Foa_Content_of_RFA-IP-24-017 final.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Collaborative research on influenza and other respiratory pathogens in South Africa

RFA-IP-24-017

03/07/2024

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 Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Collaborative research on influenza and other respiratory pathogens in South Africa Activity Code U01 – Research Project - Cooperative Agreement

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

RFA-IP-24-017

Assistance Listings Number(s) 93.083,93.326 Category of Funding Activity HL - Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct research studies on influenza and other respiratory pathogens of public health import in South Africa. The National Center for Immunization and Respiratory Diseases (NCIRD) is seeking to initiate a cooperative agreement with the National Institute for Communicable Diseases (NICD), Republic of South Africa, to conduct research on influenza and other respiratory diseases, as well as pathogens or surveillance associated with global health security, to inform respiratory disease surveillance and mitigation, prioritization of public health interventions, and scale-up of interventions in populations at higher risk of respiratory disease complications in South Africa, the region, and globally.

Key Dates Publication Date:

To receive notification of any changes to RFA-IP-24-017, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

02/07/2024 02/07/2024

Application Due Date:

03/07/2024 03/07/2024

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:

05/17/2024 Secondary Review:

06/12/2024 Estimated Start Date:

09/01/2024 Expiration Date:

03/08/2024 https://www.grants.gov/ http://grants.nih.gov/support/index.html mailto:commons@od.nih.gov

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.

Note:The Research Strategy component of the Research Plan is limited to 12 pages.

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 research studies on influenza and other respiratory pathogens of public health import in South Africa. The National Center for Immunization and Respiratory Diseases (NCIRD) is seeking to initiate a cooperative agreement with the National Institute for Communicable Diseases (NICD), Republic of South Africa, to conduct research on influenza and other respiratory diseases, as well as pathogens or surveillance associated with global health security, to inform respiratory disease and integrated surveillance and mitigation, prioritization of public health interventions, and scale-up of interventions in populations at higher risk of respiratory disease complications in South Africa, the region, and globally.

• Mechanism of Support: U01 - Research Project - Cooperative Agreement.

• Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire five (5) year project period is $15,000,000. The number of awards will be up to one (1).

• Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $2,500,000. The estimated total funding (direct and indirect) for the entire project period will be $15,000,000. The project period is anticipated to run from 09/01/2024 to 08/31/2029.

• 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 https://grants.nih.gov/grants/how-to-apply-application-guide.html 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 entity identifier [UEI] number) is allowed.

• Application Type. New

• Application Materials. See Section IV.1 for application materials. Please note that

SF424 (R&R) Form H is to be used when completing the application package. Please see https://grants.nih.gov/grants/how-to-apply-application-guide.html

Section I. Funding Opportunity Description Statutory Authority Sections 301 and 307 of the Public Health Service Act, [42 U.S.C. Sections 241 and 242l], as amended.

1. Background and Purpose This NOFO seeks to initiate a cooperative agreement with the NICD, Republic of South Africa, to conduct studies on the epidemiology and transmission of influenza and other respiratory diseases, as well as other pathogens associated with global health security, on tools for the prevention and treatment of associated morbidity and mortality, and strategies for increasing intervention coverage. Data will be used to inform prioritization of public health interventions for vulnerable populations in South Africa, the region, and globally.

During the last 17 years, CDC has collaborated with NICD to conduct influenza surveillance to better understand influenza seasonality, transmission dynamics, severe disease risk factors, and morbidity and mortality attributable to influenza virus infections. Analyses of data generated by these systems have provided estimates of burden and cost-effectiveness of interventions for policy decisions around targeted vaccine programs. During this time, NICD has developed unique capacity, currently serves a regional role in building laboratory and epidemiological capacity and serves as a reference laboratory throughout the region.

Despite these gains, intervention coverage remains low and disease burden is high among vulnerable populations (e.g., people living with HIV, pregnant women) in South Africa and the region. Knowledge gaps exist around the effectiveness of existing prevention and treatment tools. In addition, new tools, which hold promise, are currently being developed (e.g., mRNA vaccines), and needs to be trialed. Furthermore, following the COVID-19 pandemic there is a strong push for sustainable and integrated surveillance systems, and research, that can identify and respond with appropriate interventions to outbreaks of pathogens with pandemic potential for global health security. Research about appropriate interventions, and how to scale them, as well as effective and integrated surveillance systems that can be scaled throughout the region, are urgently needed.

The South African Government has strong clinical trials experience, and excellent laboratory, and surveillance systems, all of which have been leveraged to assess the burden and risk factors for other respiratory pathogens [e.g., SARS-CoV-2, respiratory syncytial virus (RSV)]. Given this, and the relatively high attack rates of these illnesses within the communities, there is opportunity to further address these knowledge gaps. Furthermore, should effective vaccines and strategies for increasing their coverage be identified, South Africa has the highest capacity for vaccine development, including mRNA vaccines, on the continent, suggesting a potential opportunity for increasing vaccinations on the African continent.

Also timely is the opportunity to leverage existing public health infrastructure for scaling up and improving preventive and routine interventions. The U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) has recently added a new pillar, “Health Systems Strengthening”. With large investments in care and treatment and health care facilities across the region, there are opportunities to evaluate whether these systems may be leveraged to increase services such as influenza vaccinations. South Africa is uniquely positioned to evaluate this as it is the site of CDC’s largest PEPFAR program.

CDC seeks to collaborate with NICD to conduct studies to further understand the epidemiology and burden of influenza and other respiratory pathogens (e.g., surveillance), as well as pathogens of significance for global health security, to evaluate the potential (efficacy and effectiveness) of new and existing tools for preventing (e.g., vaccines) and treating (e.g., pharmaceuticals) infection and disease, and to scale-up morbidity and mortality reducing tools across South Africa and the region. Addressing these gaps will inform future policy decisions locally, regionally, and globally by the South Africa Department of Health, World Health Organization’s (WHO’s) Strategic Advisory Group of Experts (SAGE) and will inform decision-making in the United States.

Health Equity:

CDC supports efforts to improve the health of populations disproportionately affected by infectious diseases by maximizing the health impact of public health services, reducing disease incidence, and advancing health equity.

A health disparity occurs when a health outcome is seen to a greater or lesser extent between populations. Health disparities in infectious diseases are inextricably linked to a complex blend of social determinants that influence which populations are most disproportionately affected by these infections and diseases.

Social determinants are conditions in the places where people live, learn, work, and play that affect a wide range of health and quality-of life-risks and outcomes (https://www.cdc.gov/socialdeterminants/index.htm). These include conditions for early childhood development; education, employment, and work; food security, health services, housing, income, and social exclusion. Health equity is a desirable goal that entails special efforts to improve the health of those who have experienced social or economic challenges. It requires:

• Continuous efforts focused on elimination of health disparities, including disparities in health and in the living and working conditions that influence health, and

• Continuous efforts to maintain a desired state of equity after health disparities are eliminated.

https://www.cdc.gov/socialdeterminants/index.htm

Applicants should use data, including social determinants data, to identify communities within their jurisdictions that are disproportionately affected by infectious diseases and related diseases and conditions, and plan activities to help eliminate health disparities. In collaboration with partners and appropriate sectors of the community, applicants should consider social determinants of health in the development, implementation, and evaluation of specific efforts and use culturally appropriate interventions and strategies that are tailored for the communities for which they are intended.

Healthy People 2030 and other National Strategic Priorities This NOFO addresses CDC’s Public Health Priorities including: 1) improving health security at home and around the world by detecting the presence of novel viruses; 2) preventing leading causes of illness, injury, disability, and death by evaluation influenza vaccination practices in the Region; and 3) strengthening public health and healthcare collaboration by partnering with international organizations that specialize in these research areas.

Public Health Impact Influenza and other respiratory diseases are a leading cause of morbidity and mortality globally.

Identifying and researching knowledge gaps in surveillance, transmission, and vulnerable populations, as well as evaluating and identifying interventions to prevent (e.g., vaccines) and treat (e.g., antiviral drugs) influenza and other respiratory diseases has the potential to reduce morbidity and mortality globally. Evaluating ways to scale-up proven interventions will allow for further reduction in morbidity and mortality.

Relevant Work

• RFA-IP21-003: Collaborative Research on Influenza, Coronavirus Disease 2019

(COVID-19), and Other Respiratory Pathogens in South Africa (https://www.grants.gov/web/grants/view-opportunity.html?oppId=330625, Keyword:

RFA-IP-21-003; Opportunity Status: Archived)

• RFA-IP21-2101: Surveillance and Response to Avian and Pandemic Influenza by National Health Authorities outside the United States (https://www.grants.gov/web/grants/view-opportunity.html?oppId=331960, Keyword:

RFA-IP21-2101; Opportunity Status: Archived)

• RFA-IP16-003: Research on the Epidemiology, Prevention, Vaccine Effectiveness and Treatment of Influenza and Other Respiratory Viruses in South Africa (https://www.grants.gov/web/grants/view-opportunity.html?oppId=279994, Keyword:

RFA-IP16-003; Opportunity Status: Archived)

• Cohen C et al. Asymptomatic transmission and high community burden of seasonal influenza in an urban and a rural community in South Africa, 2017-18 (PHIRST): a population cohort study. Lancet Glob Health. 2021 Jun. PMID: 34019838

• Cohen C et al. Household Transmission of Seasonal Influenza From HIV-Infected and HIV-Uninfected Individuals in South Africa, 2013-2014. J Infect Dis 2019. PMID:

30541140

• Cohen C et al. Cohort profile: A Prospective Household cohort study of Influenza, Respiratory syncytial virus and other respiratory pathogens community burden and Transmission dynamics in South Africa, 2016-2018. Influenza Other Respir Viruses.

2021 Nov; PMID: 34296810

• Cohen C et al. SARS-CoV-2 incidence, transmission, and reinfection in a rural and an urban setting: results of the PHIRST-C cohort study, South Africa, 2020-21. Lancet Infect Dis. 2022. PMID: 35298900

• Sun K et al. SARS-CoV-2 transmission, persistence of immunity, and estimates of Omicron's impact in South African population cohorts. Sci Transl Med. 2022 Aug 24.

PMID: 35638937.

• Edoka et al. A cost-effectiveness analysis of South Africa's seasonal influenza vaccination programme. Vaccine 2021. PMID: 33272702

• Tempia et al. Influenza economic burden among potential target risk groups for immunization in South Africa, 2013-2015. Vaccine 2020; PMID: 32980198

• Biggerstaff et al. A cost-effectiveness analysis of antenatal influenza vaccination among HIV-infected and HIV-uninfected pregnant women in South Africa. Vaccine 2019.

PMID: 31575494

• Walaza et al. Influenza and tuberculosis co-infection: A systematic review. Influenza Other Respir Viruses. 2020. PMID: 31568678

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound). Each project submitted in the application MUST address at least one objective. Each project and its accompanying work plan, budget and budget justification must be clearly identified in the application using clear headings/identifiers (please see Section IV.2 of this NOFO for more detailed information regarding application format and requirements).

The application should emphasize unique platforms (capacity to conduct cohort studies, randomized controlled trials, and translational research) whenever possible that could be utilized to improve the understanding of the community burden, transmission dynamics, the potential impact of vaccines and antivirals for preventing and treating infections, and how lessons learned here can be expanded through the region.

To accomplish the goals of this NOFO, the application should address one or more of the public health issues and priorities identified under the Objectives/Outcomes section outlined below. The applicant organization is encouraged to seek partners in-country to achieve the stated goals. The application should demonstrate using research findings and emphasize use of unique platforms that could be utilized to improve prevention and control of novel and seasonal influenza virus infections or other respiratory viruses and diseases in humans and animals in South Africa, the region and the world of global health security consequence.

The application should address selected stated objectives below and include, at a minimum, the following information for each project within the submission narrative in addition to the objective-specific information (See Objectives/Outcome section):

• Objective being addressed and the significance of the research.

o How does the research address a barrier to progress, and how will the results of the study improve scientific knowledge and/or public health practice?

o How are the research questions, design, and/or methodology innovative?

• Outline of appropriate study design, methods, data sources, and limitations of the approach for the research studies.

• Description of the population being recruited and outline of how they will be recruited.

• Outline of plans for data analysis, data use, and potential public health impact of findings in South Africa, the African continent and globally.

• Assurance of coordinated management and administrative support.

In Year 2-5 of this cooperative agreement, contingent upon the availability of funds, U.S. CDC will work with the recipient to review and refine current research objectives and to identify opportunities to expand to additional priority public health research areas within South Africa.

Objectives/Outcomes Objective 1—Surveillance Research: To develop, design, implement, and evaluate new and existing influenza and respiratory disease, as well as pathogens of global health security relevance, surveillance strategies and/or methodologies (including novel laboratory procedures) to inform best practices for understanding seasonal and novel respiratory disease epidemiology, estimation of burden, and response activities in South Africa and the region.

Outcome: Completed evaluations of existing and proposed influenza, other respiratory disease, or pathogens of global health security consequence surveillance, interventions/strategies and/or methodologies that characterize the best practices for understanding disease epidemiology and estimation of burden. These evaluations may address how the systems can be used to optimize response activities and provide updated estimates on disease burden and should focus on activities that may be realistically implemented in other countries in the region.

Examples of projects may include, but are not limited to:

• Evaluations of participatory surveillance to increase our understanding of infection in the community and how these platforms may add to our current understanding of transmission from sentinel and national surveillance systems.

• Whether a wide system of low-cost networks evaluating syndromic surveillance signals with thresholds for “turning-on” or “turning-off” laboratory testing can be cost-effective for identifying episodes requiring response.

• Evaluating the timing and diversity of genomic sequences collected from different geographic sites to determine whether broader geographic surveillance truly adds to vaccine strain selection or whether fewer sites could gather similar results (right-sizing/cost-effectiveness of system) – this would be particularly of interest if samples from multiple countries and sites could be incorporated.

• Evaluating the feasibility of a network of veterinarians or livestock farmers that could serve as a sentinel system for avian influenza viruses and other zoonotic respiratory pathogens.

• Assessing transmission dynamics within a population(s) to better understand factors associated with transmission from an index, or other, case. This may include implementing and assessing the impact of an intervention (e.g., vaccine) on transmission.

• Evaluating various molecular, serological, or other laboratory tests for use in surveillance.

For Objective 1 projects, the application should align with the stated objective and include, at a minimum, the requirements for all projects in addition to the following objective-specific information on submission:

• Description of what the study adds to the existing literature/knowledge base and how the approach may improve our understanding of and add to our efforts to decrease morbidity and mortality.

• Explanation of how the approach may be cost-effective, sustainable, and scalable within South Africa and across the region.

Objective 2—Trials of Existing and Novel Intervention Tools and Strategies for Transmission and/or Burden Reduction: To evaluate the potential of existing and novel tools for reducing transmission and burden of influenza and other respiratory diseases or pathogens of global health security consequence. These studies may also include evaluation of novel or existing laboratory tools to better characterize correlates of protection and estimations of intervention efficacy, and effectiveness and cost-effectiveness studies. They may also include studies or trials to better understand best approaches for interventions, such as immunological responses to interventions.

Outcome: Completed studies/trials of existing and novel tools for mitigating influenza, other respiratory diseases, and/or pathogens of global health security consequence that provide an evidence base describing the potential (or lack thereof) of the intervention for reducing transmission and morbidity. These may include assessments of tools for correlates of protection.

Examples of studies/trials may include, but are not limited to:

• Trials of vaccine and/or monoclonal antibody efficacy against influenza or other respiratory viruses among infants, children, and/or populations at increased risk of severe outcomes from respiratory pathogen infection. This may include trials of existing and/or novel (mRNA) vaccines.

• Trials evaluating the efficacy of antivirals against respiratory pathogens aimed at determining burden reduction and cost-effectiveness. This may include test and treat strategies.

• Trials evaluating non-pharmaceutical interventions against respiratory pathogens aimed burden reduction.

• Vaccine and/or monoclonal antibody effectiveness studies aimed at determining the effectiveness and cost-effectiveness of one or more respiratory disease vaccines in reducing burden.

• Trials to understand immunological responses to interventions to determine the best way to prime the immune system.

• Trials to assess/establish the safety of interventions in different doses or age groups, such as dose-escalation, age-de-escalation studies.

For Objective 2 projects, the application should address the stated objective and include, at a minimum, the requirements for all projects in addition to the following objective-specific information on submission:

• Description of the intervention or strategy to be tested and the existing evidence-base suggesting its potential for reducing morbidity and mortality.

• Explanation of the knowledge gap that the study/trial would be addressing and the subsequent knowledge gaps that would need to be filled. The applicant can consider including a ‘roadmap’ outlining subsequent studies/steps needed to move to policy.

Objective 3—Scaling up Intervention Coverage: To design, implement, and evaluate sustainable strategies for scaling-up coverage of novel or existing interventions shown to be effective in reducing the morbidity and mortality associated with influenza and other respiratory diseases or pathogens of global health consequence.

Outcome: Completed studies/evaluations describing the potential of a platform or strategy for increasing intervention demand and utilization, including analyses of cost-effectiveness and describing the potential for scalability and sustainability.

Examples of studies/evaluations may include, but are not limited to:

• Evaluating the feasibility of integrating influenza and other respiratory disease vaccination into existing routine care or other programmatic activities, for example HIV care and treatment platforms and/or Expanded Program on Immunizations (EPI).

• Novel or existing strategies for driving vaccine demand among vulnerable populations and making vaccination more accessible.

For Objective 3 projects, the application should address the stated objective and include, at a minimum, requirements for all projects in addition to the following objective-specific information on submission:

• Explanation of how the strategy may lead to increased coverage and which vulnerable populations it may address.

