34902 Federal Register / Vol. 63, No. 123 / Friday, June 26, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Ophthalmic Devices Panel of the

Medical Devices 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

Devices Panel of the Medical Devices

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 23, 1998, 8 a.m. to 5 p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: Sara M. Thornton,

Center for Devices and Radiological

Health (HFZ–460), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12396.

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

Agenda: The committee will discuss:

(1) Premarket approval application

(PMA) for a toric intraocular lens for

primary implantation for the visual

correction of aphakia, and (2) PMA for

an excimer laser for the surgical

correction of hyperopia, sphere only,

using photorefractive keratectomy.

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 15, 1998. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9 a.m. An additional 30-minute

time period will be given for public

comment at the end of committee

discussion and prior to voting on each

PMA. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before July 12, 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. 98–17075 Filed 6–25–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee Meeting; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that published in the Federal

Register of June 11, 1998 (63 FR 32014).

The notice announced a meeting of the

Circulatory System Devices Panel of the

Medical Devices Advisory Committee,

which is scheduled for June 29 and 30,

1998. The notice published with an

error. This document corrects that error.

FOR FURTHER INFORMATION CONTACT:

Anita Prout, Committee Management

Office (HFA–306), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–5503.

SUPPLEMENTARY INFORMATION: In the

Federal Register of June 11, 1998 (63 FR

32014), in FR Doc. 98–15602, FDA

announced that a meeting of the

Circulatory System Devices Panel of the

Medical Devices Advisory Committee

would be held on June 29 and 30, 1998.

The notice incorrectly published the

agenda for June 30, 1998.

Beginning on page 32014, in the 2d

column, under the Agenda portion of

the meeting, the agenda for June 30,

l998, should be corrected to read: ‘‘On

June 30, 1998, the committee will

discuss and make recommendations on

clinical issues related to antimicrobial

coatings on permanent cardiovascular

implants, such as heart valves and

vascular grafts.’’

Dated: June 22, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17143 Filed 6–23–98; 5:02 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Nonprescription 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: Nonprescription

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 28 and 29, 1998, 8:30 a.m.

to 5 p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Rhonda W. Stover or

Angie Whitacre, 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 12541.

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

Agenda: On July 28, 1998, the

committee will discuss class labeling for

over-the-counter (OTC) vaginal

antifungal drug products. In the Federal

Register of February 27, 1997 (62 FR

9024), the agency published a proposed

rule intended to enable consumers to

better read and understand OTC drug

product labeling and to better apply this

information in the labeling to the safe

and effective use of such products. An

important element of FDA’s proposed

rule is a standardized labeling format for

OTC drug products. The agency has

developed class labeling for OTC

vaginal antifungal drug products in

accordance with the February 27, 1997,

proposed rule. The committee will also

discuss the agency’s draft guidance

document for industry entitled ‘‘Class

Labeling of OTC Topical Drug Products

for the Treatment of Vaginal Yeast

Infections (Vulvovaginal Candidiasis)’’

and other related issues. The draft

guidance document is intended to

provide guidance for both the carton

and the educational brochure. In the

next several weeks after publication of

this notice, a copy of the draft guidance