[Federal Register Volume 69, Number 207 (Wednesday, October 27, 2004)]
[Notices]
[Pages 62694-62701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24026]


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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

[[Page 62695]]

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

[[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.
    <bullet> Demonstrated experience on the applicant's project team in 
conducting, evaluating, and publishing violence prevention research in 
peer-reviewed journals.
    <bullet> 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).
    <bullet> The overall match between the applicant's proposed 
research objectives and the program priorities as described under the 
heading, ``Research Objectives''.
    <bullet> Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
    <bullet> Note: Title 2 of the United States Code Section 1611 
states that an organization described in section 501(c)(4) of the 
Internal Revenue Code that engages in lobbying activities is not 
eligible to receive Federal funds constituting an award, grant, or 
loan.

Individuals Eligible To Become Principal Investigators

    Principal Investigator qualifications are as follows:
    <bullet> 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.
    <bullet> 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:
    <bullet> Maximum number of pages: 2.
    <bullet> Font size: 12-point unreduced.
    <bullet> Single spaced.
    <bullet> Paper size: 8.5 by 11 inches.
    <bullet> Page margin size: One inch.
    <bullet> Printed only on one side of page.
    <bullet> Written in plain language, avoid jargon.
    Your LOI must contain the following information:
    <bullet> Descriptive title of the proposed research.
    <bullet> Name, address, E-mail address, telephone number, and FAX 
number of the Principal Investigator.
    <bullet> Names of other key personnel.
    <bullet> Participating institutions.
    <bullet> Number and title of this Announcement.
    <bullet> 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:
    <bullet> Does the Description state the hypothesis?
    <bullet> Does the Description describe the objectives and specific 
aims?
    <bullet> Does the Description state the importance of the research 
and how it is innovative?
    <bullet> Does the Description outline the methods that will use to 
accomplish the goals?

[[Page 62698]]

    <bullet> 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:
    <bullet> Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
    <bullet> Reimbursement of pre-award costs is not allowed.
    <bullet> 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.

[[Page 62699]]

    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:
    <bullet> Undergo a process in which only those applications deemed 
to have the highest scientific merit by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
    <bullet> Receive a written critique.
    <bullet> 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:
    <bullet> Scientific merit (as determined by peer review).
    <bullet> Availability of funds.
    <bullet> Programmatic priorities (workplace, housing, and primary 
prevention interventions).
    <bullet> Geographic diversity.
    <bullet> Racial/ethnic diversity.
    <bullet> Balance of intervention approaches and strategies.
    <bullet> Consistency with research priorities in CDC's Injury 
Research Agenda.
    <bullet> 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:

<bullet> AR-1 Human Subjects Requirements
<bullet> AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
<bullet> AR-8 Public Health System Reporting Requirements
<bullet> AR-9 Paperwork Reduction Act Requirements
<bullet> AR-10 Smoke-Free Workplace Requirements
<bullet> AR-11 Healthy People 2010
<bullet> AR-12 Lobbying Restrictions

[[Page 62701]]

<bullet> AR-13 Prohibition on Use of CDC Funds for Certain Gun Control 
Activities
<bullet> AR-14 Accounting System Requirements
<bullet> AR-15 Proof of Non-Profit Status
<bullet> AR-21 Small, Minority, and Women-Owned Business
<bullet> AR-22 Research Integrity
<bullet> AR-23 States and Faith-Based Organizations
<bullet> 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.

<bullet> 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: 
<a href="/cdn-cgi/l/email-protection#27666972166744434409404851"><span class="__cf_email__" data-cfemail="9adbd4cfabdaf9fef9b4fdf5ec">[email protected]</span></a>.
    For questions about peer review, contact: Gwendolyn Cattledge, 
Ph.D., Scientific Review Administrator, National Center for Injury 
Prevention and Control, Centers for Disease Control and Prevention 
(CDC), 4770 Buford Highway, NE., Mailstop K-02; Telephone: 770-488-
1430, E-mail: <a href="/cdn-cgi/l/email-protection#c2a5baa1fa82a1a6a1eca5adb4"><span class="__cf_email__" data-cfemail="294e514a11694a4d4a074e465f">[email protected]</span></a>.
    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: <a href="/cdn-cgi/l/email-protection#1b557d6b2d5b787f78357c746d"><span class="__cf_email__" data-cfemail="a1efc7d197e1c2c5c28fc6ced7">[email protected]</span></a>.

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


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