate pediatric clinical trials

and pediatric use information to promote the safer and more

effective use of prescription drugs in the pediatric population.

(c) Duties

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

NIH shall -

(1) consult with the Director of the National Institute of

Child Health and Human Development and the other national

research institutes, in considering their requests for new or

expanded pediatric research efforts, and consult with the

Administrator of the Health Resources and Services Administration

and other advisors as the Director determines to be appropriate;

(2) have broad discretion in the allocation of any Initiative

assistance among the Institutes, among types of grants, and

between basic and clinical research so long as the assistance is

directly related to the illnesses and conditions of children; and

(3) be responsible for the oversight of any newly appropriated

Initiative funds and annually report to Congress and the public

on the extent of the total funds obligated to conduct or support

pediatric research across the National Institutes of Health,

including the specific support and research awards allocated

through the Initiative.

(d) Authorization

For the purpose of carrying out this section, there are

authorized to be appropriated $50,000,000 for fiscal year 2001, and

such sums as may be necessary for each of the fiscal years 2002

through 2005.

(e) Transfer of funds

The Director of NIH may transfer amounts appropriated under this

section to any of the Institutes for a fiscal year to carry out the

purposes of the Initiative under this section.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409D, as added Pub. L.

106-310, div. A, title X, Sec. 1001, Oct. 17, 2000, 114 Stat.

1127.)

-COD-

CODIFICATION

Another section 409D of act July 1, 1944, was renumbered section

409H and is classified to section 284l of this title.

-End-

-CITE-

42 USC Sec. 284i 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284i. Autoimmune diseases

-STATUTE-

(a) Expansion, intensification, and coordination of activities

(1) In general

The Director of NIH shall expand, intensify, and coordinate

research and other activities of the National Institutes of

Health with respect to autoimmune diseases.

(2) Allocations by Director of NIH

With respect to amounts appropriated to carry out this section

for a fiscal year, the Director of NIH shall allocate the amounts

among the national research institutes that are carrying out

paragraph (1).

(3) Definition

The term "autoimmune disease" includes, for purposes of this

section such diseases or disorders with evidence of autoimmune

pathogensis (!1) as the Secretary determines to be appropriate.

(b) Coordinating Committee

(1) In general

The Secretary shall ensure that the Autoimmune Diseases

Coordinating Committee (referred to in this section as the

"Coordinating Committee") coordinates activities across the

National Institutes and with other Federal health programs and

activities relating to such diseases.

(2) Composition

The Coordinating Committee shall be composed of the directors

or their designees of each of the national research institutes

involved in research with respect to autoimmune diseases and

representatives of all other Federal departments and agencies

whose programs involve health functions or responsibilities

relevant to such diseases, including the Centers for Disease

Control and Prevention and the Food and Drug Administration.

(3) Chair

(A) In general

With respect to autoimmune diseases, the Chair of the

Committee shall serve as the principal advisor to the

Secretary, the Assistant Secretary for Health, and the Director

of NIH, and shall provide advice to the Director of the Centers

for Disease Control and Prevention, the Commissioner of Food

and Drugs, and other relevant agencies.

(B) Director of NIH

The Chair of the Committee shall be directly responsible to

the Director of NIH.

(c) Plan for NIH activities

(1) In general

Not later than 1 year after October 17, 2000, the Coordinating

Committee shall develop a plan for conducting and supporting

research and education on autoimmune diseases through the

national research institutes and shall periodically review and

revise the plan. The plan shall -

(A) provide for a broad range of research and education

activities relating to biomedical, psychosocial, and

rehabilitative issues, including studies of the

disproportionate impact of such diseases on women;

(B) identify priorities among the programs and activities of

the National Institutes of Health regarding such diseases; and

(C) reflect input from a broad range of scientists, patients,

and advocacy groups.

(2) Certain elements of plan

The plan under paragraph (1) shall, with respect to autoimmune

diseases, provide for the following as appropriate:

(A) Research to determine the reasons underlying the

incidence and prevalence of the diseases.

(B) Basic research concerning the etiology and causes of the

diseases.

(C) Epidemiological studies to address the frequency and

natural history of the diseases, including any differences

among the sexes and among racial and ethnic groups.

(D) The development of improved screening techniques.

(E) Clinical research for the development and evaluation of

new treatments, including new biological agents.

(F) Information and education programs for health care

professionals and the public.

(3) Implementation of plan

The Director of NIH shall ensure that programs and activities

of the National Institutes of Health regarding autoimmune

diseases are implemented in accordance with the plan under

paragraph (1).

(d) Reports to Congress

The Coordinating Committee under subsection (b)(1) of this

section shall biennially submit to the Committee on Commerce of the

House of Representatives, and the Committee on Health, Education,

Labor and Pensions of the Senate, a report that describes the

research, education, and other activities on autoimmune diseases

being conducted or supported through the national research

institutes, and that in addition includes the following:

(1) The plan under subsection (c)(1) of this section (or

revisions to the plan, as the case may be).

(2) Provisions specifying the amounts expended by the National

Institutes of Health with respect to each of the autoimmune

diseases included in the plan.

(3) Provisions identifying particular projects or types of

projects that should in the future be considered by the national

research institutes or other entities in the field of research on

autoimmune diseases.

(e) 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 2001 through 2005. The authorization of

appropriations established in the preceding sentence is in addition

to any other authorization of appropriations that is available for

conducting or supporting through the National Institutes of Health

research and other activities with respect to autoimmune diseases.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409E, as added Pub. L.

106-310, div. A, title XIX, Sec. 1901, Oct. 17, 2000, 114 Stat.

1153.)

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

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

Seventh Congress, Jan. 3, 2001.

-FOOTNOTE-

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

-End-

-CITE-

42 USC Sec. 284j 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284j. Muscular dystrophy research

-STATUTE-

(a) Coordination of activities

The Director of NIH shall expand and increase coordination in the

activities of the National Institutes of Health with respect to

research on muscular dystrophies, including Duchenne muscular

dystrophy.

(b) Administration of program; collaboration among agencies

The Director of NIH shall carry out this section through the

appropriate institutes, including the National Institute of

Neurological Disorders and Stroke and in collaboration with any

other agencies that the Director determines appropriate.

(c) Authorization of appropriations

There are authorized to be appropriated such sums as may be

necessary to carry out this section for each of the fiscal years

2001 through 2005. Amounts appropriated under this subsection shall

be in addition to any other amounts appropriated for such purpose.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409F, as added Pub. L.

106-310, div. A, title XXII, Sec. 2201, Oct. 17, 2000, 114 Stat.

1157.)

-End-

-CITE-

42 USC Sec. 284k 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284k. Clinical research

-STATUTE-

(a) In general

The Director of National Institutes of Health shall undertake

activities to support and expand the involvement of the National

Institutes of Health in clinical research.

(b) Requirements

In carrying out subsection (a) of this section, the Director of

National Institutes of Health shall -

(1) consider the recommendations of the Division of Research

Grants Clinical Research Study Group and other recommendations

for enhancing clinical research; and

(2) establish intramural and extramural clinical research

fellowship programs directed specifically at medical and dental

students and a continuing education clinical research training

program at the National Institutes of Health.

(c) Support for the diverse needs of clinical research

The Director of National Institutes of Health, in cooperation

with the Directors of the Institutes, Centers, and Divisions of the

National Institutes of Health, shall support and expand the

resources available for the diverse needs of the clinical research

community, including inpatient, outpatient, and critical care

clinical research.

(d) Peer review

The Director of National Institutes of Health shall establish

peer review mechanisms to evaluate applications for the awards and

fellowships provided for in subsection (b)(2) of this section and

section 284l of this title. Such review mechanisms shall include

individuals who are exceptionally qualified to appraise the merits

of potential clinical research training and research grant

proposals.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409G, formerly Sec. 409C, as

added Pub. L. 106-505, title II, Sec. 203, Nov. 13, 2000, 114 Stat.

2326; renumbered Sec. 409G, Pub. L. 107-109, Sec. 3(1), Jan. 4,

2002, 115 Stat. 1408.)

-REFTEXT-

REFERENCES IN TEXT

Section 284l of this title, referred to in subsec. (d), was in

the original "section 409D", and was translated as meaning section

409D of act July 1, 1944, ch. 373, as added by section 204(b) of

Pub. L. 106-505. Such section 409D was renumbered section 409H of

act July 1, 1944, ch. 373, by Pub. L. 107-109, Sec. 3(2), Jan. 4,

2002, 115 Stat. 1408. Another section 409D of act July 1, 1944, ch.

373, as added by section 1001 of Pub. L. 106-310, is classified to

section 284h of this title.

-MISC1-

FINDINGS AND PURPOSE

Pub. L. 106-505, title II, Sec. 202, Nov. 13, 2000, 114 Stat.

2325, provided that:

"(a) Findings. - Congress makes the following findings:

"(1) Clinical research is critical to the advancement of

scientific knowledge and to the development of cures and improved

treatment for disease.

"(2) Tremendous advances in biology are opening doors to new

insights into human physiology, pathophysiology and disease,

creating extraordinary opportunities for clinical research.

"(3) Clinical research includes translational research which is

an integral part of the research process leading to general human

applications. It is the bridge between the laboratory and new

methods of diagnosis, treatment, and prevention and is thus

essential to progress against cancer and other diseases.

"(4) The United States will spend more than $1,200,000,000,000

on health care in 1999, but the Federal budget for health

research at the National Institutes of Health was $15,600,000,000

only 1 percent of that total.

"(5) Studies at the Institute of Medicine, the National

Research Council, and the National Academy of Sciences have all

addressed the current problems in clinical research.

"(6) The Director of the National Institutes of Health has

recognized the current problems in clinical research and

appointed a special panel, which recommended expanded support for

existing National Institutes of Health clinical research programs

and the creation of new initiatives to recruit and retain

clinical investigators.

"(7) The current level of training and support for health

professionals in clinical research is fragmented, undervalued,

and underfunded.

"(8) Young investigators are not only apprentices for future

positions but a crucial source of energy, enthusiasm, and ideas

in the day-to-day research that constitutes the scientific

enterprise. Serious questions about the future of life-science

research are raised by the following:

"(A) The number of young investigators applying for grants

dropped by 54 percent between 1985 and 1993.

"(B) The number of physicians applying for first-time

National Institutes of Health research project grants fell from

1226 in 1994 to 963 in 1998, a 21 percent reduction.

"(C) Newly independent life-scientists are expected to raise

funds to support their new research programs and a substantial

proportion of their own salaries.

"(9) The following have been cited as reasons for the decline

in the number of active clinical researchers, and those choosing

this career path:

"(A) A medical school graduate incurs an average debt of

$85,619, as reported in the Medical School Graduation

Questionnaire by the Association of American Medical Colleges

(AAMC).

"(B) The prolonged period of clinical training required

increases the accumulated debt burden.

"(C) The decreasing number of mentors and role models.

"(D) The perceived instability of funding from the National

Institutes of Health and other Federal agencies.

"(E) The almost complete absence of clinical research

training in the curriculum of training grant awardees.

"(F) Academic Medical Centers are experiencing difficulties

in maintaining a proper environment for research in a highly

competitive health care marketplace, which are compounded by

the decreased willingness of third party payers to cover health

care costs for patients engaged in research studies and

research procedures.

"(10) In 1960, general clinical research centers were

established under the Office of the Director of the National

Institutes of Health with an initial appropriation of $3,000,000.

"(11) Appropriations for general clinical research centers in

fiscal year 1999 equaled $200,500,000.

"(12) Since the late 1960s, spending for general clinical

research centers has declined from approximately 3 percent to 1

percent of the National Institutes of Health budget.

"(13) In fiscal year 1999, there were 77 general clinical

research centers in operation, supplying patients in the areas in

which such centers operate with access to the most modern

clinical research and clinical research facilities and

technologies.

"(b) Purpose. - It is the purpose of this title [see Short Title

of 2000 Amendments note set out under section 201 of this title] to

provide additional support for and to expand clinical research

programs."

OVERSIGHT BY GENERAL ACCOUNTING OFFICE

Pub. L. 106-505, title II, Sec. 207, Nov. 13, 2000, 114 Stat.

2330, provided that: "Not later than 18 months after the date of

the enactment of this Act [Nov. 13, 2000], the Comptroller General

of the United States shall submit to the Congress a reporting [sic]

describing the extent to which the National Institutes of Health

has complied with the amendments made by this title [see Short

Title of 2000 Amendments note set out under section 201 of this

title]."

-End-

-CITE-

42 USC Sec. 284l 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284l. Enhancement awards

-STATUTE-

(a) Mentored Patient-Oriented Research Career Development Awards

(1) Grants

(A) In general

The Director of the National Institutes of Health shall make

grants (to be referred to as "Mentored Patient-Oriented

Research Career Development Awards") to support individual

careers in clinical research at general clinical research

centers or at other institutions that have the infrastructure

and resources deemed appropriate for conducting

patient-oriented clinical research.

(B) Use

Grants under subparagraph (A) shall be used to support

clinical investigators in the early phases of their independent

careers by providing salary and such other support for a period

of supervised study.

(2) Applications

An application for a grant under this subsection shall be

submitted by an individual scientist at such time as the Director

may require.

(3) Authorization of appropriations

For the purpose of carrying out this subsection, there are

authorized to be appropriated such sums as may be necessary for

each fiscal year.

(b) Mid-Career Investigator Awards in Patient-Oriented Research

(1) Grants

(A) In general

The Director of the National Institutes of Health shall make

grants (to be referred to as "Mid-Career Investigator Awards in

Patient-Oriented Research") to support individual clinical

research projects at general clinical research centers or at

other institutions that have the infrastructure and resources

deemed appropriate for conducting patient-oriented clinical

research.

(B) Use

Grants under subparagraph (A) shall be used to provide

support for mid-career level clinicians to allow such

clinicians to devote time to clinical research and to act as

mentors for beginning clinical investigators.

(2) Applications

An application for a grant under this subsection shall be

submitted by an individual scientist at such time as the Director

requires.

(3) Authorization of appropriations

For the purpose of carrying out this subsection, there are

authorized to be appropriated such sums as may be necessary for

each fiscal year.

(c) Graduate Training in Clinical Investigation Award

(1) In general

The Director of the National Institutes of Health shall make

grants (to be referred to as "Graduate Training in Clinical

Investigation Awards") to support individuals pursuing master's

or doctoral degrees in clinical investigation.

(2) Applications

An application for a grant under this subsection shall be

submitted by an individual scientist at such time as the Director

may require.

(3) Limitations

Grants under this subsection shall be for terms of 2 years or

more and shall provide stipend, tuition, and institutional

support for individual advanced degree programs in clinical

investigation.

(4) Definition

As used in this subsection, the term "advanced degree programs

in clinical investigation" means programs that award a master's

or Ph.D. degree in clinical investigation after 2 or more years

of training in areas such as the following:

(A) Analytical methods, biostatistics, and study design.

(B) Principles of clinical pharmacology and pharmacokinetics.

(C) Clinical epidemiology.

(D) Computer data management and medical informatics.

(E) Ethical and regulatory issues.

(F) Biomedical writing.

(5) Authorization of appropriations

For the purpose of carrying out this subsection, there are

authorized to be appropriated such sums as may be necessary for

each fiscal year.

(d) Clinical Research Curriculum Awards

(1) In general

The Director of the National Institutes of Health shall make

grants (to be referred to as "Clinical Research Curriculum

Awards") to institutions for the development and support of

programs of core curricula for training clinical investigators,

including medical students. Such core curricula may include

training in areas such as the following:

(A) Analytical methods, biostatistics, and study design.

(B) Principles of clinical pharmacology and pharmacokinetics.

(C) Clinical epidemiology.

(D) Computer data management and medical informatics.

(E) Ethical and regulatory issues.

(F) Biomedical writing.

(2) Applications

An application for a grant under this subsection shall be

submitted by an individual institution or a consortium of

institutions at such time as the Director may require. An

institution may submit only one such application.

(3) Limitations

Grants under this subsection shall be for terms of up to 5

years and may be renewable.

(4) Authorization of appropriations

For the purpose of carrying out this subsection, there are

authorized to be appropriated such sums as may be necessary for

each fiscal year.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409H, formerly Sec. 409D, as

added Pub. L. 106-505, title II, Sec. 204(b), Nov. 13, 2000, 114

Stat. 2327; renumbered Sec. 409H, Pub. L. 107-109, Sec. 3(2), Jan.

4, 2002, 115 Stat. 1408.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 284k of this title.

-End-

-CITE-

42 USC Sec. 284m 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part B - General Provisions Respecting National Research Institutes

-HEAD-

Sec. 284m. Program for pediatric studies of drugs

-STATUTE-

(a) List of drugs for which pediatric studies are needed

(1) In general

Not later than one year after January 4, 2002, the Secretary,

acting through the Director of the National Institutes of Health

and in consultation with the Commissioner of Food and Drugs and

experts in pediatric research, shall develop, prioritize, and

publish an annual list of approved drugs for which -

(A)(i) there is an approved application under section 505(j)

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j));

(ii) there is a submitted application that could be approved

under the criteria of section 505(j) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(j));

(iii) there is no patent protection or market exclusivity

protection under the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 301 et seq.); or

(iv) there is a referral for inclusion on the list under

section 505A(d)(4)(C) of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 355a(d)(4)(C)); and

(B) in the case of a drug referred to in clause (i), (ii), or

(iii) of subparagraph (A), additional studies are needed to

assess the safety and effectiveness of the use of the drug in

the pediatric population.

(2) Consideration of available information

In developing and prioritizing the list under paragraph (1),

the Secretary shall consider, for each drug on the list -

(A) the availability of information concerning the safe and

effective use of the drug in the pediatric population;

(B) whether additional information is needed;

(C) whether new pediatric studies concerning the drug may

produce health benefits in the pediatric population; and

(D) whether reformulation of the drug is necessary.

