Attachment 4 - FDA Form 3398.pdf

FDA FORM 3398

CONTRACTOR’S COMMITMENT TO PROTECT

NON-PUBLIC INFORMATION (NPI) AGREEMENT

Whereas access to non-public information (NPI) from the files of the Food and Drug Administration

(FDA) is required in the performance of my official duties, under Contract Number/Order Number

________________________________________________ , and between FDA and my employer

_____________________________________________________, I, ___________________________________ , hereby agree that I shall not further release, publish or disclose such information and I shall protect such information entrusted to me in accordance with the provisions of 21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905, as well as other applicable statutory and regulatory provisions.

Further, I agree to:

1. Store NPI in the secured offices of the FDA or in FDA approved contractor facility containers if work is performed at Contractor’s facility.

2. Grant access to NPI only to known employees of the FDA or to other persons designated in writing by the FDA.

3. Return all NPI and any pertinent notes to the FDA COR assigned to the Contract upon completion of the contract, or at any time upon the FDA’s request.

4. Report in writing to the FDA COR, all incidents in which unauthorized persons may have gained access to any NPI entrusted to me.

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

Signature: ___________________________________________ Date: ______________

Type or Print Name: ___________________________________

Witnessed by: ________________________________________ Date: ______________

Type or Print Name: ___________________________________