[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