Pricing Table (Protected).xlsx
XLSX spreadsheet 20 KB Posted
- Solicitation number
- 75D301-25-R-73207
About this file
This document is a Pricing Table for a federal contract opportunity related to developing and validating diagnostic tests for emergency response. The contract requires the contractor to provide labor, materials, and equipment to rapidly develop and validate nucleic acid amplification tests for selected pathogens, submit tests for regulatory approval, and manufacture tests to meet outbreak response needs. Key requirements include developing a diagnostic development and validation plan, performing test development and validation, submitting tests for EUA or 510(k) approval, and establishing production capacity from 10,000 to over 1 million tests per week. Pricing is provided for various tasks and subtasks, including development, validation, regulatory submission, and test production in different lot sizes. The federal agency involved is the Department of Health and Human Services Centers for Disease Control and Prevention Office of Acquisition Services.
View the file
Other files
On GovTribe
Work with this file
- Download the original file
- Contacts named in this file
- Similar government files
- Ask GovTribe AI about this file
Text version
Pricing Table
| Diagnostic Testing Pricing Table | ||||||||||
| Instructions: Please complete all fields highlighted in gold. | ||||||||||
| Contractor: | ||||||||||
| Test Type per Setting | Year 1 | Year 2 | Year 3 | Year 4 | Year 5 | |||||
| Cost | Unit | Cost | Unit | Cost | Unit | Cost | Unit | Cost | Unit | |
| Task 1 (Line Item 0001) Diagnostic Development and Validation Plan | ||||||||||
| Diagnostic Development and Validation Plan (One Time) | $ 10,000.00 | Per Plan | - | - | - | - | - | |||
| Task 2 (Line Item 0002) Development and optimization for sensitivity and specificity | ||||||||||
| Test development and validation from a CDC Laboratory Developed Test, with clinical validation specimens available from CDC. Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission. (Sub-Line Item 000201) | Per Job | Per Job | Per Job | Per Job | Per Job | |||||
| Test development and validation for a pathogen with no existing LDT, with sequence data and pathogen samples available from CDC, in advance of an outbreak. Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission. (Sub-Line Item 000202) | Per Job | Per Job | Per Job | Per Job | Per Job | |||||
| Test development and validation for a pathogen with no existing LDT, with sequence data and pathogen samples available from CDC, in response to an outbreak (short timeframe required). Validation includes generation of a data package sufficient for submission to FDA for EUA or 510(k), but not actual submission. (Sub-Line Item 000203) | Per Job | Per Job | Per Job | Per Job | Per Job | |||||
| Task 3 (Line Item 0003) Test submission for regulatory approval for a selected pathogen | ||||||||||
| Submission of a completed validation data package to FDA for EUA or 510(k) approval (depending on whether or not an emergency has been declared), with follow up as needed to achieve EUA or 510(k) approval. | Per Job | Per Job | Per Job | Per Job | Per Job | |||||
| Task 4 Manufacturing of test for the selected pathogen | ||||||||||
| Test Production in response to an outbreak (Sub-Line Item 000401) | Per Test in lots of 100,000-999,999 | Per Test in lots of 100,000-999,999 | Per Test in lots of 100,000-999,999 | Per Test in lots of 100,000-999,999 | Per Test in lots of 100,000-999,999 | |||||
| Test Production in response to an outbreak (Sub-Line Item 000402) | Per Test in lots of >1,000,000 | Per Test in lots of >1,000,000 | Per Test in lots of >1,000,000 | Per Test in lots of >1,000,000 | Per Test in lots of >1,000,000 | |||||
| Travel (Line Item 0005) | ||||||||||
| For planning purposes, will be executed only if applicable to Task Order. | $ 20,000.00 | Lot | - | - | - | - | - | |||
| Proposed Totals | ||||||||||
| Subtotals: | $ 30,000.00 | $ - 0 | $ - 0 | $ - 0 | $ - 0 | |||||
| Grand Total: | $ 30,000.00 |
File details come from the government source that posted it. Updated .