Foa_Content_of_RFA-IP-22-001.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Research on the Epidemiology, Prevention and Control of Influenza and Other Respiratory Viruses in India

RFA-IP-22-001

05/09/2022

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:

National Center for Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Research on the Epidemiology, Prevention and Control of Influenza and Other Respiratory Viruses in India Activity Code U01 Research Project – Cooperative Agreement

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

RFA-IP-22-001

Assistance Listings Number(s) 93.083 Category of Funding Activity HL - Health NOFO Purpose The purpose of this notice of funding opportunity (NOFO) is to support research to estimate the incidence of influenza and other respiratory viruses, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), among working-aged adults and other priority populations, and to strengthen the evidence base to help inform influenza vaccine policy in India. The recipient should set up a multi-center hospital-based platform in India to estimate the disease and economic burden of influenza- and COVID-19-associated hospitalization of working-age adults

(18-60 years) in India. An additional goal is to increase awareness about influenza burden and prevention methods among clinicians and public health practitioners. The overarching goal is to identify potential barriers to informing influenza and/or COVID-19 vaccine policy in priority populations.

Key Dates Publication Date:

To receive notification of any changes to RFA-IP-22-001, 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:

The LOI date will generate once the Synopsis is published if Days or a Date are entered.

04/08/2022

Application Due Date:

05/09/2022 05/09/2022

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.

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:

06/30/2022 Secondary Review:

08/09/2022 Estimated Start Date:

09/30/2022 Expiration Date:

05/10/2022 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 25 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 support research to estimate the incidence of influenza and other respiratory viruses, such as SARS-CoV-2, among working-aged adults and other priority populations and to strengthen the evidence base to inform influenza vaccine policy in India. The recipient should set up a multi-center hospital-based platform in India to estimate the disease and economic burden of influenza- and COVID-19-associated hospitalization of working-age adults (18-60 years) in India. An additional goal is to increase awareness about influenza burden and prevention methods among clinicians and public health practitioners. The overarching goal is to identify potential barriers to advancing influenza and/or SARS- CoV-2 vaccine policy in the priority populations in India.

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 $10,000,000. The anticipated number of awards is one (1). Awards issued under this NOFO are contingent upon availability of funds and a meritorious application. Because the nature and scope of the proposed research will vary, it is also anticipated that the size and duration of the award may also vary. The total amount awarded will depend upon the quality, duration and cost of the application received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) is $2,000,000 with individual awards ranging from $1,000,000 to $2,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period is $10,000,000. The project period is anticipated to run from September 30, 2022 to September 29, 2027.

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.

https://grants.nih.gov/grants/how-to-apply-application-guide.html

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE: CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application.

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

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

SF424 (R&R) Form G 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

Public Health Service Act, Section 307 [42 USC 242l] The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020

(P.L. 116-123) The Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L.

116-136) The Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139) The Consolidated Appropriations Act and the Coronavirus Response and Relief

Supplement Appropriations Act, 2021 (P.L. 116-260) The American Rescue Plan of 2021 [P.L. 117-2]

1. Background and Purpose India’s current policy recommends influenza vaccine for health care workers, pregnant women, and people with comorbidities, but the vaccine is only available through the public health system in a few states. Limited studies have revealed that influenza vaccine uptake is very low. Over the years, CDC-supported research studies among priority groups, including children under 5 years old, pregnant women, and adults aged over 60 years, generated crucial data on influenza burden among these groups to inform policy in India. A recent CDC-supported, multi-site surveillance study, examining all age groups, revealed influenza as being the most common cause of severe acute respiratory illness (SARI) among adults aged less than 60 years.

The current COVID-19 pandemic in India also affected working-aged adults, who had higher case-fatality ratios than other age groups. The data on influenza burden, especially on serious illness among the economically productive age group of 18-60 years, is very limited in India and in countries with similar low-resource settings.

