Foa_Content_of_CDC-RFA-GH-23-0040 (1) extended.pdf

Centers for Disease Control and Prevention

Center for Global Health

Technical Assistance Services and Programmatic Support to Address National TB Program Needs and Priorities Towards Their Efforts to End TB

CDC-RFA-GH-23-0040

04/07/2023

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview

Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA- GH-23-0040. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Technical Assistance Services and Programmatic Support to Address National TB Program Needs and Priorities Towards Their Efforts to End TB C. Announcement Type: New - Type 1:

This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52- 2.pdf. Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr- 46/index.html (See section 45 CFR 46.102(d)).

Amendment II: Application Due Date Extention

The purpose of this amendment is to extend the Application Due Date from April 4, 2023 (04/4/2023) to April 7, 2023 (04/7/2023) due to intermittent technical issues with grants.gov.

Amendment I: Questions and Answers (Q&As)

The purpose of this amendment is to include questions and answers (Q&A) in Section H. Other Information.

Applicants should note that a Letter of Intent (LOI) is not requested or required as part of the application for this NOFO or for any CDC PEPFAR FY23 NOFO. Applicants should not submit LOIs. There may be dates populated in some NOFOs in the LOI fields (1. Due Date for Letter of Intent (LOI) under Part I. Overview, and a. Letter of Intent Deadline under D. Application and Submission Information), but this is an error CDC is working to fix. These sections should be blank to reflect that LOIs are not requested or required.

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH-23-0040

E. Assistance Listings Number:

93.494 F. Dates:

1. Due Date for Letter of Intent (LOI):

2. Due Date for Applications:

04/07/2023 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph This NOFO aims to address global TB strategic priorities in high TB-burden countries and settings. Strategies and activities outlined in this NOFO will contribute toward the World Health Organization’s (WHO) END TB strategy, STOP TB Partnership’s (STOP TB) Global Plan to End TB (2023–2030), and commitments made during the 2018 United Nations High-Level Meeting (UNHLM) on TB through the United Nations Political Declaration on the Fight Against TB. Recipient(s) will implement activities focused on TB screening and case finding, strengthening TB treatment delivery, TB infection prevention and control (IPC) measures, provision of TB preventive treatment (TPT), and incorporating efforts to reduce barriers such as stigma and discrimination, through evidence-based interventions for TB affected people.

All activities will be informed by a health equity approach, focusing on groups at higher risk for TB, including household contacts of people with TB, children and adolescents, people living with HIV (PLHIV), health care workers, migrants, mobile/displaced populations, and those who work or reside in crowded/congregate settings (criminal justice facilities, mines, etc.). The recipient(s) will advance global TB elimination goals over the award period by strengthening data-informed decision making, harmonizing efforts among partner organizations, and improving partner governments’ capacity to implement and oversee TB program delivery.

a. Eligible Applicants:

Open Competition

b. Funding Instrument Type:

CA (Cooperative Agreement)

c. Approximate Number of Awards The expected number of awards is 1-2.

d. Total Period of Performance Funding:

$0 The Approximate Project Period of Performance Funding/Estimated Total Funding for the Total 5 year Project Period is None. The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for years 2-5 will be set at continuation.

e. Average One Year Award Amount:

$1,000,000 The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for Year 1 is $1,000,000. The expected number of awards is 1-2. Exact amounts for each award under this NOFO will be determined at the time of award. Applicants are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount.

f. Total Period of Performance Length:

5 year(s)

g. Estimated Award Date:

September 30, 2023

h. Cost Sharing and / or Matching Requirements:

No Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview Despite being preventable and treatable, TB remains one of the world’s deadliest infectious diseases. Globally, nearly 2 billion people —a quarter of the world’s population— are infected with latent TB, and approximately 10 million people – including 1.1 million children – become sick with active TB disease each year. Drug-resistant TB is a further threat to public health systems around the world, with nearly half a million people becoming ill with infections that do not respond to first-line treatments, and only one in three people accessing treatment at all. CDC approaches TB with a coordinated and focused global response, as global reduction in TB is key to controlling and reducing TB rates in the U.S.

CDC is on the frontlines in more than 25 countries working with partner governments to prevent, diagnose, and treat TB. CDC supports the sustainability of country efforts to eliminate the disease. CDC leverages its country offices, decades of experience and trusted relationships with partner governments, the President’s Emergency Plan for AIDS Relief (PEPFAR) platforms, and unique expertise to develop and catalyze innovative, data-driven approaches. CDC focuses, through technical assistance, on strengthening national TB control programs and strategies in priority countries that have high rates of TB, drug-resistant TB, and TB/HIV co-infection.

CDC's global TB approach is closely aligned with the WHO’s End TB Strategy, STOP TB's Global Plan to End TB (2023–2030), the United Nations Sustainable Development Goal (SDG) for TB, the United Nations Political Declaration on the Fight Against TB (2018), and PEPFAR’s continued efforts to accelerate HIV/AIDS epidemic control. CDC is working to accelerate progress towards the global End TB targets, and to reduce TB transmission and morbidity among groups at higher risk for developing TB disease [including household contacts of people with TB, children and adolescents, PLHIV, health care workers, migrants, mobile/displaced populations], and those who work in crowded/congregate settings (criminal justice facilities, mines, etc.) by equipping partner countries with the tools and innovative approaches needed to address the underlying drivers of the epidemic, including people with undiagnosed TB, HIV/TB co-infection, and drug-resistant TB. Additionally, as the COVID-19 pandemic continues to strain and impact TB control programs in partner countries around the world, CDC is working to ensure that essential TB services are prioritized, and that access to TB care is assured and effectively maintained.

b. Statutory Authorities This program is authorized under Section 307 of the Public Health Service Act [42 USC 242l], as amended and Section 301(a) of the Public Health Service Act [42 USC 241(a)], as amended.

c. Healthy People 2030 This NOFO aligns with CDC’s current Global Health Strategy including: protecting Americans and populations across the globe by strengthening global public health prevention, detection, and response; saving lives, improving health outcomes, and fostering healthy populations globally;

and leading the advancement of global public health science and practice and serving as a leading source of credible scientific information.

This program also addresses the “Healthy People 2030” focus area of Global Health, Goal:

Improve health by preventing, detecting, and responding to public health events worldwide.

d. Other National Public Health Priorities and Strategies This NOFO aligns with the National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020-2025 [carb-national-action-plan-2020-2025.pdf (hhs.gov)]

Also, in an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also supports coordination with and among relevant partners. Recipients may be requested to participate in the following programmatic activities:

Scale-up evidence-based programs to identify and close the major TB gaps among all populations at risk of TB infection and all forms of drug-sensitive and drug-resistant TB disease, including but not limited to household contacts of people with TB, children and adolescents, people living with HIV (PLHIV), health care workers, migrants, mobile/displaced populations, and those who work in crowded/congregate settings (criminal justice facilities, mines, etc.);

Increase impact through strategic coordination and integration;

Strengthen and leverage key multilateral organizations, global health partnerships, and private sector engagement;

Encourage country ownership and invest in country-led plans, putting our national and local partners in the lead and actively enabling their growth through design of the program at all phases;

Build sustainability through investments in health systems;

Enhance health equity and reduce disparities in access to and uptake of TB services;

Improve performance metrics, monitoring and evaluation and the quality of related data;

and Promote operational research, development, and innovation to develop a body of knowledge, enhance awareness and increase the skills and abilities of stakeholders (research is not supported by this NOFO).

Geographic prioritization may change over the course of the period of performance based on the burden of disease and evolving program priorities.

This NOFO is only for non-research activities supported by CDC. Recipients may not use funds for research. Certain activities that may require human subjects review due to institutional requirements, but that are generally considered not to constitute research (e.g., formative assessments, surveys, disease surveillance, program monitoring and evaluation, field evaluation of diagnostic tests, etc.) may be funded through this mechanism. If research is proposed, the application will not be reviewed. For the definition of research, please see the CDC Web site at the following Internet address: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.102

e. Relevant Work CDC's global TB mission and strategies are aligned with WHO's End TB Strategy, the STOP TB's Global Plan to End TB (2023–2030), the United Nations SDGs for TB, the United Nations Political Declaration on the Fight Against TB (2018), and PEPFAR’s continued efforts to accelerate HIV/AIDS epidemic control. CDC works with partner organizations [Ministries of Health (MoH)]; the Global Fund to Fight AIDS, TB, and Malaria; and other U.S. agencies] through focused technical assistance to support and strengthen TB programs to prevent, diagnose, and treat TB, HIV-associated TB, and drug-resistant TB.

