[Federal Register: June 25, 1999 (Volume 64, Number 122)]
[Notices]               
[Page 34260-34261]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn99-72]                         

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

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.

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

    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