[Federal Register Volume 62, Number 50 (Friday, March 14, 1997)]
[Notices]
[Pages 12208-12216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-6489]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement Number 731]
Research Projects for Health Promotion for Persons With
Disabilities and Prevention of Secondary Conditions; Notice of
Availability of Funds for Fiscal Year 1997
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 competitive grant and cooperative
agreement funds. Part 1 of this Announcement will support research
grants to: (a) Measure the magnitude of secondary conditions in
specified populations of persons who have a disability; (b) determine
the risk and protective factors that contribute to or avert the
occurrence of secondary conditions; (c) conduct and measure the
effectiveness of health promotion interventions designed to prevent
secondary conditions; and/or (d) understand the prevention
effectiveness and cost-effectiveness of interventions. Part 2 of this
Announcement will support one cooperative agreement project to prevent
the occurrence of pressure sores and other selected secondary
conditions among persons with spinal cord injury.
CDC is committed to achieving the health promotion and disease
prevention objectives described in ``Healthy People 2000,'' a national
activity to reduce morbidity and mortality and improve the quality of
life. This Announcement is related to the Healthy People 2000 category
of Preventive Services. (For ordering a copy of ``Healthy People
2000,'' see the section Where to Obtain Additional Information.)
Authority
This program is authorized by Section 301(a) (42 U.S.C. 241(a)) and
Section 317 (42 U.S.C. 247b) of the Public Health Service Act, as
amended.
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and promote the non-use of
[[Page 12209]]
all tobacco products. 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
Eligible applicants for this program are public and private non-
profit entities, including universities; university-affiliated systems
including not-for-profit medical centers; research institutions and
rehabilitation hospitals; State health departments and other related
State government agencies; disability service groups such as advocacy
and voluntary organizations and independent living centers; and
federally recognized Indian Tribal Governments.
Note: An organization described in section 501(c)(4) of the
Internal Revenue Code of 1986 which engages in lobbying activities
shall not be eligible to receive Federal funds constituting an
award, grant, contract, loan, or any other form.
Availability of Funds
This Announcement has two separate components as noted in the
INTRODUCTION section. Under Part 1, it is anticipated that
approximately $1,800,000 will be available in FY 1997 to support 6 to 8
research grant projects, with an expected range of awards from $220,000
to $280,000 each. Under Part 2, it is estimated that approximately
$250,000 will be available in FY 1997 to support one cooperative
agreement to prevent the occurrence of pressure sores and other
selected secondary conditions among persons with spinal cord injury.
Awards are expected to be made on or before August 1, 1997, for a
twelve-month budget period within a project period of up to three
years. Funding estimates are subject to change, including funds to be
awarded in continuation years based on documented progress toward
objectives, the quality of continuation year work plans, evidence of
cost-sharing, and the availability of funds.
This program has no statutory matching requirement. However,
applicants should document their financial support for a portion of
project costs, such as salaries for key staff and tangible
contributions by collaborating agencies. Applicants should also
demonstrate their capacity to increase cost-sharing over time, and
identify other funding sources to assist in project activities.
Use of Funds
Grant funds may be used to support personnel services, supplies,
equipment, travel, subcontracts, and other services directly related to
project activities consistent with the approved scope of work. Project
funds may not be used to supplant other available applicant or
collaborating agency funds, for construction, for lease or purchase of
facilities or space, or for patient care. Project funds may not be used
for individualized preventive measures (direct patient support) such as
for wheelchairs, medical appliances, or assistive technology unless
specifically approved by the funding agency.
Purpose
The purpose of grant awards under Part 1 is to develop better
understanding of the secondary conditions that occur among prescribed
groups of persons with disabilities. These awards will allow grantees
to measure the risk factors and protective factors for preventing
secondary conditions, and to assess the cost- and prevention-
effectiveness of interventions targeted to the needs of persons with
disabilities.
The purpose of the Part 2 cooperative agreement award is to design,
conduct, and report the findings of a model project to prevent pressure
sores and other selected secondary conditions among persons with spinal
cord injury. This project should explore the feasibility of a home-
based intervention; e.g., a public health nurse visitation program
addressing medical, social, and environmental factors associated with
the development of pressure sores and other selected secondary
conditions.
Projects receiving funds for either Part 1 or Part 2 are expected
to design, document, and publish the results of their research in a
manner that promotes generalizability so that academic institutions,
State and local agencies, disabilities service programs, and other
organizations concerned with public health and health promotion
programs for persons with disabilities and rehabilitation can benefit.
Project activities must provide evidence that all project programs will
involve and be accessible to persons with disabilities.
