Federal Register / Vol. 61, No. 84 / Tuesday, April 30, 1996 / Notices 19075

and Human Services Regulations, 45

CFR Part 46, regarding the protection of

human subjects. Assurances must be

provided to demonstrate that the project

will be subject to initial and continuing

review by an appropriate institutional

review committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

In addition to other applicable

committees, Indian Health Service (IHS)

institutional review committees also

must review the project if any

component of the IHS will be involved

or will support the research. If any

American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it.

Women, Racial and Ethnic Minorities:

It is the policy of the CDC to ensure that

women and racial and ethnic groups

will be included in CDC-supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian, Alaska

Native, Asian, Pacific Islander, Black

and Hispanic. Applicants shall ensure

that women, racial and ethnic minority

populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, Friday, September 15,

1995, pages 47947–47951 (a copy is

included in the application kit).

Pre- and Post-test Counseling and

Partner Notification: Recipients are

required to provide HIV antibody testing

to determine a person’s HIV infection

status; therefore, they must comply with

State laws and regulations and CDC

guidelines regarding pre- and post-test

counseling and partner notification of

HIV-seropositive patients. A copy of the

guidelines will be included in the

application kit. Recipients must also

comply with State and local health

department requirements relating to

specific reportable diseases or

conditions. Recipients must provide

referrals for HIV diagnosis and

treatment.

HIV/AIDS Requirements: Recipients

must comply with the document

entitled ‘‘Content of AIDS-Related

Written Materials, Pictorials,

Audiovisuals, Questionnaires, Survey

Instruments, and Educational Sessions’’

(June 1992), a copy of which is included

in the application kit. In complying

with the requirements for a program

review panel, recipients are encouraged

to use an existing program review panel

such as the one created by the State

health department’s HIV/AIDS

prevention program. If the recipient

forms its own program review panel, at

least one member must be an employee

(or a designated representative) of a

government health department

consistent with the Content guidelines.

The names of the review panel members

must be listed on the Assurance of

Compliance form (CDC 0.1113), which

is included in the application kit.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Van Malone, Grants Management

Officer, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road NE.,

Room 300, Mailstop E–15, Atlanta, GA

30305, on or before July 1, 1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date, or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review committee.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) are considered late applications.

Late applications will not be considered

in the current competition and will be

returned to the applicant.

Where To Obtain Additional

Information

Questions on application procedures

and the application package, and

business management technical

assistance may be obtained from Manuel

Lambrinos, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

Room 300, Mailstop E–15, Atlanta, GA

30305, telephone (404) 842–6777, or

Internet address:

MYL5@opspgo1.em.cdc.gov.

Programmatic technical assistance

may be obtained from Veronica Greene,

D.D.S., M.P.H., Division of Tuberculosis

Elimination, National Center for STD,

HIV, and TB Prevention, Centers for

Disease Control and Prevention (CDC),

1600 Clifton Road, NE., Mailstop E–10,

Atlanta, GA 30333, telephone (404)

639–8123.

Please refer to Announcement

Number 619 when requesting

information or submitting an

application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the Introduction through

the Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: April 24, 1996.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–10629 Filed 4–29–96; 8:45 am]

BILLING CODE 4163–18–P

The National Institute for Occupational

Safety and Health of the Centers for

Disease Control and Prevention

Announces the Following Meeting

Name: Scientific and Technical Discussion

of the Draft Document, ‘‘Criteria for a

Recommended Standard: Occupational

Exposures to Metalworking Fluids (MWFs).’’

Times and Dates: 9 a.m.–5:30 p.m., June

13, 1996. 9 a.m.–5:30 p.m., June 14, 1996.

Place: Drawbridge Inn, Yeomans Hall, I–75

and Buttermilk Pike, Fort Mitchell, Kentucky

41017.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: The purpose of this meeting is to

discuss the scientific and technical content of

the draft NIOSH document, ‘‘Criteria For a

Recommended Standard: Occupational

Exposures to Metalworking Fluids (MWFs),’’

prior to finalizing the criteria document for

publication and transmittal to the

Department of Labor. This review will focus

on all aspects of the criteria document

including: composition and formulation of

MWFs, potential adverse health effects from

exposure to MWFs, occupational exposure

data, and the feasibility of controlling

exposures to the NIOSH recommended

exposure limit of 0.5 mg/m3 (total

particulate).

Contact Persons for More Information:

Technical information may be obtained from

Brenda Boutin, NIOSH, CDC, 4676 Columbia

Parkway, M/S C–32, Cincinnati, Ohio 45226,

telephone 513/533–8345, e-mail address:

hhal@NIOSDT1.em.cdc.gov.

Persons wishing to attend or make a

presentation at the meeting, obtain a copy of
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.