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<dc:title>117 S1624 IS: National Laboratory Biotechnology Research Act of 2021</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2021-05-13</dc:date>
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<dc:language>EN</dc:language>
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<distribution-code display="yes">II</distribution-code><congress>117th CONGRESS</congress><session>1st Session</session><legis-num>S. 1624</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20210513">May 13, 2021</action-date><action-desc><sponsor name-id="S409">Mr. Luján</sponsor> introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSEG00">Committee on Energy and Natural Resources</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To direct the Secretary of Energy to establish a National Laboratory Biotechnology Program to address biotechnology threats, and for other purposes. </official-title></form><legis-body><section id="S1" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>National Laboratory Biotechnology Research Act of 2021</short-title></quote>.</text></section><section id="id98c0fd592a0640b1bebc6ca6340b40c4"><enum>2.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act: </text><paragraph id="id4726d961f74c41ca83ce1fc74cbf4d46"><enum>(1)</enum><header>Department</header><text>The term <term>Department</term> means the Department of Energy.</text></paragraph><paragraph id="id21e4fdf5d48c4e7bb4914518749e20ee"><enum>(2)</enum><header>National Laboratory</header><text>The term <term>National Laboratory</term> has the meaning given the term in section 2 of the Energy Policy Act of 2005 (<external-xref legal-doc="usc" parsable-cite="usc/42/15801">42 U.S.C. 15801</external-xref>).</text></paragraph><paragraph id="id90b84f0c8e314ec78e11501fc923ed52"><enum>(3)</enum><header>NNSA</header><text>The term <term>NNSA</term> means the National Nuclear Security Administration.</text></paragraph><paragraph id="id4574C05A23E04BC2B0159F3DC7BD6B4E"><enum>(4)</enum><header>Office</header><text>The term <term>Office</term> means the joint program office established under section 3(b).</text></paragraph><paragraph id="id7e58fb5629304c8f8daa2c92ba2b60b3"><enum>(5)</enum><header>Office of Intelligence and Counterintelligence</header><text>The term <term>Office of Intelligence and Counterintelligence</term> means the Office of Intelligence and Counterintelligence of the Department.</text></paragraph><paragraph id="id23fae47398c24738a4329dd106e71a53"><enum>(6)</enum><header>Office of Science</header><text>The term <term>Office of Science</term> means the Office of Science of the Department.</text></paragraph><paragraph id="id6563dc09f7b744a2b309a74b16fd7bf0"><enum>(7)</enum><header>Program</header><text>The term <term>Program</term> means the National Laboratory Biotechnology Program established under section 3(a). </text></paragraph><paragraph id="id9ae97dc5350540cc9b49e6d9713e7648"><enum>(8)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Energy.</text></paragraph></section><section id="id8e3ad7448ddf4ae0b95a1e5303850652"><enum>3.</enum><header>National Laboratory Biotechnology Program</header><subsection id="id1d822188049e4e208e26bafa02c59cd6"><enum>(a)</enum><header>In general</header><text>The Secretary shall establish a National Laboratory Biotechnology Program to integrate the resources of the Department, including the Office of Science, the Office of Intelligence and Counterintelligence, and the NNSA, to provide research, development, test and evaluation, and response capabilities to respond to—</text><paragraph id="id6f9c94366d8f49a4a91b6374c27c8d02"><enum>(1)</enum><text>long-term biotechnology threats facing the United States; and</text></paragraph><paragraph id="id73bc1ebb67d34fd8be1fc1b6c592e1dd"><enum>(2)</enum><text>any remaining threats posed by COVID–19. </text></paragraph></subsection><subsection id="id38032ede3ccf45fb99c13da79ef66e83"><enum>(b)</enum><header>Joint program office</header><text>To carry out the Program, the Secretary shall establish a joint program office, which shall comprise appropriate leadership from the Office of Science, the NNSA, and the National Laboratories.</text></subsection><subsection id="idd794bbd2cb78461595dbb9057cd1e703"><enum>(c)</enum><header>Functions</header><text>The Office shall—</text><paragraph id="ide3bb7f854e834981a573374d1ee06775"><enum>(1)</enum><text>oversee the development and operation of major research activities of the Program;</text></paragraph><paragraph id="ide4b4f894ea654a598bff02448e51df79" commented="no" display-inline="no-display-inline"><enum>(2)</enum><text>periodically review and recommend updates as necessary to Program policies and guidelines for the development and operation of major research activities; </text></paragraph><paragraph id="idd721df4cecfc441caaadf426bfc1e374"><enum>(3)</enum><text>collaborate with the directors of research directorates of the Department, directors of National Laboratories, and other senior Department officials, as appropriate, to gain greater access to top researchers and new and potentially transformative ideas;</text></paragraph><paragraph id="id697084ae94f445e4a2a398d7711ba40b"><enum>(4)</enum><text>enable access to broad scientific and technical expertise and resources that will lead to the deployment of innovative products, including through—</text><subparagraph id="idf197a0dd80ec42cfa849298688409445"><enum>(A)</enum><text>research and development, including proof of concept, technical development, and compliance testing activities; and</text></subparagraph><subparagraph id="id30f840b93640496695e7f81a7e4570d1"><enum>(B)</enum><text>early-stage product development, including through—</text><clause id="id834ac24617604cd8a89e660d36608d70"><enum>(i)</enum><text>computational modeling and simulation;</text></clause><clause id="id1381cc78578a499fb89f8c5e0a040c7f"><enum>(ii)</enum><text>molecular structural determination;</text></clause><clause id="id6b3fd43eef784b5badb001834a3179b6"><enum>(iii)</enum><text>genomic sequencing;</text></clause><clause id="id373705e6c26848c58a6909810df3cfc2"><enum>(iv)</enum><text>epidemiological and logistics support;</text></clause><clause id="id56cf636745ba4071bc58d389f1c50832"><enum>(v)</enum><text>knowledge discovery infrastructure and scalable protected data;</text></clause><clause id="id1fe9d8f522b94c40b3c293092cef3a7a" commented="no"><enum>(vi)</enum><text>advanced manufacturing to address supply chain bottlenecks; </text></clause><clause id="id986ee2dd002542ddade3c588cb92c4ab"><enum>(vii)</enum><text>new capabilities for testing of clinical and nonclinical samples;</text></clause><clause id="id2c5905c0fd5f42edbd5d4c75e57a1ba4"><enum>(viii)</enum><text>understanding environmental fate and transport of viruses; and</text></clause><clause id="ide3571cfff13148fc97e061d067345c4f"><enum>(ix)</enum><text>discovery of potential therapeutics through computation and molecular structure determination;</text></clause></subparagraph></paragraph><paragraph id="id1d646b077850426caaf64268ad31d04f"><enum>(5)</enum><text>provide access to user facilities with advanced or unique equipment, services, materials, and other resources to perform research and testing; </text></paragraph><paragraph id="idd7a4086e44bd498ead85e4d53be80d1a"><enum>(6)</enum><text>support technology transfer and related activities; and</text></paragraph><paragraph id="id70b0d44becd74b2d9e4cc21d2c81015b"><enum>(7)</enum><text>promote access and development across the Federal Government and to United States industry, including startup companies, of early applications of the technologies, innovations, and expertise beneficial to the public that are derived from Program activities. </text></paragraph></subsection><subsection id="id46A333D4CC0E4BB895DC48DDE7F6E61B"><enum>(d)</enum><header>Biodefense expertise</header><paragraph id="idb6ca4b57b23743958e867641f630835f"><enum>(1)</enum><header>In general</header><text>In carrying out the Program, the Office shall support