[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6164 Referred in Senate (RFS)]
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 Institutes of Health, and for other
purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
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 National Centers.--The
following agencies of the National Institutes of Health are national
research institutes or national centers:
``(1) The National Cancer Institute.
``(2) The National Heart, Lung, and Blood Institute.
``(3) The National Institute of Diabetes and Digestive 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 Infectious
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 Medical Sciences.
``(16) The National Institute of Environmental Health
Sciences.
``(17) The National Institute of Nursing Research.
``(18) The National Institute of Biomedical Imaging and
Bioengineering.
``(19) The National Human Genome Research Institute.
``(20) The National Library of Medicine.
``(21) The National Center for Research Resources.
``(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, Planning, 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, Planning, 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 Research, the Office
of Research on Women's Health, the Office of Behavioral
and Social Sciences Research, the Office of Disease
Prevention, the Office of Dietary Supplements, the
Office of Rare Diseases, and any other office located
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 additional 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
authorities that were in effect for the office
before the date of enactment referred to in
subparagraph (A); and
``(ii) shall, as determined appropriate by
the Director of NIH, support the Division 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 national research
institutes and national centers may not exceed a total of 27,
including any such institutes 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 subsection (b),
and subject to paragraph (1), the Director of NIH may,
with the approval of the Secretary, reorganize the
national research institutes and the national centers,
including the addition, removal, or transfer of
functions of such institutes and centers, and the
establishment or termination of such institutes and
centers, if the Director determines that the overall
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 reorganization.
``(B) Administrative unit.--For purposes 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 institute 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 reorganization under
subparagraph (A) shall be carried out by regulation in
accordance with the procedures for substantive rules
under section 553 of title 5, United States Code.
``(3) Reorganization of office of director.--
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 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 institutes and centers.--
Notwithstanding any conflicting provisions 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 administrative units within such institute or center,
including 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 operation of programs and activities
conducted or supported by such divisions, centers, or other
units would be more efficiently 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 90 days after the Secretary submits to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education, 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 Institutes of Health Reform Act
of 2006, the Secretary 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) regarding 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--
``(i) determine whether and to what extent
the organizational authorities should be used;
and
``(ii) issue a report providing the
recommendations of the Board regarding the use
of the authorities and the reasons underlying
the recommendations.
``(B) Certain responsibilities regarding 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 determine
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 jurisdiction of
NIH.
``(iii) For any proposal for organizational
changes to which the Board gives significant
consideration as a possible recommendation in
such report--
``(I) analyzing the budgetary and
operational consequences of the
proposed changes;
``(II) estimating the level of
resources needed to implement the
proposed changes; and
``(III) assuming the proposed
changes will be made and making a
recommendation for the allocation of
the resources of NIH among the national
research institutes and national
centers.
``(C) Consultation.--In carrying out subparagraph
(A), the Board shall consult with--
``(i) the heads of national research
institutes and national centers whose directors
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
``(v) organizations representing patients.
``(3) Composition of board.--The membership 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 directors
of national research institutes or national centers.
The Secretary shall designate such officials 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 majority
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 period
of time without significant organizational
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
institutes for which such changes have been in
place for a substantial period of time; and
``(v) national centers.
``(C) 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
interests of public or private institutions of
higher education that have historically
received funds from NIH to conduct research;
and
``(ii) individuals representing the
interests of private entities that have
received funds from NIH to conduct research or
that have broad expertise regarding how the
National Institutes of Health functions,
exclusive of private entities to which clause
(i) applies.
``(4) Chair.--The Chair of the Board shall be selected by
the Secretary from among the appointed members of the Board,
except that the Secretary may select the Director of NIH as the
Chair. 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 the Board is subject to the
approval of the Director of NIH.
``(B) Particular forums.--Of the meetings held
under subparagraph (A) with respect to a report under
paragraph (2)(A)--
``(i) one or more shall be directed toward
the scientific community to address scientific
needs and opportunities related to proposals
for organizational changes under subsection
(d), or as the case may be, related to a
proposal that no such changes be made; and
``(ii) one or more shall be directed toward
consumer organizations to address the needs and
opportunities of patients and their families
with respect to proposals referred to in clause
(i).
``(C) Availability of information from forums.--For
each meeting under subparagraph (B), the Director of
NIH shall post on the Internet 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 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
subsection (c) to 4 years regarding the term of an appointed
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
within the House of Representatives;
``(ii) the Committee on Health, Education,
Labor, and Pensions within the Senate;
``(iii) the Secretary; and
``(iv) officials with organizational
authorities, other than any such official who
served as a member of the Board with respect to
the report involved.
``(B) Availability to public.--The Director of NIH
shall post each report under paragraph (2) on the
Internet site of the National Institutes of Health.
``(C) Report on board activities.--Not later than
18 months after the date of the enactment of the
National Institutes of Health Reform Act of 2006, the
Board shall submit to the committees specified in
subparagraph (A) a report describing the activities of
the Board.
``(f) Organizational Changes Per Recommendation of Scientific
Management Review Board.--
``(1) In general.--With respect to an official who has
organizational authorities within the meaning 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, except as provided in paragraph
(2) of this subsection, make the change in accordance with the
following:
``(A) Not later than 100 days after the report is
submitted under subsection (e)(7)(A), the official
shall initiate the applicable public process 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.
