PKG00257593-instructions.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in Georgia

RFA-GH-20-004

Application Due Date: 03/09/2020

Conducting Public Health Research in Georgia

RFA-GH-20-004

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 and Prevention Components of Participating Organizations Center for Global Health Notice of Funding Opportunity (NOFO) Title Conducting Public Health Research in Georgia Activity Code U01

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

RFA-GH-20-004

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 public health research projects (using quantitative, qualitative, and /or mixed methods), epidemiological studies, clinical, and surveillance of important diseases in Georgia including but not limited to activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats.

Other areas for research include 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; public health threats of local importance, and implementation research to evaluate the impact of public health programs and interventions and their cost effectiveness.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-20-004, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

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

Application Due Date: 03/09/2020 https://www.grants.gov

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: 04/13/2020

Secondary Review: 05/25/2020

Estimated Start Date: 09/30/2020

Expiration Date: 03/10/2020 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 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 http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this Notice of Funding Opportunity (NOFO) is to conduct public health research projects (using quantitative, qualitative, and /or mixed methods), epidemiological studies, clinical, and surveillance of important diseases in Georgia including but not limited to activities to address acute febrile illness, antimicrobial resistance and hospital acquired infections, respiratory infections and influenza, enteric illnesses, and other public health threats.

Other areas for research include 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; public health threats of local importance, and implementation research to evaluate the impact of public health programs and interventions and their cost effectiveness.

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 $10,000,000. 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. Since the nature and scope of the proposed research may vary from year to year, it is also anticipated that the size and duration of the award may also vary.

Budget and Period of Performance: The budget period is anticipated to run from 9/30/2020 to 9/29/2021, is estimated to range from $0 USD to $2,000,000 USD. The estimated total funding (direct and indirect) for the entire project period, 09/30/2020 to 09/29/2025, will be $10,000,000.

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

Eligible Institutions/Organizations: Institutions/organizations listed in Section III.1 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): N/A 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 This work is authorized under the Public Health Service Act 301 and 307 (42 USC 241 and 242l).

1. Background and Purpose The US Government (USG) envisions a world safe and secure from global health threats posed by emerging and re-emerging infectious diseases. The U.S Centers for Disease Control and Prevention (CDC) is working to help National Public Health Institutes around the world to meet key International Health Regulations (IHR) requirements.

The CDC South Caucasus Office (SCO) was established in 2009 and located in Georgia to train epidemiologists and laboratorians from the region, including Armenia, Azerbaijan, and Ukraine, in both the human and animal sectors as part of the Field Epidemiology and Laboratory Training Program (FELTP).

CDC SCO, supported by the Division of Global Health Protection (DGHP), addresses several key global health security priority areas by working in close partnership with the Georgia Ministry of Internally Displaced Persons from the Occupied Territories, Labor, Health, and Social Affairs (MoLHSA), National Center for Disease Control and Public Health of Georgia (NCDC), and Ministry of Environmental Protection and Agriculture of Georgia (MEPA).

Georgia, together with neighboring countries, Armenia and Azerbaijan, makes up the South Caucasus (SC) region. Despite the challenges of rebuilding after the fall of the Soviet Union and an ongoing conflict between Armenia and Azerbaijan, Georgia has persevered and has become a model country for public health and global health security.

Georgia and the South Caucasus Region is home to roughly18 million people at risk for emerging infectious diseases, including Crimean Congo Hemorrhagic Fever, Anthrax, Brucellosis, and a recently discovered orthopox virus. Due to their livelihood in agriculture or animal husbandry, the local inhabitants are at higher risk of being exposed to the emerging infectious diseases including zoonotic diseases. Additionally there is a high prevalence of multi-drug resistant tuberculosis (MDR TB), hepatitis C, respiratory disease and other infectious disease threats.

US CDC’s work in the South Caucasus and the broader region in collaboration with the L.

Sakvarelidze National Centers for Disease Control and Public Health (NCDC) demonstrates the true power of regional and international cooperation, commitment to science, and shared motivation to help others. These have always been core principles for the South Caucasus CDC regional office (CDC-SCO) in Georgia and consequently, in 2019, Georgia was selected as a

Regional Hub for the Eastern Europe and Central Asia Region.

This NOFO is a follow-on to RFA-GH-15-002. It will provide a positive health impact through epidemiologic operational research as well as develop laboratory capacity for emerging infectious. Through earlier detection, more timely prevention and treatment measures can be offered, ultimately leading to lower morbidity and mortality.

In the framework of this regional strategy, CDC will achieve its mission to implement a sustainable approach to Global Health Security (GHS) by strengthening NCDC’s ability to prevent, detect and respond rapidly to disease outbreaks.

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 this NOFO is to provide or improve health impact through conducting public health research, including implementation research, in infectious and non-infectious diseases that can guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of health threats on the population. Through better understanding of disease threats and their control and prevention, morbidity and mortality may be lowered and global health security increased.

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 guide national policies for clinical treatment, outbreak surveillance, laboratory network strengthening, ensure coordinated linkages between the public health leadership and laboratories to identify and respond to emerging/unknown pathogens, build response capacity to mitigate the impact of outbreaks and ensure sustainability of a tiered surveillance and laboratory system.

Relevant Work The National Center for Disease Control and Public Health (NCDC) works with a myriad of partners on issues of public health importance in Georgia. Current CDC/NCDC public health research activities include:

Genetic characteristics of hepatitis C genotype 2 in Georgia and its implication on DAA treatment outcomes within National Hepatitis C Elimination Program. https://www.ncbi .nlm.nih.gov/pubmed/28258606 https://www.ncbi.nlm.nih.gov/pubmed/28258606 https://www.ncbi.nlm.nih.gov/pubmed/28258606

Georgian Nutrition monitoring and surveillance system – GNMSS. The Government of Georgia, UN, and other donor organizations need comprehensive information on the nutritional status of various groups in the population and reliable information on micronutrients deficiency for defining the national food fortification strategy and planning necessary nutritional interventions. From 2018-2019, the Government of Georgia prioritized the identification of the burden of lead poisoning in the population and determining the environmental contamination source.

In-country, NCDC has long standing collaboration with the Ministry of Environmental affairs and Agriculture of Georgia (MEPA) to develop a functional One Health approach. A good example of this is the One Health approach CDC encouraged stakeholders around an investigation into a novel orthopox virus discovered in Georgia. Human and animal cases of disease were identified by a collaborative effort conducted by NCDC, MEPA and US CDC in Georgia and in Atlanta. NCDC and MEPA work closely to identify zoonotic disease/pathogens of greatest public health concern and strengthen human resources capacity, existing surveillance system and laboratory capacity to improve detection, response and strategic planning for prevention and control of these diseases.

Internationally, NCDC works with multiple partners to conduct research that addresses health concerns both regionally and world-wide. Included in these partnerships are the following institutions:

U.S. National Institutes of Health (NIH) together with NCDC conducted number of joint conferences and research projects. As of today, through the NIH funding, several medical institutions of Georgia including the NCDC, have been awarded grant projects of around 600,000 USD.

U.S. Department of Defense (DoD) established the biological threat reduction programs to operate with post-Soviet countries to prevent the proliferation of expertise, dangerous pathogens and technologies.

One of the most significant contributions from the U.S. Government is the investment in creation and development of the Electronic Integrated Disease Surveillance System (EIDSS). As of today 192 entry points are connected into the system, including 90 entries belong to human health services under the MoLHSA and the other 102 belong to entities of the Ministry of Environment Protection and Agriculture. Through the EIDSS it is able to monitor notifiable especially dangerous diseases in a real time that follows the requirements of International Health Regulations (IHR).

Since the 90s of the previous century, the NCDC has been collaborating with various US leading universities: University of Maryland, University of Florida, Emory University, John Hopkins University, University of Virginia, Los Alamos national Laboratory and University of North Arizona. They have been providing partnership realties in the process of joint studies. NCDC staff have passed long-term and short –term training courses in epidemiology, laboratory, and biostatistics at those universities.

This Notice Of Funding Opportunity is a follow on from GH15-002.

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 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 proposal.

The applicant must 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 Strategy component of the Research Plan is limited to 25 pages per project (refer Section IV.5).

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.

Applicants applying for multiple projects must provide a written plan indicating assurance of coordinated management and administrative support.

Please note CDC prefers not to receive one project to cover all administrative tasks and costs, but instead appropriate administrative tasks and costs should be included in each project budget.

Objectives/Outcomes Research projects should outline clear plans to incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Georgia and ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally. Expected outcomes from these studies include generating the data needed to guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of health threats on the population. These data will allow for faster identification of outbreaks, the development of smarter public health systems, and the generation of the evidence base needed to guide interventions and enhance public health policy.

Applicants can 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 Georgia.

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

Acute febrile illness (AFI) Antimicrobial resistance (AMR) and/or healthcare-associated infections (HAI) (i.e.

nosocomial or hospital acquired infections) Respiratory illness and influenza 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

Enteric illnesses Other public health issues of regional and local importance

RESEARCH CATEGORIES:

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:

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 are provided under each research category:

Develop, maintain, or expand one or more surveillance systems in Georgia 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 Georgia 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

Category B: Determine Most Effective Implementation Approaches:

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.

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 The cooperative agreement recipient will collaborate closely with CDC’s GDD program in Georgia, National Center of Disease Control and Public Health, of the Ministry of Labour, Health and Social Affairs as well as the National Food Agency and the Laboratory of the Ministry of Agriculture and other stakeholders that may benefit from public health related research. The recipient should collaborate with designated institutions of the Government of Georgia and national and state laboratories of the South Caucasus, where appropriate, to strengthen the detection of emerging infections, including zoonotic diseases, through the national and regional surveillance systems. The recipient should also collaborate with other local entities that may contribute the overall goal of the related work in Georgia and the South Caucasus Region (e.g., State, University, etc). In order to demonstrate the ability to collaborate with existing Georgian Institutions, applicants must include letter of support from either the Ministry of Labor, Health &, Social Welfare or Ministry of Agriculture. This research project will focus on both laboratory and epidemiological research as determined in cooperation with in-country GDD collaborators and will contribute to overall public health knowledge in the region.

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

Translation Plan The 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:

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

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

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

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?

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.

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: $10,000,000

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 and floor are for the first 12-month budget period only.

Award Ceiling: $10,000,000 Per Project Period Award Floor: $0 Per Project 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. Additional Information on Eligibility Special Eligibility Requirement:

Single Source competition. Only the application from the National Center for Disease Control Georgia will be accepted.

4. Justification for Less than Maximum Competition This single eligibility request is submitted for the National Center for Disease Control Georgia (NCDC). For more than 20 years, NCDC has operated as the Georgian national public health institute responsible for essential public health functions and the management of public health resources. The institute was originally established in 1937 as a Plague Station and then was transformed into the Scientific-Practical Center of Especially Dangerous Pathogens in 1992. In 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

1996, according to Decree #51/? of Georgian Law, the Sanitary-Epidemiological System was reorganized to become the National Center for Disease Control and Public Health.

NCDC is the most qualified and appropriate entity to conduct the activities specified in this

NOFO:

NCDC is the only entity that has the legal mandate, obligation, and technical capacity to implement activities nationally and regionally. NCDC’s mission is to protect and improve the health of the Georgian population through scientific-evidence-based prevention, preparedness and timely response to public health threats.

NCDC’s primary mandate is the prevention and early detection of disease and serves as the leading institution for the prevention and control of the communicable and non-communicable diseases. In the NCDC 2018-2022 Strategic Plan, public health applied biomedical research is a key scientific direction to help the country respond to current challenges and meet development goals.

NCDC is the Georgian National Focal Point for the International Health Regulations (IHR) and is able to communicate with the World Health Organization (WHO) contact point and national stakeholders 24/7. In addition, NCDC is a key Global Health Security Agenda partner as the responsible agency for support of Georgia’s role as the lead country for the Real-time Surveillance Action Package.

NCDC practices advanced laboratory testing and epidemiological methods to carry out evidence-based work related to addressing public health threats and the respective contingency planning, effective and timely prevention and monitoring of the disease, as well as reduction of harm due to environmental hazards and risky behavior.

In addition, NCDC is home to the Richard G. Lugar Public Health Research Center. The center is the only, state-of-art, BSL 3 facility in the South Caucasus region and serves as the national public health reference laboratory. In 2018, the Lugar Center was assessed by ANAB and met the requirements for international standard ISO15189:2012 for demonstrating technical competence in the field of medical and clinical laboratories. In addition, the quality control activities of NCDC’s Polio, Influenza and Measles/Rubella Laboratories are accredited by WHO. Four laboratories are connected to WHO Laboratory Network: Rotavirus, Invasive Meningitis, Malaria, and Salmonella. Currently, the Lugar Center working towards obtaining WHO Collaborating Center status in Anti- Microbial Resistance.

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

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

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

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

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

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

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

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.

Content and Form of Application Submission.

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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 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:

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 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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm

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:

http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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:

• A description of the data to be collected or generated in the proposed project;

• Standards to be used for the collected or generated data;

• Mechanisms for, or limitations to, providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights -this section should address access to identifiable and de-identified data);

• Statement of the 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;

and

• Plans for archiving and long-term preservation of the data, or explaining why long-term preservation and access are not justified (this section should address archiving and preservation of identifiable and deidentified data).

Examples of DMPs may be found here: USGS, http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans 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 http://grants.nih.gov/grants/how-to-apply-application-guide.htm http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans http://www.usgs.gov/products/data-and-tools/data-management/data-management-plans

PHS 398 Research Plan Component

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. Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

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.

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

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…