[Federal Register Volume 69, Number 213 (Thursday, November 4, 2004)]
[Notices]
[Pages 64300-64306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24617]


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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:
    <bullet> Solicit research applications that address the priorities 
reflected under the heading, ``Research Objectives''.
    <bullet> Build the scientific base for the prevention and control 
of fatal and nonfatal injuries and related disabilities.
    <bullet> 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.
    <bullet> 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):
    <bullet> Increase the capacity of injury prevention and control 
programs to address the prevention of injuries and violence.
    <bullet> Monitor and detect fatal and non-fatal injuries.
    <bullet> 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:
    <bullet> Public nonprofit organizations.
    <bullet> Private nonprofit organizations.
    <bullet> For profit organizations.
    <bullet> Small, minority, women-owned businesses.
    <bullet> Universities.
    <bullet> Colleges.
    <bullet> Research institutions.
    <bullet> Hospitals.
    <bullet> Community-based organizations.
    <bullet> Faith-based organizations.
    <bullet> Federally recognized Indian tribal governments.
    <bullet> Indian tribes.
    <bullet> Indian tribal organizations.
    <bullet> 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).
    <bullet> 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.
    <bullet> Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
    <bullet> 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.''
    <bullet> 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.
    <bullet> 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
    <bullet> 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.
    <bullet> 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:
    <bullet> Maximum number of pages: Two.
    <bullet> Font size: 12-point unreduced.
    <bullet> Paper size: 8.5 by 11 inches.
    <bullet> Page margin size: One inch.
    <bullet> Printed only on one side of page.
    <bullet> Single spaced.
    <bullet> Written in plain language, avoid jargon.
    Your LOI must contain the following information:
    <bullet> Descriptive title of the proposed research.
    <bullet> Name, address, e-mail address, and telephone number of the 
Principal Investigator.
    <bullet> Names of other key personnel.
    <bullet> Participating institutions.
    <bullet> Number and title of this Program Announcement.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#e6a19487889295af888089a6888f8ec8818990"><span class="__cf_email__" data-cfemail="dd9aafbcb3a9ae94b3bbb29db3b4b5f3bab2ab">[email protected]</span></a>.
    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 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:
    <bullet> Statement of the problem.
    <bullet> Purpose of the proposed research.
    <bullet> Methods, including study population, data sources and any 
statistical analyses to be performed.
    <bullet> Implications for prevention.
    The Description (abstract) should answer the following questions:
    <bullet> Does the Description state the hypothesis?
    <bullet> Does the Description describe the objectives and specific 
aims?
    <bullet> Does the Description state the importance of the research 
and how it is innovative?
    <bullet> Does the Description outline the methods that will use to 
accomplish the goals?
    <bullet> 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:
    <bullet> 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.
    <bullet> Specific, measurable, and time-framed objectives.
    <bullet> 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.
    <bullet> A description of the principal investigator's role and 
responsibilities.
    <bullet> A description of those activities related to, but not 
supported by, the grant.
    <bullet> 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.
    <bullet> 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:
    <bullet> Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board (IRB) approvals are in place.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#abe8e2fbeef9ffebe8efe885ece4fd"><span class="__cf_email__" data-cfemail="9ad9d3cadfc8cedad9ded9b4ddd5cc">[email protected]</span></a>.
    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:
    <bullet> 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.
    <bullet> 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:
    <bullet> The results of the primary review including the 
application's priority score as the primary factor in the selection 
process.
    <bullet> The relevance and balance of proposed research relative to 
the NCIPC programs and priorities.
    <bullet> 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).
    <bullet> 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:
    <bullet> 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).
    <bullet> The objectives for the new budget period are realistic, 
specific, and measurable.
    <bullet> The methods described will clearly lead to achievement of 
these objectives.
    <bullet> The evaluation plan will allow management to monitor 
whether the methods are effective.
    <bullet> 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:
    <bullet> Scientific merit (as determined by peer review).
    <bullet> Availability of funds.
    <bullet> 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:
    <bullet> AR-1 Human Subjects Requirements.
    <bullet> AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research.
    <bullet> AR-3 Animal Subjects Requirements.
    <bullet> AR-9 Paperwork Reduction Act Requirements.
    <bullet> AR-10 Smoke-Free Workplace Requirements.
    <bullet> AR-11 Healthy People 2010.
    <bullet> AR-12 Lobbying Restrictions.
    <bullet> AR-13 Prohibition on Use of CDC Funds for Certain Gun 
Control Activities.
    <bullet> AR-21 Small, Minority, and Women-Owned Business.
    <bullet> 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.
    <bullet> 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: 
<a href="/cdn-cgi/l/email-protection#2057534d55545a604344430e474f56"><span class="__cf_email__" data-cfemail="8dfafee0f8f9f7cdeee9eea3eae2fb">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#a6c1dec59ee6c5c2c588c1c9d0"><span class="__cf_email__" data-cfemail="42253a217a022126216c252d34">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#dfa5b9abed9fbcbbbcf1b8b0a9"><span class="__cf_email__" data-cfemail="ef95899bddaf8c8b8cc1888099">[email protected]</span></a>.

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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