Botswana CDC-RFA-JG-25-0084 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 19, 2025

Strengthening the Botswana Ministry of Health (MOH) laboratory and health systems through technical assistance (TA) to effectively manage and sustain a quality HIV/TB program in Botswana under the President’s Emergency Plan for AIDS Relief (PEPFAR)

Opportunity number: CDC-RFA-JG-25-0084

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 30

Get registered 31

Questions 32

Step 3: Prepare Your Application 33

Application contents and format 34

Step 4: Learn About Review and Award 44

Application review 45

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 February 19, 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:

Strengthening the Botswana Ministry of Health (MOH) laboratory and health systems through technical assistance (TA) to effectively manage and sustain a quality HIV/TB program in Botswana under PEPFAR

Opportunity number:

CDC-RFA-JG-25-0084

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 19, 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 This NOFO aims to strengthen MOH health systems to manage and sustain quality HIV/TB programs. This NOFO will also support the MOH in building capacity to address gaps in laboratory diagnostics, quality management systems, and Botswana Public Health Institute (BPHI) outbreak management.

Activities will result in high-quality sustainable HIV-related laboratory-based testing and point of care testing (POCT), resilient laboratory systems capable of responding to HIV/TB and related public health threats, and quality management systems for continuous quality improvement (CQI) of HIV/TB-related activities.

This NOFO is expected to support international accreditation of selected laboratories and ensure laboratories and testing sites adhere to national policies and guidelines. This NOFO will support the sustainability of laboratory service capacity through surveillance for timely intervention, multi-disease testing, and HIV/TB resource use through adaptation of activities by local entities.

Step 1: Review the Opportunity 5

Funding details Type: Cooperative agreement

Expected total NOFO funding for Year 1: $3,000,000 This is the expected total Year 1 funding for all awards made under this

NOFO.

Expected number of awards: 1 to 3 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: COP Q1 Targets and Activities.

◦ Component 2: COP Q2 Targets and Activities.

◦ Component 3: COP Q3 Targets and Activities.

◦ Component 4: COP Q4 Targets and Activities.

◦ Component 5: COP Additional Targets and 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 15 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 Botswana.

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 Botswana is one of the few countries that has met the UNAIDS 95-95-95 targets by attaining 95-98-98 according to the Fifth Botswana AIDS Impact Survey. Improvements are needed to sustain these gains through laboratory strengthening and health system activities.

Laboratory services play a vital role in ensuring quality HIV/TB diagnosis and monitoring. Botswana has a total of 53 public health laboratories:

• Four are state-owned serving the army and police.

• One is a proficiency testing laboratory (Botswana National Quality Assurance Laboratory).

• 24 are viral load (VL) laboratories, six of which conduct early infant diagnosis (EID).

The remaining are district, primary healthcare, and clinic laboratories, nine of which are accredited to the International Standardization Organization 15189 through CDC/PEPFAR support.

Laboratory gaps need to be addressed for Botswana to fully support people living with HIV/TB and sustain the gains made through PEPFAR support. Some of these gaps include:

• Low VL coverage amongst children and adolescents living with HIV.

• Suboptimal laboratory-clinic interface.

• Weak post market laboratory commodities management.

• Suboptimal biosafety and biosecurity procedures and infrastructure.

• Suboptimal laboratory outbreak management processes.

• Inadequate surveys and laboratory data management systems resulting in negative impact on HIV/TB programs.

Currently, the Botswana healthcare system is lacking processes and procedures for implementing CQI of HIV/TB programs. There is a need to provide TA and build capacity of the Government of Botswana to develop a national quality structure for HIV/TB service provision. National policies and procedures are deficient and are not being implemented efficiently and consistently.

Step 1: Review the Opportunity 10

It is imperative for the government to regulate healthcare sites and healthcare workers to support accreditation of healthcare facilities and quality of care to scale up HIV/TB programs and support sustainability. To build capacity of BPHI to rapidly respond to outbreaks and prevent related public health threats that could affect HIV/TB programs, the government of Botswana needs to be capacitated to lead public health responses by continuously monitoring and addressing gaps in outbreak management, survey, and surveillance.

This NOFO aims to strengthen laboratory health systems to be sustainable and resilient to HIV/TB and related public health threats, strengthen the provision of quality HIV-related laboratory-based testing and POCT across the clinical cascade, and support implementation and quality management systems for CQI of HIV/TB programs. Activities implemented through this NOFO, are aimed at improving quality of diagnostic testing, services delivery, and detection of emerging public health threats. Through these activities, HIV/ TB rates are expected to decline among all populations.

This NOFO will build on CDC’s previously funded work under CDC-RFA- GH20-2008 which supported diagnostic testing across the clinical cascade including opportunistic infections (OIs). These past efforts have improved Botswana’s capacity to provide quality laboratory services. Key successes include:

• Attainment of UNAIDS 95-95-95 targets (95-98-98).

