Federal Register / Vol. 60, No. 185 / Monday, September 25, 1995 / Notices 49415

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before (insert date

30 days after date of publication in the

Federal Register), submit to the Dockets

Management Branch (address above)

written comments. 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. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If based on its review,

the agency finds that an

environmental impact statement is not

required and this petition results in a

regulation, the notice of availability of

the agency’s finding of no significant

impact and evidence supporting that

finding will be published with the

regulation in the Federal Register in

accordance with 21 CFR 25.40(c).

Dated: September 13, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–23596 Filed 9–22–95; 8:45 am]

BILLING CODE 4160–01–F

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:

Science Board to the Food and Drug

Administration

Date, time, and place. November 6,

1995, 8:30 a.m., DoubleTree Hotel—

National Airport, Washington Room,

300 Army Navy Dr., Arlington, VA.

Type of meeting and contact person.

Open committee discussion, 8:30 a.m. to

2:30 p.m.; open public hearing, 2:30

p.m. to 3:30 p.m., unless public

participation does not last that long;

open committee discussion, 3:30 p.m. to

5 p.m.; Susan A. Homire, Office of

Science (HF–33), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–3340, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area),

Science Board to the Food and Drug

Administration, code 12603.

General function of the board. The

board shall provide advice primarily to

the agency’s Senior Science Advisor

and, as needed, to the Commissioner

and other appropriate officials on

specific complex and technical issues as

well as emerging issues within the

scientific community in industry and

academia. Additionally, the board will

provide advice to the agency on keeping

pace with technical and scientific

evolutions in the fields of regulatory

science; on formulating an appropriate

research agenda; and on upgrading its

scientific and research facilities to keep

pace with these changes. It will also

provide the means for critical review of

agency sponsored intramural and

extramural scientific research programs.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

board. Those desiring to make formal

presentations must notify the contact

person before October 23, 1995, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, and the names and

addresses of proposed participants.

Each presenter will be limited in time

and not all requests to speak may be

able to be accommodated. All written

statements submitted in a timely fashion

will be provided to the board.

Open committee discussion. The

board will discuss issues related to the

safety testing of biomaterials used in

products regulated by FDA. The

discussion is designed to give the

agency direction for future program

development.

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.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will
49416 Federal Register / Vol. 60, No. 185 / Monday, September 25, 1995 / Notices

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, rm. 12A–16, 5600

Fishers Lane, 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,

rm. 1–23, 12420 Parklawn Dr.,

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: September 14, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 94–23597 Filed 9–22–94; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Special Project Grants; Maternal and

Child Health (MCH) Services; Federal

Set-Aside Program

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice of limited competition.

SUMMARY: The Health Resources and

Services Administration is announcing

acceptance for review and funding, if

approvable, of an application from the

American Academy of Obstetricians and

Gynecologists (ACOG) for a Maternal

and Child Health (MCH) Special Project

of Regional and National Significance

(SPRANS) grant. The award will be

made under the program authority of

section 502(a) of the Social Security Act,

the MCH Federal Set-Aside Program,

from funds appropriated for fiscal year

1995 under Public Law 103–333. The

MCH SPRANS grants are intended to

improve the health of mothers and

children through development and

dissemination of new knowledge,

demonstration of new or improved ways

of delivering care or otherwise

enhancing Title V program capacity to

provide or assure provision of

appropriate services, and preparation of

personnel in MCH-relevant disciplines.

The purpose of this limited

competition is to extend and enhance

support of an existing grant through

which ACOG is stimulating office-based

research by its members. The

information collected will be used to

effect changes in the practices and

standards of care provided by

practitioners that improve access to

care, efficacy of interventions, health

status of the women being served, and

pregnancy outcomes. The American

Academy of Obstetricians and

Gynecologists is the only national

organization of and for obstetric and

gynecologic practitioners and is, thus,

the only organization with both the

necessary access to the practitioners and

the professional standing to effect

changes in practice and standards of

care.

Grant/Amount

A single grant, of approximately

$142,000, will be awarded. The project

period will be 5 years.

Eligibility

Eligibility for application and funding

is limited to the American College of

Obstetricians and Gynecologists.

FOR FURTHER INFORMATION CONTACT: For

programmatic or technical information

on MCH issues, contact Mr. James

Papai, 5600 Fishers Lane, Room 18A–

55, telephone: 301 443–2190. For

information concerning business

management issues, contact Ms.

Dorothy M. Kelley, Grants Management

Branch, Maternal and Child Health

Bureau, Room 18–12, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland, telephone: 301 443–1440.

Provision of Smoke-Free Workplace

The Public Health Service strongly

encourages all grant recipients to

provide a smoke-free workplace and

promote the non-use of all tobacco

products. This is consistent with the

PHS mission to protect the physical and

mental health of the American people.

Public Health System Reporting

Requirements

This program is subject to the Public

Health System Reporting Requirements

(approved under OMB No. 0937–0195).

Under these requirements, the

community-based nongovernmental

applicant must prepare and submit a

Public Health System Impact Statement

(PHSIS). The PHSIS is intended to

provide information to state and local

health officials to keep them apprised of

proposed health services grant

applications submitted by communitybased nongovernmental organizations

within their jurisdictions. Communitybased nongovernmental applicants are

required to submit the following

information to the head of the

appropriate State and local health

agencies in the area(s) to be impacted no

later than the Federal application

receipt date:

(a) A copy of the face page of the

application (SF 424).

(b) A summary of the project PHSIS,

not to exceed one page, which provides:

(1) A description of the population to

be served.

(2) A summary of the services to be

provided.

(3) A description of the coordination

planned with the appropriate State and

local health agencies.

Executive Order 12372

The MCH Federal Set-Aside Program

has been determined to be a program

which is not subject to the provisions of

Executive Order 12372 concerning

intergovernmental review of Federal

programs.

The OMB Catalog of Federal Domestic

Assistance number is 93.110.

Dated: September 19, 1995.

Ciro V. Sumaya,

Administrator.

[FR Doc. 95–23602 Filed 9–22–95; 8:45 am]

BILLING CODE 4160–15–P

Special Project Grants; Maternal and

Child Health (MCH) Services; Federal

Set-Aside Program; Research and

Training Grants

AGENCY: Health Resources and Services

Administration (HRSA).

ACTION: Notice of availability of funds.

SUMMARY: The Health Resources and

Services Administration is announcing

the availability of fiscal year (FY) 1995

funds for a limited competition for

Maternal and Child Health (MCH)

Special Projects of Regional and

National Significance (SPRANS)

research and training grants.

Supplemental awards will be made

under the program authority of section

502(a) of the Social Security Act, the

MCH Federal Set-Aside Program. The

MCH research and training grants

improve the health status of mothers

and children through: development and

dissemination of new knowledge;

demonstration of new or improved ways

of delivering care or otherwise

enhancing Title V program capacity to

provide or assure provision of

appropriate services; and preparation of

personnel in MCH-relevant specialties.