21 CFR 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
(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.
(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.