[Federal Register Volume 64, Number 225 (Tuesday, November 23, 1999)]
[Notices]
[Pages 65714-65715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30524]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Workshop on Implementation of Nucleic Acid Testing; Public 
Workshop

Agency: Food and Drug Administration, HHS.

Action: Notice.

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

    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Implementation of Nucleic Acid Testing.'' The 
purpose of the public workshop is to discuss the progress in 
implementation of nucleic acid testing for screening blood and plasma 
donors.

    Date and Time: The public workshop will be held on December 14, 
1999, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the National 
Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium, 
9000 Rockville Pike, Bethesda, MD 20892.
    Contacts:
    For information regarding this notice: Joseph Wilczek, Center for 
Biologics Evaluation and Research (HFM-350), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6129, FAX 301-827-2843.
    For information regarding registration: Jennifer Gormley, Laurel 
Consulting Group, 1815 Fort Meyer Dr., suite 300, Arlington, VA 22209, 
703-351-7676, FAX: 703-528-0716, e-mail: [email protected].
    Registration: Early registration is recommended on or before 
Friday, November 26, 1999. Mail or fax registration information 
(including name, title, firm name, address, telephone, and fax number) 
to Jennifer Gormley (address above). Registration at the site will be 
on a space available basis on the day of the workshop, beginning at 
7:30 a.m. There is no registration fee for the workshop. If you need 
special accommodations due to a disability, please contact Jennifer 
Gormley at least 7 days in advance.
    Agenda: FDA is holding a public workshop to evaluate progress in 
the implementation of nucleic acid testing (NAT) for screening blood 
and plasma donors. The goals of the public workshop are to: (1) Examine 
technological advances and current experience with testing plasma pools 
for hepatitis C virus (HCV), hepatitis B virus (HBV) and human 
immunodeficiency virus (HIV); (2) discuss issues in the implementation 
of NAT; (3) evaluate the application of NAT to other transmitted 
viruses; and (4) monitor progress towards single donation testing. The 
scientific information obtained from these discussions will provide FDA 
with a better understanding of the utility of nucleic acid testing of 
plasma pools in reducing the residual risk of infectious disease 
transmission from window period donations. In addition, FDA will be 
able to evaluate progress towards single unit testing by NAT for future 
implementation in screening blood and plasma donors.
    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 meeting at a cost of 10 cents 
per page. In addition, the transcript will be placed on the FDA web 
site at www.fda.gov/cber/minutes/workshop-min.htm.


[[Page 65715]]


    Dated: November 17, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-30524 Filed 11-22-99; 8:45 am]
BILLING CODE 4160-01-F