E6-7854. Testing for Malarial Infections in Blood Donors; 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: Testing for Malarial Infections in Blood Donors. The purpose of the public workshop is to gather and review current information on scientific developments that might support donor testing for malarial infections as a part of predonation screening, or alternatively, followup testing in deferred at-malaria-risk-donors to permit a reduced deferral period.

Date and Time: The public workshop will be held on July 12, 2006, from 7:30 a.m. to 5:30 p.m.

Location: The public workshop will be held at the Natcher Conference Center, National Institutes of Health, 45 Center Dr., rm. E1/E2, Bethesda, MD 20892.

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: [phone], e-mail: [e-mail].

Registration: Mail or fax your registration information (including name, title, firm name, address, telephone and fax numbers) to the contact person by June 23, 2006. 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 7:15 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:

The public workshop will feature presentations by national and international experts from government, academic institutions, and industry. Topics to be discussed include: (1) The impact of transfusion-transmitted malaria on the United States' blood supply, (2) current donor deferral policies in the United States and in Europe, (3) available and emerging technologies that could be used to test blood donors for malarial infections, and (4) the potential effects of donor testing for malarial infection on the safety and availability of the blood supply.

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. 12A-16, 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: May 15, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.