Background--General
The CDC Office on Disability and Health (proposed, current name-
Disabilities Prevention Program) has provided grant funds to
universities, rehabilitation hospitals, and State agencies since 1988
to increase understanding of the disabling process and conduct research
to prevent secondary conditions. Those research grants have focused on
the frequency, severity, cost, and significance of a specific, or a
range of secondary conditions associated with a prescribed primary
disability (e.g., spinal cord injury, traumatic brain injury, fetal
alcohol syndrome, cerebral palsy, and the late effects of polio).
Background for Part 1
Part 1 of the research emanating from this Announcement is designed
to examine, understand, and document the participation of persons with
disabilities within their social environment as related to a particular
disability domain. Disability domains are categories of activities that
individuals perform in everyday life. Applicants should propose grant
activities in at least one of the following disability domains: (1)
Mobility (locomotion); (2) personal care/home management; (3)
communication; and (4) learning. Descriptions and examples within these
disability domains are as follows:
1. Mobility (locomotion) refers to an individual's ability to
perform distinctive activities associated with moving; both himself and
objects, from place to place. Examples of underlying conditions or
diagnoses include spinal cord injury, cerebral palsy, arthritis, lower
limb loss, blindness, or stroke. Secondary conditions may include
urinary tract infections, cardiovascular deficit due to sedentary
lifestyle, pressure sores, results from falls, bowel obstruction,
dependence on assistive devices and its economic impact, lack of access
to medical care, and social isolation.
2. Personal Care/Home Management refers to an individual's ability
to perform basic self-care activities such as feeding, bladder and
bowel care, personal hygiene, dressing, financial management, and
homemaking. Examples of underlying conditions or diagnoses include
asthma, arthritis, stroke, osteoporosis, paraplegia, or multiple
sclerosis. Secondary conditions may include lack of physical fitness,
incontinence, weight gain, poor nutrition, and emotional dependence.
3. Communication refers to an individual's ability to generate and
express messages, and to receive and understand messages. Examples of
underlying conditions or diagnoses include cerebral palsy, deafness,
aphasia from varied pathology, or congenital speech impediments.
Secondary conditions may include family dysfunction, isolation, and
constraints and barriers in employment opportunity.
4. Learning refers to an individual's ability to profit from daily
experiences,
[[Page 12210]]
and includes aspects of receiving, processing, remembering, and using
information. Examples of underlying conditions or diagnoses include
mental retardation, spina bifida, fetal alcohol syndrome, or traumatic
brain injury. Secondary conditions may include depression, behavioral
problems, increased family stress, and poor academic and vocational
performance.
Note that the examples listed above are illustrative, and not
intended to be exhaustive; several secondary conditions may apply to
more than one disability domain. Because of limited funds and other
resources available, this Announcement does not include disabilities
created by psychiatric diagnoses, although mental health issues may be
appropriately included as secondary conditions.
The model of health promotion used for Part 1 of this Announcement
assumes a goal of promoting health and preventing secondary conditions
among persons with disabilities. The basic conceptual model is
represented by the International Classification of Impairments,
Disabilities, and Handicaps (ICIDH). Revisions proposed to the ICIDH
framework include definitions and concepts consistent with a broader
perspective of the disabling process. Of particular importance is the
utility of this paradigm for data collection, given its classification
of disabilities and related variables. Definitions referenced in this
framework are presented below:
1. Participation refers to the product of the interactions between
the individual and the environment, and is delineated by the outcomes
of that interaction. The intent of this dimension is to document the
nature and extent of a person's involvement in life activities. This
dimension is broadly analogous to the term ``Handicap'' in the ICIDH
(World Health Organization, 1980) model and the term ``Disability'' in
the Institute of Medicine (IOM, 1991) model.
2. Environment refers to the physical, social, and cultural
contexts in which the individual acts. Elements of the environment
create the backdrop for the individual's participation, as facilitators
or hindrances.
3. Impairment refers to loss or abnormality in a body structure,
organ, or system as a consequence of disease, injury, or congenital
disorder. In the context of health experience, an impairment is any
loss or abnormality of psychological, physiological, or anatomical
structure or function.
4. Disability refers to any restriction or lack of ability to carry
out simple or complex activities of everyday life. It is the
manifestation of an underlying impairment, but may vary by age or
developmental stage.
5. Health Promotion is the effort to educate persons with a
disability about the relationship between protective and risk factors
and secondary conditions, and to increase behaviors consistent with a
healthy lifestyle. Health promotion concerns those behaviors that
affect health status and are under the direct control of persons who
have a disability.
6. Secondary Conditions are those physical, medical, cognitive,
emotional, or psychosocial conditions, (to which persons with a
disability are more vulnerable by virtue of an underlying condition),
including adverse outcomes in health, wellness, participation, and
quality of life.
7. Protective Factors are biological, environmental (social and
physical), and lifestyle or behavioral characteristics that reduce or
mitigate the risk for adverse health outcomes, enhance coping skills,
induce a positive mediating influence against the effects of secondary
conditions, and/or promote health.
8. Risk Factors are biological, environmental (social and
physical), and lifestyle or behavioral characteristics that increase
the risk for adverse health outcomes. Identifying such factors can
contribute to determining a course of action during the disabling
process, including the development of preventive interventions.
9. Quality of Life is associated with the concept of well-being,
encompassing both physical and psychosocial determinants. Components of
quality of life include performance of social roles, physical status,
emotional status, social interactions, economic status, and self-
perceived or subjective health status.
Background for Part 2
Pressure sores are the most common and costly complication among
persons with spinal cord injury. There are an estimated 200,000 persons
with spinal cord injury in the United States. Almost all persons with
spinal cord injury will experience at least one pressure sore in their
lifetime. Although estimates vary, the prevalence of pressure sores may
be more than 20 percent among persons with spinal cord injury. One
study showed that the average institutional costs (for acute care and
rehabilitation hospitalizations) for pressure sores were $92,723. The
overall cost of hospital stays and economic loss due to pressure sores
may be over $6 billion each year (regardless of underlying condition).
Pressure sores are lesions caused by unrelieved pressure, trauma,
friction, and/or moisture which damages the skin and then the
underlying tissues. Much is known about the factors associated with
pressure sore development and treating pressure sores once they occur.
Pressure sores are also considered the secondary condition most
amenable to prevention among persons with spinal cord injury. As part
of rehabilitation, persons with spinal cord injury are taught how to
care for their skin and how to prevent pressure sores once they leave
the hospital environment and return home. Despite this training,
persons with spinal cord injury continue to experience pressure sores.
Despite what is known about the factors associated with the
development of pressure sores, little is known about why persons with
spinal cord injury do not optimize skin care and other behaviors to
prevent pressure sores from occurring. One study, conducted by the
Arkansas State Spinal Cord Commission, found initial success with an
in-home education program in which the incidence of pressure sores
decreased by 19 percent. In long-term follow-up, however, the incidence
of pressure sores actually increased among program participants.
Because few such programs have been developed and implemented,
little is known about community-based prevention programs for the
prevention of pressure sores. The emphasis here is prevention and early
intervention rather than treatment. Recognizing that individual
situations vary, assessment of risk for developing pressure sores and
education for prevention should be done in the context of individual
needs, strengths, and environment. Applicants should use available
information on pressure sore prevention in the post-rehabilitation,
community setting to develop a model program and plan, and implement
and evaluate the feasibility of doing a home-visitation program.
Program Requirements for Part 1
Applicants must design, develop, and evaluate health promotion
programs or conduct an epidemiologic study that will contribute to a
national information base for the prevention of secondary conditions.
CDC has indicated the following four areas for emphasis under Part 1 of
this Announcement and applicants must develop their proposals to
respond to one of these four areas.
1. Development of reliable and valid measurements to assess
Participation among persons with disabilities, and characteristics of
the Environment which influence that participation.
[[Page 12211]]
Applicants may choose to work across disability domains. These are
evolving dimensions to the ICIDH framework to replace the ``Handicap''
dimension. There is a pressing need to clarify and understand these
dimensions and characteristics. There is a benefit in having the
capacity to assess empirically the influence of environment on
participation in life activities for persons with disabilities. The
need to assess these dimensions to improve the health status, expand
research emphasis, and develop policy regarding persons with
disabilities is both timely and critical.
2. Work toward measuring the cost-effectiveness of one or more
intervention strategy(ies) designed to minimize the effects of or
prevent selected secondary condition(s). In order to guide the conduct
of cost-utility and cost-effectiveness analysis in federally funded
programs, the PHS recently developed consensus-based Cost-Effectiveness
Recommendations which have direct applicability to research on the
prevalence and consequences of secondary conditions. Applying cost-
utility and/or cost-effectiveness analytic techniques improves the
basis for the allocation of health care resources across a broad range
of secondary conditions among many preventive, therapeutic,
rehabilitative, and public health interventions. The PHS Cost-
Effectiveness Recommendations emphasize standardization of methods,
adoption of the societal perspective in conducting analyses, and use of
the summary measure known as the ``quality-adjusted life year'' (QALY)
as a comparable metric for recording the effects of different
interventions. Thus, there is both an opportunity and a need to
establish basic prevention strategies that focus on common secondary
conditions, and to apply methods that evaluate their comparative cost-
effectiveness, so that successful strategies and approaches can be
generalized and replicated in other settings. Reference citations for
these published recommendations are presented in the Bibliography,
which is an attachment to this Announcement.
3. Identification and measurement of protective factors and risk
factors within a disability domain, and measurement of the
effectiveness of preventive interventions that focus on an identified
age group that includes: (a) Children; (b) youth; and/or (c) older
adults. Given the paucity of research on secondary conditions
generally, there is even less data available on specific age groups
within the population which may be even more susceptible to developing
secondary conditions.
4. Identification and measurement of protective factors and risk
factors within a disability domain, and measurement of the
effectiveness of preventive interventions among specified populations
that include women and/or ethnic minority groups, or a combination of
the two. Among persons with disabilities, susceptibility to secondary
conditions may be higher in particular populations. Emphasis should be
given to populations considered to be at greatest risk.
Program Requirements for Part 2
Applicants must develop proposals to address pressure sores and
other selected secondary conditions among persons with spinal cord
injury. The model program proposed should be home-based and able to
collect information on and address medical, social, and environmental
factors associated with the development and progression of pressure
sores and other selected secondary conditions.
Applicants should address the development, implementation, and
appropriate evaluation of a home-based model project to prevent
pressure sores and other selected secondary conditions among persons
with spinal cord injury. The emphasis of the project should be to
assess the feasibility of the program, including access to persons with
spinal cord injury, recruiting and retaining study participants,
logistical management and support of a home-based visitation program,
and educational materials for the prevention of pressure sores and
other selected secondary conditions. Applicants should consider
addressing persons with spinal cord injury at greatest risk of
secondary conditions, including persons of low socioeconomic status or
persons considered medically underserved. A close working relationship
between the recipient and CDC is expected.
Applicants for Part 2 should develop a prevention program based on
a public health nurse, home-visit model. The project should include the
following elements:
1. Collect, compile, and analyze information relevant to the
prevention of pressure sores and other selected secondary conditions
among persons with spinal cord injury;
2. Develop a program consisting of the following phases:
a. A twelve month planning/recruitment phase where the recipient
explores existing materials relevant to the program, identifies and
selects other secondary conditions to be addressed, identifies
educational materials to be used for the prevention of pressure sores
and the other identified secondary conditions, hires and trains home
visitation staff, and identifies and recruits study participants.
b. An implementation phase where the home visitation project is
implemented (data collection, education) in the target population.
c. A monitoring phase where the intervention project continues with
the monitoring of the intervention, the occurrence of pressure sores,
the occurrence of other secondary conditions, and associated risk
factors.
d. A follow-up phase for continued monitoring and evaluation.
3. Develop and implement the methods (both scientific and
operational) for collecting data to assess the impact of the
intervention.
4. Determine how data will be maintained including format and
databases, and confidentiality protections.
5. Obtain the necessary clearances and agreements to proceed with
all aspects of the proposed project, including appropriate human
subjects clearances and agreements with other organizations and
individuals needed to complete the project. This specifically includes
working with CDC to obtain human subjects clearances and approval for
data collection activities.
6. Identify or develop, and pilot test data collection instruments.
7. Establish baseline rates for pressure sores or other secondary
conditions within the target group. Identify potential data sources to
provide baseline information or data for comparison.
8. Monitor progress toward achievement of project goals through the
use of realistic, measurable, time-oriented objectives for all phases
of the project.
9. Develop collaborative relationships with voluntary, community-
based public and private organizations addressing issues important to
persons with spinal cord injury. These could include centers for
independent living, and local chapters of the Paralyzed Veterans of
America and the National Spinal Cord Injury Association.
Cooperative Agreement Activities (Part 2 Only)
In conducting activities to achieve the purposes of Part 2 of this
Announcement, the recipient shall be responsible for activities listed
under A. (Recipient Activities), and CDC shall be responsible for
activities listed under B. (CDC Activities):
A. Recipient Activities:
[[Page 12212]]
1. Collect, compile, and analyze information relevant to the
prevention of pressure sores and other selected secondary conditions
among persons with spinal cord injury.
2. Develop a home-visit prevention model program consistent with
the public health nurse approach and framework.
3. Implement the home visitation project (data collection,
education) in the target population.
4. Monitor the intervention, the occurrence of pressure sores, the
occurrence of other secondary conditions, and associated risk factors.
5. Provide for ongoing project evaluation.
6. Provide for final dissemination of the products of the research
including conclusions and recommendations suitable for broad
replication in other prevention settings.
B. CDC Activities:
1. Provide technical consultation on: existing materials relevant
to the program (educational materials to be used for the prevention of
pressure sores and the other identified secondary conditions), the
selection of other secondary conditions to be targeted, and the
identification and recruitment of study participants.
2. Participate in program planning and development.
3. Participate in the development of the evaluation aspects of the
project.
4. Provide consultation in the development of data collection
instruments, methods, and procedures.
Application Contents--Part 1
1. Describe the applicant organization's current activities that
relate to the prevention of secondary conditions. Define the
populations included and the scope of any current research, specific
health promotion or training interventions, and the outcomes and use
made of such interventions and services.
2. Provide the rationale and basis for both the selection of a
disability domain(s) and the selected area for emphasis for the
proposed research agenda.
3. Discuss how the applicant organization is in an advantageous
position to conduct the proposed project, and describe the special
competencies residing in the applicant organization for conducting the
project.
4. Describe the applicant's experience and prior performance in
similar programs that would be beneficial in carrying out the proposed
project and outline the function and identity of all collaborating
organizations in the proposed project.
5. Describe the existing or proposed linkages and formal
collaborations to meet all operational and epidemiologic requirements
for achieving the goals and objectives of the research agenda,
including timely access to needed data and study populations and
clients related to the selected area for emphasis.
6. Present letters and agreements that demonstrate commitment and
support and provide tangible evidence of appropriate collaboration.
7. Describe the data to be collected, accessed, or developed to
conduct the proposed project, and the methods for collecting data from
specified sources. Discuss the strengths and weaknesses of each data
source relative to the proposed project. Explain how the
standardization and uniformity of data will be addressed to make the
information useful to other organizations.
8. Present the design of the study proposal or intervention that
includes: (a) Providing case definitions; (b) outlining methods of
enrolling and managing cases, clients, or cohorts; (c) describing plans
to ascertain cases and estimate sample size or study power; (d)
describing study methods and an analytical plan; (e) describing how the
confidentiality of cases identified through the project will be
protected; and (f) how the research will be evaluated.
9. Present the plan for dissemination of findings and
recommendations. Indicate the prospects for replicating the research in
the development of interventions that will benefit other populations,
including applications for national use.
10. Describe the placement of the project within the applicant
organization and outline how it will function to meet the objectives of
the grant. Provide an organizational chart illustrating the placement
of the project and how it will interact with partner entities.
11. Present the management plan, incorporating methods and time
frames for conducting the project including staff selection and
appointment, intra/inter-agency agreements, data access negotiations,
management oversight, and development of training or health promotion
material. Provide curriculum vitae for identified key personnel.
12. Present overall goals and objectives for the entire three year
project period, including detailed and specific goals and quarterly
objectives with timelines, in a work plan that covers the first two
budget years.
13. Present the methods, approach, and designation of
responsibilities for evaluation of the management elements of the
project over the duration of the grant.
14. Present what will occur to assure that all project activities
and facilities will permit full access to minorities, both sexes, and
persons with disabilities, and to provide opportunities for persons
with disabilities to participate in research operations.
15. Prepare specific budget and cost projections with full
narrative justification, for all listed budget class categories,
identifying both Federal and non-Federal sources. Indicate the amount
and categories of applicant cost-sharing in the total budget. Provide
projections and commitments (citing sources of funding) for cost-
sharing in both the second and third years of the project period.
16. Human Subjects: This section must describe the degree to which
human subjects may be at risk and the assurance that the project will
be subject to initial and continuing review by the appropriate
institutional review committees.
Evaluation Criteria--Part 1 (Total 100 Points)
Under Part 1, applications for Secondary Conditions Research will
be reviewed and evaluated for technical merit based on the following
factors:
1. Evidence of Understanding: (15 Points)
Evaluation will be based on:
a. The applicant's description of the public health significance of
secondary conditions and adherence to the purposes of this
Announcement, with an emphasis on the applicant's capacity to reach the
populations proposed.
b. The organizational rationale for determining the disability
domain(s) for project operations, and for addressing one of the areas
for emphasis outlined in the Program Requirements section for Part 1.
2. Research Resources and Organizational Capacity: (20 Points)
Evaluation will be based on:
a. The capability of the applicant to conduct the project, taking
into account its institutional experience and current activities in the
field proposed for this research.
b. The ability of the applicant to ensure timely access to
necessary population-based data related to the selected area for
emphasis.
c. The capacity of the applicant to identify and work with selected
targeted activities and expeditiously gather required information about
the clients or populations under investigation.
[[Page 12213]]
d. The applicant's capacity to provide evidence of effective
collaborations and research linkages enabling the applicant to meet all
protocol development and operational research requirements for the
project.
3. Research Approach: (35 Points)
Evaluation will be based on:
a. The extent to which the proposed methods, sources of data,
process for identifying individuals and cohorts with disabilities, and/
or conducting health promotion programs will be employed and function
to address the selected area for emphasis in this Announcement.
b. The overall strength of the research design including: (1) The
rationale and appropriateness of the study protocol and methods; (2)
the quality and scope of the data collection and data analysis plan;
(3) the power of the scientific dimensions in the design, including
sample size, measurements, etc; (4) the scope of the plan to assure
confidentiality as applicable to the protocol; and (5) the process by
which the research will be evaluated, including expected outcomes. For
applicants selecting the second area for emphasis pertaining to cost-
effectiveness, evaluation of the proposed methods will also be based on
adherence to generally accepted techniques for conducting and reporting
on cost-utility or cost-effectiveness analyses.
c. The overall information dissemination plan for presenting and
publishing the findings and recommendations of the research, and the
potential for generalizability and replicability of the study.
