PKG00264732-instructions.pdf

Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases Extramural Research Program

Office

Collaborative Research on Influenza, Coronavirus Disease 2019 (COVID-19), and Other

Respiratory Pathogens in South Africa

RFA-IP-21-003

Application Due Date: 03/09/2021

Collaborative Research on Influenza, Coronavirus Disease 2019 (COVID-19), and Other

Respiratory Pathogens in South Africa

RFA-IP-21-003

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health National Center for Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Collaborative Research on Influenza, Coronavirus Disease 2019 (COVID-19), 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-21-003

Assistance Listings (CFDA) Number(s) 93.083 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct surveillance and research studies on influenza, coronavirus disease 2019 (COVID-19), and other respiratory pathogens in South Africa. The National Center for Immunization and Respiratory Diseases (NCIRD) and the Center for Global Health (CGH) are seeking to initiate a cooperative agreement with the National Institute for Communicable Diseases (NICD), Republic of South Africa, to conduct surveillance studies on the epidemiology, disease burden, transmission, and risk factors for hospitalization and death from respiratory viruses, especially influenza and COVID-19. Data will be used to inform prioritization of public health interventions in high risk populations in South Africa.

Key Dates Publication Date: To receive notification of any changes to RFA-IP-21-003, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/30/2021

Application Due Date: 03/09/2021 https://www.grants.gov

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

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

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

Scientific Merit Review: 05/27/2021

Secondary Review: 06/22/2021

Estimated Start Date: 09/01/2021

Expiration Date: 02/24/2021 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

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

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

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

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

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

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348 In both the Research Strategy and Project Summary/ Abstract (Description) sections, the application should clearly list each proposed component project by name (i.e., identify the proposed project as Component A, B, C or D).

Each application must address all objectives under Mandatory Components A, B and C; if applying for Optional Component D, all Component D objectives must also be addressed.

Within the total 25-page limit for the Research Strategy of the Research Plan section of the application, the page limit for EACH Component project is limited as follows:

Component A: 7 pages Component B: 7 pages Component C: 7 pages Component D: 4 pages

Executive Summary

Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to conduct surveillance and research studies on influenza, coronavirus disease 2019 (COVID-19), and other respiratory pathogens in South Africa. The National Center for Immunization and Respiratory Diseases (NCIRD) and the Center for Global Health (CGH) are seeking to initiate a cooperative agreement with the National Institute for Communicable Diseases (NICD), Republic of South Africa, to conduct surveillance studies on the epidemiology, disease burden, transmission, risk factors for hospitalization and death from respiratory viruses, especially influenza and COVID-19. Data will be used to inform prioritization of public health interventions in high risk populations in South Africa.

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 three (3)-year project period is $3,750,000. The number of awards is estimated to be one (1) for each Component (A through D). 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 component to component, it is also anticipated that the size and duration of each component award may also vary. The total amount awarded will depend upon the number, quality, duration and cost of the components received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $1,250,000 with an individual award estimated to range from $1,000,000 to $1,250,000 for all components combined. The estimated total funding (direct and indirect) for the entire project period is $3,750,000. The project period is anticipated to run from 09/01/2021 to 08/31/2024.

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. The application may include more than one PI; however, the first PI listed on the application will be the contact PI for all correspondence with CDC. Any additional PIs are permitted but should be referred to and listed as Co-PIs.

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

Application Type. New.

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

Form F is to be used when completing the application package.

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority

Public Health Service Act, Section 307 [42 U.S.C. 242l], as amended.

Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020, Public

Law 116-123.

Coronavirus Aid, Relief, and Economic Security (CARES) Act, Public Law 116-136.

Paycheck Protection Program and Health Care Enhancement Act, Public Law 116-139.

1. Background and Purpose The NCIRD Influenza Division (ID) and the Center for Global Health (CGH) are seeking to initiate a cooperative agreement with the National Institute for Communicable Diseases (NICD), Republic of South Africa, to conduct studies on the epidemiology, disease burden, transmission, and risk factors for hospitalization and death from respiratory pathogens, especially for influenza and COVID-19. Data will be used to inform prioritization of public health interventions in high risk populations in South Africa.

Over the last 14 years, CDC’s Influenza Division collaborated with the NICD to conduct influenza surveillance to better understand influenza seasonality, determine risk factors for severe disease, and to estimate morbidity and mortality attributable to influenza virus infections.

In this capacity, NICD also served a regional role to build regional capacity for influenza surveillance and diagnostics. However, in addition to surveillance, it is evident that more work on translational research needs to be done to fill critical gaps in the knowledge and understanding of influenza epidemiology and to inform vaccine policy decisions. Addressing these gaps will inform future global policy decisions by the World Health Organization’s (WHO’s) Strategic Advisory Group of Experts (SAGE) and the South African Department of Health on influenza immunization and inform decision-making in the United States. The ongoing COVID-19 pandemic allows a unique opportunity to study the effect of large-scale non-pharmaceutical interventions (NPIs) on the transmission of influenza. Research conducted as part of this cooperative agreement will seek to fill these gaps in the understanding of influenza epidemiology in South Africa and other middle-income countries.

Fortunately, because of the quality data produced by existing influenza surveillance platforms, the South African Government has promoted their use in assessing the burden and risk factors for severe COVID-19-associated illness in South Africa. Assessments of household and community transmission of COVID-19 have only just begun. Given the serious global health threat posed by the COVID-19 pandemic, and the potential impact of other respiratory pathogens, CDC’s Influenza Division seeks to collaborate with NICD to conduct studies to understand the epidemiology, disease burden, transmission, and risk factors for hospitalization and death of COVID-19 and other emerging respiratory pathogens.

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 Identification of risk groups for severe influenza, COVID-19, and other respiratory diseases is key to appropriately targeting interventions including vaccines and antiviral drugs in resource-limited settings.

Relevant Work

RFA-IP-16-003: Research on the Epidemiology, Prevention, Vaccine Effectiveness and Treatment of Influenza and Other Respiratory Viruses in South Africa (http://www.grant s.gov/web/grants/search-grants.html, Keyword: RFA-IP-16-003; Opportunity Status:

Archived)

Biggerstaff M, Cohen C, Reed C, Tempia S, McMorrow ML, Walaza S, Treurnicht FK, Cohen AL, Hutchinson P, Stoecker C, and J Steinberg. A cost-effectiveness analysis of antenatal influenza vaccination among HIV-infected and HIV-uninfected pregnant women in South Africa. Vaccine. 2019; 37(46): 6874-6884. PMID: 31575494.

Cohen C, Tshangela A, Iyengar P, von Mollendorf C, Valley-Omar Z, Walaza S, Hellferscee O, Venter M, Martinson N, Mahlase G, McMorrow M, Cowling B, Cohen AL, and S Tempia. Household transmission of seasonal influenza in HIV-infected and -uninfected individuals in South Africa, 2013-2014. J Infect Dis. 2019; 219(10): 1605-15.

PMID: 30541140.

http://www.grants.gov/web/grants/search-grants.html http://www.grants.gov/web/grants/search-grants.html

Cohen C, Walaza S, Treurnicht F, McMorrow M, Madhi SA, McAnerney JM and S.

Tempia. In- and out-of-hospital mortality associated with seasonal and pandemic influenza and respiratory syncytial virus in South Africa, 2009-2013. Clin Infect Dis

2018; 66(1): 95-103. PMID: 29040527.

Tempia S, Walaza S, Moyes J, Cohen AL, McMorrow ML, Treurnicht FK, Hellferscee O, Wolter N, von Gottberg A, Nguweneza A, McAnerney JM, Dawood H, Variava E, Madhi SA and C Cohen. Quantifying how different clinical presentations, levels of severity and healthcare attendance shape the burden of influenza-associated illness: a modeling study from South Africa. Clin Infect Dis. 2019; 69(6): 1036-1048. PMID:

30508065.

Walaza S, Tempia S, Dawood H, Variava E, Wolter N, Dreyer A, Moyes J, von Mollendorf C, McMorrow M, von Gottberg A, Haffejee S, Venter M, Treurnicht FK, Hellferscee O, Martinson NA, Ismail N, and C Cohen. The impact of influenza and tuberculosis interaction on mortality among individuals aged ≥15 years hospitalized with severe respiratory illness in South Africa, 2010-2016. Open Forum Infect Dis. 2019;

6(3): ofz020. PMID: 30906797.

Walaza S, Cohen C, Tempia S, Moyes J, Nguweneza A, Madhi S, McMorrow M and AL Cohen. Influenza and tuberculosis co-infection: a systematic review. Influenza Other Respir Viruses. 2020; 14(1): 77-91. PMID: 31568678.

2. Approach Whenever possible, applications should include objectives written in the SMART format (e.g., Specific, Measurable, Achievable, Realistic and Time-bound).

The application MUST address all objectives under Mandatory Components A, B and C. If applying for Optional Component D, all objectives under Component D must also be addressed. Each component and its accompanying 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 and the impact of social behavior and disease co-morbidity on viral disease illness and outcome.

Objectives/Outcomes Mandatory Component A for up to $300,000 per year (direct and indirect costs).

Objectives: Determine seroprevalence of antibodies to influenza viruses from "A Prospective Household Cohort Study of Influenza, Respiratory Syncytial Virus and other Respiratory Pathogens Community Burden and Transmission Dynamics in South Africa – COVID version (PHIRST-C)" participants and within key communities in South Africa.

The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Provide narrative outlining study design, data sources, and limitations of approach.

2. Provide narrative outlining process for recruitment and enrollment eligible study households and participants.

3. Describe plans to determine the seroprevalence of antibodies to influenza viruses in PHIRST-C participants before and after the first influenza season following the COVID- 19 pandemic, by age group and HIV-infection status.

4. Describe plans to determine the seroprevalence of antibodies to influenza viruses in 1-3 selected communities of South Africa before and after the first influenza season following the COVID-19 pandemic, by age group and HIV-infection status.

5. Provide plans to document study results and findings in at least one manuscript.

Mandatory Component B for up to $400,000 per year (direct and indirect costs).

Objectives: Evaluate healthcare seeking behavior for respiratory illness during and after the COVID-19 pandemic, and seroprevalence of antibodies to influenza viruses. Assess the impact of age, HIV status, and other key variables on healthcare seeking behavior and influenza antibody seroprevalence. Assess differences in healthcare seeking by income, geographic location (urban/rural), and/or distance to nearest provider/health facility.

The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Provide narrative outlining process for recruitment and enrollment eligible study households and participants.

2. Describe plans to characterize and compare healthcare seeking behavior for respiratory illness during and after the COVID-19 pandemic.

3. Describe plans to assess the impact of age, HIV status, and other key variables on healthcare seeking behavior and the seroprevalence of antibodies to influenza viruses.

4. Describe plans to assess differences in healthcare seeking behavior by income, geographic location (urban/rural), and/or distance to nearest provider/health facility.

5. Provide plans to document study results and findings in at least one manuscript.

Mandatory Component C for up to $400,000 per year (direct and indirect costs).

Objectives: Assess recent or current TB infection as a risk factor to severe COVID-19 disease.

The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Describe plans to assess recent or current TB infection as a risk factor to severe COVID- 19 disease.

2. Provide narrative outlining study design, data sources, and limitations of approach.

3. Provide plans to document study results and findings in at least one manuscript.

Optional Component D for up to $150,000 per year (direct and indirect costs).

Objectives: Determine concordance between self-reported acute respiratory illness (ARI) symptom data collected through the CoughWatchSA surveillance platform and laboratory-confirmed respiratory virus infection.

The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Provide narrative outlining process for evaluating concordance of self-reported ARI symptom data with laboratory-confirmed ARI infection.

2. Describe plans to collect and perform RT-PCR analysis on respiratory samples from a minimum of 1,000 participants enrolled in the CoughWatchSA mobile surveillance platform.

3. Describe plans to document study results and findings in at least one manuscript.

Target Population All temporary or permanent residents of South Africa and the region, regardless of citizenship, race, or gender.

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, or others to facilitate access and cooperation in meeting research study objectives.

Evaluation/Performance Measurement 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.

The projects will be evaluated on the ability to conduct policy-relevant research to identify groups at risk for influenza, COVID-19, and other respiratory disease morbidity/mortality; and describe influenza, COVID-19, and other respiratory disease transmission dynamics in households and/or communities. Projects will also be evaluated on the timely dissemination of results to in-country partners and the larger research community through peer-reviewed publications. Primary publications should be submitted for clearance within 12 months of completion of field work (data and specimen collection).

Translation Plan Applications must include a plan to estimate and report the potential translatability and public health impact of the research. Findings should be communicated and disseminated to local stakeholders, including the local Department of Health and the National Advisory Group on Immunization, to inform vaccine policy review.

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

Application Types Allowed:

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

Estimated Total Funding: $3,750,000 Estimated Total Funds Available for Components A, B, C and D (Years 1 through 3), including direct and indirect costs: $3,750,000 Estimated Total Funds Available for the first 12-month budget period for Components A, B, C and D, including direct and indirect costs: $1,250,000

Estimated Total Funds Available for Component A (Years 1-3): $900,000 Estimated Total Funds Available for Component B (Years 1-3): $1,200,000 Estimated Total Funds Available for Component C (Years 1-3): $1,200,000 Estimated Total Funds Available for Component D (Years 1-3): $450,000

Ceiling for Component A for first 12-month budget period: $300,000 Floor for Component A for first 12-month budget period: $250,000 Ceiling for Component B for first 12-month budget period: $400,000 Floor for Component B for first 12-month budget period: $350,000 Ceiling for Component C for first 12-month budget period: $400,000 Floor for Component C for first 12-month budget period: $300,000 Ceiling for Component D for first 12-month budget period: $150,000 Floor for Component D for first 12-month budget period: $100,000

Estimated Number of Awards for each component: one (1).

Award ceiling: $1,250,000 per award for first 12-month budget period for all components combined.

Award floor: $1,000,000 per award for first 12-month budget period for all components combined.

Anticipated Number of Awards: 1

Only one overall application will be awarded with up to four components.

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

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

Award Ceiling: $1,250,000 Per Budget Period Award Floor: $1,000,000 Per Budget Period Total Period of Performance Length: 3 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

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

Foreign components of U.S. Organizations are 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 http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

National Institute for Communicable Diseases, Republic of South Africa

4. Justification for Less than Maximum Competition This Notice of Funding Opportunity (NOFO) is limited to the National Institute for Communicable Diseases (NICD), Johannesburg, South Africa, because it is the only sufficiently advanced research and public health institute and laboratory in the subregion of Southern Africa that can perform the types of sophisticated studies and laboratory analyses required to understand influenza disease burden, vaccine effectiveness, and treatment outcomes that is located in an area of high HIV prevalence in the Southern Hemisphere and is the institute mandated by the South African government to conduct infectious disease surveillance and public health research for the country.

As stated above, NICD is the national public health institute for South Africa with a mandate for conducting infectious disease surveillance and public health research. It provides reference microbiology, virology, epidemiology, surveillance and public health research to support the government's response to communicable disease threats. The NICD serves as a resource of knowledge and expertise of communicable diseases to the South African Government, Southern African Development Community countries and the African continent (please see https://www.nicd.ac.za/about-us/).

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

NICD serves as the National Influenza Center for South Africa and provides technical assistance on respiratory pathogen surveillance and diagnosis to other countries in Africa, including the Democratic Republic of Congo, Malawi, Mozambique, Zambia, Zimbabwe, and other regional partners.

NICD has cooperated with 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 in the past. 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 respiratory pathogens in South Africa that can be used as a baseline for continued studies.

Currently, NICD is a Division of the National Health Laboratory Service (NHLS). The NHLS hosted successful collaborations with the CDC Center for Global Health's Division of Global Health Protection and Division of Global HIV/AIDS and Tuberculosis and has a successful track record to support CDC's re-investment in this agency.

NICD has successfully managed one prior Influenza Division research cooperative agreement in the past 5 years. This partnership improved understanding of influenza transmission dynamics in South African communities and households including documenting that approximately 35% of South Africans are infected with influenza viruses annually, attesting to the value of CDC's collaboration with NICD to better understand influenza in this region.

NICD is the only institution in sub-Saharan Africa that estimates Southern Hemisphere https://www.nicd.ac.za/about-us/ influenza vaccine effectiveness annually. NICD also submits more virus strains to WHO Collaborating Centers than any other country on the continent. This contribution is essential to inform Southern Hemisphere vaccine strain selection to produce effective vaccines.

Failure to approve this memo will undermine the South African government's mandate to use NICD as the country's infectious disease surveillance laboratory and damage CDC's ability to support surveillance and research in the most populous country in Southern Africa. Disapproval will limit understanding influenza virus evolution during the Southern Hemisphere's influenza season which will reduce the efficacy of subsequent Northern Hemisphere influenza vaccines, and may have implications on sharing of specimens, such as those needed for vaccine development or other decisions, thereby reducing vaccine effectiveness and increasing potential morbidity and mortality caused by influenza and other respiratory diseases.

