Pub. L. 112-74, div. F, tit. II (as amended)

221.(a)Establishment of National Center for Advancing Translational Sciences; Elimination of National Center for Research Resources.—(1)In general.—Subpart 1 of part E of title IV of the Public Health Service Act (42 U.S.C. 287 et seq.) is amended—(A)in the subpart heading, by striking National Center for Research Resources and inserting National Center for Advancing Translational Sciences;(B)42 U.S.C. 287aby striking sections 480 and 481; and(C)by amending section 479 to read as follows:479.42 U.S.C. 287NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES(a)Purpose.The purpose of the National Center for Advancing Translational Sciences (in this subpart referred to as the Center) is to advance translational sciences, including by—(1)coordinating and developing resources that leverage basic research in support of translational science; and(2)developing partnerships and working cooperatively to foster synergy in ways that do not create duplication, redundancy, and competition with industry activities.(b)Clinical Trial Activities.(1)In general.The Center may develop and provide infrastructure and resources for all phases of clinical trials research. Except as provided in paragraph (2), the Center may support clinical trials only through the end of phase IIA.(2)Exception.The Center may support clinical trial activities through the end of phase IIB for a treatment for a rare disease or condition (as defined in section 526 of the Federal Food, Drug, and Cosmetic Act) so long as—(A)the Center gives public notice for a period of at least 120 days of the Center’s intention to support the clinical trial activities in phase IIB;(B)no public or private organization provides credible written intent to the Center that the organization has timely plans to further the clinical trial activities or conduct clinical trials of a similar nature beyond phase IIA; and(C)the Center ensures that support of the clinical trial activities in phase IIB will not increase the Federal Government’s liability beyond the award value of the Center’s support.(c)Annual Report.The Center shall publish an annual report that, with respect to all research supported by the Center, includes a complete list of—(1)the molecules being studied;(2)clinical trial activities being conducted;(3)the methods and tools in development;(4)ongoing partnerships, including—(A)the rationale for each partnership;(B)the status of each partnership;(C)the funding provided by the Center to other entities pursuant to each partnership, and(D)the activities which have been transferred to industry pursuant to each partnership; and(5)known research activity of other entities that is or will expand upon research activity of the Center..(2)List of institutes and centers.—Section 401(b)(21) of the Public Health Service Act (42 U.S.C. 281(b)(21)) is amended by striking National Center for Research Resources and inserting National Center for Advancing Translational Sciences.(b)Assignment of Certain Functions of Former National Center for Research Resources.—(1)42 U.S.C. 283kBiomedical and behavioral research facilities.—Section 481A of the Public Health Service Act (42 U.S.C. 287a-2)—(A)is redesignated as section 404I and is moved to follow section 404H of such Act (42 U.S.C. 283j); and(B)is amended—(i)in subsection (a)(1), by striking acting through the Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases and inserting acting through the Office of the Director of NIH or the Director of the National Institute of Allergy and Infectious Diseases;(ii)in subsections (c), (d), (e), and (f)(2), by striking Director of the Center or the Director of the National Institute of Allergy and Infectious Diseases each place it appears and inserting Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases,;(iii)in subsection (b)(2), by striking Director of the Center each place it appears and inserting Director of NIH;(iv)in subsections (b)(3)(A), (f)(1), and (g), by striking the comma at the end of Director of the Center, each place it appears;(v)by striking Director of the Center each place it appears and inserting Director of NIH, acting through the Office of the Director of NIH,;(vi)in subsection (b)—(I)in paragraph (1)(A), by striking within the Center; and(II)in paragraph (2)—(aa)in subparagraph (A), by striking and the advisory council established under section 480 (in this section referred to as the Advisory Council) and inserting and the Council of Councils established under section 402(l) (in this section referred to as the Council); and(bb)in subparagraphs (B), (C), and (D), by striking Advisory each place it appears; and(vii)in subsection (g), by striking after consultation with the Advisory Council and inserting after consultation with the Council.(2)42 U.S.C. 283lConstruction of regional centers for research on primates.—Section 481B of the Public Health Service Act (42 U.S.C. 287a-3)—(A)is redesignated as section 404J and is moved to follow section 404I, as redesignated by paragraph (1); and(B)in subsection (a), is amended—(i)by striking by the National Center for Research Resources and inserting by the Director of NIH, acting through the Office of the Director of NIH,; and(ii)by striking 481A and inserting 404I.