[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: 21CFR16.95]

[Page 182]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION--Table of Contents
 
              Subpart E--Administrative Record and Decision
 
Sec. 16.95  Administrative decision and record for decision.

    (a) With respect to a regulatory hearing at the Commissioner's 
initiative under Sec. 16.1(a), the Commissioner shall consider the 
administrative record of the hearing specified in Sec. 16.80(a) together 
with all other relevant information and views available to FDA in 
determining whether regulatory action should be taken and, if so, in 
what form.
    (b) With respect to a regulatory hearing required by the act or a 
regulation under Sec. 16.1(b)--
    (1) The administrative record of the hearing specified in 
Sec. 16.80(a) constitutes the exclusive record for decision;
    (2) On the basis of the administrative record of the hearing, the 
Commissioner shall issue a written decision stating the reasons for the 
Commissioner's administrative action and the basis in the record; and
    (3) For purposes of judicial review under Sec. 10.45, the record of 
the administrative proceeding consists of the record of the hearing and 
the Commissioner's decision.