[109th Congress Public Law 482]
[From the U.S. Government Printing Office]
[DOCID: f:publ482.109]
[[Page 120 STAT. 3675]]
Public Law 109-482
109th Congress
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. <<NOTE: Jan. 15, 2007 - [H.R. 6164]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: National Institutes of
Health Reform Act of 2006. 42 USC 201 note.>> assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Institutes of Health Reform
Act of 2006''.
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 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.
[[Page 120 STAT. 3676]]
``(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.''.
(b) Additional Provisions Regarding Organization.--Section 401 of
the Public Health Service Act, as added by subsection (a) of this
section, is amended--
[[Page 120 STAT. 3677]]
(1) in subsection (d), by adding at the end the following:
``(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.''; and
(2) by adding after subsection (d) the following:
``(e) Scientific Management Review Board for Periodic Organizational
Reviews.--
``(1) In general.--
Not <<NOTE: Deadline. Establishment.>> 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 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 resources of NIH.
[[Page 120 STAT. 3678]]
``(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) taking into account
historical funding and support for
research activities at national research
institutes and centers that have been
established recently relative to
national research institutes and centers
that have been in existence for more
than two decades;
``(III) estimating the level of
resources needed to implement the
proposed changes;
``(IV) 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; and
``(V) analyzing the consequences for
the progress of research in the areas
affected by the proposed changes.
``(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 Board shall consist of the
Director of NIH, who shall be a permanent 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:
``(A) 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
[[Page 120 STAT. 3679]]
for which such changes have been in place for a
substantial period of time; and
``(v) national centers.
``(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 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 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 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) <<NOTE: Website.>> 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) <<NOTE: Applicability.>> 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 and
the Committee on Appropriations of the House of
Representatives;
[[Page 120 STAT. 3680]]
``(ii) the Committee on Health, Education,
Labor, and Pensions and the Committee on
Appropriations of 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 <<NOTE: Website.>> 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) <<NOTE: Deadlines.>> 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 paragraphs
(2), (3), and (4) 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) Inapplicability to certain reorganizations.--Paragraph
(1) does not apply to a recommendation made in a report under
subsection (e)(2)(A) if the recommendation is for--
``(A) an organizational change under subsection
(d)(2) that constitutes the establishment, termination,
or consolidation of one or more national research
institutes or national centers; or
``(B) an organizational change under subsection
(d)(3).
``(3) Objection by director of nih.--
``(A) <<NOTE: Deadline. Reports.>> 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).
``(4) <<NOTE: Regulations.>> Congressional review.--An
organizational change under subsection (d)(2) that is initiated
pursuant to paragraph
[[Page 120 STAT. 3681]]
(1) shall be carried out by regulation in accordance with the
procedures for substantive 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 agency rulemaking).
``(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.''.
(c) 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 <<NOTE: 42 USC
287c.>> 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 <<NOTE: 42 USC
287c, 285s.>> as section 464z-1;
(B) <<NOTE: 42 USC 285s.>> 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. 102. AUTHORITY OF DIRECTOR OF NIH.
(a) Secretary Acting Through the Director.--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 ``the Secretary'' in the matter preceding
paragraph (1) and all that follows through paragraph (1) and
inserting the following: ``the Secretary, acting through the
Director of NIH--
``(1) shall carry out this title, including being
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;''.
(b) Additional Authorities.--Section 402(b) of the Public Health
Service Act, as amended by subsection (a) of this section,
[[Page 120 STAT. 3682]]
is amended by striking paragraphs (2) and (3) and inserting the
following:
``(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 duplication, 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--
[[Page 120 STAT. 3683]]
``(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 have authority to review and approve the
establishment of all centers of excellence recommended by the
national research institutes;
``(11)(A) shall oversee research training for all of the
national research institutes and National Research Service
Awards in accordance with section 487; and
``(B) may conduct and support research training--
``(i) for which fellowship support is not provided
under section 487; and
``(ii) that does not consist of residency training
of physicians or other health professionals;
``(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;''.
(c) 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.
(d) Advisory Council for Director of NIH.--Section 402 of the Public
Health Service Act, as amended by subsection (c) of this section, is
amended by adding after subsection (j) the following subsection:
``(k) Council of Councils.--
``(1) Establishment.--Not <<NOTE: Deadline.>> later than 90
days after the date of the enactment of the National Institutes
of Health Reform Act of 2006, 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).
