Amendment # 1 72062124RFA00003 - USAID Usalama wa Afya Duniani (Global Health Security).pdf

Amendment Number 1 Issue Date: April 23, 2024 Deadline for Submission of Concept Notes: May 6, 2024 Full Application Submission Date: o/a June 19, 2024; 00:00 East African Time

Reference: Notice of Funding Opportunity Number: 72062124RFA00003

Subject: Amendment Number 1 Under Request for Application Program Title: USAID Usalama wa Afya Duniani (Global Health Security) Project Dear Prospective Applicants:

The purpose of this amendment is to provide answers to the questions received regarding the subject NOFO and to make the following change to the NOFO:

● In SECTION A: PROGRAM DESCRIPTION o Previous and Related Awards, the link associated with the PREVENT project has been updated.

● In SECTION D: APPLICATION AND SUBMISSION INFORMATION o 4.1.2.1: Phase I Concept Paper - Technical Approach, the Estimated High Level

Budget template has been revised to include a separate supplemental budget line item for Crisis Modifier fund and Indirect Costs.

o 5.1.2: Phase II Full Application – Management and Staffing Approach, the following requirement has been added for the Key Personnel’s CV submission.

The responses to the questions received regarding the subject NOFO are provided as attachment.

Except as provided in this amendment, all terms and conditions of the NOFO remain unchanged and in full force and effect.

Thank you for your interest in USAID programs.

Sincerely, Brian K. Woody Agreement Officer

Notice of Funding Opportunity (NOFO) Number: 72062124RFA00003 USAID Usalama wa Afya Duniani (Global Health Security) Project

Table of Contents

SECTION A: PROGRAM DESCRIPTION

SECTION B: FEDERAL AWARD INFORMATION

SECTION C: ELIGIBILITY INFORMATION

SECTION D: APPLICATION AND SUBMISSION INFORMATION

SECTION E: APPLICATION REVIEW INFORMATION

SECTION F: FEDERAL AWARD ADMINISTRATION INFORMATION

SECTION G: FEDERAL AWARDING AGENCY CONTACT(S)

SECTION H: OTHER INFORMATION

Annexes

LIST OF ACRONYMS

AAR After Action Review AMR Antimicrobial Resistance AMS Antimicrobial Stewardship AWaRe Access, Watch and Reserve BSBS Biosafety and Biosecurity BSL Biosafety Level CDCS Country Development Cooperation Strategy EBS Event Based Surveillance EID Emerging Infectious Diseases EPR Emergency Preparedness and Response EVD Ebola Virus Disease FAO Food and Agriculture Organization of the United Nations GHS Global Health Security HCAI Health Care Associated Infections HIV Human Immunodeficiency Virus HSS Health Systems Strengthening IDDS Infectious Disease Detection and Surveillance IHR International Health Regulations IPC Infection Prevention and Control JEE Joint External Evaluation LIMS Laboratory Information Management System LGHS Local Global Health Security MCC Multisectoral Coordination Committee MDRO MultiDrug Resistant Organism MOH Ministry of Health MOLF Ministry of Livestock and Fisheries NAP-AMR National Action Plan for Antimicrobial Resistance NAPHS National Action Plan for Health Security NIH U.S. National Institutes of Health OHS One Health Section PMO Prime Minister’s Office RCCE Risk Communication and Community Engagement SARS Severe Acute Respiratory Syndrome SPAR State Party Self-Assessment Annual Reporting Tool TWG Technical Working Group UHPR Universal Health and Preparedness Review WHO World Health Organization USAID The U.S. Agency for International Development

SECTION A: PROGRAM DESCRIPTION

A. PURPOSE

The U.S. Agency for International Development (USAID) Global Health Security (GHS) Program seeks to prevent and mitigate the increasing occurrence and severity of epidemics, pandemics and other emerging infectious disease threats. We do this by partnering with countries, as well as global, regional, and local public and private sector organizations. These partnerships build and strengthen measurable, sustainable capacity while helping to develop and adopt evidence-based and innovative solutions to prevent, rapidly detect, effectively respond to, and ultimately recover from emerging infectious disease (EID) threats1 – whether naturally occurring, accidental, or deliberate.

The purpose of the USAID Usalama wa Afya Duniani (Global Health Security) Project is to support the strengthening of Tanzania’s capacities to develop, validate, and implement interventions to prevent, detect, and respond to EID threats in Tanzania using a One Health approach2. Specifically, this Project will focus on:

● Building capacity at a national level, and zonal and regional healthcare facilities, to prevent, detect and monitor antimicrobial resistance (AMR), implement antimicrobial stewardship (AMS), and prevent the spread of resistant organisms;

● Strengthening the quality of the laboratory system to rapidly and accurately detect and report EIDs and AMR;

● Supporting Government of Tanzania systems to achieve the 7-1-7 metric for timeliness of outbreak response;

● Institutionalizing consistent infection prevention and control (IPC) practices among healthcare workers in medical facilities;

● Preventing the accidental or intentional spread of pathogens within and from laboratories through consistent implementation of stringent biosafety and biosecurity (BSBS) practices;

● Empowering zonal and regional facilities to strengthen and monitor health security practices, particularly in AMS and IPC, at regional and district-level facilities; and

● Proactively conducting multisectoral engagement and coordination with stakeholders from across the national and subnational levels, public and private sectors, and both the animal and human sectors to ensure a One Health approach.

1 EIDs are defined by the U.S. National Institute of Health (NIH) and the World Health Organization (WHO) as infectious diseases that have newly appeared in a population or have existed but are rapidly increasing in incidence or geographic range including antimicrobial resistance (AMR) and a wide range of zoonotic infectious diseases and pathogens.

