[Federal Register Volume 63, Number 211 (Monday, November 2, 1998)]
[Notices]
[Pages 58744-58745]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29187]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Control of Pharmaceutical Production; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a series 
of three public meetings sponsored by the Office of Regulatory Affairs 
(ORA), Pacific Region, and participated in by representatives from the 
Center for Drug Evaluation and Research (CDER), ORA's Division of Field 
Science, and the Pacific Region. The topic to be discussed is out-of-
specification (OOS) laboratory test results, how to evaluate them and 
appropriate actions to take.

DATES:  The public meetings are scheduled as follows:
1. Monday, November 16, 1998, from 8:30 a.m. to 3:30 p.m., in Bellevue, 
WA.

[[Page 58745]]

2. Wednesday, November 18, 1998, from 8:30 a.m. to 3:30 p.m., in 
Irvine, CA.
3. Friday, November 20, 1998, from 8:30 a.m. to 3:30 p.m., in Oakland, 
CA.
ADDRESSES: The public meetings will be held at the following locations:
    Bellevue--Rockwell Institute, 13218 NE. 20th St., Bellevue, WA 
98005.
    Irvine--Los Angeles District Office, 19900 MacArthur Blvd., suite 
300, Irvine, CA 92715.
    Oakland--Roybal Auditorium, Oakland Federal Bldg., 1301 Clay St., 
Third Floor Conference Center, Oakland, CA 94612.
FOR FURTHER INFORMATION CONTACT:
    Regarding meeting content and format: Mark S. Roh, Small Business 
Representative, Pacific Region, Food and Drug Administration, Oakland 
Federal Bldg., 1301 Clay St., suite 1180N, Oakland, CA 94612, 510-637-
3980, FAX 510-637-3977.
    Regarding the Bellevue, WA, meeting: Jaimee Hansen, Registration 
Coordinator, Organization of Regulatory and Clinical Associates (ORCA), 
P.O. Box 3490, Redmond, WA 98073, 425-487-7179, FAX 425-487-8666.
    Regarding the Irvine, CA, meeting: Judy Keast, Food and Drug 
Administration, Oakland Federal Bldg., 1301 Clay St., suite 1180N, 
Oakland, CA 94612, 510-637-3960, FAX 510-637-3976.
    Regarding the Oakland, CA, meeting: Judy Keast (address above).
    Those persons interested in attending the Bellevue, WA, meeting 
should register by faxing their name(s), title, firm name, address, 
telephone, and fax number to Jaimee Hansen (fax number above). This 
meeting is being conducted in cooperation with a local nonprofit 
organization, ORCA. There is limited seating, so early registration is 
encouraged. A registration fee of $45.00 to cover the cost of the 
facilities for this meeting should be paid to ORCA. Arrangements for 
payment should be made directly with Ms. Hansen.
    Those persons interested in attending the Irvine and/or Oakland, 
CA, meetings should register by faxing their name(s), title, firm name, 
address, telephone, and fax number; and date and location of the 
meeting to Judy Keast (fax number above). There is no registration fee 
for the Irvine and Oakland meetings. However, seating is limited, so 
early registration is encouraged.
    If you need special accommodations due to a disability, please 
contact Ms. Hansen (Bellevue meeting) or Ms. Keast (Irvine and Oakland 
meetings) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: The purpose of these meetings is to continue 
the dialogue, begun in 1996, with members of trade, technical, and 
professional organizations, and other interested persons on issues 
associated with pharmaceutical laboratory practices and procedures. The 
information presented at these meetings will also be appropriate and 
useful for other industries performing laboratory analysis, including 
private laboratories and manufacturers of in vitro products.
    On November 20, 1996, FDA held a public meeting to informally 
address and outline ways to discuss problems associated with the 
development and monitoring of products. The meeting explored issues of 
concern to the agency and industry laboratories. As a result of the 
meeting, industry members asked FDA to provide guidance in two control 
aspects of pharmaceutical production: (1) Evaluating OOS test results, 
and (2) system suitability requirements in measuring performance of a 
chromatographic system.
    Interested persons who are unable to attend these meetings may 
submit comments on this topic as well as suggest additional laboratory 
training issues of interest to FDA regulated industry for future 
dialogue. Submit written comments to Mark Roh (address above).

    Dated: October 26, 1998.

William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-29187 Filed 10-30-98; 8:45 am]
BILLING CODE 4160-01-F