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 facilitate the establishment of 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 facilitate the establishment of 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 facilitating the establishment of the definition of the term artificial intelligence-ready under clause (i)(I), the Director shall take such actions as may be necessary to ensure such definition, when applied to a biological dataset, requires such dataset be 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 satisfies the definition of artificial intelligence-ready under clause (i)(I), the Director may, in consultation with the Chief Data Officer of the Federal department or 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 facilitating the establishment of the definition of the term qualified federally funded research under clause (i)(IV), the Director shall take such actions as may be necessary to include in such definition 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 that is artificial intelligence-ready. (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 facilitate the establishment of standards relating to making biological datasets artificial intelligence-ready, in accordance with the definition of artificial intelligence-ready under subparagraph (A)(i)(I). (C)

Resources and frameworks

In carrying out paragraph (1), the Director shall facilitate the establishment of 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 take such actions as may be necessary to ensure the definitions, standards, resources, and frameworks referred to in 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). (3)

Annual updates

Not later than 1 year after the date of the establishment of the definitions, standards, resources, and frameworks under paragraph (1), and annually thereafter, the Director shall review such definitions, standards, resources, and frameworks and, as the Director considers appropriate, shall update such definitions, standards, resources, and frameworks in accordance with 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 carry out the following: (A)Assess any existing standard related to biotechnology or artificial intelligence, including any standards inventoried pursuant to subsection (b)(1)(A), and, if appropriate, facilitate the incorporation of any such standards in the establishment of the standards referred to in paragraph (2)(B). (B)Consult with the following: (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 department or agency the Director considers appropriate. (C)Seek to consult with the following: (i)Private sector entities from the biotechnology industry. (ii)Members of academia. (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 2 years after the date of the enactment of this Act, 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 referred to in subsection (a)(1) on a sample of biological datasets generated as a result of qualified federally funded research to determine the following: (1)Whether such 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 such definitions, standards, resources, and frameworks 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 such definitions, standards, resources, or frameworks, as the case may be, so as to reduce such burden. (d)

Advice and assistance related to Federal department or agency data standards

(1)

In general

Not later than 2 years after the date of the enactment of this Act, the head of a Federal department or agency that provides funding for qualified federally funded research and that seeks to utilize a biological dataset of such department or agency to train an artificial intelligence model may make a request to the Director to provide advice or assistance with respect to developing the following: (A)Data standards for such training. (B)Any data management plan related to such data standards. (2)

Resources

A head of a Federal department or agency that makes a request pursuant to paragraph (1) may enter into an agreement with the Director to provide to the Director any resources as may be necessary for the Director to provide any advice or assistance related to such request. (3)

Oversight mechanisms

The Director shall establish the following: (A)A regularly updated central repository, made available to the public as the Director determines appropriate, on which the head of any Federal department or agency may publish any data standards, and data management plan related to such standards, relating to utilizing a biological dataset of such department or agency to train an artificial intelligence model. (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 department or agency may publish artificial intelligence-ready biological datasets. (C)A mechanism available to each Federal department or agency to make a request pursuant to paragraph (1). (4)

Public input

The Director may solicit input and feedback from the public with respect to any advice or assistance related to a request made pursuant to paragraph (1). (e)

Public input and feedback; consultation

In carrying out subsection (a)(1), the Director shall carry out the following: (1)Solicit input and feedback from the public regarding the definitions, standards, resources, and frameworks referred to in such subsection. (2)Consult the heads of Federal departments and agencies that provide funding for qualified federally funded research to ensure such departments and agencies are able to develop data standards, and any data management plan associated with such data standards, related to utilizing a biological dataset of such department or agency to train an artificial intelligence model, including the following: (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 department or 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)Provide recommendations relating to the definitions, standards, resources, and frameworks referred to in subsection (a)(1). (B)Review and provide feedback with respect to any advice or assistance related to a request made pursuant to subsection (d)(1). (C)Provide recommendations to academic journals for guidelines relating to artificial intelligence-ready biological datasets. (D)Solicit recommendations from the academic community regarding implementation of the definitions, standards, resources, and frameworks. (E)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. The Director shall carry out the following: (i)Appoint representatives of Federal departments or agencies that award funds to recipients to carry out qualified federally funded research. (ii)Seek to appoint 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 an 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 revise 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 facilitating the establishment of the definitions, standards, resources, and frameworks under subsection (a)(1) and any advice or assistance related to a request made pursuant to 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 referred to in subsection (a)(1). (B)Any advice or assistance related to a request made pursuant to 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 referred to in 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 intelligent-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.