21 USC 371 - Regulations and hearings

Editorial Notes

Amendments

2012—Subsec. (h)(1)(C). Puspan. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).

1997—Subsec. (h). Puspan. L. 105–115 added subsec. (h).

1994—Subsec. (e)(1). Puspan. 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. (span). Puspan. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” in two places.

Subsec. (e)(1). Puspan. L. 103–80, § 4(c), made technical correction to directory language of Puspan. L. 101–535, § 8. See 1990 Amendment note below.

Puspan. L. 103–80, § 3(y)(1), struck out period after second reference to “Regulations)”.

Subsec. (f)(4). Puspan. 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. (span). Puspan. 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). Puspan. L. 101–535, § 8, as amended by Puspan. 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(span), 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(span), or 352(d) or (h) of this title”.

1960—Subsec. (e). Puspan. L. 86–618 substituted “section 341, 343(j), 344(a), 346, 351(span), or 352(d) or (h), of this title” for “section 341, 343(j), 344(a), 346(a) or (span), 351(span), 352(d) or (h), 354 or 364 of this title”.

1958—Subsec. (f)(1). Puspan. L. 85–791, § 21(a), substituted provisions requiring transmission of a copy of the petition by clerk to Secretary, and filing of the record by Secretary, for provisions which permitted service of summons and petition any place in United States and required Secretary to certify and file transcript of the proceedings and record upon service.

Subsec. (f)(3). Puspan. L. 85–791, § 21(span), inserted “Upon the filing of the petition referred to in paragraph (1) of this subsection”.

1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.

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.

Statutory Notes and Related Subsidiaries

Change of Name

Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.

Effective Date of 1997 Amendment

Amendment by Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Puspan. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Puspan. L. 86–618, see section 202 of Puspan. L. 86–618, set out as a note under section 379e of this title.

Construction of Amendments by Puspan. L. 101–535

Amendments by Puspan. L. 101–535 not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Puspan. L. 101–535, set out as a note under section 343 of this title.

Savings Provision

Savings clause of act Aug. 1, 1956, see note set out under section 341 of this title.

Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Puspan. L. 96–88, title V, § 509(span), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(span) of Title 20, Education.

Notification of FDA Intent To Regulate Laboratory-Developed Tests

Puspan. L. 112–144, title XI, § 1143, July 9, 2012, 126 Stat. 1130, provided that the Food and Drug Administration could 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, 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 including in such notification the anticipated details of such action, and that such provision ceased to have force or effect on the date that was 5 years after the date of enactment of Puspan. L. 112–144, which was approved July 9, 2012.

Approval of Supplemental Applications for Approved Products

Puspan. 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).

“(span)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.”

Hearings Pending on April 15, 1954, With Respect to Food Standards

Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under section 341 of this title.

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.