National Laboratory Biotechnology Research Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1624 To direct the Secretary of Energy to establish a National Laboratory Bio- technology Program to address biotechnology threats, and for other pur- poses. IN THE SENATE OF THE UNITED STATES MAY 13, 2021 Mr. LUJA´N introduced the following bill; which was read twice and referred to the Committee on Energy and Natural Resources A BILL To direct the Secretary of Energy to establish a National Laboratory Biotechnology Program to address bio- technology threats, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘National Laboratory 4 Biotechnology Research Act of 2021’’. 5 SEC. 2. DEFINITIONS. 6 In this Act: 7 (1) DEPARTMENT.—The term ‘‘Department’’ 8 means the Department of Energy. 9 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 2 •S 1624 IS (2) NATIONAL LABORATORY.—The term ‘‘Na- 1 tional Laboratory’’ has the meaning given the term 2 in section 2 of the Energy Policy Act of 2005 (42 3 U.S.C. 15801). 4 (3) NNSA.—The term ‘‘NNSA’’ means the Na- 5 tional Nuclear Security Administration. 6 (4) OFFICE.—The term ‘‘Office’’ means the 7 joint program office established under section 3(b). 8 (5) OFFICE OF INTELLIGENCE AND COUNTER- 9 INTELLIGENCE.—The term ‘‘Office of Intelligence 10 and Counterintelligence’’ means the Office of Intel- 11 ligence and Counterintelligence of the Department. 12 (6) OFFICE OF SCIENCE.—The term ‘‘Office of 13 Science’’ means the Office of Science of the Depart- 14 ment. 15 (7) PROGRAM.—The term ‘‘Program’’ means 16 the National Laboratory Biotechnology Program es- 17 tablished under section 3(a). 18 (8) SECRETARY.—The term ‘‘Secretary’’ means 19 the Secretary of Energy. 20 SEC. 3. NATIONAL LABORATORY BIOTECHNOLOGY PRO- 21 GRAM. 22 (a) IN GENERAL.—The Secretary shall establish a 23 National Laboratory Biotechnology Program to integrate 24 the resources of the Department, including the Office of 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 3 •S 1624 IS Science, the Office of Intelligence and Counterintelligence, 1 and the NNSA, to provide research, development, test and 2 evaluation, and response capabilities to respond to— 3 (1) long-term biotechnology threats facing the 4 United States; and 5 (2) any remaining threats posed by COVID–19. 6 (b) JOINT PROGRAM OFFICE.—To carry out the Pro- 7 gram, the Secretary shall establish a joint program office, 8 which shall comprise appropriate leadership from the Of- 9 fice of Science, the NNSA, and the National Laboratories. 10 (c) FUNCTIONS.—The Office shall— 11 (1) oversee the development and operation of 12 major research activities of the Program; 13 (2) periodically review and recommend updates 14 as necessary to Program policies and guidelines for 15 the development and operation of major research ac- 16 tivities; 17 (3) collaborate with the directors of research di- 18 rectorates of the Department, directors of National 19 Laboratories, and other senior Department officials, 20 as appropriate, to gain greater access to top re- 21 searchers and new and potentially transformative 22 ideas; 23 (4) enable access to broad scientific and tech- 24 nical expertise and resources that will lead to the de- 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 4 •S 1624 IS ployment of innovative products, including 1 through— 2 (A) research and development, including 3 proof of concept, technical development, and 4 compliance testing activities; and 5 (B) early-stage product development, in- 6 cluding through— 7 (i) computational modeling and sim- 8 ulation; 9 (ii) molecular structural determina- 10 tion; 11 (iii) genomic sequencing; 12 (iv) epidemiological and logistics sup- 13 port; 14 (v) knowledge discovery infrastructure 15 and scalable protected data; 16 (vi) advanced manufacturing to ad- 17 dress supply chain bottlenecks; 18 (vii) new capabilities for testing of 19 clinical and nonclinical samples; 20 (viii) understanding environmental 21 fate and transport of viruses; and 22 (ix) discovery of potential therapeutics 23 through computation and molecular struc- 24 ture determination; 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 5 •S 1624 IS (5) provide access to user facilities with ad- 1 vanced or unique equipment, services, materials, and 2 other resources to perform research and testing; 3 (6) support technology transfer and related ac- 4 tivities; and 5 (7) promote access and development across the 6 Federal Government and to United States industry, 7 including startup companies, of early applications of 8 the technologies, innovations, and expertise bene- 9 ficial to the public that are derived from Program 10 activities. 11 (d) BIODEFENSE EXPERTISE.— 12 (1) IN GENERAL.—In carrying out the Pro- 13 gram, the Office shall support research that har- 14 nesses the capabilities of the National Laboratories 15 to address advanced biological threats of national se- 16 curity significance through assessments and research 17 and development programs that— 18 (A) support the near- and long-term bio- 19 defense needs of the United States; 20 (B) support the national security commu- 21 nity in reducing uncertainty and risk; 22 (C) enable greater access to top research- 23 ers and new and potentially transformative 24 ideas for biodefense of human, animal, plant, 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 6 •S 1624 IS environment, and infrastructure assets (includ- 1 ing physical, cyber, and economic infrastruc- 2 ture); and 3 (D) enable access to broad scientific and 4 technical expertise and resources that will lead 5 to the development and deployment of innova- 6 tive biodefense assessments and solutions, in- 7 cluding through— 8 (i) the accessing, monitoring, and 9 evaluation of biological threats to reduce 10 risk, including through analysis and 11 prioritization of gaps and vulnerabilities 12 across open-source and classified data; 13 (ii) development of scientific and tech- 14 nical roadmaps— 15 (I) to address gaps and vulnera- 16 bilities; 17 (II) to inform analyses of tech- 18 nologies; and 19 (III) to accelerate the application 20 of unclassified research to classified 21 applications; and 22 (iii) demonstration activities to enable 23 deployment, including— 24 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 7 •S 1624 IS (I) threat signature development 1 and validation; 2 (II) automated anomaly detection 3 using artificial intelligence and ma- 4 chine learning; 5 (III) fate and transport dynamics 6 for priority scenarios; 7 (IV) data curation, access, stor- 8 age, and security at scale; and 9 (V) risk assessment tools. 10 (2) RESOURCES.—The Secretary shall ensure 11 that the Office is provided and uses sufficient re- 12 sources to carry out paragraph (1). 13 (e) STRENGTHENING INSTITUTIONAL RESEARCH 14 AND PRIVATE PARTNERSHIPS.— 15 (1) IN GENERAL.—The Office shall, to the max- 16 imum extent practicable, promote cooperative re- 17 search and development activities under the Pro- 18 gram, including collaboration between appropriate 19 industry and academic institutions to promote inno- 20 vation and knowledge creation. 21 (2) ACCESSIBILITY OF INFORMATION.—The Of- 22 fice shall develop, maintain, and publicize informa- 23 tion on scientific user facilities and capabilities sup- 24 ported by laboratories of the Department for com- 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 8 •S 1624 IS bating biotechnology threats, which shall be acces- 1 sible for use by individuals from academic institu- 2 tions and industry. 3 (3) ACADEMIC PARTICIPATION.—The Office 4 shall, to the maximum extent practicable— 5 (A) conduct outreach about internship op- 6 portunities relating to activities under the Pro- 7 gram primarily to institutions of higher edu- 8 cation (as defined in section 101 of the Higher 9 Education Act of 1965 (20 U.S.C. 1001)) and 10 minority-serving institutions of higher edu- 11 cation; 12 (B) encourage the development of research 13 collaborations between research-intensive uni- 14 versities and the institutions described in sub- 15 paragraph (A); and 16 (C) provide traineeships at the institutions 17 described in subparagraph (A) to graduate stu- 18 dents who pursue a masters or doctoral degree 19 in an academic field relevant to research ad- 20 vanced under the Program. 21 (f) EVALUATION AND PLAN.— 22 (1) IN GENERAL.—Not less frequently than bi- 23 ennially, the Secretary shall— 24 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 9 •S 1624 IS (A) evaluate the activities carried out 1 under the Program; and 2 (B) develop a strategic research plan under 3 the Program, which shall be made publicly 4 available and submitted to the Committee on 5 Energy and Natural Resources of the Senate 6 and the Committee on Energy and Commerce 7 of the House of Representatives. 8 (2) CLASSIFIED INFORMATION.—If the stra- 9 tegic research plan developed under paragraph 10 (1)(B) contains classified information, the plan— 11 (A) shall be made publicly available and 12 submitted to the committees of Congress de- 13 scribed in paragraph (1)(B) in an unclassified 14 format; and 15 (B) may, as part of the submission to 16 those committees of Congress only, include a 17 classified annex containing any sensitive or clas- 18 sified information, as necessary. 19 (g) INTERAGENCY COLLABORATION.—The Office 20 may collaborate with the Secretary of Homeland Security, 21 the Secretary of Health and Human Services, the Sec- 22 retary of Defense, and the heads of other appropriate Fed- 23 eral departments and agencies to advance biotechnology 24 research and development under the Program. 25 VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS 10 •S 1624 IS (h) AUTHORIZATION OF APPROPRIATIONS.—There 1 are authorized to be appropriated to the Secretary to carry 2 out this section, to remain available until expended— 3 (1) $30,000,000 for fiscal year 2022; 4 (2) $40,000,000 for fiscal year 2023; 5 (3) $45,000,000 for fiscal year 2024; and 6 (4) $50,000,000 for each of fiscal years 2025 7 and 2026. 8 Æ VerDate Sep 11 2014 05:23 May 27, 2021 Jkt 019200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6301 E:\BILLS\S1624.IS S1624 kjohnson on DSK79L0C42PROD with BILLS