FDA FORM 3398.pdf
PDF 114 KB Posted
- Attached to
- Mass Spectrometry Analysis of Human Plasma Samples Federal contract opportunity
- Solicitation number
- 75F40124Q123714
About this file
This document is a Contractor's Commitment to Protect Non-Public Information (NPI) Agreement related to a federal contract opportunity with the Department of Health and Human Services Food and Drug Administration (FDA). The agreement requires the contractor to properly store and control access to any NPI obtained during the performance of the contract, and to return all NPI upon completion or at the FDA's request. Violations of the agreement may result in criminal penalties. The related federal contract opportunity is a solicitation for Mass Spectrometry Analysis of Human Plasma Samples, with a Solicitation Number of 75F40124Q123714. The solicitation is being issued by the FDA Office of Acquisition and Grant Services.
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| File | Type | Posted |
|---|---|---|
| combined synopsis-Solicitation-123714 mass spec analysis immunoglobulins.pdf |
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Text version
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 Solicitation Number
____________________/Contract 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 off an FDA site.
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 Project Officer I am assigned to upon completion of the contract, or at any time upon the FDA’s request.
4. Report in writing to the FDA Project Officer I am assigned to, 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: ___________________________________
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