Meetings: Human drug products quality assurance; first party audit program,

[Federal Register: May 19, 1998 (Volume 63, Number 96)]

[Notices]

[Page 27583]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr19my98-89]

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.

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 ``rutledgec@cder.fda.gov''), 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. 98-13163Filed5-18-98; 8:45 am]

BILLING CODE 4160-01-F