Letter of Assurance
We require assurance that the products, which you receive from List Biological Laboratories, Inc. (List Labs), will be used by qualified persons in appropriate facilities for legitimate need (bone fide research or other peaceful purposes) and will not be used in humans. We are required to comply with the due diligence requirements of US regulations 42 CFR parts 73.3 – 73.4 and 9 CFR parts 121.3 – 121.4.
By signing below, you accept this condition and certify that product(s) received from List Biological Laboratories, Inc. will be used FOR RESEARCH OR TESTING PURPOSES ONLY, NOT FOR USE IN HUMANS. Furthermore, the quantity of Select Agents & Toxins in your possession, including the amount to be furnished by List Labs, will not in the aggregate exceed that allowed by applicable laws and regulations. For current excluded amounts which US institutions may possess without being registered, consult the website for the Federal Select Agent Program: www.selectagents.gov. Custom manufacturing of material for clinical use in humans may be contracted and requires separate agreements.
Provide to List Labs the following information as attachment(s) to this letter of assurance:
- A brief description of the research or testing which will be done using List Labs’ products. Justify the legitimate need.
- References for up to ten scientific publications and/or patents (particularly your own publications and/or patents) illustrating the receiver’s research interests, experience and capabilities.
- A short description of the institution and facility where work will be done.
Complete the entire form below: