RFA-GH-19-010 FINAL 03 15 19.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Infectious Disease Detection and Response in Nigeria

RFA-GH-19-010

Application Due Date: 03/22/2019

Advancing Infectious Disease Detection and Response in Nigeria

RFA-GH-19-010

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) Center for Global Health (CGH) Notice of Funding Opportunity (NOFO) Title Advancing Infectious Disease Detection and Response in Nigeria Activity Code U01- Cooperative Agreement

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

RFA-GH-19-010

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

Health NOFO Purpose The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research. Research projects may be quantitative, qualitative, and /or mixed methods epidemiological studies to conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Nigeria, including but not limited to address acute febrile illness, emerging and re-emerging infectious diseases, zoonotic and vector borne diseases; environmental health issues effecting infectious diseases (such as water and air);

vaccine-preventable diseases; biosafety and security; and other public health threats of local importance.

Research projects should outline clear plans to incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Nigeria and ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Other areas for research include activities to antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-010, 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 https://www.grants.gov

Letter of Intent Due Date:

N/A

Application Due Date:

needed for this service.

N/A

03/22/2019

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

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

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

Scientific Merit Review: 04/23/2019

Secondary Review: 05/29/2019

Estimated Start Date: 09/30/2019

Expiration Date:

Due Dates for E.O. 12372:

03/23/2019 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf 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 Note: The Research Strategy component of the Research Plan is limited to 25 pages per project

Executive Summary Purpose:

The purpose of this Notice of Funding Opportunity (NOFO) is to conduct high quality public health research. Research projects may be quantitative, qualitative, and /or mixed methods epidemiological studies to conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Nigeria, including but not limited to address acute febrile illness, emerging and re-emerging infectious diseases, zoonotic and vector borne diseases; environmental health issues effecting infectious diseases (such as water and air);

vaccine-preventable diseases; biosafety and security; and other public health threats of local importance.

Research projects should outline clear plans to incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Nigeria and ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Other areas for research include activities to antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards. The estimated total level of funding (in U.S. dollars) available, including direct and in-direct costs, for entire 5-year project period is $5,000,000. The number of awards will be up to 1 (one). Awards issued under this NOFO are contingent upon availability of funds and a sufficient meritorious application. 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 Period of Performance. The budget period is anticipated to run from 09/30/2019 to 09/29/2020. The project period is anticipated to run from 09/30/2019 to 09/29/2024. The estimated total funding (direct and indirect) for the first budget period , 9/30/2019 to 9/29/2020, is estimated to range from $0 USD to $1,000,000 USD.. The estimated total funding (direct and indirect) for the entire period of performance;

9/30/2019 to 9/29/2024 is estimated up to $5,000,000 USD.

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

• Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 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 (1) qualified PD/PI for each application.

• Number of Applications: Only one (1) application per eligible institution (normally identified by a unique DUNS number) is allowed.

• Application Type: New

• Special Date(s): Application due date is 3/22/2019

• Application Materials: See Section IV.1 for application materials.

• 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 307 42 U.S.C. Sections 242 and 317(k) (2) of the Public Health Service Act, 42 U.S.C. Sections 241(a) and 247b (k) (2), as amended

1. Background and Purpose While CDC has worked in Nigeria for decades (mostly in areas like smallpox eradication or nutrition), the agency established a permanent country office in Abuja in February 2001. With the establishment of the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) in 2004, CDC’s presence in Nigeria greatly expanded.

In 2017, Nigeria signed the Global Health Security Agenda (GHSA) following its agreement to meet obligations under the International Health Regulations in 2005. CDC works with the Government of Nigeria and other partners to achieve these requirements by focusing on workforce development, emergency response, surveillance, laboratory, and border health/point of entry interventions. CDC supports efforts to protect the public’s health by developing and strengthening health systems in Nigeria by providing technical leadership to rapidly respond to disease outbreaks and emerging infectious diseases.

Outbreak prevention and global health security considerations are a priority in US international health strategy and for CDC in Nigeria. During the West African Ebola outbreak, there were 19 laboratory-confirmed and one probable Ebola cases in two states in Nigeria (the most populous country in Africa) after a very sick traveler from Liberia arrived at the international airport in

Lagos in July 2014. By the time it was recognized that the patient carried the Ebola virus, the traveler had exposed 72 people on the aircraft, at an airport, and at a hospital. It appeared that conditions were ripe for the disease to spread through the city and the nation. As a result of quick action by Nigerian authorities, CDC, a team of international partners, and the activation of an Ebola Incident Management Center (a precursor to Nigeria’s current Emergency Operations Center)—the virus was contained within a few weeks. With this new research cooperative agreement, CDC strives to continue supporting global health security work in Nigeria by generating evidence-based data for public health action.

Healthy People 2020 and other National Strategic Priorities While Healthy People 2020 goals are generally specific to US domestic programs, the global health activities within this NOFO extends the national strategic priorities. Ensuring Global Health Security is a national strategic priority, especially in GHSA countries and Ebola-affected and related countries. Nigeria is a priority country for CDC and for the Defense Threat Reduction Agency. The NSC is currently reassessing biologic risk profiles; at this time there is no decision of GHSA strategic priorities for 2020-2025 but irrespective of final priority listings Nigeria remains a GHS focus of high concern.

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 intention of the NOFO is to provide a global health security impact through conducting public health research in infectious diseases that can guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of the local and international ramifications of health threats. Through better understanding of disease threats, and their control and prevention, morbidity and mortality may be lowered, and global health security increased.

More importantly, the development of research partners in other countries can be accomplished through Cooperative Agreement mentoring and support.

The proposed public health research will be used to understand the data and to help define national and sub-national health policies. This allows for the appropriate allocation of resources and the ability to implement public health interventions for controlling infectious diseases in the community. The goal is to use these data to identify potential disease outbreaks and guide clinical treatment, 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 and laboratory system.

Relevant Work CDC has worked in Nigeria with the Federal Ministry of Health (FmoH) since 2004. The FMoH is the parent organization of the Nigeria Center for Disease Control (NCDC). The goal of the work is to develop and strengthen systems to enable the identification and response to emerging and re-emerging infections. CDC coordinates with local, regional, and global public health entities to rapidly detect, accurately identify, and promptly contain emerging disease threats. Collaborations with partners are essential to generate important data on the burden of a broad range of infectious diseases, detection of poorly understood and novel pathogens, as well as causes and rates of mortality in the populations under surveillance. The collaborations result in the strengthening of public health capacity within Ministries of Health (MOHs) and Ministries of Agriculture (MoAg) primarily in collaboration with Departments of Epidemiology and Surveillance, the National Laboratories, the National Public Health Institutes, and other specific disease control programs.

In the last 2 years, NCDC has successfully moved IHR engagement from inactivity to a Joint External Evaluation and national action plan development and implementation. It has built an Emergency Operations Center that is activated 4 or 5 times a year, and then added an Incident Command Center to handle overflow activity associated with the dozens of investigations and local responses. It has, with the assistance of partners, deployed electronic Integrated Disease Surveillance and Response reporting and introduced electronic case management reporting in the states most effected by outbreaks. It has built a national reference lab and developed National Reference Laboratory capability, and is forging a network of labs and sample transport. It has also led or promoted advances in Infection Prevention and Control, medical countermeasures and supply chain logistics.

CDC has several activities that support or relate specifically to this NOFO. Prospective applicants should refer to the following websites and related documents for additional information:

http://www.cdc.gov/globalhealth https://www.cdc.gov/globalhealth/healthprotection/ghs/index.html http://www.cdc.gov/globalhealth/ihregulations.htm http://www.cdc.gov/globalhealth/ghi

2. Approach

Objectives/Outcomes Applicants may propose up to three projects in the first year of award that support or develop public health–related research activities and studies. Projects should be focused on the detection, prevention, response, and elimination of communicable diseases, zoonosis, and other emerging and re-emerging public health threats in Nigeria.

