21 C.F.R. §§ 12.20–12.22

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—

If the Commissioner receives a petition under paragraph (a)(2) of this section, the Commissioner will—

[Reserved]

The notice promulgating the regulation will describe how to submit objections and requests for hearing.

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.

A proceeding under section 505 (d) or (e), 512 (d), (e), (m) (3) or (4), of section 515(g)(1) of the act, or section 351(a) of the Public Health Service Act, may be initiated—

A notice of opportunity for hearing on a proposal to deny or revoke approval of all or part of an order will be published together with an explanation of the grounds for the proposed action. The notice will describe how to submit requests for hearing. A person subject to the notice has 30 days after its issuance to request a hearing. The 30-day period may not be extended.

The Commissioner may use an optional procedure specified in § 10.30(h) to consider issuing, amending, or revoking an order.

In a proceeding under sections 505(e), 512(e) or (m), or 515(e) of the act in which a party wishes to apply for reimbursement of certain expenses under the Equal Access to Justice Act (5 U.S.C. 504 and 504 note), FDA will follow the Department of Health and Human Services' regulations in 45 CFR part 13.

Objections and requests for a hearing under § 12.20(d) must be submitted to the Dockets Management Staff and will be accepted for filing if they meet the following conditions:

Requests for hearing submitted under § 12.21 will be submitted to the Dockets Management Staff and will be accepted for filing if they meet the following conditions:

If an objection or request for a public hearing fails to meet the requirements of this section and the deficiency becomes known to the Dockets Management Staff, the Dockets Management Staff shall return it with a copy of the applicable regulations, indicating those provisions not complied with. A deficient objection or request for a hearing may be supplemented and subsequently filed if submitted within the 30-day time period specified in § 12.20(e) or § 12.21(b).

If another person objects to a regulation issued in response to a petition submitted under § 12.20(a)(2), the petitioner may submit a written reply to the Dockets Management Staff.