Caribbean CDC-RFA-JG-25-0065 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 18, 2025

Support for laboratory diagnosis and monitoring to scale up and improve HIV/ AIDS care and treatment services for Caribbean countries supported under the President’s Emergency Plan for AIDS Relief

(PEPFAR)

Opportunity number: CDC-RFA-JG-25-0065

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 29

Get registered 30

Questions 31

Step 3: Prepare Your Application 32

Application contents and format 33

Step 4: Learn About Review and Award 43

Application review 44

Award notices 49

Step 5: Submit Your Application 50

Application submission and deadlines 51

Application checklist 53

Step 6: Learn What Happens After Award 55

Post-award requirements and administration 56

Contacts and Support 63

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 February 18, 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:

Support for laboratory diagnosis and monitoring to scale up and improve HIV/AIDS care and treatment services for Caribbean countries supported under PEPFAR

Opportunity number:

CDC-RFA-JG-25-0065

Announcement type:

New

Assistance listing:

93.067 Global AIDS

Program

Key dates

Application deadline:

February 18, 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 Access to high-quality laboratory diagnostic services is key to the success of public health programs designed to address HIV, TB, and related testing.

Over the years, the Centers for Disease Control and Prevention (CDC) has provided targeted technical assistance to laboratories in the Caribbean region. This work strengthened laboratory systems and services, including capacity building of laboratory staff and the accreditation of twelve public health laboratories.

Despite these achievements, there is still work to achieve efficient and sustainable laboratory systems. Increased support is needed to build and sustain laboratory capacity and improve timely diagnostics, monitoring services, and scale-up of care and treatment programs for HIV, TB, STIs, and related diseases.

This NOFO builds on CDC’s previous work and lessons learned from our work with Jamaica and Trinidad and Tobago’s ministries of health (MOHs), with a focus on:

• Supporting and achieving accreditation of public health laboratories in the region.

• Strengthening the laboratory workforce through in-service training.

• Supporting laboratory information system expansion and integration with health information systems.

• Strengthening HIV/TB-related testing and diagnostic capacity for opportunistic infections.

• Building efficient laboratory programs to support HIV-related diagnostic and monitoring services in PEPFAR-supported countries in the region.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

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

NOFO.

Expected number of awards: 1 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.

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

Step 1: Review the Opportunity 6

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: ROP Q1 Activities.

◦ Component 2: ROP Q2 Activities.

◦ Component 3: ROP Q3 Activities.

◦ Component 4: ROP Q4 Activities.

◦ Component 5: ROP Additional Activities.

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 30 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 the Caribbean (Jamaica and Trinidad and Tobago).

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 HIV in the Caribbean region HIV prevalence in the Caribbean is estimated at 1.2% of the adult population, but it varies by country.

Between 2010 and 2022, the number of new infections in the region decreased by 15%, and AIDS-related deaths decreased by 53%.

Across the region, data show that since 2010, uptake of antiretroviral therapy has increased from 19% to 63% among men and from 21% to 74% among women.

The state of HIV in Jamaica and Trinidad and Tobago Jamaica and Trinidad and Tobago are PEPFAR-supported countries with both a generalized and concentrated epidemic. Data show HIV prevalence is much higher among key populations than the general population.

• The preliminary 2024 UNAIDS estimate of people living with HIV in Jamaica is 24,000, with a cascade of 93-54-78.

• For Trinidad and Tobago, the estimate is 11,878, with a cascade of 95-63-93.

Both countries struggle to meet the second 95 target of linking and retaining persons on treatment.

The critical role of high-quality diagnostics Access to high-quality, timely laboratory diagnostic and monitoring services has a critical effect on the success of public health programs designed to address HIV, TB, STIs, and related diseases.

Over the past decade, CDC has provided technical assistance to strengthen laboratory systems in the region, with notable achievements. The countries have progressed in scaling up and increasing access to laboratory services for clients, including HIV testing, early infant diagnosis (EID), viral load (VL) monitoring, CD4, and HIV drug resistance testing.

Through the previous NOFO, CDC-RFA-GH20-2011, we:

Step 1: Review the Opportunity 10

• Helped five laboratories achieve accreditation to the International standard International Organization for Standardization (ISO) 15189.

• Trained over 1,200 laboratory professionals in various technical topics.

• Expanded the number of sites implementing quality improvement initiatives.

• Increased the evaluation of rapid testing kits for in-country use.

• Improved safety management practices, resulting in decreased incidents.

One of the most important lessons from the previous NOFO is the importance of dedicated subject matter experts who serve as mentors and champions. These experts strengthen the laboratory network by providing customized technical assistance.

The goals of this NOFO Despite these achievements, there are still gaps in ensuring that efficient and sustainable laboratory systems operate cost-effectively within the region.

Additional support is needed to build sustainable capacity and improve diagnostic services for HIV, TB, STIs, and related diseases.

These initiatives will enhance the capability for accurate disease monitoring and support the scale-up of HIV care and treatment programs. Optimal coverage and universal access to uninterrupted diagnostic testing services are necessary for reaching epidemic control and will require novel technologies and approaches.

This NOFO aims to meet PEPFAR’s 5x3 laboratory implementation strategies and goals to achieve tangible outcomes. This NOFO seeks to:

• Improve access to quality-assured laboratory diagnostic services.

• Support the implementation of quality management systems (QMS).

• Build strong laboratory technical capacity.

• Maintain uninterrupted diagnostic services.

Expected outcomes We expect the following outcomes by the end of the project period:

• Increased implementation of QMS supported by executing the updated Strengthening Laboratory Management toward Accreditation (SLMTA) program.

• Increased use of continuous quality improvement (CQI) tools, such as:

◦ External Quality Assessment (EQA).

Step 1: Review the Opportunity 11

◦ Stepwise Laboratory Improvement Process toward Accreditation

(SLIPTA).

◦ Rapid Test Continuous Quality Improvement Initiative (RTCQI).

• Expanded implementation of quality assurance (QA) initiatives that lead to:

◦ Increased accuracy and reliability of diagnostic test results.

◦ Enhanced use of test data for clinical decision-making.

◦ Improved outcomes for patients with HIV and HIV/AIDS-related infections.

• Increased access to quality-assured laboratory services, laboratory information systems, and data dashboards.

• Strengthened organizational capacity to support testing across the HIV continuum of care and to provide data for surveillance.

• Improved capacity to identify and confirm the status of HIV-infected individuals, conduct recency testing, and facilitate training and certification of testers.

• Optimized and efficient national HIV laboratory networks that provide access to timely and reliable diagnostics to improve test quality monitoring, clinical decision-making, and data management.

• Increased access to quality-assured diagnostics and uninterrupted testing services through efficient networks, implemented throughout the clinical and diagnostic system.

Purpose The purpose of this NOFO is to:

• Support the achievement of accreditation in public health and clinical laboratories.

• Strengthen the laboratory workforce’s capacity.

• Support the expansion of information management.

• Expand QA activities.

• Build efficient programs to monitor HIV and HIV-related testing in Jamaica and Trinidad and Tobago.

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

Step 1: Review the Opportunity 12

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.

Table: Strategies and outcomes

Strategies Short-term outcomes Intermediate outcomes

Long-term outcomes

Strategy 1: Expand mentoring and technical assistance to establish efficient laboratory workflow and implement QMS in selected public health/clinical laboratories.

Strategy 2: Increase biorisk management implementation in selected public health/clinical laboratories.

Strategy 3: Develop and implement tools and processes to strengthen and optimize integrated laboratory networks.

Strategy 4: Strengthen workforce development and build capacity in public health/clinical laboratories.

Increased adoption and use of laboratory standards, guidelines, procedures, and quality practices (EQA, SLIPTA, SLMTA, RTCQI, etc.).*

Improved biosecurity and biosafety management systems and strategies to mitigate any issues identified.*

Increased use of innovative tools, technologies, and approaches to strengthen the laboratory and clinical interface.*

Improved laboratory human resource capacity to provide quality-assured diagnostic services.*

Decreased frequency and duration of unplanned testing interruptions.*

Improved data quality and increased use of timely and reliable laboratory services.

Improved laboratory capacity to safely detect and respond to outbreaks in a timely manner.

Increased use of available diagnostic test results for decision-making.

Increased participation and use of laboratory QA practices leading to

CQI.*

Increased adherence and harmonization among laboratories for good clinical practices.*

Optimized laboratory network with efficient workflow consistently meeting client needs.

Step 1: Review the Opportunity 13

Additional information on outcomes in the logic model:

• Increased adoption and use of laboratory standards, guidelines, procedures, and quality practices (EQA, SLIPTA, SLMTA, RTCQI, etc.)

◦ Laboratory standards and guidelines include ISO standards such as ISO 15189, ISO 15190, ISO 17025, ISO 17043, ISO 35001, and ISO 22367. Find more information here: https://www.iso.org/home.html.

◦ Quality practices include the implementation of RTCQI, SLMTA, and

SLIPTA.

• Improved biosecurity and biosafety management systems and strategies to mitigate any issues identified.

◦ Includes risk management, biosafety, infection prevention and control, and risk assessment.

• Increased use of innovative tools, technologies, and approaches to strengthen the laboratory and clinical interface.

◦ Innovative approaches include the use of the VL/ infant virologic testing (IVT) Scorecard, electronic Proficiency testing (ePT) dashboard, and Stepwise improvement process – rapid and recency testing (SPI-RRT) checklist and dashboard.

• Increased participation and use of laboratory QA practices leading to CQI.

◦ CQI implementation includes achieving Accreditation to International Standards, implementing RTCQI, conducting SLIPTA assessments, and executing the SLMTA program.

◦ Implementation of QA practices includes EQA, dried tube specimens (DTS), internal quality control, and laboratory inter-comparisons.

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.

The following are the strategies and the required activities captured under this NOFO. You may also propose additional related strategies and activities to achieve the expected outcomes.

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

Step 1: Review the Opportunity 14 https://www.iso.org/home.html

Strategy 1: Expand mentoring and technical assistance to establish efficient laboratory workflow and implement QMS in selected public health/clinical laboratories.

Required activities:

• Expand implementation of QMS and CQI activities in PEPFAR-supported laboratories to increase the quality and timeliness of service.

• Develop and implement QMS-related documentation in PEPFAR-supported laboratories.

• Facilitate and expand implementation of updated SLMTA and SLIPTA.

• Expand and monitor RTCQI, DTS, and ePT implementation to reduce testing errors.

• Facilitate the documentation and implementation of multi-disease testing platforms.

• Work with laboratory staff to implement activities and procedures to meet international standards and become accredited.

• Strengthen laboratory network to ensure uninterrupted testing services.

Strategy 2: Increase biorisk management implementation in selected public health/clinical laboratories.

Required activities:

• Provide technical assistance for the implementation of infection prevention and control policies and procedures in PEPFAR-supported sites.

• Conduct risk assessments and facilitate implementation of effective biosafety management systems in PEPFAR-supported laboratories.

• Facilitate implementation and monitoring of biosafety practices and remediation processes.

Strategy 3: Develop and implement tools and processes to strengthen and optimize integrated laboratory networks.

Required activities:

• Expand the use of tools, such as the VL/IVT scorecard and SPI-RRT checklist, to monitor and measure key quality indicators.

• Expand the development of improvement projects to address key quality indicators.

Step 1: Review the Opportunity 15

• Expand the use and implementation of connectivity tools to report, monitor, and facilitate the transfer of information between laboratories and MOH databases to ensure the timely return of results and improve the laboratory and clinical interface.

Strategy 4: Strengthen workforce development and build capacity in public health and clinical laboratories.

Required activities:

• Facilitate access to in-service training for laboratory professionals in PEPFAR-supported laboratories.

• Train laboratory professionals in good clinical laboratory practice, quality management, QA, and CQI.

• Develop innovative tools such as e-learning modules, web-based training, and on-demand platforms for continuing education.

• Support training of health workers on facilitating task sharing to perform rapid diagnostic testing.

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.

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

Step 1: Review the Opportunity 16 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.

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.

• 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.

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

Step 1: Review the Opportunity 17 https://www.state.gov/reports-pepfar/ https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/wp-content/uploads/2022/09/PEPFAR-Strategic-Direction_FINAL.pdf https://www.state.gov/reports-pepfar/

Focus populations The focus populations for this NOFO include laboratory professionals, clinicians, healthcare workers, and users of laboratory services.

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.

• 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.

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

Step 1: Review the Opportunity 18 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

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:

• CDC-funded MOH in the region.

• CDC/PEPFAR-supported laboratories in the region.

• Pan American Health Organization.

• Caribbean Public Health Agency.

• Other CDC-funded recipients (as needed).

• PEPFAR-supported U.S. government agencies like the United States Agency for International Development and Health Resources and Services Administration, as needed.

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 19

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 5% of the 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 period.

Required performance measures

Overview This program includes two types of indicators:

• 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 Below are some anticipated MER indicators, targets, and reporting frequencies for the first year. You may propose additional relevant MER indicators as part of your initial Evaluation and Performance Measurement Plan.

• Lab_PTCQI: Number of PEPFAR-supported laboratory-based testing and/ or Point-of-Care Testing (POCT) sites engaged in continuous quality improvement (CQI) and proficiency testing (PT) activities. [Target: at least 1 facility per country will participate in PT, from the following analyses HIV, VL, EID, CD4, TB; Reporting Frequency: Annual]

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

Step 1: Review the Opportunity 20 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

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

• Number of laboratory professionals at PEPFAR-supported laboratories trained in specialized technical subjects. [Target: 50; Reporting Frequency: Annual]

• Number of PEPFAR-supported sites with Biosafety Standard Operating Procedures or Infection Prevention and Control Standard Operating Procedures. [Target: 1 per country; Reporting Frequency: Annual]

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

Evaluation Access to high quality laboratory diagnostic services are key to public health programs designed to address HIV, TB, and related activities. Currently, there is still a gap to having efficient and sustainable laboratory systems in the Caribbean region.

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

• The extent to which the CoAg initiatives resulted in the increased number of accredited public health laboratories: outcome evaluation.

• The extent to which HIV testing sites documented and implemented a QMS: process evaluation.

Evaluation data sources Data sources may include registers, tally sheets, electronic and paper 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.

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• 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.

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.

Step 1: Review the Opportunity 22

• 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.

• 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.

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

Step 1: Review the Opportunity 23 https://www.cdc.gov/grants/additional-requirements/ar-25.html

• 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.

• 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.

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

Step 1: Review the Opportunity 24

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 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.

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

Step 1: Review the Opportunity 25 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

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.

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:

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

Step 1: Review the Opportunity 26 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

◦ 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.

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.

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

Step 1: Review the Opportunity 27 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))

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. Department of State; but to the extent that HHS/ CDC funds are added to an award, this limitation applies. We will update this limitation in future years.

Program income Program income is money earned as a result of your award-supported project activities. You must use program income for the purposes and under the conditions of the award. Find more about program income at 45 CFR 75.307.

Program-specific limitations

CDC PEPFAR terms and conditions You can find a list of PEPFAR-specific terms and conditions on our website.

They apply to all PEPFAR awards, so we strongly encourage you to read them and ask questions if you need more information. These terms and conditions will apply if you are selected for an award so you should confirm that you are able to comply with them prior to applying.

Host country laws and regulations If funded, you are expected to follow applicable host country laws and regulations related to the strategies under this NOFO; if there are conflicts with this award, contact the Grants Management Officer.

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

Step 1: Review the Opportunity 28 https://www.ecfr.gov/current/title-45/part-75#p-75.403(d) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-75/subpart-D/subject-group-ECFR911e5e1a30bfbcb/section-75.307 https://www.cdc.gov/grants/documents/PEPFAR-Terms-and-Conditions.pdf

Step 2:

Get Ready to Apply

In this step

Get registered 30

Questions 31

Get registered You must be registered in both SAM.gov and Grants.gov to apply. You can review the requirements and get started on developing your application before your registrations are complete.

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

To register, go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information you will need to register.

When you register or update your SAM.gov registration, you must agree to the financial assistance general certifications and representations. You must agree to those for grants specifically, as opposed to contracts, because the two sets of agreements are different. You will have to maintain your registration throughout the life of any award.

Grants.gov You must also have an active account with Grants.gov. You can see step-by-step instructions at the Grants.gov Quick Start Guide for Applicants.

Find the application package The application package has all the forms you need to apply. You can find it online. Go to Grants Search at Grants.gov and search for opportunity number

CDC-RFA-JG-25-0065.

If you can’t use Grants.gov to download application materials or have other technical difficulties, including issues with application submission, contact Grants.gov for assistance. The Grants.gov Contact Center is available 24 hours a day, 7 days a week, except U.S. federal holidays. The Contact Center is available by phone at 1-800-518-4726 (U.S.) and 1-606-545-5035 (international) or by email at support@grants.gov.

We will post any changes, updates, or amendments on Grants.gov. To get updates on changes to this NOFO, select Subscribe from the View Grant Opportunity page for this NOFO on Grants.gov.

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

Step 2: Get Ready to Apply 30 https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://grants.gov/search-grants https://www.grants.gov/support https://www.grants.gov/support mailto:support@grants.gov

Need help? See Contacts and Support.

Help applying For help related to the application process and tips for preparing your application, see How to Apply on our website. For other questions, see Contacts and Support.

Questions If you have questions, you must submit them by email to pepfarfoas@cdc.gov no later than 20 calendar days after the NOFO is published to Grants.gov. We will not respond to questions received later. We will post answers to questions in a Q&A document in the Grants.gov application package.

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

Step 2: Get Ready to Apply 31 https://www.cdc.gov/grants/applying/index.html mailto:pepfarfoas@cdc.gov

Step 3:

Prepare Your Application

In this step

Application contents and format 33

Application contents and format Applications include five main elements. This section includes guidance on each. Make sure you include each of the following:

Table: Application contents

Elements Grants.gov form to use

Project abstract Use the Project Abstract Summary form.

Project narrative Use the Project Narrative Attachment form.

Budget narrative justification Use the Budget Narrative Attachment form.

Attachments Insert each in the Other Attachments form.

Other required forms Upload using each standard form.

All your application materials must be in English. Express currency in U.S.

dollars.

Your organization’s authorized official must certify your application.

We will provide instructions on document formats in the following sections. If you don’t provide the required documents, your application is incomplete.

See responsiveness criteria and initial review to understand how this affects your application.

Required format for project abstract, project narrative, budget narrative justification, attachments, and other required forms

File format: PDF, Word, or Excel

Size: 12-point font, including for footnotes, tables, graphics, and charts

Spacing: Single-spaced

Margins: 1-inch

Include page numbers

These formatting requirements do not apply for any scanned or photocopied materials inserted into your application.

See merit…