[Federal Register: October 27, 2004 (Volume 69, Number 207)]
[Notices]
[Page 62694-62701]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Intervention and Evaluation Trials To Prevent Intimate Partner
Violence
Announcement Type: New.
Funding Opportunity Number: RFA CE05-017.
Catalog of Federal Domestic Assistance Number: 93.136.
Key Dates:
Letter of Intent Deadline: November 26, 2004.
Application Deadline: January 25, 2005.
I. Funding Opportunity Description
Authority: This program is authorized under section 393(a) (3)
of the Public Health Service Act (42 U.S.C. section 280b-1a(a)(3))
and 391(a)(1) of the Public Health Service Act, 42 U.S.C.
Background:
An estimated 1.9 million women are physically assaulted each year;
three-quarters of those assaults are perpetrated by an intimate partner
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(Tjaden & Thoennes, 2000). Among women, the lifetime prevalence of
physical assault by an intimate partner is 22 percent (Tjaden &
Thoennes, 2000). Over 1200 women were murdered by their intimate
partners in 2001 (Rennison, 2003). Beyond mortality, partner violence
exacts a very serious toll on women's physical and mental health, with
consequences including injury, chronic pain, gynecological problems,
stress-related problems, central nervous problems, anxiety, depression,
and post-traumatic stress disorder (Campbell, 2002). Partner violence
also produces serious negative sequelae on children who witness it.
Children exposed to IPV are at increased risk for adverse short and
long-term outcomes including: anxiety, depression, and stress symptoms;
oppositional and aggressive behavior; low self-esteem (e.g., Grych,
Jouriles, Swank, McDonald, & Norwood, 2000; Margolin, 1998); deficits
in social, relationship, and communication skills (e.g., Huth-Bocks,
Levendosky, & Semel, 2001); and later partner violence during
adolescence and adulthood (Margolin, 1998; Valle & Silovsky, 2002;
Wolfe & Jaffe, 1999). In addition to costs to individuals, the economic
burden of partner violence on society is estimated at $5.8 billion per
year in direct medical costs and lost productivity (CDC, National
Center for Injury Prevention and Control, 2003). Given the scope and
toll of partner violence on victims and society, empirically supported
interventions to prevent partner violence are greatly needed. The
scientific knowledge base regarding interventions to prevent IPV and
reduce its negative impact is still developing, but the complex
etiology and social ecology of intimate partner violence suggests that
a range of interventions are needed to prevent IPV and to minimize its
negative consequences.
Purpose: The purpose of the program is to conduct efficacy and
effectiveness trials of intervention strategies to prevent intimate
partner violence and/or its negative consequences, particularly studies
of strategies that have not been well studied, for at-risk or
underserved populations. This program addresses the ``Healthy People
2010'' focus area(s) 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): Conduct a targeted program
of research to reduce injury-related death and disability.
Special Guidelines for Technical Assistance:
Conference Call
Technical assistance will be available for potential applicants on
one conference call.
The call for eligible applicants will be held on (December 10,
2004) from 2:30 p.m. to 4 p.m. (Eastern Time). The conference can be
accessed by calling (888-528-9061) and entering access code (14836).
The purpose of the conference call is to help potential applicants:
1. Understand the Request for Application Process for RFA CE05-017
entitled ``Intervention and Evaluation Trials to Prevent Intimate
Partner Violence''.
2. Understand the scope and intent of RFA CE05-017 entitled
``Intervention and Evaluation Trials to Prevent Intimate Partner
Violence''.
3. Become familiar with the Public Health Services funding policies
and application and review procedures. Participation in this conference
call is not mandatory. At the time of the call, if you have problems
accessing the conference call, please call 404-639-7550 for assistance.
Research Objectives
The current prevention and intervention strategies that have been
evaluated have met with limited success (National Research Council
2004, Wathen & McMillen, 2003). A recent report from the National
Research Council (2004) calls for more methodologically rigorous
studies to evaluate strategies for primary, secondary, and tertiary
prevention of IPV. Primary prevention strategies are those that take
place before a violent act has occurred to prevent initial perpetration
or victimization. Secondary prevention strategies are those that take
place soon after a violent act has occurred to deal with the immediate
consequences or further prevention of violence, while tertiary
prevention strategies are those that take place over the longer-term to
lessen the trauma or injury associated with violence (e.g.,
rehabilitation, reintegration, etc.).
