Sol_QR_75F40125Q00337_Responses.pdf

Solicitation no. 75F40125Q00337 – TTIMS Questions and Responses

1. The TTIMS governance structure in the SOW indicates a Steering Committee and an Executive Committee. What are the differences between these two committees and who will participate in each? Should respondents propose structures for these committees beyond what is described in the SOW?

Response: The Steering/Monitoring Committee and the Executive Committee are used interchangeably. Please propose a structure for a single committee.

2. Is a BSL Level 3 facility a requirement of the prime contract?

Response: The Contractor shall provide facilities and equipment as needed to follow appropriate biohazard containment procedures, in order to accomplish the requirements as specified in task areas 3.1 through 3.4.

3. Please clarify if the qualifications for the Key Personnel are expected to be met by the prime contractor or by the consortium of respondents?

Response: The prime contractor is responsible for ensuring the qualifications of the subcontractors. The qualifications for the Key Personnel can include members of the consortium.

4. The current TTIMS program has separate DDCC and LRCC contracts. Will a Transition Out process be triggered for both existing contracts as detailed in the SOW for the current TTIMS program?

Response: The current TTIMS contracts require transition in and out. FDA agrees to be consulted on the process upon award of this new TTIMS contract.

5. Are letters of commitment from proposed subcontractors and key personnel required?

Response: An organizational commitment letter would be appropriate for subcontractors and individual letters of commitment from prime contractor key personnel.

6. Is cost documentation (supporting quotes, invoices, salary certifications, etc.) required to be included in the proposal?

Response: Supporting quotes, salary certifications, and an accurate and reliable cost proposal based on labor rates should be included in the proposal.

7. Will this program be subject to FDA’s upcoming single IRB mandate?

Response: Upon release of a final rule, the program would be subject to the rule should IRB approval be required for studies. Public health surveillance activities are not required to be approved by IRB.

8. The SOW states the following: Monitor and characterize relevant transfusion-transmissible infections (RTTIs) and potentially emerging TTIs identified at participating blood collection organizations and assess their prevalence and incidence rates among US blood donors, overall and by demographic and geographic subgroups. Could you clarify what is meant by ‘potentially emerging TTIs’ because there is a concern this is an open-ended commitment. Would new funds be made available to do this work if it became relevant?

Response: Should an emerging infectious disease be identified, and additional analyses be required, at the discretion of the Government. Alternatively, TTIMS activities may be reprioritized to address the government’s needs.

9. The SOW states that follow-up investigations should be performed by BCOs, triggered by significant changes in TTI incidence/prevalence rates. What would be the nature of these investigations, e.g., donor contact, data analysis, discussions with BCO and/or regions/affiliates, and the expected output, e.g., reporting, additional data elements, communication, publication, intervention?

Response: The nature of the follow-up investigations could include additional data analysis of risk factors known to the BCO, and/or discussions with the BCO and/or affiliates. The expected output would be reporting to the FDA. Additional output would be determined depending on circumstances.

10. The SOW states in Table 3 – Task 3.3 Deliverables that a “List of all HIV, HBV, HCV, Syphilis, and other marker positive donations” should be included in the Monthly status report. Would these results be aggregate counts for each agent per month, or line listing data with other variables included (e.g., demographics or testing), essentially raw data sent in every monthly report?

Response: These reports should include aggregated monthly data.

11. The SOW states the contractor should coordinate, identify, enroll, and characterize HIV, HBV, HCV, and syphilis positive blood donors by participating blood collection organization(s). Does this mean risk factor interviews or something else? If these are interviews, are only case interviews expected to be conducted in the renewed TTIMS program? Said another way, should respondents budget for completing only case interviews and not plan to complete any control (comparison group) interviews?

Response: TTI positive donors should be characterized by donor information available to BCOs, including any trends and/or associations with blood donor characteristics. Donor interviews are not included in this SOW.

12. We would like further clarification on this listed activity in the SOW: Report complete lookback data for HIV and HCV (number of recipients transfused with prior donations by HIV- or HCV- currently positive donors, status of recipients). Could you explain all the information that is desired? If such investigations are expected how should blood collection organizations budget for these activities as part of the TTIMS program? We have concerns about what is being asked here.

Response: Lookbacks are required as part of BCO operations. Blood centers should report the data that they have from lookbacks, to include:

a. How many recipients received components from prior donations from donors who tested positive for HIV and HCV?

b. If available, how many recipients were found to have tested positive for HIV and HCV in lookback investigations?

13. The existing data and specimens are stored as part of the overall program and are under the management of the existing DDCC and LRCC components of the program. If the TTIMS program should stop or end for any reason, what are expectations for the disposition of the existing data and specimens that have been collected?

Response: The contractor would be directed as to the expectations for disposition of data and specimens at that time.

14. The SOW makes several references to “reporting period”, which can be variable in the case of some deliverables. In Table 3 – Task 3.3 Deliverables, the due dates for some of these deliverables could use clarification given the cadence of data delivery, QC, processing, and release as production datasets. For example, a January BCO file may not get extracted or arrive until mid-March, with QC, processing and placed into production by late-March/Early-April. The monthly report for February would not be able to contain any information about the January BCO data until at least the monthly report that would be due on March 10th. Additionally, within the same deliverables table, the Semiannual Technical Reports are due within 15 days before the end of a reporting period. What is meant by this due date relative to the reporting period? This needs clarification as it seems to be asking for reports before the end of the reporting period. Could these be considered “Progress Reports” and labeled as such, reporting on the completed activities rather than expectations for full reports with complete data or instead should these focus on only reporting complete data in which there will be a lag time of several months?

Response: Monthly “Progress Reports” are acceptable. Annual and Semi-annual reports should include the results from the periods from the start of the contract. Semi-annual reports would include results from October 1 - March 31 and April 1 – September 30;

Annual reports, from October 1 – September 30. Appropriate dates of delivery can be proposed.