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: 21CFR58.213]
[Page 321]
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 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.