[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