[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR108.10]

[Page 202]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 108_EMERGENCY PERMIT CONTROL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  108.10  Suspension and reinstatement of permit.

    (a) Whenever the Commissioner finds that a permit holder is not in 
compliance with the mandatory requirements and conditions established by 
the permit, he shall immediately suspend the permit and so inform the 
permit holder, with the reasons for the suspension.
    (b) Upon application for reinstatement of a permit, the Commissioner 
shall, within 10 working days, reinstate the permit if he finds that the 
person is in compliance with the mandatory requirements and conditions 
established by the permit or deny the application.
    (c) Any person whose permit has been suspended or whose application 
for reinstatement has been denied may request a hearing. The hearing 
shall be conducted by the Commissioner or his designee within 5 working 
days of receipt of the request at a location agreed upon by the objector 
and the Commissioner or, if an agreement cannot be reached, at a 
location designated by the Commissioner. The permit holder shall have 
the right to present witnesses on his own behalf and to cross-examine 
the Food and Drug Administration's witnesses.
    (d) Within 5 working days after the hearing, and based on the 
evidence presented at the hearing, the Commissioner shall determine 
whether the permit shall be reinstated and shall so inform the permit 
holder, with the reasons for his decision.
    (e) Denial of an application for reinstatement of a permit 
constitutes final agency action from which appeal lies to the courts. 
The Commisioner will not stay such denial pending court appeal except in 
unusual circumstances, but will participate in expediting any such 
appeal.