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.