2 One Health is defined by the US Centers for Disease Control and Prevention (CDC) as collaborative, multisectoral, and transdisciplinary approach—working at the local, regional, national, and global levels—with the goal of achieving results that recognize the interconnection between people, animals, plants, and their shared environment.

B. BACKGROUND

Context

Global Context An analysis of 335 emerging infectious diseases (EID) in humans between 1940 and 2004 revealed a number of important characteristics including: (1) the incidence of EID events is increasing over time; (2) 60% of EIDs are zoonotic and, of those, 72% are from wildlife; (3) the origins of EIDs are correlated with socio-economic, environmental, and ecological factors and are concentrated in tropical and subtropical regions of the world; and (4) global resources to address EIDs are poorly allocated3.

There have been many examples4 between 2014 and 2022 which together demonstrate that many lower- and middle-income countries do not yet have adequate capacities and/or systems to respond to or reduce the spillover of emerging zoonotic viruses from animals to people or subsequent amplification and spread. These outbreaks underscored for countries, regions, and the world the effect that an emerging pathogen can have on people’s health and global economies, as well as the importance of strengthening country capacities to prevent, detect, and respond to EID threats -whether naturally occurring, accidental, or deliberate. Outbreaks are becoming more frequent as interactions between humans, animals, and the environment increase, exacerbated by factors such as climate change, expanded globalization, and greater population densities and migration.

Additionally, the emergence and spread of pathogens that have acquired new drug-resistance mechanisms, leading to antimicrobial resistance (AMR), is a growing global health threat. In 2019, AMR was the leading cause of death worldwide, attributed to the death of 1.27 million people -more than HIV or malaria - and sub-Saharan Africa had the highest fatality rates with 27.3 deaths per 100,000 directly attributable to resistance while 114.8 deaths per 100,000 were associated with bacterial AMR.5

While the impacts on health are clear, outbreaks can also have significant socio-economic impacts that result from reduced commerce, travel and trade. Studies have shown that the original SARS outbreak (2003) was predicted top reach $40 billion in economic losses6, the West Africa Ebola epidemic in Guinea, Liberia, and Sierra Leone (2014-2015) resulted in an estimated economic and

3 Global Trends in Emerging Infectious Diseases, Jones, et al., Nature, 2008, Vol 451: pp 990-994.

4 For example: 2014-2015 Ebola outbreak in West Africa; 2015 MERS-CoV outbreak in South Korea; 2016 yellow fever outbreak in Angola with spread to DR Congo, Kenya, and China; 2017-2018 plague outbreak in Madagascar;

2018-present Lassa outbreak in Nigeria; 2018-2022 Ebola outbreak in DR Congo with spread to Uganda; the 2019- 2022 SARS-CoV-2 epidemic; the 2021-present monkey pandemic; Nipah outbreaks in India in 2022-2023; and Marburg in Cote d’Ivoire and Tanzania in 2023. Common characteristics of many of these events include: rapid spread in urban areas (Ebola, MERS-CoV, plague, SARS-CoV-2, yellow fever); spread in health care settings (Ebola, Lassa, MERS-CoV, plague, SARS-CoV-2, Marburg); and failure to rapidly apply proven interventions including vaccination (yellow fever) or IPC (Ebola, Lassa, MERS-CoV, plague, SARS-CoV-2).

5 Antimicrobial Resistance Collaborators (2022), “Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis”, Lancet, 399(10325), pp.629-655, DOI:https://doi.org/10.1016/S0140-6736(21)02724-0 6 Lee JW, McKibbin WJ. ESTIMATING THE GLOBAL ECONOMIC COSTS OF SARS. In: Institute of Medicine (US) Forum on Microbial Threats; Knobler S, Mahmoud A, Lemon S, et al., editors. Learning from SARS: Preparing for the Next Disease Outbreak: Workshop Summary. Washington (DC): National Academies Press (US); 2004.

Available from: https://www.ncbi.nlm.nih.gov/books/NBK92473/ https://doi.org/10.1016/S0140-6736(21)02724-0 https://www.ncbi.nlm.nih.gov/books/NBK92473/ social burden of $53 billion7, and in the US alone, the cost of the COVID-19 pandemic has been estimated at $16 trillion.8,9

The U.S. National Biosecurity Strategy (2022) included GHS as national priority and proposed a target to provide direct support to at least 50 countries to achieve ‘Demonstrated Capacity’ or comparable level (depending on country context10) in at least five technical areas critical to the country, by 2025, as measured by relevant health security assessments, such as those conducted within the WHO International Health Regulations (IHR) Monitoring and Evaluation Framework, such as the Joint External Evaluation (JEE), State Party Self-Assessment Annual Reporting Tool (SPAR), and/or other relevant health security assessments. U.S. Missions in the direct support countries (including Tanzania) were requested to provide the five or more technical areas in which this aim could be achieved in their countries; for Tanzania, the areas selected were AMR, IPC, laboratory systems, biosafety and biosecurity, surveillance, zoonotic disease, human resources, health emergency management, and points of entry. Of these technical areas, the first seven fall under USAID Agency-wide GHS priorities.

In addition to this, the broader GHS community is adopting the “7-1-7” metric to measure and improve a country’s capabilities in health security, within the context of outbreak detection and response. This metric is defined as: every suspected outbreak is identified within 7 days of emergence, reported to public health authorities with initiation of investigation and response efforts within 1 day, and effectively responded to—as defined by objective benchmarks—within 7 days11.

Each of the subcomponents of this metric can be broken down to a series of capabilities. First, in order to detect within a short time frame, citizens need to be able to access care and treatment, and healthcare workers need to be fluent in disease case definitions so symptoms can be detected.

Furthermore, laboratory systems need to have the requisite materials and capabilities to conduct differential and confirmatory diagnosis. Second, countries should already be aware that notification of a public health emergency within 24 hours is already required under the IHR (2005)12. In order to do this, countries must be able to report into global systems. Additionally, it is critically important to maintain clear reporting structures between the subnational and national levels, so healthcare workers can rapidly receive information for action. They must also have robust data systems that can triangulate clinical and laboratory data for reporting. Third, a holistic, effective outbreak response is multifaceted, requiring components of coordination, epidemiology, laboratory, case

7 Caroline Huber, Lyn Finelli, Warren Stevens, “The Economic and Social Burden of the 2014 Ebola Outbreak in West Africa” (2018), The Journal of Infectious Diseases, 218(5), pp. S698–S704, https://doi.org/10.1093/infdis/jiy213 Accessed 25 October 2023 8 Cutler DM, Summers LH. The COVID-19 Pandemic and the $16 Trillion Virus. JAMA. 2020;324(15):1495–1496.

doi:10.1001/jama.2020.19759 9 Josh Michaud, Kellie Moss, and Jennifer Kates, “The US Government and Global Health Security” (KFF, July 25, 2023), https://www.kff.org/global-health-policy/issue-brief/the-u-s-government-and-global-health-security/ Accessed 25 October 2023 10 Under the JEE, this equates to a score of 4 or 5 in a specific technical area 11 Freiden TR, Lee CT, Bochner AF, Buissonnière M, McClelland A. 7-1-7: an organising principle, target, and accountability metric to make the world safer from pandemics. Lancet 398(10300): 638-640.

https://doi.org/10.1016/S0140-6736(21)01250-2 12 International Health Regulations (2005): third edition. https://www.who.int/publications/i/item/9789241580496 Date accessed: October 27, 2023.

https://extranet.who.int/sph/spar https://doi.org/10.1093/infdis/jiy213 https://www.kff.org/person/josh-michaud/ https://www.kff.org/person/kellie-moss/ https://www.kff.org/person/jennifer-kates/ https://www.kff.org/global-health-policy/issue-brief/the-u-s-government-and-global-health-security/ https://doi.org/10.1016/S0140-6736(21)01250-2 https://www.who.int/publications/i/item/9789241580496 management, supply chain, risk communications and community engagement, and as needed, countermeasures.

Tanzanian Context Tanzania is populated by 60 million people and has the third largest livestock population in Africa

– approximately 33.9 million cattle, 87.7 million poultry, 24.5 million goats, 8.5 million sheep, 4 million dogs, 3.2 million pigs, and 657,389 donkeys. Tanzania is also the fourth largest biodiversity entity globally, with approximately 20% of the species of Africa’s large mammal population. These opportunities for animal-human contact, the human encroachment of wildlife ecosystems, intensification of agriculture, population growth and migration, urbanization, climate change and the strong reliance on livestock and agriculture for livelihood enable the potential spillover of pathogens between wildlife, livestock, and humans. Because of the increased opportunities for human contact with wildlife and livestock, and the downstream socio-economic and economic impacts derived from unchecked zoonotic diseases and resistant microbes, a multisectoral “One Health” response that addresses EIDs at the intersection between humans, animals, and the environment is critically important.

As of 2020, Tanzania had an estimated 1.29 million hospital-associated drug-resistant infections per year,13 thus reiterating the critical need for solutions to increase IPC activities and address AMR. It is estimated that the highest levels of improper dispensing are at the primary level and in the private sector. The country recently updated its National Action Plan for AMR, and while the Plan has largely been disseminated, implementation has been inconsistent across the public sector

- particularly at the subnational level - and largely nonexistent in the private sector.

In 2016, Tanzania joined the other WHO African Region Member States in endorsing the Regional Strategy for Health Security and Emergencies 2016–2020, which was updated in 2022 to incorporate the lessons learned from COVID-19.14 The strategy aims to strengthen and sustain national capacity to prepare for, detect, and respond to public health emergencies, embracing a “One Health” approach. By adopting the strategy, Member States agreed to reach 12 targets by 2030 to reach the aim of contributing to the reduction of morbidity, mortality, disability and socioeconomic disruptions due to disease outbreaks and other health emergencies in the WHO African Region. These targets include 80% of Member States having predictable and sustainable health security financing, 90% mobilizing an effective response to public health emergencies within 24 hours of detection and all countries having 80% of health districts with functional service delivery and quality improvement programmes.

Tanzania has maintained a strong political commitment for One Health implementation. It is coordinated through the One Health Section (OHS), a unit under the Division of Disaster Management in the Prime Minister’s Office. The OHS was established in 2018 and is mandated to

13 Ruchita Balasubramanian, Thomas P. Van Boeckel, Yehuda Carmeli, Sara Cosgrove, and Ramanan Laxminarayan, “Global incidence in hospital-associated infections resistant to antibiotics: An analysis of point prevalence surveys from 99 countries”, PLOS Medicine June 2023, https://doi.org/10.1371/journal.pmed.1004178, Accessed October 26, 2023 14 Regional strategy for health security and emergencies 2022-2030, https://www.afro.who.int/sites/default/files/2022-07/AFR-RC72- 8%20Regional%20strategy%20for%20health%20security%20and%20emergencies%202022-2030%20.pdf https://doi.org/10.1371/journal.pmed.1004178 https://www.afro.who.int/sites/default/files/2022-07/AFR-RC72-8%20Regional%20strategy%20for%20health%20security%20and%20emergencies%202022-2030%20.pdf https://www.afro.who.int/sites/default/files/2022-07/AFR-RC72-8%20Regional%20strategy%20for%20health%20security%20and%20emergencies%202022-2030%20.pdf coordinate activities of technical working groups (training, advocacy and communication, preparedness and response, research and development, and surveillance) and a national multisectoral One Health technical committee comprised of directors from core OH sector implementing ministries of the Ministry of Health; the Ministry of Livestock and Fisheries; the Ministry of Natural Resources and Tourism; the Vice President’s Office-Environment; the Ministry of Agriculture; and the Ministry of Education, Science and Technology in order to enable appropriate interventions and information sharing across health sectors to minimize outbreaks and save lives.

Furthermore, the GoT owns implementation of the Multisectoral Coordination Committee (MCC) meetings on health security, and has appointed an IHR Coordinator. Additionally, the MCC and its technical working group have included costed activities in the new National Action Plan for Antimicrobial Resistance (NAP-AMR) 2023–2028 as a means to support broader coordination, collaboration, and governance.

Recent Assessments and Evaluations

Internal Assessments

Tanzania has been subject to several outbreaks in the past several years, including anthrax, dengue, rotavirus, measles and rubella, COVID-19, leptospirosis, Marburg virus disease, and cholera, and conducted preparedness activities during the Ebola outbreak in Uganda.

Tanzania held simulation exercises - including table-top exercises, drills and full-scale exercises -for Ebola Virus Disease (EVD) in January 2023, Rift Valley Fever (cross-border with Kenya) in 2019, EVD in Kigoma in 2019, and COVID-19 at Kilimanjaro International Airport in 2021. In addition, the country has conducted six disease outbreaks After Action Reviews (AARs) to document best practices, challenges, and recommendations of immediate and longer-term corrective actions for future response to public health emergencies. AARs were conducted for anthrax in 2016 and 2019, rabies in 2019 leptospirosis in 2022, Marburg Virus Disease in 2023, and COVID-19 in September 2023.

Findings from these assessments identified gaps and best practices in preparedness, prevention, detection and response. Some of the documented key challenges include delayed detection and reporting; gaps in consistent biosafety, biosecurity, and infection prevention and control practices;

limited resources; and inadequate multisectoral participation.

Joint External Assessments Tanzania was one of the first countries to conduct a Joint External Evaluation (JEE) on the country’s capabilities to implement International Health Regulations - the international measures for preventing the transnational spread of infectious diseases. The JEE is a voluntary, collaborative, and multisectoral process that assesses and identifies gaps in countries’ capacities to prevent, detect, and respond to public health emergencies. The JEE asks a series of complex questions in multiple technical areas in a World Health Organization-developed tool. The country is given a series of scores between one and five, with a score of five denoting a perfectly functioning technical area, so that progress between JEEs can be mapped.

As the recent JEE demonstrated, Tanzania has made remarkable improvement in its capability to prevent, detect, and respond to EID threats since it was last evaluated in 2016. In particular, it has great strengths in the foundational elements that are required for adequate implementation of health security. In addition to the strong political will, Tanzania has a very strong One Health platform that has provided a foundation for the coordination of health security preparedness. Accompanying this are laws, policies and guidelines across all the sectors to support IHR implementation.

Furthermore, there is a national disaster risk management architecture that provides a framework for health emergency management. These strengths have supported the advancements the country has made in its capacity to implement IHR in most technical areas, with significant strengths in AMR, lab systems, surveillance, immunization and Points of Entry.

2016 and 2023 JEE Results in Selected Technical Areas

Yet, gaps still remain, making Tanzania and its citizens vulnerable to disease outbreaks.

Public sector financing remains a concern, particularly at the subnational level. Legislation, policies, plans and reports need to be developed and disseminated more quickly. Human resources need to be developed within training institutions. The capacity for data analysis, management and sharing is still lacking, and there is a need to develop a strong monitoring and evaluation system. Systems, plans and capacities need to be regularly tested. And finally, the existing multisectoral coordination mechanisms need to have greater integration between the human and animal sectors.

USAID Usalama wa Afya Duniani (Global Health Security) is expected to align and prioritize its supported interventions based on the needs identified in the recent JEE, with an aim of supporting Tanzania’s progress towards well-functioning systems in the technical areas of AMR, biosafety and biosecurity, laboratory systems, surveillance, and infection prevention and control.

Universal Health and Preparedness Review

In addition, and as an objective under the Regional Strategy for Health Security and Emergencies 2022-2030, the country is in the midst of developing the Universal Health and Preparedness Review (UHPR), which is a Government of Tanzania-led, whole-of-government peer review mechanism assessing broader national capacities for health emergency preparedness. The UHPR is anticipated to be launched by the Tanzanian President by December 2023.

Previous and Related Awards

Since 2005, USAID has been a leader in in promoting sustainable, whole-of-government, whole-of-society, and One Health approaches to implement GHS across eight technical areas:

AMR, zoonotic diseases, BSBS, laboratory systems, surveillance, human resources, IPC, and risk communication and community engagement (RCCE). It has invested in programs with the dual goals of minimizing the impact of existing EID threats and pre-empting the emergence and spread of novel EID threats. In recognition of the growing risk that biological threats pose to national and international security, USAID has significantly expanded its investments in GHS. As a core element of program expansion, the USAID GHS Program will support countries to achieve demonstrated capacity in at least five key GHS technical areas in at least 50 countries by the end of 2025. In addition, USAID will help countries to achieve internationally accepted outbreak response timeliness metrics (such as 7-1-7), and support operational research to improve effectiveness.

USAID initiated its GHS investments in Tanzania in 2015. USAID Usalama wa Afya Duniani (Global Health Security) is designed to reflect advances in thinking and lessons learned from past GHS projects implemented both globally and in Tanzania, and complements other USAID mechanisms working in these areas.

USAID Usalama wa Afya Duniani (Global Health Security) will build on the investments in surveillance, laboratories, research, and partnerships that have been previously established or strengthened by USAID or other partners. It is expected to reference the best practices and lessons learned by past and current USAID-supported GHS activities in Tanzania (including those below) as well as other publicly-available resources to inform strategic planning, baseline analyses, and proposed activities in order to ensure its activities are additive and complementary to, not duplicative of, these or other efforts.

These previous and related awards include:

● PREDICT: https://ohi.vetmed.ucdavis.edu/programs-projects/predict-project)

● PREVENT: https://www.fhi360.org/resources/prevent-about-us/

● Preparedness & Response: https://www.dai.com/our-work/projects/worldwide-preparedness-and-response-pr https://ohi.vetmed.ucdavis.edu/programs-projects/predict-project https://www.fhi360.org/resources/prevent-about-us/ https://www.dai.com/our-work/projects/worldwide-preparedness-and-response-p https://www.dai.com/our-work/projects/worldwide-preparedness-and-response-p

● Food and Agriculture Organization of the United Nations (FAO):

https://www.fao.org/animal-health/our-programmes/fao-emergency-centre-for-transboundary-animal-diseases-(ectad)/en

● AFROHUN and One Health Workforce-Next Generation: https://afrohun.org/

● Medicines, Technologies and Pharmaceutical Services (MTaPS):

https://www.mtapsprogram.org/

● Infectious Disease Detection and Surveillance (IDDS): https://iddsproject.org/

● Breakthrough Action: social and behavior change activities, risk communication and community engagement.

● Local Global Health Security: supporting organizational capacity building for local GHS partners, and establishing a platform for knowledge sharing among GHS partners.

USAID Usalama wa Afya Duniani (Global Health Security) is primarily focused on the support to the public health aspects of AMR, BSBS, laboratory systems, surveillance, and IPC, with some cross-cutting work in human resources and multisectoral coordination. This focus was determined through desk review and considerable consultations with stakeholders in the public and private sectors, as well as through de-duplication of efforts supported with other U.S. government funding.

The activity is designed to complement the other GHS activities supported by USAID in Tanzania, including human resources, RCCE, and a broad array of interventions in the veterinary GHS sector.

In addition, it is complementary to other USAID-supported programs in water, sanitation and hygiene, immunization, and other systems strengthening programs. Under USAID Usalama wa Afya Duniani (Global Health Security), consistent communication and coordination with these programs is critical to ensure a holistic approach to GHS.

Alignment with Government of Tanzania

USAID expects the results and activities in the recipient’s activity to be consistent with the recommendations in the intra-action and after-action disease outbreak reports and following Tanzania strategy and planning documents:

• Tanzania WHO JEE Report (2023)

• Tanzania Universal Health and Preparedness Review Report (once completed; est.

2024)

• All Hazard Health Emergency Preparedness and Response Plan 2016:

https://www.pmo.go.tz/uploads/documents/sw-1664371895- Tanzania%20Emergency%20Preparedness%20and%20Response%20Plan%20%28TE PRP%29.pdf

• One Health Zoonotic Disease Prioritization for Multisectoral Engagement (2017):

https://www.cdc.gov/onehealth/pdfs/tanzania-report-508.pdf

• National Action Plan for Health Security 2017-2021 (revision in early 2024):

https://extranet.who.int/sph/united-republic-tanzania-national-action-plan-health-security-naphs-report

• Health Sector Strategic Plan 2021-2026 (HSSP V): https://mitu.or.tz/wp-content/uploads/2021/07/Tanzania-Health-Sector-Strategic-Plan-V-17-06-2021-Final-signed.pdf https://www.fao.org/animal-health/our-programmes/fao-emergency-centre-for-transboundary-animal-diseases-(ectad)/en https://www.fao.org/animal-health/our-programmes/fao-emergency-centre-for-transboundary-animal-diseases-(ectad)/en https://www.fhi360.org/projects/prevent-%E2%80%94-emerging-pandemic-threats https://www.fhi360.org/projects/prevent-%E2%80%94-emerging-pandemic-threats https://afrohun.org/ https://www.mtapsprogram.org/ https://www.mtapsprogram.org/ https://iddsproject.org/ https://www.pmo.go.tz/uploads/documents/sw-1664371895-Tanzania%20Emergency%20Preparedness%20and%20Response%20Plan%20%28TEPRP%29.pdf https://www.pmo.go.tz/uploads/documents/sw-1664371895-Tanzania%20Emergency%20Preparedness%20and%20Response%20Plan%20%28TEPRP%29.pdf https://www.pmo.go.tz/uploads/documents/sw-1664371895-Tanzania%20Emergency%20Preparedness%20and%20Response%20Plan%20%28TEPRP%29.pdf https://www.cdc.gov/onehealth/pdfs/tanzania-report-508.pdf https://extranet.who.int/sph/united-republic-tanzania-national-action-plan-health-security-naphs-repor https://extranet.who.int/sph/united-republic-tanzania-national-action-plan-health-security-naphs-repor https://mitu.or.tz/wp-content/uploads/2021/07/Tanzania-Health-Sector-Strategic-Plan-V-17-06-2021-Final-signed.pdf https://mitu.or.tz/wp-content/uploads/2021/07/Tanzania-Health-Sector-Strategic-Plan-V-17-06-2021-Final-signed.pdf https://mitu.or.tz/wp-content/uploads/2021/07/Tanzania-Health-Sector-Strategic-Plan-V-17-06-2021-Final-signed.pdf

• National Disaster Management Strategy 2022-2027:

https://www.pmo.go.tz/uploads/documents/sw-1677564328- National%20Disaster%20Management%20Strategy%202022%20%E2%80%93%202 027.pdf

• One Health Strategic Plan 2022-2027:

https://www.pmo.go.tz/uploads/documents/sw-1677564782- National%20One%20Health%20Strategic%20Plan%202022%20-2027.pdf

• National Action Plan for AMR 2023-2028:

https://www.mifugouvuvi.go.tz/uploads/publications/sw1679278889-

TANZANIA%20ANTIMICROBIAL%20RESISTANCE%20NATIONAL%20ACTIO

N%20PLAN%202023%20-2028.pdf

C. DEVELOPMENT HYPOTHESIS

IF: (1) IPC is enhanced to prevent hospital-associated infections;

IF: (2) laboratories are capable of safely, securely and accurately testing, analyzing, and reporting on EID and resistant bacteria;

IF: (3) effective antimicrobial stewardship is implemented to improve case management and prescribing practices; and

IF: (4) these interventions are coordinated and implemented:

● at the national and subnational levels,

● in both the public and private sectors, and

● in conjunction with those in the animal sector, THEN: the occurrence and severity of EID threats will be prevented and mitigated.

D. STRATEGIC OBJECTIVES

This project is proposed as a five (5) year activity with a goal of preventing and mitigating the occurrence and severity of epidemics, pandemics, and other EID threats in Tanzania, and to support GoT systems to achieve the 7-1-7 metric for timeliness of outbreak response.

The effort will build on previous health system investments, not just those in USAID GHS, but also in other core health activities implemented across the U.S. government and other donors in Tanzania, such as the foundational investments in COVID-19 preparedness and response, HIV, malaria, tuberculosis, maternal and child health, nutrition, and food security.

https://www.pmo.go.tz/uploads/documents/sw-1677564328-National%20Disaster%20Management%20Strategy%202022%20%E2%80%93%202027.pdf https://www.pmo.go.tz/uploads/documents/sw-1677564328-National%20Disaster%20Management%20Strategy%202022%20%E2%80%93%202027.pdf https://www.pmo.go.tz/uploads/documents/sw-1677564328-National%20Disaster%20Management%20Strategy%202022%20%E2%80%93%202027.pdf https://www.pmo.go.tz/uploads/documents/sw-1677564782-National%20One%20Health%20Strategic%20Plan%202022%20-2027.pdf https://www.pmo.go.tz/uploads/documents/sw-1677564782-National%20One%20Health%20Strategic%20Plan%202022%20-2027.pdf https://www.mifugouvuvi.go.tz/uploads/publications/sw1679278889-TANZANIA%20ANTIMICROBIAL%20RESISTANCE%20NATIONAL%20ACTION%20PLAN%202023%20-2028.pdf https://www.mifugouvuvi.go.tz/uploads/publications/sw1679278889-TANZANIA%20ANTIMICROBIAL%20RESISTANCE%20NATIONAL%20ACTION%20PLAN%202023%20-2028.pdf https://www.mifugouvuvi.go.tz/uploads/publications/sw1679278889-TANZANIA%20ANTIMICROBIAL%20RESISTANCE%20NATIONAL%20ACTION%20PLAN%202023%20-2028.pdf

This activity has three strategic objectives:

Strategic Objective 1: Avoidable EID threats prevented

USAID Usalama wa Afya Duniani (Global Health Security) will contribute to the prevention of EID threats through interventions that (1) reduce the emergence and spread of AMR, and (2) strengthen and promote BSBS practices.

In order to address AMR, the national response must be well coordinated and function with a One Health lens. Surveillance of resistant pathogens, and tracking of antimicrobial consumption and use, should be implemented across sectors in public and private health care facilities, food production, and the community. Under USAID Usalama wa Afya Duniani (Global Health Security), these interventions will be implemented in the human health sector, with the expectation that information will be shared and linked with animal and environmental sectors through the multisectoral coordination committee and through engagement with other U.S. government partners. For the environmental sector, the interventions will be coordinated with relevant authorities and partners inline with the National Environmental Health, Hygiene and Sanitation Strategy. Implementation of antimicrobial stewardship (AMS) at the facility level will be critically important, and antimicrobial resistance, consumption and use data within the facility should be shared with, and acted upon, by its medicines and therapeutics committee. In an optimal situation, AMR data should inform patient care at a facility level, with zonal or regional facilities developing their own formularies based on both the Access, Watch and Reserve (AWaRe) list and local AMR data.

BSBS aims to mitigate biological proliferation and leakage of dangerous pathogens or toxins , whether intentional or not intentional. In addition, BSBS control storage, transportation and supply of biological agents. This is best achieved through the establishment of national standards and guidelines, which can be implemented consistently in facilities across the country as a multi-sectoral, whole-of-government, national biosafety and biosecurity system in the human, animal and agriculture sectors through relevant coordination platforms including BSBS TWG. On a national level, this requires the bolstering of the regulatory framework through establishment of appropriate legislation, with dissemination and sensitization to all lower levels. It also requires the expansion of laboratory licensing to ensure both the safety and quality of laboratory services in the detection of EIDs and AMR. Within facilities, this requires stringent pathogen containment and control measures, to include monitoring and updating of inventory of pathogens, the safe transfer of biological agents, biological risk management training for all applicable staff, consistent environmental surveillance, and a robust waste management system inline with with global, regional and national standards and guidelines.

Illustrative results:

AMR

1. The national action plan on AMR is being implemented, monitored, and evaluated for improvements within the public and private sectors.

2. AMR/AMS data is regularly reported at the national level and into relevant global systems.

3. AMR/AMS data is regularly shared and analyzed with stakeholders working in animal health for the development of One Health-focused policies and practices.

4. AMR surveillance data used in a national coordination mechanism to generate reports and to inform policy and prevention and control strategies.

5. AMR stewardship programs are implemented in all major supported health facilities, and zonal and regional facilities support training to their satellite facilities.

6. Antibiotic consumption is monitored within supported facilities according to an up to date AWaRe classification.

7. Appropriate antimicrobial use based on national guidelines is expanded nationally within the public and private sectors.

8. Subnational multisectoral coordination mechanisms on AMR are strengthened and effectively supported.

BSBS

1. Strengthened BSBS regulatory framework, including maintaining robust information security measures, laboratory licensing, and pathogen control measures.

2. Supported labs working with EIDs are operating at a minimum of a biosafety level (BSL)

2, and have reached documented accreditation standards.

3. Supported labs employ consistent environmental surveillance practices and have complete disinfection, sterilization and waste management protocols and practices in place.

4. Relevant staff are trained in BSBS guidelines, practices, and monitoring and improvement of BSBS training and practices is conducted on a regular basis.

5. Support capacity building to National Labs to implement strengthening of the central biorepository system towards operationalization of BSL-3 containment.

6. Support capacity building to relevant facilities to maintain an updated inventory of dangerous pathogens.

Strategic Objective 2: EID threats detected early

USAID Usalama wa Afya Duniani (Global Health Security) will strengthen EID detection in Tanzania by supporting the development of laboratory systems capable of safely, securely, and accurately testing for EIDs, and surveillance systems capable of detecting, analyzing, and reporting on EIDs.

Labs must be operating with high quality standards, meeting international accreditation standards.

These accreditations exist in a limited number of facilities, but expansion of these accreditations to high-risk regions for priority tests will be important for the rapid detection of emerging pathogens.

Laboratory systems must be strengthened at a national level, including all relevant sectors and sub-national levels, particularly human and animal health. These systems must also ensure effective modern point-of-care and laboratory-based diagnostics, quality assurance, and safe and secure specimen collection and transport.

Currently, both the animal and human health sectors in Tanzania input EID data into the WHONET database, which aims to enhance the use and exchange of laboratory data by facilitating “the understanding of the local epidemiology of microbial populations; the selection of antimicrobial agents; the identification of hospital and community outbreaks; and the recognition of quality assurance problems in laboratory testing”.15 Despite this, there are significant gaps in the availability of an integrated surveillance system that captures zoonotic disease data from the human and animal health sectors as a means to detect events of significance, and AMR data to analyze and predict trends that can be addressed and contained early. Stakeholders desire a better integration of epidemiological and laboratory data, with improved capacity to analyze data. All of this requires greater collaboration and communication across sectors.

Illustrative results:

Laboratory systems

1. Effective and efficient referral and transport systems organized systematically for all priority diseases to and between supported labs, with capacity building conducted for lower level facilities.

2. Appropriate diagnostic, confirmation and characterization capacities for all specimens in place at all supported laboratories.

3. All supported labs are accredited to a minimum of national quality standards, with an aim of reaching international standards, as measured via external quality assurance.

4. An interoperable laboratory information management system in place, with information sharing occurring between and among the human and animal health sectors.

5. Supported labs have the capacity to test for all its endemic and priority diseases.

6. All supported laboratories maintain a quality management system with laboratory proficiency testing, maintenance, and calibration conducted regularly at all supported laboratories.

7. Tier-specific diagnostic testing strategies are in place at national level, and expanded to a subnational level.

8. Supported laboratories have sufficient quantities of necessary media, reagents, and supplies available through either sustainable procurement methods or in-country production.

9. Support adoption of WHO-recommended molecular diagnostic technologies and capacity building throughout the diagnostic network, to include genomic sequencing and genotyping.

Surveillance

1. Support for a national and subnational level coordination mechanism across human, animal (livestock, wildlife) and environment sectors for sharing and analysis of priority zoonotic diseases and AMR.

2. Enhanced interoperability and ensure surveillance data/events are integrated with laboratory results and reported in a timely manner at both intermediate and national levels

3. Contributions to the implementation of multi-hazard public health emergency response plan and related hazard specific plans.

4. Support for the strengthening of multiple pathogen sentinel surveillance and early warning systems, and linkage of veterinary and human electronic Event Based Surveillance (eEBS) systems at intermediate level.

Strategic Objective 3: EID outbreaks responded to rapidly and effectively

15 WHO, https://whonet.org/WebDocs/WHONET%201.Getting%20started.html#:~:text=Part%201.- ,What%20is%20WHONET%3F,use%20of%20laboratory%20data%3B%20and https://whonet.org/WebDocs/WHONET%201.Getting%20started.html#:%7E:text=Part%201.-,What%20is%20WHONET%3F,use%20of%20laboratory%20data%3B%20and https://whonet.org/WebDocs/WHONET%201.Getting%20started.html#:%7E:text=Part%201.-,What%20is%20WHONET%3F,use%20of%20laboratory%20data%3B%20and

The COVID-19 pandemic highlighted the importance of implementing IPC programs for preventing and containing the spread of disease and HCAI, and USAID Usalama wa Afya Duniani (Global Health Security) will support the strengthening and consistency of implementing IPC to international standards.

