[Federal Register Volume 68, Number 26 (Friday, February 7, 2003)]
[Notices]
[Pages 6479-6483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-3032]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 03028]


Grants for Traumatic Injury Biomechanics Research; Notice of 
Availability of Funds

    Application Deadline: April 8, 2003.

A. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301 (a) [42 U.S.C. 241(a)] 
of the Public Health Service Act, and section 391 (a) [42 U.S.C. 280b 
(a)] of the Public Health Service Act, as amended. The catalog of 
Federal Domestic Assistance number is 93.136.

B. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2003 funds for Grants for Traumatic 
Injury Biomechanics Research. This program addresses the ``Healthy 
People 2010'' focus areas of Injury and Violence Prevention.
    The purposes of the program are to:
    1. Solicit research applications that address the priorities 
reflected under the heading, ``Programmatic Requirements.''
    2. Build the scientific base for the prevention and control of 
injuries, disabilities, and deaths.
    3. Encourage professionals from a wide spectrum of disciplines of 
engineering, epidemiology, medicine, biostatistics, public health, law 
and criminal justice, behavioral, and social sciences to perform 
research in order to prevent and control injuries more effectively.
    4. Encourage investigators to propose research that involves 
intervention development and testing as well as research on methods; to 
encourage individuals, organizations, or communities to adopt and 
maintain effective intervention strategies.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Injury 
Prevention and Control (NCIPC): Develop new or improved approaches for 
preventing and controlling death and disability due to injuries.

C. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for profit organizations and by governments and their agencies; that 
is, universities, colleges, technical schools, research institutions, 
hospitals, other public and private nonprofit and for profit 
organizations, community-based organizations, faith-based 
organizations, State and local governments or their bona fide agents, 
including the District of Columbia, the Commonwealth of Puerto Rico, 
the Virgin Islands, the Commonwealth of the Northern Mariana Islands, 
American Samoa, Guam, the Federated States of Micronesia, the Republic 
of the Marshall Islands, and the Republic of Palau, federally 
recognized Indian tribal governments, Indian tribes, or Indian tribal 
organizations, and small, minority, and women-owned businesses.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

    Applications that are incomplete or non responsive to the following 
requirements will be returned to the applicant without further 
consideration:
    1. A principal investigator, who has conducted research, published 
the findings in peer-reviewed journals, and have specific authority and 
responsibility to carry out the proposed project.
    2. Demonstrated experience on the applicant's project team in 
conducting, evaluating, and publishing injury control research in peer-
reviewed journals.
    3. Effective and well-defined working relationships within the 
performing organization and with outside entities which will ensure 
implementation of the proposed activities.
    4. The ability to carry out injury control research projects as 
defined under Attachment 2 (1.a-c). The attachment is posted with this 
program announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.
    5. The overall match between the applicant's proposed theme and 
research objectives and the program interests as described under the 
heading, ``Program Requirements.''

D. Funds

Availability of Funds

    Approximately $600,000 is available in FY 2003 to fund 
approximately two-three awards. It is expected that the awards will 
begin on or about September 1, 2003, and will be made for a 12-month 
budget period within a project period of up to three years. Funding 
estimates may change.

[[Page 6480]]

    The maximum funding level for each project will not exceed $300,000 
per year (including both direct and indirect costs) or $900,000 for a 
three-year project period. Applications that exceed the funding caps 
noted above will be excluded from the competition and returned to the 
applicant. The availability of Federal funding may vary and is subject 
to change.
    Consideration will also be given to current grantees who submit a 
competitive supplement requesting one year of funding to enhance or 
expand existing projects, or to conduct one-year pilot studies. These 
awards will not exceed $150,000, including both direct and indirect 
costs. Supplemental awards will be made for the budget period to 
coincide with the actual budget period of the grant and are based on 
the availability of funds.
    Continuation awards within an approved 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 work plan and satisfactory progress demonstrated through 
presentations at work-in-progress monitoring 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.
    5. The budget request is clearly explained, adequately justified, 
reasonable and consistent with the intended use of grant funds.

Use of Funds

    Grant funds will not be made available to support the provision of 
direct care. Eligible applicants may enter into contracts, including 
consortia agreements, as necessary to meet the requirements of the 
program and strengthen the overall application.

Funding Priority

    Interested persons are invited to comment on the proposed funding 
priority (see the ``Program Requirements'' section of this 
announcement). All comments received within 30 days after publication 
in the Federal Register will be considered before the final funding 
priority is established. If the funding priority changes because of 
comments received, a revised announcement will be published in the 
Federal Register, and revised applications will be accepted before the 
final selections are made. Address comments to the grants management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

Recipient Financial Participation

    Matching funds are not required for this program.

E. Program Requirements

    NCIPC works to prevent non-occupational unintentional and violence-
related injuries, and to minimize the consequences of injuries when 
they do occur. It's public health approach draws on biomechanics in 
seven topic areas:
    1. Preventing Injuries at Home and in the Community.
    2. Preventing Injuries in Sports, Recreation, and Exercise.
    3. Preventing Transportation Injuries.
    4. Preventing Intimate Partner Violence, Sexual Violence, and Child 
Maltreatment.
    5. Preventing Suicidal Behavior.
    6. Preventing Youth Violence.
    7. Acute Care, Disability, and Rehabilitation.
    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for addressing priorities listed 
below:

High Priority

    Higher priority will be given to research proposals that:
    1. Use biomechanics research and the knowledge of injury tolerance 
and injury mechanisms to develop and/or evaluate interventions that 
address the following specific injury prevention and control problems:
    a. Falls that occur among older, community dwelling adults (e.g. 
hip pads).
    b. Injuries in mass trauma events.
    c. Severe and disabling falls among children.
    d. Sports, recreation, and exercise-related injuries (e.g., 
playground and other play environments, safety gear.)
    e. Injuries associated with people initiating or increasing 
physical activity (e.g., training programs or protective devices).
    f. Injuries related to outdoor recreation (e.g., vehicle design).
    g. Motorcycling, bicycling and pedestrian injuries (e.g., improved 
helmets or environments).
    h. Injuries to child occupants of motor vehicles (e.g., universal 
fasteners and alternative restraint designs).
    i. Injuries to older drivers.
    j. Injuries associated with the effects of emerging vehicle 
technologies.
    2. Identify the biomechanics and specific injuries that would be 
highly predictive of diagnoses of intimate partner violence and child 
maltreatment, and improve case definitions.

    Note: The scoring for applications addressing a high priority 
item will be weighted an additional 25 points in a scoring system of 
100-500 points.

Lower Priority

    In addition, lower priority will be given to research proposals 
that:
    1. Advance the biomechanical understanding of traumatic injury 
(e.g., injuries to the brain, spinal cord, thorax/abdomen, extremities 
and joints) including: development of biofidelic models to elucidate 
injury physiology as well as pharmacologic, surgical, rehabilitation, 
and other interventions; improvement of injury assessment technology; 
impact injury mechanisms research; and quantification of injury-related 
biomechanical responses for critical areas of the human body (e.g., 
brain and vertebral injury with spinal cord involvement).
    2. Define the human tolerance limits for injury, especially 
determining the differences in human tolerance by age, fitness level, 
and gender and the biomechanics and injury tolerances of tissue, bone, 
and other human structures as a prerequisite for developing 
interventions.
    3. Identify the modifiable risk factors for and mechanisms of 
nonfatal neck, back and soft tissue (``whiplash-like'') injuries.

F. Content

Letter of Intent (LOI)

    A LOI is optional for this program. The program announcement title 
and number must appear in the LOI. The narrative should be no more than 
two single-spaced pages, printed on one side, with one-inch margins, 
and unreduced 12-point font. The letter should identify the name of the 
principal investigator, and briefly describe the scope and intent of 
the proposed research work. The letter of intent does not influence 
review or funding decisions, but the number of letters received will 
enable CDC to plan the review more effectively and efficiently.

