Attachment 4 - Form FDA 3398.pdf
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- Solicitation number
- FDA-SOL-1224068
About this file
This document contains an employee agreement form for the protection of non-public information related to a Food and Drug Administration contract. The form requires the employee's signature agreeing not to disclose such information accessed in their official duties under Contract Number. The employee further agrees to protect the information in accordance with relevant laws governing confidentiality of non-public information and understands associated criminal penalties for violations. The form also includes fields for the employee to print their name, the date and name of the witnessing party, the description of released information, and signature and date fields.
The related federal contract opportunity is a solicitation for the CBER Biologics Effectiveness and Safety Initiative #3 seeking data sources for the surveillance of biologics. Solicitation Number FDA-SOL-1224068 is issued by the Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services. Attached solicitation files provide additional details on the requirements and scope of the opportunity.
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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
| Please type a description of information released here: |
| Please type witness's name here: |
| Please type your name here: |
| Please type date of the witness's signature here in 2 digit month/2 digit day/4 digit year format: |
| Please type the signature date here in 2 digit month/2 digit day/4 digit year format: |
| Please type the employer's name here, first line: |
| Please type the employer's name here, second line: |
| Please type the current day here: |
| Please type the current month here: |
| Please type the current 2 digit year here: 20 |
| Please type the contract number here: |
| Contract Number: Solicitation Number: FDA-SOL-1224068 |
| Attachment Number: Attachment 4 - Form FDA 3398 |
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