Federal Research and Development in Support of Domestic Manufacturing and United States Jobs, 51203-51208 [2023-16636]

Download as PDF 51203 Presidential Documents Federal Register Vol. 88, No. 147 Wednesday, August 2, 2023 Title 3— Executive Order 14104 of July 28, 2023 The President Federal Research and Development in Support of Domestic Manufacturing and United States Jobs By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Policy. The United States maintains an unparalleled innovation ecosystem with world-class universities, Federal laboratories, research centers, and technology incubators, supported in part by Federal investment. Our world is healthier, smarter, more connected, and more sustainable because of Federal taxpayers’ investment in discovery and innovation that has supported the commercialization of new products and services. My Administration has prioritized support for our unique innovation ecosystem by reinvesting across sectors in research and development (R&D), demonstrations, education, and the necessary infrastructure to accelerate the transition of discoveries quickly from the lab to the marketplace. This investment is designed to produce cutting-edge technologies that support the competitiveness, domestic manufacturing capacity, and well-being of the United States economy; United States workers; our communities; and our national security. Ensuring the commercialization of federally funded inventions by United States manufacturers—while maintaining intellectual property rights—will build on the successful legacy of the United States in spurring economic growth and enhancing United States competitiveness through R&D. It will also further our joint R&D work with partners and allies to strengthen the resilience of global critical supply chains and secure America’s leadership in delivering a net-zero emissions economy by no later than 2050. ddrumheller on DSK120RN23PROD with PRESDOC-E1 Therefore, it is the policy of my Administration that when new technologies and products are developed with support from the United States Government, they will be manufactured in the United States whenever feasible and consistent with applicable law. Sec. 2. Coordination and Consultation. (a) The Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and the Director of the Office of Science and Technology Policy (OSTP) shall coordinate the executive branch actions necessary to implement this order through the interagency process identified in National Security Memorandum 2 of February 4, 2021 (Renewing the National Security Council System). (b) In implementing this order, the heads of executive departments and agencies (agencies) shall, as appropriate and consistent with applicable law, consult outside stakeholders—such as those in industry; academia, including Historically Black Colleges and Universities, Tribal Colleges and Universities, and other Minority Serving Institutions; non-governmental organizations; communities; labor unions; and State, local, Tribal, and territorial governments—in order to implement the policy identified in section 1 of this order. Sec. 3. Strengthening Domestic Manufacturing. (a) The Secretary of Defense, the Secretary of Agriculture, the Secretary of Commerce, the Secretary of Health and Human Services, the Secretary of Transportation, the Secretary of Energy, the Secretary of Homeland Security, the Director of the National Science Foundation, and the Administrator of the National Aeronautics and VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00003 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 51204 Federal Register / Vol. 88, No. 147 / Wednesday, August 2, 2023 / Presidential Documents Space Administration should consider domestic manufacturing in Federal R&D funding agreement solicitations, as appropriate and consistent with applicable law. These agency heads shall also consider how their respective agencies’ R&D funding agreements support broader domestic manufacturing objectives, including the development of production facilities and capabilities broadly supportive of United States manufacturing, as appropriate and consistent with applicable law. (b) The Director of OSTP, working through the National Science and Technology Council (NSTC) and in coordination with the Director of the Office of Management and Budget’s Made in America Office (Made in America Director) and the heads of agencies identified in subsection (a) of this section, shall seek to add ‘‘domestic manufacturing’’ to future interagency technology R&D roadmaps, as appropriate. The Director of OSTP shall endeavor to standardize the format of domestic manufacturing considerations in technology R&D roadmaps to ensure that industry, the research community, and agencies create the conditions for new technologies to be produced in the United States once they are commercialized. (c) In collaboration with the Administrator of the Small Business Administration (SBA), the heads of agencies participating in the Small Business Innovation Research and Small Business Technology Transfer programs are encouraged to advance a coordinated interagency approach to innovation and research solicitations with the goals of reducing barriers to program participation, streamlining access to funding opportunities, and encouraging production of new technologies in the United States. The heads of these agencies are further encouraged to collaborate with the SBA to support small businesses transitioning technologies from intramural and extramural labs to commercial markets. (d) The heads of agencies that have statutory Other Transaction Authority, or that can use other business arrangements authorized by the Congress, are encouraged, when appropriate, to consider using these authorities to purchase or invest in leading-edge technologies to support their production in the United States. If these agencies use these authorities to purchase or invest in the development of new technologies, the terms of these purchases and investments should ensure that the product is substantially manufactured in the United States, as appropriate and consistent with applicable law. ddrumheller on DSK120RN23PROD with PRESDOC-E1 (e) To further support the commercialization and production in the United States of technologies developed, in part, through federally funded R&D, the heads of agencies identified in subsection (a) of this section are encouraged to establish or enhance the technology transfer and commercialization capabilities of their agencies. Sec. 4. Modernizing Reporting of Invention Utilization. (a) In an effort to streamline reporting requirements for recipients of Federal R&D funding agreements, the heads of agencies identified in section 3(a) of this order should seek to make reporting on the utilization of ‘‘subject inventions’’ (as defined in 35 U.S.C. 201(e)) easier and consistent across the United States Government. (b) To incentivize domestic manufacturing through the reporting of invention disclosures and the utilization of those inventions, the heads of agencies identified in section 3(a) of this order shall require recipients of Federal R&D funding agreements to track and update the awarding agency on the location in which subject inventions are manufactured. (c) The