Questions and Answers.docx 8 29 2023.pdf
PDF 93 KB Posted
- Attached to
- Screening of OTC Drug Products.
- Solicitation number
- 75F40123R00140
About this file
This document contains questions and answers regarding two federal contract opportunities from the Department of Health and Human Services Food and Drug Administration to develop validated test methods for screening over-the-counter drug products for benzene. The first opportunity from 2022 under solicitation number FDA-SB-22-1257734 has been awarded and is nearing completion, involving testing specific types of aerosol sprays using specialized methods. The second current opportunity from 2023 under solicitation number 75F40123R00140 builds on the previous work by focusing on developing new validated test methods for different formulations of OTC aerosol sprays with the combined aim of both contracts being to test a wide variety of such products and establish methods to quantify benzene at low levels.
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Questions and Answers (Q&A)
1. Will this be a new contract Answer: Yes
2. Why there are two, apparently overlapping, solicitations to test OTC products for the presence of benzene? How are they different? The first appears to have close one year ago on August 3, 2022. Was this contract awarded or can you tell me the current status? How is it related to the second solicitation, published this week?
Answer:
2022: Reference No. FDA-SB-22-1257734: this solicitation was awarded, and the contract is nearing completion. Testing was performed on specific types of OTC aerosol sprays requiring specialized validated test methods due to unique matrix and formulation issues.
2023: Solicitation number FDA-RFP - 75F40123R00140: this solicitation builds on the 2022 work with a primary focus on developing new validated test methods for different formulations of OTC aerosol sprays than previously tested in 2022.
In combination, these two contracts aim to test a wide variety of OTC aerosol products with varying formulations, and establish validated test methods to quantify benzene at very low levels (in parts per billion).
File details come from the government source that posted it. Updated .