FDA Notifications

FDA will hold public workshop on NAT on March 8 at NIH

The Food and Drug Administration will be conducting a public workshop entitled "Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing [NAT)."

The workshop will provide an opportunity for public discussion on the scientific basis for behavior-based donor deferral criteria, and the value of their continued use now that nucleic acid based tests (NAT) are available for certain transfusion-transmissible agents.

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 the 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, the 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.

There is no registration fee for this meeting; however, seating space is limited to 176 attendees and early registration is recommended on or before Feb. 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.