Original_NDA Single Signature.pdf

Single Signature Non-Disclosure Agreement (NDA) Form for State Agencies

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This Single Signature Non-Disclosure Agreement (NDA) Form for State Agencies allows for the head of the State agency to affirm that the sensitive information (e.g., personally identifiable information (PII), non-public information (NPI), controlled unclassified information (CUI), trade secrets, and/or commercial confidential information) accessed during the performance of a contract will not be disclosed with anyone outside of the State agency. Examples of this information includes the firm assignments and other information exchanged during workplanning, Establishment Inspection Report (EIR), FDA 483, or equivalent forms, evidence collected, and all other supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. Furthermore, this NDA Form does not require that everyone in the agency who has a need to know or official interest in the contract information to independently execute a NDA Form.

Under this single signature NDA Form, you are committing on behalf of your agency to protect the sensitive information accessed during the performance of this contract by individuals in your agency. This may include information for which public disclosure is prohibited by law and information compiled for enforcement purposes.

Limitation: The single signature NDA Form does not cover sub-contractor personnel, consultants, and other individuals who are not directly employed by the State agency.

Thus, any of those individuals, if applicable, shall execute stand-alone NDA Forms on their own behalf prior to commencing work under the contract.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

SINGLE SIGNATURE NON-DISCLOSURE AGREEMENT (NDA) FORM

FOR STATE AGENCIES

Whereas access to sensitive information (e.g., trade secrets, personally identifiable information (PII), non-public information (NPI), controlled unclassified information (CUI), and/or confidential information) from the files of the Food and Drug Administration (FDA) is required in the performance of my agency’s official duties under Contract Number

_________________________________ between FDA and my employer, ____________________________________________. Examples of this information includes the confidential commercial information, including the firm assignments and other information exchanged during workplanning, Establishment Inspection Report (EIR), FDA 483, or equivalent forms, evidence collected, and all other supporting documentation. Evidence and supporting documentation may include supplier, receiving, and distribution records, photographs, complaint records, laboratory results, and other documents collected during the performance of the contract. I, in my official capacity as an authorized agent for

_________________________________________________, on this ______ day of _________________, 20_____, hereby agree that I am committing on behalf of my agency to protect the sensitive information received or generated in the performance of official duties for this contract that is owned by FDA. All individuals in my agency who will render services in support of the FDA contract listed above agree to not release, publish, or disclose such information to any other persons except as may be necessary in the performance of the contract; and to protect such information from disclosure 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 sensitive information.

I affirm that the sensitive information accessed during the performance of this contract will not be disclosed to anyone outside of my agency, and any requests for information or records carried out under this contract will be referred to the FDA. This may include information for which public disclosure is prohibited by law, and information compiled for enforcement purposes.

Individuals in my agency understand the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18

U.S.C. 1905 and the criminal penalties prescribed by law for any violation(s) thereof.

Limitation: I hereby acknowledge that this single signature NDA Form does not cover sub-contractor personnel, consultants, and other individuals who are not directly employed by my agency. Thus, any of those individuals, if applicable, shall execute stand-alone NDA

Forms on their own behalf prior to commencing work under the contract.

EXECUTED BY: WITNESSED BY:

Signature Signature

Date Date

Printed Name and Title Printed Name and Title