19076 Federal Register / Vol. 61, No. 84 / Tuesday, April 30, 1996 / Notices

the criteria document, or reserve overnight

accommodations at the Drawbridge Inn,

should respond by May 10, 1996, to Kellie

Wilson, NIOSH, 4676 Columbia Parkway, M/

S C–34, Cincinnati, Ohio 45226, telephone

513/533–8362, fax 513/533–8588, e-mail

address: kmp0@NIOSDT1.em.cdc. gov.

Information may also be obtained by calling

1–800–35–NIOSH or by the Internet NIOSH

Homepage: http:/www.cdc.gov/niosh/

homepage. htm1.

Dated: April 23, 1996.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 96–10601 Filed 4–29–96; 8:45 am]

BILLING CODE 4160–19–M

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which

interested persons may participate in

open public hearings before FDA’s

advisory committees.

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

MEETING: The following advisory

committee meeting is announced:

Dental Drug Products Panel Plaque

Subcommittee (Nonprescription

Drugs) of the Medical Devices

Advisory Committee

Date, time, and place. June 6 and 7,

1996, 8 a.m., Holiday Inn—

Gaithersburg, Goshen Room, Two

Montgomery Village Ave., Gaithersburg,

MD.

Type of meeting and contact person.

Open public hearing, June 6, 1996, 8

a.m. to 11 a.m., unless public

participation does not last that long;

open committee discussion, 11 a.m. to

5 p.m.; open public hearing, June 7,

1996, 8 a.m. to 11 a.m., unless public

participation does not last that long;

open committee discussion, 11 a.m. to

5 p.m.; Jeanne L. Rippere or Stephanie

Mason, Center for Drug Evaluation and

Research (HFD–560), Food and Drug

Administration, 1600 Rockville Pike,

Rockville, MD 20857, 301–827–2244, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Dental Products Panel of the Medical

Devices Advisory Committee, code

12518. Please call the hotline for

information concerning any possible

changes.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational devices

and makes recommendations for their

regulation.

The Dental Products Panel of the

Medical Devices Advisory Committee

functions at times as a nonprescription

drug advisory panel. As such, the panel

reviews and evaluates available data

concerning the safety and effectiveness

of active ingredients, and combinations

thereof, of various currently marketed

nonprescription drug products for

human use, the adequacy of their

labeling, and advises the Commissioner

of Food and Drugs on the promulgation

of monographs establishing conditions

under which these drugs are generally

recognized as safe and effective and not

misbranded.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

subcommittee. Those desiring to make

formal presentations should notify the

contact person before May 24, 1996, 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

required to make their comments.

Open subcommittee discussion. On

June 6, 1996, the subcommittee will

continue its discussion concerning the

alcohol content of oral health care

mouthwash drug products begun at its

June 28 and 29, 1994, meeting. On June

7, 1996, the subcommittee will continue

its discussion of hydrogen peroxide,

sodium bicarbonate, the combination of

hydrogen peroxide and sodium

bicarbonate, and sanguinaria. The

subcommittee will also begin a

discussion of sodium lauryl sulfate. For

further information on the agenda of

this meeting, see the background

document published elsewhere in this

issue of the Federal Register.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.
Federal Register / Vol. 61, No. 84 / Tuesday, April 30, 1996 / Notices 19077

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: April 24, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–10780 Filed 4–26–96; 2:36 pm]

BILLING CODE 4160–01–F

[Docket No. 81N–033P]

Background Document for the Dental

Drug Products Panel Plaque

Subcommittee (Nonprescription

Drugs) of the Medical Devices

Advisory Committee; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a background document

for the meeting of the Dental Drug

Products Panel Plaque Subcommittee of

the Medical Devices Advisory

Committee (the subcommittee). This

meeting is announced elsewhere in this

issue of the Federal Register, and it is

scheduled for June 6 and 7, 1996. This

background document is being taken to

ensure that all interested parties are

aware of the subcommittee’s concern

regarding the relationship, if any, of

alcohol-containing mouthwashes and

oral cancer and the development of

studies to investigate the relationship.

This relationship will be the subject of

the subcommittee’s discussion on June

6, 1996.

DATES: Written comments or data

should be submitted by May 10, 1996,

in order to be considered for discussion

at the June 6, 1996, subcommittee

meeting.

ADDRESSES: Single copies of the

background briefing document may be

requested in writing from the Freedom

of Information Staff (HFI–35), Food and

Drug Administration, 5600 Fishers

Lane, rm. 12A–16, Rockville, MD 20857,

at a cost of 10 cents per page. Requests

should be identified with the docket

number found in brackets in the

heading of this document. The

background briefing document is

available for public examination at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, between 9 a.m.

and 4 p.m., Monday through Friday.

Comments and data should be

identified with the docket number listed

above. Individuals or groups wishing to

submit data or comments relevant to

alcohol-containing mouthwashes should

send them to the Dockets Management

Branch (HFA–305), 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. Three

copies of written comments should be

submitted, except that individuals may

submit one copy. The comments and

data received are available for public

examination at the Dockets Management

Branch (address above) between 9 a.m.

and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Jeanne L. Rippere or Stephanie Mason,

Center for Drug Evaluation and Research

(HFD–560), Food and Drug

Administration, 1600 Rockville Pike,

Rockville, MD 20857, 301–827–2244.

SUPPLEMENTARY INFORMATION: Elsewhere

in this issue of the Federal Register,

FDA announced that a meeting of the

Dental Drug Products Panel Plaque

Subcommittee will be held on June 6

and 7, 1996. The purpose of the meeting

scheduled for June 6, 1996, is to

continue the subcommittee’s discussion

concerning the alcohol content of oral

health care mouthwash drug products

begun at its meeting of June 28 and 29,

1994. After evaluating the available

data, the subcommittee concluded that

it should meet in a workshop

environment with representatives of the

National Cancer Institute, the National

Institute of Dental Research, other

professional groups, the agency, and

industry to address any new

information regarding a causal

relationship between alcohol-containing

mouthwashes and oral cancer. The

subcommittee recommended that this

workshop should address the

development of sound scientific studies

to determine the relationship, if any,

between alcohol-containing mouthwash

products and cancer of the oral cavity.

FDA has established a docket number

(81N–033P) as a public record of the

comments, views, and other information

submitted to the agency from interested

persons and organizations regarding

alcohol in oral health care mouthwash

drug products. After publication of the

subcommittee’s report, this docket will

be the repository of all data and

information collected by the agency for

the over-the-counter (OTC) antiplaque/

antigingivitis drug review, but currently

it will contain only those comments and

data that are not confidential under the

OTC drug review. (See the request for

data and information on dental and oral

health care drug products for antiplaque

use published in the Federal Register of

September 19, 1990 (55 FR 38560 at

38562).) Copies of the background

briefing documents have been placed in

this docket and may be seen in the

Dockets Management Branch (address

above) or obtained from the agency’s

Freedom of Information Staff (address

above). Copies of the background

briefing document will also be available

at the committee meeting.

Dated: April 23, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10781 Filed 4–26–96; 2:36 pm]

BILLING CODE 4160–01–F

Health Care Financing Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the Paperwork

Reduction Act (44 U.S.C. 3501 et seq.),

this notice is publishing the following

summaries of proposed collections for

public comment. The title, description,

and respondent description of the

information collection are shown below

with an estimate of the annual reporting

and recordkeeping burden. Included in

the estimate is the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed