[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: 21CFR58.213]



[Page 313-314]

 

                        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.  58.213  Public disclosure of information regarding disqualification.



    (a) Upon issuance of a final order disqualifying a testing facility 

under Sec.  58.206(a), the Commissioner may notify all or any interested 

persons. Such notice may be given at the discretion of the Commissioner 

whenever he believes that such disclosure would further the public 

interest or would promote compliance with the good laboratory practice 

regulations set forth in this part. Such notice, if given, shall include 

a copy of the final order issued under Sec.  58.206(a) and shall state 

that the disqualification constitutes a determination by the Food and 

Drug Administration that nonclinical laboratory studies performed by the 

facility will not be considered by the Food and Drug Administration in 

support of any application for a research or marketing permit. If such 

notice is sent to another Federal Government agency, the



[[Page 314]]



Food and Drug Administration will recommend that the agency also 

consider whether or not it should accept nonclinical laboratory studies 

performed by the testing facility. If such notice is sent to any other 

person, it shall state that it is given because of the relationship 

between the testing facility and the person being notified and that the 

Food and Drug Administration is not advising or recommending that any 

action be taken by the person notified.

    (b) A determination that a testing facility has been disqualified 

and the administrative record regarding such determination are 

disclosable to the public under part 20 of this chapter.