[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Pages 42052-42053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Biotechnology Manufacturing Grassroots Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meeting.
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SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Pacific Region, and the Center for Biologics Evaluation
and Research (CBER), is announcing the following meeting: Biotechnology
Manufacturing Grassroots Meeting. The topic to be discussed is
mechanisms and processes through which the agency could potentially
increase operational efficiency in relation to both the pre- and post-
approval inspection process; improve communication and cooperation
among CBER, FDA field offices, and industry representatives associated
with biotechnology manufacturing processes; and improve levels of
consumer protection.
DATES: The meeting will be held on Tuesday, September 15, 1998, from
8:30 a.m. to 3:30 p.m.
ADDRESSES: The meeting will be held at the Los Angeles District Office,
Food and Drug Administration, 19900 MacArthur Blvd., suite 300, Irvine,
CA 92715.
FOR FURTHER INFORMATION CONTACT: Mark Roh (HFR-PA17), Pacific Regional
Office, Food and Drug Administration, 1301 Clay St., suite 1180-N,
Oakland, CA 94612, 510-637-3980, fax 510-637-3977, e-mail
mroh@ora.fda.gov''.
[[Page 42053]]
REGISTRATION: Send registration information (including name, title,
firm name, address, telephone, and fax number), via fax or e-mail to
the contact person by Friday, September 4, 1998.
If you need special accommodations due to a disability, please
contact the contact person at least 7 days in advance.
SUPPLEMENTARY INFORMATION: Manufacturers in the Pacific Region, who
employ biotechnology in the production of FDA regulated products will
be able to identify and evaluate opportunities for implementing a
partnership approach with FDA. In the Federal Register of April 20,
1995 (60 FR 19753), FDA announced that a series of Grassroots
Regulatory Partnerships Meetings would be held to further the
President's initiative. FDA's goal at this meeting is to ``listen'' to
concerns and ideas of the biotechnology industry, and to identify next
steps for the agency.
There is no registration fee for this meeting. However,
registration is required. Early registration is recommended because of
space limitations and the need to send information about the meeting
format to each registrant. You will be asked to identify the subject
area breakout session in which you prefer to participate. To permit the
greatest number of firms to attend, each company registering for this
meeting should send no more than two representatives.
Dated: July 29, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-20955 Filed 8-5-98; 8:45 am]
BILLING CODE 4160-01-F
