[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.206]

[Page 312]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 58_GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
--Table of Contents
 
            Subpart K_Disqualification of Testing Facilities
 
Sec. 58.206  Final order on disqualification.

    (a) If the Commissioner, after the regulatory hearing, or after the 
time for requesting a hearing expires without a request being made, upon 
an evaulation of the administrative record of the disqualification 
proceeding, makes the findings required in Sec. 58.202, he shall issue 
a final order disqualifying the facility. Such order shall include a 
statement of the basis for that determination. Upon issuing a final 
order, the Commissioner shall notify (with a copy of the order) the 
testing facility of the action.
    (b) If the Commissioner, after a regulatory hearing or after the 
time for requesting a hearing expires without a request being made, upon 
an evaluation of the administrative record of the disqualification 
proceeding, does not make the findings required in Sec. 58.202, he 
shall issue a final order terminating the disqualification proceeding. 
Such order shall include a statement of the basis for that 
determination. Upon issuing a final order the Commissioner shall notify 
the testing facility and provide a copy of the order.