RFA-GH-20-001 REVISED CLOSING DATE 03 03 20. FINALpdf.pdf

Centers for Disease Control and Prevention

Center for Global Health Extramural Research Program Office

Develop, Implement, and Evaluate Evidence-based, Innovative Approaches to Prevent, Find, and Cure Tuberculosis in High-Burden Settings

RFA-GH-20-001

Application Due Date: 03/10/2020

Develop, Implement, and Evaluate Evidence-based, Innovative Approaches to Prevent, Find, and Cure Tuberculosis in High-Burden Settings

RFA-GH-20-001

TABLE OF CONTENTS

Part 1. Overview Information Key Dates Required Application Instructions Executive Summary

Part 2. Full Text Section I. Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 1. Overview Information Participating Organization(s) Centers for Disease Control and Prevention Components of Participating Organizations Center for Global Health Notice of Funding Opportunity (NOFO) Title Develop, Implement, and Evaluate Evidence-based, Innovative Approaches to Prevent, Find, and Cure Tuberculosis in High-Burden Settings Activity Code U01

Amendment 1: Summary of Changes Section VIII. Other Information Added questions and answers from 1/10/2020

Notice of Funding Opportunity Type New Agency Notice of Funding Opportunity Number

RFA-GH-20-001

Assistance Listings (CFDA) Number(s) 93.947 Category of Funding Activity:

Health NOFO Purpose The End TB Strategy envisions a world free of tuberculosis (TB)—zero deaths, disease, and suffering due to TB by 2035. This requires reducing the global TB incidence from >1250 cases per million people to <100 cases per million people within the next two decades.

Each year, an estimated 10 million people develop TB disease, and an estimated 1.6 million people die from TB – the leading cause of death from any infectious disease, including among people living with HIV (PLHIV). In 2017, 90% of all new TB cases were diagnosed in adults (15 years of age or older), and 9% were diagnosed in PLHIV with 72% living in Africa. Despite being preventable and treatable, large gaps in detection and treatment of TB cases remain; of the estimated 10 million new TB cases in 2017, only 6.4 million TB cases were officially reported.

These detection gaps are larger in vulnerable populations, including but not limited to children, persons with MDR-TB, and mobile and migrant populations.

Drug-resistant TB is on the rise, posing significant programmatic challenges. Worldwide, an estimated 580,000 multi-drug-resistant (MDR) TB cases emerge annually. Unfortunately, there are substantial gaps in MDR TB detection and treatment. Approximately 1 out of 5 persons needing MDR TB treatment actually receive it, and among those who do receive treatment, less than half (48%) who start treatment finish successfully. These rates are driven by treatment failure, loss to follow-up, and premature death.

Globally, it is estimated that 1.7 billion people (about one fourth of the world’s population) are infected with TB and contribute to the reservoir of future TB cases. Expanding testing and treatment of TB infection is critical to achieving TB elimination goals. However, in high-burden countries, the implementation of TB preventive treatment (TPT) remains a low, or at the least, competing priority.

The purpose of this Notice of Funding Opportunity (NOFO) is to develop, implement, and evaluate evidence-based and innovative approaches to:

prevent TB infection, disrupt TB transmission, and halt progression of TB disease in high-burden settings;

find TB infection and TB disease in all populations, including those most vulnerable (i.e., children, displaced persons, health care workers, economically disadvantaged, PLHIV, persons with other co-morbid conditions [alcohol use disorders, diabetes mellitus, persons who use illicit substances, undernourished] and elderly);

optimize treatment for TB infection, TB disease, TB/HIV, and MDR TB through new treatment and adherence modalities;

enhance and strengthen the use of routinely collected data to monitor, evaluate, and improve TB program performance; and implement operations research (i.e., local solutions for local problems) for broader application, adoption, and integration into routine TB care and treatment practice.

Key Dates Publication Date:

Letter of Intent Due Date:

Application Due Date:

To receive notification of any changes to RFA-GH-20-001, return to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notification Emails" link. An email address is needed for this service.

02/03/2020

03/10/2020

On-time submission requires that electronic applications be error-free and made available to CDC for processing from the NIH eRA system on or before the deadline date. Applications must be submitted to and validated successfully by Grants.gov no later than 5:00 PM U.S.

Eastern Time. Applications must be submitted using the Application Submission System & Interface for Submission Tracking (ASSIST) module which is a web-based service used for the preparation and submission of grant applications to CDC through Grants.gov. ASSIST provides the ability for applicants to prepare their applications online, and offers the applicant additional capabilities including the ability to preview the application image, validate the application against required business rules, and prepopulate data from an applicant organization's records, therefore identifying issues earlier in the application submission process.

https://www.grants.gov

Note: HHS/CDC grant submission procedures do not provide a grace period beyond the application due date time to correct any error or warning notices of noncompliance with application instructions that are identified by Grants.gov or eRA systems (i.e., error correction window).

Scientific Merit Review: 04/20/2020

Secondary Review:

Estimated Start Date:

Expiration Date:

Due Dates for E.O. 12372:

06/15/2020

09/30/2020

03/14/2020 Executive Order 12372 does not apply to this program.

Required Application Instructions

**ELECTRONIC APPLICATION SUBMISSION VIA ASSIST IS PREFERRED**

It is recommended that applicants use ASSIST for the electronic preparation and submission of applications through Grants.gov to CDC. ASSIST is an alternative method to prepare and submit applications, and provides many features to facilitate the application submission process which improves data quality (e.g., pre-population of organization data, pre-submission validation of business rules, and preview of the application image used for review). Use of the Grants.gov downloadable Adobe application packages and submission process will still be supported.

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this NOFO. Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Note: The Research Strategy component of the Research Plan is limited to 25 pages.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Pages that exceed page limits described in this NOFO will be removed and not forwarded for peer review, potentially affecting an application's score.

Telecommunications for the Hearing Impaired: TTY 1-888-232-6348

Executive Summary Purpose: The purpose of this NOFO is to develop, implement, and evaluate evidence-based and innovative approaches to:

Prevent TB infection, disrupt TB transmission, and halt progression of TB disease in high-burden settings;

http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_VerC.pdf

Find TB infection and TB disease in all populations, including those most vulnerable;

Optimize treatment for TB infection, TB disease, TB/HIV, and MDR TB through new treatment and adherence modalities;

Enhance and strengthen the use of routinely collected data to monitor, evaluate, and improve TB program performance; and Implement operations research (i.e., local solutions for local problems) for broader application, adoption, and integration into routine TB care and treatment practice.

Mechanism of Support: Research Project – Cooperative Agreement

Funds Available and Anticipated Number of Awards: The estimated total funding available, including direct and indirect costs, for the entire 5-year project period is $5,000,000. The number of awards will be up to two (2). Award(s) issued under this NOFO are contingent upon availability of funds and a sufficient number of meritorious applications. The total amount awarded and the number of awards will depend upon the number, quality, duration and cost of the applications received.

Budget and Project Period: The estimated total funding (direct and indirect) for the first year (12-month budget period 9/30/2020 to 9/29/2021) will be $1,000,000 with each individual award ranging from $0 to $1,000,000 for the first year. The estimated total funding (direct and indirect) for the entire project period will be $5,000,000. The project period is anticipated to run from 09/30/2020 to 09/29/2025

Application Research Strategy Length: Page limits for the Research Strategy are clearly specified in Section IV. “Application and Submission Information” of this announcement.

Eligible Institutions/Organizations. The institutions/organizations listed in Section III.1 of this NOFO are eligible to apply.

Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. NOTE:

CDC does not make awards to individuals directly. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply.

Number of PDs/PIs. There will only be one PD/PI for each application. If necessary, Co-PI(s) may be listed in the application but only one PI may be the primary CDC contact for the award and this must be indicated in the application.

Number of Applications: Eligible applicant institutions may submit only one application.

Application Type: New Application Materials: See Section IV.1 for application materials. Please note that

Form E is to be used when completing the application package.

Special Dates: LOI date: Feb 3, 2020; Receipt date: March 3, 2020. Applicants must submit their questions by e-mail to cgherpo@cdc.gov, within 15 days after the publication date of this NOFO in www.grants.gov. Questions received after this time will not be considered for response. All changes, updates including the Q/A will be added as an amendment to the NOFO and will be posted on grants.gov within a mailto:cgherpo@cdc.gov reasonable time

Part 2. Full Text Section I. Funding Opportunity Description

Statutory Authority 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.

