[Federal Register Volume 71, Number 161 (Monday, August 21, 2006)]
[Notices]
[Page 48551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-13695]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0320]


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: 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 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.
[FR Doc. E6-13695 Filed 8-18-06; 8:45 am]
BILLING CODE 4160-01-S