Attachment J-7 - Commitment to Protect Non-Public Information Employee Agreement FDA Form 3398.pdf

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National Center for Toxicological Research (NCTR) on-site facility Operations and Maintenance (O&M) support services
Solicitation number
75F40126R00051
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About this file

This document is a template for a Commitment to Protect Non-Public Information Employee Agreement required by the Food and Drug Administration (FDA).

The form establishes a binding agreement between the FDA and contractor employees who require access to non-public information from FDA files in performance of official duties under a specified contract number. Signatories agree not to further release, publish, or disclose such information and commit to protecting it in accordance with 21 U.S.C. 331(j), 21 U.S.C. 360(c), 18 U.S.C. 1905, and other pertinent confidentiality laws and regulations. Employees acknowledge understanding these statutory provisions and recognize they are subject to criminal penalties for any violations. The form requires signature and date from the employee, printed name, witness signature and date with printed name, and includes a section for describing the specific non-public information being released. Form FDA 3398 was last updated in January 2022.

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Text version

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

COMMITMENT TO PROTECT NON-PUBLIC INFORMATION

EMPLOYEE AGREEMENT

Whereas access to non-public information from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties, under Contract Number between FDA and my employer

I, on this day of , 20 hereby agree that I shall not further release, publish or disclose such information and that I shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905 and other pertinent laws and regulations governing the confidentiality of non-public information.

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

Signature: Date:

Type or Print Name:

Witnessed by: Date:

Type or Print Name:

DESCRIPTION OF INFORMATION RELEASED:

FORM FDA 3398 (01/22) PSC Graphics (301) 443-1090 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

COMMITMENT TO PROTECT NON-PUBLIC INFORMATION EMPLOYEE AGREEMENT

Whereas access to non-public information from the files of the Food and Drug Administration (FDA) is required in the performance of my official duties, under Contract Number between FDA and my employer I, on this day of , 20 hereby agree that I shall not further release, publish or disclose such information and that I shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905 and other pertinent laws and regulations governing the confidentiality of non-public information.

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

Signature:

Date:

Type or Print Name:

Witnessed by:

Date:

Type or Print Name:

DESCRIPTION OF INFORMATION RELEASED:

FORM FDA 3398 (01/22)

PSC Graphics (301) 443-1090

EF

Commitment to Protect Non-Public Information Employee Agreement

FORM FDA 3398

PSC Publishing Services

contractNum:
employer:
thisDay:
thisMonth:
thisYear:
sigSig:
sigDate:
sigName:
witnessSig:
witnessDate:
witnessName:
infoDesc:

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