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Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Proposed Rules
or Social Security numbers, or names of other individuals, should not be included. Do not submit confidential business information, or otherwise proprietary, sensitive or protected information. Comments that contain profanity, vulgarity, threats, or other inappropriate language will not be considered.
viii. Make sure to submit your comments by the comment period deadline identified.
ix. The following formats are preferred for comment submissions:
.doc or .docx, .pdf, and .txt.
V. References 1. National Institute of Standards and Technology 2019. Unleashing American Innovation: Return on Investment Initiative to Advance the Presidents Management Agenda, Final Green Paper. NIST Special Publication 1234, retrieved from: https
www.nist.gov/unleashing-americaninnovation/green-paper.
2. Copan, W. and Kratsios, M. 2019. Lab to Market: Cross Agency Priority Goal Quarterly Progress Update, December 2019. Retrieved from: https
www.performance.gov/CAP/action_
plans/dec_2019_Lab_to_Market.pdf.
3. Additional Actions Needed to Improve Licensing of Patented Laboratory Inventions 2018. GAO18327, Retrieved from: https www.gao.gov/
assets/700/692961.pdf.
4. National Institute of Standards and Technology 2019. Federal Laboratory Technology Transfer, Fiscal Year 2016
Summary Report to the President and the Congress. Retrieved from: https
www.nist.gov/tpo/reports-andpublications. See Federal Licenses table on page 8.
5. Federal Laboratory Consortium for Technology Transfer 2013. Technology Transfer Desk Reference. Retrieved from:
https federallabs.org/media/
publication-library/flc-technologytransfer-desk-reference.

VI. Statutory and Executive Order Reviews
This rulemaking is a significant regulatory action under Executive Order 12866. This rulemaking, however, is not an economically significant regulatory action under section 3f1 of the Executive order, as it does not have an effect on the economy of $100
million or more in any one year, and it does not have a material adverse effect on the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities.

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This proposed rule does not contain policies with federalism implications as defined in Executive Order 13132.
Executive Order 13771
This final rule is considered to be an E.O. 13771 deregulatory action. The proposed regulation is deregulatory in that it is removing duplicative text and streamlining and/or reducing regulatory burdens, all at no additional cost.
The proposed regulation: 1 Updates the definitions of patent application and initial patent application in 401.2m and n to encompass U.S. provisional and non-provisional applications, applications filed in a foreign country or international patent office directly, PCT
applications, and applications for Plant Variety Protection certificates, which reduces patent filing burdens for recipients of federal funding by providing additional options to fulfill the regulations filing requirements. 2
Clarifies 401.6 to include a provision that march-in rights shall not be exercised by an agency exclusively on the basis of business decisions of a contractor regarding the pricing of commercial goods and services arising from practical application of the invention, which limits the governments use of this provision and provides additional certainty to licensees. 3 Moves the electronic filing requirements from 401.16 into the standard clause at 401.14; update the requirements to include that if the patent information and periodic reports in 401.14c3 and/or the close-out report 401.14c1 are required by an agency, they will be electronically filed unless otherwise directed by the agency;
and permit other written notices to be electronically transmitted between the contractor and the agency, which reduces the burden on recipients of federal funding to complete and submit paper forms.
Regulatory Flexibility Act
Executive Order 12866

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Executive Order 13132

The Regulatory Flexibility Act RFA
requires the preparation and availability for public comment of an initial regulatory flexibility analysis which will describe the impact of the proposed rule on small entities. 5
U.S.C. 603a. Section 605 of the RFA
allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration SBA

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that this rulemaking, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:
A description of this proposed rule, why it is being considered, and the objectives of this proposed rule are contained in the preamble and in the SUMMARY section of the preamble. The statutory basis for this proposed rule is provided by 35 U.S.C. 200212. The Bayh-Dole Act and its implementing regulations apply to all small business firms and nonprofit organizations that have entered into a Federal funding agreement, as defined in 35 U.S.C. 201, and express a policy to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations, including universities;
and to ensure that inventions made by nonprofit organizations and small business firms are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery. 35 U.S.C. 200.
For small business firms and nonprofit organizations that deal with the Government in areas of technology development, the Bayh-Dole implementing regulations make it easier to participate in federally-supported programs by guaranteeing the protection of the intellectual property they create.
This proposed rule, if implemented, would predominantly make technical changes and clarifications, remove outdated material, and streamline the regulation, and is not anticipated to have any quantifiable economic impact with respect to small entities. Several proposed changes would reduce administrative burdens and increase the ability of small entities to fulfill regulatory requirements through electronic submissions, while clarifying the confidentiality of said submissions so as to not affect the ability to seek patent protection on a subject invention.
The proposed change to the definition of an initial patent application expands the applications by which a contractor can fulfil the filing requirement of the regulation, providing additional flexibility for small entities.
Proposed revisions to 37 CFR 401.6
provide additional clarity on the scope of the Governments march-in rights, while the proposed revision to 37 CFR
401.14d provides an avenue for an agency to release a small entity from the requirement to convey title to the Government if they have taken corrective actions after failing to meet a
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