[[Page 120 STAT. 3684]]
``(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) <<NOTE: Records.>> 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.
``(iii) Members of the Council of Public
Representatives.
``(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.''.
(e) 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''.
(f) Conforming Amendments.--
(1) Public health service act.--The Public Health Service
Act (42 U.S.C. 201 et seq.) is amended--
(A) in section 402(a), <<NOTE: 42 USC 282.>> by
striking ``Director of the National Institutes of
Health'' and all that follows through ``who shall'' and
inserting ``Director of NIH who shall''; and
[[Page 120 STAT. 3685]]
(B) in sections 405(c)(3)(A), 452(c)(1)(E)(i), and
492(a)(2), <<NOTE: 42 USC 284, 285g-4, 289a.>> by
striking the term ``402(b)(6)'' each place such term
appears and inserting ``402(b)(16)''.
(2) Federal food, drug, and cosmetic act.--Section 561(c) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb) is
amended in the matter following paragraph (7) by striking
``402(j)(3)'' and inserting ``402(i)(3)''.
(g) <<NOTE: 42 USC 281 note.>> 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 Secretary of Health and Human Services and the
Director of NIH under section 401 of the Public Health Service Act (as
amended by section 101 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. 103. 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. <<NOTE: 42 USC 282a.>> AUTHORIZATION OF APPROPRIATIONS.
``(a) In General.--For the purpose of carrying out this title, there
are authorized to be appropriated--
``(1) $30,331,309,000 for fiscal year 2007;
``(2) $32,831,309,000 for fiscal year 2008; and
``(3) such sums as may be necessary 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 such sums as
may be necessary for each of the fiscal years 2007 through 2009.
``(c) Trans-NIH Research.--
``(1) Common fund.--
``(A) Account.--For the purpose of allocations under
section 402(b)(7)(B) (relating to research identified by
the Division of Program Coordination, Planning, and
Strategic Initiatives), there is established an account
to be known as the Common Fund.
``(B) Reservation.--
``(i) In general.--Of the total amount
appropriated under subsection (a) for fiscal year
2007 or any subsequent fiscal year, the Director
of NIH shall reserve an amount for the Common
Fund, subject to any applicable provisions in
appropriations Acts.
``(ii) Minimum amount.--For each fiscal year,
the percentage constituted by the amount reserved
under clause (i) relative to the total amount
appropriated under subsection (a) for such year
may not be less than the percentage constituted by
the amount so reserved for the preceding fiscal
year relative to the total amount appropriated
under subsection (a) for
[[Page 120 STAT. 3686]]
such preceding fiscal year, subject to any
applicable provisions in appropriations Acts.
``(C) Common fund strategic planning report.--Not
later than June 1, 2007, and every 2 years thereafter,
the Secretary, acting through the Director of NIH, shall
submit a report to the Congress containing a strategic
plan for funding research described in section
402(b)(7)(A)(i) (including personnel needs) through the
Common Fund. Each such plan shall include the following:
``(i) An estimate of the amounts determined by
the Director of NIH to be appropriate for
maximizing the potential of such research.
``(ii) An estimate of the amounts determined
by the Director of NIH to be sufficient only for
continuing to fund research activities previously
identified by the Division of Program
Coordination, Planning, and Strategic Initiatives.
``(iii) An estimate of the amounts determined
by the Director of NIH to be necessary to fund
research described in section 402(b)(7)(A)(i)--
``(I) that is in addition to the
research activities described in clause
(ii); and
``(II) for which there is the most
substantial need.
``(D) Evaluation.--
During <<NOTE: Deadline. Recommen- dations.>> the 6-
month period following the end of the first fiscal year
for which the total amount reserved under subparagraph
(B) 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 regarding amounts for the Common
Fund.
``(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
[[Page 120 STAT. 3687]]
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, in cases of discrepancy, 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 subsection (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 102(b));
(2) by striking subsection (e) of section <<NOTE: 42 USC
283a.>> 403A;
(3) by striking subsection (c) of section <<NOTE: 42 USC
283d.>> 404B;
(4) by striking subsection (h) of section <<NOTE: 42 USC
283g.>> 404E;
(5) by striking subsection (d) of section <<NOTE: 42 USC
283h.>> 404F;
(6) by striking subsection (e) of section <<NOTE: 42 USC
283i.>> 404G;
(7) by striking subsection (d) of section <<NOTE: 42 USC
284e.>> 409A;
(8) in section <<NOTE: 42 USC 284f.>> 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 <<NOTE: 42 USC
284g.>> 409C;
(10) in section <<NOTE: 42 USC 284h.>> 409D--
(A) by striking subsection (d); and
(B) by redesignating subsection (e) as subsection
(d);
(11) by striking subsection (e) of section <<NOTE: 42 USC
284i.>> 409E;
(12) by striking subsection (c) of section <<NOTE: 42 USC
284j.>> 409F;
(13) in section 409H, by <<NOTE: 42 USC 284l.>> 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 <<NOTE: 42 USC
284m.>> 409I;
(15) by striking section <<NOTE: 42 USC 285a-8.>> 417B;
(16) by striking subsection (g) of section <<NOTE: 42 USC
285a-9.>> 417C;
[[Page 120 STAT. 3688]]
(17) in section 417D, <<NOTE: 42 USC 285a-10.>> by
striking--
(A) paragraph (3) of subsection (a); and
(B) paragraph (3) of subsection (b);
(18) by striking subsection (d) of section <<NOTE: 42 USC
285b-7a.>> 424A;
(19) by striking subsection (c) of section <<NOTE: 42 USC
285b-7b.>> 424B;
(20) by striking section <<NOTE: 42 USC 285b-8.>> 425;
(21) by striking subsection (d) of section <<NOTE: 42 USC
285c-9.>> 434A;
(22) by striking subsection (d) of section <<NOTE: 42 USC
285d-6a.>> 441A;
(23) by striking subsection (c) of section <<NOTE: 42 USC
285d-8.>> 442A;
(24) in section <<NOTE: 42 USC 285e-10.>> 445H--
(A) by striking subsection (b); and
(B) in subsection (a), by striking ``(a)'';
(25) by striking subsection (d) of section <<NOTE: 42
USC 285e-10a. 42 USC 285e-11. 42 USC 285f-2.>> 445I;
(26) by striking section 445J;
(27) in section 447A--
(A) by striking subsection (b); and
(B) in subsection (a), by striking ``(a)'';
(28) <<NOTE: 42 USC 285f-3. 42 USC 285g-5. 42 USC 285g-9. 42
USC 285g-10.>> by striking subsection (d) of section 447B;
42 USC
285g-5.
42 USC
285g-9.
42 USC
285g-10.
(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
Sup- port.--'';
(32) <<NOTE: 42 USC 285n. 42 USC 285o. 42 USC 285o-2. 42 USC
285o-4. 42 USC 285p. 42 USC 285r. 42 USC 286a-1.>> by striking
subsection (d) of section 464H;
42 USC
285o.
42 USC
285o-2.
42 USC
285o-4.
42 USC
285p.
42 USC
285r.
42 USC
286a-1.
(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) <<NOTE: 42 USC 286a-2.>> by striking section 468;
(40) <<NOTE: 42 USC 287a-2.>> 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, <<NOTE: 42 USC 287a-
3.>> by striking ``under section 481A(h)'' and inserting ``to
carry out section 481A'';
(42) <<NOTE: 42 USC 287a-4.>> by striking subsection (c) in
the section 481C that relates to general clinical research
centers;
(43) <<NOTE: 42 USC 287c-11. 42 USC 287c-31. 42 USC 287c-
32. 42 USC 287c-33. 42 USC 288. 42 USC 288-1.>> by striking
subsection (e) in section 485C;
42 USC
287c-31.
42 USC
287c-32.
42 USC
287c-33.
42 USC
288.
42 USC
288-1.
(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
[[Page 120 STAT. 3689]]
(49) <<NOTE: 42 USC 288-5a.>> by striking subsection (c) in
the section 487F that relates to a loan repayment program
regarding clinical researchers.
(c) <<NOTE: 42 USC 282 note.>> 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. 104. REPORTS.