• Explanation of how the strategy is cost-effective, sustainable, and scalable within South Africa and across the region.

Target Population The target population includes all permanent or temporary residents of South African and the region regardless of citizenship, race, color, national origin, age, disability, religion, or sex (including pregnancy, sexual orientation, and gender identity).

Collaboration/Partnerships Applicants are expected to establish and/or maintain partnerships with regional/sub-regional ministries of health and agriculture, provincial and municipal health departments, academic institutions, non-governmental organizations, or others to facilitate access and cooperation in meeting research study objectives. Applicants should list organizations and Principal Investigators (PIs) that will be involved in the proposed research proposal. Letters of support from partners and collaborators are encouraged.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a five (5) year research project period. The application should describe 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.

There should be a clear narrative on how the specific projects addressing their objectives leads to the ultimate goal of improving and scaling cost-effective surveillance platforms and identifying and scaling burden mitigating interventions.

The application should include a plan to track proposed cooperative agreement study activities and project milestones. CDC will monitor progress toward study outcomes of the project though meetings, discussions, conferences or other agreed upon means.

Recipient must submit an annual progress report showing project activities and outcomes based on the overall research goals and timeline. For more information on required Reporting, please see Section VI. of this NOFO.

Translation Plan The purpose of this research NOFO is to identify key strategies and interventions for improving influenza and respiratory disease surveillance, interventions for morbidity and mortality mitigation, and strategies for sustainably scaling them. As such, the purpose is to inform global recommendations. Thus, the applicant should plan for adequate resources to disseminate findings within the community, the Ministry of Health and among key stakeholders within the country, region and globally, including WHO. This may be through technical working group meetings and advocacy, as well as through presentations at meetings, conferences and publications – though not solely through publications.

The application should identify which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, the application should describe how the results of the proposed project could be generalized to populations and communities outside of the study.

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:

$15,000,000 Estimated total funding available for the first year (first 12 months), including direct and indirect costs: $2,500,000

Estimated total funding available for the entire project period, including direct and indirect costs: $15,000,000

Estimated Total Annual Budget Period Funding:

Year 1: 2,500,000

Year 2: 4,000,000

Year 3: 4,000,000

Year 4: 2,500,000

Year 5: 2,000,000

Anticipated Number of Awards:

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

Award Ceiling:

$2,500,000 Per Budget Period

Award Floor:

$1,000,000 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 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))

Additional Eligibility Category:

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

Other:

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.

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 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 National Institute for Communicable Diseases, Republic of South Africa

4. Justification for Less than Maximum Competition Eligibility is limited to South Africa’s National Institute for Communicable Disease (NICD).

• NICD is the only sufficiently advanced governmental research, public health institute, and laboratory in the sub-region that can perform sophisticated studies and laboratory analyses required to understand influenza disease burden, evaluate intervention efficacy and effectiveness, and intervention scale-up that is located in the Southern Hemisphere.

• NICD, under the National Public Health Institute of South Africa (NAPHISA), is mandated to provide microbiology, virology, epidemiology, surveillance and public health research and training to support the government’s response to communicable disease threats. NAPHISA through an act of parliament has been mandated to serve as the national focus for developing and applying disease prevention and control, provide leadership to provinces and local authorities, environmental health, and health promotion as well as educational activities which are designed to improve the health of South Africans. This mandate ensures more coordinated and efficient public health resources, better program management, fewer duplicative functions, and cost savings for South Africa’s government.

• NICD was identified as the regional reference laboratory by the WHO Regional Office for Africa (AFRO) and the Africa CDC for the COVID-19 outbreak.

• NICD serves as a National Influenza Center for South Africa and provides technical assistance on respiratory pathogen surveillance and diagnosis to other countries in the 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/ sub-region. NICD staff have provided technical assistance to Democratic Republic of Congo, Malawi, Mozambique, Zambia, Zimbabwe, and other regional partners.

• NICD has cooperated with CDC NCIRD’s Influenza Division, Division of Bacterial Diseases and Division of Viral Diseases to conduct respiratory disease surveillance, post-introduction assessments of vaccine impact, influenza household transmission studies, influenza, rotavirus and pneumococcal disease burden estimates, vaccine effectiveness studies and disease modeling studies.

• NICD possesses the scientific and management capability to meet program requirements without jeopardizing or compromising the quality of the research and other activities.

