Please note (text in red) the following amendments were made to this RFA on Tuesday March 31, 2009. 

Announcement of a conference call on April 2, 2009 from 1 to 2 pm EDT for potential applicants was added to Part I Overview Information- Key Dates 

 

Part I Overview Information


United States Department of Health and Human Services (HHS) 

Issuing Organization 

Centers for Disease Control and Prevention (CDC), at

http://www.cdc.gov


Participating Organization

National Center for Public Health Informatics (NCPHI)

http://www.cdc.gov/ncphi/

Title: Centers of Excellence in Public Health Informatics (P01)  

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 1702(a)(2) and Section 1702(a)(4)(A) [42 USC Sections 300u-1(a)(2) and 300u-1(a)(4)(A)] and Section 301(a) of the Public Health Service Act [42 USC 241a.] 

Announcement Type: New

Funding Opportunity Announcement (RFA) Number:  

RFA-HK-09-001

Catalog of Federal Domestic Assistance Number(s): 93.061, Innovations in Public Health Research
 

Key Dates

Release/Posted Date: February 9, 2009

Letter of Intent Receipt Date: March 9, 2009

Application Submission Receipt Date: April 10, 2009

Peer Review Date(s): May 1, 2009

Council Review Date(s): August 2009

Earliest Anticipated Start Date(s): September 1, 2009

Additional Information to Be Available Date: Conference Call April 2, 2009

Expiration Date: April 11, 2009

 

The National Center for Public Health Informatics (NCPHI) at the Centers for Disease Control and Prevention will host a call to provide information and opportunity for discussion by potential applicants to HK09-001 Centers of Excellence in Public Health Informatics.

 

Date and Time- April 2, 2009, 1:00 pm EDT

 

Call in Information - Toll Free- 888-324-8524

 

Participant code- 46057

 

PLEASE SEND QUESTIONS IN ADVANCE TO eih8@cdc.gov

 

Proposed Agenda Topics:

Introduction and perspective on P01 Center grants: 10 minutes

Comments from PGO-10 minutes

(Important information regarding submission due date April 10, 2009)

Program Comments- 5 to 10 minutes

Review Comments- 10 minutes

Questions and answers; discussion- 20 minutes

 

Call facilitators:

Dr. Scott McNabb- Associate Director for Science, NCPHI

Dr. Lee Husting- Scientific Program Officer, NCPHI

Ms. Nealean Austin, Team Leader & Grants Management Officer, Procurement and Grants Office

 

 

Due Date for E.O. 12372

 

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary
 

·          This RFA uses the Research Program Projects (PO1) grant award mechanism to support Centers of Excellence in Public Health Informatics to advance the study and practice of public health informatics through collaborative efforts among academic public health experts, local and/or state public health departments, developing Regional Health Information Organizations, and other health and informatics professionals. 

·          CDC/NCPHI intends to commit approximately $5,500,000 (including both direct and indirect costs) dollars in FY2009 to fund four to five (4-5) applications.

·          Average award amount is estimated to be $1,000,000 for both direct and indirect costs for the first 12 month budget period.

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

·          Proposed Project period of up to 5 years (60 months). The approximate total project period funded amount is $27,500,000. Anticipated start date for new awards is September 1, 2009.

·          Only one application per applicant can be submitted in response to this announcement. 

Eligible Applicants:  public nonprofit organizations, private nonprofit organizations, for profit organizations, 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.

 

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

    3. Reporting

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

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives  

Health People 2010 language:  The NCPHI of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority focus area(s) of health communication, public health infrastructure, and access to quality health sevices

The RFA is in alignment with NCPHI performance goals to help individuals of all ages increase life expectancy and improve their quality of life, and to eliminate health disparities among different segments of the population.

For more information, www.healthypeople.gov.  and

http://intra-apps.cdc.gov/fmo/

 

Background  

Under the original RFA (RFA-CD-05-109) the Centers were conceived to meet a national need to serve as innovative incubators for transformational public health informatics research.  Two Centers of Excellence (CoE) in Public Health Informatics were funded as P01 grants by the CDC Office of Public Health Research (OPHR) in FY05, and in FY06, the National Center for Public Health Informatics (NCPHI) funded an additional three P01 Grants as CoE.   These P01 Research Center grants were required to have at least 2 Cores and 2 or more Research Projects.  

