Table of Contents I. Synopsis of the Final Rule II. Introduction A. Authority B. Background 1. Current Standards 2. ASHRAE Standard 90.1-2016 3. ASRAC Negotiations 4. Proposed Standards III. General Discussion A. Test Procedure B. Methodology for Efficiency Crosswalk Analysis 1. Crosswalk Background and Overview 2. Crosswalk Details and Results 3. Equipment Class Structure for VRFs IV. Estimates of Potential Energy Savings V. Conclusions A. Consideration of More-Stringent Efficiency Levels B. Review Under the Six-Year-Lookback Provision C. Amended Energy Conservation Standards VI. Procedural Issues and Regulatory Review A. Review Under Executive Orders 12866 and 13563 B. Review Under the Regulatory Flexibility Act C. Review Under the Paperwork Reduction Act of 1995 D. Review Under the National Environmental Policy Act of 1969 E. Review Under Executive Order 13132 F. Review Under Executive Order 12988 G. Review Under the Unfunded Mandates Reform Act of 1995 H. Review Under the Treasury and General Government Appropriations Act, 1999 I. Review Under Executive Order 12630 J. Review Under the Treasury and General Government Appropriations Act, 2001 K. Review Under Executive Order 13211 L. Review Under the Information Quality Bulletin for Peer Review M. Congressional Notification VII. Approval of the Office of the Secretary I. Synopsis of the Final Rule

The Energy Policy and Conservation Act, Public Law 94-163, (42 U.S.C. 6291-6317, as codified) as amended (EPCA), 1 authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. Title III, Part C  2 of EPCA established the Energy Conservation Program for Certain Industrial Equipment. (42 U.S.C. 6311-6317) Such equipment includes small, large, and very large commercial package air conditioning and heating equipment, of which VRF multi-split systems, the subject of this rulemaking, are a category. (42 U.S.C. 6311(1)(B)-(D))

Pursuant to EPCA, DOE is triggered to consider amending the energy conservation standards for certain types of commercial and industrial equipment, including the equipment at issue in this document, whenever the ASHRAE amends the standard levels or design requirements prescribed in ASHRAE Standard 90.1, “Energy Standard for Buildings Except Low-Rise Residential Buildings.” Under a separate provision of EPCA, DOE is required to review the existing energy conservation standards for those types of covered equipment subject to ASHRAE Standard 90.1 every six years to determine whether those standards need to be amended. (42 U.S.C. 6313(a)(6)(A)-(C))

More specifically, under the “ASHRAE trigger” provision, EPCA directs that for each type of covered equipment, if ASHRAE Standard 90.1 is amended, DOE must adopt amended energy conservation standards at the new efficiency level in ASHRAE Standard 90.1, unless clear and convincing evidence supports a determination that adoption of a more-stringent efficiency level would produce significant additional energy savings and be technologically feasible and economically justified. (42 U.S.C. 6313(a)(6)(A)(ii)) If DOE adopts as a uniform national standard the efficiency level specified in the amended ASHRAE Standard 90.1, DOE must establish such standard not later than 18 months after publication of the amended industry standard. (42 U.S.C. 6313(a)(6)(A)(ii)(I)) If DOE determines that a more-stringent standard is appropriate under the statutory criteria, DOE must establish such more-stringent standard not later than 30 months after publication of the revised ASHRAE Standard 90.1. (42 U.S.C. 6313(a)(6)(B)(i))

Under EPCA, DOE must also review its energy conservation standards for VRF multi-split systems every six years and either: (1) issue a notice of determination that the standards do not need to be amended, as adoption of a more-stringent level under the relevant statutory criteria is not supported by clear and convincing evidence; or (2) issue a notice of proposed rulemaking including new proposed standards based on certain criteria and procedures in subparagraph (B). 3 (42 U.S.C. 6313(a)(6)(C)(i))

ASHRAE officially released ASHRAE Standard 90.1-2016 on October 26, 2016, thereby triggering DOE's previously referenced obligations pursuant to EPCA to determine for certain classes of VRF multi-split systems, whether: (1) the amended industry standard should be adopted; or (2) clear and convincing evidence exists to justify more-stringent standard levels. For any class where DOE was not triggered, the Department routinely considers those classes under the statute's six-year-lookback review provision at the same time, so as to address the subject equipment in a comprehensive fashion.

The current Federal energy conservation standards for air-cooled VRF multi-split systems with cooling capacity greater than or equal to 65,000 Btu/h and water-source VRF multi-split heat pumps (denominated in terms of EER and COP) are codified in DOE's regulations at 10 CFR 431.97. These standards are specified in terms of Energy Efficiency Ratio (EER) for cooling mode and Coefficient of Performance (COP) for heating mode based on the Federal test procedure at 10 CFR 431.96, which points to applicable appendix D which in turn references American National Standards Institute (ANSI)/Air-Conditioning, Heating, and Refrigeration Institute (AHRI) Standard 1230-2010, “ 2010 Standard for Performance Rating of Variable Refrigerant Flow (VRF) Multi-Split Air-Conditioning and Heat Pump Equipment, ” approved August 2, 2010 and updated by Addendum 1 in March 2011 (ANSI/AHRI 1230-2010).

The current Federal energy conservation standards for air-cooled, three-phase VRF multi-split systems with cooling capacity less than 65,000 Btu/h are also codified in 10 CFR 431.97. These standards are specified in terms of Seasonal Energy Efficiency Ratio (SEER) for cooling mode and Heating Seasonal Performance Factor (HSPF) for heating mode based on the rating conditions in ANSI/AHRI 1230-2010. Although the current standards levels are based on the same test procedure as used for all other categories of VRF systems ( i.e., air-cooled VRF multi-split systems with cooling capacity greater than or equal to 65,000 Btu/h and water-source VRF multi-split systems), the organizations that maintain the industry consensus test procedures have recently updated their scope such that air-cooled, three-phase VRF multi-split systems with cooling capacity less than 65,000 Btu/h are now covered under AHRI 210/240-2023 instead of AHRI 1230-2021. Consequently, DOE addressed test procedures for air-cooled, three-phase VRF multi-split systems with cooling capacity less than 65,000 Btu/h in a separate test procedure rulemaking for air-cooled, three-phase, small commercial package air conditioning and heating equipment with cooling capacity less than 65,000 Btu/h ( see 87 FR 77298 (Dec. 16, 2022)) instead of in the test procedure rulemaking for VRF multi-split systems ( see 87 FR 63860 (Oct. 20, 2022)). Accordingly, DOE is not evaluating the Federal energy conservation standards for such equipment in this document and is instead addressing energy conservation standards for air-cooled, three-phase VRF multi-split systems with cooling capacity less than 65,000 Btu/h in a separate energy conservation standards rulemaking for air-cooled, three-phase, small commercial package air conditioning and heating equipment with a cooling capacity of less than 65,000 Btu/h ( see 87 FR 18290 (March 30, 2022)).

The efficiency levels set forth in ASHRAE Standard 90.1-2016 for VRF multi-split systems with cooling capacity 65,000 Btu/h or greater are specified in terms of both EER and Integrated Energy Efficiency Ratio (IEER) for cooling mode and COP for heating mode. These efficiency levels are based on the rating conditions of ANSI/AHRI Standard 1230-2014 with addendum 1 (ANSI/AHRI 1230-2014), which are identical rating conditions to those found in AHRI 1230-2010. The EER levels found in ASHRAE 90.1-2016 are unchanged from the current Federal EER requirements; however, for certain classes of water-source VRF multi-split heat pumps, the COP levels specified in ASHRAE Standard 90.1-2016 are more stringent. See additional discussion in section II.B.2 of this document.

On April 11, 2018, DOE published in the Federal Register a Notice of Intent to establish a negotiated rulemaking working group (Working Group) under the Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC) to negotiate a proposed test procedure and amended energy conservation standards for VRF multi-split systems. 83 FR 15514. The Working Group reached consensus on an energy conservation standards term sheet (VRF ECS Term Sheet) on November 5, 2019, outlining recommended amended energy conservation standards for all equipment classes of VRF multi-split systems. The standard levels recommended by the Working Group in the VRF ECS Term Sheet  4 are in terms of the IEER and COP metrics and equivalent to the levels specified in ASHRAE Standard 90.1-2022. 5 The levels recommended by the working group are measured according to the most recent industry test standard for VRF multi-split systems  6 —AHRI Standard 1230, “ 2021 Standard for Performance Rating of Variable Refrigerant Flow (VRF) Multi-Split Air-Conditioning and Heat Pump Equipment ” (AHRI 1230-2021), which is referenced in ASHRAE Standard 90.1-2022. See additional discussion in section II.B.3 of this final rule.

