[Federal Register Volume 72, Number 47 (Monday, March 12, 2007)]
[Notices]
[Page 11028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4313]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Immune Globulins for Primary Immune Deficiency Diseases: Antibody 
Specificity, Potency and Testing; 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: Immune Globulins for Primary Immune Deficiency 
Diseases: Antibody Specificity, Potency and Testing. The purpose of the 
public workshop is to discuss approaches to identify the most relevant 
antibody specificities in Immune Globulins for the prevention of 
infections in patients with primary immune deficiency diseases (PIDD), 
and current and potential potency tests for Immune Globulins. The 
public workshop will also include a discussion about the declining 
measles antibody levels in U.S. licensed Immune Globulins and the 
potential clinical impact on patients with PIDD. The public workshop 
sponsors are FDA, the Immune Deficiency Foundation, and the Plasma 
Protein Therapeutics Association.
    Date and Time: The public workshop will be held on April 25, 2007, 
from 8 a.m. to 5 p.m., and April 26, 2007, from 8:30 a.m. to 11:30 a.m.
    Location: The public workshop will be held at the Lister Hill 
Center Auditorium, Building 38A, National Institutes of Health, 8800 
Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and 
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6129, 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 6, 2007. There is no registration fee for the 
public workshop. Early registration is recommended because seating is 
limited. Registration on the day of the public workshop will be 
provided on a space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Rhonda Dawson at least 7 days in advance of the workshop.

SUPPLEMENTARY INFORMATION: The public workshop will feature 
presentations by national and international experts from government, 
academic institutions, and industry. The first day of the workshop will 
include discussions on: (1) Epidemiology of serious infections in PIDD 
patients; (2) review of European and U.S. PIDD registry data; (3) 
surveillance questions to address the type, rate, and severity of 
infections in PIDD patients; (4) rationale for current potency tests 
for Immune Globulins; (5) antibody levels in current Immune Globulins, 
including those levels to emerging pathogens; and (6) the development 
of additional or other useful potency tests. The second day of the 
workshop will focus on the potential clinical impact on PIDD patients 
of declining measles antibody levels in U.S. licensed Immune Globulins.
    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, rm. 6-30, 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 5, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-4313 Filed 3-9-07; 8:45 am]
BILLING CODE 4160-01-S