Foa_Content_of_CDC-RFA-GH21-2166.pdf

Centers for Disease Control and Prevention

Center for Global Health

Strengthening the healthcare system of Vietnam through capacity building, policy development and quality improvement of disease surveillance, laboratory and clinical services.

CDC-RFA-GH21-2166

07/24/2021

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH21-2166. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Strengthening the healthcare system of Vietnam through capacity building, policy development and quality improvement of disease surveillance, laboratory and clinical services.

C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

New Type 1

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH21-2166

E. Assistance Listings Number:

93.318 F. Dates:

1. Due Date for Letter of Intent (LOI):

N/A

2. Due Date for Applications:

07/24/2021 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph As external support for Vietnam’s public health programs is declining, there is a need to expand and sustain the country’s capacity to ensure accuracy of diagnostic testing, consistency in the standards of care for patients, and Vietnam’s capacity to quickly and effectively respond to public health threats and emerging outbreaks. This NOFO aims to contribute to improving the quality of hospital and laboratory services within the curative system, health care services for people living with HIV (PLHIV) and workforce development support. In addition, this NOFO aims to build capacities to prevent, detect, respond, and control infectious and non-communicable diseases, injuries, and public health emergencies through strengthening laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95-95-95 goal for sustained epidemic control and strengthening health security in healthcare settings through enhanced detection of health threats, more robust responses to those threats, and establishment of evidence-based policies aimed at preventing threats in the first place.

a. Eligible Applicants:

Single

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards

d. Total Period of Performance Funding:

$ 275,000,000

e. Average One Year Award Amount:

$ 5,000,000

f. Total Period of Performance Length:

g. Estimated Award Date:

September 30, 2021

h. Cost Sharing and / or Matching Requirements:

No Part II. Full Text A. Funding Opportunity Description

1. Background

a. Overview

Vietnam has made impressive progress toward improving the health status of the population;

however, many challenges remain. Health sector reviews have identified an emerging burden of non-communicable diseases and infectious diseases, an aging population, inadequate capacity of the health system, and problems of inequities in access to health and health care. As external support for Vietnam’s public health programs is declining, there is an obvious need to expand and sustain the country’s capacity to ensure accuracy of diagnostic testing, consistency in the standards of care for patients, and Vietnam’s capacity to quickly and effectively respond to public health threats and emerging outbreaks.

To address these needs, this NOFO focuses on (i) strengthening laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95-95-95 goal for sustained epidemic control and (ii) strengthening health security in healthcare settings through enhanced detection of health threats, more robust responses to those threats, and establishment of evidence-based policies aimed at preventing threats in the first place.

Key expected long-term outcomes from this five-year cooperative agreement (CoAg) include increased access to and wide use of routine Viral Load and recency testing as an essential part of the public health response; new HIV testing platforms transferred to Government of Vietnam and that are reimbursed by social health insurance; and increased use of surveillance (e.g., community and healthcare-associated infections) and laboratory (e.g., Antimicrobial Resistance, pathogen characterization for vaccine development) data as the evidence base for national and sub-national formulation of public health and clinical policy to prevent healthcare-associated infections and AMR in healthcare settings.

In addition to Core Global Health Security Priorities and PEPFAR Country Operation Plan (COP) Target for Quarter 1 (Component 1) and COP21 Q2, 3, 4 Targets (Component 2), and COP21 Additional Targets (Component 3), this NOFO will support additional activities when a disease outbreak or other public health emergency reaches a scale that requires a moderate (Component 4, Rapid Response to Small Scale Infectious Disease Outbreaks or Other Public Health Emergencies) or substantial response (Component 5, Rapid Response to Large-Scale Infectious Disease Outbreaks or other Public Health Emergencies). This NOFO also supports activities to combat COVID-19 and other emerging infectious disease threats (Component 6, Emerging Infectious Disease Threats [EIDT]). Applicants must apply to all components.

b. Statutory Authorities This work is authorized under the Public Health Service Act 301, 307 (42 USC 241 and 242l), and Section 317(k)(1) of the Public Health Service Act [42 USC 247b(k)(1)].

c. Healthy People 2030 This project supports the following Healthy People 2030 topic areas:

Global Health Public Health Infrastructure Health Care Access and Quality Infectious Disease

Emergency Preparedness

d. Other National Public Health Priorities and Strategies Activities funded through this cooperative agreement must align with the following United States Government (USG) and HHS/CDC strategies and policies:

CDC’s strategy for improving global health security (GHS), based on three concepts embedded in the agency’s mission to protect public health worldwide: 1) Prevent 2) Detect 3) Respond https://www.cdc.gov/globalhealth/security/index.htm

The Department of Health and Human Services’ (HHS) Global Health Strategy https://www.hhs.gov/about/agencies/oga/about-oga/why-hhs-works-globally/hhs-global-strategy/index.html

International Health Regulations (IHR) and supporting policies and frameworks https://www.who.int/topics/international_health_regulations/en/

e. Relevant Work This NOFO is a follow-on to and will build on the achievements of CDC-RFA-GH15-1596, which included:

Formulation of National Strategy on HIV/AIDS Prevention and Control to 2020, with a vision to 2030; National Laboratory Strategic Plan to 2020 and the 1st Circular no.

01/2013/TT-BYT on Laboratory Quality Management for Health Facilities.

Establishment of Laboratory Quality Management Bureau under Vietnam Administration of Medical Services (VAMS) in 2010, as well as the three Regional Medical Laboratory Quality Control Centers in 2011.

Creation of the laboratory networks to support laboratories throughout the countries in quality management and quality assurance to reach national/international accreditation.

Finalization of the National Strategy on Protection, Care, and Improvement of the People's Health (2011–2020), developing National Action Plan for Viral Hepatitis Prevention Control (2014-2019) and technical guidelines of viral hepatitis diagnosis and treatment of hepatitis B (HBV) and hepatitis C (HCV) and issuing a set of criteria to assess hospitals towards improving the quality of services provided.

Standardization of hospital ranking criteria and service quality evaluation, contributing to improving quality of health care services, including HIV diagnosis, examination and treatment services.

Implementation of Vietnam’s National Action Plan to Combat Antimicrobial Resistance:

CDC-RFA-GH15-1596 provided direct support to strengthen the sentinel surveillance system through expanding the system from 16 to 34 AMR surveillance sites to monitor the use of antibiotics while encouraging antibiotic stewardship, as well as developing regulations that will protect human and animal health; conducted the quality and capacity of the AMR surveillance laboratories and training and mentoring for selected labs;

promoted proper infection prevention and control (IPC) practices to stopping spread of resistant germs in healthcare settings; and implement standardized HAI surveillance in six hospitals.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-21-2166 Logic Model Component 1: Core Global Health Security Priorities and PEPFAR Country Operation Plan (COP) Target for Quarter 1

Strategies Short-Term Outcomes (1-3yrs)

Intermediate Outcomes (3-5 years)

Long-Term Outcomes (5 years or more)

Strategy 1: Strengthen health security in healthcare settings through enhanced DETECTION of public health threats and outbreaks, more robust RESPONSES to those threats, establishment of evidence-based policies aimed at PREVENTING threats, and creating a platform for immunization.

Strategy 2: Strengthen laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95-95-95 goal for sustained epidemic control.

Improved surveillance and laboratory reporting of infectious diseases and AMR

Decreased data errors through implementation of electronic systems

Enhanced ability of clinical and public health workforce to identify unusual events and report them rapidly and comprehensively to the next higher level (e.g., district to province to national)

A new platform for immunization for children, adult, and health care workers become available

Increased implementation of continuous quality improvement program (CQI) methods by all HIV

Increased use of surveillance and laboratory data as the evidence base for national and sub-national formulation of public health and clinical policy

Improved ability of healthcare workers to respond to outbreaks of infectious diseases in healthcare settings and in communities

Reduced inappropriate use of antimicrobials in healthcare settings.

Increased assess to vaccines, include COVID-19 vaccine by all.

Increased access to and wide use of routine VL and recency testing as an essential part of

Enhanced capacity for early detection and real-time reporting of public health threats

Reduced healthcare-associated infections and

AMR

Increased vaccine coverage, reduced outbreaks and illness

Increased national use of HIV VL and recency testing to inform routine public health response in Vietnam

Expanded coverage of new HIV

Strategies Short-Term Outcomes (1-3yrs)

Intermediate Outcomes (3-5 years)

Long-Term Outcomes (5 years or more)

VL labs

Improved national LQMS scores in labs in PEPFAR supported provinces

Improved VL turnaround time

(TAT)

Reduced reporting errors for VL and HIV recency results

Increased support for innovative HIV testing platforms such as HIV self-test, multi-diseases diagnostic integration, including

STI

the public health response.

Improved access and awareness of policies and guidance available for implementation of new verified HIV testing platforms testing platforms reimbursed by GVN under social health insurance

Components 2 and 3: COP21 Q2, 3, 4 and Additional Targets

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term

Strategy 1:

Strengthen laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95- 95-95 goal for sustained epidemic

Increased implementation of continuous quality improvement program (CQI) methods by all HIV VL labs

Improved national LQMS scores in labs in PEPFAR supported provinces

Increased access to and wide use of routine VL and recency testing as an essential part of the public health response.

Improved access and awareness of policies and guidance available for

Increased national use of HIV VL and recency testing to inform routine public health response in Vietnam

Expanded coverage of new HIV testing

Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term control.

Improved VL turnaround time

(TAT)

Reduced reporting errors for VL and HIV recency results

Increased support for innovative HIV testing platforms such as HIV self-test, multi-diseases diagnostic integration, including STI implementation of new verified HIV testing platforms platforms reimbursed by GVN under social health insurance

Components 4, 5 and 6: Rapid Response to Small-Scale and Large-Scale Infectious Disease Outbreaks or other Public Health Emergencies and Emerging Infectious Disease Threats

(EIDT)

Activities

Short-Term Outcomes

Intermediate

Long Term Outcomes

Strategy 1:

Intensify active surveillance, case finding, contact tracing, monitoring and other outbreak response measures at local levels

Strategy 2:

Strengthen capabilities for epidemiologic and laboratory analysis and program

Improved time to deploy healthcare workers to respond and control the spread of infectious diseases

Strengthened coordination and robust emergency preparedness and response capacities

Reduced time to reinvigorated public health activities that have been interrupted or slowed due to outbreak response

Improved access health services by individuals in outbreak affected areas

Increased

Sustained improvements in timeliness of achieving outbreak/epidemic/pandemic control

Reduced morbidity and mortality attributed to disease outbreaks or other public health threats

Reduced spread of infectious outbreaks into other countries

Improved preparedness for potential future outbreaks and other highly infectious diseases

Activities

Short-Term Outcomes

Intermediate

Long Term Outcomes evaluation

Strategy 3:

Intensify social mobilization, community and professional education and engagement.

Strategy 4:

Improve outbreak case management and infection control

Strategy 5:

Strengthen non-outbreak related public health activities that are impacted by the outbreak

Strategy 6:

Increase security and logistics for local responders

Strategy 7:

Strengthen capabilities for preparedness and response to highly infectious diseases

Improved disease outbreak case management and infection control

Shortened time to detect highly infectious disease outbreaks through active surveillance and case finding

Reduced transmission of highly infectious diseases in clinical and community settings

Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level.

Achieved rapid identification of and containment of highly infectious disease outbreaks capacity of countries for early warning, risk reduction and management of national and global health risks

i. Purpose

The purpose of this NOFO is to contribute to improving the quality of hospital and laboratory services within the curative system, including health care services for people living with HIV;

support workforce development; and build capacities to prevent, detect, respond, and control infectious and non-communicable diseases, injuries, and public health emergencies. Please note the PEPFAR COP21 components follow the same logic model and the same strategies and activities should be accomplished over different periods of time (Q1, Q2, etc.). The emergency components (Components 4 – 6) also follow the same approach with the same overarching strategies and activities.

ii. Outcomes Component 1: Core Global Health Security Priorities and PEPFAR Country Operation Plan (COP) Target for Quarter 1

Short-term Outcomes:

o Improved surveillance and laboratory reporting of infectious diseases and AMR.

Surveillance includes both indicator and even-based surveillance systems available in healthcare facilities as well as the national surveillance system for AMR and HAI.

o Decreased data errors through implementation of electronic systems Fewer records with missing data, greater accuracy among records that are submitted o Enhanced ability of clinical and public health workforce to identify unusual events (i.e.: potential indicators of new diseases or outbreak) and report them rapidly and comprehensively to the next higher level (e.g., district to province to national) through FETP integrated training package for IPC surveillance and mentoring workshops.

o Creating a platform for immunization for children, adult, and health care workers o Increased implementation of CQI methods by all HIV VL labs

Implementation of CQI methods in VL labs should help build capacity for the labs supported to achieve national or ISO15189 accreditation o Improved national LQMS scoring in PEPFAR supported provinces o Improved VL turnaround time (TAT) o Reduced reporting errors for VL and HIV recency results o Increased support for innovative HIV testing platforms such as HIV self-test, multi-diseases diagnostic integration, including STIs

Intermediate Outcomes:

o Increased use of surveillance and laboratory data as the evidence base for national and sub-national formulation of public health and clinical policy.

o Improved ability of healthcare workers to respond to outbreaks of infectious diseases in healthcare settings and in communities through a strengthened IPC program.

o Reduced inappropriate use of antimicrobials in healthcare settings through efforts to improve capacity for AMR surveillance including improved identification of prioritized pathogens and susceptibility testing, data analysis and data use.

o Increased access to vaccines, include COVID-19 vaccine by all.

o Increased access to and wide use of routine VL and recency testing as an essential part of the public health response.

o Improved access and awareness of policies and guidance available for implementation of new verified HIV testing platforms.

Long-Term Outcomes:

o Increased vaccine coverage, reduce outbreaks and illness o Increased national use of HIV VL and recency testing to inform routine public health response in Vietnam o Expanded coverage of new HIV testing platforms reimbursed by GVN under social health insurance

Short-term Outcomes:

o Outcome 1: Increased implementation of CQI methods by all HIV VL labs

Implementation of CQI methods in VL labs should help build capacity for the labs supported to achieve national or ISO15189 accreditation o Outcome 2: Improved national LQMS scoring in PEPFAR supported provinces o Outcome 3: Improved VL turnaround time (TAT) o Outcome 4: Reduced reporting errors for VL and HIV recency results o Outcome 5: Increased support for innovative HIV testing platforms such as HIV self-test, multi-diseases diagnostic integration, including STIs

Intermediate Outcomes:

o Outcome 1: Increased access to and wide use of routine VL and recency testing as an essential part of the public health response.

Increased access involves an expansion of accredited HIV testing labs that have the ability to confirm test result and provide quality control (QC), and external quality assessments (EQA) for lower level (e.g.: provincial or district) labs.

o Outcome 2: Improved access and awareness of policies and guidance available for implementation of new verified HIV testing platforms.

Long-Term Outcomes:

o Outcome 1: Increased national use of HIV VL and recency testing to inform routine public health response in Vietnam o Outcome 2: Expanded coverage of new HIV testing platforms reimbursed by

GVN under social health insurance

(EIDT)

Short-term Outcomes o Improved time to deploy healthcare workers to respond and control the spread of infectious diseases o Strengthened coordination and robust emergency preparedness and response capacities o Improved disease outbreak case management and infection control o Shortened time to detect highly infectious disease outbreaks through active surveillance and case finding o Reduced transmission of highly infectious diseases in clinical and community settings o Increased awareness, knowledge, and support for local disease outbreak response and prevention efforts at the community level.

o Rapid identification of and containment of highly infectious disease outbreaks

Intermediate Outcomes o Reduced time to reinvigorated public health activities that have been interrupted or slowed due to outbreak response o Improved access health services by individuals in outbreak affected areas o Increased capacity of countries for early warning, risk reduction and management of national and global health risks

Long-term Outcomes o Sustained improvements in timeliness of achieving outbreak/epidemic/pandemic control o Reduced morbidity and mortality attributed to disease outbreaks or other public health threats o Reduced spread of infectious outbreaks into other countries

Improved preparedness for potential future outbreaks and other highly infectious diseases

iii. Strategies and Activities Component 1: Core Global Health Security Priorities and PEPFAR Country Operation Plan (COP) Target for Quarter 1

Strategy 1: Strengthen health security in healthcare settings through enhanced DETECTION of public health threats, more robust RESPONSES to those threats, establishment of evidence-based policies aimed at PREVENTING threats and creating a platform for immunization.

Surveillance:

Train clinical healthcare staff in case management, surveillance, electronic reporting, and basic data management/analysis of surveillance data for communicable diseases

Develop procedures for data and information sharing between clinical and preventive medicine systems

Develop and disseminate guidelines and procedures on surveillance data reporting from healthcare facilities

Implement an electronic surveillance system for both indicator-based and event-based surveillance system in all healthcare facilities

Develop case management procedures for priority diseases/syndromes Create an automatic linkage to transfer case information from hospital information system to the MOH Circular 54 reporting (electronic communicable disease surveillance

- eCDS) system

Standardize electronic health records to ensure interoperability and integration of patient information with other reporting platforms/tools for infectious diseases

Enhance laboratory capacity to detect respiratory viral pathogens including influenza and coronavirus in selected hospitals

AMR:

Develop a clear terms of reference (TORs), collaboration mechanism and coordinate activities of the relevant ministries on AMR

Conduct the AMR coordination meetings quarterly with plan and progress review Development of National Action Plan (NAP for period of 5 years (2021-2025) to address

AMR and reflected the Global Action Plan (GAP) objectives with operational plan and monitoring arrangements

Review and analysis AMR and HAI surveillance data regularly with national annual report

Upgrade AMR/HAI electronic reporting systems with data visualization and automatic function to support analysis and produce AMR report

Develop and disseminate training/mentoring materials and assessment tools on AMR lab testing capacity

Develop training packages and protocols on IPC/HAI Conducted training/mentoring to identify selected/prioritized pathogens, susceptibility testing and QMS Standardized quality improvement program for IPC Expand AMR surveillance sites based on NAP Expand HAI surveillance and include private sector Develop protocol for HAI infection target ventilation associated pneumonia (VAP) Update AMR and HAI surveillance reporting system for expand sites and new infections Develop training curriculum/package on IPC for medical students and IPC staff Implement training on IPC as professional program by medical universities or medical training centers with recognized certification (via class/distance training).

