I

104TH CONGRESS

2D SESSION S. 1897

IN THE HOUSE OF REPRESENTATIVES

SEPTEMBER 29, 1996

Referred to the Committee on Commerce

AN ACT

To amend the Public Health Service Act to revise and extend

certain programs relating to the National Institutes of

Health, and for other purposes.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE; REFERENCES; AND TABLE OF

4 CONTENTS

5 (a) SHORT TITLE.—This Act may be cited as the

6 ‘‘National Institutes of Health Revitalization Act of

7 1996’’.
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1 (b) REFERENCES.—Whenever in this Act an amend2 ment is expressed in terms of an amendment to a section

3 or other provision, the reference shall be considered to be

4 made to a section or other provision of the Public Health

5 Service Act (42 U.S.C. 201 et seq.).

6 (c) TABLE OF CONTENTS.—The table of contents for

7 this Act is as follows:

Sec. 1. Short title; references; and table of contents

TITLE I—PROVISIONS RELATING TO THE NATIONAL INSTITUTES

OF HEALTH

Sec. 101. Director’s discretionary fund.

Sec. 102. Children’s vaccine initiative.

TITLE II—PROVISIONS RELATING TO THE NATIONAL RESEARCH

INSTITUTES

Sec. 201. Research on osteoporosis, paget’s disease, and related bone disorders.

Sec. 202. National Human Genome Research Institute.

Sec. 203. Increased amount of grant and other awards.

Sec. 204. Meetings of advisory committees and councils.

Sec. 205. Elimination or modification of reports.

TITLE III—SPECIFIC INSTITUTES AND CENTERS

Subtitle A—National Cancer Institute

Sec. 301. Authorization of appropriations.

Sec. 302. DES study.

Subtitle B—National Heart Lung and Blood Institute

Sec. 311. Authorization of appropriations.

Subtitle C—National Institute of Allergy and Infectious Diseases

Sec. 321. Terry Beirn community-based AIDS research initiative.

Subtitle D—National Institute of Child Health and Human Development

Sec. 331. Research centers for contraception and infertility.

Subtitle E—National Institute on Aging

Sec. 341. Authorization of appropriations.

Subtitle F—National Institute on Alcohol Abuse and Alcoholism

Sec. 351. Authorization of appropriations.

Sec. 352. National Alcohol Research Center.
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Subtitle G—National Institute on Drug Abuse

Sec. 361. Authorization of appropriations.

Sec. 362. Medication development program.

Sec. 363. Drug Abuse Research Centers.

Subtitle H—National Institute of Mental Health

Sec. 371. Authorization of appropriations.

Subtitle I—National Center for Research Resources

Sec. 381. Authorization of appropriations.

Sec. 382. General Clinical Research Centers.

Sec. 383. Enhancement awards.

Sec. 384. Waiver of limitations.

Subtitle J—National Library of Medicine

Sec. 391. Authorization of appropriations.

Sec. 392. Increasing the cap on grant amounts.

TITLE IV—AWARDS AND TRAINING

Sec. 401. Medical scientist training program.

Sec. 402. Raise in maximum level of loan repayments.

Sec. 403. General loan repayment program.

Sec. 404. Clinical research assistance.

TITLE V—RESEARCH WITH RESPECT TO AIDS

Sec. 501. Comprehensive plan for expenditure of AIDS appropriations.

Sec. 502. Emergency AIDS discretionary fund.

TITLE VI—GENERAL PROVISIONS

Subtitle A—Authority of the Director of NIH

Sec. 601. Authority of the Director of NIH.

Subtitle B—Office of Rare Disease Research

Sec. 611. Establishment of Office for Rare Disease Research.

Subtitle C—Certain Reauthorizations

Sec. 621. National Research Service Awards.

Sec. 622. National Foundation for Biomedical Research.

Subtitle D—Miscellaneous Provisions

Sec. 631. Establishment of National Fund for Health Research.

Sec. 632. Definition of clinical research.

Sec. 633. Establishment of a pediatric research initiative.

Sec. 634. Diabetes research.

Sec. 635. Parkinson’s research.

Sec. 636. Pain research consortium.
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Subtitle E—Repeals and Conforming Amendments

Sec. 641. Repeals and conforming amendments.

1 TITLE I—PROVISIONS RELATING

2 TO THE NATIONAL INSTI3 TUTES OF HEALTH

4 SEC. 101. DIRECTOR’S DISCRETIONARY FUND.

5 Section 402(i)(3) (42 U.S.C. 282(i)(3)) is amended

6 by striking ‘‘$25,000,000’’ and all that follows through

7 the period and inserting ‘‘such sums as may be necessary

8 for fiscal year 1997.’’.

9 SEC. 102. CHILDREN’S VACCINE INITIATIVE.

10 Section 404B(c) (42 U.S.C. 283d(c)) is amended by

11 striking ‘‘$20,000,000’’ and all that follows through the

12 period and inserting ‘‘such sums as may be necessary for

13 fiscal year 1997.’’.

14 TITLE II—PROVISIONS RELAT15 ING TO THE NATIONAL RE16 SEARCH INSTITUTES

17 SEC. 201. RESEARCH ON OSTEOPOROSIS, PAGET’S DISEASE,

18 AND RELATED BONE DISORDERS.

19 Section 409A(d) (42 U.S.C. 284e(d)) is amended by

20 striking ‘‘$40,000,000’’ and all that follows through the

21 period and inserting ‘‘such sums as may be necessary for

22 fiscal year 1997.’’.
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1 SEC. 202. NATIONAL HUMAN GENOME RESEARCH INSTI2 TUTE.

3 (a) IN GENERAL.—Part C of title IV (42 U.S.C. 285

4 et seq.) is amended by adding at the end thereof the fol5 lowing new subpart:

6 ‘‘Subpart 18—National Human Genome Research

7 Institute

8 ‘‘SEC. 464Z. PURPOSE OF THE INSTITUTE.

9 ‘‘(a) IN GENERAL.—The general purpose of the Na10 tional Human Genome Research Institute is to character11 ize the structure and function of the human genome, in12 cluding the mapping and sequencing of individual genes.

13 Such purpose includes—

14 ‘‘(1) planning and coordinating the research

15 goal of the genome project;

16 ‘‘(2) reviewing and funding research proposals;

17 ‘‘(3) conducting and supporting research train18 ing;

19 ‘‘(4) coordinating international genome re20 search;

21 ‘‘(5) communicating advances in genome science

22 to the public;

23 ‘‘(6) reviewing and funding proposals to address

24 the ethical, legal, and social issues associated with

25 the genome project (including legal issues regarding

26 patents); and
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1 ‘‘(7) planning and administering intramural,

2 collaborative, and field research to study human ge3 netic disease.

4 ‘‘(b) RESEARCH.—The Director of the Institute may

5 conduct and support research training—

6 ‘‘(1) for which fellowship support is not pro7 vided under section 487; and

8 ‘‘(2) that is not residency training of physicians

9 or other health professionals.

10 ‘‘(c) ETHICAL, LEGAL, AND SOCIAL ISSUES.—

11 ‘‘(1) IN GENERAL.—Except as provided in para12 graph (2), of the amounts appropriated to carry out

13 subsection (a) for a fiscal year, the Director of the

14 Institute shall make available not less than 5 per15 cent of amounts made available for extramural re16 search for carrying out paragraph (6) of such sub17 section.

18 ‘‘(2) NONAPPLICATION.—With respect to pro19 viding funds under subsection (a)(6) for proposals to

20 address the ethical issues associated with the ge21 nome project, paragraph (1) shall not apply for a

22 fiscal year if the Director of the Institute certifies to

23 the Committee on Commerce of the House of Rep24 resentatives, and to the Committee on Labor and

25 Human Resources of the Senate, that the Director
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1 has determined that an insufficient number of such

2 proposals meet the applicable requirements of sec3 tions 491 and 492.

