Prototype wipe Questions_Answers 8-21-26.pdf

1. Phage handling. Will you provide the phage cocktail to the awardee for Iterations 2-3 and for prototype assembly, or is the awardee expected to develop formulations using a surrogate, with your team performing all titer work? If provided, at what volume, titer, and under what material-transfer terms?

Phage cocktail will be provided for formulation development and prototype assembly. The 3-phage cocktail, which specifically targets uropathogenic E. coli, will be supplied by an industrial partner and was used for SC formulation component screening.

2. Success threshold. What titer-loss limit defines a passing formulation over the 45°C / 4-week accelerated condition (e.g., ≤1 log10)? Is any real-time (non-accelerated) stability duration expected within the base year?

A passing formulation should maintain titer with ≤1 log10 loss of titer at 45°C for 4-weeks. Non-accelerated stability testing is not expected for the base year.

3. Wipes vs. spray. The notice specifies wipes, but Table 2 and portions of the text reference "sprays" and "cosmetic sprays." Could you confirm whether the base-year deliverable is a wipe article only, or whether a spray version is also desired?

The deliverable is focused on wipes only; please ignore any mention of sprays as that was included in error. The Sources Sought Notice was Amended to remove reference to sprays.

4. HRIPT scope. Is the awardee expected to conduct HRIPT within the base period, on the formulation-only (no-phage) article, and to what panel size / protocol? Should HRIPT precede or follow prototype delivery.

HRIPT to be conducted on articles with formulations only (no phage) and with phage. A panel size of 50-subjects for each will be tested with protocols such as the ASTM D6355 standard test method. Testing should precede prototype delivery.

5. Formulation component detail. Are additional formulation component details or specifications available beyond what's listed in Table 2, either in this notice or in referenced documentation?

Additional components can be considered beyond the examples listed in Table 2, providing the ≤1 log10 loss of titer performance spec is met.

6. Regulatory positioning. Could you confirm the intended pathway is cosmetic (MoCRA) only, with no drug claim and no IND anticipated for this effort?

Confirming the intended pathway is MoCRA only; do drug claim or IND for this effort.

7. Option periods. Section defines 12-month base plus two 12-month option periods. Can the government provide additional context on the intended scope of the option periods (e.g., continuation of formulation work, transition to field validation, expansion to additional format factors)?

No option periods planned for this effort. The Sources Sought Notice was amended to remove references to option periods.

8. Interim deliverables. Are there required interim reports, design reviews, or milestone deliverables within the base year beyond the final formulation and the 100 prototype packs?

In addition to the final delivery of prototypes, interim reports on results of formulation iterations to include thermal stability, challenge test, HRIPT results are required .

9. Cold-chain / shipping mechanics. For the "return on ice" steps, do you specify shipping / temperature-logging requirements or a preferred carrier/process for thermally stressed articles and final prototypes?

Overnight shipping on ice (2-8oC) will be sufficient (FEDEX is preferred). Samples need to arrive at Soldier Center no later than 1430 and by Thursday .

10. Page-limit accounting. Could you confirm the 5-page limit is inclusive of all figures, tables, and the cost/schedule, and whether a cover page or references page counts against it?

All content to be included in the 5-page limit.