Part I Overview Information


Department of Health and Human Services

Participating Organizations

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

Components of Participating Organizations

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), (http://www.cdc.gov/nccdphp/)
Health
Promotion and Disease Prevention Research Centers Program (PRC), (http://www.cdc.gov/prc/)

Title: Health Promotion and Disease Prevention Research Centers:  Special Interest Project Competitive Supplements

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

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 04-003 which was released on March 27, 2003.

Request For Applications (RFA) Number: RFA-DP-06-003

Catalog of Federal Domestic Assistance Number(s): 93.135

Key Dates
Release Date:  April 10, 2006
Letter of Intent Receipt Date: April 19, 2006
Application Receipt Date: May 19, 2006
Peer Review Date: Week of June 26, 2006
Council Review Date: Week of July 17, 2006
Earliest Anticipated Start Date: September 30, 2006
Expiration Date: 05/20/2006

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

Additional Overview Content

Executive Summary 

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Section IX.  Special Interest Projects (SIPs) Descriptions

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

Part II - Full Text of Announcement


Section I. Funding Opportunity Description

1. Research Objectives

The CDC and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority areas of Access to Quality Health Services, Public Health Infrastructure, Cancer, Disability and Secondary Conditions, Educational and Community-Based Programs, Family Planning, Sexually Transmitted Diseases, Nutrition and Overweight, Adolescent Health, and Heart Disease and Stroke and is in alignment with the NCCDPHP performance goal to support prevention research to develop sustainable and transferable community-based behavioral interventions.  For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

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

Nature of the Research Opportunity

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

Background

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

In 1984 Congress authorized HHS to create a network of academic health centers to conduct applied public health research.  CDC was selected to administer the Prevention Research Centers (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 Special Interest Projects (SIPs) mechanism, created in 1993, allow the PRCs to compete for research projects sponsored by CDC organizational units and other HHS agencies that want to utilize their resources to fund research that promotes better public health practice in specific areas.  Typically, SIPs are funded for a minimum of one year and $100,000; however, there are many SIPs that are multi-year endeavors to which several million dollars are dedicated.  The SIP mechanism is designed to maximize on the expertise and resources offered by each center and the PRC network as a whole.

Scientific Knowledge to be achieved through this Funding Opportunity

This RFA is expected to fund research that will expand our knowledge and understanding in the areas of cancer, reproductive health, child and adolescent health, and adult health.  Individual project descriptions are contained in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement.  SIP descriptions are grouped by the following topical areas:

            Cancer                                      Special Interest Projects 1-2

            Reproductive Health                Special Interest Projects 3-4

            Child and Adolescent Health  Special Interest Projects 5

            Adult Health                              Special Interest Projects 6-8

Each SIP has specific anticipated outcomes and/or expected deliverables.  Please refer to the Project Activities of the SIP description in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement.

Experimental Approach and Research Objectives

The research objectives of the SIPs are in alignment with the performance goal for the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP):  To support prevention research to develop sustainable and transferable community-based behavioral interventions.  The experimental approach and objectives for each SIP are detailed in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Project Descriptions and Objectives of the SIP description. 

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the CDC U48 award mechanism.

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

The CDC U48 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

This RFA is a one-time solicitation.

2. Funds Available

The NCCDPHP intends to commit approximately $1,850,000 in FY06 to fund approximately nine cooperative agreements ranging in total costs, direct and indirect, from $100,000 to $350,000 in response to this funding opportunity.  Because the nature and scope of the proposed research will vary by SIP, and from application to application, it is anticipated that the size and duration of each award will vary.  In previous years, the amount of funding per SIP has ranged from $100,000 to $1,250,000.

The anticipated start date for each SIP is September 30, 2006.  Performance periods will vary by SIP.  The performance period for each SIP is detailed in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Availability of Funds of the SIP description.  Following is a list of the SIPs, their titles, and total funding amounts (direct and indirect) for the first 12-month budget period:

Cancer

SIP 1:  Inventory and Assessment of National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Interventions ($250,000)

SIP 2:  Integration and Evaluation of an Existing Cancer Survivorship Educational Material into a Clinical Setting ($200,000)

Reproductive Health

SIP 3:  Identifying intervention needs of youth living in communities with high rates of teen pregnancy ($300,000)

SIP 4:  Intervention Research on Youth Development to Prevent Teen Pregnancy ($350,000)

Child and Adolescent Health

SIP 5:  Building Capacity for Community Monitoring System to Track Indicators of Child and Adolescent Well-being ($200,000 to fund two projects)

Adult Health

SIP 6:  Reliability Study of the “Actions to Control High Blood Pressure” Module in the Behavioral Risk Factor Surveillance System ($100,000)

SIP 7:  Intervention Research on Home-based Depression Treatment in People with Epilepsy ($200,000)

SIP 8:  Identification and Development of Prevention Opportunities to Promote or Maintain                Brain Health in Older Adults ($250,000)

All estimated funding amounts are subject to availability of funds. 

CDC will accept and review applications with budgets greater than the listed funding amount for the SIP.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

Only applicants who have applied for and have been selected as Prevention Research Centers under CDC Program Announcement 04-003 are eligible to compete for the Special Interest Project (SIP) supplemental funding.  Competition is limited to Prevention Research Centers funded under PA 04-003 because they are uniquely positioned to perform, oversee, and coordinate community-based participatory research that promotes the field of prevention research due to their established relationships with community partners.  The supplemental projects in this RFA complement ongoing prevention research projects being conducted as part of the CDC Prevention Research Program.   

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

2. Cost Sharing or Matching

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

The most current Grants Policy Statement can be found at:

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

3. Other-Special Eligibility Criteria

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

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

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

3. Submission Dates and Times

All requested information must be received in the CDC Procurement and Grants Office by 4:00 p.m. Eastern Time on the deadline date. If you submit your application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If CDC receives your submission after closing due to: (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline. 

This announcement is the definitive guide on LOI and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.

Otherwise, CDC will not notify you upon receipt of your submission.  If you have a question about the receipt of your 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 submissions to be processed and logged.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: April 19, 2006
Application Receipt Date:  May 19, 2006
Peer Review Date:  Week of June 26, 2006
Council Review Date: Week of July 17, 2006
Earliest Anticipated Start Date: September 30, 2006

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
FAX:   (770) 488-8046
Email: bjc4@cdc.gov

3.B. Sending an Application

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

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

Technical Information Management Section – RFA DP-06-003
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA  30341

At the time of submission, three additional copies of the application, including the appendix material, must be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion

Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
Email: bjc4@cdc.gov

3.C. Application Processing

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

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

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

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

6. Other Submission Requirements

A PRC may apply for multiple Special Interest Projects; however, a separate application must be submitted for each SIP.   The application must clearly indicate which SIP you are applying for.  Only one application per Special Interest Project will be accepted from a PRC. 

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

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. 

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

Plan for Sharing Research Data

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

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

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

Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by 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://www.cdc.gov/od/pgo/forminfo.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.

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness.  In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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

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 work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

Individual SIP Preferences:  Does the applicant adequately address the preferences detailed in the Special Interest Project they are applying for?  SIP preferences are detailed in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Additional Review Criteria and Funding Preferences of the SIP description.

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

Inclusion of Women and Minorities in Research:

Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

2.D. Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.
 
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. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. 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://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates

CDC expects to announce awards on or about September 30, 2006.

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

2. Administrative and National Policy Requirements

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2.A.1. Principal Investigator Rights and Responsibilities

The rights and responsibilities of the Principal Investigator are delineated in Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Award Administration of the SIP description.

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

2.A.2. CDC Responsibilities

A NCCDPHP Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  Each SIP lists specific responsibilities and applicants should refer to Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Award Administration of the SIP description for details.

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

2.A.3. Collaborative Responsibilities

Each SIP has specific collaborative responsibilities.   Please refer to Section IX. Special Interest Projects (SIPs) Descriptions of this announcement under Award Administration of the SIP description for details.
 
3. Reporting

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

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

2. Annual Progress Report, due 90 days after the end of the budget period. Financial status report, no more than 90 days after the end of the budget period.

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

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

Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-6295
Email: bjc4@cdc.gov

2. Peer Review Contacts:

Scientific Review Administrator
Office of Extramural Research
National Center for Chronic Disease Prevention and Health Promotion
4770 Buford Highway, MS K-92
Atlanta, GA  30341
Telephone: (770) 488-8390
Email: OER@cdc.gov
 
3. Financial or Grants Management Contacts:

Lucy Picciolo
Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road, Room 3000
Atlanta, GA 30341
Telephone: (770) 488-2683
FAX: (770) 488-2777
Email: LPicciolo@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  770-488-2700
Email:  PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

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

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

HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National AIDS Clearinghouse.

Patient Care
Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1. A description of the population to be served.

2. A summary of the services to be provided.

3. A description of the coordination plans with the appropriate state and/or local health agencies.

4. If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

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

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

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

Lobbying Restrictions

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

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

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

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

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

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

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

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

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

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

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (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.  CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

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

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) www4.law.cornell.edu/uscode/html/uscode05/usc_sec_05_00000552----000-.html.

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

Section IX. Special Interest Projects (SIPs) Descriptions


Cancer

SIP 1:  Inventory and Assessment of National Breast and Cervical Cancer Early Detection Program (NBCCEDP) Interventions

Project Description and Objectives:  The purpose of this project is to conduct an evaluation of interventions used by programs funded through the National Breast and Cervical Cancer Early Detection Program (NBCCEDP).  The types of interventions to be evaluated will include:  1) interventions used for the recruitment of women for screening in the NBCCEDP; and 2) interventions used by NBCCEDP programs for professional development of health care providers and program staff.  CDC expects, at a minimum, that the results of this project will help to assess the degree to which these interventions are evidence-based.

The NBCCEDP is a program administered by CDC which provides access to breast and cervical cancer screening services for low-income underinsured and uninsured women in the United States.  The NBCCEDP is implemented through cooperative agreements with state and territorial health departments in all 50 states, the District of Columbia, and four U.S. territories, and with 13 American Indian/Alaska Native tribes or tribal organizations.The majority of the federal funds spent through the NBCCEDP are used for direct patient services, but some funds are used to support other activities including recruitment of women for screening and professional development of staff.  Individual programs in the NBCCEDP use a variety of intervention strategies for professional development and for recruitment of women for screening.  A public health gap exists because the interventions being implemented by the public health agencies responsible for providing these critical services have not been systematically assessed to determine whether they are evidence-based and effective.

In addition, there is currently no systematic way for these breast and cervical cancer early detection programs to share the interventions used for recruitment of women for screening and for professional development of staff.  To improve public health and to assist the state and local cancer detection programs, CDC has begun developing a database of select interventions funded under the NBCCEDP for recruitment of women for screening and for professional development.  (Note:  This database will be available to investigators funded through this project.)

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

1. Describe the process and activities that will be used to create an inventory of funded NBCCEDP interventions related to professional development of health care providers and program staff and the recruitment of women for screening.  Describe how the applicant will work with CDC’s Division of Cancer Prevention and Control to gather the information needed to create the inventory.  CDC does not expect a survey to be developed.  Applicants may want to consider such activities as:   

2. Describe the process and activities that will be used to assess the evidence-base for recruitment and professional development interventions implemented by state and local health agencies as they relate to breast and cervical cancer screening.  Sources of information about the evidence base for interventions may include, but are not limited to, the Guide to Community Preventive Services (www.thecommunityguide.org), the Research Tested Intervention Programs (RTIPs) through Cancer Control Planet (www.cancercontrol.cancer.gov/rtips/), and the Cochrane Collaboration reviews (www.cochrane.org).  Sources of evidence could include systematic reviews (such as the Guide to Community Preventive Services), meta-analyses, and individual studies.  Examples of activities that the applicant may consider are:

Developing a rating system to assess the evidence supporting the interventions.  Examples of rating systems are the system used by the Guide to Community Preventive Services (Table 2 in Briss et al.2) and the system used for the Substance Abuse and Mental Health Services Administration’s National Registry of Effective Programs and Practices (www.modelprograms.samhsa.gov).  Some components of the rating system the applicant may consider are:

3. Describe the dissemination plan for the outcomes of this work and how these efforts may increase the use of evidence-based interventions by state and local public health agencies (e.g., the NBCCEDP programs).  Some activities that applicants may consider are publication of peer-reviewed manuscripts, presentation of project results at appropriate public health conferences or other appropriate venues, and technical assistance seminars to interested stakeholders.

4. Describe any activities that will be conducted to identify additional research needs associated with the breast and cervical cancer early detection programs that could enhance the delivery of cancer screening.  For example, applicants could:

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

1.      Demonstrate knowledge of the National Breast and Cervical Cancer Early Detection Program.

2.      Demonstrate understanding of community interventions to increase cancer screening.

3.      Demonstrate experience with literature reviews and/or systematic evidence reviews of intervention research.

4.      Demonstrate experience in providing technical assistance to state or local level public health programs.

5.      Receive funding as a member of the Prevention Research Centers Cancer Prevention and Control Research Network.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages.  Supporting materials in the appendices should not exceed 40 pages.  Supporting materials should show evidence of the applicant’s ability to successfully complete the project described, any needed letters of support, and any other evidence consistent with the contents of the proposal.

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

Research Status:  This project will not involve human subjects research; therefore, it does not require CDC IRB approval. 

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 collaborators and are expected to provide technical assistance for activities including development of the inventory of interventions, assessment of the evidence-base for the interventions, and dissemination of the outcomes of the project.  CDC assistance will include providing access to the existing database of interventions.

References:

1 Ryerson AB, Benard VB, Major AC.  The National Breast and Cervical Cancer Early Detection Program 1991–2002 National Report. Atlanta (GA): Department of Health and Human Services; 2005.  (http://www.cdc.gov/cancer/nbccedp/reports/nationalreport/index.htm).

2 Briss PA, Zaza S, Pappaioanou M, et al.  Developing an evidence-based Guide to Community Preventive Services – Methods.  Am J Prev Med 2000;18(1S):35-43.

SIP 2:  Integration and Evaluation of an Existing Cancer Survivorship Educational Material into a Clinical Setting

Project Description and Objectives:  The Centers for Disease Control and Prevention (CDC) is interested in efforts to create and implement successful strategies to help the millions of cancer survivors live with, through, and beyond cancer.  A recent IOM report, From Cancer Patient to Cancer Survivor: Lost in Transition (Hewitt) identifies many concerns related to having been diagnosed with cancer. These concerns include receiving and following appropriate follow-up care plans, experiencing a variety of emotions, dealing with pain or disfigurement, changing health behaviors (i.e., smoking cessation), diet and exercise, reframing personal relationships and work roles, and managing financial consequences.  A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies (CDC) charts a course for how the public health community can more effectively address the needs of cancer survivors. Recommendations include developing public education programs that empower cancer survivors to make informed decisions, conducting ongoing evaluation of activities to determine their efficacy and ensure continuous quality improvement of services, and identifying programs and services that best address the needs of cancer survivors. It is unknown, whether cancer survivors and their family find cancer survivorship educational materials understandable and useful, or whether these materials have any effect on outcomes such as follow-up care, the ability to understand and identify help for emotional and practical issues related to cancer, management of treatment-related side effects, and quality of life.

The objective of this project is to incorporate existing cancer survivorship educational materials or psychosocial resources into a clinical setting in order to evaluate the acceptability, use, and effect on the cancer survivorship experience including, receiving appropriate follow-up care, knowledge of cancer treatment received, management of emotional, social, and practical concerns (i.e. financial consequences and advance directives), and quality of life. The potential impact of this research would be to define the outcomes and value of the educational material(s) for survivors, and to identify areas for further improvement such as content and distribution of the materials.

Multiple organizations have developed survivorship educational materials and the intent of this project is to evaluate existing materials or resources in order to prevent duplication of efforts and promote further development and refinement of previous work. It is expected that the evaluation of existing survivorship educational materials will be useful in determining the effectiveness of these educational materials as well as determining their usefulness among the targeted population of survivors.  It is also expected that the results of this project will help inform comprehensive cancer control coalitions and clinicians in their recognition and recommendation of survivorship materials.

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

1. Describe the rationale and processes used to select a freely-available educational material that has been developed by a national cancer or cancer survivorship organization for a target audience of general cancer survivors (i.e., not cancer site-specific). Appropriate national community-based resources are listed in Table 4.11 of the From Cancer Patient to Cancer Survivor: Lost in Transition (Hewitt).

2. Describe the eligible study population, study design and methods to incorporate the existing survivorship educational material into a routine clinical setting using a randomized study.  Randomization may occur within the same clinic or in two separate clinic settings as long as the choice of design is justified.

3. Describe the proposed study population and how all eligible survivors will be recruited to participate and methods to assess enrollment (including invited participants, refusals, and enrolled participants).

4. Describe how the survivorship material will be distributed within a routine clinical setting to the group randomized to receive it and propose a comparable non-survivorship related material that will be offered to the control population.

5. Define desired outcomes from survivor’s use of the survivorship material.  Outcomes may include, but are not limited to:

a. Measurement/management of psychological concerns (e.g., depression, adjustment to cancer, and resilience);

b. Measurement of how materials influence survivor awareness and knowledge about cancer survivorship;

c. Measurement of whether or not exposure to materials influences participation in cancer support groups and patient information gathering; and

d. Measurement of effect of materials on the patient-provider relationship (e.g., were survivors exposed to the materials more likely to be prepared to ask their providers about concerns related to their cancer treatment, recovery, and long-term health, did exposure to the materials make survivors feel more empowered in dealing with their cancer).

6. Describe how the desired outcomes of educational material will be assessed in both the intervention and control group in terms of acceptability, use (i.e. did they use the material and to what extent), and effect on knowledge and behaviors related to the clinical, emotional, and practical issues related to cancer survivorship.  Include how the study instruments for the assessment will be developed and piloted.

7. Describe how and when the participants will be followed, including the timeframe or time interval between the distribution or administration of the educational materials and when the survivors will be assessed.

8. Describe how the data will be analyzed, including the comparison of the intervention and control groups.

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

10.  Identify how the knowledge learned from this project will be communicated back to the organization that created the survivorship material and how the results will be disseminated.

Additional Review Criteria and Funding Preferences:  In addition to the standard review criteria used to evaluate the scientific and technical merit of applications (Significance, Approach, Innovation, Investigators, and Environment), this SIP will give preference to proposals that demonstrate the following:

1. Access to a population of survivors, including but not limited to groups with known cancer outcome disparities.

2. Support from the national cancer or cancer survivorship organization which developed the proposed educational material to be evaluated.

3. Sound study design and previous experience in evaluating educational materials or programs including the development and piloting of evaluation materials.

4. Familiarity of existing standardized assessment tools used in previous survivorship research.

5. The applicants’ previous experience of successfully completed projects with similar design including dissemination of results through publications.

6. The applicants’ previous experience with incorporating patient educational materials into clinical practice.

Project Proposal Length and Supporting Materials:  Proposal narratives are limited to 20 pages.  Supporting material included in the appendices should not exceed 40 pages; the appendices should show evidence of the applicant’s ability to conduct the research, any needed letter of support (e.g. the national and/or local-branch of the established survivorship program that will be evaluated), and any other evidence that supports the ability to conduct the proposed research

Availability of Funds:  Approximately $200,000 is available to fund one application in the first year of a 3-year project.  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 need approval by the IRB at the recipient institution. Applicants should provide a federal-wide assurance registration 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 provide technical assistance as needed related to cancer survivorship, appropriate materials, and dissemination of results, and is expected to consult on the design, methodology and analysis of the data.  Awardees will retain custody of and have primary rights to the data and software developed under this SIP, subject to Government rights of access consistent with current HHS, PHS, and CDC policies. 

References:

1. CDC, Lance Armstrong Foundation. A National Action Plan for Cancer Survivorship: Advancing Public Health Strategies, Available online at: http://www.cdc.gov/cancer/survivorship/overview.htm

2. Hewitt M, Greenfield S, and Stovall E, Eds, Committee on Cancer Survivorship: Improving Care and Quality of Life, Institute of Medicine and National Research Council, From Cancer Patient to Cancer Survivor: Lost in Transition. Washington DC: National Academies Press, 2006.  Available online at: http://www.nap.edu/books/0309095956/html/

3. Pollack LA, Greer GE, Rowland JR, et al. Cancer Survivorship: A New Challenge in Comprehensive Cancer Control.  Cancer Causes Control. Oct 2005, 16 (S1), 51-59.

Reproductive Health

SIP 3:  Identifying intervention needs of youth living in communities with high rates of teen pregnancy

Project Description and Objectives:  Despite recent improvements in teen pregnancy and birth rates, much work remains to be done to achieve Healthy People 2010 teen pregnancy goals and to reduce disparities.   In 2000, the pregnancy rate among 15-17 year olds was 53.5 per 1,000 females, while the 2010 goal is to reach 43 pregnancies per 1000 females by 2010.  Geographically, teen pregnancy is unevenly distributed, with some areas more affected than others.  For example, the southern states share a disproportionate burden of teen births.  Further, within each state there is a similar pattern of uneven distribution of teen births, with some counties and communities having much higher teen birth rates than others. 

The purpose of this project is to support research that can be used to help achieve national teen pregnancy prevention goals by focusing efforts on communities with high rates of teen pregnancy.   Particular interest is in the development of research methods that can be used by state and local agencies to: 1) identify communities with high rates of teen pregnancy and births, 2) identify interventions that meet the teen pregnancy prevention needs of those communities, and 3) monitor changes in sexual behavior and teen births.  Examples of the research methodologies that will be supported by this SIP include those that employ innovative use of GIS with “place-based” approaches (e.g., Weir et al 2003 & 2005) and/or respondent driving sampling (e.g., Auerswald et al 2004), and that integrate qualitative and quantitative methodologies.

Accordingly, CDC seeks applications to develop research methods to help identify the teen pregnancy prevention needs of communities with high rates of teen pregnancy.  Applications should state how this research will fill the knowledge gaps identified above and have relevance to improving public health practice.

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

1. To develop research methods that help local governments and agencies to identify and meet the needs of communities with high rates of teen pregnancy and sexually transmitted infections.  Activities that may be included to meet this objective are:

2. To pilot test the applied research methodology.  Activities that may be included to meet this objective are:

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

1. Demonstrate evidence of capacity to develop and pilot test applied research methodologies such as those described above and to publish results of adolescent health research.

2. Demonstrate experience with and willingness to collaborate with community groups and service delivery providers who work on teen pregnancy prevention, such as state teen pregnancy coalitions.  Collaboration with community groups should be consistent with community-based participatory research approaches that engages community members, derives understanding and is the basis for interventions from local knowledge of health problems, and invests community members in all stages of research, including its products (AHRQ 2003).

Project Proposal Length and Supporting Materials:  Proposal narratives are limited to 25 pages.  Supporting materials included in the appendices should not exceed 40 pages; the appendices should include materials that show evidence of the applicant’s ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal.

Availability of Funds:  Approximately $300,000 is available to fund one application in the first year of a 3-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 the project will require local IRB approval and review by the CDC IRB.  Applicants should provide a federal-wide assurance registration number for each performance site included in this 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 co-investigator/consultant on these projects.  CDC staff is expected to collaborate on project activities including intervention and study design, methods, sampling, data analysis, and co-authoring manuscripts.

References:

1.   Agency for Health Care Research and Quality (2003).  The role of community-based participatory research: creating partnerships, improving health.  AHRQ Publication No. 03-0037.  Available online at:  www.ahrq.gov/research/cbprrole.htm .

2.   Auerswald C, Green K, Minnis A, Doherty I, Ellen J, Padian N (2004).  Qualitative assessment of venues for purposive sampling of hard-to-reach youth:  An illustration in a Latino communitySexually Transmitted Diseases, 31(2):133-138.

3.   Hamilton BE, Sutton PD, Ventura SJ (2003).  Revised birth and fertility rates for the 1990s and new rates for Hispanic populations, 2000 and 2001: United StatesNational Vital Statistics Reports, 51 (12), August 4. 