4. Management Plan and Project Goals and Objectives: (30 Points)
Evaluation will be based on:
a. The description of the management plan and approach, including
the project's location within the applicant organization, and the
described process by which the applicant will meet the goals and
objectives of the proposed research agenda.
b. The presentation of the specified tasks and responsibilities for
all positions proposed for financial assistance, and for other
personnel contributing to the requirements of the project.
c. The applicability of the proposed goals and specific objectives
related to the conduct of the project, including proposed timelines.
d. The process for overall evaluation of the management of the
project, including the assignment of responsibility for ongoing review
of specified components.
e. The extent to which the application furnishes evidence that
project activities will be fully accessible to minorities, both sexes,
and persons with disabilities, and will include opportunities for
persons with disabilities to participate in project activities.
5. Project Budget: (Not Scored)
This criteria includes the adequacy of the project application
budget in relation to program operations, collaborations, and services;
the extent of cost-sharing; and the extent to which the budget is
reasonable, clearly justified, accurate, and consistent with the
purpose of this Announcement.
6. Human Subjects: (Not Scored)
The extent to which the applicant complies with the Department of
Health and Human Services Regulations (45 CFR Part 46) regarding the
protection of human subjects.
Application Contents--Part 2
1. Describe the impact of pressure sores and other proposed
secondary conditions.
2. Describe the applicant organization's current activities related
to the prevention of pressure sores and other secondary conditions
among persons with spinal cord injuries. Define the populations
included.
3. Describe the target population, the rationale for selection of
that population, and whether and why the population is considered
undeserved.
4. Discuss how the applicant organization is in an advantageous
position to conduct the proposed project, and describe the special
competencies residing in the applicant organization for conducting the
project.
5. Describe the applicant's prior experience and performance in
similar programs that would be beneficial in carrying out the proposed
project and outline the function and identity of all collaborating
organizations in the proposed project.
6. Describe the existing and proposed linkages and formal
collaborations to meet all operational and epidemiologic requirements
for achieving the goals and objectives of the project. Letters and
agreements that demonstrate commitment and support and provide tangible
evidence of collaboration for specific aspects of the proposed research
must be included.
7. Present the design of the study proposal or intervention that
includes: (a) Providing case definitions; (b) outlining methods of
enrolling and managing cases, clients, or cohorts; (c) describing plans
to ascertain cases; (d) describing study methods and an analytical
plan; (e) describing how the confidentiality of cases identified
through the project will be protected; and (f) how the research will be
evaluated.
8. Describe the data to be collected, accessed, or developed to
conduct the proposed project, and the methods for collecting data from
specified sources. Discuss the strengths and weaknesses of each data
source to the proposed project.
9. Present the plan for dissemination of findings and
recommendations. Indicate the prospects for replicating the research in
the development of interventions that will benefit other populations,
including applications for national use.
10. Describe the placement of the project within the applicant
organization and outline how it will function to meet the objectives of
the cooperative agreement. Provide an organizational chart illustrating
the placement of the project and how it will interact with partner
entities.
11. Describe the management plan, incorporating methods and time
frames for conducting the project in operational areas including staff
selection and appointment, protocol development, intra/inter-agency
agreements, data access negotiations, study population monitoring and
tracking systems, data analysis, and development of training or health
promotion material. Provide curriculum vitae for identified key
personnel.
12. Present overall goals and objectives for the entire three year
project period, including detailed and specific goals and quarterly
objectives with timelines, in a work plan that covers the first two
budget years.
13. Present the plan, methods, approach, and designation of
responsibilities for evaluation of the management elements of the
project over the duration of the project.
14. Present what will occur to assure that all project activities
and facilities will permit full access to persons with disabilities,
and to provide opportunities for persons with disabilities to
participate in research operations.
15. Prepare specific budget and cost projections with full
narrative justification, for all listed budget class categories,
identifying both Federal and non-Federal sources. Indicate the amount
and categories of applicant cost-sharing in the total budget. Provide
projections and commitments (citing sources of funding) for cost-
sharing in
[[Page 12214]]
both the second and third years of the project period.
16. Human Subjects: This section must describe the degree to which
human subjects may be at risk and the assurance that the project will
be subject to initial and continuing review by the appropriate
institutional review committees.
Evaluation Criteria--Part 2 (Total 100 Points)
Under Part 2, applications for the Prevention of Pressure Sores and
other Secondary Conditions among Persons with Spinal Cord Injury will
be reviewed and evaluated for technical merit based on the following
factors:
1. Evidence of Understanding: (15 Points)
Evaluation will be based on:
a. The applicant's description of the public health significance of
pressure sores and other secondary conditions (as chosen by the
applicant).
b. The rationale for determining the target population of persons
with spinal cord injury.
2. Research Resources and Organizational Capacity: (20 Points)
Evaluation will be based on evidence of:
a. The capability of the applicant to conduct the project, taking
into account prior history of conducting research and disseminating
results in peer-reviewed publications and in presentations.
b. The ability of the applicant to ensure timely access to the
population, including prior history of working with the target
population.
c. The capacity of the applicant to identify and work with its
selected targeted activities and expeditiously gather required
information from the program participants and other populations related
to the program activities.
d. The applicant's capacity to provide evidence of effective
collaborations and research linkages (i.e., letters of commitment)
enabling the applicant to meet all protocol development and operational
research requirements for the project.
3. Research Approach: (35 Points)
Evaluation will be based on:
a. The extent to which the proposed methods, sources of data,
process for identifying individuals and cohorts with spinal cord
injuries will be employed to address the Program Requirements section
for Part 2.
b. The overall strength of the research design including: (1) The
rationale and appropriateness of the study protocol; (2) the quality of
the data collection plan; (3) the scope of the plan to assure
confidentiality as applicable to the protocol; and (4) the process by
which the research will be appropriately evaluated, including expected
outcomes.
c. The overall information dissemination plan for presenting and
publishing the findings and recommendations of the research, and the
potential for generalizability and replicability of the study.
4. Management Plan and Project Goals and Objectives: (30 Points)
Evaluation will be based on:
a. The description of the management plan and approach.
b. The presentation of the specified tasks and responsibilities for
all positions proposed for financial assistance, and for other
personnel contributing to the requirements of the project.
c. The applicability of the proposed goals and specific objectives
related to the conduct of the project, including proposed timelines.
d. The proposed process for overall evaluation of the management of
the project, including the assignment of responsibility for ongoing
review of specified components.
e. The extent to which the application furnishes evidence that
project activities will be fully accessible to persons with
disabilities, and will include opportunities for persons with
disabilities to participate in project activities.
5. Project Budget: (Not Scored)
This criteria includes the adequacy of the project budget in
relation to program operations, collaborations, and services; the
extent of cost-sharing; and the extent to which the budget is
reasonable, clearly justified, accurate, and consistent with the
purpose of this Announcement.
6. Human Subjects: (Not Scored)
The extent to which the applicant complies with the Department of
Health and Human Services Regulations (45 CFR Part 46) regarding the
protection of human subjects.
Reporting Requirements
Narrative progress reports will be required twice annually; and
will be due 30 days after the close of each six-month period based on
the starting date of the project. An original and four copies of the
narrative progress report should be submitted to the CDC Grants
Management Branch at dates to be specified in the Notice of Grant
Award. An original and two copies of the Financial Status Report is
required no later than 90 days after the end of each budget period.
Funding Priorities
Under Part 1, four areas are listed for emphasis within the Program
Requirements section. To the extent that there are a sufficient number
of high-ranking applications, CDC plans to make awards in all four
areas of emphasis. Part 1 applications will be reviewed by an internal
CDC review panel.
Under Part 2, CDC plans to fund one project to address pressure
sore prevention among persons with spinal cord injury. Part 2
applications will be reviewed by a Special Emphasis Panel (SEP) with
knowledge and expertise in pressure sores and/or epidemiology and
public health. The SEP may consist of a physiatrist, a physical
therapist, an epidemiologist, a program management official, and a
person with a disability or family member of a person with a
disability.
Special Instructions
Applicants must submit a separate, typed abstract or summary of
their proposal consisting of no more than two double-spaced pages as a
cover to their application. Applicants should include a table of
contents for both the project narrative and attachments. Applicants
must denote the component of this Announcement (Part 1 or Part 2) for
which they are submitting a proposal. The budget narrative and full
budget justification must be placed immediately after the table of
contents and abstract for the main application. Applicants should
follow the application contents section for the selected component of
this Announcement, as those elements are arranged to be compatible with
the respective evaluation criteria.
The main body of the application narrative should not exceed 50
double-spaced pages. Pages must be numbered and printed on only one
side of the page. All material must be typewritten; with 10 characters
per inch type (12 point) on 8-\1/2\'' by 11'' white paper with at least
1 margins, headers and footers (except for applicant-produced forms
such as organizational charts, graphs and tables, etc.). Applications
must be held together only by rubber bands or metal clips, and not
bound together in any other way.
Attachments to the application should be held to a minimum in
keeping to those items required by this Announcement. Other columns on
the Standard Form 424A budget sheet
[[Page 12215]]
should be used to define and certify other cost-sharing, with the
specific sources identified and documented in the budget narrative.
CDC expects to sponsor annual project workshops for all grantees.
By virtue of accepting an award, projects have agreed to use grant or
cooperative agreement funds to travel to and participate in these
workshops. Applicants should budget travel funds to attend a workshop
in Atlanta during the first year.
Executive Order 12372
Applications are not subject to the Intergovernmental Review of
Federal Programs as governed by Executive Order 12372.
Public Health System Reporting Requirements
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance (CFDA)
The Catalog of Federal Domestic Assistance number is 93.184.
Other Requirements
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. Applicants will be responsible for
providing assurance in accordance with the appropriate guidelines and
forms 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.
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals, and funded by grants/cooperative agreements will be
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act.
Animal Subjects
If the proposed project involves research on animal subjects, the
applicant must comply with the ``PHS Policy on Humane Care and Use of
Laboratory Animals by Awardee Institutions.'' An applicant organization
proposing to use vertebrate animals in PHS-supported activities must
file an Animal Welfare Assurance with the Office of Protection from
Research Risks at the National Institutes of Health.
Women and Minority Inclusion Policy
It is the policy of CDC to ensure that women and racial and ethnic
groups will be included in CDC-supported research projects involving
human subjects, whenever feasible and appropriate. Racial and ethnic
groups are those defined in OMB Directive Number 15 and include
American Indian, Alaska 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 the review
of applications for scientific merit, review groups will evaluate
proposed plans for inclusion of minorities and both sexes as part of
the scientific assessment and assigned score. 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, Friday,
September 15, 1995, pages 47947-47951.
Application Submission and Deadline
A. Pre-Application Letter of Intent
Although not a prerequisite of application, a non-binding letter of
intent to apply is requested from potential applicants. The letter
should be submitted to the Grants Management Officer whose name is
noted in section B below. The letter should be postmarked no later than
30 days prior to the submission deadline. The letter of intent should
identify the Announcement Number; name the proposed project director;
and in a paragraph, describe the scope of the proposed project. The
letter will not influence review or funding decisions, but it will
enable CDC to plan the review more efficiently and ensure that each
applicant receives timely and relevant information prior to application
submission.
B. Application Submission
Applicants should submit an original and four copies of the
application (PHS Form 398--OMB Number 0925-0001 revised 5/95), and
adhere to the ERRATA Instruction Sheet contained in the Grant
Application Kit. Applications must be submitted to Mr. Ron Van Duyne,
Grants Management Officer, Grants Management Branch, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), 255
East Paces Ferry Road, NE., Room 300, Mailstop E-13, Atlanta, Georgia
30305, on or before Thursday, May 15, 1997.
1. Deadline: Applications will 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 the U. S. Postal Service. Private
metered postmarks will not be acceptable 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. 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 your name, address, and telephone number and will need to
refer to Announcement Number 731. You will receive a complete program
description, information on application procedures, and application
forms. In addition, this Announcement and the bibliography attachment
for Part 1 is also available through the CDC Home Page on the Internet.
The address for the CDC Home Page is http://www.cdc.gov. If you have
questions after reviewing the contents of all the documents, business
management technical assistance may be obtained from Georgia L. Jang,
Grants Management Specialist, Grants Management Branch, Procurement and
Grants Office, Centers for Disease Control and Prevention (CDC), East
Paces Ferry Road, NE., Room 321, Mailstop E-13, Atlanta, Georgia 30305,
telephone number (404) 842-6814. (Internet address: glj2@cdc.gov).
For Part 1 applications, program assistance may be obtained from
Joseph
[[Page 12216]]
B. Smith, Office on Disability and Health, National Center for
Environmental Health, CDC, 4770 Buford Highway, Building 101, Mailstop
F-29, Atlanta, Georgia 30341, telephone (770) 488-7082. (Internet
address: jos4@cdc.gov). Epidemiologic and research-related technical
assistance is available from Donald J. Lollar, Ed.D. at the same
address, telephone (770) 488-7094. (Internet address: dcl5@cdc.gov).
For Part 2 applications, program assistance may be obtained from
Douglas R. Browne, National Center for Injury Prevention and Control,
CDC, 4770 Buford Highway, Building 101, Mailstop F-41, Atlanta, Georgia
30341, telephone (770) 488-4031. Internet address: drb7@cdc.gov.
Epidemiologic and research-related technical assistance is available
from Joe Sniezek, M.D., M.P.H. at the same address and telephone
number. Internet address: jes6@cdc.gov. A packet of background
information for Part 2 is available by contacting the above listed CDC
staff.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full Report; Stock number 017-001-00474-0) or ``Healthy People 2000''
(Summary Report; Stock number 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325, telephone (202) 512-1800.
Dated: March 7, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-6489 Filed 3-13-97; 8:45 am]
BILLING CODE 4163-18-P
