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.