oppRFA-GH-18-002-cfda93.326-cidRFA-GH-18-002-instructions.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Strengthening detection of emerging infectious diseases in India

RFA-GH-18-002

Application Due Date: 03/20/2018

Signature Date

Strengthening detection of emerging infectious diseases in India

RFA-GH-18-002

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control Components of Participating Organizations Center for Global Health Extramural Research Program Office (CGH ERPO) National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) National Center for Immunization and Respiratory Diseases (NCIRD) Notice of Funding Opportunity (NOFO) Title Strengthening detection of emerging infectious diseases in India Activity Code U01

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

RFA-GH-18-002

Catalog of Federal Domestic Assistance (CFDA) Number(s) 93.326 Category of Funding Activity:

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to build upon and strengthen the detection, response and prevention work initiated under the Global Health Security Agenda (GHSA) in India. Specifically it will: 1) advance the previous contributions by identifying etiologies, risk factors and outcomes of illness among patients admitted with acute febrile illness (AFI) in selected high burden areas in India; 2) generate data on population health-seeking behavior and utilization patterns in selected epidemiological zones of India and use these data to ascertain burden of disease for key etiologies; 3) evaluate public health impact and cost-effectiveness of implementing expanded and advanced diagnostic testing at district and sub-district levels; 4) build models of linkages to national and state emergency responses, strengthen laboratory surveillance overall; and 5) strengthen One Health activities to promote human health, and model disease patterns across India. One Health advocates the concept that the health of people is connected to the health of animals and the environment.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-18-002, 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: N/A https://www.grants.gov

N/A

Application Due Date: 03/20/2018

On-time submission requires that electronic applications be error-free and made available to CDC for processing from eRA Commons on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov/eRA Commons no later than 5:00 PM U.S. Eastern Time. Note: HHS/CDC grant submission procedures do not provide a period of time beyond the application due date 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: 04/10/2018

Secondary Review: 05/17/2018

Estimated Start Date: 09/30/2018

Expiration Date: 03/21/2018 Due Dates for E.O. 12372: Executive Order 12372 does not apply to this program.

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

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

Applications that do not comply with these instructions may be delayed or not 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 build upon and strengthen the detection, response and prevention work initiated under the Global Health Security Agenda (GHSA) in India. Specifically it will: 1) advance the previous contributions by identifying etiologies, risk factors and outcomes of illness among patients admitted with acute febrile illness (AFI) in selected high burden areas in India;

2) generate data on population health-seeking behavior and utilization patterns in selected epidemiological zones of India and use these data to ascertain burden of disease for key etiologies; 3) evaluate public health impact and cost-effectiveness of implementing expanded and advanced diagnostic testing at district and sub-district levels; 4) build models of linkages to national and state emergency responses, strengthen http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf laboratory surveillance overall; and 5) strengthen One Health activities to promote human health, and model disease patterns across India. One Health advocates the concept that the health of people is connected to the health of animals and the environment.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year project period is $15,000,000. The number of awards will be up to 1 (one). Awards issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from year to year, it is also anticipated that the size and duration of each award may also vary.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period) will be $3,000,000, ranging from $100 to $3,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $15,000,000. The project period is anticipated to run from 9/30/2018 to 09/29/2023.

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.1 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 DUNS number) is allowed.

Application Type. New Special Date(s). N/A Application Materials. See Section IV.1 for application materials. Please note that

Form D is to be used when downloading the application package.

Hearing Impaired. Telecommunications for the hearing impaired are available at:

TTY: 1-888-232-6348

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority This work is authorized under the Public Health Service Act 301 and 307 (42 USC 241 and 242l)

