Source: https://www.gpo.gov/fdsys/pkg/USCODE-2015-title21/html/USCODE-2015-title21-chap9-subchapVII-partA-sec371.htm
Timestamp: 2016-10-27 00:59:25
Document Index: 218419206

Matched Legal Cases: ['§701', '§32', '§2', '§2', '§21', '§103', '§8', '§6', '§3', '§3', '§405', '§619', '§3', '§3', '§3', '§8', '§4', 'arts 131', '§21', '§1143', '§403']

(C)(i) For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.
(ii) With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.
(June 25, 1938, ch. 675, §701, 52 Stat. 1055; June 25, 1948, ch. 646, §32, 62 Stat. 991; Apr. 15, 1954, ch. 143, §2, 68 Stat. 55; Aug. 1, 1956, ch. 861, §2, 70 Stat. 919; Pub. L. 85–791, §21, Aug. 28, 1958, 72 Stat. 948; Pub. L. 86–618, title I, §103(a)(4), July 12, 1960, 74 Stat. 398; Pub. L. 101–535, §8, Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102–300, §6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §§3(y), (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103–396, §3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105–115, title IV, §405, Nov. 21, 1997, 111 Stat. 2368; Pub. L. 112–144, title VI, §619, July 9, 2012, 126 Stat. 1063.)
2012—Subsec. (h)(1)(C). Pub. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).
1994—Subsec. (e)(1). Pub. L. 103–396 which directed the amendment of par. (1) by striking out "or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).", was executed by striking out "or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" before "shall be begun by a proposal", to reflect the probable intent of Congress.
1993—Subsec. (b). Pub. L. 103–80, §3(dd)(1), substituted "Health and Human Services" for "Agriculture" in two places.
Pub. L. 103–80, §3(y)(1), struck out period after second reference to "Regulations)".
Subsec. (f)(4). Pub. L. 103–80, §3(y)(2), substituted reference to section 1254 of title 28 for "sections 239 and 240 of the Judicial Code, as amended".
1992—Subsec. (b). Pub. L. 102–300, which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.
1990—Subsec. (e)(1). Pub. L. 101–535, §8, as amended by Pub. L. 103–80, §4(c), substituted "Any action for the issuance, amendment, or repeal of any regulation under section 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)" for "Any action for the issuance, amendment, or repeal of any regulation under section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h) of this title".
1960—Subsec. (e). Pub. L. 86–618 substituted "section 341, 343(j), 344(a), 346, 351(b), or 352(d) or (h), of this title" for "section 341, 343(j), 344(a), 346(a) or (b), 351(b), 352(d) or (h), 354 or 364 of this title".
Subsec. (f)(3). Pub. L. 85–791, §21(b), inserted "Upon the filing of the petition referred to in paragraph (1) of this subsection".
1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to section 341 of this title, before "343(j)", such section 341 now containing its own provisions with respect to hearings regarding the establishment of food standards.
Notification of FDA Intent To Regulate Laboratory-Developed Tests
Pub. L. 112–144, title XI, §1143, July 9, 2012, 126 Stat. 1130, provided that:
"(a) In General.—The Food and Drug Administration may not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance—
"(1) notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration's intent to take such action; and
"(2) including in such notification the anticipated details of such action.
"(b) Sunset.—Subsection (a) shall cease to have force or effect on the date that is 5 years after the date of enactment of this Act [July 9, 2012]."
Pub. L. 105–115, title IV, §403, Nov. 21, 1997, 111 Stat. 2367, provided that:
"(a) Standards.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).
"(b) Guidance to Industry.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall—
"(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;
"(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and
"(3) define supplemental applications that are eligible for priority review.
"(c) Responsibilities of Centers.—The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—
"(1) encouraging the prompt review of supplemental applications for approved articles; and
"(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.
"(d) Collaboration.—The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies."