From the U.S. Code Online via GPO Access
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[Laws in effect as of January 3, 2005]
[Document not affected by Public Laws enacted between
  January 3, 2005 and August 11, 2006]
[CITE: 21USC371]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                    SUBCHAPTER VII--GENERAL AUTHORITY
 
                Part A--General Administrative Provisions
 
Sec. 371. Regulations and hearings


(a) Authority to promulgate regulations

    The authority to promulgate regulations for the efficient 
enforcement of this chapter, except as otherwise provided in this 
section, is vested in the Secretary.

(b) Regulations for imports and exports

    The Secretary of the Treasury and the Secretary of Health and Human 
Services shall jointly prescribe regulations for the efficient 
enforcement of the provisions of section 381 of this title, except as 
otherwise provided therein. Such regulations shall be promulgated in 
such manner and take effect at such time, after due notice, as the 
Secretary of Health and Human Services shall determine.

(c) Conduct of hearings

    Hearings authorized or required by this chapter shall be conducted 
by the Secretary or such officer or employee as he may designate for the 
purpose.

(d) Effectiveness of definitions and standards of identity

    The definitions and standards of identity promulgated in accordance 
with the provisions of this chapter shall be effective for the purposes 
of the enforcement of this chapter, notwithstanding such definitions and 
standards as may be contained in other laws of the United States and 
regulations promulgated thereunder.

(e) Procedure for establishment

    (1) 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) shall be begun by a 
proposal made (A) by the Secretary on his own initiative, or (B) by 
petition of any interested person, showing reasonable grounds therefor, 
filed with the Secretary. The Secretary shall publish such proposal and 
shall afford all interested persons an opportunity to present their 
views thereon, orally or in writing. As soon as practicable thereafter, 
the Secretary shall by order act upon such proposal and shall make such 
order public. Except as provided in paragraph (2), the order shall 
become effective at such time as may be specified therein, but not prior 
to the day following the last day on which objections may be filed under 
such paragraph.
    (2) On or before the thirtieth day after the date on which an order 
entered under paragraph (1) is made public, any person who will be 
adversely affected by such order if placed in effect may file objections 
thereto with the Secretary, specifying with particularity the provisions 
of the order deemed objectionable, stating the grounds therefor, and 
requesting a public hearing upon such objections. Until final action 
upon such objections is taken by the Secretary under paragraph (3), the 
filing of such objections shall operate to stay the effectiveness of 
those provisions of the order to which the objections are made. As soon 
as practicable after the time for filing objections has expired the 
Secretary shall publish a notice in the Federal Register specifying 
those parts of the order which have been stayed by the filing of 
objections and, if no objections have been filed, stating that fact.
    (3) As soon as practicable after such request for a public hearing, 
the Secretary, after due notice, shall hold such a public hearing for 
the purpose of receiving evidence relevant and material to the issues 
raised by such objections. At the hearing, any interested person may be 
heard in person or by representative. As soon as practicable after 
completion of the hearing, the Secretary shall by order act upon such 
objections and make such order public. Such order shall be based only on 
substantial evidence of record at such hearing and shall set forth, as 
part of the order, detailed findings of fact on which the order is 
based. The Secretary shall specify in the order the date on which it 
shall take effect, except that it shall not be made to take effect prior 
to the ninetieth day after its publication unless the Secretary finds 
that emergency conditions exist necessitating an earlier effective date, 
in which event the Secretary shall specify in the order his findings as 
to such conditions.

(f) Review of order

    (1) In a case of actual controversy as to the validity of any order 
under subsection (e) of this section, 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 United 
States court of appeals for the circuit wherein such person resides or 
has his principal place of business, for a judicial review of such 
order. 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 of the proceedings on which the Secretary based his order, as 
provided in section 2112 of title 28.
    (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) 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. 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 
review by the Supreme Court of the United States upon certiorari or 
certification as provided in section 1254 of title 28.
    (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) Copies of records of hearings

    A certified copy of the transcript of the record and proceedings 
under subsection (e) of this section shall be furnished by the Secretary 
to any interested party at his request, and payment of the costs 
thereof, and shall be admissible in any criminal, libel for 
condemnation, exclusion of imports, or other proceeding arising under or 
in respect to this chapter, irrespective of whether proceedings with 
respect to the order have previously been instituted or become final 
under subsection (f) of this section.

(h) Guidance documents

    (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 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.

(June 25, 1938, ch. 675, Sec. 701, 52 Stat. 1055; June 25, 1948, ch. 
646, Sec. 32, 62 Stat. 991; Apr. 15, 1954, ch. 143, Sec. 2, 68 Stat. 55; 
Aug. 1, 1956, ch. 861, Sec. 2, 70 Stat. 919; Pub. L. 85-791, Sec. 21, 
Aug. 28, 1958, 72 Stat. 948; Pub. L. 86-618, title I, Sec. 103(a)(4), 
July 12, 1960, 74 Stat. 398; Pub. L. 101-535, Sec. 8, Nov. 8, 1990, 104 
Stat. 2365; Pub. L. 102-300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; 
Pub. L. 103-80, Secs. 3(y), (dd)(1), 4(c), Aug. 13, 1993, 107 Stat. 778, 
779; Pub. L. 103-396, Sec. 3(b), Oct. 22, 1994, 108 Stat. 4155; Pub. L. 
105-115, title IV, Sec. 405, Nov. 21, 1997, 111 Stat. 2368.)


                               Amendments

    1997--Subsec. (h). Pub. L. 105-115 added subsec. (h).
    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, Sec. 3(dd)(1), substituted 
``Health and Human Services'' for ``Agriculture'' in two places.
    Subsec. (e)(1). Pub. L. 103-80, Sec. 4(c), made technical correction 
to directory language of Pub. L. 101-535, Sec. 8. See 1990 Amendment 
note below.
    Pub. L. 103-80, Sec. 3(y)(1), struck out period after second 
reference to ``Regulations)''.
    Subsec. (f)(4). Pub. L. 103-80, Sec. 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, Sec. 8, as amended by Pub. L. 
103-80, Sec. 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''.
    1958--Subsec. (f)(1). Pub. L. 85-791, Sec. 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). Pub. L. 85-791, Sec. 21(b), 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.

                         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 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.


                    Effective Date of 1960 Amendment

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


              Construction of Amendments by Pub. L. 101-535

    Amendments by Pub. 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 Pub. 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 
Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, which 
is classified to section 3508(b) of Title 20, Education.
    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 note set out under section 
41 of this title.


       Approval of Supplemental Applications for Approved Products

    Section 403 of Pub. L. 105-115 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.''


   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.