rfa-ck-15-004(amend).pdf

Centers for Disease Control and Prevention

National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program Office

Epicenters for the Prevention of Healthcare Associated Infections (HAIs) - Cycle II

RFA-CK-15-004

Application Due Date: 06/01/2015

Epicenters for the Prevention of Healthcare Associated Infections (HAIs) - Cycle II

RFA-CK-15-004

TABLE OF CONTENTS

Part 1. Overview Information

Key Dates Required Application Instructions Executive Summary

Part 2. Full Text

Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations National Center for Emerging and Zoonotic Infectious Diseases Extramural Research Program Office

(NCEZID ERPO)

National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) Funding Opportunity Announcement (FOA) Title Epicenters for the Prevention of Healthcare Associated Infections (HAIs) - Cycle II Activity Code Applications in response to this FOA will be funded using the U54 activity code.

Funding Opportunity Announcement Type New Funding Opportunity Announcement Number

RFA-CK-15-004

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.823 Category of Funding Activity:

Health FOA Purpose The purpose of this FOA is to expand the number of CDC Prevention Epicenters to translate basic, epidemiologic and technologic discoveries into new strategies for preventing healthcare-associated transmission of Ebola and/or infectious pathogens (viral or bacterial) that can be spread by mechanisms similar to Ebola. This might include, but is not limited to, project proposals that focus on the effectiveness of personal protective equipment against such pathogens, healthcare worker self-contamination with pathogens, or the role of the healthcare environment in pathogen transmission.

This announcement was amended to include the Summary of the Conference Call held on Tuesday, April 16, 2015 with Potential Applicants and Answers to Questions from Potential Applicants in red text in Section VIII. of the FOA.

Key Dates Publication Date: To receive notification of any changes to RFA-CK-15-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 05/01/2015 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review. Please see Section IV.3 of this FOA for further information.

Application Due Date: 06/01/2015

On-time submission requires that electronic applications be error-free and made available to CDC for http://www.grants.gov

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note:

HHS/CDC grant submission procedures do not provide a period of time beyond the application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 06/30/2015

Secondary Review: 07/07/2015

Estimated Start Date: 09/30/2015

Expiration Date: 06/02/2015 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary

Purpose. The purpose of this FOA is to expand the number of research institutions in the CDC Prevention Epicenters Program to translate basic, epidemiologic and technologic discoveries into new strategies for preventing healthcare-associated transmission of Ebola and/or infectious pathogens (viral or bacterial) that can be spread by mechanisms similar to Ebola.

This might include, but is not limited to, project proposals that focus on the effectiveness of personal protective equipment against such pathogens, healthcare worker self-contamination with pathogens, or the role of the healthcare environment in pathogen transmission.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards. Estimated total funds available, to include direct and indirect costs for the entire project period, is $11,000,000. The project period will be three years. It is anticipated that there will be five awards. Awards issued under this FOA are contingent upon the availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period. There will be a 36-month budget period, and all funds for the three-year project period will be awarded as a lump sum at the time of initial award. The average estimated total funding (direct and indirect) for each award (36-month budget period) will be $2,200,000. The estimated total funding (direct and indirect) for all awards in the entire project period will be $11,000,000. The project period will run from 9/30/2015 to 09/29/2018.

Throughout the project period, CDC's commitment to continuation of awards will depend on http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC's determination that continued funding is in the best interest of the Federal government.

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. Application and Submission Information of this announcement.

Eligible Institutions/Organizations. Institutions/organizations listed in Section III.1. are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will be only one PD/PI for this project.

Number of Applications. Each eligible applicant institution may submit only one application.

Application Type: New.

Special Date(s). A teleconference call with potential applicants will be conducted on Thursday, April 16, 2015 at 2:00 PM Eastern Time. The call-in number and password is as follows: 1-866-662-8986; 8378091.

Application Materials. See Section IV.1 for application materials.

Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY:

(770) 488-2783.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

42 U.S.C. Section 247b(k)(2) and 42 U.S.C. Section 241(a)

1. Background and Purpose

Transmission of infectious pathogens in healthcare settings results in significant morbidity and mortality among patients treated in U.S. healthcare institutions and adds billions of dollars to healthcare costs. In addition, recent history has shown that infectious disease transmission within healthcare settings can help propagate major epidemics caused by pathogens such as Ebola virus, SARS coronavirus, MERS coronavirus, novel strains of influenza, and bacterial pathogens such as Clostridium difficile and multidrug resistant bacteria. Recent advances in preventing healthcare-associated infections have resulted from better implementation of existing recommendations for prevention practice in healthcare settings. However, recent experiences with rare and novel pathogens in US healthcare settings suggest that existing prevention strategies for preventing device- and procedure-associated infections may have insufficient effectiveness in preventing transmission of high-consequence microorganisms in healthcare settings. In light of this gap, additional innovation is needed to advance the prevention of transmission of infectious diseases in healthcare settings.

The CDC Prevention Epicenters Program has been established to develop, implement and evaluate the effectiveness of epidemiologically-based strategies to improve healthcare quality and patient safety. CDC has found the Prevention Epicenters Program to be an extremely productive model for aligning public health needs with the innovative research capacity of academic partners. Recent Prevention Epicenters’work has focused on a translational research framework for HAI prevention research proposed by Pronovost, et al, 2011 (1), which characterizes five translational phases:

http://www.cdc.gov/od/pgo/funding/grants/additional_req.shtm#SectionIV http://era.nih.gov/commons/index.cfm#SectionIII1A http://grants.nih.gov/grants/ElectronicReceipt/submit_app.htm#SectionIV1

Phase T0, in which discoveries relevant to the prevention of adverse healthcare events are made through surveillance, outbreak investigation, epidemiologic studies, and technologic advances;

Phase T1, in which T0 discoveries are used to develop novel candidate interventions and perform early testing of their efficacy or effectiveness in a small sample of patients or in limited healthcare settings;

Phase T2, in which the evidence base for candidate interventions is broadened and strengthened sufficiently to include the novel intervention in evidence-based guidelines;

Phase T3, in which evidence-based guidelines are moved into practice, through delivery, dissemination, and diffusion research, and Phase T4, in which guidelines are implemented on a broad scale (e.g., nationally) and evaluated for evidence of improvement in population health.

Recent advances in prevention of HAIs have been largely the result of Phase T3 research, which led to large-scale improvement in implementation of existing prevention recommendations in healthcare facilities.

However, even when fully implemented, current prevention recommendations are limited in their ability to prevent transmission, and many are unproven or not well-suited for a wide range healthcare settings and clinical situations (2-8). Therefore, the CDC Prevention Epicenters program has focused on early translational research (e.g., Phases T0-T2) to expedite identification and development of novel or enhanced strategies for preventing acquisition of infectious diseases in healthcare settings. Through this funding opportunity announcement, CDC hopes to address gaps in infection prevention identified during the 2014-2015 outbreak of Ebola virus disease for the purpose of improving the capacity to prevent and control both current and future infectious threats.

The CDC Prevention Epicenters Program operates as a collaborative multicenter research network of investigators who collaborate with CDC and with one another to address emerging or evolving public health research needs related to the prevention of transmission of pathogens that cause HAIs among patients and healthcare personnel. The intent of the program is to provide CDC with a resource for meeting public health research needs by creating close collaborative ties between investigators with interest in preventing infections acquired in healthcare. Whereas investigator-initiated projects will not necessarily involve other Epicenter investigators, each funded Epicenter is expected to provide regular reports on plans and progress pertaining to their individual projects, and provide opportunities for comment and technical support, if needed, from other Prevention Epicenter Investigators and from CDC personnel. Participants in the program are encouraged to identify multicenter collaborative opportunities that enhance the ability to meet the goals and objectives of applications. Applicants funded under this FOA will serve as a member of the multicenter CDC Prevention Epicenters Program.

The CDC Prevention Epicenters collaborative research network is overseen by the Epicenters Program Steering Committee. This committee will be comprised of Principal Investigators and one CDC representative who will serve as a consultant to the committee. The steering committee will serve in an advisory and consultant role to individual investigators as needed and also will discuss and oversee multicenter project ideas that emerge during the course of the program. A well-developed Program Steering Committee is integral to the Program’s success. Participation in the steering committee includes, but is not limited to, active participation in conference calls, webinars and in-person meetings (i.e., grantee meetings and special projects meetings).

The purpose of this FOA is to expand the number of CDC Prevention Epicenters to translate basic, epidemiologic and technologic discoveries into new strategies for preventing healthcare-associated transmission of Ebola and/or infectious pathogens (viral or bacterial) that are spread by similar mechanisms as Ebola. This might include, but is not limited to, project proposals that focus on effectiveness of personal protective equipment against such pathogens, healthcare worker self-contamination with pathogens, or the role of the healthcare environment in pathogen transmission. Whereas Ebola is known to be transmitted primarily by direct and indirect contact, droplet transmission may occur in certain settings, such as those that might be expected to generate splashes to unprotected mucous membranes, or during certain aerosol-generating procedures. For this reason, research supporting new or improved strategies for prevention of transmission of pathogens transmitted via droplet route would also fall under the purpose of prevention of transmission of pathogens transmitted via droplet route would also fall under the purpose of this FOA.

References

1. Pronovost PJ, Cardo DM, Goeschel CA, Berenholtz SM, Saint S, Jernigan JA. A research framework for reducing preventable patient harm. Clin Infect Dis. 2011 Feb 15; 52(4):507-13.

2. Centers for Disease Control and Prevention (CDC). Vital Signs: Carbapenem-Resistant Enterobacteriaceae. MMWR Morb Mortal Wkly Rep. 2013 March 8, 62(09): 165-170.

3. Centers for Disease Control and Prevention. Clinical Inquiries Regarding Ebola Virus Disease Received by CDC — United States, July 9–November 15, 2014. MMWR Morb Mortal Wkly Rep. 2014 December 12, 63(49); 1175-1179.

4. Centers for Disease Control and Prevention. Ebola Virus Disease Cluster in the United States — Dallas County, Texas, 2014. MMWR Morb Mortal Wkly Rep. 2014 November 21, 63(46); 1087-1088.

5. Centers for Disease Control and Prevention. Surveillance and Preparedness for Ebola Virus Disease — New York City, 2014. MMWR Morb Mortal Wkly Rep. 2014 October 17, 63(41);934-936.

6. Sharif-Yakan A, Kanj SS. Emergence of MERS-CoV in the Middle East: Origins, Transmission, Treatment, and Perspectives. Spindler KR, ed. PLoS Pathogens 2014;10(12):e1004457.

doi:10.1371/journal.ppat.1004457.

7. Cheng VC. Chan JF, To KK, Yuen KY. Clinical management and infection control of SARS: lessons learned. Antiviral Res. 2013 Nov;100(2):407-19.

8. Lessa FC, Gould CV, McDonald LC. Current status of Clostridium difficile infection epidemiology. Clin Infect Dis. 2012 Aug;55 Suppl 2:S65-70.

Healthy People 2020 and other National Strategic Priorities

On November 5th, 2014, President Obama asked Congress to consider an emergency appropriation request for Fiscal Year (FY) 2015 that included funds to implement a comprehensive strategy to contain and end the Ebola outbreak and accelerate global capability to prevent the spread of future infectious diseases. Given recent experience showing that infectious disease transmission within healthcare settings can help propagate major epidemics caused by pathogens such as Ebola virus, SARS coronavirus, MERS coronavirus, novel strains of influenza, bacterial pathogens such as Clostridium difficile and multidrug resistant bacteria, a comprehensive strategy to contain future outbreaks must include improved strategies for preventing transmission of microorganisms in healthcare settings. This funding opportunity announcement addresses the national strategic priority set out in the approved emergency appropriation request for FY 2015 to address knowledge gaps that were identified during the Ebola response. The National Center Emerging and Zoonotic Infectious Diseases (NCEZID) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020". This FOA supports and addresses the HP 2020 goal to “ Prevent, reduce, and ultimately eliminate healthcare-associated infections (HAIs)” (http://www.healt hypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections).

Public Health Impact

Research funded by this FOA will support innovative strategies to improve the capacity to prevent and control the spread of Ebola and other infectious pathogens with similar modes of transmission in healthcare settings, thereby helping to prevent and control both current and future outbreaks.

Relevant Work http://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections http://www.healthypeople.gov/2020/topics-objectives/topic/healthcare-associated-infections

CDC's Prevention Epicenter Program: For the past 18 years, the CDC Prevention Epicenter Program has been active in the field of HAI prevention research. Fourteen institutions have participated, producing 181 publications related to the prevention of infections in healthcare settings. Information on relevant work by the CDC Prevention Epicenter Program, including selected citations, can be found at: http://www.cdc.gov/HAI/epiCenters/.

Also please see:

Center for Disease Control and Prevention: Ebola (Ebola Virus Disease) Internet Resources: http://www.cdc .gov/vhf/ebola/

Centers for Disease Control and Prevention: FY 2015 Ebola Response Funding: http://www.cdc.gov/fmo /topic/Budget%20Information/

Centers for Disease Control and Prevention. Surveillance and Preparedness for Ebola Virus Disease — New York City, 2014. MMWR Morb Mortal Wkly Rep. 2014 October 17, 63(41);934-936.

2. Approach

Research applications should include a three-year research program design that develops and tests innovative strategies for preventing transmission of infectious pathogens in healthcare settings. This FOA is not intended to support projects that focus primarily on strategies for preventing healthcare-associated infections that may result from a patient’s resident flora (i.e., many device- and procedure-associated infections).

Rather, proposed research should focus on preventing spread of potentially pathogenic microorganisms among patients and healthcare workers in healthcare settings. Applications should emphasize innovative research activities consistent with translational research phases T1 and early T2 (i.e., research that seeks to build upon existing T0 discoveries by moving them into first or early application of candidate interventions in healthcare settings and patient populations), but may also include foundational T0 work that expands understanding of the mechanisms of spread of infectious pathogens in healthcare settings. Applicants should demonstrate a plan to maintain ongoing collaboration between scientists with T0 expertise and those with T1/T2 expertise. It is expected that a strong collaboration between basic, epidemiologic or laboratory scientists and clinical scientists will help ensure ability to develop and sustain an iterative research program.

It is anticipated that the proposed research will, over the course of the 36-month budget and project period, result in evidence for effective interventions and include results that are mature enough to merit either inclusion in CDC prevention recommendations or investment in larger confirmatory clinical studies.

Objectives/Outcomes

Identify and validate novel interventions that involve new translation of epidemiologic, technologic, or basic science observations into strategies that effectively prevent transmission of infectious pathogens in healthcare settings, including Ebola virus and/or other viral or bacterial pathogens that can spread by similar mechanisms as Ebola.

Examples of research topics that might be considered for funding include, but are not limited to, the following:

Assessing the effectiveness of personal protective equipment (PPE) against transmission of infectious pathogens and identifying novel strategies to improve the effectiveness of PPE;

Identifying factors related to healthcare worker self-contamination with pathogens during the course of their work and the potential role of such contamination in healthcare setting disease transmission;

Identifying strategies for preventing healthcare worker self-contamination;

Determining the role of contamination of the healthcare environment in pathogen transmission and identifying novel strategies for preventing transmission resulting from environmental contamination;

Use of molecular, epidemiologic or other markers to enhance basic understanding of how pathogens spread in healthcare settings, including but not limited to, patient-to-healthcare worker, healthcare http://www.cdc.gov/HAI/epiCenters/ http://www.cdc.gov/vhf/ebola/ http://www.cdc.gov/vhf/ebola/ http://www.cdc.gov/fmo/topic/Budget%20Information/ http://www.cdc.gov/fmo/topic/Budget%20Information/ worker-to-patient, patient/healthcare worker-to-environment, environment-to-patient/healthcare worker, patient-to-patient, and other pathways of transmission;

Research supporting better understanding and prevention of transmission of pathogens via droplets, including exposures that might result from activities that generate splashes to unprotected mucous membranes, or from certain aerosol-generating procedures.

To best meet the objectives of this FOA and the goals of the CDC Prevention Epicenter Program, applicants/institutions should possess the following research capabilities and characteristics:

Have an established program to conduct HAI prevention research;

Have research expertise and academic leadership in healthcare epidemiology and infection control or HAI prevention research;

Have access to an infrastructure that is conducive to performing a wide variety of potential studies that evaluate the impact of interventions to prevent healthcare-associated infections. This includes demonstrated ability to conduct research that involves multiple healthcare facilities, potentially those affiliated within a healthcare system (such as those affiliated with a healthcare provider company that owns or operates multiple facilities, health maintenance organizations, etc.);

Have access to multiple facilities willing to participate in research of this type, allowing for more flexibility in responding to public health research needs, more robust validation and generalization of findings and innovations than is possible in a single facility. Access to facilities across the spectrum of healthcare is also desirable (e.g., academic medical centers, community hospitals, long-term care facilities, long-term acute care centers, dialysis units and ambulatory surgery centers);

The applicant should demonstrate how multiple facilities within each healthcare system will be involved in the development and validation of both interventions and reporting measures. Links to local and state health departments are strongly encouraged;

Have the ability to collect electronic health record information from all of the facilities that are eligible and willing to collaboratively participate in HAI prevention research, including information sufficient to determine relevant clinical outcomes and process of care measures related to those outcomes;

Letters of Support, Memoranda of Understanding or Memoranda of Agreement from participating collaborators are encouraged.

Wherever possible, applicants should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

Target Population

Patients and healthcare workers in healthcare settings.

Collaboration/Partnerships

The CDC Prevention Epicenters Program operates as a research consortium that creates a multicenter network of CDC Prevention Epicenter investigators who collaborate with CDC and with one another to address emerging or evolving public health research needs related to the prevention of transmission of pathogens that cause HAIs among patients and healthcare personnel. The intent of the program is to provide CDC with a resource for meeting public health research needs by creating close collaborative ties between investigators with interest in preventing infections acquired in healthcare. Whereas investigator-initiated projects will not necessarily involve other Epicenter investigators, each funded Epicenter is expected to provide regular reports on plans and progress pertaining to their individual projects, and provide opportunities for comment and technical support, if needed, from other Prevention Epicenter Investigators and from CDC personnel. Participants in the program are encouraged to identify multicenter collaborative opportunities that enhance the ability to meet the goals and objectives of individual investigator proposals.

Evaluation/Performance Measurement

Applicants should outline appropriate plans to collect information that can be used to evaluate the impact of the CDC Prevention Epicenter Program. The following should be included in the application as part of the evaluation plan:

Identification of emerging research questions to address knowledge gaps related to prevention of transmission of infectious pathogens in healthcare settings;

Development of study protocols that address knowledge gaps related to prevention of transmission of infectious pathogens in healthcare settings;

Publication of research findings that address knowledge gaps related to prevention of transmission of infectious pathogens in healthcare settings.

Translation Plan

When relevant to the goals of the research project, the PI should describe in the application how the significant findings of the research may be used to inform the translation of research to policy or practice.

This section should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users. The PI should identify the research findings that could inform public health policy or practice and how the findings may be adopted in public health settings. This section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, describe how the results of this project could be generalized to populations and communities outside of the study. Questions to consider in preparing this section include:

How will the scientific findings inform public health policy or practice?

How will the project improve or effect the translation of research findings into practice or inform policy?

How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs or practices?

How will the findings advance or guide future research efforts or related activities?

Section II. Award Information

Funding Instrument Type: Cooperative Agreement A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $11,000,000

Estimated total funding available, to include direct and indirect costs for the entire project period, is $11,000,000. The project period will be 36 months.

Anticipated Number of Awards: 5

It is anticipated that there will be five awards.

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

Award Ceiling: $2,200,000 Per Budget Period Award Floor: $1,500,000 Per Budget Period Total Project Period Length: 3 year(s) Throughout the project period, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ asfr/ogapa/aboutog/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: State governments

County governments City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education:

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Native American tribal organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Regional Organizations Bona Fide Agents: a Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required. Attach with "Other Attachment Forms" when submitting via www.grants.gov.

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to http:// ecfr.gpoaccess.gov /cgi/t/text/ text-idx?c=ecfr& sid=512ff78311f427c00454772dcf21523a&rgn=div8 &view=text&node=48:1.0.1.6.34.0.1.18& idno=48

2. Foreign Organizations Foreign Organizations are not eligible to apply.

Foreign components of U.S. Organizations are not eligible to apply.

For this announcement, applicants may not include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Special Eligibility Requirements

Institutions/organizations that receive funds under "Epi-Centers for the Prevention of Healthcare-Associated Infections, Antimicrobial Resistance and Adverse Events (U54)" FOA CK11-001 are not eligible to apply.

4. Justification for Less than Maximum Competition

N/A

5. Responsiveness

Applications that request funds above the ceiling of the award will not move forward to peer review or be eligible for funding.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato. int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=512ff78311f427c00454772dcf21523a&rgn=div8&view=text&node=48:1.0.1.6.34.0.1.18&idno=48 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

0for%20NSPA%20NCAGE.pdf System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes.

The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements.

The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM).

Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later. SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient. Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the grantee organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the grantee organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http:// www.hhs.gov/ asfr/ ogapa/ aboutog/ hhsgps107.pdf).

10. Number of Applications https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM/%231 http://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons http://www.Grants.gov http://fedgov.dnb.com/webform https://www.sam.gov/index.html

10. Number of Applications As defined in the HHS Grants Policy Statement, (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), applications received in response to the same funding opportunity announcement generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Each eligible applicant institution may submit only one application.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Procurement and Grants Office Technical Information Management Section (PGO TIMS) staff at (770) 488-2700 or pgotim@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Standard Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/ 424/SF424_RR_Guide_General_VerC.pdf), except where instructed in this Funding Opportunity Announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this FOA includes all applicable components, mandatory and optional.

Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow the instructions in the SF 424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application. While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components.

These forms can be downloaded and uploaded as Attachment A from the following link: http://grants .nih.gov/grants/forms.htm

3. Letter of Intent Due Date for Letter of Intent: 05/01/2015 http://www.Grants.gov mailto:pgotim@cdc.gov http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf http://grants.nih.gov/grants/forms.htm http://grants.nih.gov/grants/forms.htm

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

By the date listed above and in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

Name of the Applicant Descriptive title of proposed research Name, address, and telephone number of the PD(s)/PI(s) Names of other key personnel Participating institutions Number and title of this funding opportunity announcement

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS E-60 Atlanta, GA 30333 Telephone: 404-718-8833 Fax: 404-718-8822 Email: GAnderson@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this FOA in Grants.gov includes all applicable components for this FOA, required and optional.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of 16 components. Not all 16 components of the Research Plan apply to all Funding Opportunity Announcements (FOAs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See Part I, Section 5.5 of the SF 424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Funding Opportunity Announcement Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the FOA. As applicable to and specified in the FOA, the application should include the bolded headers in this section and should address activities to be conducted over the course of the entire project, including but not limited to:

1. Introduction to Application (for Resubmission and Revision ONLY) - provide a clear description about the purpose of the proposed research and how it addresses the specific requirements of the FOA.

mailto:GAnderson@cdc.gov

2. Specific Aims – state the problem the proposed research addresses and how it will result in public health impact and improvements in population health.

3. Research Strategy – the research strategy should be organized under 3 headings: Significance, Innovation and Approach. Describe the proposed research plan, including staffing and timeline.

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the FOA.

All instructions in the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf) must be followed along with any additional instructions provided in the FOA.

6. Appendix Do not use the appendix to circumvent page limits. A maximum of 10 PDF documents are allowed in the appendix. Additionally, up to 3 publications may be included that are not publically available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations All page limitations described in this individual FOA must be followed. For this specific FOA, the Research Strategy component of the Research Plan narrative is limited to 25 pages. Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 50 pages for all appendices.

8. Format for Attachments Designed to maximize system-conducted validations, multiple separate attachments are required for a complete application. When the application is received by the agency, all submitted forms and all separate attachments are combined into a single document that is used by peer reviewers and agency staff. Applicants should ensure that all attachments are uploaded to the system.

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) text attachments conform to the agency-specific formatting requirements noted in the SF424 (R&R) Application Guide (Part I, Section 2) (http://grants.nih.gov/ grants/funding/424/ SF424_RR_Guide_General_VerC.pdf).

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov (http://www.grants.gov), the online portal to find and apply for grants across all Federal agencies. The eRA Commons systems retrieve the application from Grants.gov and check the application against CDC business rules. If no errors are found, the application will be assembled in the eRA Commons for viewing by the applicant before moving on for further CDC processing.

If errors are found, the applicant will be notified in the eRA Commons. They must make required changes to the local copy of their application and submit again through Grants.gov.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Once you can see your application in the Commons, be sure to review it carefully as this is what the reviewer will see. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons (http:// grants.nih. gov/grants /guide/url_redirect .htm? id=11123).

Information on the submission process is provided in the SF424 (R&R) Application Guide.

Note: HHS/CDC grant submission procedures do not provide a period of time beyond the grant application due date to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e. error correction window).

The application package is not complete until it has passed the Grants.gov/eRA Commons validation process. This process and email notifications of receipt, validation or rejection may take two (2) business days.

Applicants are strongly encouraged to allocate additional time prior to the submission deadline to submit their applications and to correct errors identified in the validation process.