Prohibition on contracting with certain biotechnology providers

(a)

In general

The head of an executive agency may not—(1)procure or obtain any biotechnology equipment or service produced or provided by a biotechnology company of concern; or(2)enter into a contract, or extend or renew a contract, with any entity that—(A)uses biotechnology equipment or services produced or provided by a biotechnology company of concern and acquired after the applicable effective date in subsection (c) in performance of the contract with the executive agency; or(B)enters into any contract the performance of which such entity knows will require, in performance of the contract with the executive agency, the use of biotechnology equipment or services produced or provided by a biotechnology company of concern and acquired after the applicable effective date in subsection (c).(b)

Prohibition on loan and grant funds

The head of an executive agency may not obligate or expend loan or grant funds to, and a loan or grant recipient may not use loan or grant funds to—(1)procure, obtain, or use any biotechnology equipment or services produced or provided by a biotechnology company of concern; or(2)enter into a contract, or extend or renew a contract, with an entity described in subsection (a)(2).(c)

Effective dates

(1)

Certain entities

With respect to the biotechnology companies of concern covered by subsection (f)(2)(A), the prohibitions under subsections (a) and (b) shall take effect 60 days after the Federal Acquisition Regulation is revised pursuant to subsection (h).(2)

Other entities

With respect to the biotechnology companies of concern covered by subparagraphs (B) or (C) of subsection (f)(2), the prohibitions under subsections (a) and (b) shall take effect 90 days after the Federal Acquisition Regulation is revised pursuant to subsection (h).(3)

Rules of construction

(A)

Exclusions

Prior to the date that is five years after a revision to the Federal Acquisition Regulation pursuant to subsection (h) that identifies a biotechnology company of concern covered by subsection (f)(2), subsections (a)(2) and (b)(2) shall not apply to biotechnology equipment or services produced or provided under a contract or agreement, including previously negotiated contract options, entered into before the applicable effective date under paragraphs (1) and (2).(B)

Safe harbor

The term biotechnology equipment or services produced or provided by a biotechnology company of concern shall not be construed to refer to any biotechnology equipment or services that were formerly, but are no longer, produced or provided by biotechnology companies of concern.(d)

Waiver authorities

(1)

Specific biotechnology exception

(A)

Waiver

The head of the applicable executive agency may waive the prohibition under subsections (a) and (b) on a case-by-case basis—(i)with the approval of the Director of the Office of Management and Budget; 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 365 days.(ii)

Extension

The head of the applicable executive agency, with the approval of the Director of the Office of Management and Budget, and in coordination with 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 if such head submits a notification and justification to the appropriate congressional committees not later than 10 days after granting such waiver extension.(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 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)(i)employees of the United States, including members of the uniformed services (as defined in section 101(a) of title 10, United States Code), and dependents of such employees;(ii)covered beneficiaries (as defined in section 1072 of title 10, United States Code) not otherwise described in clause (i); or(iii)any other beneficiary if such acquisition or provision is carried out or administered by the head of a department or agency of the Federal Government; 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)(i); and(ii)whose primary duty stations are located overseas or are on permissive temporary duty travel overseas;(3)the acquisition, use, or distribution of human multiomic data, lawfully compiled, that is commercially or publicly available; or(4)the procurement of medical countermeasures, medical products, and related supplies, including ancillary medical supplies, in direct response to a public health emergency declared pursuant to section 319 of the Public Health Service Act (42 U.S.C. 247d).(f)

Evaluation of certain biotechnology entities

(1)

Entity consideration

Not later than one year after the date of the enactment of this Act, the Director of the Office of Management and Budget shall publish a list of the entities that constitute biotechnology companies of concern based on a list of suggested entities that shall be provided by the Secretary of Defense in coordination with the Attorney General, the Secretary of Health and Human Services, the Secretary of Commerce, the Director of National Intelligence, the Secretary of Homeland Security, the Secretary of State, and the National Cyber Director.(2)

Biotechnology companies of concern defined

In this section, the term biotechnology company of concern means any of the following:(A)An entity that—(i)is to any extent involved in the manufacturing, distribution, provision, or procurement of any biotechnology equipment or service, as determined by the process established in paragraph (1); and(ii)is identified in the annual list published in the Federal Register by the Department of Defense of Chinese military companies operating in the United States pursuant to section 1260H of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (Public Law 116–283; 134 Stat. 3965; 10 U.S.C. 113 note).(B)Any entity that is determined by the process established in paragraph (1) to meet each of the following criteria:(i)Is subject to the administrative governance structure, direction, control, or operates on behalf of the government of a foreign adversary.(ii)Is to any extent involved in the manufacturing, distribution, provision, or procurement of a biotechnology equipment or service.(iii)Poses a risk to the national security of the United States based on—(I)engaging in joint research with, being supported by, or being affiliated with a foreign adversary’s military, internal security forces, or intelligence agencies;(II)providing multiomic data obtained via biotechnology equipment or services to the government of a foreign adversary; or(III)obtaining human multiomic data via the biotechnology equipment or services without express and informed consent.(C)Any subsidiary, parent, or successor of an entity described in subparagraphs (A) or (B), provided it meets the criteria set forth in clauses (i) through (iii) of subparagraph (B), as determined by the process established in paragraph (1).(3)

Guidance

Not later than 180 days after publication of the list pursuant to paragraph (1), and any update to the list pursuant to paragraph (4), the Director of the Office of Management and Budget, in coordination with the Secretary of Defense, the Attorney General, the Secretary of Health and Human Services, the Secretary of Commerce, the Director of National Intelligence, the Secretary of Homeland Security, the Secretary of State, and the National Cyber Director, shall establish guidance as necessary to implement the requirements of this section.(4)

Updates

The Director of the Office of Management and Budget, in coordination with or based on a recommendation provided by the Secretary of Defense, the Attorney General, the Secretary of Health and Human Services, the Secretary of Commerce, the Director of National Intelligence, the Secretary of Homeland Security, the Secretary of State, and the National Cyber Director, or upon receipt of a request pursuant to paragraph (7), shall periodically, though not less than annually, review and, as appropriate, add entities to or remove entities from the list of biotechnology companies of concern, and notify the appropriate congressional committees of any such modifications.(5)

Notice of a designation and review

(A)

In general

A notice of a designation as a biotechnology company of concern under paragraph (2)(B) shall be issued to any biotechnology company of concern named in the designation—(i)advising that a designation has been made;(ii)identifying the criteria relied upon under such subparagraph and, to the extent consistent with national security and law enforcement interests, the information that formed the basis for the designation;(iii)advising that, within 90 days after receipt of notice, the biotechnology company of concern may submit information and arguments in opposition to the designation;(iv)describing the procedures governing the review and possible issuance of a designation pursuant to paragraph (1); and(v)where practicable, identifying mitigation steps that could be taken by the biotechnology company of concern that may result in the rescission of the designation.(B)

Congressional notification requirements

(i)

Notice of designation

The Director of the Office of Management and Budget shall submit the notice required under subparagraph (A) to the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Oversight and Government Reform of the House of Representatives.(ii)

Information and argument in opposition to designations

Not later than 7 days after receiving any information and arguments in opposition to a designation pursuant to subparagraph (A)(iii), the Director of the Office of Management and Budget shall submit such information to the Committee on Homeland Security and Governmental Affairs of the Senate and the Committee on Oversight and Government Reform of the House of Representatives.(6)

No immediate public release

Any designation made under paragraph (1) or paragraph (4) shall not be made publicly available until the Director of the Office of Management and Budget, in coordination with appropriate agencies, reviews all information submitted under paragraph (5)(A)(iii) and issues a final determination that a company shall remain listed as a biotechnology company of concern.(7)

Removal requests

If an entity on the list of biotechnology companies of concern believes it no longer meets the definition of a biotechnology company of concern as described in paragraph (2), then it may provide information and arguments to request removal from the list of biotechnology companies of concern to the Director of the Office of Management and Budget. The Director shall review such information and reply to the entity within 90 days.(g)

Evaluation of national security risks posed by foreign adversary acquisition of american multiomic data

(1)

Assessment

Not later than 270 days after the enactment of this Act, the Director of National Intelligence, in consultation with the Secretary of Defense, the Attorney General of the United States, the Secretary of Health and Human Services, the Secretary of Commerce, the Secretary of Homeland Security, the Secretary of State, and the National Cyber Director, shall complete an assessment of risks to national security posed by human multiomic data from United States citizens that is collected or stored by a foreign adversary from the provision of biotechnology equipment or services.(2)

Report requirement

Not later than 30 days after the completion of the assessment developed under paragraph (1), the Director of National Intelligence shall submit a report with such assessment to the appropriate congressional committees.(3)

Form

The report required under paragraph (2) shall be in unclassified form, but may include a classified annex.(h)

Regulations

Not later than one year after the date of establishment of guidance required under subsection (f)(3), and as necessary for subsequent updates, the Federal Acquisition Regulatory Council shall revise the Federal Acquisition Regulation as necessary to implement the requirements of this section.(i)

Reporting on intelligence on nefarious activities of biotechnology companies with human multiomic data

Not later than 180 days after the date of the enactment of this Act, and annually thereafter, the Director of National Intelligence, in consultation with the heads of executive agencies, shall submit to the appropriate congressional committees a report on any intelligence in possession of such agencies related to nefarious activities conducted by biotechnology companies with human multiomic data. The report shall include information pertaining to potential threats to national security or public safety from the selling, reselling, licensing, trading, transferring, sharing, or otherwise providing or making available to any foreign country of any forms of multiomic data of a United States citizen.(j)

No additional funds

No additional funds are authorized to be appropriated for the purpose of carrying out this section.(k)

Definitions

In this section:(1)

Appropriate congressional committees

The term appropriate congressional committees means—(A)the Committee on Armed Services, the Select Committee on Intelligence, the Committee on Homeland Security and Governmental Affairs, the Committee on Health, Education, Labor, and Pensions, the Committee on Commerce, Science, and Transportation, and the Committee on Foreign Relations of the Senate; and(B)the Committee on Armed Services, the Permanent Select Committee on Intelligence, the Committee on Foreign Affairs, the Committee on Oversight and Government Reform, 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 equipment or service

The term biotechnology equipment or service means—(A)equipment, including genetic sequencers, or any other 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 equipment;(B)any service for the research, development, production, analysis, detection, or provision of information, including data storage and transmission related to biological materials, including—(i)advising, consulting, or support services with respect to the use or implementation of an 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 is designed for use in the research, development, production, or analysis of biological materials that the Director of the Office of Management and Budget, in consultation with the heads of executive agencies, as determined appropriate by the Director of the Office of Management and Budget, determines appropriate in the interest of national security.(3)

Contract

Except as the term is used under subsection (b)(2) and subsection (c)(3), the term contract means—(A)any contract subject to the Federal Acquisition Regulation issued under section 1303(a)(1) of title 41, United States Code; or(B)any transaction (other than a contract, a grant, or a cooperative agreement) entered into under section 4021 of title 10, United States Code.(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)

Executive agency

The term executive agency has the meaning given the term Executive agency in section 105 of title 5, United States Code.(6)

Foreign adversary

The term foreign adversary has the meaning given the term covered nation in section 4872(f) of title 10, United States Code.(7)

Multiomic

The term multiomic means data types that include genomics, epigenomics, transcriptomics, proteomics, and metabolomics.(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.(l)

Compliance with limitation on drug prices

For the purposes of section 1927(a)(1) of the Social Security Act (42 U.S.C. 1396r–8(a)(1)), a manufacturer is deemed to meet the requirements of section 8126 of title 38, United States Code, including the requirement of entering into a master agreement with the Secretary of Veterans Affairs under such section, if the Secretary of Veterans Affairs determines that the manufacturer would comply (and has offered to comply) with the provisions of section 8126 of title 38, United States Code, and would have entered into a master agreement under such section, but for the prohibitions under subsections (a) and (b) of this section.