Eswatini CDC-RFA-JG-25-0071 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due March 5, 2025

Advancing national epidemiologic, surveillance, research and laboratory capacities and systems to support a sustainable and resilient response to HIV/TB and related public health threats in the Kingdom of Eswatini under PEPFAR

Opportunity number: CDC-RFA-JG-25-0071

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 10

Step 2: Get Ready to Apply 31

Get registered 32

Questions 33

Step 3: Prepare Your Application 34

Application contents and format 35

Step 4: Learn About Review and Award 45

Application review 46

Award notices 52

Step 5: Submit Your Application 53

Application submission and deadlines 54

Application checklist 56

Step 6: Learn What Happens After Award 58

Post-award requirements and administration 59

Contacts and Support 66

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your SAM.gov and Grants.gov registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks) You must have an active account with SAM.gov. This includes having a Unique Entity Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days) You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply

Apply by the application due date Applications are due by 11:59 p.m. Eastern Time on March 5, 2025.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command + Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/

Jump to a step

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 8

Program description 10

Basic information U.S. Centers for Disease Control and Prevention (CDC)

Global Health Center

Division of Global HIV and Tuberculosis

Reducing HIV and TB incidence and mortality in global settings through data-driven programs and strengthened public health systems.

Have questions?

See Contacts and Support.

Key facts

Opportunity name:

Advancing national epidemiologic, surveillance, research and laboratory capacities and systems to support a sustainable and resilient response to HIV/TB and related public health threats in the Kingdom of Eswatini under PEPFAR

Opportunity number:

CDC-RFA-JG-25-0071

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

March 5, 2025

Expected award and start date:

September 30, 2025

We will inform you of your application status by the end of August 2025.

See other submissions for other time frames that may apply to this

NOFO.

Summary We expect you to partner with the Government of the Kingdom of Eswatini to strengthen national surveillance, research, and laboratory capacities, as well as emergency preparedness and response systems and structures to monitor and inform a sustainable response to HIV/TB and related public health threats.

Activities should strengthen the Ministry of Health (MOH) and other relevant government entities’ capacity to oversee, conduct, and advance public health surveillance, research, and surveys while expanding local epidemiologic competencies. Areas of focus include:

• Outbreak detection, investigation, response and recovery.

• Epidemic modeling.

• Data analytics and visualization.

As part of ongoing efforts to strengthen national laboratory systems, priority activities will:

• Tackle structural barriers.

• Enhance diagnostic network operations.

• Build molecular testing capacity.

• Advance laboratory information system interoperability.

• Improve quality management.

• Facilitate access to and uptake of quality laboratory services.

Eswatini’s public health preparedness and response systems and structures will be reinforced with activities that assist MOH in its efforts to strengthen

Step 1: Review the Opportunity 5 the Eswatini CDC (National Public Health Institute [NPHI]) pillars, which include not only early warning surveillance and the national public health laboratory, but also public health workforce, the emergency operations center, and health/risk communication.

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $5,500,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1-2 The number of awards is subject to available funds and program priorities.

Exact amounts for each award under this NOFO will be determined upon award.

We plan to award projects for five 12-month budget periods for a five-year period of performance.

Funding strategy

Funding amounts We encourage you to apply for the expected total NOFO funding for Year 1.

You may not request more than this amount.

Funding amounts for years two through five will be set at continuation. We will continue funding based on:

• Availability of funds.

• Evidence of satisfactory progress, as documented in your required reports.

• The determination that continued funding is in the best interest of the federal government.

Component funding

Overview

We fund all President’s Emergency Plan for AIDS Relief (PEPFAR) cooperative agreements using component funding.

Component funding allows us to provide funding as it becomes available. To do so, we fund sets of activities by quarter and project.

Step 1: Review the Opportunity 6

CDC may fund one or more of your components to start the budget period, and then consider other components based on available funding later.

Setting up components

You must set up your components in your application. While preparing your application:

• Review the expectations for year one activities in the strategies and activities section.

• Group your activities under the following anticipated components. Only include the activities planned for year one.

◦ Component 1: COPQ1 Targets and Activities.

◦ Component 2: COPQ2 Targets and Activities.

◦ Component 3: COPQ3 Targets and Activities.

◦ Component 4: COPQ4 Targets and Activities.

◦ Component 5: COP Additional Targets and Activities.

◦ Component 6: Central initiative funding (buffer component if needed).

For information on how to incorporate component funding into your application, see the following sections:

• Budget narrative

• Component funding instructions for SF-424A

PEPFAR Local partner funding preference This NOFO includes a funding preference for local partners. Your organization will receive 20 extra points during the selection process if you provide sufficient documentation demonstrating you meet the PEPFAR local partner definition.

Step 1: Review the Opportunity 7

Eligibility Statutory authority This program is authorized under:

• The United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003, Public Law 108-25 (22 U.S.C. 7601, et seq.).

• The Tom Lantos and Henry J. Hyde United States Global Leadership Against HIV/AIDS, Tuberculosis, and Malaria Reauthorization Act of 2008, Public Law 110-293.

• The PEPFAR Stewardship and Oversight Act of 2013, Public Law 113-56.

• Public Health Service Act (42 U.S.C. 242I).

Eligible applicants This is a fully competitive NOFO, and eligibility is unrestricted. Any and all types of organizations are eligible and encouraged to apply, including but not limited to those listed below.

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Independent school districts.

• Public and state-controlled institutions of higher education.

• Native American tribal governments (federally recognized).

• Public housing authorities and Indian housing authorities.

• Native American tribal organizations, other than federally recognized tribal governments.

• Nonprofits having a 501(c)(3) status, other than institutions of higher education.

• Nonprofits without 501(c)(3) status, other than institutions of higher education.

• Private institutions of higher education.

• For-profit organizations other than small businesses.

• Small businesses.

• Foreign or non-U.S. based entities.

Step 1: Review the Opportunity 8

Other required qualifying factors

Delivery location While any type of organization may apply, you must conduct the project in Eswatini.

Responsiveness criteria We will review your application to make sure it meets these requirements.

These are the basic requirements you must meet to move forward in the competition. We won’t consider an application that:

• Is from an organization that doesn’t meet eligibility criteria. See requirements in eligibility.

• Is submitted after the deadline.

• Proposes research activities. See 45 CFR 75.2 for the definition of research.

• Requests more funding than the expected total NOFO funding for Year 1.

• Exceeds the 20-page limit for the project narrative (see the project narrative section for what counts toward the page limit).

• Is not in English.

• Includes a budget or budget narrative that uses a currency other than U.S. dollars.

• Does not respond to and is outside the scope of this NOFO.

See the application checklist to understand your application requirements.

Application limits We do not limit the number of applications an organization may submit.

Cost sharing and matching funds This program has no cost-sharing or matching funds requirement. We will not consider cost-sharing fund contributions during your application review.

However, if you submit voluntary cost-sharing funds and we fund your project, we will require you to report on these funds.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://www.ecfr.gov/current/title-45/part-75#p-75.2(Research)

Program description Background overview and related work With a population 1.2 million, the Kingdom of Eswatini is one of the countries most impacted by the HIV epidemic. Nearly one in four adults aged 15 years and older are living with HIV. The latest national population-based HIV impact assessment, SHIMS3 2021, demonstrated significant progress towards the ambitious UNAIDS 95-95-95 targets ahead of the global 2025 benchmark. Of people aged 15 years and older living with HIV:

• 94% are aware of their HIV status.

• 97% of those aware of their HIV status are are on antiretroviral treatment

(ART).

• 96% of those on ART are virally suppressed.

At a population level, viral suppression surpassed the UNAIDS target of 86% for both men and women. Furthermore, mother-to-child transmission of HIV has dropped from 6.3% in 2017 to 1.2% in 2022.

Great progress has been made. But to avoid significant consequences in the future, these gains must be sustained and remaining gaps for all populations must be closed. Significant gaps in HIV case-finding persist among:

• Young women ages 15 to 24 years.

• Men ages 25 to 34 years.

• Children under 15.

• The military.

• Key populations.

Many men ages 25 to 34 are not consistently linked to or continually receiving ART. Children on ART are yet to reach 95% viral suppression (except those aged 5 to 9).

Women are disproportionately affected. Among people ages 25 to 29, HIV prevalence is more than five times higher among women compared to men.

More than half of women ages 35 to 49 are living with HIV.

Though the rate of new HIV infections dropped by nearly half between 2016 and 2021, approximately 4,000 individuals 15 years and older are newly infected with HIV annually. Incidence remains higher among women at 1.11%, a rate nearly seven times that of 0.17% for men. Young women between the ages of 15 to 29 are particularly vulnerable. As demonstrated by the 2022

Step 1: Review the Opportunity 10

Eswatini Violence Against Children Survey, gender-based violence persists as a risk factor for new infections. One in 12 females aged 13 to 24 reporting having experienced sexual violence at least once in their lifetime.

HIV-related deaths have also reduced, from about 10,000 in 2005 to 3,100 in 2022. However, with an aging population of people living with HIV, co-infections and co-morbidities such as TB, cervical cancer, and non-communicable diseases must be addressed to further reduce morbidity and mortality.

Underlying this response is a public health system that demands continued development, integration, and maturity of essential public health functions to maintain responsiveness to the HIV/TB landscape while strengthening its ability to monitor, detect, and respond to emerging risks of other infectious and non-infectious threats that impact people living with and affected by HIV/ TB. Strengthening the public health system and improving coordination is a critical aspect of building local resilience and capacity to effectively and sustainably address the dynamic nature of HIV and related health conditions.

In partnership with the Eswatini MOH, CDC/PEPFAR has supported the development and strengthening of surveillance and laboratory systems and capacities to support the collection, management, analysis, use, and dissemination of surveillance and laboratory data to inform program and policy.

Investments have supported integrated disease surveillance and response implementation, the establishment of routine HIV recent infection surveillance and HIV case-based surveillance, public health research capacity building, improved mortality data through vital statistics systems, and population-based surveys to measure the impact of HIV and violence prevention and response interventions. These data systems and infrastructure have been further leveraged for the country’s COVID-19 response including the development of data dashboards, situation reports, expanded points of entry surveillance, and establishment of sentinel surveillance sites.

Improving access to quality-assured laboratory services is an essential aspect of the Government of the Kingdom of Eswatini and PEPFAR’s response to the HIV and TB epidemics. CDC has partnered with MOH (through Eswatini Health Laboratory Services) to support the national laboratory network through expanding quality management systems (QMS), implementing an interoperable laboratory information system, supporting national sample transport, advancing diagnostic capacity, and strengthening governance and leadership of the national laboratory program.

Step 1: Review the Opportunity 11

The NOFO builds on past and current work aligned with PEPFAR, Global Health Security, and International Health Regulation requirements to strengthen good governance, leadership, competencies, and systems for an effective and efficient country-led HIV/TB response that can also detect and respond to related public health threats.

As essential public health functions, structures, and systems are strengthened, the country should progress towards establishing and operationalizing the local NPHI (Eswatini CDC) to lead and coordinate the national public health response.

Purpose The purpose of this NOFO is to support the Eswatini MOH to carry out essential public health functions to monitor and inform a sustainable response to HIV, TB, and related public health threats. The NOFO will achieve this through strengthening national epidemiology, surveillance, research, and laboratory capacities, as well as preparedness and response systems and structures.

Approach Program logic model The following logic model includes the expected strategies under this NOFO.

The logic model also includes the program’s expected outcomes. Outcomes are the results that you intend to achieve and usually show the intended direction of change, such as increase or decrease.

The asterisked ( * ) outcomes are those we expect you to achieve or substantially contribute to during the five-year period of performance. You must report on these outcomes.

Not all outcomes apply to all strategies. You will use these outcomes as a guide for developing performance measures.

Step 1: Review the Opportunity 12

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes

Strategy 1:

Strengthen the national surveillance system to monitor and report quality data on infectious and non-infectious threats that impact people living with and affected by HIV/TB.

Strategy 2:

Strengthen national capacity to define HIV/ TB and related public health research priorities, oversee and coordinate evidence generation, and translate data into public health policy and practice.

Strategy 3: Advance the public health workforce by improving epidemiology, surveillance, laboratory, and preparedness and response competencies.

Strategy 4:

Strengthen laboratory governance, leadership, services, and systems to effectively manage and implement the

Improved implementation of laboratory and non-laboratory-based surveillance systems.*

Improved timely access, analysis, and interpretation of high-quality and relevant surveillance, research, and laboratory data for decision-making.*

Improved knowledge and skills of the public health workforce in public health preparedness and response competencies.*

Enhanced diagnostic network operations, molecular testing capacity, and access to and uptake of quality laboratory services.*

Strengthened government structures for coordination and management of a robust public health preparedness and response.

Enhanced use of data for early detection, risk reduction, and management of the response to HIV/TB and related public health threats.*

Improved monitoring, detection, reporting, and response to HIV/ TB and related public health threats as part of a coordinated national public health response.*

Improved quality, reliability, safety, and timeliness of laboratory services at all levels.*

Increased local capacity to implement a national laboratory accreditation/ certification program.*

Sustained capacity of the public health system to mitigate the impact of HIV/TB and related public health threats.

Sustained epidemiological and surveillance capacity.

Increased MOH ownership, accountability, and capacity to sustain milestones in laboratory services.

Step 1: Review the Opportunity 13

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes national laboratory program.

Strategy 5: Build capacity of Eswatini CDC to lead national public health functions, including management and control of HIV/TB and related public health emergencies and health threats.

Strategies and activities This section elaborates on the strategies described in the logic model by providing expected activities and details about how you expect to implement your program.

Strategy 1: Strengthen the national surveillance system to monitor and report quality data on infectious and non-infectious threats that impact people living with and affected by HIV/TB.

Required activities

• Advance the implementation of routine laboratory and non-laboratory-based surveillance and related data systems, including digitization and integration, for timely monitoring and reporting of quality data.

• Support the implementation of case-based surveillance as part of routine surveillance for national monitoring and understanding longitudinal outcomes of sentinel events for timely program response.

• Expand MOH epidemiological capacities to analyze, interpret, and translate data into user-friendly and accessible information products and timely national action.

• Enhance the capacity for public health surveillance data and relevant situational awareness data to be collected, processed, managed, and exchanged in a timely manner among all levels of government and health sector.

Step 1: Review the Opportunity 14

• Provide technical support to the MOH to develop and strengthen national surveillance strategies, policies, operational plans, and workplans related to the national surveillance program.

• Enhance MOH’s use of surveillance data to track disease patterns, monitor for signals of potential outbreaks, conduct timely investigations, update guidelines and policies, and inform resource planning and allocation.

• Collaborate with relevant government entities to strengthen completeness, quality, and use of mortality data through the civil registration and vital statistics system.

Strategy 2: Strengthen national capacity to define HIV/TB and related public health research priorities, oversee and coordinate evidence generation, and translate data into public health policy and practice.

Required activities

• Develop and/or reinforce partnerships and collaborations with national and/or regional academic institutions to build and strengthen public health research capacity to address identified needs and gaps in knowledge and evidence.

• Support the implementation of surveys in collaboration with national and/or regional governments and/or academic institutions. Surveys may include conventional general population-based surveys deployed intermittently or continuously, as well as surveys among priority populations requiring complex sampling and analytic designs.

• Facilitate a sustainable information/knowledge exchange platform to support peer learning and sharing new evidence and effective methods in research practice.

• Advance the country’s technical capacity for ethical oversight of research in support of strengthened national public health functions. This may include ensuring that systems, structures, practice, and technical capacity for protocol submissions, review, approval, and monitoring oversight are integrated into a locally sustainable approach.

• Strengthen capacity for country-owned program evaluation planning, implementation, and use to inform program planning and decision-making.

Step 1: Review the Opportunity 15

Strategy 3: Advance the public health workforce by improving epidemiology, surveillance, laboratory, and preparedness and response competencies.

Required activities

• Facilitate growth of training programs such as the Field Epidemiology Training Program (FETP) or FETP equivalent for clinicians, laboratory staff, surveillance officers, and other cadre within the public health workforce to respond to HIV/TB and related public health threats. Competencies to be developed include:

◦ Data collection and analysis.

◦ Detection, monitoring, and evaluation of events and cases.

◦ Reporting of cases, clusters, and outbreaks.

• Strengthen the management, operations, and coordination of training activities toward a sustainable model using innovative approaches and technologies.

• Develop or refine systems and processes to improve the management, operations, and coordination of the public health workforce to nimbly respond to sentinel HIV/TB or related public health events or concerning trends.

• Provide input into and support implementation of the MOH-led national mentorship framework.

Strategy 4: Strengthen laboratory governance, leadership, services, and systems to effectively manage and implement the national laboratory program.

Required activities

• Support implementation of QMS and coordinate development of a roadmap for localizing laboratory auditing, licensing and accreditation/ certification, as well as proficiency testing for all HIV/TB tests, in line with the national laboratory strategy.

• Support the national sample transport system, including an assessment of cost-effective and sustainable national sample transport system options.

• Provide technical support to the MOH to improve the laboratory organizational structure, governance, and leadership for enhanced coordination between the national public health laboratory and clinical laboratory services.

Step 1: Review the Opportunity 16

• Strengthen biosafety, biosecurity, and waste management measures and systems at all levels of the laboratory network.

• Support the laboratory information system (LIS) for sample tracking, testing management, and result reporting and support LIS/Client Management Information Systems interoperability.

• Increase access to diagnostics/testing through decentralization based on a continuous quality improvement approach to diagnostic network optimization, platform multiplexing, introduction of new tests, and rollout of new technologies.

• Strengthen engagement of laboratory in the supply chain structures to respond to above-site and site-level needs.

Strategy 5: Build capacity of Eswatini CDC to lead national public health functions, including management and control of HIV/TB and related public health emergencies and health threats.

Required activities

• Support development of processes and standard operating procedures for emergency coordination across all functional areas during public health response events.

• Provide technical input and guidance to improve preparedness and response plans and implementation efforts.

• Support enhancement of processes and procedures to link laboratory and surveillance information to the emergency response communications structure.

• Strengthen existing information and communication channels, including supporting the capacity to develop and disseminate key health and risk communication messages.

• Support MOH to prioritize and implement relevant Joint External Evaluation recommendations.

To support the purpose of this NOFO, you are expected to provide copies of and/or access to all data, software, tools, training materials, guidelines, and systems developed under this NOFO to Ministry of Health and other relevant stakeholders, including HHS/CDC, for appropriate use consistent with underlying authorities.

Step 1: Review the Opportunity 17

Epidemic control activities In coordination with the Global Health Security and Diplomacy (GHSD) Bureau at the U.S. Department of State, and as part of PEPFAR, CDC works with host country governments and other partners. Together, we assess the needs of each country and design a plan for assistance that fits within the host nation’s strategic plan.

We consider a national HIV epidemic to be under control when:

• The number of HIV-related deaths is declining, and

• The number of new infections is less than the number of deaths.

Controlling the epidemic does not mean that HIV will be eliminated. Instead, it means that the number of people with HIV in the population is decreasing. If new infections or death rates increase, this means the epidemic is no longer under control.

Our work doesn’t end when we reach epidemic control; we must sustain the gains. During your award we may ask you to conduct additional activities to reach and maintain epidemic control, consistent with the scope of this NOFO and the related policies below. This may include:

• Improving prevention, testing, and treatment efforts for HIV/AIDS, TB, sexually transmitted infections (STI), and related opportunistic infections, especially among vulnerable, key, and priority populations as defined in PEPFAR’s annual Country/Regional Operational Plan (COP/ROP) Guidance.

• Promoting sustainable, country-led approaches to managing HIV/AIDS and TB and empowering national and local partners to take the lead in designing and conducting high-quality and cost-effective programs. This could involve forming new partnerships with private, public, local, and multisector entities that can complement and expand the reach of existing programs.

• Improving and expanding laboratory, surveillance, and information systems and using the PEPFAR platform for broader disease surveillance and public health programs in ways that align with PEPFAR goals and initiatives.

• Enhancing efforts to prevent, detect, respond to, and treat other diseases affecting people living with or at risk of HIV.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 18 https://www.state.gov/reports-pepfar/

Related policies If awarded, any activities you conduct must follow the directions in:

• [Reimagining PEPFAR’s Strategic Direction: Fulfilling America’s Promise to End the HIV/AIDS Pandemic by 2030].(https://www.state.gov/wp-content/ uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf)

• PEPFAR’s annual COP/ROP Guidance and approved COPs/ROPs.

• Similar forthcoming strategy, guidance, or planning documents that are consistent with relevant laws.

Geographic focus The geographic focus of this program may change during the period of performance, based on the burden of disease and changing program and PEPFAR priorities.

Outcomes We expect you to achieve or substantially contribute to the outcomes asterisked ( * ) in the logic model by the end of the five-year period of performance. You will be expected to report on these outcomes.

Focus populations The focus populations for this NOFO include:

• MOH staff within the government entities that are supporting the core public health functions, particularly across the areas of epidemiology, surveillance, laboratory, and preparedness and response.

• The general population, including people living with and affected by HIV/ TB who are impacted by infectious and non-infectious threats in Eswatini, are secondary populations benefitting by virtue of building national public health capacity and systems.

Equal opportunities This NOFO, including funding and eligibility, is not limited based on, and does not discriminate on the basis of:

• Race.

• Color.

• National origin.

• Disability.

• Age.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 19

• Sex (including gender identity, sexual orientation, and pregnancy).

• Other constitutionally protected statuses.

Health disparities The goal of health equity is for everyone to have a fair and just opportunity to be as healthy as possible. Health disparities are often caused by social determinants of health. Social determinants of health are conditions in the environments where people are born, live, learn, work, play, worship, and age.

These determinants affect a wide range of health, functioning, and quality-of-life outcomes and risks. They also influence which populations are most affected by health conditions.

A health disparity is a difference in health burdens between groups of people with differing social determinants of health.

We expect all proposed activities to affirm and advance health equity and an equitable, diverse, and inclusive workforce as core principles. In addition to the strategies and activities listed above, during your award, we may ask you to conduct activities consistent with local laws to:

• Address health disparities in access to and use of HIV and TB services.

• Reduce HIV and TB stigma and discrimination.

• Promote civil and human rights to improve health outcomes of people living with or at risk of HIV and TB.

• Make the workforce more inclusive.

Organizational capacity You must include a heading in your Project Narrative titled Organizational Capacity, under which you should include a brief description of your organizational capacity to carry out these strategies and activities.

You must also provide supporting documentation in your attachments. See the attachments section for full instructions.

Collaborations If funded, we will expect you to collaborate with:

• MOH, including the Eswatini CDC.

