oppCDC-RFA-GH18-1838-cfda93.947-cidCDC-RFA-GH18-1838-instructions.pdf

Centers for Disease Control

Center for Global Health

Accelerating the Decline of Tuberculosis (TB) in High Burden Countries and Settings

CDC-RFA-GH18-1838

Application Due Date: 04/08/2018

Accelerating the Decline of Tuberculosis (TB) in High Burden Countries and Settings

CDC-RFA-GH18-1838

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Catalog of Federal Domestic Assistance (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text 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 Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-GH18-1838. 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:

Accelerating the Decline of Tuberculosis (TB) in High Burden Countries and Settings 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)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-GH18-1838

E. Catalog of Federal Domestic Assistance (CFDA) Number:

93.947 F. Dates:

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

2. Due Date for Applications: 04/08/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

N/A

G. Executive Summary:

1. Summary Paragraph:

Despite being preventable and curable, TB is the leading infectious disease killer worldwide. A fourth of the world's population (2 billion people) are infected with TB, while more than 10 million become ill with the disease each year. More than 4 million individuals who become ill with TB are never diagnosed or treated, allowing TB to continue to be transmitted. Many of the "missing 4 million" are among vulnerable or underserved populations that are hard to reach or have difficulty accessing public health services, such as children, people living with HIV (PLHIV), migrants, refugees, and miners. To be effective in protecting the U.S. from a costly and potentially deadly disease, addressing TB globally is required. The goal of this NOFO is to work with the Stop TB Partnership towards ending the global TB epidemic by driving down TB deaths, TB incidence, and quantifying and eliminating catastrophic costs, in line with the WHO's END TB Strategy adopted by the World Health Assembly in May 2014. Through this https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov

NOFO, the Stop TB Partnership will develop models to expand TB screening and diagnosis to find the "missing" TB cases, increase efforts to address the intersecting epidemics of TB and HIV in high burden countries and settings, develop a global strategic plan to guide global TB partners in the implementation of the WHO END TB Strategy, and bolster collaboration and coordination among TB partners in a multi sectorial manner.

a. Eligible Applicants: Single

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 1

d. Total Period of Performance Funding: $0 The Approximate Project Period Funding/Estimated Total Funding for the Total 5 year Project Period is None. Award ceilings for years 2-5 will be set at continuation.

e. Average One Year Award Amount: $350,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/30/2018

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although there is no statutory match requirement for this NOFO, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview TB is found all over the world, including in the U.S. Despite being preventable and curable, TB is the leading infectious disease killer worldwide claiming 1.8 million lives in 2015. A fourth of the world's population (2 billion people) are infected with TB, while more than 10 million become ill with the disease each year. More than 4 million individuals who become ill with TB are never diagnosed or treated, allowing TB to continue to be transmitted. To be effective in protecting the U.S. from a costly and potentially deadly disease, addressing TB globally is required.

Drug-resistant TB poses another serious domestic and global threat. Nearly 500,000 people develop multidrug-resistant TB (MDR-TB) each year, while extensively drug-resistant TB has been reported in 105 countries. TB is also a serious health threat for PLHIV, as PLHIV are more likely than others to become sick with TB. Worldwide, TB is the leading cause of death among PLHIV.

Through this NOFO, the Stop TB Partnership will work towards: improving case-detection for all forms of TB by expanding access to screening and diagnostic services; increasing case-finding in the public sector from private sector linkages; increasing collaboration and coordination among partners to find, cure, and prevent all forms of TB; and disseminating best practices.

The Stop TB Partnership will achieve these outcomes through:

The development of models to expand strategies to detect TB. Each year, it is estimated that 10.4 million people develop active TB disease, but 4.3 million of these individuals are "missed" each year. More than 75% of missed cases are concentrated in just 10 countries. Many of the "missing 4 million" are among vulnerable or underserved populations that are hard to reach or have difficulty accessing public health services, such as children, PLHIV, migrants, refugees, and miners, among others. For example, the incidence of TB among men who work as gold miners in South Africa has been reported to be 3,000-7,000 per 100,000 populations, the highest rate in the world.

