54118 Federal Register / Vol. 62, No. 200 / Friday, October 17, 1997 / Notices

Dated: September 23, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–27532 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anti-Infective 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). The meeting will be open to the

public.

Name of Committee: Anti-Infective

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 November 19 and 20, 1997, 8

a.m. to 5:30 p.m.; and November 21,

1997, 8 a.m. to 2 p.m.

Location: Holiday Inn, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Ermona B.

McGoodwin or Danyiel A. D’Antonio,

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

12530. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On November 19, 1997, the

committee will discuss issues relating to

the development of fluoroquinolones for

use in pediatric patients. On the

morning of November 20, 1997, the

committee will discuss new drug

application (NDA) 50–585/S046,

ceftriaxone sodium (Rocephin sterile

vials, Roche Laboratories) for single

dose intramuscular treatment of acute

otitis media. On the afternoon of

November 20, 1997, the committee will

discuss NDA 20–799, ofloxacin otic

(Floxin, Daiichi Pharmaceuticals) for

treatment of otitis externa, chronic

suppurative otitis media with perforated

tympanic membrane, and acute otitis

media in pediatric patients with

tympanostomy tubes. On November 21,

1997, the committee will discuss NDA

50–753, tobramycin solution for

inhalation (TOBI, PathoGenesis Corp.)

for the management of cystic fibrosis

patients.

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 November 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. on November 19 and

20, and between approximately 11 a.m.

and 12 m. on November 21. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before November 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: October 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27530 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Peripheral and Central Nervous

System 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). The meeting will be open to the

public.

Name of Committee: Peripheral and

Central Nervous System Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

regulatory issues.

Date and Time: The meeting will be

held on November 18 and 19, 1997, 8:30

a.m. to 5 p.m.

Location: Quality Hotel, Maryland

Ballroom, 8727 Colesville Rd., Silver

Spring, MD.

Contact Person: Ermona McGoodwin

or Danyiel D’Antonio, 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 12543.

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

Agenda: On November 18, 1997, the

Committee will discuss the evidence of

safety and effectiveness in new drug

application (NDA) 20–861, Prosynap

(lubeluzole injection, Janssen Research

Foundation) for the treatment of acute

ischemic stroke in adults. On November

19, 1997, the Committee will discuss the

evidence of safety and effectiveness in

NDA 20–764, Lamictal CD Chewable

Dispersible Tablets (lamotrigine, Glaxo

Wellcome) for the treatment of the

generalized seizures of Lennox-Gastaut

syndrome in pediatric and adult

patients.

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 November 12, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 2 p.m. on November 18, 1997,

and between 9 a.m. and 10 a.m. on

November 19, 1997. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 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: October 9, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–27529 Filed 10–16–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee for

Pharmaceutical Science; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.