[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]


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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: <a href="/cdn-cgi/l/email-protection#03646f6931436067602d646c75"><span class="__cf_email__" data-cfemail="ed8a8187dfad8e898ec38a829b">[email protected]</span></a>).
    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: <a href="/cdn-cgi/l/email-protection#6f05001c5b2f0c0b0c41080019"><span class="__cf_email__" data-cfemail="4a2025397e0a292e29642d253c">[email protected]</span></a>). Epidemiologic and research-related technical 
assistance is available from Donald J. Lollar, Ed.D. at the same 
address, telephone (770) 488-7094. (Internet address: <a href="/cdn-cgi/l/email-protection#1a7e79762f5a797e79347d756c"><span class="__cf_email__" data-cfemail="4226212e77022126216c252d34">[email protected]</span></a>).
    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: <a href="/cdn-cgi/l/email-protection#caaeb8a8fd8aa9aea9e4ada5bc"><span class="__cf_email__" data-cfemail="7115031346311215125f161e07">[email protected]</span></a>. 
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: <a href="/cdn-cgi/l/email-protection#b2d8d7c184f2d1d6d19cd5ddc4"><span class="__cf_email__" data-cfemail="59333c2a6f193a3d3a773e362f">[email protected]</span></a>. 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


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