5. Responsiveness If an application requests a funding amount greater than the ceilings for each component as indicated in Section II. of this NOFO for direct and indirect costs, CDC will consider the application non-responsive and it will not enter into the review process. CDC will notify the applicant that the application did not meet the submission requirements. The ceiling for each component is as follows:

Ceiling for Component A for first 12-month budget period: $300,000 Ceiling for Component B for first 12-month budget period: $400,000 Ceiling for Component C for first 12-month budget period: $400,000 Ceiling for Component D for first 12-month budget period: $150,000

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://cage.dla.mil/

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/index.html .

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

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

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

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

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

9. Cost Sharing http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html

This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

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

Only one (1) application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

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

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

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

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

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide http://grants.nih.gov/grants/how-to-apply-application-guide.htm and here: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review. The package associated with this NOFO includes all applicable mandatory and optional forms.

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

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

IMPORTANT NOTE:

In both the Research Strategy and Project Summary/ Abstract (Description) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf sections, the application should clearly list each proposed component project by name (i.e., identify the proposed project as Component A, B, C or D).

The application MUST address all objectives under Mandatory Components A, B and C; if applying for Optional Component D, all objectives under Component D must also be addressed.

Within the total 25-page limit for the Research Strategy of the Research Plan section of the application, the page limit for EACH Component project is limited as follows:

o Component A: 7 pages o Component B: 7 pages o Component C: 7 pages o Component D: 4 pages

Throughout the Research Strategy and other application sections, text pertaining to a given component should be titled to begin with the words “Component A” or “Component B” or “Component C” or "Component D" to distinguish components from one another. The Research Strategy for all components will be in one section of the application but broken down by Component, sequentially (e.g., Component A followed by B followed by C followed by D).

If Optional Component D is not included in the application, the page limits for the Mandatory Components A thorough C remain the same as above (i.e., 7 pages for each component).

As part of the initial scientific merit review, Components A through D will be scored separately and each will receive a separate overall impact score.

The applicant only needs to submit one SF424R&R application for all Components (A through D); however, the budget and the budget justification needs to be listed separately for each Component (A through D) (i.e., four budgets and four budget justifications in one SF424R&R application, if all four components are included in the application).

If sub-award (e.g., Contractor Agents) budget requests are included in the application's costs, each sub-award budget request and justification must also be detailed independently in the budget request documentation for each Component (A through D).

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

Mandatory

1. SF424(R&R)[V2.0];

2. PHS 398 Cover Page Supplement [V4.0];

3. Research and Related Other Project Information [V1.4];

4. Project/Performance Site Location(s) [V2.0]

5. Research and Related Senior/Key Person Profile (Expanded) [V2.0];

6. Research and Related Budget [V1.4];

7. PHS 398 Research Plan [V4.0];

8. PHS Human Subjects and Clinical Trials Information [V1.0].

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.

3. Letter of Intent Due Date for Letter of Intent: 01/30/2021 Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

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

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

The letter of intent should be sent to:

Gregory Anderson, MPH, MS Extramural Research Program Office Office of the Associate Director of Science National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention Centers for Disease Control and Prevention U.S. Department of Health and Human Services 1600 Clifton Road, MS US8-1 Atlanta, GA 30333 Telephone: 404-718-8833 Email: GAnderson@cdc.gov

4. Required and Optional Components

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

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and http://grants.nih.gov/grants/how-to-apply-application-guide.htm for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

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

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

3. Research Strategy – the research strategy should be organized under 3 headings:

Significance, Innovation and Approach. Describe the proposed research plan, including staffing and time line.

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf and here: http://grants.nih.gov/grants/how-to-apply-application-guide.htm must be followed along with any additional instructions provided in the NOFO.

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

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

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

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

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

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

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

and

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

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

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".

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

Please note: If applications go beyond the page limit designated for a given section, excess pages will be removed from the application prior to peer review and may negatively affect the scoring.

Within the total 25-page limit for the Research Strategy of the Research Plan section of the application, the page limit for EACH Component project is limited as follows:

1. Component A: 7 pages

2. Component B: 7 pages

3. Component C: 7 pages http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

4. Component D: 4 pages

7. Page Limitations All page limitations described in this individual NOFO must be followed. For this specific NOFO, the Research Strategy component of the Research Plan narrative is limited to 25 pages.

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 25 pages for all appendices. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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

CDC requires all text attachments to the Adobe application forms be…