TB Screening and Diagnosis Many in the populations most affected by TB, including household contacts of people with TB, children and adolescents, PLHIV, health care workers, migrants, mobile/displaced populations, and those who work in crowded/congregate settings (criminal justice facilities, mines, etc.), lack support for the TB treatment they need. Each year, a person living with TB disease can infect up to 15 others. This means that each missed case can add to the current TB burden, compounding the challenge to end TB. Finding these undiagnosed TB cases is a priority for CDC and the global community. It requires sustained commitment to enhancing TB screening, surveillance, and laboratory capacity to find and diagnose persons with TB. CDC uses its robust technical expertise, peer-to-peer relationships with MoH, focused technical assistance, and a data-driven approach to find, cure, and prevent TB globally and to strengthen surveillance and laboratory systems to sustain progress.

TB Case Finding Up to 10 percent of those infected with TB eventually develop active TB disease during their lifetime. For those living with HIV and infected with TB, 10 percent will develop active TB disease each year. With a quarter of the world’s population infected with TB, a key challenge is to find those who have developed active disease, to provide effective treatment to ensure a positive individual outcome and interrupt transmission. Particular attention should be paid to groups at higher risk for infection and those at higher risk of evolving from infection to disease, including children and PLHIV.

TB IPC

CDC is building on the agency’s existing TB IPC platform, which includes a mentorship model and toolkit for preventing the spread of airborne respiratory infections in healthcare settings.

These established TB infection prevention and control partnerships, platforms, training curriculum, and toolkits are being used to prevent the spread of TB, COVID-19, and other respiratory infections in healthcare facilities.

TPT

PLHIV are up to twenty-one times more likely to develop TB than people without HIV, and children and adolescents are up to 10 times more likely to develop TB than adults. TPT, a proven course of treatment that can prevent TB disease among those infected with TB, has been shown to reduce TB-related mortality among PLHIV by 37 percent. With support from PEPFAR, CDC supported 2.9 million PLHIV to complete regimens of TPT from fiscal year 2018 to 2020, including more than 1.53 million in fiscal year 2020 alone. To further accelerate TPT scale up, CDC provided technical direction to country TB programs with a goal to provide a full course of TPT to all PLHIV on PEPFAR-supported antiretroviral treatment by the end of 2021.

Multidrug-Resistant TB CDC has used innovative models to improve diagnosis and treatment of multidrug-resistant TB (MDR TB), including mobile screening, molecular diagnostics, and point-of-care treatment monitoring to improve adherence and treatment outcomes. CDC supports an interface between public and private clinicians to improve MDR TB case reporting and to link patients to services to ensure timely and appropriate treatment. CDC is collaborating with partners to advance genome sequencing to improve diagnosis and treatment of MDR TB and to build capacity to explore transmission patterns in countries with high rates of MDR TB, including India and South Africa.

TB and COVID-19

As the COVID-19 pandemic continues to strain and impact TB control programs around the world, CDC and partners are working to ensure that essential TB services are prioritized and that access to TB care is assured and effectively maintained through differentiated service delivery (DSD) models. CDC and partners are also working to support bidirectional TB and COVID-19 screening and TB diagnosis during the pandemic, as TB and COVID-19 share many clinical features.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and Activities

Short-Term Outcomes

Intermediate Outcomes

Long-Term Outcomes

Strategy 1:

Enhance TB screening and case finding by building capacity nationally and locally to find all undiagnosed TB patients

Strategy 2:

Strengthen TB treatment delivery to ensure continuity of quality TB care among all TB patients and

PLHIV

Strategy 3: Scale up TB IPC measures in health facilities to ensure a safe environment for both clients and staff

Strategy 4: Scale up TPT to individuals who are considered at risk of TB disease

Strategy 5: Assess and mitigate barriers to accessing TB screening, case finding, diagnosis, prevention, and treatment

Improved competencies of health care providers and community workers in TB screening and case finding

Increased efficacy with identification of populations at risk for TB, including children and adolescents

Improved data use for efficient TB case finding and notification

Increased access to patient-centered quality TB prevention, diagnosis, and treatment services

Increased TPT coverage in populations with low uptake

Increased implementation of appropriate TB IPC measures in high-risk settings

Enhanced integration of stigma and discrimination reduction activities in TB programs

Increased real-time use of TB data by MoH and interested parties for decision-making

Reduced community transmission of TB

Reduced delays in TB diagnosis, notification, and treatment, especially among high-risk populations

Increased successful outcomes for all TB patients

Reduced transmission of TB infection in high-risk settings

Increased monitoring of implementation of IPC and TB treatment adherence and adverse events

Decreased stigma and discrimination associated with access to quality TB services