(b) Contracts for pediatric studies

The Secretary shall award contracts to entities that have the

expertise to conduct pediatric clinical trials (including qualified

universities, hospitals, laboratories, contract research

organizations, federally funded programs such as pediatric

pharmacology research units, other public or private institutions,

or individuals) to enable the entities to conduct pediatric studies

concerning one or more drugs identified in the list described in

subsection (a) of this section.

(c) Process for contracts and labeling changes

(1) Written request to holders of approved applications for drugs

lacking exclusivity

The Commissioner of Food and Drugs, in consultation with the

Director of the National Institutes of Health, may issue a

written request (which shall include a timeframe for negotiations

for an agreement) for pediatric studies concerning a drug

identified in the list described in subsection (a)(1)(A) of this

section (except clause (iv)) to all holders of an approved

application for the drug under section 505 of the Federal Food,

Drug, and Cosmetic Act [21 U.S.C. 355]. Such a written request

shall be made in a manner equivalent to the manner in which a

written request is made under subsection (a) or (b) of section

505A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.

355a], including with respect to information provided on the

pediatric studies to be conducted pursuant to the request.

(2) Requests for contract proposals

If the Commissioner of Food and Drugs does not receive a

response to a written request issued under paragraph (1) within

30 days of the date on which a request was issued, or if a

referral described in subsection (a)(1)(A)(iv) of this section is

made, the Secretary, acting through the Director of the National

Institutes of Health and in consultation with the Commissioner of

Food and Drugs, shall publish a request for contract proposals to

conduct the pediatric studies described in the written request.

(3) Disqualification

A holder that receives a first right of refusal shall not be

entitled to respond to a request for contract proposals under

paragraph (2).

(4) Guidance

Not later than 270 days after January 4, 2002, the Commissioner

of Food and Drugs shall promulgate guidance to establish the

process for the submission of responses to written requests under

paragraph (1).

(5) Contracts

A contract under this section may be awarded only if a proposal

for the contract is submitted to the Secretary in such form and

manner, and containing such agreements, assurances, and

information as the Secretary determines to be necessary to carry

out this section.

(6) Reporting of studies

(A) In general

On completion of a pediatric study in accordance with a

contract awarded under this section, a report concerning the

study shall be submitted to the Director of the National

Institutes of Health and the Commissioner of Food and Drugs.

The report shall include all data generated in connection with

the study.

(B) Availability of reports

Each report submitted under subparagraph (A) shall be

considered to be in the public domain (subject to section

505A(d)(4)(D) of the Federal Food, Drug, and Cosmetic Act (21

U.S.C. 355a(d)(4)(D)) (!1) and shall be assigned a docket

number by the Commissioner of Food and Drugs. An interested

person may submit written comments concerning such pediatric

studies to the Commissioner of Food and Drugs, and the written

comments shall become part of the docket file with respect to

each of the drugs.

(C) Action by Commissioner

The Commissioner of Food and Drugs shall take appropriate

action in response to the reports submitted under subparagraph

(A) in accordance with paragraph (7).

(7) Requests for labeling change

During the 180-day period after the date on which a report is

submitted under paragraph (6)(A), the Commissioner of Food and

Drugs shall -

(A) review the report and such other data as are available

concerning the safe and effective use in the pediatric

population of the drug studied;

(B) negotiate with the holders of approved applications for

the drug studied for any labeling changes that the Commissioner

of Food and Drugs determines to be appropriate and requests the

holders to make; and

(C)(i) place in the public docket file a copy of the report

and of any requested labeling changes; and

(ii) publish in the Federal Register a summary of the report

and a copy of any requested labeling changes.

(8) Dispute resolution

(A) Referral to Pediatric Advisory Subcommittee of the

Anti-Infective Drugs Advisory Committee

If, not later than the end of the 180-day period specified in

paragraph (7), the holder of an approved application for the

drug involved does not agree to any labeling change requested

by the Commissioner of Food and Drugs under that paragraph, the

Commissioner of Food and Drugs shall refer the request to the

Pediatric Advisory Subcommittee of the Anti-Infective Drugs

Advisory Committee.

(B) Action by the Pediatric Advisory Subcommittee of the

Anti-Infective Drugs Advisory Committee

Not later than 90 days after receiving a referral under

subparagraph (A), the Pediatric Advisory Subcommittee of the

Anti-Infective Drugs Advisory Committee shall -

(i) review the available information on the safe and

effective use of the drug in the pediatric population,

including study reports submitted under this section; and

(ii) make a recommendation to the Commissioner of Food and

Drugs as to appropriate labeling changes, if any.

(9) FDA determination

Not later than 30 days after receiving a recommendation from

the Pediatric Advisory Subcommittee of the Anti-Infective Drugs

Advisory Committee under paragraph (8)(B)(ii) with respect to a

drug, the Commissioner of Food and Drugs shall consider the

recommendation and, if appropriate, make a request to the holders

of approved applications for the drug to make any labeling change

that the Commissioner of Food and Drugs determines to be

appropriate.

(10) Failure to agree

If a holder of an approved application for a drug, within 30

days after receiving a request to make a labeling change under

paragraph (9), does not agree to make a requested labeling

change, the Commissioner may deem the drug to be misbranded under

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

(11) No effect on authority

Nothing in this subsection limits the authority of the United

States to bring an enforcement action under the Federal Food,

Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] when a drug lacks

appropriate pediatric labeling. Neither course of action (the

Pediatric Advisory Subcommittee of the Anti-Infective Drugs

Advisory Committee process or an enforcement action referred to

in the preceding sentence) shall preclude, delay, or serve as the

basis to stay the other course of action.

(12) Recommendation for formulation changes

If a pediatric study completed under public contract indicates

that a formulation change is necessary and the Secretary agrees,

the Secretary shall send a nonbinding letter of recommendation

regarding that change to each holder of an approved application.

(d) Authorization of appropriations

(1) In general

There are authorized to be appropriated to carry out this

section -

(A) $200,000,000 for fiscal year 2002; and

(B) such sums as are necessary for each of the five

succeeding fiscal years.

(2) Availability

Any amount appropriated under paragraph (1) shall remain

available to carry out this section until expended.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 409I, as added Pub. L.

107-109, Sec. 3(3), Jan. 4, 2002, 115 Stat. 1408.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.

(a)(1)(A)(iii) and (c)(10), (11), 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.

-MISC1-

PEDIATRIC PHARMACOLOGY ADVISORY COMMITTEE

Pub. L. 107-109, Sec. 14, Jan. 4, 2002, 115 Stat. 1419, provided

that:

"(a) In General. - The Secretary of Health and Human Services

shall, under section 222 of the Public Health Service Act (42

U.S.C. 217a), convene and consult an advisory committee on

pediatric pharmacology (referred to in this section as the

'advisory committee').

"(b) Purpose. -

"(1) In general. - The advisory committee shall advise and make

recommendations to the Secretary, through the Commissioner of

Food and Drugs and in consultation with the Director of the

National Institutes of Health, on matters relating to pediatric

pharmacology.

"(2) Matters included. - The matters referred to in paragraph

(1) include -

"(A) pediatric research conducted under sections 351, 409I,

and 499 of the Public Health Service Act [sections 262, 284m,

and 290b of this title] and sections 501, 502, 505, and 505A of

the Federal Food, Drug, and Cosmetic Act [sections 351, 352,

355, and 355a of Title 21, Food and Drugs];

"(B) identification of research priorities related to

pediatric pharmacology and the need for additional treatments

of specific pediatric diseases or conditions; and

"(C) the ethics, design, and analysis of clinical trials

related to pediatric pharmacology.

"(c) Composition. - The advisory committee shall include

representatives of pediatric health organizations, pediatric

researchers, relevant patient and patient-family organizations, and

other experts selected by the Secretary."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 290b of this title; title

21 section 355a.

-FOOTNOTE-

(!1) So in original. There probably should be an additional closing

parenthesis.

-End-

-CITE-

42 USC Part C - Specific Provisions Respecting National

Research Institutes 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

-HEAD-

PART C - SPECIFIC PROVISIONS RESPECTING NATIONAL RESEARCH

INSTITUTES

-SECREF-

PART REFERRED TO IN OTHER SECTIONS

This part is referred to in sections 284a, 289c-1 of this title.

-End-

-CITE-

42 USC subpart 1 - national cancer institute 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

SUBPART 1 - NATIONAL CANCER INSTITUTE

-SECREF-

SUBPART REFERRED TO IN OTHER SECTIONS

This subpart is referred to in section 280e-4 of this title.

-End-

-CITE-

42 USC Sec. 285 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285. Purpose of Institute

-STATUTE-

The general purpose of the National Cancer Institute (hereafter

in this subpart referred to as the "Institute") is the conduct and

support of research, training, health information dissemination,

and other programs with respect to the cause, diagnosis,

prevention, and treatment of cancer, rehabilitation from cancer,

and the continuing care of cancer patients and the families of

cancer patients.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 410, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 832; amended Pub. L.

100-607, title I, Sec. 121, Nov. 4, 1988, 102 Stat. 3054.)

-MISC1-

AMENDMENTS

1988 - Pub. L. 100-607 inserted ", rehabilitation from cancer,"

after "treatment of cancer".

-End-

-CITE-

42 USC Sec. 285a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a. National Cancer Program

-STATUTE-

The National Cancer Program shall consist of (1) an expanded,

intensified, and coordinated cancer research program encompassing

the research programs conducted and supported by the Institute and

the related research programs of the other national research

institutes, including an expanded and intensified research program

for the prevention of cancer caused by occupational or

environmental exposure to carcinogens, and (2) the other programs

and activities of the Institute.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 411, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 832.)

-End-

-CITE-

42 USC Sec. 285a-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-1. Cancer control programs

-STATUTE-

The Director of the Institute shall establish and support

demonstration, education, and other programs for the detection,

diagnosis, prevention, and treatment of cancer and for

rehabilitation and counseling respecting cancer. Programs

established and supported under this section shall include -

(1) locally initiated education and demonstration programs (and

regional networks of such programs) to transmit research results

and to disseminate information respecting -

(A) the detection, diagnosis, prevention, and treatment of

cancer,

(B) the continuing care of cancer patients and the families

of cancer patients, and

(C) rehabilitation and counseling respecting cancer,

to physicians and other health professionals who provide care to

individuals who have cancer;

(2) the demonstration of and the education of students of the

health professions and health professionals in -

(A) effective methods for the prevention and early detection

of cancer and the identification of individuals with a high

risk of developing cancer, and

(B) improved methods of patient referral to appropriate

centers for early diagnosis and treatment of cancer; and

(3) the demonstration of new methods for the dissemination of

information to the general public concerning the prevention,

early detection, diagnosis, and treatment and control of cancer

and information concerning unapproved and ineffective methods,

drugs, and devices for the diagnosis, prevention, treatment, and

control of cancer.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 412, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 832.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 285a-6, 285a-7, 285a-8 of

this title.

-End-

-CITE-

42 USC Sec. 285a-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-2. Special authorities of Director

-STATUTE-

(a) Information and education program

(1) The Director of the Institute shall establish an information

and education program to collect, identify, analyze, and

disseminate on a timely basis, through publications and other

appropriate means, to cancer patients and their families,

physicians and other health professionals, and the general public,

information on cancer research, diagnosis, prevention, and

treatment (including information respecting nutrition programs for

cancer patients and the relationship between nutrition and cancer).

The Director of the Institute may take such action as may be

necessary to insure that all channels for the dissemination and

exchange of scientific knowledge and information are maintained

between the Institute and the public and between the Institute and

other scientific, medical, and biomedical disciplines and

organizations nationally and internationally.

(2) In carrying out paragraph (1), the Director of the Institute

shall -

(A) provide public and patient information and education

programs, providing information that will help individuals take

personal steps to reduce their risk of cancer, to make them aware

of early detection techniques and to motivate appropriate

utilization of those techniques, to help individuals deal with

cancer if it strikes, and to provide information to improve

long-term survival;

(B) continue and expand programs to provide physicians and the

public with state-of-the-art information on the treatment of

particular forms of cancers, and to identify those clinical

trials that might benefit patients while advancing knowledge of

cancer treatment;

(C) assess the incorporation of state-of-the-art cancer

treatments into clinical practice and the extent to which cancer

patients receive such treatments and include the results of such

assessments in the biennial reports required under section 284b

of this title;

(D) maintain and operate the International Cancer Research Data

Bank, which shall collect, catalog, store, and disseminate

insofar as feasible the results of cancer research and treatment

undertaken in any country for the use of any person involved in

cancer research and treatment in any country; and

(E) to the extent practicable, in disseminating the results of

such cancer research and treatment, utilize information systems

available to the public.

(b) National Cancer Program

The Director of the Institute in carrying out the National Cancer

Program -

(1) shall establish or support the large-scale production or

distribution of specialized biological materials and other

therapeutic substances for cancer research and set standards of

safety and care for persons using such materials;

(2) shall, in consultation with the advisory council for the

Institute, support (A) research in the cancer field outside the

United States by highly qualified foreign nationals which can be

expected to benefit the American people, (B) collaborative

research involving American and foreign participants, and (C) the

training of American scientists abroad and foreign scientists in

the United States;

(3) shall, in consultation with the advisory council for the

Institute, support appropriate programs of education and training

(including continuing education and laboratory and clinical

research training);

(4) shall encourage and coordinate cancer research by

industrial concerns where such concerns evidence a particular

capability for such research;

(5) may obtain (after consultation with the advisory council

for the Institute and in accordance with section 3109 of title 5,

but without regard to the limitation in such section on the

period of service) the services of not more than one hundred and

fifty-one experts or consultants who have scientific or

professional qualifications;

(6)(A) may, in consultation with the advisory council for the

Institute, acquire, construct, improve, repair, operate, and

maintain laboratories, other research facilities, equipment, and

such other real or personal property as the Director determines

necessary;

(B) may, in consultation with the advisory council for the

Institute, make grants for construction or renovation of

facilities; and

(C) may, in consultation with the advisory council for the

Institute, acquire, without regard to section 8141 of title 40,

by lease or otherwise through the Administrator of General

Services, buildings or parts of buildings in the District of

Columbia or communities located adjacent to the District of

Columbia for the use of the Institute for a period not to exceed

ten years;

(7) may, in consultation with the advisory council for the

Institute, appoint one or more advisory committees composed of

such private citizens and officials of Federal, State, and local

governments to advise the Director with respect to the Director's

functions;

(8) may, subject to section 284(b)(2) of this title and without

regard to section 3324 of title 31 and section 5 of title 41,

enter into such contracts, leases, cooperative agreements, as may

be necessary in the conduct of functions of the Director, with

any public agency, or with any person, firm, association,

corporation, or educational institution; and

(9) shall, notwithstanding section 284(a) of this title,

prepare and submit, directly to the President for review and

transmittal to Congress, an annual budget estimate (including an

estimate of the number and type of personnel needs for the

Institute) for the National Cancer Program, after reasonable

opportunity for comment (but without change) by the Secretary,

the Director of NIH, and the Institute's advisory council.

Except as otherwise provided, experts and consultants whose

services are obtained under paragraph (5) shall be paid or

reimbursed, in accordance with title 5 for their travel to and from

their place of service and for other expenses associated with their

assignment. Such expenses shall not be allowed in connection with

the assignment of an expert or consultant whose services are

obtained under paragraph (5) unless the expert or consultant has

agreed in writing to complete the entire period of the assignment

or one year of the assignment, whichever is shorter, unless

separated or reassigned for reasons which are beyond the control of

the expert or consultant and which are acceptable to the Director

of the Institute. If the expert or consultant violates the

agreement, the money spent by the United States for such expenses

is recoverable from the expert or consultant as a debt due the

United States. The Secretary may waive in whole or in part a right

of recovery under the preceding sentence.

(c) Pre-clinical models to evaluate promising pediatric cancer

therapies

(1) Expansion and coordination of activities

The Director of the National Cancer Institute shall expand,

intensify, and coordinate the activities of the Institute with

respect to research on the development of preclinical models to

evaluate which therapies are likely to be effective for treating

pediatric cancer.

(2) Coordination with other institutes

The Director of the Institute shall coordinate the activities

under paragraph (1) with similar activities conducted by other

national research institutes and agencies of the National

Institutes of Health to the extent that those Institutes and

agencies have responsibilities that are related to pediatric

cancer.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 413, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 833; amended Pub. L.

100-607, title I, Sec. 122, Nov. 4, 1988, 102 Stat. 3054; Pub. L.

101-93, Sec. 5(c), Aug. 16, 1989, 103 Stat. 611; Pub. L. 103-43,

title III, Sec. 301(a)(2), June 10, 1993, 107 Stat. 150; Pub. L.

107-109, Sec. 15(b), Jan. 4, 2002, 115 Stat. 1420.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 relating to reimbursement for travel

expenses, referred to in subsec. (b), are classified generally to

section 5701 et seq. of Title 5, Government Organization and

Employees.

-COD-

CODIFICATION

In subsec. (b)(6)(C), "section 8141 of title 40" substituted for

"the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L.

107-217, Sec. 5(c), Aug. 21, 2002, 116 Stat. 1303, the first

section of which enacted Title 40, Public Buildings, Property, and

Works.

-MISC1-

AMENDMENTS

2002 - Subsec. (c). Pub. L. 107-109 added subsec. (c).

1993 - Subsec. (b)(9). Pub. L. 103-43 struck out subpar. (A)

designation and subpar. (B) which permitted Director to receive

from President and Office of Management and Budget directly all

funds appropriated by Congress for obligation and expenditure by

Institute.

1989 - Subsec. (a)(1). Pub. L. 101-93 substituted "Institute and"

for "Institute and and".

1988 - Subsec. (a). Pub. L. 100-607, Sec. 122(1), designated

existing provisions as par. (1), substituted "education program"

for "education center", inserted "and the public and between the

Institute and" after "between the Institute", and added par. (2).

Subsec. (b)(5). Pub. L. 100-607, Sec. 122(2)(A), substituted

"after consultation with" for "with the approval of".