4.   Scrimshaw NS and Gleason GR (1992).  Rapid Assessment Procedures - Qualitative Methodologies for Planning and Evaluation of Health Related Programmes.  International Nutrition Foundation for Developing Countries (INFDC), Boston, MA. USA.  Available online at:  www.unu.edu/unupress/food2/UIN08E/UIN08E00.HTM .

5.   Ventura SJ, Abma JC, Mosher WD (2004).  Estimated pregnancy rates for the US, 1990-2000: An UpdateNational Vital Statistics Reports, 52 (23), June 15.  

6.   Weir S, Pailman C, Mahlalela X, Coetzee N, Meidany F & Boerma JT (2003).  From people to places: Focing AIDS prevention efforts where it matters mostAIDS, 17:895-903. 

7.   Weir S, Tate J, Zhusupov B, Boerma J (2005).  Where the action is: Monitoring local trends in sexual behaviorSexually Transmitted Infections, 80:63-68.

1By “rapid assessment” we refer to data collection methods that help program planners to quickly develop a preliminary understanding of a situation from the insider's perspective, and can be used to inform the planning and evaluation of health programs (Scrimshaw & Gleason 1992).

SIP 4:  Intervention Research on Youth Development to Prevent Teen Pregnancy

Project Description and Objectives:  The Centers for Disease Control and Prevention (CDC) is interested in supporting research on youth development approaches to prevent teen pregnancy.  The youth development model is based upon the principle that a primary task of adolescence is to develop a positive identity and that youth who experience success are hopeful about their futures, feel supported by their families and communities, and will be less likely to engage in risk behavior.  Youth development approaches focus on developing the assets and potential of teens rather than simply seeking to reduce their “risks”.  In addition to working directly with youth, many youth development programs also attempt to engage the family (e.g., through parent skills training or parent involvement), the community (e.g., through mentoring programs, neighborhood mobilization, or modifying local policies), and/or other important social influences on adolescent development.

Although there is a growing body of literature documenting the effectiveness of youth development approaches on changing adolescent risk behavior, many important questions remain unanswered (Catalano et al 2002).  A key issue is the paucity of rigorous studies of youth development interventions, particularly for interventions to reduce adolescent sexual risk behavior.  The developmental task of learning to form healthy intimate relations (Erikson 1968, Florsheim 2003) may be particularly relevant to teen pregnancy prevention efforts, yet very few youth development interventions explicitly attempt to help adolescents accomplish this task.  Further, few intervention studies have measured the risk and protective factors that are thought to mediate behavior change and monitored how those factors change as a result of intervention activities.  

The objective of this project is to support research that develops innovative youth development interventions to reduce teen pregnancy.  Applications submitted to this SIP are, at a minimum, expected to:  1) describe how the research will fill the knowledge gaps identified above and have relevance to improving public health practice; 2) emphasize the importance of primary and secondary abstinence as a method of preventing teen pregnancy; and 3) target communities experiencing racial/ethnic, economic or other disparities, such as the Latino population. 

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

1.   Develop a youth development intervention to prevent teen pregnancy.  Activities that may be included are:

2.   Design a research study to evaluate the effectiveness of the intervention1.  Activities that may be included are:

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

1. Demonstrate evidence of capacity to conduct research, including capacity to provide, design and evaluate intervention services and publish results of adolescent health intervention research.

2. Demonstrate experience with and willingness to collaborate with community groups and service delivery providers who work on teen pregnancy prevention, such as state teen pregnancy coalitions.  Collaboration with community groups should be consistent with community based participatory research approaches that engages community members, derives understanding and is the basis for interventions from local knowledge of health problems, and invests community members in all stages of research, including its products (AHRQ 2003).

3. Emphasize working with teen pregnancy prevention programs designed to meet the needs of Latino youth.  Latino teen pregnancy rates continue to be higher than other racial/groups and in some geographic areas may be increasing as opposed to decreasing rates for other groups. 

Project Proposal Length and Supporting Materials:  Proposal narratives are limited to 25 pages.  Supporting materials included in the appendices should not exceed 30 pages; the appendices should include materials that provide evidence of the applicant’s ability to successfully conduct the research described above, any needed letters of support, and other evidence as consistent with the proposal.

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

Research Status:  It is expected that this project will be non-exempt research.   It is anticipated that these projects will need approval by the IRB at the recipient institution and that CDC IRB approval or deferral to the recipient IRB will be required.  Applicants should provide a federal-wide assurance registration number for each performance site included in this project.

Award Administration:  CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards.  CDC staff are expected to serve as co-investigator/consultant on these projects.  CDC staff is expected to collaborate on project activities including intervention and study design, methods, sampling, data analysis, and co-authoring manuscripts. 

References:

1.   Agency for Health Care Research and Quality (2003).  The role of community-based participatory research: creating partnerships, improving health.  AHRQ Publication No. 03-0037.  Available at www.ahrq.gov/research/cbprrole.htm .

2.   Erikson E (1968).  Identity: Youth and Crisis.  WW Norton & Company, NY, NY.

3.   Florsheim P (Ed.) (2003). Adolescent Romantic Relations and Sexual Behavior: Theory, Research, and Practical Implications. Lawrence Erlbaum Associates, NY, NY.

4.   Catalano R, Berglund L, Ryan J, Lonczak H, Hawkins D (2002).  Positive youth development in the US: Research findings on evaluations of positive youth development programsPrevention & Treatment, Vol. 5, Article 15, posted June 24. 

5.   Oman et al (2002).   Reliability and validity of the Youth Assets SurveyJ of Adolescent Health, 31(3): 247-255.

1Funds will not be available in this award to implement the evaluation study.  SIPs funded in FY ’06 must be completed within three years; therefore, it is too short a time to develop and evaluate an intervention study.  It is CDC’s intention to fund the evaluation in a subsequent award, depending on availability of funds, although that award may have to be obtained through a competitive process.