heads of agencies identified in section 3(a) of this order should require recipients of Federal R&D funding agreements to report annually to the awarding agency the names of licensees and manufacturing locations of the applicable subject inventions. (d) Within 60 days of the date of this order, the Secretary of Commerce, through the Director of the National Institute of Standards and Technology (NIST) and in consultation with the Office of Management and Budget (OMB), should develop award terms and conditions regarding the reporting VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00004 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 Federal Register / Vol. 88, No. 147 / Wednesday, August 2, 2023 / Presidential Documents 51205 requirements in subsections (a) through (c) of this section to be implemented by each awarding agency identified in section 3(a) of this order. Award terms and conditions shall ensure that the reporting of the information specified in subsections (b) and (c) of this section protects business confidential information, consistent with 35 U.S.C. 202(c)(5), while providing increased visibility to taxpayers on the use of Federal R&D funding in support of domestic manufacturing and job creation. (e) The Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, shall consider developing an action plan, including resource requirements, to transition all agencies identified in section 3(a) of this order to the iEdison reporting system to track unclassified subject inventions, patents, and related utilization reports by calendar year 2025. The Secretary of Commerce shall submit the action plan to the Director of OMB within 1 year of the date of this order. (f) Not later than 120 days after issuance of any final regulations implementing the action plan described in subsection (e) of this section, the heads of agencies identified in section 3(a) of this order shall report to the Director of OMB and the Director of OSTP on steps their respective agencies have taken to transition all unclassified reporting to iEdison by the end of calendar year 2025. These reports may include resource needs and timelines for implementation. (g) Within 180 days of the date of this order, the Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, should develop common invention utilization questions (utilization questions), allowing agencies to add agency-specific questions. (i) The utilization questions should be used by all agencies by May 1, 2024, for subject inventions that a Federal R&D funding agreement recipient has elected to retain title on or after the date of this order. ddrumheller on DSK120RN23PROD with PRESDOC-E1 (ii) The utilization questions should require information on the locations where subject inventions are produced or are used to produce a product. (iii) The Secretary of Commerce, through the Director of NIST, and the heads of other agencies should aim to minimize the reporting burden on recipients of Federal R&D funding agreements associated with the utilization questions, in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) and applicable OMB guidance. (h) Within 2 years after the date of this order and annually thereafter, the heads of agencies identified in section 3(a) of this order shall submit reports to the Made in America Director on the utilization of inventions that were developed through their previous R&D funding agreements and reported after the date of this order, including where products embodying a subject invention or produced through the use of a subject invention were manufactured. Sec. 5. Securing Critical and Emerging Technologies Through Domestic Manufacturing. (a) Within 90 days of the date of this order, the heads of agencies identified in section 3(a) of this order shall consider whether ‘‘exceptional circumstances’’ exist warranting a determination that a restriction of the right to retain title to any subject invention funded by their respective agencies’ R&D funding agreements will better promote the policy and objectives of the Bayh-Dole Act, as appropriate and consistent with applicable law, including 35 U.S.C. 202(a). Such consideration shall include evaluation of whether ‘‘exceptional circumstances’’ exist to warrant the extension of the requirement to manufacture ‘‘substantially in the United States’’ to recipients of Federal R&D funding agreements, to non-exclusive licensees of subject inventions, and for use or sale of subject inventions outside the United States, as appropriate and consistent with applicable law, including 35 U.S.C. 202(a). In considering the issuance of such determinations for these purposes, the heads of agencies identified in section 3(a) of this order shall: VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00005 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 51206 Federal Register / Vol. 88, No. 147 / Wednesday, August 2, 2023 / Presidential Documents (i) consider measures for technologies important to the United States economy and national security, including critical and emerging technologies such as energy storage, quantum information science, artificial intelligence and machine learning, semiconductors and microelectronics, and advanced manufacturing; and (ii) consider narrowly tailoring terms related to enhanced United States manufacturing while encouraging technology transfer and commercialization, and allowing small businesses and nonprofit organizations to retain ownership of and commercialize their federally funded subject inventions. (b) The heads of agencies identified in section 3(a) of this order shall consider whether other measures are needed to promote domestic manufacturing of subject inventions funded by their respective agencies. Sec. 6. Implementation of this Order. (a) Within 2 years of the date of this order and annually thereafter for 5 years, the heads of agencies identified in section 3(a) of this order shall submit a report on their respective agencies’ implementation of this order to the Director of OMB and the Director of OSTP. (b) Each report shall include, to the extent possible, a review of this order’s effectiveness in using the R&D funding agreements of the agencies identified in section 3(a) of this order to support domestic manufacturing, United States industrial competitiveness, and job creation. (c) Each report shall include, to the extent possible, identification of any challenges to implementation of this order or to the effectiveness of this order in accomplishing the policy goals described in section 1 of this order, as well as recommendations to address such challenges. Sec. 7. Improving the Waiver Process. (a) Under the Bayh-Dole Act, agencies may waive the requirement that certain products embodying the subject invention or produced through the use of the subject invention be ‘‘manufactured substantially in the United States’’ if, as specified in 35 U.S.C. 204, ‘‘reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States’’ or ‘‘under the circumstances domestic manufacture is not commercially feasible.’’ (b) Every agency should consider developing a process by which the agency may waive the domestic manufacturing requirements for agencyfunded technology or technology developed under an agency funding opportunity without a request from a recipient of a Federal R&D funding agreement. As part of its process, an agency should seek concurrence from the Made in America Director to waive the domestic manufacturing requirements, and should set forth specific factors that may support a waiver, including whether the manufacture of the technology outside the United States is in the economic or national security interest of the United States. ddrumheller on DSK120RN23PROD with PRESDOC-E1 (c) The heads of agencies identified in section 3(a) of this order shall ensure that the waiver process for their agency is rigorous, timely, transparent, and consistent, with due regard for all applicable authorities, including Executive Order 14005 of January 25, 2021 (Ensuring the Future Is Made in All of America by All of America’s Workers), and the Bayh-Dole Act’s requirement that a waiver be available when reasonable but unsuccessful efforts have been made to license to a company that could substantially manufacture in the United States, or when domestic manufacture is not commercially feasible. (d) The Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, the NSTC Lab-to-Market Subcommittee, and the Made in America Director, shall provide guidance to agencies on the factors and considerations that should be weighed in determining whether domestic manufacturing is not commercially feasible. Guidance shall be designed to help applicants understand the factors an agency will consider when evaluating a waiver application, and should ensure that a determination of the commercial feasibility of manufacturing abroad is not based on substandard or unacceptable working VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00006 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 Federal Register / Vol. 88, No. 147 / Wednesday, August 2, 2023 / Presidential Documents 51207 conditions. Within 90 days of the date of this order, the Secretary of Commerce, through the Director of NIST, shall make the guidance available for public comment. (e) Within 90 days of the date of this order, the Secretary of Commerce, through the Director of NIST and in consultation with the Interagency Working Group for Bayh-Dole, shall develop common waiver application questions for use by all agencies. (i) The common waiver application questions should include as relevant criteria, as appropriate and consistent with applicable law: (A) how the waiver will be used; (B) why it is important that the subject invention be brought to market; (C) any potential economic and national security impacts of manufacturing the subject invention abroad; (D) the benefits that will accrue to domestic manufacturing and United States jobs as a result of the subject invention being brought to market; (E) whether the applicant is proposing an exclusive or non-exclusive license; and (F) the conditions under which the subject invention would be manufactured abroad, including unionization of workplaces, health and safety standards, labor and wage laws, and environmental impacts. (ii) Given the need to maintain agency flexibility, the heads of agencies identified in section 3(a) of this order may add questions to the common waiver application questions, but they should do so sparingly and only as needed to accomplish the policy set forth in this order within their respective agencies’ existing authorities. (f) The heads of agencies identified in section 3(a) of this order shall adopt the common waiver application questions, to the extent consistent with applicable law. (g) The heads of agencies identified in section 3(a) of this order should acknowledge receipt of waiver applications within 10 business days, to the extent practicable. Once an applicant submits a waiver request application, the reviewing agency should seek to finalize its decision, including negotiations with the applicant as needed, as soon as possible. ddrumheller on DSK120RN23PROD with PRESDOC-E1 (h) Within 270 days of the date of this order, the heads of agencies identified in section 3(a) of this order shall establish agency guidelines for negotiating with waiver applicants to retain as much value or benefit to the United States as possible, as appropriate and consistent with applicable law, while considering technical, business, social, environmental, and economic realities. In assessing a waiver’s value to the United States economy, the heads of agencies identified in section 3(a) of this order should consider, as appropriate and in addition to any other relevant factors, potential benefits to domestic manufacturing competitiveness, to United States job creation, and to United States economic and national security. (i) The heads of agencies identified in section 3(a) of this order should consider limiting waivers to applicants that commit to manufacture in locations that maintain a market economy and for specific agreed-upon purposes. (ii) The heads of agencies identified in section 3(a) of this order should expect waiver applicants to deliver alternative benefits to the United States as part of an agreement to grant the waiver. Consideration of alternative benefits may include direct or indirect investment in domestic plants and equipment, the creation of high-quality domestic jobs, or further domestic development of the subject invention. (i) Beginning in fiscal year 2024 and on an annual basis thereafter, the heads of agencies identified in section 3(a) of this order shall provide to the Secretary of Commerce, through the Interagency Working Group for Bayh-Dole, a summary of each waiver application received, approved, and VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00007 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 51208 Federal Register / Vol. 88, No. 147 / Wednesday, August 2, 2023 / Presidential Documents rejected. The summary shall include the terms of any approved waiver and the processing time needed to reach a decision. (i) The Secretary of Commerce, through the Interagency Working Group for Bayh-Dole, shall publish a periodic summary of the waiver applications in aggregate that describes common reasons for waiver requests, processing times by agency, and recommended policy responses to common challenges. (ii) Agencies shall ensure that the information submitted for publication to the Secretary of Commerce, through the Interagency Working Group for Bayh-Dole, appropriately protects business confidential and sensitive information provided by waiver applicants as part of their justification for the waiver, consistent with 35 U.S.C. 202(c)(5). However, the names of applicants seeking a waiver and a summary of the benefits the waiver recipients will provide to the United States should be made available to the public, to the extent permitted by law. Sec. 8. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive department or agency, or the head thereof; or (ii) the functions of the Director of OMB relating to budgetary, administrative, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. THE WHITE HOUSE, July 28, 2023. Filed 8–1–23; 11:15 am] Billing code 3395–F3–P VerDate Sep<11>2014 22:36 Aug 01, 2023 Jkt 259001 PO 00000 Frm 00008 Fmt 4705 Sfmt 4790 E:\FR\FM\02AUE1.SGM 02AUE1 BIDEN.EPS</GPH> ddrumheller on DSK120RN23PROD with PRESDOC-E1 [FR Doc. 2023–16636

Agencies

[Federal Register Volume 88, Number 147 (Wednesday, August 2, 2023)]
[Presidential Documents]
[Pages 51203-51208]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-16636]



[[Page 51201]]

Vol. 88

Wednesday,

No. 147

August 2, 2023

Part V





The President





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Executive Order 14104--Federal Research and Development in Support of 
Domestic Manufacturing and United States Jobs


                        Presidential Documents 



Federal Register / Vol. 88 , No. 147 / Wednesday, August 2, 2023 / 
Presidential Documents

___________________________________________________________________

Title 3--
The President

[[Page 51203]]

                Executive Order 14104 of July 28, 2023

                
Federal Research and Development in Support of 
                Domestic Manufacturing and United States Jobs

                By the authority vested in me as President by the 
                Constitution and the laws of the United States of 
                America, it is hereby ordered as follows:

                Section 1. Policy. The United States maintains an 
                unparalleled innovation ecosystem with world-class 
                universities, Federal laboratories, research centers, 
                and technology incubators, supported in part by Federal 
                investment. Our world is healthier, smarter, more 
                connected, and more sustainable because of Federal 
                taxpayers' investment in discovery and innovation that 
                has supported the commercialization of new products and 
                services.

                My Administration has prioritized support for our 
                unique innovation ecosystem by reinvesting across 
                sectors in research and development (R&D), 
                demonstrations, education, and the necessary 
                infrastructure to accelerate the transition of 
                discoveries quickly from the lab to the marketplace.

                This investment is designed to produce cutting-edge 
                technologies that support the competitiveness, domestic 
                manufacturing capacity, and well-being of the United 
                States economy; United States workers; our communities; 
                and our national security. Ensuring the 
                commercialization of federally funded inventions by 
                United States manufacturers--while maintaining 
                intellectual property rights--will build on the 
                successful legacy of the United States in spurring 
                economic growth and enhancing United States 
                competitiveness through R&D. It will also further our 
                joint R&D work with partners and allies to strengthen 
                the resilience of global critical supply chains and 
                secure America's leadership in delivering a net-zero 
                emissions economy by no later than 2050.

                Therefore, it is the policy of my Administration that 
                when new technologies and products are developed with 
                support from the United States Government, they will be 
                manufactured in the United States whenever feasible and 
                consistent with applicable law.

                Sec. 2. Coordination and Consultation. (a) The 
                Assistant to the President for National Security 
                Affairs, the Assistant to the President for Economic 
                Policy, and the Director of the Office of Science and 
                Technology Policy (OSTP) shall coordinate the executive 
                branch actions necessary to implement this order 
                through the interagency process identified in National 
                Security Memorandum 2 of February 4, 2021 (Renewing the 
                National Security Council System).

                    (b) In implementing this order, the heads of 
                executive departments and agencies (agencies) shall, as 
                appropriate and consistent with applicable law, consult 
                outside stakeholders--such as those in industry; 
                academia, including Historically Black Colleges and 
                Universities, Tribal Colleges and Universities, and 
                other Minority Serving Institutions; non-governmental 
                organizations; communities; labor unions; and State, 
                local, Tribal, and territorial governments--in order to 
                implement the policy identified in section 1 of this 
                order.

                Sec. 3. Strengthening Domestic Manufacturing. (a) The 
                Secretary of Defense, the Secretary of Agriculture, the 
                Secretary of Commerce, the Secretary of Health and 
                Human Services, the Secretary of Transportation, the 
                Secretary of Energy, the Secretary of Homeland 
                Security, the Director of the National Science 
                Foundation, and the Administrator of the National 
                Aeronautics and

[[Page 51204]]

                Space Administration should consider domestic 
                manufacturing in Federal R&D funding agreement 
                solicitations, as appropriate and consistent with 
                applicable law. These agency heads shall also consider 
                how their respective agencies' R&D funding agreements 
                support broader domestic manufacturing objectives, 
                including the development of production facilities and 
                capabilities broadly supportive of United States 
                manufacturing, as appropriate and consistent with 
                applicable law.

                    (b) The Director of OSTP, working through the 
                National Science and Technology Council (NSTC) and in 
                coordination with the Director of the Office of 
                Management and Budget's Made in America Office (Made in 
                America Director) and the heads of agencies identified 
                in subsection (a) of this section, shall seek to add 
                ``domestic manufacturing'' to future interagency 
                technology R&D roadmaps, as appropriate. The Director 
                of OSTP shall endeavor to standardize the format of 
                domestic manufacturing considerations in technology R&D 
                roadmaps to ensure that industry, the research 
                community, and agencies create the conditions for new 
                technologies to be produced in the United States once 
                they are commercialized.
                    (c) In collaboration with the Administrator of the 
                Small Business Administration (SBA), the heads of 
                agencies participating in the Small Business Innovation 
                Research and Small Business Technology Transfer 
                programs are encouraged to advance a coordinated 
                interagency approach to innovation and research 
                solicitations with the goals of reducing barriers to 
                program participation, streamlining access to funding 
                opportunities, and encouraging production of new 
                technologies in the United States. The heads of these 
                agencies are further encouraged to collaborate with the 
                SBA to support small businesses transitioning 
                technologies from intramural and extramural labs to 
                commercial markets.
                    (d) The heads of agencies that have statutory Other 
                Transaction Authority, or that can use other business 
                arrangements authorized by the Congress, are 
                encouraged, when appropriate, to consider using these 
                authorities to purchase or invest in leading-edge 
                technologies to support their production in the United 
                States. If these agencies use these authorities to 
                purchase or invest in the development of new 
                technologies, the terms of these purchases and 
                investments should ensure that the product is 
                substantially manufactured in the United States, as 
                appropriate and consistent with applicable law.
                    (e) To further support the commercialization and 
                production in the United States of technologies 
                developed, in part, through federally funded R&D, the 
                heads of agencies identified in subsection (a) of this 
                section are encouraged to establish or enhance the 
                technology transfer and commercialization capabilities 
                of their agencies.

