Compliance checklist

Request of Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response · 75A50126R00001_RFP_NPIVS_27. 155 requirement sentences found in the notice and 6 attachments: every "shall", "must" and "required", quoted as written and sorted into submission requirements (5) and performance / contract clauses (150). Nothing is generated.

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Submission requirements · 5

01-75A50126R00001_RFP_Final.pdf · B.5.23 Clinical Terms of Award · 2

Required Time-Sensitive Notification Under an IND or IDE, the sponsor must comply with all applicable FDA safety reporting requirements, including 21 CFR 312.32 (IND) and 21 CFR 812.150 (IDE), and applicable current FDA guidance on IND safety reporting and electronic submission of IND safety reports.
Under these Clinical Terms of Award, the Contractor must also submit copies to the responsible COR as follows: 1.

01-75A50126R00001_RFP_Final.pdf · UPDATED " NIH Policy and Guidelines on the Inclusion of · 1

Results information, including the results of the valid analyses by sex and race/ethnicity, from those trials must be submitted not later than one year after the trial's primary completion date.

Performance / contract clauses · 150

Notice · 1

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.

01-75A50126R00001_RFP_Final.pdf · Page 1 · 1

OFFER (Must be fully completed by offeror) IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice. 28.

Extracted from the notice text and attachments as published. The solicitation governs; read Sections L and M in full before you submit.