• NICD has managed CDC non-research cooperative agreement funds well for the past 17 years. This partnership has built a hospital-based severe acute respiratory illness (SARI) platform that has been used to provide national disease burden estimates, examine HIV and TB as risk factors for severe influenza disease, and improve understanding of household transmission of influenza and other respiratory pathogens in South Africa.

5. Responsiveness Not Applicable

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 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 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 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).

https://sam.gov/content/home https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.fsd.gov%2Fgsafsd_sp%3Fid%3Dgsa_kb_view2%26kb_id%3Df66d8e6cdb76d4100d73f81d0f9619c6&data=04%7C01%7Ccshifflett%40dminc.com%7C8eee7a2adab549a3b3c008d925e9a364%7Cdb7ac9ef779d46e59bca00509580ad6b%7C0%7C0%7C637582507851821018%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=UrR%2B%2FM2wWF2fZG05Z8O6JS2C3FXXSl%2F7B3%2FB45XHRrg%3D&reserved=0

10. Number of Applications As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique entity identifier [UEI]) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package 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, unlike other platforms, it provides a validation of all requirements prior to submission and prevents errors.

To use ASSIST, applicants must visit https://public.era.nih.gov 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: http://grants.nih.gov/support/index.html

• Email: 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.

2. Content and Form of Application Submission Applicants must use FORMS-G application packages for due dates on or before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

Application guides for FORMS-G and FORMS-H application packages are posted to the How to Apply - Application Guide page.

It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide How to Apply - Application Guide 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 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov http://grants.nih.gov/support/index.html https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

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.

Please include all of the eight (8) mandatory forms listed below in the application package:

Mandatory

1. SF424(R&R)

2. PHS 398 Cover Page Supplement

3. Research and Related Other Project Information

4. Project/Performance Site Location(s)

5. Research and Related Senior/Key Person Profile (Expanded)

6. Research and Related Budget

7. PHS 398 Research Plan

8. PHS Human Subjects and Clinical Trials Information

In both the Research Strategy and Project Summary/ Abstract (Description) sections, the application should clearly list each proposed project by name and identify which objective it addresses (i.e., identify the proposed project as Objective 1, 2, or 3).

If multiple collaborating institutions will be involved, please include in this section of the application your single IRB (sIRB) Plan:

• Describe how you will comply with the single IRB review requirement under the Revised Common Rule at 45 CFR 46.114 (b) (cooperative research). If available, provide the name of the IRB that you anticipate will serve as the sIRB of record.

• Indicate that all identified engaged institutions or participating sites will agree to rely on the proposed sIRB and that any institutions or sites added after award will rely on the sIRB.

• Briefly describe how communication between institutions and the sIRB will be handled.

• Indicate that all engaged institutions or participating sites will, prior to initiating the study, sign an authorization/reliance agreement that will clarify the roles and responsibilities of the sIRB and participating sites.

• Indicate which institution or entity will maintain records of the authorization/reliance agreements and of the communication plan.

• Note: Do not include the authorization/reliance agreement(s) or the communication plan(s) documents in your application.

• Note: If you anticipate research involving human subjects but cannot describe the study at the time of application, include information regarding how the study will comply with the single Institutional Review Board (sIRB) requirement prior to initiating any multi-site study in the delayed onset study justification.

Letters of Support from partners or other organizations should be placed in the PHS 398 Research Plan "Other Research Plan Section" of the application under "9. Letters of Support".

Please note: If requesting indirect costs in the budget based on a federally negotiated rate, a copy of the indirect cost rate agreement is required. Include a copy of the current negotiated federal indirect cost rate agreement or cost allocation plan approval letter.

Please note: Follow the instructions in this NOFO for including a Data Management Plan in the Resource Sharing Plan section of the PHS 398 Research Plan Component of your application.

Please include the one (1) optional form listed below, if applicable, in the application package:

Optional

1. R&R Subaward Budget Attachment(s) Form 5 YR 30 ATT.

Please note: Ensure that the application describes how each project fits together and builds on the overall purpose of the research NOFO, which is to research sustainable, cost-effective and scalable surveillance platforms and to research interventions for morbidity and mortality reduction and research how to scale them.

Please note: Ensure to provide a separate budget for each partner/contractor in addition to the total budget.

Please use the form and instructions for SF424 (R&R) FORMS-H for applications due on or after January 25, 2023.

3. Letter of Intent Due Date for Letter Of Intent 02/07/2024

02/07/2024 Although a letter of intent is not binding, the information that it contains allows CDC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. “Overview Information”, prospective applicants are asked to submit a letter of intent…