Disease Areas Applicants may focus their application on one or more of the following eligible disease areas:

1. Acute febrile illness (AFI)

2. High priority diseases such as meningitis or viral hemorrhagic fevers

3. Zoonoses and emerging diseases

4. Antimicrobial resistance (AMR) and/or healthcare-associated infections (HAI) (i.e.

nosocomial or hospital acquired infections)

5. Respiratory illness and influenza

6. Enteric illnesses

7. One Health research

8. Other public health issues of regional and local importance

RESEARCH CATEGORIES

Applicants must propose projects that focus on the disease area(s) selected in at least one of the following research categories. In the first year of award, applicants may only submit up to three projects total. All three projects can be proposed in one research category or can be a combination of the three categories: A, B, or C. Examples of projects are provided under each research category:

Project Category A: Characterize Public Health Threats Includes conducting research activities to identify modifiable risk factors for priority diseases through community and/or population-based observational research. Also included are research on disease burden, transmission or other factors related to risk. Research findings should be presented at international meetings and published in the peer-reviewed literature.

Examples of projects that characterize public health threats are:

• Develop, maintain, or expand one or more surveillance systems in Nigeria, combining population-based and facility-based surveillance designed to determine burden of disease, transmission dynamics, risk factors, relative contribution of different pathogens to disease syndromes, and control of infectious agents. A multi-site system could include population/site diversity with regard to urban/rural, socioeconomic factors, etc.

• Support the development or strengthening of laboratories and/or platforms used for etiologic investigation, evaluation of novel diagnostic assays for faster and easier detection, and characterization of pathogens.

• Develop and/or maintain one or more research sites to investigate and report the interactions between specific pathogens and underlying comorbidities.

• Conduct ongoing and systematic collection, analysis and interpretation of biological samples and data for both animal and human health in collaboration with Ministries of Health and Agriculture of Nigeria in order to strengthen surveillance at national and regional levels.

• Conduct research on the human-animal interface of zoonotic diseases and risks of transmission from animals to humans.

• Provide innovative solutions identified through research to develop early warning systems to report sentinel organisms in humans that can serve as an alert for multidrug resistant organisms and interventions for adequate antimicrobials Project Category B: Determine Most Effective Implementation Approaches:

Includes research on the most effective implementation approaches for responding to global public health threats and building global health security capacity.

Examples of projects that address effective implementation approaches are:

• Conduct qualitative socio-cultural research and surveys of knowledge, attitudes, and practices related to infectious disease and the acceptance of interventions and prevention methods.

• Develop cost of disease estimates and cost effectiveness estimates for priority diseases.

• Develop processes for collecting and analyzing information on the costs associated with surveillance and research activities and the potential savings at the population level of early detection and control.

Project Category C: Measuring Impact Includes research on interventions to prevent and control diseases of importance. These projects might use various designs and sources of data. The findings should be used to guide the development and/or improvement of national and regional policies and programs for disease prevention, monitoring and control.

Examples of projects that measure impact are:

• Conduct evaluations of surveillance programs in Nigeria to determine coverage rates, barriers, best practices, and effectiveness.

• Conduct research to assess efficacy/effectiveness, immunogenicity and impact of vaccines, treatments, and non-pharmaceutical interventions and other control measures to reduce the burden of influenza disease among vulnerable populations.

• Conduct a systematic review of AMR/HAI activities in Nigeria. This includes the development of a catalogue of research and public institutions working in AMR/HAI to include information on location, description of activities, populations served, and a summary of relevant publications in the last 5 years.

• Conduct research to estimate the direct and indirect costs, and document the economic burden of priority diseases and interventions.

• Studies to measure the impact of enhancements in public health surveillance in a country (in terms of outbreaks controlled, cases averted, time lags from specimen detection to collection etc.).

Target Population The prospective applicant must identify the target populations to be addressed through this NOFO, including 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 Nigeria CDC is the national focal point for the International Health Regulations and GHSA. It is the hub through which other ministries and agencies and the 36 + 1 federated States coordinate their work. Post JEE and GHSA activity has triggered a large coalition of partners, including Public Health England and DFID, Robert Koch Institute and GIZ, Japan International Cooperation Agency, and Gates Foundation, to name a few. WHO has a longstanding relationship with NCDC and the FMoH. The World Bank REDISSE program, through ECOWAS and WAHO, has partnered with NCDC to implement global health security activities. Through this cooperative agreement, NCDC will build upon the existing programs established by these partners and ensure a comprehensive approach to global health security in Nigeria.

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 applicant 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.

Monitoring and Evaluation Work with CDC and other global partners as appropriate to develop and implement an evaluation plan to measure the impact of the activities outlined in this funding opportunity announcement (evaluation framework, evaluation design, indicators, process and outcome evaluation, and information/data collection plan).

Program Capacity Establish or retain a full-time staff person with management and technical experience, responsible for managing the planning, implementation, and evaluation of the program and serving as the CDC point of contact. Establish or retain a part-time staff person with data management and mobile data collection experience responsible for the programming and trouble-shooting of data collection instruments, cleaning of data, development of data dictionaries and storage of datasets. Establish or retain additional staff with demonstrated knowledge, skills, and expertise in administrative and fiscal management to meet the needs of the program. Over the course of the project period establish and retain other staff, contractors, and consultants sufficient in number and expertise to ensure project success.

Fiscal management Programs must use funding to support activities in alignment with requirements of this NOFO.

Programs must develop and maintain systems for sound fiscal management, including:

monitoring the cooperative agreement award and program contracts and grants, ensuring the funds are expended in support of approved activities.

Translation Plan The applicant should describe plans for how research and scientific findings will be reported and disseminated (e.g., peer-reviewed journals, scientific presentations, reports, meetings and conferences) and specify how these activities are integrated into the project plans. The translation of findings should be understandable to a variety of audiences, including policy makers, practitioners, public health programs, health care institutions, professional organizations, community groups, researchers, and other potential users.

Questions to consider in preparing this section include:

1. How will the scientific findings inform the government in Nigeria as well as other stakeholders on needed public health policies or practices at the local and national level?

2. How will the research project improve or affect the translation of study findings into policy or practice?

3. How will the research findings help promote or accelerate the dissemination, implementation, or diffusion of improvements in public health programs and practices?

4. How will the research findings advance or guide future scientific efforts or related activities?

5. How will the research activities improve public health outcomes, advance workforce development, and enhance response capacity?

Application Approach The applicant should submit one overall research proposal in response to this application, which may include no more than three projects as part of the first year of award proposal. The proposal may include epidemiologic projects, laboratory-based projects, evaluation of interventions and control methods including therapeutic and preventative treatments. Projects can focus on multiple infectious disease syndrome(s) or a group of diseases that are clinically or functionally related, to an identifiable public health concern or problem affecting health in Nigeria. Projects may be new activities for the applicant or may be aimed at continuing and enhancing ongoing activities addressing public health concerns in Nigeria.

The applicant should submit a separate research plan and budget for each proposed project within the proposal. No more than three research plans and budgets should be submitted for the first year of award proposal.

The research plans should not exceed 25 pages per project. 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 budge

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: $5,000,000

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: $1,000,000 Per Budget Period Award Floor: $0 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 (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

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

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

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

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

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

3. Special Eligibility Requirements Foreign Organizations are eligible to apply.

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

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCA GE.pdf Additional Information on Eligibility Single source competition. Only the application from Nigeria Centre for Disease Control will be http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf accepted.

4. Justification for Less than Maximum Competition Nigeria CDC is the National Public Health Institute for Nigeria and is the government parastatal organization under the MoH, which is charged with prevention, detection and response of infectious disease outbreaks. NCDC is the sole entity with a government mandate to manage data that includes disease specific information on multiple priority diseases to prevent and control outbreaks; no other organization has the breadth and depth of data. NCDC is also charged with coordinating the implementation of the International Health Regulations.NCDC mandated research functions are based on U.S. CDC research functions, and is therefore the only candidate with which CDC can develop the government's ability to research emerging diseases in the context of outbreak prevention. The NCDC focus for epidemiological expertise in Nigeria is supported by the FETP program, which provides ready access to 100 advanced fellows in training, as well as access to the professors of the 2 Nigerian universities that sponsor the program and the network of graduates of the program.The NCDC leads responses outbreaks as well as smaller investigations. This level of direct engagement with the partners of interest is not available through any other entity. The NCDC manages the two functional Nigerian National Reference Labs in Abuja and Lagos. These laboratories have no alliterative equivalent in Nigeria.