4 ‘‘(d) TRANSFER.—

5 ‘‘(1) IN GENERAL.—There are transferred to

6 the National Human Genome Research Institute all

7 functions which the National Center for Human Ge8 nome Research exercised before the date of enact9 ment of this subpart, including all related functions

10 of any officer or employee of the National Center for

11 Human Genome Research. The personnel employed

12 in connection with, and the assets, liabilities, con13 tracts, property, records, and unexpended balances

14 of appropriations, authorizations, allocations, and

15 other funds employed, used, held, arising from,

16 available to, or to be made available in connection

17 with the functions transferred under this subsection

18 shall be transferred to the National Human Genome

19 Research Institute.

20 ‘‘(2) LEGAL DOCUMENTS.—All orders, deter21 minations, rules, regulations, permits, agreements,

22 grants, contracts, certificates, licenses, regulations,

23 privileges, and other administrative actions which

24 have been issued, made, granted, or allowed to be25 come effective in the performance of functions which
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1 are transferred under this subsection shall continue

2 in effect according to their terms until modified, ter3 minated, superseded, set aside, or revoked in accord4 ance with law.

5 ‘‘(3) REFERENCES.—References in any other

6 Federal law, Executive order, rule, regulation, or

7 delegation of authority, or any document of or relat8 ing to the National Center for Human Genome Re9 search shall be deemed to refer to the National

10 Human Genome Research Institute.

11 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

12 are authorized to be appropriated to carry out this section,

13 such sums as may be necessary for fiscal year 1997.’’.

14 (b) CONFORMING AMENDMENTS.—

15 (1) Section 401(b) (42 U.S.C. 281(b)) is

16 amended—

17 (A) in paragraph (1), by adding at the end

18 thereof the following new subparagraph:

19 ‘‘(R) The National Human Genome Research

20 Institute.’’; and

21 (B) in paragraph (2)—

22 (i) by striking subparagraph (D); and

23 (ii) by redesignating subparagraph

24 (E) as subparagraph (D).
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1 (2) Subpart 3 of part E of title IV (42 U.S.C.

2 287c et seq.) is repealed.

3 SEC. 203. INCREASED AMOUNT OF GRANT AND OTHER

4 AWARDS.

5 Section 405(b)(2)(B) (42 U.S.C. 284(b)(2)(B) is

6 amended—

7 (1) in clause (i), by striking ‘‘$50,000’’ and in8 serting ‘‘$100,000’’; and

9 (2) in clause (ii), by striking ‘‘$50,000’’ and in10 serting ‘‘$100,000’’.

11 SEC. 204. MEETINGS OF ADVISORY COMMITTEES AND

12 COUNCILS.

13 (a) IN GENERAL.—Section 406 (42 U.S.C. 284a) is

14 amended—

15 (1) in subsection (e), by striking ‘‘, but at least

16 three times each fiscal year’’; and

17 (2) in subsection (h)(2)—

18 (A) in subparagraph (A)—

19 (i) in clause (iv), by adding ‘‘and’’

20 after the semicolon;

21 (ii) in clause (v), by striking ‘‘; and’’

22 and inserting a period; and

23 (iii) by striking clause (vi); and

24 (B) in subparagraph (B), by striking ‘‘, ex25 cept’’ and all that follows through ‘‘year’’.
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1 (b) PRESIDENT’S CANCER PANEL.—Section

2 415(a)(3) (42 U.S.C. 285a–4(a)(3)) is amended by strik3 ing ‘‘, but not less often than four times a year’’.

4 (c) INSTITUTE OF DIABETES AND DIGESTIVE AND

5 KIDNEY DISEASES INTERAGENCY COORDINATING COM6 MITTEES.—Section 429(b) (42 U.S.C. 285c–3(b)) is

7 amended by striking ‘‘, but not less often than four times

8 a year’’.

9 (d) INSTITUTE OF ARTHRITIS AND MUSCULO10 SKELETAL AND SKIN DISEASES INTERAGENCY COORDI11 NATING COMMITTEES.—Section 439(b) (42 U.S.C. 285d–

12 4(b)) is amended by striking ‘‘, but not less often than

13 four times a year’’.

14 (e) INSTITUTE ON DEAFNESS AND OTHER COMMU15 NICATION DISORDERS INTERAGENCY COORDINATING

16 COMMITTEES.—Section 464E(d) (42 U.S.C. 285m–5(d))

17 is amended by striking ‘‘, but not less often than four

18 times a year’’.

19 (f) INSTITUTE OF NURSING RESEARCH ADVISORY

20 COUNCIL.—Section 464X(e) (42 U.S.C. 285q–2(e)) is

21 amended by striking ‘‘, but at least three times each fiscal

22 year’’.

23 (g) CENTER FOR RESEARCH RESOURCES ADVISORY

24 COUNCIL.—Section 480(e) (42 U.S.C. 287a(e)) is amend25 ed by striking ‘‘, but at least three times each fiscal year’’.
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1 (h) APPLICATION OF FACA.—Part B of title IV (42

2 U.S.C. 284 et seq.) is amended by adding at the end there3 of the following new section:

4 ‘‘SEC. 409B. APPLICATION OF FEDERAL ADVISORY COMMIT5 TEE ACT.

6 ‘‘Notwithstanding any other provision of law, the pro7 visions of the Federal Advisory Committee Act (5 U.S.C.

8 App. 2) shall not apply to a scientific or technical peer

9 review group, established under this title.’’.

10 SEC. 205. ELIMINATION OR MODIFICATION OF REPORTS.

11 (a) PUBLIC HEALTH SERVICE ACT REPORTS.—The

12 following provisions of the Public Health Service Act are

13 repealed:

14 (1) Section 403 (42 U.S.C. 283) relating to the

15 biennial report of the Director of the National Insti16 tutes of Health to Congress and the President.

17 (2) Subsection (c) of section 439 (42 U.S.C.

18 285d-4(c)) relating to the annual report of the Ar19 thritis and Musculoskeletal Diseases Interagency Co20 ordinating Committee and the annual report of the

21 Skin Diseases Interagency Coordinating Committee.

22 (3) Subsection (j) of section 442 (42 U.S.C.

23 285d-7(j)) relating to the annual report of the Na24 tional Arthritis and Musculoskeletal and Skin Dis25 eases Advisory Board.
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1 (4) Subsection (b) of section 494A (42 U.S.C.

2 289c–1(b)) relating to the annual report of the Sec3 retary of Health and Human Services on health

4 services research relating to alcohol abuse and alco5 holism, drug abuse, and mental health.

6 (5) Subsection (b) of section 503 (42 U.S.C.

7 290aa–2(b)) relating to the triennial report of the

8 Secretary of Health and Human Services to Con9 gress.

10 (b) REPORT ON DISEASE PREVENTION.—Section

11 402(f)(3) (42 U.S.C. 282(f)(3)) is amended by striking

12 ‘‘annually’’ and inserting ‘‘biennially’’.

13 (c) REPORTS OF THE COORDINATING COMMITTEES

14 ON DIGESTIVE DISEASES, DIABETES MELLITUS, AND

15 KIDNEY, UROLOGIC AND HEMATOLOGIC DISEASES.—Sec16 tion 429 (42 U.S.C. 285c–3) is amended by striking sub17 section (c).

18 (d) REPORT OF THE TASK FORCE ON AGING RE19 SEARCH.—Section 304 of the Home Health Care and Alz20 heimer’s Disease Amendments of 1990 (42 U.S.C. 242q–

21 3) is repealed.

22 (e) SUDDEN INFANT DEATH SYNDROME RE23 SEARCH.—Section 1122 (42 U.S.C. 300c–12) is amend24 ed—

25 (1) in subsection (a)—
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1 (A) by striking the subsection designation

2 and heading; and

3 (B) by striking ‘‘of the type’’ and all that

4 follows through ‘‘adequate,’’ and insert ‘‘, such

5 amounts each year as will be adequate for re6 search which relates generally to sudden infant

7 death syndrome, including high-risk pregnancy

8 and high-risk infancy research which directly

9 relates to sudden infant death syndrome, and to

10 the relationship of the high-risk pregnancy and

11 high-risk infancy research to sudden infant

12 death syndrome,’’; and

13 (2) by striking subsections (b) and (c).

