Government Responses to Prospective Offeror Questions - 75A50122Q00017.pdf

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Attached to
Acquisition of Filovirus Point-of-Care (PoC) Diagnostic Tests
Solicitation number
75A50122Q00017
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This document contains the government's responses to questions from prospective offerors regarding solicitation number 75A50122Q00017. The solicitation seeks to purchase point-of-care diagnostic tests for Ebola virus that are FDA authorized or cleared for use on oral fluid samples from cadavers. The tests must be handheld, lateral flow, and have a nine month shelf life from date of delivery. The government clarified that a nine month shelf life would be acceptable, any additional purchases would be executed via contract modification, and options for future lots would be exercised as needed between nine to twelve months based on demand. The document also specifies that all requests to use antibodies purchased under the contract require pre-approval from the contracting officer's representative, responses to the solicitation should be emailed to the provided addresses, and the response deadline was extended to March 24, 2022.

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Government Responses to Prospective Offeror Questions

75A50122Q00017

Q1: Is a shelf-life of 9 months from the date of production acceptable?

A1: Yes, the SOW has been modified to reflect this change.

Q2: If the first 100mg is depleted, how is the second purchase up to 100mg exercised if this is an option?

A2: The contract would be modified to exercise the option and provide additional funding to purchase more antibody as outlined in the SOW.

Q3: Is there potential for modifications to this contract?

A3: Yes, the contemplated options are listed in the SOW. If exercised, they would be done via modifications to the contract. Other within scope modifications could also be contemplated.

Q4: The option includes a request for 4 lots assuming a new lot is manufactured ~every 9 months, does the option start at the end of the first year?

A4: Options are contemplated as needed every 9-12 months but will be exercised based on need. The contractor will receive advanced notice of the Government’s intent to exercise any options.

Furthermore, the requests should be 5 lots and the SOW has been amended to reflect this change.

Q5: Antibody is exclusively for BARDA use and must be approved prior to use for manufacturing and testing lots, is there a form for the written permission?

A5: Unless an alternative method is mutually agreed by the parties post-award, written permission shall be in the form of an email to the COR.

Q6: If solely reserved for BARDA, no other requests can be fulfilled for purchase orders, does this include

FIND?

A6: Yes, ALL requests using antibody purchased by BARDA would need to be pre-approved by the

BARDA COR. This includes requests from FIND.

Q7: Contractor to purchase antibody, BARDA to pay up front and then reimbursement for the cost per test when purchased, is the antibody purchase invoiced to BARDA?

A7: The contractor will be permitted to invoice BARDA for the antibody purchase.

Q8: To respond to the solicitation, is this via email or a portal?

A8: As noted in the solicitation responses to the solicitation should be sent via email to davis.perkins@hhs.gov and amber.gray@hhs.gov.

As a result of the Government’s responses to these questions the solicitation response deadline is hereby extended to Tuesday, March 24, 2022 at 11:59pm Eastern. All other terms and conditions remain unchanged.

mailto:davis.perkins@hhs.gov mailto:amber.gray@hhs.gov

File details come from the government source that posted it. Updated .