Calendar No. 583

104TH CONGRESS

2D SESSION S. 1897

[Report No. 104–364]

A BILL

To amend the Public Health Service Act to revise

poses.tional Institutes of Health, and for other purand extend certain programs relating to the NaSEPTEMBER 9, 1996

Reported with amendments
II

Calendar No. 583

104TH CONGRESS

2D SESSION S. 1897

[Report No. 104–364]

To amend the Public Health Service Act to revise and extend certain programs relating to the National Institutes of Health, and for other purposes.

IN THE SENATE OF THE UNITED STATES

JUNE 21, 1996

Mrs. KASSEBAUM (for herself, Mr. KENNEDY, Mr. JEFFORDS, Mr. PELL, Mr.

HATFIELD, and Ms. MIKULSKI) introduced the following bill; which was

read twice and referred to the Committee on Labor and Human Resources

SEPTEMBER 9, 1996

Reported by Mrs. KASSEBAUM, with amendments

[Omit the part struck through and insert the part printed in italic]

A BILL

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

2 CONTENTS

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

4 ‘‘National Institutes of Health Revitalization Act of

5 1996’’.

6 (b) REFERENCES.—Whenever in this Act an amend7 ment is expressed in terms of an amendment to a section

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

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

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

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

12 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. Research and research training regarding tuberculosis.

Sec. 322. Terry Beirn community-based aids research initiative.
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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.

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.
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Subtitle D—Miscellaneous Provisions

Sec. 631. Establishment of national fund for health research.

Sec. 632. Definition of clinical research.

Sec. 633. Senior Biomedical Research Service.

Sec. 634. Establishment of a pediatric research initiative.

Sec. 635. Diabetes research.

Sec. 636. Parkinson’s research.

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 each of the fiscal years 1997 through 1999.’’.

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 each of the fiscal years 1997 through 1999.’’.

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

2 each of the fiscal years 1997 through 1999.’’.

3 SEC. 202. NATIONAL HUMAN GENOME RESEARCH INSTI4 TUTE.

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

6 et seq.) is amended by adding at the end thereof the fol7 lowing new subpart:

8 ‘‘Subpart 18—National Human Genome Research

9 Institute

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

11 ‘‘(a) IN GENERAL.—The general purpose of the Na12 tional Human Genome Research Institute is to character13 ize the structure and function of the human genome, in14 cluding the mapping and sequencing of individual genes.

15 Such purpose includes—

16 ‘‘(1) planning and coordinating the research

17 goal of the genome project;

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

19 ‘‘(3) conducting and supporting research train20 ing;

21 ‘‘(4) coordinating international genome re22 search;

23 ‘‘(5) communicating advances in genome science

24 to the public;
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1 ‘‘(6) reviewing and funding proposals to address

2 the ethical, legal, and social issues associated with

3 the genome project (including legal issues regarding

4 patents); and

5 ‘‘(7) planning and administering intramural,

6 collaborative, and field research to study human ge7 netic disease.

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

9 conduct and support research training—

10 ‘‘(1) for which fellowship support is not pro11 vided under section 487; and

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

13 or other health professionals.

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

15 ‘‘(1) IN GENERAL.—Except as provided in para16 graph (2), of the amounts appropriated to carry out

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

18 Institute shall make available not less than 5 per19 cent of amounts made available for extramural re20 search for carrying out paragraph (6) of such sub21 section.

22 ‘‘(2) NONAPPLICATION.—With respect to pro23 viding funds under subsection (a)(6) for proposals to

24 address the ethical issues associated with the ge25 nome project, paragraph (1) shall not apply for a
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1 fiscal year if the Director of the Institute certifies

2 to the Committee on Commerce of the House of

3 Representatives, and to the Committee on Labor

4 and Human Resources of the Senate, that the Direc5 tor has determined that an insufficient number of

6 such proposals meet the applicable requirements of

7 sections 491 and 492.

8 ‘‘(d) TRANSFER.—

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

10 the National Human Genome Research Institute all

11 functions which the National Center for Human Ge12 nome Research exercised before the date of enact13 ment of this subpart, including all related functions

14 of any officer or employee of the National Center for

15 Human Genome Research. The personnel employed

16 in connection with, and the assets, liabilities, con17 tracts, property, records, and unexpended balances

18 of appropriations, authorizations, allocations, and

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

20 available to, or to be made available in connection

21 with the functions transferred under this subsection

22 shall be transferred to the National Human Genome

23 Research Institute.

24 ‘‘(2) LEGAL DOCUMENTS.—All orders, deter25 minations, rules, regulations, permits, agreements,
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1 grants, contracts, certificates, licenses, regulations,

2 privileges, and other administrative actions which

3 have been issued, made, granted, or allowed to be4 come effective in the performance of functions which

5 are transferred under this subsection shall continue

6 in effect according to their terms until modified, ter7 minated, superseded, set aside, or revoked in accord8 ance with law.

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

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

11 delegation of authority, or any document of or relat12 ing to the National Center for Human Genome Re13 search shall be deemed to refer to the National

14 Human Genome Research Institute.

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

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

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

18 1997 through 1999.’’.

19 (b) CONFORMING AMENDMENTS.—

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

21 amended—

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

23 thereof the following new subparagraph:

24 ‘‘(R) The National Human Genome Research

25 Institute.’’; and
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1 (B) in paragraph (2)—

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

3 (ii) by redesignating subparagraph

4 (E) as subparagraph (D).

5 (2) Subpart 3 of part E of title IV (42 U.S.C.

6 287c et seq.) is repealed.

7 SEC. 203. INCREASED AMOUNT OF GRANT AND OTHER

8 AWARDS.

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

10 amended—

11 (1) in clause (i), by striking ‘‘$50,000’’ and in12 serting ‘‘$100,000’’; and

13 (2) in clause (ii), by striking ‘‘$50,000’’ and in14 serting ‘‘$100,000’’.

15 SEC. 204. MEETINGS OF ADVISORY COMMITTEES AND

16 COUNCILS.

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

18 amended—

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

20 three times each fiscal year’’; and

21 (2) in subsection (h)(2)—

22 (A) in subparagraph (A)—

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

24 after the semicolon;
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1 (ii) in clause (v), by striking ‘‘; and’’

2 and inserting a period; and

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

4 (B) in subparagraph (B), by striking ‘‘, ex5 cept’’ and all that follows through ‘‘year’’.