14 (f) U.S.-JAPAN COOPERATIVE MEDICAL SCIENCE

15 PROGRAM.—Subsection (h) of section 5 of the Inter16 national Health Research Act of 1960 is repealed.

17 (g) BIOENGINEERING RESEARCH.—Not later than 6

18 months after the date of enactment of this Act, the Sec19 retary of Health and Human Services, acting through the

20 Director of the National Institutes of Health, shall pre21 pare and submit to the Committee on Labor and Human

22 Resources of the Senate and the Committee on Commerce

23 of the House of Representatives, a report containing spe24 cific plans and timeframes on how the Director will imple25 ment the findings and recommendations of the report to
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1 Congress entitled ‘‘Support for Bioengineering Research’’

2 (submitted in August of 1995 in accordance with section

3 1912 of the National Institutes of Health Revitalization

4 Act of 1993 (42 U.S.C. 282 note)).

5 (h) CONFORMING AMENDMENTS.—Title IV is amend6 ed—

7 (1) in section 404C(c) (42 U.S.C. 283e(c)), by

8 striking ‘‘included’’ and all that follows through the

9 period and inserting ‘‘made available to the commit10 tee established under subsection (e) and included in

11 the official minutes of the committee’’;

12 (2) in section 404E(d)(3)(B) (42 U.S.C.

13 283g(d)(3)(B)), by striking ‘‘for inclusion in the bi14 ennial report under section 403’’;

15 (3) in section 406(g) (42 U.S.C. 284a(g))—

16 (A) by striking ‘‘for inclusion in the bien17 nial report made under section 407’’ and insert18 ing ‘‘as it may determine appropriate’’; and

19 (B) by striking the second sentence;

20 (4) in section 407 (42 U.S.C. 284b)—

21 (A) in the section heading, to read as fol22 lows:

23 ‘‘REPORTS’’;

24 and
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1 (B) by striking ‘‘shall prepare for inclusion

2 in the biennial report made under section 403

3 a biennial’’ and inserting ‘‘may prepare a’’;

4 (5) in section 416(b) (42 U.S.C. 285a–5(b)) by

5 striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

6 (6) in section 417 (42 U.S.C. 285a–6), by strik7 ing subsection (e);

8 (7) in section 423(b) (42 U.S.C. 285b–6(b)), by

9 striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

10 (8) by striking section 433 (42 U.S.C. 285c–7);

11 (9) in section 451(b) (42 U.S.C. 285g–3(b)), by

12 striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

13 (10) in section 452(d) (42 U.S.C. 285g–4(d))—

14 (A) in paragraph (3)—

15 (i) in subparagraph (A), by striking

16 ‘‘(A) Not’’ and inserting ‘‘Not’’; and

17 (ii) by striking subparagraph (B); and

18 (B) in the last sentence of paragraph (4),

19 by striking ‘‘contained’’ and all that follows

20 through the period and inserting ‘‘transmitted

21 to the Director of NIH.’’;

22 (11) in section 464I(b) (42 U.S.C. 285n–1(b)),

23 by striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

24 (12) in section 464M(b) (42 U.S.C. 285o–

25 1)(b)), by striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;
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1 (13) in section 464S(b) (42 U.S.C. 285p–1(b)),

2 by striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

3 (14) in section 464X(g) (42 U.S.C. 285q–2(g))

4 is amended—

5 (A) by striking ‘‘for inclusion in the bien6 nial report made under section 464Y’’ and in7 serting ‘‘as it may determine appropriate’’; and

8 (B) by striking the second sentence;

9 (15) in section 464Y (42 U.S.C. 285q–3)—

10 (A) in the section heading, to read as fol11 lows:

12 ‘‘REPORTS’’;

13 and

14 (B) by striking ‘‘shall prepare for inclusion

15 in the biennial report made under section 403

16 a biennial’’ and inserting ‘‘may prepare a’’;

17 (16) in section 480(g) (42 U.S.C. 287a(g))—

18 (A) by striking ‘‘for inclusion in the bien19 nial report made under section 481’’ and insert20 ing ‘‘as it may determine appropriate’’; and

21 (B) by striking the second sentence;

22 (17) in section 481 (42 U.S.C. 287a–1)—

23 (A) in the section heading, to read as fol24 lows:

25 ‘‘REPORTS’’;

26 and
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1 (B) by striking ‘‘shall prepare for inclusion

2 in the biennial report made under section 403

3 a biennial’’ and inserting ‘‘may prepare a’’;

4 (18) in section 486(d)(5)(B) (42 U.S.C.

5 287d(d)(5)(B)), by striking ‘‘for inclusion in the re6 port required in section 403’’;

7 (19) in section 486B (42 U.S.C. 287d–2) by

8 striking subsection (b) and inserting the following

9 new subsection:

10 ‘‘(b) SUBMISSION.—The Director of the Office shall

11 submit each report prepared under subsection (a) to the

12 Director of NIH.’’; and

13 (20) in section 492B(f) (42 U.S.C. 289a–2(f)),

14 by striking ‘‘for inclusion’’ and all that follows

15 through the period and inserting ‘‘and the Director

16 of NIH.’’.

17 TITLE III—SPECIFIC INSTITUTES

18 AND CENTERS

19 Subtitle A—National Cancer

20 Institute

21 SEC. 301. AUTHORIZATION OF APPROPRIATIONS.

22 Section 417B (42 U.S.C. 286a–8) is amended—

23 (1) in subsection (a), by striking

24 ‘‘$2,728,000,000’’ and all that follows through the
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1 period and inserting ‘‘$3,000,000,000 for fiscal year

2 1997.’’;

3 (2) in subsection (b)—

4 (A) in paragraph (1)—

5 (i) in the first sentence of subpara6 graph (A), by striking ‘‘$225,000,000’’

7 and all that follows through the first pe8 riod and inserting ‘‘such sums as may be

9 necessary for fiscal year 1997.’’; and

10 (ii) in the first sentence of subpara11 graph (B), by striking ‘‘$100,000,000’’

12 and all that follows through the first pe13 riod and inserting ‘‘such sums as may be

14 necessary for fiscal year 1997.’’; and

15 (B) in the first sentence of paragraph (2),

16 by striking ‘‘$75,000,000’’ and all that follows

17 through the first period and inserting ‘‘such

18 sums as may be necessary for fiscal year

19 1997.’’; and

20 (3) in the first sentence of subsection (c), by

21 striking ‘‘$72,000,000’’ and all that follows through

22 the first period and inserting ‘‘such sums as may be

23 necessary for fiscal year 1997.’’.
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1 SEC. 302. DES STUDY.

2 Section 403A(e) (42 U.S.C. 283a(e)) is amended by

3 striking ‘‘1996’’ and inserting ‘‘1997’’.

4 Subtitle B—National Heart Lung

5 and Blood Institute

6 SEC. 311. AUTHORIZATION OF APPROPRIATIONS.

7 Section 425 (42 U.S.C. 285b–8) is amended by strik8 ing ‘‘$1,500,000,000’’ and all that follows through the pe9 riod and inserting ‘‘$1,600,000,000 for fiscal year 1997.’’.

10 Subtitle C—National Institute of

11 Allergy and Infectious Diseases

12 SEC. 321. TERRY BEIRN COMMUNITY-BASED AIDS RE13 SEARCH INITIATIVE.

14 Section 2313(e) (42 U.S.C. 300cc–13(e)) is amend15 ed—

16 (1) in paragraph (1), by striking ‘‘1996’’ and

17 inserting ‘‘1997’’; and

18 (2) in paragraph (2), by striking ‘‘1996’’ and

19 inserting ‘‘1997’’.

20 Subtitle D—National Institute of

21 Child Health and Human Devel22 opment

23 SEC. 331. RESEARCH CENTERS FOR CONTRACEPTION AND

24 INFERTILITY.

25 Section 452A(g) (42 U.S.C. 285g–5(g)) is amended

26 by striking ‘‘$30,000,000’’ and all that follows through
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1 the period and inserting ‘‘such sums as may be necessary

2 for fiscal year 1997.’’.

3 Subtitle E—National Institute on

4 Aging

5 SEC. 341. AUTHORIZATION OF APPROPRIATIONS.

6 Section 445I (42 U.S.C. 285e–11) is amended by

7 striking ‘‘$500,000,000’’ and all that follows through the

8 period and inserting ‘‘$550,000,000 for fiscal year 1997.’’.

9 Subtitle F—National Institute on

10 Alcohol Abuse and Alcoholism

11 SEC. 351. AUTHORIZATION OF APPROPRIATIONS.

12 Section 464H(d)(1) (42 U.S.C. 285n(d)(1)) is

13 amended by striking ‘‘300,000,000’’ and all that follows

14 through the period and inserting ‘‘$330,000,000 for fiscal

15 year 1997.’’.

16 SEC. 352. NATIONAL ALCOHOL RESEARCH CENTER.

17 Section 464J(b) (42 U.S.C. 285n–2(b)) is amend18 ed—

19 (1) by striking ‘‘(b) The’’ and inserting ‘‘(b)(1)

20 The’’;

21 (2) by striking the third sentence; and

22 (3) by adding at the end thereof the following

23 new paragraph:

24 ‘‘(2) As used in paragraph (1), the terms ‘construc25 tion’ and ‘cost of construction’ include—
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1 ‘‘(A) the construction of new buildings, the ex2 pansion of existing buildings, and the acquisition, re3 modeling, replacement, renovation, major repair (to

4 the extent permitted by regulations), or alteration of

5 existing buildings, including architects’ fees, but not

6 including the cost of the acquisition of land or off7 site improvements; and

8 ‘‘(B) the initial equipping of new buildings and

9 of the expanded, remodeled, repaired, renovated, or

10 altered part of existing buildings; except that

11 such term shall not include the construction or cost of con12 struction of so much of any facility as is used or is to

13 be used for sectarian instruction or as a place for religious

14 worship.’’.

15 Subtitle G—National Institute on

16 Drug Abuse

17 SEC. 361. AUTHORIZATION OF APPROPRIATIONS.

18 Section 464L(d)(1) (42 U.S.C. 285o(d)(1)) is amend19 ed by striking ‘‘$440,000,000’’ and all that follows

20 through the period and inserting ‘‘$500,000,000 for fiscal

21 year 1997.’’.

22 SEC. 362. MEDICATION DEVELOPMENT PROGRAM.

23 Section 464P(e) (42 U.S.C. 285o–4(e)) is amended

24 by striking ‘‘$85,000,000’’ and all that follows through
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1 the period and inserting ‘‘such sums as may be necessary

2 for fiscal year 1997’’.

3 SEC. 363. DRUG ABUSE RESEARCH CENTERS.

4 Section 464N(b) (42 U.S.C. 285o–2(b)) is amend5 ed—

6 (1) by striking ‘‘(b) The’’ and inserting ‘‘(b)(1)

7 The’’;

8 (2) by striking the last sentence; and

9 (3) by adding at the end thereof the following

10 new paragraph:

11 ‘‘(2) As used in paragraph (1), the terms ‘construc12 tion’ and ‘cost of construction’ include—

13 ‘‘(A) the construction of new buildings, the ex14 pansion of existing buildings, and the acquisition, re15 modeling, replacement, renovation, major repair (to

16 the extent permitted by regulations), or alteration of

17 existing buildings, including architects’ fees, but not

18 including the cost of the acquisition of land or off19 site improvements; and

20 ‘‘(B) the initial equipping of new buildings and

21 of the expanded, remodeled, repaired, renovated, or

22 altered part of existing buildings; except that

23 such term does not include the construction or cost of con24 struction of so much of any facility as is used or is to
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1 be used for sectarian instruction or as a place for religious

2 worship.’’.

3 Subtitle H—National Institute of

4 Mental Health

5 SEC. 371. AUTHORIZATION OF APPROPRIATIONS.

6 Section 464R(f)(1) (42 U.S.C. 285p(f)(1)) is amend7 ed by striking ‘‘$675,000,000’’ and all that follows

8 through the period and inserting ‘‘$750,000,000 for fiscal

9 year 1997.’’.

10 Subtitle I—National Center for

11 Research Resources

12 SEC. 381. AUTHORIZATION OF APPROPRIATIONS.

13 (a) GENERAL AUTHORIZATION.—Section 481A(h)

14 (42 U.S.C. 287a–2(h)) is amended by striking

15 ‘‘$150,000,000’’ and all that follows through the period

16 and inserting ‘‘such sums as may be necessary for fiscal

17 year 1997.’’.

18 (b) RESERVATION FOR CONSTRUCTION OF REGIONAL

19 CENTERS.—Section 481B(a) (42 U.S.C. 287a–3(a)) is

20 amended—

21 (1) by striking ‘‘shall’’ and inserting ‘‘may’’;

22 (2) by striking ‘‘through 1996’’ and inserting

23 ‘‘through 1997’’; and
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1 (3) by striking ‘‘$5,000,000’’ and inserting

2 ‘‘such sums as may be necessary for each such fiscal

3 year’’.

4 SEC. 382. GENERAL CLINICAL RESEARCH CENTERS.

5 Part B of title IV (42 U.S.C. 284 et seq.), as amend6 ed by section 205(h), is further amended by adding at the

7 end thereof the following new section:

8 ‘‘SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.

9 ‘‘(a) GRANTS.—The Director of the National Center

10 for Research Resources shall award grants for the estab11 lishment of general clinical research centers to provide the

12 infrastructure for clinical research including clinical re13 search training and career enhancement. Such centers

14 shall support clinical studies and career development in

15 all settings of the hospital or academic medical center in16 volved.

17 ‘‘(b) ACTIVITIES.—In carrying out subsection (a), the

18 Director of NIH shall expand the activities of the general

19 clinical research centers through the increased use of tele20 communications and telemedicine initiatives.

21 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There

22 are authorized to be appropriated to make grants under

23 subsection (a), such sums as may be necessary for each

24 of the fiscal years 1996 and 1997.’’.
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1 SEC. 383. ENHANCEMENT AWARDS.

2 Part B of title IV (42 U.S.C. 284 et seq.), as amend3 ed by sections 205(h) and 382, is further amended by add4 ing at the end thereof the following new section:

5 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

6 ‘‘(a) CLINICAL RESEARCH CAREER ENHANCEMENT

7 AWARD.—

8 ‘‘(1) IN GENERAL.—The Director of the Na9 tional Center for Research Resources shall make

10 grants (to be referred to as ‘clinical research career

11 enhancement awards’) to support individual careers

12 in clinical research.

13 ‘‘(2) APPLICATIONS.—An application for a

14 grant under this subsection shall be submitted by an

15 individual scientist at such time as the Director may

16 require.

17 ‘‘(3) LIMITATIONS.—The amount of a grant

18 under this subsection shall not exceed $130,000 per

19 year per grant. Grants shall be for terms of 5 years.

20 The Director shall award not more than 20 grants

21 in the first fiscal year in which grants are awarded

22 under this subsection. The total number of grants

23 awarded under this subsection for the first and sec24 ond fiscal years in which grants such are awarded

25 shall not exceed 40 grants.
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1 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

2 There are authorized to be appropriated to make

3 grants under paragraph (1), such sums as may be

4 necessary for fiscal year 1997.

5 ‘‘(b) INNOVATIVE MEDICAL SCIENCE AWARD.—

6 ‘‘(1) IN GENERAL.—The Director of the Na7 tional Center for Research Resources shall make

8 grants (to be referred to as ‘innovative medical

9 science awards’) to support individual clinical re10 search projects.

11 ‘‘(2) APPLICATIONS.—An application for a

12 grant under this subsection shall be submitted by an

13 individual scientist at such time as the Director re14 quires.

15 ‘‘(3) LIMITATIONS.—The amount of a grant

16 under this subsection shall not exceed $100,000 per

17 year per grant.

18 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

19 There are authorized to be appropriated to make

20 grants under paragraph (1), such sums as may be

21 necessary for fiscal year 1997.

22 ‘‘(c) PEER REVIEW.—The Director of NIH, in co23 operation with the Director of the National Center for Re24 search Resources, shall establish peer review mechanisms

25 to evaluate applications for clinical research fellowships,
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1 clinical research career enhancement awards, and innova2 tive medical science award programs. Such review mecha3 nisms shall include individuals who are exceptionally quali4 fied to appraise the merits of potential clinical research

5 trainees.’’.

6 SEC. 384. WAIVER OF LIMITATIONS.

7 Section 481A (42 U.S.C. 287a–2) is amended—

8 (1) in subsection (b)(3)(A), by striking ‘‘9’’ and

9 inserting ‘‘12’’;

10 (2) in subsection (e)—

11 (A) in paragraph (1)—

12 (i) in subparagraph (A), by striking

13 ‘‘50’’ and inserting ‘‘40’’; and

14 (ii) in subparagraph (B), by striking

15 ‘‘40’’ and inserting ‘‘30’’; and

16 (B) in paragraph (4), by striking ‘‘for ap17 plicants meeting the conditions described in

18 paragraphs (1) and (2) of subsection (c)’’; and

19 (3) in subsection (h), by striking

20 $150,000,000’’ and all that follows through ‘‘1996’’

21 and inserting ‘‘such sums as may be necessary for

22 fiscal year 1997’’.
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1 Subtitle J—National Library of

2 Medicine

3 SEC. 391. AUTHORIZATION OF APPROPRIATIONS.

4 Section 468(a) (42 U.S.C. 286a–2(a)) is amended by

5 striking ‘‘$150,000,000’’ and all that follows through the

6 period and inserting ‘‘$160,000,000 for fiscal year 1997.’’.

