Federal Register / Vol. 63, No. 85 / Monday, May 4, 1998 / Notices 24559

of over-the-counter antiplaqueantigingivitis drug products. On May 29,

1998, the subcommittee will discuss

recommended therapeutic combinations

for antiplaque-antigingivitis drug

products.

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 May 20, 1998. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 12 m. on May 27, 28, and 29,

1998. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before May 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.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: April 24, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–11742 Filed 5–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0191]

Testing for Skin Sensitization to

Chemicals in Latex Products; Draft

Guidance; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

document entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products.’’ This draft guidance is

intended to provide alternative claims

for medical devices containing natural

rubber latex to the ‘‘hypoallergenic’’

claim that no longer will be acceptable

after September 30, 1998. The draft

guidance, which is not in effect at this

time, is being issued for comment. This

draft guidance was reviewed by the

General Hospital and Personal Use

Devices Panel in September 1997, and it

will be posted on the Internet.

DATES: Written comments concerning

this guidance must be received by

August 3, 1998.

ADDRESSES: Written comments

concerning the draft guidance must be

submitted to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document. Submit

written requests for singles copies of the

draft guidance to the Division of Small

Manufacturers Assistance (DSMA),

Center for Devices and Radiological

Health (HFZ–220), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that

office in processing your request, or fax

your request to 301–443–8818. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (HFZ–480), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

This is the second draft of the

guidance entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products,’’ and it replaces the July 28,

1997, version that was posted on the

Internet and distributed by DSMA to

manufacturers of medical devices made

of natural rubber to consumer groups

and other agencies of the Federal

Government for comment. This draft

guidance was also discussed during the

General Hospital and Personal Use

Devices Advisory Panel meeting on

September 15, 1997. This second draft

incorporates comments received from

the General Hospital and Personal Use

Devices Advisory Panel meeting,

consumer groups, and medical device

manufacturers. This draft guidance is

intended to provide alternative claims

for medical devices containing natural

rubber latex to replace the

‘‘hypoallergenic’’ claim. The

‘‘hypoallergenic’’ claim will no longer

be acceptable after September 30, 1998,

which is the effective date of the final

rule on medical devices containing

natural-rubber that published in the

Federal Register of September 30, 1997

(62 FR 51021). This draft guidance also

includes test methods for supporting

these claims. When this draft guidance

becomes final, the manufacturers of

latex containing medical devices may

use it to address label options and what

tests FDA regards as appropriate to

support statements that replace the

current ‘‘hypoallergenic’’ statement.

II. Significance of Guidance

The draft guidance represents the

agency’s recommended tests to support

label claims for reduced chemical

sensitivity during use of latex products

and label options. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statute, regulations, or both.

The agency has adopted Good Guidance

Practices (GGP’s), which set forth the

agency’s policies and procedures for the

development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). This guidance

document is being issued as a Level 1

guidance consistent with GGP’s.

III. Electronic Access

In order to receive the draft guidance

entitled ‘‘Testing for Skin Sensitization

to Chemicals in Latex Products’’ via

your fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at second

voice prompt press 2, and then enter the

document number (944) followed by the

pound sign (#). Then follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). The Center

for Devices and Radiological Health

(CDRH) maintains an entry on the

WWW for easy access to information

including text, graphics, and files that

may be downloaded to a personal

computer with access to the Web.

Updated on a regular basis, the CDRH

home page includes ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products,’’ device safety alerts, Federal

Register reprints, information on

premarket submissions (including lists

of approved applications and

manufacturers addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. The draft

guidance entitled ‘‘Testing for Skin

Sensitization to Chemicals in Latex

Products’’ will be available at http://

www.fda.gov/cdrh/ode/ed—rp.html.

A text-only version of the CDRH Web

site is also available from a computer or

VT–100 compatible terminal by dialing

1–800–222–0185 (terminal settings are

8/1/N). Once the modem answers, press
24560 Federal Register / Vol. 63, No. 85 / Monday, May 4, 1998 / Notices

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

IV. Comments

Interested persons may, on or before

August 3, 1998, submit to the Dockets

Management Branch written comments

regarding this guidance document. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be in the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: April 14, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–11683 Filed 5–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

John E. Fogarty International Center

for Advanced Study in the Health

Sciences; Notice of Meeting of the

Fogarty International Center Advisory

Board

Pursuant to Public Law 92–463, as

amended, notice is hereby given of the

thirty-eighth meeting of the Fogarty

International Center (FIC) Advisory

Board, May 19, 1998, in the Lawton

Chiles International House (Building 16)

at the National Institutes of Health. The

Research Awards Subcommittee will

meet on May 18 in the FIC Conference

Room, Building 31, Room B2C07, from

1:00 p.m. to approximately 4:00 p.m.,

and will be closed to the public.

The meeting of the Board will be open

to the public from 8:30 a.m. to

approximately 12:00 noon.

In addition to a report by the Director,

FIC, the agenda will include

presentations on FIC Evolution and

Long-Range Planning; the Status of FIC

International Training and Research

Programs; ICD-Wide Initiatives in

Support of International Relations; and

FIC International Policy Support to NIH

and other Government Agencies.

In accordance with the provisions of

sections 552b(c)(4) and 552b(c)(6), Title

5, United States Code and section 10(d)

of Public Law 92–463, as amended, the

entire meeting of the Research Awards

Subcommittee on May 18 will be closed

to the public from 1:00 p.m. to

approximately 4:00 p.m., and the Board

meeting on May 19 will be closed to the

public from 1:00 p.m. to adjournment

for the review of applications for awards

under the Senior International

Fellowship and International

Fellowship Programs; and the Fogarty

International Research Collaboration

Awards and HIV, AIDS and Related

Illnesses Collaboration Awards.

Paula Cohen, Committee Management

Officer, Fogarty International Center,

National Institutes of Health, Building

31, Room B2C08, 31 CENTER DR MSC

2220, Bethesda, Maryland 20892–2220,

telephone: 301–496–1491, will provide

a summary of the meeting and a roster

of the committee members upon

request.

Irene Edwards, Executive Secretary,

Fogarty International Center Advisory

Board, Building 31, Room B2C08,

telephone: 301–496–1491, will provide

substantive program information.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Ms. Cohen at least 2 weeks in

advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.989, Senior International

Fellowship Awards Programs; and 93.934,

Fogarty International Research Collaboration

Award)

Dated: April 24, 1998.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 98–11676 Filed 5–1–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting of the National Cancer

Advisory Board and Its Subcommittees

Pursuant to the Federal Advisory

Committee Act, as amended, notice is

hereby given of the meeting of the

National Cancer Advisory Board

(Board), National Cancer Institute (NCI),

and its Subcommittees on May 11–13,

1998. The meeting of the Board and its

Subcommittees will be open to the

public as indicated below. Attendance

by the public will be limited to space

available.

A portion of the Board meeting will

be closed to the public as indicated

below in accordance with the provisions

set forth in sections 552(c)(4) and

552(c)(6), Title 5 U.S.C. and section

10(d) of Public Law 92–463, for the

review, discussion and evaluation of

individual grant applications and for

discussion of issues pertaining to

programmatic areas and/or NCI

personnel. These applications and

discussions could reveal confidential

trade secrets or commercial property

such as patentable material, and

personal information concerning the

individuals associated with the

applications or programs, the disclosure

of which would constitute a clearly

unwarranted invasion of personal

privacy.

The Committee Management Office,

National Cancer Institute, National

Institutes of Health, Executive Plaza

North, Room 609, 6130 Executive

Boulevard, MSC 7410, Bethesda,

Maryland 20892–7410, (310) 496–5708

will provide summaries of the meetings

and rosters of the Board members, upon

request.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact Mrs. Linda Quick-Cameron,

Committee Management Officer, at (301)

496–5708 in advance of the meetings.

Name of Committee(s): Subcommittee on

Activities and Agenda, Subcommittee on

Cancer Centers, Subcommittee on Clinical

Investigations, Subcommittee on Planning

and Budget.

Date: May 11, 1998.

Time: 7:00 p.m.—Adjournment.

Place: Hyatt Regency Bethesda, One

Bethesda Metro, Bethesda, Maryland 20814.

Agenda(s): See NCI Homepage/Advisory

Board and Groups,

http://deainfo.nci.nih.gov/ADVISORY/

boards.htm

Tentative agenda available 10 working

days prior to meetings;

Final agenda available 5 working days

prior to meetings.

Contact Person: Dr. Marvin R. Kalt,

Executive Secretary, National Cancer

Institute, NIH, Executive Plaza North, Room

600, 6130 Executive Blvd., MSC 7405,

Bethesda, MD 20892–7405, (301) 496–5147.

Name of Committee: National Cancer

Advisory Board.

Dates: May 12–13, 1998.

Place: Building 31C, Conference Room 10,

National Institutes of Health, 3100 Center

Drive, Bethesda, MD. 20892.

Open: May 12—9:00 a.m. to 4:00 p.m.; May

13—9:00 a.m. to 12:20 p.m.

Agenda: Program reports and

presentations; business of the Board. For a