63604 Federal Register / Vol. 65, No. 206 / Tuesday, October 24, 2000 / Notices

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 November 3, 2000, 8 a.m. to

5:30 p.m.

Location: Holiday Inn, Versailles I

and II, 8120 Wisconsin Ave., Bethesda,

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 November 3, 2000, the

committee will hear an update on issues

relating to transmissible spongiform

encephalopathy and will review safety

and efficacy data pertaining to a

diphtheria/tetanus/acellular pertussis

vaccine manufactured by Aventis

Pasteur Ltd.

Procedure: On November 3, 2000,

from 8:30 a.m. to 5:30 a.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 October 26, 2000. Oral

presentations from the public will be

scheduled between approximately 1:50

p.m. and 2:20 p.m., and between

approximately 3:20 p.m. and 3:50 p.m.

on November 3, 2000. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before October 26, 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

November 3, 2000, from 8 a.m. to 8:20

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)). This portion 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

November 3, 2000, meeting of the

Vaccines and Related Biological

Products Advisory Committee. Because

the agency believes there is some

urgency to bring this issue 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: October 17, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27229 Filed 10–23–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3058–N]

Medicare Program; Meeting of the

Executive Committee of the Medicare

Coverage Advisory Committee—

November 7, 2000

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting of the Executive

Committee (the Committee) of the

Medicare Coverage Advisory Committee

(MCAC). The Committee will hear and

discuss presentations from interested

parties and deliberate the scientific

evidence and potential clinical utility

concerning FDG Positron Emission

Tomography (PET). Notice of this

meeting is given under the Federal

Advisory Committee Act (5 U.S.C. App.

2, section 10(a)(1) and (a)(2)).

DATES: The Meeting will be held on

November 7, 2000, from 8 a.m. until 4

p.m., EST.

Deadline for Presentations and

Comments: October 31, 2000, 5 p.m.,

EST.

Special Accommodations: Persons

attending the meeting who are hearingimpaired and require sign language

interpretation, or have a condition that

requires other special assistance or

accommodations, are asked to notify the

Executive Secretary by October 31,

2000.

ADDRESSES: The meeting will be held at

the Baltimore Convention Center, One

West Pratt Street, Baltimore, Maryland

21201.

Presentations and Comments: Submit

formal presentations and written

comments to Constance A. Conrad,

Executive Secretary, Office of Clinical

Standards and Quality, Health Care

Financing Administration, 7500

Security Boulevard, Mail Stop S3–02–

01, Baltimore, MD 21244.

Website: You may access up-to-date

information on this meeting at

www.hcfa.gov/quality/8b.htm.

Hotline: You may access up-to-date

information on this meeting on the

HCFA Advisory Committee Information

Hotline, 1–877–449–5659 (toll free) or

in the Baltimore area (410) 786–9379.

FOR FURTHER INFORMATION CONTACT:

Constance A. Conrad, Executive

Secretary, 410–786–4631.

SUPPLEMENTARY INFORMATION: On April

27, 1999, we published a notice in the

Federal Register (64 FR 22619) to

describe the Medicare Coverage

Advisory Committee (MCAC), which

provides advice and recommendations

to HCFA regarding clinical issues.

In that notice, we announced that we

would generally give at least 30 days

advance notice of MCAC public

meetings. We also stated that persons

wishing to make presentations should

submit the presentations to us at least

20 days before the meeting. We now

realize that this could create a problem

if we shorten the 30-day notice for the

meeting. In some instances, there may

be less than 20 days before the meeting,

making it impossible to afford the

public that amount of time to submit

materials. Finally, it has also been our

practice to afford the public an

additional period of up to 20 days

following an MCAC meeting to submit

any further comments they may have.

Experience has shown that there will be

instances when public interest in

prompt consideration of an issue

outweighs the 30-day advance notice,

the 20-day pre-meeting deadline for

presentation materials, and the 20-day