7 SEC. 392. INCREASING THE CAP ON GRANT AMOUNTS.

8 Section 474(b)(2) (42 U.S.C. 286b–5(b)(2)) is

9 amended by striking ‘‘$1,000,000’’ and inserting

10 ‘‘$1,250,000’’.

11 TITLE IV—AWARDS AND

12 TRAINING

13 SEC. 401. MEDICAL SCIENTIST TRAINING PROGRAM.

14 (a) EXPANSION OF PROGRAM.—Notwithstanding any

15 other provision of law, the Secretary of Health and

16 Human Services, acting through the Director of the Na17 tional Institutes of Health, shall expand the Medical Sci18 entist Training Program to include fields that will contrib19 ute to training clinical investigators in the skills of per20 forming patient-oriented clinical research.

21 (b) DESIGNATION OF SLOTS.—In carrying out sub22 section (a), the Director of the National Institutes of

23 Health shall designate a specific percentage of positions

24 under the Medical Scientist Training Program for use

25 with respect to the pursuit of a Ph.D. degree in the dis-
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1 ciplines of economics, epidemiology, public health, bio2 engineering, biostatistics and bioethics, and other fields

3 determined appropriate by the Director.

4 SEC. 402. RAISE IN MAXIMUM LEVEL OF LOAN REPAY5 MENTS.

6 (a) REPAYMENT PROGRAMS WITH RESPECT TO

7 AIDS.—Section 487A (42 U.S.C. 288–1) is amended—

8 (1) in subsection (a), by striking ‘‘$20,000’’

9 and inserting ‘‘$35,000’’; and

10 (2) in subsection (c), by striking ‘‘1996’’ and

11 inserting ‘‘1997’’.

12 (b) REPAYMENT PROGRAMS WITH RESPECT TO CON13 TRACEPTION AND INFERTILITY.—Section 487B(a) (42

14 U.S.C. 288–2(a)) is amended by striking ‘‘$20,000’’ and

15 inserting ‘‘$35,000’’.

16 (c) REPAYMENT PROGRAMS WITH RESPECT TO RE17 SEARCH GENERALLY.—Section 487C(a)(1) (42 U.S.C.

18 288–3(a)(1)) is amended by striking ‘‘$20,000’’ and in19 serting ‘‘$35,000’’.

20 (d) REPAYMENT PROGRAMS WITH RESPECT TO

21 CLINICAL RESEARCHERS FROM DISADVANTAGED BACK22 GROUNDS.—Section 487E(a) (42 U.S.C. 288–5(a)) is

23 amended—

24 (1) in paragraph (1), by striking ‘‘$20,000’’

25 and inserting ‘‘$35,000’’; and
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1 (2) in paragraph (3), by striking ‘‘338C’’ and

2 inserting ‘‘338B, 338C’’.

3 SEC. 403. GENERAL LOAN REPAYMENT PROGRAM.

4 Part G of title IV (42 U.S.C. 288 et seq.) is amended

5 by inserting after section 487E, the following new section:

6 ‘‘SEC. 487F. GENERAL LOAN REPAYMENT PROGRAM.

7 ‘‘(a) ESTABLISHMENT.—

8 ‘‘(1) IN GENERAL.—The Secretary, acting

9 through the Director of NIH, shall carry out a pro10 gram of entering into agreements with appropriately

11 qualified health professionals under which such

12 health professionals agree to conduct research with

13 respect to the areas identified under paragraph (2)

14 in consideration of the Federal Government agreeing

15 to repay, for each year of such service, not more

16 than $35,000 of the principal and interest of the

17 educational loans of such health professionals.

18 ‘‘(2) RESEARCH AREAS.—In carrying out the

19 program under paragraph (1), the Director of NIH

20 shall annually identify areas of research for which

21 loan repayments made be awarded under paragraph

22 (1).

23 ‘‘(3) TERM OF AGREEMENT.—A loan repayment

24 agreement under paragraph (1) shall be for a mini25 mum of two years.
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1 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

2 With respect to the National Health Service Corps Loan

3 Repayment Program established in subpart III of part D

4 of title III, the provisions of such subpart shall, except

5 as inconsistent with subsection (a) of this section, apply

6 to the program established in such subsection (a) in the

7 same manner and to the same extent as such provisions

8 apply to the National Health Service Corps Loan Repay9 ment Program established in such subpart.

10 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the

11 purpose of carrying out this section, there are authorized

12 to be appropriated such sums as may be necessary for fis13 cal year 1997.’’.

14 SEC. 404. CLINICAL RESEARCH ASSISTANCE.

15 (a) NATIONAL RESEARCH SERVICE AWARDS.—Sec16 tion 487(a)(1)(C) (42 U.S.C. 288(a)(1)(C)) is amended—

17 (1) by striking ‘‘50 such’’ and inserting ‘‘100

18 such’’; and

19 (2) by striking ‘‘1996’’ and inserting ‘‘1997’’.

20 (b) LOAN REPAYMENT PROGRAM.—Section 487E

21 (42 U.S.C. 288–5) is amended—

22 (1) in the section heading, by striking ‘‘FROM

23 DISADVANTAGED BACKGROUNDS’’;

24 (2) in subsection (a)(1), by striking ‘‘who are

25 from disadvantaged backgrounds’’;
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1 (3) in subsection (b)—

2 (A) by striking ‘‘Amounts’’ and inserting

3 the following:

4 ‘‘(1) IN GENERAL.—Amounts’’; and

5 (B) by adding at the end thereof the fol6 lowing new paragraph:

7 ‘‘(2) DISADVANTAGED BACKGROUNDS SET8 ASIDE.—In carrying out this section, the Secretary

9 shall ensure that not less than 50 percent of the

10 amounts appropriated for a fiscal year are used for

11 contracts involving those appropriately qualified

12 health professionals who are from disadvantaged

13 backgrounds.’’; and

14 (4) by adding at the end thereof the following

15 new subsections:

16 ‘‘(c) CLINICAL RESEARCH TRAINING POSITION.—A

17 position shall be considered a clinical research training po18 sition under subsection (a)(1) if such position involves an

19 individual serving in a general clinical research center or

20 other organizations and institutions determined to be ap21 propriate by the Director of NIH, or a physician receiving

22 a clinical research career enhancement award or NIH in23 tramural research fellowship.
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1 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

2 are authorized to be appropriated to carry out this section

3 such sums as may be necessary for each fiscal year.’’.

4 TITLE V—RESEARCH WITH

5 RESPECT TO AIDS

6 SEC. 501. COMPREHENSIVE PLAN FOR EXPENDITURE OF

7 AIDS APPROPRIATIONS.

8 Section 2353(d)(1) (42 U.S.C. 300cc–40b(d)(1)) is

9 amended by striking ‘‘through 1996’’ and inserting

10 ‘‘through 1997’’.

11 SEC. 502. EMERGENCY AIDS DISCRETIONARY FUND.

12 Section 2356(g)(1) (42 U.S.C. 300cc–43(g)(1)) is

13 amended by striking ‘‘$100,000,000’’ and all that follows

14 through the period and inserting ‘‘such sums as may be

15 necessary for fiscal year 1997’’.

16 TITLE VI—GENERAL

17 PROVISIONS

18 Subtitle A—Authority of the

19 Director of NIH

20 SEC. 601. AUTHORITY OF THE DIRECTOR OF NIH.

21 Section 402(b) (42 U.S.C. 282(b)) is amended—

22 (1) in paragraph (11), by striking ‘‘and’’ at the

23 end thereof;

24 (2) in paragraph (12), by striking the period

25 and inserting a semicolon; and
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1 (3) by adding after paragraph (12), the follow2 ing new paragraphs:

3 ‘‘(13) may conduct and support research train4 ing—

5 ‘‘(A) for which fellowship support is not

6 provided under section 487; and

7 ‘‘(B) which does not consist of residency

8 training of physicians or other health profes9 sionals; and

10 ‘‘(14) may appoint physicians, dentists, and

11 other health care professionals, subject to the provi12 sions of title 5, United States Code, relating to ap13 pointments and classifications in the competitive

14 service, and may compensate such professionals sub15 ject to the provisions of chapter 74 of title 38,

16 United States Code.’’.

17 Subtitle B—Office of Rare Disease

18 Research

19 SEC. 611. ESTABLISHMENT OF OFFICE FOR RARE DISEASE

20 RESEARCH.

21 Part A of title IV of the Public Health Service Act

22 (42 U.S.C. 281 et seq.) is amended by adding at the end

23 thereof the following new section:
35

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1 ‘‘SEC. 404F. OFFICE FOR RARE DISEASE RESEARCH.

