An amendment was made to this Funding Opportunity Announcement 03.04.2008 to the following Sections:

1.      Section I. Funding Opportunity Description, 1. Research Objectives, Objectives.

2.      Section I. Funding Opportunity Description, 1. Research Objectives,  FOA Assistance Mechanism.

3.      Section IV. Application and Submission Information, 3. Submission Dates and Times, 3.A.1. Letter of Intent

 

All amendments are noted in red type

 

Part I Overview Information


United States Department of Health and Human Services (HHS) 

Issuing Organization  

Centers for Disease Control and Prevention (COTPER/CDC) at http://www.cdc.gov/maso/pdf/COTPERfs.pdf


Participating Organizations 

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


Components of Participating Organizations
 

Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER/CDC), at http://www.cdc.gov/maso/pdf/COTPERfs.pdf

Title:  Preparedness and Emergency Response Research Centers: A Public Health Systems Approach (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 319F(d)(7) of the Public Health Service Act, 42 U.S.C. 247d-6(d)(7). 

 

Announcement Type: New

 

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

 

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

 

Key Dates
Release/Posted Date: February 15, 2008
Letter of Intent Receipt Date:  March 17, 2008
Application Submission Receipt Date(s):
 May 15, 2008
Peer Review Date(s):
June-July, 2008
Secondary/Council Review Date(s):
August 2008

Earliest Anticipated Start Date(s):   September 30, 2008

Additional Information to Be Available Date: Teleconference for potential applicants: March 7, 2008 from 2:00 -3:00 PM, EST.  Call Teleconference Bridge Line number 1-866-741-7636 and use participant pass code number 5168692

Expiration Date:  May 16, 2008  

 

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary

 

·          The Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), Centers for Disease Control and Prevention (CDC) invites grant applications from accredited Schools of Public Health for Preparedness and Emergency Response Research Centers (PERRCs) that investigate the structure, capabilities, and performance of public health systems for preparedness and emergency response activities.   The P01 program project grant mechanism will be used to support multidisciplinary, inter-related and interdependent research projects and a core component. 

·          COTPER /CDC intends to commit a total of approximately $9,000,000 in fiscal year (FY) 2008 funds to this funding opportunity announcement (FOA) for payment of applications responsive to this announcement statement.

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

·          Five to Seven (5-7) awards are anticipated under this announcement.  An average award is estimated to be $1,700,000 in total costs (both direct and indirect costs) for a research core and no more than five inter-related and interdependent research projects for the first 12-month budget period over a five (5) year project period

·          Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the activity code, quality, duration, and costs of the applications received.

·          Eligible Organizations:  Eligible applicants for this announcement are accredited Schools of Public Health, as required by section 319F-2(d) of the Public Health Service Act. Only schools accredited by the Council on Education for Public Health are eligible.  Eligible applicants may only submit one application under this announcement.  Eligible applicants are encouraged to include research that is multidisciplinary and may enter into collaborative relationships that cut across departmental, school/college, or university boundaries.  However, the primary responsibility for the conduct of the research remains with the eligible organization which must contribute a majority of the research effort in the program project.  An eligible applicant may submit an application that includes inter-related and interdependent research in collaboration with any of the following: 

o         Non-eligible schools or colleges within the same institution or university

o         Public nonprofit organizations;

o         Private nonprofit organizations

o         For profit organizations;

o         Small, minority, and women-owned businesses;

o         Universities or colleges

o         Research institutions;

o         Hospitals or community-based organizations

o         Faith-based organizations

o         Federally recognized or state-recognized American Indian/Alaska Native tribal governments;

o         American Indian/Alaska Native tribally designated organizations

o         Alaska Native health corporations

o         Urban Indian health organizations; tribal epidemiology centers;

o         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 and approved by the state to participate as a state governmental entity.

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

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

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

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

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

3. Anticipated Announcement and Award Dates

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

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

    3. Reporting

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

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


 

Section I. Funding Opportunity Description


1. Research Objectives

Background 

The governmental public health response functions during emergencies that are performed by the Centers for Disease Control and Prevention (CDC) and other agencies of the Department of Health and Human Services (DHHS) are outlined in Emergency Support Functions (ESF) Annex 8 of the National Response Plan (http://www.dhs.gov/xlibrary/assets/NRP_FullText.pdf ).  Within the CDC, the Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER; http://www.cdc.gov/maso/pdf/COTPERfs.pdf) has primary oversight and responsibility for all programs that comprise CDC's terrorism preparedness and emergency response portfolio. Through an all-hazards approach to preparedness that focuses on large-scale threats from natural, biological, chemical, nuclear, and radiological events, COTPER helps the nation prepare for and respond to urgent threats to the public's health. COTPER’s mission is to prevent death, disability, disease and injury associated with urgent health threats by improving preparedness of the public health system, the healthcare delivery system and the public through excellence in science and services.  

The CDC 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 Program Assessment Rating Tool (PART).  This FOA addresses “Healthy People 2010” priority area(s) for Public Health Infrastructure and Environmental Health related to research on public health systems to help communities respond to and recover from disasters and for disaster preparedness plans and protocols, respectively.  For more information, see www.healthypeople.gov.    

The  Pandemic and All-Hazards Preparedness Act (PAHPA), Public Law 109-417 Section 319F(d)(7) directs the Secretary of the DHHS to “…define the existing knowledge base for public health preparedness and response systems, and establish a research agenda based on Federal, State, local and tribal public health preparedness priorities.”  This FOA specifically responds to the Congressional mandate in section 319F(d)(7) of the Public Health Service Act, as added by sections 301(d) and (e) of the Pandemic and All-Hazards Preparedness Act (PAHPA) (P.L. 109-417 (2006)) by providing funding for research centers at accredited Schools of Public Health to conduct public health systems research for preparedness and emergency response.    

The public health system is a complex network that requires the integration of services from both public and private agencies and organizations.  The purpose of this research program is to conduct public health systems research on preparedness and response capabilities at the national, state, local, and tribal levels.  Preparedness for threats to public health from chemical, radiological, or biological hazards, natural disasters, disease outbreaks and pandemics were among the challenges described in the 2006 U.S. National Security Strategy http://www.whitehouse.gov/nsc/nss/2006/nss2006.pdf.  Program activities within several operating divisions of the Department of Health and Human Services are directed toward preparing for and responding to these threats.  Within this overall HHS strategy for responding to terrorism and public health challenges, the CDC is charged with addressing strategic goals for Terrorism Preparedness and Emergency Response (http://www.hhs.gov/budget/07plan/sGoal2.html#prog2c).

Pre-Event

1. Increase the use and development of interventions known to prevent human illness from

chemical, biological, radiological agents, and naturally occurring health threats.

2. Decrease the time needed to classify health events as terrorism or naturally occurring in

partnership with other agencies.

3. Decrease the time needed to detect and report chemical, biological, radiological agents in

tissue, food or environmental samples that cause threats to the public’s health.

4. Improve the timeliness and accuracy of communications regarding threats to the public’s

health.

Event

5. Decrease the time to identify causes, risk factors, and appropriate interventions for those

affected by threats to the public’s health.

6. Decrease the time needed to provide countermeasures and health guidance to those affected by threats to the public’s health.

Post-Event

7. Decrease the time needed to restore health services and environmental safety to pre-event  levels.

8. Improve the long-term follow-up provided to those affected by threats to the public’s health.

9. Decrease the time needed to implement recommendations from after-action reports following threats to the public’s health.

 

CDC programs accomplish these goals through five strategic areas which provide a framework to focus agency efforts and include provisions to:

A.      Integrate and enhance the existing surveillance systems at the local, state, national, and international levels to detect, monitor, report, and evaluate public health threats.

B.      Support and strengthen human and technological epidemiologic resources to prevent, investigate, mitigate, and control current, emerging, and new public health threats and to conduct research and development that lead to interventions for such threats.

C.      Enhance and sustain nationwide and international laboratory capacity to gather, ship, screen, and test samples for public health threats and to conduct research and development that lead to interventions for such threats

D.      Assure an integrated, sustainable, nationwide response and recovery capacity to limit morbidity and mortality from public health threats.

E.      Expand and strengthen integrated, sustained, national foundational and surge capacities capable of reaching all individuals with effective assistance to address public health threats.  

The intent of preparedness and emergency response activities are to prevent the negative impact of a public health emergency on affected communities.  Programs to build this capacity at the state level are ongoing and the capacity to respond to an urgent health threat requires that multiple organizations cooperate and function within a fluid and dynamic public health infrastructure.  Public health systems research is a relatively new field that COTPER has defined operationally as developing and using methodologies to understand, model, and measure the influence of change in a complex entity comprised of interrelated constituent parts.  Within this context, the intent of the program for Preparedness and Emergency Response Research Centers (PERRCs) is to use the public health systems research approach to examine the organization, function, capacity, and performance of components in the public health system in preparing for and responding to any and all potential threats and hazards. This FOA is not intended to support health services research, clinical research, or research on specific agent characteristics.

 

Objectives

The goal of this program is to use a public heath systems research approach to strengthen and improve public health preparedness and emergency response capabilities with the following objectives: 

1. Respond to Congressional intent to expand the role of Centers for Public Health Preparedness (CPHP) at accredited Schools of Public Health to conduct research and improve public health emergency preparedness systems.  

2. Initiate a public health research enterprise (in the form of multi-disciplinary centers) that focuses on new knowledge for application in public health practice and that collectively produces improvement in key public health systems in a 5-year time frame.  

3. Improve capability assessment for emergency response to rare events and uptake of knowledge-to-practice such that variability in performance is reduced.  

4. Improve all-hazards performance as a priority over scenario- or agent-based system performance and target changes that can improve every-day public health practice while improving preparedness for disasters and infrequent emergencies.  

5. Leverage the academic research environment at Schools of Public Health (where a broad spectrum of research disciplines resides) to accelerate the development of research methods, standards, best practices, and templates suitable to breakthrough research in public health emergency preparedness systems.  

The goal and objectives of this program support efforts to address the national preparedness goals for response to acts of terrorism, natural disasters, or infectious disease outbreaks and threats, and are consistent with achieving the CDC’s overarching Health Protection Goals for Preparedness (http://www.cdc.gov/osi/goals/preparedness.html).  Research on public health systems will be funded in consideration of recommendations from the recent report  Research Priorities in Emergency Preparedness and Response for Public Health Systems: A Letter Report prepared by the Institute of Medicine (IOM)   http://www.iom.edu/CMS/3740/48812.aspx. 

The CDC/COTPER requested that the IOM conduct a study to identify gaps in knowledge about public health systems for preparedness and emergency response and to articulate recommendations for near-term priorities areas for research.  The IOM was directed to undertake this study within the context of: ongoing DHHS efforts to develop a broad federal research agenda for public health preparedness and response systems, resident expertise for public health preparedness within Schools of Public Health, and the CDC framework to promote preparedness and public health as described in the report Advancing the Nation’s Health: A Research Guide to Public Health Research Needs, 2006-2015, commonly referred to as “The CDC Research Guide,” http://www.cdc.gov/od/science/PHResearch/cdcra/

As described in the CDC Research Guide relative to public health systems for preparedness and emergency response, the IOM considered the following;

·          Protecting vulnerable populations in emergencies

·          Strengthening response systems 

·          Preparing the public health workforce

·          Improving timely emergency communications

·          Improving information management to increase use 

In addition to recommendations for research priorities, the IOM report provides background information, examples, and references.  The IOM report can be obtained free of charge at http://www.iom.edu/CMS/3740/48812.aspx.  Potential applicants are strongly encouraged to review the report in the development of applications to this FOA.  As recommended in the IOM report, COTPER has determined that the following broad themes are priorities for research under this announcement:

1.      Enhance the Usefulness of Training

2.      Improve Communications in Preparedness and Response

3.      Create and Maintain Sustainable Preparedness and Response Systems

4.      Generate Criteria and Metrics Applicable to An All-hazard Approach to Preparedness to Measure Effectiveness and Efficiency  

COTPER has determined that priorities for research under Theme 1, “Enhance the Usefulness of Training” must be more narrowly focused in order to avoid duplication of ongoing activities in CDC programs.  In this regard, proposed research studies to “Enhance the Usefulness of Training” should reflect and build upon (where applicable) the existing body of knowledge of systems engineering, computer science, learning and cognition, educational technology,

performance technology, and instructional systems design.  Further, research within this priority theme should result in findings that are generalizable to a larger population.  Formative and summative evaluation studies (such as training evaluation, program evaluation, needs assessment or analysis) are not considered within the scope of the intended program under this FOA and will not be accepted.  Within the broad theme of research to “Enhance the Usefulness of Training,” only proposals that address one of the following two areas will be considered:

  1. Research to assess the effectiveness of public health preparedness and response simulation games which are role-based and capability-linked to self-efficacy expectations, knowledge, skills, and/or response performance.
  2. Research to determine whether training modalities and instructional methods (including electronic performance support tools) result in improved individual and/or system performance under response conditions.

Research on the priority themes should be developed with the following specific considerations in mind: 

·         Vulnerable populations and workforce themes are considered cross-cutting for each of the themes for priority research.  In addition, ethical and legal issues also are pervasive concerns in a system of emergency preparedness and should be referenced or addressed as part of each proposed research project.

·         Although the IOM report refers specifically to current Centers for Public Health Preparedness (CPHP) programs, application to this FOA is open and competitive for all accredited Schools of Public Health.

·         Research questions included in the IOM report under each recommendation should be considered examples and are not intended to be prescriptive.  Applicants should think creatively in developing proposals to address the themes for priority research.  All research questions included by the IOM under each recommendation may not be readily framed as such.  

·         Public presentations provided at the IOM Public Workgroup Meeting and present on the IOM website (http://www.iom.edu/CMS/3740/48812.aspx) represent individual or organizational viewpoints and do not necessarily reflect the opinion or position of COTPER.  Information in these presentations should only be used as a resource and for informational purposes. 

FOA Assistance Mechanism 

This announcement uses the research program project grant mechanism to fund research for promoting and enhancing the preparedness and emergency response capabilities of the public health infrastructure at the federal, state, local, and tribal levels.  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.  Applications responsive to this announcement should describe research focused on a particular aspect of the public health system in regard to preparedness and emergency response capabilities.  The application is expected to contain a core component and up to 5 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.  In this regard the burden of proof is on the principal investigator, and on the leader for each individual research project, to demonstrate in the written application that the program project would be much less effective if parceled out 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 systems in regard to preparedness and emergency response capabilities.

The program project grant application should demonstrate an essential element of unity and interdependent research activities with a core component.  Each program project is expected to be under the leadership of an established, senior scientist designated by the applicant institution. This principal investigator is expected to bear responsibility for the overall scientific leadership and fiscal management of the program project grant.  Each of the collaborating scientists responsible for the individual research projects is expected to be an independent investigator.  Multidisciplinary research projects from investigators across departments, administrative units, institutions or universities (through a subcontract mechanism) are encouraged.  Investigators located at a proposed PERCC or who are proposing to collaborate with a PERCC should include a complete description of how the proposal in response to this FOA will utilize the core facilities funded through the PERCC. Investigators who are not directly affiliated with a PERCC may form collaborations with such centers in order to utilize the core resources. 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.  In addition, the program project and each individual research project must represent a significant effort on the part of the participating scientists and be distinct from their other funded efforts.  If individuals 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.   

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 activity code for research program project grants.

 

2. Funds Available

CDC/COTPER intends to commit approximately $9,000,000 in FY2008 dollars to fund five to seven (5-7) applications. The average award amount will be $1,700,000 total for both direct and indirect costs for the first 12-month budget period.  An applicant may request a project period of up to five years (60 months).  An applicant may request up to $2,000,000 for the first 12-month budget period for a research program core and no more than five interrelated research projects.  Applicants may request funds for a research core for up to $300,000  (to include direct and indirect costs) and individual research projects for up to $350,000 each (to include direct and indirect costs) for the first 12-month budget period. The approximate total project period funded amount is $45,000,000. 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 (2 million), 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. 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plan of the COTPER is to provide support for initiating 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.  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. 

Indirect costs requested by all components in the program project grant are to be included within the total cost limitation. 

Use of Funds

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. 

Research program project grant funds are to be designated for two types of activities.  One type is the core component, which, at a minimum, supports each of the following activities:

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

·          Provide funding and oversight for the development of up to 4 New Research Investigators

·          Provide funding, support, and oversight for up to 4 Pilot Projects for innovative research on public health systems research on preparedness and emergency response capabilities

·          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 preparedness and emergency response activities, public health leaders, community liaisons, etc.

·          Strategies and methods to evaluate and translate results from research efforts to assure relevance to public health practice, to help achieve national preparedness goals, and for enhanced, improved, or expanded preparedness and emergency response capabilities. 

 

Multidisciplinary, interdependent, research projects constitute the second type of activity funded.  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.   

Eligible applicants may enter into subcontracts, including consortia agreements (as set forth in the HHS Grants Policy Statement (http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc), as necessary to meet the requirements of the program project for public health systems research on preparedness and emergency response capabilities and to strengthen the overall application. 

Funding Preferences

At the discretion of the Director, COTPER, additional consideration may be given to funding research program projects that: address one or more Federal, state, local, or tribal public health preparedness research priority themes determined by COTPER, help to achieve a balance for addressing preparedness research needs in both urban and rural communities, and achieve a geographical or regional distribution of awarded programs.  The COTPER priority themes are based upon recommendations from the IOM report, and described under Section I. Funding Opportunity Description, Objectives.

 

  Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

·          Eligible applicants for this announcement are accredited Schools of Public Health, as required by section 319F-2(d) of the Public Health Service Act.  Only schools accredited by the Council on Education for Public Health are eligible.  Eligible applicants may only submit one application under this announcement.  Eligible applicants are encouraged to include research that is multidisciplinary and may enter into collaborative relationships that cut across departmental, school/college, or university boundaries.  However, the primary responsibility for the conduct of the research remains with the eligible organization which must contribute a majority of the effort to the overall program project and the individual research projects.  An eligible applicant may submit an application that includes inter-related research in collaboration with any of the following:

A Bona Fide Agent is an agency/organization identified and approved by the state to participate as a state governmental entity.

 

2. Cost Sharing or Matching

Cost sharing is not required. 


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

 


3. Other-Special Eligibility Criteria


Applicants must provide documentation of current accreditation by the Council on Education for Public Health.  Attach this documentation as “Appendix 1” and label as appropriate in your application form. 

Eligible applicants (an accredited School of Public Health) may only submit one application under this announcement.  

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


1. Request Application Information

The PHS 398 application instructions are available at   http://grants.nih.gov/grants/funding/phs398/phs398.html  in an interactive format.  Applicants must use the currently approved version of the PHS 398.  For further assistance, contact 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 firm.

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 core component, and each individual research projects) is no more than 25 pages, each, exclusive of budget and biosketches.

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)

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)

·          Table of contents

·          A clear statement of the preparedness and emergency response 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.

The 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  

·          Provide funding and oversight for training in public health systems research and preparedness and emergency response systems , or related areas to  develop up to 4 New Research Investigators in this field at up to $30,000 per new investigator

·          Provide funding, support, and oversight for up to 4 Pilot Projects for innovative research on public health systems research on preparedness and emergency response capabilities at up to $30,000 per pilot project

·          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 preparedness and emergency response activities, public health leaders, community liaisons, etc.

·          Strategies and methods to evaluate and translate results from research efforts to help achieve national preparedness goals and for enhanced, improved, or expanded preparedness and emergency response capabilities

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

The discussion of activities and function of the 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.   

Collaboration with and the participation of public health agencies and other public and private sector organizations engaged in public health system preparedness and emergency response    in proposed program 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.

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

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 preparedness priorities for federal, state, local, and tribal public health systems.  Where applicable, anticipated results that will have immediate application in public health practice in preparedness and emergency response systems should be described.  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 preparedness and emergency response capabilities

·          Essential elements of a unified and interdependent research program

Individual research project applications should include:

·          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.

 

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: March 17, 2008

Application Submission Receipt Date(s): May 15, 2008

Peer Review Date (s): June –July, 2008

Council Review Date (s): August 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:

·          Number and title of this funding opportunity

·          Title and brief description and of the proposed research program project

·          Title, stated preparedness and emergency response system research priority theme, and brief description of each inter-related research project

·          Activities to be conducted within the proposed research core

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

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

·          Participating institutions 

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.  For this reason, a letter of intent is beneficial, but not necessary to the review of an application. 

The letter of intent should be no more than 10 single-sided pages in length and sent by the date listed in Section IV. 3.A

 

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: 

Mildred Williams-Johnson, Ph.D.
Office of Science and Public Health Practice

Coordinating Office for Terrorism Preparedness and Emergency Response
Centers for Disease Control and Prevention
1600 Clifton Rd., N.E., Mailstop D-44

Atlanta, GA 30333
Telephone: (404) 639-7855
Fax: (404) 639-7977
Email: MWilliams-Johnson@cdc.gov

 

3.B. Submitting an Application to CDC  

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

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.
 

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

 

Technical Information Management Section – RFA-TP-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 

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

Mildred Williams-Johnson, Ph.D.

Office of Science and Public Health Practice

Coordinating Office for Terrorism Preparedness and Emergency Response

Centers for Disease Control and Prevention

Address for U.S. Postal Service Mail:

1600 Clifton Rd., Mailstop MS D-44

Atlanta, GA 30329

 

Address for Express Mail or Delivery Service:

Building 21, Room 6032.1

1600 Clifton Rd., Mailstop MS D-44

Atlanta, Georgia 30329

Tel: 404-639-7855

Fax:  404-639-7977

Email:  MWilliams-Johnson@CDC.GOV


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 COTPER 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 CDC has received documentation that 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.


6. Other Submission Requirements

Applicants must provide documentation of current accreditation by the Council on Education for Public Health.  Attach this documentation as “Appendix 1” and label as appropriate in your application form. 

Eligible applicants may only submit one application under this FOA.

 

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 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.  

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 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 (2 per project). 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 FOAs 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 COTPER to interact with other PERRC 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 preparedness and emergency response.  It is expected that funds to support attendance at such annual meetings will be included in budget requests as appropriate.   

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, 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

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 COTPER 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 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 by HHS/CDC/COTPER Secondary Review Committee consisting of members from a federal advisory committee or senior scientists. Applications submitted in response to this FOA 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 research program projects that address one or more federal, state, local, or tribal public health preparedness priority themes as determined by COTPER.

·           Preference for funding to achieve coverage of a range of priority themes for public health preparedness and emergency response systems research.

·          Preference for funding meritorious applications that leverage expertise from a broad range of disciplines to address a theme for public health preparedness and emergency response systems research.

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

·          Preference for funding to achieve a balance for addressing preparedness and emergency response research needs in both urban and rural communities.  

Final review and recommendations by the Secondary Review Committee and CDC 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 systems research on preparedness and emergency response capabilities.  It is possible that funding for some of the individual research projects or proposed core components favorably recommended by the initial review group may be deleted by COTPER staff prior to award of a grant, based on the scientific merit of these components or the lack of coherence with the rest of the program project.  In addition, the total support of the principal investigator, the group of investigators as a whole, or any individual investigator will be considered in funding the entire program project or any part thereof. 
 

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, 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.   

Primary Review

The primary review will be a peer review conducted by an Initial Peer Review Group (IRG).  Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review.  CDC will withdraw from further consideration applications judged to be noncompetitive and notify the principal investigator/program director and the official signing for the applicant organization.  Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current HHS/CDC and /NIH criteria (a scoring system of 100 - 500 points) to evaluate the methods and scientific quality of the application.

 

Review Criteria to be used by the IRG for Overall Program Project Grant Application (Core Component and Individual Research Projects)  

·          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 systems capabilities for preparedness and emergency response? 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 and will it support all-hazards preparedness and emergency response?

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 preparedness capabilities and coordination of emergency responses?  What will be the effect beyond preparedness on 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 preparedness and emergency response capabilities?  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 systems to improve, enhance, and expand preparedness and emergency response capabilities and related research?   

·          Innovation:

o         Is the project original and innovative? For example: Does the program project contribute to improvements in existing public health systems paradigms for preparedness and emergency response activities or address an innovative hypothesis or critical barrier to progress toward achieving preparedness 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 preparedness and emergency response practice, or reduce cost for comparable functionality?