While IPC has been introduced to most, if not all, facilities, there remain opportunities to strengthen these practices as consistent implementation of IPC is variable across facilities, and often the IPC focal person at subnational facilities is overtasked. Studies have shown that without regular training on IPC and a strong IPC focal person, and in part due to high staff turnover, adherence to IPC practices can wane among healthcare staff in a facility. Bolstering these practices is complemented by HCAI surveillance within the facilities, regardless of the level of the facility, or whether it is public or private.

Illustrative results:

1. All relevant staff in supported facilities have access to, and are sensitized on, national IPC standards/guidelines, tools, training programs

2. Supported health facilities are implementing and cascading national IPC guidelines.

3. Supported health facilities meet WHO minimum requirements for IPC.

4. All supported secondary and tertiary healthcare facilities conduct HCAI surveillance

5. Standards for safe built environment (including safe water, isolation areas, sterilization services) implemented at all supported healthcare facilities with WHO minimum requirements

Cross-Cutting Objective: The health security capabilities among the One Health workforce strengthened; multisectoral coordination supported; and private sector engaged to prevent, detect, and respond to EID threats

USAID Usalama wa Afya Duniani (Global Health Security) recognizes that in order to accomplish the aforementioned objectives, the health workforce, in both the public and private sectors, must have the capacity to prevent, detect, and respond to disease threats, using a One Health lens. This need to strengthen human resources was clearly described during the JEE process. While other USAID activities will support the development of workforce strategies and staff supplementation, as well as some basic capacity building, USAID Usalama wa Afya Duniani (Global Health Security) will build technical capacity in the designated technical areas at the national and intermediate levels, and build the capacity for these facilities to provide step down training to their satellite facilities. This may be done through the development of training modules, in addition to the existing activities of supportive supervision and mentorship.

USAID Usalama wa Afya Duniani (Global Health Security) will also support multisectoral implementation of IHR through participation in the MCC and its technical working groups, and proactively engaging with other sectors, including the private sector. It will also encourage and support linkages with the animal, and as available, environmental sectors in order to reinforce a One Health approach to health security. This includes through the interoperability of systems, particularly for data sharing, as cited above. Linkages must also extend across the different technical approaches as a means to establish seamless response systems. Coordination between national and subnational systems, i.e. through One Health Section and Multisectoral One Health Technical Committee at all levels, is a critical next step to be supported by USAID Usalama wa Afya Duniani (Global Health Security), in consultation with the PMO, MoH, MoLF, and other sector partners such as FAO, which also aims to pilot operationalization of One Health Technical Committees.

In addition to engaging the private sector throughout the health security value chain under the auspices of the MCC, other approaches also exist that would demonstrate a value proposition appealing to both the public and private sector. Current engagements on AMR with private sector entities have shown that effective AMS can decrease hospital expenditures, an appealing proposition for private healthcare facilities. Other opportunities include increasing private sector access to new markets, improving reputation and brand expansion, and opportunities to shape policies, practices and processes. A benefit to the health security system is that the private sector can bring research and innovation to bear on existing systems, thus providing means to test potential new, efficient, and/or effective solutions to existing security issues.

Illustrative results:

1. Additional healthcare staff trained on IHR and One Health topics, in coordination with workforce strategies for health security

2. Existence of subnational coordinating bodies and enhanced multisectoral coordination at the subnational level, with linkages to the national level and other One Health sectors

3. Innovative formal or informal partnerships established with the the private sector to increase knowledge and innovation, and to advance a holistic response to health security

G. ALIGNMENT WITH USAID PRIORITIES

USAID/Tanzania Country Development Cooperation Strategy (CDCS): The activity will advance the following Development Objectives in the USAID/Tanzania CDCS:

● DO3 (primary): Capacity of state and non-state actors strengthened to benefit future generations.

o IR 3.1 - Capacity of sub-national government to lead sustainable development improved o IR 3.2 – Enabling environment for private sector and CSOs enhanced.

● DO1 (secondary) - Foundational skills of children below age 15 improved o IR 1.2 - Household nutrition and health outcomes improve

● DO2 (secondary) - Empowerment, productivity, and engagement of Tanzanians aged 15 to

35 increased o IR 2.1 - Health and education outcomes improved

USAID/Tanzania Priorities:

Local Partnerships and Sustainability: USAID Usalama wa Afya Duniani (Global Health Security) is intended for implementation by local organizations, with coordination with the Government of Tanzania and the Tanzanian private sector. Additionally, the activity shall support, coordinate, and establish partnerships with local governments, coalitions, associations, and/or organizations, and other stakeholders to facilitate sustainable, lasting solutions to prepare Tanzania for outbreak prevention, detection, and response. In addition, partnerships with other relevant USAID and donor activities will be critical to complement and leverage ongoing investments, as appropriate. In addition, a key component of this activity is sustainability: health security coordination and planning is led by the Government of Tanzania, and the Government of Tanzania

- along with other local stakeholders - will need to be able to fund and implement these plans without reliance on donor partners. This activity will build the capacity of local actors to achieve this aim, particularly with regard to being able to sustain advancements made in those technical…