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