Text of Senate Amendment 6334

Quick facts

Record: Senate Floor
Section type: Amendments
Chamber: Senate
Date: June 24, 2026
Congress: 119th Congress
Why this source matters: This section came from the Senate floor portion of the record.

Linked context

People mentioned: Young, Todd
Committees: Committee on Commerce, Science, and Transportation, Committee on Science, Space, and Technology

Readable version of the official text

SA 6334. Mr. YOUNG (for himself, Mr. Padilla, Mr. Budd, Mr. Cotton, Mr. Coons, Mr. Fetterman, and Ms. Klobuchar) submitted an amendment intended to be proposed by him to the bill S. 4784, to authorize appropriations for fiscal year 2027 for military activities of the Department of Defense, for military construction, and for defense

activities of the Department of Energy, to prescribe military personnel

strengths for such fiscal year, and for other purposes; which was ordered to lie on the table; as follows:

At the end, add the following:

DIVISION F—AMERICAN BIOTECHNOLOGY COMPETITIVENESS ACT

SECTION 1. SHORT TITLE.

This division may be cited as the “American Biotechnology

Competitiveness Act”.

TITLE I—BIOSECURITY MODERNIZATION AND INNOVATION

SEC. 101. DEFINITIONS.

In this title:

(1) Covered provider.—

(A) In general.—Except as provided in subparagraph (B),

the term “covered provider” means a person who—

(i) synthesizes and sells synthetic nucleic acids to

persons in the United States or in a foreign country; or

(ii) produces and distributes or sells, including

resellers, equipment for synthesizing nucleic acids,

including benchtop synthesizers, to persons in the United

States.

(B) Exception.—The term “covered provider” does not

include a person the extent the person sells or distributes

synthetic nucleic acids within a commercial entity for the

purpose of such entity's research and development activities.

(2) Director.—The term “Director” means the Director of

the Office of Science and Technology Policy.

(3) Secretary.—The term “Secretary” means the Secretary

of Commerce.

(4) Under secretary.—The term “Under Secretary” means

the Under Secretary of Commerce for Standards and Technology.

SEC. 102. SENSE OF CONGRESS.

It is the Sense of Congress that—

(1) the field of biotechnology is accelerating and the

United States is at risk of losing its biotechnology

leadership to foreign adversaries;

(2) this acceleration of the field brings the United States

into a period of both great opportunity and risk;

(3) policymaking for biosecurity, biosafety, and

responsible innovation needs to be flexible to keep pace with

advances in biotechnology and ensure an environment that

allows biotechnology research and industry to flourish;

(4) the current landscape of biosecurity and biosafety

authorities is spread among multiple agencies, contributing

to slow policymaking, which, coupled with the rapid

advancement of biotechnology, becomes outdated quickly;

(5) previous studies conducted by the Government

Accountability Office, the National Security Commission for

Emerging Biotechnology, and several presidential

administrations have already identified gaps in the Federal

Government's oversight of biosecurity and biosafety risks;

(6) the United States Government needs to streamline

biosecurity and biosafety authorities to ensure efficiency

and clarity;

(7) gene synthesis technology is becoming increasingly

sophisticated and accessible, along with the ability to

design novel nucleic acid sequences;

(8) both of these factors described in paragraph (7) may

increase the risk of the development and deployment of new

pathogens by bad actors; and

(9) gene synthesis screening of orders and customers is

immediately needed to mitigate risk in the short-term, which

will act as a stopgap while the United States Government

develops a comprehensive biosecurity and biosafety strategy

that is appropriate for the dynamic and rapidly advancing

field of biotechnology.

SEC. 103. NUCLEIC ACID SYNTHESIS SECURITY.

(a) Regulations Required.—

(1) In general.—Not later than 1 year after the date of

the enactment of this Act, the Secretary shall, in

coordination with the Secretary of Health and Human Services

and the heads of other agencies as the Secretary considers

appropriate, establish and maintain by regulation the

following:

(A) A requirement for covered providers described in

section 101(1)(A)(i) to implement screening protocols to

detect orders for sequences of concern included in the list

established and maintained under subparagraph (C). Such

protocols shall—

(i) include the ability for privacy-preserving submission

of information regarding orders for potential sequences of

concern to a mechanism, which may be maintained by the

Secretary or an independent organization designated by the

Secretary, for facilitating effective split order detection

across covered providers, utilizing the list established and

maintained under subparagraph (C); and

(ii) prioritize the mitigation of misuse of sequences

capable of creating pathogens with pandemic potential.

(B) A requirement for covered providers to implement

screening protocols to verify the identity and legitimacy of

customers.

determined by the Secretary in consultation with the

Secretary of Health and Human Services and such heads of

Federal departments and agencies as the Secretary considers

appropriate.

