[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]
[[Page 31604]]
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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,
[[Page 31605]]
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
[[Page 31608]]
(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 gld1@cdc.gov.
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 byb0@cdc.gov.
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
