Foa_Content_of_RFA-IP-24-081 final.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES

Public Health Epidemiology, Prevention and Control of Influenza and Other Respiratory Pathogens in China

RFA-IP-24-081

03/08/2024

Table of Contents Section I. Funding Opportunity Description

Section II. Award Information

Section III. Eligibility Information

Section IV. Application and Submission Information

Section V. Application Review Information

Section VI. Award Administration Information

Section VII. Agency Contacts

Section VIII. Other Information

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

National Center for Immunization and Respiratory Diseases Notice of Funding Opportunity (NOFO) Title Public Health Epidemiology, Prevention and Control of Influenza and Other Respiratory Pathogens in China Activity Code U01 – Research Project - Cooperative Agreements

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

RFA-IP-24-081

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 enhanced surveillance and applied research for influenza virus or other respiratory infections in humans and animals in China. This NOFO aims to better define the global risk and to build the evidence for prevention and control of novel, and seasonal avian and non-avian seasonal influenza viruses and other respiratory diseases in China. The scope of research performed will include, but will not be limited to, activities such as estimating the burden and cost of illness for groups at high risk for severe disease; monitoring vaccine uptake and efficacy; promoting vaccine programs for groups at high risk for severe influenza complications; and conducting surveillance for detection and control of novel and seasonal influenza viruses and other respiratory pathogens.

Research activities for the prevention and control of novel and seasonal influenza viruses and other respiratory pathogens and pandemic preparedness activities will be aimed at preventing and controlling the spread and transmission within China and potentially to other countries, including the United States. Continued monitoring, detection, and reporting of these influenza viruses and other respiratory pathogens in China will advance global health efforts. These activities will assist to inform global health infection control policies and prevent and control seasonal epidemic and pandemic influenza in countries around the world. This NOFO provides an opportunity to conduct research in these important areas.

Key Dates Publication Date:

To receive notification of any changes to RFA-IP-24-081, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link.

An email address is needed for this service.

Letter of Intent Due Date:

02/08/2024 02/08/2024

Application Due Date:

03/08/2024 03/08/2024

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 11:59 PM U.S. Eastern Time.

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

For more information on accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via http://grants.nih.gov/support/index.html.

• E-mail: commons@od.nih.gov

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

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

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

Scientific Merit Review:

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

05/17/2024 Secondary Review:

06/12/2024 Estimated Start Date:

09/30/2024 Expiration Date:

03/09/2024 Required Application Instructions It is critical that applicants follow the instructions in the How to Apply - Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

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 enhanced surveillance and applied research for influenza virus or other respiratory infections in humans and animals in China. This NOFO aims to better define the global risk and to build the evidence for prevention and control of novel, and seasonal avian and non-avian seasonal influenza viruses and other respiratory diseases in China. The scope of research performed will include, but will not be limited to, activities such as estimating the burden and cost of illness for groups at high risk for severe disease; monitoring vaccine uptake and efficacy; promoting vaccine programs for groups at high risk for severe influenza complications; and conducting surveillance for detection and control of novel and seasonal influenza viruses and other respiratory pathogens. Research activities for the prevention and control of novel and seasonal influenza viruses and other respiratory pathogens and pandemic preparedness activities will be aimed at preventing and controlling the spread and transmission within China and potentially to other countries, including the United States. Continued monitoring, detection, and reporting of these influenza viruses and other respiratory pathogens in China will advance global health efforts. These activities will assist to inform global health infection control policies and prevent and control seasonal epidemic and pandemic influenza in countries around the world. This NOFO provides an opportunity to conduct research in these important areas.

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

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

• 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 $4,350,000. The number of awards will be one (1). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary.

The total amount awarded, and the number of awards will depend upon the number, quality, duration and cost of the applications received.

• Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $350,000. The estimated total funding (direct and indirect) for the entire project period will be $4,350,000. The project period is anticipated to run from 09/30/2024 to 09/29/2029.

• Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

• Eligible Institutions/Organizations. Institutions/organizations listed in Section III of this announcement are eligible to apply.

• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

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

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

• Application Type. New

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

SF424 (R&R) Form 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, Sections 301(a) [42 U.S.C. 241(a)] and 307 [42 U.S.C. 242l]

1. Background and Purpose In 1997, the highly pathogenic avian influenza A (H5N1) virus emerged in China and resulted in several outbreaks in poultry and infections in humans that affected other countries in Southeast Asia. The last human infections with A (H5N1) virus in China were in 2016. Since 2003, there have been 53 human infections with A (H5N1) virus in China and, of those, 31 (59%) cases have died. In 1998, the National Health and Family Planning Commission in China also reported human infections with avian influenza A (H9N2) virus. Although influenza A (H9N2) virus tends to cause milder illness in humans than the A (H5N1) virus, it continues to circulate and often reassorts, sharing internal genes with other influenza viruses through reassortment. As of

May 2022, there have been 78 human infections reported from China out of a total 97 reported worldwide.

In 2013, the first human infections with avian influenza A (H7N9) virus were reported from China. Through five annual epidemic periods, 1,537 human infections were reported. Of those infections, approximately 90% resulted in severe illness and 40% died. A few sporadic infections were detected in other countries that were linked to travel to China. Although human-to-human transmission is rare, and there has been no evidence of sustained transmission between humans, vigilance in the detection and testing of these viruses is critical to monitor changes in the virus that could make populations within and outside of China at risk for infection. Since the emergence of A (H7N9) virus, human infections from avian influenza A (H5N6), A (H10N8), A(H10N3) and A (H6N1) viruses have also been detected and reported in China. The continued detection of novel viruses in China, coupled with the possibility of genetic mutations or reassortment with constantly circulating human influenza A viruses, underscores the importance of continuous monitoring and the development of an evidence-based for best practices related to novel influenza virus detection, preparedness, response, and mitigation within the country.

In Asia, China is uniquely positioned to conduct implementation research to assess risks associated with seasonal and novel influenza viruses and to evaluate the benefit and effectiveness of influenza vaccination and other prevention strategies in vulnerable populations. China CDC houses a WHO-designated National Influenza Center and also serves as a WHO Collaborating Center for Influenza. The China CDC National Influenza Center regularly performs WHO and CDC proficiency panels, shares viruses with international WHO Collaborating Centers for Influenza and the Global Influenza Surveillance and Response System and has the capacity to rapidly identify novel viruses such as, but not limited to, influenza A (H5N1) and A (H7N9) viruses. China CDC has also published guidelines on seasonal influenza vaccination among high-risk groups. Recommended target groups for influenza vaccination in China follow the WHO Strategic Advisory Group of Experts (SAGE) recommendations for influenza vaccine and include pregnant women, young children, the elderly, healthcare workers and persons with chronic diseases. Despite an existing influenza vaccination policy, influenza vaccination coverage remains around 2% for the general population. This demonstrates the need for additional data to support increased vaccine supply and uptake.

Seasonal influenza vaccine coverage is higher in some municipalities and regions of China that have local policies for vaccinating certain at-risk populations. In Beijing, for example, annual seasonal influenza vaccination is offered free of charge to adults aged 60 years and older and to school children. Coverage in these high-risk groups approaches 50% in Beijing. China is also one of the few middle-income countries with several local vaccine manufacturers developing pandemic influenza vaccines. In 2015, one of China’s local biological manufacturers became the first to produce a WHO pre-qualified seasonal influenza vaccine. This allowed the donation of influenza vaccine from China to several resource-poor countries. More recently during the COVID-19 pandemic, some manufacturers pivoted to produce COVID-19 vaccines.

Novel influenza viruses infecting humans, which may have pandemic potential, are frequently detected in China [e.g., Asian influenza A (H7N9), and avian influenza A(H3N8), (H10N3), (H9N2), (H5N6)]. US CDC’s Influenza Division has collaborated with China CDC for more than 30 years. Activities include conducting influenza surveillance to better understand influenza seasonality, estimating morbidity and mortality attributable to influenza virus and evaluating risk factors for transmission of novel influenza viruses at the animal-human interface. In the last 5 years, influenza collaboration has generated and published scientific evidence, including the burden of influenza- associated outpatient and hospitalization cases among pregnant women;

vaccine effectiveness and outcomes among children under 5-years-old; strategies to increase influenza vaccination rates among healthcare workers and persons with underlying medical conditions; and surveillance of avian influenza viruses from poultry and poultry-related environments. In addition, the influenza collaboration engaged Chinese policy makers (National Immunization Advisory Group) in the development of seasonal influenza vaccine policy. For example, the collaboration research findings endorsed the National Health Commission to issue the free influenza vaccine policy for healthcare workers in 2018; and provided domestic evidence to inform national guidelines for influenza vaccination among young children, pregnant women, healthcare worker and persons with underlying medical conditions in China. However, there remains a scarcity of information regarding risk factors for the transmission of novel influenza viruses at the human-animal interface, as well as the efficacy of influenza vaccination, antiviral drugs and intervention aimed at enhancing influenza vaccination rates in vulnerable populations, such as pregnant women and persons with underlying medical conditions.

