Primary Prevention Skin Cancer Strategies for Children, Parents, and Caregivers

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 775]

Primary Prevention Skin Cancer Strategies for Children, Parents,

and Caregivers

Introduction

The Centers for Disease Control and Prevention (CDC) announces the

availability of fiscal year (FY) 1997 funds for cooperative agreement

projects for primary prevention of skin cancer, and to build a national

primary prevention effort that targets children (aged 0-13), parents,

and caregivers. Caregivers are defined as those individuals who spend a

significant number of consecutive hours with a child or children on a

daily basis, i.e., grandparents, day-care workers, teachers, foster

parents, etc. Project activities will be developed to complement

previous and ongoing efforts of the National Skin Cancer Prevention

Education Program (NSCPEP) and focus on two program options. Applicants

may choose one or both of the options. The strategies or activities

proposed for each option chosen must be clearly identified and stand

alone, and applications must include separate narratives and budgets

for each option selected.

Applicants not adhering to this requirement will be disqualified.

Option One: Develop and conduct a skin cancer primary prevention

intervention.

Option Two: Develop partnerships, coalitions, or interest groups

with the lay, professional, and scientific community that supplement

and support the primary prevention efforts of the NSCPEP.

CDC is committed to achieving the health promotion and disease

prevention objectives of ``Healthy People 2000,'' a national activity

to reduce morbidity and mortality and to improve the quality of life.

This announcement is related to the priority area of Cancer. (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) of the Public

Health Service Act, as amended (42 U.S.C. 247b(k)(2)). Applicable

program regulations are found in 42 CFR part 51b--Project Grants for

Preventive Health Services.

Smoke-Free Workplace

CDC strongly encourages all grant recipients to provide a smoke-

free workplace and to promote the non-use of all tobacco products, and

Pub. L. 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

Eligible applicants are public and private not-for-profit

organizations, governments, and their agencies. Thus, universities,

colleges, research institutions, other not-for-profit public and

private organizations, State and local governments or their bona fide

agents, federally recognized Indian tribal governments, Indian tribes

or Indian tribal organizations, and small, minority-and/or women-owned

not-for-profit businesses are eligible to apply.

Note: Organizations described in section 501(c)(4) of the

Internal Revenue Code of 1966 that engage in lobbying are not

eligible to receive Federal grant and cooperative agreement funds.

Availability of Funds

Approximately $800,000 is available in FY 1997 to fund

approximately four awards. A minimum of one award will be made for each

of the Options. The average award will be $200,000, with awards ranging

from approximately $150,000 to $250,000. It is expected that the awards

will begin on or about September 30, 1997, and will be for a 12-month

budget period within a project period of up to 3 years. Funding

estimates may vary and are subject to change.

Continuation awards within the project period will be made on the

basis of satisfactory progress and the availability of funds.

Use of Funds

Restrictions on Lobbying

Applicants should be aware of restrictions on the use of HHS funds

for lobbying of Federal or State legislative bodies. Under the

provisions of 31 U.S.C. 1352 (which has been in effect since December

23, 1989), recipients (and their subtier contractors) are prohibited

from using appropriated Federal funds (other than profits from a

Federal contract) for lobbying Congress or any Federal agency in

connection with the award of a particular contract, grant, cooperative

agreement, or loan. This includes grants/cooperative agreements that,

in whole or in part, involve conferences for which Federal funds cannot

be used directly or indirectly to encourage participants to lobby or to

instruct participants on how to lobby.

In addition, the FY 1997 HHS Appropriations Act, which became

effective October 1, 1996, expressly prohibits the use of 1997

appropriated funds for indirect or ``grass roots'' lobbying efforts

that are designed to support or defeat legislation pending before State

legislatures. This new law, Section 503 of Public Law 104-208, provides

as follows:

Section 503(a) No part of any appropriation contained in this

Act shall be used, other than for normal and recognized executive-

legislative relationships, for publicity or propaganda purposes, for

the preparation, distribution, or use of any kit, pamphlet, booklet,

publication, radio, television, or video presentation designed to

support or defeat legislation pending before the Congress, * * *

except in presentation to the Congress or any State legislative body

itself.

(b) No part of any appropriation contained in this Act shall be

used to pay the salary or expenses of any grant or contract

recipient, or agent acting for such recipient, related to any

activity designed to influence legislation or appropriations pending

before the Congress or any State legislature.