The laboratory is the influenza lab, the repository of the 170,000 sample NEISS HIV study, a CDC-supported "mega-lab", and a key PCR facility for testing Lymphatic Filariasis, Yellow Fever, measles, meningitis and monkeypox.The goal of this NOFO is to both develop research capability and to investigate characteristics of the current priority pathogens and matched interventions. With this mandate, NCDC is the only entity within Nigeria with which CDC can partner in a sustainable, capacity building approach to public health research. Without this mechanism, NCDC and CDC will be unable to generate the data needed to implement evidence-based public health research projects to better characterize disease threats, determine the most effective implementation approaches and measure impact.

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/.

https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM

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

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

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

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

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

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

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions 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 https://www.sam.gov/index.html

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.

Applicant organizations may submit only one application.

Section IV. Application and Submission Information

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

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

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

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

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

Please note that some forms marked optional in the application package are required for submission of applications for this NOFO. Follow the instructions in the SF-424 (R&R) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://public.era.nih.gov/assist http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf

Application Guide to ensure you complete all appropriate “optional” components.

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

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

Mandatory

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

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

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

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

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

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

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

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

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

Optional

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

3. Letter of Intent Due Date for Letter of Intent: [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. In ASSIST, all required and optional forms will appear as separate tabs at the top of the Application Information screen.

5. PHS 398 Research Plan Component The SF424 (R&R) Application Guide includes instructions for applicants to complete a PHS 398 Research Plan that consists of components. Not all components of the Research Plan apply to all Notices of Funding Opportunities (NOFOs). Specifically, some of the following components are for Resubmissions or Revisions only. See the SF 424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/generalforms-e.pdf and 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 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:

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

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

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

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

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

4. Progress Report Publication List (for Continuation ONLY)

Other Research Plan Sections

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan.

8. Consortium/Contractual Arrangements

9. Letters of Support

10. Resource Sharing Plan(s)

11. Authentication of Key Biological and/or Chemical Resources

12. Appendix

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-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. Applicants who contend that the public health data they collect or create are not appropriate for release must justify that contention in the DMP submitted with their application for CDC funds.

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

• Descriptions of the data to be produced in the proposed project

• How access will be provided to the data (including provisions for protection of privacy, confidentiality, security, intellectual property, or other rights)

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

• Plans for archival and long-term preservation of the data, or explaining why long-term preservation and access cannot be justified Examples of DMPs may be found here: University of California https://dmp.cdlib.org/, or USGS, http://www.usgs.gov/datamanagement/plan/dmplans.php

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 https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf 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 https://dmp.cdlib.org/ http://www.usgs.gov/datamanagement/plan/dmplans.php 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 unless otherwise specified in the NOFO

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

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

Supporting materials for the Research Plan narrative included as appendices may not exceed 10 PDF files with a maximum of 150 pages for all appendices.

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

CDC requires all text attachments to the Adobe application forms be submitted as PDFs and that all text attachments conform to the agency-specific formatting requirements noted 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.

9. Submission Dates & Times Part I. Overview Information contains information about Key Dates. Applicants are strongly encouraged to allocate additional time and submit in advance of the deadline to ensure they have time to make any corrections that might be necessary for successful submission. This includes the time necessary to complete the application resubmission process that may be necessary, if errors are identified during validation by Grants.gov and the NIH eRA systems.

The application package is not complete until it has passed the Grants.gov and NIH eRA Commons submission and validation processes.

Organizations must submit applications using the ASSIST web-based application preparation and submission process.

ASSIST will validate applications before submission. If the system detects errors, then the applicant must correct errors before their application can be submitted.

Applicants are responsible for viewing their application in ASSIST after submission to 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 ensure accurate…