Part I Overview Information


United States Department of Health and Human Services (HHS)

Issuing Organization

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

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


Participating Organizations

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


Components of Participating Organizations

Coordinating Center for Health Promotion (CoCHP), at http://www.cdc.gov/about/organization/cchp.htm/, National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), at http://www.cdc.gov/nccdphp/, National Office of Public Health Genomics (NOPHG), http://www.cdc.gov/genomics/  

Title:  Genomic Applications in Practice and Prevention (GAPP):  Translation Research (U18)  

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

 
Authority:  Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2); Section 301(a) of the PHS Act, 42 U.S.C. 241(a).   

Announcement Type:  New

Instructions for Submission of Electronic Research Applications:

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

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

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

Two steps are required for on time submission:

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

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

Funding Opportunity Announcement (FOA) Number: RFA-GD-08-001

Catalog of Federal Domestic Assistance Number:  93.068 Chronic Diseases: Research, Control, and Prevention

 

Key Dates
Release/Posted Date:  
Letter of Intent Receipt Date:  January 28, 2008  
Application Submission Receipt Date:  February 27, 2008   
Peer Review Date:  April 2008
Council Review Date:  
June 2008

Earliest Anticipated Start Date:  September 30, 2008

Expiration Date:  February 28, 2008

 

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary

·          This FOA solicits applications to conduct research that will accelerate the translation of genomic applications into public health practice.  Research supported by this FOA will advance knowledge about the validity, utility, utilization and population health impact of genomic applications for improving health and preventing disease in large, well-defined populations or practice settings in the United States, specifically research that will move genomics applications along the translation research continuum phases T2 through T4 (i.e., from development of evidence-based guidelines to outcomes research)

·          The participating organizations intend to commit approximately $2.5 million to this RFA for payment of applications responsive to this announcement.

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

·          Anticipated number of awards to be issued under this FOA in FY 2008:  6-9 awards.

·          There is no limit to the number of applications that an institution/organization may submit in response to this FOA.   

·          Budget Period, Project Period, and Award Amounts: The award range for the first 12-month budget period is $200,000-350,000 in total costs.  The total project period for applications submitted in response to this FOA may not exceed three years. 

·          Eligible Organizations:  Public nonprofit organizations; private nonprofit organizations; for-profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states.)   A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide required documentation from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

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

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

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

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

     3. Anticipated Announcement and Award Dates

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

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

    3. Reporting

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

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


 

Section I. Funding Opportunity Description


1. Research Objectives  

The National Office of Public Health Genomics (NOPHG) of CDC and the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) within HHS 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 cancer, diabetes, educational and community-based programs, heart disease and stroke, mental health and mental disorders, and public health infrastructure.  This FOA integrates genomics with public health research and is in alignment with NCCDPHP performance goals.  For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/. 

Nature of the Research Opportunity

A comprehensive agenda for translation research is needed to move human genome discoveries into health practice in a manner that maximizes health benefits and minimizes harm to individuals and populations.  This FOA will support translation research that will accelerate the integration of promising genomic and family health history applications into clinical and public health practice.

It is intended that research supported through this FOA will advance knowledge about the validity, utility, utilization and population health impact of genomic applications for improving health and preventing disease in large, well-defined populations or practice settings in the United States.   

Background

Advances in genomics have led to mounting expectations in regard to the impact of genomic applications on health care and disease prevention (Genet Med 2007:9(10):665-674).  Currently hundreds of thousands of genetic variants are being evaluated for association with common chronic diseases.  Research is accelerating the discovery and use of new biomarkers derived from gene expression, proteomic, and other “omic” technologies.  The use of family history tools is being increasingly promoted in medical practice and public health settings and genomic tests are increasingly being marketed directly to consumers and can be ordered over the internet (www.gao.gov/cgi-bin/getrpt?GAO-06-977T). 

To date, however, few human genome discoveries have led to evidence-based applications and widespread use in medicine and public health.  The only genomic application recommended by the U.S. Preventive Services Task Force (USPSTF) for use in primary care practice is BRCA1 & 2 testing for breast and ovarian cancer susceptibility (http://www.ahrq.gov/clinic/uspstfix.htm).  Neither the National Committee for Quality Assurance (http://web.ncqa.org/) nor the National Quality Forum (http://www.qualityforum.org/) has performance measures for the use of genomic applications. 

In medicine, moving scientific discoveries into practice and delivering population-level health benefit have always been slow and difficult at best (Genet Med 2007:9(10):665-674). Research on the “natural history” of promising interventions shows that only a small percentage of highly promising basic science findings are licensed for clinical use.  In addition, well-evaluated and recommended interventions are often not widely used in practice.  Renewed calls for enhancing the translation research enterprise have recently emerged from the National Institutes of Health (NIH) as part of the Roadmap initiative (http://nihroadmap.nih.gov/) as well as from clinical, academic, and public health sectors.   

Translation of genomic applications into practice has been limited by a number of factors.  Most genomics research has been in gene discovery and the development of candidate clinical applications.  In addition, there is no consensus on the developmental pathway for moving genomic applications through different phases of research into practice, such as exists for drug development (http://books.nap.edu/catalog.php?record_id=11892).  Inappropriate study designs and analytic methods, biased sampling, and inadequate statistical power have also limited genomics research.  The rules of evidence to assess the validity and utility of genomic tests are in part inadequately developed and commonly accepted rules of evidence have not always been applied.  Furthermore, there has not always been sufficient involvement of practitioners, patients and other stakeholders to ensure that translation research addresses community needs related to implementation such as acceptability, feasibility and cost.

Systematic evidence reviews of interventions in health systems and in communities to increase use of evidence-based medical practices have been conducted by such groups as the non-federal Task Force on Community Preventive Services (http://www.thecommunityguide.org/about/task-force-members.html), the Cochrane Collaborations (http://www.cochrane.org/index.htm), and the Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers (http://www.ahrq.gov/clinic/epc/).  These reviews have found that effective interventions are available to increase use of a range of clinical services.  Research on the effectiveness of interventions to increase use of evidence-based genomic tests or family medical history tools is more limited. 

There is substantial interest and opportunity within medicine and public health for genomic researchers to work with stakeholders to conduct translation research that will move promising genomic applications into practice.  In 2005, the American Academy of Family Physicians in collaboration with the American College of Physicians and other primary and specialty care medical associations conducted an educational initiative on genomics for practitioners (http://www.aafp.org/online/en/home/clinical/acf/genomics.html).  Most state Comprehensive Cancer Control coalitions supported by CDC now include language on genomics or family history in their state plans (www.cdc.gov/cancer/nccdphp/).  In 2004, the non-profit Personalized Medicine Coalition, with members from academia, industry, and patient, provider, and payer organizations, was formed to advance the understanding and adoption of personalized medicine concepts and products to better manage a patient’s disease or predisposition towards a disease (http://www.personalizedmedicinecoalition.org/).

To develop and test a systematic process of evaluating the evidence on the validity and utility of genomic applications and to identify gaps in research that are keeping applications from broader translation, CDC initiated a pilot project entitled Evaluation of Genomic Applications in Practice and Prevention (EGAPP).  An HHS interagency Steering Committee, with members from the Food and Drug Administration, the Centers for Medicare and Medicaid Services, NIH, and the AHRQ provided early guidance to the EGAPP project and is now considering how to best develop a sustainable assessment process.  An independent, non-federal, multidisciplinary EGAPP Working Group was established to prioritize genomic applications for evaluation, establish methods for evaluation, oversee evidence reviews, and develop recommendations based on a thorough evaluation of the evidence, including the analytic and clinical validity, clinical utility, and associated ethical, legal, and social implications.  The Working Group is currently developing reports and recommendations on the use of genomic tests in cardiovascular disease, depression, and cancer.  More information about this project is available at http://www.egappreviews.org/.  Systematic reviews on the clinical validity of many genomic tests (genetic variation-disease associations) have been conducted by the Human Genome Epidemiology Network (HuGENet) and are available on the CDC-sponsored website at http://www.cdc.gov/genomics/hugenet/default.htm

CDC has developed Family HealthwareTM, a family history, risk assessment, and intervention tool designed to promote changes in the use of clinical preventive services or behavioral risk factors for several chronic diseases, including coronary heart disease, stroke, diabetes, breast and ovarian cancer and colorectal cancer (http://www.cdc.gov/genomics/activities/famhx.htm) to help evaluate the utility of family history tools.  In addition, CDC and AHRQ have contracted with an Evidence-based Practice Center to have systematic evidence reviews conducted on the analytic and clinical validity and the clinical utility of family medical history tools (http://www.ahrq.gov/clinic/epcix.htm). 

Scientific Knowledge to be Achieved through this Funding Opportunity

Translation research in genomic medicine seeks to improve health outcomes for individuals and populations by integrating evidence-based genomic applications into clinical and public health practice settings.  To help move advances in genomics and family history applications through reviews conducted by groups such as USPSTF and EGAPP into practice, more focused research is needed on promising genomic applications to develop evidence-based practice guidelines necessary to move an application into widespread implementation and assess its “real world” impact.  The following table describes four linear but overlapping phases of translation research of genomic applications that revolve around evidence-based guidelines development:

 

The Continuum of Translation Research in Human Genomics

 

Translation

Notation

Types of Research

TI

Discovery to candidate health application

Phases I and II clinical trials

Observational studies

T2

Health application to evidence-based practice guidelines

Phase III clinical trials

Observational studies

 

T3

Practice guidelines to health practice

Dissemination research

Implementation research

Diffusion research

Phase IV clinical trials

T4

Practice to population health impact

Outcomes research (includes many disciplines, such as economics, health services research, epidemiology, and behavioral and social sciences)

      Table adapted from “Table 1:  The continuum of translation research in human genetics:  types of research and examples” (Genet Med 2007:9(10):665-674).

 

Translation research supported by this FOA will advance knowledge about the validity, utility, utilization and population health impact of genomic applications for improving health and preventing disease in large, well-defined populations or practice settings in the United States.  The scientific knowledge obtained from this research will be used to increase the evidence-base needed for genomic applications to be adopted and successfully integrated into established practice and policy.  This FOA specifically focuses on phases T2 through T4 of the translation continuum because of the potential of the research findings to increase the spread and usage of genomic applications to achieve the greatest health impact.  In the context of this FOA translation research does not encompass T1 research, meta-analyses or evidence-reviews.

 

Research Objectives and Experimental Approach

The objective of this FOA is to improve health outcomes for individuals and populations by supporting translation research that will accelerate the integration of promising genomic and family health history applications into clinical and public health practice.  For the purpose of this FOA, eight areas have been identified as having the greatest potential to impact clinical and public health practice or as having the widest population application (i.e., higher disorder prevalence, higher frequency of test use).  Proposed projects may utilize a variety of study designs and methodology to conduct translation research in large, well-defined populations or clinical practice settings in the United States that will build the evidence-base in these areas.   

1.      Clinical validity, clinical utility, or ethical, legal, or social implications of genomic tests currently under review  or under consideration for review by the EGAPP Working Group (see list of Genetic Tests below);

2.      Effectiveness of interventions in communities or in health systems to increase use of the clinical practices recommended by the USPSTF on the use of BRCA testing, including the use of family history and counseling prior to testing (http://www.ahrq.gov/clinic/uspstf/uspsbrgen.htm);

3.      Effectiveness of interventions in communities or in health systems to educate the public or providers about gaps in existing knowledge of the validity and utility of one of the tests for which an EGAPP-commissioned evidence review has been completed or an EGAPP report has been issued (http://www.egappreviews.org/workingrp.htm) and the potential implications in terms of benefits and harms from use of that test;

4.      Clinical utility of family medical history tools, including Family HealthwareTM and family medical history-related risk assessment tools for coronary heart disease, stroke, diabetes,  colorectal, breast, and ovarian cancer;

5.      Fidelity with which BRCA testing is being conducted in communities as recommended by USPSTF and/or the effect of testing on population health.

6.      Use of counseling and testing for BRCA;

7.      Use of family medical history tools and/or family medical history-related risk assessment tools for coronary heart disease, stroke, diabetes, and/or colorectal, breast and/or ovarian cancer; and

8.      Knowledge and attitudes of the public and clinical practice with regard to the use of BRCA or genomic tests under review by the EGAPP working group.

 

Following are examples of translation research projects: 

 

1.      Using methods consistent with quality criteria of systematic review groups, like EGAPP, USPSTF, or Cochrane, in well-defined practice settings (e.g., large HMO or clinical network), determine the clinical validity of Factor V Leiden mutation testing for use in individuals with a personal or family history of venous thromboembolism.

2.      Within a defined population or practice-based setting, determine the impact of a family history and risk assessment tool for Type 2 diabetes on clinical interventions and patient health behaviors.

3.      Evaluate the effectiveness of a family health history and risk assessment tool, in a clinical practice or public health setting, in identifying individuals at increased of colorectal cancer and in promoting cancer screening and/or changes in physical activity and obesity.

4.      Determine the prevalence of genetic testing for polymorphisms in genes of the Cytochrome P450 (CYP450) family of drug-metabolizing enzymes for individuals diagnosed with depression for use in decisions to treat with SSRIs.

5.      Using methods that meet quality criteria of evidence-review groups such as the Task Force on Community Preventive Services, Cochrane, or AHRQ EPCs, evaluate the effectiveness of a health system or community intervention, for example provider assessment and feedback, in increasing use of BRCA1 and 2 testing as recommended by USPSTF.

6.      Using methods that meet quality criteria of evidence-review groups, evaluate the effectiveness of a provider or public education intervention to increase awareness of the potential harms as well as benefits of using genomic tests that have not been fully evaluated.

7.      Using methods that meet quality criteria of evidence review groups, evaluate the effectiveness of a health system or community intervention in increasing use of a family history tool for which there is some consensus regarding its utility.

8.      In a defined population or practice setting, determine the types and frequency of genomic applications being used, and examine relations between test use, source of recommendation and evidence-base for application, and characteristics of the health system and patient populations.

9.      In a defined population or practice setting, evaluate the extent to which BRCA1 and 2 genetic testing is being used and whether it is being used in the manner recommended by the USPSTF, e.g., with appropriate counseling, and why.

 

Study designs and methods used in the proposed projects must address methodologic issues raised by such groups as the Institute of Medicine (http://www.iom.edu/) and meet evaluation criteria used by the EGAPP Working Group, Cochrane Collaborations, the USPSTF, or the Community Guide, as appropriate to the research topic.

 

Genetic Tests:

Research on genetic tests funded under this FOA is limited to tests for BRCA1 & 2 and the following tests currently under review or under consideration by EGAPP:

 

A.  Genetic tests currently under review:

1.      Gene expression profiling tests for use among women with breast cancer, for treatment decisions and to assess the risk of recurrence.

2.      Use of multigene test panels among the general population to predict cardiovascular disease risk and inform lifestyle management.

3.      UGT1A1 testing for individuals diagnosed with colorectal cancer for use in decisions to treat with irinotecan.

4.      DNA-based tests for polymorphisms in genes of the Cytochrome P450 (CYP450) family of drug-metabolizing enzymes, for individuals diagnosed with depression for use in decisions to treat with SSRIs.

5.      Hereditary nonpolyposis colorectal cancer mismatch repair gene mutation testing for individuals diagnosed with colorectal cancer in disease management and for use in patients’ family members for prevention.

6.      Genomic tests for ovarian cancer, in the general population or in women at increased risk for ovarian cancer, for detection and management.

7.      Factor V Leiden mutation testing for use in individuals with a personal or family history of venous thromboembolism, or a family history of Factor V Leiden mutation, for diagnosis and management, or for prevention in family members.

 

B.  Genetic tests currently under consideration:

1.      Apolipoprotein E (ApoE) genotyping for use in patients with dementia for diagnosis, and for individuals with a family history of dementia or the general population for predictive testing and risk assessment.

2.      The breast cancer multigene panel for use in the general population for predictive testing and risk assessment.

3.      MTHFR testing for individuals with a family history of cardiovascular disease for prevention and for management.

4.      ApoE testing for individuals with a family history or clinical symptoms of cardiovascular disease for diagnosis of Type III hyperlipoproteinemia.

5.      ApoE testing for the general population for predictive testing and risk determination for cardiovascular disease.

6.      Fecal DNA testing for colorectal cancer, for screening in the general population.

7.      PPARg2 testing for individuals with clinical suspicion or family history of diabetes for diagnosis and for the general population for predictive testing and risk assessment.

8.      TCF7L2 for the general population for predictive testing and risk assessment for type 2 diabetes.

9.      Mature-onset diabetes of the young (MODY) multigene panel, for individuals suspected of having, or diagnosed with MODY, for diagnosis and management.

10.  HFE testing for individuals with clinical suspicion of hereditary hemochromatosis for diagnosis, and for the general population for predictive testing and risk assessment.

11.  VKORC1 and CYP2C9 testing for individuals with thrombophilia prior to treatment with warfarin (Rapid ACCE Review:  CYP2C9 and VKORC1 Allele Testing to Inform Warfarin Dosing).

 

Projects should examine key variables for translation research, as appropriate to the genomic application proposed for study.  These include:  1) impediments and/or facilitators to the successful translation of the genomic application into public health and clinical practice, 2) strategies that will accelerate and enhance the widespread adoption and institutionalization of the genomic application, 3) factors necessary for the successful adaptation and integration of the genomic application in diverse public health and clinical practice settings, 4) issues of cost-effectiveness, sustainability, and long term maintenance, and/or 5) strategies for disseminating knowledge on the effectiveness and use of the genomic application in public health settings.

 

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

Section II. Award Information


 

1. Mechanism of Support

 

This funding opportunity will use the U18 activity code.  The HHS/CDC U18 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institutes and Offices (CIOs) NCCDPHP and NOPHG intend to commit approximately $2.5 million in total costs (direct and indirect) in FY 2008 to fund 6-9 awards.  The award range will be $200,000 - $350,000 (direct and indirect costs) for the first 12-month project period.  An applicant may request a project period of up to three years.  The approximate award range for the three year project period is $600,000 to $1,000,000 in total costs.  The anticipated start date for new awards is September 30, 2008.

All estimated funding amounts are subject to availability of funds.  

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements. 

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

 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.

2. Cost Sharing or Matching

 

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

 

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


3. Other-Special Eligibility Criteria


The project team must include: 1) an investigator or consultant who has successfully conducted research or clinical practice using the genomic application(s), genetic test(s) or family history tool(s), proposed for the study; and 2) a statistician with experience in study design and data analysis of the type proposed in the study.  The CV must document previous research funding, clinical practice, and/or publications. 

Applicants proposing to conduct community-based participatory research, e.g., with patients, providers, health departments, or other stakeholders, must provide Letters of Support from collaborators specifying their commitment and involvement in the project.  

There is no limit to the number of applications that an institution/organization may submit in response to this FOA.  

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


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

 

Section IV. Application and Submission Information


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

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

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

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

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

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

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

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

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

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

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

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

1. Request Application Information

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

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

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

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

2. Content and Form of Application Submission

 

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

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

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

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget

 

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:

PHS398 Cover Letter File
Research & Related Sub-award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U18 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times 

See Section IV.3.A for details


3. A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date:  January 28, 2008  

Application Submission Receipt Date:  February 27, 2008  

Peer Review Date:  April 2008

Council Review Date:  June 2008

Earliest Anticipated Start Date:  September 30, 2008

3.A.1. Letter of Intent

 

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

 

·          Descriptive title of proposed research

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

·          Names of other key personnel

·          Participating institutions

·          Number and title of this funding opportunity

 

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

 

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

 

The letter of intent should be sent to: 

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

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

Telephone: (770) 488-8390
FAX:  (770) 488-8046

Email:  bjc4@cdc.gov

 

3.B. Submitting an Application to CDC  

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

 

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

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of:  (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

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

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

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

 

Technical Information Management Section – GD-08-001

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST


3.C. Application Processing

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

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

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

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

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

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

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

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

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

 

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

 

5. Funding Restrictions

 

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

 

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

 

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

·          Reimbursement of pre-award costs is not allowed.


6. Other Submission Requirements

 

Applicants’ research plan(s) should address activities they will conduct over the entire project period.  The following other submission requirements should be included in the application:

 

1.       A proposed timeline of activities over the three year project period.  The timeline should detail objective, measurable steps for project implementation, completion, and publication and dates by which those objectives will be met.

2.      A staffing plan describing each team member’s role in carrying out the objectives of the project. 

3.      Applicants must include costs for attending an annual program meeting in their budget.

 

Only research in translation phases T2 through T4 will be funded through this FOA.  T1 research and meta-analyses and evidence-reviews are excluded from this announcement. 

 

Resources:

Following is a list of resources to guide in the development of research projects submitted in response to this FOA:

 

Detailed definitions of study designs in genomic research can be found in a recent publication by Khoury et al. (Genet Med 2007:9(10):665-674)

 

Definitions of analytic and clinical validity and clinical utility and more detailed information on steps in the evaluation of genomic applications are available online at:

1.      M. J. Khoury et al. publications (PubMed);

2.      Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (http://www.egappreviews.org/workingrp.htm); and

3.      ACCE Project (http://www.cdc.gov/genomics/gtesting/ACCE.htm). 

 

Reports and reviews on gaps in genomic research are available online at:

1.      Human Genome Epidemiology Network (HuGENet)

(http://www.cdc.gov/genomics/hugenet/default.htm);

2.      Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (http://www.egappreviews.org/workingrp.htm);

3.      Guide to Community Preventive Services (www.thecommunityguide.org/);

4.      Agency for Healthcare Research and Quality’s (AHRQ) Evidence-based Practice Centers  (http://www.ahrq.gov/clinic/epc/);

5.      Cochrane Collaborations (http://www.cochrane.org/index.htm); and  

6.      U.S. Preventive Services Task Force (USPSTF) (http://www.ahrq.gov/clinic/uspstfix.htm).

 

Awardees upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information”.

 

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately. 

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

There is no limit to the number of applications that an institution/organization may submit in response to this FOA. 

 

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

 

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  Your research plan must not exceed 25. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

 

The following materials may be included in the Appendix:

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

 

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

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

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

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

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

 

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

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

Plan for Sharing Research Data

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

 

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

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

 

Sharing Research Resources

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

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


Section V. Application Review Information


1. Criteria
 

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

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

·         Availability of funds

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

·         Diversity of genetic applications/tests and of diseases will be considered in the funding decisions.

·         For cancer research projects, priority will be given to studies related to:  a) the use of family history of colorectal cancer; b) the use of BRCA1 & 2; c) gene expression profiling tests for use among women with breast cancer, for treatment decisions and to assess the risk of recurrence; d) genomic tests for ovarian cancer in the general population or in women at increased risk for ovarian cancer, for detection and management; and e) fecal DNA testing for colorectal cancer, for screening in the general population.

2. Review and Selection Process
 

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Office of Public Health Research in accordance with the review criteria stated below.

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

 

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

·          Receive a written critique; and

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

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

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

·          Significance

·          Approach

·          Innovation

·          Investigators

·          Environment 

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

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

Does this research fill a knowledge gap identified by a systematic review conducted by HuGENet, an EGAPP report, an AHRQ-EPC review, or a USPSTF review? 

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

 

Does the applicant have a well-defined population with adequate sample size and appropriate diversity?  Is the study design and are the analytic methods adequate and appropriate to the proposed research, including unbiased sampling and statistical power?

 

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?   

Is the project on the “cutting edge” in moving the research agenda for the particular genomic application(s) under investigation from an earlier phase on the translation continuum to a later phase, e.g., from a recommendation to dissemination, from T2 to T3 or from implementation to evaluation of population health impact?  

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?  

Does the research team have experience in conducting technology assessments and access to expertise in fields related to the area of proposed research, such as clinical genetics, laboratory practice, or genetic epidemiology? 

Environment: Does the scientific environment in which the applicant will do the work contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  

Does the proposed project include appropriate collaboration with academic, public health, and general practice organizations (e.g., HMOs)?  Does the community environment in which the work will be done contribute to the probability of success?


2.A. Additional Review Criteria

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

Protection of Human Subjects from Research Risk:  When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

 Inclusion of Women and Minorities in Research:  Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). 

 2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

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

2.D. Sharing Research Resources

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

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


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



3. Anticipated Announcement and Award Dates

It is anticipated that awards will be announced August 2008.

