21 CFR § 12.30 - Judicial review after waiver of hearing on a regulation.

---
identifier: "/us/cfr/t21/s12.30"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 12.30 - Judicial review after waiver of hearing on a regulation."
title_number: 21
title_name: "Food and Drugs"
section_number: "12.30"
section_name: "Judicial review after waiver of hearing on a regulation."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "12"
part_name: "FORMAL EVIDENTIARY PUBLIC HEARING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-721; 28 U.S.C. 2112."
regulatory_source: "44 FR 22339, Apr. 13, 1979, unless otherwise noted."
cfr_part: "12"
---


# 12.30 Judicial review after waiver of hearing on a regulation.

(a) A person with a right to submit objections and a request for hearing under § 12.20(d) may submit objections and waive the right to a hearing. The waiver may be either an explicit statement, or a failure to request a hearing, as provided in 12.22(a)(4).

(b) If a person waives the right to a hearing, the Commissioner will rule upon the person's objections under §§ 12.24 through 12.28. As a matter of discretion, the Commissioner may also order a hearing on the matter under any of the provisions of this part.

(c) If the Commissioner rules adversely on a person's objection, the person may petition for judicial review in a U.S. Court of Appeals under the act.

(1) The record for judicial review is the record designated in § 12.28(b)(1).

(2) The time for filing a petition for judicial review begins as of the date of publication of the Commissioner's ruling on the objections.