35238 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 / Notices

Contact Person for More Information:

Wesley Hodgson, Hepatitis Branch, NCID,

CDC, M/S G–37, 1600 Clifton Road, NE,

Atlanta, Georgia 30333, telephone 404/639–

3048, fax 404/639–1538, e-mail

wxh9@cdc.gov.

Dated: June 23, 1998.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 98–17203 Filed 6–26–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Antiviral Drugs 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: Antiviral Drugs

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 14 and 15, 1998, from 8:30

a.m. to 5 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Rhonda W. Stover, or

John B. Schupp, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–7001, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12531.

Please call the Information Line for upto-date information on this meeting.

Agenda: On July 14, 1998, the

committee will hear presentations

concerning general regulatory issues

from the Division of Antiviral Drug

Products.

Procedure: On July 14, 1998, from

8:30 a.m. to 1 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 6, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. on July 14, 1998. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 6, 1998, 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 14, 1998, from 1 p.m to 5 p.m., and

on July 15 from 8:30 a.m. to 5 p.m., the

meeting will be closed to permit

discussion and review of trade secret

and/or confidential commercial

information (5 U.S.C. 552b(c)(4)). The

meeting will discuss information

relevant to pending investigational new

drug applications and drug

development plans.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C., app. 2).

Dated: June 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17212 Filed 6-26-98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

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: Biological

Response Modifiers 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 30, 1998, 8 a.m. to 6 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Gail M. Dapolito or

Rosanna L. Harvey, Center for Biologics

Evaluation and Research (HFM–211),

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 12389.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will discuss:

(1) Biologics license application 97–

0509, Amgen Inc.’s Stemgen

(ancestim); (2) the report from the

December 17, 1997, meeting of the

Xenotransplantation Subcommittee; and

(3) the research programs in the

Laboratory of Immunology and the

Laboratory of Molecular Immunology,

Office of Therapeutics Research and

Review, Center for Biologics Evaluation

and Research. An indication is sought,

in combination with Neupogen

(filgrastim), for use in mobilization of

peripheral blood progenitor cells.

Procedure: On July 30, 1998, from 8

a.m. to 5 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 20, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 9 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 20, 1998, 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 30, 1998, from 5 p.m. to 6 p.m., the

meeting will be closed to permit

discussion where disclosure would

constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The committee will discuss

confidential information relevant to the

scientific site visit report of the

Laboratory of Immunology and the

Laboratory of Molecular Immunology,

Office of Therapeutics Research and

Review, Center for Biologics Evaluation

and Research.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 18, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17146 Filed 6-26-98; 8:45 am]

BILLING CODE 4160–01–F