33966 Federal Register / Vol. 66, No. 123 / Tuesday, June 26, 2001 / 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 July 26, 2001, 8:30 a.m. to 5:30

p.m., and on July 27, 2001, 8:30 a.m. to

3:30 p.m.

Location: Holiday Inn, Grand

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD.

Contact: 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, 301–827–0314, 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 July 26, 2001, the

committee will hear presentations on

the available safety and efficacy data for

Aviron, Inc.’s cold adapted, live

attenuated, trivalent influenza virus

vaccine (FluMistTM). On July 27, 2001,

the committee will discuss the available

data and the proposed indications for

FluMistTM.

Procedure: On July 26, 2001, from

10:15 a.m. to 5:30 p.m., and on July 27,

2001, from 8:30 a.m. to 3:30 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 July 8, 2001. On July 27,

2001, oral presentations will be held

between approximately 9 a.m. and 10:15

a.m. Time allotted for each presentation

may be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 8, 2001,

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

July 26, 2001, from 8:30 a.m. to 10:15

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)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 19, 2001.

Bonnie Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–15912 Filed 6–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0232]

Medical Devices Premarket Guidance:

Reprocessing and Reuse of Single-Use

Devices; Draft Guidance for Industry

and FDA Staff; Availability; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of June 1, 2001 (66 FR 29822).

The document announced the

availability of the draft guidance

entitled ‘‘Premarket Guidance:

Reprocessing and Reuse of Single-Use

Devices; Draft Guidance for Industry

and FDA Staff.’’ The document

published inadvertently omitting the

address for the Dockets Management

Branch. This document corrects that

error.

FOR FURTHER INFORMATION CONTACT:

Joyce Strong, Office of Policy, Planning,

and Legislation (HF–27), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–7010.

SUPPLEMENTARY INFORMATION: In the

Federal Register of Friday, June 1, 2001,

in FR Doc. 01–13731, on page 29822, in

the third column, correct the ADDRESSES

caption to read:

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the draft

guidance document entitled ‘‘Premarket

Guidance: Reprocessing and Reuse of SingleUse Devices; Draft Guidance for Industry and

FDA Staff’’ to the Division of Small

Manufacturers Assistance (HFZ–220), Center

for Devices and Radiological Health, Food

and Drug Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that office

in processing your request, or fax your

request to 301–443–8818. Submit written

comments concerning this draft guidance to

the Dockets Management Branch (HFA–305),

Food and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the draft

guidance document.

Dated: June 19, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15911 Filed 6–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–4019–N]

Medicare Program: Meeting of the

Advisory Panel on Medicare

Education—July 12, 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with the

Federal Advisory Committee Act, 5

U.S.C. Appendix 2, section 10(a)(1) and

(a)(2) (Pub. L. 92–463), this notice

announces a meeting of the Advisory

Panel on Medicare Education (the

Panel) on July 12, 2001. This meeting is

open to the public.

DATES: The Meeting. The meeting is

scheduled for July 12, 2001, from 9 a.m.

to 5 p.m., E.D.T

Deadline for Presentations and

Comments: July 5, 2001, 12 noon, E.D.T.

ADDRESSES: The meeting will be held at

the Holiday Inn on the Hill, 415 New

Jersey Avenue, NW., Washington, DC,

20001, (202) 638–1616.

FOR FURTHER INFORMATION CONTACT:

Nancy Caliman, Health Insurance

Specialist, Partnership Development

Group, Center for Beneficiary Services,

Health Care Financing Administration,

7500 Security Boulevard, S2–23–05,

Baltimore, MD 21244–1850, (410) 786–

5052. Please refer to the HCFA Advisory

Committees Information Line (1–877–

449–5659 toll free)/(410–786–9379

local) or the Internet (http://

www.hcfa.gov/events/apme/

homepage.htm) for additional

information and updates on committee

activities, or contact Ms. Caliman via Email at APME@hcfa.gov. Press inquiries

are handled through the HCFA Press

Office at (202) 690–6145.