``(2) Objection by director of nih.--
``(A) In general.--Paragraph (1) does not apply to
a recommendation for an organizational change made in a
report under subsection (e)(2)(A) if, not later than 90
days after the report is submitted under subsection
(e)(7)(A), the Director of NIH submits to the
committees specified 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 Director of NIH
may be made to the entirety of a recommended
organizational change or to 1 or more aspects of the
change. Any aspect of a change not objected to by the
Director in a report under subparagraph (A) shall be
implemented in accordance with paragraph (1).
``(g) Definitions.--For purposes of this title:
``(1) The term `Director of NIH' means the Director of the
National Institutes of Health.
``(2) The terms `national research institute' and `national
center' mean an agency of the National Institutes of Health
that is--
``(A) listed in subsection (b) and not terminated
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 includes its agencies.''.
(b) Conforming Amendments.--Title IV of the Public Health Service
Act (42 U.S.C. 281 et seq.) is amended--
(1) by redesignating subpart 3 of part E as subpart 19;
(2) by transferring subpart 19, as so redesignated, to part
C of such title IV;
(3) by inserting subpart 19, as so redesignated, after
subpart 18 of such part C; and
(4) in subpart 19, as so redesignated--
(A) by redesignating section 485B as section 464z-
1;
(B) by striking ``National Center for Human Genome
Research'' each place such term appears and inserting
``National Human Genome Research Institute''; and
(C) by striking ``Center'' each place such term
appears and inserting ``Institute''.
SEC. 3. AUTHORITY OF DIRECTOR OF NIH.
(a) In General.--Section 402(b) of the Public Health Service Act
(42 U.S.C. 282(b)) is amended--
(1) by redesignating paragraph (14) as paragraph (22);
(2) by striking paragraphs (12) and (13);
(3) by redesignating paragraphs (4) through (11) as
paragraphs (14) through (21);
(4) in paragraph (21) (as so redesignated), by inserting
``and'' after the semicolon at the end;
(5) in the matter after and below paragraph (22) (as so
redesignated), by striking ``paragraph (6)'' and inserting
``paragraph (16)''; and
(6) by striking paragraphs (1) through (3) and inserting
the following paragraphs:
``(1) shall be responsible for the overall direction of the
National Institutes of Health and for the establishment and
implementation of general policies respecting the management
and operation of programs and activities within the National
Institutes of Health;
``(2) shall coordinate and oversee the operation of the
national research institutes, national centers, and
administrative entities within the National Institutes of
Health;
``(3) shall, in consultation with the heads of the national
research institutes and national centers, be responsible for
program coordination across the national research institutes
and national centers, including conducting priority-setting
reviews, to ensure that the research portfolio of the National
Institutes of Health is balanced and free of unnecessary,
duplicative research, and takes advantage of collaborative,
cross-cutting research;
``(4) shall assemble accurate data to be used to assess
research priorities, including information to better evaluate
scientific opportunity, public health burdens, and progress in
reducing health disparities;
``(5) shall ensure that scientifically based strategic
planning is implemented in support of research priorities as
determined by the agencies of the National Institutes of
Health;
``(6) shall ensure that the resources of the National
Institutes of Health are sufficiently allocated for research
projects identified in strategic plans;
``(7)(A) shall, through the Division of Program
Coordination, Planning, and Strategic Initiatives--
``(i) identify research that represents important
areas of emerging scientific opportunities, rising
public health challenges, or knowledge gaps that
deserve special emphasis and would benefit from
conducting or supporting additional research that
involves collaboration between 2 or more national
research institutes or national centers, or would
otherwise benefit from strategic coordination and
planning;
``(ii) include information on such research in
reports under section 403; and
``(iii) in the case of such research supported with
funds referred to in subparagraph (B)--
``(I) require as appropriate that proposals
include milestones and goals for the research;
``(II) require that the proposals include
timeframes for funding of the research; and
``(III) ensure appropriate consideration of
proposals for which the principal investigator
is an individual who has not previously served
as the principal investigator of research
conducted or supported by the National
Institutes of Health;
``(B) may, with respect to funds reserved under section
402A(c)(1) for the Common Fund, allocate such funds to the
national research institutes and national centers for
conducting and supporting research that is identified under
subparagraph (A); and
``(C) may assign additional functions to the Division in
support of responsibilities identified in subparagraph (A), as
determined appropriate by the Director;
``(8) shall, in coordination with the heads of the national
research institutes and national centers, ensure that such
institutes and centers--
``(A) preserve an emphasis on investigator-
initiated research project grants, including with
respect to research involving collaboration between 2
or more such institutes or centers; and
``(B) when appropriate, maximize investigator-
initiated research project grants in their annual
research portfolios;
``(9) shall ensure that research conducted or supported by
the National Institutes of Health is subject to review in
accordance with section 492 and that, after such review, the
research is reviewed in accordance with section 492A(a)(2) by
the appropriate advisory council under section 406 before the
research proposals are approved for funding;
``(10) shall approve the establishment of all centers of
excellence recommended by the national research institutes,
other than centers recognized under section 414;
``(11) shall oversee research training for all of the
national research institutes and National Research Service
Awards in accordance with section 487;
``(12) may, from funds appropriated under section 402A(b),
reserve funds to provide for research on matters that have not
received significant funding relative to other matters, to
respond to new issues and scientific emergencies, and to act on
research opportunities of high priority;
``(13) may, subject to appropriations Acts, collect and
retain registration fees obtained from third parties to defray
expenses for scientific, educational, and research-related
conferences;''.
(b) Certain Authorities.--Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended--
(1) by striking subsections (i) and (l); and
(2) by redesignating subsections (j) and (k) as subsections
(i) and (j), respectively.
(c) Advisory Council for Director of NIH.--Section 402 of the
Public Health Service Act, as amended by subsection (b) of this
section, is amended by adding after subsection (j) the following
subsection:
``(k) Council of Councils.--
``(1) Establishment.--The Director of NIH shall establish
within the Office of the Director an advisory council to be
known as the `Council of Councils' (referred to in this
subsection as the `Council') for the purpose of advising the
Director on matters related to the policies and activities of
the Division of Program Coordination, Planning, and Strategic
Initiatives, including making recommendations with respect to
the conduct and support of research described in subsection
(b)(7).
``(2) Membership.--
``(A) In general.--The Council shall be composed of
27 members selected by the Director of NIH with
approval from the Secretary from among the list of
nominees under subparagraph (C).
``(B) Certain requirements.--In selecting the
members of the Council, the Director of NIH shall
ensure--
``(i) the representation of a broad range
of disciplines and perspectives; and
``(ii) the ongoing inclusion of at least 1
representative from each national research
institute whose budget is substantial relative
to a majority of the other institutes.
``(C) Nomination.--The Director of NIH shall
maintain an updated list of individuals who have been
nominated to serve on the Council, which list shall
consist of the following:
``(i) For each national research institute
and national center, 3 individuals nominated by
the head of such institute or center from among
the members of the advisory council of the
institute or center, of which--
``(I) two shall be scientists; and
``(II) one shall be from the
general public or shall be a leader in
the field of public policy, law, health
policy, economics, or management.
``(ii) For each office within the Division
of Program Coordination, Planning, and
Strategic Initiatives, 1 individual nominated
by the head of such office.
``(3) Terms.--
``(A) In general.--The term of service for a member
of the Council shall be 6 years, except as provided in
subparagraphs (B) and (C).
``(B) Terms of initial appointees.--Of the initial
members selected for the Council, the Director of NIH
shall designate--
``(i) nine for a term of 6 years;
``(ii) nine for a term of 4 years; and
``(iii) nine for a term of 2 years.
``(C) Vacancies.--Any member appointed to fill a
vacancy occurring before the expiration of the term for
which the member's predecessor was appointed shall be
appointed only for the remainder of that term. A member
may serve after the expiration of that member's term
until a successor has taken office.''.
(d) Review by Advisory Councils of Research Proposals.--Section
492A(a)(2) of the Public Health Service Act (42 U.S.C. 289a-1(a)(2)) is
amended by inserting before the period the following: ``, and unless a
majority of the voting members of the appropriate advisory council
under section 406, or as applicable, of the advisory council under
section 402(k), has recommended the proposal for approval''.
(e) Conforming Amendment.--Section 402(a) of the Public Health
Service Act (42 U.S.C. 282(a)) is amended by striking ``Director of the
National Institutes of Health'' and all that follows through ``who
shall'' and inserting ``Director of NIH who shall''.
(f) Rule of Construction Regarding Authorities of National Research
Institutes and National Centers.--This Act and the amendments made by
this Act may not be construed as affecting the authorities of the
national research institutes and national centers that were in effect
under the Public Health Service Act on the day before the date of the
enactment of this Act, subject to the authorities of the Director of
NIH under section 401 of the Public Health Service Act (as amended by
section 2(a) of this Act). For purposes of the preceding sentence, the
terms ``national research institute'', ``national center'', and
``Director of NIH'' have the meanings given such terms in such section
401.
SEC. 4. AUTHORIZATION OF APPROPRIATIONS.
(a) Funding.--Title IV of the Public Health Service Act (42 U.S.C.
281 et seq.) is amended by inserting after section 402 the following:
``SEC. 402A. AUTHORIZATION OF APPROPRIATIONS.
``(a) In General.--For the purpose of carrying out this title,
there are authorized to be appropriated--
``(1) $29,747,874,000 for fiscal year 2007;
``(2) $31,235,268,000 for fiscal year 2008; and
``(3) $32,797,032,000 for fiscal year 2009.
``(b) Office of the Director.--Of the amount authorized to be
appropriated under subsection (a) for a fiscal year, there are
authorized to be appropriated for programs and activities under this
title carried out through the Office of the Director of NIH the
following amount, as applicable to the fiscal year:
``(1) $1,000,000,000 for fiscal year 2007.
``(2) $1,050,000,000 for fiscal year 2008.
``(3) $1,102,500,000 for fiscal year 2009.
