2020 NOFO Laboratory Informational Call / Mailbox Questions

 

1. Can you explain how CDC can answer questions that may not be applicable to the NOFO application process?
   Once a new CDC Notice of Funding Opportunity is announced, questions asked during the informational call are for the purpose of applying for the announcement.  These questions cannot be answered individually but rather answered to all eligible applicants to assist applicants in submitting the NOFO application. Other questions outside of the scope of the informational call, yet in regards to the NOFO, can be answered at a later date once the application process is complete.

 

2. How can the laboratory work plan Excel file be accessed?
   The laboratory work plan can be accessed by visiting the CDC TB NOFO Resource page at https://www.cdc.gov/tb/education/funding-opportunity-notice.htm. Questions from the informational call and chat box as well as the NOFO2020 mailbox will be available on the TB NOFO Resource webpage.

 

3. Are laboratories able to create their own work plan documents rather than use the work plan Excel file available on the NOFO Resource webpage?
   Yes, laboratories are able to create their own work plan document rather than using the available laboratory work plan on the TB NOFO Resource webpage.  However, laboratories must provide all information as requested on the laboratory work plan Excel file.

 

4. If a laboratory would like to implement a new test such as pyrosequencing, can the laboratory budget submitted with the NOFO application include equipment, supplies, etc. needed to implement the test?
   Yes, the laboratory budget narrative for the new NOFO application can include equipment or supplies, with associated justification, needed to implement a new test.

 

5. Will the laboratory NOFO informational call presentation be made available? Where can the laboratory work plan Excel file be found?
   Yes, the laboratory NOFO presentation and recording is in the process of being uploaded to the TB NOFO Resource Page at https://www.cdc.gov/tb/education/funding-opportunity-notice.htm.  The laboratory work plan can be found on the NOFO Resource webpage in the box at the bottom of the page listed as Work Plans.  On that page, there is a tab next to the program work plan for the laboratory work plan.

 

6. If laboratory workload volume and turnaround time data cannot be submitted by August 2, 2019, what should occur?
   CDC TB Laboratory Consultants sent emails to their site point of contacts with new workload volume and turnaround time data collection forms on Thursday, July 18^th. If a site is not able to meet the August 2, 2019 deadline, the site point of contact should email the CDC TB Laboratory Consultant to discuss a deadline extension.

 

7. Why is a five year work plan required for the NOFO laboratory application?
   The anticipated performance period for the new NOFO is five years. Therefore, the application must include a high-level five-year laboratory work plan as part of the request for funding during that performance period. This five-year work plan is an opportunity for laboratories to think about the future of tuberculosis testing in their laboratory. Goals and measures of success should be included for each year of the new five year cooperative agreement with a detailed description of the first year of the award.

 

8. The new NOFO application has a short turnaround time and now includes five year goals. Will adjustments be allowed throughout the cooperative agreement if five year goals change?
   Yes, adjustments can be made to the work plan during each year of the cooperative agreement in annual performance reports. Goals can be modified, further described, and can build from year to year. Per the NOFO guidance, recipients must update the work plan each budget period to reflect any change in period of performance outcomes, activities, timeline, etc.

 

9. Does the twenty page limit for the NOFO application include the laboratory portion?
   Yes, the twenty page limit for the Project Narrative portion of the NOFO application does include the laboratory portion as discussed on page 33 of the NOFO project narrative guidance. Attachments such as organizational chart and visual testing algorithm can be included separately in PDF format as appendices.

 

10. When will the laboratory FAQ’s be available on the NOFO Resource webpage?
    Laboratory FAQ’s will be available soon on the TB NOFO Resource webpage at https://www.cdc.gov/tb/education/funding-opportunity-notice.htm.

 

11. Please show the report due dates slide again.

 

12. Should a Tier 2 laboratory list two measurable objectives with outcomes per year or two measurable objectives with outcomes for the entire five years for Element 2 and 3?
    Tier 2 laboratories should list two measurable objectives with outcomes for Elements 2 and 3 on the application laboratory work plan. Once objectives are achieved, either the next phase of the objective or a new objective must be described in annual performance reports for years two through five.

 

13. Will floor level funding be available for this NOFO application?
    The amount established for floor funding, currently $35,000, will be the same as in the past. No laboratory will receive less than this amount.

 

14. Will the laboratory budget for this NOFO application be a part of the larger program budget narrative?
    Yes, the laboratory budget will be a part of the larger program budget for this NOFO application. The laboratory budget should be clearly indicated on the larger program budget.

 

15. For the laboratory organizational chart with personnel listed, do you need name and title for the testing personnel? Should we also include supervisor, manager, laboratory assistant director and director?  Please advise.
    Yes, the laboratory organizational chart should include the name and title for all TB testing personnel as well as TB supervisor/manager, laboratory assistant director, and director.

 

16. The goals and objectives for Elements 1&2 seem duplicative.  Do you mean to have work plans in Element 2 address deficiencies in Element 1 or should they be completely different?Element One goals, objectives, and activities should reflect how the laboratory proposes to improve national benchmark turnaround time recommendations for specimen receipt, acid-fast bacilli (AFB) smear, identification (ID) of MTBC, drug susceptibility testing (DST), and nucleic acid amplification testing (NAAT).Element two goals, objectives, and activities should reflect how the laboratory will improve laboratory efficiency and quality assurance through the monitoring of their laboratory-specific data. This element may involve collaboration among the TB laboratory and safety/quality assurance manager to determine how the laboratory can improve the quality of testing based on data the laboratory produces. For example, some laboratories will use the APHL Self-Assessment Tool to review their laboratory’s workflow and testing algorithm and best practices. Laboratories may also monitor their workload and results at scheduled dates to determine if there are areas within the laboratory that can be improved including contamination rates, false-positive results, efficiency of test result reporting, etc.The laboratory component of the NOFO application should include a laboratory point of contact (with title, telephone number, and email address), a laboratory organizational chart, an overview of testing algorithms and methods, and the laboratory work plan.  A narrative should be submitted for the overview of testing algorithms (a visual testing algorithm may be submitted) and the testing methods performed.

 

17. Can you please clarify: does the laboratory component need to include a narrative, or is submitting just a work plan acceptable?
    The laboratory component of the NOFO application should include a laboratory point of contact (with title, telephone number, and email address), a laboratory organizational chart, an overview of testing algorithms and methods, and the laboratory work plan.  A narrative should be submitted for the overview of testing algorithms (a visual testing algorithm may be submitted) and the testing methods performed.

 

18. Many of the Performance Progress results refer to “molecular DST.” If NAAT (GeneXpert) is performed, rpoB is technically assessed via a molecular method. Does this “count” as molecular DST?
    Yes, the GeneXpert MTB/RIF is considered molecular DST.

 

19. Should the 2020 laboratory narrative include summation successes/unmet goals set in the 201L8 Co-Ag narrative for Elements 1,2, and 3? Or will the information be asked for in the March wrap up report?
    The 2020 NOFO laboratory application should not include Element 1, 2, or 3 successes/unmet goals set in the 2018 CoAg annual performance report. These will be reported in the 2015-2019 CoAg Closeout Report due March 31, 2020.

 

20. If I submit a visual testing algorithm, is it in place of or in addition to the narrative describing an overview of testing algorithms and methods? And does a visual algorithm count toward the page limit or can it be submitted as a separate attachment?
    The laboratory visual testing algorithm can be used to describe a laboratory’s testing algorithm; however, laboratory testing methods should be described in detail in the project narrative. The visual testing algorithm can be submitted in PDF format as an appendix.

 

21. Should we keep the laboratory work plan separate from the program work plan? Are they reviewed separately by CDC staff?
    If an applicant chooses to use the example Excel work plans, those files can be uploaded as two separate attachments to the application in PDF format and named “TB Program Work Plan” and “Laboratory Work Plan”. Each of the work plans will be reviewed by subject matter experts in their field of expertise.

 

22. Can applicants submit a laboratory budget that is greater than the suggested 20% + FY19 amount to better reflect laboratory needs since a true needs budget is no longer requested?
    Applicants should use their 2019 laboratory funding levels plus a 20% increase to determine their budget.

 

23. Should work plans be completed for the first year only, or for the entire five year period of performance (2020-2024)?
    The laboratory work plan should include strategies and activities for laboratory elements 1, 2, and 3 for all five years (2020-2024).

 

24. Should work plans include objectives and measures for the five year period with activities listed for the first year only or should activities be planned and listed for the entire five year period?
    The work plan should include objectives, measures, and strategies/activities for the five year period not just the first year.

 

25. What should applicants include in the application with respect to “workload volume and performance measure turnaround time (TAT) data?”
    Laboratory workload volume and performance measure TAT data should not be included in the application.  For currently funded awardees, data from CY2018 and the first half of CY2019 should have been submitted to CDC Laboratory Consultants on August 2, 2019.

 

26. Should my work plan, under Laboratory Element 1, include at least one objective for each national benchmark turnaround time goal? 
    Yes.

 

27. Can I include a five-year chart in the measure section of the work plan listing the percentage of samples that will meet the turnaround time (TAT) goal? 
    Either bulleted text or a chart may be included in the work plan to detail laboratory measures of success.

 

28. Does the laboratory section of the application need an evaluation plan?
    No, there is not a requirement for a separate laboratory evaluation plan. Applicants/recipients will compare their actual progress against their laboratory work plan for evaluation purposes.

 

29. Must I include details about my five-year laboratory work plan in the narrative section of the application?
    No, the laboratory narrative section should only include details about the testing algorithm (unless you choose to submit a visual testing algorithm as a PDF attachment) and testing methods performed.

 

30. The NOFO specifies: “12-point font, 1-inch margins, number all pages. This includes the work plan”. However, if applicants use the example Excel work plan, it is not possible to include all columns on a single page and adhere to these requirements. Is there an exception to these instructions when using the example Excel work plan? 
    Applicants may choose to use the example Excel work plans provided by CDC. Since Excel formatting may pose a challenge in terms of meeting font and margin requirements for the narrative section of the application, applicants are permitted to upload Excel format work plans as attachments to their application. If choosing this option, applicants should save the Excel file as PDFs and upload as two separate attachments titled “TB Program Work Plan” and “Laboratory Work Plan”.

 

31. If I submit my work plan template as Word documents, do I need to use size 12-point font?
    If an applicant chooses not to use the example Excel work plans, then their work plans must be included within the project narrative section of the application (i.e., not separate uploaded attachments). In this case, applicants should follow the guidance for completing the project narrative (see page 33 of the NOFO), including the use of 12-point font.