Attachment 3 - CDC Program Announcement 06008

Part I Overview Information

Department of Health and Human Services

Issuing Organization
Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/)

Participating Organizations

Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/)

Components of Participating Organizations
National Center for Injury Prevention and Control (NCIPC/CDC) (http://www.cdc.gov/ncipc/)

Title: Urban Partnership Academic Centers of Excellence (U-PACE)

The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Authority: This program is authorized under sections 317(k)(2) and 391(a) of the Public Health Service Act [42 U.S.C. Sections 247b(k)(2) and 280b(a), as amended.

Announcement Type: New

Request For Applications (RFA) Number: RFA-CE06-008

Catalog of Federal Domestic Assistance Number: 93.136, Injury Prevention and Control Research and State and Community Based Programs

Key Dates
Release Date: January 30, 2006

Letters of Intent Receipt Date: February 28, 2006

Application Receipt Dates: March 30, 2006

Peer Review Date: May 2006

Council Review Date: June 2006

Earliest Anticipated Start Date: September 2006

Additional Information To Be Available Date: February 14, 2006

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on February 14, 2006 from 2:00 p.m. to 3:30 p.m. (Eastern Time). The conference can be accessed by calling 1-877-951-7375 and entering access code 603639.

Expiration Date: March 31, 2006

Due Dates for E.O. 12372
Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

• NCIPC is soliciting research applications to establish Urban Partnership Academic Centers of Excellence, one serving a high-risk community in Philadelphia and the other serving a high-risk community in a city not currently being served by CDC’s National ACE Program on Youth Violence funded under PA05018. The Centers are expected to actively foster an environment conducive to reciprocally beneficial collaborations among health scientists, social scientists and a targeted high-risk community with the common goal of reducing youth interpersonal violence, injury and death.

• Total award amount will be approximately $851,400 per Center, depending on the availability of funds.

• Two awards will be made, depending on the availability of funds.

• The award mechanism is a U49 (cooperative agreement).

• Eligible organizations include universities, colleges, and university-associated teaching hospitals.

• Eligible principal investigators must have documented prior training and experience in managing and conducting intervention evaluation research, demonstrated experience in conducting, evaluating, and publishing violence prevention research in peer-reviewed journals, and documented experience working with communities on youth violence related activities.

• Principal investigators should submit only one application in response to this RFA.

• See Section IV.1 for application materials.

• CDC Telecommunications for the hearing impaired is available at: TTY 770-488-2783.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   1. Research Objectives

Section II. Award Information
   1. Mechanism(s) of Support
   2. Funds Available

Section III. Eligibility Information
   1. Eligible Applicants
       A. Eligible Institutions
       B. Eligible Individuals
   2.Cost Sharing or Matching
   3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
   1. Address to Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
       A. Receipt and Review and Anticipated Start Dates
           1. Letter of Intent
       B. Sending an Application
       C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
       A. Additional Review Criteria
       B. Additional Review Considerations
       C. Sharing Research Data
       D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
       A. Cooperative Agreement Terms and Conditions of Award
           1. Principal Investigator Rights and Responsibilities
           2. CDC Responsibilities
           3. Collaborative Responsibilities

3. Reporting

Section VII. Agency Contact(s)
   1. Scientific/Research Contact(s)
   2. Peer Review Contact(s)
   3. Financial/ Grants Management Contact(s)

4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives
The CDC and NCIPC are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area of injury and violence prevention and is in alignment with NCIPC’s performance goal to conduct a targeted program of research to reduce injury-related death and disability. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

This RFA announces the availability of fiscal year (FY) 2006 cooperative agreement funds to establish Urban Partnership Academic Centers of Excellence (U-PACE). The Centers are expected to actively foster an environment conducive to reciprocally beneficial collaborations among health scientists, social scientists and a targeted high-risk community, with the common goal of reducing youth interpersonal violence, injury and death. The research and programmatic activities of the U-PACE are to contribute to the reduction of youth violence in the targeted high-risk community. One U-PACE is expected to serve a high-risk community in Philadelphia. The other is expected to serve a high-risk community in a city with a rate of youth homicide (for persons 15-24 years of age) that is at least twice the national average and that is not currently being served by CDC’s National Academic Centers of Excellence (ACE) Program on Youth Violence funded under PA05018. The following cities are currently participating in CDC’s National ACE Program: Baltimore, MD, Boston, MA, Chicago, IL, Kailua-Waimanalo, HI, New York, NY, Oakland, CA, Richmond, VA, and Riverside, CA.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goals for NCIPC:

1. Increase the capacity of injury prevention and control programs to address the prevention of injuries and violence.

2. Monitor and detect fatal and non-fatal injuries.

3. Conduct a targeted program of research to reduce injury-related death and disability.

Youth violence is defined as the intentional use of physical force or power, threatened or actual, exerted by or against children, adolescents or young adults, ages 10-24, which results in or has a high likelihood of resulting in injury, death, psychological harm, maldevelopment, or deprivation. It includes violence between individuals or groups who may or may not know each other. It frequently takes place outside the home, in the streets, or in institutional settings, such as schools, workplaces, and prisons. Hereafter, youth violence and youth interpersonal violence will be used synonymously.

Community is defined as individuals residing or working in a geographical area, such as a catchment area or a neighborhood. A “high-risk” community is a community that has multiple risk factors for youth violence including an already high prevalence of violent behavior, injury, and death relative to another community as indicated by law enforcement and/or hospital data. Risk factors also include a high incidence of crime, high concentration of low-income residents, limited economic opportunity, high-rates of substance abuse and drug selling, and low community participation and social capital.

Youth violence has declined in most regions of the Nation in the past decade, but rates of violent injury and death and violence perpetration among youth remain unacceptably high. For instance, approximately 715,002 youth ages 10 to 24 were injured from violent acts in 2004 (CDC, 2005). Homicide is the second leading cause of death among 15- to 24- year-olds and the fifth leading cause of death among 10- to 14-year-olds. Among individuals known to have committed homicide in 2000, approximately 48% were age 24 or younger (CDC, 2005). Violence disproportionately affects youth living in urban communities (Baum, 2005). In an urban community, such as Philadelphia, almost two thirds of the perpetrators and 40 percent of the victims of homicide are 24 years old or younger, and the homicide rate among Philadelphian youth is five times higher than the national average (Tierney & Loizillon, 1999; Tierney, McClanahan, & Hangley, 2001).

Although urban communities are often most affected by youth violence, they typically are not involved as partners in the prioritization, implementation, and evaluation of community-based interventions. The inclusion of community residents, representatives of community organizations, and youth has the advantages of increasing the likelihood that interventions will be sensitive to the cultural uniqueness of a community, that community-specific barriers can be identified and addressed early in the intervention process to yield greater immediate impact, and that broad community support can be generated to adopt and sustain intervention efforts (Green, Daniel, & Novick, 2001; Scrimshaw, White, & Koplan, 2001).

Youth violence interventions often are focused on secondary prevention, such as identifying, incarcerating, and/or rehabilitating known juvenile offenders to prevent them from committing violent acts again. Although secondary prevention is important, primary prevention is necessary to protect youth from ever becoming victims or perpetrators of violence. Many interventions are also limited by a focus on individual risk factors and by a neglect of protective factors. Research suggestions that prevention activities should attend to the accumulation of risk factors, as youth with multiple risk factors are more likely to become violent than youth exposed to only one risk factor (Herrenkohl et al., 2000), and that interventions should address both risk and protective factors (DHHS, 2001). It is important to pay attention to factors such as early aggressive behavior, social problem solving skill deficits, parental influences, and exposures to violence (e.g., media, witnessing violence in the home and community or associations with delinquent peers). These factors need to be addressed at the individual, peer/family, and community level. Attention to the role larger sociocultural, economic, and community factors play in the development and display of youth violence is also important because of the disproportionate impact of youth violence in some environments, such as urban communities.

To support a move toward primary prevention and the use of multifaceted approaches, proposed Centers are expected to draw from youth violence prevention programs that have documented efficacy [see the CDC’s Best Practices of Youth Violence Prevention: A Sourcebook for Community Action (2002); Surgeon General Report on Youth Violence (2001); Center for the Study and Prevention of Violence’s Blueprints on Violence (2005)] and to adapt research and programmatic activities to fit the targeted high-risk community’s cultural framework and the risk and protective factors specific to the youth, families, schools, and high-risk community as a whole.

The goal of each U-PACE is to actively build reciprocally beneficial collaborations among health scientists, social scientists, and the targeted community and to reduce the incidence of youth violence, injury and death in the targeted high-risk community by achieving the following objectives:

• Mobilize and empower the targeted high-risk community to address youth violence by developing a partnership with community residents, representatives of community organizations, and the youth of the community and by involving them in the prioritization, development, implementation, and evaluation of youth violence prevention activities.

• Build the scientific infrastructure necessary to support the development, implementation, and evaluation of effective youth violence prevention interventions and interdisciplinary research.

• Promote interdisciplinary research strategies to address the problem of youth violence.

• Identify and prioritize youth violence prevention activities within the targeted community.

• Identify, plan, and implement at least one core research project. Core research projects are expected to focus on primary prevention of youth violence and can be either efficacy/effectiveness studies or dissemination research studies. These studies can be targeted universally or at selected or high-risk populations. Depending on the nature of the research studies conducted, individual- and community-level measures may be needed to examine impact. Cost data on programs and their implementation should be collected and utilized in cost-effectiveness analyses.

• Identify, plan, and implement smaller studies or programmatic activities that help facilitate and support the core research activities of the Center. Such studies may include etiological studies to better understand the problem of youth violence in the targeted community or pilot studies to help develop and refine the methods of the core research project(s).

• Establish and/or enhance surveillance systems to measure the magnitude and distribution of youth interpersonal violence, injury and death and the prevalence of youth violence risk and protective factors in the targeted community in order to assess the immediate and long-term impact of the Center’s research and programmatic efforts.

• Develop a logic model adapted from the CDC National ACE Program model to guide the Center’s research and programmatic efforts and develop and implement an evaluation plan with performance indicators to track success in achieving each element in the logic model.

