97-9529. Release of Establishment Inspection Report to the Inspected Establishment

[Federal Register Volume 62, Number 71 (Monday, April 14, 1997)]
[Notices]
[Page 18138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-9529]



[[Page 18138]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Release of Establishment Inspection Report to the Inspected 
Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is revising its policy regarding the release of the Establishment 
Inspection Report (EIR) to inspected establishments. Effective April 1, 
1997, a copy of the narrative portion of the EIR will be routinely 
provided to the inspected establishment once the agency determines that 
the inspection is ``closed'' as set forth in the regulations.

FOR FURTHER INFORMATION CONTACT: Charles I. Ahn, Office of Regulatory 
Affairs (HFC-132), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-5637.

SUPPLEMENTARY INFORMATION: Under the Freedom of Information Act (FOIA) 
and FDA's regulations governing disclosures as set out in part 20 (21 
CFR part 20), inspectional information, including the list of 
inspectional observations (FDA-483), EIR, and the agency's 
communication with the regulated establishment, must be disclosed upon 
request by any member of the public unless exempt. When requested 
according to established FOI procedures, the agency has made the 
inspection-related information available to requestors in accordance 
with the above statutory and regulatory requirements. That is, the 
information becomes releasable once the inspection is deemed closed by 
the agency. Establishments wishing to obtain a copy of FDA's inspection 
report of their own establishment have been required to follow the same 
procedure. A number of industry associations have expressed concern 
that copies of EIR's may be released to other requestors before the 
inspected establishments receive the copies they requested. 
Consequently, these groups have approached the agency to request that 
it provide a copy of the EIR following an inspection of their 
facilities.
    The agency has considered this request and determined that a copy 
of the narrative portion of the EIR should be routinely provided to the 
inspected establishment once the agency concludes that the inspection 
is closed. For the purpose of this directive, the term ``closed'' will 
have the same meaning as it has under Sec.  20.64(d)(3).

    Dated: April 7, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-9529 Filed 4-11-97; 8:45 am]
BILLING CODE 4160-01-F