[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: 21CFR16.26]

[Page 168]
 
                        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 B_Initiation of Proceedings
 
Sec.  16.26  Denial of hearing and summary decision.

    (a) A request for a hearing may be denied, in whole or in part, if 
the Commissioner or the FDA official to whom authority is delegated to 
make the final decision on the matter determines that no genuine and 
substantial issue of fact has been raised by the material submitted. If 
the Commissioner or his or her delegate determines that a hearing is not 
justified, written notice of the determination will be given to the 
parties explaining the reason for denial.
    (b) After a hearing commences, the presiding officer may issue a 
summary decision on any issue in the hearing if the presiding officer 
determines from the material submitted in connection with the hearing, 
or from matters officially noticed, that there is no genuine and 
substantial issue of fact respecting that issue. For the purpose of this 
paragraph, a hearing commences upon the receipt by FDA of a request for 
hearing submitted under Sec.  16.22(b).
    (c) The Commissioner or his or her delegate may review any summary 
decision of the presiding officer issued under paragraph (b) of this 
section at the request of a party or on the Commissioner's or his or her 
delegate's own initiative.

[53 FR 4615, Feb. 17, 1988, as amended at 69 FR 17290, Apr. 2, 2004]