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<bill bill-stage="Introduced-in-Senate" dms-id="A1" public-private="public" slc-id="S1-DAV23L31-L8V-DD-TLC"><metadata xmlns:dc="http://purl.org/dc/elements/1.1/">
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<dc:title>118 S3385 IS: To prohibit contracting with certain biotechnology providers.</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2023-12-04</dc:date>
<dc:format>text/xml</dc:format>
<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>118th CONGRESS</congress><session>1st Session</session><legis-num>S. 3385</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20231204">December 4, 2023</action-date><action-desc><sponsor name-id="S407">Mr. Hagerty</sponsor> introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSGA00">Committee on Homeland Security and Governmental Affairs</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To prohibit contracting with certain biotechnology providers.</official-title></form><legis-body><section id="H4787AFEA8C8740CD8645FB501E196705" section-type="section-one"><enum>1.</enum><header>Prohibition on contracting with certain biotechnology providers</header><subsection id="H42CBCEB796E246A783B77B4B520C87A7"><enum>(a)</enum><header>In general</header><text display-inline="yes-display-inline">The head of an Executive agency may not—</text><paragraph id="HE3557850C842441C9368C8668248AB84"><enum>(1)</enum><text display-inline="yes-display-inline">procure or obtain or extend or renew a contract to procure or obtain any covered biotechnology equipment or service; or</text></paragraph><paragraph id="H25CE909BC9C046A197ACD76A67A59874"><enum>(2)</enum><text>enter into a contract or extend or renew a contract with any entity that—</text><subparagraph id="H2F187EE439C74844AF90F8BBD61DC2A9"><enum>(A)</enum><text>uses covered biotechnology equipment or services acquired after the date of the enactment of this Act; or</text></subparagraph><subparagraph id="HBF3B77A90570449D962F15493FAD9FD2"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph></subsection><subsection commented="no" id="H0142AC353BB049C88BC42CAF443FFD60"><enum>(b)</enum><header>Prohibition on loan and grant funds</header><text display-inline="yes-display-inline">The head of an Executive agency may not obligate or expend loan or grant funds to—</text><paragraph commented="no" id="H87CB683F1F8C404EBF9EA881DA214416"><enum>(1)</enum><text>procure or obtain or extend or renew a contract to procure or obtain any covered biotechnology equipment or service; or</text></paragraph><paragraph commented="no" id="H75A2F61A08F6448E8D9DDD11E94FC5E9"><enum>(2)</enum><text>enter into a contract or extend or renew a contract with an entity described in subsection (a)(2).</text></paragraph></subsection><subsection id="H3B8EC94D75094C49A52649825A7A270B"><enum>(c)</enum><header>Effective date</header><text display-inline="yes-display-inline">The prohibitions under subsections (a) and (b) shall take effect 180 days after the date of the enactment of this Act.</text></subsection><subsection id="HAF7295FB62FA44A6906C1F4FC9A01679"><enum>(d)</enum><header>Waiver authorities</header><paragraph id="HAF240C9BE0DB40DC98DC69112B88CA82"><enum>(1)</enum><header>Specific biotechnology exception</header><subparagraph id="HE164F004C75E4FB5B8A22DEBD260919B"><enum>(A)</enum><header>Waiver</header><text display-inline="yes-display-inline">The head of an Executive agency may waive the prohibitions under subsection (a) and (b) on a case-by-case basis—</text><clause id="HC686007825C44E24868F9093DA10BEAA"><enum>(i)</enum><text display-inline="yes-display-inline">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</text></clause><clause id="H74E05436FB194CA2BCFAB0A0505ABAE3"><enum>(ii)</enum><text display-inline="yes-display-inline">if such head submits a notification and justification to the appropriate congressional committees not later than 30 days after granting such waiver.</text></clause></subparagraph><subparagraph id="H5C8FA71347E84EF68B2C7550825A47AE"><enum>(B)</enum><header>Duration</header><clause id="H907F29BB8F634BB5AB5D034D99D0C458"><enum>(i)</enum><header>In general</header><text>Except as provided in clause (ii), a waiver granted under subparagraph (A) shall last for a period of not more than 180 days.