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21 CFR 12.30

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

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 12.30, § 12.30 Judicial review after waiver of hearing on a regulation, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83104
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.