Atropine and Pralidoxime Chloride Injection RFI - Attachment A.xlsx
XLSX spreadsheet 14 KB Posted
- Attached to
- Request for Information (RFI) - Atropine and Pralidoxime Chloride Injection, single dose auto-injectors
- Solicitation number
- SNS-RFI-4152024
About this file
This document is a Request for Information (RFI) issued by the Strategic National Stockpile (SNS) of the U.S. Department of Health and Human Services (HHS) Administration for Strategic Preparedness and Response (ASPR). The RFI is seeking information from vendors on their capability to provide acceptable pharmaceuticals of Atropine and Pralidoxime Chloride Injection, single dose auto-injectors. The required product specifications include a 2.1mg/0.7ml dose of atropine and a 600mg/2mg(300mg/ml) dose of pralidoxime chloride. The SNS requires that all pharmaceuticals be FDA approved.
The RFI questionnaire requests vendors to provide detailed information on their product, such as the National Drug Code (NDC) and National Stock Number (NSN), unit of measure, packaging, production capability, shelf life, compliance with trade agreements and manufacturing regulations, pricing, delivery timelines, and any prior U.S. government contracts for this product. The responses to this RFI will help inform a future solicitation for the required pharmaceuticals.
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| File | Type | Posted |
|---|---|---|
| RFI_Atropine and Pralidoxime Chloride Injection _ 4-2024 1.docx | DOCX document |
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RFI Questions 1-22 Attachment A
| REQUEST FOR INFORMATION (RFI) - ATTACHMENT A | |||||||||||||||||||||||
| Company Name | Item No. | 1) Provide Name of Product | 2) Provide your National Drug Code (NDC) number for this product and if available your National Stock Number (NSN) number to meet the prescribed product requirements. | 3) Unit of Measure (UoM) | 4) Minimum Quantity Per Case | 5) Maximum Quantity Per Case Does your company possess the capability to repackage this product in quantities exceeding the minimum quantity per case? If so, what is the maximum quantity per case that can be accommodated for this product? | 6) Provide specific details about the product’s packaging (i.e., units/carton, cartons/case, case dimensions). | 7) Production Capability: What is your company's current maximum monthly capacity for this specific product? | 8) What is the maximum shelf life that can be provided for this product? | 9) Organization Type: Manufacturer or Authorized Reseller? | 10) Are you a manufacturer approved and certified reseller? Can you provide proof of certification? certification? | 11) Provide the Shelf Life your company is able to provide for this product? | 12) What storage and shipment procedures are utilized for transporting this product? | 13) Are your products Trade Agreement Act (TAA) and Buy American Act (BAA) compliant? | 14) What country is this product manufactured in? | 15) Does your product meet Good Manufacturing Practice regulations (cGMP's) standards for manufacturing, processing, and packaging of pharmaceuticals as outlined in 21 CFR Parts 210-211? https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C | 16) Is this product included in an extended stability program? If so, please provide specific information regarding these programs. | 17) Is this product provided under the FSS schedule? If so, what is the schedule/contract number | 18) Provide rough unit price estimate for this product. | 19) Earliest Delivery Date for product | 20) Are volume discounts available for this product? | 21) Does your product adhere to applicable FDA labeling regulations? Is your product FDA licensed and approved and manufactured in accordance with all Federal, State, and local regulations, laws, and statues? | 22) Have you been awarded a US Gov contract for this product in the past 3-5 years? Is so, please provide contract number, agency/organization supported, and total quantity delivered. |
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