``(c) Trans-NIH Research.--
``(1) Common fund.--
``(A) Annual reservation of amounts.--Of the total
amount appropriated under subsection (a) for fiscal
year 2007 or any subsequent fiscal year, the Director
of NIH shall reserve the applicable amount under
subparagraph (B) for allocations under section
402(b)(7)(B) (relating to research identified by the
Division of Program Coordination, Planning, and
Strategic Initiatives), which reservations shall
constitute an account to be known as the Common Fund.
``(B) Amount of reservation.--Subject to
subparagraph (C), the amount reserved by the Director
of NIH under subparagraph (A) for a fiscal year shall
be the sum of--
``(i) the base amount determined under
subparagraph (D); and
``(ii) any additional amount determined
under subparagraph (E).
Amounts reserved under the preceding sentence shall
remain available until expended.
``(C) Maximum reservation.--
``(i) In general.--The amount reserved by
the Director of NIH under subparagraph (A) for
a fiscal year shall not exceed 5 percent of the
total amount appropriated under subsection (a)
for such fiscal year, subject to clause (ii).
``(ii) Applicability.--Clause (i) may not
apply with respect to any fiscal year beginning
after the submission of recommendations under
subparagraph (F).
``(iii) Preservation of reservation.--For
any fiscal year following the first fiscal year
for which the percentage that applies for
purposes of clause (i) is 5 percent, the
reservation under subparagraph (A) for the
fiscal year involved may not be less than 5
percent of the total amount appropriated under
subsection (a) for such fiscal year. For fiscal
year 2008 and each subsequent fiscal year, the
percentage constituted by the reservation under
subparagraph (A) relative to the total amount
appropriated under subsection (a) for the
fiscal year involved may not be less than the
percentage constituted by the reservation under
such subparagraph for the preceding fiscal year
relative to the total amount appropriated under
subsection (a) for such preceding fiscal year.
``(D) Base amount.--The base amount referred to in
subparagraph (B)(i) for a fiscal year is--
``(i) for fiscal year 2007, the amount
reserved by the Director of NIH for fiscal year
2006 for research described in section
402(b)(7)(A)(i); and
``(ii) for fiscal year 2008 and each
subsequent fiscal year, the amount reserved
under subparagraph (A) for the preceding fiscal
year.
``(E) Additional amount corresponding to increases
in appropriations.--The additional amount referred to
in subparagraph (B)(ii) is 50 percent of the amount by
which the total amount appropriated under subsection
(a) for the fiscal year involved exceeds the total
amount appropriated under such subsection for the
preceding fiscal year, except that for any fiscal year
beginning after the submission of recommendations under
subparagraph (F), such percentage may be adjusted by
the Director of NIH, and such percentage shall be
adjusted by the Director to the extent necessary for
compliance with subparagraph (C)(iii).
``(F) Evaluation.--During the 6-month period
following the end of the first fiscal year for which
the amount reserved by the Director of NIH under
subparagraph (A) is equal to 5 percent of the total
amount appropriated under subsection (a) for such
fiscal year, the Secretary, acting through the Director
of NIH, in consultation with the advisory council
established under section 402(k), shall submit
recommendations to the Congress for changes to the
amount of the reservation under subparagraph (A).
``(2) Trans-nih research reporting.--
``(A) Limitation.--With respect to the total amount
appropriated under subsection (a) for fiscal year 2008
or any subsequent fiscal year, if the head of a
national research institute or national center fails to
submit the report required by subparagraph (B) for the
preceding fiscal year, the amount made available for
the institute or center for the fiscal year involved
may not exceed the amount made available for the
institute or center for fiscal year 2006.
``(B) Reporting.--Not later than January 1, 2008,
and each January 1st thereafter--
``(i) the head of each national research
institute or national center shall submit to
the Director of NIH a report on the amount made
available by the institute or center for
conducting or supporting research that involves
collaboration between the institute or center
and 1 or more other national research
institutes or national centers; and
``(ii) the Secretary shall submit a report
to the Congress identifying the percentage of
funds made available by each national research
institute and national center with respect to
such fiscal year for conducting or supporting
research described in clause (i).
``(C) Determination.--For purposes of determining
the amount or percentage of funds to be reported under
subparagraph (B), any amounts made available to an
institute or center under section 402(b)(7)(B) shall be
included.
``(D) Verification of amounts.--Upon receipt of
each report submitted under subparagraph (B)(i), the
Director of NIH shall review and verify the accuracy of
the amounts specified in the report.
``(E) Waiver.--At the request of any national
research institute or national center, the Director of
NIH may waive the application of this paragraph to such
institute or center if the Director finds that the
conduct or support of research described in
subparagraph (B)(i) is inconsistent with the mission of
such institute or center.
``(d) Transfer Authority.--Of the total amount appropriated under
subsection (a) for a fiscal year, the Director of NIH may (in addition
to the reservation under (c)(1) for such year) transfer not more than 1
percent for programs or activities that are authorized in this title
and identified by the Director to receive funds pursuant to this
subsection. In making such transfers, the Director may not decrease any
appropriation account under subsection (a) by more than 1 percent.
``(e) Rule of Construction.--This section may not be construed as
affecting the authorities of the Director of NIH under section 401.''.
