Foa_Content_of_RFA-GH-24-033 Final.pdf

Centers for Disease Control and Prevention

Center for Global Health

Advancing Public Health Research in Bangladesh

RFA-GH-24-033

03/08/2024

Table of Contents 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

Overview Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Components of Participating Organizations:

Center for Global Health National Center for Chronic Disease Prevention and Health Promotion National Center for Emerging and Zoonotic Infectious Diseases National Center for Environmental Health National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention National Center for Immunization and Respiratory Diseases National Center for Injury Prevention and Control Office of Infectious Diseases Notice of Funding Opportunity (NOFO) Title Advancing Public Health Research in Bangladesh Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-GH-24-033

Assistance Listings Number(s) 93.326 Category of Funding Activity HL - Health

NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research and surveillance activities to support the government of Bangladesh and other partners to detect, prevent, and respond to disease threats. Research projects may be quantitative, qualitative, and /or mixed methods epidemiological studies, laboratory-based studies, or other types of research projects that focus on the following: a) Characterizing priority diseases in Bangladesh, b) Determining the most effective interventions and implementation approaches, and c) Measuring impact of public health efforts. All funded research projects should be conducted in partnership with the Government of Bangladesh and include clear mechanisms for advancing public health policy and practice at local, national, regional, and/or global levels.

Key Dates Publication Date:

To receive notification of any changes to RFA-GH-24-033, 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:

12/14/2023 Not applicable

Application Due Date:

03/08/2024 03/08/2024

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 11:59 PM U.S. Eastern Time.

Applicants will use a system or platform to submit their applications through Grants.gov and eRA Commons to CDC. ASSIST, an institutional system to system (S2S) solution, or Grants.gov Workspace are options. ASSIST is a commonly used platform because it provides a validation of all requirements prior to submission and prevents errors.

For more information on 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 http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

• Phone: 301-402-7469 or (toll-free) 1-866-504-9552

• Hours: Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding Federal holidays

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:

https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

04/15/2024 Secondary Review:

05/30/2024 Estimated Start Date:

09/30/2024 Expiration Date:

03/09/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - 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.

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

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

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

Executive Summary Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research and surveillance activities to support the government of Bangladesh and other partners to detect, prevent, and respond to disease threats. Research projects may be quantitative, qualitative, and /or mixed methods epidemiological studies, laboratory-based studies, or other types of research projects that focus on the following: a) Characterizing priority diseases in Bangladesh, b) Determining the most effective interventions and implementation approaches, and c) Measuring impact of public health efforts. All funded research projects should be conducted in partnership with the Government of Bangladesh and include clear mechanisms for advancing public health policy and practice at local, national, regional, and/or global levels.

Mechanism of Support: Cooperative Agreement

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year project period is $22,000,000. The number of awards will be up to one. 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 will vary from application to application, it is also anticipated that the size and duration of each award may also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $6,000,000 with individual awards ranging from $0 to https://grants.nih.gov/grants/how-to-apply-application-guide.html

$6,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $22,000,000. The project period is anticipated to run from [09/30/2024 to 09/29/2029].

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 of this announcement 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 PD/PI for each application.

Number of Applications. Only one application per institution (normally identified by having a unique UEI number) is allowed.

Application Type. New

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

Section I. Funding Opportunity Description Statutory Authority Section 301(a) of the Public Health Service Act [42 USC § 241(a)], as amended and Section 307 of the Public Health Service Act [42 USC §242l].

1. Background and Purpose With a population of more than 170 million people in a country the size of the U.S. State of Iowa, Bangladesh is the most densely populated country in the world (except for city-countries like Singapore). That density increases even more during the annual monsoon, when nearly 1/3 of the land mass is covered with water as the Ganges delta swells with rain and run-off from the Himalayas. With the help of development assistance, Bangladesh has reduced the poverty rate from over half of the population to less than a third, has achieved Millennium Development Goals for maternal and child health, and has made great progress in food security.

Scientists agree that Bangladesh is particularly susceptible to the emergence of novel influenza virus and other novel pathogens. In 2014, 2015 and 2016 the governments of both Bangladesh and the United States agreed to support an organized Global Health Security Agenda (GHSA), which is a coordinated effort among more than 64 nations to work together to detect, prevent, and respond to emerging infectious disease threats. As part of that effort, the U.S. Government focuses resources and technical support for achieving GHSA milestones of the 17 membership countries, including Bangladesh. The Centers for Disease Control and Prevention (CDC) has been working in Bangladesh for the last 50 years, with a primary focus of understanding infectious diseases and evaluating strategies that address global health threats. With the advent of the United States Government and the Government of Bangladesh’s commitment to the GHSA, CDC research and public health projects continue to increase focus on activities that have strong potential to result in changes to public health policy and practice, and improved health outcomes and global health security.

Healthy People 2030 and other National Strategic Priorities While the Healthy People 2030 (HP2030) goals are generally specific to US domestic programs, the global health activities within this NOFO extend the national strategic priorities through the following HP2030 Global Health Objectives:

• Increase the number of individuals trained globally to prevent, detect, or respond to public health threats (GH-D01)

• Increase the number of globally important public health events that are tracked and reported (GH-D02)

• Increase laboratory diagnostic testing capacity, surveillance, and reporting globally

(GH-D03)

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:

• Protect and promote the health and well-being of Americans through global health action.

• Provide leadership and technical expertise in science, policy, programs and practice to improve global health.

• Advance United States interests in international diplomacy, development, and security through global health action.

Public Health Impact The Public Health Impact of this proposed work will be high quality public health and implementation science research that will guide stakeholders to prioritize resources, develop policies, and implement practices and interventions that mitigate the impact of health threats on the Bangladeshi population and potentially globally. Research projects should be relevant to exploring strengthening surveillance capacity that results in a tiered laboratory system, strengthening Bangladesh’s public health workforce, supporting effective emergency response capacities, and improving clinical care and prevention interventions. Improvements in these areas should increase the ability of the government of Bangladesh and other partners to detect, prevent, and respond to disease threats, to improve population health outcomes and reduce the risk of global pandemics.

Relevant Work For more thank 50 years, the Centers for Disease Control and Prevention (CDC) has been working with Bangladesh, and often in close collaboration with the International Centre for Diarrheal Disease Research, Bangladesh (icddr,b), a premier global health research institution in Dhaka. CDC has awarded icddr,b four research cooperative agreements (FY2004-2009, FY2009- 2014, FY2014-2019, FY2019-2024) which have supported research and surveillance activities in a broad range of technical and priority GHSA areas, and one non-research cooperative agreement (FY2014-2019). More than a hundred research projects and capacity building activities have been conducted jointly under the terms of these awards. While early activities focused on diarrheal disease, the collaboration has grown to encompass research and surveillance activities in areas ranging from emerging infectious diseases, influenza, polio vaccine immunogenicity https://health.gov/healthypeople/objectives-and-data/browse-objectives/global-health https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html studies, One Health and antimicrobial resistance. Many of these efforts have had important impacts on public health policy practice, including providing evidence for updating of polio immunization guidelines, influenza surveillance and reporting to the World Health Organization (WHO), evidence for introduction of rotavirus vaccine, evidence supporting the feasibility and benefits of co-administration of oral polio and cholera vaccines in children under 1 year of age, and a much deeper understanding of the newly identified Nipah Virus. Building on the icddr,b- CDC joint efforts to support core capacity development in outbreak response and surveillance, CDC has also developed a direct-bilateral relationship with the Institute of Epidemiology Disease Control and Research (IEDCR) within the Bangladesh Ministry of Health and Family Welfare (MoHFW) to support research activities that facilitate the implementation of the GHSA.

icddr,b has been a long-time, valuable partner of the Institute for Epidemiology, Disease Control and Research (IEDCR) within the MoHFW. icddr,b and IEDCR have established guidelines for effective collaboration on icddr,b-implemented surveillance, outbreak response, and relevant research projects.

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

• Global Health Security Agenda – Prevent. Detect. Respond.

• CDC - Global Health

• Global Health Security | Division of Global Health Protection | Global Health | CDC

• Global Immunization Division | CDC

• Who We Are | NCEZID | CDC

• Immunization and Respiratory Diseases (NCIRD) Home | CDC

2. Approach RESEARCH CATEGORIES Applicants may propose projects that focus on at least one of the following research categories. Projects may be proposed in one research category or can be a combination of the three categories: A, B, or C. Examples of projects are provided under each research category:

Category A: Characterize Priority Diseases in Bangladesh

Conduct research activities to determine burden, trends, etiology, and risk factors for priority diseases in Bangladesh. These research activities may be laboratory-focused, observational, epidemiological, or utilize other rigorous methods.

Examples of projects that characterize priority diseases include:

• Develop, maintain, or expand a multi-site sentinel surveillance system in Bangladesh to determine burden of disease, transmission dynamics, risk factors, relative contribution of different pathogens to disease syndromes, and/or control of infectious agents.

• Support the development or strengthening of laboratories and/or platforms used for etiologic investigation, evaluation of novel diagnostic assays for faster and easier detection, and characterization of pathogens.

• Develop and/or maintain one or more research sites to investigate and report the interactions between specific pathogens and underlying co-morbidities.

https://globalhealthsecurityagenda.org/ https://www.cdc.gov/globalhealth/ https://www.cdc.gov/globalhealth/healthprotection/ghs/index.html https://www.cdc.gov/globalhealth/immunization/index.html https://www.cdc.gov/ncezid/who-we-are/index.html https://www.cdc.gov/ncird/

• Conduct research on the human-animal interface of zoonotic diseases and risks of transmission from animals to humans.

• Develop and test innovative solutions identified through research to develop early warning systems to report sentinel organisms in humans that can serve as an alert for multidrug resistant organisms and interventions for adequate antimicrobials.

Category B: Determine the Most Effective Implementation Approaches and Interventions

Conduct research to identify the most effective implementation approaches for responding to global public health threats and building global health security capacity. Examples of projects that address effective implementation approaches include:

• Conduct research to evaluate the effectiveness of different vaccine delivery methods, for example comparing immune responses to vaccinations provided on different schedules or when co-administered with other vaccinations.

• Conduct qualitative socio-cultural research and surveys of knowledge, attitudes, and practices related to infectious disease and the acceptance of interventions and prevention methods.

• Develop new interventions, evaluate the effectiveness of interventions, and/or make recommendations for scale-up of interventions designed to reduce the spread of disease (for example, IPC methods or poultry slaughtering methods).

• Develop and test new diagnostic or laboratory testing methods to build stronger laboratory, surveillance, and response capacity.

Category C: Measure Impact

Conduct research on the current capacity of the Bangladesh health system; examine impact of investments by donors for GHSA and International Health Regulation capabilities, or specific program effectiveness. Projects should lead to the development and/or improvement of national and regional policies and programs for disease prevention, monitoring and control. Examples of projects that measure impact include:

• Conduct evaluations of surveillance programs in Bangladesh to determine coverage rates, barriers, best practices, and effectiveness.

• Measure the impact of enhancements in public health surveillance in a country (in terms of outbreaks controlled, cases averted, time lags from specimen detection to collection etc.).

• Conduct research to estimate the direct and indirect costs, and document the economic burden of priority diseases and/or develop cost-effectiveness estimates of prevention and control programs for a priority disease.

Applicant may propose a variety of projects that address these disease areas and categories.

Within each project, the applicants must submit separate Research Plans and Budgets. Applicant must provide assurance of coordinated management and administrative support. Applicant may propose new projects, as well as existing projects that were previously reviewed and approved.

For each project proposed, the focus should be on an identifiable public health concern or problem impacting health in Bangladesh. Applicant may propose new projects, as well as existing projects that propose new objectives and activities to address emerging diseases as well as risk factors associated with the leading causes of death in Bangladesh. This may include disease surveillance, data collection, epidemiologic studies, laboratory-based studies, and the evaluation of interventions and/or control methods including therapeutic and preventative treatments.

This NOFO may fund health information systems infrastructure, including workforce and public health laboratories, to support specific strategies, activities, and outcomes described in this

NOFO.

OVERALL MANAGEMENT PLAN

An overall management plan must be included as part of the General Administrative and Central Support Services proposal. The overall management plan must address the entire 5-year project period, including how the core objectives of the General Administrative and Central Support Services Teams (see Objectives/Outcomes section below) will be met. The plan must describe how the applicant will manage common resources and address any potential overlap of costs and activities. The plan should name the principal investigator or other key staff responsible for overall programmatic oversight. The principal investigator or other key staff responsible for overall programmatic oversight should be named. This overall plan should include the following:

• A central plan to achieve oversight and awareness of the geographical distribution of research projects to avoid any potential overlap in study sites and catchment areas. For example, through creating and maintaining a central map and/or database of study sites and their catchment areas for recently completed and ongoing CDC-funded studies (and non-CDC funded studies that are in proximity).

• A research workforce development plan to ensure a cadre of highly trained junior and early career investigators who are poised to become independent researchers to sustain the key research and surveillance programs initiated through prior CDC cooperative agreements. For example, 1) trainees supervised by key senior investigators are promoted for formal and informal research training opportunities; 2) pre-doctoral and post-doctoral research fellows are meaningfully engaged in all aspects of research development and implementation.

• A plan to ensure that projects’ Translation Plans are implemented in a timely fashion to ensure the maximum impact. For example, through ensuring research findings with the potential for immediate public health practice and policy implications are shared with the appropriate Bangladeshi Government Offices and other relevant stakeholders expeditiously.

• A letter of support from the appropriate Bangladeshi Government Offices and external partners to document future collaboration to implement the proposed research program.

Objectives/Outcomes Applicants may propose research projects in the first year of award that will contribute to strengthening the ability of the government of Bangladesh and other partners to detect, prevent, and respond to disease threats through high quality public health research and surveillance activities. Specifically, the projects should focus on: a) determining burden, trends, etiology, and risk factors of priority diseases in Bangladesh, b) developing and evaluating interventions and diagnostics, c) evaluating the effectiveness of vaccinations d) informing global policy, and e) strengthening the Government of Bangladesh's surveillance, laboratory and outbreak response capacity.

Applicants may submit an application on one or more of the following eligible disease areas:

1. Acute febrile illness (AFI)

2. Encephalitic illness (including Nipah Virus and Japanese Encephalitis)

3. Antimicrobial resistance (AMR) and/or healthcare-associated infections (HAI)

4. Infection Prevention and Control (IPC) and Surgical Site Infection (SSI) stewardship activities

5. Vaccine-preventable diseases

6. Influenza and other respiratory illnesses

7. Zoonotic diseases

8. One Health studies addressing antibiotic resistance associated.

9. Other public health issues of global, regional and/or local importance

CDC’s funding is largely disease specific, as such funding decisions will be based on alignment with a particular disease area.

ADMINISTRATIVE AND CENTRAL SUPPORT SERVICES OJECTIVES

• Effective management of common resources to avoid any potential overlap of costs and activities.

• Effective budgeting and expense forecasting on a per project basis, to include utilization of templates provided by CDC as guides to prepare routine expense reports for each project and the Administrative and Central Support Teams. Reports to include:

o Quarterly burn rate reports.

o Quarterly projection reports, to include the approved budget (new and carryover funds), and projections of personnel costs, recurring and anticipated expenses.

• Proactive coordination with the CDC, Global Health Center, Extramural Research Program Office regarding expense reporting through routine (for example, quarterly) budget review calls.

• Effective oversight of the necessary registrations, including icddr,b’s Federal Wide Assurance (FWA), to ensure registrations remain active for the duration of the award.

• Effective oversight, management and documentation of study protocol review by the icddr,b Institutional Review Board (IRB) to ensure the timely annual renewal of approved studies.

• Effective oversight and central documentation of the certification of annual Human Subjects Research Training for study key personnel and IRB approvals.

• Proactive coordination with CDC Programs and the Global Health Center, Extramural Research Program Office personnel to ensure the timely and efficient submission of requests to release human subjects research restrictions.

• Effective oversight of a Material Transfer Agreement (MTA) with CDC. Please note:

CDC Global Health Center, Extramural Research Program Office personnel should be given the opportunity to review any changes to approved project titles or project IDs prior to implementing a change. For each project a table summarizing the samples to be transferred should be included. Table headings should include the species, sample type, sample volume and number of vials. Any amendments to an existing MTA should be made with track changes for to capture all changes.

• Comprehensive progress reporting through completion of all sections of the annual and final Research Performance Progress Reports (RPPRs), including personnel effort reporting, documentation of human subject research ethics training for new key personnel, and reporting on the core responsibilities and functions of the Administrative and Central Support Services teams.

• Effective oversight and awareness of the geographical distribution of research projects to avoid any potential overlap in study sites and catchment areas.

• Robust research workforce development to ensure a cadre of highly trained junior and early career investigators are poised to become independent researchers and sustain the key research and surveillance programs initiated through prior CDC cooperative agreements.

Target Population The prospective applicant must identify the target populations to be addressed through this NOFO, including risk factors for disease and impact of increased diagnostics and surveillance by population type. The prospective applicant should use data generated under this NOFO to identify communities disproportionately affected by different infectious diseases, and propose activities/interventions to reduce or eliminate these disparities. The applicant should describe how the activities under this NOFO will be inclusive of all affected populations.

Collaboration/Partnerships Collaborations with a broad range of partners will be increasingly critical to generate data, make recommendations, and implement those recommended actions and policies relevant to the Global Health Security Agenda. The successful applicant must maintain close working relationships with the Bangladesh MoHFW, particularly the Institute for Epidemiology Disease Control and Research; the Bangladesh Ministry of Fisheries and Livestock (MoFL), and the Bangladesh Ministry of Agriculture (MoA). In addition, the applicant should maintain relationships with other stakeholders such as the WHO other multinational health organizations (World Organisation for Animal Health, Food and Agriculture Organization of the United Nations, and United Nations International Children's Emergency Fund). All proposed activities should align with the goals of the GHSA and/or Bangladesh’s strategic priorities and identified gaps, for example those outlined in the sector planning process or the Joint External Evaluation.

Applicants are encouraged, but not required, to collaborate with academic and other health related organizations on research projects in which partnership(s) would add value to the project.

Project proposals that require engagement and collaboration with partners should include the appropriate letters of support.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 5-year research project period. The grantee will establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and describe the development and implementation of project performance measures based on specific programmatic objectives.

Performance will be continuously monitored during the life of the award, through routine meetings held between the recipient and CDC. The recipient will work with CDC and other global partners as appropriate to develop and implement an evaluation plan and performance measures after award. Some examples of potential performance measures for a selection of categories are listed below:

EPIDEMIOLOGIC AND LABORATORY RESEARCH, AND IMPLEMENTATION

SCIENCE:

• Number of protocols launched on planned timeline

• Proportion of participants recruited on time

• Proportion of studies completed on time

ADMINISTRATIVE AND CENTRAL SUPPORT SERVICES:

Fiscal management Programs must use funding to support activities in alignment with the requirements of this NOFO. Programs must develop and maintain systems for sound fiscal management, including: monitoring the cooperative agreement award and program contracts and grants, ensuring the funds are expended in support of approved activities. Some potential performance measures include:

• Implementation of necessary administrative standard operating procedures

• Number of key personnel with lapse in Human Subjects Research Ethics training certification

• Number of IRB protocol deviations

• Number of planned routine meetings with key stakeholders scheduled and completed

• Timely submission of quarterly financial reports with clear cost allocation breakdown

• Timely submission of progress reports and dissemination to key stakeholders

• Number of staff completed annual human subjects research training

• Number of labs maintaining required level of lab accreditation

• Number of necessary laboratory standard operating procedures drafted, reviewed and approved

• Implementation and utilization of cost allocation plans

• Number of study sites and catchment areas with activities reflected on a central map and or database

• Number of research projects engaging trainees and early career investigators

• Number of studies included in a centrally maintained map and/or database of the study sites and their catchment areas for recently completed and current CDC-funded studies (and non-CDC funded studies that are in proximity)

• Number of projects with meaningfully engaged junior or early-career investigators.

• Number of studies whose findings had impact to local, regional and global public health practice and policy

• Number of IRB protocols with exclusion criteria to avoid recruitment of participants into multiple studies or describes an approach to manage the potential issue in other ways

Translation Plan 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) and specify how these activities are integrated into the project plans. Applicant should use appropriate scientific journals to disseminate research findings to the broader scientific community in conjunction with CDC scientists. Applicant should present important evaluation and research findings at relevant international scientific meetings and conferences.

Applicant should describe the processes and mechanisms or oversight to ensure that research findings with the potential for immediate public health practice and policy implications are shared with the appropriate Bangladeshi Government Offices and other relevant stakeholders expeditiously. 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 future public health policies or practices at the local and national level?

• What are some recommendations could come from my research questions?

• How does my study respond to priorities of the government or other stakeholders?

• How could my findings inform future scientific inquiry?

2. Who are the key stakeholders in the government who could implement the recommendations or use the information that comes out of my research study?

3. How can I design my project so that stakeholders will be interested in the results of my project and be more likely to pay attention to the findings?

3. Funding Strategy N/A

Section II. Award Information Funding Instrument Type:

CA (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:

$22,000,000 Estimated Total Annual Budget Period Funding:

• Year 1: $6,000,000

• Year 2: $4,000,000

• Year 3: $4,000,000

• Year 4: $4,000,000

• Year 5: $4,000,000

Indirect costs on grants awarded to foreign organizations and foreign public entities and performed fully outside of the territorial limits of the U.S. may be paid to support the costs of compliance with federal requirements at a fixed rate of eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000.

Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

Anticipated Number of Awards:

Estimated total funding available for first year (first 12 months), including direct and indirect costs: $6,000,000

Estimated total funding available for entire project period, including direct and indirect costs: $22,000,000

Applications submitted under this notice of funding opportunity must not include activities that overlap with simultaneously funded research under other awards (no scientific, budgetary or percent effort overlap allowed).

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

Award Ceiling:

$6,000,000 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 (https://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.

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

25 (Others (see text field entitled "Additional Information on Eligibility" for clarification))

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 UEI by viewing the organizational registration on SAM.gov. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

Foreign components of U.S. Organizations are not 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 icddr,b (formally International Centre for Diarrhoeal Disease Research, Bangladesh) is the sole eligible applicant.

4. Justification for Less than Maximum Competition icddr,b is an international not-for-profit research institution headquartered in Dhaka, Bangladesh and has a long history of working on the frontlines of global health and producing high quality and impactful science. In addition, the institution maintains the largest diarrheal hospital in the world and the longest running demographic surveillance system in Asia. This grantee received an approved single eligibility status for all prior research and non-research cooperative agreements—including in 2004, 2009, 2014, and 2019 and is uniquely qualified for the following:

1. CDC has a 45-year history of collaborations with icddr,b. This includes 4 past research cooperative agreements one non-research cooperative agreement. Findings from multiple studies have informed public health practice both in Bangladesh and around the world (for example, evidence for updating polio immunization guidelines, the feasibility and benefits of co-administration of oral polio and cholera vaccines in children <1 year of age, introduction of rotavirus vaccination in Bangladesh, furthermore influenza surveillance activities provide weekly uploads to the WHO and have provided nationally representative data to the WHO’s Global Influenza Surveillance and Response System (GISRS) which helps in selecting and updating influenza vaccine candidates. CDC has funded icddr,b to establish biosafety and biosecurity program and safe and secure specimen transport system for flu surveillance program in the country with the approval from the Director General of Health Services.

2. icddr,b has been a long-time partner of the Ministry of Health and Family Welfare, CDC's http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ primary Global Health Security Partner. icddr,b and the Institute of Epidemiology Disease Control and Research (IEDCR) - part of the Ministry of Health and Family Welfare – have well established guidelines for a effective collaboration for all icddr,b-implemented surveillance, outbreak response, and applicable research projects. icddr,b also has a long collaboration with the Expanded Program for Immunization (EPI) at the National and local level for implementation of vaccine clinical trials. icddr,b also has close connections with Dhaka Medical College Hospital which is critical for many ongoing studies, including in GHSA priority areas such as antimicrobial resistance.

3. icddr,b is the only non-diplomatic partner that CDC is aware of that has the legal authority and operational expertise to process the import of laboratory supplies and reagents, including time sensitive reagents. Similarly, icddr,b has existing agreements with major biomedical transportation organizations and maintains an updated material transfer agreement (MTA) with CDC for the shipping of swabs, blood, serum and DNA.

4. CDC Programs been working closely with the icddr,b Genomic Center to conduct whole genome sequencing for multiple projects using state of the art sequencing systems and highly trained and efficient bioinformatics team.

5. Until 2014, icddr,b was the only institution within the country to have a certified BSL-3 laboratory. Unfortunately, it was damaged in an earthquake and icddr,b is now following BSL- 2+ guidelines and all international standards for biosafety and biosecurity. icddr,b is in the process of rebuilding their BSL-3 laboratory and again will soon be the only institution with a BSL-3 laboratory. Furthermore, the clinical microbiology laboratory meets the international standards of quality and is ISO 15189-2012 accredited. They have a strong and active institutional biosafety committee and Senior biosafety officer. icddr,b is the most biosafety capable institution in the country and the work under this NOFO will be critical for the Health Security Agenda, including ongoing studies on pathogens such as Nipah virus which has pandemic potential, C. auris, influenza and the testing of human, avian and bovine surveillance samples with unknown etiology. Additionally, surveillance activities contemplated under this NOFO detect and isolate high-consequence pathogens whose handling and storage require advanced biocontainment skills and capacity. To CDC’s knowledge, icddr,b is the only institution in Bangladesh with the capability to handle such pathogens according to international biosecurity standards.

6. Without continuation of this mechanism which now includes 11 CDC Programs, the relationship and much of the investment over the last 20 years will be lost and important progress and gains in key Global Health priorities will be halted. In addition, the CDC office is on the icddr,b compound and CDC's operations would be directly impacted if this mechanism were to disappear. Over the last 20 years, CDC has initiated several long-term research projects with icddr,b that we hope will continue beyond FY 2024, including 3 syndromic hospital-based sentinel surveillance platforms, a cohort of children examining respiratory outcomes, and ongoing outbreak responses to disease clusters in partnership with the government. Past CDC investments have strengthened critical scientific credibility and expertise among icddr,b staff and ensured expanded laboratory capacity and established study clinics that are used sometimes exclusively by CDC Programs, for example several immunization clinics along with skilled personnel are critical for the implementation of polio vaccine studies that are crucial to inform vaccination strategies for polio eradication. Several CDC Programs leverage icddr,b’s long-term community cohorts which are essential for studies that assess changes over time and provide an in depth understanding of a given population with regard to for example, antibiotic resistance – a

Health Security Agenda initiative.

7. icddr,b has a long history of employing both third country nationals and Bangladeshis with strong scientific skills - a requirement for the effective implementation of the NOFO activities.

5. Responsiveness Applicant must provide letters of support from the appropriate Bangladeshi Government Ministries and external partners to document their ongoing collaboration for the implementation of the research program.

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 Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

PLEASE NOTE: Effective April 4, 2022, applicants must have a Unique Entity Identifier (UEI) at the time of application submission. The UEI replaced the Data Universal Numbering System (DUNS) and is generated as part of SAM.gov registration. Current SAM.gov registrants have already been assigned their UEI and can view it in SAM.gov and Grants.gov. Additional information is available on the GSA website, SAM.gov, and Grants.gov-Finding the UEI.

• (Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

• System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, SAM.gov.

• 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 Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal 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 an 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 https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov 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 Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

Additionally, 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.gov 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 SAM.gov and the SAM.gov Knowledge Base.

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 UEI 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 NOFO 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.

https://sam.gov/content/home…