Amendment 1 - RFP Questions and Answers.pdf

RFP No. 75A50123R00002 Amendment 1

Questions and Answers

1. In Section L.2.4 (Packaging of the proposal), the Mandatory Qualification Criteria is listed as a mandatory proposal part that requires its own cover page. The page limit given for this part is 5 pages. In Section M.3 (Mandatory Qualification Criteria), the instructions state “A dedicated section in the technical proposal of not more than two (2) pages is required where the Offeror shall provide a response to satisfy the requirements listed under the Mandatory Qualification Criteria.” Can you please clarify how we correctly package the response to the “Mandatory Qualification Criteria”?

Response: The response to satisfy the requirements listed under the Mandatory Qualification Criteria can be up to five pages.

2. Depending on the answers to questions 1, if the “Mandatory Qualification Criteria” is a standalone document: Are there specific details needed for the “Mandatory Qualification Criteria” cover page similar to those described for Technical Proposal and Business Proposal.

Response: Any general cover page format is acceptable

3. The link for Attachment 7 leads to “Page not found” notification on the HHS website.

Can you directly provide us with this HHS Section 508 template?

Response: Please disregard that requirement.

4. We were unable to find reference for “Government notice for handling of proposals” in section L.4.1.1, could you please provide the statement/clause to be used for Technical Proposal Cover Page.

Response: Offerors write their government notice for handling of proposals to tell the government the sensitivity level of their proposal. Please specify if any parts are confidential and sensitive.

5. Section A is mentioned couple times in the RFP, but the RFP document start with Section B. Can you please confirm where Section A is referenced?

Response: Section A is the SF33 that is posted as an attachment.

6. Are only skin burns of interest, or also inhalation burns?

Response: This RFP pertaining only to cutaneous (skin) thermal burn injuries.

7. How large area of the body is expected to be covered within a single scan (instantaneous FOV)?

Response: No single scan or field of view (FOV) size requirement has been specified. It is up to the Offeror’s device specification and capability. The proposal shall describe the size and speed of imaging and the benefit for downstream clinical decisions in burn care.

8. Will the device be used in the field as well, besides the emergency and burn centers? If yes, what is the expected portability level? Running it from a 12V battery?

Response: As specified in the RFP the intended use case settings of the burn wound imaging technology (BWIT) are primarily in emergency departments and burn care centers.

9. Is AI/ML expected to be part of the FDA certification? This could significantly lengthen the approval process!

Response: The technology advancement intended with the scope of this RFP includes the use of AI/ML capabilities embedded as part of the BWIT. The proposal shall describe within CLIN 0001 how it will be developed including training studies and validation as part of pivotal clinical trials leading to a successful FDA 510(k) clearance. However, Offerors could propose technology which does not include AI/ML capabilities may not have the same advantage to be the preferred technology of choice which includes AI/ML capability.

10. Is there a target price for the instrument?

Response: No target price per unit has been set for this RFP. Offeror shall propose a justifiable unit price and the rationale for the associated costs to be outlined in the business proposal to enable determination of the best value to the government.

11. The solicitation states: CLIN (0001) will support product development activities, limited manufacturing and building commercial readiness, execution of clinical studies as required by the FDA. Initial procurement of imaging devices required for the clinical studies, training, back up devices etc. are part of this CLIN

The development of the product, fabrication of 30 units, and of the documentation needed for FDA 510k will certainly require at least 18 to 24 months. Therefore, is it expected the clinical trials will be finalized in 36 months since program starting date?

How many clinical sites are expected?

Response: The expected period-of-performance for CLIN 0001, as stated on page 3 is approximately from 09/29/2023 through 09/28/2026. The number of clinical sites is entirely dependent on the Offerors product development and regulatory strategy which will drive the recruitment requirements to accrue a planned number of patients (age group, body images, depth types etc) as agreed upon with the FDA as part of the pivotal protocol. The anticipated conservative patient recruitment rate which enables completion of CLIN 0001 within the proposed timeframe would drive the number of clinical sites.

12. CLIN 0002 (2026-2028) indicates additional procurement (potential lease of up to 30 units. If this is a lease activity, does it mean that BARDA will not cover the fabrication costs? Is it expected that these units will already have FDA approval?

Response: For planning purposes the 2023-2026 are anticipated to end with FDA Clearance for a BWIT device. BARDA anticipates that these dates cannot be fixed and the timelines would shift depending of the realities of clinical trials and product development factors. The activities proposed in CLIN 0002 are anticipated to be post-approval FDA clearance which would begin the expansion of market integration of the device. Such devices could be leased (and placed in 30 new locations for delivery of burn care covering ED and/or Burn centers settings). As for fabrication cost coverage when leasing, the specific situation may require evaluation. But in general, typical leasing principles and practices would apply.

13. CLIN 0003: What activities are expected within the additional development process?

Technology improvements, the addition of the AI/ML, or both? What is the expected cost sharing, percentage wise?

Response: As specified CLIN 0003 includes advancement, product improvements identified from engagement with end users which were not part of the initial product approval. These are for the Offeror to specify or have a process to capture. The cost-sharing percentage is not predetermined and would be negotiated based on several factors including ensuring best value for the taxpayer as a return on investment and high risk borne during early development.

14. CLIN 0004 (2028-2030) indicates additional procurement potential lease of up to 140 units. If this is a lease activity, does it mean that BARDA will not cover the fabrication costs?

Response: Please refer to the discussion in Answer #12 and apply it to the appropriate timeframe. A decision to lease or buy will be part of any subsequent negotiation.

15. Will BARDA cover the fabrication of the CLIN 0002 30 units and CLIN 0004 140 units?

Response: Please refer to the Answer #12 response above.

16. We were wondering if our technology which is directly responsive to the goals of the solicitation, however at this point only on porcine animal models, is advanced enough to be a good fit for this solicitation?

Response: As stated in L.3. All offers must meet the Mandatory Qualification Criteria to be further evaluated per technical criteria. Please consult Section M.3. Mandatory Qualification Criteria to assess if your product clearly meets all stated requirements.

17. We do not currently have a business formed to commercialize this technology, but we recently completed the start-up and innovation bootcamp program and planned to form an entity. Do you believe that it is best to respond to this call through a newly formed company or are we too early-stage at this point to submit a competitive proposal?

Response: The Offeror would be evaluated for organizational capabilities to execute full development of the product through FDA approval, manufacturing, and commercialization of the product. This includes full IP ownership of this technology.

Please consider the expected organizational responsibilities and the systems and process required for execution of the anticipated project as part of your readiness decision to submit the proposal.

18. If indeed our technology is too early at this point to be responsive to the mandatory requirements of this solicitation, are there any other programs or BAA at BARDA, to which you can refer us for submission of a white paper?

Response: Please refer to BARDA’s current Broad Agency Announcement (BAA) Area of Interest 6 (Burn and Blast MCMs). If your technology has the potential to addresses one of the stated funding priorities, you may request a Tech Watch to discuss the merits of your technology with BARDA Program representatives.

https://medicalcountermeasures.gov/barda/barda-baa/ https://medicalcountermeasures.gov/Request-BARDA-TechWatch-Meeting/