{"data":{"id":"us/21-cfr-12.20","jurisdiction":"us","citation":"21 CFR 12.20","heading":"Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.","body":"(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—\n(1) By the Commissioner on the Commissioner's own initiative, e.g., as provided in § 170.15 for food additives; or\n(2) By a petition—\n(i) In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in § 71.1; or\n(ii) If no form is specified, by a petition under § 10.30.\n(b) If the Commissioner receives a petition under paragraph (a)(2) of this section, the Commissioner will—\n(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);\n(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.\n(c) [Reserved]\n(d) The notice promulgating the regulation will describe how to submit objections and requests for hearing.\n(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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"3f6321f5f61d1c8ef3ec306535e7678091c7c3c2d2173de49fbf537272b0302d","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-12.1","next":"us/21-cfr-12.21"},"notice":"GroundRules: Original legal text. Not legal advice."}