[Federal Register Volume 61, Number 13 (Friday, January 19, 1996)]
[Notices]
[Pages 1381-1385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-565]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 610]
Research Program Project Grants for Biomechanics and Individual
Grants for Injury Research for Acute Care, Biomechanics, Disability
Prevention, and Primary Prevention of Unintentional Injuries; Notice of
Availability of Funds for Fiscal Year 1996
Introduction
The Centers for Disease Control and Prevention (CDC) announces that
applications are being accepted for Injury Prevention and Control
Research Grants for fiscal year (FY) 1996. The Public Health Service
(PHS) is committed to achieving the health promotion and disease
prevention objectives of ``Healthy People 2000,'' a PHS-led national
activity to reduce morbidity and mortality and improve the quality of
life. This announcement is related to the priority area of
Unintentional Injuries. (To order a copy of ``Healthy People 2000,''
see the Section Where to Obtain Additional Information.)
Authority
This program is authorized under Sections 301, 391, 392, and 394 of
the Public Health Service Act (42 U.S.C. 241, 280b, 280b-1 and 280b-3).
Program regulations are set forth in Title 42 CFR Part 52.
Eligible Applicants
Eligible applicants include all non-profit and for-profit
organizations. Thus State and local health departments and State and
local governmental agencies, universities, colleges, research
institutions, and other public and private organizations, including
small, minority and/or woman-owned businesses are eligible for these
research grants. Current holders of CDC injury control research
projects are eligible to apply.
Smoke-Free Workplace
PHS strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, child care, health care, and early childhood development
services are provided to children.
Availability of Funds
Approximately $2.7 million is expected to be available for injury
research grants that include funding for projects that address
biomechanics, unintentional injury prevention, acute care, and the
prevention of secondary conditions in disabled persons. It is expected
that the awards will begin on or about September 1, 1996, and will be
made for a 12-month budget period within the appropriate (see below)
project period. Funding estimates may vary and are subject to change.
In the area of biomechanics, $1,300,000 total is available to
support one or two individual (RO-1 type) projects for up to three
years funding at $250,000 per year (including both direct and indirect
costs) and/or up to three research program project grants (RPPG) for up
to three years funding at $350,000 per year (including both direct and
indirect costs). Applications that exceed the funding caps (i.e.,
$250,000 for RO-1 and $350,000 for RPPG proposals) will be excluded
from the competition and returned to the applicant. Awards will be made
for a 12-month budget period within a project period not to exceed
three years.
For research projects targeted at (1) unintentional injury
prevention, and (2) acute care research, $800,000 total is available to
support up to three RO-1 grants for primary prevention of unintentional
injuries and one for acute care injury research. Each RO-1 project will
be supported for up to two years of funding at $200,000 per year
(including both direct and indirect costs). Applications that exceed
the funding cap of $200,000 will be excluded from the competition and
returned to the applicant. Awards will be made for a 12-month budget
period within a project period not to exceed two years.
For research projects targeted at preventing secondary conditions
among persons with injury-related disabling conditions, $600,000 is
available for two R0-1 projects for up to three years of funding at
$300,000 per year (including both direct and indirect costs).
Applications that exceed the funding cap of $300,000 will be excluded
from the competition and returned to the applicant. Awards will be made
for a 12-month budget period within a project period not to exceed
three years.
Eligible applicants may enter into contracts, including consortia
agreements (as set forth in the PHS Grants Policy Statement) as
necessary to meet the requirements of the program and strengthen the
overall application.
The specific program priorities for these funding opportunities are
outlined with examples in this announcement under the subheading,
Programmatic Priorities. Grant funds will not be made available to
support the provision of direct care services.
Continuation awards within the project period will be made on the
basis of satisfactory progress demonstrated by investigators at work-
in-progress monitoring workshops, the achievement of workplan
milestones reflected in the continuation application, and the
availability of Federal funds. In addition, if funds are available,
continuation awards may be eligible for increased funding to offset
inflationary costs.
Purpose
The purposes of this program are to:
A. Support injury prevention and control research on priority
issues as delineated in ``Injury Control in the 1990s: A National Plan
for Action''; ``Healthy People 2000''; ``Injury In America''; ``Injury
Prevention: Meeting the Challenge''; and ``Cost of Injury.''
B. Encourage professionals from a wide spectrum of disciplines such
as engineering, medicine, health care, public health, behavioral and
social sciences, and others, to undertake research to prevent and
control injuries.