1. Background and Purpose The End TB Strategy envisions a world free of TB — zero deaths, disease, and suffering due to TB by 2035. This requires reducing the global TB incidence from >1250 cases per million people to <100 cases per million people within the next two decades. The End TB Strategy 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 cut new cases by 90% between 2015 and 2035, as well as ensure that no family is burdened with catastrophic costs due to TB.

TB is the leading cause of death from a single infectious agent globally; in 2017, TB was responsible for 1.6 million deaths. TB also ranks as the leading infectious disease cause of death in human history, claiming over a billion lives in the past two centuries alone.

Each year, an estimated 10 million people develop TB disease, and an estimated 1.6 million people die from TB – the leading cause of death from any infectious disease, including among PLHIV. In 2017, 90% of all new TB cases were diagnosed in adults (15 years of age or older), and 9% were diagnosed in PLHIV, with 72% living in Africa. Despite being preventable and treatable, large gaps in detection and treatment of TB cases remain; of the estimated 10 million new TB cases in 2017, only 6.4 million TB cases were officially reported. These detection gaps are larger in vulnerable populations, including but not limited to children, persons with MDR- TB, and mobile and migrant populations.

Drug-resistant TB is on the rise, posing significant programmatic challenges. Worldwide, an estimated 580,000 MDR TB cases emerge annually. Unfortunately, there are substantial gaps in MDR TB detection and treatment. Approximately 1 of 5 persons needing MDR TB treatment actually receive it, and among those who do receive treatment, less than half (48%) who start treatment finish successfully. These rates are driven by treatment failure, loss to follow-up, and premature death.

Globally, it is estimated that 1.7 billion people (about one fourth of the world’s population) are infected with TB and contribute to the reservoir of future TB cases. Expanding testing and treatment of TB infection is critical to achieving TB elimination goals. However, in high-burden countries, the implementation of TPT remains a low priority.

Despite this enormous toll on health and well-being, the response to TB has been slow and underfunded, particularly in the area of research. The third pillar of the End TB Strategy – research and innovation – recognizes that achieving substantial reductions in TB incidence and mortality will require the development, implementation, and evaluation of new tools and strategies, in addition to ensuring universal access to existing technologies and better use of those technologies. These include a rapid point-of-care test for diagnosing TB infection, TB disease, and detecting drug resistance; safer, shorter regimens for treating TB infection, drug-sensitive TB; shorter, safer and more effective treatment for drug-resistant TB; a new TB vaccine that is effective both before and after exposure; and innovative strategies to address the social and environmental drivers of TB.

This NOFO is not intended for animal research; basic biomedical research; nor drug, device, or vaccine development.

Healthy People 2020 and other National Strategic Priorities This NOFO aligns with the current CDC strategic priorities including strengthening surveillance, epidemiology, and laboratory services; supporting public health activities;

evaluating public health programs; conducting operational research; increasing global health impact; and preventing illness and death.

This program addresses the “Healthy People 2020” focus area of Global Health by improving public health through global disease detection, response, prevention, and control strategies.

Other Public Health Priorities and Strategies

The U.S. Department of Health and Human Services’ Centers for Disease Control and Prevention (HHS/CDC) works with host countries and other key partners to assess the needs of each country and design a customized program of assistance that fits within the host nation’s strategic plan and partnership framework. 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;

Enhance and strengthen metrics, monitoring, and evaluation for program improvement Implement research, development, and innovation.

Public Health Impact The health targets of the United Nations Sustainable Development Goals (SDGs) build on historic gains made under the United Nations Millennium Development Goals. The SDG target to “end the TB epidemic” by 2030 and more specifically the World Health Organization’s (WHO) ‘End TB Strategy’ include ensuring that no family is burdened with catastrophic expenses due to TB, and achieving a 90% reduction in TB deaths and an 80% reduction in TB incidence compared with levels in 2015, with targets for further reductions (95% and 90%, respectively) by 2035. However, there is still an enormous gap between current reality and the vision of the SDGs.

There is a need for public health research to deliver innovation for new and existing technologies, and to enable integrated people-centered prevention, diagnosis, treatment, and care of TB.

The overall impact aimed for through this NOFO is to inform optimal program implementation through identifying ‘best practices’ and employing ‘local solutions to local problems’ for broader application, adoption, and integration into routine TB care and treatment practices.

Results from these activities will provide local ministries of health and other key stakeholders with the evidence base to support innovation, adoption, and scale-up of strategies that maximize population-level impact for all TB prevention, care, and treatment services, and strengthen local health systems.

Relevant Work 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 SDGs 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.

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

Protect Americans both here and abroad by being on the frontline and providing expert technical advice, assistance, and training in high-burden TB settings — CDC and its partners are expanding access to improved screening, 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, health care workers, and mobile and migrant populations. CDC and its partners are also evaluating new treatment regimens; working to expand access to care and treatment; breaking the cycle of transmission by strengthening infection control; implementing community-based approaches to targeting the hardest hit populations; and scaling-up more effective, and shorter treatment for TB infection, drug-sensitive and drug-resistant TB.

Sustain countries' efforts to end the TB epidemic by helping countries to strengthen their surveillance and data translation capacity through promoting research capacity to support sustainable health systems.

Find and combat TB and all 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 TB prevention and treatment for those living with (or at risk for) HIV — CDC is leading global efforts to scale up TPT for PLHIV in President's Emergency Plan for AIDS Relief (PEPFAR)-funded countries.

2. Approach Research projects applied under this NOFO should reflect the applicant’s current and projected capacities and capabilities in implementing research to find, cure, and prevent TB in high-burden TB settings and in all populations, including those most vulnerable. Essential for the conduct of these activities is the institutional and investigator capacity necessary to perform this work. Applicants are encouraged to request support for the development of local research capacity necessary for the conduct of the proposed study, and to propose studies that are feasible with maximum impact within the local capacity and context.

It is expected the research findings will be broadly disseminated and translated in public health practice to facilitate the development and implementation of new and better program models, or program improvement strategies, with immediate implementation within local communities of practice for the prevention, care, and treatment of TB and TB/HIV.

Applicants should describe effective optimization of clinical and community TB prevention, care, and treatment services. Recipient(s) will be expected to have the capacity to be able to conduct evaluation and research which assess patient or population-level outcomes and the determinants and/or risk factors of those outcomes within clinical and community TB prevention, care, and treatment programs.

Objectives/Outcomes Applicants may propose research focusing on one or more of the Prevent, Find, Cure, and Sustain focus areas.

The expected objectives and examples of the type of research activities for each focus area are:

PREVENT – Break the cycle of TB transmission through contact tracing, screening, and treatment for TB infection, as well as assuring effective TB infection control strategies are implemented in health care facilities. Activities may include (but are not limited to):

o Implement and evaluate innovative strategies to improve/optimize access to TPT in all populations, including those most vulnerable.

o Implement and evaluate innovative strategies to improve/optimize TPT regimens.

o Collect and evaluate population-based data of risk-factors and biomarkers that facilitate the progression from TB infection to disease.

o Implement and evaluate innovative strategies to prevent TB transmission to TB patients and health care workers in health care facilities.

o Establish communities of practice for TB prevention, care, and treatment.

FIND – Implement and evaluate innovative strategies to improve/optimize finding active TB cases (all forms) and their contacts and linking them to care. Activities may include (but are not limited to):

o Develop, implement, and evaluate novel diagnostic and treatment algorithms and approaches for contact investigation, screening, and diagnosis TB infection and TB disease in all populations, including those most vulnerable.

o Develop innovative linkages between public and private health facilities to co-manage TB disease and TPT.

o Implement and evaluate new and novel community-based case finding approaches using rapid diagnostic technologies.

o Establish communities of practice for field-based TB outreach programs.

CURE – Optimize TPT, drug-sensitive TB treatment, drug-resistant TB treatment, and TB/HIV treatment or simultaneous treatment of TB with other co-morbid conditions (e.g., diabetes, alcohol use disorders, substance use disorders, non-tuberculous mycobacteria). Activities may include (but are not limited to):

o Evaluate and optimize new treatment regimens for all forms of TB (including TB infection).

o Evaluate and optimize the cascade of care for all forms of TB in varying settings of health care delivery (public, private, patient-centric models, clinic-centric models).

o Explore and evaluate new and innovative modalities to improve access to treatment for all forms of TB (including TB infection).

o Explore and evaluate new and innovative modalities to improve adherence support for all forms of TB (including TB infection) in varying settings of health care delivery (public, private, patient-centric models, clinic-centric models).

o Establish communities of practice for TB treatment and care in both public and private settings.

