Please note the following amendments were made to this FOA on Wednesday, August 20, 2008:

 

1.  Additional instructions on the format, content, and budget were added to Section IV. Application and Submission Information, 2. Content and Form of Application Submission.

 

2.  A descriptive title of the anticipated proposed core research project or pilot study is being requested in the LOI in Section IV. Application and Submission Information, 3.A.1. Letter of Intent.  Applicants are to submit only one research proposal using CBPR.

 

3.  Additional instructions on the contents of a complete application packet were added to Section IV. Application and Submission Information, 3.B. Submitting an Application to CDC.

 

4.  Additional information was added to the Appendix Instructions in Section IV. Application and Submission Information, 6. Other Submission Requirements.

 

5.  Clarification on the initial merit review of applications was added to Section V.  Application Review Information, 2. Review and Selection Process.

 

Part I Overview Information


 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

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

 

Participating Organizations

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

 

Components of Participating Organizations

Coordinating Center for Health Promotion (CoCHP), National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), at http://www.cdc.gov/nccdphp/

 

Title:  Health Promotion and Disease Prevention Research Centers (U48)


The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 


Authority:  Section 1706 of the Public Health Service Act (PHS Act), 42 U.S.C. 300u-5, as amended.

 

Announcement Type:  New

Funding Opportunity Announcement (FOA) Number:  RFA-DP-09-001

Catalog of Federal Domestic Assistance Number:  93.135

 

Key Dates
Release/Posted Date:  August 1, 2008

Letter of Intent Receipt Date:  September 8, 2008
Application Submission Receipt Date:  October 8, 2008
Peer Review Date:  December 2008
Council Review Date:  January 2009

Earliest Anticipated Start Date:  September 30, 2009

Additional Information to Be Available Date:  Category 1 Applicants:  Tuesday, August 12, 2008, 3:30 PM (ET), Category 2 Applicants:  Thursday, August 14, 2008, 3:30 PM (ET)

Expiration Date:  Add Information Here

 

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary

 

·          This FOA will support a network of Health Promotion and Disease Prevention Research Centers (PRCs) that:  1) focuses on the major causes of disease and disability, with an emphasis on underserved and minority populations; 2) improves public health practice through community-based participatory research; and 3) designs, tests, disseminates, or translates effective public health programs at the state and community levels.  This FOA will fund PRCs in academic health centers in two categories:  1) centers with a comprehensive organizational infrastructure, strong community collaborations, and plans in place with their partners to conduct a community-based participatory core research project; and 2) centers that need to develop infrastructure or community relationships in order to develop and implement a pilot research study.  The funding provided through this FOA will support the center’s key elements of infrastructure and administration, community engagement and partnerships, communication and dissemination, training, evaluation, and at least one a community-based participatory core research project.

·          The participating organization intends to commit a total of $25,000,000 in FY 2009 to this FOA.

·          Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

·          Anticipated number of awards to be issued under this FOA:  up to 33

·          It is anticipated that the size of each award will vary. The total amount awarded will depend upon the category, quality, and costs of the applications received.

·          Budget Period, Project Period, and Award Amounts:  The award range for the first 12-month project period is $700,000 - $1,000,000 (total costs) for Category 1 awards and $300,000 - $500,000 (total costs) for Category 2 awards.  The total project period for applications submitted in response to this FOA may not exceed five years. 

·          Eligible Organizations:  Academic health centers that meet the eligibility criteria stated in Section 1706 of the Public Health Service Act, 42, U.S.C. 300u-5 and as listed in this FOA.

·          See Section IV.1 for application materials. The PHS 398 Application Guide for this FOA is located at these Web sites:  http://grants1.nih.gov/grants/funding/phs398/phs398.doc (MS Word); http://grants1.nih.gov/grants/funding/phs398/phs398.pdf (PDF).

·          For general information on the PHS 398 Application and Submission, see the following Web site: http://grants1.nih.gov/grants/funding/phs398/phs398.html.

·          HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783. 

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

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 of Support
    2. Funds Available

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

Section IV. Application and Submission Information
    1. 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. Submitting an Application to CDC
        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

            1. Recipient Rights and Responsibilities
            2. HHS/CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

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

    4. General Questions Contact

Section VIII. Other Information - Required Federal Citations

 

Section IX. Application Evaluation Criteria
    1. Category 1

         A. Center Review Criteria – Key Elements

         B. Core Research Project Review Criteria

    2. Category 2

         A. Center Review Criteria – Key Elements

         B. Core Research Project Review Criteria

 

Part II - Full Text of Announcement


 

Section I. Funding Opportunity Description


 

1. Research Objectives

 

The National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) of CDC within HHS is 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 FOA supports the “Healthy People 2010” overarching goals of increasing quality and years of healthy life and eliminating health disparities in the focus areas of arthritis, osteoporosis, and chronic back conditions; cancer; diabetes; disabilities and secondary conditions; educational and community-based programs; environmental health; family planning; health communication; heart disease and stroke; nutrition and overweight; physical activity and fitness; sexually transmitted disease; tobacco use; and vision and hearing.  This FOA is also in alignment with NCCDPHP’s performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions.  For more information see, www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.

 

Nature of the Research Opportunity

This FOA will support a network of Health Promotion and Disease Prevention Research Centers (PRCs) that:  1) focuses on the major causes of disease and disability, with an emphasis on underserved and minority populations; 2) improves public health practice through a community-based participatory research process; and 3) designs, tests, disseminates, or translates effective public health programs at the state and community levels.  Funded centers will involve researchers, representatives from state and local health departments, community members, and public health professionals as collaborating partners to utilize available resources and expand each other’s capacity for conducting applied research in disease prevention and control.  They will also function as a part of a networked environment to support and advance health promotion and disease prevention research and serve as a national resource for developing and applying effective public health programs at the state or community level. 

 

Background

The establishment of centers for research and demonstration of health promotion and disease prevention was authorized by Congress in 1984 by Public Law 98-551.  Congress mandated that the centers be located at academic health centers capable of providing multidisciplinary faculties with expertise in public health, relationships with professionals in other relevant fields, graduate training and demonstrated curricula in disease prevention, and a capability for residency training in public health or preventive medicine.  This legislation was supported by the Association of Schools of Public Health which viewed the PRC Program as a way to enhance health promotion activities by fostering better linkages between the schools of public health and the public health practice community and between academia and CDC.  CDC was selected to administer the Prevention Research Centers (PRC) Program and to provide leadership, technical assistance, and oversight.

 

The PRC Program is now the largest extramural research program supported by CDC.  It is comprised of 33 academic research centers that are associated with schools of public health or medicine in 26 states across the country.  In accordance with the 1984 legislation, the PRCs conduct research in health promotion, disease prevention, and methods of appraising health hazards and risk factors.  They also serve as demonstration sites for the use of new and innovative research in public health techniques to prevent chronic diseases. 

 

In addition to conducting core research, the PRCs work with partners on Special Interest Projects (SIPs), as well as projects funded through other sources, as a way to increase the center’s research activities.  The partnerships and expertise each PRC builds strengthens its competitiveness for additional funding by federal agencies and private foundations.  The SIP mechanism, created in 1993, allow the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies that want to utilize their resources to fund research that promotes better public health practice in specific areas.  As a result, the PRCs’ research portfolio can include approximately 400 projects at any given time.

 

Prevention research includes all applied and public health research that develops and evaluates health promotion and disease prevention and control strategies that are community- and population-based.  It can involve testing interventions for efficacy, effectiveness, or translational power; may focus on primary, secondary, or tertiary prevention; or may improve health and prevent disease through approaches that involve changes to individual behavior, policy or environmental structure, health systems, or socio-economic factors.  Prevention research may provide initial evidence of the efficacy or effectiveness of a health promotion or prevention strategy, raise current evidence to a higher level, or provide evidence of the effectiveness of a practice-based strategy.  It may also include etiological research if there is a clear gap in the knowledge about main determinants of the disease or conditions. 

 

In 1995, CDC asked the Institute of Medicine (IOM) to review the PRC Program to examine the extent to which the program is providing the public health community with workable strategies to address major public health problems in disease prevention and health promotion.  Their report, Linking Research and Public Health Practice: A Review of the CDC’s Program of Centers for Research and Demonstration of Health Promotion and Disease Prevention (1997), identified areas of strengths and areas needing improvement.  Two major recommendations from the IOM review were that the PRC Program adopt a community-based approach to their research and dissemination efforts and develop strategies to improve community input into the PRCs.  While PRCs collaborated with their communities before the 1997 IOM report, the PRC Program formally integrated Community-Based Participatory Research (CBPR) into its expectations for each PRC’s prevention research activities. 

 

The PRC Program defines CBPR as “a joint effort that involves researchers and community representatives in all phases of the research process. The joint effort engages community members, employs local knowledge in the understanding of health problems and the design of interventions, and invests community members in the processes and products of research. In addition, the collaborative is invested in the dissemination and use of research findings to improve community health and reduce health disparities.”  CBPR alters the traditional relationship between researchers, the community, and research participants such that there is shared decision-making as well as mutual ownership of the research process and products. The importance of CBPR is based on the assumption that if the community is involved in setting research questions, gathering and analyzing data, and interpreting results, they are more likely to apply the results. 

 

CDC seeks to improve health and to do so in economically responsible ways.  The PRC Program, with its access to a wide array of public and professional audiences, is uniquely positioned to promote cost effective prevention strategies that are relevant to the U.S. population.  In the 1999 report, An Ounce of Prevention….What are the Returns?, CDC outlined 19 strategies that demonstrated the economic benefits of population-based, prevention strategies.  Smoking, for example, is the leading cause of preventable death in the United States.  Smokers incur between $9,000 - $10,000 more in medical care costs over their lifetime than nonsmokers.  Brief advice and counseling by a physician about quitting smoking costs $705 to $2,058 per life-year gained depending on the person’s gender and age.  Other strategies, such as increasing physical activity, may promote healthy lifestyles.  Coronary heart disease, for example, is the leading cause of death in the United States accounting for over 500,000 deaths annually.  Total direct care and lost productivity due to coronary heart disease cost the United States $90.9 billion in 1997 while increasing physical activity cost only $3,433 per life-year gained. 

 

Since its inception, the CDC PRC Program has made substantial progress in improving the quality of people’s lives by preventing disease, injury and disability.  The network of PRCs has served as a national resource for developing and applying effective prevention strategies at the community level and has been in the forefront of developing and practicing CBPR Through scientific rigor, collaborative partnerships, practical application, and community participation the PRC Program will continue to strive to find new ways to improve the health of all Americans.  

 

Scientific Knowledge to be Achieved through Research Supported by this Program

As the US population ages and health care costs increase, prevention becomes even more critical to the national health care agenda.  Many chronic diseases, injuries, and some infectious diseases are caused by behavioral and environmental factors that can be changed.  Prevention research is critical to helping people change risk factors in their lives and their communities.  The gaps between findings in prevention research and their translation into public health programs, practice, and policy must be eliminated so that new knowledge is effectively applied in states and communities throughout the country.

 

This FOA will support academic health centers to build on the strong achievements of the PRC Program to date and to further advance the program’s mission and research activities.  It is anticipated that the network of PRCs supported by this FOA will continue to conduct innovative and important studies in prevention research that are relevant for communities and that will result in improved health for people across the United States. 

 

The PRC model involves researchers, community members, representatives from state and local health departments, and public health professionals as equal collaborating partners to utilize available resources and expand each other’s capacity to address health issues.  The partners design, test, and disseminate strategies—often as new policies or recommended public health practices.  Centers share a common goal of addressing behaviors and environmental factors that contribute to chronic diseases that affect the health of individuals, such as cancer, heart disease, and diabetes, and that impact communities.  Several PRCs also address injury, infectious disease, mental health, oral health, and global health.  In efforts to eliminate health disparities and create healthy communities, the PRCs will remain at the forefront in advancing CBPR and sharing knowledge and expertise in applied research aimed at improving public health programs.

 

Experimental Approach and Research Objectives

The intent of this FOA is to support a network of PRCs in academic health centers across the country that will conduct health promotion and disease prevention research that focuses on the major causes of death and disability, improves public health practice within communities, and cultivates effective state and local public health programs.  The funding provided through this FOA will support the center’s infrastructure and at least one a CBPR project.

 

As national leaders in health promotion, disease prevention, and CBPR, the academic health centers that comprise the PRC network must demonstrate: 1) elements of an infrastructure and environment to lead and advance public health research, and 2) the ability to conduct CBPR research aimed at eliminating health disparities and creating healthy communities.  This FOA solicits applications from academic health centers to fund PRCs in two categories:  

 

Category 1:  Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.  

 

Category 2:  Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.  

 

Key Elements of Prevention Research Centers

Each PRC is expected to have appropriate and effective administrative and organizational capabilities to conduct a core research project using CBPR and to plan, manage, and evaluate center activities.  Key elements of a PRC include infrastructure and administration, community engagement and partnerships, communication and dissemination, training, and evaluation.  Proposed approaches, methodologies, and tools within these key elements should support a comprehensive, effective, and efficient PRC. 

 

Academic health centers should provide a supportive institutional environment that engages a wide spectrum of disciplines to support the activities of the PRC and their core research project.  The environment should foster research excellence, support methodological innovation, facilitate multidisciplinary collaborations and coordination of efforts, and encourage relationships with outside agencies and entities as appropriate to facilitate planned research.

 

Category 1 applicants are expected to have a comprehensive organizational infrastructure and leadership model with experience supporting multidisciplinary prevention research and have a defined partner community.  In addition, they must have a solid history of experience in CBPR activities that include communication and dissemination, training, and evaluation.  Category 1 institutions should be able to implement innovative, high-quality prevention research that is consistent with the PRC Program. 

 

Category 2 applicants must demonstrate an environment and the availability of resources to support the development of a comprehensive center capable of leading CBPR and related endeavors.  The center should have the capability to support long-range planning and implementation of PRC key element activities in community engagement and partnerships, communication and dissemination, training, and evaluation.  Evidence of the institutional commitment to the PRC Program, its mission, and goals should be clear and convincing.             

Each year, PRCs funded under this FOA will be eligible to compete for SIP supplemental funding to design, test, and disseminate effective prevention research strategies in specific areas sponsored by CDC and other HHS agencies.  The SIP mechanism is designed to maximize the expertise and resources offered by each center and the PRC network as a whole.  Funded PRCs are encouraged to apply for SIPs that will expand and strengthen the center’s mission and increase their research activities.  

Many of the activities of the PRCs complement National Institutes of Health (NIH)-funded institutions conducting activities under RFA RM08-002 Institutional Clinical and Translational Science Award (CTSA).  PRCs in academic health centers with CTSAs are strongly encouraged to work collaboratively on shared goals and priorities and to foster an innovative, synergistic approach to advancing health promotion, disease prevention, and CBPR.

 

PRC Core Research Projects

Each PRC will conduct a core research project in health promotion and disease prevention research that bears an essential relationship to the PRC’s mission and the community and that efficiently uses and contributes to the center’s resources. 

 

Institutions funded under Category 1 are expected to conduct at least one a high quality core prevention research project using CBPR.  Utilizing appropriate research design and methods, each PRC funded under Category 1 is expected to implement a determinant, intervention, or dissemination research project.  Research activities may include: 1) hypothesis testing research on causality of diseases and conditions, 2) efficacy or effectiveness of interventions, or 3) translation, implementation, or evaluative studies.  Intervention or dissemination research projects are encouraged, when appropriate, to identify or modify an existing evidence-based or practice-based intervention for implementation within or dissemination to a different setting (e.g., community-based rather than clinic based) or population.  Practice-based interventions must have undergone sufficient implementation to be proven acceptable by the community, sustainable due to evidence of appropriate partnerships and available resources, and likely effective.  Category 1 applicants may propose a core research project that develops a new intervention; however, a rationale for doing so must be provided that demonstrates that no applicable intervention exists, there is a gap in the literature, and that a need for it exists in the community.  Applicants that propose a core research project that is dissemination research need to demonstrate that there is evidence behind the intervention and that the results will include information and guidance for implementation of the intervention by other agencies, organizations, or communities.

 

Institutions funded under Category 2 are expected to develop and implement a pilot study using CBPR that will form the basis for a determinant, intervention, or dissemination research project.  Category 2 PRCs should utilize available resources and expertise in the development of their core research project.  In their proposal, Category 2 applicants must describe how they will collaborate with their community and engage partners during the development, implementation, and evaluation of the pilot project.

The PRCs funded under this FOA will function as a network and will serve as local, regional, and national resources for developing and applying effective prevention programs and strategies at the community level.  The PRC Program will be guided by seven committees (Steering, Program, Research, Policy, Communications and Dissemination, National Community, and Evaluation) that will provide recommendations to the PRCs on program standards and policies and on research and other activities throughout the project period.  Membership of the standing committees will be comprised of representatives from a consortium of partners, including the PRCs, their communities, and CDC’s PRC Program office.  The Steering Committee will serve as the executive committee to the CDC PRC Program office.

                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  

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

Section II. Award Information


 

1. Mechanism of Support

This funding opportunity will use the U48 activity code.  The HHS/CDC U48 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Center, Institute, and Office (CIO) NCCDPHP intends to commit approximately $25,000,000 in total dollars (direct and indirect costs) in FY 2009 to fund up to 33 awards.  An applicant may request a project period of up to five years.  The approximate funded amount is $125,000,000 in total costs for the entire five-year project period.  The FY 2009 award range for the 12-month budget period for the two categories is as follows:

Category 1:  $700,000 - $1,000,000 in total costs (direct and indirect)

 

Category 2:  $300,000 - $500,000 in total costs (direct and indirect)

Up to three PRCs may be funded under his category.                                                      

Since the scale and range of project activities will depend on the category under which an institution is funded, award amounts will vary in size based on the category and within each category. 

If an applicant requests a funding amount greater than the ceiling of the award range for the specific category, HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.  All estimated funding amounts are subject to availability of funds.  The anticipated start date for new awards is September 30, 2009.

Although the financial plans of the CIO 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.

 

Section III. Eligibility Information


 

1. Eligible Applicants

1.A. Eligible Institutions

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

In accordance with Section 1706 of the Public Health Service Act (PHS Act), 42, U.S.C. 300u-5 the following research institutions are eligible to apply for funding under this FOA: 

 

  1. Accredited schools of public health.  Eligible schools of public health must be accredited by the Council on Education in Public Health (CEPH).  Accreditation is defined by Section 799B(1)(E) of the PHS Act.
  2. Accredited schools of osteopathy and accredited schools of medicine that offer an accredited Preventive Medicine Residency program, or are in the process of obtaining accreditation for a preventive medicine residency program.  Eligible schools of osteopathy and medicine must be accredited by the Accreditation Council for Graduate Medical Education (ACGME).  Applicants in the process of obtaining accreditation from ACGME for a preventive medicine residency must include a copy of Section A.  Accreditation Information and Section B. Participating Sites of the Preventive Medicine New Application Program Information Form in their application.

 

In addition to the above criteria, eligible academic health centers must meet the following requirements:

 

1.      Have a multidisciplinary faculty with expertise in public health and which has working relationships with relevant groups in such fields as medicine, psychology, nursing, social work, education and business;

2.      Have graduate training programs relevant to disease prevention;

3.      Have core faculty in epidemiology, biostatistics, social sciences, behavioral and environmental health sciences and health administration;

4.      Have demonstrated curriculum in disease prevention;

5.      Have capability for residency training in public health or preventive medicine; and

6.      Meet such other qualifications as the Secretary may prescribe.

 

An institution may submit, or be part of, only a single application in response to this FOA.  Multiple applications from different divisions, faculties, centers, schools, etc. of the same university, school of public health, medicine, or osteopathy will be returned without further consideration by CDC. 

 

An institution may apply under one of the following categories but not both: 

 

Category 1:  Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.  

 

Category 2:  Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.  

 

2. Cost Sharing or Matching

 

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


The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc


3. Other-Special Eligibility Criteria


Not applicable.

 

Section IV. Application and Submission Information


 

1. Request Application Information

The Public Health Service Grant Application (PHS 398) instructions are available at http://grants1.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 PGO TIMS: Telephone (770) 488-2700 or PGOTIM@cdc.gov.

HHS/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 version of the PHS 398 research grant application forms and in accordance with the instruction guide (http://grants1.nih.gov/grants/funding/phs398/phs398.doc).  Applicants must have a Dun & Bradstreet Data Universal Numbering System (DUNS) 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 website 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 PHS 398 Application Guide is critical to submitting a complete and accurate application to HHS/CDC.  

The following sections supplement the instructions found in the PHS 398 and should be used for preparing and submitting an application in paper format.  A complete application will contain two separate proposals prepared using the PHS 398:  1) a proposal for the center, and 2) a proposal for the core research project or pilot study.  Applications that do not include both proposals will be incomplete and HHS/CDC will consider the application non-responsive and it will not enter into the review process.

The application should be assembled and paginated as one complete document.  Begin page numbering with the center proposal, followed by the items included in the center’s CD appendices, and continue with the core research project or pilot study proposal, followed by the items included in its CD appendices.  Provide a comprehensive Table of Contents for the application that provides enough detail to readily locate specific sections/information pertinent to the center proposal and core research project or pilot study proposal.  The Table of Contents should be the first page of the application packet.

Applicants should clearly indicate whether they are applying as a Category 1 or Category 2 institution.   An institution may apply under only one category. 

Supplemental instructions for preparing the PHS 398 for the center application:

A complete PHS 398 application should be prepared and submitted for the center application.  The PHS 398 forms (Face Page, Description, Budget, etc.) should be a composite of the overall center, key elements and core research activities.  The Research Plan section (Specific Aims, Background and Significance, etc.) should be specific to the key elements of the center.

·          PHS 398 Face Page – This should be the first page of the entire application.  Indicate if applying for Category 1 or 2 in the Title of Project.  The information on the Face Page should be a composite of the overall center, key elements and core research activities.

·          Budget – The funds requested and justification provided should be a composite for the center and include the total budget for the core research project or pilot study for the first 12-month budget period and estimates for years 2-5 of the project period.  The total budget (direct and indirect costs) for the core research project or pilot study should be listed as a line item in Other Expenses on the detailed budget form.  The overall center budget should adhere to the limits stated in the FOA for the specific category. 

·          Senior/Key Personnel – List the PD/PI for the overall center.  Include all individuals that will participate in the execution of the PRC.  Note: CDC does not accept applications reflecting multiple PDs/PIs.  Information on individuals who will be contributing in a substantive, measurable way should be entered in the Senior/Key Personnel or Other Significant Contributors section of the PHS 398.

·          Research Plan – Specific to the center proposal and limited to 25 pages.  In this section, applicants should describe in detail the organizational and administrative structure of the center, including the chain of responsibility for decision-making and administration, and address the key elements of a PRC.  Applicants funded under PA04-003 must include a progress report that highlights PRC achievements from the previous funding cycle.

Supplemental instructions for preparing the PHS 398 for the core research project or pilot study application:

A complete PHS 398 application should be prepared specific to the core research project or pilot study, bundled separately, and should follow the center application.  Keeping in mind that the core research activities will be reviewed and evaluated separately, and independent of the center application, the PHS 398 forms (Face Page, Description, Budget, etc.) should be specific to the core research project or pilot study.  Prepare the PHS 398 Research Plan section (Specific Aims, Background and Significance, etc.) in the same level of detail required for the traditional individual research grant application so that the scientific and technical merit of the core research activities can be judged on the basis of the application alone.

·          PHS 398 Face Page – Indicate if Research Project or Pilot Study in the Title of Project.  All information should reflect the core research activities only. 

·          Budget – The funds requested and justification provided should be specific to the core research activities for the first 12-month budget period and estimates for years 2-5 of the research.  These amounts must be listed as a line item in Other Expenses in the center application overall budget.

·          Senior/Key Personnel – List the PD/PI for the core research activities only.  Include all individuals (even if previously listed in the center application) who will contribute to the scientific development or execution of the core research project activities in a substantive, measurable way.

·          Research Plan – Specific to the core research project or pilot study only and limited to 20 pages.

Note: While both budget components are included in the PHS 398 forms package, the CDC U48 activity code uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

Information Sessions:

CDC will conduct informational sessions (web cast) for academic health centers considering submitting an application in response to this FOA.  Representatives from the CDC PRC Program office and from the CoCHP Extramural Research Program Office will provide information and answer questions pertinent to preparing applications in response to this FOA.

 

Web cast for Category 1 applicants:

 

Date:  Tuesday, August 12, 2008

Time:  3:30 pm – 5:30 pm (ET)

 

Audio Participant Access

Toll-free Number:  1-888-469-3092

Passcode:  4133408

Leader:  Jo Anne Grunbaum

 

Net Conference Participant Access

URL:  https://www.mymeetings.com/nc/join/ 

Conference Number:  PG2668708

Audience Passcode:  4133408

 

Participants can join the event directly at:

https://www.mymeetings.com/nc/join.php?i=PG2668708&p=4133408&t=c

 

Web cast for Category 2 applicants:

 

Date:  Thursday, August 14, 2008

Time:  3:30 pm – 5:30 pm (ET)

 

Audio Participant Access

Toll-free Number:  1-888-469-3092

Passcode:  4133408

Leader:  Jo Anne Grunbaum

 

Net Conference Participant Access

URL:  https://www.mymeetings.com/nc/join/

Conference Number:  PG2668726

Audience Passcode:  4133408

 

Participants can join the event directly at:

https://www.mymeetings.com/nc/join.php?i=PG2668726&p=4133408&t=c

 

Multiple participants from the same institution are encouraged to access the webinar from a single location.

 

Information on the PRC Program and this FOA is available at:  http://www.cdc.gov/prc/news/2008-foa-announcement.htm.

 

3. Submission Dates and Times

 

See Section IV.3.A for details


3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date:  September 8, 2008

Application Submission Receipt Date:  October 8, 2008

Peer Review Date:  December 2008

Council Review Date:  January 2009

Earliest Anticipated Start Date:  September 30, 2009

3.A.1. Letter of Intent

 

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

 

·          Descriptive title of the proposal (Indicate if the LOI is for Category 1 or 2.)

·          Descriptive title of the anticipated core research project or pilot study

·          Name, address, and telephone number of the PD/PI

·          Names of other key personnel

·          Participating institutions

·          Number and title of this funding opportunity

 

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

 

The LOI is to be sent by the date listed in Section IV. 3.A.  The LOI should be sent to:

 

Beth Patterson, M.Ed.

Extramural Research Program Office, CoCHP
4770 Buford Highway NE
Mailstop K-92

Atlanta, GA  30341
Telephone: (770) 488-8390
Fax:  (770) 488-8046

Email:  BPatterson@cdc.gov

 

3.B. Submitting an Application to CDC

 

If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.  Only paper submissions are allowed for this FOA.

 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Time on the deadline date. If an applicant submits materials 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 HHS/CDC receives your submission after closing because of: (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 have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

 

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: (770) 488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

 

Submit the complete application packet to the following address:

 

Technical Information Management Section – DP09-001

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  (770) 488-2700

 

A complete application packet includes:  1) a signed, typewritten original of the center proposal, including the PHS 398 checklist, three signed photocopies, and the CD appendices, and 2) a signed, typewritten original of the core research project or pilot study proposal, including the PHS 398 checklist, three signed photocopies, and the CD appendices.  The comprehensive Table of Contents should be the first page of the application packet.

 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

 

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Time on the application submission date described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

 

Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Health Promotion (CoCHP) Extramural Research Program Office (ERPO) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

 

5. Funding Restrictions

 

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.  Additional guidance can be found at HHS Grants Policy Statement.

 

Restrictions, which applicants must take into account while writing their budgets, are as follows:

 

·          Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place.

·          Reimbursement of pre-award costs is not allowed.


6. Other Submission Requirements

 

A complete application will contain the following two separate proposals prepared using the PHS 398:  1) a proposal for the center, and 2) a proposal for the core research project or pilot study.  Applicants should clearly indicate whether they are applying as a Category 1 or Category 2 institution.  (Note:  An institution may apply under only one category.)  Each proposal should address the other submission requirements listed for the center key elements and core research project or pilot study under the specific category.  The plan for the center and the core research project or pilot study should address activities that will be conducted over the entire project period.

 

Application Contents

 

Category 1:  Academic health centers with a comprehensive organizational infrastructure, strong community relationships, and plans in place with their community partners to conduct a core research project using CBPR.  

 

Center Key Elements for Category 1 Applications

 

A.  Infrastructure and Administration

Institutions should describe and/or provide evidence of the following infrastructure elements:

1.      An organizational chart illustrating the location of the PRC within the institution, including reporting lines and other participating schools and departments within the institution.  The organizational chart should reflect an appropriate leadership model and delegation of work activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center.

2.      A description of the PRC’s mission, goals, and health priorities and disparities that the PRC will address.

3.      Clear, detailed evidence of institutional commitment.  This may take the form of office space, personnel, equipment, other resources, return of indirect costs, additional funding, etc.

4.      A description of the qualifications of the PD/PI (PRC Director) and the planned percentage of time that they will devote to the PRC.  The PD/PI should be an established researcher with the leadership and institutional authority to direct the activities of the PRC.  The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing a research center, research in health promotion and disease prevention, funding history, and publications in peer-reviewed journals. 

5.      A staffing plan describing the PRC faculty and staff, their role and planned percent of effort.

6.      A multidisciplinary faculty with expertise that is complementary to the PRC’s mission and planned activities.  Faculty should have experience partnering with the community with which the core prevention research is conducted.

7.      Faculty and staff with demonstrated experience and expertise in conducting CBPR, statistical analysis, developing community partnerships, communicating and disseminating project materials to both scientific and lay audiences, implementing training programs, providing technical assistance and mentoring, and conducting evaluations.

8.      Evidence of on-going prevention projects and activities that are supported by other sources of funding.  Include source of funds, amount, and dates of funding.

9.      Evidence of financial support for the PD/PI and other appropriate PRC faculty and staff to participate in the semi-annual Directors’ meetings, one of which will take place during the annual PRC Program meeting.

 

B.  Community Engagement and Partnerships

Institutions should submit documentation that describes the partner community and provides evidence of experience in community engagement and establishing partnerships that includes:

1.      Expertise and experience in engaging in CBPR.

2.      A defined partner community which is, or includes, the community with which the research activities will occur (population size, geographic boundaries, racial and ethnic makeup, socioeconomic status, etc.).

3.      An existing community committee whose composition, role, and structure reflect the community with which the research will occur.  Include the community committee’s mission or purpose, role in center planning and activities, and communication procedures between the committee and PRC faculty and staff.  If there is more than one committee that will provide guidance or leadership to the PRC, provide this information for all committees.

4.      Community support for the center and buy-in to the proposed research activities as evidenced through specific, detailed letters of support from committee and community members and other key partners describing their planned involvement.

5.      A plan for obtaining community input into research, communication, training, and evaluation activities.

6.      Engagement with appropriate partners, including state and local health departments, education agencies, etc., at local, state, and federal levels as appropriate for research, communication, training, and evaluation activities.

7.      Identification of at least one community person from the community committee to be a member of the PRC Program’s National Community Committee.  Evidence of financial support for this person to participate in and travel to at least two appropriate activities and meetings should be included.

 

C.  Communication and Dissemination

Institutions should submit documentation that demonstrates expertise in communication and dissemination that includes:

  1. An infrastructure of resources and personnel to support communication and dissemination activities.  The faculty and staff within this structure need to demonstrate the ability to translate research activities and findings for different audiences.
  2. Ability to develop and maintain a PRC Website.
  3. A description of a focused and realistic center-wide communication plan that includes 5-year goals, objectives and activities that integrates communication activities into research, training, evaluation, and community activities.
  4. Demonstrated capacity and experience developing and disseminating materials to all stakeholders including communities, partners, and the scientific community.
  5. Evidence of experience communicating activities related to research projects through marketing materials and the media.

 

D.  Training

Institutions should submit documentation that demonstrates expertise in training, technical assistance, and mentoring that includes:

  1. Evidence of previous training, technical assistance, and mentoring of community partners who are involved in the core research project.
  2. Evidence of previous training, technical assistance, and mentoring for partners, practitioners, researchers, and students.
  3. A training, technical assistance, and mentoring plan that reflects the mission of the PRC and includes goals, objectives, and activities.  Include a description of how community partners will collaborate in training activities.
  4. A description of how training, technical assistance, and mentoring activities will be integral to CBPR and capacity building of the community and other partners.

 

E.  Evaluation

Institutions should submit documentation that demonstrates expertise in evaluation that includes:

  1. A logic model based on the national PRC Program logic model that is tailored to the PRC and clearly specifies inputs, activities, outputs, and outcomes.  Include a brief (2 page maximum) narrative description of the logic model.
  2. A description of a realistic and focused evaluation plan that is aligned with the logic model and describes the purpose of the evaluation.  The evaluation plan should include goals, objectives, and activities, a description of mechanisms for engaging stakeholders in evaluation activities, key local-level evaluation questions, and evaluation methods. 
  3. Ability to engage stakeholders in evaluation activities.
  4. An appropriate infrastructure to support all evaluation and monitoring activities.
  5. A description of how evaluation results are intended to be used.

 

Core Research Project for Category 1 Applications

 

Institutions funded under Category 1 are expected to conduct at least one a high quality core prevention research project using CBPR that bears an essential relationship to the PRC mission and the community, and efficiently uses center resources.  Category 1 applicants must show evidence of successful and timely implementation of a collaborative, CBPR project within the past five years. 

 

The research project plan should include the following information:

1.      Specific aims, including a description of the relationship of the research project to the center’s mission and health priorities, Healthy People 2010 focus areas, CDC public health research agenda, and the needs of the research community.  Include a specific description of the research community if it differs from the partner community. 

2.      Background and significance, including how the research furthers the fields of prevention research and public health.  Include evidence of community and partner support for, and endorsement of, the research topic, methods, and partnering community through letters of support.

3.      Evidence of community and partner input into identification of health priorities and disparities and a description of how they will be engaged throughout the research process.

4.      Preliminary Studies/Progress Report should include information on the project team’s experience in conducting research with the community in which the project will be implemented and experience in the research topic and methods

5.      A description of the study participants, including recruitment and retention strategies.

6.      Power calculations.

7.      Implementation timeline.

8.      Plans to report and disseminate research results and a description of community and partner involvement in planned dissemination.

 

Core Research Project Guidelines:

Category 1 applicants should implement a determinant (hypothesis testing research on causality of diseases and conditions), intervention (efficacy, effectiveness), or dissemination (translation, implementation, or evaluative) core research project that utilizes appropriate research designs such as quantitative (i.e., observation, quasi-experimental, or experimental), qualitative (i.e., ethnographic, focus groups, in-depth interviews), or mixed methods (e.g., combination of quantitative and qualitative).

 

Applicants that propose to conduct an intervention or dissemination core research project are encouraged, when appropriate, to identify or modify an existing evidence-based intervention for implementation within or dissemination to a different setting (e.g., community-based rather than clinic-based) or population.  The proposed intervention must be evidence-based in that it has undergone sufficient scientific evaluation to be proven efficacious or effective.  The applicant must provide evidence of efficacy or effectiveness of the intervention and justify the intervention’s relevance to the study population.  Evidence of effectiveness can be found in a variety of places, including:

§          Scientific evaluation in peer reviewed publication of 1) quantitative or qualitative research, 2) evaluation reports, 3) systematic reviews of literature, or 4) descriptive or survey research.

§          The CDC PRC Program website, The Guide to Community Preventive Services, Research Tested Intervention Programs (RTIPs), SAMHSA’s National Registry of Evidence-based Programs and Practices, Cochrane Public Health Group reviews and protocols, and The Guide to Clinical Preventive Services.

 

Applicants that propose to conduct an intervention or dissemination core research project may identify or modify an existing practice-based intervention for implementation within or dissemination to a different setting (e.g., community-based rather than clinic-based) or population.  The proposed intervention must be a practice-based strategy that has undergone sufficient implementation to be proven acceptable by the community, sustainable due to evidence of appropriate partnerships and available resources, and likely effective (i.e., intervention initiation precedes minimal positive effect and change over time). 

 

Applicants that propose a core research project to develop a new intervention need to provide a rationale for doing so and demonstrate that no applicable intervention exists.  The applicant needs to demonstrate that there is both a gap in the literature and a need for the intervention in the partner community.  The applicant needs to describe the design of the intervention and demonstrate that adoption of the intervention will be feasible for state or local agencies or community-based organizations in terms of cost and other practical limitations. 

 

Applicants that propose a core research project that is dissemination research need to demonstrate that there is evidence behind the intervention and that their results will include information and guidance for implementation of the intervention by other agencies, organizations, or communities.

 

Category 2:  Academic health centers that need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR.  

 

Center Key Elements for Category 2 Applications

 

A.  Infrastructure and Administration

Institutions should describe a plan to develop an infrastructure capable of supporting the activities of the PRC and its core research project.  Applicants should include:

1.      An organizational chart illustrating the location of the PRC within the institution, including reporting lines and other participating schools and departments within the institution. 

2.      A description of the PRCs mission, goals, and health priorities and disparities that the PRC will address.

3.      Clear, detailed evidence of institutional commitment.  This may take the form of office space, personnel, equipment, other resources, return of indirect costs, additional funding, etc.

4.      A description of the qualifications of the PD/PI (PRC Director) and the planned percentage of time that they will devote to the PRC.  The PD/PI should be an established researcher with the leadership and institutional authority to direct the activities of the PRC.  The qualifications of the PD/PI should be documented in the form of previous experience developing and/or directing a research center, research in health promotion and disease prevention, funding history, and publications in peer-reviewed journals. 

5.      A staffing plan describing the PRC faculty and staff, their role and planned percent of effort.

  1. Access to multidisciplinary faculty familiar with the community with which the PRC plans to work.
  2. Access to faculty and staff with experience conducting CBPR, developing community partnerships, and communicating and disseminating prevention research materials to both scientific and lay communities.
  3. Evidence of ongoing prevention projects and activities currently supported by other sources of funding.  Include source of funds, amount, and dates of funding.
  4. Evidence of financial support for the PD/PI and other appropriate PRC faculty and staff to participate in the semi-annual Directors’ meetings, one of which will take place during the annual PRC Program meeting.

 

B.  Community Engagement and Partnerships

Institutions should provide evidence of their capacity to engage communities and partners in research activities and describe a plan to develop relationships with a community and appropriate partners.  Applicants should include:

  1. Evidence of expertise and experience in CBPR.
  2. A defined partner community which is, or includes, the community with which the research activities will occur (population size, geographic boundaries, racial and ethnic makeup, socioeconomic status, etc.).
  3. Evidence of expertise in developing community relationships to develop and move research projects forward in a timely way.
  4. A mechanism for community input into research, communication, training, and evaluation activities.
  5. A description of an existing community committee, or how a community committee will be developed, who will be approached to be part of the committee, and a plan to develop community committee guidelines.
  6. Evidence of demonstrated partnerships and collaborations, or a plan to build partnerships and collaborations with appropriate local, state, and federal government agencies, health departments, non-governmental organizations, or for-profit sector companies.
  7. Letters of support from community members and appropriate partners.
  8. A plan to identify at least one community committee member to be a member of the PRC Program’s National Community Committee, and evidence of financial support for this person to travel to and participate in at least two appropriate activities and meetings.

 

C.  Communication and Dissemination

Institutions should submit documentation that demonstrates previous experience and expertise in communication that includes:

  1. Skill in communicating with communities and partners.
  2. Ability and experience in developing a communication plan.
  3. Ability to develop and maintain a PRC Website.
  4. Capacity and experience disseminating materials to appropriate stakeholders including communities, partners, and the scientific community.
  5. Experience communicating activities related to research projects through marketing materials and working with the media.

 

D.  Training

Institutions should submit documentation that demonstrates expertise in training, technical assistance, and mentoring that includes:

1.  Previous experience in and evidence of skill in providing training, technical assistance, and mentoring to community members, partners, practitioners, researchers, and students.

2.  A description of how training, technical assistance, and mentoring activities will be integral to CBPR and capacity-building of the community and other partners.

 

E.  Evaluation

Institutions should submit an evaluation plan that includes:

  1. A logic model based on the national PRC Program logic model that is tailored to the PRC and clearly specifies inputs, activities, outputs, and outcomes.  Include a brief (2 page maximum) narrative description of the logic model.
  2. Evidence of access to evaluation expertise.
  3. A description of a realistic and focused evaluation plan that is aligned with the logic model and assesses progress in the development of the infrastructure, community and partner relations, and the pilot research study.
  4. A description of how evaluation results are intended to be used. 

 

Core Research Project for Category 2 Applications

 

Category 2 PRCs are expected to develop and implement a pilot study using CBPR.  Institutions should submit documentation that includes:

  1. Significance of and need for the proposed pilot study within the research community and how it supports the mission and priorities of the center.  Include Healthy People 2010 focus areas addressed by the pilot study and how it supports the CDC research agenda.
  2. A description of the research community if it differs from the partner community. 
  3. Evidence of skill and expertise in developing a research project that used CBPR.
  4. A description of how the community and partners will be engaged to develop and implement the research project.  Letters of support from community members and appropriate partners should be provided.
  5. Demonstrated successful and timely implementation of a collaborative CBPR project within the past five years.
  6. Demonstrated past performance disseminating results from a CBPR project in the peer-reviewed literature. 
  7. Implementation timeline
  8. Plans to report and disseminate research results and describe community and partner involvement in planned dissemination.

 

Research Project Guidelines:

Category 2 applicants should describe resources available to develop and implement a pilot research study that will form the basis for a determinant (hypothesis testing research on causality of diseases and conditions), intervention (efficacy, effectiveness), or dissemination (translation, implementation, or evaluative) research project utilizing appropriate research designs such as quantitative (i.e., observation, quasi-experimental, or experimental), qualitative (i.e., ethnographic, focus groups, in-depth interviews), or mixed methods (e.g., combination of quantitative and qualitative).

 

Other Submission Requirements for Applicants that were funded under PA04-003

 

Academic health centers funded under PA04-003 should include a report on their accomplishments and achievements from the previous funding period.  Evidence should be provided that the center has enabled efficient and timely implementation and dissemination of high caliber prevention research that is consistent with the mission of the PRC Program.  The report should include information on previous specific aims, progress made on each specific aim, collaborations, innovative work, and highlight important research findings.  Relevant publications and other products produced in the previous funding period should be listed and included.

 

In the center application, previously funded PRCs should describe how they have served as a local, state, or national resource to the field and address how they will continue to do so.

 

Appendix Instructions

 

Appendix instructions, material, and limits apply to the two proposals separately; each proposal appendix (center and core research) must follow PHS 398 guidelines.

 

Ten CDs will be submitted in the same package with the application; five identical CDs containing all appendix material must be submitted for the center proposal and five identical CDs containing all appendix material must be submitted for the core research project or pilot study proposal.  When preparing CDs:

·          Use PDF format. Where possible, applicants should avoid creating PDF files from scanned documents. CDC recommends producing the documents electronically using text or work-processing software and then converting to PDF. Scanned documents are generally of poor quality and difficult to read.

·          Label each disk with the PD/PI name and application title.

·          If burning CD-ROM disks on a Mac, select the ISO 9660 format.

·          Do not use compression techniques for the electronic files.

·          Do not use password protection, encryption, digital signature and/or digital certification in the PDF files.

 

A summary listing all of the items included in the appendix is encouraged, but not required. When including a summary, it should be the first file on the CD. Applications that do not follow the appendix requirements may be delayed in the review process.

 

The following materials may be included in the appendix:

·          Up to 3 publications of the following types.  In each case include the entire document:

o         Manuscripts and/or abstracts accepted for publication but not yet published.

o         Published manuscripts and/or abstracts where a free, online, publicly available journal link is not available.

o         Patents directly relevant to the project.

            Do not include unpublished theses or abstracts/manuscripts submitted, but not yet accepted, for publication.

·          Surveys, questionnaires, and other data collection instruments, clinical protocols, and informed consent documents.

 

Applicants are encouraged to be as concise as possible and submit only information essential for the review of the application.

 

Publications that are publicly accessible must not be included in the appendix. For such publications, the URL or PMC submission identification numbers along with the full reference should be included as appropriate in the Bibliography and References Cited/Progress Report Publication List section of the Research Plan, and/or in the Biographical Sketch.

 

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review the specific FOA for any additional program-specific guidance on Appendix material and other application requirements.

 

Awardees upon acceptance of Notice of Award (NoA), 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.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.

 

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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions 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.

 

All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 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

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc).  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The
adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications.  The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).  See Section VI.3. Reporting.


Section V. Application Review Information


 

1. Criteria
 

Only the review criteria described below will be considered in the review process:

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

·         Availability of funds

·         Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services

·         Equitable geographical distribution of the centers among areas containing a wide range of population groups which exhibit incidence of diseases which are most amenable to preventive intervention, as specified in PL 98-551

·         Proposals that demonstrate a focus on underserved populations or those with a disproportionally high burden of morbidity and mortality

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the CoCHP ERPO in accordance with the review criteria stated in this section.

As part of the initial merit review, all 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 that consists of;

o         A separate evaluation of the center and its key elements

o         A separate evaluation of the core research project or pilot study

o         An overall application score that will be the average of the scores of the center proposal and core research project or pilot study proposal

·          Receive a second level of review by HHS/CDC CoCHP.

 

Applications submitted in response to this FOA will compete for available funds with all other eligible applications. 

 

See Section IX. Application Evaluation Criteria for the specific review criteria that will be used to evaluate the scientific and technical merit of applications submitted in response to this FOA. 

In order to allow for the differential expectations and activities of the two categories of institutions, different criteria will be used to review and evaluate Category 1 and Category 2 applications.  The two components within each category, center key elements and the core research activities, will be reviewed and evaluated separately.  An application will receive one single numerical score that reflects the overall evaluation of the center, its key elements and the core research activities. 

 

2.A. Additional Review Criteria

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

 

Protection of Human Subjects from Research Risk:  When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research [see the Research Plan, Section II on Human Subjects in the PHS 398 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm].  Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

 

Inclusion of Women and Minorities in Research:  Does the application adequately address the HHS/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. 

 

See Section IX. Application Evaluation Criteria for the additional review criteria that will be used in the review of applications submitted in response to this FOA.

 

2.B. Additional Review Considerations

Budget and Period of Support:  The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

 

See Section IX. Application Evaluation Criteria for the additional review considerations that will be used in the review of applications submitted in response to this FOA.


2.C. Sharing Research Data

 

Data Sharing Plan:  HHS/CDC will assess the reasonableness of the data sharing plan; 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. 


2.D. Sharing Research Resources

HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan on sharing research resources.

Program staff will be responsible for the administrative review of the plan for sharing research resources.


The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

 

It is anticipated that awards will be announced in February 2009.  The award start date is September 30, 2009.

 

Section VI. Award Administration Information


 

1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.


HHS/CDC will contact t
hose applicants under consideration for funding for additional information.

 

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document 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 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. Additional requirements are available Section VIII. Other Information of this document or on the HHS/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.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.


2.A. Cooperative Agreement

 

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (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/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U48 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and 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 HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities


The Recipient will have the primary responsibility for the following:

 

  1. Scientific, technical, or programmatic aspects of the cooperative agreement and for day-to-day management of the center and core research activities.
  2. Communicating with the PRC Program office and the CoCHP ERPO and providing them with timely updates on PRC activities.
  3. Participating in monitoring activities by completing an annual work plan (that includes 5-year goals, 1-year SMART objectives, and 1-year activities) and progress report through the PRC Information System, participating in conference calls with the project officer, and preparing for site visits.
  4. Participating in national evaluation activities by entering data related to the national indicators on an annual basis and participating in other national evaluation activities.
  5. Participating in the semi-annual Directors’ meetings, one of which will take place during the annual PRC Program meeting.
  6. Providing representatives to serve on the standing committees.
  7. Providing and documenting appropriate human subjects protections and obtaining necessary IRB approvals and consent forms.

 

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities


An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

 

1.      Convening semi-annual meetings of the PRC Directors (one of which will take place during the annual PRC Program meeting) to facilitate research collaboration and information sharing.

2.      Conducting on-site visits of PRCs to provide consultation and technical support and help recipients meet program objectives and cooperative agreement requirements.

3.      Providing consultation and other technical assistance to help recipient use the PRC Information System for developing work plans and progress reports.

4.      Providing consultation and other technical assistance to help recipient use the PRC national evaluation data collection system for recording PRC inputs, activities, outputs, and outcomes.

5.      Collecting, organizing, and disseminating information on PRC research projects.

6.      Serving as a scientific and professional resource for the PRCs’ standing committees.

7.      Informing recipients about the laws and regulations pertaining to human subjects research and conduct inquiries concerning allegations of scientific misconduct.

8.      Evaluating and monitoring recipients’ progress toward meeting program objectives and goals.


Additionally, an HHS/CDC agency program official or Scientific Program Officer (SPO) will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.  The CoCHP ERPO will appoint a SPO who will:

 

1.      Carry out continuous review of all activities to ensure objectives are being met;

2.      Attend committee meetings and participate in conference calls for the purposes of assessing overall progress and for program evaluation purposes;

3.      Provide scientific consultation and technical assistance in the conduct of the project; and

4.      Conduct site visits to determine the adequacy of the research and to monitor performance against approved project objectives.


2.A.3. Collaborative Responsibilities

 

The PRC program functions as a consortium of partners.  Representatives from the PRC’s academic and community partners and CDC’s PRC Program office will serve on standing committees that will provide recommendations to the PRCs on standards and policies and make recommendations for research and other activities.  Following are the standing committees responsible for guiding the PRC Program throughout the project period:

 

  1. Program Committee – plans and organizes an annual PRC Program Meeting with the assistance of the program office.
  2. Research Committee – convenes meetings of senior research staff to discuss evolving principles and methods of prevention research and to assess the program’s research agenda in light of new developments.
  3. Policy Committee – serves as liaison to many of the program’s national partners, such as the Association of Schools of Public Health, and helps coordinate efforts to keep policymakers informed about prevention research.
  4. Communications and Dissemination Committee – assists the program office in defining communication and dissemination standards and strategies and creates working groups for the design and development of communication products.
  5. National Community Committee – comprised of representatives from each PRC’s Community Committee and makes recommendations about how the community committees can share information and better serve the individual research centers as well as the national program.
  6. Evaluation Committee – brings together PRC staff and partners interested in evaluation to discuss topics such as identifying technical assistance needs and ideas for addressing them; advising the PRC Program office on evaluation and monitoring issues; and suggesting mechanisms for sharing across PRCs.

 

The PRC Steering Committee will serve as an executive committee to the CDC Program office.  It will be comprised of the chairpersons of the six standing committees as well as an overall leader elected from one of the PRCs.

 

3. Reporting

 

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

 

1.      Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

2.      An annual work plan (that includes 5-year goals, 1-year SMART objectives, and 1-year activities) and progress report through the PRC Information System.

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.

 

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.

 

Although the financial plans of the HHS/CDC CIO 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


 

HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants.  Inquiries can fall into three areas – scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

 

Beth Patterson, M.Ed.

Extramural Research Program Office
Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341

Telephone: (770) 488-8390
Email:  BPatterson@cdc.gov


2. Peer Review Contacts:

 

Juliana Cyril, PhD, MPH

Scientific Review Service

Office of Public Health Research
Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
1600 Clifton Road NE, MS D-72

Atlanta, GA  30333
Telephone: (404) 639-4639
Email:  JCyril@cdc.gov


3. Financial or Grants Management Contacts:

 

Lucy Picciolo
Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
2920 Brandywine Road, Room 3000
Atlanta, GA  30341
Telephone: (770) 488-2777
Email:  LPicciolo@cdc.gov

 

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Telephone:  (770) 488-2700

Email: PGOTIM@cdc.gov

 

Section VIII. Other Information


 

Required Federal Citations

 

Human Subjects Protection
Federal regulations (45 CFR Part 46) 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 HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  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.

 

Inclusion of Persons Under the Age of 21 in Research
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

 

Smoke-Free Workplace Requirements

HHS/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 FOA is related to one or more of the priority areas.  Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov.

 

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 HHS/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, HHS/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 HHS/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 HHS/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 HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

 

Prohibition on Use of HHS/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, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/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.

 

Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

 

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.


Security Clearance Requirement

All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

 

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity 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 (ORI) (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.

 

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.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/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 HHS/CDC data sharing agreement will be released as follows:

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

d.      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) http://www.cdc.gov/od/foia/index.htm.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide HHS/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.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.      Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.      Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

 

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

 

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.

 

Section IX. Application Evaluation Criteria


 

In order to allow for the differential expectations and activities of the two categories of institutions, different criteria will be used to review and evaluate Category 1 and Category 2 applications.  The two components within each category, center key elements and the core research activities, will be reviewed and evaluated separately.  An application will receive one single numerical score that reflects the overall evaluation of the center, its key elements and the core research activities. 

 

 In addition, applications will be reviewed for protection of human subjects from research risk and inclusion of women and minorities in research.  The appropriateness of the budget will be discussed, but will not affect the priority score.  

 

Note that an 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.

 

1. Category 1

 

Category 1 academic health centers must have a comprehensive organizational infrastructure, strong community relationships and plans in place with their community partners to conduct a core research project using CBPR.

 

1.A. Center Review Criteria – Key Elements

 

Significance:  Does the proposed center have the potential to significantly impact public health programs, prevention research, and other relevant fields at the academic health center?  Does the applicant describe the health priority and health disparity needs within their partner community and do these needs align with the PRC’s mission and goals? 

 

Approach:  Does the applicant describe anticipated challenges to implementation of CBPR and propose solutions to address those challenges?  Is there evidence of community and partner input into identification of health priorities and health disparities?

 

Innovation:  Are novel approaches, methods, technologies, etc. proposed that could facilitate the dissemination and/or translation of effective public health programs at the state and community levels and to both lay and scientific audiences?

 

Investigators:  Is the PD/PI an established researcher with the leadership and institutional and decision-making authority to direct the activities of the PRC?  Is the PD/PI’s commitment of time and effort sufficient to direct the scientific, administrative, budgetary, and operational aspects of the center?  Is there a multidisciplinary faculty with experience in CBPR and partnering with communities?  Does the faculty and staff have demonstrated experience and expertise in conducting CBPR, statistical analysis, developing community partnerships, communicating and disseminating project materials, implementing training programs, and conducting evaluations?

 

Environment:  Does the organizational chart reflect an appropriate leadership model and delegation of activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center?  Is the institutional commitment sufficient?  Has the institution been successful in attracting additional sources of funding and leveraging resources for prevention research?

 

Community Engagement and Partnerships:  Is there a defined partner community which is, or includes, the community with which the research activities will occur?  Is there evidence of the communities input into the PRC’s mission and goals?  Is there an existing community committee, appropriate representation from the community and appropriate partners on the committee, and the existence of or plans to develop committee guidelines?  Is there adequate evidence of community support for the center from committee members, community members, and other key program partners?  Does the applicant describe appropriate mechanisms for community input into research, communication, training, and evaluation activities?  Will appropriate partners be engaged in key activities and the core research project and are the roles of the partners and the community committee in the activities clearly described?  Are the partnerships maintained throughout the project period?

 

Communication and Dissemination:  Is the communication plan integrated into research, training, evaluation, and community activities and appropriate and feasible for communicating with the community and partners?  Does the applicant have the capacity and experience to disseminate materials to appropriate stakeholders including communities, partners, and the scientific community?  Does the staff have experience communicating activities related to research projects through websites, marketing materials, and the media?

 

Training, Technical Assistance, and Mentoring:  Is there an appropriate level of experience in training, technical assistance, and mentoring for community, partners, practitioners, researchers, and students?  Do the goals, objectives, activities, and partner collaborations of the training, technical assistance and mentoring plan reflect and support the mission of the PRC?  Are the training, technical assistance, and mentoring activities integrated in CBPR and will they contribute to building the capacity of the community and other partners?

 

Evaluation:  Is the logic model tailored to the PRC with clearly articulated inputs, activities, outputs, and outcomes?  Is the evaluation plan realistic and focused and aligned with the PRC logic model? Does it clearly describe the purpose of the evaluation, mechanisms for engaging stakeholders in evaluation activities, key local-level evaluation questions, and evaluation methods?  Is there evidence of an appropriate infrastructure to support proposed evaluation and monitoring activities?  Does it describe how the evaluation results will be used?


Applicable to academic health centers funded under PA04-003:  During the previous funding period, was the center successful in developing and maintaining community engagement and partner relationships, communicating activities and disseminating materials, implementing training, technical assistance and mentoring activities, and conducting evaluation activities?  Did the center serve as a resource to the field by developing and sharing data, methodologies and findings in the areas of prevention research, CBPR, and/or working within a specific community?

 

1.B. Core Research Project Review Criteria

 

Significance: Does this study address an important problem in prevention research? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventive interventions that drive this field?

 

Does the applicant adequately describe the significance of the proposed core research project?  Does the applicant adequately describe their core research community, the relevance of the core research project to that community, and the potential impact of the research on the community?  Does it address the health needs within their proposed community and/or address a gap in the literature? 

 

Approach: Are the conceptual or clinical framework, design, methods, implementation, timeline 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 proposed core research project include a determinant, intervention, or dissemination study that utilizes appropriate research designs?  Does the core research project appropriately incorporate CBPR?  Are there appropriate plans to report and disseminate research results? 

 

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?

 

Does the proposed core research project present a novel approach or methods to CBPR?  If the core research project is an intervention study, does the applicant clearly and appropriately justify the selection of an existing intervention or the development of a new intervention?

 

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?

 

Is there evidence that the applicant has partnered with the community with which the core prevention research will be conducted?  Has the research team been successful in implementing a CBPR project within the past five years?   Does the research team provide evidence of ongoing prevention research activities supported by other sources of funding?

 

Environment: Does the scientific environment in which the applicant will do the work 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 community support and buy-in for the core research project from the community committee, key program partners, and the community with which the project will be implemented?

 

Applicable to academic health centers funded under PA04-003:  During the previous funding period, was the center successful in conducting a CBPR project in a timely manner that provided new knowledge and impacted the field of prevention research for an underserved community? 

 

2. Category 2

 

Category 2 academic health centers need to develop infrastructure or community relationships in order to develop and implement a core pilot study using CBPR

 

2.A. Center Review Criteria – Key Elements

 

Significance:  Does the proposed center have the potential to significantly impact public health programs, prevention research, and other relevant fields at the academic health center?  Does the applicant adequately describe the health needs within their proposed community and how a pilot study will both impact those needs and support the mission and priorities of their center?  Does the applicant adequately describe the significance of community and partnership development?

 

Approach:  Is there evidence of community and partner input into identification of health priorities and health disparities? Does the applicant demonstrate skill and expertise developing and implementing a CBPR project in a timely manner and disseminating results in the peer-reviewed literature?

 

Investigators:  Is the PD/PI an established researcher with the leadership and institutional and decision-making authority to direct the activities of the PRC?  Is the PD/PI’s commitment of time and effort sufficient to direct the scientific, administrative, budgetary, and operational aspects of the center?  Is there access to multidisciplinary faculty familiar with the community with which the PRC plans to work? Is there access to faculty and staff with experience conducting CBPR research, developing community partnerships, and communicating and disseminating prevention research materials to both scientific and lay communities?

 

Environment:  Does the organizational chart reflect an appropriate leadership model and delegation of work activities to ensure accountability of all faculty and staff and the integration of activities into a coherent program or research center?  Will the organizational structure effectively promote multi- and cross-discipline collaborations?  Is the institutional commitment sufficient?  Will the environment support long-range planning and implementation of PRC key element activities in communication and dissemination, training, and evaluation? 

 

Community Engagement and Partnerships Is there a clear description of the community with which they plan to work?  Does the applicant have experience in engaging in CBPR?  Is there evidence of experience in developing community relationships that includes the successful and timely implementation of research projects within the community?  Is there an existing community committee or a proposal of how a community committee will be developed and plans to develop guidelines for this committee?  Is there evidence of demonstrated partnerships and collaborations, or a plan to build partnerships and collaborations with appropriate local, state, and federal government agencies, non-governmental organizations, or for-profit sector companies?  Will the level of support from community members and appropriate partners be adequate for the successful development of the center?

 

Communication and Dissemination:  Is there evidence of adequate previous experience in communicating with communities and partners?  Do they have the ability to develop a communication plan that will include the development and maintenance of a program website?  Does the applicant have the capacity and experience to disseminate materials to appropriate stakeholders including communities, partners, and the scientific community?  Does the staff have experience communicating activities related to research projects through marketing materials and the media?

 

Training, Technical Assistance, and Mentoring:  Is there evidence of skill in providing training, technical assistance, and mentoring for community members, partners, practitioners, researchers, and students?  Does the applicant describe how training, technical assistance, and mentoring activities will be integrated into CBPR and how they contribute to building the capacity of the community and other partners?

 

Evaluation:  Is the proposed logic model based on the PRC national logic model, tailored to the PRC, and have clear, specific inputs, activities, outputs, and outcomes?  Will the staff have access to experts in evaluation?  Is the evaluation plan/process realistic and focused?  Does it tie to the logic model and assess progress in the development of the infrastructure, community and partner relations, and the core pilot research project? Does it describe how the evaluation results will be used?

 

2.B. Core Research Project Review Criteria

 

Significance: Does this study address an important problem in prevention research? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventive interventions that drive this field?

 

Are the health needs within the proposed core research community adequately described? 

 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the pilot study? Does the applicant acknowledge potential problem areas and consider alternative tactics?

 

Does the proposed core pilot study form the basis for a determinant, intervention, or dissemination study that utilizes appropriate research designs?  Does the proposed core pilot study utilize a multidisciplinary approach?  Is the timeline reasonable and achievable?

 

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?

 

What is the likelihood that the proposed pilot study will contribute to the development of multidisciplinary programs and additional research endeavors?

 

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?

 

Has the research team successfully implemented and disseminated the results of a CBPR project within the past five years?

 

Environment: Does the scientific environment in which the applicant will do the work 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?

 

Will the proposed study actively engage community and partners in the development and implementation of the research project?

 


CDC Home Page: http://www.cdc.gov

CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm  

CDC Forms Web Page: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm