Foa_Content_of_CDC-RFA-PS-25-0003-Modified 7.11.2024.pdf

Centers for Disease Control and Prevention

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD AND TB PREVENTION

Tuberculosis Elimination and Laboratory Cooperative Agreement

CDC-RFA-PS-25-0003

09/09/2024

7/10/2024 - Updated Average One Year Award Amount and Total Period of Performance Funding sections (see page 3).

7/11/2024 - Added clarifying language to Other Restrictions (see page 47) ; and F. Award Administration Section 3 Reporting, Bullet #5 (see page 62)

Table of Contents A. Funding Opportunity Description

B. Award Information

C. Eligibility Information

D. Application and Submission Information

E. Review and Selection Process

F. Award Administration Information

G. Agency Contacts

H. Other Information

I. Glossary

Part I. Overview Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Subscribe" button link to ensure they receive notifications of any changes to CDC-RFA-PS- 25-0003. 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:

Tuberculosis Elimination and Laboratory Cooperative Agreement

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 purposes of this NOFO, research is defined as set forth in 45 CFR 75.2 and, for further clarity, as set forth in 42 CFR 52.2 (see eCFR :: 45 CFR 75.2 -- Definitions and https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR- 2007-title42-vol1-sec52-2.pdf. In addition, for purposes of research involving human subjects and available exceptions for public health activities, please see 45 CFR 46.102(l) (https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section- 46.102#p-46.102(l)).

New-Type 1 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.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l) https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.102#p-46.102(l)

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-PS-25-0003

E. Assistance Listings Number:

93.116

F. Dates:

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

2. Due Date for Applications:

09/09/2024 11:59 p.m. U.S. Eastern Standard Time, at www.grants.gov.

3. Due Date for Informational Conference Call:

The TB Elimination and Laboratory informational call will be conducted on Friday, July 12, 2024, from 2:00 p.m. – 3:30 p.m. Eastern Standard Time. The webinar link is:

You are invited to a Zoom webinar.

When: July 12, 2024, 02:00 PM Eastern Time (US and Canada)

Topic: 2025 TUBERCULOSIS ELIMINATION AND LABORATORY INFORMATIONAL

CONFERENCE CALL

Register in advance for this webinar:

https://cdc.zoomgov.com/webinar/register/WN_1oAfD_UgQXaSMttTu9wXww

Or an H.323/SIP room system:

H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)

Meeting ID: 160 381 5459

Passcode: 58271256

SIP: 1603815459@sip.zoomgov.com

Passcode: 58271256

After registering, you will receive a confirmation e-mail containing information about joining the webinar.

Note: Participants must register in advance of the call date(s) to participate.

Frequently Asked Questions will be made available on the Division of Tuberculosis Elimination website: TB Elimination and Laboratory Cooperative Agreement Funding | Information for Tuberculosis Programs | CDC

G. Executive Summary:

1. Summary Paragraph https://www.grants.gov/ https://cdc.zoomgov.com/webinar/register/WN_1oAfD_UgQXaSMttTu9wXww mailto:1603815459@sip.zoomgov.com https://www.cdc.gov/tb-programs/php/funding/elimination-and-laboratory-cooperative-agreement.html https://www.cdc.gov/tb-programs/php/funding/elimination-and-laboratory-cooperative-agreement.html

CDC announces available Fiscal Year (FY) 2025 funds to complement tuberculosis (TB) prevention and control activities and laboratory services at state and local levels to reduce TB morbidity and mortality. The goal of this funding is to prevent transmission of M. tuberculosis (TB) and prevent progression from latent TB infection to active TB disease. Funding levels are determined by formulas reflecting TB disease incidence, case complexity, program performance, and laboratory workload data. Strategies and activities include diagnosis/treatment of persons with TB disease and persons with latent TB infection (LTBI); examination of immigrants and refugees who have an overseas B classification for TB; targeted testing for, and treatment of, LTBI; program planning, evaluation, and improvement; epidemiologic surveillance and response; human resource development and partnership activities; and public health laboratory strengthening. Expected outcomes include (but are not limited to) decreases in TB incidence;

increases in patients completing treatment within 12 months; increases in HIV and drug susceptibility testing in TB cases; increases in LTBI testing and treatment completion rates of those recommended for treatment; increases in accuracy and completeness of surveillance, genotyping, and whole-genome sequencing data; improvement in turnaround times for specimen receipt and laboratory testing and implementation of TB elimination plans.

a. Funding Instrument Type:

CA (Cooperative Agreement)

b. Approximate Number of Awards

c. Total Period of Performance Funding:

$374,456,055

d. Average One Year Award Amount:

$1,313,880 Of special note: The actual range of individual awards is $142, 891 to $8,717,737 and are based on a funding estimator. The funding for prevention and control is allocated using a formula approach to ensure equitable distribution of resources based on changing TB epidemiology and program performance. A fixed funding amount is allocated for Human Resource Development based on the TB incidence level in each project area. Laboratory funding is allocated using a workload-based formula approach to ensure equitable distribution of resources.

e. Total Period of Performance Length:

5 year(s)

f. Estimated Award Date:

December 01, 2024

g. Cost Sharing and / or Matching Requirements:

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

Part II. Full Text

A. Funding Opportunity Description

1. Background

a. Overview Tuberculosis (TB) disease is caused by Mycobacterium tuberculosis, an airborne pathogen that spreads from person to person. An estimated one fourth of the world’s population is infected with M. tuberculosis and 5-10% of those infected persons develop TB disease in their lifetime. In 2022, 10.6 million people around the world became sick with TB disease. Globally, TB is a leading cause of death: in 2022, there were 1.3 million TB-related deaths world-wide. TB is the leading killer of people living with human immunodeficiency virus (HIV). A total of 8,331 TB cases (a rate of 2.5 cases per 100,000 persons) were reported in the United States in 2022. After declining 20% in 2020, concurrent with the COVID-19 pandemic, TB incidence rates increased by 9.6% in 2021 and a further 5.5% in 2022. Current strategies alone will not achieve TB elimination in the United States in this century. Meeting the TB elimination goal will require a focus on testing and treating persons at higher risk of latent TB infection (LTBI) to prevent TB disease. Up to 13.0 million people in the United States have LTBI and over 80% of the TB cases result from LTBI that was not treated.

TB disproportionately affects certain populations, including persons who are non-U.S.-born, who have HIV infection or diabetes, who are experiencing homelessness, who are incarcerated, or who misuse substances such as alcohol or certain drugs. Non-U.S.-born persons had 73.8% of the cases in the United States in 2022: the incidence rate among non-U.S.-born persons in 2022 was 17.1 times greater compared to the rate among U.S.-born persons.

This NOFO supports finding and curing persons with TB disease and following up on exposures to TB. It includes targeted testing for preventing TB by finding and treating LTBI among groups such as the non-U.S.-born.

CDC is continuing its 40-year approach of funding priority activities in TB programs through cooperative agreements (CoAgs). Officials in health departments are responsible for TB control and prevention activities and laboratory services under the statutes and regulations of states, cities, or territories. This funding should complement those efforts. It is not intended to replace or reduce state and local investment in priority activities and responsibilities such as diagnosing and treating TB, providing inpatient care, tracing contacts, finding, and treating LTBI, and managing health department clinics.

b. Statutory Authorities This program is authorized under Section 317E(a) of the Public Health Service Act, 42 U.S.C.

Section 247b-6(a), as amended.

c. Healthy People 2030 This NOFO addresses the Healthy People 2030 Immunization and Infectious Diseases topic area.

For more information, visit Reduce tuberculosis cases — IID17 - Healthy People 2030 | health.gov

d. Other National Public Health Priorities and Strategies https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/reduce-tuberculosis-cases-iid-17 https://health.gov/healthypeople/objectives-and-data/browse-objectives/infectious-disease/reduce-tuberculosis-cases-iid-17

• National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) Strategic Plan –

NCHHSTP Strategic Priorities | CDC NCHHSTP

• Division of Tuberculosis Elimination Strategic Plan 2022-2026-DTBE

Tuberculosis Elimination Priorities | CDC NCHHSTP

• National Action Plan for Combating Multidrug-Resistant Tuberculosis –

National Action Plan for Combating Multidrug-Resistant Tuberculosis | Document | U.S.

Agency for International Development (usaid.gov)

• U.S. National Strategy for Combating Antibiotic-Resistant Bacteria –

U.S. Actions & Events to Combat Antimicrobial Resistance | Antimicrobial Resistance |

CDC

• National Stakeholder Strategy for Achieving Health Equity –

National Stakeholder Strategy for Achieving Health Equity

e. Relevant Work This NOFO builds on the accomplishments achieved through past CDC TB prevention and control (P&C) and laboratory strengthening Cooperative Agreements (CoAgs), which contributed to the reversal of TB resurgence in the U.S. during 1985–1992, 2021 and 2022. The earlier resurgence was driven in part by budget cuts, loss of program capacity, growing incidence of HIV infection, and transmission of multidrug-resistant TB (MDR TB) in hospitals and other settings, the latter resurgence by the COVID-19 pandemic. Current and previous CDC TB CoAgs have reinforced the downward U.S. TB incidence trends of the past 40 years.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

Strategies and

Activities Short-Term Outcomes Intermediate Outcomes Long-Term

Outcomes Diagnosis and treatment of persons with TB disease

• Advise providers on TB diagnosis and treatment

• Manage cases and ensure

• Increased use of Nucleic Acid Amplification Testing (NAAT)

• Decreased time between symptom onset and diagnosis

• Increased cases with HIV and

• Earlier patient diagnoses

• Increased patients completing treatment within 12 months

• Decreased acquired drug resistance

• Decreased TB incidence overall and among populations at higher risk https://www.cdc.gov/nchhstp/priorities/?CDC_AAref_Val=https://www.cdc.gov/nchhstp/strategicpriorities/default.htm#cdc_generic_section_6-strategies https://www.cdc.gov/nchhstp/priorities/tuberculosis-elimination.html https://www.usaid.gov/document/national-action-plan-combating-multidrug-resistant-tuberculosis https://www.usaid.gov/document/national-action-plan-combating-multidrug-resistant-tuberculosis https://www.cdc.gov/antimicrobial-resistance/programs/ar-actions-events.html https://www.cdc.gov/antimicrobial-resistance/programs/ar-actions-events.html https://www.phdmc.org/agency/programs-services/local-office-on-minority-health/64-achieving-health-equity/file treatment adherence