Department of Labor, Health and Human Services, and Education, and

Related Agencies Appropriations Act, 1997, as enacted by the Omnibus

Consolidated Appropriations Act, 1997, Division A, Title I, section

101(e), Public Law 104-208 (September 30, 1996).

Background

Skin cancer is the most common form of cancer in the United States,

which accounts for more than one million new cases annually or roughly

one third of all new cancer cases. Basal and squamous cell skin cancers

are the most common types of skin cancer and tend to have a low

mortality but high morbidity that may result in disfigurement and

disability. Melanoma has a lower incidence, but a higher mortality rate

among the skin cancers. The American Cancer Society estimates that in

1997, 40,300 persons will be diagnosed with melanoma of the skin and

7,300 will die from the disease. There will be a projected total of

9,490 deaths, 2,100 resulting from basal cell, squamous cell, and a

small proportion of more rare skin cancers. From 1973-1992, the overall

percentage increase in the rate of death of melanoma (34.1%) was the

third highest of all cancers. Incidence rates are over 10 times higher

among whites than among blacks (11.7 per 100,000 v. 0.8 per 100,000 for

the period 1985-1989). Mortality from cutaneous melanoma has increased,

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although less rapidly than the incidence. Survival has improved partly

because of an increase in the proportion of cases diagnosed at the

localized stage.

Unprotected exposure to ultraviolet radiation, from the sun or

nonsolar sources such as tanning beds, is strongly associated with skin

cancer. Melanoma appears to have a strong association with early life

sun exposure and sunburns. Because of the apparent link between severe

sunburns during childhood and increased risk of melanoma later in life,

special efforts should be made to protect children from the sun. Basal

cell cancer and melanoma appear to be occurring at earlier ages, which

implies the early initiation of activities that significantly increase

sun exposure among children.

There are some predisposing risk factors that appear to heighten

the propensity for the development of skin cancer such as the presence

or family history of skin cancer; large mole count; fair or light

colored complexion, hair and eyes; and skin that readily burns from sun

exposure.

Currently, it is recommended that people of all ages, and

especially those with light complexions, limit sun exposure. Parents

and caregivers should limit sun exposure for infants and children.

Childhood education is considered a priority target for prevention

because children receive an estimated 70-80 percent of lifetime sun

exposure before the age of 18; excessive sun exposure early in life

appears to increase the risk of the subsequent development of skin

cancer later in life, and beneficial behavior patterns established

during early childhood often persist throughout life. Children are

particularly at risk for sun exposure and have the greatest lifetime

potential to benefit from positive sun protection habits. Strategies

should identify discrete actions children, parents, and caregivers can

take to assure adequate protection from the sun.

Since 1994, CDC has been developing and implementing the NSCPEP

program. Related projects funded by CDC include: development and

evaluation of skin cancer primary prevention education strategies;

media campaigns with resultant widespread media dissemination; national

skin cancer prevention education agenda-setting meetings; development

of partnerships; development of educational brochures with other

agencies and organizations, and development of guidelines for skin

cancer prevention in the school and community. In the fall of 1996, CDC

co-sponsored and participated in a workshop related to basal cell and

squamous cell skin cancers, spear-headed by the National Institute of

Arthritis, Musculoskeletal, and Skin Diseases, National Institutes of

Health. Workshop deliberations affirmed the need to develop strategies

aimed at the protection of children from over exposure to the sun and

the recommendations reflected this. The previously mentioned activities

have provided guidance and focus to CDC's advances in skin cancer

prevention. As a result, CDC will continue to focus efforts on primary

prevention strategies that support the initiation, growth, and

maintenance of the NSCPEP, partnerships with national professional

organizations, agencies, institutions, and the media.

Purpose

This program will assist in developing and building upon efforts

that are consistent with the NSCPEP. The primary goal of this program

is to develop, conduct, and evaluate strategies that effectively reach

children, parents, and caregivers, and are aimed at reducing skin

cancer through the adoption of preventive behaviors and the institution

of sun protection measures. These measures may include environmental

interventions, such as physical/structural modifications or incentives.

Such strategies could include providing physical structures and

accompanying incentives to seek shade, and requiring the use of hats,

protective clothing, etc., when outside or altered times for outdoor

activities.

Program Requirements

In conducting activities to achieve the purpose of this program,

the recipient will be responsible for the activities under A.

(Recipient Activities) and CDC will be responsible for the activities

under B. (CDC Activities).

A. Recipient Activities

Option One: Develop and conduct a skin cancer primary prevention

intervention.

1. Seek input from persons in the targeted population,

representative interest groups, and persons who can complement

activities and provide expertise such as medical, behavioral, and

public health perspectives.

2. Inventory resources needed to develop, conduct, and evaluate the

intervention, such as hardware, software, skills, capabilities, and

material and logistic resources, e.g. training materials,

transportation, etc.

3. Develop the intervention.

4. Develop procedures and tools for collecting pre-intervention

data, intervention process data, and post intervention data.

5. Create a marketing plan. Include testing of the plan to ensure

that adequate numbers of the targeted population are informed and have

the opportunity to participate.

6. Pilot test the intervention among a representative sample of the

targeted population.

7. Conduct the intervention in a defined targeted population,

taking into account modifications and adjustments identified during the

pilot test.

8. Analyze and evaluate the results of the intervention using

appropriate qualitative or quantitative methods. Include an assessment

of the fidelity of the methodology and protocol, and a description of

results with respect to awareness, knowledge, and to the degree

possible, behavioral change attributed to the intervention in the

targeted population.

9. Participate in conferences, workshops, and meetings convened by

CDC.

Option Two: Develop partnerships, coalitions, or interest groups

with the lay, professional, and scientific community that supplement

and support the primary prevention efforts of the NSCPEP.

1. Define and provide justification for the scope of the proposed

partnerships, coalition(s), or interest group(s). The scope can be a

diverse group of interested agencies and organizations, including

public health; public and private education agencies; voluntary

organizations; advocacy groups; not-for-profit and for profit

organizations, etc., or a more narrowly defined group of interested

agencies and organizations that has as their constituent base the

populations for which this program is intended, for example, children

and youth organizations; schools; media and private sector partners;

parks and recreation organizations; U.S. sport and athletic

organizations, parent organizations, etc. The magnitude of reach should

describe the level at which the activities will occur (local, State,

regional, or national).

2. Develop the purpose, mission, objectives, and expected outcomes

of the partnerships, coalition(s), or interest group(s).

3. Develop criteria for selecting members based on #2, include

length of the term and ways to optimize member involvement and buy in.

4. Define the level of involvement and expected contributions of

members. Address issues related to organizational structure and

function; composition of subcommittees and ad hoc committees; decision

making processes, etc.

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5. Identify ways to enhance process efforts, such as building

infrastructure, facilitating group process and communication, and

planning and attending to meeting logistics.

6. Establish an initial agenda for action and facilitate group

process to develop a purpose, short-and long-term goals, and

activities.

7. Develop a strategy to sustain partnerships, coalition(s), or

interest group(s).

8. Describe plans for integrating efforts and activities into

ongoing national efforts.

9. Develop a mechanism for monitoring and reporting coalition

activities and accomplishments. This may include, but is not limited

to, meeting minutes, attendance logs, operational and procedural

manuals, etc.

10. Participate in conferences, workshops, and meetings convened by

CDC.

B. CDC Activities

1. Provide scientific and programmatic technical assistance.

2. Participate with and assist recipient in identifying appropriate

agencies and organizations that will enhance project activities.

3. Collaborate with recipients to develop, implement, evaluate, and

disseminate project activities designed to improve and change the

knowledge, attitude, and impact on behaviors of the targeted groups.

4. Monitor the recipient's performance of project activities,

attainment of project objectives, and compliance with other CDC

requirements.

5. Provide periodic updates about skin cancer prevention public

knowledge, attitudes, and practices, and scientific data when

available.

6. Assist with the design and conduct of the evaluation plan,

including project outcomes and process measures, and modifications, as

deemed necessary.

7. Coordinate dissemination of recipients' experiences and results

through grantee meetings, workshops, and conferences with other CDC

recipients, other NSCPEP projects, and CDC.

8. Assist recipients with dissemination of project results in the

public domain, through venues such as professional publications,

presentations at conferences, etc.

