[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
