AUTHORITY OF DIRECTOR OF NIH.

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, 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—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 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). 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) 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), by striking “Director of the National Institutes of Health” and all that follows through “who shall” and inserting “Director of NIH who shall”; and 120 STAT. 3685(B) in sections 405(c)(3)(A), 452(c)(1)(E)(i), and 492(a)(2), 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) 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.