Subsec. (b)(8) to (10). Pub. L. 100-607, Sec. 122(2)(B), inserted

"and" after "or educational institution;" in par. (8), redesignated

par. (10) as (9), and struck out former par. (9) which related to

International Cancer Research Data Bank.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 285a-6, 285a-7, 285a-8 of

this title.

-End-

-CITE-

42 USC Sec. 285a-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-3. National cancer research and demonstration centers

-STATUTE-

(a) Cooperative agreements and grants for establishing and

supporting

(1) The Director of the Institute may enter into cooperative

agreements with and make grants to public or private nonprofit

entities to pay all or part of the cost of planning, establishing,

or strengthening, and providing basic operating support for centers

for basic and clinical research into, training in, and

demonstration of advanced diagnostic, prevention, control, and

treatment methods for cancer.

(2) A cooperative agreement or grant under paragraph (1) shall be

entered into in accordance with policies established by the

Director of NIH and after consultation with the Institute's

advisory council.

(b) Uses for Federal payments under cooperative agreements or

grants

Federal payments made under a cooperative agreement or grant

under subsection (a) of this section may be used for -

(1) construction (notwithstanding any limitation under section

289e of this title);

(2) staffing and other basic operating costs, including such

patient care costs as are required for research;

(3) clinical training, including training for allied health

professionals, continuing education for health professionals and

allied health professions personnel, and information programs for

the public respecting cancer; and

(4) demonstration purposes.

As used in this paragraph, the term "construction" does not include

the acquisition of land, and the term "training" does not include

research training for which Ruth L. Kirschstein National Research

Service Awards may be provided under section 288 of this title.

(c) Period of support; additional periods

Support of a center under subsection (a) of this section may be

for a period of not to exceed five years. Such period may be

extended by the Director for additional periods of not more than

five years each if the operations of such center have been reviewed

by an appropriate technical and scientific peer review group

established by the Director and if such group has recommended to

the Director that such period should be extended.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 414, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 835; amended Pub. L.

100-607, title I, Sec. 123, Nov. 4, 1988, 102 Stat. 3055; Pub. L.

107-206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat. 874.)

-MISC1-

AMENDMENTS

2002 - Subsec. (b). Pub. L. 107-206 substituted "Ruth L.

Kirschstein National Research Service Awards" for "National

Research Service Awards" in concluding provisions.

1988 - Subsec. (a)(1). Pub. L. 100-607 inserted "control," after

"prevention,".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 285a-6, 285a-7 of this

title.

-End-

-CITE-

42 USC Sec. 285a-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-4. President's Cancer Panel; establishment, membership,

etc., functions

-STATUTE-

(a)(1) The President's Cancer Panel (hereafter in this section

referred to as the "Panel") shall be composed of three persons

appointed by the President who by virtue of their training,

experience, and background are exceptionally qualified to appraise

the National Cancer Program. At least two members of the Panel

shall be distinguished scientists or physicians.

(2)(A) Members of the Panel shall be appointed for three-year

terms, except that (i) 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 only for the

remainder of such term, and (ii) a member may serve until the

member's successor has taken office. If a vacancy occurs in the

Panel, the President shall make an appointment to fill the vacancy

not later than 90 days after the date the vacancy occurred.

(B) The President shall designate one of the members to serve as

the chairman of the Panel for a term of one year.

(C) Members of the Panel shall each be entitled to receive the

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

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

traveltime) during which they are engaged in the actual performance

of duties as members of the Panel and shall be paid or reimbursed,

in accordance with title 5, for their travel to and from their

place of service and for other expenses associated with their

assignment.

(3) The Panel shall meet at the call of the chairman, but not

less often than four times a year. A transcript shall be kept of

the proceedings of each meeting of the Panel, and the chairman

shall make such transcript available to the public.

(b) The Panel shall monitor the development and execution of the

activities of the National Cancer Program, and shall report

directly to the President. Any delays or blockages in rapid

execution of the Program shall immediately be brought to the

attention of the President. The Panel shall submit to the President

periodic progress reports on the National Cancer Program and shall

submit to the President, the Secretary, and the Congress an annual

evaluation of the efficacy of the Program and suggestions for

improvements, and shall submit such other reports as the President

shall direct.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 415, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 835.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 relating to reimbursement for travel

expenses, referred to in subsec. (a)(2)(C), are classified

generally to section 5701 et seq. of Title 5, Government

Organization and Employees.

-MISC1-

TERMINATION OF REPORTING REQUIREMENTS

For termination, effective May 15, 2000, of provisions in subsec.

(b) of this section relating to the requirement that the Panel

submit to Congress an annual evaluation of the efficacy of the

Program and suggestions for improvements, see section 3003 of Pub.

L. 104-66, as amended, set out as a note under section 1113 of

Title 31, Money and Finance, and page 189 of House Document No.

103-7.

TERMINATION OF ADVISORY PANELS

Advisory panels 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 panel

established by the President or an officer of the Federal

Government, such panel is renewed by appropriate action prior to

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

established by the Congress, its duration is otherwise provided by

law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

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

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

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

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

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

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

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

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

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

under section 5376 of Title 5.

-End-

-CITE-

42 USC Sec. 285a-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-5. Associate Director for Prevention; appointment;

function

-STATUTE-

(a) There shall be in the Institute an Associate Director for

Prevention to coordinate and promote the programs in the Institute

concerning the prevention of cancer. The Associate Director shall

be appointed by the Director of the Institute from individuals who

because of their professional training or experience are experts in

public health or preventive medicine.

(b) The Associate Director for Prevention shall prepare for

inclusion in the biennial report made under section 284b of this

title a description of the prevention activities of the Institute,

including a description of the staff and resources allocated to

those activities.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 416, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 836.)

-End-

-CITE-

42 USC Sec. 285a-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-6. Breast and gynecological cancers

-STATUTE-

(a) Expansion and coordination of activities

The Director of the Institute, in consultation with the National

Cancer Advisory Board, shall expand, intensify, and coordinate the

activities of the Institute with respect to research on breast

cancer, ovarian cancer, and other cancers of the reproductive

system of women.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of

the Director under subsection (a) of this section with similar

activities conducted by other national research institutes and

agencies of the National Institutes of Health to the extent that

such Institutes (!1) and agencies have responsibilities that are

related to breast cancer and other cancers of the reproductive

system of women.

(c) Programs for breast cancer

(1) In general

In carrying out subsection (a) of this section, the Director of

the Institute shall conduct or support research to expand the

understanding of the cause of, and to find a cure for, breast

cancer. Activities under such subsection shall provide for an

expansion and intensification of the conduct and support of -

(A) basic research concerning the etiology and causes of

breast cancer;

(B) clinical research and related activities concerning the

causes, prevention, detection and treatment of breast cancer;

(C) control programs with respect to breast cancer in

accordance with section 285a-1 of this title, including

community-based programs designed to assist women who are

members of medically underserved populations, low-income

populations, or minority groups;

(D) information and education programs with respect to breast

cancer in accordance with section 285a-2 of this title; and

(E) research and demonstration centers with respect to breast

cancer in accordance with section 285a-3 of this title,

including the development and operation of centers for breast

cancer research to bring together basic and clinical,

biomedical and behavioral scientists to conduct basic,

clinical, epidemiological, psychosocial, prevention and

treatment research and related activities on breast cancer.

Not less than six centers shall be operated under subparagraph

(E). Activities of such centers should include supporting new and

innovative research and training programs for new researchers.

Such centers shall give priority to expediting the transfer of

research advances to clinical applications.

(2) Implementation of plan for programs

(A) The Director of the Institute shall ensure that the

research programs described in paragraph (1) are implemented in

accordance with a plan for the programs. Such plan shall include

comments and recommendations that the Director of the Institute

considers appropriate, with due consideration provided to the

professional judgment needs of the Institute as expressed in the

annual budget estimate prepared in accordance with section

285a-2(9) (!2) of this title. The Director of the Institute, in

consultation with the National Cancer Advisory Board, shall

periodically review and revise such plan.

(B) Not later than October 1, 1993, the Director of the

Institute shall submit a copy of the plan to the President's

Cancer Panel, the Secretary and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of

the plan to the President's Cancer Panel, the Secretary, and the

Director of NIH.

(D) The Secretary shall provide a copy of the plan submitted

under subparagraph (A), and any revisions submitted under

subparagraph (C), to the Committee on Energy and Commerce of the

House of Representatives and the Committee on Labor and Human

Resources of the Senate.

(d) Other cancers

In carrying out subsection (a) of this section, the Director of

the Institute shall conduct or support research on ovarian cancer

and other cancers of the reproductive system of women. Activities

under such subsection shall provide for the conduct and support of

-

(1) basic research concerning the etiology and causes of

ovarian cancer and other cancers of the reproductive system of

women;

(2) clinical research and related activities into the causes,

prevention, detection and treatment of ovarian cancer and other

cancers of the reproductive system of women;

(3) control programs with respect to ovarian cancer and other

cancers of the reproductive system of women in accordance with

section 285a-1 of this title;

(4) information and education programs with respect to ovarian

cancer and other cancers of the reproductive system of women in

accordance with section 285a-2 of this title; and

(5) research and demonstration centers with respect to ovarian

cancer and cancers of the reproductive system in accordance with

section 285a-3 of this title.

(e) Report

The Director of the Institute shall prepare, for inclusion in the

biennial report submitted under section 284b of this title, a

report that describes the activities of the National Cancer

Institute under the research programs referred to in subsection (a)

of this section, that shall include -

(1) a description of the research plan with respect to breast

cancer prepared under subsection (c) of this section;

(2) an assessment of the development, revision, and

implementation of such plan;

(3) a description and evaluation of the progress made, during

the period for which such report is prepared, in the research

programs on breast cancer and cancers of the reproductive system

of women;

(4) a summary and analysis of expenditures made, during the

period for which such report is made, for activities with respect

to breast cancer and cancers of the reproductive system of women

conducted and supported by the National Institutes of Health; and

(5) such comments and recommendations as the Director considers

appropriate.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 417, as added Pub. L.

103-43, title IV, Sec. 401, June 10, 1993, 107 Stat. 153.)

-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.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285a-8 of this title.

-FOOTNOTE-

(!1) So in original. Probably should not be capitalized.

(!2) So in original. Probably should be section "285a-2(b)(9)".

-End-

-CITE-

42 USC Sec. 285a-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-7. Prostate cancer

-STATUTE-

(a) Expansion and coordination of activities

The Director of the Institute, in consultation with the National

Cancer Advisory Board, shall expand, intensify, and coordinate the

activities of the Institute with respect to research on prostate

cancer.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of

the Director under subsection (a) of this section with similar

activities conducted by other national research institutes and

agencies of the National Institutes of Health to the extent that

such Institutes (!1) and agencies have responsibilities that are

related to prostate cancer.

(c) Programs

(1) In general

In carrying out subsection (a) of this section, the Director of

the Institute shall conduct or support research to expand the

understanding of the cause of, and to find a cure for, prostate

cancer. Activities under such subsection shall provide for an

expansion and intensification of the conduct and support of -

(A) basic research concerning the etiology and causes of

prostate cancer;

(B) clinical research and related activities concerning the

causes, prevention, detection and treatment of prostate cancer;

(C) prevention and control and early detection programs with

respect to prostate cancer in accordance with section 285a-1 of

this title, particularly as it relates to intensifying research

on the role of prostate specific antigen for the screening and

early detection of prostate cancer;

(D) an Inter-Institute Task Force, under the direction of the

Director of the Institute, to provide coordination between

relevant National Institutes of Health components of research

efforts on prostate cancer;

(E) control programs with respect to prostate cancer in

accordance with section 285a-1 of this title;

(F) information and education programs with respect to

prostate cancer in accordance with section 285a-2 of this

title; and

(G) research and demonstration centers with respect to

prostate cancer in accordance with section 285a-3 of this

title, including the development and operation of centers for

prostate cancer research to bring together basic and clinical,

biomedical and behavioral scientists to conduct basic,

clinical, epidemiological, psychosocial, prevention and

control, treatment, research, and related activities on

prostate cancer.

Not less than six centers shall be operated under subparagraph

(G). Activities of such centers should include supporting new and

innovative research and training programs for new researchers.

Such centers shall give priority to expediting the transfer of

research advances to clinical applications.

(2) Implementation of plan for programs

(A) The Director of the Institute shall ensure that the

research programs described in paragraph (1) are implemented in

accordance with a plan for the programs. Such plan shall include

comments and recommendations that the Director of the Institute

considers appropriate, with due consideration provided to the

professional judgment needs of the Institute as expressed in the

annual budget estimate prepared in accordance with section

285a-2(9) (!2) of this title. The Director of the Institute, in

consultation with the National Cancer Advisory Board, shall

periodically review and revise such plan.

(B) Not later than October 1, 1993, the Director of the

Institute shall submit a copy of the plan to the President's

Cancer Panel, the Secretary, and the Director of NIH.

(C) The Director of the Institute shall submit any revisions of

the plan to the President's Cancer Panel, the Secretary, and the

Director of NIH.

(D) The Secretary shall provide a copy of the plan submitted

under subparagraph (A), and any revisions submitted under

subparagraph (C), to the Committee on Energy and Commerce of the

House of Representatives and the Committee on Labor and Human

Resources of the Senate.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 417A, as added Pub. L.

103-43, title IV, Sec. 402, June 10, 1993, 107 Stat. 155.)

-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.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285a-8 of this title.

-FOOTNOTE-

(!1) So in original. Probably should not be capitalized.

(!2) So in original. Probably should be section "285a-2(b)(9)".

-End-

-CITE-

42 USC Sec. 285a-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-8. Authorization of appropriations

-STATUTE-

(a) Activities generally

For the purpose of carrying out this subpart, there are

authorized to be appropriated $2,728,000,000 for fiscal year 1994,

and such sums as may be necessary for each of the fiscal years 1995

and 1996.

(b) Breast cancer and gynecological cancers

(1) Breast cancer

(A) For the purpose of carrying out subparagraph (A) of section

285a-6(c)(1) of this title, there are authorized to be

appropriated $225,000,000 for fiscal year 1994, and such sums as

may be necessary for each of the fiscal years 1995 through 2003.

Such authorizations of appropriations are in addition to the

authorizations of appropriations established in subsection (a) of

this section with respect to such purpose.

(B) For the purpose of carrying out subparagraphs (B) through

(E) of section 285a-6(c)(1) of this title, there are authorized

to be appropriated $100,000,000 for fiscal year 1994, and such

sums as may be necessary for each of the fiscal years 1995

through 2003. Such authorizations of appropriations are in

addition to the authorizations of appropriations established in

subsection (a) of this section with respect to such purpose.

(2) Other cancers

For the purpose of carrying out subsection (d) of section

285a-6 of this title, there are authorized to be appropriated

$75,000,000 for fiscal year 1994, and such sums as are necessary

for each of the fiscal years 1995 through 2003. Such

authorizations of appropriations are in addition to the

authorizations of appropriations established in subsection (a) of

this section with respect to such purpose.

(c) Prostate cancer

For the purpose of carrying out section 285a-7 of this title,

there are authorized to be appropriated $72,000,000 for fiscal year

1994, and such sums as may be necessary for each of the fiscal

years 1995 through 2004. Such authorizations of appropriations are

in addition to the authorizations of appropriations established in

subsection (a) of this section with respect to such purpose.

(d) Allocation regarding cancer control

(1) In general

Of the amounts appropriated for the National Cancer Institute

for a fiscal year, the Director of the Institute shall make

available not less than the applicable percentage specified in

paragraph (2) for carrying out the cancer control activities

authorized in section 285a-1 of this title and for which budget

estimates are made under section 285a-2(b)(9) of this title for

the fiscal year.

(2) Applicable percentage

The percentage referred to in paragraph (1) is -

(A) 7 percent, in the case of fiscal year 1994;

(B) 9 percent, in the case of fiscal year 1995; and

(C) 10 percent, in the case of fiscal year 1996 and each

subsequent fiscal year.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 417B, as added Pub. L.

103-43, title IV, Sec. 403(a), June 10, 1993, 107 Stat. 157;

amended Pub. L. 105-340, title I, Sec. 103, Oct. 31, 1998, 112

Stat. 3192; Pub. L. 106-505, title VI, Sec. 602(b), Nov. 13, 2000,

114 Stat. 2346.)

-MISC1-

AMENDMENTS

2000 - Subsec. (c). Pub. L. 106-505 substituted "through 2004"

for "and 1996".

1998 - Subsec. (b)(1)(A), (B), (2). Pub. L. 105-340 substituted

"through 2003" for "and 1996".

-End-

-CITE-

42 USC Sec. 285a-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-9. Grants for education, prevention, and early detection

of radiogenic cancers and diseases

-STATUTE-

(a) Definition

In this section the term "entity" means any -

(1) National Cancer Institute-designated cancer center;

(2) Department of Veterans Affairs hospital or medical center;

(3) Federally Qualified Health Center, community health center,

or hospital;

(4) agency of any State or local government, including any

State department of health; or

(5) nonprofit organization.

(b) In general

The Secretary, acting through the Administrator of the Health

Resources and Services Administration in consultation with the

Director of the National Institutes of Health and the Director of

the Indian Health Service, may make competitive grants to any

entity for the purpose of carrying out programs to -

(1) screen individuals described under section 4(a)(1)(A)(i) or

5(a)(1)(A) of the Radiation Exposure Compensation Act (42 U.S.C.

2210 note) for cancer as a preventative health measure;

(2) provide appropriate referrals for medical treatment of

individuals screened under paragraph (1) and to ensure, to the

extent practicable, the provision of appropriate follow-up

services;

(3) develop and disseminate public information and education

programs for the detection, prevention, and treatment of

radiogenic cancers and diseases; and

(4) facilitate putative applicants in the documentation of

claims as described in section 5(a) of the Radiation Exposure

Compensation Act (42 U.S.C. 2210 note).

(c) Indian Health Service

The programs under subsection (a) of this section shall include

programs provided through the Indian Health Service or through

tribal contracts, compacts, grants, or cooperative agreements with

the Indian Health Service and which are determined appropriate to

raising the health status of Indians.