Technical Reporting Requirements

Semi-annual progress reports are required and must be submitted no

later than 30 days after each semi-annual reporting period. The semi-

annual progress reports must summarize the following: (1) A comparison

of actual accomplishments to the goals and objectives established for

the reporting period; (2) the reasons for slippage if established goals

were not met; and (3) other pertinent information, including, when

appropriate, analysis and explanation of unexpectedly high costs for

performance.

An annual financial status report must be submitted no later than

90 days after the end of each budget period. Final financial and

performance reports are required no later than 90 days after the end of

the project period. All reports must be submitted to the Grants

Management Branch, Procurement and Grants Office, CDC.

Application Content

All applicants must develop their applications in accordance with

PHS Form 5161-1 (Revised 7/92, OMB Number 0937-0189), information

contained in this program announcement, and the instructions outlined

below. Applicants are required to submit an original and two copies of

the application. Pages must be clearly numbered, and a complete index

to the application and its appendixes must be included. Begin each

separate section on a new page. The original and each copy of the

application must be submitted unstapled and unbound. All materials must

be typewritten, single-spaced, with unreduced type on 8\1/2\ by 11''

paper, with at least 1'' margins, headers and footers, and printed on

one side only.

Appendixes should be of a reasonable length; only include documents

necessary to support the application, such as Letters of Support and

examples of relevant work, as requested.

Applicants should discuss technical, programmatic, and public

health expertise they can offer in the development of national skin

cancer prevention efforts and in participation in national meetings and

on committees and task forces. An evaluation plan should be included

with the application.

Applicants may elect to submit proposals that address one or both

of the options. Each option must be treated as a separate submission or

application and the application(s) should not exceed 30 pages,

excluding appendixes.

Option One: Develop and conduct a skin cancer primary prevention

intervention.

Option Two: Develop partnerships, coalitions, or interest groups

with the lay, professional, and scientific community that supplement

and support the primary prevention efforts of the NSCPEP.

A. Executive Summary

Provide a clear, concise, one-page summary of: (1) The capabilities

and experience in conducting activities related to the Option selected.

Include any activities conducted in skin cancer prevention; (2) the

major objectives of the proposed project; (3) roles and

responsibilities of proposed project personnel, including

collaborators; and (4) the estimated total cost of the project,

including the total funds requested.

B. Demonstrated Capabilities

Provide evidence, based on previous projects, of the ability to:

Option One: Develop and conduct a skin cancer primary prevention

intervention.

1. Describe examples of previous primary prevention intervention

work, including those in skin cancer prevention or in other health

areas. Discuss organization capability, scope, magnitude of reach

(local, State, regional, national), targeted population, process and

evaluation methodology, and description of the outcomes and efficacy.

2. Include evidence of adequate resources to develop, conduct and

evaluate interventions, such as staff expertise, facilities, hardware,

and software. Describe the capabilities available to obtain additional

resources when appropriate.

3. Include evidence of direct work with children, parents, and

caregivers, and/or evidence of collaborative efforts on projects with

interest groups and organizations, representing children, parents, and

caregivers, that have conducted primary prevention interventions,

including those in skin cancer prevention or in other health areas.

Option Two: Develop partnerships, coalitions, or interest groups

with the lay, professional, and scientific community that supplement

and support the current efforts of the primary prevention educational

activities of the NSCPEP.

1. Describe previous experiences and provide examples of

development or substantive participation and sustain ability of

previous partnerships, coalition(s), or interest group(s). Include

names or types of members, scope, magnitude of reach (local, State,

regional, national), process and evaluation methodology, and a

description of outcomes and efficacy.

2. Describe the organizational role and processes employed to

ensure adequate

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resources to develop, implement, evaluate, and sustain partnerships,

coalition(s), or interest group(s).

3. Describe and include evidence of past or current experience and

participation in partnerships, coalition(s), or interest group(s) that

have children, parents, or caregivers as constituents, and that have

conducted prevention activities.

4. Include final reports, proceedings, materials developed, or a

list of accomplishments resulting from group activities in the

appendix.

C. Project Objectives

Submit overall project objectives that are specific, measurable,

realistic, and time-phased. Activities during year 01 through year 03

should be related and build on previous work. This should be reflected

in the overall project objectives. The objectives and activities

related to year 01 should be described in detail. Year 02 and 03

objectives and activities should be briefly described. End-of-year and

end-of-project expected outcomes should be included.

