TB Elimination and Laboratory Cooperative Agreement Frequently Asked Questions

Re-announcement

Why is CDC-RFA PS-25-0003 being re-announced?

The Tuberculosis Elimination and Laboratory Cooperative Agreement Notice of Funding Opportunity (NOFO) CDC-RFA-PS-25-0003 is being re-announced for a limited time. It has been brought to our attention that in some instances, attachments A and B did not successfully upload when applications were submitted.

If the attachments were not successfully submitted with your application, you have the opportunity to re-submit your application with the two attachments. Applicants that successfully included attachments A and B in their prior application are not required to re-submit.

Attachments A and B are described as follows. Refer to page 36 of the NOFO for a complete description:

Attachment A: TB Prevention, Control and Elimination Plan: A plan regarding the prevention, control, and elimination of tuberculosis in the geographic area with respect to which the grant is sought. Summary of a plan, including laboratory activities, must be included.

Attachment B: Evidence of Jurisdiction Infrastructure: Summary of jurisdiction's ability to conduct TB disease surveillance, report surveillance data to CDC, respond to outbreaks, contain emerging disease threats, conduct disease investigation, intervention, and follow-up as well as those performing laboratory testing.

Failure to upload the required documents will deem the application non-responsive.

This announcement is open September 27—October 4, 2024.

If there are any questions, please contact NOFO POC Martha Boisseau at mrb0@cdc.gov.

Notice of Funding Opportunity (NOFO) requirements

1. Are applicants required to apply for all 3 funding categories (P&C, HRD, and Laboratory)?

Yes, applicants are required to apply for all three funding categories.

2. Are applicants required to include work from all seven strategies?

Yes.

3. Is a state responsible for including [City X] objectives, strategies, etc. in our Project Narrative?

Yes, the state is responsible for including a local jurisdiction that may have previously been funded separately in their Project Narrative. The state should consider the local jurisdiction's objectives, strategies, etc. when developing the Budget Narrative. It is most imperative to include the datasets for the local jurisdiction in the Funding Estimator calculations. Collaboration is strongly encouraged. An overall plan and approach are acceptable.

4. The NOFO states by the end of year one, provide the following information to be used in the national TB workforce assessment: (1) A list of current positions with titles and percent full time equivalent (FTE), both filled and vacant and (2) A list of additional desired positions with titles and percent FTE believed necessary to fully execute the program’s elimination plan. Does this include every staff member across the applicant’s jurisdiction that performs TB activities or delivers TB services?

Yes.

5. The NOFO guidance indicates that information about FTE positions for the National TB Workforce Assessment is a part of the review and selection process, but the guidance also states that this information can be provided by the end of the year. Will applicants be rated lower if the positions are not included in the application?

No.

6. There are several NTIP indicators that are listed under “Strategy 5: Surveillance” in the logic model but are part of other sections in the “Strategies and Activities” narrative requirements. Do you have a preference where we address these items?

These items should be addressed in the Work Plan, and also summarized in the Applicant Evaluation and Performance Measurement Plan.

7. Is the Applicant Evaluation Performance Measurement Plan (EPMP) different from the Evaluation and Performance Measurement Plan – Programmatic Focus and the Evaluation and Performance Measurement Plan – Laboratory Focus?

There is one overall EPMP. The EPMP has two components - a programmatic focus and a laboratory focus. Both should be addressed.

8. 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.

9. 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.

10. Is the content in the TB Prevention, Control and Elimination plan evaluated in Scoring as 3 points or is the Scoring based on content from the Approach?

The content in the TB Prevention, Control, and Elimination plan (attachment) is worth three points.

11. How does the "Organizational Capacity of Applicants to Implement the Approach" differ from Attachment B - Evidence of Jurisdiction Infrastructure?

Many of the components are the same. Page 53 outlines the specifics for the Organizational Capacity section.

12. There are several NTIP indicators that are listed under "Strategy 5: Surveillance" in the logic model but are part of other sections in the "Strategies and Activities" narrative requirements. Do you have a preference where we address RVCT completeness, universal genotyping, ARPE-CI completeness, and EDN completeness

These items should be addressed in Strategy 5: Surveillance.

13. Which lobbying disclosure form should be used?

Use Standard Form - LLL (Rev. 7-97) DISCLOSURE OF LOBBYING ACTIVITIES. If no lobbying is being disclosed, the applicant may indicate "N/A" in sections 10a and 10b.

14. Can you please clarify “tiers” and the statement “Specify priority level to be used for period of performance and its alignment with the program strategies” (page 51)?

Tiers refers to the designation of a program as large or small based on the average number of TB cases reported over a 3-year period. A large tier program has an average above 150 cases; a small tier program has an average below 150 cases.

Priority levels for strategies are established by program personnel. Applicants should describe how they rate the importance of their own list of strategies for accomplishing their work plan.

15. Is a table format required for the Approach (Strategies, Activities, Outcomes)?

Applicants are not required to use a table format to describe how they will address the strategies, activities, and outcomes.

16. Are applicants required to submit resumes for key staff and risk questionnaires?

No. The Work Plans for Prevention and Control (page 51) outlines requirements for describing staff and administrative roles and functions to support the implementation of the NOFO.

Medical consultants

17. We are a low-incidence state, and we do not have local TB experts, nor do we have funding to support this. We rely on our Center of Excellence (COE) for medical consultations. Can we designate them as our medical consultant?

No, the COEs cannot be designated as an applicant jurisdiction’s medical consultant. Page 54 states, “Specify the name and responsibilities of the clinician serving as the state or local TB medical consultant for the jurisdiction. In circumstances where the number of cases of TB is very low and a state or local TB medical consultant is not available, describe how the program plans to liaison licensed outpatient clinicians caring for TB patients as the provider of record within the recipient jurisdiction responsible for case management and treatment, and contacts to their regional TB COE, and how program will support this partnership.” Page 11 states: “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.”

18. If we have regional TB clinicians for each of our regions, is that sufficient to meet the requirement of "Specify the name and responsibilities of the clinician serving as the state or local TB medical consultant for the jurisdiction?"

Yes, regional (i.e., local region within a given jurisdiction) TB clinicians can be named as local medical consultants for their jurisdictions. Please specify if there is a primary or lead consultant for the jurisdiction.

Page limits

1. The NOFO states the 20-page narrative includes the Background, Approach, Applicant Evaluation and Performance Measurement Plan, Organizational Capacity of Applicants to Implement the Approach, and Work Plan. Does it also include the Laboratory Strengthening, Data Management Plan, and Elimination Plan?

Yes, the 20-page limit includes Laboratory Strengthening and the Data Management Plan. The Elimination Plan must be a separate attachment.

2. Do the project narrative, multiple work plans, different evaluation plans, and the organizational chart all have to be within the 20-page project narrative limit?

Yes.

3. Is the laboratory narrative separate from the project narrative?

The laboratory narrative is to be included as part of the overall project narrative (within the 20-page limit). A specific laboratory section should be defined in the project narrative.

4. 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.”

5. Is the data management plan (DMP) part of the 20-page max for the project narrative? Can it be uploaded as an attachment?

The Data Management Plan is part of the project narrative and 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.”

6. The NOFO states the table of contents is not part of the 20-page project narrative limit and does not have a page limit, but the slide show states it does. Is the table of contents is included in the 20-page limit?

See page 40: “There is no page limit. The table of contents is not included in the project narrative page limit.): The applicant must provide, as a separate attachment, the 'Table of Contents‘ for the entire submission package.”

7. Is there a maximum page limit for the Project Abstract Summary?

No. However, page 40 of the NOFO indicates that is should be “brief.”

8. There is a 20-page limit, and we would plan to use that entire page limit for [State X] (Exclusive of City X) as we always have. Our programs are extremely different. City X is a local jurisdiction that provides actual patient care. They manage clinics, do directly observed therapy, conduct contact investigations, etc., we do not. We are a decentralized state, and our local health departments are responsible for providing that care, thus our objectives, strategies, logic model, etc., would be very different. Would we get an increased page limit to include information regarding both jurisdictions?

No increased page limit is allowable; therefore, be judicious in your summary. An overall plan and approach are acceptable.

