Purpose
- CDC announced available funds for a cooperative agreement for state and local tuberculosis (TB) prevention and control activities and laboratory services.
- The goal is to prevent TB transmission and progression from latent TB infection to active TB disease.
Background
CDC is continuing its 40-year approach of funding priority activities in TB programs through cooperative agreements to complement TB prevention and control activities and laboratory services at state and local levels to reduce TB morbidity and mortality. The goal of this five-year cooperative agreement (CDC-RFS-PS 25-0003) is to prevent TB transmission and prevent progression from latent TB infection to active TB disease.
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 complements those efforts. It is not meant 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 latent TB infection, and managing health department clinics
Resource
Applicant informational webinar
CDC held an informational webinar for applicants of CDC-RFA-PS 25-0003 on July 12, 2024.
Frequently asked questions will be added to this webpage as available.
Key dates
July 12, 2024: TB Elimination and Laboratory informational webinar
September 9, 2024: Application due date
December 1, 2024: Awards announced via electronic copy of the Notice of Award from CDC Office of Grant Services
Funding by category
CDC TB Cooperative Agreement funding consists of three parts:
- Prevention and Control (P&C)
- Human Resource Development (HRD)
- Public Health Laboratory Strengthening
CDC distributes TB Cooperative Agreement funds according to a case-based formula for P&C and HRD, and a workload-based funding formula for the laboratory. This formula is based on years of experience and collaboration with public health partners.
Part 1 - Prevention and Control
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.
The purpose of this worksheet is to help applicants estimate the maximum funding amount for P&C that may be made available to them in the first year of the 2025-2029 Cooperative Agreement, FY 2025.
- This worksheet provides the dollars ($) per case for each of the variables in the funding formula using surveillance data from the frozen 2023 dataset.
- The $ per case are calculated based on the 3-year averages of U.S. total cases and reflect the application of 100% distribution using the 2024 cooperative agreement formula.
Needs Component
- Using the data from the Frozen 2023 Dataset, Funding Formula Variables Snapshot Report in the National Tuberculosis Indicators Project (NTIP), enter the 3-year averages reported for your program in the column for Awardee 3-year Average.
- Multiply $ per Case by the Awardee 3-year Average for each variable.
- Sum the subtotals of each variable under the Needs Component to obtain the amount for the Total Needs Component.
- Replace the amount for the Total Needs Component with $125,000 if this amount is less than $125,000.
| Needs Component | $ per Case | Awardee 3-year Average | Subtotal |
|---|---|---|---|
| Incident Cases | $3,371 | x | = |
| U.S.-Born Minorities and Non-U.S.–Born | $775 | x | = |
| Smear Positive Pulmonary | $2,537 | x | = |
| Multidrug-Resistant TB | $43,719 | x | = |
| Medical Risk Factors | $1,091 | x | = |
| Social Risk Factors | $2,460 | x | = |
| Class B Arrivals | $224 | x | = |
| Total Needs Component | $ |
Performance Component
Sum the subtotals for each variable under the Performance Component to obtain the amount for the Total Performance Component.
| Performance Component | $ per Case | Awardee 3-year Average | Subtotal |
|---|---|---|---|
| Completion of Treatment | $1,077 | x | = |
| Drug Susceptibility Testing | $558 | x | = |
| Contact Latent TB Infection Completion | $984 | x | = |
| Immigrants and Refugees Examined | $625 | x | = |
| Total Performance Component | $ |
Total Estimated Prevention and Control Funding
Add the Total amounts for the Needs and Performance Components to obtain the maximum estimated P&C funding that may be available to your program for FY 2025.
Part 2 - Human Resource Development
A fixed funding amount is allocated for Human Resource Development (HRD) based on the TB incidence level in each project area.
The table below provides the funding amount available to applicants by TB incidence level. Applicants should add the HRD funding amount available for their project area to the total estimated funding from the P&C section to obtain the grand total for their FY 2025 Funding.
| Incidence Levels | HRD Funding Amount |
|---|---|
| 0 - 49 Cases | $18,000 |
| 50 - 499 Cases | $24,629 |
| ≥ 500 Cases | $41,781 |
Part 3 – Public Health Laboratory Strengthening
Laboratory funding is allocated using a workload-based formula approach to ensure equitable distribution of resources. The funding formula is calculated using a 3-year average (currently, 2021 through 2023) of reported data for each of the below categories:
- Total number of clinical specimens processed for smear and culture
- Number of individual patients for whom a clinical specimen was processed for smear and culture
- Number of individual patients for whom a reference isolate was received to rule out or confirm the identification of Mycobacterium tuberculosis complex (MTBC)
- Number of individual patients for whom a nucleic acid amplification test (NAAT) result was positive for MTBC
- A base amount for this category is determined by the number of patients for whom a clinical specimen is received and processed
- A base amount for this category is determined by the number of patients for whom a clinical specimen is received and processed
- Number of individual patients for whom first-line MTBC drug susceptibility testing (DST) was performed and/or, if DST was not performed in-house, for whom an isolate was referred to another laboratory for DST.
