In the Senate of the United States,
December 8, 2006.
Resolved, That the bill from the House of Representa-
tives (H.R. 6164) entitled ‘‘An Act to amend title IV of the
Public Health Service Act to revise and extend the authorities
of the National Institutes of Health, and for other pur-
poses.’’, do pass with the following
AMENDMENT:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘National Institutes of
Health Reform Act of 2006’’.
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TITLE I—NIH REFORM
SEC. 101. 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 NATIONAL
CENTERS.—The following agencies of the National Insti-
tutes of Health are national research institutes or national
centers:
‘‘(1) The National Cancer Institute.
‘‘(2) The National Heart, Lung, and Blood Insti-
tute.
‘‘(3) The National Institute of Diabetes and Di-
gestive and Kidney Diseases.
‘‘(4) The National Institute of Arthritis and
Musculoskeletal and Skin Diseases.
‘‘(5) The National Institute on Aging.
‘‘(6) The National Institute of Allergy and Infec-
tious Diseases.
‘‘(7) The National Institute of Child Health and
Human Development.
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‘‘(8) The National Institute of Dental and
Craniofacial Research.
‘‘(9) The National Eye Institute.
‘‘(10) The National Institute of Neurological Dis-
orders 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 Medical
Sciences.
‘‘(16) The National Institute of Environmental
Health Sciences.
‘‘(17) The National Institute of Nursing Re-
search.
‘‘(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.
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‘‘(22) The John E. Fogarty International Center
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 institute,
was established within the National Institutes of
Health as of the day before the date of the enactment
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 Di-
rector of the National Institutes of Health, there shall
be a Division of Program Coordination, Planning,
and Strategic Initiatives (referred to in this sub-
section 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 Preven-
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tion, the Office of Dietary Supplements, the Of-
fice 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 Director of
NIH may establish within the Division such ad-
ditional offices or other administrative units as
the Director determines to be appropriate.
‘‘(B) AUTHORITIES.—Each office in the
Division—
‘‘(i) shall continue to carry out the au-
thorities that were in effect for the office be-
fore the date of enactment referred to in
subparagraph (A); and
‘‘(ii) shall, as determined appropriate
by the Director of NIH, support the Divi-
sion with respect to the authorities described
in section 402(b)(7).
‘‘(d) ORGANIZATION.—
‘‘(1) NUMBER OF INSTITUTES AND CENTERS.—In
the National Institutes of Health, the number of na-
tional research institutes and national centers may
not exceed a total of 27, including any such institutes
or centers established under authority of paragraph
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(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.’’.
(b) ADDITIONAL PROVISIONS REGARDING ORGANIZA-
TION.—Section 401 of the Public Health Service Act, as
added by subsection (a) of this section, is amended—
(1) in subsection (d), by adding at the end the
following:
‘‘(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 the addi-
tion, removal, or transfer of functions of such offices,
and the establishment or termination of such offices,
if the Director determines that the overall manage-
ment and operation of programs and activities con-
ducted or supported by such offices would be more ef-
ficiently carried out under such a reorganization.
‘‘(4) INTERNAL REORGANIZATION OF INSTITUTES
AND CENTERS.—Notwithstanding any conflicting pro-
visions of this title, the director of a national research
institute or a national center may, after a series of
public hearings and with the approval of the Director
of NIH, reorganize the divisions, centers, or other ad-
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ministrative units within such institute or center, in-
cluding the addition, removal, 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 oper-
ation of programs and activities conducted or sup-
ported by such divisions, centers, or other units would
be more efficiently carried out under such a reorga-
nization.’’; and
(2) by adding after subsection (d) the following:
‘‘(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 Institutes of
Health Reform Act of 2006, the Secretary shall estab-
lish an advisory council within the National Insti-
tutes of Health to be known as the Scientific Manage-
ment 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) regard-
ing the use of the authorities established in para-
graphs (2), (3), and (4) of such subsection to re-
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organize the National Institutes of Health (re-
ferred to in this subsection as ‘organizational au-
thorities’). Not less frequently than once each 7
years, the Board shall—
‘‘(i) determine whether and to what ex-
tent 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 under-
lying 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 the research portfolio of
the National Institutes of Health (referred
to in this subsection as ‘NIH’) in order to
determine the progress and effectiveness and
value of the portfolio and the allocation
among the portfolio activities of the re-
sources of NIH.