SUSTAIN – Improve the use of routinely collected data to monitor and evaluate TB program performance, and promote operations research (i.e., local solutions for local problems) for broader application, adoption and integration into routine TB care and treatment practice. Activities may include (but are not limited to):

o Strengthen surveillance and data translation capacity of national TB programs.

o Develop novel approaches for measuring progress against new WHO TB indicators.

o Use local data to identify local challenges, solve local problems, and develop local solutions.

o Establish communities of practice for data use, monitoring and evaluation, epidemiology, and operations research.

The expected short-term outcomes for each focus area are:

PREVENT

o Increased use of best practices for improved contact tracing o Increased access to preventive care, including in Differentiated Service Delivery settings among PLHIV based on best practices o Improved prioritization of patients for TPT based on best combination of evidence-based risk factors o Increased use of best practices to prevent TB transmission to TB patients and health care workers in health care facilities

FIND

o Increased diagnosis for all forms of TB based on best modalities o Improved linkages between private and public sector for the management of TB disease and TPT o Increased best combination of novel diagnostics and approaches

CURE

o Improved linkage and access to TB services based on best practices o Improved initiation of treatment regimens for all forms of TB based on best practices o Improved adherence to TB treatment based on best modalities

SUSTAIN

o Increased use of evidence-based strategies for prevention, contact tracing, and case finding o Improved approaches validated to measure progress against program indicators o Increased use of best practices for TB prevention, diagnosis and treatment

The expected intermediate outcomes for each focus area are:

PREVENT

o Reduced TB infection o Reduced incidence of TB disease o Communities of practice for TB prevention, care, and treatment established to translate innovative strategies into practice

FIND

o Improved case detection for all forms of TB o Increased case finding in public sector from private sector linkages o Communities of practice for field-based TB outreach programs established to translate novel and innovative approaches into practice

CURE

o Decreased gap between diagnosis and treatment for all forms of TB o Decreased time between diagnosis and treatment for all forms of TB o Increased completion of TB treatment o Communities of practice for TB treatment and care in both public and private settings established to translate new treatment regimens and new and innovative modalities into practice

SUSTAIN

o Increased case detection of all forms of TB o Increased translation of evidence into action, policy, guidelines, and practices o Increased use of validated approaches to measure progress against novel indicators o Communities of practice for data use, monitoring and evaluation, epidemiology, and operations research established to translate novel approaches and solutions into practice

The expected long-term outcomes for each focus area are:

PREVENT

o Reduced TB morbidity and mortality in high-burden settings and populations

FIND

o Reduced TB morbidity and mortality in high-burden settings and populations

CURE

o Improved treatment success rates for all forms of TB o Reduced incidence of drug-resistant TB cases o Reduced TB morbidity and mortality in high-burden settings and populations

SUSTAIN

o Improved use of data to inform and drive program improvement o Increased reliability in the measurement of progress using indicators towards attaining set targets o Reduced TB morbidity and mortality in high-burden settings and populations

Applicants may propose other objectives, type of research activities, or outcomes from those listed above. However, for each proposed objectives, type of research activities, or outcomes, the focus should be on one or more of the Prevent, Find, Cure, and/or Sustain focus areas.

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.

Target Population The CDC Division of Global HIV and Tuberculosis (DGHT), Global Tuberculosis Branch (GTB) has developed a strategic plan to prioritize and focus on specific countries where GTB can apply core strengths to maximize impact. For the purposes of this NOFO, applicants with experience, working relationships, and collaborative partners in one or more of the following countries (*bold signifies a GTB priority country) are strongly encouraged:

Angola, Burundi, *Botswana, Cambodia, Cameroon, countries of the Caribbean Region (Antigua and Barbuda, Bahamas, Barbados, Dominica, Grenada, Guyana, Jamaica, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Suriname, Trinidad and Tobago), countries of the Central American Region (Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, Panama) and Central Asian Region (Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan), *China, Cote d’Ivoire, Democratic Republic of Congo, *Dominican Republic, *Ethiopia, *eSwatini, Ghana, *Haiti, *India, Indonesia, *Kenya, Laos, *Lesotho, *Malawi, *Mozambique, Myanmar, *Namibia, *Nigeria, Papua New Guinea, *Rwanda, *South Africa, South Sudan, *Tanzania, Thailand, *Uganda, Ukraine, *Vietnam, *Zambia, and *Zimbabwe CDC will only consider proposals including work in the countries listed above; if proposals include work in countries not listed above, they will not be considered for funding. Proposals including work in countries signified as a GTB priority above (bolded with asterisk) will be preferred.

