Solicitation_Questions_and_Answers.docx

Questions and Answers

W81XWH-19-R-0032

1. Will USAMMDA consider a deadline extension to July 21?

Answer: The proposal submission due date has been extended to July 1, 2019

2. To meet the solicitation requirements, does the prime offeror need to be a current manufacturer of ketamine?

Answer: Yes. The prime offeror needs to be the NDA / ANDA holder for a US FDA approved anesthetic ketamine product.

3. Is the preferred delivery format for Optional Task G (page 7 of the RFP) pre-filled syringe or autoinjector?

Answer: There is not a preferred format. Offerors should propose solution that they can provide that best meets the needs for a fielded single-dose delivery device as a best-value to the government in terms of cost, schedule, and performance. Consideration of regulatory requirements/constraints should also be part of the proposal for this optional task.

4. Must the performer and/or major subcontractors be based in the United States?

Answer: No. However, the performer must be a current manufacture of FDA approved injectable ketamine available in the United States.

5. Is there a maximum/ceiling budget for this contract?

Answer: Please propose a cost proposal in accordance with the work described in the Statement of Objectives.

6. Optional Task F (page 7 of RFP) specifies Emergency Use Authorization (EUA) for anesthetic ketamine. Should this be EUA for analgesic ketamine? Under what scenario will EUA be expected and the corresponding approval sought?

Answer: The EUA would be for analgesic ketamine. EUA would be for analgesic ketamine use needed during a military action prior to an analgesic indication being approved.

7. What is the anticipated Full Operational Capacity (FOC) quantity for vialed product?

Answer: Please note that the IOC provided is the upper limit of what would be elected in the option (high operational tempo vs. current conditions). As a controlled substance, ketamine would be procured on an as needed basis/schedule rather than guaranteed quantities. Annual purchases of vialed analgesic ketamine based on current use is likely closer to 2500 vials.

8. Can the government please provide an anticipated IOC and FOC for an injectable product (prefilled syringe, autoinjector, or equivalent)?

Answer: As above, it is difficult to predict purchases of controlled substances. An estimate of FOC would be 10,000 to 30,000 units per year.

9. The RFP (page 80) lists three specific key personnel. Are additional key personnel in beyond the roles listed acceptable?

Answer: Offerors may propose additional key personnel if deemed necessary in proposal submission.

10. To be responsive do we have to bid the optional tasks f, g, and h on page 7 of the RFP?

Answer: Please submit a proposal in accordance with the CLIN structure in section B of the solicitation (CLIN 0001-CLIN 0007).

11. Would USAMRAA consider initial sponsorship of the IND so that the PDUFA filing fee would be waived and then transferring the IND at an appropriate juncture to the contractor?

Answer: No

12. What is the planned start date pending award?

Answer: Anticipated award date is Aug 2019

13. Does the government anticipate an analgesia label claim supported by noninferiority to the standard of care, superiority to the standard of care or reduction of opioid use for pain management?

Answer: Offeror should propose regulatory approach that they believe is most appropriate. It is intended that analgesic ketamine will not have an indication that requires combination use with any other compound (opioid or otherwise).

14. What will be the anticipated DOD yearly requirement once the analgesia label is gained?

Answer: See answer to question 7.

15. Is ketamine diversion once fielded as an analgesic, a concern of DOD that the contractor should try to address?

Answer: Diversion is always a concern for controlled substances and should be addressed wherever possible.