E6-13695. Molecular Methods in Immunohematology; 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 “Molecular Methods in Immunohematology.” The purpose of the public workshop is to gather and review current information on scientific developments that might enhance immunohematologic testing of blood donor or patient blood samples as part of pre-transfusion compatibility testing, or in determination and management of feto-maternal blood group incompatibilities.

Date and Time: The public workshop will be held on September 25, 2006, from 8:30 a.m. to 5 p.m., and September 26, 2006, from 8:30 a.m. to 2 p.m.

Location: The public workshop will be held at the Lister Hill Center Auditorium, bldg. 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: [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 September 15, 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 8:00 a.m.

If you need special accommodations due to a disability, please contact Rhonda Dawson (see Contact Person) 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 main goal of the workshop is to determine potential applications of molecular methods to improve safety in transfusion medicine by overcoming current limitations in the field of immunohematology, namely, the lack of reagent grade antibodies, both polyclonal and monoclonal; variability of reactivity of monoclonal antibodies as compared to polyclonal antibodies; and inherent limitations in the hemagglutination test. Topics to be discussed include the following: (1) Use of molecular methods in platelet and leukocyte typing, (2) use of phage display technology in place of routine hemagglutination tests, (3) potential advantages of using molecular methods in donor screening and patient typing, (4) use of molecular methods to resolve unusual serologic findings, (5) potential use of molecular methods in the manufacture of immunohematology reagents, and (6) current limitations in the use of molecular methods.

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: August 14, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.