• Promote infection control drug susceptibility testing results

• Increased patients on and responding to appropriate treatment

• Increased use of appropriate drug regimens matched to DST results

• Decreased TB recurrence

• Decreased patient infectious period

• Decreased TB transmission

Conduct contact investigations for infectious TB cases

• Elicit, examine, test, and treat contacts with TB infection

• Increased contacts elicited

• Increased contacts examined

• Increased treatment initiation and completion among contacts with LTBI started on LTBI treatment

• Increased LTBI treatment completion among contacts

Test and treat populations at higher risk for TB and LTBI

• Select and conduct targeted testing among population(s) at higher risk for

TB/ LTBI

• Engage TB control program and local community organizations to reach populations at higher risk for TB/ LTBI and provide effective and culturally appropriate services

• Increased identification, testing, and treatment of persons at higher risk for developing TB

• Increased networks and coalitions with local community groups, clinics, and primary care providers to effectively diagnose and treat TB/LTBI, to advance equity and share information about TB/ LTBI

• Increased follow-up medical examinations and

• Increased treatment initiation and completion among persons in high-risk populations diagnosed with TB

/ LTBI

• Established and maintained networks and coalitions between partners and local communities that experience high TB incidence and LTBI prevalence

• Improved access to medical and social services through partnerships to

• Decreased TB mortality

• Decreased LTBI prevalence

• Elimination of TB disease in the United States

• Decreased contacts who progress from infection to disease

• Increased health equity related to TB/ LTBI testing and treatment strategies

• Increased ability to maintain program capacity toward TB elimination

• Increased availability of well-trained and informed public health practitioners, laboratorians, and health providers with knowledge and experience to accurately diagnose, treat, and prevent TB

• Examine immigrants and refugees with Class B notification treatment initiation for persons with LTBI and prior pulmonary TB who are recommended for treatment address TB/ LTBI disparities

Program planning, monitoring, evaluation, and improvement

• Conduct program evaluation and implement remediation activities to improve performance

• Implement TB elimination plans

• Establish contingency plans to manage drug shortages and distribution issues

• Increased implementation of TB elimination plans

• Increased identification and dissemination of best practices by state and local TB programs

• Increased development and implementation of contingency plans to manage drug shortage and distribution issues.

• Increased programs meeting national TB performance targets

• Increased use of findings to inform policy changes

• Increased ability to manage drug shortages and distribution issues

Surveillance

• Report TB cases in a timely, accurate, and complete manner

• Link genotype results to surveillance records in a timely and complete manner

• Routinely review TB genotype clusters and prioritize investigation and public health action

• Increased accuracy and completeness of surveillance data

• Increased verified TB cases reported to CDC ≤1 week

• Increased culture-confirmed cases with ≥1 isolate genotyped and linked to surveillance data

• Increased capacity for timely and thorough cluster and outbreak identification and investigation

• Increased use of epidemiologic analyses of surveillance data to inform TB elimination activities

• Reduced cluster-and outbreak-associated transmission

• Increased standardized (voluntary) case-level surveillance for LTBI

• Promote standardized collection and reporting of case-level LTBI surveillance data

• Report on contacts to cases and persons who were part of targeted testing among populations at higher risk

• Increased local programs collecting standardized case-level LTBI data

• Increased capacity and readiness to report core case-level LTBI surveillance data to

CDC

• Increased timely submission of annual contact investigation and targeted testing data through the Aggregate Reports for Tuberculosis Program Evaluation

Human resource development (HRD) and partnerships

• Develop and implement HRD plans

• Collaborate with organizations and providers serving high-risk populations

• Increased availability and accessibility of culturally sensitive and competency-based education and training

• Increased awareness and use of HRD resources

• Increased levels of TB awareness and knowledge among patients, providers, and communities

Laboratory strengthening

• Use laboratory data to address or evaluate methods, algorithms, and testing needs of

• Increased samples meeting recommended turnaround times for core TB laboratory services, either

• Increased capacity to diagnose and treat high-risk populations in culturally sensitive manner

• Increased adoption of new technologies for

TB/ LTBI

treatment

• Increased efficiency of laboratory operations, based on implementation of evidence-based policies and procedures and enriched collaborations

i. Purpose This NOFO will aid current state, local, and territorial TB program efforts to prevent, control, and eliminate TB in the United States by ensuring national geographic coverage and prioritizing jurisdictions with the highest TB disease burden. Funds will enhance state and local investments in TB prevention and control activities; the development of human resources through improved training, education, communications, and information dissemination; and strengthen laboratory capacity to ensure that timely, reliable TB laboratory services are available to health care providers and TB programs.

ii. Outcomes By the end of this 5-year period of performance, NOFO recipients must address all short-term, intermediate, and long-term outcomes in the logic model, and achieve all the outcomes highlighted in bold-type in the logic model.

Short Term Outcomes:

• Increased use of Nucleic Acid Amplification Testing (NAAT)

• Increased cases with HIV and drug susceptibility testing results

• Increased patients on and responding to appropriate treatment

• Increased use of appropriate drug regimens matched to DST results

• Increased contacts elicited

• Increased contacts examined

• Increased treatment initiation and completion among contacts with LTBI started on LTBI treatment

• Increased identification, testing, and treatment of persons at higher risk for developing

TB

• Increased follow-up medical examinations and treatment initiation for persons with LTBI and prior pulmonary TB who are recommended for treatment populations served

• Ensure availability of high-quality and timely core TB laboratory services

• Collaborate with partners to serve patient populations through in-house testing or referral

• Increased use of laboratory data to evaluate and inform testing practices

• Increased awareness of availability and accessibility for TB testing services

• Increased timely submission of annual contact investigation and targeted testing data through the Aggregate Reports for Tuberculosis Program Evaluation

• Increased samples meeting recommended turnaround times for core TB laboratory services, either through in-house testing or referral

Intermediate Outcomes:

• Increased patients completing treatment within 12 months

• Increased LTBI treatment completion among contacts

• Improved access to medical and social services through partnerships to address TB/ LTBI disparities

Long Term Outcome:

• Decreased TB incidence overall and among populations at higher risk

Recipients should achieve these outcomes in alignment with current National TB Program Objectives and Performance Targets found at http://www.cdc.gov/tb/programs/evaluation/indicators/default.htm and

National TB Laboratory Turnaround Time Performance Targets found at

Cooperative Agreement Toolkit (aphl.org)

iii. Strategies and Activities Strategy 1: Diagnosis and treatment of persons with TB disease

To accomplish the priority activity of identifying individuals with presumptive or confirmed TB disease and ensure standard and appropriate treatment regimens, the following should be conducted:

• Ensure case management and treatment of persons with active TB using adherence-promoting measures such as case review/cohort analysis, outreach staff who are culturally competent, extensive application of conventional and electronic directly observed therapy (DOT, and eDOT), incentives, and enablers. The recipient is responsible for case management and treatment for all persons with active TB currently residing in the recipient’s jurisdiction regardless of the person’s permanent legal residence.

• Provide drug shortage contingency plan— Drug shortages can occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. To develop a drug shortage contingency plan, programs will need to engage the highest levels of leadership at the department level, legal and procurement to obtain support for procurement contingencies including but not limited to contracting with alternate distributers, accessing anti-TB drugs from other programs within the state or a region, and arranging drop shipments directly from manufacturers, and notifying the Food and Drug Administration (FDA) and the National Tuberculosis Coalition of America (NTCA) http://www.cdc.gov/tb/programs/evaluation/indicators/default.htm https://www.aphl.org/programs/infectious_disease/tuberculosis/Pages/Cooperative-Agreement-Toolkit.aspx of drug shortages. The drug shortage contingency plan may not rely on obtaining drugs from the CDC stockpile.

• Assess adequacy and appropriateness of therapy for each patient by reviewing initial regimen, susceptibility results, adherence, and response to therapy. Therapy should be consistent with U.S. Centers for Disease Control and Prevention guidelines. Refer to the following web link for more information: Treatment for Latent TB Infection and TB Disease | TB | CDC

• Seek expert consultation for treatment of multidrug-resistant TB (MDR TB) and other complex cases from TB experts who are up-to-date on current evidence-based practices and guidelines, and who are readily available to provide timely documented advice and ongoing medical guidance. CDC’s TB Centers of Excellence (COE) for Training, Education, and Medical Consultation services should be readily used as needed, and relationships should be fostered between any local TB experts who provide the program with clinical guidance and the funded jurisdictions' regional COE. Healthcare providers of record for patients with TB disease should be expected to be familiar with laboratory and chest imaging results as well as current medications and comorbidities when seeking additional medical consultation services.

• For each patient for whom COE services are sought, TB programs will identify a licensed physician or other licensed health care provider with prescriptive authority who assumes responsibility for providing appropriate care for the patient as the healthcare provider of record within the recipient jurisdiction responsible for case management and treatment.

• Seek expert consultation regarding laboratory results for molecular detection of drug resistance or interpretation of other laboratory results when needed. Refer to the following web links for more information:

Tuberculosis Laboratories | Tuberculosis (TB) | CDC

Molecular Detection of Drug Resistance (MDDR) in Mycobacterium tuberculosis Complex by DNA Sequencing User Guide | Tuberculosis (TB) | CDC https:// www.cdc.gov/tb-programs/php/about/tb-coe.html https://www.aphl.org/programs/infectious_disease/tuberculosis/Pages/Training- Modules.aspx

• Collaborate with HIV and STD programs to ensure that all newly diagnosed TB cases are tested for HIV and referred for HIV services if infected with HIV.

• Collaborate with partners at correctional facilities, homeless shelters, and substance abuse settings to ensure that all newly diagnosed TB cases are treated to completion.

• Use, promote, and disseminate effective bi-national referral mechanisms for patients who may receive care along the U.S.-Mexico border or who may cross the border while taking treatment for TB. For more information, please see these links:

http://www.sdcounty.ca.gov/hhsa/programs/phs/cure_tb/ https://www.cdc.gov/tb/topic/treatment/default.htm https://www.cdc.gov/tb/topic/treatment/default.htm https://www.cdc.gov/tb/php/laboratory-information/?CDC_AAref_Val=https://www.cdc.gov/tb/topic/laboratory/default.htm https://www.cdc.gov/tb/php/laboratory-information/mddr-user-guide.html https://www.cdc.gov/tb/php/laboratory-information/mddr-user-guide.html https://www.cdc.gov/tb-programs/php/about/tb-coe.html https://www.aphl.org/programs/infectious_disease/tuberculosis/Pages/Training-Modules.aspx https://www.aphl.org/programs/infectious_disease/tuberculosis/Pages/Training-Modules.aspx http://www.sdcounty.ca.gov/hhsa/programs/phs/cure_tb/ http://www.migrantclinician.org/services/network/tbnet.html

• Partner with CDC Division of Global Migration Health (DGMH) to support international and bi-national TB quarantine efforts.

• Establish a process to review case management activities routinely to ensure optimal patient care.

• Develop a TB elimination plan for the new period of performance (2025-2029). A summary of the plan should be submitted with this application. If funded, a complete plan should be submitted by the end of year one. This plan should be developed and implemented with ongoing collaboration with a TB elimination advisory committee.

Strategy 2: Conduct contact investigation for infectious TB cases.

To implement this strategy, recipient will conduct the following activities:

• Interview persons with TB and utilize location-based methods to identify contacts and evaluate them and to make sure that infected contacts begin and complete LTBI treatment.

Treatment for Latent TB Infection and TB Disease | TB | CDC

• Assess reasons for cases with no contacts elicited, for delays in interviewing cases or examining contacts, and for lower rates of completion of LTBI treatment, and devise strategies for improvement. Combine epidemiologic data with TB genotyping results, where appropriate, to confirm or identify previously unidentified transmission links between TB cases and use genotyping results to evaluate the completeness of contact investigation activities.

• Submit data from contact investigations in the Aggregate Reports for Tuberculosis Program Evaluation (ARPE): Follow-up and Treatment of Contacts to Tuberculosis Cases. Additionally, programs that have a more robust database for contact investigation should continue to make improvements to the data collection instrument and ensure data are used to inform progress on TB control and prevention.

• It is highly encouraged that staff conducting contact investigations attend a TB COE contact investigation interviewing skills course.

Strategy 3: Test and treat populations at higher risk for TB and LTBI.

All programs must work on the following activities:

• Select and conduct targeted testing among population(s) at higher risk for TB/ LTBI.

Ensure that effective interventions are implemented to identify non-U.S.–born and http://www.migrantclinician.org/services/network/tbnet.html https://www.cdc.gov/tb/topic/treatment/default.htm https://www.cdc.gov/tb/programs/evaluation/ARPE.html#TTF https://www.cdc.gov/tb/programs/evaluation/ARPE.html#TTF locally-determined populations at greater risk for developing TB, and that they are evaluated and treated for TB and LTBI if recommended. Refer to the following web link for more information on treatment recommendations for LTBI: Treatment Regimens for Latent TB Infection | TB | CDC

• Establish a baseline for testing individuals identified at higher risk of having LTBI and/or progressing to TB disease and identify a goal and strategy for scaling-up targeted testing for LTBI.

• Establish a baseline for initiating and completing treatment for individuals diagnosed with LTBI who are recommended for treatment and identify a goal and strategy for increasing LTBI treatment initiation and completion rates.

• Engage TB control program and local community organizations to reach populations at higher risk for TB/ LTBI and provide effective and culturally appropriate services.

Populations at higher risk for LTBI and/or progression to TB disease should be locally defined. Definition should be based on epidemiological data, and may include but not be limited to persons who: have medical risks such as HIV; have end-stage renal disease; are non-U.S.-born and from countries with high rates of TB as defined by the World Health Organization, including persons reported by civil surgeons; have substance use disorders;

are health care workers; are homeless; or have been incarcerated. Collaborating with community partners is encouraged, such as working with homeless shelters to capture the TB screening and treatment outcomes.

• Establish partnerships with HIV, diabetes, and/or other non-communicable disease program staff (e.g., smoking, alcohol abuse) to promote testing for LTBI and referral for TB services among those with HIV, diabetes, or other behavioral risk factors which increase the risk of progressing from LTBI to TB disease.

For more information, please see these links:

TB and Diabetes | TB | CDC

TB Risk and People with HIV | Tuberculosis (TB) | CDC

National Library of Medicine http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945809/

• Partner with primary care providers serving under-resourced communities to expand LTBI testing and treatment.

https://www.cdc.gov/tb/topic/treatment/default.htm https://www.cdc.gov/tb/topic/treatment/default.htm https://www.cdc.gov/tb/risk-factors/diabetes.html#:~:text=People%20with%20diabetes%20are%20more,to%20prevent%20active%20TB%20disease.&text=In%20the%20United%20States%2C%201,TB%20disease%20also%20has%20diabetes.

https://www.cdc.gov/tb/risk-factors/hiv.html#:~:text=Worldwide%2C%20TB%20is%20one%20of,sick%20with%20active%20TB%20disease http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945809/

• Report targeted testing and treatment data using the Aggregate Reports for Tuberculosis Program Evaluation (ARPE) using the Targeted Testing and Treatment of Patients with Latent TB Infection form.

• Examination of immigrants and refugees with TB or LTBI. Ensure that immigrants and refugees classified as Class A or B are located promptly and examined and treated appropriately: http://www.cdc.gov/immigrantrefugeehealth/

• Report examination results of domestic TB follow-up activities including treatment outcomes for TB and LTBI to the Electronic Disease Notification (EDN) system:

https://www.cdc.gov/immigrant-refugee-health/php/case-reporting-edn/index.html

Strategy 4: Program planning, monitoring, evaluation, and improvement

Program evaluation helps demonstrate achievement of project outcomes, builds a stronger evidence base for specific interventions, and drives continuous program improvement through planning and implementation of remediation strategies. Recipients are expected to conduct program evaluation to improve performance and demonstrate progress toward achieving the short, intermediate, and long-term outcomes in the logic model.

Recipients must design and implement program evaluation activities that address TB indicators aligned with National TB Objectives where national performance targets are not met by the recipient. In all cases, CDC reserves the right to assign program evaluation topics that advance the goal of national TB elimination.

Each recipient is required to identify a program evaluation focal point. The designated program evaluation focal point will be responsible for the following:

• Serve as the point of contact for program evaluation activities in their jurisdiction.

• Provide leadership and serve as a resource for building program evaluation capacity within their jurisdiction.

• Share program evaluation experiences and lessons learned with partners and colleagues.

• Work closely with CDC TB program staff, including program evaluation consultants.

• Participate in TB Program Evaluation Network (PEN) activities including bimonthly conference calls. The focal point shall attend the TB ETN (Education and Training Network)/PEN biennial conference. TB CoAg funds can be used to support travel for the appointed TB program evaluation network focal point to attend the TB ETN/PEN conference.

For more information, please see this link:

https://www.cdc.gov/tb/programs/evaluation/indicators/default.htm

Strategy 5: Surveillance https://www.cdc.gov/tb/programs/evaluation/ARPE.html#TTF http://www.cdc.gov/immigrantrefugeehealth/ https://www.cdc.gov/immigrant-refugee-health/php/case-reporting-edn/index.html

This strategy requires timely assessment and reporting of all confirmed TB cases; prompt detection and investigation of and response to possible TB outbreaks; and identification of surveillance infrastructure gaps and system needs. Recipients are expected to:

• Enhance identification, reporting, and follow-up of persons with confirmed or presumptive TB by establishing collaborative relationships with appropriate reporting sources including:

o Hospitals and clinics (e.g., TB, HIV, and STD clinics) o Laboratories performing testing for mycobacteria o Healthcare providers (e.g., pulmonary and infectious disease sub-specialists) o Correctional facilities o Homeless shelters o Community and migrant health centers o Pharmacies o State and local Social Services agencies o Other public and private facilities providing care to populations at risk for TB

• Ensure complete, accurate, and timely reporting of persons with confirmed or presumptive TB by:

o Maintaining TB disease as a mandatory reportable condition as required by state and local laws.

o Increasing awareness among healthcare providers and laboratorians of the requirement to report TB cases.

o Maintaining a surveillance data collection system that includes all data elements contained in the current version of the Report of Verified Case of TB (RVCT).

o Conducting active surveillance for TB because of a known or suspected outbreak or when there is reason to believe that passive surveillance is insufficient to identify all cases of TB.

o Ensuring that testing and reporting of comorbid conditions associated with TB (e.g., HIV, diabetes, viral hepatitis) is provided for all persons with TB disease at time of diagnosis.

o Following CDC data security and confidentiality guidelines: Data Security & Confidentiality | Program Collaboration and Service Integration | CDC o Assuring surveillance data quality by:

▪ Creating, maintaining, and regularly updating a TB surveillance quality assurance protocol that is available to CDC upon request.

▪ Available resources include:

Quality Assurance for Tuberculosis Surveillance Data-A Guide and Toolkit for 2013:

ftp.cdc.gov - /pub/Software/TIMS/2009 RVCT Documentation/RVCT Training Materials/Quality Assurance Materials/ https://www.cdc.gov/program-collaboration-service-integration/php/data-security/?CDC_AAref_Val=https://www.cdc.gov/nchhstp/programintegration/data-security.htm https://www.cdc.gov/program-collaboration-service-integration/php/data-security/?CDC_AAref_Val=https://www.cdc.gov/nchhstp/programintegration/data-security.htm https://ftp.cdc.gov/pub/Software/TIMS/2009%20RVCT%20Documentation/RVCT%20Training%20Materials/Quality%20Assurance%20Materials/ https://ftp.cdc.gov/pub/Software/TIMS/2009%20RVCT%20Documentation/RVCT%20Training%20Materials/Quality%20Assurance%20Materials/ https://ftp.cdc.gov/pub/Software/TIMS/2009%20RVCT%20Documentation/RVCT%20Training%20Materials/Quality%20Assurance%20Materials/

2020 RVCT Reference Manual (cdc.gov)

• Participating in regular data quality review meetings.

• Routinely reviewing and addressing data quality issues identified through the National

Tuberculosis Surveillance System (NTSS) Reports and other systems.

• Conducting other activities as needed.

• Notifying CDC of TB cases in a complete, accurate, and timely manner by:

o Maintaining an electronic data system for verified TB cases that is compatible with the National Notifiable Disease Surveillance System (NNDSS) standards.

o Reporting complete and accurate data on all verified TB cases to CDC using the current RVCT.

o All TB case notification messages to CDC should be transmitted via NNDSS or another CDC-approved system.

o All verified TB cases should be reported to CDC regardless of whether the cases are considered “countable” in official case counts.

o All RVCT data elements should be filled out completely according to CDC instructions for the RVCT: Report of Verified Case of Tuberculosis Instruction Manual | Tuberculosis (TB) | CDC.

o Ensuring all TB case notification messages to CDC are transmitted within 1 week for newly verified cases and within 1 month for previously verified cases with updated information.

o Ensuring that all RVCT data for a TB case, including treatment completion and outcome information, are submitted to CDC within 2 years of the initial case report.

• Ensure genotype results are linked to surveillance records in a timely and complete manner by:

o Submitting one of the following within 8 weeks of culture confirmation:

▪ At least one isolate from persons with culture-positive TB to a CDC-designated laboratory for genotyping, or

▪ A sequence read set (i.e., the data from whole-genome sequencing of M.

tuberculosis isolates) to CDC that meets CDC quality specifications.

o Linking genotyping results to surveillance data as soon as possible and within 8 weeks of genotype results becoming available, either through the TB Genotyping Information Management System (TB GIMS) or by entering the genotyping laboratory accession number in the appropriate field on the RVCT.

o Regularly review TB genotype clusters and prioritize investigation and public health action:

o Ensure prompt identification and investigation of TB genotype clusters by:

▪ Reviewing genotype clusters within 1 week of receiving notification.

▪ Collaborating with CDC to investigate TB genotype cluster alerts generated by the TB Genotyping Information Management System (TB GIMS) to determine whether a TB outbreak is occurring.

https://www.cdc.gov/tb/programs/rvct/instructionmanual.pdf https://www.cdc.gov/tb/php/case-reporting/rvct-instruction-manual.html?CDC_AAref_Val=https://www.cdc.gov/tb/programs/rvct/default.htm https://www.cdc.gov/tb/php/case-reporting/rvct-instruction-manual.html?CDC_AAref_Val=https://www.cdc.gov/tb/programs/rvct/default.htm

▪ Ensure appropriate response to clusters determined to be outbreaks by:

▪ Conducting timely and appropriate epidemiologic investigation of, and response to, TB outbreaks.

▪ Providing reports at initial detection, and quarterly thereafter, of outbreak investigation and response activities, including epidemiologic data and ongoing or planned interventions to control transmission.

▪ For large outbreaks (≥10 cases diagnosed in a 3-year period that are related by recent transmission) identified by molecular surveillance or programmatic activities, these reports should include:

▪ A line list of state case numbers associated with the outbreak, selected based on molecular or epidemiologic data.

▪ Epidemiologic linkages identified among cases.

▪ Results of contact investigations, including TB and LTBI treatment outcomes.

▪ Confirmation of which cases are involved in large outbreaks, based on molecular or epidemiologic data.

▪ Descriptions of the outbreak settings (e.g., homeless overnight facilities).

▪ Barriers to outbreak investigation and control (e.g., patients not seeking care despite experiencing TB symptoms for long periods).

• Promote standardized collection and reporting of case-level LTBI surveillance data by:

o Evaluating what steps are needed to make LTBI a reportable condition in the recipient’s jurisdiction (for those jurisdictions where LTBI is not already reportable).

o Conducting a needs assessment and gap analysis to establish what actions need to be taken to implement case-level LTBI surveillance using the Tuberculosis Latent Infection Surveillance System (TBLISS).

o If feasible, submitting an LTBI surveillance plan to the CDC by the end of the performance period.

o If feasible, provide data on case-based surveillance for LTBI by:

▪ Collecting data on all contacts of infectious TB patients who are diagnosed with LTBI consistent with data elements contained in TBLISS.

▪ Collecting data on all persons diagnosed with LTBI in public health department clinics consistent with data elements contained in TBLISS and according to the CDC TBLISS Instruction Manual (available upon request).

▪ Transmitting LTBI case notification messages via NNDSS or other CDC-approved system for all verified LTBI cases to CDC in a timely manner.

Strategy 6: Human Resource Development (HRD) and Partnerships

The goal of TB Human Resource Development (HRD) is to strengthen the capacity of TB programs and other partners to prevent and control TB through improved training, education, communications, and information dissemination. As part of this strategy, recipients are expected to work on the following:

• Develop and implement HRD plans o Designate a focal point for training and education within the TB program. This person should be (or become) a member of the TB Education and Training Network (TB ETN). Areas of responsibility for TB education and training focal points will include the following:

o Serve as primary contact in their respective TB program for CDC and COE education and training activities, including needs assessments, capacity building, and resource development/sharing.

o Ensure development and implementation of annual training and HRD activities specific to their TB program.

o Provide an annual update of progress-to-date on HRD activities in the performance report.

o Attend the biennial focal point meeting and the biennial TB ETN conference.

o Identify training and HRD needs.

o Provide competency-based in-service TB training and human resource development.

o Establish evaluation strategies to improve existing training and to identify ongoing training and HRD needs.

Improve patient education and communications capacity within the program. Collaborate with organizations and providers serving high-risk populations, including:

• Coordinating training related to TB control with training for other disease control interventions, such as HIV, viral hepatitis, and STD.

• Targeting TB training to other health care providers or organizations serving high-risk populations.

Strategy 7: Laboratory Strengthening

This strategy ensures the availability of high quality and timely core laboratory services for TB, the ability to address or evaluate laboratory methods, algorithms, and testing needs for patient populations served, and to collaborate with partners. This is accomplished by public health laboratories through the following:

• Ensuring availability of reliable, timely laboratory services and use of growth-based and molecular methodologies for the detection of, isolation of, identification of, and susceptibility testing for M. tuberculosis complex (MTBC) appropriate to the individual laboratory’s workload and experience o Resources:

▪ Clinical and Laboratory Standards Institute (CLSI) Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes. 3rd

ed. CLSI standard M24.

▪ Clinical and Laboratory Standards Institute (CLSI) Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes. 2nd ed. CLSI standard M24S.

▪ Clinical and Laboratory Standards Institute (CLSI) Laboratory Detection and Identification of Mycobacteria. 2nd ed. CLSI guideline M48.

▪ Technical Report on Critical Concentrations for Drug Susceptibility Testing of Medicines Used in the Treatment of Drug-resistant Tuberculosis. Geneva: World Health Organization; 2018.

▪ Technical Report on Critical Concentrations for Drug Susceptibility Testing of Isoniazid and the Rifamycins (Rifampin, Rifabutin, and Rifapentine). Geneva: World Health Organization; 2021.

▪ Catalogue of Mutations in Mycobacterium tuberculosis Complex and Their Association with Drug Resistance. Second edition. Geneva; World Health Organization; 2023.

• Increasing the proportion of samples meeting recommended turnaround times (TAT) for core TB laboratory services, either through in-house testing or referral.

• Ensuring that testing methods and algorithms selected are the most effective for workload volume of specimens received and laboratory capacity.

• Processing fewer than 15 specimens per week (the recommended minimum level of activity to maintain proficiency) in a laboratory should prompt consideration of referral to another laboratory. Performing first-line drug susceptibility testing (DST) for <50 patient isolates per year should prompt consideration of referral of isolates to the National DST Reference Center or another laboratory Self-Assessment Tool (aphl.org).

• Ensuring access to nucleic acid amplification testing (NAAT) for rapid detection of MTBC directly from clinical specimens.

• Ensuring mutations detected by probe-based methods (i.e., rpoB mutations detected by Xpert® MTB/RIF) are confirmed by DNA sequencing.

• Ensuring laboratory algorithms for referral testing are developed, used, and include submission requirements for CDC’S Molecular Detection of Drug Resistance (MDDR) Service and reference center(s) used for DST and additional molecular testing (including genotyping).

• Ensuring that at least one isolate from all persons with culture-confirmed TB is genotyped (using whole genome sequencing either in-house or through referral) in a timely manner for national molecular surveillance efforts.

• Supporting, as applicable, the use of interferon gamma release assays (IGRA) to aid in diagnosing Mycobacterium tuberculosis infection.

• Using laboratory-specific data to guide decisions regarding testing algorithms, improving TAT, laboratory services, and business practices for gained efficiencies and rapid reporting of results.

• Implementing when practical, state-of-the-art technologies and approaches to improve service offerings and decrease TAT.

• Strengthening collaboration with partners, including TB Programs, clinicians, TB nurses, CDC Laboratory Consultants, and other laboratories, to ensure optimal use of laboratory services and timely flow of information.

https://www.aphl.org/programs/infectious_disease/tuberculosis/Pages/Self-Assessment-Tool.aspx

1. Collaborations

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

Collaborations should exist between recipients and the CDC-funded TB Centers of Excellence for Training, Education, and Medical Consultation (COEs) Tuberculosis Centers of Excellence for Training, Education, and Medical Consultation | Information for Tuberculosis Programs | CDC. The COEs provide training to TB program staff on topics including TB and LTBI clinical diagnosis and treatment, program management training, supervisor training, contact investigations, case management, TB laboratory information for non-laboratory personnel, and program evaluation.

Collaborations should also exist between TB and HIV-funded recipients at the state and local levels.

b. With organizations not funded by CDC:

Collaborating partners should include, but are not limited to the following organizations, agencies, and groups within the geographic catchment area:

• Private providers;

• Correctional facilities;

• Medical and nursing schools and related teaching hospitals, public health schools, and associations;

• Regional TB controller associations;

• TB advisory councils;

• U.S. panel physicians and civil surgeons (as guided by CDC);

• STD/HIV Prevention and Training Centers;

• Viral Hepatitis Education and Training Centers;

• Health Resources and Services Administration (HRSA) primary care centers;

• State and local social services agencies;

• AIDS Education and Training Centers;

• Substance Abuse and Mental Health Services Administration (SAMSHA);

• Addiction Technology Transfer Centers;

• Refugee resettlement assistance agencies and

• Indian Health Service and Tribal Organizations.

Applicants are required to partner with the following types of organizations external to health departments that have access to target populations:

• Each recipient will designate at least one liaison for locally determined high-risk populations.

o Liaisons will be responsible for ensuring a process is in place to foster collaborations between programs and agencies (e.g., correctional facilities, including federal bureau of prisons and immigrations and customs facilities, homeless shelters, etc.)

https://www.cdc.gov/tb-programs/php/about/tb-coe.html?CDC_AAref_Val=https://www.cdc.gov/tb/education/tb_coe/ https://www.cdc.gov/tb-programs/php/about/tb-coe.html?CDC_AAref_Val=https://www.cdc.gov/tb/education/tb_coe/ https://www.cdc.gov/tb-programs/php/about/tb-coe.html?CDC_AAref_Val=https://www.cdc.gov/tb/education/tb_coe/

• Each recipient will collaborate with HIV and STD programs, community planning groups, HIV care consortiums, and other local groups that influence funding and programmatic activities to ensure that all newly diagnosed TB cases are tested for HIV and referred to STD and hepatitis services if found to be HIV positive. Rapid HIV testing should be offered to patients in TB clinics.

• In addition, applicants are strongly recommended to collaborate with other external organizations.