[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