Diagnosis of TB is more challenging for certain groups, such as children and PLHIV, because traditional diagnostics for TB – like sputum smear microscopy – do not perform well and can fail to diagnose TB even when it is present. Without proper treatment, up to two thirds of people ill with TB will die. In addition, people who are ill with TB can infect up to 10 to 15 people with whom they are in close contact in a single year.

The continued focus and increased efforts to address the intersecting epidemics of TB and HIV in high burden countries and settings. For example, CDC has been working closely with a number of ministries of health to incorporate and scale-up systematic TB symptom screening among PLHIV. TB screening among PLHIV has improved dramatically since new guidelines were released, with more than 85 countries reporting systematic TB screening for PLHIV in 2015.

The bolstering of collaboration and coordination among TB partners in a multi sectorial manner. Out of the 10.4 million new global TB cases in 2015, 1 million occurred in children under 15 years of age with at least 210,000 child deaths. Children living with HIV are more likely to die once infected with TB. Preventing, finding, and curing TB are critical to reducing childhood mortality, especially for HIV-infected children.

Increased collaboration and coordination among TB partners led to the development of a blueprint for addressing gaps in childhood TB diagnostics and the revision of the childhood MDR-TB treatment guidelines.

b. Statutory Authorities This program is authorized under the Public Health Service Act, Sections 301(a), 307, 317(a) and 317E [42 U.S.C. sections 241(a), 242l, 247b(a), and 247b-6, as amended].

c. Healthy People 2020 N/A

d. Other National Public Health Priorities and Strategies In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC supports coordination with and among partners and integration of activities that promote Global

Health Initiative principles. As such, recipients may be requested to participate in programmatic activities that include the following activities:

Implement a woman- and girl-centered approach;

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;

Build sustainability through investments in health systems;

Improve metrics, monitoring and evaluation; and Promote research, development and innovation (research is not supported by this

NOFO).

This announcement 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: http://www.cdc.gov/od/science/integrity/docs /cdc-policy-distinguishing-public-health-research-nonresearch.pdf

e. Relevant Work Although important strides in TB prevention and control have been achieved around the world, much more needs to be done to eventually eliminate the disease aborad as well as in the U.S. In May 2014, the World Health Assembly adopted WHO's END TB Strategy, which serves as a blueprint for countries to end the TB epidemic by driving down TB deaths, incidence, and eliminating catastrophic costs. It outlines global impact targets to reduce TB deaths by 90% and to cut new cases by 80% between 2015 and 2030, and to ensure that no family is burdened with catastrophic costs due to TB.

CDC's global TB mission and strategies are aligned with WHO's END TB Strategy (2016- 2020), the Stop TB Partnership’s Global Plan to End TB (2016-2020), and the U.S.

Government’s Global TB Strategy, 2015-2019. CDC partners with these technical organizations; Ministries of Health; the Global Fund to Fight AIDS, TB, and Malaria; and other U.S. agencies to support and strengthen TB control programs to find, cure, and prevent TB, HIV-associated TB, and drug-resistant TB.

Additionally, along with global partners, CDC TB experts are also focusing on a distinct set of issues as part of CDC's effort to alleviate the toll that TB takes globally.

Find, cure, and prevent TB and protect Americans both here and abroad by working in 25 countries – CDC and its partners are expanding access to better screening, contact tracing, and diagnostic tools to find missing cases. CDC and its partners are evaluating better treatment regimens and expanding access to care and treatment; and breaking the cycle of transmission by strengthening infection control, identifying TB hotspots to target screening efforts, and scaling-up treatment to prevent TB among vulnerable http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf http://www.cdc.gov/od/science/integrity/docs/cdc-policy-distinguishing-public-health-research-nonresearch.pdf populations.

Find and combat MDR TB – CDC is on the frontlines in some of the world’s highest burden regions, working to understand what is driving the spread of drug-resistant TB and how to stop it.

Break the cycle of TB transmission by preventing infections, while supporting global programs to quickly detect and effectively treat all people with TB – CDC is working to strengthen the efforts to protect people at a high risk of developing TB, such as children, pregnant women, miners, health care workers, and PLHIV.