Although many service models and programs to address violence
against women have been developed and implemented, the scope of those
strategies and services has been limited. Often such programs exist in
shelters and in the criminal justice system, and some programs do exist
in non-traditional settings (e.g., workplace). Very few target the
primary prevention of violence, and most lack evidence of efficacy,
effectiveness, or cost-effectiveness (e.g., Graham-Bermann, 2001). In
addition, the few that have been rigorously evaluated have shown
limited impact (IOM report, National Research Council, 2004). Given the
complex etiology of the development of partner violence, and the
complex psychological and social/ecological needs of its victims, a
broader range of intervention strategies must be developed and
rigorously evaluated. Thus, one of the research objectives of this
announcement is to expand the set of intervention programs and
strategies that address IPV.
Innovative interventions are needed that employ new settings for
intervention, new strategies for prevention, and address the complex
social-ecological factors involved in IPV. Thus, research that examines
the efficacy and effectiveness, including cost effectiveness, of the
following types of strategies will be considered under this
announcement:
Workplace interventions derived from evidence-based
violence research for the prevention of IPV, particularly primary
prevention interventions that focus on populations at high risk for the
victimization and perpetration of IPV, and that propose appropriate
economic analyses.
Housing intervention programs that provide permanent or
extended-stay housing and other services to mothers (and their
children) at risk for revictimization of IPV, particularly evaluation
studies that examine the effects of housing interventions separately
from the impact of other services as usual, or any additional services
offered to mothers or children (e.g., job training, education, case
management).
Other innovative primary prevention interventions (e.g.,
the types of primary prevention strategies that have demonstrated
effectiveness with youth violence) to prevent first-time victimization
or perpetration of intimate partner violence.
Note: For this third priority, evaluations of dating violence
interventions are excluded. For applicants interested in dating
violence interventions, please see program announcement 05019.
Research funded under this announcement is expected to adhere to
high scientific standards and to incorporate the following elements:
Interventions and measures appropriate to the
developmental level(s) and cultural/ethnic backgrounds of the
population of interest. That is, interventions that are developmentally
and culturally appropriate.
Interventions that are theoretically justified (i.e.,
include a conceptual
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model or theory of change, with proposed mediators and moderators, for
how the intervention will produce the intended reductions in intimate
partner violence and related risk and protective factors), and
supported with epidemiologic, methodologic, behavioral, health
promotion, and risk prevention research.
Stringent and rigorous evaluation designs, namely
experimental and quasi-experimental designs with appropriate baseline/
pre-intervention data, post-intervention data, and at least one follow-
up data collection point; data from at least one comparison or control
community; and data collected from multiple sources.
Robust evaluation designs that collect and analyze process
data (e.g., direct assessment of intervention fidelity and program
exposure) and outcome and/or economic data associated with the
intervention using measures with documented validity and/or
reliability. Measurement is expected to match the level of
intervention. Examples of levels of measurement include: individual
(e.g., behavioral measures of violent victimization and/or
perpetration, quality of life, medical utilization and costs,
productivity), family (e.g., family functioning, marital discord), and
community (e.g., hospital or police data relevant to intimate partner
violence, school or workplace data, social capital, economic indices).
Whenever possible, multiple sources (self-report, other-report, direct
observation, and/or archival records) are used to collect data on each
outcome selected. Economic data include the systematic collection and
analysis of programmatic costs required to implement the intervention
from the perspective of the individual (e.g., time required to
participate in the intervention), and to the larger community (e.g.,
utilization and costs required by schools, workplaces, neighborhoods,
and society). Appropriate measures of risk and protective factors for
intimate partner violence are included to allow for an examination of
mediating and moderating effects.
Data analytic plans that are appropriate to the
intervention, research design and hypotheses, data collection measures,
and project period, and that anticipate and evaluate the effect of
threats to the internal and external validity of the specified research
design.
Implementation plans that ensure the intervention is
implemented as it was designed (i.e., intervention fidelity) and that
the target population received the intervention (i.e., program
exposure).
Activities
Awardee activities for this program are as follows:
1. Develop and finalize research design and methodology, data
collection measures, methods, and analysis plan.
2. Develop a research protocol for Institutional Review Board (IRB)
review and approval by all cooperating institutions participating in
the research project.
3. Develop a standardized established protocol for the
intervention. The proposed intervention must reflect cultural
sensitivity and responsiveness.
4. Provide an evaluation plan for the intervention.
5. Implement the proposed intervention.
6. Collect data on program implementation including, as
appropriate, exposure to the intervention and fidelity of the
intervention.
