[Federal Register Volume 70, Number 45 (Wednesday, March 9, 2005)]
[Notices]
[Page 11679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-4634]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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: 
[email protected].
    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://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