1. Background and Purpose Acute febrile illness (AFI) syndromes, including acute encephalitis syndrome (AES), are a common cause of hospital admission and consultation in India, and significantly contribute to infectious disease morbidity and mortality. Understanding the etiologies, burden, including economic burden, and risk factors of these syndromes is critical to guide appropriate clinical management, including empiric treatment, as well as policy guidelines for disease surveillance and control efforts. At the district and sub-districts levels in India, the timely and accurate diagnosis and management of AFI and AES continues to be challenged by limitations in diagnostic laboratory and public health capacity. Since 2014, CDC-supported AFI and AES surveillance platforms in India have implemented district and sub-district level facility-based disease surveillance under the Global Health Security Agenda (GHSA) initiative to systematically evaluate etiologies of these illness syndromes, support laboratory capacity building, and inform efforts to further strengthen routine surveillance. This NOFO intends to 1) advance the previous contributions by identifying etiologies, risk factors and outcomes of illness among patients admitted with acute febrile illness (AFI) in selected high burden areas in India; 2) generate data on population health seeking behavior and utilization patterns in selected epidemiological zones of India and use these data to ascertain burden of disease for key etiologies; 3) evaluate public health impact and cost-effectiveness of implementing expanded and advanced diagnostic testing at district and sub-district levels; 4) build models of linkages to national and state emergency responses, strengthen laboratory surveillance overall; and 5) strengthen One Health activities to promote human health, and model disease patterns across India.

Healthy People 2020 and other National Strategic Priorities Healthy People 2020 goals supported by this NOFO include:

GH-5 - Increase diagnostic testing capacity in host countries and regionally through the Global Disease Detection (GDD) Regional Centers.

Other national and international priorities include:

The Department of Health and Human Services’ (HHS) Global Health Strategy maintains three goals to support HHS’ global health vision of a healthier, safer world: 1) protect and promote the health and well-being of Americans through global health action; 2) provide leadership and technical expertise in science, policy, programs and practice to improve global health; and 3) advance United States interests in international diplomacy, development, and security through global health action.

Public Health Impact The proposed comprehensive and systematic epidemiological research will be used to elucidate the necessary data to help define national and sub-national health policies that appropriately allocate resources and propose public health interventions for controlling infectious diseases in the community. The goal is to utilize these data to guide clinical treatment and identify potential disease outbreaks, ensure coordinated linkages between the public health leadership and referral laboratories to identify and respond to emerging/unknown pathogens, and ensure sustainability of a tiered surveillance system. This will require appropriate funding, manpower, and technical support at district, state, and national levels.

Relevant Work The proposed NOFO builds directly upon and expands work done as part of CDC’s collaboration with the Government of India in Global Health Security. Specifically, the proposed research will build upon and strengthen the AES surveillance project, led by the National Institute of Mental Health and Neurosciences Bangalore (NIMHANS), which, between 2014-2016, in 14 district level facilities across Uttar Pradesh, West Bengal, and Assam tested 6,800 AES patients, of which 38% of patients received an etiologic diagnosis. Three pathogens, Japanese Encephalitis virus (JE), dengue, and scrub typhus, accounted for over 90% of detected etiologies of illness. The identification of scrub typhus and dengue, considered causes of acute febrile illness, among patients with AES, underscore the importance of considering AES as a subset of febrile illness syndromes. This NOFO further builds upon the GHSA work that Manipal University has conducted. Specifically, from 2014 to 2016, led by the Manipal Centre for Virus Research (MCVR), Manipal University, over 18,000 patients admitted with fever to 28 participating district and sub-district public health facilities across 10 states were evaluated for more than 60 different pathogens, including bacteria, viruses and parasites; 43% received an etiologic diagnosis. Among patients with an identified etiology for illness, six pathogens, with some geographic variability, accounted for almost 90% of cases: influenza, dengue, malaria, scrub typhus, Kyasanur Forest disease (KFD), and leptospirosis.

2. Approach Surveillance results show that AES is an umbrella term that encompasses both encephalitis and other causes of acute febrile illness (AFI). Therefore, the research to be done under this NOFO will combine surveillance of the most commonly identified AES and AFI pathogens (including leptospira, influenza, malaria, JE, dengue, scrub typhus) for all patients admitted with AFI and/or AES across selected districts/states in India. Further, these activities will be extended to the sub-district level in identified blocks to evaluate the same pathogens using rapid diagnostic tests among outpatients with fever at primary health care facilities. The referral level testing for influenza and other pathogens, as well as confirmatory testing and quality control for JE/dengue/scrub typhus testing, will be conducted in a tiered laboratory network that will be built and strengthened as part of this NOFO. Additional research activities include evaluation of disease burden, and public health impact, including economic impact, of new and/or increased diagnostics and a stronger public health infrastructure.

The applicant should submit one overall research proposal in response to this application, which may include more than one project as part of the proposal to address these issues under this application. The proposal may include epidemiologic and/or laboratory-based projects, and/or the evaluation of interventions and/or control methods including therapeutic and preventative treatments. The projects can focus on multiple infectious disease syndrome(s) or a group of diseases that are clinically or functionally related, on an identifiable public health concern or problem impacting health in India. Projects may be new activities for the applicant or they may be aimed at continuing and enhancing ongoing activities addressing public health concerns in India.

The applicant must submit a separate research plan and budget for each proposed project within the proposal. Each research plan should not exceed 25 pages. The research plan for each proposed project should address administrative tasks and oversight for the project as well as coordination of research objectives with other projects as appropriate. Please note CDC prefers not to receive one project to cover all administrative tasks and costs but instead appropriate administrative tasks and costs should be included in each project budget.

Objectives/Outcomes This NOFO will address 10 key research objectives as follows:

Objective 1: To identify etiologies, risk factors and outcomes of illness among patients admitted with acute febrile illness (AFI) in selected high burden areas in India Disease prevention requires identification of etiologies and associated risk factors/exposures.

Such information, combined with knowledge of disease trends and patterns are critical to develop health policies. The prospective applicant may, but is not limited to, designing and implementing research activities to identify etiologies, risk factors and outcomes of illness among patients admitted with acute febrile illness (AFI) in selected high burden areas in India including influenza, dengue, scrub typhus, leptospirosis, malaria, Kyasanur Forest Disease (KFD) and Japanese encephalitis (JE) etc. Standardized techniques of epidemiological assessment, including systematic evaluation of risk factors for specific etiologies of AFI and AES at district level using case control methodology, should be employed to generate these data.

Objective 2: To generate data on population health seeking behavior and utilization patterns in selected epidemiological zones of India and use these data to ascertain burden of disease for key etiologies The applicant may, but is not limited to, designing and implementing health utilization surveys to evaluate health facility usage patterns and health resource availability. Using these data as a population multiplier, morbidity and mortality burden estimates associated with specific infectious diseases prevalent in India can be estimated.

Objective 3: To evaluate cost-effectiveness of implementing expanded diagnostic testing at district and sub-district level This proposed research will identify financial expenditures incurred by the health system in three areas: expenditures for taking care of the patient; expenditures based on early diagnosis;

and an estimate of the man work hours lost/gained to identify the economic burden of disease on the health system and financial gains achieved as a result of rapid detection and control.

Further, this research will identify the financial expenses incurred or saved by an individual as an out of pocket expenditure during a (longer/shorter) hospitalization, the loss of employment hours or wages, and the calculation of Disability Adjusted Life years (DALYs) associated with an episode of illness.

Objective 4: To build tiered laboratory and public health capacity as a model for disease surveillance, with district level and state level apex referral laboratories.

The prospective applicant may, but is not limited to, developing activities targeted at the capacity building of laboratories and laboratory and public health personnel in a tiered model, strengthening sub-district, district and state level public health laboratories and facilities.

Comprehensive activities should be proposed which will include training programs, technical support and mentoring of laboratories, including hands-on wet lab trainings.

This capacity building initiative will build upon ongoing assessments and mentoring of public health laboratories being conducted by Ministry of Health and Family Welfare and partners in India. This new initiative will identify additional gaps and needs and propose countrywide/national measures to enhance and coordinate laboratory facilities and capacities.

These assessments should evaluate the overall quality of the selected laboratories and help develop short term as well as long-term recommendations for improvement.

As part of this, the prospective applicant should strengthen laboratory surveillance for pneumococcal meningitis to understand the impact of pneumococcal conjugate vaccine (PCV) rollout. These activities, to be implemented across different states in India, will generate data on baseline serotype distribution of pneumococcus, prior to PCV introduction. These activities should include the characterization of the evolution of pneumococcal disease, including serotypes, virulence markers, and resistance markers over time, after PCV rollout.

Training activities: Training domains will include good compliance with clinical laboratory practices (GCLP) to ensure quality in laboratory management and testing. Training shall cover the aspects of quality in laboratory testing, result reporting including result interpretations, and the significance of timeliness in reporting.

The laboratory personnel in selected laboratories should be given hands-on wet lab trainings in diagnosis of common diseases like influenza, dengue, scrub typhus, leptospirosis, malaria, Kyasanur Forest Disease (KFD) and Japanese encephalitis (J.E). Training may include various techniques in diagnostics including serology as well as molecular techniques.

Epi-lab training should empower the laboratory personnel to work in the field setting of an outbreak investigation or as part of an emergency response team. The trained personnel should be able to identify epidemiological patterns of new diseases while contributing to the routine disease surveillance system.

The laboratory personnel should also be trained on basic biosafety practices that should be followed in the laboratory, while handling laboratory specimens and other related aspects of specimen transportation, packaging etc.

Lab mentoring activities: The applicant should provide technical support and mentoring to selected laboratories in districts and states that will serve as apex laboratories in the tiered network. The selected laboratories should be supported with technical procedures and laboratory protocols. Further, the laboratories should also include an internal quality control program, which will cater to their quality assurance needs.

Objective 5: To evaluate the impact of improved diagnostic testing at the district level Evidence generated from the GHSA recent acute febrile illness activities indicate that 6-7 pathogens are responsible for more than 90% of the etiologies of known pathogens causing acute febrile illness in India. As a result of these findings, a tiered model should be implemented to strengthen diagnostic capacity across the country to routinely test for these key pathogens among hospitalized febrile patients at the district level. The model envisages leveraging existing laboratory capacity under the National Health Mission, NHSRC, IDSP, NVBDCP and Viral Research Diagnostic Laboratory network (ICMR) and would ensure 48-hour turnaround of results for patient care and management. The applicant shall support these laboratories in the implementation of this testing, and will evaluate the impact on population morbidity and mortality of this expanded testing. A baseline assessment should be done to evaluate the current diagnostic capacity of the selected laboratories. Intermediate evaluations and constant monitoring mechanisms will be put in place to evaluate the impact of the testing mechanism. The impact evaluation may also evaluate the operation of the health system in response to having increased definitive diagnoses in place of an earlier system that restricted diagnoses to a presumptive/syndromic diagnosis only.

Objective 6: To evaluate rapid diagnostic assays at various levels Recent advancements in technology and research have led to the development of novel rapid diagnostic tests that hold promise for the improved management and control of infectious diseases. The usefulness and effectiveness of these tests in various settings must be evaluated in order to propose implementation in various healthcare settings including laboratory, clinical or field settings. Lack of resources and expertise limit the scope of performing appropriate evaluations of these diagnostic tests and hence is a hurdle in proper implementation of rapid diagnostic tests in these settings.

The applicant may, but is not limited to, conduct an evaluation of the impact of implementation of rapid diagnostic testing in state, district and sub district level hospitals. The effectiveness may be evaluated in terms of sensitivity, specificity, cost effectiveness and operational factors including time taken to perform the test, user friendliness, technical simplicity and stability under different user conditions.

Objective 7: To comprehensively evaluate specimens of unknown etiology The recent advances in disease diagnostics has significantly enhanced real-time disease diagnostic capacity to identify specific etiologies of a large proportion of undifferentiated acute febrile illnesses (AFI’s). In spite of this fact, a large proportion of pathogens causing AFI still remain unidentified.

The prospective applicant may, but is not limited to employing the use of Next Generation Sequencing (NGS) as well as multi detection platforms including Luminex as well as TaqMan array platforms to detect the etiology of undiagnosed AFI cases. These strategies should be used in identifying various infectious causative agents for AFIs as well as non-infectious causes such as toxins from plants or foods. The NGS may be used to study the molecular epidemiology of various viral and bacterial pathogens. The Luminex platform will contribute significantly to the capacity for multiplex detection of antigens, antibodies, and nucleic acids for rapid pathogen discovery particularly in outbreak investigations. The Luminex platform should also be used to evaluate the contribution of vaccine preventable diseases to community morbidity and mortality at the population level. The TaqMan array platform should contribute significantly to India’s capacity for multiplex detection of pathogens particularly in outbreak investigations.

Objective 8: To create and maintain disease cohorts for disease progression evaluation, and impact evaluation of interventions

Large scale cohort studies can generate crucial evidence of disease progression and community morbidity and mortality reduction from interventions. Such studies provide essential information to policymakers by providing scientific evidence to understand the changing epidemiology of a disease and crucial inputs regarding effectiveness of vaccines or interventions in reducing mortality or morbidity associated with the disease.

The prospective applicant may, but is not limited to, proposing activities to define population disease cohorts and prospectively study disease progression, survival rates, morbidity and mortality in the common diseases prevalent across the country including influenza, dengue, scrub typhus, leptospirosis, malaria, Kyasanur Forest Disease (KFD), Japanese encephalitis and Zika virus. These cohorts of people with a specific diagnosis shall be utilized for impact evaluation of interventions including treatment and vaccinations.

Objective 9: Build models of linkages to national and state emergency responses The applicant may, but is not limited to, proposing measures to build strong linkages with national agencies including the Integrated Disease Surveillance Programme (IDSP) as well as the Emergency Medical Relief (EMR), the national agencies in disease surveillance, control and emergency response. The applicant shall identify and establish convenient modes of communication with each of the organizations to promote synergy and cooperation of the institutions to build better partnerships in disease surveillance.

The applicant should ensure that data generated as part of these research activities link to national and state level Emergency Operation Centres (EOC) and facilitates the identification and continuous monitoring of epidemics or pandemics. Timely reporting and data visualization and usage activities will be refined for state and national level use as part of this NOFO.

Objective 10: Promotion of One Health activities for human disease detection One Health advocates the concept that the health of people is connected to the health of animals and the environment. The prospective applicant should propose activities that promote the concept of one health in disease surveillance and prevention. The applicant should propose activities that encourage collaborative efforts of multiple organizations or disciplines working at the local, state and national levels and promote synergy between the institutions in the field of one health. The proposed research activities may be focused on diagnostics and control of specific diseases including anthrax, brucella, leptospirosis, avian influenza, and Kyasanur Forest Disease (KFD).

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

Collaboration/Partnerships

The successful applicant is expected to partner with the Ministry of Health and Family Welfare (MoHW), the Indian Council of Medical Research (ICMR), and Indian Global Health Security partners, including NIMHANS, NCDC, NIV and other key institutions. NIMHANS and NCDC are expected to be key partners in the strengthening of a tiered laboratory network and NIMHANS is expected to be a key partner in the execution of the meningitis activities. The applicant will also partner with subject matter experts from the Centers for Disease Control and Prevention (CDC) Atlanta or other international partners, as mutually agreed upon.

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

Translation Plan The prospective applicant should describe the anticipated strategies to be used to disseminate the findings of these research activities to CDC, the Ministry of Health and Family Welfare and the affected communities. The applicant should additionally describe the process by which these data will be translated into policies and public health action at the district, state and national levels.

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

Application Types Allowed:

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

Estimated Total Funding: $15,000,000

Anticipated Number of Awards: 1

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

Award Ceiling: $3,000,000 Per Budget Period

Award Floor: $100 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.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: 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/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

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

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

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

3. Special Eligibility Requirements Single source competition. Only the application from Manipal University will be accepted.

4. Justification for Less than Maximum Competition Manipal University is uniquely qualified to carry out the activities of this Cooperative Agreement based on the following reasons:

- The Memorandum of Agreement/ Understanding between Indian Council for Medical Research,Government of India (ICMR/GOI), Manipal University, and the National Vector Borne Institute/GOI indicates that Manipal University is the Reference lab for Virology related work.

- Is located in the state of Karnataka, in the Western Ghat, a geographically distinct region of India that is endemic to emerging disease threats that are common to India (such as encephalitis) and locally unique (such as Kyasanur Forest Disease (KFD)).

- Conducts advanced laboratory testing, including next generation sequencing for infectious diseases across all states in India.

- Is recognized by the GOI as a "Level 1" lab with facilities to detect an unknown agent. Their labs have the capacity to test more than 80 infections pathogens which cause acute febrile illness.

- Identified by the GOI's Ministry of Health and Family Welfare (MoHFW) as a sentinel lab for arbovirus, influenza, and Zika virus and is also recognized as one of the six regional virology labs within India.

