RFA-GH-21-006 Amend 1.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Strengthening Public Health Research and Implementation Science (Operations Research) to

Control and Eliminate Infectious Diseases Globally

RFA-GH-21-006

Application Due Date: 02/22/2021

Strengthening Public Health Research and Implementation Science (Operations Research) to

Control and Eliminate Infectious Diseases Globally

RFA-GH-21-006

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 Strengthening Public Health Research and Implementation Science (Operations Research) to Control and Eliminate Infectious Diseases Globally Activity Code U01 Amendment 1: Summary of Changes Section VIII. Questions received during the Q&A period and answers added Part 1. Overview Information Executive Summary – Budget and Period of Performance – Original version The estimated total funding (direct and indirect) for the first budget period, 8/31/2012 to 8/30/2022, is estimated to be $2million per year per award. Each award may support activities in up to four countries.

Executive Summary – Budget and Period of Performance – Revised version The estimated total funding (direct and indirect) for the first budget period, 8/31/2012 to 8/30/2022, is estimated to be $2million per year per award. Each award may support activities in up to two countries.

Section I. Funding Opportunity Description - 2. Approach – Original version The applicant should submit one (1) overall research proposal in response to this NOFO, which may include no more than one project focused on conducting serosurveillance and/or developing and assessing approaches to conducting serosurveillance in one to four countries in the 4 regions listed below as part of the first year of award proposal.

Section I. Funding Opportunity Description - 2. Approach – Revised version The applicant should submit one (1) overall research proposal in response to this NOFO, which may include no more than one project focused on conducting serosurveillance and/or developing and assessing approaches to conducting serosurveillance in up to two countries in the 4 regions listed below as part of the first year of award proposal.

Section III. Eligibility Information - 5. Responsiveness - Original version Applicant cannot apply to conduct the activity in more than four countries in Year one.

Section III. Eligibility Information - 5. Responsiveness - Revised version Applicant cannot apply to conduct the activity in more than two countries in Year one.

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

RFA-GH-21-006

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 science, surveillance, and research related to COVID-19 and other global public health threats in Africa, Southeast Asia, Eastern Europe and Central Asia, and the Middle East and North Africa (MENA), including, but not limited to, assessments of the extent of pathogen exposures or transmission based on serologic testing, improved understanding of immune responses to infectious pathogens, and assessments of various approaches to collecting and analyzing the results of serologic testing; and, Incorporate the results of these public health activities into operational disease detection, prevention, and response or control programs in regions noted above, 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-21-006, 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: 01/20/2021

Application Due Date: 02/22/2021

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 https://www.grants.gov 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: 04/05/2021

Secondary Review: 06/15/2021

Estimated Start Date: 08/31/2021

Expiration Date: 02/23/2021 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.

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:

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

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

Conduct and monitor epidemiologic and laboratory-based science, surveillance, and research related to COVID-19 and other global public health threats in Africa, Southeast Asia, Eastern Europe and Central Asia, and the Middle East and North Africa (MENA), including, but not limited to, assessments of the extent of pathogen exposures or transmission based on serologic testing, improved understanding of immune responses to infectious pathogens, and assessments of various approaches to collecting and analyzing the results of serologic testing; and, Incorporate the results of these public health activities into operational disease detection, prevention, and response or control programs in regions noted above, 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 $60 million The number of awards will be up to 6 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 Budget and Period of Performance: The estimated total funding (direct and indirect) for the first budget period, 8/31/2021 to 8/30/2022, is estimated to be $2 million per year per award.

Each award may support activities in up to two 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 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: Applications may include more than one PI however, the first PI listed on the application will be the contact PI for all correspondence. Any additional PIs are permitted but would be referred to, or should be listed as, Co-PIs. Consortia are welcome to apply to this NOFO. A consortium is defined as a formal agreement whereby one PD/ PI and institution is named as lead and may partner with other institutions to implement the award. The lead recipient must perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. The PD/PI of the award must be from the lead recipient. Consortium agreements are considered subawards for the purposes of this award. The consortium agreement must be in effect at the time of application submission. Applicants from institutions not located in the country where the proposed work will be conducted are encouraged to include collaborators/ Co-PIs from the country. Consortia are also encouraged to be formed and led by a PD/PI from the country in which the work is proposed.

Number of Applications: Only one (1) application per eligible institution (normally identified by a unique DUNS number) is Only one PI can be named primary, even if applying as a consortium.

Application Type: New Special Date(s): LOI due: January 20, 2021; Receipt date: February 22, 2021. Applicants must submit their questions by e-mail to cgherpo@cdc.gov, within 15 days after the publication date of this NOFO in 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 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 Section 307 of the Public Health Service Act [42 USC 242l], as amended and Section 301(a) [42 USC 214(a)], as amended and the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136).

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 has established country programs in CDC offices in scores of countries in Asia and Africa, and is establishing regional programs, including in Southeast Asia, Eastern Europe and Central Asia, and the Middle East/North Africa (MENA) to protect and promote health through collaboration with partners on science, policy, and evidence-based public health actions to improve global health security. CDC Programs work in close partnership with governments, 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 assist countries in achieving compliance with the International Health Regulations (IHR 2005) within the framework outlined by the Global Health Security Agenda (GHSA) and further the CDC’s global health goals in the areas of serosurveillance, operational disease prevention and control programs, and policy.

For decades, CDC has supported public health programs in Africa, Southeast Asia, Middle East and North Africa (MENA), and Eastern Europe and Central Asia, with multiple countries receiving support through the US President’s Emergency Plan for AIDS Relief, the US President’s Malaria Initiative, Global Immunizations, and more recently, through the Global Health Security Agenda. These long-term programs have had extensive, documented impact on mailto:cgherpo@cdc.gov http://www.grants.gov/ http://www.grants.gov/ the well-being of the populations in host countries and have helped protect populations in the US and globally from the spread of infectious diseases by building local capacity to stop outbreaks at their origin. Africa, Southeast Asia, Middle East and North Africa (MENA), and Eastern Europe and Central Asia are particularly vulnerable to zoonotic and emerging infectious disease threats, because of their size, geographic location, climate, cross-border travel and trade. When new infectious disease threats emerge, there is an urgent need to gather information about how the new pathogen is spread, risk factors for infection, information about the performance of laboratory tests, and the effectiveness of control efforts.

The pandemic of coronavirus-19 (COVID-19) has threatened the vision for a safer and more secure world. COVID-19 is caused by a novel coronavirus, SARS-CoV-2. Optimization of the response to this pandemic requires that critical information about the virus be collected and incorporated into response efforts. While there has been rapid collection of information about modes of transmission and risk factors for infection with SARS-CoV-2, most studies to date have relied on evaluation of persons who have had diagnostic tests done at the time of infection. Limited serologic studies to date have indicated that there are many times as many infections as are detected during acute infection. Measures of true rates of infection at the population level are needed to contribute to overall understanding of the transmission of SARS- CoV-2 and inform future control efforts, including vaccination programs. Identification of previously exposed and currently infected populations can assist with accurate assessment of risk factors for infection and an improved understanding of the full spectrum of clinical manifestations and outcomes of SARS-CoV-2 infection in different populations.

The World Health Organization has developed a protocol for population-based age-stratified sero-epidemiological surveys for SARS-CoV-2. The protocol is designed to facilitate systematic collection of seroprevalence data in a format that facilitates aggregation and analysis of data and serves as a useful starting point for designing surveys in diverse contexts.

In addition to the need for seroprevalence data from diverse regional and national contexts, there is need for greater understanding of the optimal approaches to assessing seroprevalence.

For example, while many laboratory assays that detect antibodies or other markers of infection have been developed, more information is needed regarding which of these provide the most useful information about exposure or past infection and about differential performance of these assays in different populations or at different times since infection. A variety of serosurveys have been conducted—including population-based surveys, repeated cross-sectional surveys in groups of individuals and repeated cross-sectional surveys in the same geographic area.

However, other approaches are possible, for example, testing of residual samples, and more information is needed about which approaches to serosurveillance are most efficient and logistically feasible and best provide valid information about population seroprevalence.