• Disseminate the Center’s findings, methods, and tools from research and programmatic efforts.

Research funded under this announcement is expected to adhere to high scientific standards and to incorporate the following elements:

• Theoretical justification or empirical evidence for the proposed Center’s activities;

• Methodologically rigorous evaluation designs, namely experimental designs in which youth are randomly assigned to various prevention and control or comparison groups, or strong quasi-experimental designs in which youth are matched appropriately on relevant characteristics;

• Appropriate baseline/pre-intervention and post-intervention data collection, and at least one follow-up data collection point one year post-intervention;

• Data collected from various sources utilizing measures with documented validity and reliability, whenever possible;

• Short-term proxy measures of outcomes, such as changes in youth violence risk and protective factors, incidents of violent behavior among youth, and incidents of violence-related injury;

• Data on program fidelity and intervention exposure;

• Data on cost of implementation for cost-effectiveness analysis;

• Data analytic plans that are appropriate to the intervention, research design and hypotheses and to the data collection measures and project period, and that anticipate and evaluate the effects of internal and external validity of the specific research design.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support
This funding opportunity will use the U49 (research cooperative agreement) award mechanism.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

The CDC U49 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, “Cooperative Agreement Terms and Conditions of Award”.

2. Funds Available

The participating CIO NCIPC, intends to commit approximately $1.7 million (includes direct and indirect costs) in FY 2006 to fund two awards in response to this RFA. The average award amount will be $851,400 for the first 12-month budget period, including both direct and indirect costs. An applicant may request a project period of up to five years. An applicant may request up to $851,400 for the first 12-month budget period. The approximate total project period funded amount is $4.25 million per Center. The anticipated start date for new awards is September 2006.

All estimated funding amounts are subject to availability of funds.

If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NCIPC provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Additionally, the availability of funds are contingent upon 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.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

• Public and private nonprofit universities

• Colleges

• University-associated teaching hospitals

A Bona Fide Agent is an agency/organization identified by the academic institution/center as eligible to submit an application under the academic institution/center in lieu of an academic institution/center application. If you are applying as a bona fide agent of an academic institution/center, you must provide a letter from the academic institution/center as documentation of your status. Place this documentation behind the first page of your application form.

Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the RFA and to strengthen the overall application.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research 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.

In order for the application to be deemed responsive and entered into the review process, the following requirements for the principle investigator must be met:

• Documented prior training and experience in managing and conducting intervention evaluation research (i.e., efficacy/effectiveness studies) as evidence by peer-reviewed publications of such research or current or previous research grants for such work.

• Demonstrated experience in conducting, evaluating, and publishing violence prevention research in peer-reviewed journals.

• Documented experience working with communities on youth violence related activities, as evidence by letters of support from community representatives or organizations.

2. Cost Sharing or Matching

Cost sharing, matching funds, or cost participation are not required.

The most current Grants Policy Statement can be found at:

http://grants.nih.gov/grants/policy/gps/

3. Other-Special Eligibility Criteria

Special eligibility criteria to be deemed responsive to this RFA include the following:

• Only one application per institution will be accepted.

• The targeted high-risk community to be served by the Center is either in Philadelphia or in a city not currently served by CDC’s National ACE Program on Youth Violence funded under PA05018. Applicants must provide documentation from law enforcement, hospital, public health, or other databases showing a homicide rate among youth 15-24 years of age in the targeted high-risk community that is more than twice the US national average for this age group.

• Demonstrated experience on the applicant’s project team in conducting, evaluating, and publishing violence prevention research in peer-reviewed journals.

• Documented effective working relationships within the academic organization and with community and other outside entities expected to participate in the proposed research that will ensure successful implementation of the proposed activities, as evidenced by letters of support from the academic institution and other outside entities in the application’s appendix.

• The overall match between the proposed research and programmatic objectives of the Center and the program priorities as described under the heading “Research Objectives”.

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered into the review process.

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.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. If the instructions in this announcement differ in any way from the PHS 398 instructions, please follow the instructions in this announcement. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

The following instructions for writing the Description (abstract) and developing the research plan supersede those provided in the PHS 398 instructions. The Description included on page 2 of PHS 398 will be used to help determine the responsiveness of the application and to aid in the review process. Accordingly, the following elements should be included in the Description: (1) the overall mission of the Center, including specific goals and objectives; (2) the targeted high-risk community to be served by the Center’s research and programmatic efforts; (3) the identification and role of other collaborators and partners; and (4) a brief description of key elements (e.g., proposed core research project, including the essential features of the interventions, methods, and measures; the smaller research studies and programmatic activities; surveillance activities, and the dissemination plan). The language of the abstract must be simple and easy to understand for a broad audience.

Please follow the instructions below in developing your research plan. The research plan should consist of the following information:

1. Overall Description of the Proposed U-PACE (~ 8 pages): Applicants should provide an overall description of the proposed Center and develop a plan for evaluating the Center’s progress toward achieving its goals and objectives. Applicants should provide, at a minimum, the following:

   1. Define and describe the U-PACE mission, goals, and objectives. Mission statements should be limited to one to two sentences.

   2. Develop a logic model for the U-PACE adapted from the CDC National ACE Program model (www.cdc.gov/ncipc/res-opps/ACE/ace.htm) to describe its future orientation, activities, and the outcomes it expects to achieve. The National ACE Program model should serve as a guide and should be modified to fit the specific inputs, activities, outputs, and outcomes of the proposed U-PACE. A narrative description of each component of the logic model must be included.

   3. Describe the U-PACE’s five-year evaluation plan to monitor success in achieving each element in the logic model and the core activities listed below. The description should include: the identification of resources and staff responsible for the evaluation; specific evaluation questions, goals, objectives, and outcomes; inclusion of quantitative and qualitative evaluation measures and outcomes; a plan for how the evaluation will be conducted; and a plan for identifying and addressing emerging challenges. Experience of core U-PACE faculty in conducting process, outcome, and impact evaluations in the past five years should be provided.

2. Administrative and Infrastructure Core (~ 10 pages): To ensure that applicants have the administrative and infrastructure capacity to achieve the program goals and objectives, applicants should describe the following:

1. Infrastructure: Applicants should describe the infrastructure of personnel and resources required to develop U-PACE functions and processes and to accomplish goals and objectives. This description should include a statement of institutional commitment to the proposed U-PACE, including the ability to develop and maintain the necessary infrastructure, and letters of support should be included to demonstrate this capacity. Additionally, to assure that applicants have this capacity, applicants should, at a minimum:

   1. Provide an organizational chart for the U-PACE showing all organizational units and functions. This chart should also reflect the activities articulated in the logic model.

   2. Describe the U-PACE’s staffing and management plan. Identify core faculty to oversee U-PACE activities and other key positions. Describe each proposed position, including the minimum criteria and the required expertise for each position, and discuss how the position provides the scientific and technical expertise needed to carry out both research and non-research activities. Describe how the proposed staff will interact with each other, with partners, and with the university’s and the community’s leaders to accomplish the U-PACE’s goals and objectives. This discussion should highlight staff responsible for the following roles: leadership, research, evaluation, communication and dissemination, information management, and fiscal and administrative management.

   3. Describe how the U-PACE will be integrated within the university structure. Describe the facilities in which staff will work and how these facilities enhance the ability to complete the proposed activities. Describe the U-PACE’s plan to enhance its core capacity over the five-year period, including the commitment and capability to obtain the communication, information systems, and other tools (i.e., computer equipment, telephones, facsimile machines, scanners, scientific software) necessary to accomplish goals and objectives.

2. Targeted Community: Applicants need to identify and describe the target community that the proposed U-PACE’s activities will serve. Applicants should, at a minimum, address the following characteristics of the target community as they pertain to the justification of the community chosen: the size of the community; the demographic makeup, socioeconomic, and cultural characteristics; levels of violent behavior, injury and death among youth and rate of youth homicide in the target community relative to the national average; the prevalence of risk and protective factors of, or encountered by, the target community; the youth violence prevention infrastructure, levels of organization and support for youth violence preventions in the target community; youth violence primary or secondary prevention activities already occurring in the target community; and the existence of health, education, justice, and other policies related to youth violence prevention in the defined community. Applicants should describe the linkages between the U-PACE and the defined community and document appropriate levels of engagement and collaboration that reflect the ability to carry out proposed activities.

3. Collaboration and Partnerships: Applicants need to describe the nature and range of partnerships needed to support the U-PACE’s interdisciplinary research strategies and intervention designs, including the necessary infrastructure of resources and personnel to support collaboration with the target community, and how those partnerships will be established and maintained. Applicants should describe how partnerships will be used to enhance the targeted community’s capacity to address the problem of youth violence and prevent or reduce youth violence. Applicants must provide evidence of commitment and cooperation of potential community members and other potential partnerships through letters of support, memorandums of understanding, or examples of prior collaboration.

   1. Community Advisory Committee: Applicants should describe how a Community Advisory Committee will be established, maintained, and evaluated. This plan should include, at a minimum, the following: The intended composition and membership of the Committee and how the proposed constituents appropriately represent the target community; how typically under-represented community members will be identified and recruited for the Committee; the proposed mission and role for the Committee in the prioritization, planning, implementation, and evaluation of activities consistent with the logic model; a plan for communication between the Committee and center staff about the prioritization, planning, implementation, and evaluation of activities; and an evaluation plan that will track success in engaging and maintaining community representatives and other partners in Committee activities, will assess Committee members’ satisfaction with the group’s functioning and activities, and will solicit feedback to be used to improve the Committee’s cohesion and functioning.

   2. Other Partnerships: Applicants should describe how other partnerships necessary to accomplish the U-PACE’s goals and objectives will be identified, established, and maintained. At a minimum, applicants need to briefly describe proposed partners; the proposed methods for establishing and maintaining these partnerships; and the partners’ involvement in the proposed activities.

3. Research Core (~18 pages): Applicants should describe the U-PACE’s five-year research agenda, including a description of the core youth violence primary prevention research project(s), and smaller studies and programmatic activities, as described below. Clear definitions of procedures used to select proposed and future projects are required. To assure that applicants have the capacity to conduct the identified core youth violence prevention research and other research and programmatic activities, they should, at a minimum, describe: their ability to effectively collaborate with partners in the prioritization, planning, implementation, evaluation, and dissemination of research; and experience in successfully conducting, evaluating, and publishing youth interpersonal violence prevention research in the past five years, including community involvement in those activities.

The applicant should use the following template to describe each proposed research project.

• Title of the project.

• Project Director/Lead investigator of project.

• Institution(s)/Partners involved in the project.

• Categorization of the type of research (e.g., efficacy/effectiveness intervention, dissemination, etiological).

• Relationship of the project to the U-PACE’s mission and health priorities.

• Evidence of community participation in the planning, implementation, and evaluation of the project. Describe how collaboration with partners on refining and developing the research methodology, recruiting of research participants, and reporting and dissemination of research findings will occur.

• Summary of the research project:

  • Background

  • Importance

  • Relevance to the targeted community

  • Integration into 5 year research agenda

  • Goals and objectives

  • Proposed timeframe for the project

  • Setting and context

  • Methods and measures

  • Study participants and recruitment strategy. The applicant should provide evidence that he/she (or a collaborating partner) has access to the study population and that participation by the study population will be adequate to test hypotheses.

  • Expected outcomes

  • Communication and dissemination

  • Data Sharing and Release: Describe plans for the sharing and release of data, if applicable (See AR-25 for additional information).

1. Core Research Project(s): The core research project(s) is the larger scale project with an annual budget of $200,000 or more, including direct and indirect costs, for a period of up to five years. These projects typically will test hypotheses and employ more sophisticated methodologies and/or larger sample sizes than smaller studies. Core research projects require an RO1 level summary as described in PHS 398 (revised 5/01 and updated 6/28/02). Applicants should identify, plan, and implement at least one core research project. The core research project(s) is expected to focus on primary prevention of youth violence in the targeted community. Projects can be either efficacy/effectiveness studies or dissemination research studies. These studies can be targeted universally or at selected or high-risk populations.

   1. Efficacy/effectiveness studies should address both risk and protective factors at two or more levels of influence (e.g., individual, family, peers, school/workplace, neighborhood, community). Such studies are expected to be rigorous and should include the collection of process measures (e.g., specific intervention components delivered, youth engaged in the various parts of the intervention) and outcome measures (i.e., violent behavior and injuries in the population of interest).

   2. Dissemination research studies should select measures and methods appropriate for the interventions, policies or programs chosen. The interventions, policies or programs chosen for dissemination research should be selected based on systematic reviews of the field or two or more well designed studies.

   3. Depending on the nature of the efficacy/effectiveness studies or the dissemination research studies conducted, individual- and community-level measures may be needed to examine impact. Cost data on programs and their implementation should be collected and utilized in cost-effectiveness analyses.

2. Smaller Studies or Programmatic Activities: The smaller studies or programmatic activities should have annual budgets of $50,000-$199,000, including direct and indirect costs, for one to three years duration. Applicants should identify, plan, implement, and evaluate smaller studies or programmatic activities that help facilitate and support the core research project(s) in the targeted community. Such studies may include etiological studies to better understand the problem of youth violence in the targeted community or pilot studies to help develop and refine the methods of the core research project(s).

4. Surveillance Core (~ 8 pages): Applicants need to describe how they will establish and/or enhance surveillance systems to measure the magnitude and distribution of youth interpersonal violence, injury and death and the prevalence of youth violence risk and protective factors in the targeted community in order to assess the immediate and long term impact of the U-PACE’s research and programmatic efforts. To demonstrate this capacity, applicants should, at a minimum:

   1. Describe the infrastructure of resources and personnel required to support surveillance activities.

   2. Document experience in successfully developing, implementing, and evaluating community level surveillance efforts in the last five years by core faculty.

   3. Describe plans to develop and/or enhance surveillance systems to be able to measure the problem of youth violence perpetration and victimization as well as determine the impact of proposed activities and research in the targeted community. Applicants should address how the system will measure youth violence patterns in the targeted community; be used to guide planning and evaluation of youth violence programs; and advance the public health research related to youth violence. All proposed surveillance activities should include an appropriate translation and dissemination plan.

5. Communication and Dissemination Core (~ 6 pages): Applicants should outline a communication and dissemination plan to accomplish U-PACE goals and objectives. The outline should include how the U-PACE’s findings, methods, and tools will be disseminated and made available to different audiences, and how the U-PACE’s stakeholders (e.g., researchers, practitioners, community members, and policy makers) will be kept abreast of accomplishments. The outline should address how the U-PACE will develop products that reflect research progress and results; and describe how they will participate in coordinated activities with other urban areas to facilitate linkages and to promote national/state/local partnerships. Attention should be given to the role members of the targeted community will play in the development and dissemination of information. The outline should also describe the infrastructure of resources and personnel necessary to support communication and dissemination activities.

The application narrative should be no more than 50 pages (8.5” X 11”), single-spaced, and printed on one side only, with one-inch margins on all sides and unreduced 12-point font. Appendices must be hard copy documents (i.e., no audiovisual materials or posters). The appendix should not be used to circumvent the page limitation. The appendix may include the following items: 1) letters of support and memorandum’s of understanding; 2) Up to 5 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the application; 3) Other relevant supporting documentation.

