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Code · CFR · Title 21 — Food and Drugs · Part 12 — Formal Evidentiary Public Hearing · § 12.30

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

155 words·~1 min read·/us/cfr/t21/s§ 12.30

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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.
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