[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR58.206]



[Page 313]

 

                        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.