4 November 2004
Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html

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[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Notices]
[Page 64306-64312]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-48]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Grants for Violence-Related Injury Prevention Research: Youth
Violence, Suicidal Behavior, Child Maltreatment, Intimate Partner
Violence, and Sexual Violence

    Announcement Type: New.
    Funding Opportunity Number: CE05-012.
    Catalog of Federal Domestic Assistance Number: 93.136.

DATES: Key Dates: Letter of Intent Deadline: December 6, 2004.
Application Deadline: February 2, 2005.

[[Page 64307]]

I. Funding Opportunity Description

    Authority: 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 Service Health Act, as amended.

    Purpose: The purposes of the program are to:
     Solicit research applications that address the priorities
reflected under the heading, ``Research Objectives''.
     Build the scientific base for the prevention and control
of fatal and nonfatal injuries and related disabilities.
     Encourage professionals from a wide spectrum of
disciplines of epidemiology, behavioral and social sciences, medicine,
biostatistics, public health, law, criminal justice, and engineering to
perform research in order to prevent and control injuries more
effectively.
     Encourage investigators to propose research that: involves
intervention development and testing as well as research on methods;
enhances the adoption and maintenance of effective intervention
strategies among individuals, organizations, or communities.
    This program addresses the ``Healthy People 2010'' focus area of
Injury and Violence Prevention.
    Measurable outcomes of the program will be in alignment with one
(or more) of the following performance goal(s) for the National Center
for Injury Prevention and Control (NCIPC):
     Increase the capacity of injury prevention and control
programs to address the prevention of injuries and violence.
     Monitor and detect fatal and non-fatal injuries.
     Conduct a targeted program of research to reduce injury-
related death and disability.
    Research Objectives: NCIPC is soliciting investigator-initiated
research that will help expand and advance our understanding of
violence, its causes, and prevention strategies. The following research
themes are the focus of this investigator-initiated solicitation:
(Applications that fail to address one of these three research
objectives will be considered non-responsive.)
    1. Conduct studies to build knowledge on methods, structures, and
processes to implement evidence-based interventions, programs and
policies to prevent intimate partner violence, child maltreatment and
youth violence. This research is intended to bridge the gap between
prevention research and everyday practice by building a knowledge base
about how evidence-based violence prevention information and strategies
are disseminated, translated and integrated for use by communities and
policy makers. ($600,000 will be reserved to fund up to two proposals
addressing this priority.)
    2. Evaluate the efficacy, effectiveness, and cost effectiveness of
primary prevention interventions, programs, and policies to prevent
perpetration of intimate partner violence, sexual violence, child
maltreatment (includes physical, sexual, emotional abuse and neglect),
youth violence or suicidal behavior. There is particular interest in
assessing the impact of interventions, programs, or policies that may
affect multiple forms of violence simultaneously.
    3. Identify protective factors across at least two levels of
influence (e.g., individual, family, peers, school/workplace,
neighborhood, community) that reduce risk for the perpetration of
intimate partner violence, sexual violence, child maltreatment, youth
violence or suicidal behavior among populations at elevated risk for
engaging in such behaviors.
    Rigorous evaluations are needed to determine the effectiveness of
interventions, programs, and policies addressing the prevention of
violence. Experimental designs are strongly encouraged. However, NCIPC
will consider other evaluation designs, if justified, as required by
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness
studies, they should follow the guidelines in the following references:
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in
Health and Medicine. New York: Oxford University Press, 1996.
    Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide
to Decision Analysis and Economic Evaluation. Second Edition. New York:
Oxford University Press, 2003.
    For randomized trials, applicants are encouraged to clearly state
how study subjects, whether individuals or groups, were selected,
randomized, and followed through the trial. One relevant useful
guidance document is Moher D, Schulz KF, Altman D. The CONSORT
Statement, JAMA 2001;285:1987-2001.

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $1,680,000. (This amount is an estimate,
and is subject to availability of funds.)
    Approximate Number of Awards: Five to six.
    Approximate Average Award: $300,000. (This amount is for the first
12-month budget period and includes both direct and indirect costs.
$900,000 total is available over the three year project period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $300,000. (This amount is for the first 12-
month budget period and includes both direct and indirect costs.
$900,000 total is available over the three year project period.)
    Anticipated Award Date: August 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal government.
    Consideration will also be given to current grantees that submit a
competitive supplement application 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.

III. Eligibility Information

III.1. Eligible applicants

    Applications may be submitted by public and private nonprofit and
for profit organizations and by governments and their agencies, such
as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the

[[Page 64308]]

Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with
States).
    A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as documentation of your status. Place this
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
    Eligible applicants may enter into contracts, including consortia
agreements, as necessary to meet the requirements of the program and
strengthen the overall application.
    It is especially important that the abstract of your grant
application (Description, PHS 398 form page 2) reflects the project's
focus, because the abstract will be used to help determine the
responsiveness of the application.
    Special Requirements: If your application is incomplete or non-
responsive to the requirements listed in this section, it will not be
entered into the review process. You will be notified that your
application did not meet submission requirements.
     Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
     Grant applications must demonstrate an overall match
between the applicant's proposed theme and research objectives and the
program priorities as described under the heading, ``Research
Objectives.''
     Applications must demonstrate effective and well-defined
working relationships within the performing organization and with
outside entities, which will ensure implementation of the proposed
activities.
     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.
    Individuals Eligible to Become Principal Investigators:
     A principal investigator who has conducted violence
prevention research, published the findings in a peer-reviewed journal,
and has specific authority and responsibility to carry out the proposed
project.
     The ability of the principal investigator to carry out
injury control research projects as defined under Attachment 1 of this
program announcement. The attachment is posted with this announcement
on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.

    Applications, which do not meet the above requirements, will be
considered non-responsive.
    Any individual with the skills, knowledge, and resources necessary
to carry out the proposed injury research as outlined above is invited
to work with their institution to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for CDC
programs.
    Principal investigators are encouraged to submit only one proposal
in response to this program announcement. With few exceptions (e.g.,
research issues needing immediate public health attention), only one
application per principal investigator will be funded under this
announcement.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.

    Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.

    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) staff at: 770-488-2700. Application forms can be mailed to
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following
format:
     Maximum number of pages: Two.
     Font size: 12-point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Single spaced.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:
     Descriptive title of the proposed research.
     Name, address, e-mail address, and telephone number of the
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement.
     Brief description of the scope and intent of the proposed
research work.
    Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further assistance with the
PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, e-mail:
GrantsInfo@nih.gov.
    You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com

or call 1-866-705-5711.
    For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm
.

    This announcement uses the non-modular budgeting format. Follow the
PHS-398 instructions for non-modular budget research grant
applications.
    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

[[Page 64309]]

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.
    In addition to the instructions provided in the PHS 398 for writing
the Description on page 2 of the PHS 398 form, structure the
Description using the following components:
     Statement of the problem.
     Purpose of the proposed research.
     Methods, including study population, data sources and any
statistical analyses to be performed.
     Implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific
aims?
     Does the Description state the importance of the research
and how it is innovative?
     Does the Description outline the methods that will be used
to accomplish the goals?
     Is the language of the Description simple and easy to
understand for a broad audience?
    You must include a research plan in your application. The research
plan should be no more than 25 pages, printed on one side, single
spaced, with one half-inch margins, and unreduced 12-point font. The
research plan should address activities to be conducted over the entire
project period. Use the information in the Research Objectives,
Administrative and National Policy Requirements, and Application Review
Information sections to develop the application content. The research
plan should include the following information:
     The project's focus, a justification for the research
proposed, and a description of the scientific basis for the research.
The focus should be based on recommendations in ``Healthy People 2010''
(http://www.healthypeople.gov) and the ``CDC Injury Research Agenda,'' (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and

should seek creative approaches that will contribute to a national
program for injury control.
     Specific, measurable, and time-framed objectives.
     A detailed plan describing the methods, which will achieve
the objectives, including their sequence. A comprehensive evaluation
plan is an essential component of the application.
     A description of the principal investigator's role and
responsibilities.
     A description of those activities related to, but not
supported by, the grant.
     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.
     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.
    Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
    For additional help in preparing your grant application please see
the ``frequently asked questions'' section on the NCIPC Web page at:
http://www.cdc.gov/ncipc/res-opps/2004pas.htm.

IV.3. Submission Dates and Times

    LOI Deadline Date: December 6, 2004.
    CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
    Application Deadline Date: February 2, 2005.
    Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office (PGO) (not NIH) by 4 p.m. eastern time on
the deadline date. If you submit your application by the United States
Postal Service or commercial delivery service, you must ensure that the
carrier will be able to guarantee delivery by the closing date and
time. If CDC receives your submission 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, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
    This announcement is the definitive guide on LOI and grant
application content, submission address, and deadline. It supersedes
information provided in the application instructions. If your
application does not meet the deadline above, it will not be eligible
for review, and will be discarded. You will be notified that you did
not meet the submission requirements.
    CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: (770) 488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for submissions to
be processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding restrictions

    Restrictions, which must be taken into account while writing your
budget, are as follows:
     Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board (IRB) approvals are in place.
     Grant funds will not be made available to support the
provision of direct care.
    If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: NCIPC Extramural Resources Team, Centers
for Disease Control and Prevention, National Center for Injury
Prevention and Control, 4770 Buford Hwy, NE., Mailstop K-62, Atlanta,
GA 30341.
    Telephone: 770-488-4037; Fax: 770-488-1662; e-mail: CIPERT@CDC.GOV.
    Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--PA 05012, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the
application, and four copies of all appendices must be sent to: NCIPC
Extramural Resources Team, CDC, National Center for Injury Prevention
and Control, Address for Express Mail or Delivery Service: 2945 Flowers
Road, Yale Building, Room 2054, Atlanta, Georgia 30341.
    Address for U.S. Postal Service Mail: 4770 Buford Hwy, NE.,
Mailstop K-62, Atlanta, GA 30341.

[[Page 64310]]

    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the grant. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to improve the control and
prevention of disease and injury and to enhance health. In the written
comments, reviewers will be asked to evaluate the application in order
to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.
    The scientific review group will address and consider each of the
following criteria equally in assigning the application's overall
score, weighting them as appropriate for each application. The
application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important
work that by its nature is not innovative, but is essential to move a
field forward.
    The review criteria are as follows:
    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?
    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?
    Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
    Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)? Is there a prior history of conducting violence prevention
injury-related research?
    Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments 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?
    Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
    Dissemination: What plans have been articulated for disseminating
findings?
    Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR Part 46
for the protection of human subjects? This will not be scored; however,
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.
    Inclusion of Women and Minorities in Research: Does the application
adequately address 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; and (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.
    Inclusion of Children as Participants in Research Involving Human
Subjects: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998. NCIPC has adopted this policy for this announcement.
    All investigators proposing research involving human subjects
should read the ``NIH Policy and Guidelines'' on the inclusion of
children as participants in research involving human subjects that is
available at http://grants.nih.gov/grants/funding/children/children.htm
.

    Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the PGO and for
responsiveness by NCIPC. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will be notified that their application
did not meet submission requirements.
    Applications that are complete and responsive to the announcement
will be evaluated for scientific and technical merit by an appropriate
peer review panel convened by the NCIPC in accordance with the review
criteria listed above. As part of the initial merit review, all
applications will:
     Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
     Receive a written critique.
    The primary review will be a peer review conducted by NCIPC Initial
Review Group (IRG). Applications may be subjected to a preliminary
evaluation (streamline review) by the IRG to determine if the
application is of sufficient technical and scientific merit to warrant
further review. NCIPC 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 the IRG. These applications will be
reviewed for scientific merit using current NIH criteria (a scoring
system of 100-500 points) to evaluate the methods and scientific
quality of the application.
    The secondary review will be conducted by the Science and Program
Review Subcommittee (SPRS) of the Advisory Committee for Injury
Prevention and Control (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

[[Page 64311]]

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 ACIPC 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:
     The results of the primary review including the
application's priority score as the primary factor in the selection
process.
     The relevance and balance of proposed research relative to
the NCIPC programs and priorities.
     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.'' (See Attachment 1, Resource
Materials. The attachment is posted with this announcement on the CDC
Web site: http://www.cdc.gov/ncipc/ncipchm.htm.)

     Budgetary considerations.
    All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee IRG, recommendations by the secondary review committee of the
Science and Program Review Subcommittee of the ACIPC, consultation with
NCIPC senior staff, and the availability of funds.
    Competing supplemental grant awards may be made, when funds are
available, to support research work or activities not previously
approved by the IRG. Applications should be clearly labeled to denote
their status as requesting supplemental funding support. These
applications will be reviewed by the IRG and the secondary review
group.
Continued Funding
    Continuation awards made after FY 2005, but within the project
period, will be made on the basis of the availability of funds and the
following criteria:
     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 is being demonstrated
through presentations at work-in-progress monitoring workshops (travel
expenses for this annual one-day meeting should be included in the
applicant's proposed budget).
     The objectives for the new budget period are realistic,
specific, and measurable.
     The methods described will clearly lead to achievement of
these objectives.
     The evaluation plan will allow management to monitor
whether the methods are effective.
     The budget request is clearly explained, adequately
justified, reasonable and consistent with the intended use of grant
funds.
    Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    August 30, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of
the application review by mail.

VI.2. Administrative and National Policy Requirements

    45 CFR part 74 and part 92.
    For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.

    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements.
     AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research.
     AR-3 Animal Subjects Requirements.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     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.
    Additional information on AR-1 through AR-22 can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.

     AR-25 Release and Sharing of Data.
    Starting with the December 1, 2003, receipt date, all ``Requests
for Applications (RFA)/Program Announcements (PA)'' soliciting
proposals for individual research projects of $500,000 or more in total
(direct and indirect) costs per year require the applicant to include a
plan describing how the final research data will be shared/released or
explain why data sharing is not possible. Details on data sharing and
release, including information on the timeliness of the data and the
name of the project data steward, should be included in a brief
paragraph immediately following the ``Research Plan'' section of the
PHS 398 form. References to data sharing and release may also be
appropriate in other sections of the application (e.g. background and
significance, or human subjects requirements). The content of the data
sharing and release plan will vary, depending on the data being
collected and how the investigator is planning to share the data. The
data sharing and release plan will not count toward the application
page limit and will not factor into the determining scientific merit or
the priority scoring. Investigators should seek guidance from

