[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]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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