Further, more information is needed about which testing approaches can be feasibly used to distinguish between natural infection and future vaccine-derived immunity in diverse populations.

Results of work supported through this funding announcement will provide useful insights into the spread, distribution, and scale of the pandemic in priority countries and into approaches to collection and use of seroprevalence data.

In addition, analysis of accurate information about who is currently or has previously been infected with COVID-19 will inform the development of control strategies, which can then be implemented and evaluated in a range of settings.

This NOFO supports activities that will fulfill four broad goals:

1. Conduct high quality sero-epidemiologic studies that inform an understanding of approaches to the collection of seroprevalence data and the extent of pathogen transmission in general populations and populations of specific interest, contributing to both national and global knowledge and databases, and building local capacity to collect, analyze, and routinely report on sero-epidemiologic data.

2. Develop host country public health capacity, prioritizing surveillance, laboratory and public health response capacities,

3. Strengthen host country 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, translate and promote the results of research into operational disease prevention and control programs and policy

Healthy People 2030 and other National Strategic Priorities Healthy People 2030 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 extent of and risk factors for COVID-19 in Africa, Southeast Asia, Middle East and North Africa (MENA), and Eastern Europe and Central Asia. 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 in Asia and Africa to prevent, detect, and respond to emerging and re-emerging disease threats for many years. Key programs include the President’s Emergency Plan for AIDS Relief the Global Health Security Agenda, global immunization programs, and the President’s Malaria Initiative. In response to the COVID-19 pandemic, CDC has supported a wide range of prevention, surveillance, detection, and mitigation activities.

CDC-sponsored response activities related to the COVID-19 pandemic have included support to incorporate surveillance for COVID-19 into established surveillance systems (both for detection of respiratory pathogens as well as general disease surveillance systems); support to increase laboratory capacity, both at respiratory virus reference laboratories and for general diagnostic and surveillance purposes; and mitigation activities (including establishing triage and strengthening infection prevention and control at health facilities; and support for hand hygiene, social distancing, and appropriate mask use in occupational and community settings). CDC collaborates closely with Ministries of Health as well as with other national, multilateral and regional partners and works with a wide range of partners supporting capacity building, program implementation, and evaluation efforts.

Even with these successful collaborations, there is still a gap in understanding the national and regional burdens for a broad range of infectious diseases, as well as causes and rates of mortality in the populations under surveillance. As a result, there is need for targeted public health research capacity building to improve the ability to detect novel emerging and reemerging pathogens.

CDC and global partners have several activities that support or relate specifically to this NOFO.

Prospective applicants should refer to the following websites and related documents for additional information:

https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/index.html www.cdc.gov/globalhealth www.cdc.gov/globalhealth/healthprotection/ghs/index.html www.cdc.gov/globalhealth/ihreg ulations.htm www.cdc.gov/globalhealth/ghi https://www.who.int/publications/i/item/WHO-2019-nCoV-Seroepidemiology-2020.2

2. Approach The applicant should submit one (1) overall research proposal in response to this NOFO, which may include no more than one project focused on conducting serosurveillance and/or developing and assessing approaches to conducting serosurveillance in one to two countries in the 4 regions listed below 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 compliance with International Health Regulations (IHR 2005).

Applicants are required to partner with National Public Health Institutes, National Institutes of Health, and/or Ministries of Health.

Applicants must focus their application on one to four countries from the following regions. For year 1, CDC has prioritized the following countries:

Africa: Botswana, Cameroon, Democratic Republic of the Congo, Eswatini, Ethiopia, Mozambique, Nigeria, Sierra Leone, Zambia.

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/ihregulations.htm http://www.cdc.gov/globalhealth/ghi https://www.who.int/publications/i/item/WHO-2019-nCoV-Seroepidemiology-2020.2

Southeast Asia: Indonesia, Myanmar Middle East and North Africa: Morocco, Egypt Eastern Europe and Central Asia: Ukraine

The applicant must submit a single research plan and budget during the first 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.

In Years 2 – 5 of this cooperative agreement, contingent upon the availability of funds, CDC will work with recipients to expand to additional priority public health research areas and to additional priority countries.

