21 U.S.C. § 394 — Scientific review groups

Page 706 TITLE 21—FOOD AND DRUGS § 393a ment poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or in- halation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious cere- monies.’’ MANAGEMENT ACTIVITIES STUDY Pub. L. 102–571, title II, § 205, Oct. 29, 1992, 106 Stat. 4502, directed Comptroller General to conduct a study of management of activities of the Food and Drug Ad- ministration that are related to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances and submit an interim report to Congress, not later than 6 months after Oct. 29, 1992, with a final report to be submitted not later than 12 months after Oct. 29, 1992. CONGRESSIONAL FINDINGS Pub. L. 100–607, title V, § 502, Nov. 4, 1988, 102 Stat. 3120, provided that: ‘‘Congress finds that— ‘‘(1) the public health has been effectively protected by the presence of the Food and Drug Administration during the last eighty years; ‘‘(2) the presence and importance of the Food and Drug Administration must be guaranteed; and ‘‘(3) the independence and integrity of the Food and Drug Administration need to be enhanced in order to ensure the continuing protection of the public health.’’ § 393a. Office of Pediatric Therapeutics (a) Establishment The Secretary of Health and Human Services shall establish an Office of Pediatric Thera- peutics within the Food and Drug Administra- tion. (b) Duties The Office of Pediatric Therapeutics shall be responsible for coordination and facilitation of all activities of the Food and Drug Administra- tion that may have any effect on a pediatric population or the practice of pediatrics or may in any other way involve pediatric issues, in- cluding increasing pediatric access to medical devices. (c) Staff The staff of the Office of Pediatric Thera- peutics shall coordinate with employees of the Department of Health and Human Services who exercise responsibilities relating to pediatric therapeutics and shall include— (1) one or more additional individuals with expertise concerning ethical issues presented by the conduct of clinical research in the pedi- atric population; (2) subject to subsection (d), one or more ad- ditional individuals with necessary expertise in a pediatric subpopulation that is, as deter- mined through consideration of the reports and recommendations issued by the Institute of Medicine and the Comptroller General of the United States, less likely to be studied as a part of a written request issued under sec- tion 355a of this title or an assessment under section 355c of this title; (3) one or more additional individuals with expertise in pediatric epidemiology; and (4) one or more additional individuals with expertise in pediatrics as may be necessary to perform the activities described in subsection (b). (d) Neonatology expertise At least one of the individuals described in subsection (c)(2) shall have expertise in neonatology. (Pub. L. 107–109, § 6, Jan. 4, 2002, 115 Stat. 1414; Pub. L. 110–85, title III, § 306(a), Sept. 27, 2007, 121 Stat. 864; Pub. L. 112–144, title V, § 511, July 9, 2012, 126 Stat. 1050; Pub. L. 115–52, title V, § 505(d)(1), Aug. 18, 2017, 131 Stat. 1047.) Editorial Notes CODIFICATION Section was enacted as part of the Best Pharma- ceuticals for Children Act, and not as part of the Fed- eral Food, Drug, and Cosmetic Act which comprises this chapter. AMENDMENTS 2017—Subsec. (d). Pub. L. 115–52 substituted ‘‘At least’’ for ‘‘For the 5-year period beginning on July 9, 2012, at least’’. 2012—Subsec. (c)(2) to (4). Pub. L. 112–144, § 511(1), added pars. (2) and (3) and redesignated former par. (2) as (4). Subsec. (d). Pub. L. 112–144, § 511(2), added subsec. (d). 2007—Subsec. (b). Pub. L. 110–85 inserted ‘‘, including increasing pediatric access to medical devices’’ before period at end. § 394. Scientific review groups Without regard to the provisions of title 5 gov- erning appointments in the competitive service and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, the Commissioner of Food and Drugs may— (1) establish such technical and scientific re- view groups as are needed to carry out the functions of the Food and Drug Administra- tion (including functions prescribed under this chapter); and (2) appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups. (June 25, 1938, ch. 675, § 1004, formerly § 903, as added Pub. L. 101–635, title III, § 301, Nov. 28, 1990, 104 Stat. 4584; renumbered § 904, Pub. L. 103–43, title XX, § 2006(1), June 10, 1993, 107 Stat. 209; re- numbered § 1004, Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784.) § 395. Loan repayment program (a) In general (1) Authority for program Subject to paragraph (2), the Secretary shall carry out a program of entering into contracts with appropriately qualified health profes- sionals under which such health professionals agree to conduct research, as employees of the Food and Drug Administration, in consider- ation of the Federal Government agreeing to repay, for each year of such service, not more