Amendment 01 to RFQ-FDA-1239700.pdf

Date: March 23, 2021

Amendment 01 to RFQ-FDA-1239700

Subject: Questions and Responses to Request for Quote (RFQ-FDA-1239700) for Microfluidic Resistive Pulse Sensor

A) Description:

The purpose of this Amendment 01 is to do the following:

1) To provide final responses to the questions received for the RFQ as part of the amendment.

All other terms and conditions outlined in the RFQ remain unchanged. No further questions will be answered.

B) Questions and Responses:

1) On page 18 of the document, under “FAR 52.212-3 Offeror Representations and Certifications - Commercial Items (Feb 2021)”: Does this form need to be explicitly filled out and returned with our response? Or is this merely a notice that this procurement incorporates this provision?

FDA Response: Please see RFQ full Clause reference on page 18 for: FAR 52.212-3 Offeror Representations and Certifications - Commercial Items (Feb 2021) applies to this acquisition.

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through

(p) of this provision.

2) Section 2, page 3 of the solicitation, in item 2.3: requires on-site installation if the system is not fully assembled. Our system does come fully assembled, and currently we are doing all installations remotely via phone and web conference. The installation procedure itself takes only minutes and simply requires plugging things in an turning them on. Is this acceptable?

FDA Response: Yes, that is acceptable if the system comes fully assembled with no workstation set up or software installation

3) Section 1, page 2 of the solicitation, in item 1.16F: designates that the training should be “on-site”. Due to the current pandemic situation, we are doing all of our training via remote means using phone and web interfaces (we supply a web cam and microphone with the system specifically for this purpose). We actually find that the remote training works better because we divide it up into a minimum of 2 sessions, rather than covering everything in one day (as we used to do on-site). We feel this gives the students more time to digest information and to have more educated questions as they gain experience with the system. Therefore, our plan was to quote our standard “Remote Training” package that we have been using since March of 2020. Is this acceptable?

FDA Response: Yes that is acceptable form of training.