Addressing these gaps will inform global assessment of the risk posed by novel influenza viruses with pandemic potential and decisions about the need for influenza vaccine development, procurement, and stockpiling for target groups.

The purpose of this collaboration is to support enhanced influenza surveillance and applied research on influenza and other respiratory diseases to better define the global risk of novel and seasonal influenza virus infections and other respiratory viruses in humans and animals in China, the region and the world. The scope of research performed will include, but will not be limited to, activities that: 1) estimate the burden and cost of illness for groups at high risk for severe disease; 2) monitor vaccine uptake and efficacy; 3) promote influenza vaccine program for groups at high risk for influenza complications; and 4) conduct surveillance for detection and control of novel and seasonal influenza viruses and other respiratory pathogens. Research activities for the prevention and control of novel influenza viruses and pandemic preparedness activities will be aimed at preventing and controlling the spread and transmission of novel influenza viruses to other countries, including the United States. Continued monitoring, detection, and reporting of these novel influenza viruses in China will advance global health efforts. These activities will assist to inform global health infection control policies and prevent and control seasonal epidemic and pandemic influenza in countries around the world. This NOFO provides an opportunity to conduct research in these important areas.

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 Not applicable.

Public Health Impact Defining the risk of novel and seasonal influenza virus infections in humans and animals through influenza surveillance, vaccine program evaluations, and special studies among vulnerable populations is critical to maintaining preparedness to detect and respond to seasonal influenza epidemics and pandemics. Likewise, assessing the safety and value of influenza and other respiratory pathogen vaccines, antiviral medications, and other mitigation strategies in vulnerable populations is important to ensure acceptability and feasibility of influenza and other respiratory pathogen prevention strategies and to optimize strategies to reduce the burden of associated illness. Finally, identifying optimal strategies for vaccine delivery and improved risk communications will improve the implementation of existing influenza policies and guidelines.

To date, China is the only country with ongoing circulation of avian influenza A (H7N9) virus in poultry, the environment, and humans. In addition to this virus, other avian influenza viruses have been detected in humans in China in the last five years including A (H6N1), A (H9N2), A (H5N1), and A (H10N8) viruses. There is an ongoing concern that the next influenza pandemic could emerge in China, posing a world-wide risk of infection in people. Defining the risk of novel and seasonal influenza viruses infections in human and animals by strengthening surveillance for influenza viruses and conduction program evaluations and special studies among vulnerable populations, is critical maintaining preparedness to detect and respond to influenza pandemics and seasonal influenza epidemics. Likewise, assessing the safety and effectiveness of influenza vaccines, antiviral medications, and other mitigation strategies in vulnerable populations is important to: 1) ensure acceptability and feasibility if influenza prevention strategies and 2) develop strategies to reduce the burden of influenza-associated illness.

Information obtained through collaboration with China will expedite information sharing and are critical to trigger the rapid development of candidate vaccine viruses at CDC. Those candidate vaccine viruses can be used for vaccine production, clinical trials, stockpiling and other pandemic preparedness purposes based on ongoing public health risk assessment.

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

Relevant Work

1. World Health Organization Influenza Surveillance and Monitoring.

http://www.who.int/influenza/surveillance_monitoring/updates/latest_update_GIP_survei llance/en/

2. World Health Organization, Human infection with avian influenza A (H7N9) virus – China. http://www.who.int/csr/don/07-august-2017-ah7n9-china/en/

3. CDC National Center for Immunization and Respiratory Diseases, Influenza Division International Program. https://www.cdc.gov/flu/international/program/index.htm

4. CDC, Asian Lineage Avian Influenza A (H7N9) Virus https://www.cdc.gov/flu/avianflu/h7n9-virus.htm

5. RFA-GH-17-005: Conducting Public Health Research in China.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=292309

6. RFA-IP-16-1605: Maintenance of Influenza Surveillance Capacity by National Health Authorities Outside the United States. https://www.grants.gov/web/grants/view-opportunity.html?oppId=283956

7. Chinese Center for Disease Control and Prevention, Human Infection with Highly Pathogenic Avian Influenza Virus. https://www.chinacdc.cn/jkzt/crb/zl/rgrgzbxqlg/

8. Chinese National Influenza Center, Influenza Weekly Report.

https://ivdc.chinacdc.cn/cnic/

9. National Immunization Advisory Committee (NIAC) Technical Working Group (TWG) , Influenza Vaccination TWG. [Technical guidelines for seasonal influenza vaccination in China (2021-2022)]. Zhonghua Liu Xing Bing Xue Za Zhi. 2021 Oct 10;42(10):1722- 1749. Chinese. doi: 10.3760/cma.j.cn112338-20210913-00732. PMID: 34814607.

10. Yang J, Atkins KE, Feng L, Pang M, Zheng Y, Liu X, Cowling BJ, Yu H. Seasonal influenza vaccination in China: Landscape of diverse regional reimbursement policy, and budget impact analysis. Vaccine. 2016 Nov 11;34(47):5724-5735. doi:

10.1016/j.vaccine.2016.10.013. Epub 2016 Oc

11. Shu Y, Song Y, Wang D, Greene CM, Moen A, Lee CK, Chen Y, Xu X, McFarland J, Xin L, Bresee J, Zhou S, Chen T, Zhang R, Cox N. A ten-year China-US laboratory collaboration: improving response to influenza threats in China and the world, 2004- 2014. BMC Public Health. 2019 May 10;19(Suppl 3):520. doi: 10.1186/s12889-019-

6776-3. PMID: 32326921; PMCID: PMC6696701.

The activities described in this NOFO build upon more than 30 years of laboratory and surveillance capacity building. The activities stipulated in this NOFO build on the laboratory and epidemiologic research capacity by supporting new activities to: 1) estimate the burden and cost of illness of groups at high-risk for severe disease; 2) monitor vaccine uptake and efficacy; 3) promote vaccine program and monitor vaccine effectiveness among priority groups at high-risk for severe disease; and 4) conduct surveillance for detection and control of novel and seasonal influenza viruses and other respiratory pathogens.

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 NOFO is to support enhanced influenza surveillance and applied research on influenza and other respiratory diseases to better define the global risk of and prevention and https://www.grants.gov/web/grants/view-opportunity.html?oppId=283956 https://www.grants.gov/web/grants/view-opportunity.html?oppId=283956 https://ivdc.chinacdc.cn/cnic/ mitigation measures for novel and seasonal influenza virus infections and other respiratory viruses in humans and animals in China, the region and the world.

To accomplish the goals of this NOFO, an applicant should submit an application of three (3) research proposals that address one or more of the public health issues and priorities identified under the Objectives/Outcomes section outlined below. The applicant organization is encouraged to seek partners in-country to achieve the stated goals. The application must include a Letter of Support from China’s national government (e.g., China CDC). The applicant should also demonstrate using research findings and emphasize use of unique platforms that could be utilized to improve prevention and control of novel and seasonal influenza virus infections and other respiratory viruses and diseases in humans and animals in China, the region and the world.

The applicant should address objectives below and include the following information within the submission narrative:

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

2. Outline of the process for recruitment and enrollment of eligible study participants, where necessary to accomplish goals of the research studies.

3. Outline of plans to collect and manage the data in a format standardized across participating sites/partners to ensure ability to pool data appropriately.

4. Description of plans to regularly disseminate and report surveillance and research findings through continued participation in the Global Influenza Surveillance and Response System (GISRS) by routinely sharing quality specimens with other WHO Collaborating Centers and by sharing data through WHO electronic systems.

5. Description of plans to regularly make published data available to partners within the country through surveillance reports or website summaries.

6. Description of plans to publish results of research studies in peer-reviewed scientific journals in a timely manner (i.e., within 6-12 months of study completion).

7. Description of plans to use the evidence from these projects and other scientific studies on influenza prevention and control of influenza and other respiratory diseases to inform policy in China.

8. Assurance of coordinated management and administrative support.

In Year 2-5 of this cooperative agreement, contingent upon the availability of funds, U.S. CDC will work with the award recipient to review and refine current research objectives that build upon Year 1 research project objectives within China.

Objectives/Outcomes The objectives of this NOFO can only be accomplished when activities are performed in China because China is a hot spot of many novel influenza viruses with high pandemic potential. Of global concern are the emerging influenza viruses and the pandemic potential posed from genetic evolution of the highly pathogenic avian influenza A (H5N1) viruses, the reassortant A (H7N9) virus, and avian influenza A (H5N6), (H9N2), (H3N8) and (H10N3) viruses.

To effectively address the domestic and global threat posed by new and emerging influenza virus strains in circulation in this part of the world, the 3 research activities proposed for Year 1 in response to this NOFO and its objectives must be conducted in China.

Objectives:

• To enhance surveillance to rapidly and reliably identify and respond to human infection with novel influenza viruses and other respiratory pathogens with pandemic potential.

• To build multisectoral and transdisciplinary collaboration at human-animal interface (e.g., poultry, wild-bird settings, etc.), and enhance capacity on surveillance, risk-assessment and pandemic preparedness for novel influenza viruses and other respiratory pathogens with pandemic potential.

• To determine the disease and economic burden of influenza illness among vulnerable populations in China including, but not limited to, older adults, individuals with chronic health conditions, pregnant women, children less than 5 years of age, and healthcare workers.

• To assess strategies and programs in increasing influenza vaccine acceptability and uptake, particularly in vulnerable populations including healthcare workers, persons with non-communicable diseases, older adults, young children and pregnant women.

• To assess the safety and effectiveness of influenza vaccines in subpopulations. These might include studies of assessing potential broader, or longer lasting, immunity and/or improved immune response of influenza vaccine, and the impact of influenza vaccine, including cost-effectiveness among a range of different subpopulations.

• To assess the value of other influenza prevention, treatment, and mitigation strategies (e.g., antiviral medications, non-pharmaceutical interventions) through operational research or program evaluations. Assessments might also include observational studies of existing public-sector programs, phase IV demonstration projects, or intervention studies among subpopulations at high risk of complications for influenza illness and where effectiveness/efficacy might be reduced (e.g., older adults).

Outcomes:

The following are expected outcomes from this cooperative agreement:

Priorities for Year 1:

1. Assess strategic implementation of a national program to increase influenza vaccination among healthcare workers in China.

2. Assess burden of influenza illness among elderly with and without chronic diseases.

3. Assess seasonal influenza vaccine effectiveness against influenza hospitalization and in attenuating disease severity among high-risk groups such as children less than five years of age.

Subsequent projects in Year 2-5:

1. Enhanced capacity to continue monitoring, detecting, reporting, and responding to these novel influenza viruses and other respiratory pathogens with pandemic potential in China.

2. Enhanced capacity to prevent and control the spread and transmission of novel influenza viruses and other respiratory pathogens with pandemic potential to other countries, including the United States.

3. Enhanced understanding of the disease burden of influenza and other respiratory pathogens nationally and among groups at increased risk of influenza complications to guide targeted public health interventions in China and other countries.

4. Enhanced understanding of scientific knowledge gaps on safety, cost, effectiveness, and feasibility of introducing strategies for seasonal influenza prevention and control in China.

5. Advance efforts to inform policies on vaccination, infection control, treatment and other mitigation strategies for influenza viruses and other respiratory pathogens with pandemic potential in China and the world.

Target Population The target population includes all migrant or permanent residents of China, with a focus on populations identified by WHO as being at increased risk for severe influenza and/or a target group for influenza vaccination. This includes, but is not limited to pregnant women, healthcare workers, children 6- to 59-months of age, older adults, those with high-risk medical conditions, and poultry workers and other persons with occupational risk for avian and novel influenza infection. Results from these activities will also indirectly inform and benefit the United States and other world populations.

Collaboration/Partnerships The application must include a Letter of Support from China’s national government (e.g., China CDC). Activities supported by this NOFO will build upon existing partnerships with local and provincial centers for disease control and ministries of agriculture or other organizations important for pandemic preparedness within China. New and established partnerships with regional/sub-regional ministries of health and agriculture, provincial and municipal health departments, academic institutions, hospitals, non-government agencies or others to facilitate access and cooperation in meeting research study objectives, will also be supported. Applicants should list organizations and Principal Investigators (PIs) that will be involved in the proposed research proposal. Letters of Support from partners and collaborators are encouraged.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 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.

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

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

Translation Plan Applications should include a plan to estimate and report upon the potential translatability and public health impact of the proposed research. Findings should be disseminated to local, regional, and international stakeholders including, but not limited to the following: the National Health Commission, China; the Ministry of Agriculture in China; and relevant provincial and local health bureaus and centers for disease control; the public health professionals, clinical health personnel and public. The application should identify the research findings that may be translated to inform public health policy or practice and how the findings may be adopted in public health settings. Dissemination of this information will inform and foster review of influenza vaccination and other prevention policies, as well as pandemic preparedness activities.

This section should address which research findings may be translated, how these findings can guide future research or related activities, and recommendations for translation. If relevant, the application should describe how the results of the proposed project could be generalized to populations and communities outside of the study. Information on seasonal and novel influenza virus detection should be shared globally with WHO and other partners through the use of a surveillance report or other publication.

3. Funding Strategy 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:

$4,350,000 Estimated Total Funding: $4,350,000

Estimated Total Annual Budget Period Funding:

Year 1: $350,000

Year 2: $1,000,000

Year 3: $1,000,000

Year 4: $1,000,000

Year 5: $1,000,000

Estimated total funding available for first year (first 12 months), including direct and indirect costs: $350,000

Estimated total funding available for entire project period, including direct and indirect costs: $4,350,000

Anticipated Number of Awards:

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

Award Ceiling:

$350,000 Per Budget Period

Award Floor:

$150,000 Per Budget Period

Total Period of Performance Length:

5 year(s)

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

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

If you are successful and receive a Notice of Award, in accepting the award, you agree that the award and any activities thereunder are subject to all provisions of 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category:

00 (State governments)

01 (County governments)

02 (City or township governments)

04 (Special district governments)

05 (Independent school districts)

06 (Public and State controlled institutions of higher education)

07 (Native American tribal governments (Federally recognized))

08 (Public housing authorities/Indian housing authorities)

11 (Native American tribal organizations (other than Federally recognized tribal governments))

12 (Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education)

13 (Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education) https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

20 (Private institutions of higher education)

22 (For profit organizations other than small businesses)

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

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions

Historically Black Colleges and Universities (HBCUs)

Tribally Controlled Colleges and Universities (TCCUs)

Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations

Regional Organizations

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

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm UEI by viewing the organizational registration on SAM.gov. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: NCAGE Tool / Products / NCS Help Center (nato.int).

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/

3. Additional Information on Eligibility Foreign Organization: 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.

4. Justification for Less than Maximum Competition N/A

5. Responsiveness It is the applicant’s responsibility to ensure that the application meets all responsiveness criteria listed in this section. Applications that do not meet all of the following Responsiveness criteria will be considered nonresponsive and will not be forwarded for peer review. The following criteria are required for responsiveness:

• Letter of Support (LOS) from China national government (e.g., China CDC)

A Letter of Support (LOS) from China national government (e.g., China CDC) is required in the application, Letter of Support section. It is to ensure that research activities will be conducted in China. Applications without such an LOS would be considered as non-responsive and will not enter into the review process. CDC will notify the applicant that the application did not meet the submission requirement.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Unique Entity Identifier (UEI) number in order to begin each of the following registrations.

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

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

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

• Grants.gov

• eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/iae-systems-information-kit/unique-entity-identifier-update https://sam.gov/content/home https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://grantsgovprod.wordpress.com/2021/09/14/how-to-find-an-applicants-uei-within-grants-gov/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://eportal.nspa.nato.int/Codification/Support/en/Products/NCAGE/ https://sam.gov/content.gov https://grants.gov https://public.era.nih.gov/commons https://www.Grants.gov submission processes. The one-time registration process will take three to five days to complete.

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

All Senior/Key Personnel (including Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principal Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have an active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process.

During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a Unique Entity Identifier (UEI) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The UEI number is a twelve-digit number assigned by SAM.gov. An AOR should be consulted to determine the appropriate number. If the organization does not have a UEI number, an AOR should register through SAM.gov. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a UEI number.

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

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

Additional information about registration procedures may be found at SAM.gov and the SAM.gov Knowledge Base.

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

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

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

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 before January 24, 2023 and must use FORMS-H application packages for due dates on or after January 25, 2023.

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

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