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21 CFR 12.20

§ 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 12.20, § 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83097
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(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 (2) By a petition— (i) In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in § 71.1; or (ii) If no form is specified, by a petition under § 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 § 10.40 (b) through (f); (2) If it involves a color additive or food additive, and meets the requirements for filing in §§ 71.1 and 71.2, or in §§ 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 § 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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.