As described in detail in section III.B of this document, DOE conducted a crosswalk analysis during the ASRAC negotiation meetings to validate the translation of the EER levels currently required by the DOE standards to IEER, as well as the IEER efficiency levels as recommended by the Working Group. DOE notes that IEER is a more comprehensive metric because it reflects the energy efficiency across a range of operating conditions, as opposed to the efficiency at a single condition. The crosswalk translates the current Federal EER standards (measured per the current DOE test procedure) to IEER levels of equivalent stringency (measured per the September 20, 2019 draft version of the AHRI 1230 standard). As described in section II.B.3 of this document, the recommended 2019 draft test procedure was later published as AHRI 1230-2021, and no substantive changes were made that impact crosswalk results. Differences in the metrics and test procedures cause the crosswalk analysis to yield a range of IEER values corresponding to a given EER value. DOE's translation of the current EER levels to IEER according to the updated test procedure shows that each value recommended by the Working Group is within the range resulting from DOE's evaluation. Given that the metric takes into account a wider breadth of energy consumption across a variety of operating conditions, DOE has determined that the recommended IEER values are at least equivalent in stringency to the current EER values. Further, given that IEER is a more comprehensive metric, DOE has concluded that the recommended IEER values would not decrease the minimum required energy efficiency of VRF basic models.

Because the updates in AHRI 1230-2021 do not affect the measurement of COP, no crosswalk was required to evaluate the stringency of the COP levels proposed in the VRF ECS Term Sheet as compared to the existing Federal COP levels.

In this final rule, DOE is adopting the energy conservation standard levels and the equipment class structure from ASHRAE Standard 90.1-2016 for air-cooled VRF multi-split systems with cooling capacity greater than or equal to 65,000 Btu/h and for all water-source VRF multi-split heat pumps. The amended standards, which are expressed in terms of IEER and COP, are presented in Table I-1. These standards will apply to all VRF multi-split systems listed in Table I-1 manufactured in, or imported into, the United States starting on January 1, 2024. The amended standard levels are equivalent to the standard levels recommended by the Working Group in the VRF ECS Term Sheet. The amended equipment class structure differs from the existing DOE equipment class structure regarding capacity break points and designations based on heating type; however, DOE has concluded that none of the changes to the equipment class structure for VRF multi-split systems constitute backsliding.

DOE has determined that the potential energy savings associated with adopting the ASHRAE 90.1-2016 standard levels for the triggered classes are de minimis. Also, as described in section V of this document, DOE has determined that insufficient data are available to determine, based on clear and convincing evidence, that more-stringent standards would result in significant additional energy savings and be technologically, feasible and economically justified. As such, DOE has not conducted further analysis of more-stringent standard levels for this final rule. Consequently, DOE is adopting the levels specified in ASHRAE Standard 90.1-2016, as required by EPCA.

Background

The Entity List (supplement no. 4 to part 744 of the EAR (15 CFR parts 730 through 774)) identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States, pursuant to § 744.11(b). The EAR impose additional license requirements on, and limit the availability of, most license exceptions for exports, reexports, and transfers (in-country) when a listed entity is a party to the transaction. The license review policy for each listed entity is identified in the “License Review Policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document that added the entity to the Entity List. The Bureau of Industry and Security (BIS) places entities on the Entity List pursuant to parts 744 (Control Policy: End-User and End-Use Based) and 746 (Embargoes and Other Special Controls) of the EAR.

The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and makes all decisions to remove or modify an entry by unanimous vote.

The ERC determined to add two entities, Aviatech and Aviazapchast, under the destination of Russia, and three entities, Miya Win, Myanmar New Era Trading Company, and Suntac Group, under the destination of Burma, to the Entity List for engaging in activities contrary to U.S. foreign policy interests. These additions are being made because Aviatech, Avizapchast, Miya Win, Myanmar New Era Trading Company, and Suntac Group sell, procure, and service military equipment that enables Burma's military regime to carry out human rights abuses, as well as brutal aerial attacks that have killed and injured civilians. These activities are contrary to the foreign policy interests of the United States under § 744.11(b) of the EAR. For these five entities, BIS imposes a license requirement for all items subject to the EAR and will review license applications under a presumption of denial.

The ERC determined to add the Nicaraguan National Police (NNP) to the Entity List under the destination of Nicaragua for engaging in activities contrary to U.S. foreign policy interests. This addition is being made because the NNP is responsible for or complicit in, or has directly or indirectly engaged in, serious human rights abuses in Nicaragua. These activities are contrary to the foreign policy interests of the United States under § 744.11(b) of the EAR. For this entity, BIS imposes a license requirement for all items subject to the EAR and will review license applications under a presumption of denial.

The ERC determined to add the following five entities: Luopu Haishi Dingxin Electronic Technology Co., Ltd., Moyu Haishi Electronic Technology Co., Ltd., Pishan Haishi Yong'an Electronic Technology Co., Ltd., Urumqi Haishi Xin'an Electronic Technology Co., Ltd., and Yutian Haishi Meitian Electronic Technology Co., Ltd., to the Entity List under the destination of China, for engaging in activities contrary to U.S. foreign policy interests. These additions are being made because Luopu Haishi Dingxin Electronic Technology Co., Ltd., Moyu Haishi Electronic Technology Co., Ltd., Pishan Haishi Yong'an Electronic Technology Co., Ltd., Urumqi Haishi Xin'an Electronic Technology Co., Ltd., and Yutian Haishi Meitian Electronic Technology Co., Ltd. have been implicated in human rights violations and abuses in the implementation of China's campaign of repression, mass arbitrary detention and high-technology surveillance against the Uyghur people and members of other Muslim minority groups in the Xinjiang Uyghur Autonomous Region (XUAR). These activities are contrary to the foreign policy interests of the United States under § 744.11(b) of the EAR. For these five entities, BIS imposes a license requirement for all items subject to the EAR and will review license applications under a presumption of denial.

For the reasons described above, this final rule adds the following eleven entities to the Entity List and includes, where appropriate, aliases:

As part of BIS's ongoing review and update of the EAR to further the foreign policy interest of protecting human rights, consistent with the Export Control Reform Act of 2018 (ECRA), in this rule BIS amends the “Criteria for revising the Entity List” paragraph (b) introductory text and the “is informed” provisions of paragraph (c)(3) (Additional prohibition on persons informed by BIS) of § 744.11 to explicitly confirm a longstanding position that the protection of human rights throughout the world is a foreign policy interest considered in assessing whether the activities of an entity—and those acting on behalf of such entity are contrary to the national security or foreign policy of the United States. This amendment is consistent with the foreign policy objectives set forth at 50 U.S.C. 4811(2)(D), which include the protection of human rights and promotion of democracy.

BIS is amending this provision to confirm this foreign policy interest and its potential application to the Entity List, similar to the current illustrative list of examples of activities that could lead to an entity's addition to the Entity List, as set forth in § 744.11(b)(1)-(5) of the EAR. This amendment is consistent with the recent decision by the United States Court of Appeals for the District of Columbia Circuit in Changji Esquel Textile Co. Ltd. v. Raimondo, 40 F.4th 716 (2022), which affirmed BIS's authority to add parties to the Entity List for human rights-related reasons. In that case, the Court found that “[a]dding human-rights violators to the Entity List falls comfortably within” the scope of 50 U.S.C. 4813(a)(16), which authorizes the Secretary of Commerce to “undertake any other action as is necessary to carry out this subchapter that is not otherwise prohibited by law,” and that it did not “discern any clear and mandatory prohibition on adding entities to the [Entity] List for human-rights abuses, particular given the breadth of section 4813(a)(16) and the deference we owe to the Executive Branch in matters of foreign affairs.” Id. at 723, 725.

Further, and as noted by the Court in the Esquel decision ( Id. at 720), years before the enactment of ECRA, BIS made explicit reference in its Entity List rules to the agency's longstanding authority to take action under the Entity List to address human rights concerns. For example, the background sections of two Entity List rules published in November 2012 and April 2014, respectively, each cite a range of “grounds for inclusion,” among them “activities contrary to U.S. national security or foreign policy interests, including terrorism and export control violations involving abuse of human rights” (77 FR 71,097 (Nov. 29, 2012)); 79 FR 21,394 (Apr. 16, 2014)). These rules relied upon authority set forth in the Export Administration Act of 1979, as amended, (50 U.S.C. 4601-4623 (Supp. III 2015)), specifically, Section 6 (Foreign Policy Controls). This provision's Congressional supporters intended that foreign policy controls apply to human rights concerns, including “changing the human rights policy of another country.” H.R. Rep. No. 96-200, at 7 (1979) (Comm. Rep.).

For the changes being made in this final rule, shipments of items removed from eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export, reexport, or transfer (in-country), on March 28, 2023, pursuant to actual orders for export, reexport, or transfer (in-country) to or within a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) before April 27, 2023. Any such items not actually exported, reexported, or transferred (in-country) before midnight, on April 27, 2023, require a license in accordance with this final rule.

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

1. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves an information collection approved by OMB under control number 0694-0088, Simplified Network Application Processing System. BIS does not anticipate a change to the burden hours associated with this collection as a result of this rule. Information regarding the collection, including all supporting materials, can be accessed at https://www.reginfo.gov/public/do/PRAMain.

