Questions Answers W911QY-21-R-0021 11 May 2021.pdf

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Stability Testing Of rBV A/B And rF1V Critical Material Lots
Solicitation number
W911QY-21-R-0021
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This solicitation seeks proposals for stability testing services of recombinant Botulinum A/B and recombinant Plague F1V vaccine materials. Offerors must be capable of conducting three, six, and twelve month stability testing of several cGMP drug product and drug substance lots, associated reference materials, and other critical reagents in compliance with FDA and ICH guidelines. The contract type is a single award firm fixed price contract with a base period of twelve months and four twelve-month option periods, for a total of sixty months. Proposers should carefully review the solicitation and associated attachments regarding testing requirements, pricing templates, and exhibits. The Department of Defense is the contracting agency, and data generated will be designated as controlled unclassified information.

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Question # Page(s) Paragraph Attachment Industry Question Government Answer

1 N/A N/A N/A

Can the Government please clarify whether offerors are permitted to modify and/or propose alternative testing methods, testing schedules or testing laboratories based on offeror’s understanding of the current stability protocols, testing history, subcontractor’s established testing methods and product availability for these products?

The offeror may propose alternatives that meet the requirements of the request for proposal (RFP).

2 152 and 153 Technical and Price "W911QY-21-R-0021 Solicitation"

The Instructions to Offerors indicate that for CLINs 0010-0015 and 0030-0035 pricing has been established within the solicitation and is to be included within the offeror’s price proposal. Based on review of the price template, the Government has also provided pricing for CLINs 0028 and 0029. Can clarification be provided as to whether CLINs 0028 and 0029 are to be submitted as included in the pricing file or should offerors propose pricing for these CLINs?

Typographical error identified within attachment "W911QY-21-R-0021 Solicitation".

Page 152 and Page 153 of this attachment amended to clarify inclusion of CLIN 0028 and CLIN 0029. See page 152 and Page 153 of updated attachment titled:"W911QY-21- R-0021 Solicitation Amendment 0002 11 May 2021"

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