Food and Drug Administration - February 13, 2006
Richard Klein

Donor deferrals based on geographical, medical and behavioral factors associated with an increased risk for exposure to transfusion transmissible infectious diseases are a first line of defense against introducing newly emerging infectious agents into the blood supply. As tests are developed to detect evidence of infection with such agents, behavioral and other risk-based deferrals are generally retained, to provide additional protection, particularly for imperfect tests and imperfect inventory management. As more advanced tests become available, particularly the highly sensitive and specific NAT tests capable of directly detecting infectious agents in blood at very early stages during infection, a question arises whether specific risk factor based deferrals should be modified or even eliminated. In the case of behavior-based criteria, retention of the deferrals has raised concerns of a social as well as a scientific nature.

To enable FDA to assess the value of current behavior-based donor deferrals in this era of NAT testing for certain infectious agents and to consider the scientific basis for the retention or potential modification or elimination of those deferrals, FDA will attempt to bring timely data and current thinking to bear on several key issues.

The public workshop will feature presentations by national and international experts from government and academic institutions and industry. Discussions will include:

•     Current practices in the United States and abroad regarding blood donor deferrals based on high-risk behavior,
•     Comparison of selected tissue donor deferral policies to blood donor deferral policies,
•     Behavioral risks for transfusion-transmitted diseases,
•     Residual risks of infection from transfusion, and Potential alternative approaches to donor screening and testing

The workshop will be held on March 8, 2006, from 8 a.m. to 5:30 p.m. at the National Institutes of Health, Lister Hill Auditorium, NIH Building 38A, 8600 Rockville Pike, Bethesda, MD 20894.

Registration

There is no registration fee for this meeting; however, seating space is limited to 176 attendees and early registration is recommended on or before February 17, 2006. On-site registration will be limited to space available on the day of the workshop beginning at 7:30 a.m.

Please mail, fax, or e-mail your registration information (including name, title, firm name, address, and telephone and fax numbers) or use the registration form in this announcement and mail, fax or e-mail it to Rhonda Dawson, Food and Drug Administration, HFM-302, 1401 Rockville Pike, Rockville, MD 20852; Fax: 301-827-2843; E-mail: rhonda.dawson@fda.hhs.gov

If you need special accommodations due to a disability, please contact Rhonda Dawson at least 7 days in advance.

Regardless of attendance at the public workshop, interested persons may submit written or electronic comments regarding the public workshop to the Division of Dockets Management . Submit electronic comments to http://www.fda.gov/dockets/ecomments. Please submit two paper copies of any mailed comments, except that individuals may submit one paper copy, to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with "docket number 2006N-0045." Written or electronic comments may be submitted until May 8, 2006.

A transcript of the public workshop will be posted, when available, on the FDA web site at http://www.fda.gov/cber/minutes/workshop-min.htm

Please note - Under current security measures, non-National Institutes of Health employees can gain access to the NIH campus by private car at only two locations:

(1) NIH's South Drive, where it intersects Rockville Pike; and
(2) NIH's Center Drive, where it intersects Old Georgetown Road.
At these sites, cars will be inspected, and drivers and passengers must show picture IDs in order to receive NIH visitor passes. Limited visitor pay parking is available along Center Drive, in lots adjoining Building 38A (Lister Hill Center) and Building 45 (Natcher).

Access to NIH by the Metro (subway stop is Medical Center, on the Red Line) is highly recommended.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

060213
FD060202

SOURCE: Food and Drug Administration (FDA).

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