,,ii #aaith ,,congress #b;d ,session ,s4 #djfi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ab1 #bjbf,mr4 ,young 7for himself and ,mr4 ,lujn7 introduced the following bill2 which was read twice and referred to the ,committee on ,commerce1 ,science1 and ,transportation ,a ,,bill ,to direct the ,director of the ,national ,institute of ,standards and ,technology to establish definitions1 standards1 resources1 and frameworks to ensure certain biological datasets are ready for use in artificial intelligence models1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,ai-,ready ,bio-,data ,standards ,act4 #b4 ,definitions1 standards1 resources1 and frameworks by the ,national ,institute of ,standards and ,technology for certain biological datasets 7a7 ,establishment 7#a7 ,in general ,not later than #b years after the date of the enactment of this ,act1 the ,director of the ,national ,institute of ,standards and ,technology 7in this section referred to as the ,director71 pursuant to recommendations from the advisory group under subsection 7f7 and taking into account any feedback received under subsection 7e71 shall establish definitions1 standards1 resources1 and frameworks to ensure each biological dataset generated as a result of qualified federally funded research is artificial intelligence-ready4 7#b7 ,requirements for definitions1 standards1 resources1 and frameworks 7,a7 ,definitions 7i7 ,in general ,in carrying out paragraph 7#a71 the ,director shall establish definitions for the following terms3 7,i7 ,artificial intelligence-ready4 7,,ii7 ,biomanufacturing4 7,,iii7 ,biotechnology4 7,,iv7 ,qualified federally funded research4 7ii7 ,requirements for definition of artificial intelligence-ready 7,i7 ,in general ,in defining artificial intelligence-ready under clause 7i77,i71 the ,director shall develop a definition that1 when applied to a biological dataset1 requires that the dataset is generated and formatted in a manner that-- 7aa7 enables the effective use of the dataset for training artificial intelligence models2 and 7bb7 supports advancements in research relating to artificial intelligence and biotechnology4 7,,ii7 ,discretion ,with respect to a biological dataset that otherwise meets the definition of artificial intelligence-ready established under clause 7i77,i71 the ,director may1 in consultation with the ,chief ,data ,officer of the ,federal agency that is responsible for such biological dataset1 determine that such dataset is not artificial intelligence-ready4 7iii7 ,requirements for definition of qualified federally funded research ,in defining qualified federally funded research under clause 7i77,,iv71 the ,director shall include certain conditions that1 if satisfied1 will result in certain federally funded research being qualified federally funded research4 ,such conditions shall include the following3 7,i7 ,the amount of ,federal funding awarded to a recipient4 7,,ii7 ,the capability of the recipient to generate a biological dataset1 which may include negative data1 that is artificial intelligence-ready1 regardless of the ability of the recipient to publish such dataset4 7,,iii7 ,the expertise of the recipient in generating a biological dataset that is artificial intelligence-ready4 7,,iv7 ,the size of the biological dataset generated by the recipient4 7,v7 ,any other condition the ,director considers appropriate4 7,b7 ,standards ,in carrying out paragraph 7#a71 the ,director shall establish standards relating to making biological datasets artificial intelligence-ready1 in accordance with the definition of artificial intelligence-ready established under subparagraph 7,a77i77,i7 of this paragraph4 7,c7 ,resources and frameworks ,in carrying out paragraph 7#a71 the ,director shall establish data management resources and cybersecurity frameworks for the following3 7i7 ,federal departments and agencies that provide either full or partial ,federal funding for research that generates biological datasets4 7ii7 ,federally funded researchers who are collecting1 cleaning1 curating1 or generating biological datasets to make the datasets artificial intelligence-ready4 7,d7 ,additional requirements ,the ,director shall ensure that the definitions1 standards1 resources1 and frameworks established under paragraph 7#a7-- 7i7 are not overly burdensome on recipients of funding for qualified federally funded research1 such that the act of generating biological datasets that are artificial intelligence-ready requires resources and expertise beyond those available to the recipients2 and 7ii7 are tested and evaluated in accordance with subsection 7c7 and in consultation with-- 7,i7 the head of any ,federal agency the ,director considers appropriate2 7,,ii7 representatives from any private sector entity the ,director considers appropriate2 and 7,,iii7 any biotechnology researcher the ,director considers appropriate4 7#c7 ,annual updates ,not later than #a year after the establishment of the definitions1 standards1 resources1 and frameworks under paragraph 7#a71 and annually thereafter1 the ,director shall review the definitions1 standards1 resources1 and frameworks and1 if the ,director considers it appropriate1 shall update the definitions1 standards1 resources1 and frameworks in accordance with the requirements of this section4 7#d7 ,consultation ,to facilitate the establishment of the definitions1 standards1 resources1 and frameworks under paragraph 7#a71 and any update under