[Federal Register Volume 64, Number 122 (Friday, June 25, 1999)]
[Notices]
[Pages 34260-34261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Blood Donor Suitability Workshop: Donor History of Hepatitis
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Blood Donor Suitability Workshop: Donor
History of Hepatitis.'' The purpose of the workshop is to discuss
whether prospective blood donors with a history of viral hepatitis
should be deferred from donating blood.
Date and Time: The workshop will be held on Wednesday, July 21,
1999, 8:30 a.m. to 5 p.m.
Location: The workshop will be held at Natcher Auditorium, Bldg.
45, 45 Center Dr., National Institutes of Health, 8800 Rockville Pike,
Bethesda, MD.
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: Early registration is recommended. Mail or fax
registration information (including name, title, firm name, address,
telephone, and fax number), to the contact person on or before Friday,
July 2, 1999.
Registration at the site will be 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.
If you need special accommodations due to disability, please
contact Joseph Wilczek at least 7 days in advance.
Agenda: The public workshop is intended to discuss a variety of
issues concerning blood donor deferrals based on a history of viral
hepatitis. These issues include, but are not limited to, the following:
(1) Definitions and clarification of terms such as ``history of
hepatitis'' and ``history of jaundice'' in the context of blood
donation; (2) whether a prospective blood donor with a history of
hepatitis A, who is anti-HAV IgG positive, is an unacceptable donor;
(3) whether deferrals are appropriate for individuals with a
[[Page 34261]]
history of viral hepatitis that was documented to be due to some other
virus other than hepatitis A through G; and (4) whether a history of
hepatitis in the absence of positive viral marker tests for hepatitis
preclude blood donations.
Transcripts: Transcripts of the 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 days after the workshop at a cost of 10 cents per
page. The workshop transcript will also be available on the Center for
Biologics Evaluation and Research website at ``http://www.fda.gov/cber/
minutes/workshop-min.htm''.
Dated: June 18, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-16147 Filed 6-24-99; 8:45 am]
BILLING CODE 4160-01-F