To facilitate the preparation and review of the application, the application components should be organized according to the Table of Contents listed below. The list below supersedes the instructions contained in the PHS 398.

• Description (abstract)

• Detailed budget for the initial 12-month budget period, reflecting the costs for each core component, along with a detailed justification for all items.

• Budget for the 5-year Project Period, reflecting the support of all components over the project period.

• Biographical Sketch-Principal Investigator/Program Director

• Other Biographical Sketches

• Other Research Support

• Application narrative (research plan):

  • Overall Description of the Proposed U-PACE

    • Mission, Goals, Objectives

    • Logic Model

    • Evaluation Plan

  • Administrative and Infrastructure Core

    • Infrastructure

    • Targeted Community

    • Collaborations/Partnerships

  • Research Core

    • Core Research Project(s)

    • Smaller Project(s) and Programmatic Activities

  • Surveillance Core

  • Communication and Dissemination Core

An applicant organization has the option of having specific salary and fringe benefit amounts for individuals omitted from the copies of the application that are made available to outside reviewing groups. To exercise this option, on the original and four copies of the application, the applicant must use asterisks to indicate those individuals for whom salaries and fringe benefits are not shown; however, the subtotals must still be shown. In addition, the applicant must submit an additional copy of page four of Form PHS-398, completed in full, with the asterisks replaced by the salaries and fringe benefits. This budget page will be reserved for internal staff use only.

3. Submission Dates and Times

All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on or before the deadline date. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier’s 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 does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.

Otherwise, 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.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: February 28, 2006

Application Receipt Date: March 30, 2006

Peer Review Date: May 2006

Council Review Date: June 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed research.

• Name, address, and telephone number of the Principal Investigator.

• Names of other key personnel.

• Participating institutions.

• Number and title of this funding opportunity.

Although a letter of intent is not required, is not binding, and does not enter into the review of the subsequent application, the information that it contains allows NCIPC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent to:

NCIPC Extramural Resources Team

CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:

2945 Flowers Road

Yale Building, Room 2054

Atlanta, GA 30341

Address for U.S. Postal Service Mail:

4770 Buford Hwy., NE, Mailstop K-62

Atlanta, GA 30341

Telephone: 770-488-4037

Fax: 770-488-1662

Email: CIPERT@CDC.GOV

3.B. Sending an Application

Applications follow the PHS 398 application instructions for content and formatting of your applications. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to:

Technical Information Management – RFA-CE06-008

CDC Procurements and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

At the time of submission, four (4) additional copies of the application, including the appendix material, must be sent to:

NCIPC Extramural Resources Team

CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:

2945 Flowers Road

Yale Building, Room 2054

Atlanta, GA 30341

Address for U.S. Postal Service Mail:

4770 Buford Hwy., NE, Mailstop K-62

Atlanta, GA 30341

Fax: 770-488-1662

Email: CIPERT@CDC.GOV

Note: Applications must be sent to CDC in Atlanta, GA not NIH in Bethesda, MD.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the PGO and for responsiveness by NCIPC and PGO. Incomplete and non-responsive applications will not be reviewed.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.

Restrictions, which must be taken into account while writing your budget, are as follows:

• Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.

• Reimbursement of pre-award costs is not allowed.

• Grant funds will not be made available to support the provision of direct care.

6. Other Submission Requirements

When developing a budget, the following guidelines should be used:

• The core research project(s) should have a minimum annual budget of $200,000, including direct and indirect costs, for a period of up to five years. If any direct and indirect costs are already included in the Administrative and Infrastructure Core Section of the overall budget, they should not be included in the budget for the core research project.

• The smaller studies or programmatic activities should have annual budgets of $50,000-$199,000, including direct and indirect costs, for a period of one to three years duration. If any direct and indirect costs are already included in the Administrative and Infrastructure Core Section of the overall budget they should not be included in the budget for the smaller studies or programmatic efforts.

• Travel expenses to Atlanta, GA for two U-PACE staff to attend annual reverse site meetings should be included.

Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI. “Award Administration Information”.

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.

Your research plan should address activities to be conducted over the entire project period.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

Proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. As such, if any of the U-PACE’s proposed research projects exceed $500,000 per year in total costs, a data sharing plan for that proposed research project must be included in the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

Not applicable.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

• Scientific merit of the proposed project as determined by peer review

• Availability of funds

• Relevance of program priorities

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCIPC in accordance with the review criteria stated below.

As part of the initial merit review, all responsive applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

• Receive a written critique.

• Receive a second level of review by the Science and Program Review Subcommittee (SPRS) of the Secretary’s Advisory Committee for Injury Prevention and Control (ACIPC).

The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness. 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.

Significance: Is the Center addressing an important problem and reaching an important population? If the aims of the application are achieved, how will scientific knowledge or practice be advanced? What will be the effect of the Center’s studies and programmatic efforts on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the U-PACE’s approach reflect an emphasis on primary prevention of youth violence? Do proposed research and programmatic activities adequately address both risk and protective factors and multiple levels of influence on youth violence? Is the target high-risk community fully described and has the applicant provided a justification for the selection of the target high-risk community? Do the proposed activities adequately involve members of the target community in the prioritization, planning, implementation, and evaluation of youth violence prevention activities? Is the five-year evaluation plan sufficient to appropriately evaluate each component of the logic model and all core activities? Are the proposed research designs for the core project(s) and smaller studies scientifically rigorous and appropriate to answer the research questions? Do the smaller studies or programmatic activities compliment the core research project(s)? Are descriptions of sampling methods, sample size and power estimates, and measures of fidelity and program exposure, and outcome measures well described, concrete, specific, and appropriate for addressing research questions? Are the proposed surveillance efforts adequate to determine the impact of the proposed activities in the targeted community?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Are plans for involving partners and members of the community in the development, implementation, evaluation, and dissemination of youth violence prevention activities innovative? Do the planned communication and dissemination efforts employ novel approaches?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Do the investigators have adequate experience to conduct process, outcome, and impact evaluations? Do the investigators have the necessary training and experience to establish partnerships with representatives of an urban community in order to achieve the proposed goals and objectives? Do the principal investigator and the members of the research team have a prior history of conducting, evaluating, and publishing violence prevention research in the past five years? Does the principal investigator and research team have prior experience working with the targeted community on youth violence prevention activities? Do the investigators have experience analyzing and disseminating youth violence research to a broad range of audiences and through a variety of mechanisms?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is the infrastructure of personnel and resources required to develop U-PACE functions and processes and to accomplish stated goals and objectives adequately defined and described? Is there evidence that the applicant can maintain the infrastructure necessary to accomplish the proposed goals and objectives? Is an organizational chart provided that shows all the necessary positions to accomplish the activities proposed in the logic model and have core faculty and other staff been identified for key roles, including leadership, research, evaluation, dissemination, information management, and fiscal and program administration? Are members of the targeted community and other partners well integrated into U-PACE activities? Is there sufficient evidence of support for the five-year research plan by the academic institution and by members of the target community and other partners?

The primary review will be a peer review conducted by NCIPC Initial Review Group (IRG). Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review. NCIPC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current NIH criteria (a scoring system of 100 - 500 points) to evaluate the methods and scientific quality of the application. The IRG may recommend the application for a site visit review that may involve a team of peer reviewers conducting an on-site visit, generating summary statements based upon the visit, and reporting the assessment to the IRG.

The secondary review will be conducted by the Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC). The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer’s briefing materials). ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared. The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities. Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session. If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered will be the same as those considered by the SPRS.

The ACIPC committee’s responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur. The secondary review committee has the latitude to recommend to the NCIPC Director, to reach over better ranked proposals in order to assure maximal impact and balance of proposed research. The factors to be considered will include:

• The results of the primary review including the application’s priority score as the primary factor in the selection process.

• The relevance and balance of proposed research relative to the NCIPC programs and priorities.

• The significance of the proposed activities in relation to the priorities and objectives stated in “Healthy People 2010," the Institute of Medicine report, “Reducing the Burden of Injury,” and the “CDC Injury Research Agenda.”

• Budgetary considerations.

All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee of the Science and Program Review Subcommittee of the ACIPC, consultation with NCIPC senior staff, and the availability of funds.

Continuation awards made after FY 2006, but within the project period, will be made on the basis of the availability of funds and the following criteria:

• The accomplishments reflected in the progress report of the continuation application indicate that the applicant is meeting previously stated objectives or milestones contained in the project’s annual work plan.

• The objectives for the new budget period are realistic, specific, and measurable.

• The methods described will clearly lead to achievement of these objectives.

• The evaluation plan will allow management to monitor whether the methods are effective.

• The budget request is clearly explained, adequately justified, reasonable and consistent with the intended use of grant funds.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

Proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. As such, if any of the U-PACE’s proposed research projects exceed $500,000 per year in total costs, a data sharing plan for that proposed research project must be included in the application.

2.D. Sharing Research Resources

Not applicable.

3. Anticipated Announcement and Award Dates

Grantees will be notified in August or early September of 2006 by CDC’s Procurement and Grants Office (PGO) if their applications were funded. It is anticipated that awards will be made in September 2006.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

Those applicants under consideration for funding will be contacted by CDC for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The notice of award signed by the Grants Management Officer (GMO) is the authorizing document. This document will be mailed and/or emailed to the recipient fiscal officer identified in the application.

Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements. For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. The following additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an “assistance” mechanism (rather than an “acquisition” mechanism), in which substantial CDC programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, the CDC purpose is to support and stimulate the recipients’ activities by involvement in and other otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

• Planning and providing oversight of the U-PACE’s research and programmatic efforts to address the described goals of this cooperative agreement.

• Developing and finalizing plans for the core research project(s), smaller studies, programmatic efforts, and surveillance activities, including developing and finalizing data collection measures, methods, and analyses.

• Collecting and reporting program costs (e.g., personnel, supplies, travel, space) and costs associated with program implementation, and costs of injury due to youth violence at the individual- and community-level. These data will be critical in conducting a cost-effectiveness analysis of the program.

• Collaborating with CDC in the development of the human subjects’ protocol for the CDC Institutional Review Board (IRB) review, if appropriate.

• Obtaining approval of study protocol(s) by the applicant’s local Institutional Review Board (IRB).

• Analyzing data, publishing data in peer-reviewed journals, and presenting results at scientific conferences.

• Disseminating study results, tools, and methods through presentations and publications to broad audiences, including public health officials and key stakeholders.

• Completing all reporting requirements listed below in Section VI.3.

• Collecting and reporting necessary data and information to CDC to assess progress toward U-PACE’s goals and objectives and to monitor overall performance. This includes, but is not limited to, information related to the logic model performance indictors, the functioning of the Community Advisory Committee, status of the core research project(s), the smaller studies or programmatic activities, and public health surveillance activities, and progress toward NCIPC’s goals and objectives.

• Participating in reverse site visits with CDC in Atlanta, GA on an annual basis.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies

2.A.2. CDC Responsibilities

A CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

• Provide scientific and technical assistance related to the design and implementation of the research; serve as a scientific and professional resource, and collaborate with U-PACE staff on programmatic efforts, interpretation of findings, and the production of publications and presentations to disseminate study results, tools, and methods.

• Provide scientific leadership in identifying data elements for and conducting cost-effectiveness analyses.

• Review, monitor and evaluate the scientific and operational accomplishments to assure progress toward program goals and objectives. The review will be based on the Center’s logic model and the critical components of the model that are related to the achievement of core performance indicators. Progress will also be monitored and evaluated through conference calls, site visits, and review of technical reports.

• Facilitate research collaboration and information sharing between grantee and others conducting similar youth violence prevention activities, including the grantees participating in CDC’s National ACE Program on Youth Violence.

• When appropriate, assist in the development of a research protocol for IRB review by all performing sites involved in the research project. If CDC researchers are significantly involved in the project, the CDC IRB will review the protocol initially and on an annual basis until the research project is complete.

• Inform recipients about any CDC policy, laws, and regulations pertaining to public health research and programmatic activities, keep abreast of potential violations, and take necessary steps to bring program into compliance.

Additionally, an agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Not applicable.

3. Reporting

You must provide CDC with an original, plus two hard copies of the following reports:

1. Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the CDC website) no less than 120 days before the beginning of the budget period. The progress report will serve as your non-competing continuation application.

2. Annual Progress Report, due 90 days after the end of the budget period. Annual outcome reports should summarize the results, including publications, and the impact resulting from the research. An outcome report format will be sent by NCIPC to the grantees.

3. Financial status report, no more than 90 days after the end of the budget period.

4. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

At the completion of the project, the grant recipient will submit a final outcome report and a brief summary of the research written in non-scientific [laymen’s] terms. The summary should highlight the findings and their implications for injury prevention programs, policies, environmental changes, etc. The grant recipient will also include a description of the dissemination plan for research findings. This plan will include publications in peer-reviewed journals and ways in which research findings will be made available to stakeholders outside of academia (e.g., state injury prevention program staff, community groups, public health injury prevention practitioners, and others). CDC will place the summary report and each grant recipient’s final report with the National Technical Information Service (NTIS) to further the agency’s efforts to make the information more available and accessible to the public.

Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Linda Anne Valle, Ph.D

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention (CDC)

4770 Buford Highway, NE, Mailstop K-60

Atlanta, GA 30341

Telephone: 770-488-4297

FAX: 770-488-1011

E-mail: LValle@cdc.gov

2. Peer Review Contacts:

Gwendolyn Cattledge, Ph.D

Scientific Review Administrator

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention (CDC)

4770 Buford Highway, NE, Mailstop K-02

Atlanta, GA 30341

Telephone: 770-488-4655

FAX: 770-488-4422

E-mail: gxc8@cdc.gov

3. Financial or Grants Management Contacts:

Brenda Hayes, Grants Management Specialist

CDC Procurement and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2741

FAX: 770-488-2670

E-mail: BHayes@cdc.gov

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

Email: PGOTIM@cdc.gov

5. Special Guidelines for Technical Assistance:

Conference Call: Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on February 14, 2006 from 2:00 p.m. to 3:30 p.m. (Eastern Time). The conference can be accessed by calling 1-877-951-7375 and entering access code 603639. Participation in this conference call is not mandatory.

NCIPC Website: For additional help in preparing your grant application please see the “frequently asked questions” section on the NCIPC webpage at: http://www.cdc.gov/ncipc/res-opps/2004pas.htm

Section VIII. Other Information

Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements

CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Prohibition on Use of CDC Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

In addition to the restrictions in the Anti-Lobbying Act, CDC interprets the language in the CDC's Appropriations Act to mean that CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

Small, Minority, And Women-owned Business

It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

Research Integrity

The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Compliance with Executive Order 13279

Faith-based organizations are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance form the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92, and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time and location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization’s name, select its board members on a religious basis, and include religious references in its organization’s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

1. In a timely manner.

2. Completely, and as accurately as possible.

3. To facilitate the broader community.

4. Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.

25