Sol_QR.docx

Clinical Study Service Contract- Solicitation Questions

am I correct that this initial quote is intended only for the initial base year September 30, 2026 through September 29, 2027 and that all subsequent ‘optional years’ should not be included in the price sheet or initial submission? (as per pg4 “one year contract […]” and pg 10 performance period) Please include the option years in your quote/price sheet. Apologies for the confusion!

would you recommend/prefer any standard subsections within the Volume1 technical approach, for us to include the required details? There are no recommended or preferred section/subsections. However, please note that subsections should clearly reflect the corresponding content of the document and paint a clear picture of your approach.

is there a target budget/range associated with this solicitation We cannot disclose the target budget/range.

Please provide a list of relevant publications, and detailed history of collaboration/funding from federal institutions such as NIH and NSF.

are there any additional page limits or formatting considerations that would be helpful to aid reviewers.

There are no hard page limits. However, the Agency recommends to please use clear headings that reflect the logical content of each section, and provide a brief overview for each section/subsection in the first paragraph of the corresponding part.

Prime offeror must satisfy all the requirements.

For requirements (d) and (e) specifically, more than 10 years of experience in artificial intelligence and machine learning, and more than 10 years of experience analyzing wearable datasets, may this experience be demonstrated through named key personnel or consultants on the proposed team, rather than as an institutional track record of the bidding entity itself?

The bidding institution (a.k.a contractor) must satisfy all the requirements.

For requirements (d) and (e) specifically, more than 10 years of experience in artificial intelligence and machine learning, and more than 10 years of experience analyzing wearable datasets, can the 10 years required be removed?

No. The bidding institution (a.k.a contractor) must satisfy all the requirements.

Section 2 of the Statement of Work indicates that the signal transformation algorithms are developed by FDA and executed at the Contractor's site. Could you clarify the intended scope of requirements (d) and (e) in light of this: is FDA seeking a Contractor with independent AI/ML algorithm development history, or technical proficiency sufficient to implement and validate FDA supplied algorithms and analyze the resulting data?

FDA is seeking a contractor that has a history of independent AI/ML algorithm development and validation.

Please confirm that under this Firm Fixed Price contract, with no Government Furnished Property identified, all costs associated with procuring the reference and test 12 lead ECG devices are the Contractor's responsibility.

We confirm that all costs associated with the tests are the contractor’s responsibility.

Will FDA furnish the retrospective ECG transformation algorithm or software to the Contractor under license for generating the synthetic wearable dataset described in Task 2, or is the Contractor expected to develop the transformation methodology independently based on FDA specifications?

The FDA will provide the transformation algorithm development protocol. However, the contractor must execute the protocol to determine and finalized the transformation function.