(D) A system for reviewing and updating on a regular basis

the list of sequences of concern established and maintained

under subparagraph (C) that—

(i) uses a docket to allow for privacy-preserving

submissions from the public on recommendations for the list

of sequences of concern;

(ii) includes an expedited procedure to rapidly add

sequences of concern to the list on a provisional basis,

which may include, as far as technically feasible, automatic

procedures such as algorithmic literature scanning, industry

self-reporting, or inter-agency submissions; and

(iii) incorporates strong data security and confidentiality

standards.

(E) A conformity assessment system to verify that covered

providers are adhering to the requirements established and

maintained under subparagraphs (A) and (B), which will

include—

(i) an auditing process to ensure orders and customers have

been scrutinized appropriately, including procedures to

conduct adversarial testing (sometimes referred to as “red-

teaming”) at random intervals to ensure compliance; and

(ii) a process to revoke conformity status of covered

providers that fail to maintain compliance with the

requirements established and maintained under subparagraphs

(A) and (B), including the establishment of a grace period

for covered providers who have failed auditing or adversarial

testing under clause (i) to demonstrate compliance or

mitigation steps.

(F) Safeguards to ensure regulations promulgated under this

subsection avoid unnecessary burden on innovation and

industry by—

(i) allowing covered providers to offer an expedited review

process for institutional customers, including considering

principal investigators at institutions of higher education,

with demonstrated records of legitimacy;

(ii) providing exemptions from customer screening

requirements for sequences or products as determined in

clause (iii) that are clearly non-hazardous and pose no

credible threat to public health or national security based

on scientific literature and industry best practices for

biosecurity screening; and

(iii) conducting regular consultations with relevant

experts to determine exempted sequences and minimize

regulatory burden while maintaining security effectiveness.

(2) Provisional additions to list of sequences of

concern.—For purposes of paragraph (1)(D)(ii), sequences of

concern may be added to the list on a provisional basis using

a rulemaking process that involves shorter periods for notice

and comment, notwithstanding section 553 of title 5, United

States Code.

(3) Rule of construction.—Paragraph (1)(A) shall not be

construed to prohibit a covered provider from synthesizing a

sequence.

(b) Program of Technical Assistance.—

(1) Program required.—The Secretary shall establish a

program to provide technical assistance upon request of a

covered provider, including assistance with orders whose

screening results are ambiguous, subject to determination by

the Secretary, in consultation with the heads of such other

Federal departments and agencies as the Secretary considers

appropriate.

(2) Treatment of information received.—Information

received as part of the technical assistance request under

paragraph (1) may not be used in any enforcement against a

covered provider.

Requirements.—The Under Secretary shall develop best

practices, technical standards, and other tools needed to

support the administration of subsection (a), including the

following:

(1) Testing and evaluation of customer and order screening

protocols to improve accuracy, efficacy, and reliability, and

to support the conformity assessment system under subsection

(a)(1)(E).

(2) Evaluation of the sequences recommended for the list

established and updated under subparagraphs (C) and (D) of

subsection (a)(1), including by developing best practices and

guidelines for determining if a novel sequence is a sequence

of concern.

(3) Research and prototype sequence-to-function models to

supplement the system established and maintained under

subsection (a)(1)(D).

(d) Updates.—As frequently as the Secretary considers

appropriate to account for technological advances, but not

less frequently than once every 2 years, the Secretary shall

review and update the regulations promulgated under

subsection (a).

(e) Protection of Customer Information.—Any information

about a customer included in a submission under subparagraph

(A)(i) or (D)(i) of subsection (a)(1) shall, be kept

confidential and shall be exempt from disclosure under

section 552(b)(3) of title 5, United States Code.

(f) Relationship With Other Federal Guidelines and

Recommendations.—The regulations established and maintained

under subparagraphs (A) and (B) of subsection (a)(1) shall

supplant any Federal guidelines or recommendations relating

to nucleic acid synthesis screening that—

(1) were in effect before the date of the enactment of this

Act; and

(2) are voluntary.

(g) Civil Enforcement.—

(1) Civil action.—The Attorney General may bring a civil

action in a court of competent jurisdiction against any

person who violates a requirement promulgated under

subparagraph (A) or (B) of subsection (a)(1),

including through providing false or misleading information

or engaging in other deceptive practices, or does not

demonstrate compliance within the grace period set forth by

subsection (a)(1)(E)(ii).

(2) Powers of the court.—In an action brought under

paragraph (1), the court may—

(A) enjoin a violation described in paragraph (1); and

(B) award damages under paragraph (3).

(3) Award of damages.—A person who violates a requirement

as described in paragraph (1) is liable for statutory

damages—

(A) in the case of an individual, in the sum of not more

than $500,000, adjusted from time to time under paragraph

(4); and

(B) in the case of a person who is not an individual, in

the sum of not more than $750,000, adjusted from time to time

under paragraph (4).

(4) Adjustments for inflation.—Effective on October 1 of

each year (beginning in the first fiscal year after the date

of the enactment of this Act), the dollar amounts in effect

under paragraph (3) shall be increased by a percentage equal

to the percentage by which the Consumer Price Index for all

urban consumers (U.S. city average) increased during the 12-

month period ending with the last month for which Consumer

Price Index data is available. In the event that such

Consumer Price Index does not increase during such period,

the dollar amount in effect under such paragraph during the

previous fiscal year shall be maintained.

(h) Reports to Congress.—Not less frequently than once

each year, the Secretary shall submit to Congress a report on

the administration of this section. Each such report shall

include an overview of how many covered providers have been

verified by the conformity assessment system established and

maintained under subsection (a)(1)(E).

SEC. 104. ESTABLISHMENT OF BIOTECHNOLOGY GOVERNANCE SANDBOX

PROGRAM.

(a) In General.—Not later than 1 year after the date of

the enactment of this Act, the Under Secretary shall, in

collaboration with the heads of such Federal agencies as the

Under Secretary considers relevant and with such persons in

the private sector, academia, and civil society as the Under

Secretary considers appropriate, establish a biotechnology

governance sandbox program.

(b) Responsibilities.—Under the program established under

subsection (a), the Under Secretary shall—

(1) provide secure testing of innovations or tools

developed to advance the science of biosecurity, biosafety,

and responsible biotechnology innovation;

(2) foster participation of nongovernmental experts in the

development and testing of appropriate levels and methods of

governance, to achieve the goals of—

(A) ensuring the continued global competitiveness of

biotechnology innovations in the United States;

(B) bolstering the national security posture of the United

States; and

robustly analyze emerging threats, anticipate concerns, and

govern proactively in the biotechnology space;

(3) carry out biological measurement research to support

the development and improvement of technical standards for

biosecurity, biosafety, and responsible biotechnology

innovation; and

(4) report annually to the Secretary of Commerce on the

administration of paragraph (2) and whether any promising

governance strategies have resulted from the development and

testing.

contract with the private sector or coordinate with other

Federal agencies to access environments necessary to provide

testing under subsection (b)(1).

(d) Temporary Waivers of Requirements.—In order to test

and experiment with a screening protocol or other tool

provided under subsection (b)(1), the Under Secretary may

temporarily waive a requirement of section 103 on a case-by-

case basis for a covered provider who is participating in the

program established under subsection (a) if the Under

Secretary considers doing so appropriate.

SEC. 105. STREAMLINING BIOSECURITY AND BIOSAFETY AUTHORITIES

ACROSS THE FEDERAL GOVERNMENT.

(a) Assessment and Plan Required.—Not later than 90 days

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

shall, in collaboration with the heads of such Federal

agencies as the Director considers relevant—

(1) assess the current state of biosecurity and biosafety

oversight by the Federal Government; and

(2) develop, based on the findings of the Director with

respect to the assessment conducted under paragraph (1), an

implementation plan to make oversight of biosecurity and

biosafety by the Federal Government more effective and

efficient.

(b) Elements of Assessment.—The assessment required by

subsection (a)(1) shall include the following:

(1) A full accounting of Federal biosecurity and biosafety

authorities and programs, including which agencies hold these

authorities, whether these authorities are exercised

effectively, and where there are overlaps or redundancies,

real or perceived, in regulatory and enforcement authorities.

(2) Engagement with industry stakeholders and academia to

understand where there are challenges with compliance,

communication, and information sharing.

(3) Identification of gaps in funding or other Government

support for the development of research, innovation, and

tools that advance the science of applied biosecurity,

biosafety, and responsible biotechnology innovation.

(4) Identification of gaps in current Federal biosecurity

and biosafety authorities and whether these gaps are

hindering effective and efficient governance and assessment

of emerging risks and opportunities in biotechnology.

(5) An evaluation of how consolidation of biosecurity and

biosafety guidelines, authorities, and regulations across

Federal agencies, including the regulations established and

maintained under section 103(a), should be implemented to

make oversight more effective and efficient and to address

the gaps in such guidelines, authorities, and regulations,

including those identified under paragraphs (3) and (4).

(1) In general.—Not later than 90 days after the date on

which the Director completes the assessment required by

paragraph (1) of subsection (a) and the implementation plan

required by paragraph (2) of such subsection, the Director

shall submit to Congress—

(A) a report on the findings of the Director with respect

to the assessment; and

(B) a copy of the implementation plan.

(2) Contents.—The report submitted pursuant to paragraph

(1)(A) shall include the following:

(A) The findings of the Director with respect to the

assessment conducted pursuant to subsection (a)(1), with an

annex for classified and business confidential information,

as needed.

