[Federal Register: October 29, 1998 (Volume 63, Number 209)]
[Notices]
[Page 58054-58055]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc98-88]

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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 kblackburn@tascon.com.
     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