Attachment 4 FDA Form 3398.pdf
PDF 114 KB Posted
- Attached to
- FDA NCTR On-Site Pathology Services Federal contract opportunity
- Solicitation number
- 75F40125R00059
About this file
The FDA Form 3398 is a Contractor's Commitment to Protect Non-Public Information (NPI) Agreement for the FDA NCTR On-Site Pathology Services contract (Solicitation Number 75F40125R00059). The document requires contractors to adhere to strict confidentiality protocols when handling sensitive FDA information, including specific obligations such as storing NPI in secured FDA or FDA-approved facilities, granting access only to authorized FDA employees or designated persons, returning all NPI materials upon contract completion, and reporting any unauthorized access incidents to the FDA Contracting Officer's Representative (COR).
The form outlines legal obligations under multiple U.S. Code sections (21 U.S.C. § 331(j), 21 U.S.C. § 360(j), 18 U.S.C. § 1905), with contractors acknowledging potential criminal penalties for violations. Signatories must complete the form by providing their signature, printed name, and having the document witnessed, thereby formally committing to protect the confidentiality of non-public FDA information throughout the contract's duration.
View the file
Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| 75F4012500059_QA_5-16-25.pdf | ||
| 75F4012500059_QA_5-12-25.pdf | ||
| 75F40125R00059.pdf | ||
| PWS Appendix 1.pdf | ||
| PWS Appendix 2.pdf | ||
| PWS Appendix 4.pdf | ||
| Attachment 3 - Wage Determination No. 2015-5121 (Rev. 25).pdf | ||
| Attachment 1 Pathology PWS.pdf | ||
| PWS Appendix 3.pdf | ||
| PWS Appendix 6.pdf | ||
| Attachment 2 - Pricing Schedule.xls | XLS spreadsheet | |
| Attachment 6 - Sample Client Letter for Past Performance.docx | DOCX document | |
| Attachment 7 SCLS Incumbent Employee Length of Service Information.pdf | ||
| PWS Appendix 5.pdf | ||
| Attachment 5 - Past Performance Evaluation Questionnaire.docx | DOCX document |
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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 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: ___________________________________
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