Attachment 1 FDA FORM 3398.docx
DOCX document 104 KB Posted
- Attached to
- CNS Organoid Neuropharmacological Analysis Federal contract opportunity
- Solicitation number
- 75F40126Q134171
About this file
This is a Contractor's Commitment to Protect Non-Public Information (NPI) Agreement form (FDA Form 3398) required for the CNS Organoid Neuropharmacological Analysis solicitation (75F40126Q134171) issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services. The form establishes binding confidentiality obligations for contractor personnel who will access FDA non-public information during contract performance.
Contractors and their employees must sign this agreement to acknowledge they will protect all NPI in accordance with 21 U.S.C. §331(j), 21 U.S.C. §360(j), 18 U.S.C. §1905, and other applicable statutory provisions. Key requirements include: storing NPI only in secured FDA offices or FDA-approved contractor facilities, limiting access to authorized FDA employees or persons designated in writing by the FDA, returning all NPI and related notes to the assigned FDA Project Officer upon contract completion or upon request, and reporting any unauthorized access incidents to the FDA Project Officer in writing. Contractors acknowledge their understanding of the cited statutes and their liability for criminal penalties for violations. The form requires signatures from both the contractor employee and a witness, along with printed names and dates for each.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| combined synopsis-solicitation 134171 organoid analysis.pdf |
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Text version
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 75F40126Q134171, 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: ___________________________________
FDA FORM 3398
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