[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR514.235]

[Page 88]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 514--NEW ANIMAL DRUG APPLICATIONS--Table of Contents
 
                       Subpart F--Judicial Review
 
Sec.  514.235  Judicial review.


    (a) The transcript and record shall be certified by the 
Commissioner. In any case in which the Commissioner enters an order 
without a hearing pursuant to Sec.  314.200(g) of this chapter, the 
request(s) for hearing together with the data and information submitted 
and the Commissioner's findings and conclusions shall be included in the 
record certified by the Commissioner.
    (b) Judicial review of an order withdrawing approval of a new drug 
application, whether or not a hearing has been held, may be sought by a 
manufacturer or distributor of an identical, related, or similar drug 
product, as defined in Sec.  310.6 of this chapter, in a United States 
court of appeals pursuant to section 505(h) of the act.

[42 FR 4717, Jan. 25, 1977]