Solicitation_FDA-13-223-1115874_Q As_Amend_1_10Jul13.pdf

Solicitation FDA-13-223-1115874: Questions and Answers (10 Jul 13) Amendment 1

1. Can animals be group housed? Yes

2. Are Indian origin rhesus a requirement? Sourcing is problematic. Does the FDA have the resources to supply Indian origin rhesus if needed? Indian origin Rhesus are a requirement for the study

3. Can Chinese origin rhesus be substituted for Indian origin rhesus? NO

4. What are the disposition requirements for:

‐animals not selected for the PK phases of the study? At the discretion of the test facility and in accordance with the test facility's IACUC

‐animals that do not get pregnant after the Experiment 1 PK phases of the study? At the discretion of the test facility and in accordance with the test facility's IACUC

‐fetuses born after the experimental phases of the study? At the discretion of the test facility and in accordance with the test facility's IACUC

5. How should the lab proceed if there is a mis‐dose in any of the PK phases? Consult with the project officer to determine if the test subject should (1) be removed from the study or (2) if a wash‐out and re‐dosing would be permitted

6. How should the lab proceed if there is a miscarriage after confirmation of pregnancy or after any of the PK doses? The test subject should be removed from the study after consultation with the project officer

7. Will the study have a non‐GLP regulatory requirement? The study is non‐GLP

8. Will the test article need to be prepared (formulated) fresh on each dose day? Dose stability data will be forwarded to the test facility. As long as the date of dosing for a specific preparation is within the stability parameters, the dosing solution does not need to be prepared fresh for each dose day

9. Will the test article need to be shipped back immediately after each preparation? The test facility must be located in the continental US such that the dose solution samples can be shipped overnight to NCTR by courier within 72 hours of preparation at the test facility. The dose solution samples will be shipped only after arrangements have been made with the NCTR staff

10. Would the FDA consider offering an extension on the submission deadline, to Friday, July 19th? Yes. In the interest of receiving the most responsive proposals possible, the due date for proposal submission is hereby extended to 7/19/13, 4:00PM (Central)

11. Will the pregnancy portion of the study be timed to coincide with rhesus monkey breeding season (fall and winter)? This is the preferred time frame

12. There will be differences between conception dates of some animals based on breeding success. Will the study allow for dosing different animals based on their time of conception? Yes

13. What is the course if 8 animals of the 16 do not become pregnant? There is an expectation of a 50 ‐ 75% pregnancy rate at the test facility. If this is not achieved, the test facility must consult with the project officer to determine the course of action

14. What will be the disposition of infants born to the study animals? At the discretion of the test facility and in accordance with the test facility's IACUC

15. Will a catheter lock solution be allowed for indwelling intravenous catheters. If so, can alteplase be used as a lock solution in between studies? Altepase may be used as a lock solution;

however, there is a concern over the increased infection risk with the use of indwelling IV catheters

16. Will it be allowed for animals to be anesthetized in between studies to allow for TB testing and other evaluations? Yes, but only for very short duration procedures and with a minimum of one week between anesthesia and study participation

17. Is there flexibility in the time for payment for the animals? Specifically, an we receive payment for the animals as soon as they are allocated to the study, prior to any work being done? Yes, the payment schedule is negotiable after award to the successful offeror

18. What is the required time line for starting the study after the contract is awarded? By this I refer to the time to animal allocation and start of menses assessment, vaccination, etc. The Government expects the successful offeror to commence work in a logical manner immediately following award. For example, the successful offeror should first focus on submitting IACUC approval from their institution, etc. Following that, ideally, we would like have the animal allocation and start of menses assessment by 9/30/13

19. Do we complete Reps and Certs application now, as part of the proposal submission? Or, is this done after the contract award? Please complete the Reps and Certs as part of the proposal submission