(b) Elimination of Other Authorizations of Appropriations.--Title
IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is
amended--
(1) by striking the first sentence of paragraph (5) of
section 402(i) (as redesignated by section 3(b));
(2) by striking subsection (e) of section 403A;
(3) by striking subsection (c) of section 404B;
(4) by striking subsection (h) of section 404E;
(5) by striking subsection (d) of section 404F;
(6) by striking subsection (e) of section 404G;
(7) by striking subsection (d) of section 409A;
(8) in section 409B--
(A) in subsection (a), by striking ``under
subsection (e)'' and inserting ``to carry out this
section''; and
(B) by striking subsection (e);
(9) by striking subsection (e) of section 409C;
(10) in section 409D--
(A) by striking subsection (d); and
(B) by redesignating subsection (e) as subsection
(d);
(11) by striking subsection (e) of section 409E;
(12) by striking subsection (c) of section 409F;
(13) in section 409H, by striking--
(A) paragraph (3) of subsection (a);
(B) paragraph (3) of subsection (b);
(C) paragraph (5) of subsection (c); and
(D) paragraph (4) of subsection (d);
(14) by striking subsection (d) of section 409I;
(15) by striking section 417B;
(16) by striking subsection (g) of section 417C;
(17) in section 417D, by striking--
(A) paragraph (3) of subsection (a); and
(B) paragraph (3) of subsection (b);
(18) by striking subsection (d) of section 424A;
(19) by striking subsection (c) of section 424B;
(20) by striking section 425;
(21) by striking subsection (d) of section 434A;
(22) by striking subsection (d) of section 441A;
(23) by striking subsection (c) of section 442A;
(24) in section 445H--
(A) by striking subsection (b); and
(B) in subsection (a), by striking ``(a)'';
(25) by striking subsection (d) of section 445I;
(26) by striking section 445J;
(27) in section 447A--
(A) by striking subsection (b); and
(B) in subsection (a), by striking ``(a)'';
(28) by striking subsection (d) of section 447B;
(29) by striking subsection (g) in section 452A;
(30) by striking paragraph (7) in section 452E(b);
(31) in section 452G--
(A) by striking subsection (b); and
(B) in subsection (a), by striking ``(a) Enhanced
Support.--'';
(32) by striking subsection (d) of section 464H;
(33) by striking subsection (d) of section 464L;
(34) by striking paragraph (4) of section 464N(c);
(35) by striking subsection (e) of section 464P;
(36) by striking subsection (f) of section 464R;
(37) by striking subsection (d) of section 464z;
(38) in section 467--
(A) by striking the first sentence;
(B) by striking ``for such buildings and
facilities'' and inserting ``for suitable and adequate
buildings and facilities for use of the Library''; and
(C) by striking ``The amounts authorized to be
appropriated by this section include'' and inserting
``Amounts appropriated to carry out this section may be
used for'';
(39) by striking section 468;
(40) in section 481A--
(A) in the matter preceding subparagraph (A) of
subsection (c)(2)--
(i) by striking the term ``under subsection
(i)(1)'' and inserting ``to carry out this
section''; and
(ii) by striking ``under such subsection''
and inserting ``to carry out this section'';
and
(B) by striking subsection (i);
(41) in subsection (a) of section 481B, by striking ``under
section 481A(h)'' and inserting ``to carry out section 481A'';
(42) by striking subsection (c) in the section 481C that
relates to general clinical research centers;
(43) by striking subsection (e) in section 485C;
(44) by striking subsection (l) in section 485E;
(45) by striking subsection (h) in section 485F;
(46) by striking subsection (e) in section 485G;
(47) by striking subsection (d) of section 487;
(48) by striking subsection (c) of section 487A; and
(49) by striking subsection (c) in the section 487F that
relates to a loan repayment program regarding clinical
researchers.
(c) Rule of Construction Regarding Continuation of Programs.--The
amendment of a program by a provision of subsection (b) may not be
construed as terminating the authority of the Federal agency involved
to carry out the program.
SEC. 5. REPORTS.
(a) Report of Director of NIH.--The Public Health Service Act (42
U.S.C. 201 et seq.), as amended by section 4(a) of this Act, is
amended--
(1) by redesignating section 403A as section 403C;
(2) in section 1710(a), by striking ``section 403A'' and
inserting ``section 403C''; and
(3) by striking section 403 and inserting the following
sections:
``SEC. 402B. ELECTRONIC CODING OF GRANTS AND ACTIVITIES.
``The Secretary, acting through the Director of NIH, shall
establish an electronic system to uniformly code research grants and
activities of the Office of the Director and of all the national
research institutes and national centers. The electronic system shall
be searchable by a variety of codes, such as the type of research
grant, the research entity managing the grant, and the public health
area of interest. When permissible, the Secretary, acting through the
Director of NIH, shall provide information on relevant literature and
patents that are associated with research activities of the National
Institutes of Health.
``SEC. 403. BIENNIAL REPORTS OF DIRECTOR OF NIH.
``(a) In General.--The Director of NIH shall submit directly to the
Congress on a biennial basis a report in accordance with this section.