These five transformational research centers have matured to become highly productive, national leaders in public health informatics.  Their academic productivity is impressive, having generated a cumulative total of over 85 peer-reviewed publications, 153 presentations at national meetings, and 92 posters and abstracts.  They also contribute indirectly to strategic national informatics activities by collaborating on such activities as the Informatics Grid and the Electronic Medical Record initiatives.   

There exists an imperative for a new RFA to fund research that will leverage and build upon the developmental accomplishments from the first series of PHI CoEs.  The translational research generated has sparked new questions and offers new possibilities in this new funding cycle for informatics.  This is essential in order to move forward to apply, translate and evaluate public health informatics.  New surveillance tools and technologies are rapidly emerging, and the public health informatics community must take part in their development and dissemination.  Additionally, President Obama's emphasis on smart technology, health IT, and infrastructure building all rely upon quickly mastering the complicated landscape of advanced informatics, proposing innovative methodologies, and conducting test interventions to assure quality and stewardship of the funds entrusted to CDC.  This emphasis will best be accomplished through an RFA that establishes a new generation of Centers of Excellence. 

This RFA fulfills a national strategic need to protect and improve the public’s health through discovery, innovation, and service in health information technology and informatics.  The research produced through this RFA will improve health care, and facilitate early detection and prevention of disease outbreaks and possible terrorist events. 

Public health informatics is the systematic application of information and computer science and technology to public health practice, research, and learning.  It is an emerging field that impacts the nation’s health and security and needs to be rapidly advanced.  It combines: (1) the use of public health information; (2) the use of information technology and; (3) the management of information systems to improve the overall effectiveness of the public health enterprise (e.g., the county, state or local health department).  

The nature of this opportunity is to support research that will develop, translate, and disseminate informatics knowledge and expertise to public health professionals that is essential to maximizing the potential of information systems to improve the health of the nation.  

The research supported should be innovative and supportive of programs linking recent advances in evidence-based public health intervention, systems development, information processes, and computer science to advance and improve the public's health. 

Public health will look to informatics infrastructure to improve the reach and effectiveness of health promotion and disease prevention programs.  Access to population and other public health data, electronic health records and data, as well as access to electronic health record system expertise are essential for developing many new public health informatics systems in local and regional centers. 

The broad objectives of this new RFA are to enhance:

(1) Electronic personal and medical health record support of public health functions and impacts;

(2) Basic capabilities that support public health practice;

(3) Public health decision support

(4) Consumer health platforms to support public health outcomes. 

This RFA will achieve improvements in health care to individual recipients. (virtually everybody), and will benefit health care providers, hospitals, local and state public health departments, collaborative groups such as the Public Health Information Network and the American Medical Information Association, academic epidemiologists and other scientific and medical professionals.   It will achieve advancement of national health information technology initiatives such as those being discussed by the new national administration.  This includes early detection of outbreaks including prevention of bioterrorism.  At the highest level informatics activities that may be developed under this RFA, such as the personal Electronic Health Record, can support the national need for health care reform.  

This RFA invites qualified applicants to work with their institutions to submit an application to fund a Center of Excellence in Public Health Informatics.  This is an open competition P01 RFA.  Applications require one Core and two Projects within each Center’s structure.  Applications should propose two (2) projects only.  Successful Center applicants will have only two (2) projects funded in addition to the core.  Applications which do not have two potentially fundable projects may be considered non-responsive.  

The successful applicants are expected to initiate and maintain a momentum of discovery and to develop research relevant to Public Health Informatics.  This will stimulate the formation of multidisciplinary, multi-institutional research teams that facilitate the translation of basic research findings to practice.

Research proposed for inclusion must represent new research projects.  Projects relevant to Public Health Informatics research that are currently supported by the R01, P01 or other funding mechanisms may not apply for supplemental funds that extend or modify their scope under this RFA.    

Dissemination of evidence-based research products into the public health domain will be encouraged.  The applicants will be encouraged to share findings, tools, and other resources with the academic and public health communities.  

Applicants are encouraged to collaborate with other organizations, especially those serving at-risk and hard-to-reach populations. The active participation of advocacy groups and appropriate community organizations is encouraged.  

The application is expected to contain at least one core component and at least two multidisciplinary and interdependent research projects that are designed to focus on various components of a well-defined program project theme.  Successful program projects generally bring together scientists in diverse fields, who would not otherwise collaborate, to apply complementary approaches to work on a well-defined problem. 