• Introduction of Rapid Testing Continuous Quality Improvement (RT-CQI) certification programs across 108 sites.

• Introduction of the rapid testing TB lipoarabinomannan and TB stool testing for infants.

• Introduction of the flagship laboratory training program.

• Accreditation of two public health laboratories.

• Provision of proficiency test materials to 830 testing sites.

• Provision of TA by regional laboratory scientists to MOH laboratory staff.

Activities under this NOFO will address existing gaps by prioritizing:

• Building healthcare worker capacity to efficiently manage HIV/TB programs and activities.

• Building local capacity of Botswana MOH in HIV-related proficiency testing including VL and EID proficiency testing.

• Managing, coordinating, and sustaining health systems for HIV/TB and emerging public health threats.

Step 1: Review the Opportunity 11

• Increasing use of HIV/TB data to support strategic decision making.

• Closing the gap between governance structure and policy implementation across health systems.

• Sustaining healthcare HIV/TB training programs.

• Supporting adherence to biosafety and biosecurity service provision.

A holistic approach is needed to sustain the gains that have been made to date. In addition, a resilient health system is needed to support frequent demands of HIV/TB and related public health threats. Activities implemented in this NOFO will ensure health systems are sustained beyond donor funding.

Purpose The purpose of this NOFO is to provide tailored TA to support the Botswana MOH to strengthen health systems, including laboratory and quality management systems. This NOFO aims to build resilient HIV/TB systems, build capacity to respond to related public health threats, strengthen CQI, and build efficient and effective (quality) HIV/TB laboratory services.

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 provision of sustainable, quality HIV-related laboratory-based testing and POCT across the clinical cascade.

Strategy 2:

Strengthen laboratory health systems to be sustainable and resilient to both emerging and related HIV/TB public health threats.

Strategy 3: Support implementation and sustainability of quality management systems for CQI of HIV/TB related programs.

Increased VL coverage for all populations.*

Increased testing of HIV-exposed infants at 6 weeks post-partum.*

Increased HIV-related POCT capacity.*

Increased HIV-related POCT quality.*

Improved integration of laboratory-clinic interface and supporting data systems.*

Improved HIV and other pathogen genotyping.*

Improved competencies of healthcare workers in providing quality health services.*

Increased quality of HIV/TB services.*

Increased use and uptake of HIV/TB quality improvement projects.*

Increased efficiency of HIV/TB laboratory services delivery.

Increased certification and accreditation of health facilities.*

Increased accreditation of laboratories.*

Increased HIV/TB program compliance to international standards.*

Improved detection of HIV/TB and related public health threats.*

Increased VL suppression among people living with HIV.

Optimized laboratory networks.*

Decreased HIV/TB morbidity and mortality.

Sustained quality of HIV/TB service provision.*

Step 1: Review the Opportunity 13

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.

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

Strategy 1: Strengthen the provision of sustainable, quality HIV-related laboratory-based testing and POCT across the clinical cascade.

Required activities:

• Strengthen the laboratory-clinic interface and testing services to ensure timely return and use of results to improve patient outcomes.

• Strengthen integration of electronic medical records and laboratory information systems.

• Implement a CQI plan for HIV-related tests (including, but not limited to rapid HIV testing, EID, CD4, VL, and TB).

• Optimize laboratory network systems and referral networks to improve HIV-related testing capacity and delivery of results.

• Design, implement, and scale up POCT for underserved and priority populations.

• Enhance MOH use and application of laboratory data for public health decision-making.

Strategy 2: Strengthen laboratory health systems to be sustainable and resilient to both emerging and related HIV/ TB public health threats.

Required activities:

• Build capacity within local institutions to deliver all PEPFAR laboratory-related trainings, including but not limited to RT-CQI, Strengthening Laboratory Management Toward Accreditation, Stepwise Laboratory Quality Improvement Process Towards Accreditation, and Infant Virologic Testing/VL Score Card.

Step 1: Review the Opportunity 14

• Implement innovative ongoing capacity building activities (for example training, mentorship, and supportive supervision) for laboratory staff at all levels.

• Support MOH to establish and maintain collaboration across all diagnostic HIV/TB regional centers.

• Build the capacity of BPHI to lead national public health activities including laboratory health workforce development, disease lab surveillance, detection and control of HIV/TB and related public health threats.

• Provide TA to MOH to develop, implement, and oversee compliance with laboratory regulatory systems, standards, and policies, including but not limited to biosecurity and biosafety.

• Build MOH laboratory capacity to describe and monitor health events, detect, and investigate outbreaks through disease-specific surveillance and surveys, and better respond to and control HIV/TB and related public health threats.

• Strengthen laboratory information management systems to enhance integration, interoperability, availability, and use of data to inform program improvement and decision making.

