CDC-RFA-GH19-1946.pdf

Centers for Disease Control

Center for Global Health

Partnering with the International Union Against Tuberculosis and Lung Disease to Foster

Sustainable and Effective Systems to Strengthen the Delivery of Quality Tuberculosis (TB) Services in Resource Limited Countries

CDC-RFA-GH19-1946

Application Due Date: 03/25/2019

Partnering with the International Union Against Tuberculosis and Lung Disease to Foster

Sustainable and Effective Systems to Strengthen the Delivery of Quality Tuberculosis (TB) Services in Resource Limited Countries

CDC-RFA-GH19-1946

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (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-GH19-1946. 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:

Partnering with the International Union Against Tuberculosis and Lung Disease to Foster Sustainable and Effective Systems to Strengthen the Delivery of Quality Tuberculosis (TB) Services in Resource Limited Countries 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-GH19-1946

E. Assistance Listings (CFDA) Number:

93.947 F. Dates:

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

2. Due Date for Applications: 03/25/2019, 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 treatable, tuberculosis (TB) is the leading infectious disease cause of death in the world, with an estimated 1.7 million TB deaths and 10.4 million new cases of TB in 2016. A fourth of the world's population - some 2 billion - are infected with TB, with an estimated 10.4 million developing active TB disease each year. 4.3 million of these individuals go undiagnosed each year by health care providers and do not get the TB care and treatment they need. Drug-resistant TB poses another serious global public health threat. TB is also the leading cause of death among people living with HIV (PLHIV). Addressing TB on a global scale is required to effectively protect the U.S. from this costly and deadly disease. The goal of this NOFO is to partner with the International Union Against Tuberculosis and Lung 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

Disease (The Union) to foster sustainable and effective systems to strengthen the delivery of quality TB services to end the global TB epidemic. Through this NOFO, The Union is to strengthen and enhance TB services and TB control efforts in resource limited countries by promoting the wider use and adoption of recommended strategies and guidelines to interrupt TB transmission and to increase access to accurate diagnosis and effective treatment for TB and providing training and access to health officials, health professionals, and health care workers (HCWs) to the most current science, epidemiology, and clinical information on TB.

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 of Performance 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: $500,000

f. Total Period of Performance Length: 5

g. Estimated Award Date: 09/30/2019

h. Cost Sharing and / or Matching Requirements: N 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

Part II. Full Text

1. Background

a. Overview TB is an airborne disease transmitted through the air without direct person-to-person contact. TB is found all over the world, including in the U.S. Despite being preventable and treatable, TB is the leading infectious disease cause of death in the world, with an estimated 1.7 million TB deaths and 10.4 million new cases of the disease in 2016. A fourth of the world's population - some 2 billion people - are infected with TB, with an estimated 10.4 million developing active TB disease each year. 4.3 million of these individuals go undiagnosed each year by health care providers and do not get the TB care and treatment they need. More than 75 percent of undiagnosed or "missed" cases are concentrated in just ten countries. Among these cases are an estimated 600,000 infected children and 400,000 people with drug-resistant forms of the disease, which poses another serious global public health threat, including in the U.S. 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. This means that each undiagnosed case can expand the current TB burden, which compounds the goal to end the TB epidemic worldwide exponentially more challenging. TB is also the leading cause of death among

PLHIV.

Addressing TB on a global scale is required to end the TB epidemic per the World Health Organization's (WHO) End TB Strategy adopted by the World Health Assembly in May 2014 and to protect the U.S. from this costly and deadly disease.

The purpose of this NOFO is to partner with and utilize the expertise of the International Union Against Tuberculosis and Lung Disease to strengthen and enhance TB services and TB control efforts in resource limited countries by: promoting the wider use and adoption of recommended strategies and guidelines to interrupt TB transmission and to increase access to accurate diagnosis and effective treatment for TB and providing training and access to health officials, health professionals, and HCWs to the most current science, epidemiology, and clinical information on

TB.

CDC is a significant driver of progress and contributor in preventing and controlling TB both in the U.S. and across the globe. CDC is on the frontlines in more than 30 high-burden countries working with partner governments to find, cure, and prevent TB, and help sustain country efforts to end the TB epidemic. CDC is:

FIND: Expanding access to improved screening, contact tracing, and diagnostic tools to find the missing TB cases;

CURE: Optimizing treatment for TB and multi-drug-resistant (MDR) TB, including identifying and evaluating better treatment regimens, and expanding access to care and treatment;

PREVENT: Breaking the cycle of TB transmission by strengthening infection control, identifying TB hotspots to target screening, and scaling-up treatment to prevent TB; and

SUSTAIN: Helping countries strengthen their surveillance and laboratory systems, and workforce and research capacity to support sustainable health systems including promoting the wider use and adoption of recommended TB strategies and guidelines.

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 2020 N/A

d. Other National Public Health Priorities and Strategies In an effort to ensure maximum cost efficiencies and program effectiveness, HHS/CDC also 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-distinguis hing-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 eliminate the disease abroad as well as in the U.S. In May 2014, the World Health Assembly adopted the 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 95% and to cut new cases by 90% between 2015 and 2035, and to ensure that no family is burdened with catastrophic costs due to TB. In September 2018, the United Nations General Assembly held its first High Level Meeting on TB and unanimously signed the Political Declaration on the Fight Against TB which outlined interim targets for treatment and prevention to be achieved by 2022 to keep the world on track to meeting the global goals to End TB by 2035.

CDC's global TB mission and strategies are aligned with the WHO's End TB Strategy (2016- 2020), the Stop TB Partnership's Global Plan to End TB (2016-2020), the United Nations Sustainable Development Goals for TB, the United Nations Political Declaration on the Fight Against TB, as well as the U.S. Government's Global TB Strategy, 2015-2019. CDC works with 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.

This NOFO is a continuation of the funded activities in cooperative agreements, PS04-04148 and PS09-9127 titled, "International Union Against Tuberculosis and Lung Disease: Improving the Effectiveness of Tuberculosis Prevention and Control Programs in Resource-Limited Countries" and PS14-1411 titled, "Improving Effectiveness of the Tuberculosis Prevention and Control Programs in Resource Limited Countries."

Additionally, along with global partners, CDC TB experts are focusing on a distinct set of strategies as part of CDC's effort to alleviate the morbidity and mortality that TB takes globally:

Find, cure, prevent, and protect Americans both here and abroad by being on the frontline and providing expert technical advice, assistance, and training in more than 30 high burden countries - CDC and its partners are expanding access to improved screening, 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 contact tracing, and diagnostic tools to find the undiagnosed or "missing" cases. Many of these cases occur among the most vulnerable and hardest to reach populations including children, pregnant women, PLHIV, miners, mobile populations, and HCWs. CDC and its partners are also evaluating new treatment regimens; working to expand 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 such as TB preventive therapy to prevent TB.

Sustain countries' efforts to end the TB epidemic by helping countries to strengthen their surveillance and laboratory systems and workforce and research capacity to support sustainable health systems.

Find and combat TB and its resistant forms- 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.

Increase access to effective prevention and treatment for those living with or at risk for HIV and TB co-infection - CDC is leading global efforts to scale up TB preventive therapy for PLHIV in President's Emergency Plan for AIDS Relief (PEPFAR)-funded countries.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

i. Purpose Despite being preventable and treatable, TB is the leading infectious disease cause of death globally with an estimated 1.7 million TB deaths and 10.4 million falling ill to the disease in 2016. Addressing TB on a global scale is required to effectively protect the U.S. from this costly and deadly disease. The purpose of this NOFO is to partner with the International Union Against Tuberculosis and Lung Disease to strengthen and enhance TB services and control efforts in resource limited countries.

ii. Outcomes Short-Term Outcomes:

Increased access to diagnostic services and modalities for all forms of TB Increased access to effective treatment for all forms of TB Improved implementation of infection control practices in health facilities and congregate settings to interrupt the transmission of TB Increased sharing of best practices and lessons learned to improve TB programs Improved implementation of TB guidelines Improved delivery of TB services Increased access and knowledge to the most current science, epidemiology, and clinical information on TB, MDR TB, XDR TB, and pediatric TB

Intermediate Outcomes:

Decreased TB transmission in health facilities and congregate settings Increased delivery of quality TB services

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

iii. Strategies and Activities The International Union Against Tuberculosis and Lung Disease is expected to implement the following strategies and activities during the 5-year project period. It may propose additional strategies and activities (beyond what is included in the logic model) to achieve the outcomes.