• Other Government of the Kingdom of Eswatini line ministries and parastatals, including but not limited to:

◦ Ministry of Home Affairs.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 20 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

◦ Ministry of Economic, Planning, and Development.

◦ Ministry of Agriculture.

◦ Ministry of Natural Resources and Water Affairs.

◦ Ministry of Information, Communication, and Technology.

◦ Ministry of Commerce.

◦ National Emergency Response Council for HIV and AIDS (NERCHA).

• Training, academic, and other research-based institutions.

• Multilateral institutions, including World Health Organization, World Bank, UNAIDS, UNICEF, Global Fund, and Africa CDC.

• Organizations working on Field Epidemiology.

• Professional associations for laboratorians, epidemiologists, etc. in the region.

• International Association of National Public Health Institutes.

• South Africa National Institute of Communicable Diseases.

• U.S. government agencies, CDC, and other PEPFAR-supported partners.

• Other implementing partners, as identified based on the evolving landscape and priorities.

Through the PEPFAR program, CDC works with partners to help prevent HIV infection, provide life-saving treatment to people living with HIV, and reduce HIV-related deaths. We encourage our partners to collaborate with local organizations, U.S.-based organizations, and international partners. The goal of this collaboration is to complement efforts to lower costs, make programs more effective, sustain the gains, and accelerate progress towards the three UNAIDS 95-95-95 targets:

• At least 95% of people living with HIV know their HIV status.

• At least 95% of people who know their HIV status are on treatment.

• At least 95% of people on treatment have a suppressed viral load.

If you work with key populations as defined in PEPFAR’s annual COP/ROP Guidance, we will expect you to collaborate with them when designing, delivering, and monitoring HIV services.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 21

Data, monitoring, and evaluation CDC expectations CDC expects you to review, clean, and use routine performance data for program management. As a result, you should hold regular review meetings to discuss performance and use data to inform program quality improvement activities.

In your application budget, you should allocate at least 10% of funds for monitoring activities and 5% for evaluation activities. We will discuss these percentages and finalize them at or after award. These are estimates for the total funding over the 5-year project.

Required performance measures

Overview This program includes two types of indicators. These include:

• PEPFAR’s Monitoring, Evaluation, and Reporting (MER) indicators common to all awards. You can find additional information regarding MER reporting in the MER Guidance and resource materials, available at DATIM’s MER Indicator Reference Guides.

• Custom indicators that either we or you create. These monitor achievement of outcomes not directly measured by MER indicators.

These include process and outcome measures that directly correlate with the logic model.

The indicators shown below may change before award or in future years. For example, any gaps or unmet needs not fulfilled in the first year may affect the targets in later years.

MER indicators There are currently no MER indicators applicable for this NOFO, but that may change in future project years.

Custom indicators Below we show some anticipated custom indicators, targets, and reporting frequencies for the first year. You may also propose custom indicators.

• Percent of laboratories participating in CQI and PT for all HIV/TB related tests. [Target: 100%; Reporting Frequency: Annual]

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 22 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• Percent of HIV/TB-related PT panels produced locally. [Target: 80%;

Reporting Frequency: Annual]

• Number of laboratories receiving international or local accreditation.

[Target: 5; Reporting Frequency: Annual]

• Percent of laboratory tests that are processed through LIS. [Target: 80%;

Reporting Frequency: Annual]

• Percent of targeted program staff trained, disaggregated by training type (e.g., FETP, biosafety, public health emergency management). [Target:

100%; Reporting Frequency: Annual]

• Percent of targeted program staff trained using virtual platforms. [Target:

>60%; Reporting Frequency: Annual]

• Number of country-led program evaluations conducted on priority topics to inform planning and implementation efforts. [Target: 3; Reporting Frequency: Annual]

• Number of monthly, quarterly, and annual surveillance and/or epidemiology reports disseminated. [Target: 17; Reporting Frequency:

Quarterly]

• Percent of disease outbreaks detected, notified, and investigated, and responded to in accordance with the 7-1-7 targets. [Target: 95%;

Reporting Frequency: Quarterly]

• Number of integrated surveillance data reports generated from multiple data sources, including laboratory and non-laboratory-based systems.

[Target: 12; Reporting Frequency: Annual]

• Percent of ART patients covered under case-based surveillance. [Target:

95%; Reporting Frequency: Quarterly]

• Percent of newly diagnosed persons living with HIV who received testing for recent infection with a documented result during the reporting period. [Target: 90%; Reporting Frequency: Quarterly]

• Percent of newly diagnosed HIV cases reported into case-based surveillance. [Target: 100%; Reporting Frequency: Quarterly]

• Percent of deceased people living with HIV who die in facility setting with a Medical Certification of Cause of Death. [Target: 80%; Reporting Frequency: Quarterly]

Data sources for MER and custom indicators Data sources may include registers, tally sheets, electronic and paper patient records, quarterly progress reports, surveillance and survey reports, and other program monitoring tools.

