[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.
<all>
AI-Ready Bio-Data Standards Act
#4069 | S Congress #119
Policy Area: Science, Technology, Communications
Subjects:
Last Action: Read twice and referred to the Committee on Commerce, Science, and Transportation. (3/12/2026)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text