27528 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices

By the Federal Maritime Commission.

Joseph C. Polking,

Secretary.

[FR Doc. 95–12669 Filed 5–23–95; 8:45 am]

BILLING CODE 6730–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Announcement 537]

State Grants To Support Development

and Evaluation of Nutrition

Intervention Programs

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for grants to support the

development and evaluation of State

and community nutrition intervention

programs.

This announcement addresses two

distinct components:

I. ‘‘Nutrition Intervention Assistance’’

for supporting the implementation of

nutrition interventions.

II. ‘‘5 A Day Evaluation’’ for

supporting the evaluation of 5 A Day for

Better Health nutrition intervention

programs.

Applicants may apply for either the

Nutrition Intervention Assistance

component or the 5 A Day Evaluation

component or both components.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related specifically to the priority area

of Nutrition and, generally, to several

other priority areas of health promotion

and preventive services—including

Physical Activity and Fitness, Heart

Disease, Cancer, and Diabetes. (For

ordering a copy of ‘‘Healthy People

2000,’’ see the Section, ‘‘Where to

Obtain Additional Information.’’ )

Authority

This program is authorized under

section 317(k)(2) (42 U.S.C. 247b (k)(2))

of the Public Health Service Act, as

amended.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

A. Nutrition Intervention Assistance

Assistance will be provided only to

the health departments of States or their

bona fide agents. This includes

American Samoa, the Commonwealth of

Puerto Rico, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments. Excluded are the States,

territories and American Indian tribes

of: Alaska, Alabama, Arizona, Arkansas,

California, Colorado, Connecticut,

District of Columbia, Hawaii, Iowa,

Kansas, Massachusetts, Maine,

Montana, Michigan, Minnesota,

Missouri, Nebraska, New Hampshire,

New York, North Dakota, Ohio, Rhode

Island, Tennessee, Texas, Utah,

Vermont, West Virginia, Washington,

Bristol Bay Area Health Corporation,

Poarch Band of Creek Indians,

Mississippi Band of Choctaw Indians,

Miccosukee Corporation, and the Virgin

Islands, which were funded for

nutrition intervention activities under

Program Announcement 494, entitled

State Grants to Support Development

and Evaluation of Nutrition Intervention

Programs.

B. 5 A Day Evaluation

Assistance will be provided only to

the health departments of States or their

bona fide agents. This includes the

District of Columbia, American Samoa,

the Commonwealth of Puerto Rico, the

Virgin Islands, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments.

Eligibility for this component is

restricted to States who have

established, clearly defined, evaluable,

long range 5 A Day for Better Health

projects in a specific community

channel.

Eligible applicants for nutrition

intervention program grants have been

restricted to official health departments

of States or their bona fide agents or

instrumentalities because:

1. The methodology to conduct this

program has been structured to support

the national goals and objectives of

‘‘Healthy People 2000.’’ In many

instances, State health departments

have already embraced or established

their own goals and objectives which

match or are synonymous with those

outlined in ‘‘Healthy People 2000.’’

2. The conduct of Statewide health

promotion, health education, and risk

reduction programs directed towards

reducing the prevalence of behavioral

risks in the population lies solely with

State Health Departments.

3. Program evaluation is expected to

be useful to State Health Departments in

program and intervention development.

Because comparable methods are used

from State to State and from year to

year, States can compare data and

intervention methods with other States

and monitor the effects of interventions

over time.

Availability of Funds

Approximately $740,000 is available

in FY 1995 to fund approximately 22

awards. Awards may be made for the

Nutrition Intervention Assistance, or 5

A Day Evaluation or both.

A. Nutrition Intervention Assistance

Approximately $450,000 is available

to fund approximately 18 awards. It is

expected that the average award will be

$25,000 ranging from $18,000 to

$32,000. States are encouraged to use

these funds to expand the community

involvement toward the goals of this

program.

B. 5 A Day Evaluation

Approximately $290,000 is available

to fund approximately 4 awards. It is

expected that the average award will be

$75,000 ranging from $60,000 to

$90,000. Awards will be considered

only for applicants who have an

established, clearly defined, and

evaluable long range 5 A Day for Better

Health project in a specific community

channel (e.g., supermarkets, schools,

churches, food assistance programs,

worksites, health clinics, media, etc.).

It is expected that the awards will

begin on or about September 28, 1995,

and will be made for a 12-month budget

period within a project period of one

year. Funding estimates may vary and

are subject to change.

Awards under this announcement

will not be sufficient to fully support an

applicant’s proposed activities, but are

meant to be used in conjunction with

other resources—whether direct funding

or in-kind contributions—that the

applicant may have available.

Purpose

The awards will support State efforts

to develop and evaluate nutrition

intervention programs. Emphasis will be

placed on supporting activities of

partnerships to carry out interventions
Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices 27529

and/or evaluations designed to increase

the consumption of fruits and

vegetables, to decrease fat intake, and/

or to increase physical activity while

improving diet.

Program Requirements

A. Nutrition Intervention Assistance

Promote programmatic activities to

achieve Healthy People 2000 dietary

objectives that relate to increased

consumption of fruits and vegetables,

reduced intake of fat, and/or improving

diet while increasing physical activity.

Applicants should propose specific and

discrete activities, but applicants are

given latitude in deciding which

specific activities to propose. Activities

proposed by applicants might include

but are not limited to the following:

1. Assist a Statewide or communitywide coalition to implement a 5 A Day

for Better Health project by using

effective public and private

partnerships.

2. Implement an intervention to

promote physical activity and improved

diet among a defined low-income

population.

3. Evaluate a health communication

campaign. (Such campaigns could be

broad-based, could target specific

populations, or could support specific

programs, such as Project LEAN or 5 A

Day for Better Health.)

4. Integrate a nutrition education

component into an existing State

chronic disease program (e.g., diabetes,

cancer, and heart disease prevention

programs) or into appropriate services of

a managed care provider.

B. 5 A Day Evaluation

An evaluation of a 5 A Day

intervention in a specific community

channel. Applicants should propose a

plan for an evaluation of a clearly

defined, long range effort in a specific

community channel.

Evaluation Criteria

Applications for the Nutrition

Intervention Assistance and the 5 A Day

Evaluation components will be

allocated 100 points each and will be

reviewed and evaluated according to the

following criteria:

A. Nutrition Intervention Assistance

1. Background

The degree to which the applicant

succinctly describes the problems to be

addressed and current activities for

resolving them. (10 points)

2. Objectives

The degree to which objectives are

realistic, time-phased, measurable, and

specific. (20 points)

3. Program Plan

The adequacy of the applicant’s plan

to carry out the proposed activities and

accomplish the stated objectives. (40

points)

4. Program Integration

The adequacy of the applicant’s

commitment to provide sufficient staff

and resources necessary to achieve the

program objectives. (20 points)

5. Evaluation

The extent to which the applicant

presents a reasonable plan to measure

progress in meeting objectives and

evaluate performance. (10 points)

6. Budget

The extent to which the applicant

provides a detailed budget and line item

justification that is consistent with the

stated objectives, program purpose, and

planned activities of the project. (not

weighted)

B. 5 A Day Evaluation

1. Background

The degree to which the applicant

clearly describes a long range, clearly

defined, evaluable 5 A Day for Better

Health project, including a description

of the intervention method and channel.

(25 points)

2. Program Plan

The adequacy of the applicant’s plan

to carry out the evaluation, including

the specific objectives and measures in

the evaluation. (45 points)

3. Capacity

The capabilities of the personnel

(including consultants where

appropriate) to carry out the evaluation.

(30 points)

4. Budget

The extent to which the applicant

provides a detailed budget and line item

justification that is consistent with the

evaluation plan. (not weighted)

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC for each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Clara M. Jenkins, 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–13, Atlanta, GA 30305, no

later than 60 days after the application

deadline date. The Program

Announcement Number and Program

Title should be referenced on the

document. CDC does not guarantee to

‘‘accommodate or explain’’ State process

recommendations it receives after the

date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to CDC, they should forward

them to Clara M. Jenkins, 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–13, Atlanta, GA 30305. This

should be done no later than 60 days

after the application date. The granting

agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

Public Health System Reporting

Requirements

This program is not subject to the Public

Health System Reporting Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.283.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (OMB

Number 0937–0189) must be submitted

to Clara M. Jenkins, 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, Mail Stop E–13, Atlanta, GA

30305, on or before June 30, 1995.

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
27530 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Notices

the objective review group. (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 accepted as proof

of timely mailing.)

2. Late Applications: Applications

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

1.(b) above 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

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Albertha Carey, 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, Mail

Stop E–13, Atlanta, GA 30305,

telephone (404) 842–6508.

Programmatic technical assistance may

be obtained from Judy Pruden, M.Ed.,

R.D., Division of Nutrition, National

Center for Chronic Disease Prevention

and Health Promotion, Centers for

Disease Control and Prevention (CDC),

4770 Buford Highway, NE., Mail Stop

K–26, Atlanta, GA, 30341–3724,

telephone (404) 488–4260.

Please refer to Announcement

Number 537 when requesting

information and 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: May 15, 1995.

Joseph R. Carter

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC)

[FR Doc. 95–12762 Filed 5–23–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

Advisory Committees; Notice of

Meetings

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces

forthcoming meetings of public advisory

committees of the Food and Drug

Administration (FDA). This notice also

summarizes the procedures for the

meetings 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.

MEETINGS: The following advisory

committee meetings are announced:

Oncologic Drugs Advisory Committee

Date, time, and place. June 8 and 9,

1995, 8 a.m., Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD.

Type of meeting and contact person.

Open public hearing, June 8, 1995, 8

a.m. to 9 a.m., unless public

participation does not last that long;

open committee discussion, 9 a.m. to 5

p.m.; open committee discussion, June

9, 1995, 8 a.m. to 11:30 a.m.; closed

committee deliberations, 11:30 a.m. to 4

p.m.; Adele S. Seifried, Center for Drug

Evaluation and Research (HFD–9), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4695, or FDA Advisory Committee

Information Hotline, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), Oncologic Drugs Advisory

Committee, code 12542.

General function of the committee.

The committee reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in treatment of cancer.

Agenda—Open public hearing.

Interested persons may present data,

information, or views, orally or in

writing, on issues pending before the

committee. Those desiring to make

formal presentations should notify the

contact person before June 5, 1995, 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 committee discussion. On June

8, 1995, the committee will discuss: (1)

New drug application (NDA) 50–704,

Daunoxome Injection (liposomal

daunorubicin, Vestar, Inc.) ‘‘as the

primary therapy for the palliative

management of advanced, HIVassociated Kaposi’s Sarcoma,’’ and (2)

NDA 20–449, Taxotere (docetaxel,

Rhone-Poulenc Rorer), for treatment of

‘‘patients with locally advanced or

metastatic breast carcinoma in whom

previous therapy has failed; prior

therapy should have included an

anthracycline unless clinically

contraindicated.’’ On June 9, 1995, the

committee will discuss NDA 20–221,

Ethyol (amifostine injection, U.S.

Bioscience, Inc.) ‘‘as a cytoprotective

agent against the cumulative renal

toxicities associated with cisplatin and

the cumulative hematologic toxicity

associated with cyclophosphamide and

cisplatin in patients with advanced

solid tumors of non-germ cell origin.’’

Closed committee deliberations. On

June 9, 1995, the committee will discuss

trade secret and/or confidential

commercial information relevant to

investigational new drugs (IND’s) and

pending NDA’s. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Orthopedic and Rehabilitation Devices

Panel of the Medical Devices Advisory

Committee

Date, time, and place. June 12, 1995,

8:30 a.m., Holiday Inn—Gaithersburg,

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD. A limited

number of overnight accommodations

have been reserved at the Holiday Inn—

Gaithersburg. Attendees requiring

overnight accommodations may contact

the hotel at 301–948–8900 and reference

the FDA panel meeting block.

Reservations will be confirmed at the

group rate based on availability.

Type of meeting and contact person.

Open public hearing, 8:30 a.m. to 9 a.m.,

unless public participation does not last

that long; open committee discussion, 9

a.m. to 12 m.; closed committee

deliberations, 12 m. to 1:30 p.m.; open

public hearing, 1:30 p.m. to 2 p.m.,

unless public participation does not last

that long; open committee discussion, 2

p.m. to 5 p.m.; Paula J. Wilkerson,