[Federal Register Volume 63, Number 137 (Friday, July 17, 1998)]
[Notices]
[Page 38658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19110]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nucleic Acid Testing for Hepatitis C Virus (HCV) and Other
Viruses in Blood Donors; Public Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing the following
public workshop: Nucleic Acid Testing for Hepatitis C Virus (HCV) and
Other Viruses in Blood Donors. The topic to be discussed is the
exploration of the current state of technology and implementation of
nucleic acid testing for screening blood donors.
Date and Time: The workshop will be held on Wednesday, September
16, 1998, 8:30 a.m. to 5 p.m.
Location: The workshop will be held at the Parklawn Bldg., 3d
floor, conference rooms D and E, 5600 Fishers Lane, Rockville, MD
20857.
Contact: 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.
Registration: Mail or fax registration information (including name,
title, firm name, address, telephone, and fax number) to the contact
person by Friday, September 4, 1998. Registration at the site will done
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. Space is
limited, therefore interested parties are encouraged to register early.
If you need special accommodations due to a disability, please
contact Joseph Wilczek at least 7 days in advance.
Agenda: The public workshop is intended to discuss nucleic acid
testing that currently is the most sensitive method available to
further reduce disease transmission by blood transfusion in the early
window phase of infection. Nucleic acid testing is being implemented
for blood donor screening by testing plasma pools, and pool testing may
be useful by serving as an interim measure until screening of
individual blood donations is technologically feasible.
Regulatory and scientific topics to be discussed at the workshop
include donor testing issues, pooling strategies, and test validation
and reference materials for standardization of various nucleic acid
technologies.
Transcripts: Transcripts of the meeting 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.
Dated: July 9, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19110 Filed 7-16-98; 8:45 am]
BILLING CODE 4160-01-F