Increased competencies of senior MoH staff to design and implement TB program monitoring and evaluation activities

Increased evidence-based and data-driven TB programs in country

Improved capacity of MoH to implement and oversee TB prevention, diagnosis, and treatment services

Reduced TB transmission

Reduced TB mortality and morbidity

Sustained progress towards TB-free regions/countries

i. Purpose The purpose of this NOFO is to achieve a world free of TB by accelerating progress toward the global End TB targets and by reducing TB transmission and morbidity among groups at higher risk for developing TB disease, including household contacts of people with TB, children and adolescents, PLHIV, health care workers, migrants, mobile/displaced populations, and those who work in crowded/congregate settings (criminal justice facilities, mines, etc.).

ii. Outcomes CDC may require or allow applicants to propose additional related project period outcomes other than those identified in the NOFO.

Short-Term Outcomes:

Improved competencies of health care providers and community workers in TB screening and case finding

Increased efficacy with identification of populations at risk for TB, including children and adolescents

Improved data use for efficient TB case finding and notification Increased access to patient-centered quality TB prevention, diagnosis, and treatment services Increased TPT coverage in populations with low uptake Increased implementation of appropriate TB IPC measures in high-risk settings Enhanced integration of stigma and discrimination reduction activities in TB programs

Intermediate Outcomes:

Increased real-time use of TB data by MoH and interested parties for decision-making Reduced community transmission of TB Reduced delays in TB diagnosis, notification, and treatment, especially among high-risk populations Increased successful outcomes for all TB patients Reduced transmission of TB infection in high-risk settings Increased monitoring of implementation of IPC and TB treatment adherence and adverse events Decreased stigma and discrimination associated with access to quality TB services Increased competencies of senior MoH staff to design and implement TB program monitoring and evaluation activities

Long-Term Outcomes:

Increased evidence-based and data-driven TB programs in country Improved capacity of MoH to implement and oversee TB prevention, diagnosis, and treatment services

iii. Strategies and Activities The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for year 1 is $1,000,000. The expected number of awards is 1-2.

For this NOFO, applicants should develop a proposal to spend up to $1,000,000 carrying out activities in one or more priority countries, up to five (priority countries are: Botswana, Cote d’Ivoire, Ethiopia, Eswatini, Haiti, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam, Zambia, and Zimbabwe).

Applicants may propose activities as a regional approach if priority countries, up to five, are in close geographic proximity.

Exact funding amounts and the geographic scope for each award under this NOFO will be determined at the time of award. Geographic prioritization may change over the course of the period of performance based on the burden of disease and evolving program priorities.

The intent of this NOFO is to solicit a comprehensive and effective programmatic approach to increase the use of evidence and data by TB programs and to improve the capacity of MoH to implement and oversee TB prevention, diagnosis, and treatment services through five main strategies. Ongoing or future activities will be expected to address TB programs needs and priorities to sustain progress towards TB free regions/countries. Finally, as the intent of some of these activities is to build capacity of local or national systems, all activity-specific work should be done in close coordination and collaboration with specific country interested parties, where relevant, and with an approach that enables country-specific interested parties to continue the work after the end of the award, if relevant.

Strategy 1: Enhance TB screening and case finding by building capacity nationally and locally to find all undiagnosed TB patients

Develop, implement, and evaluate interventions to train and mentor health care providers and community health workers to conduct clinical symptom-based screening effectively and efficiently

Partner with community-based organizations to improve access to TB screening services for groups at higher risk for developing TB disease (household contacts, children and adolescents, PLHIV, migrants, displaced/mobile populations, incarcerated individuals, and others working or living in congregate/crowded settings)

Design, evaluate, and scale up novel models such as DSD models to reach and screen groups at higher risk for developing TB disease

Promote systematic TB screening among selected groups at higher risk for developing TB disease

Support linkage to care for those diagnosed with TB disease Conduct training and capacity building with relevant interested parties to improve TB data quality, analysis, and interpretation Generate and utilize TB data to identify groups at higher risk for developing TB disease as well as populations with low TB treatment uptake (“hot spot” mapping, programmatic data, etc.)

