RFA GH-19-001.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Zoonotic Disease Detection through a One Health Approach in Ethiopia

RFA-GH-19-001

Application Due Date: 03/15/2019

Advancing Zoonotic Disease Detection through a One Health Approach in Ethiopia

RFA-GH-19-001

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 Zoonotic Disease Detection through a One Health Approach in Ethiopia Activity Code U01- Cooperative Agreement

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

RFA-GH-19-001

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. The objectives of the research projects should be to conduct and monitor epidemiologic, clinical, and laboratory-based projects; surveillance; or research of priority zoonotic diseases in Ethiopia at the human, animal, and environmental interface.

Research projects should outline clear plans to incorporate the results of multisectoral, One Health, and zoonotic disease operational research activities into new or existing disease detection, prevention, control, and response programs in Ethiopia. The research projects should also ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Other areas for research include emerging infectious diseases including, but not limited to zoonotic and vector-borne diseases; vaccine-preventable zoonotic diseases in animals; biosafety and security; and other public health threats of local importance.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

https://www.grants.gov

Letter of Intent Due Date: N/A N/A

Application Due Date: 03/15/2019

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: 03/16/2019 Due Dates for E.O. 12372: Due no later than 60 days after the application receipt date.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf 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 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. The objectives of the research project should be to conduct and monitor epidemiologic, clinical, and laboratory-based projects; surveillance; or research of priority zoonotic diseases in Ethiopia at the human, animal, and environmental interface.

Research projects should outline clear plans to incorporate the results of multisectoral, One Health and zoonotic disease operational research activities into new or existing disease detection, prevention, control, and response programs in Ethiopia. The research projects should also ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

Other areas for research include emerging infectious diseases including, but not limited to zoonotic and vector-borne diseases; vaccine-preventable zoonotic diseases in animals; biosafety and security; and other public health threats of local importance.

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). The award issued under this NOFO is contingent upon availability of funds and a sufficiently meritorious application. Because the nature, scope, duration, and cost of the proposed research will be presented in the application, it is also anticipated that the size and duration of each award will depend on the quality of the application.

Budget and Period of Performance. The budget period 09/30/2019 to 09/29/2020. The project period -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 Length: The application is limited to 25 pages per research project. The applicant may submit up to three research projects for consideration, for a maximum application page limit of 75 pages. Supporting materials included as appendices may not exceed 10 PDF files with a maximum of 100 pages for all appendices.

Eligible Institutions/Organizations: Ethiopia’s National Animal Health Diagnostic

Investigation Center is 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 3/15/2019 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 The CDC office in Ethiopia was established in 2001 and works closely with the multisector agencies of the Government of Ethiopia to develop the capacity to prevent, detect, and respond to priority diseases. In 2015, CDC began coordination with the Ministry of Agriculture (now known as Ministry of Agriculture and Livestock Resources, MOALR) as well as the National Animal Health Diagnostic Investigation Center (NAHDIC) to build Ethiopia’s capacity to achieve the International Health Regulation (IHR) targets and Performance of Veterinary Services (PVS) through implementing the Global Health Security Agenda. The initial roadmap was developed with multisector partners in 2015, and the collaboration is proving successful with the inclusion of veterinarians in field epidemiology training, the completion of a sero-prevalence surveillance protocol, and expanding safe sample collection, diagnostics, and surveillance capacity for priority zoonotic diseases. Ethiopia was the second country to conduct a joint external assessment (JEE) and has completed a costed National Action Plan for Health Security (NAPHS). Stakeholders from Ethiopia’s animal health sector engaged in both of these initiatives.

The strategic focus areas of CDC’s work in zoonotic diseases to achieve Ethiopia’s IHR and PVS compliance are the following:

1. Surveillance

2. Laboratory

3. Workforce Development

4. Emergency Management While CDC’s current efforts build towards Ethiopia’s IHR and PVS capacities by strengthening the core public health functions, evidence is limited on characterizing zoonotic disease threats in Ethiopia, the most effective implementation approaches, and the impact of program work to date. The unique context of Ethiopia’s public health and animal health infrastructure, culture, and regional variations may offer meaningful insights to accelerate implementation and achieve IHR and PVS targets.

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. 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 intention of the NOFO is to improve the health of humans, animals, and the environment by conducting operational research at the human-animal-environmental interface on priority zoonoses, diseases that can be spread between humans and animals. Using a One Health approach that can guide stakeholders to prioritize resources and implement multisectoral, One Health practices and policies to mitigate the impact of zoonotic health threats on human and animal populations, will decrease the morbidity and mortality experiences by effected populations, thus increasing global health security.

The proposed One Health and zoonotic disease operational research will be used to understand existing disease burden, ways to improve overall health, and inform national and sub-national health priorities and policies. This allows for the appropriate allocation of resources and the ability to implement multisectoral, One Health interventions for controlling priority zoonotic diseases in the community. The goal is to use these data to guide clinical treatment, identify potential disease outbreaks, ensure coordinated linkages between animal, human, and environment sectors for disease identification and response, and ensure sustainability of an integrated surveillance and laboratory system.

Relevant Work CDC has worked in Ethiopia since 2001. The goal of the work is to develop and strengthen One Health systems to enable the control of endemic diseases as well as the identification and response to emerging and re-emerging diseases – with a focus on zoonotic diseases. CDC coordinates with local, regional, and global human, animal and environment 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 multisectoral, One Health coordinating mechanisms inclusive of the Ministry of Health (MOH); Ministry of Agriculture and Livestock Resources (MOALR);

Ministries of Environment, Forest, and Climate Change (MEFCC); and the Ethiopian Wildlife Conservation Authority in the Ministry of Culture and Tourism (MOCT) in collaboration with the Ethiopian Public Health Institute, and other specific disease control programs.

As a sign of its commitment to the Global Health Security Agenda, Ethiopia was the second country to conduct a joint external assessment (JEE) and has completed a costed National Action Plan for Health Security (NAPHS). Stakeholders from Ethiopia’s animal health sector engaged in both of these initiatives. Additionally, in July 2018, Ethiopia formally established a One Health platform after ministers from MOH, MOALR, MEFCC, and MOCT signed a memorandum of understanding for collaborative prevention, detection, and response to zoonotic disease threats.

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 focus on the detection, prevention, response, and elimination of communicable diseases, zoonosis, and other emerging and re-emerging public health threats in Ethiopia.

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 operational research activities to identify modifiable risk factors for priority zoonotic diseases through a multisectoral, One Health approach at the community and/or population-based level. Also included are research on disease burden, transmission or other factors related to risk, as well as evaluation of novel One Health approaches to disease surveillance, detection, response, and control.

Examples of projects that characterize public health threats are:

• Develop, maintain, or expand one or more priority zoonotic disease surveillance systems in Ethiopia combining population-based and facility-based surveillance designed to determine burden of disease, transmission dynamics, risk factors, 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 zoonotic pathogens.

• 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;

Agriculture and Livestock Resources; Environment, Forest, and Climate Change, and the Ethiopian Wildlife Conservation Authority in order to strengthen surveillance at national and regional levels.

• Conduct research at the human-animal-environment interface on priority zoonoses or novel infectious diseases to determine zoonotic transmission risk.

Project Category B: Determine Most Effective Implementation Approaches:

Includes research on the most effective implementation approaches for responding to global zoonotic 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 priority zoonotic diseases and the acceptance of interventions and prevention methods.

• Develop cost of disease estimates and cost effectiveness estimates for priority zoonotic diseases, with a special emphasis on One Health economic approaches.

• 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, with a special emphasis on One Health economic approaches.

Project Category C: Measuring Impact Includes operational research on interventions to prevent and control priority zoonotic diseases.

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 zoonotic disease prevention, monitoring and control.

Examples of projects that measure impact are:

• Conduct evaluations of zoonotic disease surveillance and control programs in Ethiopia to determine vaccine coverage rates, barriers, best practices, and effectiveness.

• Conduct research to estimate the direct and indirect costs, and document the economic burden of priority zoonotic diseases and interventions, with a special emphasis on One Health economic approaches.

• Studies to measure the impact of enhancements in animal and human surveillance, as well as One Health approaches to surveillance, in a country (in terms of outbreaks controlled, cases averted, time lags from specimen detection to collection etc.).

Target Population The general public, target animal (both wildlife and domestic) populations, the public health community, animal health staff, human health staff, at-risk populations working directly with animal populations like hunters, butchers, farmers and livestock owners.

Collaboration/Partnerships The National Animal Health Diagnostic and Investigation Center (NAHDIC) is the referral and reference federal veterinary laboratory in Ethiopia. It is the center of excellence for animal disease surveillance, investigation, diagnosis and research which contributes a substantial role in promoting export of animal and animal products, improvement of the livelihood of the smallholder farmers and pastoralists, provision of professional support for investors involved in animal farming, and transfer technology for stakeholders. NAHDIC serves the regional and international community as the East Africa’s Regional Referral Diagnostic Laboratory for avian influenza and Newcastle diseases and supports laboratory diagnostics for transboundary animal diseases.

