[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Notices]
[Pages 9289-9292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02041]


Traumatic Injury Biomechanics Research;Notice of Availability of 
Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a grant program for 
Extramural 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 Interests.''
    2. Build the scientific base for the prevention of injuries, 
disabilities, and deaths.
    3. Encourage professionals from a wide spectrum of disciplines such 
as engineering, bioengineering, medicine, health care, public health, 
health care research, behavioral and social sciences, and others, to 
undertake research to prevent and control injuries.
    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.

B. 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, research institutions, hospitals, other 
public and private nonprofit and for-profit 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.
    Current grantees are also eligible to apply for supplemental 
funding to enhance or expand existing projects, or to conduct one year 
pilot studies.

    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 below 
requirements will be returned to the applicant without further 
consideration. The following are applicant requirements:
    1. A principal investigator, who has conducted research, published 
the findings in peer-reviewed journals, and has 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) in the application kit.
    5. The overall match between the applicant's proposed theme and 
research objectives, and the program interests as described under the 
heading, ``Programmatic Interests.''

C. Availability of Funds

    Approximately $1,000,000 is available in FY 2002 to fund 
approximately four to five awards. The specific program priorities for 
these funding opportunities are outlined with examples in this 
announcement under the section, ``Programmatic Interests.''
    It is expected that the awards will begin on or about September 30, 
2002, and will be made for a 12-month budget period within a three year 
project period. The maximum funding level will not exceed $300,000 
(including both direct and indirect costs) per year or $900,000 for the 
three-year project period. Those grantees applying for supplemental 
funding may request up to $150,000 (including both direct and indirect 
costs) for one year. 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 end-of-fiscal year funds. Applications 
that exceed the funding cap of $300,000 per year will be excluded from 
the competition and returned to the applicant. The availability of 
Federal funding may vary and is subject to change.
    Continuation awards within the project period will be made based on 
satisfactory progress demonstrated by investigators at work-in-progress 
monitoring workshops (travel expenses for this annual one-day meeting 
should be included in the applicant's proposed budget), and the 
achievement of work plan milestones reflected in the continuation 
application.

    Note: Grant funds will not be made available to support the 
provision of direct care. Eligible applicants may enter into 
contracts, including consortia agreements (as set forth in the PHS 
Grants Policy Statement, dated April 1, 1994), as necessary to meet 
the requirements of the program and strengthen the overall 
application.

Funding Preferences

    While extending and adapting results and conclusions of the above 
efforts to

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the entire population is desirable, additional consideration will be 
given to proposals that emphasize research especially applicable to 
young children, women (and, in particular, pregnant women), and/or the 
elderly.

D. Program Requirements

    The National Center of Injury Prevention and Control (NCIPC) is 
soliciting investigator-initiated research that will help expand and 
advance our understanding of injury causation. Traumatic injury 
biomechanics research is especially needed to understand the injury 
mechanisms that lead to long-term disability from brain and spinal cord 
injuries.
    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the following activities:
    1. Research to advance the biomechanical understanding of traumatic 
brain and spinal cord injuries (TBI/SCI), thoracic and abdominal 
injuries resulting from blunt impact, and injuries occurring to the 
extremities and joints.
    2. Evaluate, from a biomechanical perspective, intervention 
concepts and strategies such as multi-use recreational helmets, mouth- 
and face-protection devices for athletes, energy-absorbing playground 
surfaces, hip pads, and motor vehicle side-impact and rollover 
countermeasures.
    3. Define human tolerance limits for injury; develop biofidelic 
models to elucidate injury physiology as well as pharmacologic, 
surgical, rehabilitation, and other interventions; improve injury 
assessment technology; increase understanding of impact injury 
mechanisms; and quantify injury-related biomechanical responses for 
critical areas of the human body (e.g., brain and vertebral injury with 
spinal cord involvement).
    4. Applicants are required to provide Measures of Effectiveness 
that will demonstrate the accomplishment of the various identified 
objectives of the grant. Measures must be objective/quantitative and 
must measure the intended outcome. These Measures of Effectiveness 
shall be submitted with the application and shall be an element of the 
evaluation (See Attachment 4 in the application kit).

E. Content

Letter of Intent (LOI)

    A LOI is optional for this program. The narrative should be no more 
than two double-spaced pages, printed on one side, with one inch 
margins, and unreduced font. The letter should identify the 
announcement number, 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.

Application

    Use the information in the Program Requirements, Other 
Requirements, and 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.
    Applications should follow the PHS-398 (Rev. 5/2001) application 
and Errata sheet (See attachment 3 in the application kit), and 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 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 that 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 five 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 4 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)

    On or before March 18, 2002, submit the LOI to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.

Application

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before April 16, 2002, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
submission to the independent review group. (Applicants must request a 
legibly dated U.S. Postal Service postmark or obtain a legibly dated 
receipt from a commercial carrier or U.S. Postal Service. Private 
metered postmarks shall not be acceptable as proof of timely mailing.)
    Late: Applications which do not meet the criteria in 1. or 2. above 
will be returned to the applicant.

G. Evaluation Criteria

    Upon receipt, 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

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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 (triage) 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.
    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 
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 by a committee 
of no less than three reviewers with appropriate expertise using 
current National Institutes of Health (NIH) criteria to evaluate the 
methods and scientific quality of the application. 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. 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 (See attachment 4 in the application kit). 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 Committee (SPRC) from the ACIPC. The ACIPC Federal ex 
officio members 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). Federal ex officio members 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 Federal ex officio members to assure that 
research priorities of the announcement are understood and to provide 
background regarding current research activities. Only SPRC 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 SPRC, the factors considered will be the same as 
the factors that the SPRC considered.
    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

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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'' and the 
Institute of Medicine report, ``Reducing the Burden of Injury''.
    d. Budgetary considerations.
    3. Continued Funding. Continuation awards made after FY 2002, but 
within the project period, will be made on the basis of the 
availability of funds and the following criteria:
    a. 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.
    b. The objectives for the new budget period are realistic, 
specific, and measurable.
    c. The methods described will clearly lead to achievement of these 
objectives.
    d. The evaluation plan will allow management to monitor whether the 
methods are effective.
    e. The budget request is clearly explained, adequately justified, 
reasonable and consistent with the intended use of grant funds.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of:
    1. Annual progress report (the results of the Measures of 
Effectiveness shall be a data requirement to be submitted with or 
incorporated into the progress report. See Attachment 4 in the 
application kit);
    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; and
    4. At the completion of the project, the grant recipient will 
submit a brief (2,500 to 4,000 words written in non-scientific 
[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 outside of academia, 
(e.g., state injury prevention program staff, community groups, public 
health injury prevention practioners, 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.
    The following additional requirements are applicable to this 
program. For a complete description of each see Attachment 1 in the 
application kit.

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

I. 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. 
280(b)] of the Public Service Health Act, as amended. The catalog of 
Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
on the Internet. The address for the CDC home page is http://www.cdc.gov. Click on ``Funding Opportunities'' then ``Grants and 
Cooperative Agreements.''
    To receive additional written information and to request an 
application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Van A. King, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Program Announcement #02041, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
Room 3000, Atlanta, Georgia 30341, Telephone: (770) 488-2751, Internet 
address: [email protected].
    For program technical assistance, contact: Ted Jones, Program 
Manager, Office of Research Grants, National Center for Injury 
Prevention and Control, Centers for Disease Control and Prevention 
(CDC), 4770 Buford Highway, NE, Mailstop K-58, Atlanta, GA 30341-3724, 
Telephone: (770) 488-4824, Internet address: [email protected].

Robert L. Williams,
Branch Chief, Acquisition and Assistance Branch B, Procurement and 
Grants Office, Centers for Disease Control and Prevention (CDC).
[FR Doc. 02-4775 Filed 2-27-02; 8:45 am]
BILLING CODE 4163-18-P