6 (b) PRESIDENT’S CANCER PANEL.—Section

7 415(a)(3) (42 U.S.C. 285a–4(a)(3)) is amended by strik8 ing ‘‘, but not less often than four times a year’’.

9 (c) INSTITUTE OF DIABETES AND DIGESTIVE AND

10 KIDNEY DISEASES INTERAGENCY COORDINATING COM11 MITTEES.—Section 429(b) (42 U.S.C. 285c–3(b)) is

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

13 a year’’.

14 (d) INSTITUTE OF ARTHRITIS AND MUSCULO15 SKELETAL AND SKIN DISEASES INTERAGENCY COORDI16 NATING COMMITTEES.—Section 439(b) (42 U.S.C. 285d–

17 4(b)) is amended by striking ‘‘, but not less often than

18 four times a year’’.

19 (e) INSTITUTE ON DEAFNESS AND OTHER COMMU20 NICATION DISORDERS INTERAGENCY COORDINATING

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

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

23 times a year’’.

24 (f) INSTITUTE OF NURSING RESEARCH ADVISORY

25 COUNCIL.—Section 464X(e) (42 U.S.C. 285q–2(e)) is
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1 amended by striking ‘‘, but at least three times each fiscal

2 year’’.

3 (g) CENTER FOR RESEARCH RESOURCES ADVISORY

4 COUNCIL.—Section 480(e) (42 U.S.C. 287a(e)) is amend5 ed by striking ‘‘, but at least three times each fiscal year’’.

6 (h) APPLICATION OF FACA.—Part B of title IV (42

7 U.S.C. 284 et seq.) is amended by adding at the end there8 of the following new section:

9 ‘‘SEC. 409B. APPLICATION OF FEDERAL ADVISORY COMMIT10 TEE ACT.

11 ‘‘Notwithstanding any other provision of law, the pro12 visions of the Federal Advisory Committee Act (5 U.S.C.

13 Ap. 2) shall not apply to a scientific or technical peer re14 view group, established under this title.’’.

15 SEC. 205. ELIMINATION OR MODIFICATION OF REPORTS.

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

17 following provisions of the Public Health Service Act are

18 repealed:

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

20 biennial report of the Director of the National Insti21 tutes of Health to Congress and the President.

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

23 285d-4(c)) relating to the annual report of the Ar24 thritis and Musculoskeletal Diseases Interagency Co-
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1 ordinating Committee and the annual report of the

2 Skin Diseases Interagency Coordinating Committee.

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

4 285d-7(j)) relating to the annual report of the Na5 tional Arthritis and Musculoskeletal and Skin Dis6 eases Advisory Board.

7 (4) Subsection (b) of section 494A (42 U.S.C.

8 289c–1(b)) relating to the annual report of the Sec9 retary of Health and Human Services on health

10 services research relating to alcohol abuse and alco11 holism, drug abuse, and mental health.

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

13 290aa–2(b)) relating to the triennial report of the

14 Secretary of Health and Human Services to Con15 gress.

16 (b) REPORT ON DISEASE PREVENTION.—Section

17 402(f)(3) (42 U.S.C. 282(f)(3)) is amended by striking

18 ‘‘annually’’ and inserting ‘‘biennially’’.

19 (c) REPORTS OF THE COORDINATING COMMITTEES

20 ON DIGESTIVE DISEASES, DIABETES MELLITUS, AND

21 KIDNEY, UROLOGIC AND HEMATOLOGIC DISEASES.—Sec22 tion 429 (42 U.S.C. 285c–3) is amended by striking sub23 section (c).

24 (d) REPORT OF THE TASK FORCE ON AGING RE25 SEARCH.—Section 304 of the Home Health Care and Alz-
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1 heimer’s Disease Amendments of 1990 (42 U.S.C. 242q–

2 3) is repealed.

3 (e) SUDDEN INFANT DEATH SYNDROME RE4 SEARCH.—Section 1122 (42 U.S.C. 300c–12) is amend5 ed—

6 (1) in subsection (a)—

7 (A) by striking the subsection designation

8 and heading; and

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

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

11 amounts each year as will be adequate for re12 search which relates generally to sudden infant

13 death syndrome, including high-risk pregnancy

14 and high-risk infancy research which directly

15 relates to sudden infant death syndrome, and to

16 the relationship of the high-risk pregnancy and

17 high-risk infancy research to sudden infant

18 death syndrome,’’; and

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

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

21 PROGRAM.—Subsection (h) of section 5 of the Inter22 national Health Research Act of 1960 is repealed.

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

24 months after the date of enactment of this Act, the Secretary

25 of Health and Human Services, acting through the Director
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1 of the National Institutes of Health, shall prepare and sub2 mit to the Committee on Labor and Human Resources of

3 the Senate and the Committee on Commerce of the House

4 of Representatives, a report containing specific plans and

5 timeframes on how the Director will implement the findings

6 and recommendations of the report to Congress entitled

7 ‘‘Support for Bioengineering Research’’ (submitted in Au8 gust of 1995 in accordance with section 1912 of the Na9 tional Institutes of Health Revitalization Act of 1993 (42

10 U.S.C. 282 note)).

11 (g) (h) CONFORMING AMENDMENTS.—Title IV is

12 amended—

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

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

15 period and inserting ‘‘made available to the commit16 tee established under subsection (e) and included in

17 the official minutes of the committee’’;

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

19 283g(d)(3)(B)), by striking ‘‘for inclusion in the bi20 ennial report under section 403’’;

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

22 (A) by striking ‘‘for inclusion in the bien23 nial report made under section 407’’ and insert24 ing ‘‘as it may determine appropriate’’; and

25 (B) by striking the second sentence;
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1 (4) in section 407 (42 U.S.C. 284b)—

2 (A) in the section heading, to read as fol3 lows:

4 ‘‘REPORTS’’; AND

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

6 in the biennial report made under section 403

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

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

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

10 (6) in section 417 (42 U.S.C. 285a–6), by strik11 ing subsection (e);

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

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

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

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

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

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

18 (A) in paragraph (3)—

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

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

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

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

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

24 through the period and inserting ‘‘transmitted

25 to the Director of NIH.’’;
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1 (11) in section 464I(b) (42 U.S.C. 285n–1(b)),

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

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

4 1)(b)), by striking ‘‘407’’ and inserting ‘‘402(f)(3)’’;

5 (13) in section 464S(b) (42 U.S.C. 285p–1(b)),

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

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

8 is amended—

9 (A) by striking ‘‘for inclusion in the bien10 nial report made under section 464Y’’ and in11 serting ‘‘as it may determine appropriate’’; and

12 (B) by striking the second sentence;

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

14 (A) in the section heading, to read as fol15 lows:

16 ‘‘REPORTS’’; AND

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

18 in the biennial report made under section 403

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

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

21 (A) by striking ‘‘for inclusion in the bien22 nial report made under section 481’’ and insert23 ing ‘‘as it may determine appropriate’’; and

24 (B) by striking the second sentence;

25 (17) in section 481 (42 U.S.C. 287a–1)—
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1 (A) in the section heading, to read as fol2 lows:

3 ‘‘REPORTS’’; AND

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

5 in the biennial report made under section 403

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

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

8 287d(d)(5)(B)), by striking ‘‘for inclusion in the re9 port required in section 403’’;

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

11 striking subsection (b) and inserting the following

12 new subsection:

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

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

15 Director of NIH.’’; and

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

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

18 through the period and inserting ‘‘and the Director

19 of NIH.’’.

20 TITLE III—SPECIFIC INSTITUTES

21 AND CENTERS

22 Subtitle A—National Cancer

23 Institute

24 SEC. 301. AUTHORIZATION OF APPROPRIATIONS.

25 Section 417B (42 U.S.C. 286a–8) is amended—
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1 (1) in subsection (a), by striking

2 ‘‘$2,728,000,000’’ and all that follows through the

3 period and inserting ‘‘$3,000,000,000 for fiscal year

4 1997, and such sums as may be necessary for each

5 of the fiscal years 1998 and 1999.’’;

6 (2) in subsection (b)—

7 (A) in paragraph (1)—

8 (i) in the first sentence of subpara9 graph (A), by striking ‘‘$225,000,000’’

10 and all that follows through the first pe11 riod and inserting ‘‘such sums as may be

12 necessary for each of the fiscal years 1997

13 through 1999.’’; and

14 (ii) in the first sentence of subpara15 graph (B), by striking ‘‘$100,000,000’’

16 and all that follows through the first pe17 riod and inserting ‘‘such sums as may be

18 necessary for each of the fiscal years 1997

19 through 1999.’’; and

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

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

22 through the first period and inserting ‘‘such

23 sums as may be necessary for each of the fiscal

24 years 1997 through 1999.’’; and
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1 (3) in the first sentence of subsection (c), by

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

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

4 necessary for each of the fiscal years 1997 through

5 1999.’’.

6 SEC. 302. DES STUDY.

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

8 striking ‘‘1996’’ and inserting ‘‘1999’’.

9 Subtitle B—National Heart Lung

10 and Blood Institute

11 SEC. 311. AUTHORIZATION OF APPROPRIATIONS.

12 Section 425 (42 U.S.C. 285b–8) is amended by strik13 ing ‘‘$1,500,000,000’’ and all that follows through the pe14 riod and inserting ‘‘$1,600,000,000 for fiscal year 1997,

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

16 years 1998 and 1999.’’.

17 Subtitle C—National Institute of

18 Allergy and Infectious Diseases

19 SEC. 321. RESEARCH AND RESEARCH TRAINING REGARD20 ING TUBERCULOSIS.

21 Subpart 6 of part C of title IV is amended in the

22 first section 447(b) (42 U.S.C. 285f–2(b)) by striking

23 ‘‘$50,000,000’’ and all that follows through the first pe24 riod 1998’’ and inserting ‘‘such sums as may be necessary

25 for each of the fiscal years 1997 through 1999.’’.
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1 SEC. 322. TERRY BEIRN COMMUNITY-BASED AIDS RE2 SEARCH INITIATIVE.

3 Section 2313(e) (42 U.S.C. 300cc–13(e)) is amend4 ed—

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

6 inserting ‘‘1999’’; and

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

8 inserting ‘‘1999’’.

9 Subtitle D—National Institute of

10 Child Health and Human Devel11 opment

12 SEC. 331. RESEARCH CENTERS FOR CONTRACEPTION AND

13 INFERTILITY.

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

15 by striking ‘‘$30,000,000’’ and all that follows through

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

17 for each of the fiscal years 1997 through 1999.’’.

18 Subtitle E—National Institute on

19 Aging

20 SEC. 341. AUTHORIZATION OF APPROPRIATIONS.

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

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

23 period and inserting ‘‘$550,000,000 for fiscal year 1997,

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

25 years 1998 and 1999.’’.
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1 Subtitle F—National Institute on

2 Alcohol Abuse and Alcoholism

3 SEC. 351. AUTHORIZATION OF APPROPRIATIONS.

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

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

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

7 year 1997, and such sums as may be necessary for each

8 of the fiscal years 1998 and 1999.’’.

9 SEC. 352. NATIONAL ALCOHOL RESEARCH CENTER.

10 Section 464J(b) (42 U.S.C. 285n–2(b)) is amend11 ed—

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

13 The’’;

14 (2) by striking the third sentence; and

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

16 new paragraph:

17 ‘‘(2) As used in paragraph (1), the terms ‘construc18 tion’ and ‘cost of construction’ include—

19 ‘‘(A) the construction of new buildings, the ex20 pansion of existing buildings, and the acquisition, re21 modeling, replacement, renovation, major repair (to

22 the extent permitted by regulations), or alteration of

23 existing buildings, including architects’ fees, but not

24 including the cost of the acquisition of land or off25 site improvements; and
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1 ‘‘(B) the initial equipping of new buildings and

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

3 altered part of existing buildings; except that

4 such term shall not include the construction or cost of con5 struction of so much of any facility as is used or is to

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

7 worship.’’.

8 Subtitle G—National Institute on

9 Drug Abuse

10 SEC. 361. AUTHORIZATION OF APPROPRIATIONS.

11 Section 464L(d)(1) (42 U.S.C. 285o(d)(1)) is amend12 ed by striking ‘‘$440,000,000’’ and all that follows

13 through the period and inserting ‘‘$480,000,000 for fiscal

14 year 1997, and such sums as may be necessary for each

15 of the fiscal years 1998 and 1999.’’.

