[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