RFA-GH-21-001.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of

Public Health (MOPH) in the Kingdom of Thailand

RFA-GH-21-001

Application Due Date: 02/15/2021

Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of

Public Health (MOPH) in the Kingdom of Thailand

RFA-GH-21-001

TABLE OF CONTENTS

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

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

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health National Center for Chronic Disease Prevention and Health Promotion National Center for Emerging and Zoonotic Infectious Diseases National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention National Center for Immunization and Respiratory Diseases National Center on Birth Defects and Developmental Disabilities Notice of Funding Opportunity (NOFO) Title Conducting Public Health Research in Thailand: Technical collaboration with the Ministry of Public Health (MOPH) in the Kingdom of Thailand Activity Code U01

Notice of Funding Opportunity Type Reissue of RFA-GH-16-003 Agency Notice of Funding Opportunity Number

RFA-GH-21-001

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

Health NOFO Purpose The purpose of the Notice of Funding Opportunity is to conduct epidemiologic, clinical, field and laboratory research on important human infectious diseases, with an emphasis on HIV/AIDS, malaria, emerging and re-emerging infectious diseases, zoonotic diseases, neglected tropical diseases, tuberculosis, influenza, coronaviruses and other diseases with pandemic potential, to include research on mobile and vulnerable populations. Environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, biosafety, and injury control and prevention are also priority areas for this funding opportunity.

Key Dates Publication Date: To receive notification of any changes to RFA-GH-21-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

Letter of Intent Due Date: 01/15/2021 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: 04/01/2021

Secondary Review: 06/01/2021

Estimated Start Date: 09/01/2021

Expiration Date: 02/16/2021 Due Dates for E.O. 12372: 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 instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

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.

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 epidemiologic, clinical, field and laboratory research on important human infectious diseases, with an emphasis on HIV/AIDS, malaria, emerging and re-emerging infectious diseases, zoonotic diseases, neglected tropical diseases, tuberculosis, influenza, coronaviruses and other diseases with pandemic potential to include research on mobile and vulnerable populations. Environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, biosafety, and injury control and prevention are also priority areas for this funding opportunity.

Mechanism of Support: Cooperative Agreement Funds Available and Anticipated Number of Awards: 1 Approximately $35,000,000 is expected to be available for the total project period.

Funding to be awarded through this NOFO is contingent upon availability of funds.

Because the nature and scope of the proposed research will vary from application to application, it is also anticipated that the size and duration of each award may also vary.

Because this is an umbrella cooperative agreement, the total amount awarded, and the number of awards, will depend upon the number, quality, duration and cost of the applications received and program priorities.

Budget and Period of Performance: 09/01/2021 - 08/31/2026 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: Sole source – Thailand MOPH Institutions/organizations listed in Section III.1 are eligible to

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

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): Letter of Intent Due Date: 01/15/2021

Application Materials: See Section IV.1 for application 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 Section 307 of the Public Health Service Act [42 USC 242l], as amended and Section 301 (a) of the Public Health Service Act [42 USC 241(a)], as amended.

1. Background and Purpose The Centers for Disease Control and Prevention (CDC) within HHS is committed to achieving the health promotion and disease prevention objectives of the National Prevention Strategy, National HIV/AIDS Strategy, and the National Health Security Strategy. The Thailand Ministry of Public Health (MOPH) is the key governmental agency that will enable CDC to execute its approved global health strategy and other public health priorities in Thailand. CDC, working through its strong partnerships with Ministries of Health, will assure the implementation and evaluation of public health research programs that will result in the prevention and control of both communicable and non-communicable diseases in Thailand, and apply these to other international settings. Over the past 20 years, MOPH and CDC have conducted research, achieved goals and accomplished objectives that have improved the health and quality of life of Thai citizens and had global health impact. These collaborations between CDC and Thailand MOPH have led to breakthroughs in research, improved programmatic practices, and strengthened laboratory systems. The MOPH has in place the central, provincial and district-based organizational and public health structures required to immediately engage in these and future activities. This is an umbrella cooperative agreement that will facilitate collaboration between multiple CIOs within CDC and the Thailand MOPH for the conduct of public health research on diseases of importance to both the United States and Thailand.

