Attachment C - Non-Disclosure Agreement.pdf

This is a template for FDA Form 3398, a "Commitment to Protect Non-Public Information Employee Agreement" required under solicitation number 75F40126O00006. The form establishes a legally binding agreement between the Food and Drug Administration (FDA) and employees of contractors who require access to non-public information from FDA files in performance of their official duties under a federal contract.

The agreement obligates signatories to protect confidential information in accordance with 21 U.S.C. § 331(j), 21 U.S.C. § 360j(c), 18 U.S.C. § 1905, and other applicable laws and regulations governing confidentiality of non-public information. Signatories acknowledge understanding these statutory provisions and accept that they are subject to criminal penalties for any violations. The form requires completion of contract number, employer name, execution date, employee signature with printed name, witness signature with printed name and date, and a description of the specific non-public information being released. This is a standard compliance document used to ensure contractor personnel handling sensitive FDA information maintain appropriate confidentiality protections throughout the contract period.