Implement IPC integrated FETP training and mentoring for hospital system, target IPC staff/respond to outbreak and unusual events.

Conduct survey/assessment of stewardship policies and activities, including regulatory framework and supply chain management of antimicrobials Develop and disseminate national stewardship and clinical/treatment guidelines for antibiotics use.

Implement stewardship program, including monitoring of antimicrobial use, education/communication and other interventions to improve antibiotic use at designated healthcare facilities.

Immunization:

Create facility-based immunization policy Develop model and system Develop guidelines and other material Implementation Monitoring and supervision

Strategy 2: Strengthen laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95-95-95 goal for sustained epidemic control

On-going monitoring of hospital VL labs to ensure high-quality VL testing Link laboratory information management system (LIMS), including VL, to the existing hospital HIS platforms to improve TAT and reduce reporting error of results Update HEALTHQUAL indicators and assess the viability of increasing reporting frequency to twice a year Provide technical assistance and training to ensure continuous quality improvement methods applied in all HIV VL labs.

Improve turnaround time (TAT) and reduce reporting error of results in HIV diagnosis, VL and recency testing.

Develop and support policy and guidance for implementation of new platforms of HIV testing which are verified and performed Introduce new HIV testing (HIV serology and VL) platform to contribute to 95-95-95 goals Support GVN to operate and register for social health insurance for new HIV testing platforms Provide training to strengthen capacity of health care staff, including but not limited to

CQI methods, reporting results of HIV diagnosis, VL and recency testing and new HIV testing platforms.

Increase use of routine VL and recency testing and testing results in data analysis to identify new outbreaks/hotspots and provide evidence base for appropriate public health responses.

Strategy 1: Strengthen laboratory and clinical quality management within the curative system to ensure high quality of HIV testing towards 95-95-95 goal for sustained epidemic control

On-going monitoring of hospital VL labs to ensure high-quality VL testing

Link laboratory information management system (LIMS), including VL, to the existing hospital HIS platforms to improve TAT and reduce reporting error of results

Update HEALTHQUAL indicators and assess the viability of increasing reporting frequency to twice a year

Provide technical assistance and training to ensure continuous quality improvement methods applied in all HIV VL labs.

Improve turnaround time (TAT) and reduce reporting error of results in HIV diagnosis, VL and recency testing.

Develop and support policy and guidance for implementation of new platforms of HIV testing which are verified and performed

Introduce new HIV testing (HIV serology and VL) platform to contribute to 95-95-95 goals

Support GVN to operate and register for social health insurance for new HIV testing platforms

Provide training to strengthen capacity of health care staff, including but not limited to CQI methods, reporting results of HIV diagnosis, VL and recency testing and new HIV testing platforms.

Increase use of routine VL and recency testing and testing results in data analysis to identify new outbreaks/hotspots and provide evidence base for appropriate public health responses.

(EIDT)

Strategy 1: Intensify active surveillance, case finding, contact tracing, monitoring, and other critical response efforts at local levels

Conduct and improve ongoing active surveillance, with laboratory confirmation to ensure rapid identification of missed, new or newly imported outbreak cases

Strengthen capacity for general surveillance including support for personnel required for surveillance and epidemiology activities.

Strengthen surveillance at entry points (border posts, airports and maritime ports) from countries with ongoing transmission

Strategy 2: Strengthen capabilities for epidemiologic and laboratory analysis and program evaluation

Improve operational and technical analysis, coordination and monitoring of interventions Assess the impact of the epidemic on health care seeking and health care provision

Strategy 3: Intensify social mobilization, community and professional education and engagement, and psychosocial care for infected persons and their families where applicable

Conduct intensified social mobilization and community engagement to enhance awareness and gather community support, acceptance and participation in implementation of containment measures

Provide psychosocial first aid training for community agents and their supervisors so they can provide direct psychosocial support to contact cases and their families.

Develop and conduct communications to contain the outbreaks and enforce the theme of "Staying at Zero Cases."

