[Federal Register Volume 62, Number 130 (Tuesday, July 8, 1997)]
[Notices]
[Pages 36522-36528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17698]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 761]
Replication and Dissemination of Effective Breast and Cervical
Cancer Health Education Interventions
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of funds in fiscal year (FY) 1997 for cooperative
agreements to replicate and disseminate effective interventions for the
early detection of breast and cervical cancer. These efforts should
address health education for priority populations or professional
education for health service providers. Activities under this Program
Announcement are to be conducted in conjunction with the National
Breast and Cervical Cancer Early Detection Program (NBCCEDP).
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. (To order a
copy of Healthy People 2000, see the section WHERE TO OBTAIN ADDITIONAL
INFORMATION.)
Authority
This program is authorized by Sections 317(k)(2) and 1507 [42
U.S.C. 247b(k)(2) and 42 U.S.C. 300n-3] of the Public Health Service
Act, as amended.
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the nonuse of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, day care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Assistance will be provided to nonprofit public or private
organizations. Applicants must have affiliate/local offices or
organizations in more than, or with access to, two or more States, U.S.
territories, or Indian tribes or Indian tribal organizations. In
addition, applicants must have a primary relationship to one or more of
the priority populations or the health care providers who serve them. A
primary relationship is one in which the organization's service to the
priority population or to the health care providers who serve them is
viewed as the most important component of its mission.
National organizations; professional associations of health care
providers and their regional, State, and local constituents and
affiliates; are eligible to apply. These organizations provide a unique
opportunity to replicate and disseminate interventions that address
barriers to screening, enhance the quality of care, and improve the
priority population's access to and utilization of early detection
programs.
* * Applicants must complete the enclosed Eligibility Assurance
included in the application package and must attach documentation to
support compliance with these eligibility criteria.
Note: Effective January 1, 1996, Public Law 104-65 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code of 1986 which engages in lobbying activities shall not
be eligible for the receipt of Federal funds constituting an award,
grant (cooperative agreement), contract, loan, or any other form.
Glossary
Priority populations include uninsured or underinsured women, women
who are aged 50 years and older; women who are racial, ethnic, and
cultural minorities, such as American Indians, Alaskan Natives,
African-Americans, Hispanics, Asian/Pacific Islanders, Lesbians, women
with disabilities, and women who live in hard-to-reach communities in
urban and rural areas. Priority populations, as defined above, will be
used throughout this document.
Replication can include applying a proven, researched, and
theoretically-based intervention proven to be effective:
(a) With one disease and one priority population and then adapted
to breast and/or cervical cancer for another population or in a new
geographic area;
(b) For increased screening for breast and cervical cancer and
adapted for
[[Page 36523]]
another population or geographic area; or
(c) In increasing breast and cervical cancer screening in a limited
population and then expanded to reach more members of the same
population.
Intended partners are agencies working with priority populations
and health care providers for whom an intervention is appropriate.
These agencies will work with the cooperative agreement recipient to
implement the replication package.
Additional program definitions and information are included in the
application kit.
Availability of Funds
Approximately $3.5 million will be available in FY 1997 to fund
approximately 10 awards. It is expected that the average award will be
approximately $350,000, ranging from $250,000 to $400,000. It is the
intent of CDC to fund a balanced distribution of organizations that
propose a health education intervention for priority populations and
those that propose a professional education intervention, e.g. award
approximately five programs in each category.
It is expected that these awards will begin on September 29, 1997,
and will be made for 12-month budget periods within a project period of
up to 4 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. Funds may
not be expended for the purchase or lease of land or buildings,
construction of facilities, renovation of existing space, or the
delivery of clinical and therapeutic services. The purchase of
equipment is discouraged but will be considered for approval if
justified on the basis of being essential to the program and documented
that equipment is not available from any other source.
Use of Funds
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of Department
of Health and Human Services (HHS) funds for lobbying of Federal or
State legislative bodies. Under the provisions of 31 U.S.C. Section
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 Departments of Labor, HHS, and Education,
and Related Agencies 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.
Section 503 of this new law, as enacted by the Omnibus Consolidated
Appropriations Act, 1997, Division A, Title I, Section 101(e), Pub. L.
No. 104-208 (September 30, 1996), provides as follows:
Sec. 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.
