[Federal Register: November 5, 2001 (Volume 66, Number 214)]
[Notices]
[Page 55944]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no01-58]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
wilczek@cber.fda.gov.
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