Amendment_01_RFQ-FDA-133845-133915_QA.pdf

ALP: HFP-133845-133915

Four (4) each Genomic Sequencing Systems

RFQ-FDA-133845-133915

*****************Amendment 0001 to RFQ-FDA-133845-133915 ****************

I. Description:

The purpose of this amendment is to do the following:

• To provide questions and responses submitted in response to RFQ posted on SAM.gov under Solicitation ID: RFQ-FDA-133845-133915

All other terms and conditions remain unchanged

II. Questions and Responses

1. If this is a brand new contract OR if there is (was) an incumbent performing these services.

FDA response: it is a brand-new contract.

2. Offer Submission Deadline: The solicitation notes that offers are due as listed on the SAM.gov notice. Could you please confirm the exact date and time the quotation is required to be submitted?

FDA response: Please refer to the SAM.gov Solicitation ID:

RFQ-FDA-133845-133915, which states exact date and time as: Jun 26, 2026 10:00 am EDT

3. FDA CIO Pre-Approval Timelines: The solicitation states that prior to award, all hardware and software must be submitted for approval by the FDA CIO. Is this approval process intended to occur after the submission of proposals but prior to the final contract execution, and what is the anticipated turnaround time for this approval?

FDA response: Per the RFQ Section 2.9.3, it states “Prior to award, all hardware and software must be submitted for approval by the FDA Chief Information Officer (CIO) in accordance with HHS acquisition policies.” This will take place prior to award. There is no estimated turnaround time available at this time. Contractors whose quotes are deemed technically acceptable should be prepared to submit the required information promptly, and are advised to factor additional lead time into their proposed delivery schedules to account for this process.

4. Training Scheduling: For the hands-on training for 5-8 FDA staff per site, does the FDA prefer this training to happen concurrently with the installation, or should we

ALP: HFP-133845-133915

Four (4) each Genomic Sequencing Systems

RFQ-FDA-133845-133915

anticipate scheduling dedicated training sessions at a later date using the FDA-provided samples?

FDA response: FDA prefers that the hands-on training be conducted concurrently with instrument installation and system start-up. This approach is intended to ensure that the instrument is fully operational, functioning properly, and ready for use at the time training is provided. Training should be conducted for approximately 5–8 FDA staff per site as part of the installation process. Specific scheduling details will be coordinated between the contractor and the Government point(s) of contact.

5. Preventative Maintenance Visits: For the four Option Years, is there a specific SLA or target response time required for the preventative maintenance visits, or can they be flexibly scheduled with the site POCs annually?

FDA response: No specific SLA is required for preventative maintenance visits.

Preventative maintenance may be scheduled annually in coordination with the Government point(s) of contact