§ 371. Regulations and hearings

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 75–675 § 701 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 371

   June 25, 1938, ch. 675, § 701, 52 Stat. 1055

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 701, 52 Stat. 1055

   Enacted provision · exact public law section
   Sec. 701. regulations and hearings (a) The authority to promulgate regulations for the efficient Regulations. enforcement of this Act, except as otherwise provided in this section, is hereby vested in the Secretary. (b) The Secretary of the Treasury and the Secretary of Agriculture shall jointly prescribe regulations for the efficient enforcement of the provisions of section 801, except as otherwise provided therein. Post, p. 1058. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Agriculture shall determine. (c) Hearings authorized or required by this Act shall be conducted Hearings. by the Secretary or such officer or employee as he may designate for the purpose. (d) The definitions and standards of identity promulgated in Definitions and standards of identity. accordance with the provisions of this Act shall be effective for the purposes of the enforcement of this Act, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder. (e) The Secretary, on his own initiative or upon an application of Public hearing upon proposal to issue, amend, or repeal any regulation. any interested industry or substantial portion thereof stating reasonable grounds therefor, shall hold a public hearing upon a proposal to issue, amend, or repeal any regulation contemplated by any of the following sections of this Act: 401, 403 (j), 404 (a), 406 (a) and (b), Ante, pp. 1048, 1049, 1050, 1051, 1052. Procedure. 501 (b), 502 (d), 502 (h), 504, and 604. The Secretary shall give appropriate notice of the hearing, and the notice shall set forth the proposal in general terms and specify the time and place for a public hearing to be held thereon not less than thirty days after the date of the notice, except that the public hearing on regulations under section 404 (a) may be held within a reasonable time, to be fixed by the Secretary, after notice thereof. At the hearing any interested person may be heard in person or by his representative. As soon as practicable after completion of the hearing, the Secretary shall by order make public his action in issuing, amending, or repealing the regulation or determining not to take such action. The Secretary shall base his order only on substantial evidence of record at the hearing and shall set forth as part of the order detailed findings of fact on which the order is based. No such order shall take effect prior to the ninetieth day after it is issued, except that if the Secretary finds that emergency conditions exist necessitating an earlier effective date, then the Secretary shall specify in the order his findings as to such conditions and the order shall take effect at such earlier date as the Secretary shall specify therein to meet the emergency. (f) (1) In a case of actual controversy as to the validity of any Controversies over validity of orders. Petition to proper Circuit Court of Appeals for review. order under subsection (e), any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the Circuit Court of Appeals of the United States for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. The summons and petition may be served at any place in the United States. The Secretary, promptly upon service of the summons and petition, shall certify and file in the court the transcript of the proceedings and the record on which the Secretary based his order. (2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence. (3) The court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive. (4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to 28 U. S. C. §§ 346, 347. review by the Supreme Court of the United States upon certiorari or certification as provided in sections 239 and 240 of the Judicial Code, as amended. (5) Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office. (6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law. (g) A certified copy of the transcript of the record and proceedings under subsection (e) shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and Admissibility. shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this Act, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f).

2. 1954

   Public Law not identified

   Struck · 21 U.S.C. § 371(e)

   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

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   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.

3. 1956

   Public Law not identified

   Changed · 21 U.S.C. § 371(e)

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

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

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

4. 1958

   Pub. L. 85–791 § 21(a) · 72 Stat. 941

   Substituted · 21 U.S.C. § 371(f)(1)

   Pub. 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

   Source evidence

   Code amendment note
   Subsec. (f)(1). Pub. 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.

   Enacted provision · exact public law section
   (a) The second and third sentences of paragraph (1) of HEW. subsection (f) of section 701 of the Federal Food, Drug, and Cosmetic 21 USC 371. Act (52 Stat. 1055), as amended, are amended to read as follows: “A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record or the proceedings on which the Secretary based his order, as provided in section 2112 of title 28, United States Code.”

5. 1958

   Pub. L. 85–791 § 21(b) · 72 Stat. 941

   Inserted · 21 U.S.C. § 371(f)(3)

   Pub. L. 85–791, § 21(b), inserted “Upon the filing of the petition referred to in paragraph (1) of this subsection”

   Source evidence

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

   Enacted provision · exact public law section
   (b) The first sentence of paragraph (3) of subsection (f) of 21 USC 371. section 701 of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1055), as amended, is amended to read as follows: “Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently.”

6. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 title I § 103(a)(4) · 74 Stat. 397

   Substituted · 21 U.S.C. § 371(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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   (4) amending section 701(e) by (A) striking out “406 (a) or (b)” and inserting in lieu thereof “406”; (B) striking out “504, or 604,”; and (C) inserting the word “or” after “501(b),”.

7. 1990

   Nutrition Labeling and Education Act of 1990

   Pub. L. 101–535 § 8 · 104 Stat. 2353

   1. Amended · 21 U.S.C. § 371(e)(1)

      Pub. L. 101–535, § 8, as amended by Pub. L. 103–80, § 4(c)

   2. Repealed · 21 U.S.C. § 371(e)(1)

      Pub. L. 101–535, § 8, as 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”

   Source evidence

   Code amendment note
   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”.

   Enacted provision · exact public law section
   SEC. 8. STANDARD OF IDENTITY REGULATION. Section 701(e) (21 U.S.C. 371(e)) is amended by striking out “Any action for the issuance, amendment, or repeal of any regulation under section 401, 403(j), 404(a), 406, 501(b), or 502 (d) or (h) of this Act” and inserting in lieu thereof the following: “Any action for the issuance, amendment, or repeal of any regulation under section 403(j), 404(a), 406, 501(b), or 502 (d) or (h) of this Act, and any action for the amendment or repeal of any definition and standard of identity under section 401 of this Act 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).

8. 1992

   Medical Device Amendments of 1992

   Pub. L. 102–300 § 6(b)(1) · 106 Stat. 238

   Substituted · 21 U.S.C. § 371(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

   Source evidence

   Code amendment note
   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.

   Enacted provision · exact public law section
   (1) Subsections (c) and (d) of sections 201, subsections (a), (d), (h), (i), (1), (m), and (o) of section 408, subsections (a) and (b) of section 536, section 701(b), and subsections (a) and (b) of section 801 (21 U.S.C. 321 (c) and (d), 346a (a), (d), (h), (i), (1), (m), and (o), 360mm (a) and (b), 371(b), and 381 (a) and (b)) and section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) are each amended by striking out “Health, Education, and Welfare” each place it appears and inserting in lieu thereof “Health and Human Services”.

9. 1993

   Nutrition Labeling and Education Act Amendments of 1993

   Pub. L. 103–80 § 3(dd)(1) · 107 Stat. 773

   Substituted · 21 U.S.C. § 371(b)

   Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” in two places

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” in two places.

   Enacted provision · exact public law section
   SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT. (a) Reference.— Whenever in this section an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (b) Section 201.— Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively. (c) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (j), by striking out “721, or 708” and inserting in lieu thereof “708, or 721”; and (2) in subsection (s), by striking out “412(d)” and inserting in lieu thereof “412(e)”. (d) Section 302.— Section 302 (21 U.S.C. 332) is amended— (1) in subsection (a), by striking out “, and subject to” and all that follows through “381),”, and (2) in subsection (b), by striking out the second sentence. (e) Section 303.— Section 303 (21 U.S.C. 333) is amended by redesignating the second subsection (e) and subsection (f) as subsections (f) and (g), respectively. (f) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(1), by striking out “: Provided, however, That no” and inserting in lieu thereof a period and “No”, and (2) in subsection (d)(1)— (A) by striking out “: Provided, That after” and inserting in lieu thereof a period and “After”, (B) by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”, (C) by striking out “: And provided further, That where” and inserting in lieu thereof a period and “Where”, and (D) by striking out “the foregoing proviso” and inserting in lieu thereof “the preceding sentence”. (g) Section 307.— Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is amended by striking out “Act” and inserting in lieu thereof “section”. (h) Section 401.— Section 401 (21 U.S.C. 341) is amended by striking out “and/or reasonable standards of fill of container: Provided, That no” and inserting in lieu thereof “or reasonable standards of fill of container. No”. (i) Section 402.— Section 402 (21 U.S.C. 342) is amended— (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”, (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”. (j) Section 403.— Section 403 (21 U.S.C. 343) is amended— (1) in paragraph (e), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (2) in paragraph (i), by striking out “, other than those sold as such” and inserting in lieu thereof “unless sold as spices, flavorings, or such colors” and by striking out “: Provided, That, to the extent” and inserting in lieu thereof a period and “To the extent”, (3) in paragraph (k), by striking out “: Provided, That” and inserting in lieu thereof “, except mat”, (4) in paragraph (l), by striking out “: Provided, however, That” and inserting in lieu thereof “, except that”, (5) in paragraph (r)(1)(B), by striking out “5(D)” and inserting in lieu thereof “(5)(D)”, and (6) in paragraph (r)(4)(B), by striking out “subsection” and inserting in lieu thereof “paragraph”. (k) Section 408.— Section 408 (21 U.S.C. 346a) is amended— (1) in subsection (a)(1), by striking out “Secretary of Health and Human Services” and inserting in lieu thereof “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)”, (2) in subsection (d)(5), by striking out “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))” and inserting in lieu thereof “section 556(c) of title 5, United States Code”, (3) in subsection (1), by striking out “It the event” and inserting in lieu thereof “In the events”, (4) in subsection (n), by striking out “of the Federal Food, Drug, and Cosmetic Act”, (5) in subsection (o), by striking out “Secretary of Health and Human Services” each place it occurs and inserting in lieu thereof “Administrator”, and (6) by striking out “Secretary” each place it occurs except when followed by “of Agriculture” and inserting in lieu thereof “Administrator”. (l) Section 412.— Section 412(h) (21 U.S.C. 350a(h)) is amended by striking out “(c)(1)(B),” and inserting in lieu thereof “(e)(1)(B)”. (m) Section 502.— Section 502 (21 U.S.C. 352) is amended— (1) in paragraph (e)(3), by striking out “: Provided further, That” and inserting in lieu thereof “, except that”, (2) in paragraph (f), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (3) in paragraph (g), by striking out “: Provided, That the method” and inserting in lieu thereof a period and “The method” and by striking out “: Provided further, That,” and inserting in lieu thereof “, except that”, and (4) in paragraph (n), by striking out “: Provided, That” and inserting in lieu thereof “, except that”. (n) Section 505.— Section 505 (21 U.S.C. 355) is amended— (1) in subsection (j)(6)(A)— (A) by striking out “Secretry” in clause (ii) and inserting in lieu thereof “Secretary”, and (B) by inserting a comma after “Secretary” the first time it appears in clause (iii). (2) in subsection (k)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”. (o) Section 506.— Section 506(a) (21 U.S.C. 356(a)) is amended by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”. (p) Section 507.— Section 507 (21 U.S.C. 357) is amended— (1) in subsection (a), by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”, (2) in subsection (e)— (A) by striking out “section 507” each place it occurs and inserting in lieu thereof “this section”, (B) by striking out “or 507” and inserting in lieu thereof “or this section”, and (C) by striking out “: Provided, That, for purposes” and inserting in lieu thereof a period and “For purposes”, (3) in subsection (g)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”, and (4) in subsection (h), by striking out “507”. (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”. (r) Section 512.— Section 512 (21 U.S.C. 360b) is amended— (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”, (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”, (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”, (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”. (s) Section 513.— Section 513(b)(3) (21 U.S.C 360c(b)(3)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (t) Section 515.— Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”. (u) Section 519.— Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (7)”; (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”. (w) Section 534.— Section 534(f)(2) (21 U.S.C. 360kk) is amended by striking out “this Act” and inserting in lieu thereof “the Public Health Service Act”. (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”. (y) Section 701.— Section 701 (21 U.S.C. 371) is amended— (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”. (z) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by striking out “: Provided, That” and inserting in lieu thereof “, except that”, and (2) by striking out “: Provided further, That” and inserting in lieu thereof “, and except that”. (aa) Section 704.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended— (1) by striking out the semicolon after “materials” and inserting in lieu thereof a comma, and (2) by striking out “(j)” the first time it appears and inserting in lieu thereof “(k)”. (bb) Section 721.— Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (cc) Section 801.— Section 801(b) (21 U.S.C. 381(b)) is amended— (1) by striking out “Administrator” the first time it occurs and inserting in lieu thereof “Secretary of Health and Human Services”, (2) by striking out “Administrator” the second and third time it occurs and inserting in lieu thereof “Secretary”, (3) by striking out “Administrator’s” and inserting in lieu thereof “Secretary’s”, and (4) by striking out “Federal Security Agency” and inserting in lieu thereof “Department of Health and Human Services”. (dd) Agriculture.— (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are each amended by striking out “Agriculture” each place it appears and inserting in lieu thereof “Health and Human Services”. (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are each amended by striking out “of Agriculture” each place it appears.

10. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 4(c) · 107 Stat. 773

    Changed · 21 U.S.C. § 371(e)(1)

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

    Source evidence

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

    Enacted provision · exact public law section
    (c) Nutrition Labeling and Education Act of 1990.— Section 8 of the Nutrition Labeling and Education Act of 1990 is amended 21 USC 371. by striking the period at the end and inserting close quotation marks and a period.

11. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(y)(1) · 107 Stat. 773

    Struck · 21 U.S.C. § 371(e)(1)

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

    Target inherited from the preceding amendment note.

    Source evidence

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

    Enacted provision · exact public law section
    (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and

12. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(y)(2) · 107 Stat. 773

    Substituted · 21 U.S.C. § 371(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”

    Source evidence

    Code amendment note
    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”.

    Enacted provision · exact public law section
    (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”.

13. 1994

    Animal Medicinal Drug Use Clarification Act of 1994

    Pub. L. 103–396 § 3(b) · 108 Stat. 4153

    Struck · 21 U.S.C. § 371(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

    Source evidence

    Code amendment note
    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.

    Enacted provision · exact public law section
    (b) Procedure.— Section 701(e)(1) (21 U.S.C. 371(e)(1)) is amended by striking “or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).”.

14. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 title IV § 405 · 111 Stat. 2296

    Added · 21 U.S.C. § 371(h)

    Pub. L. 105–115 added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 105–115 added subsec. (h).

    Enacted provision · exact public law section
    SEC. 405. INFORMAL AGENCY STATEMENTS. Section 701 (21 U.S.C. 371) is amended by adding at the end the following: “(h) (1) (A) The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration. “(B) Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents. “(C) 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. “(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation. “(2) In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents. “(3) The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public. “(4) The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection. “(5) Not later than July 1, 2000, the Secretary after evaluating Regulations. the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents”.

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

15. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 title VI § 619 · 126 Stat. 993

    1. Amended · 21 U.S.C. § 371(h)(1)(C)

       Pub. L. 112–144 designated existing provisions as cl. (i)

    2. Added · 21 U.S.C. § 371(h)(1)(C)

       Pub. L. 112–144 added cl. (ii)

    Source evidence

    Code amendment note
    Subsec. (h)(1)(C). Pub. L. 112–144 designated existing provisions as cl. (i) and added cl. (ii).

    Enacted provision · exact public law section
    SEC. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.   Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended— (1) by striking “(C) For guidance documents” and inserting “(C)(i) For guidance documents”; and (2) by adding at the end the following: “(ii) Notification. 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.” .

15 of 17 references resolved to an enrolled provision · 2 unresolved