(3)42 U.S.C. 283mSanctuary system for surplus chimpanzees.—Section 481C of the Public Health Service Act (42 U.S.C. 287a-3a)—(A)is redesignated as section 404K and is moved to follow section 404J, as redesignated by paragraph (2); and(B)in subsection (d)(4)(A)(ii), is amended by striking that is carried out by the National Center for Research Resources and inserting that is carried out by the Director of NIH, acting through the Office of the Director of NIH,.(4)42 U.S.C. 283nShared instrumentation grant program.—Section 305 of the Public Health Improvement Act (42 U.S.C. 287 note)—(A)is redesignated as section 404L of the Public Health Service Act and is moved to follow section 404K of that Act, as redesignated by paragraph (3); and(B)is amended—(i)by striking subsection (a) and redesignating subsections (b) and (c) as subsections (a) and (b), respectively;(ii)in subsection (a), as so redesignated, by striking under the program described in subsection (a) and inserting under the Shared Instrumentation Grant Program;(iii)by striking Director of the National Center for Research Resources each place it appears and inserting Director of NIH, acting through the Office of the Director of NIH,; and(iv)in subsection (b), as so redesignated—(I)by striking in subsection (a) and inserting in subsection (a), the; and(II)by striking of the Public Health Service Act (42 U.S.C. 289a).(5)Institutional development award program.—Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended—(A)42 U.S.C. 285kin section 461, by striking the section heading and designation and all that follows through The general purpose and inserting the following:461.NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES(a)General Purpose.The general purpose;(B)42 U.S.C. 282by moving subsection (g) of section 402 to the end of section 461, as amended, and redesignating that subsection as subsection (b); and(C)42 U.S.C. 285kin section 461(b), as so redesignated—(i)by striking (b)(1)(A) In the case of and inserting the following:(b)Institutional Development Award Program.(1)(A)In the case of;(ii)by moving two ems to the right—(I)subparagraphs (B) and (C) of paragraph (1);(II)clauses (i), (ii), and (iii) of such subparagraph (C); and(III)paragraph (2); and(iii)in paragraph (1)(A), by striking acting through the Director of the National Center for Research Resources and inserting acting through the Director of the National Institute of General Medical Sciences.(c)Assignment of Certain Offices and Functions to National Center for Advancing Translational Sciences.—(1)42 U.S.C. 287aCures acceleration network.—Section 402C of the Public Health Service Act (42 U.S.C. 282d)—(A)is redesignated as section 480 and is moved to follow section 479;(B)in subsection (b), is amended in the matter that precedes paragraph (1) by striking within the Office of the Director of NIH and inserting within the Center;(C)by striking Director of NIH each place it appears and inserting Director of the Center; and(D)in the headings of subsections (d)(4) and (d)(4)(B), by striking Director of nih each place it appears and inserting Director of the center.(2)Office of rare diseases.—Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended—(A)in section 404F—(i)42 U.S.C. 283hby redesignating such section as section 481 and moving such section to follow section 480, as redesignated by paragraph (1);(ii)42 U.S.C. 287a-1in subsection (a)—(I)by striking within the Office of the Director of NIH and inserting within the Center; and(II)by striking Director of NIH and inserting Director of the Center; and(iii)42 U.S.C. 287a-1in subsection (b)(1)(C), by striking 404G and inserting 481A; and(B)42 U.S.C. 281in section 401(c)(2)(A), by striking the Office of Rare Diseases,.(3)42 U.S.C. 287a-2Rare disease regional centers of excellence.—Section 404G of the Public Health Service Act (42 U.S.C. 283i) is redesignated as section 481A and is moved to follow section 481, as redesignated by paragraph (2).(4)General clinical research centers.—Section 481D of the Public Health Service Act (42 U.S.C. 287a-4)—(A)is redesignated as section 481B; and(B)in subsection (a), is amended by striking Director of the National Center for Research Resources and inserting Director of the Center.(d)Conforming Amendments.—Title IV of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended—(1)in section 402(b)(24) (42 U.S.C. 282(b)(24)), by striking 402C and inserting 480;(2)in section 404C(e)(3)(A) (42 U.S.C. 283e(e)(3)(A)), by striking and the Director of the Center for Research Resources;(3)in section 464z-3(i)(1) (42 U.S.C. 285t(i)(1))—(A)by striking Director of National Institute for Research Resources and inserting Director of NIH;(B)by striking 481(c)(3) and inserting 404I(c)(2); and(C)by inserting under such section after Institutions of Emerging Excellence;(4)in section 499(c)(1)(E) (42 U.S.C. 290b(c)(1)(E)), by striking section 402C and inserting section 480.