CDC encourages research proposals that are inclusive of all populations affected by TB without regard to race, ethnicity, gender identity, sexual orientation, and socioeconomic status.

However, given that TB disproportionally affects some vulnerable populations, proposals that include (but are not limited to) the following vulnerable populations will be prioritized: persons exposed to active TB disease (household contacts and social contacts), children, racial and ethnic minorities, health care workers, elderly, PLHIV, migrants or mobile populations, and those with co-morbid health conditions that exacerbate TB treatment and care (e.g., diabetes mellitus, malnutrition, alcohol use disorders, substance use disorders, other respiratory diseases). Vulnerable populations may also include persons living in rural areas or slums, who often encounter barriers to accessing health care services. TB also intersects with a variety of social factors: including unstable housing, food security, poverty, incarceration, and inadequate education; proposals that account for these factors will also be prioritized.

Collaboration/Partnerships The specific activities listed in this NOFO should take place in high-burden TB settings. The recipient(s) will be expected to collaborate not only with CDC but also with other partners, including (but not limited) to local ministries of health and WHO, to avoid duplication and promote synergies across proposed or planned activities. The recipient(s) will be expected to work closely with local and international agencies or organizations and other government entities responsible for engaging in the global strategies of malaria.

Applicants should clearly specify how local partners will lead or assist these projects, how research capacity will be strengthened at local institutions, and how research findings will be disseminated to have maximum impact on public health.

Evaluation/Performance Measurement The application should include measurable goals and aims based on a 5-year research project period. The recipient(s) will establish specific, measurable, achievable, realistic and time-phased (SMART) project objectives for each activity described in the application’s project plan, and describe the development and implementation of project performance measures based on specific programmatic objectives.

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 long-term successes and accomplishments of a program.

A plan for study activation visits (SAV) for each project to be conducted by the study team should be included with the application. The SAV is required to ensure that the proposed activities have met all regulatory requirements to begin the data collection phase of the research.

The overall objective of the SAV is to assess the readiness level of the staff and research sites from the perspective of protection of human subjects and adherence to the research protocol.

Recipient(s) should expect to be joined on the SAV by CDC staff.

A plan for ongoing monitoring of study activities should also be included in the application, including investigator monitoring of regulatory compliance, data quality, and laboratory quality, as applicable to the proposed research.

A timeline with measures of study progress should be described in the application. Progress towards those measures will be reported monthly, annually, and at project closeout (Section VI).

Data use and data sharing agreements shall be developed at the time of individual protocol development.

Translation Plan The application should include a timeline for completing the report of the main research findings and for developing and implementing a plan in collaboration with all relevant stakeholders to disseminate the results/findings. This plan should include a process for sharing data, adapting project instruments and training materials that are relevant for programmatic use, and for making these widely available to the ministry(s) of health and other local partners, and to the global public health community. The plan should be specific to the project’s objectives and be designed to ensure that the research findings can be utilized rapidly and broadly for maximum public health impact.

In addition, the recipient(s) will be expected to pursue dissemination avenues in public domains, such as workshops, regional meetings, and through informal channels (e.g., website, newsletters). Use of public health journals, as well as national and international conferences should be pursued to share with global TB partners to the greatest extent possible the best practices to prevent, find, and cure TB and sustain TB programs. Identified best practices could be used by other countries to improve their national TB programs for the total treatment cascade.

Section II. Award Information Funding Instrument Type: Cooperative Agreement

A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed:

New - An application that is submitted for funding for the first time. Includes multiple submission attempts within the same round.

Estimated Total Funding: $5,000,000 Estimated Total Annual Budget Period Funding for each award:

Year 1: $1,000,000 Year 2: $1,000,000 Year 3: $1,000,000 Year 4: $1,000,000 Year 5: $1,000,000 Estimated total funding available for first year (first 12 months), including direct and indirect costs for each award: $1,000,000 Estimated total funding available for entire project period, including direct and indirect costs: $5,000,000

Anticipated Number of Awards: 2 Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Throughout the project period, CDC's commitment to continuation of awards will be conditional on the availability of funds, 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.

Awards issued under this NOFO are contingent on the availability of funds and submission of a sufficient number of meritorious applications.

Award ceiling and floor are for the first 12-month budget period only.

Award Ceiling: $1,000,000 Per Budget Period Award Floor: $0 Per Budget Period Total Period of Performance Length: 5 year(s)

Throughout the Period of Performance, CDC's commitment to continuation of awards will depend on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and CDC’s determination that continued funding is in the best interest of the Federal government.

HHS/CDC grants policies as described in the HHS Grants Policy Statement (http://www.hhs.gov/ sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) will apply to the applications submitted and awards made in response to this NOFO.

Section III. Eligibility Information

1. Eligible Applicants Eligibility Category: County governments

City or township governments Special district governments Independent school districts Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits without 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

For profit organizations other than small businesses Small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification)

Additional Eligibility Category:

The following types of Higher Education Institutions are always encouraged to apply for CDC support as Public or Private Institutions of Higher Education:

Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions

Nonprofits (Other than Institutions of Higher Education):

Nonprofits (Other than Institutions of Higher Education)

Governments:

Eligible Agencies of the Federal Government U.S. Territory or Possession

Other:

Faith-based or Community-based Organizations Regional Organizations Foreign Organizations: a Foreign Organization is a public or private organization, whether non-profit or for-profit, located in a country other than the United States (U.S.) and its territories that is subject to the laws of the country in which it is located, irrespective of the citizenship of project staff or place of performance.

Bona Fide Agents: A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.

If applying as a bona fide agent of a state or local government, a legal, binding agreement from the state or local government as documentation of the status is required.

Attach with "Other Attachment Forms."

Federally Funded Research and Development Centers (FFRDCs): FFRDCs are operated, managed, and/or administered by a university or consortium of universities, other not-for-profit or nonprofit organization, or an industrial firm, as an autonomous organization or as an identifiable separate operating unit of a parent organization. A FFRDC meets some special long-term research or development need which cannot be met as effectively by an agency's existing in-house or contractor resources. FFRDC's enable agencies to use private sector resources to accomplish tasks that are integral to the mission and operation of the sponsoring agency. For more information on FFRDCs, go to https://gov.ecfr.io/cgi-bin/searchECFR

2. Foreign Organizations Foreign Organizations are eligible to apply.

Foreign (non-US) organizations must follow policies described in the HHS Grants Policy Statement (http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf), and procedures for foreign organizations described throughout the SF424 (R&R) Application Guide. International registrants can confirm DUNS by sending an e-mail to ccrhelp@dnb.com, including Company Name, D-U-N-S Number, and Physical Address, and Country. Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https://eportal.nspa.nato.int/AC135 Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf.

Foreign components of U.S. Organizations are eligible to apply.

For this announcement, applicants may include collaborators or consultants from foreign institutions. All applicable federal laws and policies apply.

3. Additional Information on Eligibility N/A https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true https://gov.ecfr.io/cgi-bin/searchECFR?ob=r&idno=&q1=FFRDC&r=&SID=1510a9feb7999d185d40b026ad998cc0&mc=true http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf mailto:ccrhelp@dnb.com https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf

4. Justification for Less than Maximum Competition N/A

5. Responsiveness Responsiveness :

Applications submitted without an LOI submission by due date of February 3, 2020, will be deemed non responsive.

If the application proposes funding in excess of $1,000,000 for the first year (12-month budget period) and each subsequent 12-month budget period (direct and indirect).

If the application is incomplete, meaning required components of the application package are missing. The applicant will be notified that the application did not meet submission requirements.

Late submissions will be considered non-responsive. See Section IV.9. Submission Dates and Time for more information on deadlines.

Total amount of appendices should not include more than 50 pages. For this purpose, all appendices must have page numbers and must be clearly identified in the Table of Contents.

6. Required Registrations Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

(Foreign entities only): Special Instructions for acquiring a Commercial and Governmental Entity (NCAGE) Code: https:// eportal.nspa.nato. int/ AC135Public/ Docs/ US%20Instructions%2 0for%20NSPA%20NCAGE.pdf

System for Award Management (SAM) – must maintain current registration in SAM (the replacement system for the Central Contractor Registration) to be renewed annually, https://www.sam.gov/portal/SAM/.