(a) Report of Director of NIH.--The Public Health Service Act (42
U.S.C. 201 et seq.), as amended by section 103(a) of this Act, is
amended--
(1) by redesignating section 403A <<NOTE: 42 USC 283a, 283a-
3. 42 USC 300u-9.>> as section 403C;
(2) in section 1710(a), by striking ``section 403A'' and
inserting ``section 403C''; and
(3) by striking section 403 <<NOTE: 42 USC 283.>> and
inserting the following sections:
``SEC. 402B. <<NOTE: 42 USC 282b.>> 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. <<NOTE: 42 USC 283.>> BIENNIAL REPORTS OF DIRECTOR OF NIH.
``(a) In General.--The Director of NIH shall submit 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.
[[Page 120 STAT. 3690]]
``(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 minority health and health
disparities.
``(C) Research activities listed in the catalog
shall include, where applicable, 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--
``(I) National Research Service
Awards and Clinical Transformation
Science Awards;
``(II) graduate medical education
programs, including information on the
number and type of graduate degrees
awarded during the period in which the
programs received funding under this
title;
``(III) investigator-initiated
awards for postdoctoral training;
``(IV) a breakdown by demographic
variables and other appropriate
categories; and
``(V) an evaluation and comparison
of outcomes and effectiveness of various
training programs.
``(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, where applicable:
``(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) Minority health and health disparities.
``(L) Such additional categories as the Director
determines to be appropriate.
``(6) A review of each entity receiving funding under this
title in its capacity as a center of excellence (in this
paragraph referred to as a `center of excellence'), including
the following:
``(A) An evaluation of the performance and research
outcomes of each center of excellence.
[[Page 120 STAT. 3691]]
``(B) Recommendations for promoting coordination of
information among the centers of excellence.
``(C) Recommendations for improving the
effectiveness, efficiency, and outcomes of the centers
of excellence.
``(D) If no additional centers of excellence have
been funded under this title since the previous report
under this section, an explanation of the reasons for
not funding any additional centers.
``(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 or the head of a national
research institute or national center may submit to the Congress such
additional reports as the Director or the head of such institute or
center determines to be appropriate.
``SEC. 403A. <<NOTE: 42 USC 283a.>> 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(i).
``(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. <<NOTE: 42 USC 283a-1.>> 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 and the Committee on Appropriations of the
House of Representatives, and the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate a report summarizing the activities
[[Page 120 STAT. 3692]]
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
and the Committee on Appropriations of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations 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.
``SEC. 403C. <<NOTE: 42 USC 283a-2.>> ANNUAL REPORTING REGARDING
TRAINING OF GRADUATE STUDENTS FOR DOCTORAL DEGREES.
``(a) In General.--Each institution receiving an award under this
title for the training of graduate students for doctoral degrees shall
annually report to the Director of NIH, with respect to each degree-
granting program at such institution--
``(1) the percentage of students admitted for study who
successfully attain a doctoral degree; and
``(2) for students described in paragraph (1), the average
time between the beginning of graduate study and the receipt of
a doctoral degree.
``(3) Provision of information to applicants.--Each
institution described in subsection (a) shall provide to each
student submitting an application for a program of graduate
study at such institution the information described in
paragraphs (1) and (2) of such subsection with respect to the
program or programs to which such student has applied.''.
(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 103(b) of this
Act, is amended--
(A) in section <<NOTE: 42 USC 283g.>> 404E(b)--
(i) by amending paragraph (3) to read as
follows:
[[Page 120 STAT. 3693]]
``(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), <<NOTE: 42 USC 283h.>> by
striking subparagraphs (F) and (G);
(C) by striking section <<NOTE: 42 USC 284b.>> 407;
(D) in section 409C(b), <<NOTE: 42 USC 284g.>> by
striking paragraph (4) and redesignating paragraphs (5)
and (6) as paragraphs (4) and (5), respectively;
(E) in section 409E, <<NOTE: 42 USC 284i.>> by
striking subsection (d);
(F) in section 417C, <<NOTE: 42 USC 285a-9.>> by
striking subsection (f);
(G) in section <<NOTE: 42 USC 285b-7b.>> 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, <<NOTE: 42 USC 285c-3.>> by
striking subsections (c) and (d);
(I) in section 442, <<NOTE: 42 USC 285d-7.>> by
striking subsection (j) and redesignating subsection (k)
as subsection (j);
(J) in section 464D, <<NOTE: 42 USC 285m-4.>> by
striking subsection (j);
(K) in section 464E, <<NOTE: 42 USC 285m-5.>> by
striking subsection (e);
(L) in section 464T, <<NOTE: 42 USC 285p-2.>> by
striking subsection (e);
(M) in section 481A, <<NOTE: 42 USC 287a-2.>> by
striking subsection (h);
(N) in section 485E, <<NOTE: 42 USC 287c-31.>> by
striking subsection (k);
(O) in section <<NOTE: 42 USC 287c-34.>> 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 <<NOTE: 42 USC 289c.>> 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, <<NOTE: 42 USC 280e-3.>> by
striking subsection (e);
(B) in section <<NOTE: 42 USC 300c-12.>> 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 <<NOTE: 42 USC
300cc.>> 2301;
(D) in section 2354, <<NOTE: 42 USC 300cc-41.>> by
striking subsection (b) and redesignating subsection (c)
as subsection (b);
(E) in section 2356, <<NOTE: 42 USC 300cc-43.>> by
striking subsection (e) and redesignating subsections
(f) and (g) as subsections (e) and (f), respectively;
and
(F) in section <<NOTE: 42 USC 300cc-45.>> 2359(b)--
(i) by striking paragraph (2);
(ii) <<NOTE: Deadline.>> 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
[[Page 120 STAT. 3694]]
(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 <<NOTE: 42 USC
241 note.>> 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 <<NOTE: 42
USC 242q-3.>> and redesignating section 305 and
306 <<NOTE: 42 USC 242q-4, 242q-5.>> as sections 304 and
305, respectively.
(C) Section 4923 of Public Law 105-33 <<NOTE: 42 USC
254c-2 note.>> is amended by striking subsection (b).
(D) Public Law 106-310 is amended <<NOTE: 42
USC 247b-4e.>> by striking section 105.
(E) Section 1004 of Public Law 106-310 <<NOTE: 42
USC 285g note.>> is amended by striking subsection (d).
(F) Section 3633 of Public Law 106-310 (as amended
by section 2502 of Public Law 107-273) <<NOTE: 114 Stat.
1236.>> is repealed.
(G) Public Law 106-525 is amended by striking
section 105. <<NOTE: 42 USC 287c-31 note.>>
(H) Public Law 107-84 is amended by striking section
6. <<NOTE: 42 USC 247b-18 note.>>
(I) Public Law 108-427 is amended by striking
section 3 <<NOTE: 118 Stat. 2430, 2431.>> and
redesignating sections 4 and 5 as sections 3 and 4,
respectively.
SEC. 105. <<NOTE: 42 USC 284n.>> 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.
[[Page 120 STAT. 3695]]
(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 102(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 Secretary,
acting through 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 when appropriate 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 102(c) of this Act).
(c) Report to Congress.--Not later than the end of fiscal year 2009,
the Secretary, acting through 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 terms in section 401 of the Public Health
Service Act.
[[Page 120 STAT. 3696]]
SEC. 106. <<NOTE: 42 USC 284 note.>> ENHANCING THE CLINICAL AND
TRANSLATIONAL SCIENCE AWARD.
(a) In General.--In administering the Clinical and Translational
Science Award, the Director of NIH shall establish a mechanism to
preserve independent funding and infrastructure for pediatric clinical
research centers by--
(1) allowing the appointment of a secondary principal
investigator under a single Clinical and Translational Science
Award, such that a pediatric principal investigator may be
appointed with direct authority over a separate budget and
infrastructure for pediatric clinical research; or
(2) otherwise securing institutional independence of
pediatric clinical research centers with respect to finances,
infrastructure, resources, and research agenda.
(b) Report.--As part of the biennial report under section 403 of the
Public Health Service Act, the Director of NIH shall provide an
evaluation and comparison of outcomes and effectiveness of training
programs under subsection (a).
(c) Definition.--For purposes of this section, the term ``Director
of NIH'' has the meaning given such term in section 401 of the Public
Health Service Act.
SEC. 107. 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) <<NOTE: Termination.>> 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
(ii) 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:
[[Page 120 STAT. 3697]]
``(C) The Foundation shall make copies of each
report submitted under subparagraph (A) available--
``(i) <<NOTE: Public information.>> 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. 108. MISCELLANEOUS AMENDMENTS.
(a) Certain Authorities of the Secretary.--
(1) In general.--Section 401 of the Public Health Service
Act, as added and amended by section 101, is amended in
subsection (d) by inserting after paragraph (1) a subsection
that is identical to section 401(c) of such Act as in effect on
the day before the date of the enactment of this Act. The
subsection so inserted is amended--
(A) by striking ``(c)(1) The Secretary may'' and
inserting the following:
``(2) Reorganization of institutes.--
``(A) In general.--The Secretary may'';
(B) by striking ``(A) the Secretary determines'' and
inserting the following:
``(i) the Secretary determines'';
(C) by striking ``(B) the additional'' and inserting
the following:
``(ii) the additional''; and
(D) by striking ``(2) The Secretary may'' and
inserting the following:
``(B) Additional authority.--The Secretary may''.
(2) Conforming amendments.--Section 401(d)(2) of the Public
Health Service Act, as designated by paragraph (1) of this
subsection, is amended--
(A) in subparagraph (A)(ii), by striking
``subparagraph (A)'' and inserting ``clause (i)''; and
(B) by striking ``Labor and Human Resources'' each
place such term appears and inserting ``Health,
Education, Labor, and Pensions''.
(b) Certain Research Centers.--Section 414 of the Public Health
Service Act (42 U.S.C. 285a-3) is amended by adding at the end the
following subsection:
``(d) Research centers under this section may not be considered
centers of excellence for purposes of section 402(b)(10).''.
SEC. 109. <<NOTE: 42 USC 281 note.>> APPLICABILITY.
This title and the amendments made by this title apply only with
respect to amounts appropriated for fiscal year 2007 or subsequent
fiscal years.
[[Page 120 STAT. 3698]]
TITLE II--MISCELLANEOUS PROVISIONS
SEC. 201. REDISTRIBUTION OF CERTAIN UNUSED SCHIP ALLOTMENTS FOR FISCAL
YEARS 2004 AND 2005 TO REDUCE FUNDING SHORTFALLS FOR FISCAL
YEAR 2007.
(a) Redistribution of Certain Unused SCHIP Allotments.--Section 2104
of the Social Security Act (42 U.S.C. 1397dd) is amended by adding at
the end the following new subsection:
``(h) Special Rules to Address Fiscal Year 2007 Shortfalls.--
``(1) Redistribution of unused fiscal year 2004
allotments.--
``(A) In general.--Notwithstanding subsection (f)
and subject to subparagraphs (C) and (D), with respect
to months beginning during fiscal year 2007, the
Secretary shall provide for a redistribution under such
subsection from the allotments for fiscal year 2004
under subsection (b) that are not expended by the end of
fiscal year 2006, to a shortfall State described in
subparagraph (B), such amount as the Secretary
determines will eliminate the estimated shortfall
described in such subparagraph for such State for the
month.
``(B) Shortfall state described.--For purposes of
this paragraph, a shortfall State described in this
subparagraph is a State with a State child health plan
approved under this title for which the Secretary
estimates, subject to paragraph (4)(B) and on a monthly
basis using the most recent data available to the
Secretary as of such month, that the projected
expenditures under such plan for such State for fiscal
year 2007 will exceed the sum of--
``(i) the amount of the State's allotments for
each of fiscal years 2005 and 2006 that was not
expended by the end of fiscal year 2006; and
``(ii) the amount of the State's allotment for
fiscal year 2007.
``(C) Funds redistributed in the order in which
states realize funding shortfalls.--The Secretary shall
redistribute the amounts available for redistribution
under subparagraph (A) to shortfall States described in
subparagraph (B) in the order in which such States
realize monthly funding shortfalls under this title for
fiscal year 2007. The Secretary shall only make
redistributions under this paragraph to the extent that
there are unexpended fiscal year 2004 allotments under
subsection (b) available for such redistributions.
