[Federal Register: August 6, 1998 (Volume 63, Number 151)] [Notices] [Page 42052-42053] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr06au98-64] ----------------------------------------------------------------------- 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 ``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