Attachment F - Form FDA 3398.pdf

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Attached to
Facility Management System (FMS) Systems Administration and Data Management
Solicitation number
75F40125Q00010
Issued by

About this file

This is Form FDA 3398, "Commitment to Protect Non-Public Information Employee Agreement," which is a required form for contractor employees who need access to non-public FDA information to perform their duties under a specific contract.

The form requires the employee to agree not to release, publish, or disclose non-public FDA information and to protect such information in accordance with specified U.S. Code provisions (21 U.S.C. 331(j), 21 U.S.C. 360j(c), and 18 U.S.C. 1905). The form includes fields for the contract number, employer name, date of agreement, employee signature, witness signature, and a section for describing the information released. It explicitly states that violations are subject to criminal penalties. This form is specifically associated with a solicitation for Facility Management System (FMS) Systems Administration and Data Management services (Solicitation #75F40125Q00010) for the FDA.

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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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