[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
