21 U.S.C. § 399a — Office of the Chief Scientist

Page 709 TITLE 21—FOOD AND DRUGS § 399b (e) Duration of awards The Secretary may award grants to an indi- vidual grant recipient under this section for pe- riods of not more than 3 years. In the event the Secretary conducts a program evaluation, fund- ing in the second year or third year of the grant, where applicable, shall be contingent on a suc- cessful program evaluation by the Secretary after the first year. (f) Progress and evaluation (1) In general The Secretary shall measure the status and success of each grant program authorized under the FDA Food Safety Modernization Act (and any amendment made by such Act), in- cluding the grant program under this section. A recipient of a grant described in the pre- ceding sentence shall, at the end of each grant year, provide the Secretary with information on how grant funds were spent and the status of the efforts by such recipient to enhance food safety. To the extent practicable, the Secretary shall take the performance of such a grant recipient into account when deter- mining whether to continue funding for such recipient. (2) No duplication In carrying out paragraph (1), the Secretary shall not duplicate the efforts of the Secretary under other provisions of this chapter or the FDA Food Safety Modernization Act that re- quire measurement and review of the activi- ties of grant recipients under either this chap- ter or such Act. (g) Supplement not supplant Grant funds received under this section shall be used to supplement, and not supplant, non- Federal funds and any other Federal funds avail- able to carry out the activities described in this section. (h) Authorization of appropriations For the purpose of making grants under this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2011 through 2015. (June 25, 1938, ch. 675, § 1009, formerly § 909, as added Pub. L. 107–188, title III, § 311, June 12, 2002, 116 Stat. 673; renumbered § 1009 and amend- ed Pub. L. 111–31, div. A, title I, §§ 101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II, § 210(a), Jan. 4, 2011, 124 Stat. 3948.) Editorial Notes REFERENCES IN TEXT The FDA Food Safety Modernization Act, referred to in subsec. (f), is Pub. L. 111–353, Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§ 2201 et seq.) and sec- tions 350g to 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and section 280g–16 of Title 42, The Public Health and Wel- fare, amended sections 331, 333, 334, 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 2201 of this title and Tables. AMENDMENTS 2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to grants to States for inspections. 2009—Subsec. (b). Pub. L. 111–31, § 103(n), made tech- nical amendment to reference in original act which ap- pears in text as reference to section 398 of this title. Statutory Notes and Related Subsidiaries CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under cer- tain other Acts, or in a manner inconsistent with inter- national agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title. § 399a. Office of the Chief Scientist (a) Establishment; appointment The Secretary shall establish within the Office of the Commissioner an office to be known as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead such Of- fice. (b) Duties of the Office The Office of the Chief Scientist shall— (1) oversee, coordinate, and ensure quality and regulatory focus of the intramural re- search programs of the Food and Drug Admin- istration; (2) track and, to the extent necessary, co- ordinate intramural research awards made by each center of the Administration or science- based office within the Office of the Commis- sioner, and ensure that there is no duplication of research efforts supported by the Reagan- Udall Foundation for the Food and Drug Ad- ministration; (3) develop and advocate for a budget to sup- port intramural research; (4) develop a peer review process by which intramural research can be evaluated; (5) identify and solicit intramural research proposals from across the Food and Drug Ad- ministration through an advisory board com- posed of employees of the Administration that shall include— (A) representatives of each of the centers and the science-based offices within the Of- fice of the Commissioner; and (B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic science, and public health; and (6) develop postmarket safety performance measures that are as measurable and rigorous as the ones already developed for premarket review. (June 25, 1938, ch. 675, § 1010, formerly § 910, as added Pub. L. 110–85, title VI, § 602, Sept. 27, 2007, 121 Stat. 898; renumbered § 1010, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 399b. Office of Women’s Health (a) Establishment There is established within the Office of the Commissioner, an office to be known as the Of- fice of Women’s Health (referred to in this sec-