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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules implementing the rule to benefit from the publics input.
B. Regulatory Flexibility Act: Under the Regulatory Flexibility Act 5 U.S.C.
601 et seq., whenever an agency is required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking NPRM, the agency must prepare and make available for public comment an Initial Regulatory Flexibility Analysis, unless the agency certifies under 5 U.S.C. 605b that the proposed rule, if implemented, will not have a significant economic impact on a substantial number of small entities. 5
U.S.C. 603, 605.
For the reasons set forth herein, the Senior Counsel for Regulatory and Legislative Affairs of the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule will not have a significant economic impact on a substantial number of small entities.
See 5 U.S.C. 605b.
The USPTO proposes to amend the rules of practice to require submission of biological sequence data in eXtensible Markup Language where the rules of practice incorporate by reference WIPO Standard ST.26, Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings Using XML
eXtensible Markup Language as disclosed in the WIPO Handbook on Industrial Property Information and Documentation.
This rulemaking would make more technical data associated with biotechnology inventions available to the public because the new rules of practice based on WIPO Standard ST.26
2020 provide for enhanced biological sequence data related to disclosures of nucleotides and amino acids in patent applications. WIPO Standard ST.26
provides clear rules as to what must be included in a sequence listing and how sequences must be represented, for example, standardization of representation of modified nucleic acids and amino acids as well as variants derived from primary sequences. WIPO
Standard ST.26 contains a guidance document that demonstrates the requirement for inclusion and representation of biological sequence data. As a result, patent applicants will have a clearer understanding as to the requirements and presentation of biological sequence data in a compliant sequence listing under WIPO Standard ST.26. Additionally, since WIPO
Standard ST.26 only allows XML
format, applicants will not be burdened or confused with the requirements of filing a sequence listing in paper or PDF
format, and IPOs will not be burdened
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with processing paper sequence listings and performing necessary checks on the contents of the paper documents. This rulemakings proposed changes are largely procedural in nature, and do not impose any additional requirements or fees on applicants. For the foregoing reasons, the changes proposed in this NPRM will not have a significant economic impact on a substantial number of small entities.
C. Executive Order 12866 Regulatory Planning and Review: This rulemaking has been determined to be not significant for purposes of Executive Order 12866 Sept. 30, 1993.
D. Executive Order 13563 Improving Regulation and Regulatory Review: The USPTO has complied with Executive Order 13563 Jan. 18, 2011.
Specifically, to the extent feasible and applicable, the USPTO has 1
reasonably determined that the benefits of the rule justify its costs; 2 tailored the rule to impose the least burden on society consistent with obtaining the agencys regulatory objectives; 3
selected a regulatory approach that maximizes net benefits; 4 specified performance objectives; 5 identified and assessed available alternatives; 6
involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole, and provided online access to the rulemaking docket; 7 attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; 8 considered approaches that reduce burdens while maintaining flexibility and freedom of choice for the public; and 9 ensured the objectivity of scientific and technological information and processes.
E. Executive Order 13132
Federalism: This rulemaking does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 Aug. 4, 1999.
F. Executive Order 13175 Tribal Consultation: This rulemaking will not 1 have substantial direct effects on one or more Indian tribes; 2 impose substantial direct compliance costs on Indian tribal governments; or 3
preempt tribal law. Therefore, a tribal summary impact statement is not required under Executive Order 13175
Nov. 6, 2000.
G. Executive Order 13211 Energy Effects: This rulemaking is not a significant energy action under Executive Order 13211 because this
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rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211
May 18, 2001.
H. Executive Order 12988 Civil Justice Reform: This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3a and 3b2 of Executive Order 12988 Feb. 5, 1996.
I. Executive Order 13045 Protection of Children: This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 Apr. 21, 1997.
J. Executive Order 12630 Taking of Private Property: This rulemaking will not effect a taking of private property or otherwise have taking implications under Executive Order 12630 Mar. 15, 1988.
K. Congressional Review Act: Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 5 U.S.C. 801 et seq., prior to issuing any final rule, the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
Therefore, this rulemaking is not expected to result in a major rule as defined in 5 U.S.C. 8042.
L. Unfunded Mandates Reform Act of 1995: The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, of $100 million as adjusted or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million as adjusted or more in any one year, and will not significantly or uniquely affect small governments.
Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2
U.S.C. 1501 et seq.
M. National Environmental Policy Act of 1969: This rulemaking will not have
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