3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to section 1762 of the Export Control Reform Act of 2018, this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows:

Table of Contents I. Executive Summary A. Purpose of the Final Rule B. Summary of the Major Provisions of the Final Rule C. Legal Authority D. Costs and Benefits II. Table of Abbreviations/Commonly Used Acronyms in This Document III. Background A. History of This Rulemaking B. Summary of Comments to the Proposed Rule IV. Legal Authority V. Comments on the Proposed Rule and FDA Response A. Introduction B. Description of Comments and FDA Response VI. Effective/Compliance Dates VII. Economic Analysis of Impacts A. Introduction B. Summary of Costs and Benefits VIII. Analysis of Environmental Impact IX. Paperwork Reduction Act of 1995 X. Federalism XI. Consultation and Coordination With Indian Tribal Governments XII. Reference I. Executive Summary A. Purpose of the Final Rule

FDA is classifying spinal spheres for use in intervertebral fusion procedures (spinal spheres), which are unclassified, preamendments devices, into class III. A spinal sphere is a prescription device used to provide stabilization of a spinal segment as an adjunct to fusion. FDA currently regulates these unclassified devices as devices requiring premarket notification, with the product code NVR. The classification of spinal spheres was consistent with the recommendation of the Orthopaedic and Rehabilitation Devices Panel meeting held on December 12, 2013 (the Panel) and our consideration and analysis of public comments received following the publication of the proposed rule. FDA is also, by final order published elsewhere in this issue of the Federal Register , requiring the filing of PMAs for such devices.

This rule establishes the identification and classification for spinal spheres as class III devices. In addition, the use of spinal spheres devices is limited to prescription use.

The Agency is issuing this rule under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301). Specifically, the relevant authority related to the classification includes section 513(a) through (d) of the FD&C Act (21 U.S.C. 360c(a) through (d)), regarding device classes, classification, and panels, and section 515 (21 U.S.C. 360e), regarding PMAs.

This rule classifies spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a PMA. The costs of the rule include one-time costs associated with reading the rule. FDA is only able to identify the costs of this rule. We estimate that the present value of the costs of the rule are between $335 and $16,093, with a primary estimate of $8,214. Annualizing over a 10-year period at a discount rate of 3 percent, the costs of this rule are estimated to be between $23 and $1,082, with a primary estimate of $552. Annualizing over a 10-year period at a discount rate of 7 percent, the costs of this rule are estimated to be between $32 and $1,519, with a primary estimate of $775.

In the Federal Register of December 15, 2021 (86 FR 71191) FDA issued a proposed rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA requires the filing of a PMA and invited interested persons to comment on the proposed regulation by March 15, 2022. These proposals were consistent with feedback received from the Panel meeting held on December 12, 2013.

FDA received two comments on the proposed rule—one from academia and another from an anonymous source. The comments were supportive of the classification of spinal spheres into class III as stated in the proposed rule and no changes were made in response to the comments in the final rule.

We are issuing this final rule under the authority of the FD&C Act (21 U.S.C. 301). Specifically, the relevant authority related to the classification includes sections 513(a) through (d), regarding device classes, classification, and panels; and section 515, regarding PMAs.

We received a few comment letters on the proposed rule by the close of the comment period. We received comments from academia and from an anonymous source. We describe and respond to the comments in section V.B of this document.

Both commenters supported FDA's proposed classification of spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA would require the filing of a PMA. The academic commenter agreed with FDA's assessment that this device type poses “a potential unreasonable risk of illness or injury.” The commenter described negative patient outcomes as reported in the literature and noted that classification of these devices into class III will safeguard patients undergoing spine surgery from a potentially devastating process and prevent the sale of a risky, unproven device.

Additionally, another commenter stated that strong evidence is necessary to demonstrate the medical benefits of this device type prior to subjecting patients to the risks associated with these devices.

We agree with both commenters supporting classification of spinal spheres to class III because there is a lack of available evidence to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness, and these devices present an unreasonable risk of illness or injury. As described in the preamble to the proposed rule, the risks to health from spinal spheres include reoperation, pain and loss of function, infection, adverse tissue reaction, soft tissue injury, vertebral endplate injury, pseudarthrosis, implant migration and/or instability, and implant breakage during insertion. FDA is not making any changes in the final rule in response to these comments.

In the final rule, we are revising the section number from § 888.3085 (21 CFR 888.3085) to 21 CFR 888.3083, because a De Novo was previously granted under § 888.3085. No other substantive changes were made to the regulation.

This final rule will become effective 30 days after its date of publication in the Federal Register .

After this rule and related order to require the filing of a PMA are effective, spinal spheres for use in intervertebral fusion procedures will be considered adulterated if a PMA is not filed with FDA within 30 months after the classification of the device into class III, and commercial distribution of the product must cease (see section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B))). However, the product may be distributed for investigational use only if the requirements of the investigational device exemptions regulations in 21 CFR part 812 are met.

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the estimated costs imposed on any affected firm are very low, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $165 million, using the most current (2021) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.

This final rule classifies spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately issuing an order to require the filing of a PMA.

The costs of the final rule are summarized in table 2; we did not quantify benefits for this rule. The costs of the rule include one-time costs associated with reading and understanding the rule. The present value of the costs of the rule are estimated to be between $335 and $16,093, with a primary estimate of $8,214. The annualized value of the primary estimate of costs over 10 years at a 3 percent discount rate is approximately $552. The annualized value of the primary estimate of costs over 10 years at a 7 percent discount rate is approximately $775.

We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this final rule (Ref. 1) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that would have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.

The following reference is on display at the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

I. Background—Regulatory Authorities

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment of the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), on May 28, 1976, (generally referred to as “preamendments devices”), are classified after FDA has: (1) received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

A person may market a preamendments device that has been classified into class III through premarket notification procedures, without submission of a PMA, until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.

Section 515(f) of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515(f), manufacturers may meet the premarket approval requirement if they file a notice of completion of a product development protocol (PDP) approved under section 515(f)(4) of the FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the manufacturer of a preamendments class III device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for filing and obtaining approval of a PMA.

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) publication of a proposed order in the Federal Register ; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments from all affected stakeholders, including patients, payors, and providers.

Section 515(b)(2) of the FD&C Act provides that a proposed order to require premarket approval shall contain: (1) the proposed order; (2) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved PMA and the benefit to the public from the use of the device; (3) an opportunity for the submission of comments on the proposed order and the proposed findings; and (4) an opportunity to request a change in the classification of the device based on new information relevant to the classification of the device.

Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, 1 consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order requiring premarket approval for the device, or 30 months after the classification of the device in class III under section 513 of the FD&C Act becomes effective, whichever is later (section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)). Elsewhere in this issue of the Federal Register , FDA is classifying spinal spheres for use in intervertebral fusion procedures (spinal spheres) to class III. Therefore, a PMA for spinal spheres for use in intervertebral fusion procedures must be filed within the 30-month period because that is the later of the two time periods. If a PMA is not filed in a timely manner for such devices, then the device would be deemed adulterated under section 501(f) of the FD&C Act.

Also, a preamendments device subject to the order process under section 515(b) of the FD&C Act is not required to have an approved investigational device exemption (IDE) (see part 812 (21 CFR part 812)) contemporaneous with its interstate distribution until the date identified by FDA in the final order requiring the filing of a PMA for the device. At that time, an IDE is required only if a PMA has not been filed. If the manufacturer, importer, or other sponsor of the device submits an IDE application and FDA approves it, the device may be distributed for investigational use. If a PMA is not filed by the later of the two dates, and the device is not distributed for investigational use under an IDE, the device is deemed adulterated within the meaning of section 501(f)(1)(A) of the FD&C Act and subject to enforcement action.

After the enactment of the Medical Device Amendments of 1976, FDA undertook an effort to identify and classify all preamendments devices, in accordance with section 513(d) of the FD&C Act. FDA issued a proposed rule for classification of 77 generic types of orthopedic devices in the Federal Register of September 4, 1987 (52 FR 33686). However, spinal spheres for use in intervertebral fusion procedures were not identified in this effort. Subsequently and consistent with the FD&C Act, FDA held a panel meeting on December 12, 2013, regarding the classification of spinal sphere devices for use in intervertebral fusion procedures (Ref. 1). Spinal sphere devices, intended for use in fusion procedures, are no longer used due to the widespread adoption of intervertebral body fusion devices (“interbody cages”). Unlike spinal sphere devices, interbody cages generally possess different features to engage with vertebral endplates, allowing them to resist migration and subsidence, and features that allow for the packing of graft material, facilitating bone growth into and through the device.

Elsewhere in this issue of the Federal Register , FDA is issuing a rule to classify unclassified, preamendments spinal spheres for use in intervertebral fusion procedures into class III. A PMA, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device. The rule establishes the identification, classification, and regulatory controls for spinal spheres.

Spinal spheres for use in intervertebral fusion procedures are unclassified preamendments devices. These devices have been subject to premarket review through a 510(k) submission and have been cleared for marketing if FDA considers the device to be substantially equivalent to a legally marketed predicate in accordance with section 513(i) of the FD&C Act. To date, FDA has cleared six spinal sphere devices from four manufacturers.