The program project grant is intended to support an organized group of investigators with differing areas of expertise who collaborate to conduct research that is synergistic and addresses a major theme. 

The types of research and experimental approaches that are being sought to achieve the objectives have the characteristics of being open-source with interoperability.   These may include projects supporting or enhancing development of an informatics grid or an electronic medical record. 

 

Potential Project Areas 

The following list is provided to assist potential applicants in selecting and articulating suitable project topics that meet the NCPHI RFA objectives. 

  

Examples of types of research projects that would be appropriate include, but are not limited to, the following:

 

 Area 1. Further Develop Electronic Health Record Integration of Public Health Functions and Outcomes  

•          Develop methods for integrating public health functions into electronic health record systems.  

•          Investigate approaches for integration of local / regional outbreak management, public health decision support, public health communications and alerting, and countermeasure and response administration capabilities with state / national systems and needs.  

 

Area 2.  Enhance Basic Capabilities that Support Public Health Practice  

•          Develop methods for the integration of local and regional public health with state and national data and systems needs in the context of the Public Health Information Network requirements, standards, and specifications.  

•          Create, assess, and validate public health algorithms and approaches to enhance automated electronic detection and reporting of notifiable conditions from the healthcare sector to local/county/state public health authorities. 

•          Evaluate innovative approaches for the federation of public health data, systems, and services. 

•          Develop an extremely low cost grid appliance, simplifying web services development (drag & drop), simplifying data access and data exchange (drag & drop), connecting a public health grid to other grids, and to other data sources. 

•          Develop a low cost Open Source Model that simplifies data access and data exchange 

 

 Area 3.  Explore Innovative Applications of Informatics to Public Health Decision Support  

•          Examine approaches for evidence-based public health decision support systems.

•          Develop methods for visualization, Geographic Information Systems (GIS), dynamic mapping, and spatial / temporal analysis of community data.  

 

Area 4.  Transform and expand Consumer Health Platforms to Support Public Health Outcomes 

•          Evaluate consumer health platforms that encourage and enable healthy living. 

•          Develop, evaluate and translate tools that expand the design of consumer health platforms to improve their usefulness for public health. 

•          Examine the utility of consumer health platforms as supplemental data collection tools for public health. 

•          Develop, evaluate and translate innovative approaches that integrate consumer health platforms and public health functions and outcomes.

 

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

Section II. Award Information


1. Mechanism(s) of Support 

This funding opportunity will use the P01 for research program project grants

2. Funds Available

The participating CDC/NCPHI intends to commit approximately $5,500,000 (including both direct and indirect costs) dollars in FY2009 to fund four to five (4-5) applications. The average award amount is estimated to be $1,000,000 for both direct and indirect costs for the first 12 month budget period. An applicant may request a project period of up to 5 years (60 months). The approximate total project period funded amount is $27,500,000. The earliest anticipated start date for new awards is September 1, 2009.

All estimated funding amounts are subject to availability of funds. 

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

The ongoing support for this program and any awards made pursuant to this funding opportunity is 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 III. Eligibility Information


 1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) 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.

The program project grant is not intended to be a vehicle for departmental support, nor is the research support of a single senior investigator and several postdoctoral and research associate-level scientists appropriate under this mechanism.

2. Cost Sharing or Matching

 

Cost Sharing is not required.


3. Other-Special Eligibility Criteria


Eligible applicants may only submit one application under this announcement.   If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
 

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

 

Section IV. Application and Submission Information


1. Request Application Information

The PHS 398 application instructions are available at   http://grants1.nih.gov/grants/funding/phs398/phs398.html  in an interactive format.  Applicants must use the currently approved version of the PHS 398.  For further assistance, contact Grants Info, Telephone (301) 435-0714, E-mail GrantsInfo@nih.gov.

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

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section, (PGO-TIM) at: Telephone 770-488-2700, Email:  PGOTIM@cdc.gov.  Application forms can be mailed to you.

2. Content and Form of Application Submission
 

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

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

The page limit for each major component of the grant (i.e., the overall program project description including the administrative core component, and each individual research project) is no more than 25 pages, each, exclusive of budget and biosketches and progress reports for renewal applications. Applicants are required to use the format provided below in organizing their applications.  The entire application should be paginated sequentially from front to back. All sections and subsections of the application including appendices should be listed with corresponding page numbers in a Master Table of Contents.

