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: 21CFR58.10]
[Page 311]
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 A--General Provisions
Sec. 58.10 Applicability to studies performed under grants and contracts.
When a sponsor conducting a nonclinical laboratory study intended to
be submitted to or reviewed by the Food and Drug Administration utilizes
the services of a consulting laboratory, contractor, or grantee to
perform an analysis or other service, it shall notify the consulting
laboratory, contractor, or grantee that the service is part of a
nonclinical laboratory study that must be conducted in compliance with
the provisions of this part.