Strategy 2: Strengthen TB treatment delivery to ensure continuity of quality TB care among all TB patients and PLHIV

Implement novel client-centered DSD models for TB treatment Improve DSD models’ effectiveness and cost-effectiveness Expand access to shorter TB treatment regimens for eligible persons Develop, implement, evaluate, and scale up interventions to promote adherence and monitor adverse events to TB treatment

Strategy 3: Scale up TB IPC measures in health facilities to ensure a safe environment for both clients and staff

Scale up implementation of TB IPC measures in health facilities Provide IPC training and capacity building for health care workers and conduct ongoing

IPC mentorship Develop and scale up IPC monitoring and evaluation systems and processes Establish effectiveness of TB IPC activities in health facilities

Strategy 4: Scale up TPT to individuals who are considered at risk of TB disease

Design, evaluate, and/or scale up models to provide TPT to groups at higher risk for developing TB disease (including contacts of people with TB disease)

Develop strategies to identify additional populations that may benefit from TPT Support the roll-out and assessment of shorter TPT regimens

Strategy 5: Assess and mitigate barriers to accessing TB screening, case finding, diagnosis, prevention, and treatment

Examine catastrophic costs to patients and other socioeconomic barriers to better understand the financial challenges and costs incurred when seeking TB care and treatment

Implement and evaluate interventions to increase patient (and patient families’) knowledge of TB and their TB treatment regimen

Incorporate evidence-based interventions to reduce TB stigma and discrimination

In furtherance of the underlying purposes of this NOFO, Recipient is 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.

1. Collaborations

a. With other CDC projects and CDC-funded organizations:

The recipient(s) will be expected to collaborate with CDC country offices, CDC-funded MoHs and local health authorities, CDC-funded multilateral organizations such as the STOP TB Partnership and WHO, and other CDC-funded global TB implementing partners to avoid duplication and promote synergies across proposed or planned activities.

b. With organizations not funded by CDC:

The recipient(s) may also work closely with non-CDC-funded MoHs and local health authorities as well as regional interested parties or partners, including but not limited to local and international agencies or organizations, and other entities closely aligned with WHO's End TB Strategy, the STOP TB's Global Plan to End TB (2023–2030), the United Nations SDGs for TB, and the United Nations Political Declaration on the Fight Against TB (2018).

2. Target Populations The target populations for this NOFO include all populations at risk of TB infection and all forms of drug-sensitive and drug-resistant TB disease, including but not limited to household contacts of people with TB, children and adolescents, PLHIV, health care workers, migrants, mobile/displaced populations, and those who work in crowded/congregate settings (criminal justice facilities, mines, etc.).

CDC’s Division of Global HIV and Tuberculosis (DGHT), Global Tuberculosis Branch (GTB) has also developed a strategic plan to prioritize and focus on specific countries where GTB can apply its core strengths to maximize impact. These priority countries are listed below:

Botswana, Cote d’Ivoire, Ethiopia, Eswatini, Haiti, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam, Zambia, and Zimbabwe.

CDC will only fund activities in the priority countries listed above; applicants should only propose to conduct activities in countries included in the above list. Applicants can propose to work in one or more priority countries (up to five). Applicants may propose activities as a regional approach if priority countries, up to five, are in close geographic proximity.

Geographic prioritization may change over the course of the period of performance based on the burden of disease and evolving program priorities.

a. Health Disparities In an effort to assure that activities funded through this NOFO (1) affirm and advance, as appropriate, the role of health equity and an equitable, diverse, and inclusive workforce as core principles, and (2) advance the reduction of stigma and discrimination through the promotion, consistent with applicable laws, of civil and human rights to improve the health outcomes of persons at risk of, or living with, HIV and/or TB infection, CDC awards resulting from this NOFO may address the following activities, where and when appropriate:

Community involvement in the design, implementation, and monitoring of HIV and TB services.

Training for implementing partners involved in the design, implementation, and/or monitoring of activities on stigma, discrimination, gender equitable norms, human rights, and community engagement to minimize the likelihood for activities to unintentionally increase stigma and discrimination directed towards PLHIV and all populations at risk of TB infection.

Programs to address evidenced health disparities and social barriers (e.g., HIV-related stigma) to HIV and TB services.

Use of data to monitor disparities and implement strategies to improve access, service use, and outcomes.

iv. Funding Strategy The Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount for year 1 is $1,000,000. The expected number of awards is 1-2.

For this NOFO, applicants should develop a proposal to spend up to $1,000,000 carrying out activities in one or more priority countries, up to five (priority countries are: Botswana, Cote d’Ivoire, Ethiopia, Eswatini, Haiti, India, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, South Africa, Tanzania, Uganda, Vietnam, Zambia, and Zimbabwe).

Applicants may propose activities as a regional approach if priority countries, up to five, are in close geographic proximity.

Exact funding amounts and the geographic scope for each award under this NOFO will be determined at the time of award. Geographic prioritization may change over the course of the period of performance based on the burden of disease and evolving program priorities.

Applicants to this NOFO are encouraged to apply to the Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award amount. Applications must not exceed this amount.

Component Funding: It is required that all CDC/Division of Global HIV and TB (DGHT)-funded cooperative agreements be formulated for component funding. A component is a discrete set of activities with an associated budget. CDC will use component funding to provide funding for activities proposed in an application that received merit review but were not selected for funding in the initial award (i.e., at the onset of budget period 1) but may be funded at a later point in the budget period as programmatically necessary and as funding becomes available.

Please review the following key points about component funding:

Component funding must be setup at the time of the application. While preparing the application, applicants should review the expectations listed in the NOFO for Year 1 activities and group them under the anticipated components listed below. Only activities planned for Year 1 should be grouped into components; applicants do not need to group activities in the high-level plan for the subsequent years 2-5 of the award into components. Funding amounts and components for years 2-5 will be determined at continuation.

Each component must be a discrete set of activities with an associated budget. Distinguishable component budget narratives are required. Setting up components based on time (i.e., quarterly) is an appropriate distinction of activities, provided activities are clearly outlined.

Applicants should submit the anticipated components on an SF-424A form as part of their application which shows all components for the budget period. The amounts should exactly match what is being requested for funding. Each component has its own approved amount and cannot be funded above the established amount. The combined total of all components must total the requested amount.

If more than 4 components are proposed, multiple SF-424As will be needed. Applicants may include the first 4 components on one SF-424A form and the remaining components on a second SF-424A form. Applicants may download additional SF-424A forms and upload them as PDFs under “Budget Narrative Attachment Form” or “Other Attachments Form.” These should be clearly labeled for easy identification and included in the Table of Contents for the entire submission.

If possible, applicants are encouraged to submit a separate budget justification for each component, but it is not a requirement. Applicants will not be deemed incomplete if separate budget justifications are not provided with the submission. A separate budget justification will ultimately be required for all components that are funded.

Any component that is not funded at the time of a new award may be deemed “Approved but Unfunded (ABU)”. There is no guarantee that all components will be funded in a budget period as ABU components are subject to the availability of funds and the underlying legal authority for the work.

o Components may not be awarded in order. All ABU components are eligible to receive funding once (and if) funds become available.

o If funding becomes available, multiple components can be funded through the same funding action (single NOA).

o If funding is awarded for an amount less than the ABU component approved amount, it is not possible to fund the difference at a later time. Components can only be funded once.

If, during the funding confirmation, the Program Office approves a budget that differs from what was submitted at the time of application (reflected in the budget markup), a revised budget may be required in addition to the technical review responses. If required, the revised budget is due within thirty (30) days of the start of the budget period. If required, technical review responses will also be due within thirty (30) days of the start of the budget period and must be submitted separately from revised budget applications.

Future funding for ABU components will not be awarded until a revised budget, if required, is submitted and approved by CDC.

Once components are awarded, funds cannot be redirected between components.

However, funds may be redirected within a component between object class categories.

It is critical to ensure accountability, transparency, and programmatic performance of all U.S.

taxpayer dollars.

Applicants are encouraged to consider the following in the development of their budgets and budget narratives:

For Year 1, CDC anticipates an Approximate Total Fiscal Year Funding/Average One Year Award Amount/Approximate Average Award of $1,000,000 with the below listed components:

Component 1 – Strategy 1: TB screening and case finding;

Component 2 – Strategy 2: TB treatment delivery;

Component 3 – Strategy 3: TB infection prevention and control;

Component 4 – Strategy 4: TB preventive treatment;

Component 5 – Strategy 5: TB barriers mitigation;

Component 6 – Additional TB priorities.

Applicants must specify a descriptive title for each corresponding column shown on the SF- 424A, followed by the total (cumulative) in the column to the far right of the SF-424A.

Applicants are encouraged to use the components listed above, but may propose alternative budget components so long as the general component funding guidance is followed.

Funding provided under this NOFO is subject to the availability of funds. The total number of years for which federal support has been programmatically approved (project period) will be shown in the “Notice of Award.” This information does not constitute a commitment by the federal government to fund the entire period. All future year funding will be based on satisfactory programmatic progress and the availability of funds.

