section_subject: "Judicial review after waiver of hearing on a regulation."
cfr_reference: "21 CFR 12.30"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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.