Questions and Answers.docx 8 29 2023.pdf
PDF 93 KB Posted
- Attached to
- Development of a Validated Analytical Method and Screen for DEG/EG in OTC Childrens Cough Syrup.
- Solicitation number
- 75F40123R00139
About this file
This document contains questions and answers regarding two federal contract opportunities for analytical testing services. The first opportunity from 2022 focused on developing validated test methods for specific types of over-the-counter aerosol sprays, and that contract has been awarded and is nearing completion. The second opportunity, with a response date in 2023, aims to build on the previous work by establishing new validated test methods for different formulations of over-the-counter aerosol sprays. Both contracts jointly seek to test a wide range of over-the-counter aerosol products and quantify benzene levels down to parts per billion. A related federal contract opportunity involves developing a validated analytical method and screening for diethylene glycol and ethylene glycol in children's cough syrups through the Department of Health and Human Services Food and Drug Administration.
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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).
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