B18 - Questions_Answers - Final.pdf

Solicitation - 75D301-26-Q-79099 Questions and Answers:

Q1. Will the positive and negative control LAMP reactions be provided for validation or is the contractor required to generate these internally?

A1. These controls will be provided by CDC in the form of low and high positive and negative reactions.

Q2. Will the contractor be providing LAMP primers and probes to be included with the strips?

A2 . The LAMP reagents are maintained at CDC, see setion .

Q3. Can we propose to use a OSD LAMP probe system which may provide specificity benefit?

A3. This current design is already used by the CDC, with FAM and biotin for 2-step specificity. However, a design with measurable increased performance can be provided for evauation.

Q4. Will cassette housing need to include or integrate the LAMP reaction?

A4. There is a separate contract pending for cassette housing design.

Q5. Will the test be performed in a laboratory setting and have access to a heater?

A5. The CDC already has a heater in use amenable to clinical and non-clinical settings.

Q6. What is the sample type?

A6. Whole blood, this will be evaluated separately from strip manufacturing.

Q7. Will a lateral flow reader be used or needed in this system?

A7. A reader is not required and its use is discouraged.

Q8. The SOW describes a cassette-housing-agnostic strip but also refers to plastic consumables. Please clarify whether the required deliverable is:

* bare lateral-flow strips,

* individually packaged dipsticks,

* strips installed in a housing, or

* strips accompanied by separate plastic components.

A8. The strips ( bare lateral-flow strips) are required deliverables. If a buffer is needed for the lateral flow strips to work, the buffer must be also delivered with the strips. The housing is being designed under a different contract mechanism. The strips (and buffer if applicable) will be provided to the vendor who manufactures the cassettes for final test construction and packaging into kits.

Q9. Are the 200 prototype strips in addition to the 4,000 final strips?

A9. The 200 or more prototype strips are in addition to the 4000 final strips.

Q10. How many prototype adjustment or optimization cycles should be included in the quotation?

A10. This depends on how well the initial strip design works with the LAMP assay. It may take more than one design update for the strips to achieve acceptable performance.

Q11. What CDC review and feedback period should the contractor assume following delivery of the prototype lot?

A11. The CDC will test strips ASAP upon receipt using CDC’s internal testing pipeline. CDC Turn-around time would be measured in days and weeks (around 2 weeks).

Q12. Are individual pouches, desiccants, labels, instructions for use, or external packaging required?

A12. No. Not for this production contract.

Q13. Is there a required shelf-life or stability target? If so, what accelerated or real-time stability testing is expected during the period of performance?

A13. The shelf-life target should be at least 1 year after manufacture at refrigeration and at least 3 months at room temperature, if possible given reagent stability. This will be tested by accelerated stability conditions. The test kits could experience high temperatures in various clinic settings.

Q14. Will CDC conduct all testing involving clinical specimens or potentially infectious HIV-containing materials, allowing contractor development and QC testing to use synthetic targets and noninfectious LAMP products?

A14. Yes.

Q15. Please confirm the exact submission time and time zone for the July 23, 2026 quotation deadline.

A15. All responses must be received no later than 3:00 P.M., Eastern Standard Time on Wednesday, July 29, 2026.

Q16. Should the complete quotation be submitted directly to you by email?

A16. Yes, submit to the email address at zvm0@cdc.gov

Q17. If the award is issued after the anticipated August 1 start date, will the period of performance and associated deliverable dates shift accordingly?

A17. Yes, the PoP would shift based on the starting date.

Q18. The RFQ indicates payment upon delivery of the prototype and final products. May the contractor propose milestone payments associated with prototype delivery, final production delivery, and delivery of the final Design History File?

A18. Yes – Include a milestone payment schedule, The Contractor is requested to include the proposed milestone payment schedule with each payment explicitly linked to a defined, inspectable deliverable or acceptance milestone, and the largest payment reserved for final delivery and Government acceptance of the complete 4,000 strip quantity.

Q19. What constitutes formal CDC acceptance of the prototype lot and final production lot?

A19. The vendor must meet the sensitivity/specificity performance specified in the SOW, see SECTION 4b – TASKS TO BE PERFORMED page 3 of the revised RFQ.

Q20. If CDC feedback requires work beyond the agreed specifications or more than the quoted number of optimization cycles, would that additional work be addressed through a contract modification?

A20. There is no specified number of optimization cycles. The vendor must meet the sensitivity/specificity performance specified in SECTION 4 – TASKS TO BE PERFORMED page 3 of the revised RFQ.

Q21. If CDC-provided materials, evaluation results, or technical feedback are delayed, will the delivery schedule be adjusted accordingly?

A21. Based on CDC’s experience with in-house and prior strip production, CDC has allotted sufficient time for iterations and delivery of the strips.

Q22. Please clarify the anticipated ownership and use rights for:

* the contractor’s pre-existing lateral-flow technology, formulations, methods, and manufacturing know-how;

* project-specific designs developed under the contract; and

* the final Design History File and manufacturing-transfer documentation.

A22. Contract materials are purchased free from licensure. The components and design files must support CDC’s future plan to manufacture by 3rd party under competitive contract opportunities. All files and components delivered for this work will be the property of the federal government.

* the contractor’s pre-existing lateral-flow technology, formulations, methods, and manufacturing know-how;

*The materials must be free

* project-specific designs developed under the contract; and

* the final Design History File and manufacturing-transfer documentation.

Q23. Are imported raw materials or components permissible when properly identified and compliant with the applicable Buy American and trade-agreement provisions?

A23. Yes— when properly identified and compliant with the applicable Buy American and trade-agreement provisions

Q24. Is direct FDA submission or approval experience mandatory, or is experience developing and manufacturing products under FDA-regulated design-control practices sufficient?

A24. Manufacturing under regulated GMP (good manufacturing practice) /QC (quality control) practices is sufficient.

Q25. Does the Section 508 requirement apply primarily to electronic reports, presentations, and the Design History File? If so, which accessibility checklist or conformance document should be submitted with the quotation?

A25. Yes, it applies to the listed items. Offeres may submit either a Federal Accessibility Conformance Report (ACR) OR a completed HHS Accessibility Checklist (from http://508.hhs.gov/)

26. If Attogene does not anticipate using artificial intelligence during contract performance, is an AI Compliance and Risk Management Plan unnecessary?

A26. No, if not anticipate using artificial intelligence during contract performance, an AI Compliance and Risk Management Plan is unnecessary.

Q27. Does CDC require approval of proposed subcontractors before award or only before subcontracted work begins?

A27. Key/critical subcontractors (those identified in the proposal and material to the award decision) must be approved before award, with Government consent required for any substitution afterward.

Q28. Please confirm the delivery location and whether shipping and freight should be included in the firm-fixed price.

A28. ATTN: Thomas Vanderford or Caryn Kim at CDC, 1600 Clifton Road, NE, Building17, Room 3016, Atlanta, GA 30333. Included in the Firm-fixed-price.

http://508.hhs.gov/