[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