RFPAttachment10ContractorNDA.pdf

FDA-RFQ-18-1192468 – FDA Adverse Event Reporting System (FAERS II) RFP Attachment No. 10 - Contractor Non-Disclosure Agreement (Form 3398)

This NDA is to be completed by a contractor upon award of contract.

Information Technology Systems Security Contractor Non-Disclosure Agreement

Access to sensitive information (such as personally identifiable information [PII]), non-public information, confidential information, and/or Controlled Unclassified Information (CUI) from the files of the Food and Drug Administration is required in the performance of my official duties, under contract number ______________between (FDA I/C Name or Component) and my employer (Employer’s Name)_____________________ . I agree that I shall not release, publish, or disclose such information to unauthorized personnel, and I shall protect such information in accordance with relevant federal laws, regulations, and guidelines.

I shall protect such information in accordance with the provisions of 21 U.C.S. 331 (j), 21 U.C.S. 360j(c), 18 U.C.S. 1905 and other pertinent laws and regulations governing the confidentiality of non-public information.

I understand the provisions of 21 U.C.S. 331 (j), 21 U.C.S. 360j(c), 18 U.C.S. 1905 and that I am subject to criminal penalties prescribed by law for any violation(s) thereof.

I affirm that I have received a written and/or verbal briefing by my company concerning my responsibilities under this agreement. I understand that violation of this agreement may subject me to criminal and civil penalties.

Signed:

Type or Print Name:

Date:

Witnessed by:

Date:

Copies are to be retained by: FDA Contracting Officer Representative Contractor’s Contract Management Individual Signatory