Child and Adolescent Health

SIP 5:  Building Capacity for Community Monitoring System (CMS) to Track Indicators of Child and Adolescent Well-being

Project Description and Objectives:  Monitoring the well-being of children and adolescents is a critical component of efforts to prevent psychological, behavioral, and health problems and of efforts to promote young people’s successful development (Mrazek, Biglan, & Hawkins, 2004).  The Society for Prevention Research published a report on the need for Community Monitoring Systems (CMS) and highlighted several exemplary systems across the country.  Currently, efforts to monitor global trends in child well-being are established federally in such publications as America’s Children (2005) while, with a few notable exceptions (e.g. Connect Kansas, Partnerships for Success in Ohio), state or local-area efforts are not as well-developed.  In many cases, community monitoring systems track important health and health risk behavior indicators, but are less often collecting important indicators of mental health status, behavioral health, and development health.  Additionally, many monitoring systems cannot assess resource needs in their communities because systems are not in place to monitor receipt of, or need for, services and interventions.  It is estimated that approximately 10% of children and adolescents in the general population experience mental illness severe enough to cause impairment at home, in school, and in the community and that less than half will receive the treatment that they need (DHHS, 1999, 2001).  The developmental health of children and adolescents may also be less often monitored because indicators of developmental health are often considered merely the absence of risk behaviors or poor outcomes.

CDC is seeking to support the infrastructure and coordination of a multi-disciplinary group vested in:  1) monitoring child and adolescent well-being; 2) the development of community-specific indicators of child and adolescent well-being with consideration for data gaps such as mental health, behavioral health, and developmental health; 3) environmental scanning and assessment of available data specific to the targeted geographic community; and 4) the development of a consensus-driven plan for implementing a community-wide monitoring system of children’s well-being.  It is desired that such a plan includes indicators of cognitive, social, emotional, and behavioral well-being across ages 3 to 19, and include indicators of community resources that promote youth’s health and development such as after school programs, mentoring programs, community centers, etc.  The objective of this project is to engage state and local area health agencies, non-profit and advocacy organizations, school health and education partners, as well as institutions of higher education, to develop a realistic plan for a CMS that could be implemented and sustained over time.

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

1. Describe the organization and interaction of the collaborating organizations and/or governmental agencies.  Define the community of interest geographically, demographically, and the history of the applicant’s work in the defined community.

2. Describe how the proposed CMS would draw on community collaborations to enhance children and adolescents well-being as it relates to their mental, physical, and developmental health.  Discuss additional stakeholders who may have an interest in the work taking place.  Define performance expectations for the Community Monitoring System.

3. Describe how the proposed CMS would collaboratively develop indicators of well being from a holistic approach that includes children’s mental and physical health and development in a defined community.  Specifically, CDC expects the applicant to:

4. Describe the processes for systematically identifying all readily available data supporting the indicators selected by the partner group; identify those indicators that do not currently have a data source.  Applicants may:

5.Describe the processes for generating a plan for disseminating easily understandable information resulting from the CMS to decision makers and community leaders so the data will be user-friendly and can answer some specific questions on domains of well-being.

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

1.  Demonstrated experience working with community partners to develop sustainable collaborations and commitment to supporting local/state efforts to monitor child and adolescent well-being in the defined community; and

2.  Demonstrated experience in building data systems as well as expertise in indicators of mental health, behavioral health, and developmental health. 

Project Proposal Length and Supporting Materials:  Proposal narratives are limited to 20 pages.  Supporting materials included as appendices should not exceed 40 pages; the appendices should include materials that show evidence of the applicant’s ability to successfully complete the proposed project, letters of support, and other evidence deemed necessary to support the contents of the proposal from potential or existing community partners.

Availability of Funds:  Approximately $200,000 is available to fund two Prevention Research Centers in the first year of a 2-year project period. The average award for each recipient is expected to be approximately $100,000.  Funding may vary and is subject to change.

Research Status: The development and planning of a Community Monitoring System itself will not involve research on human subjects; however, the projects chosen by the awardees may involve 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 awardees in making human subjects determinations.

Adult Health

SIP 6:  Reliability Study of the “Actions to Control High Blood Pressure” Module in the Behavioral Risk Factor Surveillance System

Project Description and Objectives:  Almost 30% of the population of the United States has high blood pressure (HBP) but less than 30% of persons with high blood pressure have it under control. To address this problem, Healthy People 2010 (HP2010) Objective 12-11 was developed to increase the proportion of adults changing their diet, cutting down on salt, reducing alcohol use, exercising, and taking medication to decrease their HBP.

A new ten question module was introduced in the 2005 Behavioral Risk Factor Surveillance System (BRFSS) questionnaire entitled “Actions to Control High Blood Pressure” that measures HP2010 objective 12-11. The BRFSS is a state-based telephone survey of the civilian, noninstitutionalized, adult (i.e., persons aged greater than or equal to 18 years) population (www.cdc.gov/brfss). The module asks respondents about their behavior and advice from health professionals to change eating habits, cut down on salt intake, reduce alcohol consumption, and exercise. The Actions to Control High Blood Pressure module also has a question about advice to take medication and a question about being told one has high blood pressure during more than one medical visit. Only respondents who report being told that they have high blood pressure in an earlier question found in the BRFSS Hypertension Awareness module complete the Actions to Control High Blood Pressure module.

A number of reliability studies have been conducted on questions in the BRFSS.1-4  The questions in the Actions to Control High Blood Pressure module were developed from other established surveys and appropriate science suggests that questions should be periodically examined to ensure their continued usefulness. The purpose of this project is to assess the reliability of the questions in the new Actions to Control High Blood Pressure module in the BRFSS, as well as their reliability by race/ethnic group and gender.  The objective of this project is to provide results that will assist public health professionals, researchers, and practitioners in evaluating and interpreting data in order to better address high blood pressure risk factors.

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

1.   Describe the design of the study, including but not limited to, how data will be collected, cleaned, and weighted.  A detailed time line for all study activities should be included.

2.   Describe any demographic or other types of questions to be asked outside of the Actions to Control High Blood Pressure module for purposes of analysis.

3.   Describe how representation of diverse race/ethnic groups will be assured in the study.

4.   Describe the expected sample size of respondents with self-reported high blood pressure for each race/ethnic group and gender and its sufficiency for estimation of reliability measures.

5.   Describe the statistical measures to be used in calculation of reliability.

6.   Describe how the research results will be disseminated.

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

1.   Demonstrate prior experience working with BRFSS data.

2.   Demonstrate prior experience in related research (e.g. surveillance, surveys, reliability and validity) and publications from that research.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 20 pages. Supporting materials included in the appendices should not exceed 40 pages; the appendices should include materials that provide evidence of the ability of the applicant to successfully conduct the research described above, any needed letters of support, and other evidence deemed necessary to support the contents of the proposal.

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

Research Status:  It is expected that this will be non-exempt research.  It is anticipated that this project will need approval by the IRB at the recipient institution. Applicants should provide a federal-wide assurance registration 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 not serve as co-investigators on this project but will provide technical assistance on activities such as research design, data collection methodology, analysis, and dissemination of results. 

References:

1. Nelson DE, Holtzman D, Bolen J, Stanwyck CA, Mack KA. Reliability and validity of measures from the Behavioral Risk Factor Surveillance System (BRFSS). Soz Praventivmed. 2001;46 Suppl 1:S3-42.

2. Shea S, Stein AD, Lantigua R, Basch CE. Reliability of the behavioral risk factor survey in a triethnic population. Am J Epidemiol. 1991;133:489-500.

3. Stein AD, Lederman RI, Shea S. The Behavioral Risk Factor Surveillance System questionnaire: its reliability in a statewide sample. Am J Public Health. 1993;83:1768-1772.

4. Bowlin SJ, Morrill BD, Nafziger AN, Lewis C, Pearson TA. Reliability and changes in validity of self-reported cardiovascular disease risk factors using dual response: the behavioral risk factor survey. J Clin Epidemiol. 1996;49:511-517.

SIP 7:  Intervention Research on Home-based Depression Treatment in People with Epilepsy

Project Description and Objectives:  Psychiatric comorbidity is highly prevalent in people with epilepsy, with psychological distress and depressive disorders being the most common and the most significant predictors of impaired function and quality of life—independent of seizure frequency and seizure control—in people with epilepsy (Kanner 2003; Gilliam et al. 2003; Devinsky 2003; Barry et al. 2005).  In a community sample of individuals with epilepsy, more than one-third reported depressive symptoms (Ettinger et al, 2002, 2004). Several recent population-based studies have found more days with depressive symptoms (CDC 2000) and psychological distress in adults self-reporting epilepsy or seizures (CDC 2000, Strine et al. 2005, CDC 2005).  It is known, however, that many depressive disorders are underdiagnosed and undertreated in people with epilepsy (Barry et al. 2005). 

Living Well with Epilepsy II, the 2nd national conference on public health and epilepsy held in 2003, identified the need to “improve access to psychiatric care by building bridges between the mental health and epilepsy communities; train community advocates and specialists to bridge gaps affecting people with epilepsy among public health, community, and health care systems; and develop and test mechanisms to successfully connect people with resources in diverse geographical areas” (LWE II, 2004).  Recently, Ciechanowski et al. (2004) demonstrated that their community-integrated, home-based depression treatment intervention in 138 community-dwelling older adults significantly reduced depressive symptoms and improved health status at a mean cost of $630 per patient. This model may be useful to guide the development of similar home-based treatment interventions in people with epilepsy, many of whom cannot drive to obtain needed medical care.

Consistent with the priority of CDC to improve care for persons with epilepsy, the main objective of this project is to develop and test a home-based depression intervention for adolescents or adults with epilepsy.  Funds will be made available to support intervention research on home-based depression treatment for people with epilepsy to reduce the substantial burden of comorbid depression in this population.  There is a need for an interdisciplinary effort to develop and test a home-based treatment program that can reduce depressive symptoms in community-dwelling people with epilepsy. Given the preliminary nature of this study, the difficulty with recruiting clinic-patients with epilepsy, and evidence of substantial psychological distress in population-based studies of adults self-reporting epilepsy it is recommended, but not a requirement, that inclusion criteria include community-dwelling adults screened for epilepsy. A copy of selected CDC epilepsy publications and the 2003 Living Well with Epilepsy symposium proceedings will be made available to applicants.

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

1.   Describe and document how an interdisciplinary team will be organized to conduct the proposed research.  It is expected that the team, at a minimum, will be composed of clinical investigators (e.g., neurologists/epileptologists; psychiatrists/psychologists; nurses), allied health professional (e.g., social workers, vocational rehabilitation counselors), and other technical experts (e.g., MPH-level staff) as applicable;

2.   Document the processes that will be used to identify and recruit, screen and verify, and retain community-dwelling individuals with epilepsy to participate in the study;

3.   Describe and document the current expertise, resources, and community-partnerships for the design and implementation of an intervention targeting community-dwelling individuals;

4.   Describe and justify the choice of screening instruments, therapeutic approaches, and expected outcomes;

5.   Identify the evaluation criteria and methodology that will be used to test the program, including the feasibility and utility of the intervention, and evaluation of recruitment strategies of the targeted sample;

6.   Describe the project activities that are specific, measurable, and time-framed for a 2-year funding period;

7.   Identify any anticipated barriers to conducting the project and plans to address them; and

8.   Identify treatment protocols for responding to emergency mental health needs, including suicidal thoughts, of study subjects.

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

1.   Demonstrate their experience in the design of and testing of interventions to reduce psychiatric comorbidity;

2.   Demonstrate their experience in reaching hard-to-reach populations such as people with epilepsy; 

3.   Demonstrate their experience with earlier studies related to mental health and chronic disease;

4.   Incorporate an interdisciplinary team that can develop a community-integrated home-based intervention (Ciechanowski et al. 2004) that addresses screening and pharmacologic and/or cognitive-behavioral therapy in community-dwelling individuals screened for epilepsy; and

5.   Build on their effective relationships with various community partners to develop and test their intervention.

Project Proposal Length and Supporting Material:  Proposal narratives are limited to 25 pages. Supporting materials included in the appendices should not exceed 40 pages; the appendices should include materials that provide evidence of the applicant’s ability to successfully conduct the research, any needed letters of support, and other evidence as consistent with the proposal.

Availability of Funds:  Approximately $200,000 will be made available to fund one Prevention Research Center for the first year of a 2-year project period.  Funding may vary and is subject to change.

Research Status:  It is expected that this will be non-exempt research.  It is anticipated that this project will need approval by the IRB at the recipient institution.  Applicants should provide a federal-wide assurance registration 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 not serve as co-investigators on this project, but will provide technical assistance on both the design and nature of the intervention.

SIP 8:  Identification and Development of Prevention Opportunities to Promote or Maintain                Brain Health in Older Adults

Project Description and Objectives:  The Centers for Disease Control and Prevention (CDC) and the Alzheimer’s Association are collaborating on a multi-faceted approach to brain health that includes both programmatic and public health research components. This collaboration, which will involve other key partners such as the Prevention Research Centers (PRC), presents a unique opportunity to identify public health opportunities and develop a needed roadmap of recommended public health strategies to address brain health, a critical health issue for all Americans.

It is recognized that the public’s interest in maintaining and promoting brain health will continue to grow as the U.S. population ages, and as an ever-growing number of people encounter their own experiences with cognitive decline or go through the family trauma of dealing with a relative with Alzheimer’s disease. The ability of older adults to maintain full lives as individuals and members of their communities should include attention to improving and maintaining their cognitive abilities.  Specifically:

1.   Cognitive decline affects approximately one in four community-dwelling older adults.  Cognitive decline is a risk factor for developing dementia later in life.  (Unverzagt et al. Prevalence of cognitive impairment. Neurology 2001;57:1655-1662).

2.   The prevalence of dementia in Americans 65 years and older is approximately 6-10%.  Alzheimer’s disease accounts for two-thirds of people with dementia. (Hendrie HC, Epidemiology of dementia and Alzheimer's disease. Am J Geriatr Psychiatry. 1998 Spring;6(2 Suppl 1):S3-18.)

3.   The annual economic cost of dementia is estimated to be $100 billion. (Ernst RL, Hay JW. The US economic and social costs of Alzheimer's disease revisited. Am J Public Health 1994;84(8):1261-4)

With researchers beginning to see potential indications that preventing cognitive decline is possible, the identification and refinement of public health prevention opportunities in addressing the improvement and maintenance of cognition among older adults are of particular interest.

The objective of this Special Interest Project is to fund a multi-site project to identify and develop effective interventions for the primary prevention of cognitive impairment, memory loss, and loss of executive function in older adults through the promotion of healthy lifestyles in collaboration with at least one member of the PRC Healthy Aging Research Network (PRC-HAN).  The focus of the interventions developed through this collaboration should be on community-based strategies for older adults that can be implemented throughout the United States utilizing the public health and aging services network.  (Note: For more information on the public health and aging services networks see: The Aging State Project:  Promoting Opportunities Between the Public Health and Aging Services Networks at:  http://www.chronicdisease.org/interest_groups/health_age/Buttons/aging_states_project.pdf)

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

1.   Describe how the proposed work relates to and supports the ongoing initiatives that are part of CDC’s Alzheimer’s-specific segment within the CDC Healthy Aging Program, which includes, but is not limited to, a) current extramural funding activities such as CDC’s work with the Alzheimer’s Association, the National Institutes of Aging, and the Administration on Aging, as well as other public health and aging partners, and b) the development of a national public health action plan concerning public health strategies related to the promotion and maintenance of brain health.

2.   Describe how the proposed project will support and increase collaboration with members of the PRC-HAN and other partners to review or develop evidence-based interventions that can be implemented in communities around the United States.

3.   Describe the organizational structure of the project.  This should include, but is not be limited to: 1) selection of the PRC-HAN network center participants; 2) roles and responsibilities of the lead center and supporting member centers; and 3) how the centers would collaborate with each other, the PRC-HAN, and CDC to advance a prevention research agenda for cognitive brain health for older adults.  Letters of support, identifying the roles and support of the project should be provided from all identified participating members. Indicate how this activity relates to the mission and activities of the PRC Healthy Aging Research Network.

4.   Describe the formative work that has been done to date in the area of promising primary prevention strategies for maintaining cognitive vitality and brain health including any community needs assessments. If the scope of the background literature is limited, the applicant should propose a plan to assess the community’s needs and interests with respect to the relationship between healthy lifestyles and brain health.

5.   Describe the proposed study design and implementation methods for a multi-site community-based intervention project that focuses on healthy lifestyles and the healthy brain for older adults aged 50 years and older.  The proposed project should build on existing effective health promotion interventions for older adults.  Include the behavioral science theory and translational research model(s) that the study design is based upon in your application. 

6.   Describe the implementation and evaluation of the proposed intervention in multiple sites throughout the US targeting adults 50 years old and older, including those from diverse backgrounds, racial/ethnic minorities, rural/urban, and socioeconomic status. 

7.   Describe how the research will provide evidence of the effectiveness of the community intervention in promoting cognitive brain health in older adults through the public health and aging services networks.     

8.   Describe how the applicant will work with CDC to frame the public health role and parameters for interventions and outcomes, including health outcomes and costs, related to cognition and brain health for older adults.

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

1.   Partner with one or more members of the PRC Healthy Aging Research Network;

2.   Provide letters of support from contributing member centers that define each center’s role and responsibilities; and

3.   Have demonstrated research experience in the area of cognition and brain health for older adults.

It is expected that applicants who plan to work collaboratively with other PRCs or members of the PRC Healthy Aging Research Network, will coordinate their application and submit a single or joint proposal.  Joint applications should include one lead PRC and other PRC members.

Project Proposal Length and Supporting Materials:  Proposal narratives are limited to 20 pages.  Supporting materials included as appendices should not exceed 40 pages; the appendices should include materials that provide evidence of the applicant’s ability to conduct the research, any letters of support, and other evidence deemed necessary to support the contents of the proposal.

Availability of Funds:  Approximately $250,000 is available to fund one Prevention R esearch Center in the first year of a 3-year project.  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 need approval by the IRB at the recipient institution. Applicants should provide a federal-wide assurance registration 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 not serve as co-investigators on this project, but will provide technical assistance on activities such as research design, data collection methodology, analysis, dissemination of results, and co-authoring of manuscripts.


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