Access to effective prevention and treatment for those living with or at risk for HIV and TB co-infection – TB is the leading killer of people with HIV globally. CDC works hand-in-hand with government partners, community groups, and health organizations to align TB and HIV programs. These efforts include helping those living with HIV to start and stay on HIV treatment, and increasing access to TB preventive therapy by including it as part of standard services already being provided to PLHIV.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose Despite being preventable and curable, TB is the leading infectious disease killer worldwide and the leading cause of death among PLHIV. To protect the U.S. from a costly and deadly disease, addressing TB globally is required. This NOFO will expand and scale-up proven strategies to detect TB, increase efforts to address the intersecting epidemics of TB and HIV in high burden countries and settings, and bolster collaboration and coordination among TB partners to end the global TB epidemic by driving down TB deaths, TB incidence, and eliminating catastrophic costs due to TB.

ii. Outcomes Short-Term Outcomes:

Increased access to diagnostic services and modalities for all forms of TB among vulnerable populations

Increased and improved linkages between private and public sector Increased use of novel diagnostics and screening approaches to reach and find all people with TB Increased sharing of lessons learned and evidence to shape TB policy and programs Improved coordination and implementation of the WHO END TB Strategy Increased coordination among partners to scale-up evidence-based interventions to find, cure, and prevent all forms of TB

Intermediate Outcomes:

Improved case-detection for all forms of TB among vulnerable populations Increased case-finding in public sector from private sector linkages Increased collaboration and coordination among partners to find, cure, and prevent all forms of TB

Applicant may propose additional related project period outcomes other than those identified in the NOFO.

iii. Strategies and Activities Due to TB being a common opportunistic infection in PLHIV and being the leading cause of morbidity and mortality among PLHIV, accounting for one third of all deaths, TB control and prevention is pivotal to HIV treatment and care. Screening PLHIV for TB and providing early, appropriate treatment improves treatment success rates and reduces ongoing transmission in the community. In addition, for PLHIV who do not have active TB, providing isoniazid preventive therapy (IPT) is a critical component of reducing morbidity and is recommended in the WHO guidelines for management of persons with HIV, at all CD4 counts and age levels.

The Stop TB Partnership is expected to implement the following strategies and activities during the 5-year project period. However, it may propose additional strategies and activities (beyond what is included in the logic model) to achieve the outcomes.

FIND – Address case-finding and linkage to care for all forms of TB

Develop models to expand TB screening and diagnosis for vulnerable populations including:

o PLHIV o Mobile populations such as miners and migrant workers o Persons in contact with TB cases, including children

Develop innovative approaches and establish linkages between public and private health facilities to increase TB case-finding

Test novel diagnostic algorithms and screen approaches for scale-up Evaluate new case-finding approaches and diagnostic technologies to reach and find all people with TB for roll-out

PARTNERSHIP – Collaboration and coordination among partners

Disseminate TB scientific findings, latest research results, programmatic and policy developments, lessons learned, and successes and challenges

Develop a global strategic plan to guide the implementation of the WHO END TB Strategy

Foster a multi sectorial approach and strategic engagement for the fight against TB Develop strategic partnerships/collaborations to meet TB program needs and stimulate progress toward national and global targets

In furtherance of the underlying purpose of this announcement, Recipient is expected to provide copies 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 for appropriate use. CDC should be provided access consistent with applicable grants regulations.

1. Collaborations

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

The specific activities listed in this NOFO may take place in countries and settings with high TB burden. The recipient is expected to collaborate with CDC implementing partners, such as WHO and Ministries of Health, to avoid duplication and promote synergies across proposed or planned activities.

b. With organizations not funded by CDC:

The recipient is expected to work closely with international agencies or organizations such as the U.S. Agency for International Development (USAID) and other government entities responsible for engaging in the global elimination of TB. In addition, the recipient is expected to work with other TB partners to ensure effective collaboration and synergies across proposed or planned activities.

2. Target Populations The target populations for this NOFO include, but are not limited to: healthcare workers, PLHIV, children, the elderly, persons with drug-resistant TB, institutionalized populations such as prisoners, miners, migrant workers, people who inject drugs, displaced populations, and those living in poverty.

a. Health Disparities

iv. Funding Strategy N/A

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy The overall CDC Evaluation and Performance Measurement Strategy will focus on both process and outcome evaluation. Process evaluation is conducted to monitor activities during the implementation and operation of a program while an outcome evaluation examines the longer-term successes and accomplishments of a program.