7. Collect data on the costs of implementation of the intervention.
8. Pilot test data collections instruments, if necessary.
9. Analyze data and disseminate findings through peer review
journals and presentations.
10. Conduct one reverse-site visit to meet with CDC staff in
Atlanta on an annual basis.
11. Complete all required reports as specified under section VI.3
Reporting.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring. CDC
Activities for this program will be conducted through direct
consultation via monthly conference calls, site visits, and e-mail
communications, and are as follows:
1. CDC will collaborate with project staff on decision-making
regarding research design and methodology, data collection and
analyses, programmatic issues, and dissemination of the study results
in publications and presentations.
2. Assist in the development of a research protocol for
Institutional Review Board (IRB) review by all performance sites
involved in the research project. The CDC IRB will review and approve
the protocol initially and on at least an annual basis until the
research project is completed.
II. Award Information
Type of Award: Cooperative Agreement. CDC involvement in this
program is listed in the Activities Section above.
Mechanism of Support: U49 (research cooperative agreement).
Fiscal Year Funds: 2005.
Approximate Total Funding: $1,800,000 (This amount is an estimate,
and is subject to availability of funds.)
Approximate Number of Awards: 3-6.
Approximate Average Award: Awards are anticipated to range from
$300,000 to $600,000, with an average award of $450,000.
Floor of Award Range: None.
Ceiling of Award Range: $600,000 (Ceilings are for the first 12-
month budget period and include both indirect and direct costs.)
Anticipated Award Date: August 31, 2005.
Budget Period Length: 12 months.
Project Period Length: Four 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.
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 Mariana
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
[[Page 62697]]
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, which includes both direct and indirect costs, 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.
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.
Demonstrated experience on the applicant's project team in
conducting, evaluating, and publishing violence prevention research in
peer-reviewed journals.
Effective and well-defined working relationships within
the performing organization and with outside entities expected to
participate in the proposed research that will ensure implementation of
the proposed activities, as evidenced by letters of support from the
performing organization and outside entities (include in appendices).
The overall match between the applicant's proposed
research objectives and the program priorities as described under the
heading, ``Research Objectives''.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
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
Principal Investigator qualifications are as follows:
A principal investigator who has documented prior training
and experience in conducting efficacy and effectiveness trials as
evidenced by peer-reviewed publications of such studies, and current or
previous research grants for efficacy or effectiveness trials.
A principal investigator who has conducted violence
prevention research, published the findings in peer-reviewed journals,
and has specific authority and responsibility to carry out the proposed
project.
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. Forms and
instructions are also available in an interactive format on the
National Institutes of Health (NIH) Web site.
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: 2.
Font size: 12-point unreduced.
Single spaced.
Paper size: 8.5 by 11 inches.
Page margin size: One inch.
Printed only on one side of page.
Written in plain language, avoid jargon.
Your LOI must contain the following information:
Descriptive title of the proposed research.
Name, address, E-mail address, telephone number, and FAX
number of the Principal Investigator.
Names of other key personnel.
Participating institutions.
Number and title of this Announcement.
Identify which of the priority research areas the
application will address: (1) Workplace interventions; (2) housing
interventions, or (3) other primary prevention interventions (please
specify the nature and type).
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.
Your research plan should address activities to be conducted over
the entire project period.
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, call 1-866-705-5711.
This announcement uses the non-modular budgeting format. Provide a
detailed budget for each activity with accompanying justification of
all operating expenses that is consistent with the stated objectives
and planned activities of the project.
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: (1) Statement of the
problem, (2) Purpose of the proposed research, (3) Methods, including
study population, data sources and any statistical analyses to be
performed, and (4) 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?
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Is the language of the Description simple and easy to
understand for a broad audience?
Please follow the content requirements below in developing your
research plan instead of those listed for the Research Plan in the PHS
398.
The research plan should consist of the following information:
1. Purpose of the proposed research: Describe the goals and
objectives the proposed research. Specific research questions,
hypotheses, and implications for prevention should also be included.
2. Program Participants: Describe the demographic and geographic
characteristics of the community or population targeted by the
intervention. This section should include incidence, prevalence,
morbidity, and/or mortality rates of intimate partner violence within
the target community or population. In addition, the proposal should
provide evidence that the recipient (or collaborating partner) has
access to the target population, and that the participation by the
target population or community in the intervention will be adequate.
3. Intervention: Describe the proposed strategies or components of
the intervention and the plan for implementing the intervention.
Proposals should explicate the theoretical and empirical justification
for the potential effectiveness of the intervention for reducing
intimate partner violence, its negative consequences, or other
appropriate outcomes in the target community or population. This should
include a discussion of the modifiable risk and protective factors that
will be influenced by the intervention of interest. The proposal should
describe the location or setting in which the intervention component(s)
will occur, and describe the relevance of this setting to the strategy
and desired outcomes. The proposal should also describe how
intervention fidelity would be monitored and measured.
4. Methods: Describe the proposed evaluation design, data sources,
methods, and analysis plan for assessing the efficacy or effectiveness,
and/or cost-effectiveness of the intervention. The specific type of
evaluation method chosen should reflect the nature of the intervention,
feasibility, and ethical considerations. Potential threats to the
validity of the study should be described along with how such threats
will be recognized and addressed. The status of all necessary
measurement instruments should be described. If any materials are not
extant, the methods and time frame for measure development, pilot
testing, and validation should be given. For data collected from
archival records (e.g., hospital records, police records, employee
leave records, etc.), the proposal should discuss issues of
accessibility, reliability, and validity of those data.
5. Project Management: Provide evidence of the expertise, capacity,
and community support necessary to successfully implement and evaluate
the impact of the intervention. Existing and proposed positions for the
project should be described by title, function, general duties, level
of effort and allocation of time. Management operation principles,
structure, and organization should also be noted.
6. Collaborative Efforts: List and describe any current or proposed
collaboration with government, health, community-or faith-based
organizations, minority organizations, and/or other researchers and
academic institutions. Include letters of support and memoranda of
understanding that specify the nature of past, present, and proposed
collaborations, and the products/services/activities that will be
provided by and to the applicant.
The research plan should be no more than 25 pages (8.5'' x 11'' in
size), single-spaced, printed on one side only, with one-inch margins
on all sides, and unreduced 12-point font.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: November 26, 2004.
CDC requests that you send a LOI if you intend to apply for to 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 25, 2005.
Explanation of Deadlines: 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 application
content, submission address, and deadline. It supersedes information
provided in the application instructions. If your application is not
received in the CDC Procurement and Grants office by 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 approvals are in place.
Reimbursement of pre-award costs is not allowed.
Funds are for research purposes only and cannot be used to
provide or subsidize housing or other services for program
participants.
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: Address for Express Mail or Delivery
Service: NCIPC Extramural Resources Team, CDC, National Center for
Injury Prevention and Control, 2945 Flowers Road, Yale Building, Room
2054, Atlanta, Georgia 30341.
Address for U.S. Postal Service Mail: NCIPC Extramural Resources
Team, CDC, 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.
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Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--PA 05017, 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:
Address for Express Mail or Delivery Service: NCIPC Extramural
Resources Team, CDC, National Center for Injury Prevention and Control,
2945 Flowers Road, Yale Building, Room 2054, Atlanta, Georgia 30341.
Address for U.S. Postal Service Mail: NCIPC Extramural Resources
Team, CDC, National Center for Injury Prevention and Control, 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 cooperative agreement. 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 advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and 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? How well justified is the significance
of the study?
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? Is the selection of a research
design justified, and is the research design appropriate to answer the
research question? Does the evaluation design reflect a rigorous
examination of the effectiveness of the intervention? Are descriptions
of sampling methods, sample size and power estimates, and data
collection measures well-described and justified? How complete are
planned investigations of intervention fidelity and program exposure?
Are the outcome measures concrete, specific, and directly relevant to
intimate partner violence? Does the data analytic plan appropriately
consider the level of intervention and data collection, and the
longitudinal design of the study?
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)? Does the investigator have relevant knowledge and experience
to develop and/or evaluate the proposed intervention? Is there evidence
of the cultural sensitivity/competence of the research team and
supporting organizations? Is there evidence of a working relationship
between the principal investigator and research team and the community
or population targeted?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Does the proposed
research take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support? If collaborations are being
proposed, are the partners and their skills and expertise well
described? Can proposed collaborations reasonably be expected to
improve the quality of the implementation and evaluation of the
intervention?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
Intervention: Is the potential effectiveness of the proposed
intervention within the target population theoretically justified and
supported with epidemiological, methodological, behavioral and/or
economic research? How feasible is the implementation of the
intervention as proposed? Can the intervention reasonably be predicted
to produce the expected reductions in intimate partner violence? Is the
setting of implementation appropriate? Where appropriate, does the
intervention focus on communities or individuals with increased risk
for IPV? Is the intervention developmentally and culturally sensitive?
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
[[Page 62700]]
inclusion of children as participants in research involving human
subjects.
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 Procurement
and Grants Office (PGO), and for responsiveness by the National Center
for Injury Prevention and Control. 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 group or charter study section convened by the National
Center for Injury Prevention and Control in accordance with the review
criteria listed above. As part of the initial merit review, all
applications may:
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.
Receive, if deemed to have the highest scientific merit, a
second programmatic level review by the Science and Program Review
Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and
Control (ACIPC).
Applications which are complete and responsive may be subjected to
a preliminary evaluation (streamline review) by an external peer review
committee, the NCIPC and Control Initial Review Group (IRG), to
determine if the application is of sufficient technical and scientific
merit to warrant further review by the IRG. CDC will withdraw from
further consideration applications judged to be noncompetitive and
promptly notify the principal investigator/program director and the
official signing for the applicant organization. Those applications
judged to be competitive would be further evaluated by a dual review
process.
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 Advisory Committee for
Injury Prevention and Control (ACIPC), consultation with NCIPC senior
staff, and the availability of funds.
The primary review will be an external peer review conducted by the
IRG. All applications will be reviewed for scientific merit using
current National Institutes of Health (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 ACIPC. The external 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 secondary review committee's responsibility is to develop
funding recommendations for the NCIPC Director based on the results of
the primary review, the relevance and balance of proposed research
relative to the NCIPC programs and priorities, and to assure that
unwarranted duplication of federally funded research does not occur.
The secondary review committee has the latitude to recommend to the
NCIPC Director, to reach over better-ranked proposals in order to
assure maximal impact and balance of proposed research. The factors to
be considered will include:
a. The results of the primary review including the application's
priority score as the primary factor in the selection process.
b. The relevance and balance of proposed research relative to the
NCIPC programs and priorities.
c. The significance of the proposed activities in relation to the
priorities and objectives stated in ``Healthy People 2010,'' the
Institute of Medicine report, ``Reducing the Burden of Injury,'' and
the ``CDC Injury Research Agenda.''
d. Budgetary considerations.
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 (workplace, housing, and primary
prevention interventions).
Geographic diversity.
Racial/ethnic diversity.
Balance of intervention approaches and strategies.
Consistency with research priorities in CDC's Injury
Research Agenda.
Availability of funds within categories of violence and
injury funding streams.
V.3. Anticipated Announcement and Award Dates
August 31, 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 Web site.
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-8 Public Health System Reporting Requirements
AR-9 Paperwork Reduction Act Requirements
AR-10 Smoke-Free Workplace Requirements
AR-11 Healthy People 2010
AR-12 Lobbying Restrictions
[[Page 62701]]
AR-13 Prohibition on Use of CDC Funds for Certain Gun Control
Activities
AR-14 Accounting System Requirements
AR-15 Proof of Non-Profit Status
AR-21 Small, Minority, and Women-Owned Business
AR-22 Research Integrity
AR-23 States and Faith-Based Organizations
AR-24 Health Insurance Portability and Accountability Act
Requirements
Additional information on AR-1 through AR-24 can be found on the
CDC Web site.
AR-25 Release and Sharing of Data
Starting with the December 1, 2004 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. For this proposal, those
applicants requesting >=$450,000 will be required to write a brief
paragraph describing their data sharing/release plan or justification
as to why they will not be sharing their data. 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 Web site.
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 after
the end of the project period.
4. At the completion of the project, the grant recipient will
submit a brief (2500 to 5000 words) summary highlighting the findings
and their implications for injury prevention programs, policies, etc.,
that includes a plan for dissemination of the research findings. The
dissemination plan will include publications in peer-reviewed journals
and other methodologies for sharing results with stakeholders outside
of academic settings (e.g., state and community groups, public health
injury prevention practitioners).
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: Jennifer Wyatt, Ph.D.,
Extramural Program Official, National Center for Injury Prevention and
Control, Centers for Disease Control and Prevention (CDC), 4770 Buford
Highway, NE., Mailstop K-60; Telephone: 770-488-4058, E-mail:
ANU1@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; Telephone: 770-488-
1430, E-mail: gxc8@cdc.gov.
For financial, grants management, or budget assistance, contact:
Nancy Pillar, Grants Management Specialist, CDC Procurement and Grants
Office, 2920 Brandywine Road, Atlanta, GA 30341, E-mail: Nfp6@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site. Click on ``Funding'' then ``Grants and Cooperative
Agreements.''
Dated: October 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-24026 Filed 10-26-04; 8:45 am]
BILLING CODE 4163-18-P