21 CFR § 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

(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.

[44 FR 22339, Apr. 13, 1979, as amended at 64 FR 399, Jan. 5, 1999]