The purpose of the NOFO is to conduct epidemiologic, clinical, field and laboratory research on important human infectious diseases, with an emphasis on HIV/AIDS, malaria, emerging and re-emerging infectious diseases, zoonotic diseases, neglected tropical diseases, tuberculosis, influenza, coronaviruses and other diseases with pandemic potential, to include research on mobile and vulnerable populations. Environmental health issues, chronic diseases, birth defects and developmental disabilities, maternal and child health, public health preparedness, biosafety, and injury control and prevention are also priority areas. This NOFO is in alignment with HHS/CDC performance goals and Global Health security objectives to prepare for, prevent, detect, respond to, and contain health threats globally by providing global health promotion, health protection and health diplomacy. It also aligns with theUnited States Government Global Health Security Strategy (2019) (https://www.whitehouse.gov/wp-content/uploads/2019/05 /GHSS.pdf).

In addition, many of the lifestyle risk factors for non-communicable diseases (NCDs) like https://www.whitehouse.gov/wp-content/uploads/2019/05/GHSS.pdf https://www.whitehouse.gov/wp-content/uploads/2019/05/GHSS.pdf improper nutrition, sedentary lifestyle, alcohol and tobacco use are becoming more prevalent in Thailand. This has led to the emergence of NCDs as important causes of morbidity and mortality. The three leading causes of death in Thailand in 2017 were ischemic heart disease, stroke and lower respiratory infections (http://www.healthdata.org/thailand). NCDs also have an impact on the Thai health care system. There are dramatically increasing numbers of inpatient and outpatient visits for hypertension, diabetes, stroke, and ischemic heart disease even though the death rate for cardiovascular diseases, diabetes and injury are delayed and decreased. These trends also have a major impact on health care financing, thus underscoring the importance of placing more effort on proven health promotion strategies and research that are known to be effective in reducing the burden of NCDs and injury. Research project proposals submitted in response to this NOFO will broadly address:

Health Impact: Improve the health and well-being of people in Thailand, the ASEAN region and the world.

Health Security: Improve the capabilities to prevent, prepare, detect, and respond.

Health Capacity: Strengthen and sustain public health capacity, infrastructure, management and monitoring.

Healthy People 2030 and other National Strategic Priorities This NOFO aligns with the current CDC strategic priorities including strengthening surveillance, epidemiology and laboratory services; supporting public health activities;

increasing global health impact; increasing impact on public health policy; and preventing illness, injury, disability and death.

Public Health Impact The Thailand MOPH, in collaboration with CDC, has produced new disease prevention and intervention strategies that have had significant global public health impact. From the establishment of the Field Epidemiology Training Program in 1980 to current efforts to meet the growing challenges of drug-resistant malaria, TB, HIV, emerging infectious diseases, migrant and border health, and NCDs, Thailand MOPH stands ready to work with CDC to meet new challenges.

Relevant Work The MOPH has the primary responsibility within the Thailand government to address public health issues and is the only organization in Thailand that possesses the requisite scientific and technical expertise and infrastructure capacity to do so. These combined attributes make the MOPH uniquely qualified as the only organization in Thailand capable of effectively conducting public health research and other program activities proposed for this umbrella cooperative agreement. In addition, the MOPH is uniquely positioned in terms of constitutional authority, mandate and ability to oversee and safeguard public health, and to collect and analyze information and disseminate research reports related to multiple health issues. They can utilize existing public health networks and other partners to assure the accomplishment of research goals as required in this cooperative agreement.

The MOPH–TUC Coordinating Unit (Co-Unit), established according to the Memorandum of http://www.healthdata.org/thailand

Agreement of the Thailand MOPH – U.S. CDC Collaboration (TUC), is under the jurisdiction of the Strategy and Planning Division, Office of the MOPH Permanent Secretary. The Co-unit is overseen by the Director of the Strategy and Planning Division (SPD) who serves as the Co- Unit Business Official and supervised by the Deputy Directors who serve as the Co-Unit Manager and the Co-Unit Assistant Manager. Assigned officials from the SPD are serving as the full-time Co-Unit staff of the Research Project Cluster and the Non-Research Project Cluster. The Co-Unit cooperates closely with the Thailand MOPH – U.S.CDC Collaboration (TUC) Center on its main role to support the TUC project implementation of all collaborative programs under the current five-year Cooperative Agreement (CoAg) Phase 4 (Fiscal Year 2017

– 2021). The responsibilities of the Co-Unit include the following:

1. Serving as the TUC Committees’ Secretariat and organizing the committee meetings

2. Coordinating and supporting the Office of International Cooperation, Department of Disease Control and the TUC Center on the TUC Steering and Sub-Steering Committees’ meetings, screening of proposed projects, follow up of project progress and other activities including establishment of strategic framework and logic models, submission of policy issues for consultation to the TUC Executive Committee and administrative issues to the TUC Administrative Committee

3. Supports the TUC project implementation of all collaborative programs that receive funding awards from the U.S. CDC

4. Tracking performances and submitting timely reports to the U.S. CDC, such as the Federal Financial Reports, Equipment Inventory Report, Research Performance Progress Report

(RPPR)

5. Managing and/or supporting the monitoring and evaluation of the project implementation

6. Organizing and/or supporting workforce development related to the collaboration through workshop, training, and study visits within Thailand and abroad.

