Federal Register / Vol. 63, No. 122 /Thursday, June 25, 1998 / Notices 34655

may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: June 18, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

[FR Doc. 98–16850 Filed 6–24–98; 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’s regulatory issues.

Date and Time: The meeting will be

held on July 29, 30, and 31, 1998, 8 a.m.

to 5 p.m.

Location: Gaithersburg Hilton, Grand

Ballroom, 620 Perry Pkwy.,

Gaithersburg, MD.

Contact Person: Ermona B.

McGoodwin, 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

12530. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss

documents on ‘‘Guidance to Industry’’

being developed by the Office of Drug

Evaluation IV’s Division of AntiInfective Drug Products and the

Division of Special Pathogens and

Immunologic Drug Products. Copies of

these draft guidance documents can be

obtained from the Center for Drug

Evaluation and Research (HFD–210),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–4573, or requested by FAX at

301–827–4577. Electronic versions of

these guidance documents will be

available via Internet using the World

Wide Web (www). To access the

documents on the www, connect to

CDER Home Page at http://

www.fda.gov/cder/guidance.htm.

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 July 22, 1998. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 1:30 p.m. on July 29, 30, and

31, 1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 22, 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.

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. 98–16934 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Arthritis 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: Arthritis

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 August 7, 1998, 8 a.m. to 5 p.m.

Location: Bethesda Holiday Inn,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Kathleen R. Reedy or

LaNise S. Giles, 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 12532.

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

Agenda: The committee will discuss

the safety and efficacy of new drug

application 20–905 Arava (leflunomide,

Hoechst Marion Roussel, Inc., Germany)

for the treatment of rheumatoid arthritis.

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 July 30, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 30, 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 15, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–16837 Filed 6–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Drugs Subcommittee of

the Dermatologic and Ophthalmic

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: Ophthalmic

Drugs Subcommittee of the

Dermatologic and Ophthalmic 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 22, 1998, 8 a.m. to 5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.