- Recognized by the GOI and internationally as a key Global Health Security Agenda partner

- Serves as a regional virology laboratory partner for both the National Centre for Disease Control (NCDC) and the National Institute of Virology (NIV), both essential institutions of MoHFW, appropriate national authorities and national partners for CDC.

- Recognized by India's MoHFW for sentinel surveillance across India for the Integrated Disease Surveillance Program.

- Works with labs across India to collect specimens and conduct testing of infectious diseases, including acute febrile illness. Currently has developed model specimen transport systems and has trained numerous government partners in numerous wet-lab trainings, serving as a lead diagnostic training center. Additionally participates in outbreak investigations.

- This institute's lab has essential technical capacity to provide diagnostic oversight, quality control, and training within the region.

- The institute's virology department has worked with the Centers for Disease Control & Prevention as part of the national influenza network within India to detect and discover etiologies for infectious diseases causing acute febrile illness in India. Until recently, the etiologies and lab diagnostics for acute febrile diseases, such as KFD have been limited. This project will provide both technical and financial assistance to national, state and district public health laboratories and epidemiology units to improve the detection and response for emerging pathogens in India.

5. Responsiveness N/A

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

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.

int/AC135Public/Docs/US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/#1.

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 Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing 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 registration process at least four (4) weeks prior to the application due date.

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

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, https://www.sam.gov/portal/SAM/%231 https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.Grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform until a final financial report is submitted or the final payment is received, whichever is later.

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

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

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

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

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

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

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

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.

Section IV. Application and Submission Information

1. Address to Request Application Package Applicants must download the SF424 (R&R) application package associated with this funding opportunity from www.Grants.gov.

https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.Grants.gov

If access to the Internet is not available or if the applicant encounters difficulty accessing the forms on-line, contact the HHS/CDC Office of Grants Services (OGS) Technical Information Management Section (TIMS) staff at (770) 488-2700 or ogstims@cdc.gov for further instructions. Hours: Monday - Friday, 7am – 4:30pm U.S. Eastern Time. CDC Telecommunications for the hearing impaired or disabled is available at: TTY 1-888-232-6348.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf, except where instructed in this Notice of Funding Opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

The forms package associated with this NOFO includes all applicable components, mandatory and optional. Please note that some components 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.

In conjunction with the SF424 (R&R) components, CDC grants applicants should also complete and submit additional components titled “PHS398.” Note the PHS398 should include assurances and certifications, additional data required by the agency for a complete application.

While these are not identical to the PHS398 application form pages, the PHS398 reference is used to distinguish these additional data requirements from the data collected in the SF424 (R&R) components. A complete application to CDC will include SF424 (R&R) and PHS398 components. These forms can be downloaded from http://grants.nih.gov/grants/funding/424/index.htm.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

mailto:pgotim@cdc.gov https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf http://grants.nih.gov/grants/funding/424/index.htm

3. Letter of Intent Due Date for Letter of Intent: [Insert 0 days from date of publication] N/A

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.

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 16 components. Not all 16 components of the Research Plan apply to all Notices of Funding Opportunities(NOFOs). Specifically, some of the following 16 components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guidehttps://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf for additional information. Please attach applicable sections of the following Research Plan components as directed in Part 2, Section 1 (Notice of Funding Opportunity Description).

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

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

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

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

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

4. Inclusion Enrollment Report (Renewal and Revision applications ONLY)

5. Progress Report Publication List (for Continuation ONLY)

Human Subjects Section

6. Protection of Human Subjects

7. Inclusion of Women and Minorities

8. Targeted/Planned Enrollment Table (for New Application ONLY)

9. Inclusion of Children

Other Research Plan Sections

10. Vertebrate Animals

11. Select Agent Research

12. Multiple PD/PI Leadership Plan.

13. Consortium/Contractual Arrangements https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf

14. Letters of Support

15. Resource Sharing Plan(s)

16. Appendix

Component 4 (Inclusion Enrollment Report) applies only to Renewal and Revision applications for clinical research. Clinical research is that which is conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 (R&R) Application Guide unless otherwise specified in the NOFO. All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf and here:

https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf must be followed along with any additional instructions provided in the NOFO.

Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed.