[Federal Register Volume 61, Number 16 (Wednesday, January 24, 1996)]
[Notices]
[Page 1939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-940]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95D-0166]


Quality Assurance Program Audits and Inspections; Compliance 
Policy Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a revised Compliance Policy Guide (CPG) 7151.02 
entitled ``FDA Access to Results of Quality Assurance Program Audits 
and Inspections.'' This revised CPG provides general policy and 
guidance to FDA field and headquarters staff (engaged in the inspection 
and investigation of any regulated entity) regarding routine access to 
review reports or copying of records that result from the entity's 
audits and inspections of a written quality assurance program.

ADDRESSES: CPG 7151.02 is available for public examination in the 
Dockets Management Branch (HFA-305), Food and Drug Administration, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 
p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Tom M. Chin, Office of Enforcement 
(HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-0410.

SUPPLEMENTARY INFORMATION: FDA has revised CPG 7151.02 entitled ``FDA 
Access to Results of Quality Assurance Program Audits and 
Inspections.'' This CPG was revised to provide general policy and 
clearer guidance to FDA field and headquarters staff (engaged in the 
inspection and investigation of any regulated entity) regarding routine 
access to review reports or copying of records that result from the 
entity's audits and inspections of a written quality assurance program.
    The statements made in CPG 7151.02 are not intended to bind the 
courts, the public, or FDA, or to create or confer any rights, 
privileges, immunities, or benefits on or for any private person, but 
are intended merely for internal FDA guidance.

    Dated: January 3, 1996.
Gary Dykstra
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 96-940 Filed 1-23-96; 8:45 am]
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