[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.20]
[Page 114.115]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart B Initiation of Proceedings
Sec. 12.20 Initiation of a hearing involving the issuance, amendment, or
revocation of a regulation.
(a) A proceeding under section 409(f), 502(n), 512(n)(5), 701(e), or
721(d) of the act or section 4 or 5 of the Fair Packaging and Labeling
Act may be initiated--
(1) By the Commissioner on the Commissioner's own initiative, e.g.,
as provided in Sec. 170.15 for food additives; or
(2) By a petition--
(i) In the form specified elsewhere in this chapter, e.g., the form
for a color additive petition in Sec. 71.1; or
[[Page 115]]
(ii) If no form is specified, by a petition under Sec. 10.30.
(b) If the Commissioner receives a petition under paragraph (a)(2)
of this section, the Commissioner will--
(1) If it involves any matter subject to section 701(e) of the act
or section 4 or 5 of the Fair Packaging and Labeling Act, and meets the
requirements for filing, follow the provisions of Sec. 10.40 (b)
through (f);
(2) If it involves a color additive or food additive, and meets the
requirements for filing in Sec. Sec. 71.1 and 71.2, or in Sec. Sec.
171.1, 171.6, 171.7, and 171.100, publish a notice of filing of the
petition within 30 days after the petition is filed instead of a notice
of proposed rulemaking.
(c) [Reserved]
(d) The notice promulgating the regulation will describe how to
submit objections and requests for hearing.
(e) On or before the 30th day after the date of publication of a
final regulation, or of a notice withdrawing a proposal initiated by a
petition under Sec. 10.25(a), a person may submit to the Commissioner
written objections and a request for a hearing. The 30-day period may
not be extended except that additional information supporting an
objection may be received after 30 days upon a showing of inadvertent
omission and hardship, and if review of the objection and request for
hearing will not thereby be impeded. If, after a final color additive
regulation is published, a petition or proposal relating to the
regulation is referred to an advisory committee in accordance with
section 721(b)(5)(C) of the act, objections and requests for a hearing
may be submitted on or before the 30th day after the date on which the
order confirming or modifying the Commissioner's previous order is
published.
[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]
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