The first report shall be submitted not later than 1 year after the
date of the enactment of the National Institutes of Health Reform Act
of 2006. Each such report shall include the following information:
``(1) An assessment of the state of biomedical and
behavioral research.
``(2) A description of the activities conducted or
supported by the agencies of the National Institutes of Health
and policies respecting the programs of such agencies.
``(3) Classification and justification for the priorities
established by the agencies, including a strategic plan and
recommendations for future research initiatives to be carried
out under section 402(b)(7) through the Division of Program
Coordination, Planning, and Strategic Initiatives.
``(4) A catalog of all the research activities of the
agencies, prepared in accordance with the following:
``(A) The catalog shall, for each such activity--
``(i) identify the agency or agencies
involved;
``(ii) state whether the activity was
carried out directly by the agencies or was
supported by the agencies and describe to what
extent the agency was involved; and
``(iii) identify whether the activity was
carried out through a center of excellence.
``(B) In the case of clinical research, the catalog
shall, as appropriate, identify study populations by
demographic variables and other variables that
contribute to research on health disparities.
``(C) Research activities listed in the catalog
shall include the following:
``(i) Epidemiological studies and
longitudinal studies.
``(ii) Disease registries, information
clearinghouses, and other data systems.
``(iii) Public education and information
campaigns.
``(iv) Training activities, including
National Research Service Awards and a
breakdown by demographic variables and other
appropriate categories.
``(v) Clinical trials, including a
breakdown of participation by study populations
and demographic variables and such other
information as may be necessary to demonstrate
compliance with section 492B (regarding
inclusion of women and minorities in clinical
research).
``(vi) Translational research activities
with other agencies of the Public Health
Service.
``(5) A summary of the research activities throughout the
agencies, which summary shall be organized by the following
categories:
``(A) Cancer.
``(B) Neurosciences.
``(C) Life stages, human development, and
rehabilitation.
``(D) Organ systems.
``(E) Autoimmune diseases.
``(F) Genomics.
``(G) Molecular biology and basic science.
``(H) Technology development.
``(I) Chronic diseases, including pain and
palliative care.
``(J) Infectious diseases and bioterrorism.
``(K) Health disparities.
``(L) Such additional categories as the Director
determines to be appropriate.
``(b) Requirement Regarding Disease-Specific Research Activities.--
In a report under subsection (a), the Director of NIH, when reporting
on research activities relating to a specific disease, disorder, or
other adverse health condition, shall--
``(1) present information in a standardized format;
``(2) identify the actual dollar amounts obligated for such
activities; and
``(3) include a plan for research on the specific disease,
disorder, or other adverse health condition, including a
statement of objectives regarding the research, the means for
achieving the objectives, a date by which the objectives are
expected to be achieved, and justifications for revisions to
the plan.
``(c) Additional Reports.--In addition to reports required by
subsections (a) and (b), the Director of NIH may submit to the Congress
such additional reports as the Director determines to be appropriate.
``SEC. 403A. ANNUAL REPORTING TO INCREASE INTERAGENCY COLLABORATION AND
COORDINATION.
``(a) Collaboration With Other HHS Agencies.--On an annual basis,
the Director of NIH shall submit to the Secretary a report on the
activities of the National Institutes of Health involving collaboration
with other agencies of the Department of Health and Human Services.
``(b) Clinical Trials.--Each calendar year, the Director of NIH
shall submit to the Commissioner of Food and Drugs a report that
identifies each clinical trial that is registered during such calendar
year in the databank of information established under section 402(j).
``(c) Human Tissue Samples.--On an annual basis, the Director of
NIH shall submit to the Congress a report that describes how the
National Institutes of Health and its agencies store and track human
tissue samples.
``(d) First Report.--The first report under subsections (a), (b),
and (c) shall be submitted not later than 1 year after the date of the
enactment of the National Institutes of Health Reform Act of 2006.
``SEC. 403B. ANNUAL REPORTING TO PREVENT FRAUD AND ABUSE.
``(a) Whistleblower Complaints.--
``(1) In general.--On an annual basis, the Director of NIH
shall submit to the Inspector General of the Department of
Health and Human Services, the Secretary, the Committee on
Energy and Commerce of the House of Representatives, and the
Committee on Health, Education, Labor, and Pensions of the
Senate a report summarizing the activities of the National
Institutes of Health relating to whistleblower complaints.
``(2) Contents.--For each whistleblower complaint pending
during the year for which a report is submitted under this
subsection, the report shall identify the following:
``(A) Each agency of the National Institutes of
Health involved.
``(B) The status of the complaint.
``(C) The resolution of the complaint to date.
``(b) Experts and Consultants.--On an annual basis, the Director of
NIH shall submit to the Inspector General of the Department of Health
and Human Services, the Secretary, the Committee on Energy and Commerce
of the House of Representatives, and the Committee on Health,
Education, Labor, and Pensions of the Senate a report that--
``(1) identifies the number of experts and consultants,
including any special consultants, whose services are obtained
by the National Institutes of Health or its agencies;
``(2) specifies whether such services were obtained under
section 207(f), section 402(d), or other authority;
``(3) describes the qualifications of such experts and
consultants;
``(4) describes the need for hiring such experts and
consultants; and
``(5) if such experts and consultants make financial
disclosures to the National Institutes of Health or any of its
agencies, specifies the income, gifts, assets, and liabilities
so disclosed.