FDA is issuing a rule for classification of spinal spheres, into class III elsewhere in this issue of the Federal Register . In accordance with sections 501(f)(2)(B) and 515(b) of the FD&C Act, FDA requires that a PMA be filed with the Agency for spinal sphere devices by the last day of the 30th calendar month beginning after the month in which the classification of the device in class III became effective. An applicant whose product was legally in commercial distribution before May 28, 1976, or whose product has been found to be substantially equivalent to such a product, will be permitted to continue marketing such class III product during FDA's review of the PMA, provided that a PMA is filed in a timely manner. FDA intends to review any PMA for the device within 180 days. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days, unless the Agency finds that “. . . the continued availability of the device is necessary for the public health.”

If a PMA for a class III device is not filed with FDA within 30 months after the classification of the device into class III, commercial distribution of the device must cease. The device may be distributed for investigational use, only if the requirements of the IDE regulations in part 812 are met. The requirements for investigational use of significant risk devices include submitting an IDE application to FDA for review and approval. An approved IDE is required to be in effect before an investigation of the device may be initiated or continued under 21 CFR 812.30. FDA, therefore, recommends that IDE applications be submitted to FDA at least 30 days before the date a PMA is required to be filed to avoid interrupting investigations.

A spinal sphere is a prescription device that is an implanted, solid, spherical device manufactured from metallic ( e.g., cobalt-chromium-molybdenum) or polymeric ( e.g., polyetheretherketone) materials. They are intended to be inserted into the intervertebral disc space of the lumbar spine following a discectomy in order to maintain disc space height and provide postoperative stabilization to the affected spinal segment during fusion procedures. The device is to be used with bone graft material. FDA currently regulates these unclassified devices as devices requiring a 510(k) submission under product code NVR.

In response to the proposed order, FDA received a total of five comments on the proposed order and they are supportive of the rule to classify spinal spheres to class III and the call for PMA for this device type. The comments and FDA responses to the comments are summarized in this section. Certain comments are grouped together because the subject matter of the comments is similar. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value, importance, or the order in which it was received.

(Comment 1) Commenters supported the requirement for PMA for spinal spheres and had no concern with the time period of 30 months after the effective date for PMA submission.

(Response) FDA agrees. FDA has made no changes to the final order.

(Comment 2) Although supportive of the classification of spinal spheres into class III and the call for PMA, a comment suggested it would “promote efficiency” to apply the proposed rule to all manufacturers of preamendments devices to be classified into class III. Additionally, the commenter requested that the effective date requirement for PMAs for spinal spheres be applied to all manufacturers of preamendments devices to be classified into class III. Finally, the commenter stated that the title of the rule should be revised to reflect a process by which all such preamendments devices would be classified into class III.

(Response) FDA disagrees. FDA notes that under the FD&C Act, it is required to classify preamendments devices and establish the controls necessary to provide reasonable assurance of safety and effectiveness for devices based on each device type's intended use and following the public process established in section 513 of the FD&C Act. Each classification action for a preamendments device requires FDA to engage the appropriate classification panel and make a recommendation for classification specific to the facts and information relevant to the device at issue (see section 513(d) of the FD&C Act). The FD&C Act does not require that FDA classify all devices for class III at the same time. Nor can FDA apply the PMA requirement to devices that were not discussed at the panel meeting, summarized in the proposed rule, or that are not the subject of the proposed order to require PMAs. With the rule published elsewhere in the Federal Register , FDA is completing the classification of spinal spheres, which is the only device subject to the classification. FDA, therefore, cannot include other preamendments devices at this time and, as such, we will not change the title of the rule.

(Comment 3) Commenters stated that FDA should consider extending the amount of time that manufacturers of spinal spheres preamendments devices are required to file PMAs. The commenters expressed concern that 30 months would not be sufficient to collect evidence needed to support safe and effective use of these devices.

(Response) FDA disagrees. The 30-month time period to file for a PMA is dictated by statute (section 501(f)(2)(B) of the FD&C Act). Additionally, as described in the preamble to the proposed classification rule (86 FR 71191), there are safety concerns associated with these devices, including reoperation, pain and loss of function, infection, adverse tissue reaction, soft tissue injury, vertebral endplate injury, pseudarthrosis, implant migration and/or instability, and implant breakage during insertion. Because of these risks in combination with the fact that there are no devices currently marketed, FDA continues to consider the 30-month time period to be appropriate and reasonable.

In the final order, we are revising the section number from § 888.3085 (21 CFR 888.3085) to 21 CFR 888.3083, because a De Novo was previously granted under § 888.3085. No other substantive changes were made to the regulation.

A PMA for spinal sphere devices for use in fusion procedures must include the information required by section 515(c)(1) of the FD&C Act. Such a PMA should also include a detailed discussion of the risks, as well as a discussion of the effectiveness of the product for which premarket approval is sought. In addition, a PMA must include all data and information on the following: (1) any risks known, or that should be reasonably known, to the applicant that have not been identified in this document; (2) the effectiveness of the device that is the subject of the application; and (3) full reports of all non-clinical and clinical information from investigations on the safety and effectiveness of the device for which premarket approval is sought.

A PMA must include valid scientific evidence to demonstrate reasonable assurance of the safety and effectiveness of the spinal sphere for its intended use (see § 860.7(c)(2) (21 CFR 860.7(c)(2))). FDA defines valid scientific evidence in § 860.7(c)(2).

To present reasonable assurance of safety and effectiveness of spinal sphere devices, FDA concludes that manufacturers should submit performance testing, including clinical trials of their product, to support PMA approval. Existing published clinical literature relevant to the product may also be leveraged as part of the PMA submission. In addition, FDA strongly encourages manufacturers to meet with the Agency early through the Q-Submission Program for any assistance in preparation of their PMA.

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

While this final order contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this order. The previously approved collections of information are subject to review by the OMB under the PRA. The collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231; and the collections of information in part 812 have been approved under OMB control number 0910-0078.

This final order will become effective 30 days after its publication in the Federal Register .

The following reference is on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it also is available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

The Coast Guard will enforce the safety zone in 33 CFR 165.1198 for the Military Ocean Terminal Concord, CA (MOTCO) regulated area from 12:01 a.m. on March 30, 2023, until 11:59 p.m. on April 14, 2023, or as announced via marine local broadcasts. This safety zone is necessary to protect personnel, vessels, and the marine environment from potential explosion within the explosive arc. The regulation for this safety zone, § 165.1198, specifies the location of the safety zone which encompasses the navigable waters in the area between 500 yards of MOTCO Pier 2 in position 38°03′30″ N, 122°01′14″ W and 3,000 yards of the pier. During the enforcement periods, as reflected in § 165.1198(d), if you are the operator of a vessel in the regulated area you must comply with the instructions of the COTP or the designated on-scene patrol personnel. Vessel operators desiring to anchor or otherwise loiter within the safety zone must contact Sector San Francisco Vessel Traffic Service at 415-556-2760 or VHF Channel 14 to obtain permission.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via marine information broadcasts.

I. Table of Abbreviations AOR Area of Responsibility COTP Captain of the Port Sector Ohio Valley CFR Code of Federal Regulations DHS Department of Homeland Security E.O. Executive Order FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Captain of Port Sector Ohio Valley (COTP) is amending 33 CFR 165.801 to update the table of annual fireworks displays and other events in Coast Guard Sector Ohio Valley Area of Responsibility (AOR). These events include air shows, fireworks displays, and other events requiring a safety zone.

On January 23, 2023, the Coast Guard published a notice of proposed rulemaking (NPRM) titled, Safety Zones; Coast Guard Sector Ohio Valley Annual and Recurring Safety Zones Update (86 FR 68948). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to those recurring safety zones. During the comment period that ended on February 22, 2023, no comments were received.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to ensure the safety of the events occurring in March.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Coast Guard is amending and updating the safety zones under 33 CFR part 165 to include the most up to date list of recurring safety zones for events held on or around navigable waters within the Sector Ohio Valley AOR. These events include fireworks displays, air shows, and festivals. The current list in 33 CFR 165.801 requires amending to provide new information on existing safety zones and to include new safety zones expected to recur annually or biannually. Issuing individual regulations for each new safety zone, amendment of existing safety zones creates unnecessary administrative costs and burdens. This rulemaking reduces administrative overhead and provides the public with notice through publication in the Federal Register of the upcoming recurring safety zones. Based on the nature of these events, large numbers of participants and spectators, and event locations, the COTP has determined that the events listed in this rule could pose a risk to participants or waterways users if the normal vessel traffic were to interfere with the events. Possible hazards include risks of injury or death from near or actual contact among participant vessels and spectators or mariners traversing through the regulated area. This purpose of this rule is to ensure the safety of all waterway users, including event participants and spectators, during the scheduled events.

As noted above, we received no comments on our NPRM published January 23, 2023. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule amends and updates part 165 of 33 CFR by revising the current table for Sector Ohio Valley, and by adding eight new recurring safety zones, removing four safety zones, and amending four safety zones as described in the NPRM. Vessels intending to transit the designated waterway through the safety zone will only be allowed to transit the area when the COTP, or designated representative, has deemed it safe to do so or at the completion of the event.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and duration of the safety zones. These safety zones are limited in size and duration, and are usually positioned away from high vessel traffic areas. Moreover, the Coast Guard would issue a Broadcast Notices to Mariners, Local Notices to Mariners, and Marine Safety Information Broadcasts to inform the community of these safety zones.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. It is categorically excluded from further review under paragraph L60 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce a security zone in 33 CFR 165.846 for events related to the French Quarter Festival from 10 a.m. on April 13, 2023, through 10 p.m. on April 16, 2023. This action is being taken to provide security and protection for visiting personnel during the events related to the French Quarter Festival. The security zone will cover all navigable waters within 400 yards of the Left Descending Bank on the Lower Mississippi River from MM 94.4 to MM 95.1 AHP, New Orleans, LA. Except for Vessel Movement Reporting System Users operating in the Algiers Point VT Special Area, no person or vessel may enter this security zone unless authorized by the COTP or a designated representative. A designated representative means any Coast Guard commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Sector New Orleans; to include a Federal, State, and/or local officer designated by or assisting the COTP in the enforcement of the security zone. To seek permission to enter, contact the COTP or a designated representative on VHF-FM Channel 12 or 67. Those in the security zone must transit at their slowest speed and comply with all lawful orders or directions given to them by the COTP or a designated representative.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Vessel Traffic Service Advisories, Broadcast Notices to Mariners (BNMs), and/or Marine Safety Information Bulletins (MSIBs).

1. Background

The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the Inflation Adjustment Act)  1 directs each Executive agency to make an annual inflation adjustment for each civil monetary penalty provided by law within the jurisdiction of the agency, and to publish notice of each such adjustment in the Federal Register . An agency adjusts a civil monetary penalty by increasing the maximum amount of such penalty (or the range of minimum and maximum amounts, as applicable) by the percentage by which the Consumer Price Index for All Urban Consumers (CPI-U) for the month of October preceding the date of adjustment (in this case, October 2022) exceeds the CPI-U for the October one year prior to the October immediately preceding the date of the adjustment (in this case, October 2021), then rounding each amount to the nearest dollar. The formula for the amount of a civil monetary penalty inflation adjustment is prescribed by law, as explained in Office of Management and Budget (OMB) Memorandum M-16-06 (February 24, 2016), and therefore the amount of the adjustment is not subject to the exercise of discretion by the Chair of the National Endowment for the Humanities.

OMB has issued guidance on implementing and calculating the 2023 adjustment under the Inflation Adjustment Act. 2 Per this guidance, the CPI-U adjustment multiplier for this annual adjustment is 1.07745. In its prior rules, NEH identified two civil monetary penalties which require adjustment pursuant to the Inflation Adjustment Act: a civil monetary penalty that NEH may impose for violation of its New Restrictions on Lobbying regulation (the Lobbying Civil Monetary Penalty)  3 and a civil monetary penalty that NEH may impose under its Program Fraud Civil Remedies Act Regulations (the PFCRA Civil Monetary Penalty). 4 NEH made the initial “catch-up” adjustments to the Lobbying Civil Monetary Penalty when it amended its New Restrictions on Lobbying regulation on April 21, 2020, 5 and to the PFCRA Civil Monetary Penalty when it adopted its Program Fraud Civil Monetary Penalties Act regulations on August 13, 2021. 6 With this rule, NEH is adjusting the amount of those civil monetary penalties accordingly.

Two civil monetary penalties in NEH regulations require adjustment in accordance with the Inflation Adjustment Act: (1) the Lobbying Civil Monetary Penalty and (2) the PFCRA Civil Monetary Penalty.

The Lobbying Civil Monetary Penalty is currently set at a range of a minimum amount of $22,021 and a maximum amount of $220,213. The post-adjustment penalty or range is obtained by multiplying the pre-adjustment penalty or range by the percent change in the CPI-U over the relevant time period and rounding to the nearest dollar. Between October 2021 and October 2022, the CPI-U increased by a multiplier of 107.745%. Therefore, the new post-adjustment minimum Lobbying Civil Monetary Penalty is $23,727 ($22,021 multiplied by 1.07745) and the maximum Lobbying Civil Monetary Penalty is $237,268 ($220,213 multiplied by 1.07745).

Thus, the range for the Lobbying Civil Monetary Penalty shall be between $23,727 and $237,268.

The current maximum PFCRA Civil Monetary Penalty is set at $12,537. The post-adjustment penalty or range is obtained by multiplying the pre-adjustment penalty or range by the percent change in the CPI-U over the relevant time period and rounding to the nearest dollar. Between October 2021 and October 2022, the CPI-U increased by a multiplier of 107.745%. Therefore, the new, post-adjustment maximum penalty NEH's PFCRA regulation is $13,508 ($12,537 multiplied by 1.07745).

For subsequent annual adjustments to civil penalty amounts made in accordance with the Inflation Adjustment Act, the amount of the adjustment is based on the percent increase between the CPI-U for the month of October preceding the date of the adjustment and the CPI-U for the October one year prior to the October immediately preceding the date of the adjustment. If there is no increase, there is no adjustment of civil penalties. Therefore, if NEH adjusts penalties in January 2024, the adjustment will be calculated based on the percent change between the CPI-U for October 2023 (the October immediately preceding the date of adjustment) and October 2022 (the October one year prior to October 2023). With this rule, NEH will publish a notice of the amount of these annual inflation adjustments in the Federal Register no later than January 15 of each year, starting in 2024.

Pursuant to section 4 of the Inflation Adjustment Act, each Federal agency is required to publish adjustments no later than January 15 each year. In accordance with section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 553, most rules are subject to notice and comment and are effective no earlier than 30 days after publication in the Federal Register . However, section 4(b)(2) of the Inflation Adjustment Act provides that each agency shall make the annual inflation adjustments “notwithstanding section 553” of the APA. Consistent with the language of the Inflation Adjustment Act, this rule is not subject to notice and an opportunity for public comment and will be effective on March 30, 2023.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget for review.

This rulemaking does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government.

This rulemaking meets the applicable standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988. Specifically, this rulemaking is written in clear language designed to help reduce litigation.

Under the criteria in Executive Order 13175, NEH evaluated this rulemaking and determined that it will not have any potential effects on federally recognized Indian Tribes.

Under the criteria in Executive Order 12630, this rulemaking does not have significant takings implications. Therefore, a takings implication assessment is not required.

This rulemaking will not have a significant adverse impact on a substantial number of small entities, including small businesses, small governmental jurisdictions, or certain small not-for-profit organizations.

This rulemaking does not impose an information collection burden under the Paperwork Reduction Act. This action contains no provisions constituting a collection of information pursuant to the Paperwork Reduction Act.

This rulemaking does not contain a Federal mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year.

This rulemaking will not have a significant effect on the human environment.

This rulemaking will not be a major rule as defined in section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rulemaking will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

All information about NEH required to be published in the Federal Register may be accessed at www.neh.gov. The website www.regulations.gov contains electronic dockets for NEH's rulemakings under the Administrative Procedure Act of 1946.

To ensure this rule speaks in plain and clear language so that the public can use and understand it, NEH modeled the language of the rule on the Federal Plain Language Guidelines.

For the reasons stated in the preamble, the National Endowment for the Humanities amends 45 CFR chapter XI, subchapter D, as follows:

This is a summary of the Commission's Order, document FCC 23-19, released March 17, 2023, in WC Docket Nos. 12-375 and 23-62. The full text of document FCC 23-19 can be accessed electronically via the FCC's Electronic Document Management System (EDOCS) website at www.fcc.gov/edocs or via the FCC's Electronic Comment Filing System (ECFS) website at www.fcc.gov/ecfs . To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov, or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice) or (202) 418-0432 (TTY).

1. In this Order, the Commission builds on its efforts to date, bolstered by the new authority Congress has bestowed, and begins the process of implementing the Martha Wright-Reed Just and Reasonable Communications Act of 2022 (Martha Wright-Reed Act or Act) to adopt just and reasonable rates and charges for incarcerated people's audio and video communications services. Martha Wright-Reed Act, Public Law 117-338, 136 Stat. 6156. This Order continues and expands on the Commission's ongoing efforts to reform providers' rates, charges, and practices in connection with interstate and international inmate calling services in WC Docket No. 12-375. At the same time, document FCC 23-19 initiates a new docket, WC Docket No. 23-62, to specifically address implementation of, and changes required by, the provisions of the Martha Wright-Reed Act.

2. In the Order, the Commission reaffirms its prior delegation of data collection authority to WCB and OEA and directs them to update and restructure their most recent data collection as appropriate in light of the requirements of the new statute, so that the Commission may meet its statutory obligation to ensure that the rates and charges for communications services between incarcerated people and their friends and families are just and reasonable. The Commission also reaffirms and updates its prior delegation of authority to WCB and CGB to modify the instructions and reporting template for the annual reports required from service providers as appropriate to supplement the information that will be received in this data collection.

3. Data Collection. On January 5, 2023, President Biden signed into law the Martha Wright-Reed Act. The Act was the product of efforts by multiple individuals and committed stakeholders over a number of years to comprehensively address the persistent problem of unreasonably high rates and charges incarcerated people and their families pay for communications services. At its core, the Act removes the statutory limitations that previously prevented the Commission from setting comprehensive and effective just and reasonable rates for incarcerated people's communications services.

4. Specifically, the Martha Wright-Reed Act modifies section 276 of the Communications Act of 1934 (Communications Act) to explicitly enable the Commission to require that rates for incarcerated people's communications services be just and reasonable, irrespective of the “calling device” used. The Act expressly allows the Commission to “use industry-wide average costs,” as well as the “average costs of service of a communications service provider” in setting just and reasonable rates. The Martha Wright-Reed Act also requires that the Commission “shall consider,” as part of its ratemaking, “costs associated with any safety and security measures necessary to provide” telephone service and advanced communications services. The statute further directs the Commission to promulgate regulations necessary to implement the statutory provisions not earlier than 18 months and not later than 24 months after the date of its enactment.

5. In 2013, the Commission adopted interim interstate rate caps and adopted the Commission's first mandatory data collection regarding inmate calling services (ICS), requiring all providers of those services to submit data on their underlying costs of service. Rates for Interstate Inmate Calling Services, 78 FR 67956, November 13, 2013. It also adopted an annual reporting obligation requiring providers to provide specific information on their operations, including their rates and ancillary service charges.

6. In 2015, in light of record evidence of continued “egregiously high” rates, the Commission adopted a comprehensive framework for regulating rates and charges for both interstate and intrastate calling services for incarcerated people, re-adopting the interim interstate rate caps it adopted in 2013, and extending them to intrastate calls pending the effectiveness of the new rate caps. The Commission also adopted a Second Mandatory Data Collection to enable it to identify trends in the market and adopt further reforms. Rates for Interstate Inmate Calling Services, 80 FR 79135, December 18, 2015.

7. Subsequently, after seeking comment on additional steps to address unreasonable rates, the Commission released a comprehensive order in which, among other actions, it reformed the treatment of site commissions, set new interim interstate rate caps for prisons and jails with average daily populations of 1,000 or more incarcerated people, and capped international calling rates for the first time. Rates for Interstate Inmate Calling Services, 86 FR 40682, July 28, 2021 ( 2021 ICS Order ).

8. In the 2021 ICS Order, the Commission also sought to improve the data it collected on calling services for incarcerated people as part of its efforts to set reasonable permanent rate caps. It delegated authority to WCB and OEA to establish a Third Mandatory Data Collection to collect uniform cost data to use in setting rate caps that more closely reflect inmate service providers' costs of providing service at correctional facilities. After seeking public comment, in January 2022, WCB and OEA released an Order adopting the data collection. Parties' responses to the Third Mandatory Data Collection were due June 30, 2022, and the Commission affirmatively incorporates those responses into the record in this proceeding.

9. The Martha Wright-Reed Act directs the Commission to promulgate regulations necessary to implement its provisions not earlier than 18 months and not later than 24 months after the date of its enactment, and includes specific language addressing the use of data in promulgating implementing regulations. The statutory language provides both guidance and directives regarding the use of data, including allowing the Commission to “use industry-wide average costs of telephone service and advanced communications services and the average costs of service of a communications service provider” in determining just and reasonable rates while ensuring providers are fairly compensated. It further states that the Commission “shall consider costs associated with safety and security measures necessary to provide a service” and “differences in costs” by “small, medium and large facilities or other characteristics.” These provisions contemplate and require the collection and analysis of advanced communications services' costs and related data, especially for video communications, among other data that, prior to the Act, the Commission either had no jurisdiction to collect or reason for doing so. The data analysis to implement the statute's mandate that rates and charges be “just and reasonable” must be completed within the required 18 to 24 month timeframe.

10. The Commission's most recent data collection, limited only to inmate telephone services data, took nearly 14 months from the date the Commission delegated authority to WCB and OEA to conduct the data collection on May 24, 2021, to obtaining OMB approval of the data collection instructions and templates, issuing the order directing providers to file their responses and waiting for responses to be filed on June 30, 2022 (a total 402 days for Commission staff to receive responses from the date of delegation of authority). In addition to these steps, WCB and OEA will need time to compile the data into a consistent and meaningful format, analyze the data, and make recommendations for Commission consideration to result in the Act's implementing rules.

11. To ensure that the Commission has the data it needs, in time to meet this statutory mandate, and given the procedurally complex and time-consuming process for data collections generally, the Commission reaffirms its prior delegation of authority to WCB and OEA and directs them to update the prior data collection to encompass, and collect, data on all incarcerated people's communications services from all providers of those services now subject to its expanded authority under the Martha Wright-Reed Act and the Communications Act of 1934, as amended. Specifically, the Commission delegates authority to WCB and OEA to update and restructure the most recent data collection as appropriate to implement the Martha Wright-Reed Act. The Commission has conducted three data collections related to incarcerated people's calling services in the past ten years. To allow for consistent data reporting, the Commission directed the Commission staff to develop a template for providers to use when submitting their data and to furnish providers with instructions to implement the collection. The Commission also directed staff to review the providers' submissions and delegated to the staff the authority to require providers to submit additional data as necessary to perform its review.

12. The Commission concludes that it must immediately begin the process of updating and restructuring the most recent data collection if it is to meet both its procedural obligations (to consider certain types of data) and its substantive responsibilities (to set just and reasonable rates and charges) under the Martha Wright-Reed Act and the Communications Act. It therefore delegates to WCB and OEA authority to implement any appropriate modifications to this data collection, including with respect to information concerning intrastate services and “any audio or video communications service used by inmates for the purpose of communicating with individuals outside of the correctional institution where the inmate is held, regardless of technology used.” The Commission directs WCB and OEA to modify the template and instructions for the collection to the extent appropriate to timely collect such information to cover the additional services and providers now subject to its authority. It also delegates to WCB and OEA the authority to require providers now covered by section 276 of the Communications Act to submit any additional information that they find will assist the Commission in implementing the Martha Wright-Reed Act, including, but not limited to, the authority to request more recent data for additional years not covered by the most recent data collection. Finally, the Commission delegates to WCB and OEA the authority to conduct the requisite Paperwork Reduction Act analysis for any new or modified data collection(s) that they implement pursuant to this Order. Any new or modified requirements that require approval from the Office of Management and Budget (OMB) under the Paperwork Reduction Act shall be effective on the date specified in a notice published in the Federal Register announcing OMB's approval.

13. Annual Reports. The Commission also reaffirms and updates its prior delegation of authority to WCB and the CGB to revise the instructions and reporting template for the Annual Reports that all service providers are required to file each year. Specifically, it delegates authority to WCB and CGB to modify, supplement, and update those instructions and that template as appropriate to supplement the information the Commission will be receiving in response to the Mandatory Data Collection described above. The Commission finds that this additional information is needed to enable it to understand the rates and ancillary service fees incarcerated people's communications service providers charge for or in connection with the audio and video services now subject to its authority. However, the Commission notes that incarcerated people's communications services providers that do not provide any services classified as inmate calling services under its current rules will not be subject to this reporting requirement. Finally, the Commission delegates to WCB and CGB the authority to conduct the requisite Paperwork Reduction Act analysis for any changes to the Annual Report requirements that are implemented pursuant to this Order.

14. Effective Date of Delegations of Authority. The Commission's delegations of authority to WCB, OEA, and CGB will take effect on March 30, 2023. Making the delegations effective at that time will enable WCB, OEA, and CGB to move as expeditiously as practicable toward modifying, supplementing, and updating the Third Mandatory Data Collection to include additional information to facilitate the Commission's ability to fully implement the Martha Wright-Reed Act. Indeed, the Martha Wright-Reed Act directs the Commission to “promulgate any regulations necessary” to establish just and reasonable rates “not later than 24 months” after enactment. Any unnecessary delay in its efforts to collect appropriate information would be inconsistent with, and undermine its ability to meet the deadlines contained in, the Act. Furthermore, given the importance of these areas to incarcerated people, including those with communication disabilities, any unnecessary delay in these initiatives would be inconsistent with the public interest.

15. For purposes of administrative efficiency and to further assist the Commission in its efforts to implement the Martha Wright-Reed Act, the Commission intends to consider the extensive record developed in WC Docket No. 12-375, Rates for Interstate Inmate Calling Services, and hereby incorporates the record of that proceeding into WC Docket No. 23-62.

16. Congressional Review Act. The Commission has determined that this Order does not adopt any rules as defined under 5 U.S.C. 551, 804. Accordingly, the Commission is not required to submit, and will not be submitting, a copy of document FCC 23-19 to Congress and the Government Accountability Office pursuant to the Congressional Review Act, 5 U.S.C. 801(a)(1)(A).

17. Regulatory Flexibility Act. The Commission has determined that this Order does not adopt any rules as defined under 5 U.S.C. 551. Accordingly, the Commission is not required to issue, and will not be issuing, a final regulatory flexibility analysis concerning the impact of this Order. See 5 U.S.C. 604.

18. Paperwork Reduction Act. The Commission has determined that this Order does not contain information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198.

19. Pursuant to the authority contained in sections 1, 2, 4(i)-(j), 5(c), 201(b), 218, 220, 225, 255, 276, 403, and 716 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i)-(j), 155(c), 201(b), 218, 220, 225, 255, 276, 403, and 617, and the Martha Wright-Reed Just and Reasonable Communications Act of 2022, Public Law 117-338, 136 Stat 6156 (2022), the Order in document FCC 23-19 is adopted.

20. Pursuant to the authority contained in sections 1, 2, 4(i)-(j), 5(c), 201(b), 218, 220, 225, 255, 276, 403, and 716, of the Communications Act of 1934, as amended, 47 U.S.C. 151, 152, 154(i)-(j), 155(c), 201(b), 218, 220, 225, 255, 276, 403, and 617, and the Martha Wright-Reed Just and Reasonable Communications Act of 2022, Public Law 117-338, 136 Stat 6156 (2022), and sections 0.201 and 1.103(a) of the Commission's rules, 47 CFR 0.201, 1.103(a), the Order in document FCC 23-19 shall be effective on March 30, 2023.

Previous Federal Actions

Please refer to the proposed listing rule for the Egyptian tortoise published in the Federal Register on November 9, 2021 (86 FR 62122), for a detailed description of previous Federal actions concerning this species.

In preparing this final rule, we reviewed and fully considered comments from the public on our November 9, 2021, proposed rule. In this final rule, we make only two minor changes from the proposed rule: (1) We clarify that the listed entity of Egyptian tortoise ( Testudo kleinmanni ) includes the scientific name Testudo werneri as an accepted synonym; and (2) we present new information on the species' population size, based on updated information regarding the size of the population in Israel. Additionally, while the preambular discussion in this final rule is not as detailed as the proposed rule, it is not meant to imply any changes between the proposed and final rules.

In the proposed rule published on November 9, 2021 (86 FR 62122), we requested that all interested parties submit written comments on the proposal by January 10, 2022. We also contacted appropriate Federal agencies, scientific experts, organizations, and management authorities from the range countries, as well as other interested parties, and invited them to comment on the proposal. All substantive information we received during the comment period has either been incorporated directly into this final determination or is addressed below.

We received comments from three peer reviewers. We reviewed all comments for substantive issues and new information regarding the information contained in the species status assessment (SSA) report. The peer reviewers generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions to improve the final SSA report. Comments from peer reviewers provided general technical corrections and updates on status of the species within the range countries. We incorporated the peer reviewer comments into the final SSA report as appropriate.

Comment (1): Numerous commenters stated that the Act (16 U.S.C. 1531 et seq. ) was only meant to protect species native to the United States and the Egyptian tortoise should not be listed because it is a foreign species.

Response: The Act does not distinguish between domestic and foreign species as it applies to our responsibilities to determine whether species are endangered or threatened. For example, the broad definitions of “species,” “fish or wildlife,” and “plant” in section 3 of the Act (16 U.S.C. 1532) do not differentiate between species native to the United States, species native to both the United States and one or more other countries, and species not native to the United States. Further, sections 4(b)(1)(A) and 4(b)(1)(B) of the Act (16 U.S.C. 1533(b)(1)(A) and (b)(1)(B)) expressly require the Service to consider efforts by a foreign nation prior to making a listing determination. The Act's section 4(b)(5)(B) (16 U.S.C. 1533(b)(5)(B)) expressly requires the Service, insofar as practical, to provide notice of proposed regulations to and invite comment from foreign nations in which a species is believed to occur. Additionally, the findings and purposes at sections 2(a) and 2(b) of the Act (16 U.S.C. 1531(a) and (b)) also speak to the application of the Act to foreign species, and numerous provisions of the Act and its implementing regulations refer to foreign jurisdictions ( e.g., 16 U.S.C. 1537 and 1537a, 50 CFR 424.11(e)). In summary, if a species meets the Act's definition of an endangered or threatened species, the Service must list that species regardless of the country where it is found.

Comment (2): Numerous commenters stated there is no demonstrable benefit to listing the Egyptian tortoise under the Act because it is already protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

Response: The purpose of CITES is to ensure that international trade in plants and animals does not threaten their survival in the wild. Protection provided by other laws, such as CITES, was taken into consideration when determining the status of the species. However, simply being protected by these other laws does not preclude the need to list a species under the Act if it meets the Act's definition of an endangered or threatened species. Further, while the Egyptian tortoise is already protected by CITES, additional conservation measures are provided to species listed as endangered or threatened under the Act, including recognition, requirements for Federal protection, and prohibitions against certain activities with the species. Recognition through listing results in public awareness and may encourage and result in conservation actions by foreign governments, Federal and State governments, private agencies and interest groups, and individuals. For example, listing the Egyptian tortoise under the Act can support the conservation efforts undertaken for the species in Libya, Egypt, and Israel, as well as under the CITES' Appendix-I listing, including research efforts to address conservation needs and funding for range-country conservation.

Listing under the Act can also help ensure that the United States and its citizens do not contribute to the further decline of the Egyptian tortoise through resulting Federal protections and prohibitions on certain activities such as import, export, take, interstate commerce, and foreign commerce (see also Available Conservation Measures, below). For instance, adding a violation under the Act on top of a CITES violation could serve as an additional disincentive for any illegal trade in the species.

Comment (3): One commenter recommended that both Testudo kleinmanni and Testudo werneri be used as scientific names when listing the species under the Act.

Response: The valid taxonomic status of the Egyptian tortoise is Testudo kleinmanni, and Testudo werneri is accepted as a junior synonym (ITIS 2022, unpaginated; Attum et al. 2007a, p. 399). Thus, in this rule, we clarify that the Egyptian tortoise includes Testudo werneri as a synonym for Testudo kleinmanni, and we include the synonym Testudo werneri in the entry for the species in the List of Endangered and Threatened Wildlife at 50 CFR 17.11(h). All Egyptian tortoises are included in this rule. See the SSA report for a thorough discussion of the taxonomic status of the species (Service 2022, pp. 2-4).

Comment (4): One commenter stated that the species is extinct in Egypt, and another commenter stated that the species occurs in very low numbers in the North Coast of Egypt.

Response: According to the best available information, both of these statements regarding the status of the species in Egypt are inaccurate. The Egyptian tortoise is extant in Egypt as it occurs in a very small population east of the Nile River in and on the periphery of the Zaranik Protected Area in North Sinai, Egypt. Conversely, the best available information indicates that the Egyptian tortoise is extirpated from the North Coast of Egypt where habitat quality decreases east of Libya, and formerly suitable habitat for the species has become uninhabitable to the degree that no individuals could survive in Egypt west of the Nile River.

Comment (5): Numerous commenters recommended that we issue a rule under section 4(d) of the Act to provide an exception for the commercial trade of Egyptian tortoises within the United States for private individuals because captively-bred tortoises could be used for reintroductions into the wild and aid in the conservation of the species.

Response: We recognize that in well-managed circumstances captive breeding of wildlife can support conservation, for example by producing animals that could be used for reintroductions. However, we are not aware of any captive-breeding programs for the Egyptian tortoise in the United States for this purpose, and thus we are also not aware of captive-breeding programs practicing conservation breeding in a manner that would produce animals suitable for reintroduction. For threatened wildlife, such as the Egyptian tortoise, we may issue permits for scientific purposes, to enhance the propagation or survival of the species, for incidental take in connection with otherwise lawful activities, for economic hardship, for zoological exhibition, for education purposes, and for special purposes consistent with the purposes of the Act.

We may also register persons subject to the jurisdiction of the United States through a captive-bred wildlife (CBW) program if certain established requirements are met under the CBW regulations (see 50 CFR 17.21(g); see also Available Conservation Measures, below). In addition, the 4(d) rule includes an exception for interstate commerce from public institutions to other public institutions, specifically museums, zoological parks, and scientific institutions, meeting the definition of “public” at 50 CFR 10.12. We found that the demand for Egyptian tortoises held at or captive-bred by these types of institutions and sold or otherwise transferred only to other qualifying institutions in the United States is likely not substantial nor is it likely to pose a significant threat to the wild population in the species' range countries. Only specimens that have been legally imported and their offspring can qualify for this exception; possession of specimens traded contrary to CITES and their offspring is prohibited (16 U.S.C. 1538(c)(1); 50 CFR 23.13).

Comment (6): Numerous commenters stated that tortoises bred in captivity by private individuals in the United States provide a source of genetic diversity for future reintroduction efforts and they produce more captively-bred tortoises than just the Association of Zoos and Aquarium facilities. Therefore, providing an exception for interstate commerce for private individuals will provide a crucial source of genetic diversity for future captive breeding and reintroduction efforts.

Response: The intent of the Act is to recover wild populations in their natural habitat whenever possible. Controlled propagation can support the recovery of some listed species and can be used to reverse declines and return listed species to suitable habitat in the wild. However, controlled propagation is not a substitute for addressing the primary threats to the species. Egyptian tortoises captive-bred in the United States by private individuals are not addressing primary threats to the species nor are the tortoises captive-bred for reintroduction purposes. Additionally, introducing captive-bred individuals increases the risk of releasing pathogens into wild populations. Therefore, captive breeding by private individuals in the United States could not be used to increase the wild population of the species in its range countries. However, well-managed captive-breeding programs by registered public zoos practicing conservation breeding in a manner that would produce animals suitable for reintroduction could be used to reintroduce species into the wild if that became warranted and justified.