The purpose of this notice of funding opportunity (NOFO) is to support research to estimate the incidence of influenza and other respiratory viruses, such as SARS-CoV-2, among working-aged adults and other priority populations and to strengthen the evidence base to inform influenza vaccine policy in India. An additional goal is to increase awareness about influenza burden and prevention methods among clinicians and public health practitioners. The overarching goal is to generate scientific evidence to advance influenza and/or COVID-19 vaccine policy in priority populations in India.

The goals of this NOFO should be achieved through performance of the following primary and secondary objectives:

Objective 1 - To estimate the proportion of SARI hospitalizations associated with influenza and other respiratory viruses, such as SARS-CoV-2, among adults aged 18-60 years and characterize the detected viruses.

Objective 2 - To estimate the disease and economic burden of long-term sequelae of SARI hospitalizations due to influenza and SARS-CoV-2, including risk of re-infection, among adults aged 18-60 years.

Objective 3 - To establish a network of medical professionals to build capacity for infectious disease epidemiology, public health leadership, scientific research, and support for prevention and control of influenza and COVID-19 disease in India.

Objective 4 - To study the effectiveness of influenza and COVID-19 vaccine against serious illness and long-term sequelae among adults aged 18-60 years, priority groups, or vulnerable populations.

The estimated duration of the project is five years. This includes time to: 1) establish the multi-institutional network, obtain ethical clearances from all performance sites, and obtain administrative clearances from the host country health ministry; and 2) once the network is established, 2-3 years to enroll a sufficient number of participants (~12,000 SARI hospitalizations). The influenza and COVID-19 patients enrolled under Objective 2 should be followed over a period of 2 years to detect any long-term sequelae. Data collation, analysis and dissemination may require 6-12 months.

The following are expected outcomes of this cooperative agreement:

1. Enhanced understanding of the burden of SARI hospitalization associated with influenza and other respiratory virus infections, such as SARS-CoV-2, among adults aged 18-60 years.

2. Improved understanding of the burden of influenza and COVID-19 among adults aged 18-60 years, including the economic burden.

3. Increased laboratory capacity for characterization of influenza and SARS-CoV2 viruses using advanced molecular technologies.

4. Enhanced understanding of the effectiveness of influenza and COVID-19 vaccines against serious illness and long-term sequelae among adults aged 18-60 years.

5. Informed needs for facilities and resources for post-acute COVID-19 management.

6. Established network of clinicians, public health professionals, and laboratory scientists to build capacity for infectious disease epidemiology, public health leadership, scientific research and advocacy for prevention and control of influenza and COVID-19 in India.

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.

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 N/A

Public Health Impact The knowledge gained from this research should allow India to strengthen its scientific evidence base to inform influenza and/or COVID-19 vaccine policy for the economically productive age group of 18-60 years using a high standard of active surveillance, epidemiology, and laboratory methods. A serious illness episode in working-age adults often adversely impacts the livelihood of the family, which has a cascade effect on the health of the entire family, especially vulnerable sections of the population. Because India has a population of approximately 1.3 billion people with an increasing life expectancy, influenza prevention and control in India could have a large impact on overall global health. Likewise, assessing the safety and effectiveness of influenza and/or COVID-19 vaccines in these populations is important to ensure acceptability, improve vaccine coverage and appropriate antiviral usage, and decrease disease burden.

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

1. RFA-IP-17-004: Research on the Epidemiology, Prevention and Control of Influenza and Other Respiratory Viruses in India (http://www.grants.gov/web/grants/search-grants.html, Keyword: RFA-IP-17-004; Opportunity Status: Archived)

2. Chadha MS, Potdar VA, Saha S, Koul PA, Broor S, et al. (2015) Dynamics of influenza seasonality at sub-regional levels in India and implications for vaccination timing. PLoS ONE 10(5): e0124122. doi: 10.1371/journal.pone.0124122 (http ://journals.plos.org /ploso ne /artic le?id =10.1371 /journal.pone.01241 22

3. Kumar R, Dar L, Amarchand R, Saha S, Lafond KE, et al. Incidence, risk factors, and viral etiology of community-acquired acute lower respiratory tract infection among older adults in rural north India. J Glob Health. 2021 Apr 3;11:04027. doi:

10.7189/jogh.11.04027. PMID: 33880179; PMCID: PMC8035979.

4. Narayan VV, Iuliano AD, Roguski K, Bhardwaj R, Chadha M, et al. Burden of influenza-associated respiratory and circulatory mortality in India, 2010-2013. J Glob Health. 2020 Jun;10(1):010402. doi: 10.7189/jogh.10.010402. PMID: 32373326; PMCID:

PMC7182391.

5. Krishnan A, Kumar R, Broor S, Gopal G, Saha S, et al. Epidemiology of viral acute lower respiratory infections in a community-based cohort of rural north Indian children. J Glob Health. 2019 Jun;9(1):010433. doi: 10.7189/jogh.09.010433. PMID: 31131104;

PMCID: PMC6513504.

6. Krishnan A, Dar L, Saha S, Narayan VV, Kumar R, et al. Efficacy of live attenuated and inactivated influenza vaccines among children in rural India: A 2-year, randomized, triple-blind, placebo-controlled trial. PLoS Med. 2021 Apr 29;18(4):e1003609. doi:

10.1371/journal.pmed.1003609. PMID: 33914729; PMCID: PMC8118535.

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

The purpose of this research is to establish a multi-center, hospital-based platform in India to estimate the disease and economic burden of influenza- and COVID-19-associated hospitalizations on working-age adults (18-60 years) in India.

Investigators are encouraged to seek multiple partners in-country to achieve the stated goals. To be nationally relevant, at least four sites should be included and, ideally, from different geographic regions of India. This is because it is well-known that influenza virus circulation varies from region to region in India (see Relevant Work). At least one site should perform community-based active surveillance and at least one site should conduct surveillance for medically attended influenza virus infection.

Objectives/Outcomes

Objectives:

Objective 1:

To estimate the proportion of SARI hospitalizations associated with influenza and other respiratory viruses, such as SARS-CoV-2, among adults aged 18-60 years and characterize the http://www.grants.gov/web/grants/search-grants.html http://www.grants.gov/web/grants/search-grants.html detected viruses. The application should address the stated objective and include, at a minimum, the following information in the submission:

1. Narrative outlining the study design, data sources, and limitations of the approach.

2. Narrative outlining the process for recruitment and enrollment of eligible participants

(e.g., working-age adults aged 18-60 years, priority groups, or vulnerable populations).

3. Description of plans to estimate the proportion of SARI hospitalizations associated with influenza and other respiratory viruses, such as SARS-CoV-2, among adults 18-60 years and characterize the detected viruses.

4. Description of plans to collect and manage the data in a format standardized across participating sites to ensure ability to pool data.

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

Objective 2:

To estimate the disease and economic burden of long-term sequelae of SARI hospitalization due to influenza and other respiratory viruses, such as SARS-CoV-2, including risk of re-infection among adults 18-60 years. The application should address the stated objective and include, at a minimum, the following information in the submission:

1. Narrative outlining the study design, data sources, and limitations of the approach.

2. Description of plans to estimate the disease and economic burden of long-term sequelae of SARI hospitalization due to influenza and other respiratory viruses, such as SARS- CoV-2, including risk of re-infection among adults 18-60 years.

3. Description of plans to collect and manage the data in a format standardized across

4. Description of plans to document study results and findings in at least one manuscript.

Objective 3:

To establish a network of medical professionals to build capacity for infectious disease epidemiology, public health leadership, scientific research and support for prevention and control of influenza and COVID-19 in India. The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Description of plans to establish a network of medical professionals to build capacity for infectious disease epidemiology, public health leadership, scientific research and advocacy for the prevention and control of influenza and COVID-19 in India.

2. Description of plans to conduct in-person/virtual/hybrid mode workshops with medical professionals and scientists of partnering network institutes who have knowledge of the research studies and/or direct participation in the studies. Workshops should focus on the topics listed above, including development of short course modules, mentorship guides, or communication materials.