16 SEC. 362. MEDICATION DEVELOPMENT PROGRAM.

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

18 by striking ‘‘$85,000,000’’ and all that follows through

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

20 for each of the fiscal years 1997 through 1999’’.

21 SEC. 363. DRUG ABUSE RESEARCH CENTERS.

22 Section 464N(b) (42 U.S.C. 285o–2(b)) is amend23 ed—

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

25 The’’;
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1 (2) by striking the last sentence; and

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

3 new paragraph:

4 ‘‘(2) As used in paragraph (1), the terms ‘construc5 tion’ and ‘cost of construction’ include—

6 ‘‘(A) the construction of new buildings, the ex7 pansion of existing buildings, and the acquisition, re8 modeling, replacement, renovation, major repair (to

9 the extent permitted by regulations), or alteration of

10 existing buildings, including architects’ fees, but not

11 including the cost of the acquisition of land or off12 site improvements; and

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

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

15 altered part of existing buildings; except that

16 such term does not include the construction or cost of con17 struction of so much of any facility as is used or is to

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

19 worship.’’.

20 Subtitle H—National Institute of

21 Mental Health

22 SEC. 371. AUTHORIZATION OF APPROPRIATIONS.

23 Section 464R(f)(1) (42 U.S.C. 285p(f)(1)) is amend24 ed by striking ‘‘$675,000,000’’ and all that follows

25 through the period and inserting ‘‘$750,000,000 for fiscal
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1 year 1997, and such sums as may be necessary for each

2 of the fiscal years 1998 and 1999.’’.

3 Subtitle I—National Center for

4 Research Resources

5 SEC. 381. AUTHORIZATION OF APPROPRIATIONS.

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

7 (42 U.S.C. 287a–2(h)) is amended by striking

8 ‘‘$150,000,000’’ and all that follows through the period

9 and inserting ‘‘such sums as may be necessary for each

10 of the fiscal years 1997 through 1999.’’.

11 (b) RESERVATION FOR CONSTRUCTION OF REGIONAL

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

13 amended—

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

15 (2) by striking ‘‘1994 through 1996’’ and in16 serting ‘‘1997 through 1999’’; and

17 (3) by striking ‘‘$5,000,000’’ and inserting

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

19 year’’.

20 SEC. 382. GENERAL CLINICAL RESEARCH CENTERS.

21 Part B of title IV (42 U.S.C. 284 et seq.), as amend22 ed by section 205(h), is further amended by adding at the

23 end thereof the following new section:
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1 ‘‘SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.

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

3 for Research Resources shall award grants for the estab4 lishment of general clinical research centers to provide the

5 infrastructure for clinical research including clinical re6 search training and career enhancement. Such centers

7 shall support clinical studies and career development in

8 all settings of the hospital or academic medical center in9 volved.

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

11 Director of NIH shall expand the activities of the general

12 clinical research centers through the increased use of tele13 communications and telemedicine initiatives.

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

15 are authorized to be appropriated to make grants under

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

17 of the fiscal years 1996 and 1999.’’.

18 SEC. 383. ENHANCEMENT AWARDS.

19 Part B of title IV (42 U.S.C. 284 et seq.), as amend20 ed by sections 205(h) and 382, is further amended by add21 ing at the end thereof the following new section:

22 ‘‘SEC. 409D. ENHANCEMENT AWARDS.

23 ‘‘(a) CLINICAL RESEARCH CAREER ENHANCEMENT

24 AWARD.—

25 ‘‘(1) IN GENERAL.—The Director of the Na26 tional Center for Research Resources shall make
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1 grants (to be referred to as ‘clinical research career

2 enhancement awards’) to support individual careers

3 in clinical research.

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

5 grant under this subsection shall be submitted by an

6 individual scientist at such time as the Director may

7 require.

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

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

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

11 The Director shall award not more than 20 grants

12 in the first fiscal year in which grants are awarded

13 under this subsection. The total number of grants

14 awarded under this subsection for the first and sec15 ond fiscal years in which grants such are awarded

16 shall not exceed 40 grants.

17 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

18 There are authorized to be appropriated to make

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

20 necessary for each of the fiscal years 1997 through

21 1999.

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

23 ‘‘(1) IN GENERAL.—The Director of the Na24 tional Center for Research Resources shall make

25 grants (to be referred to as ‘innovative medical
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1 science awards’) to support individual clinical re2 search projects.

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

4 grant under this subsection shall be submitted by an

5 individual scientist at such time as the Director re6 quires.

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

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

9 year per grant.

10 ‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—

11 There are authorized to be appropriated to make

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

13 necessary for each of the fiscal years 1997 through

14 1999.

15 ‘‘(c) PEER REVIEW.—The Director of NIH, in co16 operation with the Director of the National Center for Re17 search Resources, shall establish peer review mechanisms

18 to evaluate applications for clinical research fellowships,

19 clinical research career enhancement awards, and innova20 tive medical science award programs. Such review mecha21 nisms shall include individuals who are exceptionally quali22 fied to appraise the merits of potential clinical research

23 trainees.’’.

24 SEC. 384. WAIVER OF LIMITATIONS.

25 Section 481A (42 U.S.C. 287a–2) is amended—
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1 (1) in subsection (b)(3)(A), by striking ‘‘9’’ and

2 inserting ‘‘12’’;

3 (2) in subsection (e)—

4 (A) in paragraph (1)—

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

6 ‘‘50’’ and inserting ‘‘40’’; and

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

8 ‘‘40’’ and inserting ‘‘30’’; and

9 (B) in paragraph (4), by striking ‘‘for ap10 plicants meeting the conditions described in

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

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

13 $150,000,000’’ and all that follows through ‘‘1996’’

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

15 each of the fiscal years 1997 through 1999’’.

16 Subtitle J—National Library of

17 Medicine

18 SEC. 391. AUTHORIZATION OF APPROPRIATIONS.

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

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

21 period and inserting ‘‘$160,000,000 for fiscal year 1997,

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

23 years 1998 and 1999.’’.
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1 SEC. 392. INCREASING THE CAP ON GRANT AMOUNTS.