9. 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

10. The laboratory workplan requires inclusion of an organizational chart. We have a state public health laboratory, and our big city also has a public health laboratory. Are we required to submit both organizational charts? This could greatly reduce the available space to address objectives, strategies, etc. with a 20-page limit.

Yes, the state would need to include both the state and city laboratory staff organizational charts. These can be included as attachments, which are not counted as part of the 20-page limit.

Attachments

1. Should applicants submit the Appendix A attachments (TB Prevention, Control and Elimination Plan and Evidence of Jurisdiction Infrastructure) as two separate attachments titled Attachment A and Attachment B or one attachment?

See page 36: These should be separate attachments, one titled Attachment A- “TB Prevention and Control Elimination Plan” and one titled Attachment B- “Evidence of Jurisdiction Infrastructure.” Required documents must be uploaded as Attachment A and Attachment B under Appendix A.

2. Are the two attachments part of the maximum 20 pages?

No.

3. Are the two attachments (A and B) separate from the project narrative? Under H. Information (page 69) the allowed documents are listed and do not include either Attachment A (TB Prevention and Control Elimination Plan) or Attachment B (Evidence of Jurisdiction Infrastructure).

Yes.

4. How do we include the work plan, Appendix A attachments, organizational charts, etc.? In section H, Other information, it states that only the project abstract, project narrative, budget narrative, reports on programmatic, budgetary and commitment overlap, and table of contents are the only attachments that will be reviewed?

All attachments will be reviewed.

5. Are there limitations to the number of attachments?

No.

6. Are PDF attachments part of the maximum 20 pages?

No.

7. Are letters of support collated into a PDF document allowed?

Yes.

8. Is the attachment B (Evidence of Jurisdiction Infrastructure) an organization chart of our TB program and associated laboratory organizational chart?

No. The organizational chart and laboratory organizational chart may be a part of the applicant’s response.

See page 36. Attachment B must include: Evidence of Jurisdiction Infrastructure: “Summary of jurisdiction’s ability to conduct TB disease surveillance, report surveillance data to CDC, respond to outbreaks, contain emerging disease threats, conduct disease investigation, intervention, and follow-up as well as those performing laboratory testing.”

9. Can you please clarify if the following can be included as attachments: TB Clinician List (page 51), Laboratory Organizational Chart (page 52), Description of Laboratory Testing Methods (page 61), Laboratory Testing Algorithm (page 61), Performance Progress and Monitoring Report – Workload Volume Data (page 61), and Performance Progress and Monitoring Report – Turnaround Time (TAT) Performance (page 61)?

Yes, they may be included as attachments.

Data and reporting requirements

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. 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.

3. The NOFO states programs should “Report on contacts to cases and persons who were part of targeted testing among populations at higher risk” (page 9). This used to be a requirement only for jurisdictions above a certain incidence level. Will this be required of all jurisdictions going forward?

Yes.

4. 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.

5. 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.

6. Are we supposed to collect those data for a year (2025) to develop a baseline or is there another method?

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 measures for achieving the NOFO outcomes. The baseline for targeted testing of individuals at higher risk would be the 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.

7. In the NOFO, the bolded logic model item in Strategy 3 describes: “Improved access to medical and social services through partnerships to address TB/ Latent TB infection disparities.” Does CDC have a national indicator for this? Additional guidance on creating a metric for this item would be helpful. We do not currently have data sources to measure this.

No, CDC does not have a national indicator for partnerships. Applicants could describe current access to medical and social services and current partnerships to address disparities as well as how access and partnerships to address disparities will be measured and improved over the project period.

8. In the NOFO describing the Increased use of Nucleic Acid Amplification Testing (NAAT) (page 5) can you explain more of what CDC is looking for? With new FDA rules on limiting LDT, laboratories may be hesitant to validate more PCR tests outside of the FDA approved uses for GeneXpert.

NAAT testing on at least one specimen is recommended by CDC- to diagnose pulmonary TB disease. Direct detection of MTBC by NAAT offers earlier and more precise diagnosis than growth-based methods. For these reasons, increased use of NAAT testing is encouraged. GeneXpert is an FDA-approved NAAT test.

9. Should applicants submit this NOFO application in grants.gov and the APR in GrantSolutions?

Yes. The APR will be due 120 days prior to the end of the budget year (Aug 31).