2 ‘‘(a) ESTABLISHMENT.—There is established within

3 the Office of the Director of the National Institutes of

4 Health an office to be known as the Office for Rare Dis5 ease Research (in this section referred to as the ‘Office’).

6 The Office shall be headed by a director, who shall be ap7 pointed by the Director of the National Institutes of

8 Health.

9 ‘‘(b) PURPOSE.—The purpose of the Office is to pro10 mote and coordinate the conduct of research on rare dis11 eases through a strategic research plan and to establish

12 and manage a rare disease research clinical database.

13 ‘‘(c) ADVISORY COUNCIL.—The Secretary shall es14 tablish an advisory council for the purpose of providing

15 advice to the director of the Office concerning carrying

16 out the strategic research plan and other duties under this

17 section. Section 222 shall apply to such council to the

18 same extent and in the same manner as such section ap19 plies to committees or councils established under such sec20 tion.

21 ‘‘(d) DUTIES.—In carrying out subsection (b), the di22 rector of the Office shall—

23 ‘‘(1) develop a comprehensive plan for the con24 duct and support of research on rare diseases;

25 ‘‘(2) coordinate and disseminate information

26 among the institutes and the public on rare diseases;
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1 ‘‘(3) support research training and encourage

2 the participation of a diversity of individuals in the

3 conduct of rare disease research;

4 ‘‘(4) identify projects or research on rare dis5 eases that should be conducted or supported by the

6 National Institutes of Health;

7 ‘‘(5) develop and maintain a central database

8 on current government sponsored clinical research

9 projects for rare diseases;

10 ‘‘(6) determine the need for registries of re11 search subjects and epidemiological studies of rare

12 disease populations; and

13 ‘‘(7) prepare biennial reports on the activities

14 carried out or to be carried out by the Office and

15 submit such reports to the Secretary and the Con16 gress.’’.

17 Subtitle C—Certain

18 Reauthorizations

19 SEC. 621. NATIONAL RESEARCH SERVICE AWARDS.

20 Section 487(d) (42 U.S.C. 288(d)) is amended by

21 striking ‘‘$400,000,000’’ and all that follows through the

22 first period and inserting ‘‘such sums as may be necessary

23 for fiscal year 1997.’’.
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1 SEC. 622. NATIONAL FOUNDATION FOR BIOMEDICAL RE2 SEARCH.

3 Section 499(m)(1) (42 U.S.C. 290b(m)(1)) is amend4 ed by striking ‘‘an aggregate’’ and all that follows through

5 the period and inserting ‘‘such sums as may be necessary

6 for fiscal year 1997.’’.

7 Subtitle D—Miscellaneous

8 Provisions

9 SEC. 631. ESTABLISHMENT OF NATIONAL FUND FOR

10 HEALTH RESEARCH.

11 Part A of title IV (42 U.S.C. 281 et seq.), as amend12 ed by section 611, is further amended by adding at the

13 end thereof the following new section:

14 ‘‘SEC. 404G. ESTABLISHMENT OF NATIONAL FUND FOR

15 HEALTH RESEARCH.

16 ‘‘(a) ESTABLISHMENT.—There is established in the

17 Treasury of the United States a fund, to be known as the

18 ‘National Fund for Health Research’ (hereafter in this

19 section referred to as the ‘Fund’), consisting of such

20 amounts as are transferred to the Fund and any interest

21 earned on investment of amounts in the Fund.

22 ‘‘(b) OBLIGATIONS FROM FUND.—

23 ‘‘(1) IN GENERAL.—Subject to the provisions of

24 paragraph (2), with respect to the amounts made

25 available in the Fund in a fiscal year, the Secretary

26 shall distribute all of such amounts during any fiscal
38

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1 year to research institutes and centers of the Na2 tional Institutes of Health in the same proportion to

3 the total amount received under this section, as the

4 amount of annual appropriations under appropria5 tions Acts for each member institute and centers for

6 the fiscal year bears to the total amount of appro7 priations under appropriations Acts for all research

8 institutes and centers of the National Institutes of

9 Health for the fiscal year.

10 ‘‘(2) TRIGGER AND RELEASE OF MONIES.—No

11 expenditure shall be made under paragraph (1) dur12 ing any fiscal year in which the annual amount ap13 propriated for the National Institutes of Health is

14 less than the amount so appropriated for the prior

15 fiscal year.’’.

16 SEC. 632. DEFINITION OF CLINICAL RESEARCH.

17 Part A of title IV (42 U.S.C. 281 et seq.) as amended

18 by sections 611 and 631, is further amended by adding

19 at the end thereof the following new section:

20 ‘‘SEC. 404H. DEFINITION OF CLINICAL RESEARCH.

21 ‘‘As used in this title, the term ‘clinical research’

22 means patient oriented clinical research conducted with

23 human subjects, or research on the causes and con24 sequences of disease in human populations, or on material

25 of human origin (such as tissue specimens and cognitive
39

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1 phenomena) for which an investigator or colleague directly

2 interacts with human subjects in an outpatient or inpa3 tient setting to clarify a problem in human physiology,

4 pathophysiology, or disease, epidemiologic or behavioral

5 studies, outcomes research, or health services research.’’.

6 SEC. 633. ESTABLISHMENT OF A PEDIATRIC RESEARCH INI7 TIATIVE.

8 Part A of title IV (42 U.S.C. 281 et seq.), as amend9 ed by sections 611, 631, and 632, is further amended by

10 adding at the end the following new section:

11 ‘‘SEC. 404I. PEDIATRIC RESEARCH INITIATIVE

12 ‘‘(a) ESTABLISHMENT.—The Secretary shall estab13 lish within the Office of the Director of NIH a Pediatric

14 Research Initiative (hereafter in this section referred to

15 as the ‘Initiative’). The Initiative shall be headed by the

16 Director of NIH.

17 ‘‘(b) PURPOSE.—The purpose of the Initiative is to

18 provide funds to enable the Director of NIH to encour19 age—

20 ‘‘(1) increased support for pediatric biomedical

21 research within the National Institutes of Health to

22 ensure that the expanding opportunities for advance23 ment in scientific investigations and care for chil24 dren are realized;
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1 ‘‘(2) enhanced collaborative efforts among the

2 Institutes to support multidisciplinary research in

3 the areas that the Director deems most promising;

4 ‘‘(3) increased support for pediatric outcomes

5 and medical effectiveness research to demonstrate

6 how to improve the quality of children’s health care

7 while reducing cost;

8 ‘‘(4) the development of adequate pediatric clin9 ical trials and pediatric use information to promote

10 the safer and more effective use of prescription

11 drugs in the pediatric population; and

12 ‘‘(5) recognition of the special attention pedi13 atric research deserves.

14 ‘‘(c) DUTIES.—In carrying out subsection (b), the Di15 rector of NIH shall—

16 ‘‘(1) consult with the Institutes and other advi17 sors as the Director determines appropriate when

18 considering the role of the Institute for Child Health

19 and Human Development;

20 ‘‘(2) have broad discretion in the allocation of

21 any Initiative assistance among the Institutes,

22 among types of grants, and between basic and clini23 cal research so long as the—

24 ‘‘(A) assistance is directly related to the ill25 nesses and diseases of children; and
41

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1 ‘‘(B) assistance is extramural in nature;

2 and

3 ‘‘(3) be responsible for the oversight of any

4 newly appropriated Initiative funds and be account5 able with respect to such funds to Congress and to

6 the public.

7 ‘‘(d) AUTHORIZATION.—There is authorized to be ap8 propriated to carry out this section, $50,000,000 for fiscal

9 years 1997 through 1999.