 

Section VI. Award Administration Information


1. Award Notices

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


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

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

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


2. Administrative and National Policy Requirements


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

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


2.A. Cooperative Agreement  

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

The administrative and funding instrument used for this program will be the cooperative agreement U18 an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.
Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities 

The Recipient will have the primary responsibility for the following:

 

1.      Defining objectives and approaches and planning and implementing the study.  The PD/PI is responsible for identifying specific milestones that will be achieved during the project period.

2.      Presenting research plans and reporting on progress, findings and conclusions at an annual meeting with CDC collaborators.

3.      Participating in planning sessions on how to enhance the translation research process to improve research quality and accelerate translation of proven applications into practice.

4.      Communicating with CDC on a regular basis about the progress of the research (information on the sample, protocol, design, methods, data analysis, etc. in comparison with the timeline initially proposed for the study).

5.      Assuring and maintaining confidentiality of all relevant data.

6.      Preparing and coordinating the submission of the protocol(s) to the designated IRB(s) and ensuring that the protocol(s) is(are) conducted in compliance with the terms and conditions of IRB approval.

7.      Analyzing data and publishing results, interpretations, and conclusions of the study. 

8.      Maintaining an adequate management and staffing plan to support the project activities.

 

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

2.A.2. HHS/CDC Responsibilities


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

As consultants, CDC scientists will review PD/PIs plans, protocols, and data collection instruments, and provide technical assistance on study design, sampling, methods of data collection and analysis, and interpretation of study findings.  Consultants may participate as co-authors in manuscript development.  Consultants may not interact with study participants or their data or receive identifiable data. 

HHS/CDC Project Scientists will have responsibility for the following:

1.      Supporting the grantee’s activities by providing ongoing public health consultation in the development of activities related to the cooperative agreement.

2.      Serving as liaison for scientific matters that may require access to CDC subject matter experts. 

3.      Verifying adherence to human subjects requirements and approval of study protocol by the designated IRB(s).

4.      Participating in reporting of the results of the study in technical reports and conferences. 

CDC scientists with specific expertise may also serve as co-investigators on an award.  This determination will be made by CDC at the time of award based on the specific disease(s) and genomic application(s) of the research project and the availability of CDC investigators with expertise in those areas.

As co-investigators, CDC scientists will provide technical assistance and collaborate on protocol and study instrument development, consult in study implementation, participate in data analysis and interpretation of findings, and co-author and/or first-author publications. 

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


2.A.3. Collaborative Responsibilities  

CDC scientists and PD/PIs will participate in regularly scheduled conference calls and site visits to monitor progress of the projects and participate in program planning. 

CDC scientists and PD/PIs will plan and participate in an annual program meeting to present research plans, findings and conclusions, and to plan sessions on how to enhance the translation research process to improve research quality and accelerate translation of proven applications into practice.  The CDC scientist responsible for the overall program will lead the planning and coordination of the annual meeting and chair the meeting.

Awardees and CDC scientists will collaboratively develop and plan procedures and methods to enhance genomics translational research.

 

3. Reporting

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

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

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

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

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

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

 

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research

National Center for Chronic Disease Prevention and Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Center-Williams Building, MS K-92
2877 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-8390
Email:  bjc4@cdc.gov


2. Peer Review Contacts:

Juliana Cyril, PhD, MPH

Scientific Review Service

Office of Public Health Research
Centers for Disease Control and Prevention

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

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


3. Financial or Grants Management Contacts:

Cynthia Thompson

Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Center-Colgate Building, MS E-09
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2714
Email:  cbt1@cdc.gov

 

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Telephone:  (770) 488-2700

Email: PGOTIM@cdc.gov

 

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

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

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

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

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

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

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

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.

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

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

 

Healthy People 2010

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

 

Lobbying Restrictions

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

 

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

 

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

 

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

 

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

 

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

 

Accounting System Requirements

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

 

Capability Assessment

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


Proof of Nonprofit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.


Security Clearance Requirement

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

 

Small, Minority, And Women-owned Business

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

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

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

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

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

Research Integrity

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

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

For example:

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

Compliance with Executive Order 13279

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

http://www.whitehouse.gov/government/fbci/.

 

Release and Sharing of Data

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

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

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

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

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

 

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

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

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