21 U.S.C. § 399b — Office of Women’s Health

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- Page 710 TITLE 21—FOOD AND DRUGS § 399c tion as the ‘‘Office’’). The Office shall be headed by a director who shall be appointed by the Commissioner of Food and Drugs. (b) Purpose The Director of the Office shall— (1) report to the Commissioner of Food and Drugs on current Food and Drug Administra- tion (referred to in this section as the ‘‘Ad- ministration’’) levels of activity regarding women’s participation in clinical trials and the analysis of data by sex in the testing of drugs, medical devices, and biological products across, where appropriate, age, biological, and sociocultural contexts; (2) establish short-range and long-range goals and objectives within the Administra- tion for issues of particular concern to wom- en’s health within the jurisdiction of the Ad- ministration, including, where relevant and appropriate, adequate inclusion of women and analysis of data by sex in Administration pro- tocols and policies; (3) provide information to women and health care providers on those areas in which dif- ferences between men and women exist; (4) consult with pharmaceutical, biologics, and device manufacturers, health profes- sionals with expertise in women’s issues, con- sumer organizations, and women’s health pro- fessionals on Administration policy with re- gard to women; (5) make annual estimates of funds needed to monitor clinical trials and analysis of data by sex in accordance with needs that are identi- fied; and (6) serve as a member of the Department of Health and Human Services Coordinating Committee on Women’s Health (established under section 237a(b)(4) of title 42). (c) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2010 through 2014. (June 25, 1938, ch. 675, § 1011, as added Pub. L. 111–148, title III, § 3509(g), Mar. 23, 2010, 124 Stat. 536.) Editorial Notes CODIFICATION Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–353, title II, § 209(a), Jan. 4, 2011, 124 Stat. 3945, and subsequently renumbered section 1012 by Pub. L. 114–255, div. A, title III, § 3073(b)(2), Dec. 13, 2016, 130 Stat. 1137, and is classified to section 399c of this title. § 399c. Improving the training of State, local, ter- ritorial, and tribal food safety officials (a) Training The Secretary shall set standards and admin- ister training and education programs for the employees of State, local, territorial, and tribal food safety officials relating to the regulatory responsibilities and policies established by this chapter, including programs for— (1) scientific training; (2) training to improve the skill of officers and employees authorized to conduct inspec- tions under sections 372 and 374 of this title; (3) training to achieve advanced product or process specialization in such inspections; (4) training that addresses best practices; (5) training in administrative process and procedure and integrity issues; (6) training in appropriate sampling and lab- oratory analysis methodology; and (7) training in building enforcement actions following inspections, examinations, testing, and investigations. (b) Partnerships with State and local officials (1) In general The Secretary, pursuant to a contract or memorandum of understanding between the Secretary and the head of a State, local, terri- torial, or tribal department or agency, is au- thorized and encouraged to conduct examina- tions, testing, and investigations for the pur- poses of determining compliance with the food safety provisions of this chapter through the officers and employees of such State, local, territorial, or tribal department or agency. (2) Content A contract or memorandum described under paragraph (1) shall include provisions to en- sure adequate training of such officers and em- ployees to conduct such examinations, testing, and investigations. The contract or memo- randum shall contain provisions regarding re- imbursement. Such provisions may, at the sole discretion of the head of the other depart- ment or agency, require reimbursement, in whole or in part, from the Secretary for the examinations, testing, or investigations per- formed pursuant to this section by the officers or employees of the State, territorial, or tribal department or agency. (3) Effect Nothing in this subsection shall be con- strued to limit the authority of the Secretary under section 372 of this title. (c) Extension service The Secretary shall ensure coordination with the extension activities of the National Insti- tute of Food and Agriculture of the Department of Agriculture in advising producers and small processors transitioning into new practices re- quired as a result of the enactment of the FDA Food Safety Modernization Act and assisting regulated industry with compliance with such Act. (d) National Food Safety Training, Education, Extension, Outreach and Technical Assist- ance Program (1) In general In order to improve food safety and reduce the incidence of foodborne illness, the Sec- retary shall, not later than 180 days after Jan- uary 4, 2011, enter into one or more memo- randa of understanding, or enter into other co- operative agreements, with the Secretary of Agriculture to establish a competitive grant program within the National Institute for Food and Agriculture to provide food safety training, education, extension, outreach, and technical assistance to— (A) owners and operators of farms;