Part I Overview Information


 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

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


Participating Organizations

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


Components of Participating Organizations

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:  FY08 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 might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 

 

Authority:  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 strongly 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-08-002

Catalog of Federal Domestic Assistance Number:  93.135 Centers for Research and Demonstration for Health Promotion and Disease Prevention

 

Key Dates
Release/Posted Date: February 1, 2008

Letter of Intent Receipt Date: 
March 3, 2008
Application Submission Receipt Date:  
April 1, 2008
Peer Review Date(s):  
April/May 2008
Council Review Date:  
July 2008

Earliest Anticipated Start Date:  September 30, 2008

 

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary

·          This FOA will provide supplemental funding using the cooperative agreement (U48) funding mechanism to Prevention Research Centers (PRC) to design, test, and disseminate effective prevention research strategies in the areas of epilepsy, aging, and the built environment to promote public health.

·          The participating organization intends to commit approximately $550,000 in FY 2008 to this FOA.

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

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

·          Because the nature and scope of the proposed research will vary by Special Interest Project (SIP) and from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the quality and costs of the applications received.

·          Budget Period, Project Period, and Award Amounts:  The total project and budget period for an application submitted in response to this funding opportunity may not exceed one year.  Award amounts will vary by SIP.

·          Eligible Organizations:  PRCs funded under CDC Program Announcement 04003 are eligible to compete for 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. 

·           See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:  http://grants.nih.gov/grants/funding/424/index.htm (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf  (PDF)

·          For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/

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

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


 

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
 
        A. Cooperative Agreement

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

    3. Reporting

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

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

 

Section IX. Special Interest Projects (SIP) Descriptions

1.    Project Title

2.    Project Description and Objectives

3.    Project Activities and Submission Requirements

4.    Eligibility Criteria

5.    Additional Review Criteria

6.    Funding Preferences

7.    Research Plan Length and Supporting Material

8.    Availability of Funds

9.    Research Status

10.Award Administration

11.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 FOA addresses “Healthy People 2010” priority areas of disability and secondary conditions, educational and community-based programs, physical activity and fitness, and public health infrastructure.  It is in alignment with NCCDPHP’s performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions.  For more information see, www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.

 

Nature of the Research Opportunity

This FOA builds upon the infrastructure of the Prevention Research Center (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 FY08 Special Interest Projects (SIP) mechanism to provide supplemental funding to PRCs to design, test, and disseminate effective prevention research strategies in the areas of epilepsy, aging, and in the built environment to promote public health.

 

Background

As the U.S. 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.   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 Research Supported by this Program

This FOA is expected to fund research that will expand our knowledge and understanding in the areas of epilepsy, aging, and in the built environment.  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.

 

            Special Interest Project 1                    Epilepsy

            Special Interest Project 2                    Aging

            Special Interest Project 3                    Built Environment

 

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 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 $550,000 in FY08 to fund approximately five cooperative agreements, ranging in total costs (direct and indirect) from $100,000 to $150,000 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 size of each award will also vary.

An applicant may request a project period of up to one year.  The anticipated start date for new awards is September 30, 2008.  Following is a list of the SIPs, the total funding amount (direct and indirect) for the one year project/budget period, and anticipated number of awards:

SIP 1:  Managing Epilepsy Well (MEW) Collaborating Center for Epilepsy Self-management Intervention Research ($300,000, 3 awards at $100,000 each)

SIP 2:  Data on the Health of Older Adults at State and Local Levels ($100,000, 1 award)

SIP 3:  Technical Support for Health Impact Assessment at the Community Level ($150,000, 1 award)

 

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 provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

 

Section III. Eligibility Information


 

1. Eligible Applicants

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.  


2. Cost Sharing or Matching

 

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


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


3. Other-Special Eligibility Criteria

 

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 Grants.gov/Apply and follow the directions provided on that Web site.

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

 

·          Grants.gov Get Registered:  http://www.grants.gov/applicants/get_registered.jsp

·          eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

 

IMPORTANT:  Both the applicant organization, as well as, the Project Director/Principal Investigator (PD/PI) must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

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

The following three steps are required before an applicant institution/organization can submit an electronic application:

1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp

  • Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
  • If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
  • The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
  • Direct questions regarding Grants.gov registration to:
    Grants.gov Customer Support
    Contact Center Phone: 800-518-4726
    Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
    Email:  support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

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

  • The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
  • The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
  • This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
  • Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

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 Personnel
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 3, 2008

Application Submission Receipt Date:  April 1, 2008

Peer Review Date (s):  April/May 2008

Council Review Date:  July 2008

Earliest Anticipated Start Date:  September 30, 2008

3.A.1. Letter of Intent

 

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

·          Descriptive title of proposed research

·          Name, address, and telephone number of the Principal Investigator

·          Names of other key personnel

·          Participating institutions

·          Number and title of this funding opportunity

 

Although a LOI is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.  The LOI is to be sent by the date listed in Section IV. 3.A.  The LOI should be sent to:

 

Brenda Colley Gilbert, PhD, MSPH
Extramural Research Program Office
Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-8390
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 SF424 (R&R) instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via 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.  The applicants’ Authorized Organization Representative (AOR) 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 the 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 SF424 (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 – DP08-002

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST


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.

·          If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·          Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·          If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·          If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·          Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness and responsiveness by CoCHP 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.  Additional guidance can be found at HHS Grants Policy Statement.

 

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

 

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

·          Reimbursement of pre-award costs is not allowed.


6. Other Submission Requirements

 

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. 

 

Applicants’ research 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 Research Plan 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 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.

 

·          Publications in press:  Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

·          Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

·          Manuscripts published but a publicly available online journal link is not available:  The entire article may be submitted electronically as a PDF attachment.

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

·          Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

 

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.

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 Research Plan 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://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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


Section V. Application Review Information


 

1. Criteria
 

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

 

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

·          Availability of funds

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

·          For individual SIP review criteria, please refer to Section IX. Special Interest Projects (SIP) Descriptions of this announcement under Additional Review Criteria of the SIP description.  

 

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 CoCHP in accordance with the review criteria stated below.

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

 

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

·          Receive a written critique; and

·          Receive a second level of review by a Secondary Review Committee convened by HHS/CDC CoCHP.

 

Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.

 

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 the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals.  Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications.

 

·          Significance

·          Approach

·          Innovation

·          Investigators

·          Environment

 

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 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). 

 

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

 

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan; however, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.


2.D. Sharing Research Resources

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

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

 

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

3. Anticipated Announcement and Award Dates

 

HHS/CDC expects to announce awards in September 2008.

 

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 courtesy copy to the PD/PI at the time of award.


2.A. Cooperative Agreement

 

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

The administrative and funding instrument used for this program will be the cooperative agreement U48 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities


The Recipient will have the primary responsibility for the following:

 

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

2.A.2. HHS/CDC Responsibilities


An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  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.      Financial status report, no more than 90 days after the end of the budget period.

2.      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 provides 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
Extramural Research Program Office
Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-8390
Email:  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.

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

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

 

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

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

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

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

 

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 www.healthypeople.gov

 

Lobbying Restrictions

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

 

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

 

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

 

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

 

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

 

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

 

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 (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

 

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

 

For example:

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

 

Health Insurance Portability and Accountability Act Requirements

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

 

Release and Sharing of Data

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

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

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

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

 

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

 

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.

 

IX. Special Interest Projects (SIP) Descriptions


 

SIP 1:  Managing Epilepsy Well (MEW) Collaborating Center for Epilepsy Self-management Intervention Research

 

Project Description and Objectives:  The intent of this SIP is to develop the network of Prevention Research Centers (PRCs) for epilepsy self-management intervention research by supporting Managing Epilepsy Well (MEW) Collaborating Centers.  The 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 network is intended to address the applied research needs of CDCs’ Epilepsy Program’s priority areas, and the following 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 up to three collaborating centers to work toward completing a set of activities.  SIP activities will include:  1) coordination of a multidisciplinary epilepsy self-management research team; 2) 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) 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 and Submission Requirements:  Collaborating Centers are expected to actively participate in the existing MEW network which is managed by the MEW Coordinating Center.  The MEW Coordinating Center coordinates the network, documents network results, and works with collaborating centers to identify promising self-management interventions to evaluate.  Collaborating Centers will undertake one or more activities related to components 1 and/or 2.

 

Component 1   

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

 

Activities:

 

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

Objective:  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.

 

Activities:

 

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 process and impact outcomes of the intervention.

 

Eligibility Criteria:  None

 

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

 

1.      Experience in developing, planning, and implementing chronic disease self-management research, epilepsy self management research, or public health prevention research as evidenced by publications and/or previous funding.

2.      Experience with formal working agreements with partners engaged in intervention research.

3.      Experience in working with hard to reach populations.

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

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

6.      Experience in evaluating the impact of public health interventions.

 

Funding Preferences:  None

 

Research Plan Length and Supporting Material:  The research plan should not exceed 25 pages.  Supporting material included as appendices may not exceed five PDF attachments.  The appendices should include materials that show evidence of the applicant’s ability to successfully conduct the project, any needed letters of support, and other evidence as consistent with the proposal. 

 

Availability of Funds:  Up to three centers will receive funding as collaborating members (Collaborating Centers) of the MEW Network.  This funding is expected to be $100,000 per center for the 1-year project period.  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 specific component, and/or 2) research areas deemed a priority by the network and CDC are assigned to at least one PRC.  Funding may vary and is subject to change.

 

Research Status:  All data and data systems will be developed by the network and will not involve human subject research; therefore, CDC IRB approval should not be required.  Pilot projects chosen may involve local IRB review.

 

Award Administration:  CDC project scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff will assist collaborating centers in making human subject determinations.  The CDC staff for this project will serve as technical advisors and/or consultants.

 

 

SIP 2:  Data on the Health of Older Adults at State and Local Levels

 

Project Description and Objectives:  The U.S. population aged 65 years or older is growing at an unprecedented rate and will double to roughly 71 million in the next 25 years. The impact of this demographic shift will be far reaching and have major implications for health care spending, which is expected to increase by 25% by 2030.  In an attempt to improve and maintain the health of the “baby boom” generation and older adults, there is a critical need for increasing capacity to obtain local and state data to support translational research at the community level.  This is clearly evident from recent efforts to move evidence-based programs into public health practice.  As a result, we need to identify current data sources and innovative approaches to assist with planning, implementing, and evaluating the public health impact of programs for older adults in diverse communities.  Specifically, we need to identify current data sources and create new approaches for using available data that move away from traditional research models.

 

State and community practitioners recognize the importance of data on older adults for local program planning, implementation, and evaluation, but they consistently report that they do not know how or where to obtain such data.   Data on the use of Clinical Preventive Services (CPS) by older adults exist at the state and national level from a variety of sources such as the Behavioral Risk Factor Surveillance System (BRFSS).  In the BRFSS survey respondents are asked about the number of times the person has received CPS in the last 12 months (the person giving the survey provides a list of those services).  Results from the 2004 BRFSS indicated that the majority of older adults had not received CPS services as recommended (only 38.4% of men and 31.6% of women aged 65 years or older) despite Medicare coverage of these services. 

 

      State and community programs for older adults must also address other important issues related to the aging of America.  According to the Alzheimer’s Association, an estimated 5.1 million Americans currently have Alzheimer’s disease and this number is expected to rise to between 11 and 16 million by 2050. Currently, about 10 million Americans are caring for someone with Alzheimer’s disease or another dementia, which constitutes approximately 29% of all caregiving among people aged 60 years or older. This translates into almost $83 billion of unpaid care, which is not reflected in most national health care estimates (Alzheimer’s Association, Alzheimer’s Facts and Figures 2007).  Although surveys have been done at the national and state levels to characterize caregiving, these data are not readily accessible at the state level.  Even less information is available at the community level, making this issue even harder to address.

 

Depression among older adults is a cross-cutting issue among older adults that is important to many programs and activities in public health.  Depression is not a normal part of growing older but rather a treatable condition.  Associated with psychological distress and suffering that leads to impairments in physical, mental, and social functioning, depression is a widely under-recognized condition and often untreated or under-treated  in older adults. (Mental Health: A Report of the Surgeon General).  For example, among those aged 65 years and older, 15% experience some degree of depressive symptoms. (Alexopoulos GS et al: Postgraduate Medicine October:1-86, 2001).  Recently, CDC supported a systematic literature review that appraised published studies on community-based interventions and screening for depression in older adults when depression is the primary outcome (Frederick JT, Steinman LE, Prohaska T, Satariano WA, et al. Community-Based Treatment of Late Life Depression: An Expert Panel–Informed Literature Review. Am J Prev Med 2007;33(3):222–249).

 

This SIP will fund one PRC to conduct activities that will focus on a select set of clinical preventive services, such as those in the State of Aging and Health Report 2007 (www.cdc.gov/aging/) and one of the aging related topics – caregiving specifically related to Alzheimer’s disease or depression.  The intent of this project is to inform public health programming and decision making by:

a.      Characterizing the types of data available at the state and local level;

b.      Identifying gaps in current data availability;

c.       Developing a “proof of concept” or “pilot” demonstrating how the data and methods could be applied to an evidence-based program; and

d.      Disseminating the identified data sources and pilot data to states and communities.

 

Project Activities and Submission Requirements:  Applications submitted in response to this SIP should address CPS and either:  (1) caregiving specifically related to Alzheimer’s disease, or (2) depression. Data collection and reporting activities need to consider differences in guidelines and data sources for adults in the U.S. in both people aged 50-64 and people aged 65 and older.  Project activities will include:   

 

1.      Convening a group of subject matter experts for the project.  At a minimum the research plan should describe the types of experts to be consulted, roles and responsibilities of the group, and the method by which they will be selected.

2.      Systematically identify and access data sources for the CPS and activities in the selected topic (i.e., caregiving or depression).  The research plan should address each of the items below:

a.   Describe the procedures for identifying data sources. This may include, but is not limited to, reviewing existing data reports; examining a sample of federal, state, and local public health and aging agencies data systems; and reviewing the literature. Provide examples of potential data and datasets that may be relevant at the state and local levels. If national datasets are included indicate how this is relevant to state and local program use;

b.   Describe the methods for consulting with public health and aging services network professionals at the state and local levels to understand their need for such data, their ability and barriers to access and analyze it, and the formats in which they find it most useful;  

c.    Indicate how the proposed approach moves away from traditional research models of data collection and embraces a system approach that can permit on-going data collection and comparable information across related programs; and

d.   Identify and document current gaps in data based on the needs described by state and local professionals and the expert team.

3.      Developing the “proof of concept” or “pilot” for one issue (CPS, caregiving, or depression). This may include, but is not limited to, the following:

a.      Provide a rationale for the issue selected; and

b.      Describe the methods for the “proof of concept” or “pilot” project illustrating how the data and methods could be applied to a specific evidence-based program:  (a) CPS (e.g., Sickness Prevention Achieved through Regional Collaboration [SPARC] www.sparc-health.org/); (b) caregiving (e.g., Resources for Enhancing Alzheimer's Caregiver Health [REACH] www.cmha.ua.edu/resources.html); or (c) depression/mental health (e.g., Program to Encourage Active, Rewarding Lives for Seniors [PEARLS] www.seattle.gov/humanservices/aging/Staff-Peers/Pearls.htm).

4.      Describe how the identified data from items #2 and #3 will be made available to state and local public health and aging service network professionals in a timely and user-friendly format.

 

Eligibility Criteria:  None

 

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

 

1.      Experience working with evidence-based programs.

2.      Experience with developing and using data systems in evidence-based programming.

 

Funding Preferences:  None

 

Research Plan Length and Supporting Material:  The Research Plan is limited to 20 pages.  Supporting material included as appendices may not exceed five PDF 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 $100,000 is available to fund one PRC for the 1-year project period. Funding may vary and is subject to change.

 

Research Status:  This project will not involve human subject research; therefore, it does not require CDC IRB approval.  All data and data systems will be existing data and free of identifying data.

 

Award Administration:  CDC Project Scientist 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 will provide technical assistance on activities such as identifying expert team members, identifying existing data sources, and engaging the public health and aging service network professionals at the state and local level.

 

References:

Administration on Aging. A profile of older Americans:  2005.  (2007). Washington, DC, Department of Health and Human Services.

Alzheimer’s Association.  Alzheimer’s disease facts and figures 2007.  Chicago, IL: Alzheimer’s Association; 2007.

Centers for Disease Control and Prevention and The Merck Co. Foundation.  The State of Aging and Health in America 2007.  Whitehouse Station, NJ: The Merck Company Foundation; 2007.

Talley, R. C. & Crews, J. E. (2007). Framing the public health of caregiving. Am.J.Public Health, 97, 224-228.

 

 

SIP 3:  Technical Support for Health Impact Assessment at the Community Level

 

Project Description and Objectives:  To promote regular physical activity, improve dietary quality, and prevent and control obesity, the Division of Nutrition, Physical Activity and Obesity’s (DNPAO) mission recognizes that an ecological approach to these efforts is necessary.  Built environment approaches, such as placement of sidewalks or trails in neighborhoods to encourage walking or biking or locating farmers markets in neighborhoods to promote fruit and vegetable consumption, are community-based approaches which make the right choice the easy choice. 

 

Health Impact Assessment (HIA) is a tool to help decision makers better recognize the health consequences of proposed policies or built environment projects, and provide recommendations to mitigate negative health and promote positive health outcomes.  To date, 26 HIAs have been completed in the U.S. that assessed health outcomes such as physical activity, obesity, pedestrian injuries, asthma, academic performance, stress, mental health, social capital, well-being, and air and water quality.  These HIAs have impacted community decisions.  For example, in San Francisco, the Trinity Plaza and Rincon Hill HIAs led to increased affordable housing units, funds for parks, and community facilities.  The living wage ordinance HIA contributed to its passage by the San Francisco board of supervisors, and the public housing flooring policy HIA led to better recommendations for design.

 

Over the past four years, CDC has emerged as a national leader in HIA.  To date, there are few individuals who have been trained in HIA methodology in the U.S. and even fewer people who have completed HIAs.  To address this need for training CDC has worked with numerous internal and external partners to create and conduct one-to-three-day HIA courses and, since 2005, over 400 local public health practitioners, urban planners, and transportation engineers across the country have been trained.  The goal of the more intensive two-to-three-day courses is for participants to complete a HIA in their community within one year of the course with ongoing technical support.  Six month and one year evaluations of participants from the longer courses, who come to the training as teams with a HIA project selected, revealed that the biggest barriers to completing the HIA is staff turnover and insufficient time to devote to HIA. 

 

An expert panel concluded that “Based on HIA experience elsewhere, barriers to HIA use in the U.S. include the lack of domestic experience and the need for tools, documentation, training, and resources” (Dannenberg et al., 2006).   The objective of this SIP is to increase the use of HIA in communities by decreasing current barriers to completing HIAs, increasing domestic experience, and increasing HIA tools, documentation, and resources that will further develop HIA methodology.  The intent is to assess the feasibility of using external partners to provide technical assistance to local agencies in the use of HIA.  Types of technical assistance may include: 1) staff and stakeholder HIA training to local agencies; 2) continuity of expert staff and researchers to assist local agencies throughout the HIA process, including scoping, data collection, and qualitative and quantitative assessment; and 3) expertise in and capacity to conduct HIA process and impact evaluations. 

 

This SIP will fund one Prevention Research Centers (PRC) to develop, implement, and evaluate a pilot project that will assist local agencies already trained in HIA methodology to successfully complete their first HIA.  The PRC will provide HIA technical assistance, support, and expertise.

 

Project Activities and Submission Requirements:  Applications submitted in response to this SIP should present the following information:  

 

1.      Provide a description of the organization’s mission, history, and current programs that address land use planning or public health and organizational structure.  Emphasis should be given on expertise in HIA, capacity to provide HIA technical assistance to assist local agencies throughout the HIA process, capacity to conduct process and impact evaluation on the HIA(s) and current successful collaborative activities with local public health agency(ies), local planning or transportation agency(ies), and other community stakeholders.

2.      Provide a rationale for selecting an HIA for implementation and identify potential collaborators at the local level.  Describe the issues that will be addressed in conjunction with community stakeholders through health impact assessment, including how HIA will be implemented, what parties will be involved in implementation, desired outcomes from the process.

3.      Describe the type of technical assistance that will be provided by the PRC during the project.

4.      Describe an evaluation plan that will assess the effectiveness of technical assistance provided by an external partner in HIA completion and the success of the project toward completing the HIA.  The assessment plan should include identification of barriers and facilitators to HIA at the local level.

5.      Describe how results from the project can be utilized and disseminated to promote HIA to communities and stakeholders.

 

Eligibility Criteria:  The following criteria specific to this SIP will be used to determine the institution’s eligibility:

 

1.      The PRC must have previous experience with HIA or at least one member of the project team must have attended a HIA training.  Evidence must be provided in the CV of a research team member.

2.      The applicant must have a policy or project identified for the HIA.  Evidence must be provided in the form of a description of the project or policy that will be examined as part of the project activities.

 

Additional Review Criteria:  None

 

Funding Preferences:  None

   

Research Plan Length and Supporting Material:  The Research Plan is limited to15 pages.  Supporting material included as appendices may not exceed ten PDF 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 $150,000 is available to fund one PRC for the 1-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 number for each performance site included in the project.

 

Award Administration:  CDC Project Scientist 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 will provide technical assistance on activities such as provide consultation on the design and scope of the HIA(s), data analysis, formulation of recommendations resulting from the HIA and dissemination of results.

 

References:

Dannenberg AL, Bhatia R, Cole BL, Dora C, Fielding JE, Kraft K, et al. Growing the field of health impact assessment in the United States: an agenda for research and practice. Am J Public Health 2006;96(2):262-70.

San Francisco Department of Public Health, Environmental Health Section, http://www.dph.sf.ca.us/phes/ENCHIA.htm.

 

 

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

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

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