[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
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.