Background
Breast Cancer
In the United States, approximately 500,000 women will die of
breast cancer this decade. Among women, breast cancer accounts for 29
percent of all new cancer cases and is the second leading cause of
cancer-related deaths. In 1996, the American Cancer Society estimated
that 184,300 women were diagnosed with invasive breast cancer and that
44,300 women died of this disease. Death rates from the disease are
highest among women aged 40 years or more, and among black women
compared with white women for those aged less than 70 years.
It is not currently known how to prevent breast cancer. Thus,
detecting carcinoma of the breast in its early stages is the key to
more treatment options, improved survival, and decreased mortality.
Research has shown that the use of mammography can reduce the mortality
attributable to breast cancer among women aged 50 years and older by 30
percent.
The percent of women who are regularly screened for breast cancer
decreases with age. The baseline data on mammography use from the 1992
National Health Interview Survey show that only 49 percent of women
aged 50 years and older reported having had a mammogram within the past
three years. This proportion was lower for racial and ethnic minority
women, for women who had less than a high school education, for women
who were over age 75 years, and for women who were living below the
poverty level. In Healthy People 2000, the CDC established that by the
year 2000, sixty (60) percent of women aged 50 years and older should
receive a mammogram annually.
Cervical Cancer
The overall incidence of invasive cervical cancer has decreased
steadily over the last several decades, but in recent years, this rate
has increased among women who are less than 50 years old. In 1996,
invasive cervical cancer was diagnosed among approximately 15,700
women, and carcinoma in situ was diagnosed among about 65,000 women,
and about 4,900 women died of cervical cancer.
The primary goal for cervical cancer screening is to increase
detection and treatment of precancerous cervical lesions and thus
prevent the occurrence of cervical cancer. Although no clinical trials
have studied the efficacy of Papanicolaou (Pap) test in reducing
cervical cancer mortality, experts agree that it is an effective
technology. Since the introduction of the Pap test in the 1940s,
cervical cancer mortality rates have decreased by 75 percent in the
United States.
In 1991, the PHS established that by the year 2000, 75 percent of
women should be receiving a Pap test within the preceding one to three
years. Baseline data on the use of the Pap test from the 1992 National
Health Interview Survey (NHIS) show that only 65 percent of women aged
18 years and older reported having had a Pap test within the past three
years. As with mammography screening, this proportion was lower for
racial and ethnic minority women, for women who had less than a high
school education, for women who were over 75 years of age, and for
women who had low incomes.
[[Page 36524]]
National Breast And Cervical Cancer Early Detection Program
In 1990, the U.S. Congress passed The Breast and Cervical Cancer
Mortality Prevention Act, Pub. L. 101-354 to reduce the morbidity and
mortality from breast and cervical cancer. This legislation enables
CDC, in partnership with State health departments, U.S. Territories,
and Indian tribes or Indian tribal organizations to make breast and
cervical cancer screening, referral, tracking, and follow-up services
available and accessible to women, with priority for services given to
low-income, and uninsured and underinsured women. Many women do not
have access to a well-coordinated and integrated approach to screening,
follow-up, and treatment services because of social, financial, and
geographic barriers.
In accordance with Pub. L. 101-354, a comprehensive program
includes the following program components: (1) breast and cervical
cancer screening, (2) referral and follow-up, (3) public health
education, (4) professional education, (5) quality assurance, and (6)
surveillance and program evaluation. Additionally, the success in
carrying out these programs requires appropriate partnership
development and community involvement. The importance of these program
components and a systematic, coordinated approach is necessary to
ensure maintenance of quality and comprehensive services. In FY 1997,
with a Congressional appropriation of $140 million, CDC funded 50
States, five U.S. territories, the District of Columbia, and 13 Indian
tribes or Indian tribal organizations.
Program success is enhanced when State, territorial, and tribal
resources and efforts are combined with those of other State,
territorial, and tribal programs, voluntary organizations, private
sector organizations, and community-based organizations through
partnership development. Statewide, territorial and tribal
comprehensive breast and cervical cancer control programs can make a
vital contribution to the nationwide effort to reduce morbidity and
mortality and to improve quality of life.
Purpose
The purpose of this program is to improve and change the knowledge,
attitudes, and behaviors of priority populations and/or the health care
providers that serve them related to breast and cervical cancer early
detection.
