Attachment H-Commitment to Protect Non-Public Information (NPI) Employee Agreement Form FDA 3398.pdf

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Attached to
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Solicitation number
75F40126R00009
Issued by

About this file

This is a Form FDA 3398, an Employee Agreement for Commitment to Protect Non-Public Information issued by the Food and Drug Administration (FDA) under the Department of Health and Human Services.

The form serves as 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. 360j(c), 18 U.S.C. 1905, and other applicable laws and regulations governing confidentiality of non-public information. The employee acknowledges understanding these statutory provisions and accepts that violations subject them to criminal penalties as prescribed by law. The form requires signature and date from the employee, printed name, witness signature and date, and witness printed name. A section titled "Description of Information Released" provides space to document the specific non-public information to which access is being granted.

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Text version

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 (10/10)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

PSC Graphics (301) 443-1090 EF

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 (10/10)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

PSC Graphics (301) 443-1090

EF

Department of Health and Human Services Food and Drug Administration Commitment to Protect Non-Public Information Employee Agreement

FDA-3398

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