RFA-GH-19-009 FINAL 01 17 19.pdf

Centers for Disease Control

Center for Global Health Extramural Research Program Office

Advancing Infectious Disease Detection and Response in Viet Nam

RFA-GH-19-009

Application Due Date: 03/11/2019

Advancing Infectious Disease Detection and Response in Viet Nam

RFA-GH-19-009

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) Notice of Funding Opportunity (NOFO) Title Advancing Infectious Disease Detection and Response in Viet Nam Activity Code U01

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

RFA-GH-19-009

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 solicit applications that will:

Conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Vietnam 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.

Incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Vietnam and ensure the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

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; and other public health threats of local importance.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-19-009, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is https://www.grants.gov

Letter of Intent Due Date:

Application Due Date:

needed for this service.

N/A

03/11/2019

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: 04/24/2019

Secondary Review: 05/30/2019

Estimated Start Date: 09/30/2019

Expiration Date:

Due Dates for E.O. 12372:

03/12/2019 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

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

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read 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

Executive Summary Purpose:

The purpose of this cooperative agreement is to:

Conduct and monitor epidemiologic, clinical, and laboratory-based projects, surveillance, and research of important diseases in Vietnam 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.

Incorporate the results of research activities into operational disease detection, prevention, and response or control programs in Vietnam and the strengthening of local workforce capacity and dissemination of findings across the region, with partners, and globally.

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; 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 the entire 5-year project period is $5,000,000. The number of awards will be up to 1 (one). Awards issued under this NOFO are contingent upon availability of funds and a sufficient meritorious application. Because the nature and scope of the proposed research 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 estimated total funding (direct and indirect) for the first budget period, 9/30/2019 to 9/29/2020, is estimated to be $1,000,000 USD, ranging 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 $5,000,000

USD.

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 U.S. Centers for Disease Control and Prevention (CDC) has partnered with the Government of Vietnam (GVN) since 1998 to build quality sustainable health systems to provide long-term public health impact and to protect the health of the Vietnamese people. In 2001, CDC established the CDC Vietnam office and has been working in partnership with the GVN to strengthen public health capacity and infrastructure, and to foster sustainable surveillance, research, preparedness and outbreak response to address key health priorities and concerns in the country.

Vietnam has made impressive progress toward improving the health status of the population, with progress that equals or surpasses that of many neighboring countries. These improvements in health outcomes are attributable to developments in the country’s health care system, however, many difficulties and challenges still remain. Recent health sector reviews have identified a number of issues including an emerging burden of non-communicable diseases (cardiovascular diseases, cancer, diabetes, etc.) and infectious diseases (HIV/AIDS, H1A1, etc.), an ageing population, inadequate capacity of the health system, and problems of inequities in access to health and health care.

Vietnam is particularly vulnerable to serious zoonotic and emerging infectious disease threats because of its geographic location, climate, and significant amount of travel and trade across borders with China, Laos, and Cambodia. In addition, the country’s health system remains challenged with how to improve detection and response to emerging and re-emerging disease threats. The regional increase of avian influenza in humans and poultry and the outbreak of

SARS in 2003 are examples of these vulnerabilities. Vietnam’s capacity to quickly and effectively respond to public health threats and emerging outbreaks will be critical to protecting the health of the global community.

CDC’s collaborative projects extend across Vietnam at the national, provincial, and local level to build strong bilateral relationships between Vietnam and the United States. Vietnam is one of the original CDC Global Health Security Agenda (GHSA) pilot sites and was an early partner in global health security efforts. The USG has supported the GVN public health priorities through the GHSA framework focusing on surveillance, emergency management, laboratory, and workforce development.

The purpose of this program is to support activities that will fulfill four broad goals:

1. Conduct high quality research around influenza, emerging and re-emerging infectious diseases, and other public health programs including non-communicable diseases;

2. Provide training for public health professionals and select staff in basic and applied public health research, program planning, and evaluation;

3. Strengthen the MOH’s institutional capacity to conduct research, plan, implement, and evaluate public health programs, including the capacity to detect and respond to emerging and re-emerging infectious diseases; and

4. Incorporate and promote the results of research into operational disease prevention and control programs and policy development.

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

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

Other national and international priorities include:

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

Public Health Impact The intention of the NOFO is to provide a health impact through conducting public health research in infectious diseases that can guide stakeholders to prioritize resources and implement health practices and policies to mitigate the impact of 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 identify potential disease outbreaks and guide clinical treatment, ensure coordinated linkages between the public health leadership and referral laboratories to identify and respond to emerging/unknown pathogens, and ensure sustainability of a tiered surveillance and laboratory system.

Relevant Work The CDC Vietnam country office was established in 2001 to address the HIV and TB epidemics. Through the established CDC-MOH collaboration, capabilities have been built across a number of critical global health security areas that have enhanced the International Health Regulations core capacities in surveillance, laboratory systems, antimicrobial resistance, and workforce to prevent, detect, and respond to disease outbreaks.

In 2013, Vietnam was one of only two countries selected for GHSA demonstration projects and in 2015 it was designated as a USG GHSA Phase I country. Key CDC GHSA areas of focus in Vietnam include workforce development, surveillance and health information systems development, lab strengthening, establishing emergency operations centers (EOCs) and improving emergency response, antimicrobial resistance testing and surveillance, and promoting infection prevention and control. CDC has worked with the MOH to establish a communicable disease surveillance system working at different administrative levels (regional, provincial department of health, district health center, and commune health stations).

CDC has also been working with the MOH to develop national laboratory strategic plans, policies and guidelines for biosafety, and implementation of a quality management system to strengthen national referral hospitals’ and four regional institutes’ laboratories. In August of 2017, HHS signed a Memorandum of Understanding with the Minister of Health agreeing to collaborate on the establishment of a National Public Health Reference Laboratory Network.

Building upon work started by PEPFAR and the Influenza Division, this lab network will improve the country’s ability to detect novel emerging pathogens and establish standards for laboratory practice in the country, including biosafety.

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 five projects as part of the first year of award proposal. The proposal may include epidemiologic projects, laboratory-based projects, evaluation of interventions and control methods including therapeutic and preventative treatments. Projects can focus on multiple infectious disease syndrome(s) or a group of diseases that are clinically or functionally 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 related, to an identifiable public health concern or problem affecting health in Vietnam Projects may be new activities for the applicant or may be aimed at continuing and enhancing ongoing activities addressing public health concerns in Vietnam.

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

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

Objectives/Outcomes Applicants may propose a variety of projects that address these objectives. For each project, the applicant must submit a separate Research Plan and Budget. The Research Strategy component of the Research Plan is limited to 25 pages per project per component refer Section IV.5.

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

For each project proposed, the focus should be on an identifiable public health concern or problem impacting health in Vietnam. Applicant may propose new projects, as well as continuation of existing projects (if applicable) that propose new objectives and activities to address emerging diseases as well as risk factors associated with the leading causes of death in Vietnam. This may include disease surveillance, data collection, epidemiologic studies, laboratory-based studies, and the evaluation of interventions and/or control methods including therapeutic and preventative treatments.

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

1. Acute febrile illness (AFI)

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

nosocomial or hospital acquired infections)

3. Vaccine-preventable diseases

4. Vector-borne diseases

5. Respiratory illness and influenza

6. Enteric illnesses

7. Other public health issues of regional and local importance

RESEARCH CATEGORIES

Applicants must propose projects that focus on the disease area(s) selected in at least one of the following research categories. In the first year of award, applicants may only submit up to five projects total. All 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:

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

Examples of projects that characterize public health threats are:

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

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

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

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

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

Provide innovative solutions identified through research to develop early warning systems to report sentinel organisms in humans that can serve as an alert for multidrug resistant organisms and interventions for adequate antimicrobials.

Project Category B: Determine Most Effective Implementation Approaches:

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

Examples of projects that address effective implementation approaches are:

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

Develop cost of disease estimates and cost effectiveness estimates for priority diseases and associated interventions, e.g., vaccines, infection prevention and control in healthcare settings.

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

Project Category C: Measuring Impact

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

Examples of projects that measure impact are:

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

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

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

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

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

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

Collaboration/Partnerships The MOH is the focal point for global health security and IHR compliance in Vietnam. The MOH is located in the Vietnam capital city, Hanoi, and operates through a network of four public health regional institutes: National Institute of Hygiene and Epidemiology (NIHE), Pasteur Institute in Ho Chi Minh City (PD-HCMC), Tay Nguyen Institute of Hygiene and Epidemiology (TIHE), and Pasteur Institute in Nha Trang (PI-NT). The MOH collaborates across all administrative levels of the Vietnam health system and other governmental sectors.

In addition to the U.S. government agencies (CDC, USAID, Department of Defense, and Department of State), the MOH collaborates with the following partners to implement GHSA and advance the country’s ability to combat infectious diseases:

Domestic

1. Ministry of Agriculture and Rural Development

2. Ministry of National Defense

3. Ministry of Natural Resources and Environment

4. Ministry of Science and Technology

5. National Universities

International partners

1. World Health Organization (WHO)

2. World Organisation for Animal Health (OIE)

3. Food and Agriculture Organization of the United Nations (FAO)

4. Program for Appropriate Technology in Health (PATH)

5. World Bank

6. Asian Development Bank

7. Association of Public Health Laboratories

8. South Asia Field Epidemiology and Technology Network (SafetyNet)

9. Oxford University Clinical Research Unit

10. Partnership for Avian and Human Influenza

11. American Society for Microbiology

12. Sandia National Laboratories

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.

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

Questions to consider in preparing this section include:

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

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

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

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

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

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

Questions to consider in preparing this section include:

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

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

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

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

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

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

Questions to consider in preparing this section include:

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

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

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

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

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

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 The estimated total level of funding (in U.S. dollars) available, including direct and indirect costs, for the first budget period period is $1,000,000. The estimated total level of funding (in U.S. dollars) available, including direct and indirect costs, for the full five year period of performance is $5,000,000.

Anticipated Number of Awards: 1 The estimated total level of funding (in U.S. dollars) available, including direct and indirect costs, for the first budget period period is $1,000,000. The estimated total level of funding (in U.S. dollars) available, including direct and indirect costs, for the full five year period of performance is $5,000,000. The number of awards will be up to 1 (one).

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

Award Ceiling: $1,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

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

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

Section III. Eligibility Information

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

Information on Eligibility" for clarification) http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

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 Single source competition. Only the application from the Ministry of Health (MOH) in the Socialist Republic of Viet Nam will be accepted.

4. Justification for Less than Maximum Competition Eligibility for funding under this NOFO is limited to the Ministry of Health (MOH) in the Socialist Republic of Vietnam in order to expand the collaboration with CDC. The MOH assists the Minister in implementing state management functions and organizing the implementation of legal regulations in the field of preventive medicine. Within the MOH are four public health regional institutes: National Institute of Hygiene and Epidemiology (NIHE), Pasteur Institute in Ho Chi Minh City (PI-HCMC), Tay Nguyen Institute of Hygiene and Epidemiology (TIHE), and Pasteur Institute in Nha Trang (PI-NT), that are responsible for epidemiologic surveillance, response, and laboratory confirmation for priority pathogens. VietnamThe MOH provides essential public health services nationally and regionally and is responsible for the prevention, detection and response of infectious diseases.

The MOH is the most qualified and appropriate entity in Vietnam to conduct activities specified under this NOFO:

1. MOH is the only entity that has the legal mandate, obligation, and technical capacity to implement activities nationally and regionally. The GVN relies heavily upon the MOH to execute essential functions that will advance the country's public health agenda.

2. MOH is responsible for coordinating “the formulation of assigned strategies, plans, programs, projects and proposals in the field of preventive medicine” and submitting them to the relevant authorities for approval and direction. MOH is also responsible for the implementation of scientific research, application of information technologies, and 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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf international cooperation in the field of preventive medicine.

3. The MOH is positioned to oversee and safeguard public health and to collect, analyze, and disseminate information via research reports. They have the ability to utilize existing public health networks and other partners to assure the accomplishments of the research goals of this NOFO.

4. MOH is the focal point for Vietnam's GHSA and IHR implementation. In 2015, the USG designated Vietnam as a GHSA Phase 1 country and committed to working with the government to build capacity to prevent, detect, and respond to infectious disease threats.

MOH/GDPM is the key governmental agency that will enable CDC to execute this commitment.

5. The MOH has the infrastructure and capacity to effectively conduct research activities in Vietnam. CDC working through its strong partnerships with the MOH will assure the implementation and evaluation of public health research programs that will result in the prevention and control of diseases both communicable and non-communicable nationally and regionally.

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 https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf 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 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 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), http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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 applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

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

As defined in the HHS Grants Policy Statement, (https://www.hhs.gov/sites/default/files/grants /grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit.

HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Section IV. Application and Submission Information

1. Address to Request Application Package 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.

https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf https://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 (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 requirements of the NOFO.

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

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:…