Ultimately the goal is to increase the number of women from the
priority populations served by the NBCCEDP through the development of
effective interventions and health care provider education. Examples of
interventions can include:
Public Health Education--
Interventions that reach priority populations and address
cultural differences between individual providers and their clients.
Interventions that have been effective with select
priority populations for other health concerns or chronic diseases that
have the potential to increase breast and cervical cancer screening for
priority populations.
Professional Education--
Training for health care providers that focus on breast
and cervical cancer skills building and application in a culturally
sensitive manner.
Interventions that incorporate culturally sensitive breast
and cervical cancers prevention education in medical, nursing, and
other health service provider curricula.
Interventions that change institutional polices and health
provider practices to improve access to screening services for priority
populations.
Program Requirements
CDC's intent is to support programs that will result in increased
screening and rescreening at CDC supported National Breast and Cervical
Cancer Early Detection Program (NBCCEDP) sites for priority
populations. Applicants:
A. Should focus on affecting the priority population with whom they
have the greatest likelihood of impacting or a professional
organization that can influence health provider behavior.
B. Are encouraged to collaborate with other agencies in the
replication and dissemination of an intervention that would target both
the women to be screened and the health care providers that serve them.
C. Must have a currently existing or develop a collaborative
relationship with recipients of the NBCCEDP in conducting these
projects.
In conducting activities to achieve the purpose of this program,
the recipient shall be responsible for conducting the activities under
A. Recipient Activities, and CDC shall be responsible for conducting
activities under B. CDC Activities.
A. Recipient Activities
Activities under this Cooperative Agreement are divided into five
phases. It is anticipated that recipients will complete and move from
one phase to the next at different times, depending on the expertise
and capabilities possessed by each. However, funding for each
successive phase will depend on the availability of funds and
documentation to CDC by the recipient that the previous phase has been
successfully completed.
1. Phase 1: Recipients will develop the replication package.
2. Phase 2: Recipients will develop plans to implement and evaluate
the replication package.
3. Phase 3: The replication package will be piloted.
4. Phase 4: The package will be refined based on the pilot
experience and then implemented to others.
5. Phase 5: Recipients will analyze the replication package and
prepare summary reports that address the effectiveness of the
replication. Good replication of interventions should include proper
process and outcome evaluation conducted throughout the span of the
cooperative agreement.
The program requirements for the first phase of activity are:
Develop the replication package in collaboration with grantees of
the NBCCEDP. The package will be written in language understandable to
nonresearchers and contain:
1. A full description of the intervention on which the replication
is based.
2. A list of the priority populations or the health care providers
for whom the replication would target.
3. A time line of specific steps and costs for setting up the
replication.
4. A list of the types of agencies needed for collaboration on the
replication and approaches to establishing linkages with them.
5. A list of all necessary materials, other resources, staff
commitment (numbers and time) and skills, and cost breakdowns for
conducting the replication.
6. Protocols for implementing the replication and ensuring its
quality and consistency.
7. If appropriate, plans for formative research with new or
expanded target audiences, with an explanation of how the original
intervention will be adapted or changed.
8. Specific strategies for overcoming barriers to implementation.
9. The replication package should include practical examples,
strategies, and suggestions from the original intervention and should
contain copies of all relevant materials.
The program requirements for the second phase of activity are:
[[Page 36525]]
Create a strategy to implement and evaluate the replication
package. The recipient will:
1. Compile a list of intended partners.
2. Select ways to inform intended partners about the availability
of the package. This strategy will be used to identify intended
partners who are interested in carrying out the intervention package
with the technical assistance of the recipient.
3. Create a timeline of specific steps and costs for marketing the
intervention.
4. Develop methods and procedures for evaluating process, outcome,
and cost-implications of the replication.
The program requirements for the third phase of activity are:
Pilot the replication package. The recipient will pilot test the
replication package with at least two selected sites. This should
include:
1. Develop procedures for collecting process data, e.g., on
unforeseen barriers to implementation, solutions to barriers, and cost
containment.
2. Implement the replication package with the partners at the pilot
sites.
3. Provide on-going technical assistance and consultation.
4. Provide a timeline of specific steps and costs for implementing
the intervention.