(B) Recommendations for legislative or administrative

action to support the implementation plan developed under

subsection (a)(2), according to—

(i) what, if any, new biosecurity and biosafety authorities

are needed; and

(ii) where the Federal Government can consolidate

biosecurity and biosafety authorities, including which, if

any, should be reside under a common government entity, and

whether this necessitates establishing a new government

entity.

(d) Implementation.—

(1) In general.—Not later than 90 days after the date on

which the Director completes the implementation plan required

by subsection (a)(2), the Director shall commence

implementing the plan through administrative action in

accordance with applicable provisions of law.

(2) Governance strategies.—In carrying out the

implementation plan developed under subsection (a)(2), the

Director shall consider which, if any, of the governance

strategies reported under section 104(b)(4) should be

included in the plan.

(e) Authorization of Appropriations.—There is authorized

to be appropriated $6,000,000 for the National Institute of

Standards and Technology to carry out this section.

TITLE II—AI-READY BIO-DATA STANDARDS

SEC. 201. DEFINITIONS, STANDARDS, RESOURCES, AND FRAMEWORKS

BY THE NATIONAL INSTITUTE OF STANDARDS AND

TECHNOLOGY FOR CERTAIN BIOLOGICAL DATASETS.

Not later than 2 years after the date of the enactment of

this Act, the Director of the National Institute of Standards

and Technology (in this section referred to as the

“Director”), shall establish, and make publicly available,

definitions, standards, resources, and frameworks to ensure

each biological dataset generated as a result of qualified

federally funded research—

(1) is artificial intelligence-ready;

(2) enables the effective use of the dataset for training

artificial intelligence models; and

(3) supports advancements in research relating to

artificial intelligence and biotechnology.

TITLE III—NATIONAL PROGRAMMABLE CLOUD LABORATORIES NETWORK

SEC. 301. DEFINITIONS.

(a) Definitions.—In this title:

(1) Artificial intelligence.—The term “artificial

intelligence” has the meaning given that term in section

5002 of the William M. (Mac) Thornberry National Defense

Authorization Act for Fiscal Year 2021 (15 U.S.C. 9401).

(2) Biological data.—The term “biological data” means

the information, including associated descriptors, derived

from the structure, function, or process of a biological

system that is either measured, collected, or aggregated for

analysis.

(3) Director.—Unless otherwise provided, the term

“Director” means the Director of the National Science

Foundation.

(4) Institution of higher education.—The term

“institution of higher education” has the meaning given

that term in section 101 of the Higher Education Act of 1965

(20 U.S.C. 1001).

(5) Network.—The term “Network” means the National

Programmable Cloud Laboratories Network.

(6) Node.—The term “node” means a programmable cloud

laboratory designated as part of the Network.

(7) Non-designated laboratory.—The term “non-designated

laboratory” means any Federal, academic, nonprofit, or

private industry programmable cloud laboratory not selected

as a node under section 302.

(8) Programmable cloud laboratory.—The term “programmable

cloud laboratory”

means a physical laboratory that is equipped with research

instrumentation and advanced manufacturing capabilities,

including robotics and artificial intelligence, that can be

securely and remotely programmed and controlled in order to

conduct experiments and collect associated data.

SEC. 302. NATIONAL PROGRAMMABLE CLOUD LABORATORIES NETWORK.

(a) Purposes.—The purposes of the Network established

under this title are—

(1) to maintain leadership by the United States in advanced

experimentation, laboratory automation, and artificial

intelligence for scientific research, advanced manufacturing,

long-term economic competitiveness, and national security;

(2) to reduce the cost of federally funded research through

automation and reproducibility;

(3) to accelerate national competitiveness by transferring

government-funded research to private-sector commercial

applications;

(4) to improve collaboration among federally funded

national laboratories, institutions of higher education, and

private industry;

(5) to ensure that investment in programmable cloud

laboratories results in measurable cost savings,

efficiencies, and long-term fiscal sustainability;

(6) to incentivize private-sector cost-sharing in research

infrastructure and equipment;

(7) to support workforce development aligned with the

technical needs of industry in the United States;

(8) to provide funding for nodes;

(9) to advance the development of a domestic industrial

base for scientific automation tools, artificial intelligence

systems for experimentation, and robotics platforms for use

in laboratory settings; and

(10) to further programmable cloud laboratory research in

areas such as materials science, biotechnology, chemistry,

and other scientific or engineering disciplines where

automation and cloud-enabled experimentation can deliver

transformative results, including advanced materials

synthesis and characterization, scalable biotechnology

experimentation, and high-throughput chemical catalyst

development.