Content and format of applications should include the following:

Abstract (Overall Application Summary and Relevance)

It is especially important that the abstract (Description, PHS 398 form page 2) of your grant application reflect the overall application’s (both core and research) focus, because if your application is funded, your abstract will become public information. 

The language of the abstract must be simple and easy to understand for a broad audience.  For more information on how to write an abstract please see “Structured Abstracts” section at: http://jama.ama-assn.org/ifora-current.dtl.

Program Project Description (Maximum 25 pages allowed for the Program Project Description combined with the Administrative Core section)

An overview section must contain justification for the program project grant mechanism and describe those goals that are not readily attainable through individual research project grants.  This section should include information detailing activities to be conducted for the first budget year and describe more briefly activities to be conducted over the entire five-year project period.  A description of the administrative arrangements for overall scientific leadership, quality control, and management of the program project grant should be provided in the overview as well as a description of facilities available, including major equipment or instruments and special program resources that will support the program project.  Applications should include the following:

·          Face page

·          Description (ABSTRACT)

·          Master Table of contents

·          A clear statement of the public health informatics system research priority theme on which the project program is based.  The goals and objectives of the program in addressing this theme as a whole and a description of the relationship of the individual research projects to the entire program project should be described.  The special benefits and synergism to be achieved by funding as a program project grant rather than as a series of individual research grants should be discussed.

·          List of all key research personnel and critical core staff and the percent effort to be devoted to activities described in the proposed program project

·          Detailed budget for the first budget period and estimated budgets for the entire five-year project period (direct and indirect costs). The budget should reflect the composite figures (core plus individual projects) for the grant application.  In addition, separate budgets (direct and indirect costs) and justifications should be provided for the following categories of activities.

Administrative Core Component, which, at a minimum should include:

·                      An operational Plan for program project activities and administrative/grant management and support for the research projects 

·                      Establish and convene an advisory group to support the program project.  The advisory group should include representatives from state, local, and/or tribal organizations, and may include medical or health care facilities that are involved in public health informatics activities, public health leaders, community liaisons, etc.

·                      Strategies and methods to evaluate and translate results from research efforts to help achieve national goals and for enhanced, improved, or expanded public health informatics capabilities

·                      Up to $300,000 (to include direct and indirect costs) for the first budget period

The discussion of activities and function of the administrative core component should include information on where the program project will reside within the organizational structure of the applicant institution and the clear lines of authority for the principal investigator and individual project lead investigators.  Clear institution-wide support should be documented for program project activities that involve collaborating scientists from multiple departments, university schools, or institutions so as to ensure oversight for interdisciplinary activities.  Program project grant applications that include individual research projects from varying disciplines, such as engineering, business, medicine, social science, law, religion, computer science, government, etc., are strongly encouraged.  

Applicants should discuss how the application compliments efforts to build or enhance a base in public health informatics systems research.

Collaboration with and the participation of public health agencies and other public and private sector organizations engaged in public health informatics in proposed project activities is strongly encouraged.  Letters of commitment or support should be provided for each agency to document agreed collaboration or participation and indicate expected roles and activities.

Individual research projects (Maximum 25 pages for each project):

Each research project in the program project grant should represent both an independent and an interdependent research effort, and should be prepared in the format of an individual research grant application. The cover page, abstract, budget pages, biographical information, description of the research to be conducted, and any justification for research involving human subjects, if applicable, should be included as noted below.  A detailed research plan (design and methods), including aims, hypothesis, expected outcomes, and measurable and time-framed objectives, should be included.  The focus of the research should be consistent with efforts to achieve public health informatics priorities for federal, state, local, and tribal public health systems.  Where applicable, describe the anticipated results that will have immediate application in public health informatics systems.  The special benefits and synergism to be achieved from the program project must also be discussed.  Individual research projects should be:

·          Up to $350,000 (to include direct and indirect costs) for the first budget period.

·          Focused on various aspects of the research theme and contribute to a total research program investigating some element of the public health system for public health informatics capabilities

·          Essential elements of a unified and interdependent research program

Individual research project applications should include:

·          Abstract

·          Budget for the entire proposed project period, including budgets for each individual research project and any consortium/contractual arrangements.

·          The detailed budget request must be provided in the form, format, and to the level of detail as indicated in the CDC Budget Guidelines located at http://www.cdc.gov/od/pgo/funding/grants/Budget_Guidelines.doc

·          Biographical sketches of key personnel, consultants, and collaborators, including the Principal Investigator and lead investigators for each research project

·          Listing of other (pending or currently available) support in relation to the proposed program project and a description of planned modifications in the event of funding,  The source of funding for each grant or contract should be indicated as well as the amount of funding and date of funding (start and end dates).

·          A description of resources and environment that will support the proposed project program.

Additional Formatting Requirements:  Each application must include a Master Table of Contents that lists all sections and subsections of the application with page numbers.  Applications must have consecutive and continuous page numbers front to back of the application with the page number placed at the bottom center of each page as a footer.  All Appendices must be collected together at the end of the application and clearly identified with references to the relevant sections of the application.  Each page of the application must include a header that includes the name of the Program Project Principal Investigator.

Required Components:

SECTION I                                                                                                 

 Face Page . . . . . . . . . . . . . . . . . . . .

Description (Abstract), Performance Site Locations, and Key Personnel . . . . . . . . . .

Master Table of Contents . . . . . . . . . . . . . . . .

Detailed Composite Budget for First 12-month Budget Period

Composite Budget for All Years, All Projects. . .

Detailed Administrative Core Budget for First 12-month Budget Period. . . . . . . . . . . . . . .

Administrative Core Budget for All Years

List of All Professional and Non-Professional Personnel.

Bibliographical Sketch - Program Project Principal Investigator. . . . . . . . . . . . . . . . .

Bibliographical Sketches of Other Key Personnel - Alphabetical Order. . . . . . . . . . . . . . . . . . .

Summary of Sources of Support . . . . . . . . . .

Institutional Environment and Resources . . . . .

Checklist

  

SECTION II  

PROGRAM PROJECT RESEARCH PLAN AND ADMINISTRATIVE CORE

Specific Aims

Background and Significance. . . . . . . . . . . . . . .

Summary Report of Progress. . . . . . . . . . . .

(Competing Continuation and Supplemental Applications)

Brief Progress Summaries of Continuing Projects and Administrative Core Activities

Detailed Reports for Non-Continuing Projects. . . .

Listing of Projects: Discontinued, Modified or Completed Since Last Review. .

Publications Resulting from Program Project . . .

Program Project Design and Methods

            Scientific Plan

Organizational and Administrative Structure . . .

New Investigator Recruitment and Training Plan

Pilot Project Plan

Advisory Board Structure

Translational Research Plan

Bibliography and References Cited

 

SECTION III  

RESEARCH PROJECTS (numbered 1, 2, 3 . . .): Identify by Title and Principal Investigator

Description (Abstract), Performance Site Locations, and Key Personnel for Research Project

Table of Contents for Research Project

Detailed Budget for First 12-month Budget Period of Research Project

Budget for All Years of Research Project

Bibliographical Sketch - Principal Investigator

Bibliographical Sketches of Other Investigators - Alphabetical Order. . . . . . . . . . . . . . . . . . .

Relation of Project to Program Project . . .

Specific Aims. . . . . . . . . . . . . . . .

Background and Significance. . . . . . . . .

Detailed Progress Report/Preliminary Studies. . . . .

Experimental Design and Methods. . . . . . .

Bibliography and References Cited

Human Subjects . . . . . . . . . . . . . . .

Vertebrate Animals (only if applicable). . . . . . . . . . . .

Facilities Available . . . . . . . . . . . .

Consultants/Collaborative Arrangements (if applicable)

Consortium/Contractual Arrangements (if applicable)

Checklist

  

REPEAT THE ABOVE CATEGORIES IN SECTION III FOR EACH RESEARCH PROJECT

  

SECTION IV. 

APPENDICES  

Table of Contents for Appendices

Appendix 1 - Title

Appendix 2 – Title

Appendix . . . - Title

 

Appendix titles should reference the relevant sections of the application. See PHS 398 Application Instructions for additional Appendix requirements


Optional Components:

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

SPECIAL INSTRUCTIONS  

 

3. Submission Dates and Times

 

See Section IV.3.A for details


3. A. Submission, Review and Anticipated Start Dates

Release/Posted Date: February 9, 2009

Letter of Intent Receipt Date: March 9, 2009

Application Submission Receipt Date: April 10, 2009

Peer Review Date(s): May 1, 2009

Council Review Date(s): August 2009

Earliest Anticipated Start Date(s): September 1, 2009

Additional Information to Be Available Date: Conference Call April 2, 2009

Expiration Date: April 11, 2009


3.A.1. Letter of Intent
 

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

·          Number and title of this funding opportunity

·          Title and brief description of the proposed Program Project

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

·          Names of other key personnel including lead investigators for each inter-related research project

·          Name of participating institutions or subunits, including physical address and primary contact telephone number.

