Part I Overview Information


United States Department of Health and Human Services (HHS)

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

Components of Participating Organizations
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: Special Interest Project Competitive Supplements (U48)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may 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 applicants will be directed elsewhere for that information.

Authority:  Awards are made under the authorization of Public Health Service Act, Section 1706, 42 U.S.C. 300u-5, as amended; Section 2(d), Public Law 98-551.   

Announcement Type:  
This is a supplement to Program Announcement 04003 which was released on March 27, 2003.

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number:  RFA-DP-07-002

Catalog of Federal Domestic Assistance Number(s):  
93.135

Key Dates
Release/Posted Date:  February 28, 2007
Letter of Intent Receipt Date:  March 19, 2007
Application Submission Receipt Date:  April 17, 2007
Peer Review Date:  June 2007
Secondary Review Date:  Week of July 9, 2007
Earliest Anticipated Start Date:  September 30, 2007
Expiration Date:  April 18, 2007

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

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(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        B. Eligible Investigators
    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(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)
    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

IX. Special Interest Projects (SIP) Descriptions

1.    Title
2.    Project Description and Objectives
3.    Project Activities
4.    Additional Review Criteria and Funding Preferences
5.    Project Proposal Length and Supporting Material
6.    Availability of Funds
7.    Research Status
8.    Award Administration
9.    References

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 RFA addresses “Healthy People 2010” priority areas of cancer, nutrition and overweight, physical fitness and activity, disability and secondary conditions, and public health infrastructure and is in alignment with NCCDPHP performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions.  For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

This program also addresses the department-wide initiative, Steps to a HealthierUS, which advances the HealthierUS goal of helping Americans live longer, better and healthier lives by focusing on the importance of prevention.  The Steps initiative envisions a healthy, strong U.S. population supported by a health care system in which diseases are prevented when possible, controlled when necessary, and treated when appropriate.  This funding opportunity supports the Steps focus areas of obesity and physical fitness.

Nature of the Research Opportunity

This RFA builds upon the infrastructure of the Prevention Research Centers (PRC) program and solicits applications in the form of cooperative agreements to support supplemental health promotion and disease prevention research projects that: 1) focus on the major causes of death and disability; 2) improve public health practice within communities; and 3) cultivate effective state and local public health programs.  CDC will use the FY07 Special Interest Projects (SIP) mechanism to provide supplemental funding to PRCs to design, test, and disseminate effective prevention research strategies in the areas of cancer, epilepsy, adolescent health, nutrition, and physical activity.

Background

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 research findings 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.

In 1984 Congress authorized HHS to create a network of academic health centers to conduct applied public health research.  CDC was selected to administer the PRC program and to provide leadership, technical assistance, and oversight.  Today, the PRCs comprise a national network of 33 academic-based research centers that are committed to community-based participatory research and to the translation of research into programs and policies.  The PRC infrastructure and their various research projects are supported by CDC and guided by community committees.  The consortium of academic, public health, and community partners engages in community-based prevention research, research translation, and education to address the leading causes of death and disability.  The combined research portfolio for the 33 PRCs includes nearly 500 projects across the country.

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.  Typically, SIPs are funded for a minimum of one year and $100,000; however, there are many SIPs that are multi-year endeavors to which several million dollars are dedicated.  The SIP mechanism is designed to maximize the expertise and resources offered by each center and the PRC network as a whole.

Scientific Knowledge to be achieved through this Funding Opportunity

This RFA is expected to fund research that will expand our knowledge and understanding in the areas of cancer, epilepsy, adolescent health, nutrition, and physical activity.  Each SIP has specific activities and anticipated outcomes.  Section IX. Special Interest Projects (SIP) Descriptions of this announcement lists each SIP and provides a complete description of the project.   

            Cancer                                          Special Interest Projects   1-4

            Epilepsy                                        Special Interest Projects   5-6

            Adolescent Health                          Special Interest Project       7

            Nutrition                                        Special Interest Project       8

            Physical Activity                            Special Interest Projects   9-11                     

Experimental Approach and Research Objectives

The research objectives of the SIPs are in alignment with the following performance goal for NCCDPHP:  To support prevention research to develop sustainable and transferable community-based behavioral interventions.  The experimental approach and research objectives for each SIP are detailed in Section IX. Special Interest Projects (SIP) Descriptions of this announcement.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the 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 $2,390,000 in FY07 to fund approximately 15 cooperative agreements ranging in total costs, direct and indirect, from $60,000, to $550,000 in response to this FOA.  Because the nature and scope of the proposed research will vary by SIP, and from application to application, it is anticipated that the funding amount and duration of each award will vary.   

The anticipated start date for each SIP is September 30, 2007.  The project period will vary by SIP and is detailed in Section IX. Special Interest Projects (SIP) Description of this announcement.  Following is a list of the SIPs with the project period and total funding amount (direct and indirect) for the first 12-month budget period:

Cancer

SIP 1:  General Practitioners’ Ovarian Cancer Screening and Testing Practices and Awareness of Published Guidelines (2-years, $350,000)         

SIP 2:  Assessing the Needs of Ovarian Cancer Caregivers (2-years, $210,000)

SIP 3:  Intervention to Increase Screening for Cervical Cancer in Women of Mexican Descent - Phase 3 (2-years, $550,000)

SIP 4:  Impact of Cultural and Socioeconomic Factors on Post-treatment Surveillance among African Americans with Colorectal Cancer (2-years, $250,000)

Epilepsy

SIP 5:  Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-management Intervention Research -- Coordinating Center (2-years, $150,000)

SIP 6:  Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-management Intervention Research -- Collaborating Center (2-years, $280,000 to fund four projects at $70,000 each)

Adolescent Health

SIP 7:  Urban Stressors and Problem Behaviors among Adolescents in High Risk Urban Environments (2-years, $100,000)

Nutrition

SIP 8:  Understanding Motivators and Barriers for Changing Sugar-sweetened Beverage Intake in the Home Environment of Overweight Youth (2-years, $150,000)

Physical Activity

SIP 9:  Expansion of the Physical Activity Policy Research Network (PAPRN) – Coordinating Center (2-years, $130,000)

SIP 10:  Expansion of the Physical Activity Policy Research Network (PAPRN) – Collaborating Center (2-years, $120,000 to fund two projects at $60,000 each)

SIP 11: Implementation and Evaluation of Interventions in the Built Environment to Improve Public Health (2-years, $100,000)

All estimated funding amounts are subject to availability of funds.

CDC will accept and review applications with budgets greater than the ceiling amount.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Only applicants who have applied for and have been selected as PRCs under CDC Program Announcement 04003 are eligible to compete for the SIP supplemental funding.  Competition is limited to PRCs funded under PA 04003 because they are uniquely positioned to perform, oversee, and coordinate community-based participatory research that promotes the field of prevention research due to their established relationships with community partners.  The supplemental projects in this RFA complement ongoing prevention research projects being conducted as part of the CDC Prevention Research Program.  

1. B. Eligible Investigators

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

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: HHS GPS

3. Other-Special Eligibility Criteria

A PRC may apply for multiple SIPs; however, a separate application must be submitted for each SIP.  A PRC may submit only one application per SIP.

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

Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA); although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U48 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

3. A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date:  March 19, 2007
Application Submission Receipt Date:  April 17, 2007
Peer Review Date:  June 2007
Secondary Review Date:  Week of July 9, 2007
Earliest Anticipated Start Date:  September 30, 2007

3.A.1. Letter of Intent

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

Although a letter of intent 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 review workload and plan the review.

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

The letter of intent should be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and 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
FAX:   (770) 488-8046
Email: bjc4@cdc.gov

3. B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application. 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard 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. 

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.

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.

If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

Technical Information Management Section – DP07-002

CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Phone:  (770) 488-2700

3. C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) 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.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness and responsiveness by NCCDPHP and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.  

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.

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

6. Other Submission Requirements

The application must clearly indicate which SIP you are applying for.  Please refer to the individual SIP description in Section IX. Special Interest Projects (SIP) Descriptions of this announcement.  

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. 

Applicantsresearch plan(s) should address activities they will conduct over the entire project period.

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a. PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  If your research plan exceeds the page limitation specified in Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Project Proposal Length and Supporting Material of the SIP description, your application may be considered unresponsive and ineligible for review.

The following materials may be included in the Appendix: Publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

Do not to 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 specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.  Please refer to Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Project Proposal Length and Supporting Material of the SIP description.

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 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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

Sharing Research Resources  

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://grants.nih.gov/grants/policy/gps/8postnew.htm#phs).  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:

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 NCCDPHP in accordance with the review criteria stated below.

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

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness.  In their written comments, reviewers evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  Each of the following criteria will be addressed by the reviewers and considered in their assignment of the overall score, weighting them as appropriate for each application. 

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.

Significance: Does this study address an important problem? 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 preventative interventions that drive this field?

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

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?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

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?

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:

Individual SIP Preferences:  Does the applicant adequately address the additional review criteria detailed in the SIP they are applying for?  Please refer to Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Additional Review Criteria and Funding Preferences of the SIP description for any additional review criteria that may apply to an individual SIP.  

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 2, item 8 on Human Subjects in the SF424 (R&R)] 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 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). 

Care and Use of Vertebrate Animals in Research:
If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R).   Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

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 effect the priority score.

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.

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

HHS/CDC expects to announce awards in September 2007.

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 those 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 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 dominant role and primary responsibility for the project.

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 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.  Each SIP lists specific HHS/CDC responsibilities.  Please refer to Section IX. Special Interest Projects (SIP) Descriptions of the announcement under Award Administration of the individual SIP description.   

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

2. A.3. Collaborative Responsibilities

Each SIP has specific collaborative responsibilities.  Please refer to Section IX. Special Interest Projects (SIP) Descriptions of the announcement under Award Administration of the individual SIP description.   

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

3.      Final financial and performance reports, no more than 90 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:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and 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: bjc4@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.

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at 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.

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

Smoke-Free Workplace Requirements
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 http://www.health.gov/healthypeople.

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

In addition no part of 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.

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.

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 (HHS) 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 HHS 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:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with CDC policy on Releasing and Sharing Data.

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

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide 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. 

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. Special Interest Project (SIP) Descriptions


Cancer

SIP 1:  General Practitioners’ Ovarian Cancer Screening and Testing Practices and Awareness of Published Guidelines

Project Description and Objectives: The purpose of this project is to evaluate physicians’ self-reported ovarian cancer screening and testing practices, determine physician awareness of the published guidelines regarding the lack of evidence for routine ovarian cancer screening, and assess physicians’ adherence to published guidelines on ovarian cancer screening among a nationally representative sample of practicing primary care physicians and gynecologists.

Numerous medical organizations, advocacy groups, and governmental organizations have developed cancer screening guidelines including the U.S Preventive Services Task Force (USPSTF), the American Cancer Society (ACS), the American College of Obstetricians and Gynecologist (ACOG), the American College of Physicians-American Society of Internal Medicine (ACP-ASIM), and the Canadian Task Force on Preventative Health. These various organizations have generally achieved consensus on many screening guidelines such as breast, cervical, and colorectal cancer; however, they often have a broad, sometimes conflicting set of recommendations for other cancer sites.1  Among the organizations making statements about ovarian cancer screening, they generally agree that there is not enough evidence to recommend routine screening with the currently available procedures (transvaginal ultrasound, cancer antigen (CA) -125, pelvic examinations, or various combinations of the three). However, there currently is some variation among the different groups especially with regard to certain high-risk populations who often present a challenge to physicians making clinical decisions.1

Despite the strong governmental and private support to publish and disseminate the various evidence-based cancer screening recommendations, several studies show that primary care physicians do not always comply with them.2-6  More specifically, anecdotal evidence and some small descriptive cross-sectional studies have suggested that patients may be screened for ovarian cancer more frequently than the evidence-based guidelines recommend.7,8  Besides the often fragmented recommendations by the various organizations, other physician-related factors for non-compliance include forgetfulness, disagreement with recommendations, perceptions of guidelines, clinical practice experience, and influence of colleagues.4,9  Additionally, determinants of cancer screening decision-making with regard to conflicting or unclear guidelines include patient factors such as anxiety, expectations and family history.9

Lastly, most of the existing body of literature has focused on the determinants of cancer screening decisions associated with adherence or non-adherence to commonly recommended guidelines (e.g. USPSTF grade A and B recommendations such as breast and cervical cancer screening). There is little, if any research dealing with factors associated with adopting the “neutral” or “negative” (USPSTF grade C, D and I) recommendations. Clearly clinical decisions involve more complex considerations than scientific, population-based evidence alone. It is important that public health researchers understand the additional factors involved in making decisions at the individual patient/provider level, as well as the penetration of the guidelines related to ovarian cancer in clinical practice, so that a more focused dissemination of the guidelines can be achieved. 

Project Activities: Applications submitted in response to this SIP should present information that address the activities listed below:

  1. Describe the proposed study population and how a nationally-representative group of practicing primary care physicians and gynecologists will be identified and recruited.
  2. Describe the sampling plan and target sample size, including a discussion of the total number of surveys to be administered in order to have a final response rate with sufficient power to answer the research questions of interest.
  3. Describe the study design and which research questions will be used to guide the project.  Examples of the research questions of interest include, but are not limited to:

    • What are the screening and testing practices (e.g. use of CA-125, transvaginal ultrasounds, genetic testing, etc) of physicians among asymptomatic women in different risk categories and how do they define the different risk categories?
    • What are the diagnostic testing practices of physicians among women with symptoms of ovarian cancer and what symptoms prompt the work-up?
    • Are practicing general practitioners aware of published guidelines regarding ovarian cancer screening? If so, which guidelines do they prefer and/or most frequently cite?
    • Are there practice-specific or organizational policies specific to ovarian cancer screening procedures that physicians adhere to?
    • Are there other factors that may contribute to the adherence or non-adherence of practicing primary care physicians and gynecologists to the current recommendations for ovarian cancer screening (e.g., reimbursement issues, patient factors, litigation concerns, etc.)?

  4. Describe methods for developing and piloting the survey instrument.
  5. Describe how the survey will be administered.
  6. Describe the methods for encouraging completion of the survey, follow-up of non-responses, and methods for identifying the characteristics of refusals.
  7. Describe how the data will be analyzed.
  8. Identify the key staff and describe the qualifications of all individuals who will be involved in the design and execution of this project.
  9. Identify how the results will be disseminated.
  10. Provide a detailed timeline for completing the above activities within the 2-year project period.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluated the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:

1.      Access to a population of nationally-representative practicing primary care physicians and gynecologists.

2.      Sound study design and previous experience in survey administration including the development and piloting of survey questions.

3.      Previous experience with successfully completed projects with similar design including dissemination of results through publications.

4.      The project team includes expertise on issues related to the early detection and diagnosis of ovarian cancer.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages. Supporting material included as appendices is limited to ten attachments.  The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds: Approximately $350,000 is available to fund one PRC in the first year of a 2-year project period. Funding may vary and is subject to change.

Research Status: It is expected that this project will be non-exempt research.  It is anticipated that this project will require local IRB approval. Applicants should provide a federal-wide assurance registration number for each performance site included in the project.

Award Administration: CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. CDC staff will serve as consultants on this project and provide technical assistance related to ovarian cancer screening and diagnostic practices.  CDC staff is expected to consult on the design, methodology, analysis of the data, and will co-author manuscripts.

References:

1.      Zoorob R, Anderson R, Cefalu C, Sidani M. Cancer screening guidelines. Am Fam Physician 2001 Mar 15;63(6):1101-12.

2.      Hamblin J, Connor PD. Cancer screening guideline preference surveys: physicians’ perceptions of the American Cancer Society. Tenn Med 1998 Jan;91(1):17-20.

3.      Holland-Barkis P, Forjuoh SN, Couchman GR, Capen C, Rascoe TG, Reis MD. Primary care physicians’ awareness and adherence to cervical cancer screening guidelines in Texas. Prev Med 2006 Feb;42(2):140-5.

4.      McPhee SJ, Bird JA. Implementation of cancer prevention guidelines in clinical practice. J Gen Intern Med 1990 Sep;5(5 Suppl):S116-S122.

5.      Selinger HA, Goldfarb NI, Perkel RL, Carlson BL. Physician compliance with mammography guidelines: a retrospective chart review. Fam Med 1989 Jan;21(1):56-8.

6.      Young JM, Ward JE. Strategies to improve cancer screening in general practice: are guidelines the answer? Fam Pract 1999 Feb;16(1):66-70.

7.      MacDonald DJ, Sarna L, Uman GC, Grant M, Weitzel JN. Cancer screening and risk-reducing behaviors of women seeking genetic cancer risk assessment for breast and ovarian cancers. Oncol Nurs Forum 2006 Mar;33(2):E27-E35.

8.      McGinley PJ, Kilpatrick ES. Tumour markers: their use and misuse by clinicians. Ann Clin Biochem 2003 nov;40(Pt 6):643-7.

9.      Tudiver F, Brown JB, Medved W, Herbert C, Ritvo P, Guibert R, et al. Making decisions about cancer screening when the guidelines are unclear of conflicting. J Fam Pract 2001 Aug;50(8)”682-7.

SIP 2:  Assessing the Needs of Ovarian Cancer Caregivers

Project Description and Objectives: The Centers for Disease Control and Prevention (CDC) is interested in efforts that aim to identify and address the needs of cancer survivors, including the caregivers of those diagnosed with cancer. The purpose of this project is to conduct research to better understand the unmet needs of caregivers of ovarian cancer survivors. This includes a clarification of the needs of caregivers by phases of cancer survivorship (i.e., diagnosis/ treatment, long term survival, end of life, and bereavement).  This project would use formative research methodology to identify important but unmet caregiver needs, paying close attention to those that may be addressed and met through future interventions.

Previous research has found that caregivers commonly experience unmet mental, physical, social, and economic needs that lead to poor quality of life and high levels of distress1 and that caregivers are especially likely to suffer when caring for a patient with illness that is advanced, debilitating, and terminal.2 Ovarian cancer is the most deadly of the female gynecologic cancers. Most women with ovarian cancer are diagnosed at late stages of the disease, when chances of survival are low, and a combination of invasive surgeries and aggressive chemotherapy treatments are prescribed, leaving patients physically and emotionally debilitated. The low probabilities of survival, debilitating effects of treatment, and emotional aftermath of an ovarian cancer diagnosis present a gravely unique situation for caregivers of ovarian cancer patients, but little research has focused on the unmet needs of this group of caregivers.

This project is expected to examine the needs of ovarian cancer caregivers, clarifying the types of needs by phase of cancer survivorship (i.e., diagnosis/treatment, long term survival, end of life, and bereavement) by using formative research methodology to identify important but unmet caregiver needs. Closest attention should be paid to identifying needs that could be addressed and met through future interventions (e.g., social support needs through support groups; informational needs through educational resources). By focusing on the identification of modifiable unmet needs, this study has potential to add to the literature in a way that could guide future efforts to improve caregivers’ quality of life.  It is believed that through the use of formative research, this study will serve to identify important but unmet needs, generate hypotheses for future research, and guide future efforts in intervention that may improve the quality of life of ovarian cancer caregivers, as well as caregivers of persons with other cancers or diseases.   

Project Activities: Applications submitted in response to this SIP should present information that address the activities listed below: 

1.      Describe the study design and methods used to gather information on the met and un-met needs of ovarian cancer caregivers at different stages of survivorship. For example, a series of focus groups comprised of individuals providing care to ovarian cancer patients at various stages could be used to accomplish the goals of this project.

2.      Describe plans for gaining access to and recruiting a sufficient sample of ovarian cancer caregivers who are currently caring for patients in one of the four phases of cancer survivorship (i.e., diagnosis/treatment, long term survival, end of life, and bereavement).  It may be necessary to use different methods for gaining access to caregivers at different stages of survivorship.

3.      Describe plans for determining participant eligibility and methods used to recruit participants. Include proposed strategies for dealing with insufficient numbers of eligible participants and high refusal rates.

4.      Describe detailed plans for developing study materials and carrying out proposed activities.

5.      Describe which research questions will be used to guide the project and how data will be collected to address the research questions. Examples of the questions of interest include, but are not limited to:

6.      Describe the types of caregiver needs (e.g., informational, financial, emotional) that will be addressed by the research.

7.      Describe how findings may be used to guide future research and interventions for cancer caregivers.

8.      Describe how data will be stored and analyzed.

9.      Provide a detailed timeline for completing the proposed activities within the 2-year project period.

10.  Identify key staff and describe the qualifications of all individuals who will be involved in the design and execution of this project.

11.  Describe how the results from this project will be disseminated.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process: 

1.      Research experience in the topic areas of social support and/or caregiving, especially in the context of cancer or other chronic diseases or disabilities.

2.      Sound study design and evidence of experience conducting formative research.

3.      Ability to recruit sufficient numbers of caregivers of ovarian cancer patients at each stage of survivorship (diagnosis/treatment, long term survival, end of life, and bereavement).

4.      Plans for including, but not limiting study participation to, groups with known cancer outcome disparities.

5.      Demonstrated support from agencies, medical facilities, registries, or other groups that will be used to identify eligible participants and conduct the research.  

6.      Previous experience with successfully completed projects with similar design including dissemination of results through publications.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages.  Supporting material included as appendices is limited to ten attachments.  The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $210,000 is available to fund one PRC in the first year of a 2-year project period.  Approximately $235,000 is available in the second year. Funding may vary and is subject to change.

Research Status:  It is expected that this project will be non-exempt research and will require local IRB approval.  Applicants should provide a federal-wide assurance registration number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will serve as consultants on this project and provide technical assistance related to ovarian cancer, public health priorities in cancer survivorship, and participant recruitment.  CDC staff is expected to consult on the design, methodology, analysis of the data, dissemination of results, and will co-author manuscripts.

References:

1.  Sales, E. (2003) Family burden and quality of life. Quality of Life Research 12 Suppl 1:33-41.

2.  Schumacher, K. L., Dodd, M. J., Paul, S. M. (1993) The stress process in family caregivers of persons receiving chemotherapy. Research in Nursing & Health 16(6):395-404.

SIP 3:  Intervention to Increase Screening for Cervical Cancer in Women of Mexican Descent - Phase 3

Project Description and Objectives:  This SIP encompasses Phase 3 of a larger research study, to increase screening for cervical cancer among women of Mexican descent who are rarely or never screened. From its inception, this project has included a Lay Health Worker Advisory Committee (LHWAC) made up of promotoras or managers of promotoras.

The research study has four phases of research.  In Phase 1, formative research was conducted to better understand why women of Mexican heritage do not participate in cervical cancer screening programs. Results from Phase 1 were discussed with the LHWAC in Phase 2 with the objective of developing or adapting an intervention and its delivery process. In keeping with current dissemination and implementation research, this intervention was designed with future implementation in mind.1,2  An intervention prototype, AMIGAS, was developed which includes a flip chart, video, and Promotora Instruction Guide. The Guide contains lesson plans, games, posters, resource sheet, educational pieces for the educational session, checklists, and appointments cards.  Currently the primary components are seen as the flip chart, video, and resource sheet. Some Phase 2 activities are waiting OMB approval, but are expected to be concluded by the time of award for this SIP.

This SIP is soliciting applications to test an intervention prototype (developed from Phase 1 and 2 of the research study) in a scientifically rigorous manner to identify 1) the core components of the intervention, 2) the features of the intervention, and 3) delivery mechanisms that facilitate its use in different settings.  The intervention prototype was developed by an outside contractor and will be provided to the award recipient.  The specific research questions to be addressed in Phase 3 are:

  1. What are the core components of the intervention?
  2. Does this strategy (e.g., delivery of the intervention by trained promotoras) increase screening for cervical cancer?
  3. What is the effect of the intervention conditions vs. control in three distinct populations?

Project Activities:  Applications submitted in response to this SIP should present information that address the activities listed below:

1.      Causally link receipt of a screening test for cervical cancer to exposure to the intervention. Neither measures of intermediate points, such as knowledge change, attitude change, or intention to be screened, nor patient self-report of screening for cervical cancer will be accepted as demonstration of screening.

2.      Identify the effect size for each component of the intervention for three subpopulations of women of Mexican heritage living in the US: those living at the US-Mexico border, in rural areas, and in urban areas. These data will provide evidence of the components which are the most robust in the intervention and which are relevant to the population regardless of setting.

3.      Evaluate which characteristics of the intervention, the organization adopting the intervention, and the processes of delivery of the intervention by promotoras will facilitate more widespread use of AMIGAS.

4.      Collect basic cost data; however, a thorough economic evaluation is not requested.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:

1.      Scientific soundness of the proposed study design and execution plan independent of familiarity with AMIGAS intervention package.

2.      Experience in managing multi-site initiatives.

3.      Experience in testing behavioral interventions.

4.      Previous relationships with intended population and outcomes of such relationships, including but not limited to, behavioral interventions or publications in peer-reviewed journals.

5.      Experience in implementation research, and the design and delivery of an intervention.

6.      Activities proposed in multiple sites in collaboration with other PRCs.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages.  Supporting material included as appendices is limited to ten attachments. The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $550,000 is available to fund one PRC in the first year of a 2-year project period.  Funding may vary and is subject to change.

Research Status:  It is expected that this project will be non-exempt research.  It is anticipated that this project will require local IRB approval and approval by the CDC IRB.  Applicants should provide a federal-wide assurance number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will serve as collaborators and/or co-investigators on this project and will have joint responsibility for protocol development, co-authoring manuscripts, and presentations at scientific meetings.

References:

1.      Glasgow RE, Lichtenstein E, Marcus AC, 2003. Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition. American Journal of Public Health, 93(8):1261-1267.

2.      Glasgow RE, Marcus AC, Bull SS, Wilson KM, 2004. Disseminating effective cancer screening interventions. Cancer, 101(5 Suppl): 1239-50.

SIP 4:  Impact of Cultural and Socioeconomic Factors on Post-treatment Surveillance among African Americans with Colorectal Cancer

Project Description and Objectives: The purpose of this project is to perform a qualitative study to determine the impact of socioeconomic and cultural factors on the disproportionate non-participation of African Americans in post-treatment surveillance for colorectal cancer (CRC). CRC is the third leading cause of cancer deaths for African Americans in the United States.1 High CRC mortality rates for African Americans may be attributable to a variety of factors (e.g., screening, access to standard care/treatment, presentation with more advanced stages of disease).2 Research has suggested that African Americans are significantly less likely than whites to receive post-treatment colorectal surveillance even after adjusting for several demographic and clinical factors.3,4,5  The lack of post-treatment surveillance is problematic as 50% of all survivors treated for CRC will experience a recurrence within three to five years.6,7 The apparent lack of adherence to post-treatment surveillance guidelines among African American CRC survivors may attribute to increased mortality rates. While several studies have documented this problem, none have attempted to explain why some patients did not receive the follow-up examination. Consequently, limited information is available on patient level and health system level barriers that prevent African Americans from receiving surveillance colorectal examinations.

The objective of this study is to develop a better understanding of patient level factors that influence decisions to participate in post-treatment surveillance after CRC. This proposal seeks to address gaps in knowledge of specific factors (i.e., socioeconomic status and culture) that influence African American participation in post-treatment CRC surveillance. Socioeconomic and cultural factors may affect the way people perceive health messages and information. Various indicators of socioeconomic conditions and culture have been shown to predict health behavior, morbidity, and mortality across a range of risk factors and health problems.8  As cultural factors such as beliefs, attitudes, and knowledge about cancer are known to vary dramatically by race9,10,11 they should be examined more closely to understand their impact on cancer disparities.

Identifying the cultural and socioeconomic factors that contribute to the lack of adherence to post-treatment CRC surveillance guidelines among African Americans will inform the design and implementation of interventions to address this problem.

Project Activities:  Applicants should present information that addresses the following:

1.      Provide a conceptual framework, design, methods, and analyses appropriate to the aims of the project.

a.      Demonstrate knowledge of CRC post-treatment surveillance recommendations and issues related to disparities in patient participation in post-treatment surveillance. 

b.      Demonstrate knowledge of recent literature and explain how the proposed research furthers what is already known.

c.      Demonstrate access to and research experience with target population (e.g., African American CRC survivors living in urban and rural areas).

d.      Include policies, criteria, and processes for selecting candidates; provide plans for patient recruitment and retention.

e.      Demonstrate knowledge of quantitative data collection and analysis research methods.

f.        Describe the methods which will be used to analyze the data.

g.      Address potential problem areas and consider alternative tactics.

h.      Describe how data items will be selected and collected for each area of interest (socioeconomic and cultural factors). For example, questions related to socioeconomic condition may assess the impact of factors such as cost of care, access to care, insurance coverage, education levels, income, and marital status on receipt of post-treatment surveillance. Culture-related questions may assess the impact of factors such as fear, fatalism, myths and lack of knowledge about cancer, perceptions of and/or mistrust of the medical community, and religious beliefs (i.e., spirituality, prayer, beliefs about healing, etc.) on receipt of post-treatment surveillance. Study items such as general demographic and health information data (e.g., age, sex, date of completion of treatment, receipt of surveillance colonoscopy or other test methods with dates) may also be included.

1.      Provide evidence of infrastructure suitable for qualitative community-based participatory research.

a.   Describe the scientific environment in which the work will be conducted.

b.   Describe nature of infrastructure or partnership.

c.   Provide evidence of commitment and cooperation of potential partners (e.g., recent letters of support, and memoranda of understanding).

d.   Provide documented examples of prior collaborations with potential research partners.

3.      Identify key staff who will be devoted to this project.  Where appropriate, the applicant should describe the person’s demonstrated knowledge, experience, and ability to contribute to this study (e.g., data collection and analysis, qualitative research experience, community-based participatory research experience, etc.).

4.      Provide evidence of sufficient institutional support (e.g., space, equipment, etc.).  Describe the established resources and expertise available to the study staff (e.g., intervention research, health services research, community-based participatory research, behavioral sciences, communication theory and practice, etc.).

5.      Include specific, measurable, time-framed objectives for the 2-year project period.

6.      Describe a dissemination plan of how the information gained from this study will be made available.

7.      Describe how research findings are expected to be used to improve treatment and follow-up of cancer CRC patients in the future.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:

  1. PI/PD’s publication history or literature reviews in this area.
  2. Accessibility to African American CRC patients (including the ability to recruit and retain for study participation).
  3. Evidence of skills in conducting behavioral intervention and community-based participatory research studies.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages.  Supporting materials included in the appendices is limited to ten attachments.  The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $250,000 is available to fund one PRC for the first year of a 2-year project period.  Funding may vary and is subject to change. 

Research Status:  It is expected that this project will be non-exempt research. CDC staff will serve as co-investigators on these projects. It is anticipated that this project will require local and CDC IRB approval. Applicants should provide a federal-wide assurance number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will serve as co-investigators on this project, and will provide technical assistance on activities such as the design and nature of the interview study, development of the interview study instrument, protocol development, co-authoring manuscripts, and the dissemination of results.

References:

1.      U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999-2002 Incidence and Mortality Web–based Report Version. Atlanta: Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2005. Available at: www.cdc.gov/cancer/npcr/uscs/.

2.      Fairley TL, Cardinez CJ, Martin J, Alley L, Friedman C, Edwards B, Jamison P. Colorectal cancer in U.S. adults younger than 50 years of age, 1998-2001. Cancer 2006;107(5 Suppl):1153–61

3.      Rolnick S, Alford S, Kucera G, Fortman K, Yood M, Jankowski M, Johnson C. Racial and age differences in colon examination surveillance following a diagnosis of colorectal cancer. J Natl Cancer Inst Monogr 2005;35:96-101.

4.      Cooper GS, Yuan Z, Chak A, Rimm AA. Geographic and patient variation among Medicare beneficiaries in the use of follow-up testing after surgery for nonmetastatic colorectal carcinoma. Cancer 1999;85:2124-31.1999

5.      Ellison GL, Warren JL, Knopf KB, Brown ML. Racial differences in the receipt of bowel surveillance following potentially curative colorectal cancer surgery. Health Services Res 2003;38:1668-904.

6.      Fusai G, Davidson BR. Management of colorectal liver metastases. Colorectal Dis 2003;5:2-23.

7.      Hugh TJ, Kinsella AR, Poston GJ. Management strategies for colorectal liver metastases—part I. Surg Oncol 1997;6:283-5.

8.      U.S. Department of Health and Human Services. Report of the Secretary’s Task Force on Black and Minority Health. Washington, D.C. Government Printing Office, 1987.

9.      Pachter LM. Culture and clinical care: folk illness beliefs and behaviors and their implications for health care delivery. JAMA 1994;271:690-94.

10.  Denniston RW. Cancer knowledge, attitudes, and practices among black Americans. In: Medlin C, Murphy GP, eds. Cancer among black populations. New York, NY: Alan R. Liss Inc; 1981:225-35.

11.  Loehrer PJ, Greger HA, Weinberger M, et al. Knowledge and beliefs about cancer in a socioeconomically disadvantaged population. Cancer. 1991;68:1665-71.

Epilepsy

SIP 5:  Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-management Intervention Research -- Coordinating Center

Project Description and Objectives:  The intent of this SIP is to fund a Coordinating Center (CC) to lead the development of a network of PRCs for epilepsy self-management intervention research.  The Managing Epilepsy Well (MEW) Network is expected to:  1) develop and implement a coordinated, applied research agenda; 2) conduct high-quality research activities that promote self-management and quality of life that can be incorporated into home, clinical, or community-based settings; and 3) identify and collaborate with state, local public health and/or state or local mental health and other social services agencies to implement activities. 

The MEW Network is intended to address the applied research needs of CDCs’ Epilepsy Program’s priority areas, and Living Well with Epilepsy 2003 priority recommendations related to promoting self-management:  1) enhance the behavioral and social science research of people “living with epilepsy” and self-management of epilepsy; 2) facilitate the development and testing of self-management models that incorporate critical components for epilepsy; 3) ensure that programs recognize the spectrum of epilepsy and tailor content appropriately to people with well-controlled, refractory, and new-onset seizures; and 4) promote self-management and self-determination principles and programs in the care and services for people with epilepsy.

This SIP will fund a CC to develop the infrastructure to lead and facilitate the activities of the members of the MEW Network, including coordination of the network and documenting network results.  This SIP will also support the CC’s activities as a collaborating center in the MEW Network which will include evaluating promising self-management interventions identified by the network.

Project Activities:  Applicants should describe how they plan to address the following activities:

1.      Create a plan that addresses logistics as well as organization, structure, and how coordination with collaborating centers will be achieved. Define performance expectations for the network.

2.      Identify relevant community stakeholders that will participate in the network. Address the dissemination of relevant information beyond the scientific literature, specifically to communities.

3.      Provide a timetable for a fully functioning network. Describe how the CC will provide leadership in fostering and growing the network. Indicate how this growth will be assessed and monitored during the project period.

4.      Describe how the CC will represent and promote the MEW Network and its member centers within the PRCs and to external partners.

5.      Describe how the CC will work with other network centers to prioritize topics for research and intervention development.

6.      Describe the process by which each member center’s contributions, including individual roles and responsibilities for the projects and activities, will be determined.

7.      Describe how the CC will foster the participation of non-funded/affiliate members of the network.

8.      Oversee the pilot testing of the establishment of the network.

The CC will also participate as a collaborating center in the network and will undertake the project activities described in SIP 6.  Applicants should describe how they will participate as a  member of the MEW Network, including identifying established resources in areas relevant to epilepsy self-management within or available to the PRC.  The applicant should describe how they plan to address the following collaborating center activities:

Based on research evidence, develop plans for the implementation and evaluation of one or more promising interventions into healthcare system, home or community-based settings.

            1.      Develop plans for the implementation and testing of a promising intervention into a specific setting.

            2.      Identify barriers to implementation and clarify methods to overcome barriers.

            3.      Identify and obtain support from at least one underused community resource that could be useful in improving self-management outcomes in a particular population.
            4.      Evaluate internal and external validity of the intervention.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of the applications (Significance, Approach, Innovation, Investigators, and Environment), preference will be given to applicants who have experience with:

1.   Managing multi-site initiatives.

2.   Developing, planning, and implementing chronic disease self-management research, epilepsy self-management research, or public health prevention research in hard to reach populations.

3.   Leading groups and working with partners, including a group of academic institutions around a common agenda.

4.   Experience working with federal, state, or local public health and other social service agencies.

5.   Experience working with hard to reach populations.

6.   Experience working in priority public health settings such as health care, work sites, communities, or schools.

7.   Experience working with multimedia technology or public health or medical informatics for health outcomes research.

8.   Synthesizing research literature.

9.   Evaluating the impact of public health interventions for both internal and external validity.

Project Proposal and Length:  Proposal narratives are limited to 25 pages.  Five pages of the proposal narrative should address the activities to be performed by the applicant in its role as a collaborating center in the MEW Network.  Supporting material included as appendices is limited to ten attachments.  The appendices should include the materials supportive of ability to successfully conduct the project described above, any needed letters of support, and other evidence as consistent with the proposal.

The award recipient of SIP 5 will function as the CC and will serve as a member of the network, thus a separate application to SIP 6 (collaborating center) is not required. However, a PRC that applies to SIP 5 may want to consider applying to SIP 6 in the case that they are not selected as the CC and would like to be considered as a collaborating center.

Availability of Funds:  Approximately $150,000 is available to support one CC ($80,000 for CC activities/$70,000 for collaborating center activities) for the first year of a 2-year project period.  Funding may vary and is subject to change.

Research Status:  The operations and development of the network will not involve human subject research.  Projects chosen as a collaborating center may involve local IRB review.  CDC staff will assist in making human subject determinations. 

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will serve in an advisory capacity as technical consultants.

SIP 6:  Managing Epilepsy Well (MEW) -- Network for Epilepsy Self-Management Intervention Research -- Collaborating Center

Project Description and Objectives:  The intent of this SIP is to develop a network of PRC Collaborating Centers for epilepsy self-management intervention research. The Managing Epilepsy Well (MEW) Network is expected to:  1) develop and implement a coordinated, applied research agenda; 2) conduct high-quality research activities that promote self-management and quality of life that can be incorporated into home, clinical, or community-based settings; and 3) identify and collaborate with state, local public health and/or state or local mental health and other social services agencies to implement activities. 

The MEW Network is intended to address the applied research needs of CDCs’ Epilepsy Program’s priority areas, and Living Well with Epilepsy 2003 priority recommendations related to promoting self-management:  1) enhance the behavioral and social science research of people “living with epilepsy” and self-management of epilepsy; 2) facilitate the development and testing of self-management models that incorporate critical components for epilepsy; 3) ensure that programs recognize the spectrum of epilepsy and tailor content appropriately to people with well-controlled, refractory, and new-onset seizures; and 4) promote self-management and self-determination principles and programs in the care and services for people with epilepsy. 

MEW Network activities are expected to include:  1) the development of a multidisciplinary epilepsy self-management research network; 2) an examination of the evidence on the effectiveness of chronic disease self-management programs applied in various settings such as health care system (e.g., Chronic Care Model), community-based (e.g., Chronic Disease Self-Management Program), or self-administered interventions (e.g., Arthritis Self-Help Course) that could be relevant to epilepsy; 3) an examination of the evidence on the effectiveness of epilepsy self-management programs; 4) recommendations for the implementation and evaluation of one or more promising interventions into healthcare system, home, or community-based settings; 5) partnering with relevant federal (e.g., VA, community-based health centers) state or county agencies (e.g., public health, mental health, transportation, Area Agency on Aging), social service agencies (e.g., local Epilepsy Foundation) to address unmet needs associated with self-management; and 6) the dissemination of research project outcomes.

Project Activities:  Collaborating centers will work with each other and the Coordinating Center (CC) to develop an effective network to conduct project activities.  Applicants should describe how they plan to work with the CC to accomplish the activities described in the following two components: 

Component 1:  Develop a research plan that will identify effective models of chronic disease self-management programs and epilepsy self-management programs.

1.  Based on research evidence, identify promising chronic disease self-management models and epilepsy self-management models.

2.  Based on research evidence, identify effective implementation channels (e.g., group-based programs; self-administered mail programs; home-based programs; telephone or Internet-based programs) and barriers to implementation for chronic disease and epilepsy self-management programs.

3.  Identify underused community resources of potential use related to self-management (e.g., funding from state mental health service agencies; transportation services available to veterans through the VA; free computer and Internet access through local libraries; medication availability through community-based health centers for low-income individuals).

4.  Identify relevant behavioral and health outcomes to assess improvements in self-management.

5.  Coordinate the reporting of findings from the research synthesis with stakeholders.

6.  Make recommendations for a research project proposal specific to epilepsy self-management that could be initiated and evaluated within the network.

Component 2:  Based on research evidence, develop plans for the implementation and evaluation of one or more promising interventions into healthcare system, home or community-based settings.

            1.      Develop plans for the implementation and testing of a promising intervention into a specific setting.

            2.      Identify barriers to implementation and clarify methods to overcome barriers.

            3.      Identify and obtain support from at least one underused community resource that could be useful in improving self-management outcomes in a particular population.
            4.      Evaluate internal and external validity of the intervention.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of the applications (Significance, Approach, Innovation, Investigators, and Environment), preference will be given to applicants who have:

  1. Established formal working agreements with partners engaged in intervention research.
  2. Developed, planned, and implemented chronic disease self-management research, epilepsy self-management research, or public health prevention research in hard to reach populations.
  3. Experience working with multimedia technology or public health or medical informatics for health outcomes research.
  4. Evaluated the impact of public health interventions.

Project Proposal and Length:  Proposal narratives are limited to 20 pages.  Supporting material included as appendices is limited to ten attachments.  The appendices should include the materials supportive of ability to successfully conduct the project described above, any needed letters of support, and other evidence as consistent with the proposal. 

Availability of Funds:  Approximately $280,000 is available to fund four PRCs as collaborating centers of the MEW Network. This funding is expected to be up to $70,000 per center, per year for a period of two years. Funding may vary and is subject to change.

Note: The composition of the network and the individual projects proposed by the collaborating centers cannot be known in advance; therefore, a collaborating center may be asked to revise their scope of work so that: 1) two or more sites collaborate on a specific component; and/or 2) research areas deemed a priority by the network and CDC are assigned to at least one PRC. 

Research Status:  Projects chosen may involve local IRB review.  CDC staff will assist collaborating centers in making human subject determinations. 

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will serve in an advisory capacity as technical consultants.

Adolescent Health

SIP 7:  Urban Stressors and Problem Behaviors among Adolescents in High Risk Urban Environments

Project Description and Objectives: The goal of the proposed research is to identify modifiable sociocultural and community factors that may influence adolescent problem behaviors, including youth violence. The objective is to explore the relationship between chronic exposure to urban stressors1 and problem behaviors among adolescents in high risk urban settings. Prior research suggests that constant exposure to certain social and environmental stressors may be a significant risk factor for poor behavioral outcomes for children and adolescents.2;3;4

The prevalence of violence, substance abuse, and other forms of problem behaviors among adolescents in high risk urban environments makes it imperative to explore the various social processes that may be related to these outcomes. In order to more accurately assess experiences with urban stressors, coping mechanisms, and behavioral outcomes, research efforts should attend to the unique challenges associated with living in high risk urban environments. This includes contextually relevant survey methods as some behaviors may be specific to a particular social or environmental context.  Not all adolescents from high risk urban environments engage in problem behaviors; some are able to make resourceful, creative adaptations and achieve positive outcomes despite exposure to an array of urban stressors.5 Thus, the exploration of purported protective factors such as parental support, social support, personal identity, and self-efficacy may further our understanding of those things which may buffer against aforementioned risks and increase the likelihood for positive outcomes.

Few studies to date have explored the unique interplay among experiences with urban stressors and protective factors in relation to problem behaviors in a single investigation. The proposed research is cross-cutting and contributes directly to our knowledge and understanding of social dynamics that may be linked to problem behaviors among adolescents who live in high risk urban environments, and context specific coping strategies that may diminish the risks associated with living in such environs.

Findings from the proposed research are expected to enhance public health knowledge of the nature and extent of urban stressors, and how exposure to said stressors may impact attitudes and behaviors. Moreover, findings related to the efficacy of the proposed protective factors may be used to inform cross-cutting, multi-level prevention and intervention efforts for adolescent populations in high risk urban environments.  The development and implementation of culturally competent, contextually relevant, prevention and intervention efforts that target adolescents in high risk urban environments may serve to ease their transition into adulthood and increase the likelihood for positive social and health outcomes over the life course.

Project Activities: Applications in response to this SIP should present information that address the activities listed below:

  1. Describe the eligible study population, study design, and research methodology appropriate to aims of this project (i.e., to investigate the relationship between chronic exposure to urban stressors and problem behaviors among adolescents in high risk urban settings).  Applicants may consider qualitative and quasi-experimental research designs including mixed method and multitrait - multimethod approaches.
  2. Describe the recruitment of proposed study population and how eligibility for the proposed study will be determined.
  3. Define the desired outcome(s) of the investigation. Outcomes may include, but are not limited to: (a) measurement of urban stressors, (b) measurement of protective factors, (c) measurement of gender differences in nature and extent of experiences with urban stressors, and (d) measurement of gender differences in process and function of protective factors.
  4. Describe how the desired outcomes are expected to be assessed in the study population.
  5. Describe how the data are analyzed including differences across race and gender.
  6. Identify key personnel and describe the qualifications of persons involved in the design and execution of the project.
  7. Describe how research may be used to inform future intervention and prevention activities.
  8. Describe how findings from this project will be communicated back to the organization and disseminated.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria specific to this SIP will be considered in the review process:

  1. Access to a population of adolescents in high risk urban settings.
  2. Letters of support from community organizations, agencies, and institutions.
  3. Previous funded research with adolescent populations in high risk urban settings.
  4. Familiarity with culturally competent, contextually relevant assessment tools used in prior research.
  5. Record of successfully completed research and/or intervention projects.
  6. Dissemination of research in scholarly, peer reviewed journals.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 25 pages. Supporting material included as appendices is limited to ten attachments. The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $100,000 is available to fund one PRC in the first year of a 2-year project period.  Funding may vary and is subject to change.

Research Status:  It is expected that this project will be non-exempt research. It is anticipated that this project will require local IRB approval and review by the CDC IRB. Applicants should provide a federal-wide assurance registration number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards. CDC staff will serve as collaborators and/or co-investigators on this project and will have joint responsibility for protocol development, the dissemination of results and co-authoring manuscripts.

References:

1.      Bennett, M. D., & Miller, D. B. (2006). An exploratory study of the Urban Hassles Index: A contextually relevant measure of chronic multidimensional stress? Research on Social Work practice, 16, 305-314.

2.      Bennett, M. D., & Fraser, M. W. (2000). Urban violence among African American males: Integrating neighborhood, family and peer perspectives. Journal of Sociology and Social Welfare, 27(3), 93-117.

3.      Horowitz, K., McKay, M., & Marshall, R. (2005) Community violence and urban families: Experiences, effects, and directions for intervention. American Journal of Orthopsychiatry 75(3) 356-368.

4.      Song, L.-y., Singer, M. I., & Anglin, T. M. (1998). Violence Exposure and Emotional Trauma as Contributors to Adolescents' Violent Behaviors. Archives of Pediatric Adolescent Medicine, 152(6), 531-536.

5.      Zimmerman, M. A., Ramirez-Valles, J., & Maton, K. I. (1999). Resilience among urban African American male adolescents: A study of the protective effects of sociopolitical control on their mental health. American Journal of Community Psychology, 27(6), 733-751.

Nutrition

SIP 8:  Understanding Motivators and Barriers for Changing Sugar-sweetened Beverage Intake in the Home Environment of Overweight Youth

Project Description:  The prevalence of overweight among 6- to 11-year old US children has nearly doubled since the 1960s, with the most recent prevalence estimates at approximately 16%.1 The prevalence of overweight is also 16% among US children 12-19 years old.2 The health risks associated with childhood overweight include elevated blood pressure, dyslipidemia, impaired glucose tolerance, insulin resistance, body image disparagement, and increased mortality in males.3-10

The prevention of childhood overweight is one of the most important public health challenges.  The intake of sugar-sweetened beverages (SSB) has been linked to weight gain in observational longitudinal studies11-15 and in experimental studies.16-19  Decreasing the availability of SSB and replacing them with non-caloric beverages in the home and school environments has been shown as a promising intervention strategy to reduce SSB intake.  For example, a 25 week study18 using a randomized controlled trial design changed the home environment by delivering non-caloric beverages in order to displace SSB availability in the home and SSB consumption.  This intervention reduced SSB consumption by 82% in the intervention group and adolescents in the upper baseline body mass index (BMI) tertile experienced a significant net BMI change of -0.75 +0.34 kg/m2 compared to the control group.18  Another environmental intervention in a school setting reduced intake of SSB among high school students by ~4.8 oz/day/student.20

The objective of this SIP is to better understand how to reduce the consumption of and availability of SSB in the homes of at-risk and overweight youth who are regular consumers of SSB and have these beverages available in their homes.  The funding will support a qualitative study among these youth and their families to understand motivators for SSB intake; motivators for reducing SSB intake; barriers to change SSB intake; motivators for having SSB in the home beverage environment; motivators for limiting SSB availability in the home environment; and barriers to changing the availability of SSB in the home.  Priority will be given to protocols that examine how these differences vary by race/ethnicity.

Project Activities:  Applications submitted in response to this SIP should present information that address the activities listed below:

1.      Conduct formative qualitative data collection with youth 8-18 years of age and their families on motivators for drinking SSB, motivators for reducing SSB intake, and barriers to changing intake behaviors.  In addition, collect qualitative data on motivators for maintaining the home beverage environment, motivators for changing the home beverage environment, and barriers to changing the home beverage environment.  The youth should be at-risk for overweight or overweight, regular consumers of SSB (>1 serving daily), and have SSB regularly available in their homes.

2.      Description of the proposed study population, including eligibility and plans for recruitment of study participants, data collection methods, and analytic plan.

3.      Proposed dissemination plan for results of the qualitative study.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of the application (Significance, Approach, Innovation, Investigators, and Environment), the following additional review criteria and preferences specific to this SIP will be considered in the review process:

1.  Experience in reducing SSB intake among youth;

2.  Experience in the conduct of qualitative research studies; and

3.  Protocols that examine how the motivators and barriers vary by race/ethnicity.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 15 pages.  Supporting material included as appendices is limited to ten attachments.  The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $150,000 is available to fund one PRC for the first year of a 2-year project period.  Funding may vary and is subject to change.

Research Status:  It is expected that this will be non-exempt research.  It is anticipated that this project will require local IRB approval.  Applications should provide a federal wide assurance registration number for each performance site included in the project.

Award Administration: CDC Project Scientists will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will not serve as co-investigators on the project; however, they will provide technical assistance and consultation on activities such as research design, data collection and analysis, and dissemination of results.  CDC staff also may be co-authors on manuscripts from the study.

References:

1.  Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among U.S. children and adolescents, 1999-2000. JAMA 2002; 288(14):1728-1732.

2.  Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA 2004; 291(23):2847-2850.

3.   Sherry B, Mei Z, Scanlon KS, Mokdad AH, Grummer-Strawn LM. Trends in State-Specific Prevalence of Overweight and Underweight in 2- Through 4-Year-Old Children From Low-Income Families From 1989 Through 2000. Arch Pediatr Adolesc Med 2004; 158(12):1116-1124.

4.   Freedman DS, Dietz WH, Srinivasan SR, Berenson GS. The relation of overweight to cardiovascular risk factors among children and adolescents: the Bogalusa Heart Study. Pediatrics 1999; 103:1175-1182.

5.   Ford E, Galuska D, Gillespie C, Will J, Giles W, Deitz W. C-reactive protein and body mass index: findings from the Third National Health and Nutrition Examination Survey, 1988-1994. J Pediatr 2001; 138:486-492.

6.   American Diabetes Association. Type 2 diabetes in children and adolescents. Pediatrics 2000; 105(3):671-680.

7.   Garn SM, Clark DC. Nutrition, growth, development, and maturation: findings from the ten-state nutrition survey of 1968-1970. Pediatrics 1975; 56(2):306-319.

8.   Dietz WH. Health consequences of obesity in youth: childhood predictors of adult disease. Pediatrics 1998; 101(3):518-525.

9.   Kinugasa A, Tsunamoto K, Furukawa N, et al. Fatty liver and its fibrous changes found in a simple obesity of children. J Pediatr Gastroenterol Nutr 1984; 3:408-414.

10. Crichlow R, Seltzer M, Jannetta P. Cholecystitis in adolescents. Dig Dis 1972; 17(68):72.

11. Schulze M, Manson J, Ludwig D, Colditz G, Stampfer M, Willett W et al. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA 2004; 292(8):927-934.

12. Striegel-Moore RH, Thompson D, Affenito SG, Franko DL, Obarzanek E, Barton BA et al. Correlates of beverage intake in adolescent girls: The National Heart, Lung, and Blood Institute Growth and Health Study. The Journal of Pediatrics 2006; 148(2):183-187.

