[Federal Register Volume 65, Number 247 (Friday, December 22, 2000)]
[Notices]
[Pages 80884-80887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32752]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 01014]


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

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces that 
grant applications are being accepted for Injury Prevention and Control 
Research Grants for fiscal year (FY) 2001. This announcement is related 
to the Healthy People 2010 focus areas of Injury and Violence 
Prevention.
    The purposes of this program announcement 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.

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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, and federally recognized 
Indian tribal governments, Indian tribes, or Indian tribal 
organizations, and small, minority, and women-owned businesses.
    Current holders of CDC R49 Research grants and R49 Injury Control 
Research Center (ICRC) grants are eligible to apply for supplemental 
funding to enhance or expand existing projects or to conduct one year 
pilot studies. Grantees currently funded under announcements 
00024(Grants for Injury Control Training and Demonstration Center) and 
00043 (Grants for National Academic Centers of Excellence on Youth 
Violence Prevention) are not eligible to apply for supplements.


    Note: Public Law 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan 
or any other form.


    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 Addendum 2,(1.a-c). The addendum is contained in the 
application package.
    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 $1.2 million is expected to be available in FY 2001 
for injury research grants 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, 
2001, 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 eligible 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. 
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 workplan 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.


Programmatic Interests

    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.

    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).

Funding Preferences

    While extending and adapting results and conclusions of the above 
efforts to 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. Application Content

    Applications should follow the PHS-398 (Rev. 4/98) application and 
Errata sheet, 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.

[[Page 80886]]

    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.

E. Submission and Deadline

Letter of Intent

    Although not a prerequisite of application, a non-binding letter of 
intent-to-apply is requested from potential applicants. The letter of 
intent shall be submitted on or before February 7, 2001, to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement. The letter should identify 
the announcement number, name 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 Submission

    Submit the original and five copies of PHS 398 (OMB Number 0925-
0001 and adhere to the instructions on the Errata Instruction sheet for 
PHS 398). Forms are in the application kit.
    On or before March 7, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Applications shall be considered as meeting the deadline if they 
are received at the above address on or before the deadline date; or 
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 the U.S. Postal Service. Private 
metered postmarks will not be acceptable as proof of timely mailing.
    Late Applications: Applications which do not meet the criteria 
above are considered late applications, will not be considered, and 
will be returned to the applicant.

F. 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 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?
    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?

[[Page 80887]]

    h. Dissemination. What plans have been articulated for 
disseminating findings?
    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 Work Group (SPRWG) 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 SPRWG 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 SPRWG, the factors 
considered will be the same as the factors that the SPRWG 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 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 2001, 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 workplan 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.

G. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of
    1. Progress report annually,
    2. Financial status report, no more than 90 days after the end of 
the budget period, and
    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) summary highlighting the findings 
and their implications for research and policy. 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 Addendum 1 in the 
application package.

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-7  Executive Order 12372 Review--not applicable for this program 
announcement
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

H. Authority and Catalog of Federal Domestic Assistance Number

    In addition to being authorized under 301 (a) [42 U.S.C. 241(a)] of 
the Public Health Service Act, this program announcement is also 
authorized under 391 (a) [42 U.S.C. 280(b)] of the Public Service 
Health Act. The catalog of Federal Domestic Assistance number is 
93.136.

I. Where To Obtain Additional Information

    This and other CDC announcements are available through the CDC 
homepage on the Internet. The address for the CDC homepage is http://www.cdc.gov.
    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:
    Angela Webb, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office
    Program Announcement #01014, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 
30341, Telephone (770) 488-2784, 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].

    Dated: December 18, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 00-32752 Filed 12-21-00; 8:45 am]
BILLING CODE 4163-18-P