10. Please confirm which data reporting years will include hepatitis C as a medical risk factor that will count towards the funding formula (FF)? (We understand that Hep C is not currently displayed on the FF Snapshot in NTIP).  

Since 2020, all years have included viral hepatitis B or C in the count toward the funding formula as a risk factor. Viral hepatitis is a risk factor that can be included in the RVCT report for each and any patient with TB. Hepatitis will show as a medical risk factor in the funding formula report in NTIP starting in calendar year 2025.

11. Does CDC have a national indicator for the bolded logic model item in Strategy 3: “Improved access to medical and social services through partnerships to address TB/latent TB infection disparities?” Additional guidance on creating a metric for this item would be helpful. We do not currently have data sources to measure this.

CDC does not have a national indicator. Applicants will find information and data on health disparities in tuberculosis at Health Disparities in Tuberculosis | Tuberculosis (TB) | CDC.

12. Our local jurisdiction does not currently have an automated data system to track the different components required by the cooperative agreement for patients promptly. In order to calculate the needs and performance components for the funding formula, our team would have to manually go through each patient’s file individually over the last three years. The team expects this to take 4-6 weeks. To ensure our team has enough time to calculate the funding formula and complete the application can we calculate the needs and performance components using a sample of 5 patients’ information – either a random sample or purposive sample with the most severe cases to estimate the Awardee 3-year Average?

A sample or subset of the data cannot be used. To receive funding using the funding formula, the data needed to calculate the funding must be available. The data cannot be estimated. The funding is based on actual data only. Please communicate with your state programs as you complete your application.

13. For the targeted testing and treatment baseline, do we include or exclude contacts who are reported on the ARPE-CI, and Class immigrants and refugees who are reported in EDN?

Contacts reported in ARPE and in EDN should not be included in the targeted testing and treatment form. Targeted testing is based on a focused effort. The instructions on the targeted testing form note “Testing and follow-up of contacts, however, are not included in this report.” Active case-finding (i.e., primarily seeking TB disease) also should not be included in this report, unless the person is also being tested for latent TB infection.

14. Where can applicants find the "Frozen 2023 Dataset, Funding Formula Variables Snapshot Indicator Report” in the National TB Indicators Project (NTIP) database?

Follow the steps below:

1. Open the NTIP application tool.
2. Click on the word Reports which is found on the top right side of the screen.
3. Under the word Data Source, it will say Current Data (change). Click on the word change.
4. After clicking on the word change, it will show the available Frozen Dataset options.
5. Click on the option that you're interested in.
6. Type in your Program Area. Once you type in your program area the Funding Formula Variable Snapshot indicator should be enabled for you to select.

Latent TB infection

15. 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...”

16. Please address thoughts/ideas around reporting latent TB infection to CDC for jurisdictions where latent TB infection is not reportable.

On page 8 of the NOFO guidance, the Surveillance strategy indicates the applicant will “Promote standardized collection and reporting of case-level latent TB infection surveillance data,” with a short-term outcome being “Increased capacity and readiness to report core case-level latent TB infection surveillance data to CDC.”

17. How should applicants establish a baseline for latent TB infection if we currently don’t require reporting?

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.” Recipients should analyze their own targeted testing data to determine their own baselines and develop measures for achieving the NOFO outcomes. The baseline for targeted testing of individuals at higher risk would be the 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. Do we need to collect all latent TB infection screening results (both positive and negative) for a denominator or are we just looking at the number of positive latent TB infection screening results reported to the health department?

All latent TB infection screening results to use for the denominator should be collected.

19. Is the TB Latent Infection Surveillance System (TBLISS) the only option for reporting latent TB infection data to CDC?

Yes, the TBLISS is the only option for reporting newly diagnosed cases of latent TB infection to CDC. TBLISS is intended to capture data on latent TB infection epidemiology and allow monitoring of national latent TB infection prevalence trends. Currently, national-level latent TB infection case reporting is optional/voluntary for jurisdictions. Similar to the way TB disease case reports are electronically transmitted to the National TB Surveillance System (NTSS), latent TB infection case reports can also be transmitted electronically to TBLISS. For more information, please see the TBLISS Data Collection Form and the TB and Latent TB Infection Message Mapping Guide.

