Section I - Draft Clauses.pdf

Section I

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998)

This contract incorporates one or more FAR and/or HHSAR clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/far and https://www.acquisition.gov/hhsar.

FAR CLAUSE TITLE DATE

52.204-9 Personal Identity Verification of Contractor Personnel (Jan 2011) 52.204-13 System for Award Management and Maintenance (Oct 2018) 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial (Nov 2023) 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—

Commercial Products and Commercial Services (OCT 2025) 52.217-8 Option to Extend Services (Nov 1999) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) 52.224-2 Privacy Act (Apr 1984) 52.224-3 Privacy Training (Jan 2017) 52.227-1 Authorization and Consent (Jun 2020) 52.227-2 Notice and Assistance Regarding Patent and Copyright Infringement (Jun 2020) 52.227-14 Rights in Data - General (May 2014) 52.237-2 Protection of Government Buildings, Equipment, and Vegetation (Apr 1984) 52.237-3 Continuity of Services (Jan 1991) 52.242-13 Bankruptcy (Jul 1995) 52.245-1 Government Property (Sep 2021) 52.245-9 Use and Charges (Apr 2012) 52.247-34 F.O.B. Destination (Nov 1991) 52.252-6 Authorized Deviations in Clauses (Nov 2020)

The following HHSAR clauses apply to this acquisition and are incorporated by reference:

HHSAR CLAUSE TITLE DATE

352.203-70 Anti-Lobbying Dec 2015 352.204-72 Records Management (Feb 2024) Deviation 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.227-70 Publications and Publicity (Dec 2015) 352.232-71 Electronic Submission of Payment Requests (Feb 2022) 352.237-75 Key Personnel (Dec 2015) 352.239-70 Standards for Health Information Technology (Dec 2022 (Deviation) 352.239-71 Security Requirements for Information Technology Resources (Feb 2024) Deviation 352.239-72 Information Technology Security Plan and Accreditation (Feb 2024) Deviation

352.239-76 Security Requirements of Government-Owned Contractor-Operated Resources (Feb 2024) Deviation

352.239-78 Information and Communication Technology Accessibility Notice (Feb 2024) Deviation 352.239-79 Information and Communication Technology Accessibility (Feb 2024) Deviation

The following HHSAR clauses apply to this acquisition and appear in their full text below:

352.203-70 Anti-Lobbying Dec 2015 Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or

(c) Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

352.208-70 Printing and Duplication (Dec 2015)

(a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor shall submit camera-ready copies to the Contracting Officer's Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 3/4 by 14 1/4 inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

(c) Approval for all printing, as well as duplicating/copying in excess of the stated limits, shall be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

352.224-71 Confidential Information (Feb 2024) (Deviation)

(a) [Definition. As used in this clause— Confidential information, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

(b) Identification of information. Specific confidential information or categories of information that the Government will furnish to the Contractor, or that the Contractor is expected to generate, is identified in this contract.

(c) Disclosure. The Contractor shall not disclose confidential information or records written notice is provided to the Contracting Officer at least 45 days in advance of the Contractor's intent to release findings of studies or research, to which an agency response may be appropriate to protect the public interest or that of the agency. The Contractor shall not disseminate or publish such information without the written consent of the Contracting Officer.

(d) Government furnished or provided information: For information provided by or on behalf of the government—

(1) The publication or dissemination of the following types of information are restricted under this contract: “Any information provided to the contractor (and/or any subcontractor) by FDA or collected by the contractor on behalf of FDA must be used only for the purpose of carrying out the provisions of this contract and must not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and must ensure that all work performed by its employees and subcontractors must be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any FDA records may be made available or disclosed must be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

(2) The reason(s) for restricting the types of information identified in subparagraph (d)(1) is/are: The confidentiality, integrity, and availability of such information must be protected in accordance with HHS and FDA policies. Unauthorized disclosure of information will be subject to the HHS and FDA sanction policies and/or governed by the following laws and regulations:

• 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

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• 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

• 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).”

(e) The Contractor shall consult with the Contracting Officer when there is uncertainty with regard to the confidentiality of, or a property interest in, information under this contract prior to the release, disclosure, dissemination, or publication of such information. (End of clause)