[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.20]

[Page 125-126]
 
                        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
    (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 Secs. 71.1 and 71.2, or in Secs. 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

[[Page 126]]

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]