                Sec. 4. Modernizing Reporting of Invention Utilization. 
                (a) In an effort to streamline reporting requirements 
                for recipients of Federal R&D funding agreements, the 
                heads of agencies identified in section 3(a) of this 
                order should seek to make reporting on the utilization 
                of ``subject inventions'' (as defined in 35 U.S.C. 
                201(e)) easier and consistent across the United States 
                Government.

                    (b) To incentivize domestic manufacturing through 
                the reporting of invention disclosures and the 
                utilization of those inventions, the heads of agencies 
                identified in section 3(a) of this order shall require 
                recipients of Federal R&D funding agreements to track 
                and update the awarding agency on the location in which 
                subject inventions are manufactured.
                    (c) The heads of agencies identified in section 
                3(a) of this order should require recipients of Federal 
                R&D funding agreements to report annually to the 
                awarding agency the names of licensees and 
                manufacturing locations of the applicable subject 
                inventions.
                    (d) Within 60 days of the date of this order, the 
                Secretary of Commerce, through the Director of the 
                National Institute of Standards and Technology (NIST) 
                and in consultation with the Office of Management and 
                Budget (OMB), should develop award terms and conditions 
                regarding the reporting

[[Page 51205]]

                requirements in subsections (a) through (c) of this 
                section to be implemented by each awarding agency 
                identified in section 3(a) of this order. Award terms 
                and conditions shall ensure that the reporting of the 
                information specified in subsections (b) and (c) of 
                this section protects business confidential 
                information, consistent with 35 U.S.C. 202(c)(5), while 
                providing increased visibility to taxpayers on the use 
                of Federal R&D funding in support of domestic 
                manufacturing and job creation.
                    (e) The Secretary of Commerce, through the Director 
                of NIST and in consultation with the Interagency 
                Working Group for Bayh-Dole, shall consider developing 
                an action plan, including resource requirements, to 
                transition all agencies identified in section 3(a) of 
                this order to the iEdison reporting system to track 
                unclassified subject inventions, patents, and related 
                utilization reports by calendar year 2025. The 
                Secretary of Commerce shall submit the action plan to 
                the Director of OMB within 1 year of the date of this 
                order.
                    (f) Not later than 120 days after issuance of any 
                final regulations implementing the action plan 
                described in subsection (e) of this section, the heads 
                of agencies identified in section 3(a) of this order 
                shall report to the Director of OMB and the Director of 
                OSTP on steps their respective agencies have taken to 
                transition all unclassified reporting to iEdison by the 
                end of calendar year 2025. These reports may include 
                resource needs and timelines for implementation.
                    (g) Within 180 days of the date of this order, the 
                Secretary of Commerce, through the Director of NIST and 
                in consultation with the Interagency Working Group for 
                Bayh-Dole, should develop common invention utilization 
                questions (utilization questions), allowing agencies to 
                add agency-specific questions.

(i) The utilization questions should be used by all agencies by May 1, 
2024, for subject inventions that a Federal R&D funding agreement recipient 
has elected to retain title on or after the date of this order.

(ii) The utilization questions should require information on the locations 
where subject inventions are produced or are used to produce a product.

(iii) The Secretary of Commerce, through the Director of NIST, and the 
heads of other agencies should aim to minimize the reporting burden on 
recipients of Federal R&D funding agreements associated with the 
utilization questions, in accordance with the Paperwork Reduction Act (44 
U.S.C. 3501 et seq.) and applicable OMB guidance.

                    (h) Within 2 years after the date of this order and 
                annually thereafter, the heads of agencies identified 
                in section 3(a) of this order shall submit reports to 
                the Made in America Director on the utilization of 
                inventions that were developed through their previous 
                R&D funding agreements and reported after the date of 
                this order, including where products embodying a 
                subject invention or produced through the use of a 
                subject invention were manufactured.

