PKG00257611-instructions.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in South America

RFA-GH-20-005

Application Due Date: 03/09/2020

Conducting Public Health Research in South America

RFA-GH-20-005

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 Center for Global Health Notice of Funding Opportunity (NOFO) Title Conducting Public Health Research in South America Activity Code U01

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-GH-20-005

Assistance Listings (CFDA) Number(s) 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this NOFO is to:

Conduct and monitor epidemiologic and laboratory-based projects, surveillance, and research of important diseases in South America (Brazil, Bolivia, Argentina, Chile, Peru, Uruguay, Paraguay, Venezuela, Guyana, Suriname, and Ecuador) including, but not limited to, activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats of local importance; and, Incorporate the results of these public health activities into operational disease detection, prevention, and response or control programs in South America, strengthen public health capacity as outlined in the Global Health Security Agenda, and disseminate findings across the region, with partners, and globally.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-20-005, 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: 02/10/2020 https://www.grants.gov

Application Due Date: 03/09/2020

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

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time 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: 04/01/2020

Secondary Review: 06/01/2020

Estimated Start Date: 08/31/2020

Expiration Date: 03/10/2020 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) 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.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

Executive Summary Purpose:

The purpose of this Notice of Funding Opportunity (NOFO) is to support the following activities:

Conduct and monitor epidemiologic and laboratory-based projects, surveillance, and research of important diseases in South America (Brazil, Bolivia, Argentina, Chile, Peru, Uruguay, Paraguay, Venezuela, Guyana, Suriname, and Ecuador) including, but not limited to, activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats of local importance; and, Incorporate the results of these public health activities into operational disease detection, prevention, and response or control programs in South America, strengthen public health capacity as outlined in the Global Health Security Agenda, and disseminate findings across the region, with partners, and globally.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total level of funding (in U.S. dollars) available, including direct and in-direct costs, for the entire 5-year project period is $25,000,000. The number of awards will be up to 5 (five). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research may vary from year to year, it is also anticipated that the size and duration of the awards may also vary.

Budget and Period of Performance: The estimated total funding (direct and indirect) for the first budget period, 9/30/2020 to 9/29/2021, is estimated to be $5,000,000 USD, ranging from $0 USD to $1,000,000 USD per application up to (5) five different countries.

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 only be one (1) qualified PD/PI for each application.

Number of Applications: Only one (1) application per eligible institution (normally identified by a unique DUNS number) is allowed.

Application Type: New Special Date(s): LOI due: Feb 10, 2020; Receipt date: March 9, 2020. Applicants must submit their questions by e-mail to cgherpo@cdc.gov, within 15 days after the publication date of this NOFO in www.grants.gov. Questions received after this time will not be considered for response. All changes, updates, including the Q/A will be added as an amendment to the NOFO and will be posted on www.grants.gov within a reasonable time

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

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

TTY: 1-888-232-6348.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This work is authorized under the Public Health Service Act 301 and 307 (42 USC 241 and 242l).

1. Background and Purpose The U.S. Centers for Disease Control and Prevention (CDC), envisions a world safe and secure from global health threats posed by emerging and re-emerging infectious diseases. In order to work toward this goal, CDC is establishing a regional program in South America to protect and promote health through collaboration with partners on science, policy, and evidence-based public health actions to improve global health security. The CDC South America Regional Program will work in close partnership with governments in the region, as well as with other local, national, and international partners to build capacity and generate necessary data to inform country-specific and regional public health policy. These activities and the data collected will allow CDC to achieve its mission to assist countries in achieving compliance with the International Health Regulations (WHO 2005) within the framework outlined by the Global Health Security Agenda (GHSA).

For decades, CDC has provided intermittent, short-term support to South America for outbreak response and containment of infectious diseases. These short, albeit, successful collaborations identified the need to work closely with on-the-ground partners to build local public health capacity in order to stop outbreaks where they start. South America is particularly vulnerable to zoonotic and emerging infectious disease threats, including arboviruses, because of its size, geographic location, climate, cross-border travel and trade. These circumstances can lead to the evolution of new public health threats. This evolution can present a challenge for timely reporting of public health events of international concern (PHEICs) as well as for syndromic surveillance and disease control strategies.

South America has a broad range of public health concerns from alleviating poverty and the health threats associated with it to acute febrile illness, making it difficult to identify gaps across the counties in their capacity to prevent, detect, and respond to regional health threats.

According to the Pan America Health Organization (PAHO), influenza, cholera, antimicrobial resistance, hand, foot and mouth disease, chikungunya, Zika, Yellow fever, dengue, malaria and vaccine preventable diseases are public health priorities across the Americas. In 2018 and 2019, WHO certified malaria elimination in Paraguay and Argentina while Venezuela saw a 50% increase in its malaria cases between 2014 and 2015. As many of the region’s prioritized infectious diseases present with undifferentiated fever, it is critical to conduct syndromic surveillance in order to rapidly identify outbreaks before they spread. In addition, there has been an increase of measles and malaria in migrants from Venezuela which further highlights the need for coordinated surveillance efforts in a region working to mitigate the effects of civil unrest. According to PAHO, there are vast differences in communicable disease mortality in the Andean Area (Bolivia, Ecuador, Peru, and Venezuela ); 85.3 per 100,000 people compared to

70.6 per 100,000 people in the Southern Cone (Argentina Chile Paraguay and Uruguay); with Bolivia having the highest communicable disease mortality rate of 145.9 per 100,000 people and Chile having the lowest communicable diseases mortality rate of 38 per 100,000 people.

The CDC South America Regional Program aims to establish sentinel surveillance activities in multiple countries in order to characterize at risk populations, identify causes of disease, build public health capacity, and generate data to inform public health policy.

With many of the prioritized infectious diseases in South America causing undifferentiated fever, timely and accurate pathogen detection is essential for the rapid response to and control of outbreaks. Communicable disease outbreaks of epidemic potential may initially present with non-specific signs and symptoms, such as fever. Fever is among the most common reasons for people in low resource areas to seek medical treatment. Acute febrile illness (AFI), often defined as acute fever without localizing symptoms, is a common clinical syndrome associated with a broad spectrum of underlying infectious etiologies. Public health investigations to identify infectious AFI etiologies are often conducted to guide empiric patient management, target prevention measures, and detect emerging pathogens. Accurate and timely pathogen detection is essential for the rapid response to and control of outbreaks and is a key tenet to improving global health security. Pathogen detection can only occur if the needed surveillance and laboratory systems are established. This highlights the need for a coordinated surveillance network that collects the needed information to characterize the populations at risk and incorporates laboratory information to understand the causes of disease. Such a network has the potential to detect emerging pathogens in a timely manner and improve South America’s capacity to quickly and effectively respond to public health threats and emerging outbreaks; an increasingly critical regional component to protecting the health of the global community.

This NOFO supports activities that will fulfill four broad goals:

1. Conduct high quality research in AFI through the establishment of a surveillance network that incorporates the use of multi-pathogen detection platforms, that in the future, can be expanded to include other public health priorities such as antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats including non-communicable diseases to characterize disease threats and better understand the populations affected in the South America Region;

2. Capacity development, prioritizing the GHSA core four of surveillance, laboratory, workforce development, and emergency management and response;

3. Strengthen institutional capacity to conduct research, plan, implement, and evaluate public health programs, including the capacity to detect and respond to emerging and re-emerging infectious diseases; and

4. Incorporate and promote the results of research into operational disease prevention and control programs and policy development.

Healthy People 2020 and other National Strategic Priorities Healthy People 2020 goals supported by this NOFO include:

GH-5 - Increase diagnostic testing capacity in host countries and regionally through the Global Disease Detection (GDD) Regional Centers.