FIND: Expand access to improved screening, contact tracing, and diagnostic tools to find missing TB cases

Produce and disseminate a variety of resources such as technical guides, handbooks, case studies, factsheets, toolkits, reports, etc. aimed at supporting resource limited countries' effort to increase access to accurate diagnostics.

CURE: Optimize treatment for TB and its drug resistant forms, including identifying and evaluating better treatment regimens and expanding access to care and treatment

Produce and disseminate a variety of resources such as technical guides, handbooks, case studies, factsheets, toolkits, reports, etc. aimed at supporting resource limited countries' effort to increase access to effective treatment for all forms of TB.

PREVENT: Break the cycle of TB transmission by strengthening infection control

Implement and evaluate infection control interventions in health facilities and high-risk congregate settings.

Support the implementation of TB Building and Strengthening Infection Control Strategies (BASICS) as an innovative tool and a mentoring model to improve infection control practices in resource limited countries.

SUSTAIN: Help countries strengthen their surveillance and laboratory systems, and workforce and research capacity to support sustainable health systems, including promoting the wider use and adoption of recommended TB strategies and guidelines.

Produce and publish monographs and related publications to share best practices and lessons learned to improve diagnosis, prevention, control, and treatment of TB including drug-resistant TB.

Provide technical assistance in the introduction of various TB guidelines at the local and national levels in resource limited countries.

Develop specialized training courses to strengthen the delivery of quality TB services at all levels of a resource limited country's health care system.

Organize and conduct special symposia and workshops to provide training and access to health officials, health professionals, and HCWs from resource limited countries with the most current science, epidemiology, and clinical information on TB, MDR TB, XDR TB, and pediatric TB.

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 resource limited countries and settings with high TB burden. The recipient is expected to collaborate with other 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.

2. Target Populations The target populations for this NOFO include, but are not limited to: health officials, health professionals, HCWs, and health managers working to prevent, control, and eliminate TB. People with TB or at risk for TB will also benefit from the NOFO as well as PLHIV.

a. Health Disparities N/A

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 International Union Against Tuberculosis and Lung Disease 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.

FIND: Expand access to improved screening, contact tracing, and diagnostic tools to find missing TB cases

Process measures:

o Number of resources produced to support resource limited countries' effort to increase access to accurate diagnostics and available for dissemination (at least 1 per year: Year 1 - 5; Frequency: annually)

Outcome measures:

o Percentage of new and relapse TB patients tested using a WHO-recommended rapid test at time of diagnosis (WHO 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) o TX_TB denominator and disaggregates (PEPFAR Indicator): Number of antiretroviral treatment patients screened for TB at least once

CURE: Optimize treatment for TB and its drug resistant forms including identifying and evaluating better treatment regimens and expanding access to care and treatment

Process measures:

o Number of resources produced to support resource limited countries' effort to increase access to effective TB treatment and available for dissemination (at least 1 per year: Year 1 - 5; Frequency: annually)

Outcome measures:

o TB treatment coverage (WHO 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.

PREVENT: Break the cycle of TB transmission by strengthening infection control

Process measures:

o Number of infection control interventions in health facilities and high-risk congregate settings evaluations conducted (4 per year: Year 1 - 5; Frequency:

annually) o Number of site visits conducted to support the implementation of TB BASICS to improve infection control practices in health facilities (2 per year: Year 1 - 5;

Frequency: annually)

Outcome measures:

o Number of recommendations implemented as recommended by each infection control interventions evaluation o Number of health facilities establishing or improving their infection control programs

SUSTAIN: Help countries strengthen their surveillance and laboratory systems, and workforce and research capacity to support sustainable health systems including promoting the wider use and adoption of recommended TB strategies and guidelines.

Process measures:

o Number of monographs and related publications to share best practices and lessons learned to improve diagnosis, prevention, control, and treatment of TB including drug-resistant TB produced and published (at least 6 per year: Year 1 - 5;

Frequency: annually) o Number of technical assistance provided at local or national level for the introduction of various TB guidelines (2 per year: Year 1 - 5; Frequency: annually) o Number of special symposia and workshops conducted to provide training and access with the most current science, epidemiology, and clinical information on TB, MDR TB, XDR TB, and pediatric TB (at least 2 per year: Year 1 - 5;

Frequency: annually)

Outcome measures:

o Number of documented TB program improvements made based on the dissemination of scientific findings, lessons learned, and best practices o Number of TB programs having adopted TB guidelines that were introduced to them o Percent improvement by symposia and workshops participants in their knowledge on the science, epidemiology, and clinical information on TB, MDR TB, XDR TB, or pediatric TB

The International Union Against Tuberculosis and Lung Disease 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 International Union Against Tuberculosis and Lung

Disease; however, since routine monitoring of progress will be reported to both organizations, it should be expected that no more than 5% of funds available through this NOFO be used to fund monitoring activities and no more than 5% 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 Annual Progress Reports (APR), meeting minutes, trip reports, technical reports, assessment/evaluation reports, and interviews with key informants, and, if relevant, the recipients 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 type of resource was the most effective in supporting resource-limited countries' efforts to increase access to accurate diagnostics and to effective TB treatment?

To what extent does providing technical assistance at the local or national level to introduce TB guidelines help in the adoption of these guidelines?

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.

https://www.cdc.gov/grants/additionalrequirements/ar-25.html

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 Applicant should submit the following materials as part of the appendix:

Statement of experience (maximum 4 pages) Curriculum Vitae (CVs)/Resumes for key staff who will work on the activities, including but not limited to: the Principal Investigator (PI), business official, technical area advisors/leads, Finance/Business Manager, and other relevant technical staff.

o CVs/resumes should highlight technical skills and experience related to carrying out the proposed activities including demonstrated expertise in strengthening and enhancing TB services and control efforts in resource limited countries.

Job descriptions for all positions key to the performance of the award, including positions applying less than 100% Level of Effort (LOE) on the award. Positions should include but are not limited to: PI, business official, technical area advisors/leads, and Finance/Business Manager.

Organizational chart (maximum 1 page)

The above referenced materials to be submitted in the appendix should demonstrate organizational capacity to address the requirements of the NOFO.

Applicants must title these documents "Experience" "CVs/Resumes" "Job Descriptions" "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, 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:

http://www.grants.gov/

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.

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 subrecipients 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 Paperwork Reduction Act of 1995 (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: U2G

3. Fiscal Year: 2019

4. Approximate Total Fiscal Year Funding: $500,000

5. Approximate Period of Performance Funding: $0

This amount is subject to the availability of funds.

The Approximate Project Period of Performance 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: $500,000 Per Budget Period

9. Award Ceiling: $500,000 Per Budget Period

This amount is subject to the availability of funds.

10. Award Floor: $0 Per Budget Period None

11. Estimated Award Date: 09/30/2019

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 NOFO.

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:

International Union Against Tuberculosis and Lung Disease (The Union)

3. Justification for Less than Maximum Competition The International Union Against Tuberculosis and Lung Disease (The Union) was founded in 1920 by the League of Nations and the U.S. at the first post-war international conference on TB held in Paris as the Federation of 31 national tuberculosis and lung disease associations. Under its Constitution, The Union was given the mandate to establish a Federation amongst the national associations or organizations engaged in the campaign against TB, to coordinate their efforts throughout the world, and to work in collaboration with international organizations to end TB disease; to organize scientific conferences and congress regarding TB; to compare national legislation in preventing and controlling TB; to collect international TB statistics; to stimulate scientific and social investigations regarding the distribution, spread, prevention, and treatment of TB in various countries; and to collect and distribute information to national organizations included in The Union on all questions concerning scientific and sociological study of TB. The Union's mandate was extended in 1973 to include other lung diseases. The Union is the only federation of national TB and lung disease associations and individuals with the goal of combating these diseases globally, making it uniquely positioned to facilitate training/capacity building, adoption of best practices and guidelines, information sharing, and improve access to accurate diagnosis and effective treatment for TB.

Soon after the World Health Organization (WHO) was created in 1946, The Union became the first non-governmental organization (NGO) to enter in to official relations with WHO. "Official relations" is a privilege that the WHO Executive Board may grant to nongovernmental organizations, international business associations and philanthropic foundations that have and continue to have a sustained and systematic engagement in the interest of WHO and whose activities conforms to the spirit, purposes, and principles of WHO's Constitution and contribute significantly to the advancement of public health. This recognition also carries certain privileges, including participating in sessions of WHO's governing bodies. Since its official recognition and the collaboration of the two organizations began in 1947, WHO considers The Union to be the primary leader in international efforts for TB elimination and often uses their annual conference and network of national TB associations to work with countries and partners to develop and refine strategic and programmatic approaches to improve global TB control and prevention and to discuss and release newly developed or updated TB guidelines.

