S. 4069

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4069 Introduced in Senate (IS)]

<DOC>

119th CONGRESS
2d Session
S. 4069

To direct the Director of the National Institute of Standards and 
Technology to establish definitions, standards, resources, and 
frameworks to ensure certain biological datasets are ready for use in 
artificial intelligence models, and for other purposes.

_______________________________________________________________________

IN THE SENATE OF THE UNITED STATES

March 12, 2026

Mr. Young (for himself and Mr. Lujan) introduced the following bill; 
which was read twice and referred to the Committee on Commerce, 
Science, and Transportation

_______________________________________________________________________

A BILL

To direct the Director of the National Institute of Standards and 
Technology to establish definitions, standards, resources, and 
frameworks to ensure certain biological datasets are ready for use in 
artificial intelligence models, and for other purposes.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the ``AI-Ready Bio-Data Standards Act''.

SEC. 2. DEFINITIONS, STANDARDS, RESOURCES, AND FRAMEWORKS BY THE 
NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY FOR 
CERTAIN BIOLOGICAL DATASETS.

(a) Establishment.--
(1) In general.--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''), pursuant to recommendations from the 
advisory group under subsection (f) and taking into account any 
feedback received under subsection (e), shall establish 
definitions, standards, resources, and frameworks to ensure 
each biological dataset generated as a result of qualified 
federally funded research is artificial intelligence-ready.
(2) Requirements for definitions, standards, resources, and 
frameworks.--
(A) Definitions.--
(i) In general.--In carrying out paragraph 
(1), the Director shall establish definitions 
for the following terms:
(I) Artificial intelligence-ready.
(II) Biomanufacturing.
(III) Biotechnology.
(IV) Qualified federally funded 
research.
(ii) Requirements for definition of 
artificial intelligence-ready.--
(I) In general.--In defining 
``artificial intelligence-ready'' under 
clause (i)(I), the Director shall 
develop a definition that, when applied 
to a biological dataset, requires that 
the dataset is generated and formatted 
in a manner that--
(aa) enables the effective 
use of the dataset for training 
artificial intelligence models; 
and
(bb) supports advancements 
in research relating to 
artificial intelligence and 
biotechnology.
(II) Discretion.--With respect to a 
biological dataset that otherwise meets 
the definition of ``artificial 
intelligence-ready'' established under 
clause (i)(I), the Director may, in 
consultation with the Chief Data 
Officer of the Federal agency that is 
responsible for such biological 
dataset, determine that such dataset is 
not artificial intelligence-ready.
(iii) Requirements for definition of 
qualified federally funded research.--In 
defining ``qualified federally funded 
research'' under clause (i)(IV), the Director 
shall include certain conditions that, if 
satisfied, will result in certain federally 
funded research being qualified federally 
funded research. Such conditions shall include 
the following:
(I) The amount of Federal funding 
awarded to a recipient.
(II) The capability of the 
recipient to generate a biological 
dataset, which may include negative 
data, that is artificial intelligence-
ready, regardless of the ability of the 
recipient to publish such dataset.
(III) The expertise of the 
recipient in generating a biological 
dataset that is artificial 
intelligence-ready.
(IV) The size of the biological 
dataset generated by the recipient.
(V) Any other condition the 
Director considers appropriate.
(B) Standards.--In carrying out paragraph (1), the 
Director shall establish standards relating to making 
biological datasets artificial intelligence-ready, in 
accordance with the definition of artificial 
intelligence-ready established under subparagraph 
(A)(i)(I) of this paragraph.
(C) Resources and frameworks.--In carrying out 
paragraph (1), the Director shall establish data 
management resources and cybersecurity frameworks for 
the following:
(i) Federal departments and agencies that 
provide either full or partial Federal funding 
for research that generates biological 
datasets.
(ii) Federally funded researchers who are 
collecting, cleaning, curating, or generating 
biological datasets to make the datasets 
artificial intelligence-ready.
(D) Additional requirements.--The Director shall 
ensure that the definitions, standards, resources, and 
frameworks established under paragraph (1)--
(i) are not overly burdensome on recipients 
of funding for qualified federally funded 
research, such that the act of generating 
biological datasets that are artificial 
intelligence-ready requires resources and 
expertise beyond those available to the 
recipients; and
(ii) are tested and evaluated in accordance 
with subsection (c) and in consultation with--
(I) the head of any Federal agency 
the Director considers appropriate;
(II) representatives from any 
private sector entity the Director 
considers appropriate; and
(III) any biotechnology researcher 
the Director considers appropriate.
(3) Annual updates.--Not later than 1 year after the 
establishment of the definitions, standards, resources, and 
frameworks under paragraph (1), and annually thereafter, the 
Director shall review the definitions, standards, resources, 
and frameworks and, if the Director considers it appropriate, 
shall update the definitions, standards, resources, and 
frameworks in accordance with the requirements of this section.
(4) Consultation.--To facilitate the establishment of the 
definitions, standards, resources, and frameworks under 
paragraph (1), and any update under paragraph (3), the Director 