Other national and international priorities supported by this NOFO include:

The Department of Health and Human Services’ (HHS) Global Health Strategy maintains three goals to support HHS’ global health vision of a healthier, safer world: 1) protect and promote the health and well-being of Americans through global health action; 2) provide leadership and technical expertise in science, policy, programs and practice to improve global health; and 3) advance United States interests in international diplomacy, development, and security through global health action.

Public Health Impact The impact of the research conducted under this NOFO will generate data to inform public health leaders about the causes of disease and the populations at risk in the South America Region. This information is needed to better allocate and prioritize resources, implement and improve public health practices and interventions, and develop sustainable laboratory and surveillance systems to identify and mitigate the impact of health threats. Through better understanding of disease threats, and their control and prevention, morbidity and mortality may be lowered, and global health security increased. In addition, the activities funded under this NOFO will strengthen national and regional surveillance and laboratory systems, train the public health workforce, and develop faster and smarter outbreak responses.

Relevant Work U.S. Centers for Disease Control and Prevention (CDC) has collaborated with various governmental and non-governmental partners within South America to prevent, detect, and respond to emerging and re-emerging disease threats for many years. Most recently, CDC’s work has focused on providing pathogen specific outbreak response support to countries in South America and to enhance public health practice in the region.

For more than two decades, CDC has partnered with TEPHINET to launch the Field Epidemiology Training Program (FETP) in the Americas. Over time, FETP has developed three training tracks, frontline at the local level, advanced at the regional level and intermediate at the national level. In South America, these partnerships resulted in the establishment of an

Advanced program in Brazil and Frontline programs in other countries including Paraguay, Peru, and Uruguay. During the height of the Zika outbreak in 2016, TEPHINET established a Zika focused FETP. CDC also worked with other partners to enhance population- and hospital-based syndromic surveillance; to support laboratory, epidemiology and outbreak response, to build upon and strengthen laboratory and surveillance capacity and to strengthen public health.

Building upon established robust and continuous public health relationships, CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) expanded collaborations in Brazil by partnering with the Pan American Health Organization (PAHO) in 2013 and focusing on strengthening Brazil's National Response to HIV and other diseases through innovative and evidence-based approaches in laboratory, strategic information, prevention and care activities. CDC’s Division of Global Health Protection and the National Center for Emerging and Zoonotic Infectious Diseases’ (NCEZID) Arbovirus Disease Branch collaborated to establish a sentinel surveillance site for ZIKA using existing AFI and other surveillance platforms in Brazil, Colombia, and Peru. The goal of the ecological study was to obtain pertinent epidemiological and ecological information to better understand the dynamics of the Zika virus introduction and identify factors that may be involved in its potential zoonotic circulation. CDC, PAHO, and local ministries of health have also partnered through bilateral agreements in Bolivia, Suriname, Argentina, Uruguay, Guyana, to build sustainable capacity in the Americas to prevent, detect and respond to novel seasonal influenza in accordance with the International Health Regulations 2005 (IHR).

Even with these successful collaborations, there is still a gap in understanding the regional burden of a broad range of infectious diseases, detection of poorly understood and novel pathogens, as well as causes and rates of mortality in the populations under surveillance. As a result, there is need for targeted regional public health capacity building to improve the region’s ability to detect novel emerging and reemerging pathogens and enhance the laboratory and surveillance activities.

CDC has several activities that support or relate specifically to this NOFO. Prospective applicants should refer to the following websites and related documents for additional information:

www.cdc.gov/globalhealth www.cdc.gov/globalhealth/healthprotection/ghs/index.html www.cdc.gov/globalhealth/ihregulations.htm www.cdc.gov/globalhealth/ghi

2. Approach The applicant should submit one (1) overall research proposal in response to this application, which may include no more than one project focused on establishing an AFI syndromic surveillance network in no more than two countries in the South American Region as part of the first year of award proposal. This NOFO will support the GHSA and its targets and will facilitate collaboration toward specific public health protection objectives, including, IHR compliance. Applicants are required to partner with National Public Health Institutes, National Institutes of Health, and/or Ministries of Health.

