Att D - FDA Form 3398.pdf

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Safe Medication Use
Solicitation number
75F40125Q00401
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The document is a FDA Form 3398 (10/10) "Commitment to Protect Non-Public Information Employee Agreement" from the Department of Health and Human Services' Food and Drug Administration. The form requires an employee to agree not to release, publish, or disclose non-public FDA information obtained during their official duties under a specific contract. The employee acknowledges understanding legal provisions including 21 U.S.C. 331(j), 21 U.S.C. 360j(c), and 18 U.S.C. 1905, and recognizes potential criminal penalties for violations of confidentiality. The form provides spaces for the employee's signature, printed name, and a witness, with a section at the bottom for describing any information being released.

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Other files

File Type Posted
75F40125Q00401-SafeMedUse-QA.pdf PDF
Att A - Records management cert.pdf PDF
Att B - Records management training.pdf PDF
SOL_RFQ (75F40125Q00401) SafeMedUse.docx DOCX document
Att C - Pricing Worksheet.xlsx XLSX spreadsheet
Att F - Data Disclosure Clearance Form.docx DOCX document
Att E - Data Disclosure Clearance Procedures.docx DOCX document

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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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