[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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