This electronic document was downloaded from the GPO web site, September 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.206]
[Page 320]
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.