[[Page 64312]]

their institutions on issues related to institutional policies, and
local IRB rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule.
    Further detail on the requirements for addressing data sharing in
applications for NCIPC funding may be obtained by contacting NCIPC
program staff or by visiting the NCIPC Internet at: http://www.cdc.gov/ncipc/osp/sharing_policy.htm
.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of
the budget period.
    3. Final financial and performance reports, 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 summary 2,500 to 4,000 words written in non-scientific
[laymen's] terms. The narrative should highlight 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 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.
    These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.
    For general questions, contact: Technical Information Management
Section, CDC Procurement and Grants Office, 2920 Brandywine Road,
Atlanta, GA 30341. Telephone: (770) 488-2700.
    For scientific/research issues, contact: Paul Smutz, Ph.D, Project
Officer, National Center for Injury Prevention and Control, Centers for
Disease Control and Prevention (CDC), 4770 Buford Highway, NE.,
Mailstop K-02, Atlanta, GA 30341. Telephone: (770) 488-1508; e-mail:
wsmutz@cdc.gov.
    For questions about peer review, contact: Gwendolyn Cattledge,
Ph.D, Scientific Review Administrator, National Center for Injury
Prevention and Control, Centers for Disease Control and Prevention
(CDC), 4770 Buford Highway, NE., Mailstop K-02, Atlanta, GA 30341.
Telephone: (770) 488-1430; e-mail: gxc8@cdc.gov.
    For financial, grants management, or budget assistance, contact:
Pamela Render, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: (770) 488-
2712; e-mail: PLR3@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on

``Funding'' then ``Grants and Cooperative Agreements.''

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-24618 Filed 11-3-04; 8:45 am]

BILLING CODE 4163-18-P

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[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Notices]
[Page 64293-64300]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-46]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Grants for New Investigator Training Awards for Unintentional
Injury, Violence Related Injury, Injury Biomechanics, and Acute Injury
Care Research

    Announcement Type: New.
    Funding Opportunity Number: CE05-021.
    Catalog of Federal Domestic Assistance Number: 93.136.
    Key Dates:
    Letter of Intent (LOI) Deadline: December 6, 2004.
    Application Deadline: February 2, 2005.

I. Funding Opportunity Description

    Authority: 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 Service Health Act, as
amended.

    Purpose: The Centers for Disease Control and Prevention (CDC)
announces the availability of fiscal year (FY) 2005 funds for grants
for new investigator training awards in four research areas:
unintentional injury prevention, violence-related injury prevention,
injury-related acute care/mass trauma research, and injury-related
biomechanics research. This program addresses the ``Healthy People
2010'' focus areas of Injury and Violence Prevention.
    The purposes of this program are to:
     Solicit research applications that address the priorities
reflected under the heading, ``Research Objectives''.
     Encourage professionals from a wide spectrum of
disciplines to conduct research aimed at preventing and controlling
injuries more effectively.
     Support injury research by new investigators who are
doctoral-level graduates and who have not previously received injury-
related CDC R49 or their equivalent grants.
     Build the scientific base for the prevention and control
of unintentional- and violence-related injuries, disabilities, and
deaths.

[[Page 64294]]

     Encourage qualified applicants who are beginning to focus
on injury-related research.
    The career development objectives of this program are to encourage
scientists to develop independent research skills and to gain
experience in advanced methods and experimental approaches in injury-
related research. This program is also intended to jump start the
careers of researchers in injury prevention and control by providing
support for pilot studies, enhancements to existing studies, or other
studies that will serve as a foundation for a career in injury
prevention and control. Applicants are required to have a mentor with
extensive injury research experience who will assist the applicant with
scientific and career-related issues during the period of the award.
    This program addresses the ``Healthy People 2010'' focus area of
Injury and Violence Prevention.
    Measurable outcomes of the program will be in alignment with one
(or more) of the following performance goal(s) for the National Center
for Injury Prevention and Control (NCIPC):
     Increase the capacity of injury prevention and control
programs to address the prevention of injuries and violence.
     Monitor and detect fatal and non-fatal injuries.
     Conduct a targeted program of research to reduce injury-
related death and disability.

Background and Significance

Unintentional Injury Research
    For the purposes of this program announcement, unintentional
injuries are defined as unintentional damage to the body resulting from
acute exposure to thermal, mechanical, electrical, or chemical energy
or from the absence of such essentials as heat or oxygen.
    Unintentional injuries continue to be a major public health
problem. In 2000, 97,900 people died in the United States as a result
of unintentional injuries. Someone dies every six minutes in the U.S.
from causes such as motor vehicle crashes, falls, poisoning, drowning,
fires and burns, pedestrians struck by vehicles, bicycle crashes, or
choking and suffocation. In addition to deaths, injuries also
constitute a significant cause of both permanent and temporary
disability. In 2000, unintentional injuries resulted in an estimated
29.1 million emergency department visits and millions more seek
treatment for injuries from health care professionals. In addition to
the emotional costs of injuries, the financial costs of unintentional
injuries are staggering: well over $200 billion a year in medical care,
wage and productivity losses and employer costs alone. Unintentional
injuries are not accidents, they are predictable and they are
preventable.
Violence Related Injury Research
    Deaths and injuries associated with interpersonal violence and
suicidal behavior are also a major public health problem in the United
States and around the world. In 2000, over 46,000 people died from
homicide and suicide in the United States. Among 15 to 24 year olds,
homicide and suicide ranked as the second and third leading causes of
death. Violent deaths are the most visible consequence of violent
behavior in our society. Morbidity associated with physical and
emotional injuries and disabilities resulting from violence, however,
also constitute an enormous public health problem. For every homicide
that occurs each year there are over 100 nonfatal injuries resulting
from interpersonal violence. For every completed suicide it is
estimated that there are 20 to 25 suicide attempts. The mortality and
morbidity resulting from violence are associated with a variety of
types of violence including child maltreatment, youth violence,
intimate partner violence, sexual violence, elder abuse, and self-
directed violence or suicidal behavior.
Biomechanics Research
    The field of biomechanics quantifies the response and tolerance of
the human body to impact (e.g., motor vehicle collisions, playground
falls, and child battering) and addresses the underlying mechanisms of
injury, the forces deforming the body and the physiologic effects of
injury to infants, children, adults and the aged population. Based on
interdisciplinary research, the engineering factors are determined that
deform the body and the medical consequences are quantified that affect
vital functions. This knowledge is used to modify the design of
protective systems to improve safety. Improved safety systems protect
an individual from impact forces that can injure, and they can include
protective equipment (cycling helmets) and environments (playground
surfaces), occupant restraints (airbags and safety belts), and policies
(rules to minimize spearing in football). Biomechanical knowledge can
also be used to improve post-injury outcomes through physiologic models
to address emergency medical treatments, pharmacologic interventions
and rehabilitation to advance recovery.
    NCIPC's biomechanics program attempts to build on the basic
knowledge of biomechanics and encourage interdisciplinary intervention-
oriented injury control research as supported in the CDC Injury
Research Agenda.
Acute Injury Care Research
    Each year, Americans make between 30 and 40 million emergency
department (ED) visits for injuries. While most injured patients are
treated and released, many are admitted to inpatient trauma units and
later receive rehabilitative services. The most favorable outcomes are
achieved when acute care and subsequent rehabilitation are offered as
early as possible and focus on returning patients to baseline or to an
optimal level of functioning. Trauma systems are designed to match
trauma patients with the acute care and rehabilitative facilities they
need, but in many parts of the U.S. trauma systems are not fully
operational or are nonexistent. Where these systems are lacking, as
many as 30 percent to 40 percent of deaths among trauma patients are
due to preventable problems in clinical care, including missed
diagnoses and treatment delays.
    Injuries are a major cause of disabilities in the U.S. Central
nervous system injuries (those to the brain and spinal cord) are most
likely to result in serious long-term disability. Each year, an
estimated 80,000 Americans sustain a traumatic brain injury (TBI) that
results in disability; an estimated 5.3 million Americans live with
TBI-related disability. Although physical impairments from the injury
may contribute to TBI disability, cognitive deficits are the hallmark,
frequently resulting in secondary conditions such as depression and
other adverse outcomes such as the inability to work. An estimated
177,000 to 200,000 people in the U.S. live with spinal cord injuries
(SCI), and this number increases annually by as many as 20,000
individuals.

Research Objectives

    Applicants are encouraged to propose studies that can feasibly be
completed within the available funds and funding period. Proposed
research for this program announcement must address one of the
following research priorities. Applications that fail to address one of
these topics will be deemed nonresponsive.
Unintentional Injury
    1. Develop a theory-based intervention for use of supervision of
children to reduce unintentional injury outcomes.
    2. Evaluate existing and develop new methods to obtain exposure and
injury

[[Page 64295]]

incidence data for sports, exercise and recreation-related injuries.
    3. Identify risk and protective factors related to injury from
childhood falls, crashes involving young drivers or related to motor
vehicle and pedestrian travel of older adults.
    4. Evaluate the effectiveness of environmental, behavioral,
legislative or regulatory interventions to prevent pedestrian injuries
or injuries related to sports, exercise, and recreation (including
drowning).
    5. Assess how tailoring, training, packaging, feasibility (and
other dimensions of an effective intervention or policy) would promote
greater adoption, usability and uptake, especially for interventions
that impact older adult falls injury, transportation safety, and sports
& recreation injury prevention (including drowning).
    6. Evaluate theory-based strategies to increase dissemination of
effective interventions that reduce injuries related to transportation,
at home, or during recreation.
    For more information on the unintentional injury research
objectives, see Attachment 2 of this announcement. The attachment is
posted along with this announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm
.

Violence Related Injury
    1. Conduct studies to build knowledge on methods, structures, and
processes to implement evidence-based interventions, programs and
policies to prevent intimate partner violence, child maltreatment and
youth violence. This research is intended to bridge the gap between
prevention research and everyday practice by building a knowledge base
about how evidence-based violence prevention information and strategies
are disseminated, translated and integrated for use by communities and
policymakers.
    2. Evaluate the efficacy, effectiveness, and cost effectiveness of
primary prevention interventions, programs, and policies to prevent
perpetration of intimate partner violence, sexual violence, child
maltreatment (includes physical, sexual, emotional abuse and neglect),
youth violence or suicidal behavior. There is particular interest in
assessing the impact of interventions, programs, or policies that may
affect multiple forms of violence simultaneously.
    3. Identify protective factors across at least two levels of
influence (e.g., individual, family, peers, school/workplace,
neighborhood, community) that reduce risk for the perpetration of
intimate partner violence, sexual violence, child maltreatment, youth
violence or suicidal behavior among populations at elevated risk for
engaging in such behaviors.
Injury Biomechanics
    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.
An intervention can be broadly defined as a specific action, policy,
device or strategy designed to address injury prevention and control:
    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.
    3. Advance the biomechanical understanding of traumatic injury
(e.g., injuries to the brain, spinal cord, thorax/abdomen, extremities
and joints) in children and older adults (greater than 65 years old)
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).
    4. Define the human tolerance limits for injury in children and
older adults (greater than 65 years old), 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.
    5. Identify the modifiable risk factors for and mechanisms of
nonfatal whiplash injuries of the neck and back.
Acute Injury Care
    1. Develop and evaluate protocols that provide onsite interventions
in acute care settings or linkages to off-site services for patients at
risk of injury or psychosocial problems following injury.
    2. Identify methods and strategies to ensure that people with
traumatic brain injuries (TBI) and spinal cord injuries (SCI) receive
needed services.
    3. Identify the effects on acute injury care of inter-
jurisdictional, legal, governmental, and interdisciplinary issues
related to mass casualty events.
    4. Identify and evaluate the components of trauma systems which
contribute to improvement in care of the injured.
    5. Develop and evaluate new methods for linking prehospital
databases to trauma registries, and other hospital databases, including
those related to subsequent levels of care (e.g., rehabilitation).
    Approximately $500,000 of the total award amount will be reserved
to fund up to five proposals that address acute injury care research.
    Rigorous evaluations are needed to determine the effectiveness of
interventions, programs, and policies addressing the prevention of
injury. Experimental designs are strongly encouraged. However, NCIPC
will consider other evaluation designs, if justified, as required by
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness
studies, they should follow the guidelines in the following references:

Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in
Health and Medicine. New York: Oxford University Press, 1996.
Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to
Decision Analysis and Economic Evaluation. Second Edition. New York:
Oxford University Press, 2003.

    For randomized trials, applicants are encouraged to clearly state
how study subjects, whether individuals or groups, were selected,
randomized, and followed through the trial. One relevant useful
guidance document is Moher D, Schulz KF, Altman D, The CONSORT
Statement, JAMA 2001;285:1987-2001.

[[Page 64296]]

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $900,000. (This amount is an estimate,
and is subject to availability of funds.)
    Approximate Number of Awards: Nine (Up to five of these awards will
be made in the area of acute care research).
    Approximate Average Award: $100,000. (This amount includes both
direct and indirect costs.)
    Floor of Award Range: None.
    Ceiling of Award Range: $100,000. (This amount includes both direct
and indirect costs.)
    Anticipated Award Date: August 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: One year.
    Allowable costs include partial salary and tuition support for the
applicant; direct research project expenses, such as trainee stipends,
interviewer costs, data processing, participant incentives, statistical
consultation services, and supplies; and travel to one scientific
meeting, if adequately justified. Applicants should also include travel
costs for one, two-day trip to CDC in Atlanta to present research
findings.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit and
for profit organizations and by governments and their agencies, such
as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with
States).
    A Bona Fide Agent is an agency/organization identified by the State
as eligible to submit an application under the State eligibility in
lieu of a State application. If you are applying as a bona fide agent
of a State or local government, you must provide a letter from the
State or local government as documentation of your status. Place this
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
    Eligible applicants may enter into contracts, including consortia
agreements, as necessary to meet the requirements of the program and
strengthen the overall application.
    It is especially important that the abstract of your grant
application (Description, PHS 398 form page 2) reflects the project's
focus, because the abstract will be used to help determine the
responsiveness of the application.
Special Requirements
    If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
     Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
     Grant applications must demonstrate an overall match
between the applicant's proposed theme and research objectives and the
program priorities as described under the heading, ``Research
Objectives.''
     Applications must demonstrate effective and well-defined
working relationships within the performing organization and with
outside entities, which will ensure implementation of the proposed
activities.
     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.
Individuals Eligible To Become Principal Investigators
     The principal investigator must have a research or a
health-professional doctorate-level degree from an accredited program
and have demonstrated the capacity or potential for highly productive
research in the period after the doctorate, commensurate with level of
experience.
     Applicants who have been the principal investigator on an
RO1 or RO1-equivalent health-related research grant or who have had
equivalent injury-related research support from an existing Injury
Control Research Center (ICRC) are not eligible. Recipients of
dissertation research grants or NIH Small Grant Awards are eligible to
apply.
     A principal investigator who has specific authority and
responsibility to carry out the proposed project.
     The ability of the principal investigator to carry out
injury control research projects as defined under Attachment 1 of this
program announcement. The attachment is posted along with this
announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.

    Applications, which do not meet the above requirements, will be
considered non-responsive.
    Any individual with the skills, knowledge, and resources necessary
to carry out the proposed injury research as outlined above is invited
to work with their institution to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for CDC
programs.
    Principal investigators are encouraged to submit only one proposal
in response to this program announcement. With few exceptions (e.g.,
research issues needing immediate public health attention), only one
application per principal investigator will be funded under this
announcement.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.

    Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address:

[[Page 64297]]

http:// grants. nih. gov/grants /funding/ phs398/ phs398.html.

    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) staff at: (770) 488-2700. Application forms can be mailed to
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following
format:
     Maximum Number of Pages: Two.
     Font Size: 12-point unreduced.
     Paper Size: 8.5 by 11 inches.
     Page Margin Size: One inch.
     Printed only on one side of page.
     Single spaced.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:
     Descriptive title of the proposed research.
     Name, address, e-mail address, and telephone number of the
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement.
     Brief description of the scope and intent of the proposed
research work.
    Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further assistance with the
PHS 398 application form, contact PGO-TIM staff at (770) 488-2700, or
contact GrantsInfo, Telephone (301) 435) 0714, E-mail:
GrantsInfo@nih.gov.
    You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal Government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com

or call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/ funding/pubcommt.htm.

    This announcement uses the non-modular budgeting format. Follow the
PHS-398 instructions for non-modular budget research grant
applications.
    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.
    In addition to the instructions provided in the PHS 398 for writing
the Description on page 2 of the PHS 398 form, structure the
Description using the following components:
     Statement of the problem.
     Purpose of the proposed research.
     Methods, including study population, data sources and any
statistical analyses to be performed.
     Implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific
aims?
     Does the Description state the importance of the research
and how it is innovative?
     Does the Description outline the methods that will be used
to accomplish the goals?
     Is the language of the Description simple and easy to
understand for a broad audience?
    You must include a research plan in your application. The research
plan should be no more than 25 pages, printed on one side, single
spaced, with one half-inch margins, and unreduced 12-point font. The
research plan should address activities to be conducted over the entire
project period. Use the information in the Research Objectives,
Administrative and National Policy Requirements, and Application Review
Information sections to develop the application content. The research
plan should include the following information:

     The project's focus, a justification for the research
proposed, and a description of the scientific basis for the research.
The focus should be based on recommendations in ``Healthy People 2010''
(http://www.healthypeople.gov) and the ``CDC Injury Research Agenda,'' (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and

should seek creative approaches that will contribute to a national
program for injury control.
     Specific, measurable, and time-framed objectives.
     A detailed plan describing the methods, which will achieve
the objectives, including their sequence. A comprehensive evaluation
plan is an essential component of the application.
     A description of the roles and responsibilities of the
principal investigator and the mentor.
     A description of those activities related to, but not
supported by, the grant.
     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.
     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.
    Additional materials required: In addition to the completed PHS 398
application form, the applicant must also submit the following
materials, attached to the application as appendices:
     An official transcript of the applicant's graduate school
record.
     A statement describing the applicant's prior research
training and experience and short and long term career goals in injury
research, including a paragraph describing why he or she qualifies as a
new investigator.
     A letter from a senior injury researcher acknowledging
that he or she has read the application and agrees to serve as a
mentor. The letter should also include: (1) An outline of the mentor's
specific roles and responsibilities and time commitment (percent time);
(2) a proposed plan for providing scientific advice and consultation to
the applicant; and (3) a two-page biography of the mentor. (Use the
Biographical Sketch page in application form PHS 398.)
     A justification for any proposed tuition support.
    Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
    For additional help in preparing your grant application please see
the ``frequently asked questions'' section on the NCIPC Web page at:
http://www.cdc.gov/ncipc/res-opps/2004pas.htm.

IV.3. Submission Dates and Times

    LOI Deadline Date: December 6, 2004.

[[Page 64298]]

    CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
    Application Deadline Date: February 2, 2005.
    Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office (PGO) (not NIH) by 4 p.m. eastern time on
the deadline date. If you submit your application by the United States
Postal Service or commercial delivery service, you must ensure that the
carrier will be able to guarantee delivery by the closing date and
time. If CDC receives your submission 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, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
    This announcement is the definitive guide on LOI and grant
application content, submission address, and deadline. It supersedes
information provided in the application instructions. If your
application does not meet the deadline above, it will not be eligible
for review, and will be discarded. You will be notified that you did
not meet the submission requirements.
    CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: (770) 488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for submissions to
be processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your
budget, are as follows:
     Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board (IRB) approvals are in place.
     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.
     Allowable costs include partial salary and tuition support
for the applicant; direct research project expenses, such as trainee
stipends, interviewer costs, data processing, participant incentives,
statistical consultation services, and supplies; and travel to one
scientific meeting, if adequately justified.
     Applicants should also include travel costs for one, two-
day trip to CDC in Atlanta to present research findings.
     Funds for tuition support are limited to no more than 20
percent of the overall award and their use must be generally related to
the content and methods of the proposed research.
     Indirect costs for this trainee-related grant are limited
to eight percent.
    If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: NCIPC Extramural Resources Team, Centers
for Disease Control and Prevention, National Center for Injury
Prevention and Control, 4770 Buford Hwy, NE., Mailstop K-62, Atlanta,
GA 30341, Telephone: (770) 488-4037, Fax: (770) 488-1662, e-mail:
CIPERT@CDC.GOV.
    Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--CE05-021, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the
application, and four copies of all appendices must be sent to: NCIPC
Extramural Resources Team, CDC, National Center for Injury Prevention
and Control.
    Address for Express Mail or Delivery Service: 2945 Flowers Road,
Yale Building, Room 2054, Atlanta, Georgia 30341.
    Address for U.S. Postal Service Mail: 4770 Buford Hwy, NE.,
Mailstop K-62, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the grant. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to improve the control and
prevention of disease and injury and to enhance health. In the written
comments, reviewers will be asked to evaluate the application in order
to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.
    The scientific review group will address and consider each of the
following criteria equally in assigning the application's overall
score, weighting them as appropriate for each application. The
application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important
work that by its nature is not innovative, but is essential to move a
field forward.
    The review criteria are as follows:
    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?
    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?
    Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
    Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)? Is there a

[[Page 64299]]

prior history of conducting injury-related research?
    Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments 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?
    Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
    Dissemination: What plans have been articulated for disseminating
findings?
    Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR part 46
for the protection of human subjects? This will not be scored; however,
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.
    Inclusion of Women and Minorities in Research: Does the application
adequately address 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; and (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.
    Inclusion of Children as Participants in Research Involving Human
Subjects: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998. NCIPC has adopted this policy for this announcement.
    All investigators proposing research involving human subjects
should read the ``NIH Policy and Guidelines'' on the inclusion of
children as participants in research involving human subjects that is
available at http://grants.nih.gov/grants/funding/children/children.htm
.

    Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the PGO and for
responsiveness by NCIPC. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will be notified that their application
did not meet submission requirements.
    Applications that are complete and responsive to the announcement
will be evaluated for scientific and technical merit by an appropriate
peer review panel convened by the NCIPC in accordance with the review
criteria listed above. As part of the initial merit review, all
applications will:
     Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
     Receive a written critique.
    The primary review will be a peer review conducted by NCIPC Initial
Review Group (IRG). Applications may be subjected to a preliminary
evaluation (streamline review) by the IRG to determine if the
application is of sufficient technical and scientific merit to warrant
further review. NCIPC 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 the IRG. These applications will be
reviewed for scientific merit using current NIH criteria (a scoring
system of 100-500 points) to evaluate the methods and scientific
quality of the application.
    The secondary review will be conducted by the Science and Program
Review Subcommittee (SPRS) of the Advisory Committee for Injury
Prevention and Control (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 ACIPC 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:
     The results of the primary review including the
application's priority score as the primary factor in the selection
process.
     The relevance and balance of proposed research relative to
the NCIPC programs and priorities.
     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.'' (See Attachment 1, Resource
Materials.) The attachment is posted along with this announcement on
the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm).

     Budgetary considerations.
    All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee IRG, recommendations by the secondary review committee of the
Science and Program Review Subcommittee of the ACIPC, consultation with
NCIPC senior staff, and the availability of funds.
    Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:

[[Page 64300]]

     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    August 30, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.

    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements.
     AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research.
     AR-3 Animal Subjects Requirements.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     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.
    Additional information on AR-1 through AR-22 can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.

     AR-25 Release and Sharing of Data.
    Starting with the December 1, 2003 receipt date, all ``Requests for
Applications (RFA)/Program Announcements (PA)'' soliciting proposals
for individual research projects of $500,000 or more in total (direct
and indirect) costs per year require the applicant to include a plan
describing how the final research data will be shared/released or
explain why data sharing is not possible. Details on data sharing and
release, including information on the timeliness of the data and the
name of the project data steward, should be included in a brief
paragraph immediately following the ``Research Plan'' section of the
PHS 398 form. References to data sharing and release may also be
appropriate in other sections of the application (e.g. background and
significance, or human subjects requirements) The content of the data
sharing and release plan will vary, depending on the data being
collected and how the investigator is planning to share the data. The
data sharing and release plan will not count toward the application
page limit and will not factor into the determining scientific merit or
the priority scoring. Investigators should seek guidance from their
institutions on issues related to institutional policies, and local IRB
rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule.
    Further detail on the requirements for addressing data sharing in
applications for NCIPC funding may be obtained by contacting NCIPC
program staff or by visiting the NCIPC Internet: at http://www.cdc.gov/ncipc/osp/sharing_policy.htm
.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the
following reports:
    1. Financial status report, no more than 90 days after the end of
the budget period.
    2. The final performance report, no more than 90 days after the end
of the project period. The final performance report will be a brief
summary (2,500 to 4,000 words in length) written in non-scientific
[laymen's] terms. The report should highlight 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 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.
    These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement. For general
questions, contact: Technical Information Management Section, CDC
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341,
Telephone: (770) 488-2700.
    For scientific/research issues, contact: Paul Smutz, Ph.D, Project
Officer, National Center for Injury Prevention and Control, Centers for
Disease Control and Prevention (CDC), 4770 Buford Highway, NE.,
Mailstop K-02, Atlanta, GA 30341, Telephone: (770) 488-1508, E-mail:
wsmutz1@cdc.gov.
    For questions about peer review, contact: Gwendolyn Cattledge,
Ph.D, Scientific Review Administrator, National Center for Injury
Prevention and Control, Centers for Disease Control and Prevention
(CDC), 4770 Buford Highway, NE., Mailstop K-02, Atlanta, GA 30341,
Telephone: 770-488-1430, E-mail: gxc8@cdc.gov.
    For financial, grants management, or budget assistance, contact:
Pamela Render, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-
2712, E-mail: PLR3@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on

``Funding'' then ``Grants and Cooperative Agreements.''

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-24616 Filed 11-3-04; 8:45 am]

BILLING CODE 4163-18-P

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[Federal Register: November 4, 2004 (Volume 69, Number 213)]
[Notices]
[Page 64300-64306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no04-47]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Grants for Traumatic Injury Biomechanics Research

    Announcement Type: New.
    Funding Opportunity Number: CE05-023.
    Catalog of Federal Domestic Assistance Number: 93.136.

[[Page 64301]]

    Key Dates:
    Letter of Intent Deadline: December 6, 2004. Application Deadline:
February 2, 2005.

I. Funding Opportunity Description

    Authority: 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 Service Health Act, as amended.

    Purpose: The purposes of the program are to:
     Solicit research applications that address the priorities
reflected under the heading, ``Research Objectives''.
     Build the scientific base for the prevention and control
of fatal and nonfatal injuries and related disabilities.
     Encourage professionals from a wide spectrum of
disciplines of epidemiology, behavioral and social sciences, medicine,
biostatistics, public health, law, criminal justice, and engineering to
perform research in order to prevent and control injuries more
effectively.
     Encourage investigators to propose research that: involves
intervention development and testing as well as research on methods;
enhances the adoption and maintenance of effective intervention
strategies among individuals, organizations, or communities.
    This program addresses the ``Healthy People 2010'' focus area of
Injury and Violence Prevention.
    Measurable outcomes of the program will be in alignment with one
(or more) of the following performance goal(s) for the National Center
for Injury Prevention and Control (NCIPC):
     Increase the capacity of injury prevention and control
programs to address the prevention of injuries and violence.
     Monitor and detect fatal and non-fatal injuries.
     Conduct a targeted program of research to reduce injury-
related death and disability.

Research Objectives

    NCIPC is soliciting investigator-initiated research that will help
expand and advance our understanding of non-occupational unintentional
and violence-related injuries, and to minimize the consequences of
injuries when they do occur. NCIPC'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.
    The following research themes are the focus of this solicitation:
(Applications that fail to address one of these research objectives
will be considered non-responsive).

High Priority

    It is expected that half of the total awards will address high
priority objectives.
    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.
An intervention can be broadly defined as a specific action, policy,
device or strategy designed to address injury prevention and control:
    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.

Lower Priority

    3. Advance the biomechanical understanding of traumatic injury
(e.g., injuries to the brain, spinal cord, thorax/abdomen, extremities
and joints) in children and older adults (greater than 65 years old)
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).
    4. Define the human tolerance limits for injury in children and
older adults (greater than 65 years old), 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.
    5. Identify the modifiable risk factors for and mechanisms of
nonfatal whiplash injuries of the neck and back.
    Applicants need to identify and explain in their grant application
whether they are addressing a high or lower priority research
objective. They also need to provide a short justification as to why
they feel their grant application fits into the high or lower priority
research objectives. This justification should not exceed one page in
length.
    Rigorous evaluations are needed to determine the effectiveness of
interventions, programs, and policies addressing the prevention of
injury. Experimental designs are strongly encouraged. However, NCIPC
will consider other evaluation designs, if justified, as required by
the needs and constraints in a particular setting.
    For effective interventions, it is possible to do cost-
effectiveness studies. To be comparable to other cost effectiveness
studies, they should follow the guidelines in the following references:

Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in
Health and Medicine. New York: Oxford University Press, 1996.
Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to
Decision Analysis and Economic Evaluation. Second Edition. New York:
Oxford University Press, 2003.

    For randomized trials, applicants are encouraged to clearly state
how study subjects, whether individuals or groups, were selected,
randomized, and followed through the trial. One relevant useful
guidance document is Moher D, Schulz KF, Altman D. The CONSORT
Statement, JAMA 2001; 285:1987-2001.