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 preparedness systems needs?

o         Does the project achieve preparedness objectives in a manner that strengthens the probability of appropriate response during emergencies, such as through relevance to daily public health practice? 

·          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         Are partners from public and private organizations engaged in preparedness and emergency response activities 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:

Review Criteria for the Core Component

The primary criterion for a core component is the extent to which the proposed activities are adequate and necessary for the accomplishment of program project goals. The intent of core funding is to improve the effectiveness and efficiency of the research enterprise around one or more themes of public health preparedness and emergency response research.  Additionally, the core is intended to strengthen the research field through support for mentoring and training new investigators, winnowing promising research ideas to improve new research project proposals, and assuring the relevance of the research enterprise to public health practice and the mission of public health for preparedness and emergency response (http://www.hhs.gov/budget/07plan/sGoal2.html#prog2c.)  The review will consider the adequacy of:

·         The operational plan for managing the program project and the extent to which the activities described will achieve goals and provide optimum support for individual research projects and other activities.  

·         The plan to conduct pilot projects.  This includes, but is not limited to; the procedures for announcing the funding opportunity, the mechanism for reviewing and funding the pilot projects, and the plans for tracking and reporting the results of  the pilot projects.

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). 

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

2.B. Additional Review Considerations

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

Secondary Review  

The secondary review will be conducted by a Secondary Review Committee (SRC).  Only SRC members will vote on funding recommendations in a closed session. The recommendations of the SRC will be carried to the Director, COTPER.   

The SRC will receive briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and extramural research program office staff briefing materials).  The SRC will deliberate and consider whether applications address overlapping areas of research interest, to avoid the unwarranted duplication in federally-funded research.   

·          The SRC’s responsibility is to develop funding recommendations for the HHS/CDC/COTPER Director based on the results of the primary review, the relevance and balance of proposed research relative to the HHS/CDC/COTPER programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur.  The SRC has the latitude to recommend to the HHS/CDC/COTPER Director to reach over better ranked proposals in order to assure maximum impact and balance of proposed research.  The factors to be considered by the Secondary Review are listed under Section 2. Selection and Review Process, Funding Criteria of this FOA.

All awards will be determined by the Director of the HHS/CDC/COTPER based on priority scores assigned to applications by the IRG, recommendations by the Secondary Review Committee and CDC staff, consultation with HHS/CDC/COTPER senior staff as appropriate, and other considerations and priorities as described above under Funding Criteria. 

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.  COTPER 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 30, 2008 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.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  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.
 

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. 

4. Continued Funding

Continuation awards made after FY 2008, but within the project period, will be made on the basis of the availability of funds and the following criteria:

·          The accomplishments reflected in the progress report of the continuation application 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.

·          The objectives for the new budget period are realistic, specific, and measurable.

·          The methods described will clearly lead to achievement of these objectives.

·          The evaluation plan will allow management to monitor whether the methods are effective.

·          Any impediments to progress are 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.

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

Between the third and fourth budget periods COTPER 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 PERRC 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 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:

Mildred Williams-Johnson, PhD, DABT

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
Building Number 21, Room Number 6203
1600 Clifton Rd.
, N.E., Mailstop D-44
Atlanta, GA 30329
Telephone: (404) 639-7719
Fax: 404-639-7977
Email: MWilliams-Johnson@cdc.gov

 

2. Peer Review Contacts:

Barbara Ellis, Ph.D.
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
Building Number 21, Room Number 6203
1600 Clifton Rd.
, N.E., Mailstop D-44
Atlanta, GA 30329
Telephone: (404) 639-7855
Fax: 404-639-7977
Email: BEllis@cdc.gov

 

3. Financial or Grants Management Contacts:
 

Kaleema McLean
Procurement and Grants Office
Center for Disease Control and Prevention

U.S. Department of Health and Human Services
Koger Colgate
Building, Room Number 3115

2920 Brandywine Road, Mailstop K-69

Atlanta, GA 30341
Telephone: (770) 488-2742
Fax: (770) 488-2670
Email: KMcLean@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.

HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.


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 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. 

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.      Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.      Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

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 42 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