21 CFR §12.20

1. (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. (1)By the Commissioner on the Commissioner's own initiative, e.g., as provided in § 170.15 for food additives; or
   2. (2)By a petition—
      1. (i)In the form specified elsewhere in this chapter, e.g., the form for a color additive petition in § 71.1; or
      2. (ii)If no form is specified, by a petition under § 10.30.
2. (b)If the Commissioner receives a petition under paragraph (a)(2) of this section, the Commissioner will—
   1. (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. (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.
3. (c)[Reserved]
4. (d)The notice promulgating the regulation will describe how to submit objections and requests for hearing.
5. (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.