Objectives/Outcomes For each country proposed, the initial focus should be on conducting sero-epidemiologic activities that focus on collection of important information about the extent, duration of, and risk factors for infection with SARS-CoV-2 in general or priority special populations; and/or approaches to conducting sero-surveillance work. Expected outcomes from these studies include an improved understanding of the extent, duration of, and risk factors for infection with SARS-Cov-2 and/or of the utility of different epidemiologic and laboratory approaches to collection of serosurveillance data. These data will inform ongoing surveillance efforts and development of COVID-19 mitigation strategies, including vaccination, and will contribute to the evidence base needed to guide interventions and enhance public health policy in each country and region.

Applicants should focus their application on the following activities in year 1 and in subsequent years as described below:

Year One Applicants must apply to conduct SARS-CoV-2 Sero-epidemiologic Studies in Humans and specify which country or countries will be included.

Subsequent Years (Years Two – Five)

1. Expand activities related to sero-surveillance for SARS-CoV-2 and other health threats

2. Evaluation of disease control activities, including those developed based on information collected through sero-epidemiologic studies of SARS-CoV-2 and laboratory test performance.

3. Expand to new public health activities of regional and local importance.

4. Expand activities to include additional CDC priority countries.

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 COVID-19 and other infectious diseases, or at risk for becoming infected by an infectious disease. The work under this NOFO may also benefit those impacted by increased research and public health 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 equitable collaborations with key national 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 and equitable partnership with 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 and dissemination 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 align 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 national governments in the noted regions as well as other stakeholders on needed public health policies or practices at the local, national and regional levels? For example, how will year 1 activities help countries develop near-term approaches to monitor SARS-CoV-2 transmission over time?

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 (IHR 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?

For example, how will year 1 activities inform SARS-CoV-2 mitigation measures or vaccination strategies?

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: $60,000,000

Anticipated Number of Awards: 6

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: $2,000,000 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 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:

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 http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher

Education)

Governments:

U.S. Territory or Possession

Other:

Faith-based or Community-based

Organizations Regional Organizations Foreign Organizations: a Foreign

Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

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 https://gov.ecfr.io/cgi-bin/searchECFR

2. Foreign Organizations Foreign Organizations are eligible to apply.

https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true

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

• Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of the project staff or place of performance.

• Governmental Organizations – MOH, NPHIs, etc.

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 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. Applicants are encouraged to submit a Letter of Intent (LOI) by the due date of LOI.

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.

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 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

2. Applicant cannot apply to conduct the activity in more than two countries in Year one.

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

4. Applicants must include coinvestigators from the country/countries in which they propose to work.

5. Applicant must provide letters of support from the national level Ministry of Health, and

Ministry of Agriculture when applicable, in the countries where work activities are proposed.

6. If an applicant requests a funding amount greater than the ceiling of $2,000,000 as indicated in Section II. of this NOFO, under Executive Summary and under Application and Submission Instructions, HHS/CDC will consider the application non-responsive and it will not enter the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

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://cage.dla.mil/

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/index.html .

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.

https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov

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 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.

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 http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf 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.

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-f/general-forms-f.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.

Application and Submission Instructions Specific to this NOFO:

Include a “Consortium/Contractual Arrangements” attachment if you have consortia/contracts in your budget. The Agreement must explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s). If consortium/contractual activities represent a significant portion of the overall project, explain why the applicant organization, rather than the ultimate performer of the activities, should be the grantee.

3. Letter of Intent https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf

Due Date for Letter of Intent: 01/20/2021 Although a letter of intent is not required, is not binding, and does not enter the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

Prospective applicants are encouraged to submit a letter of intent by the date listed in Part 1.

“Overview Information”, 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 Countries where proposed work is expected to be conducted Number and title of this funding opportunity announcement

The letter of intent should be emailed to:

Dr. Sheila Okoth Scientific Program Official, Email: jyo3@cdc.gov Extramural Research Program Office Office of the Associate Director of Science Center for Global Health Centers for Disease Control and Prevention U.S.