Attachment 7 - Form FDA 3398.pdf

460 KB Posted

Attached to
Transfusion-Transmissible Infections Monitoring System (TTIMS) Laboratory & Risk Factor Database Coordinating Center (LRCC)
Solicitation number
FDARFP1238397
Issued by

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This document contains an employee agreement and commitment form for contractors working with non-public information from the Food and Drug Administration (FDA). The form outlines the legal obligations of signatories to protect confidential FDA information under various statutes and regulations. Individuals signing the agreement pledge not to disclose such information obtained through an FDA contract. They also acknowledge understanding applicable criminal penalties for violations. The blank fields require specification of the information released, witness name, signatory name, signature and witness dates, and employer information.

The related federal contract opportunity notice seeks proposals for a Transfusion-Transmissible Infections Monitoring System Laboratory and Risk Factor Database Coordinating Center. The Department of Health and Human Services FDA Center for Biologics Evaluation and Research requires a coordinating center to support the TTIMS database. Interested offerors should review the attached solicitation, statement of work, and other documents for details on proposal requirements, deliverables, and period of performance.

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Other files

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Responses to TTIMS LRCC CONTRACTOR QUESTIONS.pdf PDF
FDA-RFP-1238397 TTIMS LRCC Solicitation 8 22 2021 7 04 PM.pdf PDF
Attachment 6 - HHS Small Business Subcontracting Plan.doc DOC document
Attachment 4 - Sample Client Authorization Letter for Past Performance.pdf PDF
Attachment 5 - Past Performance Evaluation Questionnaire.pdf PDF
Attachment 3 - Sample Letter of Commitment.pdf PDF
Attachment 2 - Reserved for Wage Determinations (1).pdf PDF
TTIMS LRCC SOW 7-28-21.pdf PDF

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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

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: 21
Please type the contract number here:
Contract Number: Solicitation Number: FDA-RFP-1238397
Attachment Number: Attachment 7 - Form FDA 3398

File details come from the government source that posted it. Updated .