Below are examples of process and outcome measures for the strategies/activities and outcomes previously discussed in the logic model and associated narrative sections. The Stop TB Partnership is encouraged to propose relevant measures beyond those presented below that will show progress toward implementing proposed or planned activities and on achieving the project outcomes. CDC will work with the Stop TB Partnership throughout the life of this award to ensure that all activities and expected outcomes are in alignment with the WHO END TB Strategy’s indicators and targets.

FIND – Address case-finding and linkage to care for all forms of TB Process measures:

Number of models developed to expand TB screening and diagnosis for vulnerable populations (3 models per year: Year 1 – 5; Frequency: annually)

Number of innovative approaches developed to establish linkages between public and private facilities (3 innovative approaches per year: Year 1 – 5; Frequency: annually)

Number of TB algorithms tested (2 TB algorithms tested per year: Year 1 – 5;

Frequency: annually)

Number of new case-finding approaches introduced (2 new case-finding approaches per year: Year 1 – 5; Frequency: annually)

Number of new diagnostic technologies ready for evaluation (1 new diagnostic technology per year: Year 1 – 5; Frequency: annually)

Outcome measures:

Contact investigation coverage (End TB Indicator): Number of contacts of people with bacteriologically-confirmed TB who were evaluated for TB, divided by the number eligible, expressed as a percentage.

TB treatment coverage (End TB Indicator):

o National level: Number of new and relapse cases that were notified and treated, divided by the estimated number of incident TB cases in that same year [national level indicator, because must have estimates of incident TB cases] o Alternative (subnational level): Percentage of diagnosed cases that start treatment.

Percentage of new and relapse TB patients tested using a WHO-recommended rapid test at time of diagnosis (End TB Indicator): Patients tested using a WHO-recommended rapid test at the time of diagnosis, divided by the total number of new and relapse TB patients (expressed as a percentage)

TX_TB denominator and disaggregates (PEPFAR Indicator): Number of antiretroviral treatment patients screened for TB at least once

PARTNERSHIP – Collaboration and coordination among partners Process measures:

Number of meetings or workshops conducted to disseminate and share scientific findings, lessons learned, and best practices (1 meeting or workshop per year: Year 1 – 5; Frequency: annually)

Final draft of global strategic plan to guide the implementation of the WHO END TB Strategy (Final draft: Year 1; Frequency: revision to the draft on an annual basis)

Number of joint projects or collaborations initiated to meet national TB program needs (2 joint projects or collaborations per year: Year 1 – 5; Frequency: annually)

Outcome measures:

Number of documented program improvements made based on program data or the dissemination of scientific findings, lessons learned, and best practices

Number of TB programs using the global strategic plan to implement the WHO END TB Strategy

Number of recommendations implemented by national TB programs

The Stop TB Partnership should dedicate funds made available under this NOFO for evaluation and performance monitoring. The final funding amount will be agreed upon by both CDC and the Stop TB Partnership; however, since routine monitoring of progress will be reported to both organizations, it should be expected that not more than 5% of this NOFO's funds will be used to fund monitoring activities and 5% of this NOFO's funds will be used to fund evaluation activities.

As part of the overall evaluation of the project, the recipient should take into consideration answering the evaluation questions below. By the end of the project period, evaluation results and findings demonstrating value of the NOFO will be captured through the APR, meeting minutes, trip reports, technical reports, assessment/evaluation reports, and interviews with key informants, and, if relevant, the recipient will be expected to pursue additional dissemination avenues in public domains, including in public health journals, conferences, and through informal channels (e.g., website, newsletters) to share with global TB partners to the greatest extent possible the pertinent evaluation results and findings.

Sample evaluation questions:

Which of the innovative case find approaches developed and diagnostic technologies tested were most effective, efficient, and sustainable?

To what extent did the development of models to expand screening and diagnosis contribute to finding the missing TB cases among vulnerable populations?

What types of strategic partnerships/collaborations have been the most effective in scaling-up evidence-based interventions?

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 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), if applicable, for accuracy throughout the lifecycle of the project. 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/additionalrequirements/ar-25.html.

Where the applicant chooses to, or is expected to, take on specific evaluation studies, they 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, 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 Applicant should provide a current organizational chart as an appendix to the application.

