[Federal Register: March 9, 2005 (Volume 70, Number 45)]
[Notices]
[Page 11679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09mr05-92]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Intravenous Immune Globulins in the 21st Century: Progress and
Challenges in Efficacy, Safety, and Paths to Licensure; 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: ``Intravenous Immune Globulins in the 21st Century:
Progress and Challenges in Efficacy, Safety, and Paths to Licensure.''
The purpose of the workshop is to address current topics on the safety
and efficacy of immune globulin products.
Date and Time: The workshop will be held on April 13, 2005, from 8
a.m. to 5:30 p.m.
Location: The workshop will be held at the Lister Hill Auditorium,
Bldg. 38A, National Institutes of Health, 8600 Rockville Pike,
Bethesda, MD 20894.
Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-827-3514, FAX: 301-827-2843, e-mail:
dawsonr@cber.fda.gov.
Registration: Mail or fax your registration information (including
name, title, firm name, address, telephone, and fax numbers) to the
contact person by April 1, 2005. There is no registration fee for the
public workshop. Because seating is limited, we recommend early
registration. Registration on the day of the public workshop will be
provided on a space available basis beginning at 7:15 a.m.
If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.
SUPPLEMENTARY INFORMATION: FDA, in cooperation with the Primary Immune
Deficiency Foundation, is announcing the following public workshop:
``Intravenous Immune Globulins in the 21st Century: Progress and
Challenges in Efficacy, Safety, and Paths to Licensure.'' The 1-day
workshop, consisting of three successive sessions, will discuss the
following topics:
Specific antibody levels in intravenous immune globulins
(IGIVs) to common and emerging pathogens, including research questions
concerning antibody levels and efficacy;
Adverse events, including specific categories of adverse
events, as well as current methods of surveillance, responses to
adverse event information, and the utility of different monitoring
strategies; and
Paradigms for IGIV and subcutaneous immune globulin
licensure for treatment of Primary Immune Deficiency.
Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, approximately
15 working days after the public workshop at a cost of 10 cents per
page.
A transcript of the public workshop will be available on the
Internet 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.
Dated: March 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4634 Filed 3-8-05; 8:45 am]
BILLING CODE 4160-01-S