[Federal Register Volume 62, Number 111 (Tuesday, June 10, 1997)]
[Notices]
[Pages 31604-31610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15062]



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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

[[Page 31609]]

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