The applicant must submit a single research plan and budget for AFI activities during the first http://www.cdc.gov/globalhealth http://www.cdc.gov/globalhealth/healthprotection/ghs/index.html http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi year of the project. The research plan should not exceed 25 pages in total. The research plan should address administrative tasks and oversight for the project as well as coordination of research objectives as appropriate in one budget.

Objectives/Outcomes For each country proposed, the initial focus should be on establishing an Acute febrile illness (AFI) surveillance network that can be expanded to additional disease syndromes and priority diseases in subsequent years. Expected outcomes from these studies include generating the data needed to guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of health threats on the population. These data will allow for faster identification of outbreaks, the development of successful public health systems, and the generation of the evidence base needed to guide interventions and enhance public health policy in each country and the region.

Disease Areas. Applicants may focus their application on one or more of the following eligible disease areas:

Year One

1. Strengthen or implement AFI surveillance and enhance laboratory capacity for diagnostics and monitoring of emerging infectious diseases in no more than two countries in the region

Subsequent Years

1. Continue expansion of AFI in additional South American countries

2. Expansion of established surveillance sites to include other public health issues of regional and local importance

Target Population The target populations to benefit from the work in this NOFO include, but are not limited to, those individuals infected and affected by infectious diseases, or at risk for becoming infected by an infectious disease. The work under this NOFO may also benefit those impacted by increased capacity at the national and sub-national level to implement activities in alignment with the objectives of this NOFO.

Recipients of funding are expected to use epidemiologic, social determinants, and linked laboratory, and surveillance data to identify communities disproportionately affected by infectious diseases in the target areas to ensure that program activities that are developed from these data appropriately cover these populations. Recipients should ensure that supported services are accessible and available to all patients regardless of age, sex, race/ethnicity, sexual orientation, gender identity, or socio-economic status in order to achieve the objectives of this

NOFO.

Collaboration/Partnerships Applicants are expected to develop and maintain collaborations with key regional organizations, including but not limited to National Public Health Institutes, National Institutes of Health, Ministries of Health and other research institutions.

Applicants must show evidence of support from the Ministries of Health or other ministries at the national level as appropriate in any country in which activities are proposed.

Applications must include plans to involve local collaborators and improve local workforce capacity in design, conduct, data analysis and interpretation, and development of written research products (reports, manuscripts, presentations, etc.).

Applicants must develop and maintain collaborations and share data generated in the surveillance activities with the Ministries of Health in the countries in which they work and with associated organizations for the execution of proposed activities. Projects must include plans for supporting the use of research findings by Ministries of Health.

Consortia of research institutes, health organizations and other relevant parties are encouraged to apply but are not required.

Evaluation/Performance Measurement Successful applicants will work with CDC to jointly develop formal evaluation criteria and an evaluation plan based on activities within each project as part of the post award process.

Recipients will provide quarterly reporting as outlined in the plan on the agreed upon indicators and on an ad hoc basis as required by CDC. The purpose of collecting and reporting these data is to determine the progress toward achieving increased public health capacity in host countries.

The results will also be used for program planning, development and improvement, accountability and reporting, and for sharing with partners and other stakeholders. CDC will work with the recipient throughout the life of this award to ensure that all activities and expected outcomes are in alignment with current USG and the recipient’s strategies and goals.

The recipient should dedicate funds made available under this NOFO for evaluation and performance monitoring within each project.

In the application, the applicant should describe plans for how research and scientific findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations, reports, meetings and conferences). The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users.

It should be expected that approximately 3% (of a given project’s funding) will be dedicated to monitoring, reporting, and evaluation activities. CDC and the recipient will agree upon the specific funding amounts within review of each project’s proposal and budget.