Develop and disseminate key health risk communication messages.

Strategy 4: Improve outbreak case management and infection control Develop plans for patient management as community and clinical settings.

Improve infection control practices, particularly in facilities that might receive outbreak cases for example, on a border with a country with ongoing transmission

Strategy 5: Strengthen non-outbreak related public health activities that are impacted by the outbreak

Restore priority aspects of the health/public health system such as surveillance and assessment of vaccination coverage for epidemic-prone disease (e.g., measles), that are negatively impacted or stalled due to the outbreak.

Strategy 6: Increase security and logistics for local responders Strengthen field security to ensure operational security, and protect national and international staff involved in the response

Strategy 7: Strengthen capabilities for preparedness and response to highly infectious diseases

Develop/implement partnership mechanisms for a more robust and responsive global health emergency workforce.

Train frontline responders on emerging infectious diseases.

Strengthen critical International Health Regulations (IHR) and health systems capacities in affected region and elsewhere.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

Recipient(s) are required to work with other CDC implementing partners, including non-governmental organizations, universities, Ministries of Health and other host governmental bodies and multi-lateral organizations that receive CDC funds. Recipient(s) should ensure their proposed activities are not duplicating activities already implemented by other CDC-funded organizations.

b. With organizations not funded by CDC:

The recipient(s) will work primarily and directly with partner governments specifically with the Ministries of Health and other government entities who are working towards the objectives of this NOFO. In addition, the recipient(s) will be expected to work with other in-country and global stakeholders, including but not limited to government entities, non-governmental organizations, universities, civil society, the private sector, and other USG agencies.

2. Target Populations The target population for this NOFO include those populations that fall under the following jurisdiction(s): Vietnam

The target populations for this NOFO include, but are not limited to, those individuals infected and affected by infectious diseases, or at risk for becoming infected by an infectious disease. The target population for this NOFO may also include at-risk population for non-communicable diseases and/or other public health emergencies.

The work under this NOFO may also target increased capacity at the national and sub-national level to implement activities in alignment with the objectives of this NOFO.

a. Health Disparities Recipients are expected to use epidemiologic, social determinants, and linked laboratory, epidemiological, and surveillance data to identify communities disproportionately affected by infectious diseases or non-communicable diseases in the target areas to ensure that program activities appropriately cover these populations. Recipients should ensure that supported services are accessible and available to all patients regardless of age, sex, race/ethnicity, sexual orientation, gender identity, or socio-economic status in order to achieve the outcomes of this

NOFO.

iv. Funding Strategy This NOFO is divided into six components. Applicants are required to apply for all components and include a separate budget and work plan for each component. The applicant’s application package should be inclusive of all component work plans and budgets; multiple applications will not be reviewed. Applicants are encouraged to submit component budgets toward the year one award ceiling for each component. However, budget proposals for year one may not exceed the year one award ceiling. Please note these amounts are subject to approval and the availability of funds.

Components 1, 2, and 3 are specific to PEPFAR Country Operation Plan (COP)21 targets.

Component 1 is specific to the PEPFAR COP target for Quarter 1. Component 2 is specific to the PEPFAR targets for Quarters 2 through 4. Component 3 includes additional PEPFAR activities and targets. The PEPFAR COP21 components intend to fund the same activities over different periods of time. The emergency components (Components 4 – 6) also follow the same approach with identical overarching strategies and activities. Please note Component 1 covers both core Global Health Security (GHS) priorities, as well as, the PEPFAR COP21 target for Quarter 1.

Component 1: Core Global Health Security Priorities and PEPFAR Country Operation Plan (COP) Target for Quarter 1 These GHS activities are intended to be funded on an annual basis. The estimated year one ceiling is $5,000,000. Future years funding level will be dependent on funding availability.

Component 2: PEPFAR COP21 Q2, Q3, Q4 Targets This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities in quarter 2, quarter 3 and quarter 4 of the fiscal year. Expected amount to be funded is $10,000,000.

Component 3: PEPFAR COP21 Additional Targets This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities and targets needed within the budget period. Expected funding amount is $10,000,000.

Component 4: Rapid Response to small scale infectious disease outbreaks or other Public Health Emergencies This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities needed within a budget period when a disease outbreak or other public health emergency reaches a scale that requires a moderate response. Estimated year one ceiling is $5,000,000.

Component 5: Rapid Response to Large Scale Infectious Disease Outbreaks or other Public Health Emergencies This is intended to be approved but unfunded (ABU) as a baseline practice. It would be funded to support additional activities needed within a budget period when a disease outbreak or other public health emergency reaches a scale that requires a substantial response. Estimated year one ceiling is $10,000,000.

Component 6: Emerging Infectious Disease Threats (EIDT) This is intended to be an approved but unfunded (ABU) component that will support activities to combat COVID-19 and other emerging infectious disease threats globally, including efforts related to global health security, global disease detection and response, global health protection, global immunization, and global coordination on public health. It would be funded to support additional activities needed within a budget period for COVID-19 and other emerging disease threats. Estimated year one funding amount is $15,000,000.

Emergency Management and Response The ability to respond rapidly and effectively to public health emergencies is a key component of global health security. International public health emergencies including humanitarian crises are by nature unpredictable, requiring fulfilment of changing and often unpredictable needs that vary widely according to context. Consequently, funding for public health emergencies is also unpredictable and based on external factors. In recent years, there has been a sharp rise in the number of people living in regions of the world affected by public health emergencies, including humanitarian emergencies, which has often led to additional funding resources from the USG to respond to these threats. Given this unpredictability and the resulting need for rapid, flexible, and efficient process to award funding under an emergency situation, recipients that are selected for funding under this NOFO will be eligible to receive additional expedited supplemental funding when a public health emergency occurs to scale up activities included within the scope of work of this NOFO.

Definition of public health emergency:

In order to qualify for supplemental emergency funding, one of the following situations must apply:

1. When UN or WHO classifies the emergency as a Level 3 (L3)

2. When the US Congress appropriates funding for an international response related to humanitarian or public health crisis with the words containing “emergency” in the program title. The appropriated funding could be for CDC directly or is transferred to CDC through an Interagency Agreement (IAA) by HHS or another USG department or agency

3. When the U.S. government (Congress, White House, National Security Council, etc.)

declares a public health emergency as national security priority

4. When the CDC Director activates the Emergency Operation Center (EOC) in response to an international public health threat

5. When U.S. Department of State or U.S. Agency for International Development (USAID) transfer funds to CDC to respond to an international disaster or humanitarian assistance under 2 FAM 060 (International Disaster and Humanitarian Assistance)

If a public health emergency situation meets any one criteria listed above, then selected recipients under this NOFO will be eligible to receive supplemental emergency funding to scale up public health activities included in the scope of work of this NOFO on a single-source basis, (i.e., without additional competition), within a 12-month budget period and throughout the 60-month period of performance. There is no limit on the number of emergency supplemental funding that a recipient may receive within a 12-month budget period or the 60-month period of performance under a public health emergency situation. Recipients receiving funds under a public health emergency will be eligible to receive emergency funding without constraint to the period of performance funding ceiling, annual budget period ceiling, or lack of component funding. In addition, applications for funding under a public health emergency will not need a merit review and will only require approval from the CDC Project Officer and Grants Management Officer (GMO) in order to be funded.

All reporting requirements listed under this NOFO still applies to any emergency supplemental funding.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The applicant should describe how they plan to measure and collect data on the funded activities and bolded outcomes identified in the logic model. The purpose of collecting and reporting these data is to determine the progress toward achieving the NOFO activities and outcomes. The results will also be used for program planning, development and improvement, accountability and reporting, and for sharing with partners and other stakeholders. CDC will work with the recipient throughout the life of this award to ensure that all activities and expected outcomes are in alignment with current USG and the recipient’s strategies and goals. The recipient should dedicate funds made available under this NOFO for evaluation and performance monitoring within each project. The final funding amount will be agreed upon by both CDC and the recipient; however, it should be expected that approximately 3% (of a given project’s funding) will be dedicated to monitoring, reporting, and evaluation activities. CDC and the recipient will agree upon the specific funding amounts within review of each project’s work plan and budget.

Monitoring CDC expects that the work conducted under this NOFO will be structured as a series of discrete projects oriented at achieving elements of the NOFO’s strategic objectives. CDC and the recipient will jointly develop formal performance measures shortly after award based on activities within each project. For each project, these performance measures must include CDC’s Division of Global Health Protection’s Division-wide Indicators (DWIs), as well as other CDC or recipient’s standard indicators relevant to the intended outcomes of the project. The DWIs include indicators that are required reporting for CDC, such as for OMB, HHS, USG Global Health Security Agenda (GHSA) interagency, and Healthy People. At a minimum, applicants should describe proposed process measures for the strategies and activities in the logic model, and proposed outcome measures for the period of performance outcomes in the logic model.

