Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response

BARDA seeks Contractor(s) to support the continuation of the Vaccine Medical Counermeasures (MCM's) for Pandemic Influenza Preparedness and Response Program. Contractors will furnish all the necessary services, qualified personnel, materials, supplies, equipment and facilities (U.S. facilities preferred) not otherwise provided by the USG as needed to provide MCMs, such as vaccines, antigens, and adjuvants, for pandemic preparedness and response or as required in response to a public health emergency; produce antigen and vaccines against influenza virus or other viruses with pandemic potential as required by BARDA; produce antigens, adjuvants, and/or vaccines to support USG efforts to further improve influenza vaccines (for which feasibility data is available); and support rapid regulatory decisions and manufacturing readiness by generating and submitting to FDA all relevant data (e.g., analytical, nonclinical, clinical, and/or chemistry, manufacturing, and controls (CMC)), including data generated during interpandemic periods. Mandatory Qualification Requirements: To be eligible for award, the Offeror must produce vaccines against influenza and influenza strains with pandemic potential; must demonstrate a successful experience in the manufacturing of influenza vaccine by: 1. Holding a U.S. influenza vaccine license; or 2. Have developed an influenza vaccine as evidenced by: a. Submission of a Biologics License Application (BLA) for seasonal or pandemic influenza vaccine Please see full solicitation details and proposal submission instructions detailed in attachments 01-19 of this notice.

• NAICS541714
• PSCAN12

• 18-75A50126R00001_RFP Att 18 BCP SCP Continuity Plans.pdf

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• 09-75A50126R00001_RFP Att 9 ACH Vendor Misc Payment Enrollment Form.docx

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• 04-75A50126R00001_RFP Att 3 Vendor Production Facilities.xlsx

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• 16-75A50126R00001_RFP Att 16 Bill of Materials (BOM) Template.xlsx

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• 11-75A50126R00001_RFP Att 11 SF LLL Disclosure of Lobbying Activities Form Instructions.pdf

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• 03-75A0126R00001_RFP Att 2 ASPR Security Requirements.pdf

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• 08-75A50126R00001_ RFP Att 8 Summary of Related Activities.docx

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• 10-75A50126R00001_RFP Att 10 SF LLL Disclosure of Lobbying Activities Form.pdf

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• 15-75A50126R00001_RFP Att 15 Contractor Questions.xlsx

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• 17-75A50126R00001_RFP Att 17 Manufacturing Plan.pdf

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• 06-75A50126R00001_RFP Att 5 BARDA Dose Tracker Template.xlsx

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• 12-75A50126R00001_RFP Att 12 HHS Subcontracting Plan Template.docx

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• 05-75A50126R00001_RFP Att 4 Agent Request Form.docx

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• 19_75A50126R0001_RFP Att 19 Surge Manufacturing and Supply Chain Readiness Assessment.pdf

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• 02-75A50126R00001_RFP Att 1 Prod Handling Guidance Don Nat.pdf

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• 07-75A50126R00001_RFP Att 7 Breakdown of Proposed Costs.xlsx

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• 14-75A50126R00001_RFP Att 14 Past Perfomance Questionnaire Template.docx

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• 01-75A50126R00001_RFP_Final.pdf

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• 13-75A50126R00001_RFP Att 13 Risk Mitigation Plan Matrix Template.docx

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• Laura Saddison
  laura.saddison@hhs.gov