Translation Plan The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users.

Questions to consider in preparing this section include:

1. How will the scientific findings inform the governments in South America as well as other stakeholders on needed public health policies or practices at the local, national and regional levels?

2. How will the research project improve or affect the translation of study findings into policy or practice in order to assist countries achieve International Health Regulations (WHO 2005) compliance and improve global health security?

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

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

5. How will the research activities improve public health outcomes, advance workforce development, improve surveillance and laboratory capacity, and enhance response capacity?

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: $25,000,000

Anticipated Number of Awards: 5

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

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $5,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, 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/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Public and State controlled institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility

Private institutions of higher education Governmental Organizations – MOH, NPHIs, etc.

Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com 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 http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int /AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Any application that does not fully respond to the items in this section will be deemed "nonresponsive" and will not be moved forward for scientific peer review.

1. Applicant must have submitted a Letter of Intent (LOI) received by the due date of LOI..

2. Applicant can apply only in two South American countries focused on establish an AFI surveillance platform. The application must specify each country to be covered by the activity.

3. Applicants cannot apply to conduct any single activity in more than two countries in Year 1 but can propose the activity in >2 countries in subsequent years. For example, an applicant can propose to begin a surveillance project of AFI risk factors in Brazil and Chile in Year 1 and add Peru and Ecuador in Year 2.

4. Applicant may not exceed budget limit specified in Year 1.

5. Applicant must include a list of investigators who will be involved in the project, their roles, and qualifications for their proposed roles.

6. Applicant must demonstrate three (3) years or more of in country experience working with the National Public Health Institutes, Ministries of Health (or designee) and other scientific partners on public health science and animal health activities in the countries where they propose to have activities within the last ten (10) years. This experience should highlight the activities and collaborations that physically took place on the ground in each proposed South America country. This can be shown through listing publications and/or project summaries.

7. Applicant must provide letters of support from the Ministry of Health, and Ministry of Agriculture when applicable, in the countries where work activities are proposed.

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

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/.

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 Principle Investigator (PD/PI) 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 eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

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 https://www.sam.gov/portal/SAM https://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 https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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 recipient 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 recipient 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/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity 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 NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf, except where instructed in this Notice of Funding Opportunity 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 package associated with this NOFO includes all applicable mandatory and optional forms.

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

When using ASSIST, all mandatory forms will appear as separate tabs at the top of the Application Information screen; applicants may add optional forms available for the NOFO by selecting the Add Optional Form button in the left navigation panel.

3. Letter of Intent Due Date for Letter of Intent: 02/10/2020 By the date listed 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 Applicant should state which countries they plan to work in in Year 1 (maximum 2) 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:

Lata Kumar Director, Extramural Research Program Office Office of the Associate Director of Science Center for Global Health Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS D-69 Atlanta, GA 30333 http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

Telephone: 404-639-7618 Fax: 404-639-7490 Email: lkumar@cdc.gov

4. Required and Optional Components A complete application has many components, both required and optional. The forms package associated with this NOFO in Grants.gov includes all applicable components for this NOFO, required and optional. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

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 components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

Follow the page limits stated in the SF 424 unless otherwise specified in the NOFO. As applicable to and specified in the NOFO, 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 NOFO.

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 time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

http://grants.nih.gov/grants/how-to-apply-application-guide.htm must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

The DMP may be outlined in a narrative format or as a checklist but, at a minimum, should include:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights -this section should address access to identifiable and de-identified data);

• Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use;

and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

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.

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 publicly available. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

7. Page Limitations https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

All page limitations described in this individual NOFO must be followed. For this specific NOFO, 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 100 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems.

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

Organizations must submit applications using the ASSIST web-based application preparation and submission process.

ASSIST will validate applications before submission. If the system detects errors, then the applicant must correct errors before their application can be submitted.

Applicants are responsible for viewing their application in…