While recipients will be responsible for reporting on DWIs relevant to proposed strategies and activities, they are not limited to only DWIs listed below. Applicants can, and are encouraged to, propose additional relevant indicators that, combined with relevant DWIs, will be monitored over the life of the NOFO. Recipients will also be encouraged to identify relevant USG GHSA Interagency Metrics, WHO Joint External Evaluation (JEE), and/or Healthy People 2030 standardized metrics and WHO benchmarks.

Technical Area Division of Global Health Protection (DGHP) Division-wide Indicators (DWIs) as of April 2019* WD#1: Number of individuals trained by CDC to prevent, detect and respond to public health threats

WD#2: Number of Field Epidemiology Training Program (FETP) residents trained by CDC that have participated in outbreak investigations and responses WD#3: Number and proportion of subnational jurisdictions per country that have had at least one staff member trained by FETP-Frontline

Workforce Development

(WD)

WD#4: Number of CDC staff ready to provide emergency management and response assistance EMR#1: Number of public health events of international importance monitored and reported

EMR#2: Number of public health events and other global health emergency responses supported by CDC

Emergency Management and Response (EMR)

EMR#3: Number of outbreaks investigated and responded to by the country

EMR#4: Number and proportion of countries with an established Public Health Emergency Operations Center (PHEOC) that have used their PHEOC for a real-world response or simulation SS/LS#1: Number and proportion of country-prioritized diseases and pathogens with laboratory testing capacity, surveillance system, and routine reporting to public health authorities

SS#2: Number and proportion of countries with a centralized national database that includes linked suspect case reports and laboratory data from subnational jurisdictions for the country’s priority notifiable diseases/syndromes LS#2: Number and proportion of designated laboratories that have bio-risk management policies, physical security controls and inventories for potential high consequence pathogens and toxins LS#3: Number of new diagnostic tests established in national or regional laboratories with CDC support LS#4: Number of new strains or pathogens detected or discovered with CDC support LS#5: Number and proportion of countries that have developed a national laboratory specimen referral system and transport networks LS#6: Number and proportion of laboratory facilities, designated in the national action plan for antimicrobial resistance (AMR) or as part of a national surveillance system, that conduct antimicrobial susceptibility testing (AST) and have reported susceptibility data to a designated national body

Surveillance Systems (SS) and Laboratory Systems (LS)

LS #7: Number and proportion of countries that have adopted and implemented a national program of quality management systems (QMS) ID#1: Number of countries with a National Public Health Institute (NPHI) that was strengthened with CDC support

Institutional Development (ID) ID#2: Number of countries whose core public health functions

(laboratory, surveillance, workforce development and emergency management and response) are coordinated by the NPHI

* These indicators are subject to change; the latest iteration of the DGHP DWIs should be incorporated into the recipient’s EPMP.

Performance reports will be based on which NOFO activities and outcomes are identified in the logic model. Performance reports will be submitted to CDC in accordance with the requirements listed under this NOFO and overall performance will be reviewed on regular technical calls as well as through joint strategic review meetings.

Evaluation

The potential evaluation questions and/or topics below are examples of what the applicant may be expected to answer through evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation questions, or evaluation topics if specific questions are unknown. It is acceptable to provide only evaluation questions, only evaluation topics, or a combination of both evaluation questions and topic, as needed. Applicants should consider but are not limited to the following areas when developing evaluation questions and/or topics.

Sample Evaluation Topics:

Program evaluations to measure the differences in outbreak responses, or other public health responses, in a country, before and after public health investments (in terms of days of outbreak start, days to outbreak detection, laboratory confirmation of outbreak, days to control outbreak, etc.).

Extent to which enhancements in public health surveillance in a country improved outbreak response (in terms of outbreak(s) controlled, cases averted, and time lags from specimen detection to collection).

Extent to which enhancements of the public laboratory systems, such as addition of a specific laboratory capacity in a country, improved outbreak response (in terms of outbreaks detected controlled, cases averted, and time lags from specimen collection to detection).

Program evaluations to measure if the coverage and capacity of the specimen referral network increased

Final evaluation questions and data sources will be determined together with CDC within six months after the award and will be included in the submission of the evaluation and performance measurement plan (EPMP). Evaluations are expected to align with national, USG, and agency priorities and programmatic gaps, and maybe be reviewed by global action committees. As such, the evaluation topics listed in this announcement may be amended.

Dissemination of Evaluation and Performance Measures: By the end of the period of performance, evaluation and performance measures will yield findings to demonstrate the value of the NOFO. The findings should be disseminated through the Annual Performance Report (APR) and the recipient is expected to pursue additional dissemination in public domains, including in public health journals, including global health journals, conferences and through informal channels (e.g., website, newsletters) where applicable

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award,…