(b) Establishment.—

(1) In general.—

(A) Establishment.—Not later than 1 year after the date of

the enactment of this Act, the Director, in consultation with

the Director of the National Institute of Standards and

Technology, shall designate and oversee a National

Programmable Cloud Laboratories Network of not more than 6

nodes to support secure, standards-based, and cost-effective

remote experimentation and automated research.

(B) Awards.—The Director shall award a grant to each node,

in an amount not to exceed $5,000,000 per fiscal year for a

period of not more than 5 years, to support the Network.

(2) Assessment sequencing.—The assessment required under

section 304 shall be conducted only after the final

designation of nodes under paragraph (1).

(3) Nodes.—The Network shall consist of nodes that—

(A) enable programmable workflows and automated science;

(B) provide access to advanced scientific and manufacturing

instruments, including artificial intelligence-enabled tools;

protocols, and best practices; and

(D) support interoperability across and between nodes.

(1) In general.—The Director shall issue a public

solicitation for eligible entities to apply for node

designation.

(2) Eligible entities.—Eligible entities that may apply

for designation as a node include—

(A) institutions of higher education;

(B) nonprofit research organizations;

(D) consortia or collaborations of the entities described

in subparagraphs (A) through (C).

(d) Applications for Designation.—

(1) In general.—An eligible entity that desires to apply

for designation as a node in the Network shall submit an

application to the Director at such time and in such manner

as the Director may require.

(2) Matters to be included.—The application required under

paragraph (1) shall include—

(A) a technical and programmatic plan for laboratory

operations, automation capabilities, and data integration;

(B) a plan to achieve long-term self-sustainability,

including metrics, interim milestones, and a timeline for

reducing reliance on Federal funding; and

other third-party contributions demonstrating self-

sustainability potential.

(e) Evaluation of Applicants.—The Director shall ensure

that the process for selecting eligible entities for

designation in the Network is competitive, merit-based, and

transparent, through the evaluation of, with respect to each

entity—

(1) pre-existing laboratory infrastructure and suitability

for automated science;

(2) capacity to support distributed, cloud-enabled

programmable workflows for multiple users;

(3) likelihood of achieving long-term sustainability

without continued Federal funding;

(4) demonstrated ability to collaborate with other nodes,

academic partners, industry partners, or other Federal

research agencies (as defined in section 10002 of the

Research and Development, Competition, and Innovation Act (42

U.S.C. 18901));

(5) protocols for research security, cybersecurity, and

responsible access; and

(6) demonstration of user interest and research needs.

(f) Designation.—In designating nodes, the Director

shall—

(1) give preference to applicants demonstrating meaningful

third-party cost share and pre-existing infrastructure; and

(2) to the extent practicable, ensure that at least 1 node

demonstrates the capability to support cloud-enabled

biotechnology research, including automated experimentation

or quality control workflows.

(g) Responsibilities.—Each node selected by the Director

shall—

(1) support the purposes described in subsection (a);

(2) facilitate collaboration among Network members to

expand and integrate automated science capabilities and best

practices;

(3) actively participate with the Director of National

Institute of Standards and Technology in developing network-

wide interoperability, data-sharing, cybersecurity, and

artificial intelligence-assisted experimentation standards;

(4) support secure sharing of experimental data, models,

and results across institutions of higher education

participating in the Network, if applicable;

(5) provide a secure digital infrastructure to enable

remote experimentation, artificial intelligence-assisted

analysis, and reproducible science;

(6) engage in public-private partnerships to streamline the

transfer of technology developed using Network

infrastructure;

(7) develop and maintain a financial sustainability plan to

reduce long-term reliance on Federal funds, including through

user fees, licensing, consortia membership, or other revenue-

generating models;

(8) establish performance metrics, including scientific

output, cost-effectiveness, academic engagement, private-

sector engagement, user satisfaction, and reproducibility of

results; and

(9) where practicable, leverage commercially available

hardware and software solutions to minimize cost and

accelerate deployment of automated science capabilities.

SEC. 303. INTERAGENCY COLLABORATION.

Not later than 180 days after all nodes of the Network are

designated, the Director of the National Institute of

Standards and Technology, in cooperation with the Director

and participating eligible entities (including institutions

of higher education), shall—

(1) develop and promulgate standards to ensure

interoperability across Network nodes, including laboratory

instrumentation, data infrastructure, communication

protocols, and experiment execution systems;

(2) establish protocols for secure, seamless, and

standardized data-sharing among all members of the Network

aligned with node-level cybersecurity and research security

protocols;

(3) define minimum technical requirements and operating

procedures to support remote experimentation, experiment

reproducibility, and artificial intelligence-assisted

workflows; and

(4) periodically update such standards in consultation with

private-sector partners and nodes of the Network to reflect

advancements in hardware, software, and automation

technology.

SEC. 304. ASSESSMENT OF NON-DESIGNATED LABORATORIES.

(a) Assessment Requirement.—Not later than 180 days after

the Director designates the final node of the Network under

section 302, the Director, in consultation with the Secretary

of Energy and the Director of the National Institute of

Standards and Technology, shall conduct and submit to the

appropriate committees of Congress, a comprehensive

assessment of non-designated laboratories.

(b) Scope.—The assessment under subsection (a) shall

identify, to the extent practicable—

(1) Federal laboratories, institutions of higher education,

nonprofit organizations, and private-sector laboratories that

possess or are developing programmable, automated, or

remotely accessible research infrastructure;

(2) the instrumentation, automation, and data capabilities

of such laboratories;

(3) cybersecurity and research security measures relevant

to interoperability;

(4) existing or potential pathways for such laboratories to

coordinate with Network nodes in areas such as data-sharing,

standards adoption, or pilot interoperability projects; and

(5) legal, contractual, or intellectual property

considerations that may affect participation in the Network.

(1) In general.—In carrying out the assessment under

subsection (a), the Director shall ensure that proprietary

information is protected from public disclosure consistent

with applicable law.

(2) Publication of nonproprietary public summary.—The

Director shall publish a nonproprietary public summary of the

assessment under subsection (a) and may submit a

proprietary annex for that assessment to the Committee on

Commerce, Science, and Transportation of the Senate and the

Committee on Science, Space, and Technology of the House of

Representatives.

SEC. 305. REPORTING AND OVERSIGHT.

(a) Annual Briefings.—Not later than 1 year after the date

of the enactment of this Act, and annually thereafter, the

Director shall brief the Committee on Commerce, Science, and

Transportation of the Senate and the Committee on Science,

Space, and Technology of the House of Representatives on the

status of the Network.

(b) Contents.—Each briefing required under subsection (a)

shall include an assessment of—

(1) the alignment of supported research with national

scientific and economic priorities;

(2) the progress each node of the Network has made toward

achieving self-sustainability as described in section

302(d)(2)(B); and

(3) the performance metrics established in section

302(g)(8).

SEC. 306. AUTHORIZATION OF APPROPRIATIONS.

(a) Authorization of Appropriations.—There are authorized

to be appropriated to carry out the activities under this

title—

(1) $30,000,000 for fiscal year 2027;

(2) $30,000,000 for fiscal year 2028;

(3) $30,000,000 for fiscal year 2029;

(4) $30,000,000 for fiscal year 2030; and

(5) $30,000,000 for fiscal year 2031.

(b) Derivation of Funds.—Amounts made available to carry

out this title shall be derived from amounts appropriated or

otherwise made available to the National Science Foundation

SEC. 307. SUNSET.

The National Programmable Cloud Laboratories Network,

including all authorities, programs, and funding provided

under this title, shall terminate on September 30, 2031.

TITLE IV—BIOMANUFACTURING INNOVATION

SEC. 401. FINDINGS; SENSE OF CONGRESS.

(a) Findings.—Congress finds the following:

(1) Biotechnology is the designing and engineering of

biological systems. Biotechnology allows scientists to grow

everything from medicines to crops to materials, enabling

“biology by design”.

(2) Biotechnology holds the potential for the United States

to transform its military capabilities, strengthen food

security and agricultural resilience, and cure life-

threatening diseases, but it holds that same potential for

other countries. The countries that master biotechnology

first will gain the ability to shape how those technologies

are used for decades to come.

(3) Biotechnology unlocks the capabilities of producing

medicines via biological systems, known as biopharmaceutical

manufacturing. Biopharmaceutical manufacturing will enable

better and less invasive treatments that extend and improve

lives.

(4) By investing in biomanufacturing, the United States

Government would reduce dependency on foreign supply chains.

(5) For United States manufacturers, the biggest roadblock

to commercialization is proving that their products and

processes can scale and produce a return on investment.

Biomanufacturing requires flexible and affordable

infrastructure for development, to ensure that innovative

products can rapidly move from the lab to commercial-scale

production.

(b) Sense of Congress.—It is the sense of Congress that—

(1) to realize the potential of biotechnology in the

pharmaceutical sector, the United States Government should

establish and operate a biopharmaceutical manufacturing

innovation center;

(2) the center should facilitate and accelerate

manufacturing innovation, support good manufacturing

practices, and provide for collaboration among public,

private, and nonprofit institutions; and

(3) the center should also facilitate training for workers

to operate biotechnology tools and equipment and to bolster

talent throughout the biotechnology sector.

SEC. 402. ESTABLISHMENT OF NATIONAL BIOPHARMACEUTICAL

INNOVATION CENTER.