Applicants must title these documents in their appendix as follows:“Organizational Chart” and upload it at www.grants.gov.

d. Work Plan Applicant must include a work plan that demonstrates how the outcomes, strategies, activities, https://www.cdc.gov/grants/additionalrequirements/ar-25.html http://www.grants.gov/ 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, notification, and management of high-risk recipients.

f. CDC Program Support to Recipients (THIS SECTION APPLIES ONLY TO

COOPERATIVE AGREEMENTS)

In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC activities for this program include, but are not limited to, the following:

1. Organize an orientation meeting with the recipient for a briefing on applicable U.S.

Government, HHS/CDC regulations and key management requirements, as well as report formats and contents.

2. Review and make recommendations as necessary to the process used by the recipient to select key personnel and/or post-award subcontractors and/or sub-recipient to be involved in the activities performed under this agreement.

3. Review and approve recipient’s annual work plan and detailed budget.

4. Review and approve the recipient’s monitoring and evaluation plan.

5. Meet on a regular basis with the recipient to assess expenditures in relation to approved work plan and modify plans as necessary.

6. Meet on a quarterly basis with the recipient to assess quarterly technical and financial progress reports and modify plans as necessary.

7. Meet on an annual basis with the recipient to review annual progress report for each U.S.

Government Fiscal Year, and to review annual work plans and budgets for the subsequent year.

8. Provide technical assistance, as mutually agreed upon, and revise annually during validation of the first and subsequent annual work plans. This could include expert technical assistance and targeted training activities in specialized areas, such as strategic information, project management, and confidential counseling and testing.

9. Provide in-country administrative support to help the recipient meet U.S. Government financial and reporting requirements approved by the Office of Management and Budget

(OMB).

10. Collaborate with the recipient on designing and implementing the activities listed above, including, but not limited to: the provision of technical assistance to develop program activities, data management and analysis, quality assurance, the presentation and possibly publication of program results and findings, and the management and tracking of finances.

11. Provide technical assistance or advice on any data collections on 10 or more people that are planned or conducted by the recipient. All such data collections-- where CDC staff will be or are approving, directing, conducting, managing, or owning data-- must undergo OMB project determinations by CDC and may require OMB PRA clearance prior to the start of the project.

12. Provide consultation and scientific and technical assistance based on appropriate HHS/CDC documents to promote the use of best practices known at the time.

13. Assist the recipient in developing and implementing quality-assurance criteria and procedures.

14. Facilitate in-country planning and review meetings for technical assistance activities.

15. Provide technical oversight for all activities under this award.

16. Provide ethical reviews, as necessary, for evaluation activities, including from HHS/CDC headquarters. Evaluations can be process, outcome or impact.

1. Process Evaluation: measures how the intervention was delivered, what worked/did not, differences between the intended population and the population served, and access to the intervention

2. Outcome Evaluation: determines effects of intervention in target population(s) (e.g., change in knowledge, attitudes, behavior, capacity, etc.).

3. Impact Evaluation: measures net effects of program and prove of causality.

17. Supply the recipient with protocols for related evaluations.

B. Award Information

1. Funding Instrument Type: Cooperative Agreement CDC's substantial involvement in this program appears in the CDC Program Support to Recipients Section.

2. Award Mechanism: CoAg

3. Fiscal Year: 2018

4. Approximate Total Fiscal Year Funding: $350,000

5. Approximate Period of Performance Funding: $0

This amount is subject to the availability of funds.

The Approximate Project Period Funding/Estimated Total Funding for the Total 5 year Project Period is None. Award ceilings for years 2-5 will be set at continuation.

Estimated Total Funding: $0

6. Approximate Period of Performance Length: 5 year(s)

7. Expected Number of Awards: 1

8. Approximate Average Award: $350,000 Per Budget Period

9. Award Ceiling: $350,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Budget Period None

11. Estimated Award Date: 09/30/2018

12. Budget Period Length: 12 month(s)

Throughout the project period, CDC will continue the award based on the availability of funds, the evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. The total number of years for which federal support has been 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. The total period of performance comprises the initial competitive segment and any subsequent non-competitive continuation award(s).

13. Direct Assistance Direct Assistance (DA) is not available through this FOA.

C. Eligibility Information

1. Eligible Applicants Eligibility Category: Others (see text field entitled "Additional

Information on Eligibility" for clarification)

Additional Eligibility Category:

2. Additional Information on Eligibility Eligible applicants that can apply for this NOFO are:

Stop TB Partnership

3. Justification for Less than Maximum Competition The STOP TB Partnership is the only organization that has been charged by the World Health Assembly, through Resolution WHA67.1 passed in May 2014 during its 67th convening to work with WHO to develop a global investment plan to guide the implementation of the global strategy and targets for TB prevention, care, and control after 2015 (also known as the WHO END TB Strategy) that was approved and adopted by all member states.

The Stop TB Partnership is uniquely qualified to develop a global strategic plan to guide the implementation of the WHO END TB Strategy and to foster a multi-sectorial approach and strategic engagement for the fights against TB, which are the two most important activities to be performed under this NOFO, as it is the only global, multi-stakeholder partnership organization (bringing together over 1500 partners) housed within the United Nations with a truly global reach, which has the capacity and capability to represent the views of all TB partners and not just a single sector. This multi-sectorial approach is one of the key principles of the WHO END TB Strategy to achieve the strategy's milestones and targets. This principle calls for the building of a strong coalition with civil society organizations, communities, and other stakeholders as such coalition of partners can assist people in both accessing high-quality care and in demanding high-quality services for TB.

Additionally, the Stop TB Partnership, since it was established in May 2000 following the Ministerial Conference on Tuberculosis and Sustainable Development in Amsterdam, Netherlands, has been working closely with WHO to guide ministries of health and partners in the implementation of prior strategic plans endorsed by WHO and adopted by the global TB community (the Global Plan to Stop TB 2001-2005, the Global Plan to Stop TB 2006-2015, the Rio Recommendations, and the Global Plan to Stop TB 2011-2015) to stop the TB epidemic.

Therefore, as recognized as recently as this past May (2017) by the Ministers of Health from the 20 world leading economies at the First Meeting of the G20 Health Ministers, the Stop TB Partnership is the only organization with a long-term and on-going working relationship with WHO to guide the implementation of the new WHO strategy to end TB. Since CDC's global TB mission and strategies are aligned with the WHO END TB Strategy, it is essential for CDC to collaborate closely with the Stop TB Partnership in the development of a global strategic plan to guide countries in the implementation of the the WHO END TB Strategy to ensure that CDC's global TB goals and targets are met successfully.

Since its establishment in 2001, CDC has worked closely with the Stop TB Partnership to develop a number of consensus documents endorsed by WHO and adopted by the global TB community, including the Amsterdam Declaration to Stop TB, the Global Plan to Stop TB 2001-2005, the Global Plan to Stop TB 2006-2015, the Rio Recommendations, and the Global

Plan to Stop TB 2011-2015, that outline to the global TB community clear internationally agreed strategies and plan for TB prevention, diagnosis, and treatment and research for improving all three.

This new project is closely tied to CDC's prior and ongoing global TB activities and is intrinsically linked to CDC's long-term goal to reduce TB morbidity and mortality in high burden countries and settings. CDC has worked and continues to work closely with WHO to end the TB epidemics by 2030 as called by the UN Sustainable Development Goals. CDC's global TB mission and strategies are aligned with WHO END TB Strategy, which outlines global impact targets to reduce TB deaths by 90% and to cut new TB cases by 80% between 2015 and 2030, and to ensure that no family is burdened with catastrophic costs due to TB.

The Stop TB Partnership is governed by a Coordinating Board and its day-to-day operations are managed by a Secretariat (with the Executive Secretary appointed by the WHO Director General) based in Geneva, Switzerland. The Stop TB Partnership was established by the World Health Assembly of WHO in May 2000. It now brings together over 1500 partners globally (including civil society, communities, developed and developing country non-governmental organizations, donors, foundations, industry, multilateral agencies, private sector companies, technical agencies, etc.) and 10 working groups uniting and acting together to end the TB epidemics by 2030.

No same or similar deviation has been previously requested for the Stop TB Partnership.

Competition is limited to the Stop TB Partnership as the Stop TB Partnership is the only organization that has been given the charge by the World Health Assembly to work with WHO to prepare the global action and investment plan to guide the implementation of the WHO END TB Strategy. As mentioned previously, the Stop TB Partnership is uniquely qualified to perform the most critical activities under this NOFO as it is the only global, multi-stakeholder partnership organization that brings together over 1500 TB partner organizations and that has a long-term and on-going working relationship with WHO to guide the implementation of the WHO strategies to end TB.