II. Award Information

    Type of Award: Grant.
    Mechanism of Support: R49.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $840,000. (This amount is an estimate,
and is subject to availability of funds.)

[[Page 64302]]

    Approximate Number of Awards: Three.
    Approximate Average Award: $280,000. (This amount is for the first
12-month budget period and includes both direct and indirect costs.
$840,000 total is available over the three year project period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $280,000. (This amount is for the first 12-
month budget period and includes both direct and indirect costs.
$840,000 total is available over the three year project period.)
    Anticipated Award Date: August 30, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Three years.
    Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
    Consideration will also be given to current grantees that submit a
competitive supplement application 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.

III. Eligibility Information

III.1. Eligible Applicants

    Applications may be submitted by public and private nonprofit and
for profit organizations and by governments and their agencies, such
as:
     Public nonprofit organizations.
     Private nonprofit organizations.
     For profit organizations.
     Small, minority, women-owned businesses.
     Universities.
     Colleges.
     Research institutions.
     Hospitals.
     Community-based organizations.
     Faith-based organizations.
     Federally recognized Indian tribal governments.
     Indian tribes.
     Indian tribal organizations.
     State and local governments or their Bona Fide Agents
(this includes the District of Columbia, the Commonwealth of Puerto
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna
Islands, American Samoa, Guam, the Federated States of Micronesia, the
Republic of the Marshall Islands, and the Republic of Palau).
     Political subdivisions of States (in consultation with
States).
    A Bona Fide Agent is an agency/organization identified by the State
as eligible to submit an application under the State eligibility in
lieu of a State application. If you are applying as a bona fide agent
of a State or local government, you must provide a letter from the
State or local government as documentation of your status. Place this
documentation behind the first page of your application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
    Eligible applicants may enter into contracts, including consortia
agreements, as necessary to meet the requirements of the program and
strengthen the overall application.
    It is especially important that the abstract of your grant
application (Description, PHS 398 form page 2) reflects the project's
focus, because the abstract will be used to help determine the
responsiveness of the application.
Special Requirements
    If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
     Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
     Grant applications must demonstrate an overall match
between the applicant's proposed theme and research objectives and the
program priorities as described under the heading, ``Research
Objectives.''
     Applications must demonstrate effective and well-defined
working relationships within the performing organization and with
outside entities, which will ensure implementation of the proposed
activities.
     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.
Individuals Eligible To Become Principal Investigators
     A principal investigator who has conducted injury
prevention and control research, published the findings in a peer-
reviewed journal, and has specific authority and responsibility to
carry out the proposed project.
     The ability of the principal investigator to carry out
injury control research projects as defined under Attachment 1 of this
program announcement. The attachment is posted along with this
announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.

    Applications, which do not meet the above requirements, will be
considered non-responsive.
    Any individual with the skills, knowledge, and resources necessary
to carry out the proposed injury research as outlined above is invited
to work with their institution to develop an application for support.
Individuals from underrepresented racial and ethnic groups as well as
individuals with disabilities are always encouraged to apply for CDC
programs.
    Principal investigators are encouraged to submit only one proposal
in response to this program announcement. With few exceptions (e.g.,
research issues needing immediate public health attention), only one
application per principal investigator will be funded under this
announcement.

IV. Application and Submission Information

IV.1. Address to Request Application Package

    To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.

    Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.

    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) staff at: (770) 488-2700. Application forms can be mailed to
you.

[[Page 64303]]

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following
format:
     Maximum number of pages: Two.
     Font size: 12-point unreduced.
     Paper size: 8.5 by 11 inches.
     Page margin size: One inch.
     Printed only on one side of page.
     Single spaced.
     Written in plain language, avoid jargon.
    Your LOI must contain the following information:
     Descriptive title of the proposed research.
     Name, address, e-mail address, and telephone number of the
Principal Investigator.
     Names of other key personnel.
     Participating institutions.
     Number and title of this Program Announcement.
     Brief description of the scope and intent of the proposed
research work.
    Application: Follow the PHS 398 application instructions for
content and formatting of your application. If the instructions in this
announcement differ in any way from the PHS 398 instructions, follow
the instructions in this announcement. For further assistance with the
PHS 398 application form, contact PGO-TIM staff at (770) 488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
    You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal Government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or

call 1-866-705-5711. For more information, see the CDC Web site at:
http://www.cdc.gov/od/pgo/funding/pubcommt.htm.

    This announcement uses the non-modular budgeting format. Follow the
PHS-398 instructions for non-modular budget research grant
applications.
    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.
    In addition to the instructions provided in the PHS 398 for writing
the Description on page 2 of the PHS 398 form, structure the
Description using the following components:
     Statement of the problem.
     Purpose of the proposed research.
     Methods, including study population, data sources and any
statistical analyses to be performed.
     Implications for prevention.
    The Description (abstract) should answer the following questions:
     Does the Description state the hypothesis?
     Does the Description describe the objectives and specific
aims?
     Does the Description state the importance of the research
and how it is innovative?
     Does the Description outline the methods that will use to
accomplish the goals?
     Is the language of the Description simple and easy to
understand for a broad audience?
    You must include a research plan in your application. The research
plan should be no more than 25 pages, printed on one side, single
spaced, with one half-inch margins, and unreduced 12-point font. The
research plan should address activities to be conducted over the entire
project period. Use the information in the Research Objectives,
Administrative and National Policy Requirements, and Application Review
Information sections to develop the application content. The research
plan should include the following information:
     The project's focus, a justification for the research
proposed, and a description of the scientific basis for the research.
The focus should be based on recommendations in ``Healthy People 2010''
(http://www.healthypeople.gov) and the ``CDC Injury Research Agenda,'' (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and

should seek creative approaches that will contribute to a national
program for injury control.
     Specific, measurable, and time-framed objectives.
     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.
     A description of the principal investigator's role and
responsibilities.
     A description of those activities related to, but not
supported by, the grant.
     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.
     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.
    Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
    For additional help in preparing your grant application please see
the ``frequently asked questions'' section on the NCIPC Web page at:
http://www.cdc.gov/ncipc/res-opps/2004pas.htm.

IV.3. Submission Dates and Times

    LOI Deadline Date: December 6, 2004.
    CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
    Application Deadline Date: February 2, 2005.
    Explanation of Deadlines: Applications must be received in the CDC
Procurement and Grants Office (PGO) (not NIH) by 4:00 p.m. Eastern Time
on the deadline date. If you submit your application by the United
States Postal Service or commercial delivery service, you must ensure
that the carrier will be able to guarantee delivery by the closing date
and time. If CDC receives your submission 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, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the submission as having
been received by the deadline.
    This announcement is the definitive guide on LOI and grant
application content, submission address, and deadline. It supersedes
information provided in the application instructions. If your
application does not meet the deadline above, it will not be eligible
for review, and will be discarded. You will

[[Page 64304]]

be notified that you did not meet the submission requirements.
    CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question, contact the PGO-TIM
staff at: 770-488-2700. Before calling, please wait two to three days
after the submission deadline. This will allow time for submissions to
be processed and logged.

IV.4. Intergovernmental Review of Applications

    Executive Order 12372 does not apply to this program.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your
budget, are as follows:
     Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board (IRB) approvals are in place.
     Grant funds will not be made available to support the
provision of direct care.
    If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: NCIPC Extramural Resources Team, Centers
for Disease Control and Prevention, National Center for Injury
Prevention and Control, 4770 Buford Hwy, NE., Mailstop K-62, Atlanta,
GA 30341, Telephone: (770) 488-4037, Fax: (770) 488-1662, E-mail:
CIPERT@CDC.GOV.
    Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--CE05-023, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the
application, and four copies of all appendices must be sent to: NCIPC
Extramural Resources Team, CDC, National Center for Injury Prevention
and Control.
    Address for Express Mail or Delivery Service: 2945 Flowers Road,
Yale Building, Room 2054, Atlanta, Georgia 30341.
    Address for U.S. Postal Service Mail: 4770 Buford Hwy, NE.,
Mailstop K-62, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that
will demonstrate the accomplishment of the various identified
objectives of the grant. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to improve the control and
prevention of disease and injury and to enhance health. In the written
comments, reviewers will be asked to evaluate the application in order
to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals.
    The scientific review group will address and consider each of the
following criteria equally in assigning the application's overall
score, weighting them as appropriate for each application. The
application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important
work that by its nature is not innovative, but is essential to move a
field forward.
    The review criteria are as follows:
    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?
    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?
    Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
    Investigator: Is the investigator appropriately trained and well
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)? Is there a prior history of conducting injury-related
research?
    Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments 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?
    Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
    Dissemination: What plans have been articulated for disseminating
findings?
    Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR part 46
for the protection of human subjects? This will not be scored; however,
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.
    Inclusion of Women and Minorities in Research: Does the application
adequately address 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; and (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.
    Inclusion of Children as Participants in Research Involving Human
Subjects: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998. NCIPC has adopted this policy for this announcement.

[[Page 64305]]

    All investigators proposing research involving human subjects
should read the ``NIH Policy and Guidelines'' on the inclusion of
children as participants in research involving human subjects that is
available at http://grants.nih.gov/grants/funding/children/children.htm
.

    Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the PGO and for
responsiveness by NCIPC. Incomplete applications and applications that
are non-responsive to the eligibility criteria will not advance through
the review process. Applicants will be notified that their application
did not meet submission requirements.
    Applications that are complete and responsive to the announcement
will be evaluated for scientific and technical merit by an appropriate
peer review panel convened by the NCIPC in accordance with the review
criteria listed above. As part of the initial merit review, all
applications will:
     Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
     Receive a written critique.
    The primary review will be a peer review conducted by NCIPC Initial
Review Group (IRG). Applications may be subjected to a preliminary
evaluation (streamline review) by the IRG to determine if the
application is of sufficient technical and scientific merit to warrant
further review. NCIPC 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 the IRG. These applications will be
reviewed for scientific merit using current NIH criteria (a scoring
system of 100-500 points) to evaluate the methods and scientific
quality of the application.
    The secondary review will be conducted by the Science and Program
Review Subcommittee (SPRS) of the Advisory Committee for Injury
Prevention and Control (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 ACIPC 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:
     The results of the primary review including the
application's priority score as the primary factor in the selection
process.
     The relevance and balance of proposed research relative to
the NCIPC programs and priorities.
     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.'' (See Attachment 1, Resource
Materials. The attachment is posted with this announcement on the CDC
Web site: http://www.cdc.gov/ncipc/ncipchm.htm).

     Budgetary considerations.
    All awards will be determined by the Director of the NCIPC based on
priority scores assigned to applications by the primary review
committee IRG, recommendations by the secondary review committee of the
Science and Program Review Subcommittee of the ACIPC, consultation with
NCIPC senior staff, and the availability of funds.
    Competing supplemental grant awards may be made, when funds are
available, to support research work or activities not previously
approved by the IRG. Applications should be clearly labeled to denote
their status as requesting supplemental funding support. These
applications will be reviewed by the IRG and the secondary review
group.
Continued Funding
    Continuation awards made after FY 2005, but within the project
period, will be made on the basis of the availability of funds and the
following criteria:
     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 is being demonstrated
through presentations at work-in-progress monitoring workshops (travel
expenses for this annual one-day meeting should be included in the
applicant's proposed budget).
     The objectives for the new budget period are realistic,
specific, and measurable.
     The methods described will clearly lead to achievement of
these objectives.
     The evaluation plan will allow management to monitor
whether the methods are effective.
     The budget request is clearly explained, adequately
justified, reasonable and consistent with the intended use of grant
funds.
    Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
     Scientific merit (as determined by peer review).
     Availability of funds.
     Programmatic priorities.

V.3. Anticipated Announcement and Award Dates

    August 30, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of
the application review by mail.

[[Page 64306]]

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92.
    For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.

    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements.
     AR-2 Requirements for Inclusion of Women and Racial and
Ethnic Minorities in Research.
     AR-3 Animal Subjects Requirements.
     AR-9 Paperwork Reduction Act Requirements.
     AR-10 Smoke-Free Workplace Requirements.
     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.
    Additional information on AR-1 through AR-22 can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.

     AR-25 Release and Sharing of Data.
    Starting with the December 1, 2003 receipt date, all ``Requests for
Applications (RFA)/Program Announcements (PA)'' soliciting proposals
for individual research projects of $500,000 or more in total (direct
and indirect) costs per year require the applicant to include a plan
describing how the final research data will be shared/ released or
explain why data sharing is not possible. Details on data sharing and
release, including information on the timeliness of the data and the
name of the project data steward, should be included in a brief
paragraph immediately following the ``Research Plan'' section of the
PHS 398 form. References to data sharing and release may also be
appropriate in other sections of the application (e.g. background and
significance, or human subjects requirements) The content of the data
sharing and release plan will vary, depending on the data being
collected and how the investigator is planning to share the data. The
data sharing and release plan will not count toward the application
page limit and will not factor into the determining scientific merit or
the priority scoring. Investigators should seek guidance from their
institutions on issues related to institutional policies, and local IRB
rules, as well as local, State and Federal laws and regulations,
including the Privacy Rule.
    Further detail on the requirements for addressing data sharing in
applications for NCIPC funding may be obtained by contacting NCIPC
program staff or by visiting the NCIPC Internet at: http://www.cdc.gov/ncipc/osp/sharing_policy.htm
.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the
following reports:
    1. Interim progress report (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of
the budget period.
    3. Final financial and performance reports, 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 summary 2,500 to 4,000 words written in non-scientific
[laymen's] terms. The narrative should highlight 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 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.
    These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement. For general
questions, contact: Technical Information Management Section, CDC
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341,
Telephone: (770) 488-2700.
    For scientific/research issues, contact: Paul Smutz, Ph.D, Project
Officer, National Center for Injury Prevention and Control, Centers for
Disease Control and Prevention (CDC), 4770 Buford Highway, NE.,
Mailstop K-02, Telephone: (770) 488-1508, Atlanta, GA 30341, E-mail:
wsmutz@cdc.gov.
    For questions about peer review, contact: Gwendolyn Cattledge,
Ph.D, Scientific Review Administrator, National Center for Injury
Prevention and Control, Centers for Disease Control and Prevention
(CDC), 4770 Buford Highway, NE., Mailstop K-02, Atlanta, GA 30341,
Telephone: (770) 488-1430, E-mail: gxc8@cdc.gov.
    For financial, grants management, or budget assistance, contact:
James Masone, Contract Specialist, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341, Telephone: (770) 488-2736, E-
mail: zft2@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on

``Funding'' then ``Grants and Cooperative Agreements.''

William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-24617 Filed 11-3-04; 8:45 am]

BILLING CODE 4163-18-P

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