[Federal Register: November 1, 2004 (Volume 69, Number 210)]
[Notices]
[Page 63392-63398]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01no04-89]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Grants for Dissertation Awards for Doctoral Candidates for
Violence-Related and Unintentional Injury Prevention Research in
Minority Communities
Announcement Type: New.
Funding Opportunity Number: CE05-025.
Catalog of Federal Domestic Assistance Number: 93.136.
Key Dates:
Letter of Intent Deadline: December 1, 2004.
Application Deadline: January 31, 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. 280 b (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 injuries, disabilities, and deaths disproportionately experienced in
minority communities.
Encourage doctoral candidates from a wide spectrum of
disciplines, including epidemiology, medicine, biostatistics, public
health, law and criminal justice, behavioral, and social sciences to
perform research in order to prevent and control injuries more
effectively.
Assist students in the completion of their dissertation
research on a violence-related or unintentional injury topic.
Encourage investigators to build research careers related
to the prevention of violence-related or unintentional injuries,
disabilities, and deaths in minority communities.
This program addresses the ``Healthy People 2010'' focus area of
Injury and Violence Prevention.
A dissertation represents the most extensive research experience
formulated and carried out by a doctoral candidate, with the advice and
guidance of a mentor (the chair or another member of the dissertation
committee). Dissertation research involves a major investment of the
doctoral student's time, energy, and interest and its substance is
often the basis for launching a research career. This research
initiative is aimed at providing students with assistance to complete
their dissertation research on a violence-related or unintentional
injury topic and, thereby, increasing representation of junior
investigators in violence-related or unintentional injury research.
Injuries are the number-one killer of children and young adults in
the United States. They are the leading cause of years of potential
life lost before age 65. More than five million people in the U.S.
report suffering from chronic, injury-related disabilities, and the
lives of millions of others have been dramatically affected by injuries
to themselves or someone they love. Funding for research to prevent
these injuries falls into two categories: violence prevention, and the
prevention of unintentional injury.
Violence
Deaths and injuries associated with interpersonal violence and
suicidal behavior are a major public health problem in the United
States and around the world. In 1999, more than 46,000 people died from
homicide and suicide in the United States. Among 15 to 24 year olds,
homicide and suicide rank as the second and the 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 constitutes an enormous public health problem. For every homicide
that occurs each year there are more than 100 non-fatal injuries
resulting from interpersonal violence. For every completed suicide it
is estimated that there are 20 to 25 suicide attempts. The mortality
and morbidity associated with violence are associated with a variety of
types of violence including child mistreatment, youth violence,
intimate partner violence, sexual violence, elder abuse, and self-
directed violence or suicidal behavior.
Violence has a disproportionate impact on racial and ethnic
minorities. In 1999, homicide was the leading cause of death for
African Americans and the second leading cause of death for Hispanics
between the ages of 15 and 34. Suicide was the second leading cause of
death for American Indians and Alaskan Natives and Asian and Pacific
Islanders 15 to 34 years of age. It is important to note that existing
research indicates that race or ethnicity, per se, is not a risk factor
for violent victimization or a cause of violent behavior. Rather,
racial or ethnic status is associated with many other factors that do
influence the risk of becoming a victim or behaving violently. As a
result, racial and ethnic minorities in the United States experience
high rates of both violent victimization and perpetration. A better
understanding of the factors that contribute to this vulnerability or
protection from such risk is important to furthering effective violence
prevention programs that address racial and ethnic minorities.
Unintentional Injury
Unintentional injuries are a leading cause of death for Americans
of all ages, regardless of gender, race, or economic status.
Unintentional injuries are the leading cause of death for persons ages
1-34 years, and the fifth leading cause of death overall. Nearly
100,000 people
[[Page 63393]]
die each year as a result of unintentional injury. In fact, on average,
every six minutes someone in the U.S. dies from causes such as motor
vehicle crashes, falls, poisonings, drownings, fires, bicycle crashes,
suffocation, or pedestrians being struck by motor vehicles. Millions of
Americans also experience nonfatal unintentional injuries each year.
Approximately one in ten people a year experience a nonfatal injury
serious enough to require a visit to an emergency department.
Although everyone is vulnerable to injury, some groups are at
higher risk for unintentional injuries than others. For example, among
all ethnic groups in the U.S., American Indians/Alaska Natives have the
highest unintentional injury death rate (i.e., 61 per 100,000
population compared with 41 per 100,000 for African Americans and 36
per 100,000 for Whites). African American children from birth through
nine years have unintentional injury death rates almost twice as high
as those of White children. Hispanic teenagers have higher motor
vehicle occupant death rates than African American or White teenagers
after adjusting for amount of travel.
There is a critical need for highly qualified scientists to carry
out research on violence and unintentional injury that can help in the
development, implementation, and evaluation of effective injury
prevention programs. In particular, scientists are needed who bring an
understanding and sensitivity to the problems of violence and
unintentional injury as they affect minority communities. The purpose
of this extramural research training grant program is to attract young
scientists to the field of injury prevention by encouraging doctoral
candidates from a variety of disciplines to conduct violence and
unintentional injury prevention research and hopefully carry this focus
on throughout their careers. The number of individuals, who are members
of minority groups, and who are engaged in injury-related prevention
research, is currently small. This research program should also attract
young minority scientists to the field of violence and unintentional
injury prevention research.
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
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 in a minority community. Applications
that fail to address these topics will be deemed nonresponsive.
Violence Related Injury
Any research priority listed in following chapters from NCIPC's
research agenda: Preventing Intimate Partner Violence, Sexual Violence,
and Child Maltreatment, Preventing Suicidal Behavior, or Preventing
Youth Violence. NCIPC's research agenda can be accessed online at the
following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm
.
Unintentional Injury
Any research priority listed in following chapters from NCIPC's
research agenda; Preventing Injuries at Home and in the Community,
Preventing Injuries in Sports, Recreation, and Exercise, or Preventing
Transportation Injuries. NCIPC's research agenda can be accessed online
at the following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm
.
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: $125,000. (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: Five (four awards will be made in the
area of violence prevention research and 1 award will be made in the
area of unintentional injury prevention research).
Approximate Average Award: $ 25,000. (This amount includes both
direct and indirect costs.)
Floor of Award Range: None.
Ceiling of Award Range: $ 25,000. (This amount includes both direct
and indirect costs.)
Anticipated Award Date: August 30, 2005.
Budget Period Length: 12 months.
Project Period Length: One year.
III. Eligibility Information
III.1. Eligible applicants
Assistance will be provided to any United States public or private
institution. The institution must support an accredited doctoral level
training program. The performance site must be domestic.
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.
A dissertation research training grant may not be transferred to
another institution, except under unusual and compelling circumstances
(such as if the mentor moves to a new institution and both the mentor
and the applicant wish to move together).
The responsible program official for CDC must be informed if there
is a change of a mentor. A biographical sketch of the new mentor must
be provided for approval by the CDC program official.
[[Page 63394]]
Two copies of the completed dissertation, including abstract, must
be submitted to the CDC program official and will constitute the final
report of the grant. The dissertation must be officially accepted by
the dissertation committee or university official responsible for the
candidate's dissertation and must be signed by the responsible
university official.
Any publications directly resulting from the grant should be
reported to the CDC program official. The grantee also should cite
receiving support from the NCIPC and CDC, both in the dissertation and
any publications directly resulting from the dissertation-training
grant.
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 doctoral candidate must be the designated principal
investigator. The principal investigator will be responsible for
planning, directing, and executing the proposed project with the advice
and consultation of the mentor and dissertation committee.
Applicants must be students in good standing enrolled in
an accredited doctoral degree program.
The applicant must have the skill and academic training to
conduct the proposed research and have the authority and responsibility
to carry out the proposed project.
To receive this funding, applicants must have successfully
defended their dissertation proposal. This must be verified in a letter
of certification from the mentor (the chair or another member of the
dissertation committee). CDC requests that if available, the letter of
certification be submitted with the grant application, or before the
negotiation and award.
Applicants must be conducting or intending to conduct
research in one of the areas described under the ``Research
Objectives'' in the Program Requirement's section of this announcement.
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: //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) website 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, email 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.
In addition to the instructions provided in the PHS 398 for writing
the Description on page 2 of the PHS 398
[[Page 63395]]
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 15 pages, printed on one side, single
spaced, with one half-inch margin, 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 principal
investigator.
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:
A letter from the applicant's mentor which:
a. Fully identifies the members of the dissertation committee.
b. Certifies that the mentor has read the application and believes
that it reflects the work to be completed in the dissertation. (Letters
certifying approval of the dissertation proposal must be received
before negotiation and award of the grant.)
c. Certification that the institution's facilities and general
environment are adequate to conduct the proposed research.
A tentative time line for completion of the research, the
dissertation, and the dissertation defense.
An official transcript of the applicant's graduate school
record showing that the applicant has completed all required course
work for the degree with the exception of the dissertation.
A statement of the applicant's career goals and intended
career trajectory.
A biography of the mentor, limited to two pages (use the
Biographical Sketch page in application form PHS 398).
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 1, 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: January 31, 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 including medical and/or psychiatric 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 support for the
applicant; such as interviewer expenses, data processing, participant
incentives, statistical consultant services, supplies, dissertation
printing costs, and travel to one scientific meeting, if adequately
justified.
[[Page 63396]]
Applicants should also include travel costs for one, two-
day trip to CDC in Atlanta to present research findings.
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--CE05-025, 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.
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
[[Page 63397]]
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 would 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:
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
[[Page 63398]]
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, Project
Officer, Office of the Director, 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: pos1@cdc.gov.
For questions about peer review, contact: Gwendolyn Cattledge,
Scientific Review Administrator, Associate Director for Extramural
Research, 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.''
Dated: October 21, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-24027 Filed 10-29-04; 8:45 am]
BILLING CODE 4163-18-P