Currently, NAHDIC has implemented ISO/IEC17025:2005 and was accredited for 11 serological and molecular diagnostic tests by South African National Accreditation System in May 2012. The accreditation facilitates NAHDIC’s collaboration with national, sub-regional and international organizations, laboratories and universities working on animal health.

NAHDIC has ten laboratories:

1. Four are engaged in microbiology (viral serology, bacterial serology, bacteriology, and cell culture and virus isolation)

2. Two for parasitology (protozoology, acarology-entomology-helminthology)

3. One for pathology with autopsy facilities

4. One for pharmacology- toxicology

5. One for molecular diagnosis

6. One BSL-3 for the diagnosis of zoonotic diseases.

Additionally, NAHDIC has experimental and laboratory animal facilities to conduct animal health experiment to solve animal health problems.

Evaluation/Performance Measurement As part of the application, applicant 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 research proposal, 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 research 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 Indonesia, 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?

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 may be new activities for the applicant or may be aimed at continuing and enhancing ongoing activities addressing One Health or priority zoonotic disease concerns in Ethiopia.

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

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

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 http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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.

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.

Additional Information on Eligibility Single source competition.

Only applications from the Ethiopia’s National Animal Health Diagnostic Investigation Center will be accepted.

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

4. Justification for Less than Maximum Competition The National Animal Health Diagnostic and Investigation Center (NAHDIC) is the referral and reference federal veterinary laboratory in Ethiopia. It is the Government of Ethiopia’s agency for animal disease surveillance, investigation, diagnosis and research. NAHDIC serves the regional and international community as the East Africa’s Regional Referral Diagnostic Laboratory for avian influenza and Newcastle diseases and supports laboratory diagnostics for transboundary animal diseases. South African National Accreditation System accredited NAHDIC for 11 serological and molecular diagnostic tests in May 2012 in line with ISO 17025. NAHDIC has the infrastructure, staffing, and equipment to operate the following laboratories:

1. Four microbiology laboratories (viral serology, bacterial serology, bacteriology, and cell culture and virus isolation)

2. Two parasitology laboratories (protozoology, acarology-entomology-helminthology)

3. One laboratory for pathology with autopsy facilities

4. One laboratory for pharmacology- toxicology

5. One laboratory for molecular diagnosis

6. One BSL-3 laboratory for the diagnosis of zoonotic diseases.

Additionally, NAHDIC has experimental and laboratory animal facilities to conduct animal health experiment to solve animal health problems.

NAHDIC is the animal health laboratory in Ethiopia with the mandate to protect and improve animal health, and with the facilities to achieve this mandate.

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/.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least https://www.sam.gov/portal/SAM 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

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

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.

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) 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.

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

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:

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 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 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 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.

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

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 100 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 ensure accurate and successful submission through Grants.gov. If the submission is not successful and post-submission errors are found, then those errors must be corrected and the application resubmitted in ASSIST.

Applicants are able to access, view, and track the status of their applications in the eRA 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

Commons.

Information on the submission process is provided in the SF-424 (R&R) Application Guidance and ASSIST User Guide at https://era.nih.gov/files/ASSIST_user_guide.pdf.

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the grant 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).

Applicants who encounter problems when submitting their applications must attempt to resolve them by contacting the NIH eRA Service desk at:

Toll-free: 1-866-504-9552; Phone: 301-402-7469 http://grants.nih.gov/support/index.html Hours: Mon-Fri, 7 a.m. to 8 p.m. Eastern Time (closed on federal holidays)

Problems with Grants.gov can be resolved by contacting the Grants.gov Contact Center at:

Toll-free: 1-800-518-4726 https://www.grants.gov/web/grants/support.html support@grants.gov Hours: 24 hours a day, 7 days a week (closed on federal holidays) If the applicant encounters problems that prevent the ability to submit an application which cannot be resolved by Grants.gov or NIH eRA Service Desks, then applicants must contact CDC Technical Information Management Section (TIMS) at 770-488-2700; ogstims@cdc.gov for guidance at least 3 calendar days before the deadline date. Therefore, it is important that applicants complete the application submission process well in advance of the due date time.

After submission of your application package, applicants will receive a "submission receipt" email generated by Grants.gov.