Grants.gov eRA Commons

All applicant organizations must register with Grants.gov. Please visit www.Grants.gov at least 30 days prior to submitting your application to familiarize yourself with the registration and submission processes. The “one-time” registration process will take three to five days to complete. However, it is best to start the registration process at least two weeks prior to application submission.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing Principle Investigator (PD/PI) eRA Commons account is affiliated with the eRA commons account of the applicant organization. All registrations must be successfully completed and active before the application https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://eportal.nspa.nato.int/AC135Public/Docs/US%20Instructions%20for%20NSPA%20NCAGE.pdf https://www.sam.gov/portal/SAM https://www.Grants.gov https://public.era.nih.gov/commons/public/login.do?TYPE=33554433&REALMOID=06-1edb031f-46c7-44b3-b803-60b537de74d2&GUID=&SMAUTHREASON=0&METHOD=GET&SMAGENTNAME=-SM-938PYmoLVb4VrDeXo04LZUDVDvc%2b3899ByInEAjuSUvWNIGfB2zRpWiCivYGCogG&TARGET=-SM-http%3a%2f%2fpublic%2eera%2enih%2egov%2fcommons https://www.grants.gov due date. Applicant organizations are strongly encouraged to start the eRA Commons registration process at least four (4) weeks prior to the application due date. ASSIST requires that applicant users have active eRA Commons account in order to prepare an application. It also requires that the applicant organization's Signing Official have an active eRA Commons Signing Official account in order to initiate the submission process. During the submission process, ASSIST will prompt the Signing Official to enter their Grants.gov Authorized Organizational Representative (AOR) credentials in order to complete the submission, therefore the applicant organization must ensure that their Grants.gov AOR credentials are active.

7. Universal Identifier Requirements and System for Award Management (SAM) All applicant organizations must obtain a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number is a nine-digit number assigned by Dun and Bradstreet Information Services. An AOR should be consulted to determine the appropriate number. If the organization does not have a DUNS number, an AOR should complete the US D&B D-U-N-S Number Request Web Form or contact Dun and Bradstreet by telephone directly at 1-866-705-5711 (toll-free) to obtain one. A DUNS number will be provided immediately by telephone at no charge. Note this is an organizational number. Individual Program Directors/Principal Investigators do not need to register for a DUNS number.

Additionally, all applicant organizations must register in the System for Award Management (SAM). Organizations must maintain the registration with current information at all times during which it has an application under consideration for funding by CDC and, if an award is made, until a final financial report is submitted or the final payment is received, whichever is later.

SAM is the primary registrant database for the Federal government and is the repository into which an entity must provide information required for the conduct of business as a recipient.

Additional information about registration procedures may be found at the SAM internet site at https://www.sam.gov/index.html.

If an award is granted, the recipient organization must notify potential sub-recipients that no organization may receive a subaward under the grant unless the organization has provided its DUNS number to the recipient organization.

8. Eligible Individuals (Project Director/Principal Investigator) in Organizations/Institutions Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for HHS/CDC support.

9. Cost Sharing This FOA does not require cost sharing as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf).

10. Number of Applications As defined in the HHS Grants Policy Statement, http://fedgov.dnb.com/webform http://fedgov.dnb.com/webform https://www.sam.gov/index.html http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf

(https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf), applications received in response to the same Notice of Funding Opportunity generally are scored individually and then ranked with other applications under peer review in their order of relative programmatic, technical, or scientific merit. HHS/CDC will not accept any application in response to this NOFO that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

Section IV. Application and Submission Information

1. Address to Request Application Package In order to use ASSIST, applicants must visit https://public.era.nih.gov/assist where you can login using your eRA Commons credentials, and enter the Notice of Funding Opportunity Number to initiate the application, and begin the application preparation process.

If you experience problems accessing or using ASSIST, you can refer to the ASSIST Online Help Site at: https://era.nih.gov/erahelp/assist. Additional support is available from the NIH eRA Service desk via:

· E-mail: http://grants.nih.gov/support/index.html

· Phone: 301-402-7469 or (toll-free) 1-866-504-9552. The NIH eRA Service desk is available Monday - Friday, 7 a.m. to 8 p.m. Eastern Time, excluding federal holidays.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the SF-424 (R&R) Application Guide…