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

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

4 ‘‘$1,250,000’’.

5 TITLE IV—AWARDS AND

6 TRAINING

7 SEC. 401. MEDICAL SCIENTIST TRAINING PROGRAM.

8 (a) EXPANSION OF PROGRAM.—Notwithstanding any

9 other provision of law, the Secretary of Health and

10 Human Services, acting through the Director of the Na11 tional Institutes of Health, shall expand the Medical Sci12 entist Training Program to include fields that will contrib13 ute to training clinical investigators in the skills of per14 forming patient-oriented clinical research.

15 (b) DESIGNATION OF SLOTS.—In carrying out sub16 section (a), the Director of the National Institutes of

17 Health shall designate a specific percentage of positions

18 under the Medical Scientist Training Program for use

19 with respect to the pursuit of a Ph.D. degree in the dis20 ciplines of economics, epidemiology, public health, bio21 engineering, biostatistics and bioethics, and other fields

22 determined appropriate by the Director.

23 SEC. 402. RAISE IN MAXIMUM LEVEL OF LOAN REPAY24 MENTS.

25 (a) REPAYMENT PROGRAMS WITH RESPECT TO

26 AIDS.—Section 487A (42 U.S.C. 288–1) is amended—
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1 (1) in subsection (a), by striking ‘‘$20,000’’

2 and inserting ‘‘$35,000’’; and

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

4 inserting ‘‘1999’’.

5 (b) REPAYMENT PROGRAMS WITH RESPECT TO CON6 TRACEPTION AND INFERTILITY.—Section 487B(a) (42

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

8 inserting ‘‘$35,000’’.

9 (c) REPAYMENT PROGRAMS WITH RESPECT TO RE10 SEARCH GENERALLY.—Section 487C(a)(1) (42 U.S.C.

11 288–3(a)(1)) is amended by striking ‘‘$20,000’’ and in12 serting ‘‘$35,000’’.

13 (d) REPAYMENT PROGRAMS WITH RESPECT TO

14 CLINICAL RESEARCHERS FROM DISADVANTAGED BACK15 GROUNDS.—Section 487E(a) (42 U.S.C. 288–5(a)) is

16 amended—

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

18 and inserting ‘‘$35,000’’; and

19 (2) in paragraph (3), by striking ‘‘338C’’ and

20 inserting ‘‘338B, 338C’’.

21 SEC. 403. GENERAL LOAN REPAYMENT PROGRAM.

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

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

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

25 ‘‘(a) ESTABLISHMENT.—
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1 ‘‘(1) IN GENERAL.—The Secretary, acting

2 through the Director of NIH, shall carry out a pro3 gram of entering into agreements with appropriately

4 qualified health professionals under which such

5 health professionals agree to conduct research with

6 respect to the areas identified under paragraph (2)

7 in consideration of the Federal Government agreeing

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

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

10 educational loans of such health professionals.

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

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

13 shall annually identify areas of research for which

14 loan repayments made be awarded under paragraph

15 (1).

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

17 agreement under paragraph (1) shall be for a mini18 mum of two years.

19 ‘‘(b) APPLICABILITY OF CERTAIN PROVISIONS.—

20 With respect to the National Health Service Corps Loan

21 Repayment Program established in subpart III of part D

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

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

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

25 same manner and to the same extent as such provisions
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1 apply to the National Health Service Corps Loan Repay2 ment Program established in such subpart.

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

4 purpose of carrying out this section, there are authorized

5 to be appropriated such sums as may be necessary for

6 each of the fiscal years 1997 through 1999.’’.

7 SEC. 404. CLINICAL RESEARCH ASSISTANCE.

8 (a) NATIONAL RESEARCH SERVICE AWARDS.—Sec9 tion 487(a)(1)(C) (42 U.S.C. 288(a)(1)(C)) is amended—

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

11 such’’; and

12 (2) by striking ‘‘1996’’ and inserting ‘‘1999’’.

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

14 (42 U.S.C. 288–5) is amended—

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

16 DISADVANTAGED BACKGROUNDS’’;

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

18 from disadvantaged backgrounds’’;

19 (3) in subsection (b)—

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

21 the following:

22 ‘‘(1) IN GENERAL.—Amounts’’; and

23 (B) by adding at the end thereof the fol24 lowing new paragraph:
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1 ‘‘(2) DISADVANTAGED BACKGROUNDS SET2 ASIDE.—In carrying out this section, the Secretary

3 shall ensure that not less than 50 percent of the

4 amounts appropriated for a fiscal year are used for

5 contracts involving those appropriately qualified

6 health professionals who are from disadvantaged

7 backgrounds.’’; and

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

9 new subsections:

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

11 position shall be considered a clinical research training po12 sition under subsection (a)(1) if such position involves an

13 individual serving in a general clinical research center or

14 other organizations and institutions determined to be ap15 propriate by the Director of NIH, or a physician receiving

16 a clinical research career enhancement award or NIH in17 tramural research fellowship.

18 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There

19 are authorized to be appropriated to carry out this section

20 such sums as may be necessary for each fiscal year.’’.
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1 TITLE V—RESEARCH WITH

2 RESPECT TO AIDS

3 SEC. 501. COMPREHENSIVE PLAN FOR EXPENDITURE OF

4 AIDS APPROPRIATIONS.

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

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

7 ‘‘through 1999’’.

8 SEC. 502. EMERGENCY AIDS DISCRETIONARY FUND.

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

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

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

12 necessary for each of the fiscal years 1997 through 1999’’.

13 TITLE VI—GENERAL

14 PROVISIONS

15 Subtitle A—Authority of the

16 Director of NIH

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

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

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

20 end thereof;

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

22 and inserting a semicolon; and

23 (3) by adding after paragraph (12), the follow24 ing new paragraphs:
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1 ‘‘(13) may conduct and support research train2 ing—

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

4 provided under section 487; and

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

6 training of physicians or other health profes7 sionals; and

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

9 other health care professionals, subject to the provi10 sions of title 5, United States Code, relating to ap11 pointments and classifications in the competitive

12 service, and may compensate such professionals sub13 ject to the provisions of chapter 74 of title 38,

14 United States Code.’’.

15 Subtitle B—Office of Rare Disease

16 Research

17 SEC. 611. ESTABLISHMENT OF OFFICE FOR RARE DISEASE

18 RESEARCH.

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

20 (42 U.S.C. 281 et seq.) is amended by adding at the end

21 thereof the following new section:

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

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

24 the Office of the Director of the National Institutes of

25 Health an office to be known as the Office for Rare Dis-
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1 ease Research (in this section referred to as the ‘Office’).

2 The Office shall be headed by a director, who shall be ap3 pointed by the Director of the National Institutes of

4 Health.

5 ‘‘(b) PURPOSE.—The purpose of the Office is to pro6 mote and coordinate the conduct of research on rare dis7 eases through a strategic research plan and to establish

8 and manage a rare disease research clinical database.

9 ‘‘(c) ADVISORY COUNCIL.—The Secretary shall es10 tablish an advisory council for the purpose of providing

11 advice to the director of the Office concerning carrying

12 out the strategic research plan and other duties under this

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

14 same extent and in the same manner as such section ap15 plies to committees or councils established under such sec16 tion.

17 ‘‘(d) DUTIES.—In carrying out subsection (b), the di18 rector of the Office shall—

19 ‘‘(1) develop a comprehensive plan for the con20 duct and support of research on rare diseases;

21 ‘‘(2) coordinate and disseminate information

22 among the institutes and the public on rare diseases;

23 ‘‘(3) support research training and encourage

24 the participation of a diversity of individuals in the

25 conduct of rare disease research;
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1 ‘‘(4) identify projects or research on rare dis2 eases that should be conducted or supported by the

3 National Institutes of Health;

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

5 on current government sponsored clinical research

6 projects for rare diseases;

7 ‘‘(6) determine the need for registries of re8 search subjects and epidemiological studies of rare

9 disease populations; and

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

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

12 submit such reports to the Secretary and the Con13 gress.’’.

14 Subtitle C—Certain

15 Reauthorizations

16 SEC. 621. NATIONAL RESEARCH SERVICE AWARDS.

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

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

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

20 for each of the fiscal years 1997 through 1999.’’.

21 SEC. 622. NATIONAL FOUNDATION FOR BIOMEDICAL RE22 SEARCH.

23 Section 499(m)(1) (42 U.S.C. 290b(m)(1)) is amend24 ed by striking ‘‘an aggregate’’ and all that follows through
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1 the period and inserting ‘‘such sums as may be necessary

2 for each of the fiscal years 1997 through 1999.’’.

3 Subtitle D—Miscellaneous

4 Provisions

5 SEC. 631. ESTABLISHMENT OF NATIONAL FUND FOR

6 HEALTH RESEARCH.

7 Part A of title IV (42 U.S.C. 281 et seq.), as amend8 ed by section 611, is further amended by adding at the

9 end thereof the following new section:

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

11 HEALTH RESEARCH.

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

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

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

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

16 amounts as are transferred to the Fund and any interest

17 earned on investment of amounts in the Fund.

18 ‘‘(b) OBLIGATIONS FROM FUND.—

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

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

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

22 shall distribute all of such amounts during any fiscal

23 year to research institutes and centers of the Na24 tional Institutes of Health in the same proportion to

25 the total amount received under this section, as the
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1 amount of annual appropriations under appropria2 tions Acts for each member institute and centers for

3 the fiscal year bears to the total amount of appro4 priations under appropriations Acts for all research

5 institutes and centers of the National Institutes of

6 Health for the fiscal year.

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

8 expenditure shall be made under paragraph (1) dur9 ing any fiscal year in which the annual amount ap10 propriated for the National Institutes of Health is

11 less than the amount so appropriated for the prior

12 fiscal year.’’.

13 SEC. 632. DEFINITION OF CLINICAL RESEARCH.

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

15 amended by sections 611 and 631, is further amended by

16 adding at the end thereof the following new section:

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

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

19 means patient oriented clinical research conducted with

20 human subjects, or research on the causes and con21 sequences of disease in human populations, or on material

22 of human origin (such as tissue specimens and cognitive

23 phenomena) for which an investigator or colleague directly

24 interacts with human subjects in an outpatient or inpa25 tient setting to clarify a problem in human physiology,
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1 pathophysiology, or disease, epidemiologic or behavioral

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

3 SEC. 633. SENIOR BIOMEDICAL RESEARCH SERVICE.

4 Section 228 (42 U.S.C. 237) is amended by adding

5 at the end thereof the following new subsection:

6 ‘‘(h) Notwithstanding any other provision of law, the

7 Secretary shall be treated as a non-profit entity for the

8 purposes of making contributions to the retirement sys9 tems of appointees under this section in a manner that

10 will permit such appointees to continue to be fully covered

11 under the retirement systems that such appointees were

12 members of immediately prior to their appointment under

13 this section.’’.

14 SEC. 634. ESTABLISHMENT OF A PEDIATRIC RESEARCH INI15 TIATIVE.

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

17 by sections 611, 631, and 632, is further amended by adding

18 at the end the following new section:

19 ‘‘SEC. 404I. PEDIATRIC RESEARCH INITIATIVE

20 ‘‘(a) ESTABLISHMENT.—The Secretary shall establish

21 within the Office of the Director of NIH a Pediatric Re22 search Initiative (hereafter in this section referred to as the

23 ‘Initiative’). The Initiative shall be headed by the Director

24 of NIH.
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1 ‘‘(b) PURPOSE.—The purpose of the Initiative is to

2 provide funds to enable the Director of NIH to encourage—

3 ‘‘(1) increased support for pediatric biomedical

4 research within the National Institutes of Health to

5 ensure that the expanding opportunities for advance6 ment in scientific investigations and care for children

7 are realized;

8 ‘‘(2) enhanced collaborative efforts among the In9 stitutes to support multidisciplinary research in the

10 areas that the Director deems most promising;

11 ‘‘(3) increased support for pediatric outcomes

12 and medical effectiveness research to demonstrate how

13 to improve the quality of children’s health care while

14 reducing cost;

15 ‘‘(4) the development of adequate pediatric clini16 cal trials and pediatric use information to promote

17 the safer and more effective use of prescription drugs

18 in the pediatric population; and

19 ‘‘(5) recognition of the special attention pediatric

20 research deserves.

21 ‘‘(c) DUTIES.—In carrying out subsection (b), the Di22 rector of NIH shall—

23 ‘‘(1) consult with the Institutes and other advi24 sors as the Director determines appropriate when con-
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1 sidering the role of the Institute for Child Health and

2 Human Development;

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

4 any Initiative assistance among the Institutes, among

5 types of grants, and between basic and clinical re6 search so long as the—

7 ‘‘(A) assistance is directly related to the ill8 nesses and diseases of children; and

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

10 and

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

12 appropriated Initiative funds and be accountable

13 with respect to such funds to Congress and to the pub14 lic.

15 ‘‘(d) AUTHORIZATION.—There is authorized to be ap16 propriated to carry out this section, $50,000,000 for fiscal

17 years 1997 through 1999.

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

19 transfer amounts appropriated to any of the Institutes for

20 a fiscal year to the Initiative to carry out this section.’’.

21 SEC. 635. DIABETES RESEARCH.

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

23 (1) Diabetes is a serious health problem in

24 America.
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1 (2) More than 16,000,000 Americans suffer from

2 diabetes.

3 (3) Diabetes is the fourth leading cause of death

4 in America, taking the lives of more than 169,000

5 people annually.

6 (4) Diabetes disproportionately affects minority

7 populations, especially African-Americans, Hispanics,

8 and Native Americans.

9 (5) Diabetes is the leading cause of new blind10 ness in adults over age 30.

11 (6) Diabetes is the leading cause of kidney fail12 ure requiring dialysis or transplantation, affecting

13 more than 56,000 Americans each year.

14 (7) Diabetes is the leading cause of nontraumatic

15 amputations, affecting 54,000 Americans each year.

16 (8) The cost of treating diabetes and its com17 plications are staggering for our Nation.

18 (9) Diabetes accounted for health expenditures of

19 $105,000,000,000 in 1992.

20 (10) Diabetes accounts for over 14 percent of our

21 Nation’s health care costs.

22 (11) Federal funds invested in diabetes research

23 over the last two decades has led to significant ad24 vances and, according to leading scientists and

25 endocrinologists, has brought the United States to the
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1 threshold of revolutionary discoveries which hold the

2 potential to dramatically reduce the economic and so3 cial burden of this disease.

4 (12) The National Institute of Diabetes and Di5 gestive and Kidney Diseases supports, in addition to

6 many other areas of research, genetic research, islet

7 cell transplantation research, and prevention and

8 treatment clinical trials focusing on diabetes. Other

9 research institutes within the National Institutes of

10 Health conduct diabetes-related research focusing on

11 its numerous complications, such as heart disease, eye

12 and kidney problems, amputations, and diabetic neu13 ropathy.

14 (b) INCREASED FUNDING REGARDING DIABETES.—

15 With respect to the conduct and support of diabetes-related

16 research by the National Institutes of Health, there are au17 thorized to be appropriated for such purpose—

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

19 1999, an amount equal to the amount appropriated

20 for such purpose for fiscal year 1996; and

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

22 fiscal year 1997, an additional amount equal to 25

23 percent of the amount appropriated for such purpose

24 for fiscal year 1996.
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1 SEC. 636. PARKINSON’S RESEARCH.

2 Part B of title IV (42 U.S.C. 284 et seq.), as amended

3 by sections 204, 382 and 383, is further amended by adding

4 at the end the following section:

5 ‘‘PARKINSON’S DISEASE

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

7 shall establish a program for the conduct and support of

8 research and training with respect to Parkinson’s disease.

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

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

11 provide for the coordination of the program estab12 lished under subsection (a) among all of the national

13 research institutes conducting Parkinson’s research.

14 ‘‘(2) CONFERENCE.—Coordination under para15 graph (1) shall include the convening of a research

16 planning conference not less frequently than once

17 every 2 years. Each such conference shall prepare and

18 submit to the Committee on Appropriations and the

19 Committee on Labor and Human Resources of the

20 Senate and the Committee on Appropriations and the

21 Committee on Commerce of the House of Representa22 tives a report concerning the conference.

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

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

25 award Core Center Grants to encourage the develop26 ment of innovative multidisciplinary research and
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1 provide training concerning Parkinson’s. The Direc2 tor shall award not more than 10 Core Center Grants

3 and designate each center funded under such grants

4 as a Morris K. Udall Center for Research on Parkin5 son’s Disease.

6 ‘‘(2) REQUIREMENTS.—

7 ‘‘(A) IN GENERAL.—With respect to Parkin8 son’s, each center assisted under this subsection

9 shall—

10 ‘‘(i) use the facilities of a single insti11 tution or a consortium of cooperating insti12 tutions, and meet such qualifications as

13 may be prescribed by the Director of the

14 NIH; and

15 ‘‘(ii) conduct basic and clinical re16 search.

17 ‘‘(B) DISCRETIONARY REQUIREMENTS.—

18 With respect to Parkinson’s, each center assisted

19 under this subsection may—

20 ‘‘(i) conduct training programs for sci21 entists and health professionals;

22 ‘‘(ii) conduct programs to provide in23 formation and continuing education to

24 health professionals;
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1 ‘‘(iii) conduct programs for the dis2 semination of information to the public;

3 ‘‘(iv) develop and maintain, where ap4 propriate, a brain bank to collect specimens

5 related to the research and treatment of

6 Parkinson’s;

7 ‘‘(v) separately or in collaboration

8 with other centers, establish a nationwide

9 data system derived from patient popu10 lations with Parkinson’s, and where pos11 sible, comparing relevant data involving

12 general populations;

13 ‘‘(vi) separately or in collaboration

14 with other centers, establish a Parkinson’s

15 Disease Information Clearinghouse to facili16 tate and enhance knowledge and under17 standing of Parkinson’s disease; and

18 ‘‘(vii) separately or in collaboration

19 with other centers, establish a national edu20 cation program that fosters a national focus

21 on Parkinson’s and the care of those with

22 Parkinson’s.

23 ‘‘(3) STIPENDS REGARDING TRAINING PRO24 GRAMS.—A center may use funds provided under

25 paragraph (1) to provide stipends for scientists and
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1 health professionals enrolled in training programs

2 under paragraph (2)(B).

3 ‘‘(4) DURATION OF SUPPORT.—Support of a cen4 ter under this subsection may be for a period not ex5 ceeding five years. Such period may be extended by

6 the Director of NIH for one or more additional peri7 ods of not more than five years if the operations of

8 such center have been reviewed by an appropriate

9 technical and scientific peer review group established

10 by the Director and if such group has recommended

11 to the Director that such period should be extended.

12 ‘‘(d) MORRIS K. UDALL AWARDS FOR INNOVATION IN

13 PARKINSON’S DISEASE RESEARCH.—The Director of NIH

14 shall establish a grant program to support innovative pro15 posals leading to significant breakthroughs in Parkinson’s

16 research. Grants under this subsection shall be available to

17 support outstanding neuroscientists and clinicians who

18 bring innovative ideas to bear on the understanding of the

19 pathogenesis, diagnosis and treatment of Parkinson’s dis20 ease.

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

22 purpose of carrying out this section, there are authorized

23 to be appropriated $80,000,000 for fiscal year 1997, and

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

25 1998 and 1999.’’.
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1 Subtitle E—Repeals and

2 Conforming Amendments

3 SEC. 641. REPEALS AND CONFORMING AMENDMENTS.

4 (a) RENAMING OF DIVISION OF RESEARCH RE5 SOURCES.—Section 403(5) (42 U.S.C. 283(5)) is amended

6 by striking ‘‘Division of Research Resources’’ and insert7 ing ‘‘National Center for Research Resources’’.

8 (b) RENAMING OF NATIONAL CENTER FOR NURSING

9 RESEARCH.—

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

11 amended by striking ‘‘National Center for Nursing

12 Research’’ and inserting ‘‘National Institute of

13 Nursing Research’’.

14 (2) Section 408(a)(2) (42 U.S.C. 284c(a)(2)) is

15 amended by striking ‘‘National Center for Nursing

16 Research’’ and inserting ‘‘National Institute of

17 Nursing Research’’.

18 (c) RENAMING OF CHIEF MEDICAL DIRECTOR FOR

19 VETERANS AFFAIRS.—

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

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

22 ‘‘Chief Medical Director of the Department of

23 Veterans Affairs or the Chief Dental Director

24 of the Department of Veterans Affairs’’ and in-
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1 serting ‘‘Under Secretary for Health of the De2 partment of Veterans Affairs’’; and

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

4 ‘‘Chief Medical Director of the Department of

5 Veterans Affairs,’’ and inserting ‘‘Under Sec6 retary for Health of the Department of Veter7 ans Affairs’’.

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

9 7(c)(3)(B)(x)) is amended by striking ‘‘Chief Medi10 cal Director of the Veterans’ Administration’’ and

11 inserting ‘‘Under Secretary for Health of the De12 partment of Veterans Affairs’’.

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

14 amended by striking ‘‘Chief Medical Director of the

15 Veterans’ Administration’’ and inserting ‘‘Under

16 Secretary for Health of the Department of Veterans

17 Affairs’’.

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

19 4(b)(2)(A)(i)) is amended by striking ‘‘Chief Medical

20 Director of the Department of Veterans Affairs’’

21 and inserting ‘‘Under Secretary for Health of the

22 Department of Veterans Affairs’’.

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

24 amended by striking ‘‘Chief Medical Director of the

25 Department of Veterans Affairs’’ and inserting
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1 ‘‘Under Secretary for Health of the Department of

2 Veterans Affairs’’.

3 (6) Section 452(f)(3)(B)(ix)(xi) (42 U.S.C.

4 285g–4(f)(3)(B)(ix)(xi)) is amended by striking

5 ‘‘Chief Medical Director of the Department of Veter6 ans Affairs’’ and inserting ‘‘Under Secretary for

7 Health of the Department of Veterans Affairs’’.

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

9 286a(a)(1)(B)) is amended by striking ‘‘Chief Medi10 cal Director of the Department of Veterans Affairs’’

11 and inserting ‘‘Under Secretary for Health of the

12 Department of Veterans Affairs’’.

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

14 287a(b)(2)(A)) is amended by striking ‘‘Chief Medi15 cal Director of the Department of Veterans Affairs’’

16 and inserting ‘‘Under Secretary for Health of the

17 Department of Veterans Affairs’’.

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

19 U.S.C. 284a(h)) is amended—

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

21 (2) in paragraph (2)—

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

23 ‘‘(1) The’’;

24 (B) by redesignating subparagraph (B) as

25 paragraph (2); and
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1 (C) by redesignating clauses (i) through

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

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

4 (c) DIABETES AND DIGESTIVE AND KIDNEY DIS5 ORDERS ADVISORY BOARDS.—Section 430 (42 U.S.C.

6 285c–4) is repealed.

7 (d) NATIONAL ARTHRITIS AND MUSCULOSKELETAL

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

9 U.S.C. 285d–7) is repealed.

10 (e) RESEARCH CENTERS REGARDING CHRONIC FA11 TIGUE SYNDROME.—Subpart 6 of part C of title IV (42

12 U.S.C. 285f et seq.) is amended by redesignating the sec13 ond section 447 (42 U.S.C. 285f–1) as section 447A.

14 (f) NATIONAL INSTITUTE ON DEAFNESS ADVISORY

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

16 (g) BIOMEDICAL AND BEHAVIORAL RESEARCH PER17 SONNEL STUDY.—Section 489 (42 U.S.C. 288b) is

18 amended—

19 (1) by striking subsections (b); and

20 (2) by redesignating subsection (c) as sub21 section (b).

22 (h) NATIONAL COMMISSION ON ALCOHOLISM AND

23 OTHER ALCOHOL-RELATED PROBLEMS.—Section 18 of

24 the Comprehensive Alcohol Abuse and Alcoholism Preven-
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1 tion, Treatment, and Rehabilitation Act Amendments of

2 1979 (42 U.S.C. 4541 note) is repealed.

3 (i) ADVISORY COUNCIL ON HAZARDOUS SUBSTANCES

4 RESEARCH AND TRAINING.—Section 311(a) of the Com5 prehensive Environmental Response, Compensation and

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

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

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

9 striking ‘‘the relevant Federal agencies referred to in

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

11 ‘‘relevant Federal agencies’’.