[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Pages 58054-58055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28908]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Product and Clinical Development of Tumor Vaccines; Public 
Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop: Product and Clinical Development of Tumor Vaccines. 
This workshop, which is cosponsored by FDA and the National Institutes 
of Health, will assist FDA and the interested public in developing 
policies and standards for product and clinical development for tumor 
vaccines.
    Date and Time: The public workshop will be held on Thursday, 
December 10,

[[Page 58055]]

7:30 a.m. to 5 p.m., and Friday, December 11, 1998, 8 a.m. to 5:30 p.m.
    Location: The public workshop will be held at the Jack Masur 
Auditorium, Bldg. 10, National Institutes of Health, 9000 Rockville 
Pike, Bethesda, MD 20892.
    Contact: Abdur Razzaque, Center for Biologics Evaluation and 
Research (HFM-530), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-0675.
    Registration and Requests for Oral Presentations: Send registration 
information (including name, title, firm name, address, telephone, and 
fax number) to Karen Blackburn, Tascon, Inc., 1803 Research Blvd., 
suite 305, Rockville, MD 20850, 301-315-9000, ext. 514, FAX 301-738-
9786, or e-mail [email protected].
     On December 10, 1998, beginning at 7:30 a.m., registration will be 
held at the public workshop location on a space available basis. 
However, because space is limited, interested parties are encouraged to 
register early. There is no registration fee for the public workshop.
    If you need special accommodations due to a disability, please 
contact Karen Blackburn at least 7 days in advance.
SUPPLEMENTARY INFORMATION:  The goals of the workshop include 
discussing the following: (1) Regulatory considerations in the clinical 
development process for tumor vaccines; (2) morphological, 
immunophenotypic,and functional characteristics of dendritic cells; (3) 
current methods for physicochemical and functional characterization of 
autologous and allogeneic whole cell tumor vaccines, tumor cell 
lysates, polyvalent tumor antigen preparations, antigen presenting 
cells and other cell-derived vaccines; (4) novel preclinical strategies 
and biological/immunological assessments in early clinical trials; and 
(5) issues regarding the detection and monitoring of tumor cell 
contamination in cellular vaccines. The information obtained from these 
discussions will assist FDA and the interested public in developing 
policies and standards for product and clinical development for tumor 
vaccines.
    Transcripts: Transcripts of the public workshop may be requested in 
writing from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857, 
approximately 15 working days after the public workshop at a cost of 10 
cents per page.

    Dated: October 21, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-28908 Filed 10-28-98; 8:45 am]
BILLING CODE 4160-01-F