20. Is there more specific guidance on the requirement or format for the needs assessment and gap analysis related to surveillance for latent TB infection (3g)?

No. There are no specific requirements or format that must be included as part of the needs assessment and gap analysis, as each applicant’s situation will likely be different. Applicants could conduct a comprehensive review of necessary steps to implement reporting of case-level latent TB infection surveillance through the Tuberculosis Latent Infection Surveillance System (TBLISS). This may include examining available and needed resources (human and capital), policies around latent TB infection reporting, flow of information related to latent TB infection IT system capabilities and needs, message mapping guides, and data elements.

21. 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).

22. Is there more specific guidance on the requirement or format for the needs assessment and gap analysis in the latent TB infection surveillance section (3g)?

There are no specific format requirements for the needs assessment or gap analysis. A needs assessment is a process for determining the needs, sometimes known as "gaps," between current and desired outcomes. We suggest that applicants use NTIP to identify areas where program improvement is indicated, based on program performance in prior years and national performance targets.

Program evaluation

23. Does the contact investigation report referenced on page 65 refer to the Aggregate Reports for TB Program Evaluation (ARPE)?

Yes, this is referencing the Contact Investigation Report in ARPE.

24. Are all recipients required to conduct targeted testing and submit Aggregate Reports for TB Program Evaluation (ARPE) 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.

25. The Aggregate Reports for TB Program Evaluation (ARPE) report is due each year by March 31. The Final ARPE report is due for the current year minus two (for example, in 2025, the Final report is due for year 2023). The Preliminary ARPE report is due for the current year minus one (for example in 2025, the Preliminary report is due for year 2024). The due dates for the Targeted Testing report for all program areas follows the same scheduled as the Contact Investigation Report. Is the Contact Investigation Report the same thing as the ARPE? Is the Targeted Testing Report due on March 31 as well? Does it follow the same reporting guidelines as the ARPE (i.e., what year(s) should be included)?

There are two (ARPE) reports, Contact Investigation and Targeted Testing. They are both due March 31st.

26. The NOFO states (page 12—Strategy 3) “Test and treat populations at higher risk from TB and latent TB infection: Select and Conduct targeted testing among population(s) at high risk for TB/latent TB infection" How will we report our targeted testing numbers? Will this require a targeted testing Aggregate Reports for TB Program Evaluation (ARPE)?

Yes, targeted testing numbers are entered through the Targeted Testing report within ARPE.

27. What is considered “not meeting the national targets?”

National TB Performance targets are listed in National Tuberculosis Indicators Project (NTIP) for TB Indicators. The targets are aspirational, and recipients are not expected to achieve every target every year but should continually strive to reach the targets. Recipients should choose one focus area per year where they are not reaching a performance target for evaluation to determine why they are not meeting the target and then to develop a remediation plan to improve their performance in this area.

28. If a program is not meeting targets, does that mean a new Program Evaluation is required every budget period?

Yes. Recipients should choose one focus area per year where they are not reaching a performance target for evaluation to determine why they are not meeting the target and then to develop a remediation plan to improve their performance in this area.

29. If a program is close to or meeting the National Tuberculosis Indicators Project (NTIP) objectives, can the Program Evaluation focus on something other than an NTIP objective?

Yes. Recipients may identify areas outside of NTIP objectives for program evaluation. If an awarded recipient believes program evaluation and subsequent program improvement efforts are needed outside of the areas addressed by TB objectives and performance targets, the recipient should discuss the rationale for this effort with their DTBE program evaluation consultant and project officer.

30. What are the evaluation focus areas programs can choose from? Are they TB Incidence, Case Management and Treatment, Laboratory Reporting, Contact Investigations, Examination of Immigrants and Refugees, or something else?

The evaluation focus area can be any National Tuberculosis Indicators Project (NTIP) measure needing improvement or focus area outside of program objectives as justified by the program.

31. Is the Program Evaluation portion due within 6 months for all 5 years? Or just the first year (2025)?

The program evaluation plan is due with the application (see Strategy 4 on page 14). “An outline of an evaluation and performance measurement plan must be submitted with this application. Recipients will be required to submit a more detailed Evaluation and Performance Measurement plan, including a DMP, if applicable, within the first 6 months of award, as described in the Reporting Section of this NOFO" (see page 26).

32. On page 9 of the NOFO under ii. Outcomes it says, “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 of the outcomes highlighted in bold-type in the logic model.”

In the Outcomes section of our application, should we include this logic model as written in the NOFO and have that serve as the Outcome section?

Applicants should be using the logic model outcomes to describe how they plan to achieve outcomes listed in the logic model.

Budget and funding

1. 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.

2. 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.

3. For states that include subunit data from Big Cities, how should they account for Human Resource Development (HRD) and Laboratory portions in the funding estimate?

HRD amounts are determined by morbidity. Laboratory amounts are determined by workload.

4. As including City X in the budget is a new requirement, our application may require an additional level of review in our department and could greatly reduce the amount of time we have to develop these budgets. We would likely need at least a month to get through clearance and would need to give City X a very short date to provide their information to us. Is there any flexibility in the timeline due to this new requirement?

There is no flexibility at this time to extend the deadline for the application.

5. 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.

6. 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.”

7. Although a funding calculator has been provided, is it appropriate/recommended for applicants to prepare a “true needs” budget for submission, especially given the many and varied new requirements associated with this NOFO?

No, a true needs budget is not required. Page 36 indicates, “The applicant cannot request an award greater than the anticipated budget formula for the project area.”

8. Given flat funding, how does DTBE prioritize the numerous requirements outlined in the NOFO? What guidance can be given to applicants regarding the greatest emphasis on the stated requirements?

All seven strategies are priorities. Recipients should determine their priorities, given their available resources.

9. Will all Funding Formula discrepancies be resolved soon so that we have the appropriate data in the Frozen 2023 Dataset?

Yes. Applicants should contact DTBE Support (2025nofo@cdc.gov) if they need counts.

10. Based on our interpretation of the funding opportunity for the Cooperative Agreement, we believe it would be “supplemental” funding and separate from our current funding received by the state under this NOFO. We do not want to jeopardize or replace how we are funded from the state. Can you confirm whether we would be able to apply or not to the state for these “supplemental” funds.

These are not supplemental funds. Page 3 of NOFO describes how funding levels are determined by formulas reflecting TB disease incidence. Cases are not counted twice with the funding formulas so any case funded at a state level would not also be funded at a big city, county, or local level, and vice versa.

11. For states including subunit data from Big Cities, how do they account for HRD/Lab portion in the funding estimate?

For states including subunit data from big city programs, the state should incorporate the big city (P&C/HRD) data in their funding formula estimate for PS25-0003. The funding estimate calculator is on p. 44 of 77 in the NOFO .pdf instructions and online.

HRD funding is a calculation based on the number of cases. The request of HRD funds by a state should include all cases counted within the state including the number of cases counted by any big city programs.

Laboratory funding should be estimated using laboratory-specific criteria in the laboratory funding estimator also available on page 44 of the NOFO instructions or online. The laboratory component is a separately funded entity within the TB and Laboratory cooperative agreement.

12. Can applicants request more money than what is calculated using the budget formula?

Page 36 indicates, “The applicant cannot request an award greater than the anticipated budget formula for the project area.”

13. Will applicants be awarded more than what is requested in their budget?

No. Additionally, page 36 indicates, the applicant cannot request an award greater than the anticipated budget formula for the project area.

14. Should the Budget Narrative include the total 5-year budget or just Year 1?

The Budget Narrative should only reflect Year 1 (2025).

15. For "New or Revised Budget", under the "Federal" column should applicants request the full 5-year amount or just Year 1?

Applicants should request funding for only Year 1 (2025).

16. For "New or Revised Budget", under the "Non-Federal" column should applicants put the amount of state funding received for TB?

Yes. Include any additional non-federal resources in the "Non-Federal" column.

Budget forms

Standard Form 424A (Section C - Non-federal resources)

1. Under "(a) Grant Program" lines 8–11 do applicants list 8) Prevention and Control, 9) Human Resource Development, and 10) Laboratory?

Yes, all three should be listed.

Standard form 424A (Section E - Budget estimates of federal funds needed for balance of the project)

2. Under "(a) Grant Program" lines 16–19 do applicants list 16) Prevention and Control, 17) Human Resource Development, and 18) Laboratory?

Yes, all three should be listed.

Standard form 424 (Application for federal assistance)

3. Should applicants mark 'New' on the SF 424 since this is a new grant cycle?

Yes.

4. Where can I find "Applicant Identifier"? I don't see this anywhere in our previous grant documents.

"Applicant Identifier" is an optional field. CDC does not assign this identifier. A different federal agency may have assigned an identifier to your organization.

5. Where can I find "Federal Entity Identifier"? I don't see this anywhere in our previous grant documents.

"Federal Entity Identifier" is an optional field. CDC does not assign this identifier. A different federal agency may have assigned an identifier to your organization.

6. Is "Federal Award Identifier" the same as FAIN?

Yes, but the "Federal Award Identifier" field should remain blank because this is a new application. A Federal Award Identifier Number (FAIN) will be assigned to applicants awarded funds in response to this NOFO.

TB medications and drug contingencies

1. 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.”

2. Recipients may not use funds for clinical care except as allow by law. Does this mean funds may not be used to purchase medications?

Correct. See page 48: “The use of Cooperative Agreement funds for hospitalization, construction, and the purchase of medications is prohibited.”

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 there guidance on what to include in the drug contingency plan for decentralized programs that do not supply drugs?

No. The NOFO asks for a plan. The applicant must determine what their plan is for drug contingency and outline a plan for their jurisdiction. The guidance is limited to allow for maximum flexibility in the development of a plan that can be tailored.

5. Regarding developing a contingency plan for drug shortages - many of us have sole source contract with distributors and developing a contingency plan involves people at a higher executive level. Can we outline what we plan to do to explore options for a back-up?

Yes, an outline of a plan is acceptable. Page 19 indicates “To develop a drug shortage contingency plan, programs will need to engage the highest levels of leadership at the department level...”

Competition and eligibility

1. 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.

2. What is the rationale for changing the funding approach to being more competitive?

The change in funding approach is based on guidance from HHS.

3. Why up to 57 awards?

CDC-RFA-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.

4. If states include all subunit data (e.g., big cities), will that inflate their numbers?

No. All program subunits should be included in state applications. Once funding decisions are made, a revised budget may be requested.

5. City X has always been a separate jurisdiction. Does our state need to include City X? City X is not submitting their own application. Our state does not have access to their funding formula data.

Yes. States should include all programs within their subunits.

6. If a state does not include objectives, strategies, etc., from a local jurisdiction that may have previously been funded separately, will the application be considered non-responsive?

No, the application will not be considered non-responsive.

7. Our understanding is that City X will submit their own NOFO application, containing their objectives, strategies, etc. If I do not include those in our State’s NOFO application, will their application be considered non-responsive?

States should include all subunits in their applications. The application for City X is treated as separate and equal in this competitive review.

8. Though we will most certainly collaborate with City X, we can’t control what they submit in their application. Will there be any penalties to either jurisdiction if what we include in the budget doesn’t match what they include? In other words, if City X had to make last minute changes and forgot to tell us, or something like that.

No, each application is treated as separate and equal in this competitive review.

9. Can multiple neighboring jurisdictions which share many cases within one metro region collaborate to apply jointly?

No. As outlined in the Purpose section on page 5: “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.” Additionally, there is no mechanism to fund multiple jurisdictions with the same award. It is conceivable that one recipient could contract with its subunits.

10. Can two organizations submit a joint application with a primary and secondary applicant?

Joint applications are not permitted. Applicants may contract with the subordinate organization after the award has been made.

Patient care

1. 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. Funds may be used for outpatient clinical personnel, supplies, and services, as described on page 45. On page 47, Other restrictions state: “The use of Cooperative Agreement funds for hospitalization, construction, and the purchase of medications is prohibited.” and “Recipients may not use funds for inpatient clinical care.”

2. 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.”

3. 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 outpatient clinical care.

4. Are applicants required to describe their provisions for non-adherent infectious TB patients?

Yes. 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.”

5. Can CDC provide an example of increased adoption of new technologies for TB and latent TB infection treatment?

Yes, examples could include Interferon Gamma Release Assays, rapid molecular methodologies, and video directly observed therapy.

Training

1. Will there be enough spots for staff to attend the TB Centers of Excellence (COE) contact investigations and interviewing skills course?

The intent is to make as many positions available as possible for staff to attend the COE contact investigations and interviewing skills course, depending upon availability of funds.

2. Could you please elaborate on what "competency-based in-service TB training" entails/is defined?

Competency-based in-service TB training and education strengthens the capacity of TB programs and other partners to prevent and control TB. Essential Components of a Public Health Tuberculosis Prevention, Control, and Elimination Program: Recommendations of the Advisory Council for the Elimination of Tuberculosis and the National Tuberculosis Controllers Association outlines aspects that TB programs should include in TB education and training. Resources are available to assist TB programs with fulfilling training and education responsibilities. The resources below may also be helpful:

• The CDC-funded TB Centers of Excellence for Training, Education, and Medical Consultation (TB COEs) support domestic TB control and prevention efforts though communication, education, and training activities
• Information on competencies for public health professionals can be found in CDC’s Public Health Professionals Gateway.
• CDC’s Training Development website provides tools and resources to develop quality training for public health, including Quality Training Standards, which serve as quality benchmark for trainings developed or funded by CDC.

Laboratory

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.

8. Is the Laboratory narrative separate from the project narrative?

The laboratory narrative is to be included as part of the overall project narrative (within the 20-page limit). A specific laboratory section should be defined in the project narrative.

9. What does "X% split across sites proportionately" mean in calculating the estimated laboratory funding?

To determine laboratory funding, a laboratory funding formula is used. The formula uses an average of three years of laboratory data for specific workload volume laboratory indicators. The laboratory has a total amount of funding; a percentage of the total funding (as seen in the formula) is available for each indicator. This amount for each indicator is proportionately calculated for each laboratory awardee based on awardee’s averaged data for that indicator. Visit the DTBE NOFO Webpage for more information.

10. If IGRA testing is performed in another section of the laboratory (other than the TB Laboratory), should workload volume and TAT performance PDF data forms and laboratory work plan include TAT and mean/range data and activities, obstacles, and responsible person?

Yes. For example, if the Serology section performs IGRA testing, not the TB Laboratory, data forms and laboratory work plan should be completed in collaboration with the laboratory that performs IGRA testing.

11. With the new NOFO grant cycle 2025-2029, should the laboratory work plan include what the laboratory wants to accomplish the first year of the NOFO or the entire five years of the NOFO?

The laboratory workplan should include laboratory objectives and activities for the full five years of the new NOFO grant cycle (2025-2029).

12. Should applicants use a 3-year average of reported data or 2023 workload volume data to calculate our laboratory funding?

Use 2023 workload volume data to estimate the amount of TB laboratory funding to request for Year 1 (2025).

13. The previous turnaround time (TAT) indicator 3 was worded as "Report the percent of MTBC culture confirmed patients with a positive NAAT or other direct detection method that was reported within 48 hours of specimen receipt." and the 2024 NOFO has it worded as "Report percent of patients tested by NAAT that had a positive result reported within 48 hours of specimen receipt."

Should applicants submit data on the percentage of patients with NAAT positive result reported in 48 hours, regardless of the culture result?

Yes, for this new cooperative agreement, there is an update to the national TB laboratory turnaround time (TAT) recommendation language and calculation for nucleic acid amplification testing (NAAT). This was discussed during the Informational Call and is indicated by the blue star on page 50 of the NOFO PowerPoint PDF found on the TB Elimination and Laboratory Cooperative Agreement Funding webpage.

Laboratories will now calculate NAAT TAT by reporting the percent of patients tested by NAAT that had a positive result reported within 48 hours of specimen receipt. To calculate NAAT TAT, determine the number of patients with a positive NAAT result (denominator), and of those, the number that were reported within 48 hours of specimen receipt (numerator). The "How to Calculate Turnaround Times (TAT)" PDF found at Cooperative Agreement Toolkit (aphl.org) provides additional information on calculating all laboratory TAT indicators.

Resources