[Federal Register Volume 63, Number 96 (Tuesday, May 19, 1998)]
[Notices]
[Page 27583]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13163]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


First Party Audit Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of industry exchange meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
industry exchange meeting to discuss with the regulated industry a new 
initiative being considered by the agency. The First Party Audit 
Program (FPAP) is intended to gather information from selected human 
use pharmaceutical manufacturers regarding their quality assurance 
measures. This information would be submitted to FDA by those firms and 
would substitute, in some measure, for information the agency would 
otherwise obtain from its direct inspectional activities. The industry 
exchange meeting is intended to present the broad concepts of this 
initiative, discuss attendant issues, and obtain feedback from all 
interested parties as to the merits of proceeding with the project. 
This meeting is cosponsored by the Center for Drug Evaluation and 
Research's (CDER's) Office of Compliance and the Office of the 
Commissioner's Industry Small Business and Community Affairs Staff.

DATES: The industry exchange meeting will be held on June 23, 1998, 
from 9 a.m. to 4 p.m. Registration is required by June 12, 1998.

ADDRESSES: The industry exchange meeting will be held at the Hyatt 
Regency Bethesda Hotel, One Bethesda Metro Center, Bethesda, MD.

FOR FURTHER INFORMATION CONTACT: C. Russ Rutledge, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2455.
    Those persons interested in attending this meeting should FAX or e-
mail their registration to C. Russ Rutledge (FAX 301-594-2202 or e-mail 
via the Internet at ``[email protected]''), including name of 
attendee(s), title, affiliation, mailing address, phone number, fax 
number, and e-mail address. There is no registration fee for this 
meeting, but advance registration is required. Interested parties are 
encouraged to register early because space is limited.

SUPPLEMENTARY INFORMATION: FDA relies in large part on information 
acquired during inspections of manufacturing facilities, conducted by 
the agency's investigators, to ensure that firms are meeting the 
minimum levels of product quality assurance for human drug products. 
Although the agency believes that full inspection by its investigators 
is the ideal situation, FDA is evaluating alternative methods of 
acquiring information it would otherwise directly obtain from 
traditional onsite inspections. One approach the agency is considering 
is the FPAP. The first party is the manufacturing firm itself. The 
concept is to limit program participation to those manufacturers FDA 
recognizes as having both a quality assurance program that is effective 
and a record of substantial compliance with FDA requirements. Program 
participation would be strictly voluntary. Firms the agency selects for 
the program would supply FDA with information from its self-audits 
apart from FDA onsite inspections. The agency would use this 
information along with modified inspections to document minimum levels 
of assurance of manufacturing quality of the pharmaceuticals produced 
in that site.
    FDA is holding this industry exchange meeting to present the core 
concepts of FPAP, discuss the relevant issues, and afford interested 
parties the opportunity to pose questions and provide comments. The 
agency will consider this public input in deciding on whether and how 
to proceed with the program, initially on a pilot basis.
    The agenda and any other relevant information will be available 
electronically via the Internet at ``http://www.fda.gov/cder/dmpq/
fpap.htm'' beginning Monday, May 18, 1998.

    Dated: May 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13163 Filed 5-18-98; 8:45 am]
BILLING CODE 4160-01-F