- For enhancement of laboratory systems, an equal amount of funding is given to each laboratory to strengthen and enhance TB laboratory services through exploration and incorporation of new or best technologies and practices (e.g., MALDI-TOF, laboratory information management systems, etc.).
| Per patient basis | ||||||
|---|---|---|---|---|---|---|
| Total number of specimens | TB culture inoculated | TB culture inoculated | NAA testing of clinical specimen | DST for first-line drugs | Lab System-Equal Amounts | |
| FY2025 | 10%
Split across sites proportionately |
10%
Split across sites proportionately |
10%
Split across sites proportionately |
10%
Split across sites by base amounts and remaining proportionately |
25%
Split across sites proportionately |
10%
Split across sites evenly |
Funding estimation for laboratory systems
For funding estimation, applicants should use the formula variables described above at the following funding amounts to calculate an estimated maximum laboratory funding amount using 2023 workload volume data based on these indicators:
- $10 per total number of clinical specimens processed for smear and culture (Indicator 1)
- $20 per number of individual patients for whom a clinical specimen was processed for smear and culture (Indicator 2)
- $100 per number of individual patients for whom a reference isolate was received to rule out or confirm the identification of MTBC (Indicator 4)
- $700 per number of individual patients for whom a NAAT result was positive for MTBC (Indicator 3a)
- $340 per number of individual patients for whom first-line MTBC DST was performed and/or, if DST was not performed in-house, for whom an isolate was referred to another laboratory for DST (Indicator 5)
- $12,908 for laboratory systems
These amounts are then totaled to estimate the amount of laboratory funding to request for FY2025.
Example
Laboratory A estimates FY2025 laboratory funding using the calculations below:
| 1257 clinical specimens processed x $10 | = $12,570 |
| 281 patients with specimens processed for smear and culture x $20 | = $5,620 |
| 0 patients with reference isolate received x $100 | = $0 |
| 44 patients with NAAT positive results x $700 | = $30,800 |
| 47 patients with first-line DST performed x $340 | = $15,980 |
| Laboratory systems | = $12,908 |
| Total funding amount for laboratory budget | $77,878 |
Note: A revised budget may be requested once the final funding formula is applied.
Project priorities
Strategies and activities
- Diagnosis/treatment of persons with TB disease and persons with latent TB infection,
- Examination of immigrants and refugees who have an overseas B classification for TB;
- Targeted testing for, and treatment of latent TB infection
- Program planning, evaluation, and improvement;
- Epidemiologic surveillance and response;
- Human resource development and partnership activities; and
- Public health laboratory strengthening.
Expected outcomes
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 latent TB infection 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.
Example work plans
Example work plans are provided below. CDC-RFA-PS 25-0003 applicants may use this layout if desired. Applicants may choose to format their required work plan in a different manner, as long as it contains all of the required elements for each strategy.
Frequently asked questions
1. Are applicants required to list how they count and report TB cases to CDC?
Yes. On page 35 (Additional Information on Eligibility), the NOFO states that applicants should provide evidence that they have the necessary public health infrastructure and authority to conduct TB disease surveillance and report TB surveillance data to CDC.
2. Are applicants required to have or list cost sharing or matching funds?
No. On page 3, under Cost Sharing and/or Matching Requirements, the NOFO indicates: “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.”
3. Are applicants required to describe how they obtain anti-TB medications in addition to stating how they will obtain anti-TB medications during shortages?
No. On page 10, under Strategy 1, Diagnosis and treatment of persons with TB disease, the NOFO instructs applicants to provide a drug shortage contingency plan. It does not require applicants to describe how they obtain anti-TB medications in non-drug shortage scenarios.
4. Is this a competitive cooperative agreement?
Yes, this is a competitive NOFO. Eligibility information can be found in section C1-Eligibility Information under Eligible Applicants and Additional Information on Eligibility, starting on page 34.
