109 HR 6164 EH: National Institutes of Health Reform Act of 2006
U.S. House of Representatives
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text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the National Institutes of Health Reform Act of 2006
.
(b)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.
2.Organization of National Institutes of Health
(a)Section 401 of the Public Health Service Act (42 U.S.C. 281) is amended to read as follows:
401.Organization of National Institutes of Health
(a)Relation to Public Health ServiceThe National Institutes of Health is an agency of the Service.
(b)National research institutes and national centersThe 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)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)
(A)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)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)
(1)Number of institutes and centersIn 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)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)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)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 directorNotwithstanding 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 centersNotwithstanding 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 dateA 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)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)
(A)Reports on organizational issuesThe 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 reportsThe 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)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)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)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)
(A)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)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 forumsFor 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 officeThe 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)
(A)Recommendations for changesEach 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)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 activitiesNot 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)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)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)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)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)For purposes of this title, a reference to the National Institutes of Health includes its agencies.
.
(b)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
.
3.Authority of Director of NIH
(a)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)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 NIHSection 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)
(1)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)
(A)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)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)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)
(A)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 appointeesOf 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)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 proposalsSection 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)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 centersThis 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.
4.Authorization of appropriations
(a)Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended by inserting after section 402 the following:
402A.Authorization of appropriations
(a)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)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)
(1)
(A)Annual reservation of amountsOf 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)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)
(i)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)Clause (i) may not apply with respect to any fiscal year beginning after the submission of recommendations under subparagraph (F).
(iii)Preservation of reservationFor 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)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 appropriationsThe 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)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)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)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)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)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)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)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)This section may not be construed as affecting the authorities of the Director of NIH under section 401.
.
(b)Elimination of other authorizations of appropriationsTitle 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 programsThe 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.
5.
(a)Report of director of NIHThe 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:
402B.Electronic coding of grants and activitiesThe 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.
403.Biennial reports of Director of NIH
(a)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 activitiesIn 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)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.
403A.Annual reporting to increase interagency collaboration and coordination
(a)Collaboration with other HHS agenciesOn 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)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)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)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.
403B.Annual reporting to prevent fraud and abuse
(a)
(1)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)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)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)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 IVTitle 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)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 provisionsThe 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)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.
6.Certain demonstration projects
(a)
(1)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 collaborationThe 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)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)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)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 programActivities 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 partnershipsIn 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)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)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)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.
7.Foundation for the National Institutes of HealthSection 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)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.
.
8.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.Karen L. HaasClerk.