‘‘(ii) Determining pending scientific
opportunities, and public health needs, with
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respect to research within the jurisdiction of
NIH.
‘‘(iii) For any proposal for organiza-
tional changes to which the Board gives sig-
nificant consideration as a possible rec-
ommendation in such report—
‘‘(I) analyzing the budgetary and
operational consequences of the pro-
posed changes;
‘‘(II) taking into account histor-
ical funding and support for research
activities at national research insti-
tutes and centers that have been estab-
lished recently relative to national re-
search institutes and centers that have
been in existence for more than two
decades;
‘‘(III) estimating the level of re-
sources needed to implement the pro-
posed changes;
‘‘(IV) 
assuming 
the 
proposed
changes will be made and making a
recommendation for the allocation of
the resources of NIH among the na-
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tional research institutes and national
centers; and
‘‘(V) analyzing the consequences
for the progress of research in the areas
affected by the proposed changes.
‘‘(C) CONSULTATION.—In carrying out sub-
paragraph (A), the Board shall consult with—
‘‘(i) the heads of national research in-
stitutes and national centers whose directors
are not members of the Board;
‘‘(ii) other scientific leaders who are of-
ficers 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
‘‘(v) organizations representing pa-
tients.
‘‘(3) COMPOSITION OF BOARD.—The Board shall
consist of the Director of NIH, who shall be a perma-
nent nonvoting member on an ex officio basis, and an
odd number of additional members, not to exceed 21,
all of whom shall be voting members. The voting
members of the Board shall be the following:
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‘‘(A) Not fewer than 9 officials who are di-
rectors of national research institutes or national
centers. The Secretary shall designate such offi-
cials for membership and shall ensure that the
group of officials so designated includes 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 majority 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);
‘‘(iv) as applicable, national research
institutes that have undergone significant
organization changes under such subsection,
or that have been established under such
subsection, other than national research in-
stitutes for which such changes have been in
place for a substantial period of time; and
‘‘(v) national centers.
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‘‘(B) Members appointed by the Secretary
from among individuals who are not officers or
employees of the United States. Such members
shall include—
‘‘(i) individuals representing the inter-
ests of public or private institutions of high-
er education that have historically received
funds from NIH to conduct research; and
‘‘(ii) individuals representing the in-
terests of private entities that have received
funds from NIH to conduct research or that
have broad expertise regarding how the Na-
tional Institutes of Health functions, exclu-
sive of private entities to which clause (i)
applies.
‘‘(4) CHAIR.—The Chair of the Board shall be se-
lected by the Secretary from among the members of
the Board appointed under paragraph (3)(B). The
term of office of the Chair shall be 2 years.
‘‘(5) MEETINGS.—
‘‘(A) IN GENERAL.—The Board shall meet
at the call of the Chair or upon the request of the
Director of NIH, but not fewer than 5 times with
respect to issuing any particular report under
paragraph (2)(A). The location of the meetings of
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the Board is subject to the approval of the Direc-
tor of NIH.
‘‘(B) PARTICULAR FORUMS.—Of the meet-
ings held under subparagraph (A) with respect
to a report under paragraph (2)(A)—
‘‘(i) one or more shall be directed to-
ward the scientific community to address
scientific needs and opportunities related to
proposals for organizational changes under
subsection (d), or as the case may be, re-
lated to a proposal that no such changes be
made; and
‘‘(ii) one or more shall be directed to-
ward consumer organizations to address the
needs and opportunities of patients and
their families with respect to proposals re-
ferred to in clause (i).
‘‘(C) AVAILABILITY OF INFORMATION FROM
FORUMS.—For each meeting under subparagraph
(B), the Director of NIH shall post on the Inter-
net site of the National Institutes of Health a
summary of the proceedings.
‘‘(6) COMPENSATION; TERM
OF
OFFICE.—The
provisions of subsections (b)(4) and (c) of section 406
apply with respect to the Board to the same extent
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and in the same manner as such provisions apply
with respect to an advisory council referred to in such
subsections, except that the reference in such sub-
section (c) to 4 years regarding the term of an ap-
pointed member is deemed to be a reference to 5
years.
‘‘(7) REPORTS.—
‘‘(A) RECOMMENDATIONS FOR CHANGES.—
Each report under paragraph (2)(A) shall be
submitted to—
‘‘(i) the Committee on Energy and
Commerce and the Committee on Appro-
priations of the House of Representatives;
‘‘(ii) the Committee on Health, Edu-
cation, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate;
‘‘(iii) the Secretary; and
‘‘(iv) officials with organizational au-
thorities, other than any such official who
served as a member of the Board with re-
spect to the report involved.
‘‘(B) AVAILABILITY TO PUBLIC.—The Direc-
tor of NIH shall post each report under para-
graph (2) on the Internet site of the National In-
stitutes of Health.
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‘‘(C) REPORT ON BOARD ACTIVITIES.—Not
later than 18 months after the date of the enact-
ment of the National Institutes of Health Reform
Act of 2006, the Board shall submit to the com-
mittees specified in subparagraph (A) a report
describing the activities of the Board.
‘‘(f) ORGANIZATIONAL CHANGES PER RECOMMENDA-
TION OF SCIENTIFIC MANAGEMENT REVIEW BOARD.—
‘‘(1) IN GENERAL.—With respect to an official
who has organizational authorities within the mean-
ing of subsection (e)(2)(A), if a recommendation to
the official for an organizational change is made in
a report under such subsection, the official shall, ex-
cept as provided in paragraphs (2), (3), and (4) of
this subsection, make the change in accordance with
the following:
‘‘(A) Not later than 100 days after the re-
port is submitted under subsection (e)(7)(A), the
official shall initiate the applicable public proc-
ess required in subsection (d) toward making the
change.
‘‘(B) The change shall be fully implemented
not later than the expiration of the 3-year period
beginning on the date on which such process is
initiated.
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‘‘(2) INAPPLICABILITY TO CERTAIN REORGANIZA-
TIONS.—Paragraph (1) does not apply to a rec-
ommendation made in a report under subsection
(e)(2)(A) if the recommendation is for—
‘‘(A) an organizational change under sub-
section (d)(2) that constitutes the establishment,
termination, or consolidation of one or more na-
tional research institutes or national centers; or
‘‘(B) an organizational change under sub-
section (d)(3).
‘‘(3) OBJECTION BY DIRECTOR OF NIH.—
‘‘(A) IN GENERAL.—Paragraph (1) does not
apply to a recommendation for an organiza-
tional change made in a report under subsection
(e)(2)(A) if, not later than 90 days after the re-
port is submitted under subsection (e)(7)(A), the
Director of NIH submits to the committees speci-
fied in such subsection a report providing that
the Director objects to the change, which report
includes the reasons underlying the objection.
‘‘(B) SCOPE OF OBJECTION.—For purposes
of subparagraph (A), an objection by the Direc-
tor of NIH may be made to the entirety of a rec-
ommended organizational change or to 1 or more
aspects of the change. Any aspect of a change not
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objected to by the Director in a report under sub-
paragraph (A) shall be implemented in accord-
ance with paragraph (1).
‘‘(4) CONGRESSIONAL
REVIEW.—An organiza-
tional change under subsection (d)(2) that is initiated
pursuant to paragraph (1) shall be carried out by
regulation in accordance with the procedures for sub-
stantive rules under section 553 of title 5, United
States Code. A rule under the preceding sentence shall
be considered a major rule for purposes of chapter 8
of such title (relating to congressional review of agen-
cy rulemaking).
‘‘(g) DEFINITIONS.—For purposes of this title:
‘‘(1) The term ‘Director of NIH’ means the Di-
rector of the National Institutes of Health.
‘‘(2) The terms ‘national research institute’ and
‘national center’ mean an agency of the National In-
stitutes of Health that is—
‘‘(A) listed in subsection (b) and not termi-
nated under subsection (d)(2)(A); or
‘‘(B) established by the Director of NIH
under such subsection.
‘‘(h) REFERENCES TO NIH.—For purposes of this
title, a reference to the National Institutes of Health in-
cludes its agencies.’’.