Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 12 - Formal Evidentiary Public Hearing |
Subpart B - Initiation of Proceedings |
§ 12.20 - Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
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§ 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 § 170.15 for food additives; or
(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 § 10.40 (b) through (f);
(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 § 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]