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Immune Globulins for Primary Immune Deficiency Diseases: Antibody Specificity, Potency and Testing; Public Workshop

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

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: rhonda.dawson@fda.hhs.gov.

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.

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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.

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Dated: March 5, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-4313 Filed 3-9-07; 8:45 am]

BILLING CODE 4160-01-S