The National Institute of Standards and Technology Act (15

U.S.C. 271 et seq.) is amended—

(1) by redesignating section 36 as section 37; and

(2) by inserting after section 35 the following:

“SEC. 36. NATIONAL BIOPHARMACEUTICAL INNOVATION CENTER.

“(a) Establishment of Innovation Center.—

“(1) In general.—The Director shall award a grant to or

enter into an other transaction agreement with, on a

competitive basis, an eligible entity to establish and

operate the National Biopharmaceutical Manufacturing

Innovation Center (in this section referred to as the

`Innovation Center').

“(2) Objectives.—The objectives of the Innovation Center

include—

“(A) advancing the science of biopharmaceutical

manufacturing, especially with respect to products of

particular importance to the national security, health

security, or economic security of the United States,

including by—

“(i) developing and demonstrating flexible

biopharmaceutical manufacturing technologies and systems that

connect the United States pharmaceutical industry with the

research of the National Institute of Standards and

Technology, including propagation of measurement science and

standards related to biopharmaceutical manufacturing;

“(ii) improving upstream and downstream processes for

multiple biopharmaceutical manufacturing platforms or product

modalities;

“(iii) improving biopharmaceutical manufacturing equipment

and capabilities; and

“(iv) reducing supply bottlenecks and strengthening supply

chain self-sufficiency through demonstration of innovative

technologies;

“(B) supporting good manufacturing practices, quality by

design, and standardization of chemistry, manufacturing, and

controls to ensure effective and efficient manufacturing and

to improve the regulation of innovative methods of

manufacturing;

“(C) advancing workforce training and development by

working with educational and community partners to bolster

biotechnology talent;

“(D) developing the science of and deploying the

infrastructure for innovative biopharmaceutical manufacturing

by engaging with—

“(i) institutions of higher education;

“(ii) small, medium, and large pharmaceutical

manufacturers;

“(iii) Federal, State, and local government agencies and

institutes;

“(iv) non-profit organizations;

“(v) professional organizations; and

“(vi) any other entity the Director considers relevant;

“(E) aligning with and complementing existing Department

of Commerce initiatives, including the Manufacturing

Innovation Institutes, metrology research and standards

setting, and research programs;

“(F) ensuring small- and medium-size biopharmaceutical

manufacturers have equal access to the Innovation Center and

its resources;

“(G) sharing with the head of any Executive agency that

oversees the planning, management, or coordination of Federal

activities relating to biotechnology research generated by

the Innovation Center, including data regarding best

practices for biopharmaceutical manufacturing; and

“(H) any other objective the Director considers relevant.

“(3) Funding.—Subject to the availability of

appropriations, the Director shall award the Innovation

Center funding for any of the following:

“(A) To facilitate the construction, expansion, or

renovation of facilities necessary to accomplish the

objectives described in paragraph (2).

“(B) To conduct collaborative research on new technology

for scaling biopharmaceutical manufacturing in the United

States for commercial production, including with the National

Institute of Standards and Technology as appropriate.

“(C) To facilitate workforce training programs for

biopharmaceutical manufacturing.

“(D) To fund relevant research and programs for the

development of biopharmaceutical manufacturing and for the

practical adoption of measurement science and standards

setting in biopharmaceutical manufacturing.

“(b) Application; Award.—

“(1) In general.—Not later than 180 days after the date

of the enactment of this section, the Director shall solicit

applications from eligible entities specified in paragraph

(2) and award to or enter into with one such entity a grant

or other transaction agreement to establish the Innovation

Center.

“(2) Eligibility.—An entity is eligible to submit an

application pursuant to paragraph (1) if—

“(A) the entity is—

“(i) a public-private partnership;

“(ii) an institution of higher education; or

“(iii) a consortia of entities specified in clauses (i) or

(ii); and

“(B) the entity is not a Federal entity.

“(3) Content of application.—An application submitted by

an entity pursuant to paragraph (1) shall include—

“(A) examples from the entity of previous research,

development, implementation, and demonstration of innovative

practices of biopharmaceutical manufacturing;

“(B) a description of the manner by which the entity plans

to advance the science of biopharmaceutical manufacturing,

especially with respect to products of particular importance

to the national security, health security, or economic

security of the United States;

“(C) a description of the manner by which the entity plans

to incorporate good manufacturing practices, quality by

design, and standardization of chemistry, manufacturing, and

controls, and similar guidance to ensure effective and

efficient manufacturing and to make innovative methods of

manufacturing more understandable to Executive agencies that

are tasked with regulating such methods;

“(D) examples of trainings facilitated by the entity that

prepare workers for the biotechnology sector;

“(E) a description of any existing partnerships with

educational or community partners that help facilitate

workforce training for the biotechnology sector;

“(F) a description of any experience participating in or

leading biopharmaceutical manufacturing partnerships,

including those

with institutions of higher education, pharmaceutical

manufacturers, non-profit organizations, and governmental

agencies—

“(i) to organize and conduct research and development

aimed at—

“(I) creating and standardizing new and more effective

technology;

“(II) developing best practices and sharing knowledge

about such technology;

“(III) creating intellectual property; and

“(IV) maintaining technological leadership in the United

States;

“(ii) to support the deployment of innovative practices

and infrastructure of biopharmaceutical manufacturing in the

United States; and

“(iii) to support developing a skilled workforce ready to

use innovations in the biopharmaceutical manufacturing

sector; and

“(G) a description of how the entity intends to utilize

any funds authorized under this section to build or expand

facilities and infrastructure to achieve any of the

objectives described in subsection (a)(2).

