21 C.F.R. § 12.30 Judicial review after waiver of hearing on a regulation.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 12—FORMAL EVIDENTIARY PUBLIC HEARING
Subpart B—Initiation of Proceedings
§ 12.30 Judicial review after waiver of hearing on a regulation.