10 ‘‘(e) TRANSFER OF FUNDS.—The Director of NIH

11 may transfer amounts appropriated to any of the Insti12 tutes for a fiscal year to the Initiative to carry out this

13 section.’’.

14 SEC. 634. DIABETES RESEARCH.

15 (a) FINDINGS.—The Congress finds as follows:

16 (1) Diabetes is a serious health problem in

17 America.

18 (2) More than 16,000,000 Americans suffer

19 from diabetes.

20 (3) Diabetes is the fourth leading cause of

21 death in America, taking the lives of more than

22 169,000 people annually.

23 (4) Diabetes disproportionately affects minority

24 populations, especially African-Americans, His25 panics, and Native Americans.
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1 (5) Diabetes is the leading cause of new blind2 ness in adults over age 30.

3 (6) Diabetes is the leading cause of kidney fail4 ure requiring dialysis or transplantation, affecting

5 more than 56,000 Americans each year.

6 (7) Diabetes is the leading cause of nontrau7 matic amputations, affecting 54,000 Americans each

8 year.

9 (8) The cost of treating diabetes and its com10 plications are staggering for our Nation.

11 (9) Diabetes accounted for health expenditures

12 of $105,000,000,000 in 1992.

13 (10) Diabetes accounts for over 14 percent of

14 our Nation’s health care costs.

15 (11) Federal funds invested in diabetes re16 search over the last two decades has led to signifi17 cant advances and, according to leading scientists

18 and endocrinologists, has brought the United States

19 to the threshold of revolutionary discoveries which

20 hold the potential to dramatically reduce the eco21 nomic and social burden of this disease.

22 (12) The National Institute of Diabetes and Di23 gestive and Kidney Diseases supports, in addition to

24 many other areas of research, genetic research, islet

25 cell transplantation research, and prevention and
43

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1 treatment clinical trials focusing on diabetes. Other

2 research institutes within the National Institutes of

3 Health conduct diabetes-related research focusing on

4 its numerous complications, such as heart disease,

5 eye and kidney problems, amputations, and diabetic

6 neuropathy.

7 (b) INCREASED FUNDING REGARDING DIABETES.—

8 With respect to the conduct and support of diabetes-relat9 ed research by the National Institutes of Health, there are

10 authorized to be appropriated for such purpose—

11 (1) for each of the fiscal years 1997 through

12 1999, an amount equal to the amount appropriated

13 for such purpose for fiscal year 1996; and

14 (2) for the 3-fiscal year period beginning with

15 fiscal year 1997, an additional amount equal to 25

16 percent of the amount appropriated for such purpose

17 for fiscal year 1996.

18 SEC. 635. PARKINSON’S RESEARCH.

19 Part B of title IV (42 U.S.C. 284 et seq.), as amend20 ed by sections 204, 382 and 383, is further amended by

21 adding at the end the following section:

22 ‘‘PARKINSON’S DISEASE

23 ‘‘SEC. 409E. (a) IN GENERAL.—The Director of

24 NIH shall establish a program for the conduct and sup25 port of research and training with respect to Parkinson’s

26 disease.
44

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1 ‘‘(b) INTER-INSTITUTE COORDINATION.—

2 ‘‘(1) IN GENERAL.—The Director of NIH shall

3 provide for the coordination of the program estab4 lished under subsection (a) among all of the national

5 research institutes conducting Parkinson’s research.

6 ‘‘(2) CONFERENCE.—Coordination under para7 graph (1) shall include the convening of a research

8 planning conference not less frequently than once

9 every 2 years. Each such conference shall prepare

10 and submit to the Committee on Appropriations and

11 the Committee on Labor and Human Resources of

12 the Senate and the Committee on Appropriations

13 and the Committee on Commerce of the House of

14 Representatives a report concerning the conference.

15 ‘‘(c) MORRIS K. UDALL RESEARCH CENTERS.—

16 ‘‘(1) IN GENERAL.—The Director of NIH shall

17 award Core Center Grants to encourage the develop18 ment of innovative multidisciplinary research and

19 provide training concerning Parkinson’s. The Direc20 tor shall award not more than 10 Core Center

21 Grants and designate each center funded under such

22 grants as a Morris K. Udall Center for Research on

23 Parkinson’s Disease.

24 ‘‘(2) REQUIREMENTS.—
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1 ‘‘(A) IN GENERAL.—With respect to Par2 kinson’s, each center assisted under this sub3 section shall—

4 ‘‘(i) use the facilities of a single insti5 tution or a consortium of cooperating insti6 tutions, and meet such qualifications as

7 may be prescribed by the Director of the

8 NIH; and

9 ‘‘(ii) conduct basic and clinical re10 search.

11 ‘‘(B) DISCRETIONARY REQUIREMENTS.—

12 With respect to Parkinson’s, each center as13 sisted under this subsection may—

14 ‘‘(i) conduct training programs for

15 scientists and health professionals;

16 ‘‘(ii) conduct programs to provide in17 formation and continuing education to

18 health professionals;

19 ‘‘(iii) conduct programs for the dis20 semination of information to the public;

21 ‘‘(iv) separately or in collaboration

22 with other centers, establish a nationwide

23 data system derived from patient popu24 lations with Parkinson’s, and where pos-
46

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1 sible, comparing relevant data involving

2 general populations;

3 ‘‘(v) separately or in collaboration

4 with other centers, establish a Parkinson’s

5 Disease Information Clearinghouse to fa6 cilitate and enhance knowledge and under7 standing of Parkinson’s disease; and

8 ‘‘(vi) separately or in collaboration

9 with other centers, establish a national

10 education program that fosters a national

11 focus on Parkinson’s and the care of those

12 with Parkinson’s.

13 ‘‘(3) STIPENDS REGARDING TRAINING PRO14 GRAMS.—A center may use funds provided under

15 paragraph (1) to provide stipends for scientists and

16 health professionals enrolled in training programs

17 under paragraph (2)(B).

18 ‘‘(4) DURATION OF SUPPORT.—Support of a

19 center under this subsection may be for a period not

20 exceeding five years. Such period may be extended

21 by the Director of NIH for one or more additional

22 periods of not more than five years if the operations

23 of such center have been reviewed by an appropriate

24 technical and scientific peer review group established
47

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1 by the Director and if such group has recommended

2 to the Director that such period should be extended.

3 ‘‘(d) MORRIS K. UDALL AWARDS FOR INNOVATION

4 IN PARKINSON’S DISEASE RESEARCH.—The Director of

5 NIH shall establish a grant program to support innovative

6 proposals leading to significant breakthroughs in Parkin7 son’s research. Grants under this subsection shall be avail8 able to support outstanding neuroscientists and clinicians

9 who bring innovative ideas to bear on the understanding

10 of the pathogenesis, diagnosis and treatment of Parkin11 son’s disease.

12 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—For the

13 purpose of carrying out this section, there are authorized

14 to be appropriated $80,000,000 for fiscal year 1997.’’.

15 SEC. 636. PAIN RESEARCH CONSORTIUM.

16 (a) SHORT TITLE.—This section may be cited as the

17 ‘‘Pain Research Consortium Act of 1996’’.

18 (b) OPERATION.—Part E of title IV (42 U.S.C. 287

19 et seq.) is amended by adding at the end thereof the fol20 lowing new subpart:

21 ‘‘Subpart 5—Pain Research Consortium

22 ‘‘SEC. 485E. ESTABLISHMENT AND PURPOSE OF THE CON23 SORTIUM.

24 ‘‘(a) ESTABLISHMENT.—The Director of NIH shall,

25 subject to the availability of appropriations, and acting in
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1 cooperation with appropriate Institutes and with leading

2 experts in pain research and treatment, establish within

3 the National Institutes of Health, a Pain Research Con4 sortium (hereafter referred to in this subpart as the ‘Con5 sortium’).

6 ‘‘(b) PURPOSE.—It is the purpose of the Pain Re7 search Consortium to—

8 ‘‘(1) provide a structure for coordinating pain

9 research activities;

10 ‘‘(2) facilitate communications among Federal

11 and State governmental agencies and private sector

12 organization (including extramural grantees) con13 cerned with pain;

14 ‘‘(3) share information concerning research and

15 related activities being conducted in the area of

16 pain;

17 ‘‘(4) encourage the recruitment and retention of

18 individuals desiring to conduct pain research;

19 ‘‘(5) develop collaborative pain research efforts;

20 ‘‘(6) avoid unnecessary duplication of pain re21 search efforts; and

22 ‘‘(7) achieve a more efficient use of Federal and

23 private sector research funds.

24 ‘‘(c) COMPOSITION.—The Consortium shall be com25 posed of representatives of—
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1 ‘‘(1) the National Institute of Neurological Dis2 orders and Stroke;

3 ‘‘(2) the National Institute of Drug Abuse;

4 ‘‘(3) the National Institute of General Medical

5 Sciences;

6 ‘‘(4) the National Institute of Dental Research;

7 ‘‘(5) the National Health, Lung, and Blood In8 stitute;

9 ‘‘(6) the National Cancer Institute;

10 ‘‘(7) the National Institute of Mental Health;

11 ‘‘(8) the National Institute of Nursing Re12 search;

13 ‘‘(9) the National Center for Research Re14 sources;

15 ‘‘(10) the National Institute of Child Health

16 and Human Development;

17 ‘‘(11) the National Institute of Arthritis and

18 Musculoskeletal and Skin Diseases;

19 ‘‘(12) the National Institute on Aging;

20 ‘‘(13) pain management practitioners, which

21 may include physicians, psychologists, physical medi22 cine and rehabilitation service representatives (in23 cluding physical therapists and occupational thera24 pists), nurses, dentists, and chiropractors; and

25 ‘‘(14) patient advocacy groups.
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1 ‘‘(d) ACTIVITIES.—The Consortium shall coordinate

2 and support research, training, health information dis3 semination and related activities with respect to—

4 ‘‘(1) acute pain;

5 ‘‘(2) cancer and HIV-related pain;

6 ‘‘(3) back pain, headache pain, and facial pain;

7 and

8 ‘‘(4) other painful conditions.

9 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There

10 is authorized to be appropriated to carry out this section,

11 $5,000,000 for fiscal year 1997.’’.

12 Subtitle E—Repeals and

13 Conforming Amendments

14 SEC. 641. REPEALS AND CONFORMING AMENDMENTS.

15 (a) RENAMING OF DIVISION OF RESEARCH RE16 SOURCES.—Section 403(5) (42 U.S.C. 283(5)) is amended

17 by striking ‘‘Division of Research Resources’’ and insert18 ing ‘‘National Center for Research Resources’’.

19 (b) RENAMING OF NATIONAL CENTER FOR NURSING

20 RESEARCH.—

21 (1) Section 403(5) (42 U.S.C. 283(5)) is

22 amended by striking ‘‘National Center for Nursing

23 Research’’ and inserting ‘‘National Institute of

24 Nursing Research’’.
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1 (2) Section 408(a)(2) (42 U.S.C. 284c(a)(2)) is

2 amended by striking ‘‘National Center for Nursing

3 Research’’ and inserting ‘‘National Institute of

4 Nursing Research’’.

5 (c) RENAMING OF CHIEF MEDICAL DIRECTOR FOR

6 VETERANS AFFAIRS.—

7 (1) Section 406 (42 U.S.C. 284a) is amended—

8 (A) in subsection (b)(2)(A), by striking

9 ‘‘Chief Medical Director of the Department of

10 Veterans Affairs or the Chief Dental Director

11 of the Department of Veterans Affairs’’ and in12 serting ‘‘Under Secretary for Health of the De13 partment of Veterans Affairs’’; and

14 (B) in subsection (h)(2)(A)(v) by striking

15 ‘‘Chief Medical Director of the Department of

16 Veterans Affairs,’’ and inserting ‘‘Under Sec17 retary for Health of the Department of Veter18 ans Affairs’’.

19 (2) Section 424(c)(3)(B)(x) (42 U.S.C. 285b–

20 7(c)(3)(B)(x)) is amended by striking ‘‘Chief Medi21 cal Director of the Veterans’ Administration’’ and

22 inserting ‘‘Under Secretary for Health of the De23 partment of Veterans Affairs’’.

24 (3) Section 429(b) (42 U.S.C. 285c–3(b)) is

25 amended by striking ‘‘Chief Medical Director of the
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1 Veterans’ Administration’’ and inserting ‘‘Under

2 Secretary for Health of the Department of Veterans

3 Affairs’’.

4 (4) Section 430(b)(2)(A)(i) (42 U.S.C. 285c–

5 4(b)(2)(A)(i)) is amended by striking ‘‘Chief Medical

6 Director of the Department of Veterans Affairs’’

7 and inserting ‘‘Under Secretary for Health of the

8 Department of Veterans Affairs’’.

9 (5) Section 439(b) (42 U.S.C. 285d–4(b)) is

10 amended by striking ‘‘Chief Medical Director of the

11 Department of Veterans Affairs’’ and inserting

12 ‘‘Under Secretary for Health of the Department of

13 Veterans Affairs’’.

14 (6) Section 452(f)(3)(B)(xi) (42 U.S.C. 285g–

15 4(f)(3)(B)(xi)) is amended by striking ‘‘Chief Medi16 cal Director of the Department of Veterans Affairs’’

17 and inserting ‘‘Under Secretary for Health of the

18 Department of Veterans Affairs’’.

19 (7) Section 466(a)(1)(B) (42 U.S.C.

20 286a(a)(1)(B)) is amended by striking ‘‘Chief Medi21 cal Director of the Department of Veterans Affairs’’

22 and inserting ‘‘Under Secretary for Health of the

23 Department of Veterans Affairs’’.

24 (8) Section 480(b)(2)(A) (42 U.S.C.

25 287a(b)(2)(A)) is amended by striking ‘‘Chief Medi-
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1 cal Director of the Department of Veterans Affairs’’

2 and inserting ‘‘Under Secretary for Health of the

3 Department of Veterans Affairs’’.

4 (b) ADVISORY COUNCILS.—Section 406(h) (42

5 U.S.C. 284a(h)) is amended—

6 (1) by striking paragraph (1); and

7 (2) in paragraph (2)—

8 (A) by striking ‘‘(2)(A) The’’ and inserting

9 ‘‘(1) The’’;

10 (B) by redesignating subparagraph (B) as

11 paragraph (2); and

12 (C) by redesignating clauses (i) through

13 (vi) of paragraph (1) (as so redesignated) as

14 subparagraphs (A) through (F), respectively.

15 (c) DIABETES AND DIGESTIVE AND KIDNEY DIS16 ORDERS ADVISORY BOARDS.—Section 430 (42 U.S.C.

17 285c–4) is repealed.

18 (d) NATIONAL ARTHRITIS AND MUSCULOSKELETAL

19 AND SKIN DISEASES ADVISORY BOARD.—Section 442 (42

20 U.S.C. 285d–7) is repealed.

21 (e) RESEARCH CENTERS REGARDING CHRONIC FA22 TIGUE SYNDROME.—Subpart 6 of part C of title IV (42

23 U.S.C. 285f et seq.) is amended by redesignating the sec24 ond section 447 (42 U.S.C. 285f–1) as section 447A.
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1 (f) NATIONAL INSTITUTE ON DEAFNESS ADVISORY

2 BOARD.—Section 464D (42 U.S.C. 285m–4) is repealed.

3 (g) BIOMEDICAL AND BEHAVIORAL RESEARCH PER4 SONNEL STUDY.—Section 489 (42 U.S.C. 288b) is

5 amended—

6 (1) by striking subsection (b); and

7 (2) by redesignating subsection (c) as sub8 section (b).

9 (h) NATIONAL COMMISSION ON ALCOHOLISM AND

10 OTHER ALCOHOL-RELATED PROBLEMS.—Section 18 of

11 the Comprehensive Alcohol Abuse and Alcoholism Preven12 tion, Treatment, and Rehabilitation Act Amendments of

13 1979 (42 U.S.C. 4541 note) is repealed.

14 (i) ADVISORY COUNCIL ON HAZARDOUS SUBSTANCES

15 RESEARCH AND TRAINING.—Section 311(a) of the Com16 prehensive Environmental Response, Compensation and

17 Liability Act of 1980 (42 U.S.C. 9660(a)) is amended—

18 (1) by striking paragraph (5); and

19 (2) in the last sentence of paragraph (6), by

20 striking ‘‘the relevant Federal agencies referred to in

21 subparagraph (A) of paragraph (5)’’ and inserting

22 ‘‘relevant Federal agencies’’.

Passed the Senate September 26, 1996.

Attest: GARY SISCO,

Secretary.