·          Title and brief description of each research project component

 

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 in time for receipt by the date listed in Section IV. 3.A

The letter of intent should be sent to: 

Lee Husting, Ph.D., MPH

Scientific Program Officer, Extramural

National Center for Public Health Informatics

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Rd. NE Mailstop E-78

Building 2500 Century Center

Atlanta, GA 30329-4018

Telephone: (404) 498-1186

Email: eih8@cdc.gov

 

3.B. Submitting an Application to CDC  

If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

 

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.
 

When submitting a paper application, it must be prepared using the latest 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

 

Technical Information Management Section – RFA-HK09-001

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(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.
 

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

4. Intergovernmental Review

Executive Order 12372 does not apply to this program. 

5. Funding Restrictions

 

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

 

Additional guidance can be found at HHS Grants Policy Statement.

http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc

 

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

 

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

·          Reimbursement of pre-award costs is not allowed.

·          Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application.  The application must submit two research projects to be responsive.   


6. Other Submission Requirements

 

Special Requirements

·         The burden of proof is on the applicant organization to demonstrate in the written application that the program project is more effective than it would be as a set of independent research grants.  Each research project in the program is expected to contribute and be directly related to the total research effort on public health informatics.

·         Research program project grant funds are to be designated for two types of activities.  One activity is the core component.  The second is multidisciplinary, interdependent, research projects.  Each individual project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts.  If researchers have substantial support in areas closely related to the program project, their support should be folded into the program project.  If their support cannot be folded in, they may participate as associate members.  Associate members have full use of, for example, core facilities, and contribute to the overall collegiality of the project, but derive no financial support from it. 

Overall Proposal

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. 

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

Program Project Center Core Component and Research Component Sections

The length of the core component section (which combines the Program Project Description and Administrative Core sections) should be no more than 25 pages, exclusive of budget, budget justification, and biosketches. The recommended guidance for completing a detailed justified budget can be found on the CDC Web site at the following address: http://www.cdc.gov/od/pgo/funding/budgetguide.htmhttp://www.cdc.gov/od/pgo/funding/budgetguide.htm.   

This 25 page limit also applies for each individual research project for the P01 program project research grant application.  

The following materials may be included in the Appendix for the entire P01 program project application:

No more than 2 (two) publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to each of the proposed individual research projects.  Do not include manuscripts submitted for publication.

•          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 along with the letter of acceptance.

•          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.

Please note the following restriction on appendix attachments: The Program Project Plan Appendix attachments are limited to 10 attachments.

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

Applicants are expected to participate in one meeting, conference, or workshop annually as determined by NCPHI to interact with other award recipients and to share and disseminate ongoing results and findings from research and activities in their program project.  These meetings may occur in conjunction with national annual meetings related to public health informatics.  It is expected that funds to support attendance at such annual meetings will be included in budget requests as appropriate.  

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants 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
The scientific merit of the entire program project grant application, as well as its coherence as a program, will be assessed on the basis of the criteria outlined below.  In addition, the scientific merit of each individual project will be assessed and a priority score assigned based on the criteria outlined below.  The review will take into account the additional strength the overall program project will gain from interaction of the individual research project with other components of the proposed program project grant, and the potential importance of an individual research project to the success of the total effort.  In this context, it may be the case that an individual research project may be highly meritorious in the context of the entire program project, but not be competitive as a stand-alone research grant.

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

2. Review and Selection Process

The overall application will be evaluated as an integrated research effort focused on a central theme.  Individual research projects, the supporting Administrative Core, and Program as an Integrated Effort are collectively considered.   The relationship and contributions of each research project and core to the overall theme of the program project will be discussed and evaluated.  Projects not recommended for inclusion in a Center will be considered in scoring the overall program project, and such projects may reflect on the leadership capabilities of the PD/PI.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCPHI 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 that consists of:

o         A separate evaluation of the Administrative Core Component and proposed activities

o         A separate evaluation of each of the individual research projects

o         A summary evaluation of the overall program project 

·          Receive a second level of review for programmatic relevance.  Applications submitted in response to this RFA will compete for available funds with all other eligible applications.