3. Description of plans to document activities/workshops and outcomes achieved by this network of professionals in at least one summary report.

Objective 4:

To study the effectiveness of influenza and COVID-19 vaccine against serious illness and long-term sequelae among working-age adults aged 18-60 years, priority groups, or vulnerable populations. The application should address all stated objectives and include, at a minimum, the following information in the submission:

1. Narrative outlining the study design, data sources, and limitations of the approach.

2. Narrative outlining the process for recruitment and enrollment of eligible study participants.

3. Description of plans to study the effectiveness of influenza and COVID-19 vaccine against serious illness and long-term sequelae among working-age adults aged 18-60 years, priority groups, or/and vulnerable populations.

4. Description of plans to collect and manage the data in a format standardized across

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

Outcomes:

The following are expected outcomes from this cooperative agreement:

1. Enhanced understanding of the burden of SARI hospitalizations associated with influenza and other respiratory viruses, such as SARS-CoV-2, among adults aged 18-60 years.

2. Enhanced understanding of the burden of influenza and COVID-19 among adults aged 18-60 years, including the economic burden.

3. Increased laboratory capacity for characterization of influenza and SARS-CoV2 viruses using advanced molecular technologies.

4. Enhanced understanding of the effectiveness of influenza and COVID-19 vaccines against serious illness and long-term sequelae among adults aged 18-60 years.

5. Increased information regarding the facilities and resources needed for post-acute COVID-19 management.

6. A network of clinicians, public health professionals, and laboratory scientists to build capacity for infectious disease epidemiology, public health leadership, and scientific research for the prevention and control of influenza and COVID-19 in India.

The network should use the evidence from these projects and other scientific studies on influenza prevention and control to inform policy in India.

Target Population The target population is working-age adults in India, which is defined as persons between 18 - 60 years of age. These populations can be identified in the community, clinics, or hospitals but a population denominator should be available for whichever population is chosen. Multiple sites of identification can be enlisted, depending on context, availability, and practical considerations. In addition, if other priority groups are identified to be at high risk for influenza virus infection, those groups could also be targeted (i.e., health care workers, pregnant women, children, adults aged over 60 years). At a minimum, the working-age population in India should be targeted and any additional groups of interest should be clearly identified. Because India is geographically and socioeconomically diverse, a mix of surveillance sites in different regions of India is desired, encompassing rural and urban settings, as well as poor communities where factors such as crowding may lead to increased influenza virus transmission.

Collaboration/Partnerships Investigators should seek multiple partners in-country to achieve the stated goals. To be nationally relevant, at least four sites should be included and, ideally, from different geographic regions in India. This is because it is well-known that influenza virus circulation varies from region to region in India (see Relevant Work, reference 2). The in-country partners should have the capacity to test for influenza and other respiratory viruses using molecular methods such as polymerase chain reaction (PCR); partners should also have populations with a defined catchment, where active surveillance can be performed.

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.

In addition to the required reporting listed in Section VI. of this NOFO, there should be an annual review of stated objectives to determine what has been accomplished and where gaps exist in moving forward to achieving the stated objectives; this could take the form of an annual meeting between the grantee, participating sites, and CDC staff. However, the grantee should have regular teleconferences and meetings with participating sites to ensure that goals are being met throughout the study period - at least monthly and more often, as necessary - to ensure that goals are accomplished and in a timely manner. All meetings and teleconferences should have recorded minutes and clear action items by the recipient.

Projects will also be evaluated on the timely dissemination of preliminary and final results to in-country partners and the larger research community. Primary publications should be submitted for clearance within 12 months of completion of field work (data and specimen collection).

Translation Plan Applications should include a plan to estimate and report the potential translatability and public health impact of the research. The recipient should disseminate results in several ways. Whereas final results should be shared through publication, preliminary results should be shared annually with all site investigators and the CDC, as well as through abstracts for national and international conferences. For true translation, results should be shared with known governmental and non-governmental stakeholders in-country throughout the study period – ideally, at least once per year and at the end of the study. The stakeholders should be identified at the initiation of the study and should be engaged in influenza prevention and control in India, such that the evidence has the potential to inform public health practice and policy.

3. Funding Strategy Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the

“CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

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:

$10,000,000

Estimated Total Annual Budget Period Funding, including direct and indirect costs:

https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf

Year 1: $2,000,000 Year 2: $2,000,000 Year 3: $2,000,000 Year 4: $2,000,000 Year 5: $2,000,000

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

Estimated total funding available for the entire project period, including direct and indirect costs: $10,000,000

Anticipated Number of Awards:

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

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

Award Ceiling:

$2,000,000 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 https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

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

Additional Eligibility Category:

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 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/ AC135Public/Docs/US%20Instructions%2 0for%2 0NSPA%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 All-India Institute for Medical Sciences (AIIMS, New Delhi)

4. Justification for Less than Maximum Competition This NOFO will build upon research conducted under previous CDC cooperative agreements with the All-India Institute for Medical Sciences (AIIMS, New Delhi), which were designed to assess the burden of influenza in both children and the elderly in India. This NOFO seeks to expand the existing collaboration between CDC and AIIMS, New Delhi, establishing a platform to study influenza disease and economic burden among working-age adults (18-60 years old) in India. This will allow a more robust and nationally representative estimate of influenza in this age group. A similar approach will be taken for COVID-19 disease and economic burden among 18- to 60-year-old adults.

This project aligns with activities conducted under the CDC Influenza Division's International Program to build the evidence base for better understanding the disease and economic burden of influenza and to identify strategies for influenza prevention, including vaccination in low- and 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 middle-income settings.

AIIMS, New Delhi, is in a unique position to conduct this work, as it is the only institution in India with the required scientific and technical expertise to conduct multi-site cohort studies on influenza and other respiratory viruses, like SARS-CoV–2, which require robust epidemiological and laboratory capacity and maintains the high research standards required by CDC. AIIMS, New Delhi, is governmentally mandated by the AIIMS Act of 1956 and operates autonomously as an institution of national importance under the Ministry of Health and Family Welfare.

AIIMS, New Delhi, is the leader of basic, clinical, and translational medical research in India.

5. Responsiveness If applications request a funding amount greater than $2,000,000 for the first (12-month) budget period, as indicated in Section II. of this NOFO, HHS/CDC may consider the application non-responsive.

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.

PLEASE NOTE: For applications due on or after April 4, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. In preparation for the federal government’s April 4, 2022, transition from the Data Universal Numbering System (DUNS) to the Unique Entity Identifier (UEI), applicants must obtain a UEI. The UEI 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:

https://eportal.nspa.nato.int/AC135Public/Docs/US Instructions for NSPA NCAGE.pdf

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

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The one-time registration process will take three to five days to complete.

However, it is best to start the registration process at least two weeks prior to application submission.

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their 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://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov 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 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.

PLEASE NOTE: For applications due on or after April 4, 2022, applicants must have a unique entity identifier (UEI) at the time of application submission. In preparation for the federal government’s April 4, 2022, transition from the Data Universal Numbering System (DUNS) to the Unique Entity Identifier (UEI), applicants must obtain a UEI. The UEI 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.

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 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 DUNS number to the recipient organization.

http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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://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

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

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

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

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 after April 4, 2022 and must use FORMS-F application packages until April 3, 2022.

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

Application guides for FORMS-F and FORMS-G 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 (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.

Please use the form and instructions for SF424 (R&R) FORMS-G. Applicants must use FORMS-G application packages for due dates on or after April 4, 2022.

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);

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.

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 04/08/2022

04/08/2022 https://grants.nih.gov/grants/how-to-apply-application-guide.html https://grants.nih.gov/grants/how-to-apply-application-guide.html

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 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 that includes the following information:

Name of the applicant organization 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, 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.