(d) Grant and contract authority

Entities receiving a grant under subsection (b) of this section

may expend the grant to carry out the purpose described in such

subsection.

(e) Health coverage unaffected

Nothing in this section shall be construed to affect any coverage

obligation of a governmental or private health plan or program

relating to an individual referred to under subsection (b)(1) of

this section.

(f) Report to Congress

Beginning on October 1 of the year following the date on which

amounts are first appropriated to carry out this section and

annually on each October 1 thereafter, the Secretary shall submit a

report to the Committee on the Judiciary and the Committee on

Health, Education, Labor, and Pensions of the Senate and to the

Committee on the Judiciary and the Committee on Commerce of the

House of Representatives. Each report shall summarize the

expenditures and programs funded under this section as the

Secretary determines to be appropriate.

(g) Authorization of appropriations

There are authorized to be appropriated for the purpose of

carrying out this section $20,000,000 for fiscal year 1999 and such

sums as may be necessary for each of the fiscal years 2000 through

2009.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 417C, as added Pub. L.

106-245, Sec. 4, July 10, 2000, 114 Stat. 508.)

-REFTEXT-

REFERENCES IN TEXT

Sections 4 and 5 of the Radiation Exposure Compensation Act,

referred to in subsec. (b)(1) and (4), are sections 4 and 5 of Pub.

L. 101-426, which are set out as a note under section 2210 of this

title.

-CHANGE-

CHANGE OF NAME

Committee on Commerce of House of Representatives changed to

Committee on Energy and Commerce of House of Representatives, and

jurisdiction over matters relating to securities and exchanges and

insurance generally transferred to Committee on Financial Services

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

Seventh Congress, Jan. 3, 2001.

-End-

-CITE-

42 USC Sec. 285a-10 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 1 - national cancer institute

-HEAD-

Sec. 285a-10. Research, information, and education with respect to

blood cancer

-STATUTE-

(a) Joe Moakley Research Excellence Program

(1) In general

The Director of NIH shall expand, intensify, and coordinate

programs for the conduct and support of research with respect to

blood cancer, and particularly with respect to leukemia,

lymphoma, and multiple myeloma.

(2) Administration

The Director of NIH shall carry out this subsection through the

Director of the National Cancer Institute and in collaboration

with any other agencies that the Director determines to be

appropriate.

(3) Authorization of appropriations

For the purpose of carrying out this subsection, there is

authorized to be appropriated such sums as may be necessary for

fiscal year 2002 and each subsequent fiscal year. Such

authorizations of appropriations are in addition to other

authorizations of appropriations that are available for such

purpose.

(b) Geraldine Ferraro Cancer Education Program

(1) In general

The Secretary shall direct the appropriate agency within the

Department of Health and Human Services, in collaboration with

the Director of NIH, to establish and carry out a program to

provide information and education for patients and the general

public with respect to blood cancer, and particularly with

respect to the treatment of leukemia, lymphoma, and multiple

myeloma.

(2) Administration

The Agency determined by the Secretary under paragraph (1)

shall carry out this subsection in collaboration with private

health organizations that have national education and patient

assistance programs on blood-related cancers.

(3) Authorization of appropriations

For the purpose of carrying out this subsection, there is

authorized to be appropriated such sums as may be necessary for

fiscal year 2002 and each subsequent fiscal year. Such

authorizations of appropriations are in addition to other

authorizations of appropriations that are available for such

purpose.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 417D, as added Pub. L.

107-172, Sec. 3, May 14, 2002, 116 Stat. 541.)

-COD-

CODIFICATION

Section 3 of Pub. L. 107-172, which directed that section 417D

(this section) be inserted after section 419C of part C of title IV

of the Public Health Service Act, was executed by adding section

417D to part C of title IV of the Public Health Service Act, to

reflect the probable intent of Congress, notwithstanding that part

C does not contain a section 419C.

-MISC1-

CONGRESSIONAL FINDINGS

Pub. L. 107-172, Sec. 2, May 14, 2002, 116 Stat. 541, provided

that: "Congress finds that:

"(1) An estimated 109,500 people in the United States will be

diagnosed with leukemia, lymphoma, and multiple myeloma in 2001.

"(2) New cases of the blood cancers described in paragraph (1)

account for 8.6 percent of new cancer cases.

"(3) Those devastating blood cancers will cause the deaths of

an estimated 60,300 persons in the United States in 2001. Every 9

minutes, a person in the United States dies from leukemia,

lymphoma, or multiple myeloma.

"(4) While less than 5 percent of Federal funds for cancer

research are spent on those blood cancers, those blood cancers

cause 11 percent of all cancer deaths in the United States.

"(5) Increased Federal support of research into leukemia,

lymphoma, and multiple myeloma has resulted and will continue to

result in significant advances in the treatment, and ultimately

the cure, of those blood cancers as well as other cancers."

-End-

-CITE-

42 USC subpart 2 - national heart, lung, and blood

institute 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

SUBPART 2 - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

-End-

-CITE-

42 USC Sec. 285b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b. Purpose of Institute

-STATUTE-

The general purpose of the National Heart, Lung, and Blood

Institute (hereafter in this subpart referred to as the

"Institute") is the conduct and support of research, training,

health information dissemination, and other programs with respect

to heart, blood vessel, lung, and blood diseases and with respect

to the use of blood and blood products and the management of blood

resources.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 418, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 836.)

-End-

-CITE-

42 USC Sec. 285b-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-1. Heart, blood vessel, lung, and blood disease

prevention and control programs

-STATUTE-

(a) The Director of the Institute shall conduct and support

programs for the prevention and control of heart, blood vessel,

lung, and blood diseases. Such programs shall include

community-based and population-based programs carried out in

cooperation with other Federal agencies, with public health

agencies of State or local governments, with nonprofit private

entities that are community-based health agencies, or with other

appropriate public or nonprofit private entities.

(b) In carrying out programs under subsection (a) of this

section, the Director of the Institute shall give special

consideration to the prevention and control of heart, blood vessel,

lung, and blood diseases in children, and in populations that are

at increased risk with respect to such diseases.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 419, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 836; amended Pub. L.

103-43, title V, Sec. 505, June 10, 1993, 107 Stat. 160.)

-MISC1-

AMENDMENTS

1993 - Pub. L. 103-43 substituted subsecs. (a) and (b) for former

section which read as follows: "The Director of the Institute,

under policies established by the Director of NIH and after

consultation with the advisory council for the Institute, shall

establish programs as necessary for cooperation with other Federal

health agencies, State, local, and regional public health agencies,

and nonprofit private health agencies in the diagnosis, prevention,

and treatment (including the provision of emergency medical

services) of heart, blood vessel, lung, and blood diseases,

appropriately emphasizing the prevention, diagnosis, and treatment

of such diseases of children."

-End-

-CITE-

42 USC Sec. 285b-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-2. Information and education

-STATUTE-

The Director of the Institute shall collect, identify, analyze,

and disseminate on a timely basis, through publications and other

appropriate means, to patients, families of patients, physicians

and other health professionals, and the general public, information

on research, prevention, diagnosis, and treatment of heart, blood

vessel, lung, and blood diseases, the maintenance of health to

reduce the incidence of such diseases, and on the use of blood and

blood products and the management of blood resources. In carrying

out this section, the Director of the Institute shall place special

emphasis upon the utilization of collaborative efforts with both

the public and private sectors to -

(1) increase the awareness and knowledge of health care

professionals and the public regarding the prevention of heart

and blood vessel, lung, and blood diseases and the utilization of

blood resources; and

(2) develop and disseminate to health professionals, patients

and patient families, and the public information designed to

encourage adults and children to adopt healthful practices

concerning the prevention of such diseases.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 420, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 837; amended Pub. L.

100-607, title I, Sec. 126, Nov. 4, 1988, 102 Stat. 3055.)

-MISC1-

AMENDMENTS

1988 - Pub. L. 100-607 amended second sentence generally. Prior

to amendment, second sentence read as follows: "In carrying out

this section the Director of the Institute shall place special

emphasis upon -

"(1) the dissemination of information regarding diet and

nutrition, environmental pollutants, exercise, stress,

hypertension, cigarette smoking, weight control, and other

factors affecting the prevention of arteriosclerosis and other

cardiovascular diseases and of pulmonary and blood diseases; and

"(2) the dissemination of information designed to encourage

children to adopt healthful habits respecting the risk factors

related to the prevention of such diseases."

-End-

-CITE-

42 USC Sec. 285b-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-3. National Heart, Blood Vessel, Lung, and Blood Diseases

and Blood Resources Program; administrative provisions

-STATUTE-

(a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases

and Blood Resources Program (hereafter in this subpart referred to

as the "Program") may provide for -

(A) investigation into the epidemiology, etiology, and

prevention of all forms and aspects of heart, blood vessel, lung,

and blood diseases, including investigations into the social,

environmental, behavioral, nutritional, biological, and genetic

determinants and influences involved in the epidemiology,

etiology, and prevention of such diseases;

(B) studies and research into the basic biological processes

and mechanisms involved in the underlying normal and abnormal

heart, blood vessel, lung, and blood phenomena;

(C) research into the development, trial, and evaluation of

techniques, drugs, and devices (including computers) used in, and

approaches to, the diagnosis, treatment (including the provision

of emergency medical services), and prevention of heart, blood

vessel, lung, and blood diseases and the rehabilitation of

patients suffering from such diseases;

(D) establishment of programs that will focus and apply

scientific and technological efforts involving the biological,

physical, and engineering sciences to all facets of heart, blood

vessel, lung, and blood diseases with emphasis on the refinement,

development, and evaluation of technological devices that will

assist, replace, or monitor vital organs and improve

instrumentation for detection, diagnosis, and treatment of and

rehabilitation from such diseases;

(E) establishment of programs for the conduct and direction of

field studies, large-scale testing and evaluation, and

demonstration of preventive, diagnostic, therapeutic, and

rehabilitative approaches to, and emergency medical services for,

such diseases;

(F) studies and research into blood diseases and blood, and

into the use of blood for clinical purposes and all aspects of

the management of blood resources in the United States, including

the collection, preservation, fractionation, and distribution of

blood and blood products;

(G) the education (including continuing education) and training

of scientists, clinical investigators, and educators, in fields

and specialties (including computer sciences) requisite to the

conduct of clinical programs respecting heart, blood vessel,

lung, and blood diseases and blood resources;

(H) public and professional education relating to all aspects

of such diseases, including the prevention of such diseases, and

the use of blood and blood products and the management of blood

resources;

(I) establishment of programs for study and research into

heart, blood vessel, lung, and blood diseases of children

(including cystic fibrosis, hyaline membrane, hemolytic diseases

such as sickle cell anemia and Cooley's anemia, and hemophilic

diseases) and for the development and demonstration of

diagnostic, treatment, and preventive approaches to such

diseases; and

(J) establishment of programs for study, research, development,

demonstrations and evaluation of emergency medical services for

people who become critically ill in connection with heart, blood

vessel, lung, or blood diseases.

(2) The Program shall be coordinated with other national research

institutes to the extent that they have responsibilities respecting

such diseases and shall give special emphasis to the continued

development in the Institute of programs related to the causes of

stroke and to effective coordination of such programs with related

stroke programs in the National Institute of Neurological and

Communicative Disorders and Stroke. The Director of the Institute,

with the advice of the advisory council for the Institute, shall

revise annually the plan for the Program and shall carry out the

Program in accordance with such plan.

(b) In carrying out the Program, the Director of the Institute,

under policies established by the Director of NIH -

(1) may, after consultation with the advisory council for the

Institute, obtain (in accordance with section 3109 of title 5,

but without regard to the limitation in such section on the

period of such service) the services of not more than one hundred

experts or consultants who have scientific or professional

qualifications;

(2)(A) may, in consultation with the advisory council for the

Institute, acquire and construct, improve, repair, operate,

alter, renovate, and maintain, heart, blood vessel, lung, and

blood disease and blood resource laboratories, research,

training, and other facilities, equipment, and such other real or

personal property as the Director determines necessary;

(B) may, in consultation with the advisory council for the

Institute, make grants for construction or renovation of

facilities; and

(C) may, in consultation with the advisory council for the

Institute, acquire, without regard to section 8141 of title 40,

by lease or otherwise, through the Administrator of General

Services, buildings or parts of buildings in the District of

Columbia or communities located adjacent to the District of

Columbia for the use of the Institute for a period not to exceed

ten years;

(3) subject to section 284(b)(2) of this title and without

regard to section 3324 of title 31 and section 5 of title 41, may

enter into such contracts, leases, cooperative agreements, or

other transactions, as may be necessary in the conduct of the

Director's functions, with any public agency, or with any person,

firm, association, corporation, or educational institutions;

(4) may make grants to public and nonprofit private entities to

assist in meeting the cost of the care of patients in hospitals,

clinics, and related facilities who are participating in research

projects; and

(5) shall, in consultation with the advisory council for the

Institute, conduct appropriate intramural training and education

programs, including continuing education and laboratory and

clinical research training programs.

Except as otherwise provided, experts and consultants whose

services are obtained under paragraph (1) shall be paid or

reimbursed, in accordance with title 5, for their travel to and

from their place of service and for other expenses associated with

their assignment. Such expenses shall not be allowed in connection

with the assignment of an expert or consultant whose services are

obtained under paragraph (1) unless the expert or consultant has

agreed in writing to complete the entire period of the assignment

or one year of the assignment, whichever is shorter, unless

separated or reassigned for reasons which are beyond the control of

the expert or consultant and which are acceptable to the Director

of the Institute. If the expert or consultant violates the

agreement, the money spent by the United States for such expenses

is recoverable from the expert or consultant as a debt due the

United States. The Secretary may waive in whole or in part a right

of recovery under the preceding sentence.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 421, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 837; amended Pub. L.

100-607, title I, Sec. 127, Nov. 4, 1988, 102 Stat. 3055; Pub. L.

103-43, title V, Sec. 501, title XX, Sec. 2008(b)(3), June 10,

1993, 107 Stat. 158, 211.)

-REFTEXT-

REFERENCES IN TEXT

The provisions of title 5 relating to reimbursement for travel

expenses, referred to in subsec. (b), are classified generally to

section 5701 et seq. of Title 5, Government Organization and

Employees.

-COD-

CODIFICATION

In subsec. (b)(2)(C), "section 8141 of title 40" substituted for

"the Act of March 3, 1877 (40 U.S.C. 34)" on authority of Pub. L.

107-217, Sec. 5(c), Aug. 21, 2002, 116 Stat. 1303, the first

section of which enacted Title 40, Public Buildings, Property, and

Works.

-MISC1-

AMENDMENTS

1993 - Subsec. (b)(1). Pub. L. 103-43, Sec. 2008(b)(3), inserted

comma after "may".

Subsec. (b)(5). Pub. L. 103-43, Sec. 501, added par. (5).

1988 - Subsec. (a)(1)(D). Pub. L. 100-607, Sec. 127(1), inserted

"and rehabilitation from" after "and treatment of".

Subsec. (b)(1). Pub. L. 100-607, Sec. 127(2), substituted "after

consultation with" for ", after approval of".

-End-

-CITE-

42 USC Sec. 285b-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-4. National research and demonstration centers

-STATUTE-

(a) Heart, blood vessel, lung, blood diseases, and blood resources;

utilization of centers for prevention programs

(1) The Director of the Institute may provide, in accordance with

subsection (c) of this section, for the development of -

(A) ten centers for basic and clinical research into, training

in, and demonstration of, advanced diagnostic, prevention, and

treatment and rehabilitation methods (including methods of

providing emergency medical services) for heart and blood vessel

diseases;

(B) ten centers for basic and clinical research into, training

in, and demonstration of, advanced diagnostic, prevention, and

treatment and rehabilitation methods (including methods of

providing emergency medical services) for lung diseases

(including bronchitis, emphysema, asthma, cystic fibrosis, and

other lung diseases of children);

(C) ten centers for basic and clinical research into, training

in, and demonstration of, advanced diagnostic, prevention, and

treatment methods (including methods of providing emergency

medical services) for blood diseases and research into blood, in

the use of blood products and in the management of blood

resources; and

(D) three centers for basic and clinical research into,

training in, and demonstration of, advanced diagnostic,

prevention, and treatment (including genetic studies,

intrauterine environment studies, postnatal studies, heart

arrhythmias, and acquired heart disease and preventive

cardiology) for cardiovascular diseases in children.

(2) The centers developed under paragraph (1) shall, in addition

to being utilized for research, training, and demonstrations, be

utilized for the following prevention programs for cardiovascular,

pulmonary, and blood diseases:

(A) Programs to develop improved methods of detecting

individuals with a high risk of developing cardiovascular,

pulmonary, and blood diseases.

(B) Programs to develop improved methods of intervention

against those factors which cause individuals to have a high risk

of developing such diseases.

(C) Programs to develop health professions and allied health

professions personnel highly skilled in the prevention of such

diseases.

(D) Programs to develop improved methods of providing emergency

medical services for persons with such diseases.

(E) Programs of continuing education for health and allied

health professionals in the diagnosis, prevention, and treatment

of such diseases and the maintenance of health to reduce the

incidence of such diseases and information programs for the

public respecting the prevention and early diagnosis and

treatment of such diseases and the maintenance of health.

(3) The research, training, and demonstration activities carried

out through any such center may relate to any one or more of the

diseases referred to in paragraph (1) of this subsection.

(b) Sickle cell anemia

The Director of the Institute shall provide, in accordance with

subsection (c) of this section, for the development of ten centers

for basic and clinical research into the diagnosis, treatment, and

control of sickle cell anemia.

(c) Cooperative agreements and grants for establishing and

supporting; uses for Federal payments; period of support,

additional periods

(1) The Director of the Institute may enter into cooperative

agreements with and make grants to public or private nonprofit

entities to pay all or part of the cost of planning, establishing,

or strengthening, and providing basic operating support for centers

for basic and clinical research into, training in, and

demonstration of the management of blood resources and advanced

diagnostic, prevention, and treatment methods for heart, blood

vessel, lung, or blood diseases.

(2) A cooperative agreement or grant under paragraph (1) shall be

entered into in accordance with policies established by the

Director of NIH and after consultation with the Institute's

advisory council.

(3) Federal payments made under a cooperative agreement or grant

under paragraph (1) may be used for -

(A) construction (notwithstanding any limitation under section

289e of this title);

(B) staffing and other basic operating costs, including such

patient care costs as are required for research;

(C) training, including training for allied health

professionals; and

(D) demonstration purposes.

As used in this subsection, the term "construction" does not

include the acquisition of land, and the term "training" does not

include research training for which Ruth L. Kirschstein National

Research Service Awards may be provided under section 288 of this

title.

(4) Support of a center under paragraph (1) may be for a period

of not to exceed five years. Such period may be extended by the

Director for additional periods of not more than five years each if

the operations of such center have been reviewed by an appropriate

technical and scientific peer review group established by the

Director and if such group has recommended to the Director that

such period should be extended.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 422, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 839; amended Pub. L.

100-607, title I, Sec. 128, Nov. 4, 1988, 102 Stat. 3055; Pub. L.

103-43, title V, Sec. 502, June 10, 1993, 107 Stat. 158; Pub. L.

107-206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat. 874.)

-MISC1-

AMENDMENTS

2002 - Subsec. (c)(3). Pub. L. 107-206 substituted "Ruth L.

Kirschstein National Research Service Awards" for "National

Research Service Awards" in concluding provisions.

1993 - Subsec. (a)(1)(D). Pub. L. 103-43 added subpar. (D).

1988 - Subsec. (a)(1)(A), (B). Pub. L. 100-607 inserted "and

rehabilitation" after "prevention, and treatment".

-End-

-CITE-

42 USC Sec. 285b-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-5. Repealed. Pub. L. 100-607, title I, Sec. 129, Nov. 4,

1988, 102 Stat. 3055

-MISC1-

Section, act July 1, 1944, ch. 373, title IV, Sec. 423, as added

Nov. 20, 1985, Pub. L. 99-158, Sec. 2, 99 Stat. 841, directed

Secretary to establish an Interagency Technical Committee on Heart,

Blood Vessel, Lung, and Blood Diseases and Blood Resources.

-End-

-CITE-

42 USC Sec. 285b-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-6. Associate Director for Prevention; appointment;

function

-STATUTE-

(a) There shall be in the Institute an Associate Director for

Prevention to coordinate and promote the programs in the Institute

concerning the prevention of heart, blood vessel, lung, and blood

diseases. The Associate Director shall be appointed by the Director

of the Institute from individuals who because of their professional

training or experience are experts in public health or preventive

medicine.

(b) The Associate Director for Prevention shall prepare for

inclusion in the biennial report made under section 284b of this

title a description of the prevention activities of the Institute,

including a description of the staff and resources allocated to

those activities.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 423, formerly Sec. 424, as

added Pub. L. 99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 841;

renumbered Sec. 423, Pub. L. 100-607, title I, Sec. 129, Nov. 4,

1988, 102 Stat. 3055.)

-MISC1-

PRIOR PROVISIONS

A prior section 423 of act July 1, 1944, was classified to

section 285b-5 of this title prior to repeal by Pub. L. 100-607.

-End-

-CITE-

42 USC Sec. 285b-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-7. National Center on Sleep Disorders Research

-STATUTE-

(a) Establishment

Not later than 1 year after June 10, 1993, the Director of the

Institute shall establish the National Center on Sleep Disorders

Research (in this section referred to as the "Center"). The Center

shall be headed by a director, who shall be appointed by the

Director of the Institute.

(b) Purpose

The general purpose of the Center is -

(1) the conduct and support of research, training, health

information dissemination, and other activities with respect to

sleep disorders, including biological and circadian rhythm

research, basic understanding of sleep, chronobiological and

other sleep related research; and

(2) to coordinate the activities of the Center with similar

activities of other Federal agencies, including the other

agencies of the National Institutes of Health, and similar

activities of other public entities and nonprofit entities.

(c) Sleep Disorders Research Advisory Board

(1) The Director of the National Institutes of Health shall

establish a board to be known as the Sleep Disorders Research

Advisory Board (in this section referred to as the "Advisory

Board").

(2) The Advisory Board shall advise, assist, consult with, and

make recommendations to the Director of the National Institutes of

Health, through the Director of the Institute, and the Director of

the Center concerning matters relating to the scientific activities

carried out by and through the Center and the policies respecting

such activities, including recommendations with respect to the plan

required in subsection (c) (!1) of this section.

(3)(A) The Director of the National Institutes of Health shall

appoint to the Advisory Board 12 appropriately qualified

representatives of the public who are not officers or employees of

the Federal Government. Of such members, eight shall be

representatives of health and scientific disciplines with respect

to sleep disorders and four shall be individuals representing the

interests of individuals with or undergoing treatment for sleep

disorders.

(B) The following officials shall serve as ex officio members of

the Advisory Board:

(i) The Director of the National Institutes of Health.

(ii) The Director of the Center.

(iii) The Director of the National Heart, Lung and Blood

Institute.

(iv) The Director of the National Institute of Mental Health.

(v) The Director of the National Institute on Aging.

(vi) The Director of the National Institute of Child Health and

Human Development.

(vii) The Director of the National Institute of Neurological

Disorders and Stroke.

(viii) The Assistant Secretary for Health.

(ix) The Assistant Secretary of Defense (Health Affairs).

(x) The Chief Medical Director of the Veterans' Administration.

(4) The members of the Advisory Board shall, from among the

members of the Advisory Board, designate an individual to serve as

the chair of the Advisory Board.

(5) Except as inconsistent with, or inapplicable to, this

section, the provisions of section 284a of this title shall apply

to the advisory board (!2) established under this section in the

same manner as such provisions apply to any advisory council

established under such section.

(d) Development of comprehensive research plan; revision

(1) After consultation with the Director of the Center and the

advisory board (!2) established under subsection (c) of this

section, the Director of the National Institutes of Health shall

develop a comprehensive plan for the conduct and support of sleep

disorders research.

(2) The plan developed under paragraph (1) shall identify

priorities with respect to such research and shall provide for the

coordination of such research conducted or supported by the

agencies of the National Institutes of Health.

(3) The Director of the National Institutes of Health (after

consultation with the Director of the Center and the advisory board

(!2) established under subsection (c) of this section) shall revise

the plan developed under paragraph (1) as appropriate.

(e) Collection and dissemination of information

The Director of the Center, in cooperation with the Centers for

Disease Control and Prevention, is authorized to coordinate

activities with the Department of Transportation, the Department of

Defense, the Department of Education, the Department of Labor, and

the Department of Commerce to collect data, conduct studies, and

disseminate public information concerning the impact of sleep

disorders and sleep deprivation.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 424, as added Pub. L.

103-43, title V, Sec. 503, June 10, 1993, 107 Stat. 159.)

-CHANGE-

CHANGE OF NAME

Reference to Chief Medical Director of Department of Veterans

Affairs deemed to refer to Under Secretary for Health of Department

of Veterans Affairs pursuant to section 302(e) of Pub. L. 102-405,

set out as a note under section 305 of Title 38, Veterans'

Benefits.

Reference to Chief Medical Director of Veterans' Administration

deemed to refer to Chief Medical Director of Department of Veterans

Affairs pursuant to section 10 of Pub. L. 100-527, set out as a

Department of Veterans Affairs Act note under section 201 of Title

38.

-MISC1-

TERMINATION OF ADVISORY BOARDS

Advisory boards 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 board

established by the President or an officer of the Federal

Government, such board is renewed by appropriate action prior to

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

established by Congress, its duration is otherwise provided by law.

See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86 Stat.

770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

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

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

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

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

-FOOTNOTE-

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

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

-End-

-CITE-

42 USC Sec. 285b-7a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-7a. Heart attack, stroke, and other cardiovascular

diseases in women

-STATUTE-

(a) In general

The Director of the Institute shall expand, intensify, and

coordinate research and related activities of the Institute with

respect to heart attack, stroke, and other cardiovascular diseases

in women.

(b) Coordination with other institutes

The Director of the Institute shall coordinate activities under

subsection (a) of this section with similar activities conducted by

the other national research institutes and agencies of the National

Institutes of Health to the extent that such Institutes and

agencies have responsibilities that are related to heart attack,

stroke, and other cardiovascular diseases in women.

(c) Certain programs

In carrying out subsection (a) of this section, the Director of

the Institute shall conduct or support research to expand the

understanding of the causes of, and to develop methods for

preventing, cardiovascular diseases in women. Activities under such

subsection shall include conducting and supporting the following:

(1) Research to determine the reasons underlying the prevalence

of heart attack, stroke, and other cardiovascular diseases in

women, including African-American women and other women who are

members of racial or ethnic minority groups.

(2) Basic research concerning the etiology and causes of

cardiovascular diseases in women.

(3) Epidemiological studies to address the frequency and

natural history of such diseases and the differences among men

and women, and among racial and ethnic groups, with respect to

such diseases.

(4) The development of safe, efficient, and cost-effective

diagnostic approaches to evaluating women with suspected ischemic

heart disease.

(5) Clinical research for the development and evaluation of new

treatments for women, including rehabilitation.

(6) Studies to gain a better understanding of methods of

preventing cardiovascular diseases in women, including

applications of effective methods for the control of blood

pressure, lipids, and obesity.

(7) Information and education programs for patients and health

care providers on risk factors associated with heart attack,

stroke, and other cardiovascular diseases in women, and on the

importance of the prevention or control of such risk factors and

timely referral with appropriate diagnosis and treatment. Such

programs shall include information and education on

health-related behaviors that can improve such important risk

factors as smoking, obesity, high blood cholesterol, and lack of

exercise.

(d) Authorization of appropriations

For the purpose of carrying out this section, there are

authorized to be appropriated such sums as may be necessary for

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

appropriations established in the preceding sentence is in addition

to any other authorization of appropriation that is available for

such purpose.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 424A, as added Pub. L.

105-340, title I, Sec. 104, Oct. 31, 1998, 112 Stat. 3192.)

-End-

-CITE-

42 USC Sec. 285b-7b 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-7b. Coordination of Federal asthma activities

-STATUTE-

(a) In general

The Director of (!1) Institute shall, through the National Asthma

Education Prevention Program Coordinating Committee -

(1) identify all Federal programs that carry out asthma-related

activities;

(2) develop, in consultation with appropriate Federal agencies

and professional and voluntary health organizations, a Federal

plan for responding to asthma; and

(3) not later than 12 months after October 17, 2000, submit

recommendations to the appropriate committees of the Congress on

ways to strengthen and improve the coordination of asthma-related

activities of the Federal Government.

(b) Representation of the Department of Housing and Urban

Development

A representative of the Department of Housing and Urban

Development shall be included on the National Asthma Education

Prevention Program Coordinating Committee for the purpose of

performing the tasks described in subsection (a) of this section.

(c) 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 2001 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 424B, as added Pub. L.

106-310, div. A, title V, Sec. 521, Oct. 17, 2000, 114 Stat. 1116.)

-FOOTNOTE-

(!1) So in original. Probably should be followed by "the".

-End-

-CITE-

42 USC Sec. 285b-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 2 - national heart, lung, and blood institute

-HEAD-

Sec. 285b-8. Authorization of appropriations

-STATUTE-

For the purpose of carrying out this subpart, there are

authorized to be appropriated $1,500,000,000 for fiscal year 1994,

and such sums as may be necessary for each of the fiscal years 1995

and 1996.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 425, as added Pub. L.

103-43, title V, Sec. 504, June 10, 1993, 107 Stat. 160.)

-End-

-CITE-

42 USC subpart 3 - national institute of diabetes and

digestive and kidney diseases 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

SUBPART 3 - NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY

DISEASES

-End-

-CITE-

42 USC Sec. 285c 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c. Purpose of Institute

-STATUTE-

The general purpose of the National Institute of Diabetes and

Digestive and Kidney Diseases (hereafter in this subpart referred

to as the "Institute") is the conduct and support of research,

training, health information dissemination, and other programs with

respect to diabetes mellitus and endocrine and metabolic diseases,

digestive diseases and nutritional disorders, and kidney, urologic,

and hematologic diseases.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 426, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 841.)

-MISC1-

STUDY ON METABOLIC DISORDERS

Pub. L. 106-310, div. A, title XXVIII, Sec. 2802, Oct. 17, 2000,

114 Stat. 1167, provided that:

"(a) In General. - The Secretary of Health and Human Services (in

this section referred to as the 'Secretary') shall, in consultation

with relevant experts or through the Institute of Medicine, study

issues related to treatment of PKU and other metabolic disorders

for children, adolescents, and adults, and mechanisms to assure

access to effective treatment, including special diets, for

children and others with PKU and other metabolic disorders. Such

mechanisms shall be evidence-based and reflect the best scientific

knowledge regarding effective treatment and prevention of disease

progression.

"(b) Dissemination of Results. - Upon completion of the study

referred to in subsection (a), the Secretary shall disseminate and

otherwise make available the results of the study to interested

groups and organizations, including insurance commissioners,

employers, private insurers, health care professionals, State and

local public health agencies, and State agencies that carry out the

Medicaid program under title XIX of the Social Security Act

[section 1396 et seq. of this title] or the State children's health

insurance program under title XXI of such Act [section 1397aa et

seq. of this title].

"(c) Authorization of Appropriations. - There are authorized to

be appropriated to carry out this section such sums as may be

necessary for each of the fiscal years 2001 through 2003."

REVIEW OF DISEASE RESEARCH PROGRAMS OF THE NATIONAL INSTITUTE OF

DIABETES AND DIGESTIVE AND KIDNEY DISEASES

Section 10 of Pub. L. 99-158 provided that: "The Secretary of

Health and Human Services shall conduct an administrative review of

the disease research programs of the National Institute of Diabetes

and Digestive and Kidney Diseases to determine if any of such

programs could be more effectively and efficiently managed by other

national research institutes. The Secretary shall complete such

review within the one-year period beginning on the date of

enactment of this Act [Nov. 20, 1985]."

-End-

-CITE-

42 USC Sec. 285c-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-1. Data systems and information clearinghouses

-STATUTE-

(a) National Diabetes Data System and National Diabetes

Clearinghouse

The Director of the Institute shall (1) establish the National

Diabetes Data System for the collection, storage, analysis,

retrieval, and dissemination of data derived from patient

populations with diabetes, including, where possible, data

involving general populations for the purpose of detection of

individuals with a risk of developing diabetes, and (2) establish

the National Diabetes Information Clearinghouse to facilitate and

enhance knowledge and understanding of diabetes on the part of

health professionals, patients, and the public through the

effective dissemination of information.

(b) National Digestive Diseases Data System and National Digestive

Diseases Information Clearinghouse

The Director of the Institute shall (1) establish the National

Digestive Diseases Data System for the collection, storage,

analysis, retrieval, and dissemination of data derived from patient

populations with digestive diseases, including, where possible,

data involving general populations for the purpose of detection of

individuals with a risk of developing digestive diseases, and (2)

establish the National Digestive Diseases Information Clearinghouse

to facilitate and enhance knowledge and understanding of digestive

diseases on the part of health professionals, patients, and the

public through the effective dissemination of information.

(c) National Kidney and Urologic Diseases Data System and National

Kidney and Urologic Diseases Information Clearinghouse

The Director of the Institute shall (1) establish the National

Kidney and Urologic Diseases Data System for the collection,

storage, analysis, retrieval, and dissemination of data derived

from patient populations with kidney and urologic diseases,

including, where possible, data involving general populations for

the purpose of detection of individuals with a risk of developing

kidney and urologic diseases, and (2) establish the National Kidney

and Urologic Diseases Information Clearinghouse to facilitate and

enhance knowledge and understanding of kidney and urologic diseases

on the part of health professionals, patients, and the public

through the effective dissemination of information.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 427, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 841.)

-End-

-CITE-

42 USC Sec. 285c-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-2. Division Directors for Diabetes, Endocrinology, and

Metabolic Diseases, Digestive Diseases and Nutrition, and Kidney,

Urologic, and Hematologic Diseases; functions

-STATUTE-

(a)(1) In the Institute there shall be a Division Director for

Diabetes, Endocrinology, and Metabolic Diseases, a Division

Director for Digestive Diseases and Nutrition, and a Division

Director for Kidney, Urologic, and Hematologic Diseases. Such

Division Directors, under the supervision of the Director of the

Institute, shall be responsible for -

(A) developing a coordinated plan (including recommendations

for expenditures) for each of the national research institutes

within the National Institutes of Health with respect to research

and training concerning diabetes, endocrine and metabolic

diseases, digestive diseases and nutrition, and kidney, urologic,

and hematologic diseases;

(B) assessing the adequacy of management approaches for the

activities within such institutes concerning such diseases and

nutrition and developing improved approaches if needed;

(C) monitoring and reviewing expenditures by such institutes

concerning such diseases and nutrition; and

(D) identifying research opportunities concerning such diseases

and nutrition and recommending ways to utilize such

opportunities.

(2) The Director of the Institute shall transmit to the Director

of NIH the plans, recommendations, and reviews of the Division

Directors under subparagraphs (A) through (D) of paragraph (1)

together with such comments and recommendations as the Director of

the Institute determines appropriate.

(b) The Director of the Institute, acting through the Division

Director for Diabetes, Endocrinology, and Metabolic Diseases, the

Division Director for Digestive Diseases and Nutrition, and the

Division Director for Kidney, Urologic, and Hematologic Diseases,

shall -

(1) carry out programs of support for research and training

(other than training for which Ruth L. Kirschstein National

Research Service Awards may be made under section 288 of this

title) in the diagnosis, prevention, and treatment of diabetes

mellitus and endocrine and metabolic diseases, digestive diseases

and nutritional disorders, and kidney, urologic, and hematologic

diseases, including support for training in medical schools,

graduate clinical training, graduate training in epidemiology,

epidemiology studies, clinical trials, and interdisciplinary

research programs; and

(2) establish programs of evaluation, planning, and

dissemination of knowledge related to such research and training.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 428, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 842; amended Pub. L.

103-43, title XX, Sec. 2008(b)(4), June 10, 1993, 107 Stat. 211;

Pub. L. 107-206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat.

874.)

-MISC1-

AMENDMENTS

2002 - Subsec. (b)(1). Pub. L. 107-206 substituted "Ruth L.

Kirschstein National Research Service Awards" for "National

Research Service Awards".

1993 - Subsec. (b). Pub. L. 103-43 substituted "the" for "the

the" before "Division Director for Diabetes" in introductory

provisions.

-End-

-CITE-

42 USC Sec. 285c-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-3. Interagency coordinating committees

-STATUTE-

(a) Establishment and purpose

For the purpose of -

(1) better coordination of the research activities of all the

national research institutes relating to diabetes mellitus,

digestive diseases, and kidney, urologic, and hematologic

diseases; and

(2) coordinating those aspects of all Federal health programs

and activities relating to such diseases to assure the adequacy

and technical soundness of such programs and activities and to

provide for the full communication and exchange of information

necessary to maintain adequate coordination of such programs and

activities;

the Secretary shall establish a Diabetes Mellitus Interagency

Coordinating Committee, a Digestive Diseases Interagency

Coordinating Committee, and a Kidney, Urologic, and Hematologic

Diseases Coordinating Committee (hereafter in this section

individually referred to as a "Committee").

(b) Membership; chairman; meetings

Each Committee shall be composed of the Directors of each of the

national research institutes and divisions involved in research

with respect to the diseases for which the Committee is

established, the Division Director of the Institute for the

diseases for which the Committee is established, the Under

Secretary for Health of the Department of Veterans Affairs, and the

Assistant Secretary of Defense for Health Affairs (or the designees

of such officers) and shall include representation from all other

Federal departments and agencies whose programs involve health

functions or responsibilities relevant to such diseases, as

determined by the Secretary. Each Committee shall be chaired by the

Director of NIH (or the designee of the Director). Each Committee

shall meet at the call of the chairman, but not less often than

four times a year.

(c) Annual report

Each Committee shall prepare an annual report for -

(1) the Secretary;

(2) the Director of NIH; and

(3) the Advisory Board established under section 285c-4 of this

title for the diseases for which the Committee was established,

detailing the work of the Committee in carrying out paragraphs (1)

and (2) of subsection (a) of this section in the fiscal year for

which the report was prepared. Such report shall be submitted not

later than 120 days after the end of each fiscal year.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 429, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 843; amended Pub. L.

100-527, Sec. 10(4), Oct. 25, 1988, 102 Stat. 2641; Pub. L.

102-405, title III, Sec. 302(e)(1), Oct. 9, 1992, 106 Stat. 1985.)

-MISC1-

AMENDMENTS

1992 - Subsec. (b). Pub. L. 102-405 substituted "Under Secretary

for Health of the Department of Veterans Affairs" for "Chief

Medical Director of the Department of Veterans Affairs".

1988 - Subsec. (b). Pub. L. 100-527 substituted "Chief Medical

Director of the Department of Veterans Affairs" for "Chief Medical

Director of the Veterans' Administration".

EFFECTIVE DATE OF 1988 AMENDMENT

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

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

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

-End-

-CITE-

42 USC Sec. 285c-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-4. Advisory boards

-STATUTE-

(a) Establishment

The Secretary shall establish in the Institute the National

Diabetes Advisory Board, the National Digestive Diseases Advisory

Board, and the National Kidney and Urologic Diseases Advisory Board

(hereafter in this section individually referred to as an "Advisory

Board").

(b) Membership; ex officio members

Each Advisory Board shall be composed of eighteen appointed

members and nonvoting ex officio members as follows:

(1) The Secretary shall appoint -

(A) twelve members from individuals who are scientists,

physicians, and other health professionals, who are not

officers or employees of the United States, and who represent

the specialties and disciplines relevant to the diseases with

respect to which the Advisory Board is established; and

(B) six members from the general public who are knowledgeable

with respect to such diseases, including at least one member

who is a person who has such a disease and one member who is a

parent of a person who has such a disease.

Of the appointed members at least five shall by virtue of

training or experience be knowledgeable in the fields of health

education, nursing, data systems, public information, and

community program development.

(2)(A) The following shall be ex officio members of each

Advisory Board:

(i) The Assistant Secretary for Health, the Director of NIH,

the Director of the National Institute of Diabetes and

Digestive and Kidney Diseases, the Director of the Centers for

Disease Control and Prevention, the Under Secretary for Health

of the Department of Veterans Affairs, the Assistant Secretary

of Defense for Health Affairs, and the Division Director of the

National Institute of Diabetes and Digestive and Kidney

Diseases for the diseases for which the Board is established

(or the designees of such officers).

(ii) Such other officers and employees of the United States

as the Secretary determines necessary for the Advisory Board to

carry out its functions.

(B) In the case of the National Diabetes Advisory Board, the

following shall also be ex officio members: The Director of the

National Heart, Lung, and Blood Institute, the Director of the

National Eye Institute, the Director of the National Institute of

Child Health and Human Development, and the Administrator of the

Health Resources and Services Administration (or the designees of

such officers).

(c) Compensation

Members of an Advisory Board who are officers or employees of the

Federal Government shall serve as members of the Advisory Board

without compensation in addition to that received in their regular

public employment. Other members of the Board shall receive

compensation at rates not to exceed the daily equivalent of the

annual rate in effect for grade GS-18 of the General Schedule for

each day (including traveltime) they are engaged in the performance

of their duties as members of the Board.

(d) Term of office; vacancy

The term of office of an appointed member of an Advisory Board is

four years, except that no term of office may extend beyond the

expiration of the Advisory Board. Any member appointed to fill a

vacancy for an unexpired term shall be appointed for the remainder

of such term. A member may serve after the expiration of the

member's term until a successor has taken office. If a vacancy

occurs in an Advisory Board, the Secretary shall make an

appointment to fill the vacancy not later than 90 days from the

date the vacancy occurred.

(e) Chairman

The members of each Advisory Board shall select a chairman from

among the appointed members.

(f) Executive director; professional and clerical staff;

administrative support services and facilities

The Secretary shall, after consultation with and consideration of

the recommendations of an Advisory Board, provide the Advisory

Board with an executive director and one other professional staff

member. In addition, the Secretary shall, after consultation with

and consideration of the recommendations of the Advisory Board,

provide the Advisory Board with such additional professional staff

members, such clerical staff members, such services of consultants,

such information, and (through contracts or other arrangements)

such administrative support services and facilities, as the

Secretary determines are necessary for the Advisory Board to carry

out its functions.

(g) Meetings

Each Advisory Board shall meet at the call of the chairman or

upon request of the Director of the Institute, but not less often

than four times a year.

(h) Functions of National Diabetes Advisory Board and National

Digestive Diseases Advisory Board

The National Diabetes Advisory Board and the National Digestive

Diseases Advisory Board shall -

(1) review and evaluate the implementation of the plan

(referred to in section 285c-7 of this title) respecting the

diseases with respect to which the Advisory Board was established

and periodically update the plan to ensure its continuing

relevance;

(2) for the purpose of assuring the most effective use and

organization of resources respecting such diseases, advise and

make recommendations to the Congress, the Secretary, the Director

of NIH, the Director of the Institute, and the heads of other

appropriate Federal agencies for the implementation and revision

of such plan; and

(3) maintain liaison with other advisory bodies related to

Federal agencies involved in the implementation of such plan, the

coordinating committee for such diseases, and with key

non-Federal entities involved in activities affecting the control

of such diseases.

(i) Subcommittees; establishment and membership

In carrying out its functions, each Advisory Board may establish

subcommittees, convene workshops and conferences, and collect data.

Such subcommittees may be composed of Advisory Board members and

nonmember consultants with expertise in the particular area

addressed by such subcommittees. The subcommittees may hold such

meetings as are necessary to enable them to carry out their

activities.

(j) Termination of predecessor boards; time within which to appoint

members

The National Diabetes Advisory Board and the National Digestive

Diseases Advisory Board in existence on November 20, 1985, shall

terminate upon the appointment of a successor Board under

subsection (a) of this section. The Secretary shall make

appointments to the Advisory Boards established under subsection

(a) of this section before the expiration of 90 days after November

20, 1985. The members of the Boards in existence on November 20,

1985, may be appointed, in accordance with subsections (b) and (d)

of this section, to the Boards established under subsection (a) of

this section for diabetes and digestive diseases, except that at

least one-half of the members of the National Diabetes Advisory

Board in existence on November 20, 1985, shall be appointed to the

National Diabetes Advisory Board first established under subsection

(a) of this section.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 430, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 844; amended Pub. L.

100-607, title I, Sec. 131, Nov. 4, 1988, 102 Stat. 3056; Pub. L.

102-405, title III, Sec. 302(e)(1), Oct. 9, 1992, 106 Stat. 1985;

Pub. L. 102-531, title III, Sec. 312(d)(6), Oct. 27, 1992, 106

Stat. 3504; Pub. L. 103-43, title XX, Sec. 2008(b)(5), June 10,

1993, 107 Stat. 211; Pub. L. 105-362, title VI, Sec. 601(a)(1)(C),

Nov. 10, 1998, 112 Stat. 3285.)

-MISC1-

AMENDMENTS

1998 - Subsecs. (j), (k). Pub. L. 105-362 redesignated subsec.

(k) as (j) and struck out former subsec. (j) which read as follows:

"Each Advisory Board shall prepare an annual report for the

Secretary which -

"(1) describes the Advisory Board's activities in the fiscal

year for which the report is made;

"(2) describes and evaluates the progress made in such fiscal

year in research, treatment, education, and training with respect

to the diseases with respect to which the Advisory Board was

established;

"(3) summarizes and analyzes expenditures made by the Federal

Government for activities respecting such diseases in such fiscal

year; and

"(4) contains the Advisory Board's recommendations (if any) for

changes in the plan referred to in section 285c-7 of this title."

1993 - Subsec. (b)(2)(A)(i). Pub. L. 103-43 substituted

"Department of Veterans Affairs" for "Veterans' Administration".

1992 - Subsec. (b)(2)(A)(i). Pub. L. 102-531 substituted "Centers

for Disease Control and Prevention" for "Centers for Disease

Control".

Pub. L. 102-405 substituted "Under Secretary for Health" for

"Chief Medical Director".

1988 - Subsecs. (k), (l). Pub. L. 100-607 redesignated subsec.

(l) as (k) and struck out former subsec. (k) which read as follows:

"Each Advisory Board shall expire on September 30, 1988."

TERMINATION OF ADVISORY BOARDS

Advisory boards 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 board

established by the President or an officer of the Federal

Government, such board is renewed by appropriate action prior to

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

established by the Congress, its duration is otherwise provided by

law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

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

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

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

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

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

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

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

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

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

under section 5376 of Title 5.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285c-3 of this title.

-End-

-CITE-

42 USC Sec. 285c-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-5. Research and training centers; development or

expansion

-STATUTE-

(a) Diabetes mellitus and related endocrine and metabolic diseases

(1) Consistent with applicable recommendations of the National

Commission on Diabetes, the Director of the Institute shall provide

for the development or substantial expansion of centers for

research and training in diabetes mellitus and related endocrine

and metabolic diseases. Each center developed or expanded under

this subsection shall -

(A) utilize the facilities of a single institution, or be

formed from a consortium of cooperating institutions, meeting

such research and training qualifications as may be prescribed by

the Secretary; and

(B) conduct -

(i) research in the diagnosis and treatment of diabetes

mellitus and related endocrine and metabolic diseases and the

complications resulting from such diseases;

(ii) training programs for physicians and allied health

personnel in current methods of diagnosis and treatment of such

diseases and complications, and in research in diabetes; and

(iii) information programs for physicians and allied health

personnel who provide primary care for patients with such

diseases or complications.

(2) A center may use funds provided under paragraph (1) to

provide stipends for nurses and allied health professionals

enrolled in research training programs described in paragraph

(1)(B)(ii).

(b) Digestive diseases and related functional, congenital,

metabolic disorders, and normal development of digestive tract

Consistent with applicable recommendations of the National

Digestive Diseases Advisory Board, the Director shall provide for

the development or substantial expansion of centers for research in

digestive diseases and related functional, congenital, metabolic

disorders, and normal development of the digestive tract. Each

center developed or expanded under this subsection -

(1) shall utilize the facilities of a single institution, or be

formed from a consortium of cooperating institutions, meeting

such research qualifications as may be prescribed by the

Secretary;

(2) shall develop and conduct basic and clinical research into

the cause, diagnosis, early detection, prevention, control, and

treatment of digestive diseases and nutritional disorders and

related functional, congenital, or metabolic complications

resulting from such diseases or disorders;

(3) shall encourage research into and programs for -

(A) providing information for patients with such diseases and

the families of such patients, physicians and others who care

for such patients, and the general public;

(B) model programs for cost effective and preventive patient

care; and

(C) training physicians and scientists in research on such

diseases, disorders, and complications; and

(4) may perform research and participate in epidemiological

studies and data collection relevant to digestive diseases and

disorders and disseminate such research, studies, and data to the

health care profession and to the public.

(c) Kidney and urologic diseases

The Director shall provide for the development or substantial

expansion of centers for research in kidney and urologic diseases.

Each center developed or expanded under this subsection -

(1) shall utilize the facilities of a single institution, or be

formed from a consortium of cooperating institutions, meeting

such research qualifications as may be prescribed by the

Secretary;

(2) shall develop and conduct basic and clinical research into

the cause, diagnosis, early detection, prevention, control, and

treatment of kidney and urologic diseases;

(3) shall encourage research into and programs for -

(A) providing information for patients with such diseases,

disorders, and complications and the families of such patients,

physicians and others who care for such patients, and the

general public;

(B) model programs for cost effective and preventive patient

care; and

(C) training physicians and scientists in research on such

diseases; and

(4) may perform research and participate in epidemiological

studies and data collection relevant to kidney and urologic

diseases in order to disseminate such research, studies, and data

to the health care profession and to the public.

(d) Nutritional disorders

(1) The Director of the Institute shall, subject to the extent of

amounts made available in appropriations Acts, provide for the

development or substantial expansion of centers for research and

training regarding nutritional disorders, including obesity.

(2) The Director of the Institute shall carry out paragraph (1)

in collaboration with the Director of the National Cancer Institute

and with the Directors of such other agencies of the National

Institutes of Health as the Director of NIH determines to be

appropriate.

(3) Each center developed or expanded under paragraph (1) shall -

(A) utilize the facilities of a single institution, or be

formed from a consortium of cooperating institutions, meeting

such research and training qualifications as may be prescribed by

the Director;

(B) conduct basic and clinical research into the cause,

diagnosis, early detection, prevention, control and treatment of

nutritional disorders, including obesity and the impact of

nutrition and diet on child development;

(C) conduct training programs for physicians and allied health

professionals in current methods of diagnosis and treatment of

such diseases and complications, and in research in such

disorders; and

(D) conduct information programs for physicians and allied

health professionals who provide primary care for patients with

such disorders or complications.

(e) Geographic distribution; period of support, additional periods

Insofar as practicable, centers developed or expanded under this

section should be geographically dispersed throughout the United

States and in environments with proven research capabilities.

Support of a center under this section may be for a period of not

to exceed five years and such period may be extended by the

Director of the Institute for additional periods of not more than

five years each if the operations of such center have been reviewed

by an appropriate technical and scientific peer review group

established by the Director and if such group has recommended to

the Director that such period should be extended.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 431, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 846; amended Pub. L.

103-43, title VI, Sec. 601(b), June 10, 1993, 107 Stat. 161.)

-MISC1-

AMENDMENTS

1993 - Subsecs. (d), (e). Pub. L. 103-43 added subsec. (d) and

redesignated former subsec. (d) as (e).

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285c-7 of this title.

-End-

-CITE-

42 USC Sec. 285c-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-6. Advisory council subcommittees

-STATUTE-

There are established within the advisory council for the

Institute appointed under section 284a of this title a subcommittee

on diabetes and endocrine and metabolic diseases, a subcommittee on

digestive diseases and nutrition, and a subcommittee on kidney,

urologic, and hematologic diseases. The subcommittees shall be

composed of members of the advisory council who are outstanding in

the diagnosis, prevention, and treatment of the diseases for which

the subcommittees are established and members of the advisory

council who are leaders in the fields of education and public

affairs. The subcommittees are authorized to review applications

made to the Director of the Institute for grants for research and

training projects relating to the diagnosis, prevention, and

treatment of the diseases for which the subcommittees are

established and shall recommend to the advisory council those

applications and contracts that the subcommittees determine will

best carry out the purposes of the Institute. The subcommittees

shall also review and evaluate the diabetes and endocrine and

metabolic diseases, digestive diseases and nutrition, and kidney,

urologic, and hematologic diseases programs of the Institute and

recommend to the advisory council such changes in the

administration of such programs as the subcommittees determine are

necessary.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 432, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 847.)

-End-

-CITE-

42 USC Sec. 285c-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-7. Biennial report

-STATUTE-

The Director of the Institute shall prepare for inclusion in the

biennial report made under section 284b of this title a description

of the Institute's activities -

(1) under the current diabetes plan under the National Diabetes

Mellitus Research and Education Act; and

(2) under the current digestive diseases plan formulated under

the Arthritis, Diabetes, and Digestive Diseases Amendments of

1976.

The description submitted by the Director shall include an

evaluation of the activities of the centers supported under section

285c-5 of this title.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 433, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 848.)

-REFTEXT-

REFERENCES IN TEXT

The National Diabetes Mellitus Research and Education Act,

referred to in par. (1), is Pub. L. 93-354, July 23, 1974, 88 Stat.

373, as amended, which enacted former sections 289c-1a, 289c-2, and

289c-3 of this title, amended section 247b and former section

289c-1 of this title, and enacted provisions formerly set out as

notes under section 289c-2 of this title. For complete

classification of this Act to the Code, see Short Title of 1974

Amendments note set out under section 201 of this title and Tables.

The Arthritis, Diabetes, and Digestive Diseases Amendments of

1976, referred to in par. (2), is Pub. L. 94-562, Oct. 19, 1976, 90

Stat. 2645, as amended, which enacted former sections 289c-3a,

289c-7, and 289c-8 of this title, amended former sections 289c-2,

289c-5, and 289c-6 of this title, and enacted provisions formerly

set out as notes under sections 289a, 289c-3a, and 289c-7 of this

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

Short Title of 1976 Amendments note set out under section 201 of

this title and Tables.

-End-

-CITE-

42 USC Sec. 285c-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-8. Nutritional disorders program

-STATUTE-

(a) Establishment

The Director of the Institute, in consultation with the Director

of NIH, shall establish a program of conducting and supporting

research, training, health information dissemination, and other

activities with respect to nutritional disorders, including

obesity.

(b) Support of activities

In carrying out the program established under subsection (a) of

this section, the Director of the Institute shall conduct and

support each of the activities described in such subsection.

(c) Dissemination of information

In carrying out the program established under subsection (a) of

this section, the Director of the Institute shall carry out

activities to facilitate and enhance knowledge and understanding of

nutritional disorders, including obesity, on the part of health

professionals, patients, and the public through the effective

dissemination of information.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 434, as added Pub. L.

103-43, title VI, Sec. 601[(a)], June 10, 1993, 107 Stat. 161.)

-End-

-CITE-

42 USC Sec. 285c-9 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 3 - national institute of diabetes and digestive and kidney

diseases

-HEAD-

Sec. 285c-9. Juvenile diabetes

-STATUTE-

(a) Long-term epidemiology studies

The Director of the Institute shall conduct or support long-term

epidemiology studies in which individuals with or at risk for type

1, or juvenile, diabetes are followed for 10 years or more. Such

studies shall investigate the causes and characteristics of the

disease and its complications.

(b) Clinical trial infrastructure/innovative treatments for

juvenile diabetes

The Secretary, acting through the Director of the National

Institutes of Health, shall support regional clinical research

centers for the prevention, detection, treatment, and cure of

juvenile diabetes.

(c) Prevention of type 1 diabetes

The Secretary, acting through the appropriate agencies, shall

provide for a national effort to prevent type 1 diabetes. Such

effort shall provide for a combination of increased efforts in

research and development of prevention strategies, including

consideration of vaccine development, coupled with appropriate

ability to test the effectiveness of such strategies in large

clinical trials of children and young adults.

(d) 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 2001 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 434A, as added Pub. L.

106-310, div. A, title IV, Sec. 402, Oct. 17, 2000, 114 Stat.

1112.)

-End-

-CITE-

42 USC subpart 4 - national institute of arthritis and

musculoskeletal and skin diseases 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

SUBPART 4 - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND

SKIN DISEASES

-End-

-CITE-

42 USC Sec. 285d 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d. Purpose of Institute

-STATUTE-

The general purpose of the National Institute of Arthritis and

Musculoskeletal and Skin Diseases (hereafter in this subpart

referred to as the "Institute") is the conduct and support of

research and training, the dissemination of health information, and

other programs with respect to arthritis and musculoskeletal and

skin diseases (including sports-related disorders), with particular

attention to the effect of these diseases on children.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 435, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 848; amended Pub. L.

103-43, title VII, Sec. 701(a), June 10, 1993, 107 Stat. 162.)

-MISC1-

AMENDMENTS

1993 - Pub. L. 103-43 substituted "(including sports-related

disorders), with particular attention to the effect of these

diseases on children" for ", including sports-related disorders".

-End-

-CITE-

42 USC Sec. 285d-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-1. National arthritis and musculoskeletal and skin

diseases program

-STATUTE-

(a) Plan to expand, intensify, and coordinate activities;

submission; periodic review and revision

The Director of the Institute, with the advice of the Institute's

advisory council, shall prepare and transmit to the Director of NIH

a plan for a national arthritis and musculoskeletal and skin

diseases program to expand, intensify, and coordinate the

activities of the Institute respecting arthritis and

musculoskeletal and skin diseases. The plan shall include such

comments and recommendations as the Director of the Institute

determines appropriate. The plan shall place particular emphasis

upon expanding research into better understanding the causes and

the development of effective treatments for arthritis affecting

children. The Director of the Institute shall periodically review

and revise such plan and shall transmit any revisions of such plan

to the Director of NIH.

(b) Coordination of activities with other national research

institutes; minimum activities under program

Activities under the national arthritis and musculoskeletal and

skin diseases program shall be coordinated with the other national

research institutes to the extent that such institutes have

responsibilities respecting arthritis and musculoskeletal and skin

diseases, and shall, at least, provide for -

(1) investigation into the epidemiology, etiology, and

prevention of all forms of arthritis and musculoskeletal and skin

diseases, including sports-related disorders, primarily through

the support of basic research in such areas as immunology,

genetics, biochemistry, microbiology, physiology, bioengineering,

and any other scientific discipline which can contribute

important knowledge to the treatment and understanding of

arthritis and musculoskeletal and skin diseases;

(2) research into the development, trial, and evaluation of

techniques, drugs, and devices used in the diagnosis, treatment,

including medical rehabilitation, and prevention of arthritis and

musculoskeletal and skin diseases;

(3) research on the refinement, development, and evaluation of

technological devices that will replace or be a substitute for

damaged bone, muscle, and joints and other supporting structures;

(4) the establishment of mechanisms to monitor the causes of

athletic injuries and identify ways of preventing such injuries

on scholastic athletic fields; and

(5) research into the causes of arthritis affecting children

and the development, trial, and evaluation of techniques, drugs

and devices used in the diagnosis, treatment (including medical

rehabilitation), and prevention of arthritis in children.

(c) Program to be carried out in accordance with plan

The Director of the Institute shall carry out the national

arthritis and musculoskeletal and skin diseases program in

accordance with the plan prepared under subsection (a) of this

section and any revisions of such plan made under such subsection.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 436, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 848; amended Pub. L.

100-607, title I, Sec. 136, Nov. 4, 1988, 102 Stat. 3056; Pub. L.

103-43, title VII, Sec. 701(b), June 10, 1993, 107 Stat. 162.)

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-43, Sec. 701(b)(1), inserted

after second sentence "The plan shall place particular emphasis

upon expanding research into better understanding the causes and

the development of effective treatments for arthritis affecting

children."

Subsec. (b)(5). Pub. L. 103-43, Sec. 701(b)(2), added par. (5).

1988 - Pub. L. 100-607 inserted "and skin" after

"musculoskeletal" in section catchline and wherever appearing in

text.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285d-7 of this title.

-End-

-CITE-

42 USC Sec. 285d-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-2. Research and training

-STATUTE-

The Director of the Institute shall -

(1) carry out programs of support for research and training

(other than training for which Ruth L. Kirschstein National

Research Service Awards may be made under section 288 of this

title) in the diagnosis, prevention, and treatment of arthritis

and musculoskeletal and skin diseases, including support for

training in medical schools, graduate clinical training, graduate

training in epidemiology, epidemiology studies, clinical trials,

and interdisciplinary research programs; and

(2) establish programs of evaluation, planning, and

dissemination of knowledge related to such research and training.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 437, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 849; amended Pub. L.

107-206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat. 874.)

-MISC1-

AMENDMENTS

2002 - Par. (1). Pub. L. 107-206 substituted "Ruth L. Kirschstein

National Research Service Awards" for "National Research Service

Awards".

-End-

-CITE-

42 USC Sec. 285d-3 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-3. Data system and information clearinghouse

-STATUTE-

(a) The Director of the Institute shall establish the National

Arthritis and Musculoskeletal and Skin Diseases Data System for the

collection, storage, analysis, retrieval, and dissemination of data

derived from patient populations with arthritis and musculoskeletal

and skin diseases, including where possible, data involving general

populations for the purpose of detection of individuals with a risk

of developing arthritis and musculoskeletal and skin diseases.

(b) The Director of the Institute shall establish the National

Arthritis and Musculoskeletal and Skin Diseases Information

Clearinghouse to facilitate and enhance, through the effective

dissemination of information, knowledge and understanding of

arthritis and musculoskeletal and skin diseases, including juvenile

arthritis and related conditions, by health professionals,

patients, and the public.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 438, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 849; amended Pub. L.

106-310, div. A, title III, Sec. 302, Oct. 17, 2000, 114 Stat.

1111.)

-MISC1-

AMENDMENTS

2000 - Subsec. (b). Pub. L. 106-310 inserted ", including

juvenile arthritis and related conditions," after "skin diseases".

-End-

-CITE-

42 USC Sec. 285d-4 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-4. Interagency coordinating committees

-STATUTE-

(a) Establishment and purpose

For the purpose of -

(1) better coordination of the research activities of all the

national research institutes relating to arthritis,

musculoskeletal diseases, and skin diseases, including

sports-related disorders; and

(2) coordinating the aspects of all Federal health programs and

activities relating to arthritis, musculoskeletal diseases, and

skin diseases in order to assure the adequacy and technical

soundness of such programs and activities and in order to provide

for the full communication and exchange of information necessary

to maintain adequate coordination of such programs and

activities,

the Secretary shall establish an Arthritis and Musculoskeletal

Diseases Interagency Coordinating Committee and a Skin Diseases

Interagency Coordinating Committee (hereafter in this section

individually referred to as a "Committee").

(b) Membership; chairman; meetings

Each Committee shall be composed of the Directors of each of the

national research institutes and divisions involved in research

regarding the diseases with respect to which the Committee is

established, the Under Secretary for Health of the Department of

Veterans Affairs, and the Assistant Secretary of Defense for Health

Affairs (or the designees of such officers), and representatives of

all other Federal departments and agencies (as determined by the

Secretary) whose programs involve health functions or

responsibilities relevant to arthritis and musculoskeletal diseases

or skin diseases, as the case may be. Each Committee shall be

chaired by the Director of NIH (or the designee of the Director).

Each Committee shall meet at the call of the chairman, but not less

often than four times a year.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 439, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 849; amended Pub. L.

102-405, title III, Sec. 302(e)(1), Oct. 9, 1992, 106 Stat. 1985;

Pub. L. 103-43, title XX, Sec. 2008(b)(6), June 10, 1993, 107 Stat.

211; Pub. L. 105-362, title VI, Sec. 601(a)(1)(D), Nov. 10, 1998,

112 Stat. 3285.)

-MISC1-

AMENDMENTS

1998 - Subsec. (c). Pub. L. 105-362 struck out subsec. (c) which

read as follows: "Not later than 120 days after the end of each

fiscal year, each Committee shall prepare and transmit to the

Secretary, the Director of NIH, the Director of the Institute, and

the advisory council for the Institute a report detailing the

activities of the Committee in such fiscal year in carrying out

paragraphs (1) and (2) of subsection (a) of this section."

1993 - Subsec. (b). Pub. L. 103-43 substituted "Department of

Veterans Affairs" for "Veterans' Administration".

1992 - Subsec. (b). Pub. L. 102-405 substituted "Under Secretary

for Health" for "Chief Medical Director".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285d-7 of this title.

-End-

-CITE-

42 USC Sec. 285d-5 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-5. Arthritis and musculoskeletal diseases demonstration

projects

-STATUTE-

(a) Grants for establishment and support

The Director of the Institute may make grants to public and

private nonprofit entities to establish and support projects for

the development and demonstration of methods for screening,

detection, and referral for treatment of arthritis and

musculoskeletal diseases and for the dissemination of information

on such methods to the health and allied health professions.

Activities under such projects shall be coordinated with Federal,

State, local, and regional health agencies, centers assisted under

section 285d-6 of this title, and the data system established under

subsection (c) of this section.

(b) Programs included

Projects supported under this section shall include -

(1) programs which emphasize the development and demonstration

of new and improved methods of screening and early detection,

referral for treatment, and diagnosis of individuals with a risk

of developing arthritis and musculoskeletal diseases;

(2) programs which emphasize the development and demonstration

of new and improved methods for patient referral from local

hospitals and physicians to appropriate centers for early

diagnosis and treatment;

(3) programs which emphasize the development and demonstration

of new and improved means of standardizing patient data and

recordkeeping;

(4) programs which emphasize the development and demonstration

of new and improved methods of dissemination of knowledge about

the programs, methods, and means referred to in paragraphs (1),

(2), and (3) of this subsection to health and allied health

professionals;

(5) programs which emphasize the development and demonstration

of new and improved methods for the dissemination to the general

public of information -

(A) on the importance of early detection of arthritis and

musculoskeletal diseases, of seeking prompt treatment, and of

following an appropriate regimen; and

(B) to discourage the promotion and use of unapproved and

ineffective diagnostic, preventive treatment, and control

methods for arthritis and unapproved and ineffective drugs and

devices for arthritis and musculoskeletal diseases; and

(6) projects for investigation into the epidemiology of all

forms and aspects of arthritis and musculoskeletal diseases,

including investigations into the social, environmental,

behavioral, nutritional, and genetic determinants and influences

involved in the epidemiology of arthritis and musculoskeletal

diseases.

(c) Standardization of patient data and recordkeeping

The Director shall provide for the standardization of patient

data and recordkeeping for the collection, storage, analysis,

retrieval, and dissemination of such data in cooperation with

projects assisted under this section, centers assisted under

section 285d-6 of this title, and other persons engaged in

arthritis and musculoskeletal disease programs.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 440, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 850.)

-End-

-CITE-

42 USC Sec. 285d-6 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-6. Multipurpose arthritis and musculoskeletal diseases

centers

-STATUTE-

(a) Development, modernization, and operation

The Director of the Institute shall, after consultation with the

advisory council for the Institute, provide for the development,

modernization, and operation (including staffing and other

operating costs such as the costs of patient care required for

research) of new and existing centers for arthritis and

musculoskeletal diseases. For purposes of this section, the term

"modernization" means the alteration, remodeling, improvement,

expansion, and repair of existing buildings and the provision of

equipment for such buildings to the extent necessary to make them

suitable for use as centers described in the preceding sentence.

(b) Duties and functions

Each center assisted under this section shall -

(1)(A) use the facilities of a single institution or a

consortium of cooperating institutions, and (B) meet such

qualifications as may be prescribed by the Secretary; and

(2) conduct -

(A) basic and clinical research into the cause, diagnosis,

early detection, prevention, control, and treatment of and

rehabilitation from arthritis and musculoskeletal diseases and

complications resulting from arthritis and musculoskeletal

diseases, including research into implantable biomaterials and

biomechanical and other orthopedic procedures;

(B) training programs for physicians, scientists, and other

health and allied health professionals;

(C) information and continuing education programs for

physicians and other health and allied health professionals who

provide care for patients with arthritis and musculoskeletal

diseases; and

(D) programs for the dissemination to the general public of

information -

(i) on the importance of early detection of arthritis and

musculoskeletal diseases, of seeking prompt treatment, and of

following an appropriate regimen; and

(ii) to discourage the promotion and use of unapproved and

ineffective diagnostic, preventive, treatment, and control

methods and unapproved and ineffective drugs and devices.

A center may use funds provided under subsection (a) of this

section to provide stipends for health professionals enrolled in

training programs described in paragraph (2)(B).

(c) Optional programs

Each center assisted under this section may conduct programs to -

(1) establish the effectiveness of new and improved methods of

detection, referral, and diagnosis of individuals with a risk of

developing arthritis and musculoskeletal diseases;

(2) disseminate the results of research, screening, and other

activities, and develop means of standardizing patient data and

recordkeeping; and

(3) develop community consultative services to facilitate the

referral of patients to centers for treatment.

(d) Geographical distribution

The Director of the Institute shall, insofar as practicable,

provide for an equitable geographical distribution of centers

assisted under this section. The Director shall give appropriate

consideration to the need for centers especially suited to meeting

the needs of children affected by arthritis and musculoskeletal

diseases.

(e) Period of support; additional periods

Support of a center under this section may be for a period of not

to exceed five years. Such period may be extended by the Director

of the Institute for one or more additional periods of not more

than five years if the operations of such center have been reviewed

by an appropriate technical and scientific peer review group

established by the Director and if such group has recommended to

the Director that such period should be extended.

(f) Treatment and rehabilitation of children

Not later than October 1, 1993, the Director shall establish a

multipurpose arthritis and musculoskeletal disease center for the

purpose of expanding the level of research into the cause,

diagnosis, early detection, prevention, control, and treatment of,

and rehabilitation of children with arthritis and musculoskeletal

diseases.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 441, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 851; amended Pub. L.

100-607, title I, Sec. 137, Nov. 4, 1988, 102 Stat. 3056; Pub. L.

103-43, title VII, Sec. 701(c), June 10, 1993, 107 Stat. 162.)

-MISC1-

AMENDMENTS

1993 - Subsec. (f). Pub. L. 103-43 added subsec. (f).

1988 - Subsec. (b)(2)(A). Pub. L. 100-607 inserted "and

rehabilitation from" after "and treatment of".

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285d-5 of this title.

-End-

-CITE-

42 USC Sec. 285d-6a 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-6a. Lupus

-STATUTE-

(a) In general

The Director of the Institute shall expand and intensify research

and related activities of the Institute with respect to lupus.

(b) Coordination with other institutes

The Director of the Institute shall coordinate the activities of

the Director under subsection (a) of this section with similar

activities conducted by the other national research institutes and

agencies of the National Institutes of Health to the extent that

such Institutes and agencies have responsibilities that are related

to lupus.

(c) Programs for lupus

In carrying out subsection (a) of this section, the Director of

the Institute shall conduct or support research to expand the

understanding of the causes of, and to find a cure for, lupus.

Activities under such subsection shall include conducting and

supporting the following:

(1) Research to determine the reasons underlying the elevated

prevalence of lupus in women, including African-American women.

(2) Basic research concerning the etiology and causes of the

disease.

(3) Epidemiological studies to address the frequency and

natural history of the disease and the differences among the

sexes and among racial and ethnic groups with respect to the

disease.

(4) The development of improved diagnostic techniques.

(5) Clinical research for the development and evaluation of new

treatments, including new biological agents.

(6) Information and education programs for health care

professionals and the public.

(d) 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 2001 through 2003.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 441A, as added Pub. L.

106-505, title V, Sec. 511, Nov. 13, 2000, 114 Stat. 2342.)

-MISC1-

FINDINGS

Pub. L. 106-505, title V, Sec. 502, Nov. 13, 2000, 114 Stat.

2342, provided that: "The Congress finds that -

"(1) lupus is a serious, complex, inflammatory, autoimmune

disease of particular concern to women;

"(2) lupus affects women nine times more often than men;

"(3) there are three main types of lupus: systemic lupus, a

serious form of the disease that affects many parts of the body;

discoid lupus, a form of the disease that affects mainly the

skin; and drug-induced lupus caused by certain medications;

"(4) lupus can be fatal if not detected and treated early;

"(5) the disease can simultaneously affect various areas of the

body, such as the skin, joints, kidneys, and brain, and can be

difficult to diagnose because the symptoms of lupus are similar

to those of many other diseases;

"(6) lupus disproportionately affects African-American women,

as the prevalence of the disease among such women is three times

the prevalence among white women, and an estimated 1 in 250

African-American women between the ages of 15 and 65 develops the

disease;

"(7) it has been estimated that between 1,400,000 and 2,000,000

Americans have been diagnosed with the disease, and that many

more have undiagnosed cases;

"(8) current treatments for the disease can be effective, but

may lead to damaging side effects;

"(9) many victims of the disease suffer debilitating pain and

fatigue, making it difficult to maintain employment and lead

normal lives; and

"(10) in fiscal year 1996, the amount allocated by the National

Institutes of Health for research on lupus was $33,000,000, which

is less than one-half of 1 percent of the budget for such

Institutes."

-End-

-CITE-

42 USC Sec. 285d-7 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-7. Advisory Board

-STATUTE-

(a) Establishment

The Secretary shall establish in the Institute the National

Arthritis and Musculoskeletal and Skin Diseases Advisory Board

(hereafter in this section referred to as the "Advisory Board").

(b) Membership; ex officio members

The Advisory Board shall be composed of twenty appointed members

and nonvoting, ex officio members, as follows:

(1) The Secretary shall appoint -

(A) twelve members from individuals who are scientists,

physicians, and other health professionals, who are not

officers or employees of the United States, and who represent

the specialties and disciplines relevant to arthritis,

musculoskeletal diseases, and skin diseases; and

(B) eight members from the general public who are

knowledgeable with respect to such diseases, including one

member who is a person who has such a disease, one person who

is the parent of an adult with such a disease, and two members

who are parents of children with arthritis.

Of the appointed members at least five shall by virtue of

training or experience be knowledgeable in health education,

nursing, data systems, public information, or community program

development.

(2) The following shall be ex officio members of the Advisory

Board:

(A) the Assistant Secretary for Health, the Director of NIH,

the Director of the National Institute of Arthritis and

Musculoskeletal and Skin Diseases, the Director of the Centers

for Disease Control and Prevention, the Under Secretary for

Health of the Department of Veterans Affairs, and the Assistant

Secretary of Defense for Health Affairs (or the designees of

such officers), and

(B) such other officers and employees of the United States as

the Secretary determines necessary for the Advisory Board to

carry out its functions.

(c) Compensation

Members of the Advisory Board who are officers or employees of

the Federal Government shall serve as members of the Advisory Board

without compensation in addition to that received in their regular

public employment. Other members of the Advisory Board shall

receive compensation at rates not to exceed the daily equivalent of

the annual rate in effect for grade GS-18 of the General Schedule

for each day (including traveltime) they are engaged in the

performance of their duties as members of the Advisory Board.

(d) Term of office; vacancy

The term of office of an appointed member of the Advisory Board

is four years. Any member appointed to fill a vacancy for an

unexpired term shall be appointed for the remainder of such term. A

member may serve after the expiration of the member's term until a

successor has taken office. If a vacancy occurs in the Advisory

Board, the Secretary shall make an appointment to fill the vacancy

not later than 90 days after the date the vacancy occurred.

(e) Chairman

The members of the Advisory Board shall select a chairman from

among the appointed members.

(f) Executive director, professional and clerical staff;

administrative support services and facilities

The Secretary shall, after consultation with and consideration of

the recommendations of the Advisory Board, provide the Advisory

Board with an executive director and one other professional staff

member. In addition, the Secretary shall, after consultation with

and consideration of the recommendations of the Advisory Board,

provide the Advisory Board with such additional professional staff

members, such clerical staff members, and (through contracts or

other arrangements) with such administrative support services and

facilities, such information, and such services of consultants, as

the Secretary determines are necessary for the Advisory Board to

carry out its functions.

(g) Meetings

The Advisory Board shall meet at the call of the chairman or upon

request of the Director of the Institute, but not less often than

four times a year.

(h) Duties and functions

The Advisory Board shall -

(1) review and evaluate the implementation of the plan prepared

under section 285d-1(a) of this title and periodically update the

plan to ensure its continuing relevance;

(2) for the purpose of assuring the most effective use and

organization of resources respecting arthritis, musculoskeletal

diseases and skin diseases, advise and make recommendations to

the Congress, the Secretary, the Director of NIH, the Director of

the Institute, and the heads of other appropriate Federal

agencies for the implementation and revision of such plan; and

(3) maintain liaison with other advisory bodies for Federal

agencies involved in the implementation of such plan, the

interagency coordinating committees for such diseases established

under section 285d-4 of this title, and with key non-Federal

entities involved in activities affecting the control of such

diseases.

(i) Subcommittees; establishment and membership

In carrying out its functions, the Advisory Board may establish

subcommittees, convene workshops and conferences, and collect data.

Such subcommittees may be composed of Advisory Board members and

nonmember consultants with expertise in the particular area

addressed by such subcommittees. The subcommittees may hold such

meetings as are necessary to enable them to carry out their

activities.

(j) Annual report

The Advisory Board shall prepare an annual report for the

Secretary which -

(1) describes the Advisory Board's activities in the fiscal

year for which the report is made;

(2) describes and evaluates the progress made in such fiscal

year in research, treatment, education, and training with respect

to arthritis, musculoskeletal diseases, and skin diseases;

(3) summarizes and analyzes expenditures made by the Federal

Government for activities respecting such diseases in such fiscal

year for which the report is made;

(4) contains the Advisory Board's recommendations (if any) for

changes in the plan prepared under section 285d-1 of this title;

and

(5) contains recommendations for expanding the Institute's

funding of research directly applicable to the cause, diagnosis,

early detection, prevention, control, and treatment of, and

rehabilitation of children with arthritis and musculoskeletal

diseases.

(k) Termination of predecessor board; time within which to appoint

members

The National Arthritis Advisory Board in existence on November

20, 1985, shall terminate upon the appointment of a successor Board

under subsection (a) of this section. The Secretary shall make

appointments to the Advisory Board established under subsection (a)

of this section before the expiration of 90 days after November 20,

1985. The member of the Board in existence on November 20, 1985,

may be appointed, in accordance with subsections (b) and (d) of

this section, to the Advisory Board established under subsection

(a) of this section.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 442, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 852; amended Pub. L.

102-405, title III, Sec. 302(e)(1), Oct. 9, 1992, 106 Stat. 1985;

Pub. L. 102-531, title III, Sec. 312(d)(7), Oct. 27, 1992, 106

Stat. 3504; Pub. L. 103-43, title VII, Sec. 701(d), title XX, Sec.

2008(b)(7), June 10, 1993, 107 Stat. 162, 211.)

-MISC1-

AMENDMENTS

1993 - Subsec. (a). Pub. L. 103-43, Sec. 701(d)(1), inserted "and

Musculoskeletal and Skin Diseases" after "Arthritis".

Subsec. (b). Pub. L. 103-43, Secs. 701(d)(2), 2008(b)(7),

substituted "twenty" for "eighteen" in introductory provisions,

"eight" for "six" and "including one member who is a person who has

such a disease, one person who is the parent of an adult with such

a disease, and two members who are parents of children with

arthritis" for "including at least one member who is a person who

has such a disease and one member who is a parent of a person who

has such a disease" in par. (1)(B), and "Department of Veterans

Affairs" for "Veterans' Administration" in par. (2)(A).

Subsec. (j)(5). Pub. L. 103-43, Sec. 701(d)(3), added par. (5).

1992 - Subsec. (b)(2)(A). Pub. L. 102-531 substituted "Centers

for Disease Control and Prevention" for "Centers for Disease

Control".

Pub. L. 102-405 substituted "Under Secretary for Health" for

"Chief Medical Director".

TERMINATION OF ADVISORY BOARDS

Advisory boards 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 board

established by the President or an officer of the Federal

Government, such board is renewed by appropriate action prior to

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

established by the Congress, its duration is otherwise provided by

law. See sections 3(2) and 14 of Pub. L. 92-463, Oct. 6, 1972, 86

Stat. 770, 776, set out in the Appendix to Title 5, Government

Organization and Employees.

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

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

committee established pursuant to the Public Health Service Act

shall terminate at such time as may be specifically prescribed by

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

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

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

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

considered references to rates payable under specified sections of

Title 5, Government Organization and Employees, see section 529

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

under section 5376 of Title 5.

-End-

-CITE-

42 USC Sec. 285d-8 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 4 - national institute of arthritis and musculoskeletal and

skin diseases

-HEAD-

Sec. 285d-8. Juvenile arthritis and related conditions

-STATUTE-

(a) Expansion and coordination of activities

The Director of the Institute, in coordination with the Director

of the National Institute of Allergy and Infectious Diseases, shall

expand and intensify the programs of such Institutes with respect

to research and related activities concerning juvenile arthritis

and related conditions.

(b) Coordination

The Directors referred to in subsection (a) of this section shall

jointly coordinate the programs referred to in such subsection and

consult with the Arthritis and Musculoskeletal Diseases Interagency

Coordinating Committee.

(c) 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 2001 through 2005.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 442A, as added Pub. L.

106-310, div. A, title III, Sec. 301(a), Oct. 17, 2000, 114 Stat.

1111.)

-End-

-CITE-

42 USC subpart 5 - national institute on aging 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 5 - national institute on aging

-HEAD-

SUBPART 5 - NATIONAL INSTITUTE ON AGING

-End-

-CITE-

42 USC Sec. 285e 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 5 - national institute on aging

-HEAD-

Sec. 285e. Purpose of Institute

-STATUTE-

The general purpose of the National Institute on Aging (hereafter

in this subpart referred to as the "Institute") is the conduct and

support of biomedical, social, and behavioral research, training,

health information dissemination, and other programs with respect

to the aging process and the diseases and other special problems

and needs of the aged.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 443, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 854.)

-MISC1-

STUDY OF MALNUTRITION IN ELDERLY

Pub. L. 103-43, title XIX, Sec. 1902, June 10, 1993, 107 Stat.

201, directed Secretary of Health and Human Services, acting

through National Institute on Aging, to conduct a 3-year study on

health benefits and cost-effectiveness of nutrition screening and

intervention activities of the elderly, and a 3-year study to

determine extent of malnutrition in elderly individuals in

hospitals and long-term care facilities and in elderly individuals

who are living independently, provided for creation of advisory

panel to oversee studies, provided for submission to Congress of

reports containing findings of such studies, and provided for

termination of advisory panel 3 years after June 10, 1993.

STUDY OF PERSONNEL FOR HEALTH NEEDS OF ELDERLY

Section 8 of Pub. L. 99-158 directed Secretary to conduct a study

on the adequacy and availability of personnel to meet the current

and projected health needs (including needs for home and

community-based care) of elderly Americans through the year 2020,

and report the results of the study, with recommendations, to

Congress by Mar. 1, 1987.

-End-

-CITE-

42 USC Sec. 285e-1 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 5 - national institute on aging

-HEAD-

Sec. 285e-1. Special functions

-STATUTE-

(a) Education and training of adequate numbers of personnel

In carrying out the training responsibilities under this chapter

or any other Act for health and allied health professions

personnel, the Secretary shall take appropriate steps to insure the

education and training of adequate numbers of allied health,

nursing, and paramedical personnel in the field of health care for

the aged.

(b) Scientific studies

The Director of the Institute shall conduct scientific studies to

measure the impact on the biological, medical, social, and

psychological aspects of aging of programs and activities assisted

or conducted by the Department of Health and Human Services.

(c) Public information and education programs

The Director of the Institute shall carry out public information

and education programs designed to disseminate as widely as

possible the findings of research sponsored by the Institute, other

relevant aging research and studies, and other information about

the process of aging which may assist elderly and near-elderly

persons in dealing with, and all Americans in understanding, the

problems and processes associated with growing older.

(d) Grants for research relating to Alzheimer's Disease

The Director of the Institute shall make grants to public and

private nonprofit institutions to conduct research relating to

Alzheimer's Disease.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 444, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 854.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 285e-10 of this title.

-End-

-CITE-

42 USC Sec. 285e-2 01/06/03

-EXPCITE-

TITLE 42 - THE PUBLIC HEALTH AND WELFARE

CHAPTER 6A - PUBLIC HEALTH SERVICE

SUBCHAPTER III - NATIONAL RESEARCH INSTITUTES

Part C - Specific Provisions Respecting National Research Institutes

subpart 5 - national institute on aging

-HEAD-

Sec. 285e-2. Alzheimer's Disease centers

-STATUTE-

(a) Cooperative agreements and grants for establishing and

supporting

(1) The Director of the Institute may enter into cooperative

agreements with and make grants to public or private nonprofit

entities (including university medical centers) to pay all or part

of the cost of planning, establishing, or strengthening, and

providing basic operating support (including staffing) for centers

for basic and clinical research (including multidisciplinary

research) into, training in, and demonstration of advanced

diagnostic, prevention, and treatment methods for Alzheimer's

disease.

(2) A cooperative agreement or grant under paragraph (1) shall be

entered into in accordance with policies established by the

Director of NIH and after consultation with the Institute's

advisory council.

(b) Use of Federal payments under cooperative agreement or grant

(1) Federal payments made under a cooperative agreement or grant

under subsection (a) of this section may, with respect to

Alzheimer's disease, be used for -

(A) diagnostic examinations, patient assessments, patient care

costs, and other costs necessary for conducting research;

(B) training, including training for allied health

professionals;

(C) diagnostic and treatment clinics designed to meet the

special needs of minority and rural populations and other

underserved populations;

(D) activities to educate the public; and

(E) the dissemination of information.

(2) For purposes of paragraph (1), the term "training" does not

include research training for which Ruth L. Kirschstein National

Research Service Awards may be provided under section 288 of this

title.

(c) Support period; additional periods

Support of a center under subsection (a) of this section may be

for a period of not to exceed five years. Such period may be

extended by the Director for additional periods of not more than

five years each if the operations of such center have been reviewed

by an appropriate technical and scientific peer review group

established by the Director and if such group has recommended to

the Director that such period should be extended.

-SOURCE-

(July 1, 1944, ch. 373, title IV, Sec. 445, as added Pub. L.

99-158, Sec. 2, Nov. 20, 1985, 99 Stat. 855; amended Pub. L.

101-557, title II, Sec. 201, Nov. 15, 1990, 104 Stat. 2767; Pub. L.

107-206, title I, Sec. 804(c), Aug. 2, 2002, 116 Stat. 874.)

-MISC1-

AMENDMENTS2002 - Subsec. (b)(2). Pub. L. 107-206 substituted "Ruth L.

Kirschstein National Research Service Awards" for "National

Research Service Awards".

1990 - Subsec. (a)(1). Pub. L. 101-557, Sec. 201(1), inserted

"(including university medical centers)" after "nonprofit

entities", "(including staffing)" after "operating support", and

"(including multidisciplinary research)" after "clinical research"

and substituted "Alzheimer's disease" for "Alzheimer's Disease".

Subsec. (b). Pub. L. 101-557, Sec. 201(2), amended subsec. (b)

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

"Federal payments made under a cooperative agreement or grant under

subsection (a) of this section may be used for -

"(1) construction (notwithstanding any limitation under section

289e of this title);

"(2) staffing and other basic operating costs, including such

patient care costs as are required for research;

"(3) training, including training for allied health

professionals; and

"(4) demonstration purposes.

As used in this subsection, the term 'construction' does not

include the acquisition of land, and the term 'training' does not

include research training for which National Research Service

Awards may be provided under section 288 of this title."

ALZHEIMER'S DISEASE RESEARCH

Pub. L. 100-175, title III, Nov. 29, 1987, 101 Stat. 972,

provided that:

"SEC. 301. REQUIREMENT FOR CLINICAL TRIALS.

"(a) In General. - The Director of the National Institute on

Aging shall provide for the conduct of clinical trials on the

efficacy of the use of such promising therapeutic agents as have

been or may be discovered and recommended for further scientific

analysis by the National Institute on Aging and the Food and Drug

Administration to treat individuals with Alzheimer's disease, to

retard the progression of symptoms of Alzheimer's disease, or to

improve the functioning of individuals with such disease.

"(b) Rule of Construction. - Nothing in this title shall be

construed to affect adversely any research being conducted as of

the date of the enactment of this Act [Nov. 29, 1987].

"SEC. 302. AUTHORIZATION OF APPROPRIATIONS.

"For the purpose of carrying out section 301, there is authorized

to be appropriated $2,000,000 for fiscal year 1988."

ALZHEIMER'S DISEASE REGISTRY

Section 12 of Pub. L. 99-158, which was formerly set out as a

note under this section, was renumbered section 445G of the Public

Health Service Act by Pub. L. 103-43, title VIII, Sec. 801(a), June

10, 1993, 107 Stat. 163, and is classified to section 285e-9 of

this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 285e-4, 285e-5, 11212,

11221, 11251, 11292, 11293 of this title.

-End-