[Federal Register Volume 63, Number 222 (Wednesday, November 18, 1998)]
[Notices]
[Page 64092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30751]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pilot Program for Streamlining Licensure of Blood and Blood 
Components; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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     The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Pilot Program for Streamlining Licensure of Blood 
and Blood Components.'' At the workshop, FDA will describe a pilot 
program that is under development and solicit input from blood and 
blood component manufacturers about streamlining the licensure review 
process.

    Date and Time: The workshop will be held on Wednesday, December 9, 
1998, 8:30 a.m. to 4:30 p.m.
    Location: The workshop will be held at the Doubletree Hotel, 1750 
Rockville Pike, Rockville, MD.
    Contact: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-350), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, or Cody Bridges, Laurel 
Consulting Group, 3030 Clarendon Blvd., suite 240, Arlington, VA 22201, 
703-351-7676, FAX 703-528-0716, or email ``[email protected]''.
    Registration: Send or fax registration information (including name, 
title, firm name, address, telephone, and fax number) to Cody Bridges 
by Friday, November 27, 1998. Registration at the site will be done on 
a space available basis on the day of the workshop beginning at 7:30 
a.m. There is no registration fee for the workshop.
    If you need special accommodations due to a disability, please 
contact Cody Bridges at least 7 days in advance.
    Transcripts: Transcripts of the workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 days after the workshop at a cost of 10 cents per 
page. The workshop transcript will also be available on CBER's website 
at ``http://www.fda.gov/cber/minutes/workshop-min.htm''.
    Supplementary Information: FDA will sponsor a 1-day workshop to 
provide guidance to blood and blood component manufacturers on how to 
certify that they are in compliance with pilot monographs in lieu of 
traditional blood applications and supplements. Two pilot monographs to 
be discussed at the workshop apply to irradiation of blood and blood 
components and red blood cell immunization programs.
    The objectives of the workshop are to describe FDA's pilot program 
and to solicit input from blood and blood component manufacturers about 
streamlining the licensure review process for certain blood products.

    Dated: November 10, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-30751 Filed 11-17-98; 8:45 am]
BILLING CODE 4160-01-F