5. Why up to 57 awards?
CDC-FDA-PS-25-0003 is competitive for eligible applicants. The number of proposed awards will ensure complete national geographic coverage and that jurisdictions with the highest number of TB disease cases are funded.
6. Are applicants required to describe how they provide outpatient clinical care?
No. On page 35, Under Additional Information on Eligibility, the NOFO states: “The applicant must provide evidence that they have the necessary public health infrastructure and authority to conduct TB disease surveillance; report TB surveillance data to CDC; respond to TB outbreaks; contain emerging TB disease threats; conduct TB disease investigation, intervention, and follow-up and perform TB laboratory testing for the eligible project area for which funding is sought.” This could include a description of how the applicant provides out-patient clinical care.
7. Are applicants required to describe their provisions for non-adherent infectious TB patients?
Yes – see below regarding page 10 and question and the answer to question 8.
On page 10, under Strategy 1: Diagnosis and treatment of persons with TB disease, applicants are instructed to “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 electronic DOT), incentives, and enablers.”
8. Are applicants required to describe their provisions for in-patient or hospitalized TB patients?
Yes. On page 29, under Organizational Capacity of Recipients to Implement the Approach, applicants are instructed to “confirm their ability to provide or refer TB patients for inpatient care and confinement if required.”
9. How should grantees plan for converting Financial Assistance (FA) to Direct Assistance (DA) in their budgets?
Please refer to the Budget, Grants, & Funding: Direct Assistance webpage for information on applying for direct assistance.
10. Are all recipients required to conduct targeted testing and submit ARPEs for targeted testing?
Yes, all programs are required to conduct targeted testing and submit targeted testing Aggregate Reports for Tuberculosis Program Evaluation (ARPE) information. See pages 12-14, Strategy 3, Test and treat populations at higher risk for TB and latent TB infection.
11. Are recipients required to submit and implement a new TB elimination plan?
Yes, see pages 10-12, Strategy 1, Diagnosis and treatment of persons with TB disease states: “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."
As noted on page 36, the applicant’s plan is required to be submitted as Attachment A.
12. Are all recipients required to collect standardized case level latent TB infection data and to report latent TB infection surveillance data to CDC?
No. On page 17 the NOFO indicates: “Promote standardized collection and reporting of case-level latent TB infection surveillance data...” and “If feasible, provide case-based surveillance for latent TB infection...”
13. Under the funding restrictions, it says funds cannot be used for clinical care. In the past we could use cooperative agreement funds for outpatient clinical care, but we could not use the funds for in-patient care. Has this changed?
No, this has not changed. On page 47, the additional instructions under Other restrictions states: “Recipients may not use funds for inpatient clinical care.”
14. Should states come in with a plan to fully fund TB Prevention and Control (P&C), Human Resources Development (HRD) and Laboratory for all cases in the state, including previously funded counties/big cities under prior cooperative agreements?
Yes. Any state that has a subdivision funded now are advised to come in with an application as if none of the currently funded cities and counties will be funded.
15. If I’m at the state level and a county/city in my state has previously received direct funding, should I include that jurisdiction in my application?
Yes.
16. Regarding required outcomes, when an increase is expected, what is the baseline to which outcomes would be compared?
Page 9 of the NOFO states: “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.” The baseline values for comparison with the 5-year period of performance should be based on an applicant’s 2022-2023 data.
17. Regarding Strategy 3 (bottom of page 12), what is meant by establishing a "baseline’" for targeted testing and initiating and completing treatment among individuals at higher risk?
Page 13 of the NOFO states: “Establish a baseline for testing individuals identified at higher risk of having latent TB infection and/or progressing to TB disease and identify a goal and strategy for scaling-up targeted testing for latent TB infection.” Recipients should analyze their own targeted testing data to determine their own baselines and develop own measures for achieving the NOFO outcomes. The baseline for targeted testing of individuals at higher risk would be number of people at higher risk reached by targeted testing in 2022-2023.
Information may be available through National Tuberculosis Indicators Project data (NTIP), program reports such as laboratory reports or annual reports, or routine data collection conducted by applicants.
18. Is CDC expecting grantees to provide quarterly reporting on contact investigation for all genotype clusters or just for large outbreaks? If so, what information will be necessary to report?
Yes, page 16 of the NOFO indicates that grantees are responsible for “Reviewing genotype clusters within 1 week of receiving notification” and “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.”
After review of genotyping clusters, grantees are responsible for “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.” Specific information to report if the outbreak meets criteria for a large outbreak (≥10 cases diagnosed in a 3-year period that are related by recent transmission) is listed on page 17.
19. How should the TB Elimination Plan, that is due at the end of year one, differ from what is written in the application?
The TB Elimination Plan that is due with the application should be a summary of the approach to prevention, control and elimination in the geographic area. The TB Elimination Plan that is due at the end of year one should be more extensive with details regarding prevention, control and laboratory activities in the geographic area. In addition, the plan should be developed and implemented with ongoing collaboration with a TB elimination advisory committee.
20. Regarding latent TB infection reporting (page 17), what is meant by conducting a gap analysis? Will CDC provide guidance or training on this topic?
Needs assessment and gap analysis are methods proposed to assess the status of latent TB infection reporting in the jurisdiction and what actions might be taken to promote latent TB infection reporting. CDC project and program evaluation consultants as well as the TB Program Evaluation Network can provide additional guidance to grantees if needed during the funded project period (see page 32 under CDC Program Support to Recipients).
21. Does the 20-page project narrative max include the laboratory strengthening portion?
Yes. See page 40 of the NOFO: "The Project Narrative must include all of the following headings (including subheadings): Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. It must address outcomes and activities to be conducted over the entire period of performance as identified in the CDC Project Description section.”
22. Is the data management plan (DMP) part of the 20-page max for the project narrative? Can it be uploaded as an attachment?
Yes, see the previous answer. The Data Management Plan should not be submitted as an attachment. As described on page 47, “applications involving data collection or generation must include a Data Management Plan (DMP) as part of their evaluation and performance measurement plan.”
23. Is there a max page limit for the abstract summary?
No, there is no max page limit for the abstract summary, however page 40 of the NOFO indicates that is should be “brief.”
24. Is the contact investigation report referenced on page 65 the ARPE?
Yes, this is referencing the Contact Investigation Report in ARPE.
25. Can you clarify the page limit discrepancy for the Annual Performance Report (APR) on page 57 (45 max) and page 58 (65 max)?
The 45 pages limit listed is template NOFO language that could not be removed from the document.
The 65 pages limit is allowable as stated on page 58, “Within the 65-page limit of the APR, recipients should use a maximum of:
- 40 pages for P&C,
- 10 pages for HRD, and
- 15 pages for Laboratory Strengthening
to cover performance reporting and the funding application. Applicants are allowed more than the 45 pages outlined in the instructions.”
APRs are due 120 days prior to the end of the first budget period for funded period.
26. If awarded these cooperative agreement funds, can they be used to buy medications?
No. Page 47 of the NOFO under Other restrictions states:“The use of Cooperative Agreement funds for hospitalization, construction, and the purchase of medications is prohibited.”
1. Can a jurisdiction apply for laboratory funding if specimens are referred for testing?
Yes, if specimens are referred to another laboratory through a contract, Memorandum of Agreement (MOA)/Memorandum of Understanding (MOU), etc., laboratory funding may be applied for.
2. If Xpert® is performed as molecular sequencing DST, should this data be reported for workload volume?
No, probe-based methods such as Xpert® MTF/RIF and line probe assays should not be included for molecular sequencing DST data. This information can be found on page 62 and 63 and within the Workload Volume (number 6) and Performance TAT PDF data (number 6) forms.
3. For Element 1 strategies, do I need to address all targets even if meeting the national TAT benchmarks?
Yes, if the laboratory is currently meeting the national target for an indicator, “maintaining the current TAT” or a new measurable goal should be listed (see page 28 of the NOFO).
4. When determining laboratory TAT percentages, should indicators be measured in a calendar or business days?
Yes, all indicators should be measured in calendar days, not working days, and should include weekends and holidays (e.g., a specimen that arrives at the laboratory on a Friday afternoon and is processed with the acid-fast bacilli (AFB) smear read and the result reported on the following Monday would have a TAT of three days). See page 62 of the NOFO.
5. Should full year 2023 data be used to calculate the estimated laboratory funding budget?
Yes, full year 2023 data should be used to calculate the estimated laboratory funding budget. See Funding by Category for more information.
6. The QR code was not working in the PowerPoint, could this webpage link be shared?
- APHL TB CoAg Toolkit
- The QR code has also been updated on the webinar presentation slides.
7. Are we required to submit laboratory workload and turnaround time (TAT) for CY21, CY22, and CY23 (the updated template) with the grant renewal submission this summer?
Yes, for the application due September 9, 2024, workload volume data is required for 2021, 2022, and 2023. TAT performance data is also required for the application, however, only 2023 data is required. See the workload volume and TAT performance PDF data forms.