Responses to TTIMS LRCC CONTRACTOR QUESTIONS.pdf

TTIMS CONTRACTOR QUESTIONS

1. What is the number of samples, retrospective or prospective, projected for analysis during the performance period?

Government Response: Each year the number of samples varies. During the period of 9/1/2015 to 9/24/2020, the TTIMS LRCC received approximately 10,000 samples.

2. Pg 2, section 1.2. There is mention of a Steering/Monitoring Committee. Has the government already identified the members of the Steering/Monitoring Committee that the awardee will need to engage with?

Government Response: The government and TTIMS DDCC and subcontractors have been identified for the Steering/Monitoring Committee. After award of this contract, the TTIMS LRCC Steering/Monitoring Committee members will be identified.

3. Pg 3, section 2.1 Task 1. Protocol Development. Have any draft protocols been developed or will all protocols used be developed from scratch?

Government Response: The protocol was created for the previous contract award; however, we will require that new protocols be created for this award. Please reference the previous protocol in the link provided: https://www.reginfo.gov/public/do/DownloadDocument?objectID=102829001 Use of an independent IRB is preferred in order to expedite projects of time critical regulatory nature.

4. Pg 3, Section 2.2 Task 2. The SOW mentions coordinating with the blood donation organizations. Has the FDA already established these relationships?

Government Response: Yes, these relationships have already been established.

5. Pg 4, Section 2.2 Task 2 sub section g. For the surveys, will they fall under PRA and if so has OMB approval already been granted?

Government Response: The current survey for the Donor Risk Assessment Questionnaire for the FDA/National Heart, Lung, and Blood Institute - Sponsored Transfusion-Transmissible Infections Monitoring System - Risk Factor Elicitation expires August 31, 2023.

https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202007-0910-008 Use of an independent IRB is preferred in order to expedite projects of time critical regulatory nature.

6. Pp. 3-5. Task 2: which group, among the DDCC, LRCC and CDC, is expected to provide the expertise in biostatistics and epidemiology needed to perform the correlative analyses such as monitoring trends in incidence, risk factor associations?

Government Response: This is a collaborative effort between the DDCC, LRCC, and FDA.

7. Pg. 4. Task 2h, k, and l: Is the LRCC expected to conduct risk factor interviews by donor counselors?

Government Response: The LRCC will determine the appropriate staff and experience to conduct the interviews.

https://www.reginfo.gov/public/do/DownloadDocument?objectID=102829001 https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202007-0910-008

8. Pg. 5. Task 2n: is the analytical plan to be developed in coordination with just DDCC or will CDC be involved?

Government Response: The analytical plan will be developed in collaboration with the Steering/Monitoring Committee. CDC is not part of this process.

9. Pg. 6. Task 3c: What depth of coverage is needed for the sequencing?

Government Response: Task 3c should be omitted. The task to be omitted is:

Perform sequencing of HIV (prevalent and incident), HBV, and HCV viruses from donors with newly acquired infections to monitor evolving molecular epidemiology of viruses in the donor population, drug resistance profiles of HIV, and to help ensure that donor screening assays are optimized to detect circulating strains of infections

10. Pg 7. Section 2.4 Task 4. Given the requirement that we include dial in information, can we assume all committee meetings will be virtual?

Government Response: Per the SOW, “ The Committee shall meet no less than every month by teleconference and in person at least twice a year. Unforeseen circumstances may arise requiring additional communication, which would likely be by teleconference.“ You may assume that committee meetings will be virtual during the pandemic and the first year of the contract should not include travel costs for in person meetings.

11. Pg. 7. Task 3i and j. Which ARV metabolites are to be tested? Is a particular methodology and batch size specified, or can this be chosen by the LRCC?

Government Response: The awardee will work with the CDC and utilize the protocol that has been established for the prior award.

12. Pg. 10: 2.6.1: We believe that this processing falls under the BSL2 classification. Does the FDA have any requirements for this to be performed at the BSL3 level?

Government Response: We agree that the processing falls under a BSL2 facility classification with BSL3 practices.

13. The response is due on September 3 at 12:00 PM Eastern. We request an extension to this due date in order for us to prepare a thoughtful and thorough response.

Government Response: We agree to extend the response date to September 7, 2021, 2:00 PM ET.

14. Please confirm the submission deadline. The RFP states that the deadline is September 3, 2021, at 12:00pm EDT; however, an email notification from Angela Moy on August 23rd states that responses are due Friday, September 3rd by 2:00 AM EDT. Which is correct?

Government Response: We are extending the response date to September 7, 2021, 2:00 PM ET.

15. Page 8 of the solicitation refers to a pricing table provided in Section B. We could not locate Section B or the pricing table to include in the Business/Pricing proposal.

Government Response: See page 3 of 42 for pricing schedule

16. Please elaborate on the small business subcontracting plan requirements for subcontractors.

Are all subcontractors required to submit a SBSP if their total proposed budget for the Base.

year and all option years combined exceeds $700,000? Or is the $700,000 threshold an annual threshold?

Government Response: Combined

17. Regarding including a complete copy of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items, as specified in Article 10 of the solicitation, if we have no changes to our representations and certifications posted in SAM.gov, and the reps and certs are current, accurate, complete and applicable to this solicitation, are we required to include a copy of the electronically posted reps and certs in our Business/Pricing proposal?

Government Response: Yes

18. Are we required to complete and include Section 10.c., pages 14 – 26 of the solicitation in our Business/Pricing proposal?

Government Response: Yes

19. Are FAR 52-225-1 and 52.225-3 included in this solicitation?

Government Response: See FAR 52.212-5