[Federal Register Volume 61, Number 197 (Wednesday, October 9, 1996)] [Notices] [Pages 52950-52951] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-26040] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES International Conference on the Virological Safety of Plasma Derivatives; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), is announcing a public meeting that will address the risks posed by blood-borne viruses that persist in human plasma-derived products. CBER is sponsoring the meeting with the National Heart, Lung, and Blood Institute of the National Institutes of Health, the Centers for Disease Control and Prevention, The World Health Organization, and the International Association of Biological Standards. The goals of the meeting include assessing the virological safety of currently available plasma-derived products and gathering information useful in the evaluation of such products. DATES: The meeting will be held on November 20, 21, and 22, 1996, from 8:30 a.m. to 5 p.m. Preregistration is requested by November 8, 1996. Registration at the site will be done on a space-available basis on each day of the public meeting beginning at 8 a.m. ADDRESSES: The public meeting will be held at the National Institutes of Health, Natcher Conference Center, Main Auditorium, Bldg. 45, 9000 Rockville Pike, Bethesda, MD. FOR FURTHER INFORMATION CONTACT: For information concerning the meeting: Thomas J. Lynch, Center for Biologics Evaluation and Research (HFM-340), Food and Drug Administration, 8800 Rockville Pike, rm. 311, Bethesda, MD 20892-001, 301-496-6890. For information concerning registration and agenda for the meeting: Viral Safety '96, KRA Corp., 1010 Wayne Ave., Silver Spring, MD 20910, 301-495-1591. Fax registration to 301-443-9410, including name, title, firm name, address, and telephone number. There is no registration fee for this meeting, but advance registration is recommended because seating is limited to about 700. SUPPLEMENTARY INFORMATION: FDA has the responsibility for helping to ensure that plasma derivatives pose as little risk as possible to those who depend on them. The safety of plasma-derived therapeutic proteins is also an important global public health issue. Recently, considerable progress has been made in developing improved methods for screening plasma derivatives for the presence of viruses. Advances made in detecting viruses have been accompanied by improvements in viral inactivation and removal procedures. Nevertheless, current risks of transmitting blood-borne viruses through the use of products derived from human plasma have not been fully eliminated, and there are concerns about future, unknown risks. The goal of this meeting is to exchange views and information regarding the present and future safety of these products. To achieve this goal interested members of the medical, research, industry, regulatory, and patient communities are invited to attend the meeting to hear an international group of experts present their experiences and recommendations concerning the virological safety of plasma derivatives. Topics to be covered include: Virology and epidemiology, testing for viral markers, developments in viral detection, techniques and validation of viral inactivation and removal, manufacturing practices and safeguards, validation of viral safety, nonenveloped viruses, transmissible spongiform encephalopathies, and surveillance and response. Information presented at this meeting will assist the sponsoring and participating public health agencies to evaluate the current virological safety of plasma derivatives and to determine what future action may be appropriate. [[Page 52951]] Dated: October 3, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 96-26040 Filed 10-8-96; 8:45 am] BILLING CODE 4160-01-F