Step 1: Review the Opportunity 23

Evaluation Below, we include examples of evaluation topics that we may expect you to answer through process, outcome, or economic evaluation. In your application, include at least one, but no more than three potential evaluation questions. We will expect you to conduct a mid-term evaluation.

• Improvements in outbreak detection and response resulting from enhancements in and coordination of public health surveillance, laboratory, and emergency operations systems: outcome evaluation.

• Facilitators/barriers to establishing local laboratory accreditation/ certification scheme: process evaluation.

The effectiveness of the case-based surveillance system in monitoring population-level progress of the HIV epidemic for timely decision-making and public health response: outcome evaluation.

Evaluation data sources Data sources may include registers, tally sheets, electronic and paper patient records, recipient progress reports, focus groups, in-depth interviews, surveys, and other program monitoring tools.

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• Other approved products in print and electronic media.

The primary intended users of evaluation results and findings will be the wider program stakeholders.

CDC and stakeholders will use overall evaluation findings during the 5-year project period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement after the award ends.

All evaluation reports will be publicly available on PEPFAR resource sites.

Step 1: Review the Opportunity 24

Evaluation and performance measurement plan You must submit an initial draft of your evaluation and performance measurement plan with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

As you develop your evaluation and performance measurement plan, align it with national, PEPFAR, and agency priorities as detailed in the NOFO. If awarded, we will work with you to finalize the plan and ensure it takes into account agreements made during COP/ROP planning.

Include the following elements in your evaluation and performance measurement plan.

Methods Describe how you will:

• Collect the performance measures.

• Respond to the evaluation topics.

• Use evaluation findings for continuous program quality improvement.

• Incorporate evaluation and performance measurement into planning, implementing, and reporting of project activities.

Additionally, explain:

• How findings will contribute to reducing or eliminating health disparities, as relevant.

• How key program partners will participate in the evaluation and performance measurement process.

• How feasible it will be to collect appropriate evaluation and performance data.

• How you will share evaluation findings with communities and populations of interest in a way that meets their needs.

• Other relevant information, such as performance measures you propose.

Evaluation activities You must carry out specific evaluation activities.

At least one evaluation must be carried out for each cooperative agreement during the course of funding. The evaluation can be:

• Process evaluation: Measures how the intervention was delivered, what worked and did not, the differences between the intended population and the population served, and access to the intervention.

Step 1: Review the Opportunity 25

• Outcome evaluation: Determines the effects of the intervention in the focus population, such as change in knowledge, attitudes, behavior, or capacity.

• Economic evaluation: Determines cost, cost drivers, cost effectiveness, efficiency, factors influencing economic behavior and choices, or the economic impact of interventions or activities to justify the investment.

Describe:

• The type of evaluations you will complete (process, outcome, and/or economic).

• Key evaluation questions these evaluations will address.

• Other information, such as measures and data sources.

Data management plan (DMP) For all public health data you plan to collect, a DMP is required. For a definition of “public health data” and other key information, see AR 25: Data Management and Access on our website.

You must submit an initial draft of your DMP with your application. You must submit a more detailed plan within the first six months of the award. See reporting.

Submit your initial DMP with your application and include:

• The data you will collect or generate and their sources.

• Any reasons why you cannot share this data with CDC. These could include legal, regulatory, policy, or technical reasons.

• Who can access the data and how you will protect and secure it.

• Data standards that explain what documentation released data will have.

That documentation should describe collection methods, what the data represent, and data limitations.

• Archival and long-term data preservation plans.

• How you will update the DMP as new information becomes available during the project. You will provide updates to the DMP in annual reports. For more information about CDC’s policy on the DMP, see Data Management and Access Requirement at CDC’s website.

In addition to the other requirements listed, also include:

• Cybersecurity plans.

• How you will protect personally identifiable information (PII) when you collect, store, transfer, and use this data.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 26 https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html https://www.cdc.gov/grants/additional-requirements/ar-25.html

• How you will remove information from the data that could reveal participants’ identities (de-identify the data) in intermediate and final data sets.

CDC and PEPFAR will inform you of data you need to share with us and how and when it should be shared.

Work plan You must provide a work plan for your project. The work plan connects your performance outcomes, strategies and activities, and measures. It provides more detail on how you will measure outcomes and processes. A sample work plan is provided below.

You should provide a detailed work plan for the first year and a high-level work plan for later years.

Table: Sample format

Activities you will implement

Progress or process measures

From the data, monitoring, and evaluation section.

Relevant period of performance outcomes

From the logic model.

Responsible position or party

Funding component / completion date

Strategy 1:

1.

2.

3.

Strategy 2:

1.

2.

3.

Paperwork Reduction Act Any activities involving information collection from 10 or more individuals or organizations may require Paperwork Reduction Act (PRA) approval. The PRA requires review and approval of the information collection by the White House Office of Management and Budget. For further information to

Step 1: Review the Opportunity 27 determine if a proposed activity requires PRA approval, contact your project officer. Collections include items like surveys and questionnaires. If you have collections requiring PRA approval, CDC is responsible for working with OMB to gain the approval.

For more information about CDC’s requirements under PRA see CDC Paperwork Reduction Act Compliance.

Funding policies and limitations General policies

• Your budget is arranged in eight categories: salaries and wages, fringe benefits, consultant costs, equipment, supplies, travel, other, and contractual.

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply to the award. If you have questions about this determination, ask the grants management officer.

• Generally, you may not use funds to purchase furniture or equipment.

Clearly identify and justify any such proposed spending in the budget.

• All requests for funds contained in the budget should be stated in U.S.

dollars.

• Cost increases due to changes in exchange rates are allowed if enough funding is available. If an increase in the exchange rate would reduce the scope of the project or cause you to need more federal funding, you must get prior approval for exchange rate fluctuations.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your project’s objectives.

◦ A decision that continued funding is in the government’s best interest.

• If we receive more funding for this program, we will consider:

◦ Funding more applicants.

◦ Extending the period of performance.

◦ Awarding supplemental funding.

See also program-specific limitations.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 28 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.law.cornell.edu/definitions/index.php?width=840&height=800&iframe=true&def_id=13f24ea1f961f5f0d14b87ec1b39b25f&term_occur=999&term_src=Title:45:Chapter:A:Subchapter:A:Part:75:Subpart:E:Subjgrp:39:75.440

Unallowable costs You may not use funds for:

• Research.

• Clinical care, except as allowed by law.

• Pre-award costs, unless we give you prior written approval.

• Other than for normal and recognized executive-legislative relationships:

◦ Publicity or propaganda purposes, including preparing, distributing, or using any material designed to support or defeat the enactment of legislation before any legislative body.

◦ The salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or executive order proposed or pending before any legislative body.

◦ See Anti-Lobbying Restrictions for CDC Recipients.

• Needle exchange programs.

For guidance on some types of costs that we restrict or do not allow, see 45 CFR part 75, General Provisions for Selected Items of Cost.

Indirect costs Indirect costs have a common or joint purpose across more than one project and cannot be easily separated by project. Learn more at CDC Budget Preparation Guidelines.

To charge indirect costs you can select one of two methods:

Method 1 — Approved rate. You currently have an indirect cost rate approved by your cognizant federal agency.

Provide a summary of the rate. Enclose a copy of the current approved rate agreement in your attachments.

Method 2 — De minimis rate. Per 2 CFR 200.414(f), if you have never received a negotiated indirect cost rate, you may elect to charge a de minimis rate. If you choose this method, costs included in the indirect cost pool must not be charged as direct costs.

This rate is 15% of modified total direct costs (MTDC). See 2 CFR 200.1 for the definition of MTDC. You can use this rate indefinitely.

1. Review 2. Get Ready 3. Prepare 4. Learn 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 29 http://www.cdc.gov/grants/documents/Anti-Lobbying_Restrictions_for_CDC_Grantees_July_2012.pdf https://www.ecfr.gov/current/title-45/part-75/subject-group-ECFR5d90ba314caea08 https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.cdc.gov/grants/documents/budget-preparation-guidance.pdf https://www.ecfr.gov/current/title-2/section-200.414 https://www.ecfr.gov/current/title-2/part-200#p-200.1(Modified%20Total%20Direct%20Cost%20(MTDC))

Foreign organizations and foreign public entities Indirect costs on awards to foreign organizations and foreign public entities performed fully outside of the U.S. and its territories may be paid to support the costs of complying with federal requirements. This rate is fixed at eight percent of MTDC exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. Negotiated indirect costs may be paid to the American University, Beirut, and the World Health Organization.

Other indirect cost policies

• As described in 45 CFR 75.403(d), you must consistently charge items as either indirect or direct costs and may not double charge.

• Indirect costs may include the cost of collecting, managing, sharing, and preserving data.

Salary rate limitation As of January 2024, the HHS/CDC salary rate limitation is $221,900. This salary rate limitation does not apply to PEPFAR funds, which are part of an appropriation from the U.S.