[Federal Register Volume 61, Number 13 (Friday, January 19, 1996)]
[Notices]
[Page 1389]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-638]
Food and Drug Administration
Design of Experimental Studies of Transmission of Creutzfeldt-
Jakob Disease (CJD) by Plasma and Plasma Derivatives; Notice of Public
Workshop
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of a public workshop.
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SUMMARY: The Food and Drug Administration (FDA), Center for Biologics
Evaluation and Research (CBER), is announcing a public workshop on
design of experimental studies to investigate possible transmission of
Creutzfeldt-Jakob Disease (CJD) by plasma and plasma derivatives. This
scientific workshop, sponsored by FDA and the National Heart, Lung, and
Blood Institute, is intended to foster an indepth discussion of the
available laboratory methods which would underlie experimental studies
on the transmission of CJD and related diseases by plasma and derived
products.
DATES: The public workshop will be held on Monday, January 29, 1996,
from 8 a.m. to 4:30 p.m. Preregistration is recommended due to limited
seating. Registration is requested by January 22, 1996. There is no
registration fee.
ADDRESSES: The public workshop will be held at the National Institutes
of Health, Bldg. I, Wilson Hall, 9000 Rockville Pike, Bethesda, MD
20892.
FOR FURTHER INFORMATION CONTACT:
Regarding information on registration: Joseph Wilczek, Center for
Biologics Research and Evaluation (HFM-350), FDA, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-594-6700, or FAX 301-594-6764.
Regarding other information: Joseph C. Fratantoni, Center for
Biologics Research and Evaluation (HFM-330), FDA, 1401 Rockville Pike,
Rockville, MD 20852-1448, 301-496-4396, or FAX 301-402-2780.
SUPPLEMENTARY INFORMATION: The purpose of this workshop is to provide
an opportunity to discuss the elements required to initiate and execute
meaningful experiments that will further our understanding of the risk
of potential transmission of CJD and related disorders by blood,
plasma, and derived products. The workshop will foster detailed
discussion of available techniques among investigators, manufacturers,
and regulators.
Topics to be presented include the following: (1) Detection systems
available for use in studies of CJD; (2) animal models and the biology
of CJD and related disorders; (3) experimental design for testing the
infectivity of plasma derivatives; and (4) inactivation and
partitioning of the infectious agent in the manufacturing process for
plasma derivatives.
FDA will consider information presented and discussed at the
workshop in identifying topics for future discussion.
Transcripts of the public workshop may be requested in writing from
the Freedom of Information Office (HFI-35), Food and Drug
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,
approximately 15 working days after the meeting, at a cost of 10 cents
per page.
Dated: January 16, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-638 Filed 1-17-96; 8:45 am]
BILLING CODE 4160-01-M
