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 (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 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 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?
• 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″ × 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.

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 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
• 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.”