13. Berkey C, Rockett H, Field A, Gillman M, Colditz G. Sugar-added beverages and adolescent weight change. Obesity Res 2004; 12(5):778-788.

14. Phillips S, Bandini L, Naumova E, Cyr H, Colclough S, Dietz W et al. Energy-dense snack food intake in adolescence: Longitudinal relationship to weight and fatness. Obesity Res 2004; 12(3):461-472.

15. Ludwig D, Peterson K, Gortmaker S. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. The Lancet 2001; 357(9255):505-508.

16. Tordoff MG, Alleva AM. Effect of drinking soda sweetened with aspartame or high-fructose corn syrup on food intake and body weight. Am J Clin Nutr 1990; 51(6):963-969.

17. DiMeglio D, Mattes R. Liquid versus solid carbohydrate: effects on food intake and body weight. Int J Obes Relat Metab Disord 2000; 24(6):794-800.

18. Ebbeling CB, Feldman HA, Osganian SK, Chomitz VR, Ellenbogen SJ, Ludwig DS. Effects of Decreasing Sugar-Sweetened Beverage Consumption on Body Weight in Adolescents: A Randomized, Controlled Pilot Study. Pediatrics 2006; 117(3):673-680.

19. James J, Thomas P, Cavan D, Kerr D. Preventing childhood obesity by reducing consumption of carbonated drinks: cluster randomised controlled trial. BMJ 2004; 328(7450):1237.

20. Ritenbaugh C, Teufel-Shone N, Aickin M, Joe J, Poirier S, Dillingham D et al. A lifestyle intervention improves plasma insulin levels among Native American high school youth. Prev Med 2003; 36(3):309-319.

Physical Activity

SIP 9:  Expansion of the Physical Activity Policy Research Network (PAPRN) – Coordinating Center

Project Description and Objectives: The Physical Activity and Health Branch, Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Promotion seeks to support a Coordinating Center (CC) to lead the expansion of a Physical Activity Policy Research Network (PAPRN) to foster understanding of the effectiveness of health policies related to increasing physical activity in communities. The network, which would have long-term sustainability for physical activity policy research, will have one CC and several collaborating centers. 

Recently, accomplishments have been made toward developing a framework for physical activity public health policy research. This framework was developed through a series of three CDC workshops that gathered information and opinions from national experts. During these workshops, the following priorities were identified as critical to future physical activity policy research:  1) schools; 2) worksites; 3) parks and public spaces; 4) walkability; 5) safety and crime; 6) economic factors; and 7) liability.  Participants also concluded that policy research involves more than just understanding whether or not a policy is effective.  Policy research can involve: 1) the identification of policies that affect physical activity levels; 2) identifying determinants of why some policies are adopted and others are not; 3) research on how to implement a policy so that it is effective; and 4) the outcomes of policy implementation.

The original PAPRN has built on previous CDC policy research and agenda setting efforts by conducting a Concept Mapping Exercise.  This project included the systematic collection of input on Physical Activity Policy Research priorities from individuals across a wide range of disciplines.  Findings from this exercise are expected to increase the quantity and quality of physical activity policy research.  Results of this research effort can be found at http://prc/slu.edu./paprn (March 2007).  Applicants should use the results from this concept mapping project, in addition to the policy framework developed by CDC (see “A framework for physical activity policy research, J of Physical Activity and Health, 2006, 1, S20-29), to guide and inform their research proposals.

This SIP will fund a CC to lead the development, expansion, and collaborative activities of a multidisciplinary physical activity policy research network comprised of member collaborating centers.  This SIP will also support the CC’s activities as a member of the PAPRN Network, including identifying and developing one pilot project in physical activity policy research. 

Project Activities:  The CC will be expected to coordinate the PAPRN, document network results, and plan and coordinate a meeting at which the work of network members will be presented.  The CC will coordinate any activities undertaken with partners external to the network.  Working with CDC, the CC will divide the work among the members of the network.   Applicants should address the following:

1.      Explain the organization and interaction of the CC and collaborating centers.  Discuss the relationship with relevant CDC activities.  Define performance expectations for the network.

2.      Explain how the proposed PAPRN would draw on community collaborations to enhance physical activity public health policy research.  Discuss additional partners who may have a stake in the work.  Address the dissemination of relevant information beyond the scientific literature, specifically to communities.

3.      Describe how the CC will provide leadership in fostering and growing the network. Indicate how this growth will be assessed and monitored during the project period. 

4.      Describe how the CC will represent and promote the PAPRN and its member centers within the PRCs and to external partners. 

5.      Describe how the CC will participate as a collaborating member of the PAPRN, including identifying established resources in areas relevant to public health and physical activity within or available to the PRC, and how the CC will work with the other network centers to prioritize topics for research and intervention development. 

6.      Describe the process by which each member center’s contributions, including individual roles and responsibilities for the projects and activities, will be determined.

7.      Describe how the CC will foster the participation of non-funded/affiliate members of the network.

The CC will also have a role as a collaborating member of the network as described in SIP 10.  Collaborating centers are expected to actively participate in the network and to identify and develop one pilot project in physical activity policy research.  Applicants should address the following collaborating center activities:

1.      Discuss how they will collaborate with the PAPRN CC and CDC to advance a physical activity research policy agenda.

2.      Identify resources in areas relevant to public health and physical activity within or available to their PRC.  Discuss how these resources could be involved in and enhanced through the proposed network.  Discuss the potential and need for collaboration with community-based organizations and public health departments to enhance dissemination and impact of policy research.

3.      Document that they will work with the other PAPRN network centers in prioritizing and choosing topics for research, intervention or translation.

4.      Describe how they will work with the PAPRN network and other partners to develop evidence-based interventions that can be implemented in communities.

5.      Identify and develop one pilot project for physical activity policy research that builds on the results of the Concept Mapping Exercise as well as the CDC policy framework.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of the applications (Significance, Approach, Innovation, Investigators, and Environment), preference will be given to applicants who:

1.      Document or demonstrate the ability to manage multi-discipline, multi-site initiatives;  

2.      Document or demonstrate the ability to establish formal working agreements with disciplines such as law, economics, political science, and architecture and urban design;  and 

3.      Include a state health department as part of the project team.

Project Proposal Length and Supporting Materials:  The application proposal narrative may not exceed 25 pages.  Five pages of the proposal narrative must include the activities to be performed by the applicant in its role as a collaborating member of PAPRN.  The appendix is limited to ten attachments.

The award recipient of SIP 9 will function as the CC and will serve as a member of the network, thus a separate application to SIP 10 (collaborating center) is not required.  However, a PRC that applies to SIP 9 may want to consider applying to SIP 10 in the case that they are not selected as the CC and would like to be considered as a collaborating center.

Availability of Funds:  Approximately $130,000 is available to fund one CC in the first year of a 2-year project period ($70,000 to support CC activities/$60,000 to support collaborating center activities).  Funding may vary and is subject to change.

Research Status:  The coordination of the network itself will not involve research on human subjects; however, the research project chosen as a collaborating center may be non-exempt human subjects research.  If so, it will require local IRB approval.  Applicants should provide a federal wide assurance number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and the beyond the normal stewardship role in awards.  CDC staff will serve as consultants on the project and will provide consultation on the design and implementation of the network as well as well as research projects within the network.  CDC staff may be co-authors on manuscripts.  CDC staff will not have contact with human subjects or data collected from human subjects.

SIP 10:  Expansion of the Physical Activity Policy Research Network (PAPRN) – Collaborating Center

Project Description and Objectives: The Physical Activity and Health Branch, Division of Nutrition and Physical Activity, National Center for Chronic Disease Prevention and Health Promotion seeks to support the expansion of a Physical Activity Policy Research Network (PAPRN) to foster understanding of the effectiveness of health policies related to increasing physical activity in communities. The network, which would have long-term sustainability for physical activity policy research, will have one coordinating center and several collaborating centers. 

Recently, accomplishments have been made toward developing a framework for physical activity public health policy research. This framework was developed through a series of three CDC workshops that gathered information and opinions from national experts. During these workshops, the following priorities were identified as critical to future physical activity policy research:  1) schools; 2) worksites; 3) parks and public spaces; 4) walkability; 5) safety and crime; 6) economic factors; and 7) liability.  Participants also concluded that policy research involves more than just understanding whether or not a policy is effective.  Policy research can involve: 1) the identification of policies that affect physical activity levels; 2) identifying determinants of why some policies are adopted and others are not; 3) research on how to implement a policy so that it is effective; and 4) the outcomes of policy implementation.

The original PAPRN has built on previous CDC policy research and agenda setting efforts by conducting a Concept Mapping Exercise.  This project included the systematic collection of input on Physical Activity Policy Research priorities from individuals across a wide range of disciplines.  Findings from this exercise are expected to increase the quantity and quality of physical activity policy research.  Results of this research effort can be found at http://prc/slu.edu./paprn (March 2007).  Applicants should use the results from this concept mapping project, in addition to the policy framework developed by CDC (see “A framework for physical activity policy research, J of Physical Activity and Health, 2006, 1, S20-29), to guide and inform their research proposals.

The expected results from this SIP are:  1) development and expansion of a multidisciplinary physical activity policy research network; 2) satisfactory progress in at least one of the substantive areas identified in the mapping process; 3) communication of progress and findings through meetings and publications; and 4) documented plans for network sustainability and growth. Research results should help inform activities of CDC-funded state programs for promoting physical activity.  Issues related to diversity, social equity, and health disparities should be built into the core policy agenda.  Multiple traditional and non-traditional partnerships necessary for a successful project should be addressed.

Project Activities:  Collaborating centers will work with each other and the Coordinating Center (CC) to develop an effective network to conduct project activities.  Collaborating centers are expected to actively participate in the network and to identify and develop one pilot project in physical activity policy research. Applicants should address the following:

1.      Discuss how they will collaborate with the PAPRN CC and CDC to advance a physical activity research policy agenda.

2.      Identify resources in areas relevant to public health and physical activity within or available to their PRC.  Discuss how these resources could be involved in and enhanced through the proposed network.  Discuss the potential and need for collaboration with community-based organizations and public health departments to enhance dissemination and impact of policy research.

3.      Document how they will work with the other PAPRN network centers in prioritizing and choosing topics for research, intervention or translation.

4.      Describe how they will work with the PAPRN network and other partners to develop evidence-based interventions that can be implemented in communities.

5.      Identify and develop one pilot project for physical activity policy research that builds on the results of the Concept Mapping Exercise as well as the CDC policy framework.

Note:  The composition of the network and the individual projects proposed by the sites cannot be known in advance; therefore, some sites may be asked to revise their scope of work so that 1) two or more sites collaborate on a policy research project and/or 2) policy research areas deemed a priority by the network and CDC are assigned to at least one PRC.  

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of the applications (Significance, Approach, Innovation, Investigators, and Environment), preference be given to applicants that:

1.      Document or demonstrate the ability to establish formal working agreements with multiple disciplines such as law, economics, political science, architecture, urban design and with individuals or institutions that are currently engaged in policy research; and

2.      Include a state health department as part of the project team.

Project Proposal Length and Supporting Materials:  Application proposal narratives may not exceed 20 pages, excluding appendices and supporting materials.  The appendix is limited to ten attachments.

Availability of Funds:  Approximately $120,000 is available to fund at least two centers as collaborating members of PAPRN.  This funding is expected to be up to $60,000 per center, per year for a period of two years.  Funding may vary and is subject to change.

Research Status:  The research projects chosen may be non-exempt human subjects research.  If so, these research projects will require local IRB approval.  Applicants should provide a federal wide assurance number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is above and the beyond the normal stewardship role in awards.  CDC staff will serve as consultants on the project and will provide consultation on the design and implementation of the network as well as research projects within the network.  CDC staff may be co-authors on manuscripts.  CDC staff will not have contact with human subjects or data collected from human subjects.

SIP 11:  Implementation and Evaluation of Interventions in the Built Environment to Improve Public Health

Project Description and Objectives:  CDC’s National Center for Environmental Health (NCEH) conducts programs designed to promote health and prevent disease and disability that result from interactions between people and the environment.  The Center's Public Health Built Environment Initiative supports innovative research to better document the relationship between public health and community design.  A key component of this initiative focuses on identifying and evaluating project, policy, and program interventions in the built environment that improve public health.

The built environment includes all the physical places where people live, work, and play. The availability and accessibility of certain neighborhood characteristics, such as sidewalks, bicycle paths, parks, public transit, housing, schools, and grocery and other retail stores, can influence behavior.  There is increasing evidence that a mixed-use community design, based on Smart Growth principles, will generate multiple health benefits including increased physical activity from walking and bicycling, reduced automobile dependence and associated air pollution, and increased social capital and mental health benefits associated with the presence of parks and other places that promote social interactions.  These health benefits are especially important for underserved vulnerable populations such as children, seniors, persons with disabilities, persons with low incomes, and members of minority groups. However, more research is needed to determine effective solutions for improving public health through innovative healthy community designs and enhanced transportation options.

This proposal is expected to support research to address gaps in knowledge in the relationship between the built environment and public health and to evaluate community design/built environment interventions that promote health.  Research projects are expected to be cross-disciplinary (e.g. public health, transportation, urban planners, policy makers, architects, developers) and identify effective state and local public health projects, programs, and policies that promote healthy communities.  Research efforts that leverage resources and funds from other sources are encouraged, such as conducting a supplemental research project in conjunction with an existing large longitudinal study.  Changes in a local built environment, such as redevelopment, new construction, or policy, may create an opportunity for evaluation of a natural experiment.  For example, in one natural experiment, investigators documented a reduction in pediatric emergency department visits for asthma during the 1996 Atlanta Olympics when traffic volume and air pollution were temporarily reduced.

Project Activities:  Applications submitted in response to this SIP should focus on health and built environment issues which may include, but are not limited to, the following areas:

  1. Use of Health Impact Assessment methods to identify possible health effects of proposed built environment projects and policies, especially at the local and state level, and evaluation of whether the decision-makers modify their final decisions after being informed of such possible health effects.
  2. Conduct of supplemental work within existing longitudinal research studies, or development of case studies, to document improvements in health outcomes in natural experiments and in well-designed livable walkable communities.
  3. Collaborative projects with transportation planners to document health benefits of developing balanced transportation systems that include “complete streets” with sidewalks, bicycle lanes, and public transit.
  4. Identification and evaluation of incentives to encourage planners and developers to choose community designs (e.g. dense, connected mixed-use neighborhoods with sidewalks and parks) that promote rather than discourage healthy behaviors.
  5. Exploration of use of social marketing methods to increase public demand for communities designed to promote healthy behaviors such as walking and bicycling.
  6. Identification of methods to foster communication, trust, and common vocabulary between public health and community planners, engineers, transportation planners, architects, and builders.
  7. Evaluation of health impacts of various types of land use, zoning codes and/or parking regulations.
  8. Identification and evaluation of state and local policies that promote healthy community designs.
  9. Evaluation of community designs that promote health for vulnerable populations such as children, seniors, persons with disabilities, persons with low incomes, and minorities.
  10. Development of cost-effectiveness studies of the health impacts of building sidewalks, trails, and transit, and exploration of the economics of Smart Growth developments in relation to health benefits.
  11. Evaluation of the costs, benefits, and health impacts of Safe Routes to School programs.
  12. Development and evaluation of policies and programs to reduce adverse impacts of gentrification.

Applications submitted in response to this SIP should include the following:

  1. Proposed study objectives and methods, study population, and relationships between the built environment and public health to be investigated.
  2. Description of the innovative aspects of the proposed activity.
  3. Data sources, data analysis methods, and measurable outcomes.
  4. Description of the range of disciplines that will be involved with the study.
  5. Description of key project staff and their qualifications.
  6. Study timeframe, milestones, and expected outcomes.
  7. Description of how the proposal may be used to leverage the proposed activity with other support or resources, if applicable.
  8. Description of the project’s use of GIS data, if any.
  9. Description of any human subjects issues, if any.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (significance, approach, innovation, investigators, and environment), the following additional criteria specific to this SIP will be considered in the review process:

1.      Degree of interdisciplinary collaboration in conduct of project, working with public health, urban planners, transportation professionals, developers, architects, and other relevant disciplines.

2.      Likelihood that project results will have measurable impacts on public health.

3.      Degree of leveraging of support and resources from other sources.

4.      Scientific rigor of methods to evaluate the impacts of built environment on health outcomes.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages. Supporting material included as appendices is limited to ten attachments. The appendices should include material that show evidence of the applicant’s ability to successfully conduct the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $100,000 is available to fund one PRC in the first year of a 2-year project period. Funding may vary and is subject to change.

Research Status:  This project may or may not be classified as research involving human subjects.  If it is considered non-exempt research, the project will require local IRB approval, and applicants should provide a federal-wide assurance number for each performance site included in the project.

Award Administration:  CDC Project Scientists will have substantial programmatic involvement that is beyond the normal stewardship role in awards. CDC staff may serve as consultants or collaborators on this project, and will provide technical assistance on activities as needed.

References:

1.      American Journal of Public Health, Vol 93(9).  September 2003.  Special issue on  “Built Environment and Health”

2.      Transportation Research Board Special Report No. 282:  “Does the Built Environment Influence Physical Activity?  Examining the Evidence.” 2005. Available at http://onlinepubs.trb.org/onlinepubs/sr/sr282.pdf.  Accessed November 17, 2006.

3.      Ewing R, Kreutzer R.  Understanding the Relationship Between Public Health and the Built Environment, A Report Prepared for the LEED-ND Core Committee, May 2006.  Available at https://www.usgbc.org/ShowFile.aspx?DocumentID=1480.  Accessed November 17, 2006.

4.      Booth KM, Pinkston MM, Poston WSC.  Obesity and the Built Environment.  J Amer Diet Assoc.  2005; 105:S110-S117.


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