• Strengthen MOH capacity for laboratory commodity management and prevention of stockouts.

• Support MOH’s leadership and coordination of strategic information, clinical services, and laboratory arms of the government of Botswana National Mentorship Program.

Strategy 3: Support implementation and sustainability of quality management systems for CQI of HIV/TB related programs.

Required activities:

• Strengthen national capacity to implement quality management systems to support achievement of national certification and international accreditation for both laboratories and facilities.

• Implement external quality assurance programs for new and existing HIV/TB related diagnostic tests.

• Support the MOH to maintain and sustain accreditation of HIV/TB facilities.

• Integrate effective quality assurance and CQI practices to enhance service delivery and site-level program management.

Step 1: Review the Opportunity 15

• Provide TA to MOH to develop, implement, and oversee compliance with CQI policies and standards at all levels.

• Support the MOH to conduct quality learning collaboratives for improvement of service delivery for HIV/TB programs.

• Capacitate the MOH to implement quality improvement projects.

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 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.

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

Step 1: Review the Opportunity 16 https://www.state.gov/reports-pepfar/

• 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.

Focus populations The focus populations for this NOFO include:

• Healthcare workers:

◦ Laboratory staff.

◦ Doctors.

◦ Nurses.

◦ Data clerks.

◦ Other healthcare staff.

• General population.

• HIV-exposed infants.

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

Step 1: Review the Opportunity 17 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

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 by implementing care and treatment, prevention, strategic information, and laboratory activities with but not limited to:

• CDC-funded partners.

• Government of Botswana entities, including but not limited to:

◦ MOH departments (Laboratory, Quality Assurance, Monitoring and Evaluation (M&E).

◦ Health Policy Research and Development.

◦ Nursing and Midwifery.

◦ Nursing and Midwifery Council of Botswana.

◦ Health Inspectorate.

◦ HIV services.

◦ Central Medical Stores.

◦ Botswana Health Profession Council.

◦ Botswana Health and Policy Development.

◦ District Health Management Teams.

◦ BPHI.

◦ National AIDS and Health Promotion Agency.

◦ Government Health Training Institutions.

◦ Botswana Bureau of Standards.

• Multilateral partners, including but not limited to:

◦ World Health Organization.

◦ United Nation’s Children Fund.

◦ Joint United Nations Program on HIV/AIDS.

◦ Global Fund and their implementing partners.

• United States Government, including but not limited to:

Step 1: Review the Opportunity 19

◦ United States Agency for International Development.

◦ Peace Corps.

• Public health programs and organizations, such as civil society, faith-based, and community organizations as it relates to HIV/TB.

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.

Data, monitoring, and evaluation CDC expectations CDC expects you to regularly update them on the implementation progress.

You are expected 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 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.

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

Step 1: Review the Opportunity 20

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 Below, we show some anticipated MER indicators, targets, and reporting frequencies for the first year. You can propose any 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: 53 Labs and 123 Rapid HIV Testing sites; Reporting Frequency: Annual]

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

• Percentage of HIV-related testing (POCT EID, VL, TB, human papillomavirus (HPV), OIs, Xpert, Acid Fast Bacillus (AFB) smear, or TB culture) staff with current competency certification. [Target: 80%;

Reporting Frequency: Quarterly]

• Percentage of facilities which are accredited by the international accreditation standards. [Target: 30%; Reporting Frequency: Annual]

• Percentage of rejected samples at HIV-related testing sites in the reporting period (POCT, EID, VL, HPV, OI’s, Xpert, AFB smear, or TB culture). [Target: <5%; Reporting Frequency: Quarterly]

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

Step 1: Review the Opportunity 21 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• Percentage of HIV-related testing laboratories (POCT, EID, VL, HPV, OIs, Xpert, AFB smear, or TB culture) with testing outage over the past quarter. [Target: <5%; Reporting Frequency: Quarterly]

• Percentage of sites that have quality improvement projects in place.

[Target: 80%; Reporting Frequency: Annual]

• Percentage of staff trained on the updated outbreak management plan (i.e., standard operating procedure posted at all levels and staff are aware of their roles, associated strategies, etc.). [Target: 90%; Reporting Frequency: Annual]

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.

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 and end-term evaluation.

• The extent to which the laboratory-clinic interface has improved its efficiency and service delivery: outcome evaluation.

• Improvements and gaps in implementing health systems strengthening in facilities: process 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.

Step 1: Review the Opportunity 22

• 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.

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

Step 1: Review the Opportunity 23

• 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 24 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 25

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 26 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 27 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 28 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 29 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 31

Questions 32

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-25-0084.

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 31 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 32 https://www.cdc.gov/grants/applying/index.html mailto:pepfarfoas@cdc.gov

Step 3:

Prepare Your Application

In this step

Application contents and format 34

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…