[Federal Register Volume 65, Number 183 (Wednesday, September 20, 2000)]
[Notices]
[Pages 56914-56915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Evaluation of New Vaccines: How Much Safety Data?; Public 
Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing the following 
public workshop: ``Evaluation of New Vaccines: How Much Safety Data?'' 
The purpose of the workshop is to address issues in the safety 
evaluation of new vaccines, including the feasibility and desirability 
of performing larger pre-licensure trials of vaccines in order to 
provide more precise measures of safety prior to widespread use, and to 
discuss the optimal balance between pre-licensure and post-licensure 
evaluation of vaccine safety.
    Date and Time: The workshop will be held on November 14, 2000, from 
1 p.m. to 5:30 p.m. and on November 15, 2000, from 8:30 a.m. to 5 p.m.
    Location: The workshop will be held at the Lister Hill Conference 
Center, National Institutes of Health, Bldg. 38A, 8600 Rockville Pike, 
Bethesda, MD 20814.
    Contact:
    For information regarding this notice: Nathaniel L. Geary, Center 
for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210, FAX 301-827-1944.
    For information regarding the workshop: Mary A. Foulkes, Center for 
Biologics Evaluation and Research (HFM-210), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3034, FAX 301-827-3529.
    For registration information: Sandy L. Coffin, Center for Biologics 
Evaluation and Research (HFM-210), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-

[[Page 56915]]

827-3034, FAX 301-827-3529, or e-mail: [email protected].
    Registration: Send or fax your registration form (including name, 
title, firm name, address, telephone, fax number, and e-mail address) 
to the Sandy L. Coffin (address above) by Friday, October 20, 2000. 
There is no registration fee for the workshop, however, seating is 
limited. Therefore, interested parties are encouraged to register 
early.
    You may get a copy of the registration form and additional 
information about this workshop from the Internet at http://www.fda.gov/cber/meetings/vac111400.htm.
    If you need special accommodations due to a disability, please 
contact Sandy L. Coffin (address above) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: This workshop is cosponsored by the 
following organizations: FDA, Center for Biologics Evaluation and 
Research; National Institutes of Health, National Institute of Allergy 
and Infectious Diseases; Centers for Disease Control and Prevention 
(CDC); Health Resources and Services Administration; and National 
Vaccine Program Office, CDC. The workshop will be of primary interest 
to public health professionals evaluating new vaccines and to vaccine 
manufacturers developing new vaccines. The objectives of the workshop 
are to: Describe the evolution of new vaccine evaluation and the 
current approaches to postmarketing safety evaluation, discuss public 
concerns about vaccine safety, and explore alternatives for enhancing 
postmarketing safety evaluation and the value and feasibility of larger 
pre-licensure trials.
    Transcripts: Transcripts of the meeting 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 meeting at a cost of 10 cents 
per page. The transcript will also be available at the Center for 
Biologics Evaluation and Research Internet site at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: September 14, 2000.
William K. Hubbard,
Senior Associate, Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-24125 Filed 9-19-00; 8:45 am]
BILLING CODE 4160-01-F