C. Evaluate current and new intervention methods and strategies for
the prevention and control of injuries.
Program Requirements
The following are applicant requirements:
A. A principal investigator who has conducted research, published
the findings, and has specific authority and responsibility to carry
out the proposed project.
B. Demonstrated experience in conducting, evaluating, and
publishing injury control research (as previously defined) on the
applicant's project team.
C. Effective and well-defined working relationships within the
performing organization and with outside entities that will ensure
implementation of the proposed activities.
D. An explanation as to what extent research findings will lead to
feasible, cost-effective injury interventions.
E. The ability to carry out injury control research project.
F. The overall match between the applicant's proposed theme and
research objectives and the program priorities as described under the
heading Programmatic Priorities.
Programmatic Priorities
Grant applications for acute care, biomechanics, disability
prevention, and primary prevention of unintentional
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injuries are sought. The focus of grants should reflect the broad-based
need to control injury morbidity, mortality, disability, and costs.
Examples of possible projects listed under the priority areas below are
not exhaustive. Innovative alternative approaches are encouraged.
In biomechanics, there is special programmatic interest in
traumatic brain and spinal cord injury (TBI/SCI). This interest
includes the biomechanical evaluation of intervention concepts and
strategies (e.g., multi-use recreational helmets, mouth and face
protection devices for athletes, energy absorbing playground surfaces,
hip pads, motor vehicle side impact and rollover countermeasures,
etc.); development of models to elucidate injury physiology and
pharmacologic, surgical, rehabilitation, and other interventions;
defining human tolerance limits for injury among children, women, the
chronically ill and older persons; improvements in injury assessment
technology; and understanding impact injury mechanisms and quantifying
injury-related biomechanical responses for critical areas of the human
body (e.g., brain and vertebral injury with spinal cord involvement).
Consideration will also be given to the biomechanics of thoracic and
abdominal viscera, musculature and joints including the articular
cartilage, tendons and ligaments.
In acute care, there is special programmatic interest in
intensifying the role of the emergency department and in-patient
hospital trauma services in regard to hospital-based public health
surveillance and prevention of traumatic injuries (e.g., emergency
department surveillance systems or inpatient trauma registries that
provide comprehensive coverage of a defined population and that
identify cause-specific patterns of injury that are amenable to
preventive countermeasures). In acute care settings, identifying
underlying risk factors for injury and intervening to reduce or
eliminate them can help minimize the impact of violence, substance
abuse, and other factors associated with injury recidivism (e.g.,
screening and brief interventions for injured patients with mild to
moderate alcohol problems, identification and referral of injured
patients with severe alcohol problems to specialized alcohol treatment
services). There is interest in comprehensive evaluations of the
effectiveness of inclusive trauma care systems ( e.g., a baseline and
follow-up study of an inclusive trauma care system measured in terms of
the system's impact on morbidity, mortality, and disability from
traumatic injury).
In disability prevention, there is special programmatic interest in
community-based research to prevent the occurrence of or reduce the
severity of adverse outcomes (e.g., secondary conditions) among persons
with traumatic brain and spinal cord injury (TBI/SCI). This research
could include identifying risk factors associated with adverse outcomes
in the post-rehabilitation phase (i.e., community setting); describing
the natural history of the occurrence of adverse outcomes and secondary
conditions (e.g., identifying factors associated with disability in
persons with TBI/SCI; or evaluating interventions in the community
setting addressing adverse outcomes/secondary conditions). Adverse
outcomes may include pressure sores; contracture; cognitive,
behavioral, or psychological disorders; and other definable conditions
associated with TBI/SCI. This research should cover methods to prevent
or minimize the impact of adverse outcomes or secondary conditions,
taking into account the injured person's need for education to prevent
secondary conditions. The role of the family and community in
preventing secondary conditions should be considered. Population-based
and longitudinal studies are needed to better establish the occurrence
of adverse outcomes and the rehabilitation needs of patients with TBI/
SCI.
For primary prevention of unintentional injuries, there is special
programmatic interest in the areas of home and leisure, and motor
vehicle injuries. Specifically, there is programmatic interest in the
development and evaluation of unintentional injury prevention
strategies that can be applied in an outpatient clinical and/or managed
care setting (e.g., HMOs, clinics, clinicians offices, academic health
centers, etc.). Programs that prevent injuries through education,
behavior change and clinical counseling programs, safety device
distribution programs, economic incentive systems, policy change and
clinical preventive services are sought. Special emphasis will be
placed on how these approaches apply to children, community-dwelling
elderly persons, teen drivers, older drivers, as well as drivers and
their use of alcohol.
There is also programmatic interest in research that evaluates the
effectiveness of interventions in preventing injuries or reducing their
impact (prevention effectiveness research). This includes the
evaluation of innovative methods to reduce motor vehicle injuries among
teenagers, (e.g., graduated licensing systems or components of such
systems) or research that evaluates the effectiveness of modifying the
home environment of older persons (65 or more years of age) on reducing
the incidence of falls and fall-related injuries. A more complete
discussion of methodologies for conducting prevention effectiveness
research is presented in ``A Framework for Assessing the Effectiveness
of Disease and Injury Prevention,'' (CDC, ``Morbidity and Mortality
Weekly Report,'' March 27, 1992, Volume 41, Number RR-3, pp. 5-11) and
in ``Assessing the Effectiveness of Disease and Injury Prevention
Programs: Costs and Consequences'' (CDC, ``Morbidity and Mortality
Weekly Report,'' August 18, 1995, Vol 44, No. RR10). To receive
information on these reports see the section Where to Obtain Additional
Information.''
Evaluation Criteria
Upon receipt, applications will be reviewed by CDC staff for
completeness and responsiveness as outlined under the previous heading,
``Program Requirements'' (A-F). Incomplete applications and
applications that are not responsive will be returned to the applicant
without further consideration. Applications that are complete and
responsive may be subjected to a preliminary evaluation by a peer
review group to determine if the application is of sufficient technical
and scientific merit to warrant further review (triage); the CDC will
withdraw from further consideration applications judged to be
noncompetitive and promptly notify the principal investigator/program
director and the official signing for the applicant organization. Those
applications judged to be competitive will be further evaluated by a
dual review process. Awards will be made based on priority score
ranking by the Injury Research Grants Review Committee (IRGRC),
programmatic priorities and needs by the Advisory Committee for Injury
Prevention and Control, and the availability of funds.
A. The first review following the preliminary review will be a peer
review conducted by the IRGRC on all applications. Factors to be
considered will include:
1. The specific aims of the research project, i.e., the broad long-
term objectives, the intended accomplishment of the specific research
proposal, and the hypothesis to be tested.
2. The background of the proposal, i.e., the basis for the present
proposal, the critical evaluation of existing knowledge, and specific
identification
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of the injury control knowledge gaps which the proposal is intended to
fill.
3. The significance and originality from a scientific or technical
standpoint of the specific aims of the proposed research, including the
adequacy of the theoretical and conceptual framework for the research.
4. For competitive renewal applications, the progress made during
the prior project period. For new applications, (optional) the progress
of preliminary studies pertinent to the application.
5. The adequacy of the proposed research design, approaches, and
methodology to carry out the research, including quality assurance
procedures, plan for data management, statistical analysis plans; and
plans for inclusion of minorities and both sexes.
6. The extent to which the research findings will lead to feasible,
cost-effective injury interventions.
7. The extent to which the evaluation plan will allow for the
measurement of progress toward the achievement of the stated
objectives.
8. Qualifications, adequacy, and appropriateness of personnel to
accomplish the proposed activities.
9. The degree of commitment and cooperation of other interested
parties (as evidenced by letters detailing the nature and extent of the
involvement).
10. The reasonableness of the proposed budget to the proposed
research and demonstration program.
11. Adequacy of existing and proposed facilities and resources.
B. The second review will be conducted by the Advisory Committee
for Injury Prevention and Control. The factors to be considered will
include:
1. The results of the peer review.
2. The significance of the proposed activities in relation to the
priorities and objectives stated in ``Injury Control in the 1990s: A
National Plan for Action''; ``Healthy People 2000''; ``Injury In
America''; ``Injury Prevention: Meeting the Challenge''; and ``Cost of
Injury.''
3. National needs.
4. Program balance among: the three phases of injury control:
prevention, acute care, and rehabilitation; the major disciplines of
injury control: biomechanics and epidemiology; populations addressed
(e.g., adolescents, children, racial and ethnic minorities, rural
residents, farm families, and people with low incomes).