shall consult with the following:
(A) Private sector entities from the biotechnology 
industry.
(B) Private sector entities from the frontier 
artificial intelligence model industry.
(C) Members of academia.
(D) The following heads of Federal agencies that 
provide funding for qualified federally funded research 
relating to the generation of biological datasets:
(i) The Secretary of Agriculture.
(ii) The Secretary of Defense.
(iii) The Secretary of Energy.
(iv) The Director of the National 
Aeronautics and Space Administration.
(v) The Director of the National Institutes 
of Health.
(vi) The Administrator of the National 
Science Foundation.
(vii) The head of any other Federal agency 
the Director considers appropriate.
(5) Personnel.--To facilitate the establishment of the 
definitions, standards, resources, and frameworks under 
paragraph (1), and any update under paragraph (3), the Director 
shall hire staff as the Director determines necessary.
(b) Information Gathering.--
(1) In general.--Not later than 1 year after the date of 
the enactment of this Act, the Director shall inventory the 
following:
(A) Existing biotechnology standards utilized by 
recipients of Federal funding for biotechnology 
research to generate biological datasets.
(B) Existing biological datasets generated by 
recipients of Federal funding for biotechnology 
research.
(2) Publication.--Not later than 1 year after the Director 
completes the inventory requirement under paragraph (1), the 
Director shall make any information inventoried under that 
paragraph available to the public through a website of the 
National Institute of Standards and Technology.
(c) Test and Evaluation.--Not later than 1 year after the date of 
the enactment of this Act, and not less frequently than every 2 years 
thereafter, the Director shall coordinate with the Administrator of the 
National Science Foundation to conduct a test and evaluation of the 
definitions, standards, resources, and frameworks established pursuant 
to subsection (a)(1) on a sample of biological datasets generated as a 
result of qualified federally funded research to determine the 
following:
(1) Whether the definitions, standards, resources, and 
frameworks are clearly written, easy to follow, and easily 
applicable for the generation of biological datasets that are 
artificial intelligence-ready.
(2) Whether compliance with the definitions, standards, 
resources, and frameworks established under subsection (a)(1) 
when generating or curating biological datasets results in an 
undue burden on the recipients of such qualified federally 
funded research, and if so, how to modify the definitions, 
standards, resources, and frameworks, as the case may be, so as 
to reduce the burden.
(d) Agency-Specific Data Management Policies.--
(1) In general.--Not later than 2 years after the date of 
the enactment of this Act and in accordance with requirements 
under subsection (e), the Director shall establish or, if 
already established, review and revise agency-specific data 
management policies for each Federal agency that provides 
funding for qualified federally funded research to ensure 
implementation of policies that require that any biological 
dataset generated by a recipient of qualified federally funded 
research is artificial intelligence-ready.
(2) Elements.--The data management policies described in 
paragraph (1) shall include the following:
(A) A mechanism to ensure sufficient Federal 
funding to a recipient to satisfy the requirements of 
the definitions, standards, resources, and frameworks 
established under subsection (a)(1).
(B) A process for the Chief Data Officer of each 
Federal agency to designate an individual of such 
agency to ensure compliance with the policies 
established or revised under paragraph (1).
(3) Oversight mechanisms.--As part of the agency-specific 
data management policies under paragraph (1), the Director 
shall establish the following:
(A) A regularly updated central repository of the 
policies established at each Federal agency, made 
available to the public as the Director determines 
appropriate, for the purpose of tracking available 
policies.
(B) A publicly available database to serve as a 
single point of access, updated as the Director 
determines necessary, on which the head of any Federal 
agency may publish artificial intelligence-ready 
biological datasets.
(C) A reporting mechanism available to each Federal 
agency to report to the Director how the agency is 
complying with the policies.
(D) A mechanism available to each Federal agency to 
request assistance from the Director regarding 
compliance with the policies.
(e) Public Input and Feedback; Consultation.--In establishing the 
definitions, standards, resources, and frameworks under subsection 
(a)(1) and the agency-specific data management policies under 
subsection (d)(1), the Director shall carry out the following:
(1) Solicit input and feedback from the public regarding 
the definitions, standards, resources, and frameworks and the 
agency-specific data management policies.
(2) Consult with the following heads of Federal agencies 
that provide funding for qualified federally funded research to 
ensure such agencies are able to comply with the definitions, 
standards, resources, and frameworks and the agency-specific 
data management policies:
(A) The Secretary of Agriculture.
(B) The Secretary of Defense.
(C) The Secretary of Energy.
(D) The Director of the National Aeronautics and 
Space Administration.
(E) The Director of the National Institutes of 
Health.
(F) The Administrator of the National Science 
Foundation.
(G) The head of any other Federal agency as 
determined by the Director.
(f) Advisory Group.--
(1) In general.--Not later than 180 days after the date of 
the enactment of this Act, the Director shall establish an 
advisory group to carry out the following:
