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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3385 Introduced in Senate (IS)]

<DOC>

118th CONGRESS
  1st Session
                                S. 3385

     To prohibit contracting with certain biotechnology providers.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                            December 4, 2023

  Mr. Hagerty introduced the following bill; which was read twice and 
referred to the Committee on Homeland Security and Governmental Affairs

_______________________________________________________________________

                                 A BILL

 
     To prohibit contracting with certain biotechnology providers.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. PROHIBITION ON CONTRACTING WITH CERTAIN BIOTECHNOLOGY 
              PROVIDERS.

    (a) In General.--The head of an Executive agency may not--
            (1) procure or obtain or extend or renew a contract to 
        procure or obtain any covered biotechnology equipment or 
        service; or
            (2) enter into a contract or extend or renew a contract 
        with any entity that--
                    (A) uses covered biotechnology equipment or 
                services acquired after the date of the enactment of 
                this Act; or
                    (B) that enters into any contract the performance 
                of which such entity knows or has reason to believe 
                will require the direct use of covered biotechnology 
                equipment or services.
    (b) Prohibition on Loan and Grant Funds.--The head of an Executive 
agency may not obligate or expend loan or grant funds to--
            (1) procure or obtain or extend or renew a contract to 
        procure or obtain any covered biotechnology equipment or 
        service; or
            (2) enter into a contract or extend or renew a contract 
        with an entity described in subsection (a)(2).
    (c) Effective Date.--The prohibitions under subsections (a) and (b) 
shall take effect 180 days after the date of the enactment of this Act.
    (d) Waiver Authorities.--
            (1) Specific biotechnology exception.--
                    (A) Waiver.--The head of an Executive agency may 
                waive the prohibitions under subsection (a) and (b) on 
                a case-by-case basis--
                            (i) with the approval of the Director of 
                        the Office of Management and Budget, in 
                        consultation with the Federal Acquisition 
                        Security Council and the Secretary of Defense; 
                        and
                            (ii) if such head submits a notification 
                        and justification to the appropriate 
                        congressional committees not later than 30 days 
                        after granting such waiver.
                    (B) Duration.--
                            (i) In general.--Except as provided in 
                        clause (ii), a waiver granted under 
                        subparagraph (A) shall last for a period of not 
                        more than 180 days.
                            (ii) Extension.--The Director of the Office 
                        of Management and Budget, in consultation with 
                        the Federal Acquisition Security Council and 
                        the Secretary of Defense, may extend a waiver 
                        granted under subparagraph (A) one time, for a 
                        period up to 180 days after the date on which 
                        the waiver would otherwise expire, if such an 
                        extension is in the national security interests 
                        of the United States and the Director submits 
                        to the appropriate congressional committees a 
                        notification of such waiver.
            (2) Overseas health care services.--The head of an 
        Executive agency may waive the prohibitions under subsections 
        (a) and (b) with respect to a contract, subcontract, or 
        transaction for the acquisition or provision of health care 
        services overseas on a case-by-case basis--
                    (A) if the head of such Executive agency determines 
                that the waiver is--
                            (i) necessary to support the mission or 
                        activities of the employees of such Executive 
                        agency described in subsection (e)(2)(A); and
                            (ii) in the interest of the United States;
                    (B) with the approval of the Director of the Office 
                of Management and Budget, in consultation with the 
                Federal Security Acquisition Council and the Secretary 
                of Defense; and
                    (C) if such head submits a notification and 
                justification to the appropriate congressional 
                committees not later than 30 days after granting such 
                waiver.
    (e) Exceptions.--The prohibitions under subsections (a) and (b) 
shall not apply to--
            (1) any activity subject to the reporting requirements 
        under title V of the National Security Act of 1947 (50 U.S.C. 
        3091 et seq.) or any authorized intelligence activities of the 
        United States;
            (2) the acquisition or provision of health care services 
        overseas for--
                    (A) employees of the United States, including 
                members of the uniformed services (as defined in 
                section 101(a) of title 10, United States Code), whose 
                official duty stations are located overseas; or
                    (B) employees of contractors or subcontractors of 
                the United States--
                            (i) who are performing under a contract 
                        that directly supports the missions or 
                        activities of individuals described in 
                        subparagraph (A); and
                            (ii) whose primary duty stations are 
                        located overseas; or
            (3) the acquisition, use, or distribution of genetic 
        sequencing data, however complied, that is commercially 
        available.
    (f) Evaluation of Certain Biotechnology Entities.--Not later than 
90 days after the date of the enactment of this Act, the Secretary of 
Defense shall determine whether Wuxi AppTec, AxBio, and any subsidiary, 
affiliate, or successor of such entities, or any other entity 
headquartered in or organized under the laws of the People's Republic 
of China is a biotechnology company of concern.
    (g) Regulations.--
            (1) Guidance.--Not later than 180 days after the date of 
        the enactment of this Act, the Director of the Office of 
        Management and Budget, in coordination with the Federal 
        Acquisition Security Council, the Federal Acquisition 
        Regulatory Council, the Secretary of Defense, and other heads 
        of Executive agencies as determined appropriate by the Director 
        of the Office of Management and Budget, shall establish 
        guidance, as necessary, to implement the requirements of this 
        section.
            (2) Federal acquisition regulation.--Not later than 270 
        days after the date of the enactment of this Act, the Federal 
        Acquisition Regulatory Council shall revise the Federal 
        Acquisition Regulation as necessary to implement the 
        requirements of this section.
    (h) Definitions.--In this section:
            (1) Appropriate congressional committees.--The term 
        ``appropriate congressional committees'' means--
                    (A) the Committee on Armed Services and the 
                Committee on Homeland Security and Governmental Affairs 
                of the Senate; and
                    (B) the Committee on Armed Services, the Committee 
                on Foreign Affairs, the Committee on Oversight and 
                Accountability, the Committee on Energy and Commerce, 
                and the Select Committee on Strategic Competition 
                between the United States and the Chinese Communist 
                Party of the House of Representatives.
            (2) Biotechnology company of concern.--The term 
        ``biotechnology company of concern'' means--
                    (A) the BGI Group, MGI Group, or Complete Genomics, 
                or any subsidiary, parent, affiliate, or successor of 
                such entities; and
                    (B) any entity that--
                            (i) is subject to the jurisdiction, 
                        direction, or control of a foreign adversary;
                            (ii) operates primarily in the 
                        biotechnology industry; and
                            (iii) the Secretary of Defense deems to 
                        pose a risk to the national security of the 
                        United States.
            (3) Biotechnology equipment or service.--The term 
        ``biotechnology equipment or service'' means--
                    (A) any instrument, apparatus, machine, or device, 
                including components and accessories thereof, that is 
                designed for use in the research, development, 
                production, or analysis of biological materials as well 
                as any software, firmware, or other digital components 
                that are specifically designed for use in, and 
                necessary for the operation of, such an instrument, 
                apparatus, machine, or device;
                    (B) any service for the research, development, 
                production, analysis, detection, or provision of 
                information related to biological materials, 
                including--
                            (i) advising, consulting, or support 
                        services provided by a biotechnology company of 
                        concern with respect to the use or 
                        implementation of a instrument, apparatus, 
                        machine, or device described in subparagraph 
                        (A); and
                            (ii) disease detection, genealogical 
                        information, and related services; and
                    (C) any other service, instrument, apparatus, 
                machine, component, accessory, device, software, or 
                firmware that the Federal Acquisition Security Council, 
                in coordination with the Secretary of Defense and such 
                other heads of Executive agencies (as determined by the 
                Federal Acquisition Security Council), determines 
                appropriate.
            (4) Control.--The term ``control'' has the meaning given to 
        that term in section 800.208 of title 31, Code of Federal 
        Regulations, or any successor regulations.
            (5) Covered biotechnology equipment or service.--The term 
        ``covered biotechnology equipment or service'' means a 
        biotechnology equipment or service produced or provided by a 
        biotechnology company of concern.
            (6) Executive agency.--The term ``Executive agency'' has 
        the meaning given such term in section 105 of title 5, United 
        States Code.
            (7) Foreign adversary.--The term ``foreign adversary'' has 
        the meaning given the term ``covered nation'' in section 
        4872(d) of title 10, United States Code.
            (8) Overseas.--The term ``overseas'' means any area outside 
        of the United States, the Commonwealth of Puerto Rico, or a 
        territory or possession of the United States.
                                 <all>
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