 

Funding Criteria

The following criteria will be considered in making funding decisions:  

·          Scientific merit of the proposed program 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

·          Preference for funding to achieve a geographical or regional distribution of awarded programs.  

Final review and recommendations by the Secondary Review and NCPHI program staff will take into account the scientific merit of both the individual research projects and the program project as a whole and the relevance of the project to achieving goals and priorities for public health informatics systems research.   

Evidence of readiness and capability might include:  a history of successful prior CDC or other funded research in informatics, an established infrastructure, the availability of faculty and staff from graduate degree programs, career development, training programs in informatics; evidence of accomplishments including peer-reviewed publications; evidence of strong partnerships in informatics.    

Since a successful application must have two projects, applications must submit two potentially fundable projects. 

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

Applications are required to include an explicit detailed plan for translation of results into practice.   Absence of appropriate translation plan(s) will cause an application to be considered non-responsive and not considered further.   An application should include an overall translation plan for the proposed Center, and a plan for each project.  Applications also should document the capability to establish and maintain a functional core to support relevant projects.  Applications that fail to demonsgtrate this capability will be rejected as non-responsive.  Applicants should clearly identify the above material and related evidence in a readily observable section. 

·          Significance:

o         Does this program project or individual research project address an important problem?

o         Are the proposed core component functions clearly defined and essential for achieving the program project goals and supporting individual research projects?

o         If the applicant achieves the aims of the application, how much will it advance scientific knowledge of and impact public health informatics? How much will it advance public health practice?  How will it advance science and practice?

o         Is this program project or individual research project generalizable?

o         What is the added scientific gain from the linkage of individual research projects?

o         What will be the effect of these studies on the concepts, methods, technologies, or strategies for public health informatics?  What will be the effect  everyday practice of public health? 

·          Approach:

o         To what extent are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project?

o         Does the program project include sound strategies and/or methods to evaluate and translate results of the research effort for enhanced, improved or expanded public health informatics?  How strong are the metrics for measuring outcomes?

o         How adequate and appropriate are proposed activities in the Core Component for guiding and managing the overall program project and contributing to the total effort?   Will the Core activities strengthen the relevance of research to public health practice and increase the translation of research into practice?

o         To what extent are the individual research projects interdependent, multidisciplinary, and integral to achieving overall center program project goals?

o         How well does the program project incorporate a multidisciplinary approach to achieve program goals as reflected by the interrelatedness of the individual projects? 

o         Does the applicant acknowledge potential problem areas and consider alternative tactics?

o         How well do the proposed core activities advance the field for public health informatics?   

·          Innovation:

o         Is the project original and innovative? For example: Does the program project contribute to improvements in existing public health informatics or address an innovative hypothesis or critical barrier to progress toward achieving informatics goals?

o         Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies to increase the timeliness, scale, or quality of public health informatics?

o         Does the project leverage research talent from other schools (e.g., engineering, business, nursing, government, theology, law, etc.) or universities to establish multidisciplinary solutions to public health informatics needs?  

·          Investigators:

o         Are the investigators appropriately trained and well suited to carry out this work?  For example: does the experience of the principal investigator for the program project indicate the capacity to lead a multidisciplinary research team  and manage the administrative requirements for the grant; do investigators for the individual research projects have adequate training and knowledge to conduct the proposed research?

o         Is the work proposed appropriate to the experience level of the principal investigator and other researchers?

o         Does the investigative team bring complementary and integrated expertise to the project?   

·          Environment:

o         How well does the scientific environment in which the applicant will do the work contribute to the probability of success?

o         To what extent do the proposed research projects benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? 

o         Is the commitment of the institution evident and adequate to support the program project in terms of space, resources, or administrative authority?

o         Does the location of the program project within the applicant organization provide the authority to facilitate multidisciplinary work for investigators across departmental lines or across schools in the university environment?

o         Is there an operational plan that will provide optimal support for projects to achieve goals?

o         Is there a plan for recruiting and developing new investigators?

o         Is there a plan to convene and organize an external advisory board?

o         Is there a plan to conduct pilot projects?

o         Are partners from public and private organizations engaged in public health informatics  involved in program project activities?  Do these organizations provide letters of support that describe their role and the extent of their participation?   

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.

 

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 E on Human Subjects in the PHS Form 398) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm  Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available  on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm. 

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 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. 
The recommended guidance for completing a detailed justified budget can be found on the CDC Web site at the following address: http://www.cdc.gov/od/pgo/funding/budgetguide.htmhttp://www.cdc.gov/od/pgo/funding/budgetguide.htm.


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.  NCPHI 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.


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
 

Applicants will be notified on or before September 1, 2009 by the CDC Procurement and Grants Office (PGO) if their applications were funded.

 

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.  Pre-award costs are not allowed. See also Section IV.5. Funding Restrictions.


2. Administrative and National Policy Requirements


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

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


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.      Recipient Organization also must provide quarterly performance progress reports submitted as an original and 2 copies to the GMS and to the Project Officer.  The suggested format for these reports may include a list of peer-reviewed publications in accepted bibliographic format, and a brief list and description of translational, innovative, and collaborative activities, and dissemination including press releases. 

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

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

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

Continued Funding

Continuation awards within the project period, will be made on the basis of the availability of funds and the following criteria. 

1.      The accomplishments reflected in the progress report of the continuation application should indicate that the applicant is meeting previously stated objectives or milestones contained in the project’s annual work plan and satisfactory progress is being demonstrated.   The report should contain progress in core activities, including a report on advisory committee meeting(s), activities, etc., and progress in individual research projects. 

2.      The objectives for the new budget period should be realistic, specific, and measurable. 

3.      The methods described should clearly lead to achievement of these objectives. 

4.      The evaluation plan is adequate to allow management to monitor whether the methods are effective.  

5.      Any impediments to progress must be described, e.g., milestones that are deficient or deferred are fully explained, and the corrective action taken to address the impediment is described including specific information on revised dates of completion of the milestones impacted. 

6.      The budget request must be clearly explained, adequately justified, reasonable and consistent with the intended use of program project grant funds. 

7.      Between the third and fourth budget periods NCPHI program staff intends to conduct a comprehensive mid-course evaluation of the research centers in conjunction with consideration for continued funding.  This evaluation may include, but is not limited to, an institutional visit to review ongoing program activities, consultation with advisory committees, program partners, individual research investigators, or other parties as determined necessary.  Such an evaluation may be conducted sooner if warranted by less than satisfactory progress.   

 

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

 

Section VII. Agency Contacts


 HHS/CDC encourages your inquiries concerning this RFA 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:

Lee Husting, Ph.D., MPH

Scientific Program Officer, Extramural

National Center for Public Health Informatics

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Rd. NE Mailstop E-78

Atlanta, GA 30329

Telephone: (404) 498-1186

Email:  eih8@cdc.gov

 

2. Peer Review Contacts:

Charles N. Rafferty Ph.D.

Senior Scientific Review Officer

Office of Science and Public Health Practice

Coordinating Office for Terrorism Preparedness and Emergency Response

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

1600 Clifton Rd. NE Mailstop D-44

Atlanta, GA 30333

Telephone: (404) 639-7495

Fax (404) 639-7977   

Email: cor9@cdc.gov


 

3. Financial or Grants Management Contacts:

Pamela Baker

Grants Management Specialist

Procurement and Grants Office

Center for Disease Control and Prevention

U.S. Department of Health and Human Services

Koger Center, Colgate Building, Room 3115

Mailstop K-69 Atlanta, GA  30341

Telephone: (770) 488-2689

FAX:   (770) 488-2670  

Email:  pybaker@cdc.gov

 

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Telephone:  770-488-2700

Email: PGOTIM@cdc.gov

 

Section VIII. Other Information


Required Federal Citations
 

Human Subjects Protection

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

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

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

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH


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

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

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

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

 

Paperwork Reduction Act Requirements

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

 

Smoke-Free Workplace Requirements

 

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

 

Healthy People 2010

 

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA 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 Non-profit 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/

 

Health Insurance Portability and Accountability Act Requirements

 

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

 

Release and Sharing of Data

 

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

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

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

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

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

Conference Disclaimer and Use of Logos

{Mandatory for all grants and cooperative agreements.}

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

 

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

 

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

 

 


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