Applications

    The Program Announcement title and number must appear in the 
application. Use the information in the Program Requirements, Other 
Requirements, and

[[Page 6481]]

Evaluation Criteria sections to develop the application content. Your 
application will be evaluated on the criteria listed, so it is 
important to follow them in laying out your program plan. The narrative 
should be no more than 25 single-spaced pages, printed on one side, 
with one-inch margins, and unreduced 12-point font.
    Applications should follow the PHS-398 (Rev. 5/2001) application 
and Errata sheet (See attachment 3 of this announcement as it is posted 
on the CDC web site). The narrative should include the following 
information:
    1. The project's focus that justifies the research needs and 
describes the scientific basis for the research, the expected outcome, 
and the relevance of the findings to reduce injury morbidity, 
mortality, disability, and economic losses. This focus should be based 
on recommendations in ``Healthy People 2010'' and the ``CDC Injury 
Research Agenda,'' and should seek creative approaches that will 
contribute to a national program for injury control.
    2. Specific, measurable, and time-framed objectives.
    3. A detailed plan describing the methods by which the objectives 
will be achieved, including their sequence. A comprehensive evaluation 
plan is an essential component of the application.
    4. A description of the principal investigator's role and 
responsibilities.
    5. A description of all the project staff regardless of their 
funding source. It should include their title, qualifications, 
experience, percentage of time each will devote to the project, as well 
as the portion of their salary to be paid by the grant.
    6. A description of those activities related to, but not supported 
by the grant.
    7. A description of the involvement of other entities that will 
relate to the proposed project, if applicable. It should include 
commitments of support and a clear statement of their roles.
    8. A detailed first year's budget for the grant with future annual 
projections, if relevant.
    9. An explanation of how the research findings will contribute to 
the national effort to reduce the morbidity, mortality and disability 
caused by injuries within three to five years from project start-up.
    An applicant organization has the option of having specific salary 
and fringe benefit amounts for individuals omitted from the copies of 
the application which are made available to outside reviewing groups. 
To exercise this option: on the original and two copies of the 
application, the applicant must use asterisks to indicate those 
individuals for whom salaries and fringe benefits are not shown; 
however, the subtotals must still be shown. In addition, the applicant 
must submit an additional copy of page four of Form PHS-398, completed 
in full, with the asterisks replaced by the salaries and fringe 
benefits. This budget page will be reserved for internal staff use 
only.

F. Submission and Deadline

Letter of Intent (LOI) Submission

    On or before March 10, 2003. Submit the LOI to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.

Application Forms

    Submit the signed original and two copies of PHS-398 (OMB Number 
0925-0001). Forms are available at the following Internet address: 
http://www.cdc.gov/od/pgo/forminfo.htm.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

    The application must be received by 4 p.m. Eastern Standard Time, 
April 8, 2003. Submit the application to: Technical Information 
Management-PA03028, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146.
    Applications may not be submitted electronically.

Deadline

    Letters of intent and applications shall be considered as meeting 
the deadline if they are received before 4 p.m. Eastern Time on the 
deadline date. Applicants sending applications by the United States 
Postal Service or commercial delivery services must ensure that the 
carrier will be able to guarantee delivery of the application by the 
closing date and time. If an application is received after closing due 
to (1) carrier error, when the carrier accepted the package with a 
guarantee for delivery by the closing date and time, or (2) significant 
weather delays or natural disasters, CDC will upon receipt of proper 
documentation, consider the application as having been received by the 
deadline.
    Any application which does not meet the above criteria will not be 
eligible for competition and will be discarded. The applicant will be 
notified of their failure to meet the submission requirements.

CDC Acknowledgment of Application Receipt

    A postcard will be mailed by PGO-TIM, notifying you that CDC has 
received your application.

H. Evaluation Criteria

    Applications will be reviewed by CDC staff for completeness and 
responsiveness as outlined under the ``Eligible Applicants'' Section 
(Items 1-5). Incomplete applications and applications that are not 
responsive will be returned to the applicant without further 
consideration. It is especially important that the applicant's abstract 
reflects the project's focus, because the abstract will be used to help 
determine the responsiveness of the application.
    Applications which are complete and responsive may be subjected to 
a preliminary evaluation (streamline review) by a peer review 
committee, the Injury Research Grant Review Committee (IRGRC), to 
determine if the application is of sufficient technical and scientific 
merit to warrant further review by the IRGRC. 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.
    Competing supplemental grant awards may be made, when funds are 
available, to support research work or activities not previously 
approved by the IRGRC. Applications should be clearly labeled to denote 
their status as requesting supplemental funding support. These 
applications will be reviewed by the IRGRC and the secondary review 
group.
    All awards will be determined by the Director of the NCIPC based on 
priority scores assigned to applications by the primary review 
committee IRGRC, recommendations by the secondary review committee of 
the Science and Program Review Subcommittee of the Advisory Committee 
for Injury Prevention and Control(ACIPC), consultation with NCIPC 
senior staff, and the availability of funds.
    1. The primary review will be a peer review conducted by the IRGRC. 
All applications will be reviewed for scientific merit using current 
National Institutes of Health (NIH) and CDC criteria (a scoring system 
of 100-500 points) to evaluate the methods and scientific quality of 
the application. All categories are of equal importance, however, the 
application does not need to be strong in all categories to be

[[Page 6482]]

judged likely to have a major scientific impact. Factors to be 
considered will include:
    a. Significance. Does this study address an important problem? If 
the aims of the application are achieved, how will scientific knowledge 
be advanced? What will be the effect of these studies on the concepts 
or methods that drive this field?
    b. Approach. Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the applicant acknowledge potential problem 
areas and consider alternative tactics? Does the project include plans 
to measure progress toward achieving the stated objectives? Is there an 
appropriate work plan included?
    c. Innovation. Does the project employ novel concepts, approaches 
or methods? Are the aims original and innovative? Does the project 
challenge or advance existing paradigms, or develop new methodologies 
or technologies?
    d. Investigator. Is the principal investigator appropriately 
trained and well-suited to carry out this work? Is the proposed work 
appropriate to the experience level of the principal investigator and 
other significant investigator participants? Is there a prior history 
of conducting injury-related research?
    e. Environment. Does the scientific environment in which the work 
will be done contribute to the probability of success? Does the 
proposed research take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support? Is there an appropriate degree of 
commitment and cooperation of other interested parties as evidenced by 
letters detailing the nature and extent of the involvement?
    f. Ethical Issues. What provisions have been made for the 
protection of human subjects and the safety of the research 
environments? How does the applicant plan to handle issues of 
confidentiality and compliance with mandated reporting requirements, 
e.g., suspected child abuse? Does the application adequately address 
the requirements of 45 CFR 46 for the protection of human subjects? (An 
application can be disapproved if the research risks are sufficiently 
serious and protection against risks is so inadequate as to make the 
entire application unacceptable.) The degree to which the applicant has 
met the CDC Policy requirements regarding the inclusion of women, 
ethnic, and racial groups in the proposed research (See Attachment 1, 
AR-2).
    This includes:
    (1) The proposed plan for the inclusion of both sexes and racial 
and ethnic minority populations for appropriate representation.
    (2) The proposed justification when representation is limited or 
absent.
    (3) A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    (4) A statement as to whether the plans for recruitment and 
outreach for study participants include the process of establishing 
partnerships with community(ies) and recognition of mutual benefits.
    g. Study Samples. Are the samples sufficiently rigorously defined 
to permit complete independent replication at another site? Have the 
referral sources been described, including the definitions and 
criteria? What plans have been made to include women and minorities and 
their subgroups as appropriate for the scientific goals of the 
research? How will the applicant deal with recruitment and retention of 
subjects?
    h. Dissemination. What plans have been articulated for 
disseminating findings?
    i. Measures of Effectiveness. The Peer Review Panel shall assure 
that measures set forth in the application are in accordance with CDC's 
performance plans. How adequately has the applicant addressed these 
measures?
    The IRGRC will also examine the appropriateness of the proposed 
project budget and duration in relation to the proposed research and 
the availability of data required for the project.
    2. The secondary review will be conducted by the Science and 
Program Review Subcommittee (SPRS) of the ACIPC. The ACIPC Federal 
agency experts will be invited to attend the secondary review and will 
receive modified briefing books (i.e., abstracts, strengths and 
weaknesses from summary statements, and project officer's briefing 
materials). ACIPC Federal agency experts will be encouraged to 
participate in deliberations when applications address overlapping 
areas of research interest, so that unwarranted duplication in 
federally-funded research can be avoided and special subject area 
expertise can be shared. The NCIPC Division Associate Directors for 
Science (ADS) or their designees will attend the secondary review in a 
similar capacity as the ACIPC Federal agency experts to assure that 
research priorities of the announcement are understood and to provide 
background regarding current research activities. Only SPRS members 
will vote on funding recommendations, and their recommendations will be 
carried to the entire ACIPC for voting by the ACIPC members in closed 
session. If any further review is needed by the ACIPC, regarding the 
recommendations of the SPRS, the factors considered will be the same as 
those considered by the SPRS.
    The committee's responsibility is to develop funding 
recommendations for the NCIPC Director based on the results of the 
primary review, the relevance and balance of proposed research relative 
to the NCIPC programs and priorities, and to assure that unwarranted 
duplication of federally-funded research does not occur. The secondary 
review committee has the latitude to recommend to the NCIPC Director, 
to reach over better ranked proposals in order to assure maximal impact 
and balance of proposed research. The factors to be considered will 
include:
    a. The results of the primary review including the application's 
priority score as the primary factor in the selection process.
    b. The relevance and balance of proposed research relative to the 
NCIPC programs and priorities.
    c. The significance of the proposed activities in relation to the 
priorities and objectives stated in ``Healthy People 2010,'' the 
Institute of Medicine report, ``Reducing the Burden of Injury,'' and 
the ``CDC Injury Research Agenda.''
    d. Budgetary considerations.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Annual progress report. The progress report will include a data 
requirement that demonstrates measures of effectiveness.
    2. A financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    4. At the completion of the project, the grant recipient will 
submit a brief (2,500 to 4,000 words written in nonscientific 
[laymen's] terms) summary highlighting the findings and their 
implications for injury prevention programs, policies, environmental 
changes, etc. The grant recipient will also include a description of 
the dissemination plan for research findings. This plan will include 
publications in peer-reviewed journals and ways in which research 
findings will be made available to stakeholders

[[Page 6483]]

outside of academia, (e.g., state injury prevention program staff, 
community groups, public health injury prevention practitioners, and 
others). CDC will place the summary report and each grant recipient's 
final report with the National Technical Information Service (NTIS) to 
further the agency's efforts to make the information more available and 
accessible to the public.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.

Additional Requirements

    The following additional requirements are applicable to this 
program. For a complete description of each see Attachment 1 of this 
announcement as it appears on the CDC Web site.

AR-1 Human Subjects Certification
AR-2 Requirements for inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-3 Animal Subjects Requirement
AR-9 Paperwork Reduction Requirements
AR-10 Smoke-Free Workplace Requirement
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
AR-13 Prohibition on Use of CDC funds for Certain Gun Control 
Activities
AR-21 Small, Minority, and Women-owned Business
AR-22 Research Integrity

    Executive Order 12372 does not apply to this program.

J. Where To Obtain Additional Information

    This and other CDC announcements, the necessary applications, and 
associated forms can be found on the CDC Web site, Internet address: 
http://www.cdc.gov Click on ``Funding,'' then ``Grants and Cooperative 
Agreements.''
    For general questions about this announcement, contact: Technical 
Information Management, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.
    For business management and budget assistance, contact: Steve 
Lester, Grants Management Specialist, Procurement and Grants Office, 
Centers for Disease Control and Prevention, 2920 Brandywine Road, 
Atlanta, GA 30341-4146, Telephone: (770) 488-1998, E-mail address: 
[email protected].
    For program technical assistance, contact: Tom Voglesonger, Program 
Manager, Office of the Director, National Center for Injury Prevention 
and Control, Centers for Disease Control and Prevention (CDC), 4770 
Buford Highway, NE, Mailstop K-02, Atlanta, GA 30341-3724, Telephone: 
(770) 488-4823, E-mail address: [email protected].

    Dated: February 1, 2003.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 03-3032 Filed 2-6-03; 8:45 am]
BILLING CODE 4163-18-P