                Sec. 5. Securing Critical and Emerging Technologies 
                Through Domestic Manufacturing. (a) Within 90 days of 
                the date of this order, the heads of agencies 
                identified in section 3(a) of this order shall consider 
                whether ``exceptional circumstances'' exist warranting 
                a determination that a restriction of the right to 
                retain title to any subject invention funded by their 
                respective agencies' R&D funding agreements will better 
                promote the policy and objectives of the Bayh-Dole Act, 
                as appropriate and consistent with applicable law, 
                including 35 U.S.C. 202(a). Such consideration shall 
                include evaluation of whether ``exceptional 
                circumstances'' exist to warrant the extension of the 
                requirement to manufacture ``substantially in the 
                United States'' to recipients of Federal R&D funding 
                agreements, to non-exclusive licensees of subject 
                inventions, and for use or sale of subject inventions 
                outside the United States, as appropriate and 
                consistent with applicable law, including 35 U.S.C. 
                202(a). In considering the issuance of such 
                determinations for these purposes, the heads of 
                agencies identified in section 3(a) of this order 
                shall:

[[Page 51206]]

(i) consider measures for technologies important to the United States 
economy and national security, including critical and emerging technologies 
such as energy storage, quantum information science, artificial 
intelligence and machine learning, semiconductors and microelectronics, and 
advanced manufacturing; and

(ii) consider narrowly tailoring terms related to enhanced United States 
manufacturing while encouraging technology transfer and commercialization, 
and allowing small businesses and nonprofit organizations to retain 
ownership of and commercialize their federally funded subject inventions.

                    (b) The heads of agencies identified in section 
                3(a) of this order shall consider whether other 
                measures are needed to promote domestic manufacturing 
                of subject inventions funded by their respective 
                agencies.

                Sec. 6. Implementation of this Order. (a) Within 2 
                years of the date of this order and annually thereafter 
                for 5 years, the heads of agencies identified in 
                section 3(a) of this order shall submit a report on 
                their respective agencies' implementation of this order 
                to the Director of OMB and the Director of OSTP.

                    (b) Each report shall include, to the extent 
                possible, a review of this order's effectiveness in 
                using the R&D funding agreements of the agencies 
                identified in section 3(a) of this order to support 
                domestic manufacturing, United States industrial 
                competitiveness, and job creation.
                    (c) Each report shall include, to the extent 
                possible, identification of any challenges to 
                implementation of this order or to the effectiveness of 
                this order in accomplishing the policy goals described 
                in section 1 of this order, as well as recommendations 
                to address such challenges.

                Sec. 7. Improving the Waiver Process. (a) Under the 
                Bayh-Dole Act, agencies may waive the requirement that 
                certain products embodying the subject invention or 
                produced through the use of the subject invention be 
                ``manufactured substantially in the United States'' if, 
                as specified in 35 U.S.C. 204, ``reasonable but 
                unsuccessful efforts have been made to grant licenses 
                on similar terms to potential licensees that would be 
                likely to manufacture substantially in the United 
                States'' or ``under the circumstances domestic 
                manufacture is not commercially feasible.''

                    (b) Every agency should consider developing a 
                process by which the agency may waive the domestic 
                manufacturing requirements for agency-funded technology 
                or technology developed under an agency funding 
                opportunity without a request from a recipient of a 
                Federal R&D funding agreement. As part of its process, 
                an agency should seek concurrence from the Made in 
                America Director to waive the domestic manufacturing 
                requirements, and should set forth specific factors 
                that may support a waiver, including whether the 
                manufacture of the technology outside the United States 
                is in the economic or national security interest of the 
                United States.
                    (c) The heads of agencies identified in section 
                3(a) of this order shall ensure that the waiver process 
                for their agency is rigorous, timely, transparent, and 
                consistent, with due regard for all applicable 
                authorities, including Executive Order 14005 of January 
                25, 2021 (Ensuring the Future Is Made in All of America 
                by All of America's Workers), and the Bayh-Dole Act's 
                requirement that a waiver be available when reasonable 
                but unsuccessful efforts have been made to license to a 
                company that could substantially manufacture in the 
                United States, or when domestic manufacture is not 
                commercially feasible.
                    (d) The Secretary of Commerce, through the Director 
                of NIST and in consultation with the Interagency 
                Working Group for Bayh-Dole, the NSTC Lab-to-Market 
                Subcommittee, and the Made in America Director, shall 
                provide guidance to agencies on the factors and 
                considerations that should be weighed in determining 
                whether domestic manufacturing is not commercially 
                feasible. Guidance shall be designed to help applicants 
                understand the factors an agency will consider when 
                evaluating a waiver application, and should ensure that 
                a determination of the commercial feasibility of 
                manufacturing abroad is not based on substandard or 
                unacceptable working

[[Page 51207]]

                conditions. Within 90 days of the date of this order, 
                the Secretary of Commerce, through the Director of 
                NIST, shall make the guidance available for public 
                comment.
                    (e) Within 90 days of the date of this order, the 
                Secretary of Commerce, through the Director of NIST and 
                in consultation with the Interagency Working Group for 
                Bayh-Dole, shall develop common waiver application 
                questions for use by all agencies.

(i) The common waiver application questions should include as relevant 
criteria, as appropriate and consistent with applicable law:

  (A) how the waiver will be used;

  (B) why it is important that the subject invention be brought to market;

  (C) any potential economic and national security impacts of manufacturing 
the subject invention abroad;

  (D) the benefits that will accrue to domestic manufacturing and United 
States jobs as a result of the subject invention being brought to market;

  (E) whether the applicant is proposing an exclusive or non-exclusive 
license; and

  (F) the conditions under which the subject invention would be 
manufactured abroad, including unionization of workplaces, health and 
safety standards, labor and wage laws, and environmental impacts.

(ii) Given the need to maintain agency flexibility, the heads of agencies 
identified in section 3(a) of this order may add questions to the common 
waiver application questions, but they should do so sparingly and only as 
needed to accomplish the policy set forth in this order within their 
respective agencies' existing authorities.

                    (f) The heads of agencies identified in section 
                3(a) of this order shall adopt the common waiver 
                application questions, to the extent consistent with 
                applicable law.
                    (g) The heads of agencies identified in section 
                3(a) of this order should acknowledge receipt of waiver 
                applications within 10 business days, to the extent 
                practicable. Once an applicant submits a waiver request 
                application, the reviewing agency should seek to 
                finalize its decision, including negotiations with the 
                applicant as needed, as soon as possible.
                    (h) Within 270 days of the date of this order, the 
                heads of agencies identified in section 3(a) of this 
                order shall establish agency guidelines for negotiating 
                with waiver applicants to retain as much value or 
                benefit to the United States as possible, as 
                appropriate and consistent with applicable law, while 
                considering technical, business, social, environmental, 
                and economic realities. In assessing a waiver's value 
                to the United States economy, the heads of agencies 
                identified in section 3(a) of this order should 
                consider, as appropriate and in addition to any other 
                relevant factors, potential benefits to domestic 
                manufacturing competitiveness, to United States job 
                creation, and to United States economic and national 
                security.

(i) The heads of agencies identified in section 3(a) of this order should 
consider limiting waivers to applicants that commit to manufacture in 
locations that maintain a market economy and for specific agreed-upon 
purposes.

(ii) The heads of agencies identified in section 3(a) of this order should 
expect waiver applicants to deliver alternative benefits to the United 
States as part of an agreement to grant the waiver. Consideration of 
alternative benefits may include direct or indirect investment in domestic 
plants and equipment, the creation of high-quality domestic jobs, or 
further domestic development of the subject invention.

                    (i) Beginning in fiscal year 2024 and on an annual 
                basis thereafter, the heads of agencies identified in 
                section 3(a) of this order shall provide to the 
                Secretary of Commerce, through the Interagency Working 
                Group for Bayh-Dole, a summary of each waiver 
                application received, approved, and

[[Page 51208]]

                rejected. The summary shall include the terms of any 
                approved waiver and the processing time needed to reach 
                a decision.

(i) The Secretary of Commerce, through the Interagency Working Group for 
Bayh-Dole, shall publish a periodic summary of the waiver applications in 
aggregate that describes common reasons for waiver requests, processing 
times by agency, and recommended policy responses to common challenges.

(ii) Agencies shall ensure that the information submitted for publication 
to the Secretary of Commerce, through the Interagency Working Group for 
Bayh-Dole, appropriately protects business confidential and sensitive 
information provided by waiver applicants as part of their justification 
for the waiver, consistent with 35 U.S.C. 202(c)(5). However, the names of 
applicants seeking a waiver and a summary of the benefits the waiver 
recipients will provide to the United States should be made available to 
the public, to the extent permitted by law.

                Sec. 8. General Provisions. (a) Nothing in this order 
                shall be construed to impair or otherwise affect:

(i) the authority granted by law to an executive department or agency, or 
the head thereof; or

(ii) the functions of the Director of OMB relating to budgetary, 
administrative, or legislative proposals.

                    (b) This order shall be implemented consistent with 
                applicable law and subject to the availability of 
                appropriations.
                    (c) This order is not intended to, and does not, 
                create any right or benefit, substantive or procedural, 
                enforceable at law or in equity by any party against 
                the United States, its departments, agencies, or 
                entities, its officers, employees, or agents, or any 
                other person.
                
                
                    (Presidential Sig.)

                THE WHITE HOUSE,

                    July 28, 2023.

[FR Doc. 2023-16636
Filed 8-1-23; 11:15 am]
Billing code 3395-F3-P
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