GroundRules
21 CFR 12.30: Judicial review after waiver of hearing on a regulation.
Where this section sits in the code
- 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
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON