[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR12.30]
[Page 118]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 12 FORMAL EVIDENTIARY PUBLIC HEARING--Table of Contents
Subpart B Initiation of Proceedings
Sec. 12.30 Judicial review after waiver of hearing on a regulation.
(a) A person with a right to submit objections and a request for
hearing under Sec. 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 Sec. Sec. 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 Sec.
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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