Questions and Answers Pt1 2PAM.pdf
PDF 135 KB Posted
- Attached to
- 2 PAM Autoinjectors Federal contract opportunity
- Solicitation number
- 75A50122R00022
About this file
This document contains questions and answers regarding a solicitation by the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response for the development and procurement of 2-PAM autoinjectors to treat organophosphate poisoning. The solicitation seeks late-stage clinical development, regulatory approval of 2-PAM autoinjectors as a drug-device combination product for adult and pediatric populations, as well as procurement of the autoinjectors for the Strategic National Stockpile. Questions were due by July 21, 2022 and proposals are due by August 15, 2022. While no specific autoinjector design is required or excluded, human factors studies are considered part of clinical development. Manufacturing capacity must be demonstrated to meet procurement numbers and timelines, and FDA feedback on an offeror's autoinjector platform will be accepted if for the same platform proposed. An extension to the August 15th proposal deadline was not available at the time of issuing the questions and answers document.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Questions and Answers 2PAM AI (Parts 1-4).pdf | ||
| Questions and Answers Pts1-3 2PAM AI.pdf | ||
| Questions and Answers Pts1and2 2PAM.pdf | ||
| Budget Template Spreadsheet.xlsx | XLSX spreadsheet | |
| 75A50122R00022 SF33.pdf | ||
| RFP for 2PAM AutoInjectors.pdf |
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Questions and Answers (Part 1) 2-PAM Autoinjectors
Government responses are in red.
• Evaluation Criterion 1: Technical Manufacturing Capabilities - Safety considerations (e.g., unintended injection prevention features and needle shield, when applicable). Can BARDA provide clarification on "when applicable?" Are autoinjectors with exposed needles post-dose excluded from this Notice?
“When applicable” refers specifically to the needle shield. No autoinjector design is specifically required or excluded; however offerors should bear in mind that this product is being developed for civilian (general public) use.
• Section 2. - This RFP only covers late-stage clinical development and regulatory, no late-stage R&D (example, design verification or human factors validation), is this correct?
Human factors studies are considered clinical development.
• M3 Mandatory Qualification Criteria - for point one (1) on facilities, infrastructure and equipment to manufacture, does this mean full commercial scale equipment needs to be in place by August 15th? Or is it sufficient for equipment to be at FAT and in place/qualified by award?
For Mandatory Qualification Criteria on manufacturing capacity, the offeror doesn’t have to have the commercial scale equipment in place by August 15th. However, the offeror must provide information that supports their ability to be able to meet procurement numbers and timeline as stated in the RFP.
• M3 Mandatory Qualification Criteria - for point two (2) on the reliability requirement, does the FDA feedback need to be specific to the proposed autoinjector for 2-PAM or can it be non-product specific feedback on reliability methodology being used for other products within the same product line/portfolio?
FDA feedback on an offeror’s autoinjector platform is acceptable, as long as it is the same autoinjector platform that is being proposed for the 2-PAM AI RFP.
• General - This is a substantial RFP for such a short turnaround. Would BARDA consider an extension on the proposal submission date of August 15?
At this time, BARDA is not considering an extension of the proposal submission date.
File details come from the government source that posted it. Updated .