[Federal Register Volume 62, Number 162 (Thursday, August 21, 1997)]
[Notices]
[Page 44478]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22267]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Grass Roots Biotechnology Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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    The Food and Drug Administration (FDA) is announcing the following 
meeting: Grass Roots Biotechnology Meeting. The topics to be discussed 
are product classification (Biologic/Device/Drug/Food), the preapproval 
inspection process, the inspectional environment after product 
approval, and overall communications with the field offices. This 
meeting, which is cosponsored by FDA's Office of External Affairs and 
the New England District, Northeast Region; the Massachusetts 
Biotechnology Council; and the Biotechnology Association of Maine, is 
being held to promote the President's initiative for a partnership 
approach between frontline regulators and the people affected by the 
work of the agency.

    Date and Time: The meeting will be held on Tuesday, September 23, 
1997 (8 a.m. to 8:30 a.m. registration), 8:30 a.m. to 4 p.m.
    Location: The meeting will be held at Ramada Hotel, 15 Middlesex 
Canal Park, Woburn, MA, 617-279-1675.

    Contact: Donald J. Johnson, Special Assistant to the District 
Director, New England District Office, Northeast Region, Food and Drug 
Administration (HFR-NE 252), Food and Drug Administration, One Montvale 
Ave., Stoneham, MA 02180, 617-279-1675, ext. 129, FAX 617-279-1733.

    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to Janice T. Bourque, 
Executive Director, Massachusetts Biotechnology Council, 245 First St., 
14th Fl., Cambridge, MA 02142, 617-577-8198. Because attendance is 
limited to 100, preregistration is recommended. However, there is no 
cutoff date for registration.

    If you need special accommodations due to a disability, please 
contact Donald J. Johnson at least 7 days in advance.

    Supplementary Information: This meeting will feature a general 
session at which Federal regulations and procedures will be discussed, 
followed by four morning breakout sessions to identify problems or 
concerns in the topical areas, and four afternoon breakout sessions to 
recommend solutions to the problems or concerns identified previously.
    A summary of the meeting will be provided to all registered 
participants. However, the public may request a summary of the meeting 
in writing from the Freedom of Information Office (HFI-35), Food and 
Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 
20857.

    Dated: August 15, 1997.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 97-22267 Filed 8-20-97; 8:45 am]
BILLING CODE 4160-01-F