India CDC-RFA-JG-25-0102 Final NOFO for Publication.pdf

Division of Global HIV and Tuberculosis

Notice of Funding Opportunity

Application due February 25, 2025

Strengthening India’s integrated HIV/STI tiered laboratory network through continuous quality improvement, surveillance, and laboratory data management under the President’s Emergency Plan for AIDS Relief (PEPFAR) Opportunity number: CDC-RFA-JG-25-0102

Contents Before you begin 3

Step 1: Review the Opportunity 4

Basic information 5

Eligibility 8

Program description 11

Step 2: Get Ready to Apply 32

Get registered 33

Questions 34

Step 3: Prepare Your Application 35

Application contents and format 36

Step 4: Learn About Review and Award 45

Application review 46

Award notices 50

Step 5: Submit Your Application 51

Application submission and deadlines 52

Application checklist 54

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 25, 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 11

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.

Havequestions?

See Contacts and Support.

Key facts

Opportunity name:

Strengthening India’s integrated HIV/STI tiered laboratory network through continuous quality improvement, surveillance, and laboratory data management under

PEPFAR

Opportunity number:

CDC-RFA-JG-25-0102

Announcement type:

New

Assistance listing: 93.067 Global AIDS Program

Key dates

Application deadline:

February 25, 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 You will support the National AIDS Control Program (NACP) under the Ministry of Health (MoH) to strengthen the national HIV/STI laboratory systems and services in India. This NOFO aims to maintain gains and strengthen the delivery of high-quality, integrated HIV/STI diagnostic services across the country through the following:

• Optimizing diagnostic networks to ensure efficiencies and testing accessibility through innovative strategies.

• Saturating viral load coverage (VLC).

• Improving biosafety.

• Achieving and maintaining International Organization for Standardization (ISO) accreditation and national certifications.

• Expanding proficiency testing (PT) programs to multiple testing parameters.

• Prioritizing the scaling of patient-centered approaches and point-of-care testing (POCT) to address the following:

◦ Barriers to access.

◦ Integration of multi-disease tests.

◦ Quality improvement, certification, and validation.

• Incorporating molecular epidemiology to pinpoint transmission networks and emerging needs.

• Conducting HIV drug resistance testing.

Step 1: Review the Opportunity 5

• Using implementation science to incorporate innovative laboratory models to improve detection, coverage, and access to HIV/STI diagnostic services.

Funding details Type: Cooperative agreement

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

NOFO.

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

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

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

Funding strategy

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

You may not request more than this amount.

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

• Availability of funds.

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

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

Component funding

Overview

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

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

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

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 India.

FCRA registration Any local partner (prime applicant or proposed sub-partner), applying for this NOFO must be compliant with Government of India’s Foreign Contribution Regulation Act (FCRA) and must submit documentation of active FCRA registration.

The prime partner applicant must have the capability to engage local sub-partners, as needed, to meet the program objectives.

Failure to provide FCRA registration as part of the application will render an application nonresponsive and your application will not move forward.

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.

• Does not provide FCRA registration as part of the application.

See the application checklist to understand your application requirements.

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)

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.

Step 1: Review the Opportunity 10

Program description Background overview and related work For two decades, India has seen a gradual decline in estimated new HIV infections, prevalence, and AIDS-related mortality. Between 2010 and 2023, the number of new HIV infections declined by 44% and AIDS-related mortality declined by 79%; however, the pace of decline in new HIV infections has plateaued.

Epidemiological data for India in 2023 shows that:

• Approximately 2.54 million people are living with HIV.

• Approximately 68,450 new HIV infections are occurring annually.

• Adult prevalence is at 0.20%.

India continues to make progress towards achieving the UNAIDS 95-95-95 targets. In 2023, it is estimated:

• 79% of people living with HIV are aware of their status.

• 86% of those aware are on ART.

• 93% of those already on ART are virally suppressed.

We are aligned with the following NACP Phase V goals:

• Reduce annual new infections by 80% by 2025-2026.

• Reduce AIDS-related mortality by 80% by 2025-2026.

• Eliminate the vertical transmission of HIV and syphilis by 2030.

• Promote universal access to quality STI/reproductive tract infection services to at risk and underserved populations.

Under the NOFO CDC-RFA-GH20-2037 cooperative agreement, PEPFAR and CDC supported and collaborated with NACP State AIDS Control Society (SACS), and other implementing partners to improve HIV laboratories by:

• Providing support for applying quality management systems in HIV and STI laboratories.

• Expanding the cervical cancer screening program for women living with

HIV.

• Increasing viral load (VL) testing capacity in the public sector.

• Introducing differentiated service delivery models such as:

Step 1: Review the Opportunity 11

◦ Hub and Spoke model.

◦ Community-led approaches.

Notable achievements from the previous NOFO include:

• Development of national laboratory policies, guidelines, and training materials for laboratory staff.

• 100% (13/13) accreditation of National Reference Laboratories.

• 94% (110/117) accreditation of State Reference Laboratories.

• 84% (54/64) accreditation of VL laboratories.

• 100% (6/6) accreditation of Early Infant Diagnosis (EID) laboratories under the ISO 15189 Accreditation program.

We aim to continue to expand accessibility and coverage of HIV and STI diagnostic services for hard-to-reach underserved populations through diverse strategies including:

• Optimizing and integrating the HIV/STI laboratory network.

• Implementing demonstration models and scaling successful early detection models and clinical management across the continuum of care.

Focus remains on enhancing service quality and scaling efforts to improve healthcare delivery. We aim to strengthen the government of India’s coordinated HIV and STI laboratory readiness and response plan towards HIV epidemic control through:

• Onsite mentoring and in-service staff training.

• Developing and implementing a functional tiered VL laboratory network within the public sector.

• Enhancing testing by:

◦ Providing linkage and access to annual VL testing.

◦ Ensuring continuous quality improvement (CQI) for HIV, VL, and EID tests in facility or community-based settings.

• Adopting a comprehensive approach to ensure:

◦ Rapid VL result turnaround time and expansion of uptake of VL results among all people living with HIV, including key populations.

◦ Integration of services into broader laboratory networks for comprehensive HIV management for people living with HIV.

• Supporting enhancement of laboratory capacity for molecular epidemiology testing to:

Step 1: Review the Opportunity 12

◦ Decode viral transmission networks.

◦ Guide resource allocation for public health interventions.

Achieving this requires the following:

• Using innovative strategies to enhance and implement established laboratory testing methods.

• Using cost-effective drug resistance testing strategies.

• Expanding laboratory network coverage.

• Integrating with other laboratory such as EID, COVID 19 Lab networks.

Targeted outcomes of this NOFO include:

• Strengthening the quality and diagnostic capabilities of HIV/STI testing.

• Increasing VLC.

• Achieving 95% suppression rates in PEPFAR-supported districts.

Purpose The purpose of this NOFO is to continue supporting India NACP’s flagship program by:

• Ensuring quality assurance for HIV/STI diagnostic services.

• Supporting VL testing expansion.

• Strengthening HIV/STI laboratory networks.

• Improving biosafety.

• Optimizing VL laboratory use through:

◦ Improving diagnostic network capabilities.

◦ External quality assurance.

We will accomplish this by building local and regional capacities for durable laboratory and diagnostic systems that respond to public health threats and emergencies, as well as continued alignment with MoH HIV epidemic control efforts.

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.

Step 1: Review the Opportunity 13

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: Scale-up the national integrated HIV/STI diagnostic capacity of the laboratory network to expand testing within the public sector.

Strategy 2: Build capacity of the MoH to effectively manage quality assured HIV/ STI diagnostic services for a sustained response.

Strategy 3: Facilitate the integration of CQI activities in HIV/STI conventional laboratories and POCT services to achieve ISO accreditations and national certifications.

Strategy 4:

Strengthen the comprehensive HIV/ STI diagnostic services network under the MoH to enhance identification of pathogens, timely linkage to care, and

Increased optimized use of laboratory equipment at laboratory and POCT sites.*

Improved integration of the enhanced laboratory network in national surveillance and clinical programs.*

Increased access to laboratory diagnostic services for all populations.*

Increased access to quality, timely data through systems and dashboards.*

Increased capacity of laboratory staff to implement national and international standards and guidelines.*

Increased adoption of standardized testing protocols and quality assurance measures.*

Sustained optimized use of laboratory equipment at laboratory and POCT sites.*

Increased VLC for people living with

HIV.*

Reduced turnaround time for laboratory services.*

Increased use of laboratory diagnostic services by all populations.*

Increased use of high-quality, timely data to monitor national diagnostic services.*

Increased capacity to monitor treatment failure for priority populations.*

Increased adherence to national and biosafety laboratory guidelines and procedures at MoH and testing laboratories.*

Sustained integration of laboratory services within the healthcare system.

Sustained laboratory system resiliency against public health threats.

Improved timely detection of public health threats.

Sustained high-quality, timely, and reliable testing services at all laboratory levels.

Reduced mortality rates from cervical cancer in women living with HIV.

Increased VL suppression for people living with

HIV.*

Increased use of ISO subject matter expertise for a quality assured, sustainable laboratory network.

Step 1: Review the Opportunity 14

Strategies Short-term outcomes Intermediate outcomes Long-term outcomes the overall surveillance capacity of the national program.

Increased capacity of laboratories to obtain ISO accreditation or certification.*

Increased integration of the enhanced laboratory network in national surveillance and clinical programs.*

Additional logic model details:

• Improved optimized use of laboratory equipment includes, but is not limited to:

◦ Staff appropriately trained to use and maintain laboratory equipment.

◦ Clinical laboratory interface.

• Increased access to laboratory diagnostic services for all populations includes, but is not limited to:

◦ Cancer screening methods.

◦ Genomic sequencing.

◦ STI testing.

◦ HIV testing.

• All populations include, but are not limited to priority populations, people living with HIV.

• Increased capacity of laboratories to obtain ISO accreditation refers to relevant ISO accreditation for medical laboratories such as ISO 15189 and

ISO 17043.

• Increased capacity of laboratories to obtain certification refers to relevant national certification awarded by the MoH or equivalent bodies.

Step 1: Review the Opportunity 15

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

Strategy 1: Scale-up the national integrated HIV/STI diagnostic capacity of the laboratory network to expand testing within the public sector.

Required activities:

• Identify gaps then enhance and optimize testing capacity for HIV, VL, EID, and STIs to achieve the national goals and UNAIDS 95-95-95 targets.

• Strengthen referral and linkage mechanism between laboratory and clinical services.

• Optimize use of laboratory equipment in conventional and POCT sites.

• Establish integration of laboratory services within the broader healthcare system through collaborations.

• Facilitate the adoption and implementation of standardized testing protocols and quality assurance measures in compliance with national and international standards and guidelines.

• Implement standardized biosafety protocols and guidelines and conduct regular monitoring and auditing compliance with biosafety standards.

• Strengthen the STI laboratory network to successfully test for common and treatable STIs with quality assured measures to support key, priority, and underserved populations.

• Build the national capacity for HIV drug resistance testing for people living with HIV who are on ART.

• Build the national capacity for screening for cervical cancer and linkage to care for women living with HIV and other applicable populations.

• Use implementation science to incorporate innovative laboratory models to improve detection, coverage, and access to HIV/STI diagnostic services.

• Implement differentiated service delivery models in cluster districts.

Step 1: Review the Opportunity 16

Strategy 2: Build capacity of the MoH to effectively manage quality assured HIV/STI diagnostic services for a sustained response.

Required activities:

• Strengthen monitoring systems in the HIV/STI tiered laboratory network.

• Strengthen the data systems and dashboards used to capture information and provide real-time monitoring.

• Enhance MoH’s capacity through laboratory mentoring programs.

• Enhance existing laboratory information management systems.

• Provide technical assistance for revising and updating documents related to national laboratory guidelines and standard operating procedures at MoH and testing laboratories.

• Conduct training to enhance capacity and adherence to national guidelines and standard operating procedures.

Strategy 3: Facilitate the integration of CQI activities in HIV/ STI conventional laboratories and POCT services to achieve ISO accreditations and national certifications.

Required activities:

• Train lab staff on national and international standards and guidelines for testing protocols, quality assurance practices, and adherence to standards.

• Implement a stepwise quality improvement plan and provide technical support to laboratories to achieve and maintain appropriate certification or ISO accreditation (e.g., ISO 15189 and ISO 17043).

• Ensure continual successful participation in PT for HIV/STI testing and implement action plans to address any issues.

• Streamline processes for collection, processing, and turnaround time of test results.

Step 1: Review the Opportunity 17

Strategy 4: Strengthen the comprehensive HIV/STI diagnostic services network under the MoH to enhance identification of pathogens, timely linkage to care, and the overall surveillance capacity of the national program.

