[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
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
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]
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