[Federal Register Volume 65, Number 82 (Thursday, April 27, 2000)]
[Notices]
[Pages 24706-24707]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-10457]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Vaccines and Related Biological Products Advisory Committee; 
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Vaccines and Related Biological Products 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 11, 2000, 8 a.m. to 
5:30 p.m. and on May 12, 2000, 8 a.m. to 3 p.m.
    Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave., 
Silver Spring, MD.
    Contact Person: Nancy T. Cherry or Denise H. Royster, Center for 
Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12391. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: On May 11, 2000, the committee will hear updates on 
activities in the Office of Vaccines Research and Review. The committee 
will also be informed of issues pertaining to the status of vaccines 
for the prevention of rotavirus disease. On May 12, 2000, the committee 
will review issues relating to the development of policy regarding the 
use of various types of neoplastic cells as substrates for vaccine 
manufacture.
    Procedure: On May 11, 2000, from 9:15 a.m. to 1:45 p.m., and on May 
12, 2000, from 9:15 a.m. to 3 p.m., the meeting is open to the public. 
Interested persons may present data, information, or views, orally or 
in writing, on issues pending before the committee. Written submissions 
may be made to the contact person by May 4, 2000. Oral presentations 
from the public will be scheduled between approximately 12:20 p.m. to 
12:50 p.m. on May 11, 2000, and between approximately 10:35 a.m. to 
10:50 a.m. and between approximately

[[Page 24707]]

1:30 p.m. to 1:45 p.m. on May 12, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 4, 2000, and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Closed Committee Deliberations: On May 11, 2000, from 8 a.m. to 9 
a.m., and from approximately 1:45 p.m. to 5:30 p.m., and on May 12, 
2000, from 8 a.m. to 9 a.m., the meeting will be closed to permit 
discussion and review of trade secret and/or confidential information. 
(5 U.S.C. 552b(c)(4)). These portions will be closed to permit 
discussion of pending investigational new drug applications or pending 
product licensing applications.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the May 11 and 12, 2000, Vaccines and Related Biological Products 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring these issues to public discussion and qualified 
members of the Vaccines and Related Biological Products Advisory 
Committee were available at this time, the Commissioner of Food and 
Drugs concluded that it was in the public interest to hold this meeting 
even if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 21, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-10457 Filed 4-26-00; 8:45 am]
BILLING CODE 4160-01-F