Required activities:

• Enhance surveillance systems for early detection and outbreak response through molecular epidemiology capacity.

• Strengthen and expand the integrated HIV/STI surveillance into the national program.

• Implement the timely use and reporting of high-quality surveillance system data.

• Establish a process for the timely and efficient transfer of samples and clinical information to specialized laboratories.

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:

Step 1: Review the Opportunity 18

• 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 19 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:

• People affected by and living with HIV.

• Key populations include:

◦ Men who have sex with men.

◦ Female sex workers.

◦ Transgender individuals.

◦ People who inject drugs.

• Priority populations include:

◦ Mobile populations.

◦ Individuals in prisons and other closed settings.

◦ Partners of sex workers.

◦ Adolescent girls and young women.

◦ Adolescent boys and young men.

• Underserved and other populations that have a higher risk of HIV compared to general population groups.

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.

Step 1: Review the Opportunity 20

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

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

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

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

• Reduce HIV and TB stigma and discrimination.

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

• Make the workforce more inclusive.

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

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

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

Government agencies and programs:

• MoH.

• NACP.

• SACS.

• Digital Information Security in Healthcare Act (DISHA).

• Local government agencies.

• PEPFAR agencies and programs.

Non-government organizations and programs:

• Community groups.

• Key, priority, and underserved populations.

• Multilateral organizations.

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

Step 1: Review the Opportunity 21 https://www.cdc.gov/about/priorities/why-is-addressing-sdoh-important.html?CDC_AAref_Val=https://www.cdc.gov/about/sdoh/index.html

• Global Fund recipients.

• Private sector organizations.

• Current CDC-funded implementing partners supporting activities in:

◦ Prevention and treatment.

◦ Strategic information.

◦ Quality improvement.

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

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

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

Step 1: Review the Opportunity 22

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: Not Assigned; Reporting Frequency: Annual]

• CXCA_SCRN: Number of women living with HIV on ART screened for cervical cancer. [Target: 10,000; Reporting Frequency: Semi-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 laboratories that achieve ISO 15189 accreditation. [Target:

5%; Reporting Frequency: Annual]

• Percentage of cadres of laboratory staff trained to implement national and international standards and guidelines. [Target: 50%; Reporting Frequency: Semi-Annual]

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

Step 1: Review the Opportunity 23 https://help.datim.org/hc/en-us/articles/360000084446-MER-Indicator-Reference-Guides

• Percentage of cadres of laboratory staff trained on optimized use of laboratory equipment at laboratory sites. [Target: 80%; Reporting Frequency: Quarterly]

• Percentage of cadres of laboratory staff trained on optimized use of laboratory equipment at point of care sites. [Target: 80%; Reporting Frequency: Quarterly]

• Percentage of laboratory staff trained on data quality processes and procedures. [Target: 25%; Reporting Frequency: Semi-Annual]

• Percentage of laboratory staff trained on data monitoring and surveillance. [Target: 25%; Reporting Frequency: Semi-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.

• Facilitators/barriers to achieving ISO accreditations and national certifications in laboratories and point of care centers: process evaluation.

• Effects of integrated CQI activities on achieving and maintaining ISO accreditations and national certifications in laboratories and point of care centers: outcome evaluation.

• Effects of integration of HIV/STI diagnosis network on achieving national goals and UNAIDS targets: outcome evaluation.

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

Dissemination of evaluation results Dissemination channels could include:

• Local and international conferences and forum abstract presentations.

Step 1: Review the Opportunity 24

• Conference poster displays.

• Manuscripts.

• Bulletins.

• Reports.

• Presentations to technical working groups and stakeholder meetings.

• 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.

Step 1: Review the Opportunity 25

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

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

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

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

Evaluation activities You must carry out specific evaluation activities.

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

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

• 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.

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

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

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

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

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

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

• Archival and long-term data preservation plans.

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

In addition to the other requirements listed, also include:

• Cybersecurity plans.

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

• 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.

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 27

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 28 https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm https://www.cdc.gov/scientific-integrity/php/public-information-collection/?CDC_AAref_Val=https://www.cdc.gov/os/integrity/reducepublicburden/index.htm

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 29 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 30 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 31 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 33

Questions 34

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-25-0102.

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 33 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…