``(c) First Report.--The first report under subsections (a) and (b)
shall be submitted not later than 1 year after the date of the
enactment of the National Institutes of Health Reform Act of 2006.''.
(b) Striking of Other Reporting Requirements for NIH.--
(1) Public health service act; title iv.--Title IV of the
Public Health Service Act, as amended by section 4(b) of this
Act, is amended--
(A) in section 404E(b)--
(i) by amending paragraph (3) to read as
follows:
``(3) Coordination of centers.--The Director of NIH shall,
as appropriate, provide for the coordination of information
among centers under paragraph (1) and ensure regular
communication between such centers.''; and
(ii) by striking subsection (f) and
redesignating subsection (g) as subsection (f);
(B) in section 404F(b)(1), by striking
subparagraphs (F) and (G);
(C) by striking section 407;
(D) in section 409C(b), by striking paragraph (4)
and redesignating paragraphs (5) and (6) as paragraphs
(4) and (5), respectively;
(E) in section 409E, by striking subsection (d);
(F) in section 417C, by striking subsection (f);
(G) in section 424B(a)--
(i) in paragraph (1), by adding ``and''
after the semicolon at the end;
(ii) in paragraph (2), by striking ``;
and'' and inserting a period; and
(iii) by striking paragraph (3);
(H) in section 429, by striking subsections (c) and
(d);
(I) in section 442, by striking subsection (j) and
redesignating subsection (k) as subsection (j);
(J) in section 464D, by striking subsection (j);
(K) in section 464E, by striking subsection (e);
(L) in section 464T, by striking subsection (e);
(M) in section 481A, by striking subsection (h);
(N) in section 485E, by striking subsection (k);
(O) in section 485H--
(i) by striking ``(a)'' and all that
follows through ``The Secretary,'' and
inserting ``The Secretary,''; and
(ii) by striking subsection (b); and
(P) in section 494--
(i) by striking ``(a) If the Secretary''
and inserting ``If the Secretary''; and
(ii) by striking subsection (b).
(2) Public health service act; other provisions.--The
Public Health Service Act (42 U.S.C. 201 et seq.) is amended--
(A) in section 399E, by striking subsection (e);
(B) in section 1122--
(i) by striking ``(a) From the sums'' and
inserting ``From the sums''; and
(ii) by striking subsections (b) and (c);
(C) by striking section 2301;
(D) in section 2354, by striking subsection (b) and
redesignating subsection (c) as subsection (b);
(E) in section 2356, by striking subsection (e) and
redesignating subsections (f) and (g) as subsections
(e) and (f), respectively; and
(F) in section 2359(b)--
(i) by striking paragraph (2);
(ii) by striking ``(b) Evaluation and
Report'' and all that follows through ``Not
later than 5 years'' and inserting ``(b)
Evaluation.--Not later than 5 years'';
(iii) by redesignating subparagraphs (A)
through (C) as paragraphs (1) through (3),
respectively; and
(iv) by moving each of paragraphs (1)
through (3) (as so redesignated) 2 ems to the
left.
(3) Other acts.--Provisions of Federal law are amended as
follows:
(A) Section 7 of Public Law 97-414 is amended--
(i) in subsection (a)--
(I) in paragraph (2), by inserting
``and'' at the end;
(II) in paragraph (3), by striking
``; and'' and inserting a period; and
(III) by striking paragraph (4);
and
(ii) in subsection (b), by striking the
last sentence of paragraph (3).
(B) Title III of Public Law 101-557 (42 U.S.C. 242q
et seq.) is amended by striking section 304 and
redesignating section 305 and 306 as sections 304 and
305, respectively.
(C) Section 4923 of Public Law 105-33 is amended by
striking subsection (b).
(D) Public Law 106-310 is amended by striking
section 105.
(E) Section 1004 of Public Law 106-310 is amended
by striking subsection (d).
(F) Section 3633 of Public Law 106-310 (as amended
by section 2502 of Public Law 107-273) is repealed.
(G) Public Law 106-525 is amended by striking
section 105.
(H) Public Law 107-84 is amended by striking
section 6.
(I) Public Law 108-427 is amended by striking
section 3 and redesignating sections 4 and 5 as
sections 3 and 4, respectively.
SEC. 6. CERTAIN DEMONSTRATION PROJECTS.
(a) Bridging the Sciences.--
(1) In general.--From amounts to be appropriated under
section 402A(b) of the Public Health Service Act, the Secretary
of Health and Human Services, acting through the Director of
NIH, (in this subsection referred to as the ``Secretary'') in
consultation with the Director of the National Science
Foundation, the Secretary of Energy, and other agency heads
when necessary, may allocate funds for the national research
institutes and national centers to make grants for the purpose
of improving the public health through demonstration projects
for biomedical research at the interface between the
biological, behavioral, and social sciences and the physical,
chemical, mathematical, and computational sciences.