Coronavirus Disease 2019 (COVID-19) Funds: A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116-139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID-19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.

In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf.

Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.

This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy

CDC expects that routine performance data is reviewed, cleaned, and used for program management. To this effect, the recipient(s) should hold regular review meetings to discuss performance and use data in program quality improvement activities.

The recipient(s) should allocate funds made available under this NOFO for both evaluation activities and performance monitoring. While the final funding amount will be agreed upon by both CDC and the recipient(s), a minimum of 5% of funds should be allocated for monitoring activities and 5% of funds used for evaluation activities. These are estimates for the total funding over the 5-year project.

PERFORMANCE MONITORING

Some anticipated indicators, targets, and reporting frequencies corresponding to Year 1 of the NOFO are shown below. Applicants should also propose any additional relevant indicators as part of their initial Evaluation and Performance Measurement Strategy.

Applicants should note that these may be adjusted, or new targets and indicators may be identified in subsequent years based on implementation of TB control strategies and program priorities. Any gaps or unmet needs not fulfilled in the first year may affect the targets of the subsequent years.

Performance Measures (Custom Indicators) Applicants should propose additional custom performance measures to monitor achievement of outcomes. Custom indicators should include process and outcome measures directly correlated with the logic model. Below are examples of process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated narrative sections.

Number of health care providers and community health workers trained in clinical symptom-based screening [Target: 1000; reporting frequency: quarterly]

Number of partnerships established with community-based organizations to improve access to TB screening services [Target: 25; reporting frequency: quarterly]

Number of novel interventions developed for screening groups at higher risk for developing TB disease, including adolescents and children [Target: 10; reporting frequency: quarterly]

Percentage of persons diagnosed with TB disease referred for/linked to care [Target:

100%; reporting frequency: quarterly]

TB screening yield from adoption of novel screening interventions (percentage of persons screened who are found to be symptomatic for TB disease) [Target: 5-15%; reporting frequency: quarterly]

Percentage of health facilities that offer DSD model options to TB patients [Target:

100%; reporting frequency: quarterly]

Percentage of persons diagnosed with active TB disease who initiate TB treatment [Target: 100%; reporting frequency: quarterly]

Percentage of TB patients and PLHIV who receive TB treatment through a DSD model [Target: 100%; reporting frequency: quarterly]

Percentage of TB patients and PLHIV who complete TB treatment without experiencing a treatment interruption [Target: 100%; reporting frequency: quarterly]

Percentage of TB patients and PLHIV who receive an outcome of cure or completed treatment [Target: 100%; reporting frequency: quarterly]

Percentage reduction in TB treatment patient costs through a DSD model compared to a traditional model [Target: > 20%; reporting frequency: quarterly]

Number of facilities who have undergone an IPC assessment [Target: 100; reporting frequency: quarterly]

Percentage of facilities who report IPC assessment results in national IPC HMIS [Target:

100%; reporting frequency: quarterly]

Percentage of facilities that adhere to basic safety and IPC standards [Target: 100%;

reporting frequency: quarterly]

Number of TB cases reported among health care workers [Target: 0; reporting frequency:

quarterly]

Percentage of health facilities who have a team of community health workers that conduct home visits for contact investigations [Target: > 50%; reporting frequency:

quarterly]

TPT coverage percentage among adult household contacts of people with TB disease [Target: 100%; reporting frequency: quarterly]

TPT coverage among children <5 years old who are household contacts of people with TB disease [Target: 100%; reporting frequency: quarterly]

Percentage of people who complete their TPT regimen [Target: 100%; reporting frequency: quarterly]

Percentage of health facilities that offer support groups, home visits, or other evidence-based interventions to reduce TB stigma and discrimination [Target: > 50%; reporting frequency: quarterly]

Percentage of TB patients that utilize evidence-based interventions to reduce TB stigma and discrimination [Target: > 50%; reporting frequency: quarterly]

Data Sources for 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

The evaluation topics below are examples of areas that the recipient(s) may be expected to answer through process or outcome evaluation(s). Applicants should include at least 1, but no more than 3 potential evaluation questions. Recipient(s) will be expected to conduct a mid-term and end-year evaluation.

Sample Evaluation Topics:

DSD implementation and related costs (Outcome Evaluation) DSD implementation and decreased stigma (Outcome Evaluation) Extent DSD implementation improved TB case finding or TB treatment adherence

(Process/Outcome Evaluation)

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

Dissemination of Evaluation Results: Dissemination channels may include local and international conferences and forum abstract presentations, conference poster displays, manuscripts, bulletins, reports, presentations to technical working groups and stakeholder meetings, and other approved products in print and electronic media. The primary intended users of evaluation results and findings will be program stakeholders. CDC and stakeholders will use overall evaluation findings during the five-year NOFO period to share and implement key recommendations to strengthen program implementation and effectiveness, sustainability, and continued program improvement upon completion of the award.

ii. Applicant Evaluation and Performance Measurement Plan Applicants must provide an evaluation and performance measurement plan that demonstrates how the recipient will fulfill the requirements described in the CDC Evaluation and Performance Measurement and Project Description sections of this NOFO. At a minimum, the plan must describe:

How the applicant will collect the performance measures, respond to the evaluation questions, and use evaluation findings for continuous program quality improvement.

How key program partners will participate in the evaluation and performance measurement planning processes.

Available data sources, feasibility of collecting appropriate evaluation and performance data, and other relevant data information (e.g., performance measures proposed by the applicant)

Plans for updating the Data Management Plan (DMP) as new pertinent information becomes available. If applicable, throughout the lifecycle of the project. Updates to DMP should be provided in annual progress reports. The DMP should provide a description of the data that will be produced using these NOFO funds; access to data;

data standards ensuring released data have documentation describing methods of collection, what the data represent, and data limitations; and archival and long-term data preservation plans. For more information about CDC’s policy on the DMP, see https://www.cdc.gov/grants/additional-requirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, the applicant should be directed to:

Describe the type of evaluations (i.e., process, outcome, or both).

Describe key evaluation questions to be addressed by these evaluations.

Describe other information (e.g., measures, data sources).

Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO.

c. Organizational Capacity of Recipients to Implement the Approach Applicants must provide supporting documentation to show evidence of their organizational capacity to implement the approach. Documentation supporting this element must be submitted in the appendix, be clearly labeled, and be easily identifiable. Applicants must submit the following materials in their appendix:

Statement of Experience demonstrating organizational capacity to address the requirements of the NOFO and specifically in the following areas:

o Capacity to develop, implement, and evaluate TB interventions internationally and in alignment with WHO’s End TB Strategy and the STOP TB’s Global Plan to End TB (2023–2030) o Experience in planning and implementing activities aimed to improve TB screening and case finding o Experience in designing, implementing, and scaling-up a range of TB prevention strategies including IPC and TPT o Experience in planning and implementing novel approaches to ensure quality of TB care o Experience in building local partner capacity to support efforts to improve global health o Experience, working relationships, and established collaborative partnerships in the country(ies) the applicant is proposing to carry out activities

CVs/Resumes for key personnel (at the applicant’s discretion but may include Principal Investigator [PI], Business Official, etc.)

Job Descriptions for key personnel Organizational Chart

Financial Management Statement that describes the following:

o Systems and procedures used to manage funds o Procurement procedures o Previous experience managing budgets greater than $750,000

Justification statement for selected country(ies)

Applicants must title these documents in their appendix as follows: “Experience,” “CVs/Resumes,” “Job Descriptions,” “Organizational Chart,” “Financial Statement,” and "Justification Statement" include in the Table of Contents.

d. Work Plan Applicants must include a work plan within the Project Narrative that demonstrates how the outcomes, strategies, activities, monitoring, evaluation, timelines, and staffing will take place over the course of the award. Applicants must submit a detailed work plan for the first year of the project and a high-level plan for the subsequent years.

e. CDC Monitoring and Accountability Approach Monitoring activities include routine and ongoing communication between CDC and recipients, site visits, and recipient reporting (including work plans, performance, and financial reporting).

Consistent with applicable grants regulations and policies, CDC expects the following to be included in post-award monitoring for grants and cooperative agreements:

Tracking recipient progress in achieving the desired outcomes.

Ensuring the adequacy of recipient systems that underlie and generate data reports.

Creating an environment that fosters integrity in program performance and results.

Monitoring may also include the following activities deemed necessary to monitor the award:

Ensuring that work plans are feasible based on the budget and consistent with the intent of the award.

Ensuring that recipients are performing at a sufficient level to achieve outcomes within stated timeframes.

Working with recipients on adjusting the work plan based on achievement of outcomes, evaluation results and changing budgets.

Monitoring performance measures (both programmatic and financial) to assure satisfactory performance levels.

Monitoring and reporting activities that assist grants management staff (e.g., grants management officers and specialists, and project officers) in the identification,…