D. Operational Plan

Describe the operational plan for achieving each of the objectives

established in section C. Provide a concise description of each major

activity, and how it will be carried out. Include proposed

collaborative efforts. Include relevance to the National Skin Cancer

Prevention Education Program efforts. The plan must have a timeline for

completion of each major activity. The year 01 timeline must include

specific process steps and include CDC review and approval.

Letters of support that specify the precise nature of proposed

collaboration, and the products, services, capabilities, or other

activities that will be provided through the collaboration should be

included in the appendix.

Specifically for the Option selected, the Operational Plan should

include the following:

Option One: Develop and conduct a skin cancer primary prevention

intervention.

1. Describe and provide a rationale for the proposed intervention.

Include specific process steps that will be undertaken to accomplish

the proposed project. These steps should include, but are not limited

to:

(a) The extent of problem; targeted population selection and

rationale; baseline data on knowledge, attitudes, and practices;

literature review; incorporation of existing primary prevention or skin

cancer prevention efforts; theoretical framework; goals and objectives;

development of intervention and marketing plan, including testing of

the intervention, to ensure that adequate numbers of the targeted

population are informed and have the opportunity to participate, and

development of data collection tools. Include the availability of

resources to be used on this project, such as skills, capabilities,

materials, and facilities.

(b) Plans for the implementation of the intervention, following the

pilot or pretesting of the intervention in a sample population. Include

sampling, mechanisms for modification and retesting, and conduct of the

intervention in the population.

(c) The formative, outcome, and process measures proposed, and the

methodology used to evaluate these measures.

(d) The expected impact on the efforts of the NSCPEP.

2. Include specific plans to collaborate with key agencies and

organizations representing targeted populations, CDC, other grantee

recipients, and current NSCPEP efforts. Include letters of support (in

the appendixes) from agencies and organizations with a substantive role

in the proposed activities.

3. Include a detailed timeline for all proposed activities.

4. Include evaluation methodology of the intervention by using

appropriate qualitative or quantitative methods. Include an assessment

of the fidelity of the selected methodology and protocol, and a

description of proposed results with respect to awareness, knowledge,

and to the degree possible, behavioral change attributed to the

intervention in the targeted population.

Option Two: Develop partnerships, coalitions, or interest groups

with the lay, professional, and scientific community that supplement

and support the primary prevention efforts of the NSCPEP.

1. Include the scope of partnerships, coalition(s), or interest

group(s). This should include the proposed composition (diverse versus

narrow) and the proposed magnitude of reach (local, State, regional, or

national).

2. Include the proposed purpose, objectives, and expected outcomes

of the partnerships, coalition(s), or interest group(s).

3. Include criteria used for selecting members, ways to use and

optimize member involvement, plans to sustain membership and proposed

members or types of members. Include in the appendix, Letters of

Support from persons interested and willing to participate.

4. Include process steps used to conduct the meetings; facilitate

group process; build group infrastructure; communicate with the group

before, during, after, and between meetings; and manage and plan for

meeting activity logistics, including travel, meeting space, etc.

5. Include an initial plan for action and methods for facilitating

the group to develop the purpose; short- and long-term goals; and

activities of the group.

6. Include a detailed timeline for all proposed activities.

7. Include plans to coordinate with other grantees, and other

NSCPEP skin cancer prevention coalitions currently in progress, and

CDC.

E. Project Management

Describe the capabilities, function, time dedication, and

qualifications required for each position. Include collaborators, their

qualifications, and reason for their selection.

Specifically for Option selected, Project Management should include

the following:

Option One: Provide evidence that a well-balanced team of experts

has been assembled to assure that the intervention selected will be

designed and developed by using necessary sciences. Include behavioral

scientists, evaluation scientists, dermatologists, public health

personnel, and the targeted audience in all steps of the process.

Option Two: Provide evidence that a staff person or a consultant

has been retained who has expertise in group process and facilitation,

as well as substantive experience in coalition development, management,

and evaluation. Include evidence of strong management, organizational,

and human relations skills.

F. Budget

Provide a detailed budget request (using Standard Form 424A

``Budget Information'') and line-item justification of all proposed

operating expenses consistent with the option selected and the proposed

activities. Use the sample budget included in the application kit as a

guide to budget development. Include the following:

1. Travel plans in year 01: Budget two trips to CDC in Atlanta,

Georgia, for conferences, workshops, or a reverse site visit. Plan to

travel one or two persons, for one to three days.

2. All proposed contracts must indicate the following: (1) Name of

contractor, (2) Method of selection, (3) Period of performance, (4)

Scope of work, (5) Method of accountability, and

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(6) Detailed budget with a justification for costs.

Evaluation Criteria (Total of 100 Points)

The application will be reviewed and evaluated according to the

following criteria:

A. Demonstrated Capabilities (20 Points Each)

The extent to which all items in the application content are

addressed for Option selected including:

1. Provides examples of previous work similar to the nature of

Option selected. Includes targeted populations, scope, magnitude of

reach (local, State, regional, national), evaluation methodology, and

outcomes and efficacy.

2. Provides evidence of adequate resources to develop, conduct, and

evaluate activities, such as staff expertise, working knowledge of

Option selected, facilities, logistical support, and hardware and

software.

3. Provides evidence of direct work with children, parents and

caregivers, or evidence of collaborative efforts on projects with

interest groups and organizations representative of these that have

conducted prevention activities.

B. Project Objectives (20 Points)

The extent to which all items in the application content are

addressed for Option selected including:

The appropriateness of proposed objectives that are specific,

measurable, time-phased, and realistic for year 01 activities, and a

brief description of proposed objectives for years 02 and 03, and the

extent to which end-of-year, and end-of-project expected outcomes are

described and effect the effort of the National Skin Cancer Prevention

Education Program. Epidemiologic data should be included to support and

prioritize the need for a targeted primary prevention activity in the

Option selected.

C. Operational Plan (Option One: 40 Points Total, 25 Points for the

General Operational Plan and 15 Points for the Evaluation Plan; Option

Two: 35 Points Total, 25 Points for the General Operational Plan and 10

Points for the Evaluation Plan)

The extent to which all items in the application content are

addressed for Option selected including:

1. Provides evidence of a planning process that includes data and

needs assessment, literature review, activity selection, and selection

of the targeted population (Option One), partnerships, coalition(s), or

interest group(s) (Option Two).

2. Provides a cogent, logical, complete description and process

steps of activities.

3. Provides goals, project objectives, and expected outcomes.

4. Provides a timeline that includes CDC review and approval at

critical decision-making and work-related steps.

5. Provides evidence of resources necessary to successfully address

the activities, such as skills, capabilities and staff, logistical

support, and hard and software necessary to carry out Option selected.

6. Provides a plan to market and disseminate activities.

7. Provides an Evaluation Plan that includes the methodology for

monitoring formative process, and outcome measures. Includes a

description of data collection tools; CDC collaboration, review and

approval; Human Subjects, Minorities and Women Research review and

other agency review.

D. Project Management (Option One: 20 Points Each; Option Two: 25

Points)

The extent to which all items in the application content are

addressed for Option selected including:

Provides a description of the capabilities, function, and

qualifications of the proposed staff, staff functions, and other

resources needed to effectively perform requested activities in

selected Option.

E. Budget (Not Weighted)

The extent to which the applicant provides a detailed budget and

justification consistent with the stated objectives and proposed

project activities for Option selected included in the application

content and with this program announcement.

F. Human Subject (Not Weighted)

Whether or not exempt from the Department of Health and Human

Services (DHHS) regulations, are procedures adequate for the protection

of human subjects? Recommendations on the adequacy of protections

include: (1) Protections appear adequate and there are no comments to

make or concerns to raise; (2) protections appear adequate, but there

are comments regarding the protocol, (3) protections appear inadequate

and the Objective Review Group (ORG) has concerns related to human

subjects; or (4) disapproval of the application is recommended because

the research risks are sufficiently serious and protection against the

risks are inadequate as to make the entire application unacceptable.

Noncompeting Continuation Application Content

In compliance with 45 CFR 74.121(d) and 92.10(b)(4), as applicable,

noncompeting continuation applications submitted within the project

period need only include:

A. A brief progress report that describes the accomplishments of

the previous budget period.

B. Any new or significantly revised items or information

(objectives, scope of activities, operational methods, evaluation,

etc.) not included in the Year 01 application.

C. An annual budget and justification. Existing budget items that

are unchanged from the previous budget period do not need re-

justification. Simply list the items in the budget and indicate that

they are continuation items. Supporting justification should be

provided where appropriate.

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 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 of 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 Sharron P. Orum, Grants Management Officer,

Grants Management Branch, Procurement and Grants Office, Centers for

Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,

Room 314, Mailstop E-18, 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. The granting agency

does not guarantee to ``accommodate or explain'' State process

recommendations it receives after that 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 Sharron P. Orum, Grants Management Officer,

Grants Management Branch, Procurement and

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Grants Office, Centers for Disease Control and Prevention (CDC), 255

East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA 30305.

This should be done no later than 60 days after the application

deadline 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 subject to the Public Health System Reporting

Requirements. Under these requirements, all community-based

nongovernmental applicants must prepare and submit the items identified

below to the head of the appropriate State and/or local health

agency(s) in the program area(s) that may be impacted by the proposed

project no later than the receipt date of the Federal application. The

appropriate State and/or local health agency is determined by the

applicant. The following information must be provided:

a. A copy of the face page of the application (SF 424).

b. A summary of the project that should be titled ``Public Health

System Impact Statement'' (PHSIS), not exceed one page, and include the

following:

(1) A description of the population to be served;

(2) A summary of the services to be provided; and,

(3) A description of the coordination plans with the appropriate

State and/or local health agencies.

If the State and/or local health official should desire a copy of

the entire application, it may be obtained from the state Single Point

of Contact (SPOC) or directly from the applicant.

Catalog of Federal Domestic Assistance Number

The Catalog of Federal Domestic Assistance Number is 93.283.

Other Requirements

Paperwork Reduction Act

Projects that involve the collection of information from 10 or more

individuals and funded by the cooperative agreement will be subject to

review by the Office of Management and Budget (OMB) under the Paperwork

Reduction Act.

Human Subjects

If the proposed project involves research on human subjects, the

applicant must comply with the Department of Health and Human Services

Regulations, 45 CFR part 46, regarding the protection of human

subjects. Assurance 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 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 and the Agency for Toxic Substances and

Disease Registry (ATSDR) to ensure that individuals of both sexes and

the various racial and ethnic groups will be included in CDC/ATSDR-

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, Alaskan 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. In conducting review for scientific merit, review

groups will evaluate proposed plans for inclusion of minorities and

both sexes as part of the scientific assessment of scoring.

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, pages 47947-47951, dated Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the application PHS Form 5161-1

(Revised 7/92, OMB Number 0937-0189), must be submitted to Sharron P.

Orum, Grants Management Officer, Grants Management Branch, Procurement

and Grants Office, Centers for Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room 314, Mailstop E-18, Atlanta, GA

30305, on or before July 29, 1997.

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 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 acceptable as proof of timely mailing.)

2. Late Applications: Application which 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

To receive additional written information, call (404) 332-4561. You

will be asked to leave your name, address, and telephone number. Please

refer to Announcement 775. You will receive a complete program

description, information on application procedures and application

forms. If you have questions after reviewing the contents of all the

documents, business management technical assistance may be obtained

from Glynnis D. Taylor, Grants Management Specialist, Grants Management

Branch, Procurement and Grants Office, Centers for Disease Control and

Prevention, 255 East Paces Ferry Road, NE., Room 314, Mailstop E-18,

Atlanta, GA 30305, telephone (404) 842-6593, or Internet or CDC WONDER

electronic mail at [email protected].

Programmatic technical assistance may be obtained from Barbara A.

Bewerse, M.N., M.P.H., Division of Cancer Prevention and Control,

National Center for Chronic Disease Prevention and Health Promotion,

Centers for Disease Control and Prevention (CDC), 4770 Buford Highway,

NE., Mailstop K-57, Atlanta, GA 30341-3724, telephone (404) 488-4347,

or Internet or CDC WONDER electronic mail at [email protected].

Please refer to Announcement 775 when requesting information and

submitting an application.

You may obtain this and other announcements from one of two sites

on the actual publication date: CDC's homepage at http://www.cdc.gov or

the Government Printing Office homepage (including free on-line access

to the Federal Register at http://www.access.gpo.gov).

Potential applicants may obtain a copy of ``Healthy People 2000''

Full

[[Page 31610]]

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: June 4, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-15062 Filed 6-9-97; 8:45 am]

BILLING CODE 4163-18-P