paragraph 7#c71 the ,director shall consult with the following3 7,a7 ,private sector entities from the biotechnology industry4 7,b7 ,private sector entities from the frontier artificial intelligence model industry4 7,c7 ,members of academia4 7,d7 ,the following heads of ,federal agencies that provide funding for qualified federally funded research relating to the generation of biological datasets3 7i7 ,the ,secretary of ,agriculture4 7ii7 ,the ,secretary of ,defense4 7iii7 ,the ,secretary of ,energy4 7iv7 ,the ,director of the ,national ,aeronautics and ,space ,administration4 7v7 ,the ,director of the ,national ,institutes of ,health4 7vi7 ,the ,administrator of the ,national ,science ,foundation4 7vii7 ,the head of any other ,federal agency the ,director considers appropriate4 7#e7 ,personnel ,to facilitate the establishment of the definitions1 standards1 resources1 and frameworks under paragraph 7#a71 and any update under paragraph 7#c71 the ,director shall hire staff as the ,director determines necessary4 7b7 ,information gathering 7#a7 ,in general ,not later than #a year after the date of the enactment of this ,act1 the ,director shall inventory the following3 7,a7 ,existing biotechnology standards utilized by recipients of ,federal funding for biotechnology research to generate biological datasets4 7,b7 ,existing biological datasets generated by recipients of ,federal funding for biotechnology research4 7#b7 ,publication ,not later than #a year after the ,director completes the inventory requirement under paragraph 7#a71 the ,director shall make any information inventoried under that paragraph available to the public through a website of the ,national ,institute of ,standards and ,technology4 7c7 ,test and evaluation ,not later than #a year after the date of the enactment of this ,act1 and not less frequently than every #b years thereafter1 the ,director shall coordinate with the ,administrator of the ,national ,science ,foundation to conduct a test and evaluation of the definitions1 standards1 resources1 and frameworks established pursuant to subsection 7a77#a7 on a sample of biological datasets generated as a result of qualified federally funded research to determine the following3 7#a7 ,whether the definitions1 standards1 resources1 and frameworks are clearly written1 easy to follow1 and easily applicable for the generation of biological datasets that are artificial intelligence-ready4 7#b7 ,whether compliance with the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a7 when generating or curating biological datasets results in an undue burden on the recipients of such qualified federally funded research1 and if so1 how to modify the definitions1 standards1 resources1 and frameworks1 as the case may be1 so as to reduce the burden4 7d7 ,agency-,specific data management policies 7#a7 ,in general ,not later than #b years after the date of the enactment of this ,act and in accordance with requirements under subsection 7e71 the ,director shall establish or1 if already established1 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-ready4 7#b7 ,elements ,the data management policies described in paragraph 7#a7 shall include the following3 7,a7 ,a mechanism to ensure sufficient ,federal funding to a recipient to satisfy the requirements of the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a74 7,b7 ,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 7#a74 7#c7 ,oversight mechanisms ,as part of the agency-specific data management policies under paragraph 7#a71 the ,director shall establish the following3 7,a7 ,a regularly updated central repository of the policies established at each ,federal agency1 made available to the public as the ,director determines appropriate1 for the purpose of tracking available policies4 7,b7 ,a publicly available database to serve as a single point of access1 updated as the ,director determines necessary1 on which the head of any ,federal agency may publish artificial intelligence-ready biological datasets4 7,c7 ,a reporting mechanism available to each ,federal agency to report to the ,director how the agency is complying with the policies4 7,d7 ,a mechanism available to each ,federal agency to request assistance from the ,director regarding compliance with the policies4 7e7 ,public input and feedback2 consultation ,in establishing the definitions1 standards1 resources1 and frameworks under subsection 7a77#a7 and the agency-specific data management policies under subsection 7d77#a71 the ,director shall carry out the following3 7#a7 ,solicit input and feedback from the public regarding the definitions1 standards1 resources1 and frameworks and the agency-specific data management policies4 7#b7 ,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 definitions1 standards1 resources1 and frameworks and the agency-specific data management policies3 7,a7 ,the ,secretary of ,agriculture4 7,b7 ,the ,secretary of ,defense4 7,c7 ,the ,secretary of ,energy4 7,d7 ,the ,director of the ,national ,aeronautics and ,space ,administration4 7,e7 ,the ,director of the ,national ,institutes of ,health4 7,f7 ,the ,administrator of the ,national ,science ,foundation4 7,g7 ,the head of any other ,federal agency as determined by the ,director4 7f7 ,advisory group 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,director shall establish an advisory group to carry out the following3 7,a7 ,to provide recommendations relating to the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a74 7,b7 ,to review and provide feedback on the agency-specific data management policies established or revised under subsection 7d77#a74 7,c7 ,to provide recommendations to academic journals for guidelines relating to artificial intelligence-ready biological datasets4 7,d7 ,to solicit recommendations from the academic community regarding implementation of the definitions1 standards1 resources1 and frameworks4 7,e7 ,to provide any other guidance the ,director may request4 7#b7 ,membership 7,a7 ,in general ,the advisory group established under paragraph 7#a7 shall be composed of not fewer than #ab members to include-- 7i7 representatives of ,federal agencies that award funds to recipients to carry out qualified federally funded research2 and 7ii7 representatives of academia1 private sector entities1 and academic publishers4 7,b7 ,terms 7i7 ,in general ,each member shall serve for a term of #b years4 7ii7 ,renewal ,subject to the discretion of the ,director1 the term of each member may be renewed for an additional #b-year term4 7#c7 ,chairperson 7,a7 ,appointment ,the ,chairperson of the advisory group shall be designated by the ,director from among the members4 7,b7 ,term ,the term of the ,chairperson shall be #a year4 7,c7 ,renewal ,subject to the discretion of the ,director1 the term of a ,chairperson may be renewed for an additional #a-year term4 7#d7 ,reports 7,a7 ,interim report ,not later than #a year after the date of the enactment of this ,act1 the advisory group shall submit to the ,director a interim report that contains advice and guidance with respect to the matters described in paragraph 7#a74 7,b7 ,subsequent reports ,if the advisory group or the ,director determines appropriate1 the advisory group shall submit to the ,director subsequent reports relating to the matters described in paragraph 7#a74 7g7 ,federal ,acquisition ,regulation revisions ,the ,federal ,acquisition ,regulatory ,council shall revised the ,federal ,acquisition ,regulation as necessary to implement the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a74 7h7 ,annual report 7#a7 ,interim report ,not later than #a year after the date of the enactment of this ,act1 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 definitions1 standards1 resources1 and frameworks under subsection 7a77#a7 and the agency-specific data management policies under subsection 7d77#a74 7#b7 ,subsequent reports ,not later than #b years after the date of the enactment of this ,act1 and annually thereafter1 the ,director shall submit to ,congress and the ,comptroller ,general of the ,united ,states a report that includes information relating to the following3 7,a7 ,the establishment1 implementation1 and1 if applicable1 revision1 of the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a74 7,b7 ,the establishment1 implementation1 and1 if applicable1 revision of the agency-specific data management policies established or revised under subsection 7d77#a74 7#c7 ,additional requirement for first subsequent report ,with respect to the first subsequent report under paragraph 7#b71 the ,director shall include a summary of the testing and evaluation under subsection 7c7 that includes information relating to the following3 7,a7 ,the findings of the testing and evaluation4 7,b7 ,the manner by which the ,director addressed any concern identified as a result of the testing and evaluation4 7,c7 ,an assessment of any burden on recipients of funding for qualified federally funded research regarding ensuring that biological datasets are artificial intelligence-ready4 7,d7 ,a cost-benefit analysis of the value of ensuring that biological datasets are artificial intelligence-ready in relation to any such burden4 7i7 ,government ,accountability ,office report ,not later than #e years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report on the impact of the definitions1 standards1 resources1 and frameworks established under subsection 7a77#a71 including the following3 7#a7 ,an assessment of the effectiveness of the definitions1 standards1 resources1 and frameworks in ensuring each biological dataset generated by a recipient of funding for qualified federally funded research is artificial intelligence-ready4 7#b7 ,an assessment of whether the implementation of the definitions1 standards1 resources1 and frameworks1 as the case may be1 has resulted in an undue burden on any recipient of ,federal funding4 7#c7 ,any recommendations with respect to the implementation of the definitions1 standards1 resources1 and frameworks4 7j7 ,sunset ,this section shall terminate on the date that is #aj years after the date of the enactment of this ,act4 7k7 ,definitions ,in this section3 7#a7 ,biological data ,the term biological data means information that is measured1 collected1 or aggregated for analysis1 including associated descriptors1 derived from the structure1 function1 or process of a biological system4 7#b7 ,biological dataset ,the term biological dataset means a discreet collection of biological data4 7#c7 ,biological data repository ,the term biological data repository means any centralized data storage capacity meant for managing or storing biological data4 7#d7 ,negative data ,the term negative data means data that disproves1 fails to support1 or explains through previously unknown or contradictory means a research hypothesis but that otherwise still advances scientific knowledge or understanding4