research that harnesses the capabilities of the National Laboratories to address advanced biological threats of national security significance through assessments and research and development programs that—</text><subparagraph id="idA4D1049B0BA94C0B8BCFC92C6C012DBC"><enum>(A)</enum><text>support the near- and long-term biodefense needs of the United States;</text></subparagraph><subparagraph id="id88E72DADA12441238BAFC02FA4A319B3"><enum>(B)</enum><text>support the national security community in reducing uncertainty and risk;</text></subparagraph><subparagraph id="id04F62C79E77C41D68F203EECB0130FD2"><enum>(C)</enum><text>enable greater access to top researchers and new and potentially transformative ideas for biodefense of human, animal, plant, environment, and infrastructure assets (including physical, cyber, and economic infrastructure); and </text></subparagraph><subparagraph id="ida3e62e9d031746578e637c0280a16402"><enum>(D)</enum><text>enable access to broad scientific and technical expertise and resources that will lead to the development and deployment of innovative biodefense assessments and solutions, including through—</text><clause id="idd1dff198f9d44301b3b40d13d6bc7b47"><enum>(i)</enum><text>the accessing, monitoring, and evaluation of biological threats to reduce risk, including through analysis and prioritization of gaps and vulnerabilities across open-source and classified data;</text></clause><clause id="idfd46b8d6a8e147e4b6dc2e4011dab87f"><enum>(ii)</enum><text>development of scientific and technical roadmaps—</text><subclause id="idE9D1E5B31343447D8AF3ADBDE1E512A4"><enum>(I)</enum><text>to address gaps and vul­ner­a­bil­i­ties;</text></subclause><subclause id="idD41E41CA701B4EBCAE0B9157595C1C68"><enum>(II)</enum><text>to inform analyses of technologies; and </text></subclause><subclause id="id91F28ED3EE9E4815832C387D3DC9AC9B"><enum>(III)</enum><text>to accelerate the application of unclassified research to classified applications; and</text></subclause></clause><clause id="id75ccc11be74a4bb8a2a97e6324a935b0"><enum>(iii)</enum><text>demonstration activities to enable deployment, including—</text><subclause id="ida2f2e0ec2fe14f798cca6d8edf263519"><enum>(I)</enum><text>threat signature development and validation;</text></subclause><subclause id="id1c974ae05cae489c8ce22141f290d1ff"><enum>(II)</enum><text>automated anomaly detection using artificial intelligence and machine learning;</text></subclause><subclause id="id1a5031aa1f61431098eb50d5a8f8b98e"><enum>(III)</enum><text>fate and transport dynamics for priority scenarios;</text></subclause><subclause id="idc27fc05a90ed461c885536d9ab6022f7"><enum>(IV)</enum><text>data curation, access, storage, and security at scale; and</text></subclause><subclause id="idf915fe92239543768b2dfef39e680385"><enum>(V)</enum><text>risk assessment tools.</text></subclause></clause></subparagraph></paragraph><paragraph id="idba5fcf108dd54de18a6f592259c4e5ee" commented="no"><enum>(2)</enum><header>Resources</header><text>The Secretary shall ensure that the Office is provided and uses sufficient resources to carry out paragraph (1).</text></paragraph></subsection><subsection id="ide974e92993dc4bdfba96cd6f17ab276f"><enum>(e)</enum><header>Strengthening institutional research and private partnerships</header><paragraph id="idfc6271c9e5424475a124b33c715a4f7b"><enum>(1)</enum><header>In general</header><text>The Office shall, to the maximum extent practicable, promote cooperative research and development activities under the Program, including collaboration between appropriate industry and academic institutions to promote innovation and knowledge creation.</text></paragraph><paragraph id="ide34b2e0a71c4446cbf230151efbe61cf"><enum>(2)</enum><header>Accessibility of information</header><text>The Office shall develop, maintain, and publicize information on scientific user facilities and capabilities supported by laboratories of the Department for combating biotechnology threats, which shall be accessible for use by individuals from academic institutions and industry.</text></paragraph><paragraph id="iddba0cb7f0b9b4614a63c6d658412c466"><enum>(3)</enum><header>Academic participation</header><text>The Office shall, to the maximum extent practicable—</text><subparagraph id="ided33fde97dec47b4bd092b70ddcb83f8"><enum>(A)</enum><text>conduct outreach about internship opportunities relating to activities under the Program primarily to institutions of higher education (as defined in section 101 of the Higher Education Act of 1965 (<external-xref legal-doc="usc" parsable-cite="usc/20/1001">20 U.S.C. 1001</external-xref>)) and minority-serving institutions of higher education;</text></subparagraph><subparagraph id="idf93e4607f1b64608a022b571162f3b5d"><enum>(B)</enum><text>encourage the development of research collaborations between research-intensive universities and the institutions described in subparagraph (A); and</text></subparagraph><subparagraph id="id5c9b900aa3694695a0f6b1f22b7e667c"><enum>(C)</enum><text>provide traineeships at the institutions described in subparagraph (A) to graduate students who pursue a masters or doctoral degree in an academic field relevant to research advanced under the Program. </text></subparagraph></paragraph></subsection><subsection id="id7ea813008bf740c5896f9bf507e8142b"><enum>(f)</enum><header>Evaluation and plan</header><paragraph id="id9f440980efa84bedb9f443ab9aa29975"><enum>(1)</enum><header>In general</header><text>Not less frequently than biennially, the Secretary shall—</text><subparagraph id="id4c0105d41b4c48bd9b59e6f7eb0a1b16"><enum>(A)</enum><text>evaluate the activities carried out under the Program; and</text></subparagraph><subparagraph id="id2480B84B4E7843C6B2FCB1F2C59F0443"><enum>(B)</enum><text>develop a strategic research plan under the Program, which shall be made publicly available and submitted to the Committee on Energy and Natural Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives.</text></subparagraph></paragraph><paragraph id="id9e26636e2e854287bf5ae9797d3d6e3e"><enum>(2)</enum><header>Classified information</header><text>If the strategic research plan developed under paragraph (1)(B) contains classified information, the plan—</text><subparagraph id="id8906BB16048D46028EDC188C48B6B2D0"><enum>(A)</enum><text>shall be made publicly available and submitted to the committees of Congress described in paragraph (1)(B) in an unclassified format; and</text></subparagraph><subparagraph id="idf8497f8d4d044c8289c31238f90141dd"><enum>(B)</enum><text>may, as part of the submission to those committees of Congress only, include a classified annex containing any sensitive or classified information, as necessary.</text></subparagraph></paragraph></subsection><subsection id="id758c21001e4e4161ad83d87ddecf7f75"><enum>(g)</enum><header>Interagency collaboration</header><text display-inline="yes-display-inline">The Office may collaborate with the Secretary of Homeland Security, the Secretary of Health and Human Services, the Secretary of Defense, and the heads of other appropriate Federal departments and agencies to advance biotechnology research and development under the Program. </text></subsection><subsection id="id1bc736ff610c492089d6eeec474fdfa7"><enum>(h)</enum><header>Authorization of appropriations</header><text display-inline="yes-display-inline">There are authorized to be appropriated to the Secretary to carry out this section, to remain available until expended—</text><paragraph id="id727e7e85d08a4de4b9e5ce972eadd5bb"><enum>(1)</enum><text>$30,000,000 for fiscal year 2022;</text></paragraph><paragraph id="id6d65534e6d4d4a2094892125071462a9"><enum>(2)</enum><text>$40,000,000 for fiscal year 2023;</text></paragraph><paragraph id="idc5f0e6fd5603459f8b4867623cd53878"><enum>(3)</enum><text>$45,000,000 for fiscal year 2024; and</text></paragraph><paragraph id="idfb27838dd70b463ab8682f2939e09774"><enum>(4)</enum><text>$50,000,000 for each of fiscal years 2025 and 2026.</text></paragraph></subsection></section></legis-body></bill> 

