[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: 21CFR58.206]
[Page 314-315]
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
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
[[Page 315]]
shall notify the testing facility and provide a copy of the order.
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