II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. PROHIBITION ON CONTRACTING WITH CER4 TAIN BIOTECHNOLOGY PROVIDERS. 

5 (a) IN GENERAL.—The head of an Executive agency 

6 may not— 

7 (1) procure or obtain or extend or renew a con8 tract to procure or obtain any covered biotechnology 

9 equipment or service; or 

10 (2) enter into a contract or extend or renew a 

11 contract with any entity that— 

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1 (A) uses covered biotechnology equipment 

2 or services acquired after the date of the enact3 ment of this Act; or 

4 (B) that enters into any contract the per5 formance of which such entity knows or has 

6 reason to believe will require the direct use of 

7 covered biotechnology equipment or services. 

8 (b) PROHIBITION ON LOAN AND GRANT FUNDS.— 

9 The head of an Executive agency may not obligate or ex10 pend loan or grant funds to— 

11 (1) procure or obtain or extend or renew a con12 tract to procure or obtain any covered biotechnology 

13 equipment or service; or 

14 (2) enter into a contract or extend or renew a 

15 contract with an entity described in subsection 

16 (a)(2). 

17 (c) EFFECTIVE DATE.—The prohibitions under sub18 sections (a) and (b) shall take effect 180 days after the 

19 date of the enactment of this Act. 

20 (d) WAIVER AUTHORITIES.— 

21 (1) SPECIFIC BIOTECHNOLOGY EXCEPTION.— 

22 (A) WAIVER.—The head of an Executive 

23 agency may waive the prohibitions under sub24 section (a) and (b) on a case-by-case basis— 

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1 (i) with the approval of the Director 

2 of the Office of Management and Budget, 

3 in consultation with the Federal Acquisi4 tion Security Council and the Secretary of 

5 Defense; and 

6 (ii) if such head submits a notification 

7 and justification to the appropriate con8 gressional committees not later than 30 

9 days after granting such waiver. 

10 (B) DURATION.— 

11 (i) IN GENERAL.—Except as provided 

12 in clause (ii), a waiver granted under sub13 paragraph (A) shall last for a period of not 

14 more than 180 days. 

15 (ii) EXTENSION.—The Director of the 

16 Office of Management and Budget, in con17 sultation with the Federal Acquisition Se18 curity Council and the Secretary of De19 fense, may extend a waiver granted under 

20 subparagraph (A) one time, for a period 

21 up to 180 days after the date on which the 

22 waiver would otherwise expire, if such an 

23 extension is in the national security inter24 ests of the United States and the Director 

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1 submits to the appropriate congressional 

2 committees a notification of such waiver. 

3 (2) OVERSEAS HEALTH CARE SERVICES.—The 

4 head of an Executive agency may waive the prohibi5 tions under subsections (a) and (b) with respect to 

6 a contract, subcontract, or transaction for the acqui7 sition or provision of health care services overseas on 

8 a case-by-case basis— 

9 (A) if the head of such Executive agency 

10 determines that the waiver is— 

11 (i) necessary to support the mission or 

12 activities of the employees of such Execu13 tive agency described in subsection 

14 (e)(2)(A); and 

15 (ii) in the interest of the United 

16 States; 

17 (B) with the approval of the Director of 

18 the Office of Management and Budget, in con19 sultation with the Federal Security Acquisition 

20 Council and the Secretary of Defense; and 

21 (C) if such head submits a notification and 

22 justification to the appropriate congressional 

23 committees not later than 30 days after grant24 ing such waiver. 

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1 (e) EXCEPTIONS.—The prohibitions under sub2 sections (a) and (b) shall not apply to— 

3 (1) any activity subject to the reporting require4 ments under title V of the National Security Act of 

5 1947 (50 U.S.C. 3091 et seq.) or any authorized in6 telligence activities of the United States; 

7 (2) the acquisition or provision of health care 

8 services overseas for— 

9 (A) employees of the United States, includ10 ing members of the uniformed services (as de11 fined in section 101(a) of title 10, United 

12 States Code), whose official duty stations are 

13 located overseas; or 

14 (B) employees of contractors or sub15 contractors of the United States— 

16 (i) who are performing under a con17 tract that directly supports the missions or 

18 activities of individuals described in sub19 paragraph (A); and 

20 (ii) whose primary duty stations are 

21 located overseas; or 

22 (3) the acquisition, use, or distribution of ge23 netic sequencing data, however complied, that is 

24 commercially available. 

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1 (f) EVALUATION OF CERTAIN BIOTECHNOLOGY EN2 TITIES.—Not later than 90 days after the date of the en3 actment of this Act, the Secretary of Defense shall deter4 mine whether Wuxi AppTec, AxBio, and any subsidiary, 

5 affiliate, or successor of such entities, or any other entity 

6 headquartered in or organized under the laws of the Peo7 ple’s Republic of China is a biotechnology company of con8 cern. 

9 (g) REGULATIONS.— 

10 (1) GUIDANCE.—Not later than 180 days after 

11 the date of the enactment of this Act, the Director 

12 of the Office of Management and Budget, in coordi13 nation with the Federal Acquisition Security Coun14 cil, the Federal Acquisition Regulatory Council, the 

15 Secretary of Defense, and other heads of Executive 

16 agencies as determined appropriate by the Director 

17 of the Office of Management and Budget, shall es18 tablish guidance, as necessary, to implement the re19 quirements of this section. 

20 (2) FEDERAL ACQUISITION REGULATION.—Not 

21 later than 270 days after the date of the enactment 

22 of this Act, the Federal Acquisition Regulatory 

23 Council shall revise the Federal Acquisition Regula24 tion as necessary to implement the requirements of 

25 this section. 

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1 (h) DEFINITIONS.—In this section: 

2 (1) APPROPRIATE CONGRESSIONAL COMMIT3 TEES.—The term ‘‘appropriate congressional com4 mittees’’ means— 

5 (A) the Committee on Armed Services and 

6 the Committee on Homeland Security and Gov7 ernmental Affairs of the Senate; and 

8 (B) the Committee on Armed Services, the 

9 Committee on Foreign Affairs, the Committee 

10 on Oversight and Accountability, the Committee 

11 on Energy and Commerce, and the Select Com12 mittee on Strategic Competition between the 

13 United States and the Chinese Communist 

14 Party of the House of Representatives. 

15 (2) BIOTECHNOLOGY COMPANY OF CONCERN.— 

16 The term ‘‘biotechnology company of concern’’ 

17 means— 

18 (A) the BGI Group, MGI Group, or Com19 plete Genomics, or any subsidiary, parent, affil20 iate, or successor of such entities; and 

21 (B) any entity that— 

22 (i) is subject to the jurisdiction, direc23 tion, or control of a foreign adversary; 

24 (ii) operates primarily in the bio25 technology industry; and 

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1 (iii) the Secretary of Defense deems 

2 to pose a risk to the national security of 

3 the United States. 

4 (3) BIOTECHNOLOGY EQUIPMENT OR SERV5 ICE.—The term ‘‘biotechnology equipment or serv6 ice’’ means— 

7 (A) any instrument, apparatus, machine, 

8 or device, including components and accessories 

9 thereof, that is designed for use in the research, 

10 development, production, or analysis of biologi11 cal materials as well as any software, firmware, 

12 or other digital components that are specifically 

13 designed for use in, and necessary for the oper14 ation of, such an instrument, apparatus, ma15 chine, or device; 

16 (B) any service for the research, develop17 ment, production, analysis, detection, or provi18 sion of information related to biological mate19 rials, including— 

20 (i) advising, consulting, or support 

21 services provided by a biotechnology com22 pany of concern with respect to the use or 

23 implementation of a instrument, appa24 ratus, machine, or device described in sub25 paragraph (A); and 

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1 (ii) disease detection, genealogical in2 formation, and related services; and 

3 (C) any other service, instrument, appa4 ratus, machine, component, accessory, device, 

5 software, or firmware that the Federal Acquisi6 tion Security Council, in coordination with the 

7 Secretary of Defense and such other heads of 

8 Executive agencies (as determined by the Fed9 eral Acquisition Security Council), determines 

10 appropriate. 

11 (4) CONTROL.—The term ‘‘control’’ has the 

12 meaning given to that term in section 800.208 of 

13 title 31, Code of Federal Regulations, or any suc14 cessor regulations. 

15 (5) COVERED BIOTECHNOLOGY EQUIPMENT OR

16 SERVICE.—The term ‘‘covered biotechnology equip17 ment or service’’ means a biotechnology equipment 

18 or service produced or provided by a biotechnology 

19 company of concern. 

20 (6) EXECUTIVE AGENCY.—The term ‘‘Executive 

21 agency’’ has the meaning given such term in section 

22 105 of title 5, United States Code. 

23 (7) FOREIGN ADVERSARY.—The term ‘‘foreign 

24 adversary’’ has the meaning given the term ‘‘covered 

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1 nation’’ in section 4872(d) of title 10, United States 

2 Code. 

3 (8) OVERSEAS.—The term ‘‘overseas’’ means 

4 any area outside of the United States, the Common5 wealth of Puerto Rico, or a territory or possession 

6 of the United States. 

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