[Federal Register Volume 68, Number 202 (Monday, October 20, 2003)]
[Notices]
[Pages 59942-59943]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Factor VIII Inhibitors; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Factor VIII Inhibitors.'' The purpose of the public 
workshop is to provide a forum for addressing

[[Page 59943]]

regulatory and scientific concerns about inhibitors to Factor VIII, one 
of the components of blood necessary for clotting, with regard to 
inhibitor antibodies in Factor VIII products.
    Date and Time: The workshop will be held on November 21, 2003, from 
8 a.m. to 5 p.m.
    Location: The workshop will be held at Lister Hill Auditorium, 
Bldg. 38A, National Institutes of Health, 8600 Rockville Pike, 
Bethesda, MD 20894.
    Contact Person: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX: 301-827-2843, e-mail: 
[email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number) to the contact person by 
November 7, 2003. Early registration is recommended because seating is 
limited to 176 participants. Registration will be done on a space 
available basis on the day of the workshop, beginning at 7:15 a.m. 
There is no registration fee.
    If you need special accommodations due to a disability, please 
contact Joseph Wilczek (see Contact Person) 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 working days after the meeting at a cost of 10 cents 
per page. In addition, the transcript will be placed on the FDA Web 
site at http://www.fda.gov/cber/minutes/workshop-min.htm.

SUPPLEMENTARY INFORMATION: FDA and the International Association for 
Biologicals (IABs) are co-sponsoring a public workshop on regulatory 
and scientific concerns pertaining to the potential immunogenicity of 
Factor VIII products. The purpose of the workshop is to provide a forum 
for discussion of the inhibitor phenomenon with respect to currently 
available products and products that are under development by various 
sponsors. National and international regulatory authorities, 
manufacturers, clinicians, and academics will discuss their experiences 
with this issue regarding preclinical testing requirements, the results 
of clinical trials, and post-marketing surveillance. Other issues to be 
discussed at the workshop include properties of Factor VIII inhibitor 
assays, epidemiological aspects of inhibitor formation, and the design 
of prospective clinical studies. The public workshop agenda is posted 
on the FDA Internet at http://www.fda.gov/cber/meetings/fctrviii112103.htm.

    Dated: October 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26386 Filed 10-17-03; 8:45 am]
BILLING CODE 4160-01-S