[Federal Register: October 20, 2003 (Volume 68, Number 202)]
[Notices]
[Page 59942-59943]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20oc03-50]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: wilczek@cber.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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