“(4) Selection criteria.—In selecting an applicant for a

grant or other transaction agreement under paragraph (1), the

Director shall consider the following:

“(A) The potential of the applicant to establish a

Innovation Center that would achieve the objectives set forth

in subsection (a)(2).

“(B) The past performance of the applicant in

biopharmaceutical manufacturing workforce development and the

potential of the applicant to support workforce development

activities in various regions throughout the United States.

“(C) The extent to which the applicant proposes to

leverage the activities of other biopharmaceutical

manufacturing innovation, development, and scaling

initiatives, including Manufacturing USA institutes (as

defined in section 34(d)).

“(D) Whether the proposed location for the Innovation

Center is proximate to other biomanufacturing infrastructure,

training facilities, or industrial clusters.

“(E) The time the applicant estimates is needed for the

Innovation Center to be fully operational and to start

delivering impact.

“(F) The amount of co-investment committed by Federal,

State, private, and other sources to establish the Innovation

Center.

“(G) The alignment with the other initiatives of the

Department of Commerce and the National Institute of

Standards and Technology, including the Manufacturing

Innovation Institutes, biometrology research and standards

setting, and research programs.

“(H) Plans for the Innovation Center to engage in

collaborative research with the National Institute of

Standards and Technology.

“(I) Any additional criteria that the Director considers

relevant.

“(c) Annual Reports.—

“(1) Initial report.—Not later than one year after the

date on which the Director awards to or enters into with an

eligible entity a grant or other transaction agreement to

establish the Innovation Center under subsection (b)(1), the

Director shall submit to Congress a report describing the

progress on establishing the Innovation Center, including—

“(A) the construction of facilities;

“(B) any activities, partnerships, and collaborations by

the Innovation Center; and

“(C) any other information regarding the formation of the

Innovation Center that the Director considers relevant.

“(2) Progress report.—Not later than one year after the

date on which operations at the Innovation Center officially

begin, the Director shall submit to Congress a report

describing—

“(A) the activities, partnerships, collaborations, and

findings of the Innovation Center; and

“(B) any other information regarding the Innovation Center

that the Director considers relevant.

“(3) Final report.—Not later than 5 years after the date

on which operations at the Innovation Center officially

begin, the Director shall submit to Congress a report

describing—

“(A) the activities, partnerships, collaborations, and

findings of the Innovation Center; and

“(B) any other information regarding the Innovation Center

that the Director considers relevant.

“(4) Publication.—The Director shall make the reports

required by paragraphs (1), (2), and (3) available to the

public in an easily accessible electronic format on a website

of the Federal Government that includes information on

biotechnology.

“(d) Guidelines.—The Director shall ensure that, prior to

commencing operations, the Innovation Center, in

collaboration with similar existing institutions, such as

Manufacturing USA institutes (as defined in section 34(d)),

establishes guidelines for research conducted within or in

collaboration with the Innovation Center, including

guidelines with respect to intellectual property and any

other guideline that the Director considers relevant.

“(e) Authorization of Appropriations.—There is authorized

to be appropriated to the Director to carry out this

section—

“(1) $40,000,000 for fiscal year 2027;

“(2) $40,000,000 for fiscal year 2028; and

“(3) $40,000,000 for fiscal year 2029.

“(f) Definitions.—In this section:

“(1) Biomanufacturing.—The term `biomanufacturing' means

the use of a biological system to produce goods and services

at commercial scale.

“(2) Biopharmaceutical.—The term `biopharmaceutical'

means a pharmaceutical drug product manufactured using,

extracted from, or synthesized from living cells or

biological organisms.

“(3) Biotechnology.—The term `biotechnology' means

technology that applies to or is enabled by life sciences

innovation or product development.

“(4) Executive agency.—The term `Executive agency'—

“(A) has the meaning given that term in section 105 of

title 5, United States Code; and

“(B) includes the Executive Office of the President and

the Office of the Vice President.

“(5) Institution of higher education.—The term

`institution of higher education' has the meaning given that

term in section 101 of the Higher Education Act of 1965 (20

U.S.C. 1001).”.

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