FDA-RFQ-1238058 COVID Testing Additional QA (no. 3).pdf

FDA-RFQ-1238058

Additional Q&A (#3)

ADDITIONAL QUESTIONS AND ANSWERS

The following are the questions submitted prior to receipt of quotes/proposals and their corresponding answers.

Question 1: Is this requirement meant as a set aside for small business?

Response: This solicitation did omit the information indicating whether the acquisition is or is not set aside for small business. This acquisition is not set aside for small business; any size business can submit a quote. That is also why the Small Business SubK Plan is attached (Attachment 2) because we have expectations that Large Businesses will strive to meet the goals listed in the Attachment 2 for supporting small businesses.

Question 2: Does this require CLIA certification? I read through the SOW and did not see mention of CLIA certification as a requirement. Can you confirm?

Response: CLIA certification is not required for the test itself; however, it is required for any lab conducting COVID-19 testing. Please refer to the following FDA link for information on CLIA.

https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia

Question 3: I wanted to see if you might have any availability tomorrow for a quick call to discuss the bid further? There are just a few points of clarification I'm hoping to obtain prior to submitting the bid.

Response: I cannot participate in any discussions regarding this solicitation. All questions must be submitted, in writing, by the cutoff date listed in the solicitation and responses are being posted to the same beta.sam site where the original solicitation is posted. All documents posted to beta.sam are meant to provide the full scope and intent of the FDA’s requirement, so please fully familiarize yourself with those documents. The date for submitting questions on this requirement was Feb 26, 2021. Any further questions submitted may or may not receive a response.

(End of Q&A) https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia