IIB 
109TH CONGRESS 
2D SESSION 
H. R. 6164 
IN THE SENATE OF THE UNITED STATES 
SEPTEMBER 27, 2006 
Received 
NOVEMBER 13, 2006 
Read twice and referred to the Committee on Health, Education, Labor, and 
Pensions 
AN ACT 
To amend title IV of the Public Health Service Act to 
revise and extend the authorities of the National Insti-
tutes of Health, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
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SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘National Institutes of Health Reform Act of 2006’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Organization of National Institutes of Health. 
Sec. 3. Authority of Director of NIH. 
Sec. 4. Authorization of appropriations. 
Sec. 5. Reports. 
Sec. 6. Certain demonstration projects. 
Sec. 7. Foundation for the National Institutes of Health. 
Sec. 8. Applicability. 
SEC. 2. ORGANIZATION OF NATIONAL INSTITUTES OF 
HEALTH. 
(a) IN GENERAL.—Section 401 of the Public Health 
Service Act (42 U.S.C. 281) is amended to read as follows: 
‘‘SEC. 401. ORGANIZATION OF NATIONAL INSTITUTES OF 
HEALTH. 
‘‘(a) RELATION TO PUBLIC HEALTH SERVICE.—The 
National Institutes of Health is an agency of the Service. 
‘‘(b) NATIONAL RESEARCH INSTITUTES
AND NA-
TIONAL CENTERS.—The following agencies of the Na-
tional Institutes of Health are national research institutes 
or national centers: 
‘‘(1) The National Cancer Institute. 
‘‘(2) The National Heart, Lung, and Blood In-
stitute. 
‘‘(3) The National Institute of Diabetes and Di-
gestive and Kidney Diseases. 
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‘‘(4) The National Institute of Arthritis and 
Musculoskeletal and Skin Diseases. 
‘‘(5) The National Institute on Aging. 
‘‘(6) The National Institute of Allergy and In-
fectious Diseases. 
‘‘(7) The National Institute of Child Health 
and Human Development. 
‘‘(8) The National Institute of Dental and 
Craniofacial Research. 
‘‘(9) The National Eye Institute. 
‘‘(10) The National Institute of Neurological 
Disorders and Stroke. 
‘‘(11) The National Institute on Deafness and 
Other Communication Disorders. 
‘‘(12) The National Institute on Alcohol Abuse 
and Alcoholism. 
‘‘(13) The National Institute on Drug Abuse. 
‘‘(14) The National Institute of Mental Health. 
‘‘(15) The National Institute of General Med-
ical Sciences. 
‘‘(16) The National Institute of Environmental 
Health Sciences. 
‘‘(17) The National Institute of Nursing Re-
search. 
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‘‘(18) The National Institute of Biomedical Im-
aging and Bioengineering. 
‘‘(19) The National Human Genome Research 
Institute. 
‘‘(20) The National Library of Medicine. 
‘‘(21) The National Center for Research Re-
sources. 
‘‘(22) The John E. Fogarty International Cen-
ter for Advanced Study in the Health Sciences. 
‘‘(23) The National Center for Complementary 
and Alternative Medicine. 
‘‘(24) The National Center on Minority Health 
and Health Disparities. 
‘‘(25) Any other national center that, as an 
agency separate from any national research insti-
tute, was established within the National Institutes 
of Health as of the day before the date of the enact-
ment of the National Institutes of Health Reform 
Act of 2006. 
‘‘(c) DIVISION OF PROGRAM COORDINATION, PLAN-
NING, AND STRATEGIC INITIATIVES.— 
‘‘(1) IN GENERAL.—Within the Office of the 
Director of the National Institutes of Health, there 
shall be a Division of Program Coordination, Plan-
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ning, and Strategic Initiatives (referred to in this 
subsection as the ‘Division’). 
‘‘(2) OFFICES WITHIN DIVISION.— 
‘‘(A) OFFICES.—The following offices are 
within the Division: The Office of AIDS Re-
search, the Office of Research on Women’s 
Health, the Office of Behavioral and Social 
Sciences Research, the Office of Disease Pre-
vention, the Office of Dietary Supplements, the 
Office of Rare Diseases, and any other office lo-
cated within the Office of the Director of NIH 
as of the day before the date of the enactment 
of the National Institutes of Health Reform Act 
of 2006. In addition to such offices, the Direc-
tor of NIH may establish within the Division 
such additional offices or other administrative 
units as the Director determines to be appro-
priate. 
‘‘(B) AUTHORITIES.—Each office in the 
Division— 
‘‘(i) shall continue to carry out the 
authorities that were in effect for the office 
before the date of enactment referred to in 
subparagraph (A); and 
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‘‘(ii) shall, as determined appropriate 
by the Director of NIH, support the Divi-
sion with respect to the authorities de-
scribed in section 402(b)(7). 
‘‘(d) ORGANIZATION.— 
‘‘(1) NUMBER OF INSTITUTES AND CENTERS.— 
In the National Institutes of Health, the number of 
national research institutes and national centers 
may not exceed a total of 27, including any such in-
stitutes or centers established under authority of 
paragraph (2) or under authority of this title as in 
effect on the day before the date of the enactment 
of the National Institutes of Health Reform Act of 
2006. 
‘‘(2) REORGANIZATION
OF
INSTITUTES
AND 
CENTERS.— 
‘‘(A) IN GENERAL.—Notwithstanding sub-
section (b), and subject to paragraph (1), the 
Director of NIH may, with the approval of the 
Secretary, reorganize the national research in-
stitutes and the national centers, including the 
addition, removal, or transfer of functions of 
such institutes and centers, and the establish-
ment or termination of such institutes and cen-
ters, if the Director determines that the overall 
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mission of the National Institutes of Health, or 
the management and operation of programs 
and activities conducted or supported by the 
National Institutes of Health, would be more 
efficiently carried out under such a reorganiza-
tion. 
‘‘(B) ADMINISTRATIVE
UNIT.—For pur-
poses of paragraph (1), an administrative unit 
within the National Institutes of Health that is 
established under authority of subparagraph 
(A) shall be considered a national research in-
stitute or a national center, without regard to 
whether the administrative unit is designated 
by the Director of NIH as such an institute or 
center. 
‘‘(C) PUBLIC PROCESS.—Any reorganiza-
tion under subparagraph (A) shall be carried 
out by regulation in accordance with the proce-
dures for substantive rules under section 553 of 
title 5, United States Code. 
‘‘(3) REORGANIZATION OF OFFICE OF DIREC-
TOR.—Notwithstanding subsection (c), the Director 
of NIH may, after a series of public hearings, and 
with the approval of the Secretary, reorganize the 
offices within the Office of the Director, including 
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the addition, removal, or transfer of functions of 
such offices, and the establishment or termination of 
such offices, if the Director determines that the 
overall management and operation of programs and 
activities conducted or supported by such offices 
would be more efficiently carried out under such a 
reorganization. 
‘‘(4) INTERNAL
REORGANIZATION
OF
INSTI-
TUTES
AND
CENTERS.—Notwithstanding any con-
flicting provisions of this title, the director of a na-
tional research institute or a national center may, 
after a series of public hearings and with the ap-
proval of the Director of NIH, reorganize the divi-
sions, centers, or other administrative units within 
such institute or center, including the addition, re-
moval, or transfer of functions of such units, and 
the establishment or termination of such units, if the 
director of such institute or center determines that 
the overall management and operation of programs 
and activities conducted or supported by such divi-
sions, centers, or other units would be more effi-
ciently carried out under such a reorganization. 
‘‘(5) 
NOTICE
TO
CONGRESS; 
EFFECTIVE 
DATE.—A reorganization under paragraph (2), (3), 
or (4) may not take effect before the expiration of 
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90 days after the Secretary submits to the Com-
mittee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate written 
notice of the reorganization. 
‘‘(e) SCIENTIFIC MANAGEMENT REVIEW BOARD FOR 
PERIODIC ORGANIZATIONAL REVIEWS.— 
‘‘(1) IN
GENERAL.—Not later than 60 days 
after the date of the enactment of the National In-
stitutes of Health Reform Act of 2006, the Sec-
retary shall establish an advisory council within the 
National Institutes of Health to be known as the 
Scientific Management Review Board (referred to in 
this subsection as the ‘Board’). 
‘‘(2) DUTIES.— 
‘‘(A) 
REPORTS
ON
ORGANIZATIONAL 
ISSUES.—The Board shall provide advice to the 
appropriate officials under subsection (d) re-
garding the use of the authorities established in 
paragraphs (2), (3), and (4) of such subsection 
to reorganize the National Institutes of Health 
(referred to in this subsection as ‘organizational 
authorities’). Not less frequently than once each 
7 years, the Board shall— 
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‘‘(i) determine whether and to what 
extent the organizational authorities should 
be used; and 
‘‘(ii) issue a report providing the rec-
ommendations of the Board regarding the 
use of the authorities and the reasons un-
derlying the recommendations. 
‘‘(B) CERTAIN RESPONSIBILITIES REGARD-
ING REPORTS.—The activities of the Board with 
respect to a report under subparagraph (A) 
shall include the following: 
‘‘(i) Reviewing all programs of the 
National Institutes of Health (referred to 
in this subsection as ‘NIH’) in order to de-
termine the progress and cost-effectiveness 
of such programs and the allocation among 
the programs of the resources of NIH. 
‘‘(ii) Determining pending scientific 
opportunities, and public health needs, 
with respect to research within the juris-
diction of NIH. 
‘‘(iii) For any proposal for organiza-
tional changes to which the Board gives 
significant consideration as a possible rec-
ommendation in such report— 
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‘‘(I) analyzing the budgetary and 
operational consequences of the pro-
posed changes; 
‘‘(II) estimating the level of re-
sources needed to implement the pro-
posed changes; and 
‘‘(III) assuming the proposed 
changes will be made and making a 
recommendation for the allocation of 
the resources of NIH among the na-
tional research institutes and national 
centers. 
‘‘(C) CONSULTATION.—In carrying out 
subparagraph (A), the Board shall consult 
with— 
‘‘(i) the heads of national research in-
stitutes and national centers whose direc-
tors are not members of the Board; 
‘‘(ii) other scientific leaders who are 
officers or employees of NIH and are not 
members of the Board; 
‘‘(iii) advisory councils of the national 
research institutes and national centers; 
‘‘(iv) organizations representing the 
scientific community; and 
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‘‘(v) organizations representing pa-
tients. 
‘‘(3) COMPOSITION OF BOARD.—The member-
ship of the Board may not exceed 21 individuals, all 
of whom shall be voting members. The Board shall 
be composed of the following: 
‘‘(A) The Director of NIH, who shall be a 
permanent member on an ex officio basis. 
‘‘(B) Not fewer than 9 officials who are di-
rectors of national research institutes or na-
tional centers. The Secretary shall designate 
such officials for membership and shall ensure 
that the group of officials so designated in-
cludes directors of— 
‘‘(i) national research institutes whose 
budgets are substantial relative to a major-
ity of the other institutes; 
‘‘(ii) 
national 
research 
institutes 
whose budgets are small relative to a ma-
jority of the other institutes; 
‘‘(iii) national research institutes that 
have been in existence for a substantial pe-
riod of time without significant organiza-
tional change under subsection (d); 
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