The program requirements for the fourth phase of activity are:
Implement the replication package. Based on the results of the
pilot test, the recipient will:
1. Refine the package and select at least four intended partners to
participate in the implementation of the replication package.
2. Provide the intended partners with the replication package and
with specific instructions for implementation.
3. Provide ongoing technical assistance and consultation.
4. Provide a timeline of specific steps and costs for conducting
the intervention.
The program requirements for the fifth phase of activity are:
Analyze and Evaluate the replication package. Such evaluation
should:
1. Use appropriate qualitative or quantitative methods.
2. Include an assessment of the fidelity of the implementation of
the intervention to the methods and protocols presented in the
replication package.
3. Provide a timeline of specific steps and costs for evaluating
the replication package.
4. Describe results of the replication package on priority
populations' or health care providers' behaviors.
Any materials developed in whole or in part with CDC funds shall be
subject to a nonexclusive, irrevocable, royalty-free license to the
Federal government to reproduce, translate, publish, or otherwise use
and authorize others to use for government purposes.
B. CDC Activities
1. Provide consultation and technical assistance regarding the
adaptation, implementation, and evaluation of the replication package.
2. Collaborate with recipients in developing, implementing,
evaluating and disseminating the replication packages designed to
improve and change the knowledge, attitude, and screening behaviors of
priority populations and/or the health care providers who serve them.
3. Monitor the recipient's performance of project activities and
attainment of project objectives through the provisions of technical
assistance and progress reporting.
4. Provide periodic updates about public knowledge, attitudes, and
practices regarding the early detection and control of breast and
cervical cancer and up-to-date scientific information.
5. Assist with the evaluation of project activities including the
analysis of ongoing process measures and the redirection of activities
as necessary.
6. CDC will cooperate with the preparation and publication of study
findings.
Technical Reporting Requirements
Progress Reports
An original and two copies of a progress report must be submitted
on a semiannual basis, no later than 30 days after the end of each 6-
month period. The semiannual progress reports should include:
A. A brief program description.
B. A comparison of the actual accomplishments to the goals and
objectives established for the period.
C. If established goals and objectives were not accomplished or
were delayed, describe both the reason for the deviation and
anticipated corrective action or deletion of the activity from the
project.
D. Other pertinent information including, when appropriate,
analysis and explanation of unexpectedly high costs for performance.
Financial Status Reports
An original and two copies of the financial status reports (FSR)
must be submitted no later than 90 days after the end of each budget
period. Final financial status and performance reports are required no
later than 90 days after the end of the project period. All reports are
submitted to the Grants Management Branch, Procurement and Grants
Office, CDC.
Application Content
Applicants may elect to submit proposals that address one of the
following types of activities: (1) health education interventions
designed to increase the participation of priority populations in
screening services; or (2) health care provider interventions designed
to build skills of health service providers to better encourage client
participation in screening services.
Applicants must develop their applications in accordance with PHS
Form 5161-1 (Rev. 7-92), information contained in the program
announcement, and the instructions below. The application, excluding
appendixes, should not exceed 50 pages.
A. Health Education and Professional Education Intervention(s)
1. Description and justification.
(a) Supply permission from the original developers of the proposed
intervention to replicate the intervention, including use of
appropriate materials, etc.
(b) Describe the intervention(s) to include:
(1) priority population for whom the replication package was
designed (including behavioral risks), (2) theoretical basis, (3)
intervention design and components, (4) programmatic objectives, (5)
behavior change goal, (6) methods of delivery, and (7) outcome
evaluation method. Identify the agency(ies) that originally developed,
conducted, and evaluated the intervention that will be the object of
the replication and dissemination.
(c) Substantiate the need for replication in terms of (1) size of
priority population, (2) appropriateness to selected population groups
(on the basis of analysis of the current data), (3) program objectives
of the intended partners, (4) and address the inclusion of women and
members of minority groups and their sub-populations.
2. Demonstrated effectiveness.
(a) Provide appropriate documentation of the original
intervention's effectiveness. This includes professional publications,
technical reports, or other appropriate documents. These documents
should address a description of the original intervention including the
population served, intervention components, and the time period in
which the intervention was conducted.
[[Page 36526]]
(b) Describe the research methods used that include what variables
were measured.