(A) To provide recommendations relating to the 
definitions, standards, resources, and frameworks 
established under subsection (a)(1).
(B) To review and provide feedback on the agency-
specific data management policies established or 
revised under subsection (d)(1).
(C) To provide recommendations to academic journals 
for guidelines relating to artificial intelligence-
ready biological datasets.
(D) To solicit recommendations from the academic 
community regarding implementation of the definitions, 
standards, resources, and frameworks.
(E) To provide any other guidance the Director may 
request.
(2) Membership.--
(A) In general.--The advisory group established 
under paragraph (1) shall be composed of not fewer than 
12 members to include--
(i) representatives of Federal agencies 
that award funds to recipients to carry out 
qualified federally funded research; and
(ii) representatives of academia, private 
sector entities, and academic publishers.
(B) Terms.--
(i) In general.--Each member shall serve 
for a term of 2 years.
(ii) Renewal.--Subject to the discretion of 
the Director, the term of each member may be 
renewed for an additional 2-year term.
(3) Chairperson.--
(A) Appointment.--The Chairperson of the advisory 
group shall be designated by the Director from among 
the members.
(B) Term.--The term of the Chairperson shall be 1 
year.
(C) Renewal.--Subject to the discretion of the 
Director, the term of a Chairperson may be renewed for 
an additional 1-year term.
(4) Reports.--
(A) Interim report.--Not later than 1 year after 
the date of the enactment of this Act, the advisory 
group shall submit to the Director a interim report 
that contains advice and guidance with respect to the 
matters described in paragraph (1).
(B) Subsequent reports.--If the advisory group or 
the Director determines appropriate, the advisory group 
shall submit to the Director subsequent reports 
relating to the matters described in paragraph (1).
(g) Federal Acquisition Regulation Revisions.--The Federal 
Acquisition Regulatory Council shall revised the Federal Acquisition 
Regulation as necessary to implement the definitions, standards, 
resources, and frameworks established under subsection (a)(1).
(h) Annual Report.--
(1) Interim report.--Not later than 1 year after the date 
of the enactment of this Act, the Director shall submit to 
Congress and the Comptroller General of the United States an 
interim report that includes information relating to the 
progress of establishing the definitions, standards, resources, 
and frameworks under subsection (a)(1) and the agency-specific 
data management policies under subsection (d)(1).
(2) Subsequent reports.--Not later than 2 years after the 
date of the enactment of this Act, and annually thereafter, the 
Director shall submit to Congress and the Comptroller General 
of the United States a report that includes information 
relating to the following:
(A) The establishment, implementation, and, if 
applicable, revision, of the definitions, standards, 
resources, and frameworks established under subsection 
(a)(1).
(B) The establishment, implementation, and, if 
applicable, revision of the agency-specific data 
management policies established or revised under 
subsection (d)(1).
(3) Additional requirement for first subsequent report.--
With respect to the first subsequent report under paragraph 
(2), the Director shall include a summary of the testing and 
evaluation under subsection (c) that includes information 
relating to the following:
(A) The findings of the testing and evaluation.
(B) The manner by which the Director addressed any 
concern identified as a result of the testing and 
evaluation.
(C) An assessment of any burden on recipients of 
funding for qualified federally funded research 
regarding ensuring that biological datasets are 
artificial intelligence-ready.
(D) A cost-benefit analysis of the value of 
ensuring that biological datasets are artificial 
intelligence-ready in relation to any such burden.
(i) Government Accountability Office Report.--Not later than 5 
years after the date of the enactment of this Act, the Comptroller 
General of the United States shall submit to Congress a report on the 
impact of the definitions, standards, resources, and frameworks 
established under subsection (a)(1), including the following:
(1) An assessment of the effectiveness of the definitions, 
standards, resources, and frameworks in ensuring each 
biological dataset generated by a recipient of funding for 
qualified federally funded research is artificial intelligence-
ready.
(2) An assessment of whether the implementation of the 
definitions, standards, resources, and frameworks, as the case 
may be, has resulted in an undue burden on any recipient of 
Federal funding.
(3) Any recommendations with respect to the implementation 
of the definitions, standards, resources, and frameworks.
(j) Sunset.--This section shall terminate on the date that is 10 
years after the date of the enactment of this Act.
(k) Definitions.--In this section:
(1) Biological data.--The term ``biological data'' means 
information that is measured, collected, or aggregated for 
analysis, including associated descriptors, derived from the 
structure, function, or process of a biological system.
(2) Biological dataset.--The term ``biological dataset'' 
means a discreet collection of biological data.
(3) Biological data repository.--The term ``biological data 
repository'' means any centralized data storage capacity meant 
for managing or storing biological data.
(4) Negative data.--The term ``negative data'' means data 
that disproves, fails to support, or explains through 
previously unknown or contradictory means a research hypothesis 
but that otherwise still advances scientific knowledge or 
understanding.
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