</text></clause><clause id="HB400240D1957408CB077DF9E17D02920"><enum>(ii)</enum><header>Extension</header><text display-inline="yes-display-inline">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.</text></clause></subparagraph></paragraph><paragraph id="H1EA904E121BA406F96663DE03A9A02E9"><enum>(2)</enum><header>Overseas health care services</header><text display-inline="yes-display-inline">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—</text><subparagraph id="HEB53D553A5084EAAAB748A066C1BDCB0"><enum>(A)</enum><text display-inline="yes-display-inline">if the head of such Executive agency determines that the waiver is—</text><clause id="HCCFEF1B67AC640C096A86841FA4B9979"><enum>(i)</enum><text>necessary to support the mission or activities of the employees of such Executive agency described in subsection (e)(2)(A); and</text></clause><clause id="H7A4B170E672F485E984CB30CC4F9E61C"><enum>(ii)</enum><text>in the interest of the United States;</text></clause></subparagraph><subparagraph id="HA7760B7E3ACA445EA59B405A1A272503"><enum>(B)</enum><text display-inline="yes-display-inline">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</text></subparagraph><subparagraph id="H13EE0233A2064447913A6C83AB2A233F"><enum>(C)</enum><text display-inline="yes-display-inline">if such head submits a notification and justification to the appropriate congressional committees not later than 30 days after granting such waiver.</text></subparagraph></paragraph></subsection><subsection id="HFDAD806C6CE544629950D52811E5694C"><enum>(e)</enum><header>Exceptions</header><text display-inline="yes-display-inline">The prohibitions under subsections (a) and (b) shall not apply to—</text><paragraph id="H4D97B7668F2543C8AB60C705E6AA9C05"><enum>(1)</enum><text>any activity subject to the reporting requirements under title V of the National Security Act of 1947 (<external-xref legal-doc="usc" parsable-cite="usc/50/3091">50 U.S.C. 3091 et seq.</external-xref>) or any authorized intelligence activities of the United States;</text></paragraph><paragraph id="H94B680D237C940A3AD2A6C924978A72E"><enum>(2)</enum><text display-inline="yes-display-inline">the acquisition or provision of health care services overseas for—</text><subparagraph id="H676E3061FA834EA18AB92B1BC55412BF"><enum>(A)</enum><text>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</text></subparagraph><subparagraph id="HC09F72D437AC45A3B8636E60296CB8CA"><enum>(B)</enum><text>employees of contractors or subcontractors of the United States—</text><clause id="H6EE4195E3A5548FA897179B2924F6E4A"><enum>(i)</enum><text>who are performing under a contract that directly supports the missions or activities of individuals described in subparagraph (A); and</text></clause><clause id="H578B3AB772AC48EC8CE1DA8364F94BEC"><enum>(ii)</enum><text>whose primary duty stations are located overseas; or</text></clause></subparagraph></paragraph><paragraph id="H722E691BE8FC400AB4E7C47FBFA4672D"><enum>(3)</enum><text>the acquisition, use, or distribution of genetic sequencing data, however complied, that is commercially available.</text></paragraph></subsection><subsection id="H928087356C5445E5B7C2F0AA98BDE91F"><enum>(f)</enum><header>Evaluation of certain biotechnology entities</header><text>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.</text></subsection><subsection id="H1174A13E91F243E286696A71561AEDEE"><enum>(g)</enum><header>Regulations</header><paragraph id="H232BB32A515C4CDB9CBB1C1F9376753F"><enum>(1)</enum><header>Guidance</header><text>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.</text></paragraph><paragraph id="HDFD79B3DBCE64E9A87C3D331B43A41D5"><enum>(2)</enum><header>Federal Acquisition Regulation</header><text>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.</text></paragraph></subsection><subsection id="H6A0209FF76A341DFB84F06E0004A5690"><enum>(h)</enum><header>Definitions</header><text>In this section:</text><paragraph id="H15F4945244B049C29EB3BB186F7BFB39"><enum>(1)</enum><header>Appropriate congressional committees</header><text>The term <term>appropriate congressional committees</term> means—</text><subparagraph id="H27BFAA1DC90A4218A2D028DF6827D666"><enum>(A)</enum><text display-inline="yes-display-inline">the Committee on Armed Services and the Committee on Homeland Security and Governmental Affairs of the Senate; and</text></subparagraph><subparagraph id="HC490FEFF1A364F87A0945D74A07BD68B"><enum>(B)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="HFA971AEDBD6F429686217F8324500779"><enum>(2)</enum><header>Biotechnology company of concern</header><text>The term <term>biotechnology company of concern</term> means—</text><subparagraph id="HB541E35CDD6743F2A486C130F4E3926B"><enum>(A)</enum><text display-inline="yes-display-inline">the BGI Group, MGI Group, or Complete Genomics, or any subsidiary, parent, affiliate, or successor of such entities; and</text></subparagraph><subparagraph id="H85398EF599944B06BF37D66091701DF1"><enum>(B)</enum><text>any entity that—</text><clause id="HD7F55F3D49DD44B993B29CD58C6BCB2E"><enum>(i)</enum><text>is subject to the jurisdiction, direction, or control of a foreign adversary;</text></clause><clause id="H379F2CB733AA4035A58747B9B4C29801"><enum>(ii)</enum><text>operates primarily in the biotechnology industry; and</text></clause><clause id="H1D8573F300164259B46DF22F09A8FA9F"><enum>(iii)</enum><text>the Secretary of Defense deems to pose a risk to the national security of the United States.</text></clause></subparagraph></paragraph><paragraph id="H48E008B55FC743A497E9A74C6CAFD045"><enum>(3)</enum><header>Biotechnology equipment or service</header><text display-inline="yes-display-inline">The term <term>biotechnology equipment or service</term> means—</text><subparagraph id="HD9E172DA94504C6FA0FE1F65E5E898A4"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="HC4DAD44F387749C9B2F39CD2F0DB2FBB"><enum>(B)</enum><text display-inline="yes-display-inline">any service for the research, development, production, analysis, detection, or provision of information related to biological materials, including—</text><clause id="H2CA92B52DFCF42B8A3FAD82AA20FCB31"><enum>(i)</enum><text>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</text></clause><clause id="HA68759C4185A4D149E62F85A26052C5A"><enum>(ii)</enum><text>disease detection, genealogical information, and related services; and</text></clause></subparagraph><subparagraph id="H0E7C298800654D9E93746F0897735E68"><enum>(C)</enum><text display-inline="yes-display-inline">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.</text></subparagraph></paragraph><paragraph id="HF388B7D4BBD0438FB5E96E565451A3CF"><enum>(4)</enum><header>Control</header><text display-inline="yes-display-inline">The term <term>control</term> has the meaning given to that term in section 800.208 of title 31, Code of Federal Regulations, or any successor regulations.</text></paragraph><paragraph id="HDA544DE46A48435D92C6D98682D820AF"><enum>(5)</enum><header>Covered biotechnology equipment or service</header><text display-inline="yes-display-inline">The term <term>covered biotechnology equipment or service</term> means a biotechnology equipment or service produced or provided by a biotechnology company of concern.</text></paragraph><paragraph id="HEFF20F53268C455E9A41018A96BFBBAA"><enum>(6)</enum><header>Executive agency</header><text>The term <term>Executive agency</term> has the meaning given such term in section 105 of title 5, United States Code.</text></paragraph><paragraph id="H9586CAA7B0BC47E5A7D57C465C5FA225"><enum>(7)</enum><header>Foreign adversary</header><text>The term <term>foreign adversary</term> has the meaning given the term <term>covered nation</term> in section 4872(d) of title 10, United States Code.</text></paragraph><paragraph id="H9E76CC3A0D064C6397EE180BA2A33C38"><enum>(8)</enum><header>Overseas</header><text display-inline="yes-display-inline">The term <term>overseas</term> means any area outside of the United States, the Commonwealth of Puerto Rico, or a territory or possession of the United States. </text></paragraph></subsection></section></legis-body></bill> 