(c) Describe results of the evaluation.
B. Replication Package Plans for Implementation and Evaluation
1. Discuss the (1) purpose, (2) intended users, (3) programmatic
objectives, (4) format, and (5) message concepts of each component of
the package, and (6) how these features are appropriate for the
intended partners' needs and capabilities.
2. Explain how recipients of CDC's National Breast and Cervical
Cancer Early Detection Programs will be involved in the development of
the package.
3. Describe the proposed package (materials, protocols, and
guidelines). Examples: (1) priority populations for whom the
replication would be appropriate; (2) specific steps for setting up the
replication; (3) necessary collaborators; (4) necessary materials,
other resources, and staff commitment (numbers and time) and skills for
conducting the intervention; (5) protocols for carrying out the
replication and ensuring quality and consistency; (6) barriers to
implementation and how they were overcome; and (7) evaluation methods.
4. Outline the planned procedures for reviewing and piloting
materials developed as part of the package.
5. Present a timeline for developing the replication package.
C. Piloting the Replication Package
1. Discuss a plan to identify intended partners and indicate any
that have already shown interest in or may be interested in
implementing the replication package.
2. Describe how the participation of partners will be solicited.
3. Elaborate on the criteria and mechanism for selecting the
partners who will pilot the replication package.
D. Implementing the Replication Package
1. Describe the strategy to facilitate implementation of the
package, including direct technical assistance from the recipient to
the partners selected.
2. Discuss procedures to involve selected partners in implementing
the package to include use of the selected partner's existing staff and
resources, and barriers to implementation and how to overcome them.
Feasibility and ability to sustain the replication with existing
resources are important for the successful adoption of the package.
E. Evaluation Activities
Describe the plan for evaluating the replication package. Address:
(1) methods, (2) research protocols that should include ongoing process
and outcome measures, (3) supervision, (4) quality assurance, (5)
consistency, (6) confidentiality of participant information, (7)
employee recruitment and retention, (8) participant recruitment and
follow-up, (9) accuracy and completeness of record keeping, (10)
documentation of intervention episodes, (11) monitoring of intervention
delivery, and (12) forming and maintaining collaborative relationships.
F. Capacity
1. Demonstrate capacity to conduct the proposed activities.
2. Explain the proposed staffing, show percentages of each staff
member's commitment to this and other projects, division of duties and
responsibilities for this project; include brief position descriptions
for existing and proposed personnel.
3. Demonstrate that the staff have the expertise to complete this
project.
4. Discuss any partnership between the applicant and recipients of
CDC's National Breast and Cervical Cancer Early Detection Programs and
also general activities, such as project oversight that will contribute
to the completion of activities.
5. Name the staff members that are key to the completion of the
project. Include: (a) their curriculum vitae; (b) a description of
their experience with interventions, particularly those involving
breast and cervical cancer control, or the development, implementation,
and evaluation of other health interventions, (c) a description of
their work in developing partnerships with others, (d) and their
experience in providing technical assistance.
6. Describe equipment and facilities that will be used for the
proposed activities.
G. Budget
Provide a detailed budget and justification of all operating
expenses consistent with the stated objectives and planned activities
of the project. Be precise about the program purpose of each budget
item and itemize calculations when appropriate.
Typing and Mailing
Applicants are required to submit an original and two copies of the
application. Appendixes should be of a reasonable length; only include
documents necessary to support the application. Pages should be clearly
numbered and a complete index to the application and any appendixes
included. 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.
Evaluation Criteria (100 Points)
Applications will be reviewed and evaluated according to the
following criteria:
A. Health Education and Professional Education Intervention (17 Points
Total)
1. Description and justification (7 points) Thoroughness of the
description and quality of the original intervention design,
components, and methods. Appropriateness of the intervention methods
for the proposed priority population. Convincing need for the
intervention's replication. Feasibility of implementation by
organizations with limited resources. Documented permission from the
developers of the intervention proposed for replication to publicize
and market replication materials and protocols. As appropriate,
information is provided on the extent to which the proposed work
addresses the inclusion of women, racial and other ethnic minorities.
2. Documented effectiveness (10 points) Thoroughness of the
description of the documented effect of the intervention to be
replicated including evaluation and research findings. Extent of the
intervention's effectiveness, as defined in the APPLICATION CONTENT
section. Inclusion of publications.
B. Description of the Replication Package (18 Points)
Level of detail in the description or outline of the proposed
package, including materials, protocols, and guidelines. Clarity of
described intended audiences, objectives, format, and concepts.
Justification of the appropriateness of the package's objectives,
format, and concepts to the intended users' (e.g. health care providers
or community-based organizations) needs and capabilities. Level of
involvement from recipients of CDC's National Breast and Cervical
Cancer Early Detection Programs in development of the package. Adequacy
of method or strategy to review and pretest proposed materials. Time
scheduled for completing the proposed steps of the package's
development is realistic.
[[Page 36527]]
C. Description of Plan to Pilot the Package (15 Points)
Quality of plan identifying proactive methods to identify and
solicit intended partnerships. Adequacy of criteria and mechanism for
selecting the partnerships for carrying out the package.
D. Description of Replication Implementation (15 Points)
Clarity of the strategy to coordinate with selected partners in
adopting and implementing the replication package. Understanding of
barriers to implementation and demonstration of how to identify and
overcome them. Adequacy and feasibility of plan to assist selected
partners in implementing the replication package using their existing
resources and staff.
E. Description of Plan to Evaluate Implementation (15 Points)
Feasibility and appropriateness of the plan to evaluate the
selected partner's implementation of the replication package.
Intervention components to be evaluated are thorough and realistic.
F. Demonstrated Capacity (20 Points)
Overall ability of the applicant to perform the proposed activities
as reflected in their staff's and consultant's qualifications,
experience with intervention development, evaluation, dissemination,
and demonstrated familiarity with breast and cervical cancer screening
interventions. The ability to publicize the replication. Adequacy of
existing support staff, equipment, and facilities.
G. Budget (Not Weighted)
Extent to which the budget is reasonable, itemized, clearly
justified, and consistent with the intended use of the funds.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants (other than federally recognized
Indian tribal Governments) should contact their State Single Point of
Contact (SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC 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, mail Stop E-18, Atlanta, Georgia 30305, no later than 30 days
after the application deadline. 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 Office,
Grants Management Branch, Centers for Disease Control and Prevention
(CDC), 255 East Paces Ferry Road, NE., Room 314, Mailstop E-18,
Atlanta, Georgia 30305. This should be done no later than 30 days after
the application deadline. 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 to 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
individuals or more 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, including those surrounding the
issues of human subjects.
Women, Racial, and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(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 Indians, Alaskan Natives, Asian/Pacific Islanders, Blacks and
Hispanics. Applicants shall ensure that 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. This policy does not apply to
research studies when the investigator cannot control the race,
ethnicity, or sex of participants. Further guidance to this policy is
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951,
and dated Friday, September 15, 1995.
[[Page 36528]]
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1
(Revised 7-92, OMB #0937-0189) must be submitted to Sharron P. Orum,
Grants Management Officer, Procurement and Grants Office, Centers for
Disease Control and Prevention, 255 East Paces Ferry Road, NE., Room
314, MS E-18, Atlanta, GA 30305, on or before August 15, 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 will not be accepted as proof of timely mailing.)
2. Late Applications: Applications that do not meet the criteria in
1.a. or 1.b. above are considered late applications. Late applications
will not be considered in the current competition and will be returned
to the applicant.
Where to Obtain Additional Information
To receive additional written information, call (404) 332-4561. You
will be asked to leave your name, address, and telephone number. Please
refer to Program Announcement 761. 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 Albertha Carey, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 314, Mail Stop
E-18, Atlanta, Georgia 30305, telephone (404) 842-6591; electronic mail
at ayc1@cdc.gov.
Programmatic technical assistance may be obtained from Corinne
Graffunder or Patti Poindexter, Program Services Branch, 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 (770) 488-4880; electronic mail at com5@cdc.gov
and pxt1@cdc.gov, respectively.
You may obtain this announcement from one of two Internet 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).
Please refer to Announcement Number 761 when requesting information
and submitting an application.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report; Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report; Stock No. 017-001-00473-1) referenced in the Introduction
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325; telephone (202) 512-1800.
Dated: July 1, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-17698 Filed 7-7-97; 8:45 am]
BILLING CODE 4163-18-P