(2) Goals, priorities, and methods; interagency
collaboration.--The Secretary shall establish goals,
priorities, and methods of evaluation for research under
paragraph (1), and shall provide for interagency collaboration
with respect to such research. In developing such goals,
priorities, and methods, the Secretary shall ensure that--
(A) the research reflects the vision of innovation
and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum of
projects, funded at various levels, with varying
timeframes.
(3) Peer review.--A grant may be made under paragraph (1)
only if the application for the grant has undergone technical
and scientific peer review under section 492 of the Public
Health Service Act (42 U.S.C. 289a) and has been reviewed by
the advisory council under section 402(k) of such Act (as added
by section 3(c) of this Act) or has been reviewed by an
advisory council composed of representatives from appropriate
scientific disciplines who can fully evaluate the applicant.
(b) High-Risk, High-Reward Research.--
(1) In general.--From amounts to be appropriated under
section 402A(b) of the Public Health Service Act, the Director
of NIH may allocate funds for the national research institutes
and national centers to make awards of grants or contracts or
to engage in other transactions for demonstration projects for
high-impact, cutting-edge research that fosters scientific
creativity and increases fundamental biological understanding
leading to the prevention, diagnosis, and treatment of diseases
and disorders. The head of a national research institute or
national center may conduct or support such high-impact,
cutting-edge research (with funds allocated under the preceding
sentence or otherwise available for such purpose) if the
institute or center gives notice to the Director of NIH
beforehand and submits a report to the Director of NIH on an
annual basis on the activities of the institute or center
relating to such research.
(2) Special consideration.--In carrying out the program
under paragraph (1), the Director of NIH shall give special
consideration to coordinating activities with national research
institutes whose budgets are substantial relative to a majority
of the other institutes.
(3) Administration of program.--Activities relating to
research described in paragraph (1) shall be designed by the
Director of NIH or the head of a national research institute or
national center, as applicable, to enable such research to be
carried out with maximum flexibility and speed.
(4) Public-private partnerships.--In providing for research
described in paragraph (1), the Director of NIH or the head of
a national research institute or national center, as
applicable, shall seek to facilitate partnerships between
public and private entities and shall coordinate with the
Foundation for the National Institutes of Health.
(5) Peer review.--A grant for research described in
paragraph (1) may be made only if the application for the grant
has undergone technical and scientific peer review under
section 492 of the Public Health Service Act (42 U.S.C. 289a)
and has been reviewed by the advisory council under section
402(k) of such Act (as added by section 3(c) of this Act).
(c) Report to Congress.--Not later than the end of fiscal year
2009, the Director of NIH shall conduct an evaluation of the activities
under this section and submit a report to the Congress on the results
of such evaluation.
(d) Definitions.--For purposes of this section, the terms
``Director of NIH'', ``national research institute'', and ``national
center'' have the meanings given such term in section 401 of the Public
Health Service Act.
SEC. 7. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.
Section 499 of the Public Health Service Act (42 U.S.C. 290b) is
amended--
(1) in subsection (d)--
(A) in paragraph (1)--
(i) by amending subparagraph (D)(ii) to
read as follows:
``(ii) Upon the appointment of the
appointed members of the Board under clause
(i)(II), the terms of service as members of the
Board of the ex officio members of the Board
described in clauses (i) and (ii) of
subparagraph (B) shall terminate. The ex
officio members of the Board described in
clauses (iii) and (iv) of subparagraph (B)
shall continue to serve as ex officio members
of the Board.''; and
(iii) in subparagraph (G), by inserting
``appointed'' after ``that the number of'';
(B) by amending paragraph (3)(B) to read as
follows:
``(B) Any vacancy in the membership of the
appointed members of the Board shall be filled in
accordance with the bylaws of the Foundation
established in accordance with paragraph (6), and shall
not affect the power of the remaining appointed members
to execute the duties of the Board.''; and
(C) in paragraph (5), by inserting ``appointed''
after ``majority of the'';
(2) in subsection (j)--
(A) in paragraph (2), by striking
``(d)(2)(B)(i)(II)'' and inserting ``(d)(6)'';
(B) in paragraph (4)--
(i) in subparagraph (A), by inserting ``,
including an accounting of the use of amounts
transferred under subsection (l)'' before the
period at the end; and
(ii) by striking subparagraph (C) and
inserting the following:
``(C) The Foundation shall make copies of each
report submitted under subparagraph (A) available--
``(i) for public inspection, and shall upon
request provide a copy of the report to any
individual for a charge that shall not exceed
the cost of providing the copy; and
``(ii) to the appropriate committees of
Congress.''; and
(C) in paragraph (10), by striking ``of Health.''
and inserting ``of Health and the National Institutes
of Health may accept transfers of funds from the
Foundation.''; and
(3) by striking subsection (l) and inserting the following:
``(l) Funding.--From amounts appropriated to the National
Institutes of Health, for each fiscal year, the Director of NIH shall
transfer not less than $500,000 and not more than $1,250,000 to the
Foundation.''.
SEC. 8. APPLICABILITY.
This Act and the amendments made by this Act apply only with
respect to amounts appropriated for fiscal year 2007 or subsequent
fiscal years.
Passed the House of Representatives September 26, 2006.
Attest:
KAREN L. HAAS,
Clerk.