[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR10.25]

[Page 92]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES--Table of Contents
 
              Subpart B--General Administrative Procedures
 
Sec. 10.25  Initiation of administrative proceedings.

    An administrative proceeding may be initiated in the following three 
ways:
    (a) An interested person may petition the Commissioner to issue, 
amend, or revoke a regulation or order, or to take or refrain from 
taking any other form of administrative action. A petition must be 
either: (1) In the form specified in other applicable FDA regulations, 
e.g., the form for a color additive petition in Sec. 71.1, for a food 
additive petition in Sec. 171.1, for a new drug application in 
Sec. 314.50, for a new animal drug application in Sec. 514.1, or (2) in 
the form for a citizen petition in Sec. 10.30.
    (b) The Commissioner may initiate a proceeding to issue, amend, or 
revoke a regulation or order or take or refrain from taking any other 
form of administrative action. FDA has primary jurisdiction to make the 
initial determination on issues within its statutory mandate, and will 
request a court to dismiss, or to hold in abeyance its determination of 
or refer to the agency for administrative determination, any issue which 
has not previously been determined by the agency or which, if it has 
previously been determined, the agency concluded should be reconsidered 
and subject to a new administrative determination. The Commissioner may 
utilize any of the procedures established in this part in reviewing and 
making a determination on any matter initiated under this paragraph.
    (c) The Commissioner will institute a proceeding to determine 
whether to issue, amend, or revoke a regulation or order, or take or 
refrain from taking any other form of administrative action whenever any 
court, on its own initiative, holds in abeyance or refers any matter to 
the agency for an administrative determination and the Commissioner 
concludes that an administrative determination is feasible within agency 
priorities and resources.

[44 FR 22323, Apr. 13, 1979, as amended at 54 FR 9034, Mar. 3, 1989]