[Federal Register Volume 61, Number 166 (Monday, August 26, 1996)]
[Notices]
[Pages 43770-43771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-21729]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Blood Donor Incentive Programs for Volunteer (Non-remunerated) 
Donors; Notice of Public Workshop

AGENCY: Food and Drug Administration, HHS

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) and the National Heart, 
Lung, and Blood Institute (NHLBI) of the National Institutes of Health 
are announcing a public workshop to discuss the use of donor

[[Page 43771]]

incentive programs to recruit donors of blood and blood products. The 
purpose of the workshop, sponsored by FDA and NHLBI, is to gather 
information regarding the use of blood donor incentive programs to 
motivate persons to become donors and the suitability of donors 
recruited by the incentives. The information gathered during the 
workshop will be useful to FDA and NHLBI in determining whether donor 
incentive programs could affect the safety and/or availability of 
blood.

DATES: The public workshop will be held on Wednesday, September 25, 
1996, from 8 a.m. to 4:30 p.m. Registration is requested by September 
18, 1996, and is recommended because seating is limited to 350. 
Registration at the site will be done on a space-available basis on the 
day of the workshop beginning at 7:30 a.m.

ADDRESSES: The public workshop will be held at the Holiday Inn 
Bethesda, 8120 Wisconsin Ave., Bethesda, MD.
FOR FURTHER INFORMATION CONTACT: Joseph Wilczek, Office of Blood 
Research and Review (HFM-350), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852, 301-827-3514.
    Those persons interested in attending this workshop should FAX 
their registration to 301-827-2843, including name, title, firm name, 
address, and telephone number. There is no registration fee for this 
workshop, but advance registration is requested. Interested parties are 
encouraged to register early because space is limited.

SUPPLEMENTARY INFORMATION: FDA is charged with overseeing the safety of 
the nation's blood supply. In 1978, FDA published labeling requirements 
for blood and blood products that were intended to reduce the risk of 
transfusion-associated hepatitis by establishing categories of paid and 
volunteer donors. Paid donor labeling did not include donor incentives 
such as lotteries, time off from work, novelties, and other similar 
incentives. Such incentives have been used with increasing frequency 
since the labeling requirements were published. Recent circumstances 
have raised concerns within the agency and prompted FDA to schedule 
this workshop. One concern is that some currently used incentives may 
lead to recruitment of donors whose blood is unsuitable for blood and 
plasma donation. FDA is concerned that some unsuitable donors, intent 
on receiving a particular incentive, may not be fully candid and 
truthful during predonation screening. In addition, there may be 
certain recruiting situations where unsuitable donors who are members 
of a recruited group may feel compelled or coerced to participate 
(donate) in support of the group initiative. Another general concern is 
the possibility that an increased level of competition for suitable 
donors may affect the safety of the blood supply. A goal of the 
workshop is to gather data and information on the positive and negative 
effects of donor incentive programs. Interested members of the public 
are invited to attend the workshop and to present their experiences 
with blood and plasma donor incentive programs. Discussion sessions 
allowing for questions and answers are planned for the following 
topics: (1) Current Definitions: Paid vs. Volunteer Blood Donors; (2) 
Paid Donations and Recruitment Practices; (3) Donor Motivational 
Factors-Volunteer/Autologous/Designated/Non-volunteer; (4) Public 
Health Risk/Benefits of Using Donor Incentives; and (5) Panel 
Discussions and Questions. Information presented at this workshop will 
assist FDA in determining whether further action may be appropriate.

    Dated: August 20, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-21729 Filed 8-21-96; 3:33 pm]
BILLING CODE 4160-01-F