The Union is uniquely positioned as a federation of national TB and lung disease associations to combat TB and lung disease globally to offer training and other capacity-building activities leading to health solutions for the poor in resource limited countries, the key activities under this NOFO, due to its WHO-recognized accomplishments and leadership role in the global TB fight since its founding. The Union developed the first drug combination that could completely cure TB, created the first diagnostic model of using microscopy to diagnose and treat TB, and created the directly observed treatment short course (DOTS) that has been universally accepted and recommended by WHO as the gold standard for TB treatment since 1995. As the only federation of national TB and lung disease associations, the Union has a key role in the communication of developments and updated guidelines globally through its annual conference and two official journals.

Three previous awards have been made to The Union, under the following NOFOs/award numbers:

NOFO #PS04-04148; award #PS024277 NOFO #PS09-9127; award #PS001623 NOFO #PS14-1411; award #PS004641

Similar deviations have been previously requested for the International Union Against Tuberculosis and Lung Disease, and they were all approved (in 2004, 2009, and 2014).The deviation was requested because of The Union's mandate to establish and work with the only global Federation to end TB disease and WHO's official recognition of The Union's crucial role in the fight against TB and its elimination globally. This new project is closely tied to CDC's prior and ongoing activities and is intrinsically linked to CDC's long-term goal to reduce TB morbidity and mortality in high burden countries and settings and CDC's contribution to end the global TB epidemic by driving down TB deaths, incidence, and eliminating catastrophic costs as outlined in the WHO END TB Strategy adopted by the World Health Assembly in May 2014. Since 2004, CDC has been working closely with The Union to improve the quality, efficiency and effectiveness of TB prevention and control programs in resource-limited countries, leveraging The Union's global federation of national TB and lung disease association. Through this new project, it is expected that many of these activities will continue due to the critical need.

Single Source Memo approved on October 11, 2018.

4. Cost Sharing or Matching Cost Sharing / Matching Requirement: 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.

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.

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.

https://www.grants.gov/ http://fedgov.dnb.com/webform/displayHomePage.do https://www.sam.gov/portal/public/SAM/

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 "Applicant Registration" 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 Award Management

(SAM)

formerly Central Contractor Registration

(CCR)

1. Retrieve organizations 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)

3-5 Business Days but up to 2 weeks and must be renewed once a year

For SAM 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

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

MUST

obtain a

DUNS

number and

Register early!

Log into grants.gov and check AOR status until it shows you have been approved https://grants.gov/ https://www.grants.gov/ http://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 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

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

SAM

account before applying on grants.gov)

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.

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: 03/25/2019 , 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 N/A

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 https://www.grants.gov https://www.grants.gov mailto:ogstims@cdc.gov https://www.grants.gov http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx http://wwwn.cdc.gov/grantassurances/(S(mj444mxct51lnrv1hljjjmaa))/Homepage.aspx 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.

Risk Assessment Questionnaire Requirement CDC is required to conduct pre-award risk assessments to determine the risk an applicant poses to meeting federal programmatic and administrative requirements by taking into account issues such as financial instability, insufficient management systems, non-compliance with award conditions, the charging of unallowable costs, and inexperience. The risk assessment will include an evaluation of the applicant’s CDC Risk Questionnaire, located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, as well as a review of the applicant’s history in all available systems; including OMB-designated repositories of government-wide eligibility and financial integrity systems (see 45 CFR 75.205(a)), and other sources of historical information. These systems include, but are not limited to: FAPIIS (https://www.fapiis.gov/), including past performance on federal contracts as per Duncan Hunter National Defense Authorization Act of 2009; Do Not Pay list; and System for Award Management (SAM) exclusions.

CDC requires all applicants to complete the Risk Questionnaire, OMB Control Number 0920- 1132 annually. This questionnaire, which is located at https://www.cdc.gov/grants/documents/PPMR-G-CDC-Risk-Questionnaire.pdf, along with supporting documentation must be submitted with your application by the closing date of the Notice of Funding Opportunity Announcement. If your organization has completed CDC’s Risk Questionnaire within the past 12 months of the closing date of this NOFO, then you must submit a copy of that questionnaire, or submit a letter signed by the authorized organization representative to include the original submission date, organization’s EIN and DUNS.

When uploading supporting documentation for the Risk Questionnaire into this application package, clearly label the documents for easy identification of the type of documentation.