[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]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Biotechnology Manufacturing Grassroots Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

-----------------------------------------------------------------------

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 
``[email protected]''.

[[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