[Federal Register Volume 66, Number 214 (Monday, November 5, 2001)]
[Notices]
[Page 55944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27644]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Application of Nucleic Acid Testing to Blood Borne Pathogens and 
Emerging Technologies; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Application of Nucleic Acid Testing to Blood Borne 
Pathogens and Emerging Technologies.'' The purpose of the public 
workshop is to focus on issues surrounding the implementation of 
nucleic acid testing (NAT) to screen blood and plasma donors.
    Date and Time: The 2-day public workshop will be held on December 4 
and 5, 2001, from 8:30 a.m. to 5 p.m.
    Location: The public workshop will be held at the Lister Hill 
Center, National Institutes of Health, Bldg. 38A, 8600 Rockville Pike, 
Bethesda, MD.
    Contact: Joseph Wilczek, Center for Biologics Evaluation and 
Research (HFM-305), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-6129, FAX 301-827-2843, e-mail:
[email protected].
    Registration: Preregistration is not required. However, early 
registration is recommended because there are only 175 seats at the 
site. Registration at the site will be done on a space available basis 
on the days of the workshop, beginning at 7:30 a.m. Mail, e-mail, or 
fax your registration information (including name, title, firm name, 
address, telephone and fax number, and e-mail address) to the contact 
person on or before November 23, 2001. A registration form is available 
on the Internet at http://www.fda.gov/cber/scireg.htm. There is no 
registration fee. If you need special accommodations due to a 
disability, please contact Joseph Wilczek (address above) at least 7 
days in advance.
    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. The public workshop transcript will also be available on the 
Internet at 
http://www.fda.gov/cber/minutes/workshop-min.htm.

SUPPLEMENTARY INFORMATION: FDA is sponsoring a public workshop on 
issues surrounding the implementation of NAT for blood borne pathogens. 
These issues for testing blood and plasma donors include screening for 
human immunodeficiency virus, hepatitis C virus, hepatitis B virus, and 
testing manufacturing pools for hepatitis A virus and parvovirus B-19. 
The goals of the public workshop are to examine: (1) International 
developments and regulatory issues regarding the implementation of 
minipool and single unit NAT; (2) standardization and quality assurance 
of NAT methods; (3) industry experience with minipool NAT for donor 
screening and in-process plasma pools; (4) potential replacement of 
current viral marker tests by NAT; and (5) emerging issues in nucleic 
acid testing, including new pathogens and new screening technologies. 
Another goal of the workshop is to evaluate future directions in NAT 
for blood borne pathogens. The public workshop agenda is posted on the 
Internet at 
http://www.fda.gov/cber/scireg.htm.

    Dated: October 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-27644 Filed 11-2-01; 8:45 am]
BILLING CODE 4160-01-S