Single Source Justification Memo approved on September 7, 2017.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: No Cost sharing or matching funds are not required for this program. Although there is no statutory match requirement for this NOFO, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

5. Maintenance of Effort Maintenance of effort is not required for this program.

D. Application and Submission Information

1. Required Registrations An organization must be registered at the three following locations before it can submit an application for funding at www.grants.gov.

https://www.grants.gov/

a. Data Universal Numbering System:

All applicant organizations must obtain a Data Universal Numbering System (DUNS) number.

A DUNS number is a unique nine-digit identification number provided by Dun & Bradstreet (D&B). It will be used as the Universal Identifier when applying for federal awards or cooperative agreements.

The applicant organization may request a DUNS number by telephone at 1-866-705-5711 (toll free) or internet at http:// fedgov.dnb. com/ webform/ displayHomePage.do. The DUNS number will be provided at no charge.

If funds are awarded to an applicant organization that includes sub-recipients, those sub-recipients must provide their DUNS numbers before accepting any funds.

b. System for Award Management (SAM):

The SAM is the primary registrant database for the federal government and the repository into which an entity must submit information required to conduct business as a recipient. All applicant organizations must register with SAM, and will be assigned a SAM number. All information relevant to the SAM number must be current at all times during which the applicant has an application under consideration for funding by CDC. If an award is made, the SAM information must be maintained until a final financial report is submitted or the final payment is received, whichever is later. The SAM registration process can require 10 or more business days, and registration must be renewed annually. Additional information about registration procedures may be found at www.SAM.gov.

c. Grants.gov:

The first step in submitting an application online is registering your organization at www.grants.gov, the official HHS E-grant Web site. Registration information is located at the “Get Registered” option at www.grants.gov.

All applicant organizations must register at www.grants.gov. The one-time registration process usually takes not more than five days to complete. Applicants should start the registration process as early as possible.

Step System Requirements Duration Follow Up 1 Data

Universal Number System

(DUNS)

1. Click on http:// fedgov.dnb.com/ webform

2. Select Begin DUNS search/request process

3. Select your country or territory and follow the instructions to obtain your DUNS 9-digit #

4. Request appropriate staff member(s) to obtain DUNS number, verify & update information under DUNS number

1-2 Business Days

To confirm that you have been issued a new DUNS number check online at (http:// fedgov.dnb.com/ webform) or call 1-866-705-5711

2 System for 1. Retrieve organizations 3-5 Business For SAM http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/ https://grants.gov/ https://www.grants.gov/ https://www.grants.gov/ https://www.grants.gov/ http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform

Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

DUNS number

2. Go to www.sam.gov and designate an E-Biz POC (note CCR username will not work in SAM and you will need to have an active SAM account before you can register on grants.gov)

Days but up to 2 weeks and must be renewed once a year

Customer Service Contact https://fsd.gov/ fsd-gov/ home.do Calls:

866-606-8220

3 Grants.gov 1. Set up an individual account in Grants.gov using organization new DUNS number to become an authorized organization representative (AOR)

2. Once the account is set up the E-BIZ POC will be notified via email

3. Log into grants.gov using the password the E- BIZ POC received and create new password

4. This authorizes the AOR to submit applications on behalf of the organization

Same day but can take 8 weeks to be fully registered and approved in the system (note, applicants

MUST

obtain a

DUNS

number and

SAM

account before applying on grants.gov)

Register early!

Log into grants.gov and check AOR status until it shows you have been approved

2. Request Application Package Applicants may access the application package at www.grants.gov.

3. Application Package Applicants must download the SF-424, Application for Federal Assistance, package associated with this notice of funding opportunity at www.grants.gov. If Internet access is not available, or if the online forms cannot be accessed, applicants may call the CDC OGS staff at 770-488- 2700 or e-mail OGS ogstims@cdc.gov for assistance. Persons with hearing loss may access CDC telecommunications at TTY 1-888-232-6348.

4. Submission Dates and Times If the application is not submitted by the deadline published in the NOFO, it will not be processed. Office of Grants Services (OGS) personnel will notify the applicant that their application did not meet the deadline. The applicant must receive pre-approval to submit a paper application (see Other Submission Requirements section for additional details). If the applicant is authorized to submit a paper application, it must be received by the deadline provided by

OGS.

http://www.sam.gov https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://fsd.gov/fsd-gov/home.do https://www.grants.gov mailto:ogstims@cdc.gov

a. Letter of Intent Deadline (must be emailed or postmarked by) Due Date for Letter of Intent: N/A

b. Application Deadline Due Date for Applications: 04/08/2018 , 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov. If Grants.gov is inoperable and cannot receive applications, and circumstances preclude advance notification of an extension, then applications must be submitted by the first business day on which grants.gov operations resume.

Date for Information Conference Call

5. CDC Assurances and Certifications All applicants are required to sign and submit “Assurances and Certifications” documents indicated at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa)) /Homepage.aspx.

Applicants may follow either of the following processes:

Complete the applicable assurances and certifications with each application submission, name the file “Assurances and Certifications” and upload it as a PDF file with at www.grants.gov

Complete the applicable assurances and certifications and submit them directly to CDC on an annual basis at http://wwwn.cdc.gov/ grantassurances/ (S(mj444mxct51lnrv1hljjjmaa))/ Homepage.aspx

Assurances and certifications submitted directly to CDC will be kept on file for one year and will apply to all applications submitted to CDC by the applicant within one year of the submission date.

Duplication of Efforts Applicants are responsible for reporting if this application will result in programmatic, budgetary, or commitment overlap with another application or award (i.e. grant, cooperative agreement, or contract) submitted to another funding source in the same fiscal year.

Programmatic overlap occurs when (1) substantially the same project is proposed in more than one application or is submitted to two or more funding sources for review and funding consideration or (2) a specific objective and the project design for accomplishing the objective are the same or closely related in two or more applications or awards, regardless of the funding source. Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salaries) are requested in an application but already are provided by another source.

Commitment overlap occurs when an individual’s time commitment exceeds 100 percent, whether or not salary support is requested in the application. Overlap, whether programmatic, budgetary, or commitment of an individual’s effort greater than 100 percent, is not permitted.

Any overlap will be resolved by the CDC with the applicant and the PD/PI prior to award.

Report Submission: The applicant must upload the report in Grants.gov under “Other https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx

Attachment Forms.” The document should be labeled: "Report on Programmatic, Budgetary, and Commitment Overlap.”

6. Content and Form of Application Submission Applicants are required to include all of the following documents with their application package at www.grants.gov.

7. Letter of Intent LOI is not requested or required as part of the application for this NOFO.

8. Table of Contents (There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the “Table of Contents” for the entire submission package.

Provide a detailed table of contents for the entire submission package that includes all of the documents in the application and headings in the "Project Narrative" section. Name the file "Table of Contents" and upload it as a PDF file under "Other Attachment Forms" at www.grants.gov.

9. Project Abstract Summary (Maximum 1 page) A project abstract is included on the mandatory documents list and must be submitted at www.grants.gov. The project abstract must be a self-contained, brief summary of the proposed project including the purpose and outcomes. This summary must not include any proprietary or confidential information. Applicants must enter the summary in the "Project Abstract Summary" text box at www.grants.gov.

10. Project Narrative (Unless specified in the "H. Other Information" section, maximum of 20 pages, single spaced, 12 point font, 1-inch margins, number all pages. This includes the work plan. Content beyond the specified page number will not be reviewed.)

Applicants must submit a Project Narrative with the application forms. Applicants must name this file “Project Narrative” and upload it at www.grants.gov. The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. The Project Narrative must be succinct, self-explanatory, and in the order outlined in this section. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section. Applicants should use the federal plain language guidelines and Clear Communication Index to respond to this Notice of Funding Opportunity. Note that recipients should also use these tools when creating public communication materials supported by this NOFO. Failure to follow the guidance and format may negatively impact scoring of the application.

https://www.grants.gov https://www.grants.gov https://www.grants.gov

a. Background Applicants must provide a description of relevant background information that includes the context of the problem (See CDC Background).

b. Approach

i. Purpose Applicants must describe in 2-3 sentences specifically how their application will address the public health problem as described in the…