2. Approach Applicant should prepare research project proposals based on the overarching objectives and the program specific objectives listed below. Each project should have a project name and ID.

Projects that are continuing from prior cooperative agreements should retain the same project name and unique project identifier in the new cooperative agreement. These should be submitted as continuation projects. The new projects should be identified as new and should follow all the components of the SF 424 Research Strategy section. Please refer to Section IV for application submission and guidance for more specific information.

Objectives/Outcomes The recipient of the award from this NOFO may be supported by multiple programs from within CDC, hence the term ‘umbrella cooperative agreement’. There are 7 different components in this NOFO (labeled A-G), each of which represents a different CDC CIO that will be supporting activities under the respective component.

Project proposals from each component will address one or more of the following broad focus areas as outlined in the CDC-MOPH Collaboration Framework:

1. Workforce capacity development and capacity in epidemiology, laboratory and evidence-based action

2. Quality public health systems and services

3. Prevention, preparedness, and response to public health threats

4. Enhance research and innovation capacity and opportunities collaboration

Results of this research will be incorporated into operational health promotion and disease prevention and control programs in the Kingdom of Thailand. Expertise and research findings will be shared with other nations, non-governmental agencies and academic institutions.

Components A-G are listed below along with the program specific objectives;

A. DIVISION OF HIV/AIDS PREVENTION (DHAP)

• Evaluate the efficacy and effectiveness of new and/or improved modalities for the prevention of HIV, reduction of HIV morbidity and related conditions. Modalities include, but are not limited to; biomedical, behavioral, and structural interventions, such as vaccines, pharmacological prophylaxis, treatment as prevention, and other forms of prevention.

• Improve treatment and diagnosis of HIV infection and associated conditions for adults and children including, but not limited to, collaborative/network studies and studies of acute infections and potential strategies for cure of HIV infection.

B. DIVISION OF PARASITIC DISEASES AND MALARIA (DPDM)

• Conduct malaria operational research and monitoring and evaluation activities to assess the efficacy/effectiveness of currently deployed malaria diagnosis and control tools, and improve routinely collected surveillance data.

• Evaluate the effectiveness of malaria control interventions including long-lasting insecticide-treated nets (LLITNS), indoor residual spraying (IRS) and other methods of transmission reduction.

• Evaluate the effectiveness of all aspects of the case management pathway including appropriate referral, diagnosis, correct prescribing and appropriate messaging at all levels of the health systems.

• Evaluate the therapeutic efficacy of antimalarials to treat uncomplicated and severe malaria.

• Evaluate the therapeutic efficacy of antimalarials used to address the negative consequences of malaria in pregnancy.

• Evaluate the use of innovative vector control intervention measures such as insecticide treated materials, including use of combination insecticide-treated bednets and insecticide-treated wall liners.

• Evaluate the use of new strategies that target malaria parasite reservoirs, such as mass screen and treat and mass drug administration.

• Support research and infrastructure to accelerate progress towards malaria elimination in the Mekong region, including testing new tools/interventions to further reduce malaria transmission.

• Build epidemiological, entomological, laboratory, health economics, and social science capacity at MOPH and other regional Ministries of Health.

C. DIVISION OF GLOBAL HEALTH PROTECTION (DGHP)

• Intervention studies to reduce the burden of priority diseases and syndromes.

• Public health research studies to determine disease burden and risk factors in special populations.

• Research studies for disease burden and risk factors at the animal-human interface (One Health).

• Projects to foster innovations in science and technology for the development of new public health interventions and operational research to improve uptake of known interventions.

• Research to address infectious diseases as well as zoonotic diseases, including developing and expanding innovative and improved detection, interventions, treatments, and responses and the implementation or expansion of sustainable surveillance systems.

• Operational research studies formalizing monitoring and evaluation for public health program implementation in Thailand.

o Includes the evaluation of emergency preparedness and response o Includes health system strengthening o Implement and evaluate systems and projects for increasing capacity for point-of-care diagnostics o Evaluate existing and novel technologies and methodologies for disease surveillance ? Best practices ? Relative value

• Conduct Field Epidemiology Training Program activities to include outbreak investigations, surveillance system assessments, as well as non-communicable and communicable research projects.

• Projects focusing on improved capacity to respond to disease outbreaks and other public health emergencies.

D. DIVISION OF GLOBAL HIV/AIDS and TUBERCULOSIS (DGHT)

• Conduct research on tuberculosis epidemiology, prevention, case finding and diagnosis, and treatment, including clinical trials, implementation-focused research and evaluation, and other forms of investigation.

• Improve the use of TB research data to inform public health policy both by building capacity to use data in this manner and by working with the Ministry of Health to translate findings into action.

E. INFLUENZA

• To enhance influenza surveillance, not only to monitor influenza viruses and generate evidence to inform estimation of burden; but also, to extend these platforms to monitor vaccine immunogenicity, efficacy and effectiveness, and antiviral effectiveness. This will occur in the context or broader capacity building on pandemic preparedness, outbreak and advanced laboratory support, and support for Thailand to develop capacity to manufacture its own influenza vaccines.

• To monitor vaccine effectiveness and uptake, including identifying barriers to vaccination in high-risk groups.

F. NON-COMMUNICABLE DISEASES (NCD)

• Develop field research and program implementation and evaluation on NCDs and injury.

• Strengthen public health officers’ capacity in NCD research development, program planning and evaluation.

• Strengthen laboratory research capacity for screening and diagnosis of NCDs.

• Strengthen NCD surveillance activity and its data utilization.

• Research to address Environmental Health issues, chronic diseases, Maternal and Child

Health, Public Health Preparedness, Biosafety, and Injury Control and Prevention.

G. SURVEILLANCE AND LABORATORY STRENGTHENING

• Projects to strengthen surveillance activities and impact assessment capacity.

• Projects to strengthen laboratory capabilities necessary for the diagnosis of human and animal infectious diseases of public health priority in Thailand and the region.

Applicants may propose a variety of projects that address the priorities under each of the components listed above. Applicants must specify the component addressed and include a project title. All continuation projects from the previous award cycle must be labeled ‘CONTINUATION’ and use the exact same project title as that in the previous cooperative agreement. New projects should be labeled ‘NEW’. Applicants must submit a separate Research Plan and Budget for each project as a single PDF. Applicants must also provide 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 Thailand. Applicant may propose new projects, as well as continuation of existing projects that propose new objectives and activities to address emerging diseases as well as risk factors associated with the leading causes of death in Thailand.

Applicant should be cautious not to submit projects that are funded and expected to be continued under the previous CoAg (GH16-003), specifically the ones that are funded as supplements in budget year 4.

Target Population Target populations at high-risk for influenza-associated morbidity and mortality include individuals aged ≥65 years, individuals with chronic underlying medical conditions, young children aged six months to five years, pregnant women, and healthcare personnel.

Target populations for malaria research should include people living or working in epidemiologically defined areas of malaria transmission. Sub-population target groups within these malaria transmission zones should include those most at-risk e.g., children under five years of age and pregnant women.

Target populations at high-risk for HIV/AIDS include people living with HIV, men who have sex with men, and transgender women in geographic areas where those populations are concentrated.

Non-communicable disease and injury interventions/research target populations include general populations groups (all age groups), high risk populations, and populations with NCDs and injuries.

Other target populations for research activities include children less than five years of age at risk for respiratory diseases and vaccine preventable diseases including diphtheria, pertussis, and measles; and all age groups at risk for food and water borne diseases, specifically salmonellosis and Hepatitis B and C and non-communicable diseases including road traffic injuries, cancer, hypertension, and diabetes. In addition, vulnerable populations to include migrant and mobile populations.

Collaboration/Partnerships Applicants should list organizations and Principal Investigators (PIs) that will be involved in the proposed research proposal. Letters of support from partners and collaborators are encouraged.

Evaluation/Performance Measurement The awardee will be evaluated on a project by project basis under each component. Evaluation metrics will include:

1. The ability to perform research and evaluation addressing the public health priorities outlined in the NOFO

2. Whether the research has the potential to contribute to reduction of burden of disease, and

3. If recommendations derived from the studies will result in the development or refinement of public health policies or improved implementation of effective prevention, control, and treatment activities.

Translation Plan Applicant should be prepared to exchange and share research results, materials and tools with CDC and other public health partners for further research development. Applicant should describe plans for how research findings will be reported and disseminated (e.g., peer-reviewed journals, national fora, scientific presentations, meetings and conferences) and specify how these activities are integrated into the project plan. The translation of findings should be understandable to a variety of audiences (both professional and public), including policy makers, practitioners, public health programs, healthcare institutions, professional organizations, community groups, researchers, and other potential users.

Incorporate results of research or study on NCD and injury into operational NCD prevention and control programs. Translate results to develop policies and programs in the region and internationally.

Questions to consider in preparing this section include:

How will the scientific findings inform public health policy or practice?

How will the project improve or affect the translation of research 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 findings advance or guide future research efforts or related activities?

How will the research improve health outcomes?

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: $35,000,000

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: $7,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

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

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

Section III. Eligibility Information

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

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf 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 Only the application from the Ministry of Public Health (MOPH) in the Kingdom of Thailand will be accepted.

4. Justification for Less than Maximum Competition The MOPH is the only organization in Thailand that possesses the requisite scientific and technical expertise and the infrastructure capacity to address public health issues. MOPH also has the primary responsibility within the Thailand government to address public health issues.

These combined attributes make them uniquely qualified as the only organization in Thailand capable of effectively conducting the research and public health program activities proposed for this umbrella cooperative agreement. The MOPH is uniquely positioned in terms of its constitutional authority, mandate and ability to oversee and safeguard public health, to collect and analyze information, and to disseminate research findings related to multiple health issues.

They can utilize existing public health networks and other partners to assure the accomplishment of research goals as required in this cooperative agreement.

The MOPH has in place the central, provincial and district-based structures required to immediately engage in the activities listed in this announcement. The MOPH is the key governmental agency that will enable CDC to execute its approved global health strategy.

Specifically, the Center for Global Health (CGH) working through its strong partnerships with MOPH 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, in Thailand. Over the past 20 years, with four consecutive Cooperative Agreements, the MOPH has strengthened HIV/AIDS prevention, care, training and surveillance programs; increased TB surveillance; and scaled up successful pilot projects. Under the second, third and fourth Cooperative agreement, the collaboration expanded to include International Emerging Infectious Diseases, migrant and border health (DGMQ), and influenza and non-communicable disease (NCD) activities. The MOPH has achieved their goals and accomplished objectives that have led to improving the health and quality of life of Thai citizens. These collaborations between CDC and Thailand MOPH have led to breakthroughs in research, improved programmatic practices, strengthened laboratory systems and improved vaccine capacity in Thailand. These advances benefit not only Thailand, but also have had regional and global impact.

5. Responsiveness If an applicant requests a funding amount greater than the ceiling of $7,000,000 as indicated in 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

Section II. of this NOFO, HHS/CDC will consider the application non-responsive and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

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://cage.dla.mil/

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/index.html .

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 https://cage.dla.mil/ https://www.sam.gov/index.html https://www.Grants.gov https://era.nih.gov/ https://www.grants.gov http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform 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), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Applicant organizations may submit one application.

Section IV. Application and Submission Information

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

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH 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 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-f/general-forms-f.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: 01/15/2021 Letter of Intent Applicant:

Please include the following information in the Letter of Intent:

PI name Institution name Components being applied for:

New projects under each component, with titles Continuation projects under each component, with titles

LOI should be sent via e-mail by Jan 15th, 2021 to: Email: lkumar@cdc.gov

Lata Kumar, ERPO Director, Office of Science, Office of the Director, Center for Global Health, CDC http://grants.nih.gov/grants/how-to-apply-application-guide.htm https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf

1600 Clifton Road, MS D-69 Atlanta, GA 30033

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-f/general-forms-f.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:

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

All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.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

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

Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies). Follow the page limits in the SF 424 unless otherwise specified in the NOFO. All instructions in the SF424 (R&R) Application Guide https://grants.nih.gov/grants/how-to-apply-application-guide/forms- e /general-forms-e.pdf and here: https://apply07.grants.gov/apply/forms/sample/SF424B- V1.1 .pdf must be followed along with any additional instructions provided in the NOFO. Applicants that plan to collect public health data must submit a Data Management Plan (DMP) in the Resource Sharing Plan section of the PHS 398 Research Plan Component of the application. A DMP is required for each collection of public health data proposed. 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.

https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general-forms-f.pdf http://grants.nih.gov/grants/how-to-apply-application-guide.htm 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 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 https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf https://apply07.grants.gov/apply/forms/sample/SF424B-V1.1.pdf

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…