Federal Register / Vol. 62, No. 157 / Thursday, August 14, 1997 / Notices 43539

Affairs (HFE–1), Food and Drug

Administration, Parklawn Bldg., 5600

Fishers Lane, rm. 16–85, Rockville, MD

20857, 301–827–4404, FAX 301–827–

3052, or e-mail

‘‘clewis@bangate.fda.gov’’.

SUPPLEMENTARY INFORMATION: The

purpose of this meeting is to provide an

opportunity for consumers to discuss

their concerns and thereby participate

in agency decision and policymaking on

key health care and consumer

protection issues. To register for the

meeting and obtain directions, please

call, fax, or e-mail the contact person

(address above). Include the name, title,

telephone and fax numbers of the

person attending, and the name of the

organization being represented.

If special accommodations are

required due to a disability, please

contact Carol M. Lewis at least 7 days

in advance of the meeting.

Dated: August 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–21573 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of public advisory committees

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committees: Joint meeting of

the Nonprescription Drugs Advisory

Committee and Pulmonary-Allergy

Drugs Advisory Committee.

General Function of the Committees:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 19, 1997, 8:30 a.m.

to 5 p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Andrea G. Neal or

Leander B. Madoo, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), codes 12541 and

12545. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committees will jointly

consider new drug application (NDA)

20–840, Beconase Allergy Nasal Spray

(belcomethasone dipropionate 0.042%,

monohydrate, Glaxo Wellcome, Inc.) for

over-the-counter treatment and

prevention of the symptoms of seasonal

allergic rhinitis in patients 12 years of

age and older.

Procedure: 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 September 5, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. to 9:30 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 5, 1997, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 7, 1997.

William B. Schultz,

Acting Lead Deputy Commissioner for the

Food and Drug Administration.

[FR Doc. 97–21571 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

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). The meeting will be open to the

public.

Name of Committee: Nonprescription

Drugs Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 18, 1997, from 8:30

a.m. to approximately 5 p.m.

Location: Holiday Inn, The Ballroom,

Two Montgomery Village Ave.,

Gaithersburg, MD.

Contact Person: Andrea G. Neal,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12541. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The Committee will discuss

issues relating to the labeling and

dosing of over-the-counter (OTC)

pediatric analgesic/antipyretic drug

products. The Committee will discuss

topics such as: (1) What is an

appropriate lower age limit for the

dosing of OTC analgesic/antipyretic

drug products; and (2) the safety

implications of the OTC availability of

children’s analgesic/antipyretic

suspension products and double

concentrated infant drops with

overlapping age directions.

Procedure: 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 September 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 12, 1997, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

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

Dated: August 7, 1997.

William B. Schultz,

Acting Lead Deputy Commissioner for the

Food and Drug Administration.

[FR Doc. 97–21574 Filed 8–13–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.