``(D) Proration rule.--If the amounts available for
redistribution under subparagraph (A) for a month are
less than the total amounts of the estimated shortfalls
determined for the month under that subparagraph, the
amount computed under such subparagraph for each
shortfall State shall be reduced proportionally.
``(2) Funding remainder of reduction of shortfall for fiscal
year 2007 through redistribution of certain unused fiscal year
2005 allotments.--
[[Page 120 STAT. 3699]]
``(A) In general.--Subject <<NOTE: Effective
date.>> to subparagraphs (C) and (D) and paragraph
(5)(B), with respect to months beginning during fiscal
year 2007 after March 31, 2007, the Secretary shall
provide for a redistribution under subsection (f) from
amounts made available for redistribution under
paragraph (3) to each shortfall State described in
subparagraph (B), such amount as the Secretary
determines will eliminate the estimated shortfall
described in such subparagraph for such State for the
month.
``(B) Shortfall state described.--For purposes of
this paragraph, a shortfall State described in this
subparagraph is a State with a State child health plan
approved under this title for which the Secretary
estimates, subject to paragraph (4)(B) and on a monthly
basis using the most recent data available to the
Secretary as of March 31, 2007, that the projected
expenditures under such plan for such State for fiscal
year 2007 will exceed the sum of--
``(i) the amount of the State's allotments for
each of fiscal years 2005 and 2006 that was not
expended by the end of fiscal year 2006;
``(ii) the amount, if any, that is to be
redistributed to the State in accordance with
paragraph (1); and
``(iii) the amount of the State's allotment
for fiscal year 2007.
``(C) Funds redistributed in the order in which
states realize funding shortfalls.--The Secretary shall
redistribute the amounts available for redistribution
under subparagraph (A) to shortfall States described in
subparagraph (B) in the order in which such States
realize monthly funding shortfalls under this title for
fiscal year 2007. The Secretary shall only make
redistributions under this paragraph to the extent that
such amounts are available for such redistributions.
``(D) Proration rule.--If the amounts available for
redistribution under paragraph (3) for a month are less
than the total amounts of the estimated shortfalls
determined for the month under subparagraph (A), the
amount computed under such subparagraph for each
shortfall State shall be reduced proportionally.
``(3) Treatment of certain states with fiscal year 2005
allotments unexpended at the end of the first half of fiscal
year 2007.--
``(A) Identification of states.--The Secretary, on
the basis of the most recent data available to the
Secretary as of March 31, 2007--
``(i) shall identify those States that
received an allotment for fiscal year 2005 under
subsection (b) which have not expended all of such
allotment by March 31, 2007; and
``(ii) for each such State shall estimate--
``(I) the portion of such allotment
that was not so expended by such date;
and
``(II) whether the State is
described in subparagraph (B).
``(B) States with funds in excess of 200 percent of
need.--A State described in this subparagraph is a
[[Page 120 STAT. 3700]]
State for which the Secretary determines, on the basis
of the most recent data available to the Secretary as of
March 31, 2007, that the total of all available
allotments under this title to the State as of such
date, is at least equal to 200 percent of the total
projected expenditures under this title for the State
for fiscal year 2007.
``(C) Redistribution and limitation on availability
of portion of unused allotments for certain states.--
``(i) <<NOTE: Deadline.>> In general.--In the
case of a State identified under subparagraph
(A)(i) that is also described in subparagraph (B),
notwithstanding subsection (e), the applicable
amount described in clause (ii) shall not be
available for expenditure by the State on or after
April 1, 2007, and shall be redistributed in
accordance with paragraph (2).
``(ii) Applicable amount.--For purposes of
clause (i), the applicable amount described in
this clause is the lesser of--
``(I) 50 percent of the amount
described in subparagraph (A)(ii)(I); or
``(II) $20,000,000.
``(4) Special rules.--
``(A) Expenditures limited to coverage for
populations eligible on october 1, 2006.--A State shall
use amounts redistributed under this subsection only for
expenditures for providing child health assistance or
other health benefits coverage for populations eligible
for such assistance or benefits under the State child
health plan (including under a waiver of such plan) on
October 1, 2006.
``(B) Regular fmap for expenditures for coverage of
nonchild populations.--To the extent a State uses
amounts redistributed under this subsection for
expenditures for providing child health assistance or
other health benefits coverage to an individual who is
not a child or a pregnant woman, the Federal medical
assistance percentage (as defined in the first sentence
of section 1905(b)) applicable to the State for the
fiscal year shall apply to such expenditures for
purposes of making payments to the State under
subsection (a) of section 2105 from such amounts.
``(5) Retrospective adjustment.--
``(A) In general.--The <<NOTE: Deadline.>> Secretary
may adjust the estimates and determinations made under
paragraphs (1), (2), and (3) as necessary on the basis
of the amounts reported by States not later than
November 30, 2007, on CMS Form 64 or CMS Form 21, as the
case may be and as approved by the Secretary, but in no
case may the applicable amount described in paragraph
(3)(C)(ii) exceed the amount determined by the Secretary
on the basis of the most recent data available to the
Secretary as of March 31, 2007.
``(B) Funding of any retrospective adjustments only
from unexpended 2005 allotments.--Notwithstanding
subsections (e) and (f), to the extent the Secretary
determines it necessary to adjust the estimates and
determinations made for purposes of paragraphs (1), (2),
and
[[Page 120 STAT. 3701]]
(3), the Secretary may use only the allotments for
fiscal year 2005 under subsection (b) that remain
unexpended through the end of fiscal year 2007 for
providing any additional amounts to States described in
paragraph (2)(B) (without regard to whether such
unexpended allotments are from States described in
paragraph (3)(B)).
``(C) Rules of construction.--Nothing in this
subsection shall be construed as--
``(i) authorizing the Secretary to use the
allotments for fiscal year 2006 or 2007 under
subsection (b) of States described in paragraph
(3)(B) to provide additional amounts to States
described in paragraph (2)(B) for purposes of
eliminating the funding shortfall for such States
for fiscal year 2007; or
``(ii) limiting the authority of the Secretary
to redistribute the allotments for fiscal year
2005 under subsection (b) that remain unexpended
through the end of fiscal year 2007 and are
available for redistribution under subsection (f)
after the application of subparagraph (B).
``(6) 1-year availability; no
further <<NOTE: Deadline.>> redistribution.--Notwithstanding
subsections (e) and (f), amounts redistributed to a State
pursuant to this subsection for fiscal year 2007 shall only
remain available for expenditure by the State through September
30, 2007, and any amounts of such redistributions that remain
unexpended as of such date, shall not be subject to
redistribution under subsection (f). Nothing in the preceding
sentence shall be construed as limiting the ability of the
Secretary to adjust the determinations made under paragraphs
(1), (2), and (3) in accordance with paragraph (5).
``(7) Definition of state.--For purposes of this subsection,
the term `State' means a State that receives an allotment for
fiscal year 2007 under subsection (b).''.
(b) Extending Authority for Qualifying States to Use Certain Funds
for Medicaid Expenditures.--Section 2105(g)(1)(A) of such Act (42 U.S.C.
1397ee(g)(1)(A)) is amended by striking ``or 2005'' and inserting
``2005, 2006, or 2007''.
(c) Report to Congress.--Not later than April 30, 2007, the
Secretary of Health and Human Services shall submit a report to the
Committee on Energy and Commerce of the House of Representatives and the
Committee on Finance of the Senate regarding the amounts redistributed
to States under section 2104 of the Social Security Act to reduce
funding shortfalls for the State Children's Health Insurance Program
(SCHIP) for fiscal year 2007. Such report shall include descriptions and
analyses of--
(1) the extent to which such redistributed amounts have
reduced or eliminated such shortfalls on the basis of reports by
States submitted to the Secretary as of April 1, 2007; and
(2) the effect of the redistribution and limited
availability of unexpended fiscal year 2005 allotments under
such program on the States described in section 2104(h)(3)(B) of
the Social
[[Page 120 STAT. 3702]]
Security Act (42 U.S.C. 1397dd(h)(3)(B)) on the basis of reports
by States submitted to the Secretary as of such date.
Approved January 15, 2007.
LEGISLATIVE HISTORY--H.R. 6164:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 109-687 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 152 (2006):
Sept. 26, considered and passed House.
Dec. 8, considered and passed Senate, amended. House
concurred in Senate amendment.
<all>