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Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Proposed Rules
applications and any patent issuing thereon covering a subject invention, a statement that the invention was made with Government support under the grant or contract awarded by the Federal agency, and that the Government has certain rights in the invention, 37 CFR
401.14f4.
In addition, a contractor is obligated to include the requirements of the standard clauses in any subcontracts under the contractors award, 37 CFR
401.14g; to submit periodic reports as requested on the utilization of a subject invention or on efforts at obtaining such utilization that are being made by the contractor or its licensees or assignees, 37 CFR 401.14h; and to agree that neither the contractor nor any assignee will grant to any person the exclusive right to use or sell any subject inventions in the United States unless such person agrees that any products embodying the subject invention or produced through the use of the subject invention will be manufactured substantially in the United States, 37
CFR 401.14i, subject to waiver.
Bayh-Dole and its implementing regulations also specify certain conditions applicable to licenses granted by Federal agencies in any federally owned invention. The implementing regulations include 37
CFR 404.5, which sets forth restrictions and conditions applicable to all Federal agency licenses, 37 CFR 404.6, which addresses requirements pertaining to nonexclusive licenses, and 37 CFR
404.7, which addresses requirements pertaining to exclusive and partially exclusive licenses.
Pursuant to authority delegated to it by the Secretary of Commerce, NIST is providing notice to the public of a proposed rulemaking to revise Parts 401
and 404 of Title 37 of the Code of Federal Regulations which address rights to inventions made under Government grants, contracts, and cooperative agreements, and licensing of government owned inventions. NIST is seeking public comments on the proposed amendments. Brief explanations of the proposed changes are included below; the full text of 37
CFR part 401 is available at https
www.gpo.gov/fdsys/pkg/CFR-2010title37-vol1/pdf/CFR-2010-title37-vol1part401.pdf and the full text of 37 CFR
part 404 is available at https
www.gpo.gov/fdsys/granule/CFR-2004title37-vol1/CFR-2004-title37-vol1part404.
III. Return on Investment Initiative In 2018, NIST undertook a large-scale stakeholder engagement effort to inform the development of the Lab-to-Market
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Cross Agency Priority CAP goal, part of the 2018 Presidents Management Agenda. The Lab-to-Market CAP goals stated purpose is to . . .improve the transition of federally funded innovations from the laboratory to the marketplace by reducing the administrative and regulatory burdens for technology transfer and increasing private sector investment in later-stage research and development R&D;
develop and implement more effective partnering models and technology transfer mechanisms for Federal agencies; and enhance the effectiveness of technology transfer by improving the methods for evaluating the ROI and economic and national security impacts of federally funded R&D, and using that information to focus efforts on approaches proven to work.
Beginning in April 2018, NIST
utilized a number of avenues to seek input from the public on ways to improve federal technology transfer and the commercialization of federally funded inventions. These included a Request for Information that NIST
published in the Federal Register,1 four public meetings,2 a summit hosted by NIST, extensive consultations with interagency working groups responsible for technology transfer issues, and multiple stakeholder engagement sessions. These public inputs, as well as an extensive literature review of government and academic publications on federal technology transfer, ultimately informed NIST Special Publication 1234: Return on Investment Initiative To Advance the Presidents Management Agenda, Final Green Paper.
The Green Paper described 15
findings from NISTs stakeholder engagement process that may have the potential to unleash American innovation and advance the goals of Lab-to-Market through regulatory or legislative changes, updates to policy and guidance, and the development of new tools and services. In addition to the overall Lab-to-Market strategy to Identify regulatory impediments and administrative improvements in Federal technology transfer policies and practices which supports the Administrations stated goal to streamline and reduce regulatory burdens, seven of the Green Papers 15
findings noted potential changes to the 1 Request for Information Regarding Federal Technology Transfer Authorities and Process published in the Federal Register on May 1, 2018
83 FR 19052.
2 San Jose, California, May 17, 2018; Denver, Colorado, May 21, 2018; Oak Lawn, Illinois, May 29, 2018; NIST Campus Gaithersburg, Maryland, June 14, 2018.

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Bayh-Dole implementing regulations that could improve compliance, enhance a contractors ability to commercialize subject inventions, and increase the return on investment of Federal funding through new goods and services to the public. Four of those seven findings are considered in this notice of proposed rulemaking NPRM
or proposed rule.
As part of the overall streamlining effort in this proposed rule, some outdated or redundant text has been proposed for removal. This includes 401.1a, 401.1c, 401.1d, 401.1f, 401.3g, 401.8, 401.11a, 401.11b5, 401.13b and 404.4. Other text has been moved or substantially reincorporated into new sections in the proposed rule as follows: 401.5f moved to 401.14c1 and 3; 401.7 and 401.14m incorporated into 401.14k4 through 6; 401.13a moved to 401.14c6; 401.15
incorporated into 401.9; 401.16
moved to 401.14m; 404.2
incorporated into 404.1b; and 404.4
incorporated into 404.5g.
In addition to these changes and technical corrections throughout the regulation, the proposed revisions to 37
CFR part 401 will:
1 Clarify in 401.1 the scope of the regulation and applicability to large businesses unless otherwise directed by statute, and remove the outdated requirement for multiple copies of agency regulations to be submitted to the Secretary prior to OMB review.
2 Update the definitions of electronically filed and electronic system in 401.2k and l to remove outdated references to optical electronic system.
3 Update the definitions of patent application and initial patent application in 401.2m and n to encompass U.S. provisional and nonprovisional applications, applications filed in a foreign country or international patent office directly, PCT
applications, and applications for Plant Variety Protection certificates.
4 Update 401.5a to reflect that modifications to paragraph 401.14g are no longer needed due to the applicability of 37 CFR part 401 to all businesses regardless of size pursuant to E.O. 12591.
5 Revise 401.5b for clarity by removing the ambiguity of instructions to the agency versus instructions to the contractor.
6 Revise the existing text at 401.6b new 401.6a1 to clarify the informal agency consultation process with the contractor prior to the exercise of march-in rights, and increase the allowable time frame an agency has
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