5. Budgetary considerations.
C. Continued Funding: Continuation awards made after FY 1996, but
within the project period, will be made on the basis of the
availability of funds and the following criteria:
1. The accomplishments reflected in the progress report of the
continuation application indicate that the applicant is meeting
previously stated objectives or milestones contained in the project's
annual workplan and satisfactory progress has been demonstrated through
monitoring presentations or work-in-progress workshops;
2. The objectives for the new budget period are realistic,
specific, and measurable;
3. The methods described will clearly lead to achievement of these
objectives;
4. The evaluation plan will allow management to monitor whether the
methods are effective; and
5. The budget request is clearly explained, adequately justified,
reasonable and consistent with the intended use of grant funds.
Executive Order 12372 Review
This program is not subject to the Executive Order 12372 review.
Public Health System Reporting Requirement
This program is not subject to the Public Health System Reporting
Requirements.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.136.
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. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
forms provided in the application kit.
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 the 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 No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that women, racial and ethnic
minority populations are appropriately represented in applications for
research involving human subjects. Where clear and compelling rationale
exist that inclusion is inappropriate or not feasible, this situation
must be explained as part of the application. In conducting 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 Deadlines
A. Preapplication 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 Specialist (whose address
is reflected in section B, ``Applications''). It should be postmarked
no later than one month prior to the planned submission deadline,
(e.g., February 11 for March 11 submission). The letter should identify
the announcement number, name the principal investigator, and specify
the injury phase or discipline addressed by the proposed project. The
letter of intent does not influence review or funding decisions, but it
will enable CDC to plan the review more efficiently, and will ensure
that each applicant receives timely and relevant information prior to
application submission.
B. Applications
Applicants should use Form PHS-398 (OMB No. 0925-0001 Revised 5/95)
and adhere to the ERRATA Instruction Sheet contained in the Grant
Application Kit. Please submit an original and five copies on or before
March 11, 1996, to: Lisa G. Tamaroff, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Room 321, Atlanta, Georgia 30305.
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C. Deadlines
1. Applications shall be considered as meeting a deadline if they
are either:
A. Received at the above address on or before the deadline date, or
B. Sent on or before the deadline date to the above address, and
are received in time for the review process. Applicants should 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 shall not be acceptable as proof of timely mailings.
2. Applications that do not meet the criteria above are considered
late applications and will be returned to the applicant.
Where to Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and phone number and will
need to refer to Announcement 610. You will receive a complete program
description, information on application procedures, and application
forms. The announcement is also available through the CDC homepage on
the Internet. The address for the CDC homepage is [http://www.cdc.gov].
CDC will not send application kits by facsimile or express mail.
If you have questions after reviewing the contents of all the
documents, business management technical assistance may be obtained
from Lisa G. Tamaroff, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Mailstop E-13,
Atlanta, GA 30305, telephone (404) 842-6796.
Programmatic technical assistance may be obtained from Ted Jones,
Project Officer, Office of Research Grants, National Center for Injury
Prevention and Control, Centers for Disease Control and Prevention
(CDC), Mailstop K-58, 4770 Buford Highway, NE., Atlanta, GA 30341-3724,
telephone (770) 488-4824.
Potential applicants may obtain a copy of ``Healthy People 2000''
(Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000''
(Summary Report, Stock No. 017-001-00473-1) through the Superintendent
of Documents, Government Printing Office, Washington, DC 20402-9325,
telephone (202) 512-1800.
Information is included on a separate sheet with the application
kit for obtaining copies of: ``Injury Control in the 1990s: A National
Plan for Action,'' (Atlanta: Centers for Disease Control and
Prevention, 1993); ``Injury In America'' (National Academy Press, 2101
Constitution Avenue, NW, Washington, DC 20418--ISBN0-309-03545-7);
``Injury Prevention: Meeting the Challenge'' (supplement to the
American Journal of Preventive Medicine, (Vol. 5, no. 3, 1989)); ``Cost
of Injury'' (Dorothy P. Rice, Ellen J. MacKenzie, and Associates),
``Cost of Injury: A Report to the Congress'' (San Francisco,
California: Institute for Health and Aging, University of California
and Injury Prevention Research Center, The Johns Hopkins University,
1989); ``A Framework for Assessing the Effectiveness of Disease and
Injury Prevention,'' (CDC, ``Morbidity and Mortality Weekly Report,''
March 27, 1992, Volume 41, Number RR-3, pages 5-11) and ``Assessing the
Effectiveness of Disease and Injury Prevention Programs: Costs and
Consequences'' (CDC, ``Morbidity and Mortality Weekly Report,'' August
18, 1995, Volume 44, Number RR10).
Dated: January 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-565 Filed 1-18-96; 8:45 am]
BILLING CODE 4163-18-P