Comment (7): Some commenters stated that if the Egyptian tortoise is harder to obtain in the United States because of prohibitions on interstate commerce, prices will increase, which in turn will increase illegal imports of the species into the United States.

Response: Commercial trade of the Egyptian tortoise is already largely prohibited as a result of species' inclusion in Appendix I of CITES in 1995. CITES Appendix-I species are considered threatened with extinction, and international trade is permitted only under exceptional circumstances, which generally precludes commercial trade. Very few live tortoises or parts have been imported into the United States since then (CITES 2022, unpaginated). No evidence exists that listing the Egyptian tortoise as a threatened species will lead to an increase in illegal imports to the United States. Listing under the Act can also help ensure that the United States and its citizens do not contribute to the further decline of the Egyptian tortoise through resulting Federal protections and prohibitions on certain activities such as import, export, take, interstate commerce, and foreign commerce (see also Available Conservation Measures, below). For instance, adding a violation under the Act on top of a CITES violation could serve as an additional disincentive for any illegal trade in the species. Therefore, the CITES regulations in place and the additional protections provided by this final rule minimize the risk of illegal imports of wild Egyptian tortoises coming into the United States.

Comment (8): One commenter stated that the Service erred in its significant-portion-of-its-range analysis and advocated that we undertake a new analysis to evaluate whether the populations of the species are endangered in North Coast, Egypt; North Sinai, Egypt; and Israel. The commenter implied that because the populations are small in each of these three areas, the analysis should have led to a determination that the species is endangered in a significant portion of its range.

Response: In this final rule, we expand on the analysis we included in the November 9, 2021, proposed rule (see Status Throughout a Significant Portion of Its Range, below) for the three populations the commenter identifies, which we summarize in this response.

The Egyptian tortoise is extirpated from the North Coast of Egypt because of a combination of historical habitat loss and collection for the pet trade; thus, no population occurs in this area. Formerly suitable habitat for the species has become uninhabitable to the degree that no individuals could survive in Egypt west of the Nile River. As outlined in our Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37578; July 1, 2014), the term “range” means the general geographical area occupied by the species at the time we make a status determination under section 4 of the Act (see 79 FR 37578, July 1, 2014, pp. 37583-37585). In other words, we interpret “range” in these definitions to be current range, i.e., range at the time of our analysis. Several courts have upheld this interpretation ( Humane Society v. Zinke, 865 F.3d 585 (D.C. Cir. 2017); Center for Biological Diversity v. Zinke, 900 F.3d 1053, 1066-67 (9th Cir. 2018); Desert Survivors v. Dep't of the Interior, F. Supp. 3d 1131 (N.D. Cal. 2018)). Therefore, under our significant portion of its range policy, the North Coast of Egypt does not merit evaluation as a significant portion of the species' range because the best available science indicates that the species has been extirpated from the North Coast of Egypt.

The two other Egyptian tortoise populations (in North Sinai, Egypt, and in Israel) discussed by the commenter are extant and are much smaller than the population in Libya; however, the smaller sizes of these two populations do not necessarily equate to the species being in danger of extinction in these portions of its range. The current condition of the populations of the Egyptian tortoise in North Sinai, Egypt and in Israel do not have imminent threats that place the species in danger of extinction. These populations partially occur within protected areas, are protected by those countries' laws, and are not subject to collection pressure. Even considering the smaller population sizes in North Sinai, Egypt, and in Israel, we considered whether either of these two populations is in danger of extinction and found that they are not, and would not have a different status than the rangewide status of the species. Because we reached a negative answer with respect to the status question for each population, we do not need to evaluate the significance question for that portion of the species' range.

The SSA report for the Egyptian tortoise represents a compilation of the best scientific and commercial data available concerning the status of the species, including the impacts of past, present, and future factors (both negative and beneficial) affecting the species.

In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we sought peer review of the SSA report. We sent the SSA report to five independent peer reviewers who have expertise in the biology, habitat, and threats to the species, and we received three responses. As described above under Peer Reviewer Comments in Summary of Comments and Recommendations, we reviewed these responses for substantive issues and new information regarding the information contained in the SSA report, to ensure that our determination is based on scientifically sound data, assumptions, and analyses. The peer reviewers generally concurred with our methods and conclusions, and provided additional information, clarifications, and suggestions to improve the final SSA report. We incorporated the peer reviewer comments into the final SSA report as appropriate.

A thorough review of the taxonomy, life history, distribution and population status, and ecology of the Egyptian tortoise is presented in the SSA report and the proposed rule (Service 2022; available at https://www.regulations.gov under Docket No. FWS-HQ-ES-2020-0114). We provide a very brief summary below.

The most distinguishing characteristic of the Egyptian tortoise is its remarkably small size (Highfield and Martin 2014, p. 1). The Egyptian tortoise is the smallest and least-known tortoise species inhabiting the Mediterranean basin (Buskirk 1985, pp. 35, 37), and the second smallest species of tortoise in the world (Woodland Park Zoo 2014, p. 1). Egyptian tortoises are herbivores with low reproductive potential. Males reach maturity at 5 years old, and females take at least 8 years because of physical limitations of laying eggs (Baha El Din 2020, pers. comm.; Attum et al. 2011, p. 10). One generation in the wild is estimated to be about 20 years (Perälä 2006, p. 60; Macale et al. 2009, p. 143), although the average age can be much shorter (Egyptian Environmental Affairs Agency 2009, p. 222).

The Egyptian tortoise is restricted to a narrow coastal zone in North Africa and the western and central Negev Desert in Israel, in the southeast Mediterranean, and has the most restricted range of all tortoises in the Mediterranean Basin (Baha El Din et al. 2003, entire). They need areas of sandy dunes to more solidified sands with plant cover from bushes and small shrubs and annual plants to eat. The species is active during the cooler part of the year and aestivates or experiences prolonged dormancy during the summer when temperatures are high and rainfall and food availability are low.

Historically, the Egyptian tortoise occurred on both sides of the Nile River, distributed along the southeast Mediterranean coast in Libya and Egypt, and in the western and central Negev Desert in Israel. The species currently exists in the three regions in Libya, in five small subpopulations in North Sinai, Egypt, and in the western and central Negev Desert in Israel. The Egyptian tortoise has been extirpated from the North Coast of Egypt and no longer occupies the historical part of its range from the Libyan border east to the Nile River.

The shaded area along the southeastern Mediterranean coast, on the coastline of Libya and Egypt, and into the Western and Central Negev Desert in Israel on the map above reflects the approximate historical range of the species. The Egyptian tortoise has been extirpated from the North Coast of Egypt; therefore, the species no longer occupies the historical part of the range in Egypt from the Libyan border east to the Nile Delta. The dots are recorded locations from the literature including both historical and current occurrence of the species. (Rhodin 2020, pers. comm; Rhodin et al. 2017).

Over the last three generations (or about 60 years), the Egyptian tortoise population has been reduced by approximately 90 percent throughout its range, including the extirpation of the species in North Coast, Egypt, which accounted for about 30 percent of the species' historical population (Perälä 2005, p. 894; Perälä 2006, p. 61; Rhodin 2020, pers. comm; Rhodin et al. 2017, p. 154; Baha El Din 1994, p. 6; Baha El Din et al. 2003, p. 651). The best available information indicates that the current population of Egyptian tortoise is approximately 10,000 individuals (see table, below).

Section 4 of the Act (16 U.S.C. 1533) and the implementing regulations in title 50 of the Code of Federal Regulations set forth the procedures for determining whether a species is an endangered species or a threatened species, issuing protective regulations for threatened species, and designating critical habitat for endangered and threatened species. In 2019, jointly with the National Marine Fisheries Service, the Service issued a final rule that revised the regulations in 50 CFR part 424 regarding how we add, remove, and reclassify endangered and threatened species and the criteria for designating listed species' critical habitat (84 FR 45020; August 27, 2019). On the same day, the Service also issued final regulations that, for species listed as threatened species after September 26, 2019, eliminated the Service's general protective regulations automatically applying to threatened species the prohibitions that section 9 of the Act applies to endangered species (84 FR 44753; August 27, 2019).

The regulations that are in effect and therefore applicable to this final rule are 50 CFR part 424, as amended by (a) revisions that we issued jointly with the National Marine Fisheries Service in 2019 regarding both the listing, delisting, and reclassification of endangered and threatened species and the criteria for designating listed species' critical habitat (84 FR 45020; August 27, 2019); and (b) revisions that we issued in 2019 eliminating for species listed as threatened species are September 26, 2019, the Service's general protective regulations that had automatically applied to threatened species the prohibitions that section 9 of the Act applies to endangered species (84 FR 44753; August 27, 2019).

The Act defines an “endangered species” as a species that is in danger of extinction throughout all or a significant portion of its range, and a “threatened species” as a species that is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. The Act requires that we determine whether any species is an endangered species or a threatened species because of any of the following factors:

(A) The present or threatened destruction, modification, or curtailment of its habitat or range;

(B) Overutilization for commercial, recreational, scientific, or educational purposes;

(C) Disease or predation;

(D) The inadequacy of existing regulatory mechanisms; or

(E) Other natural or manmade factors affecting its continued existence.

These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.

We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may either encompass—together or separately—the source of the action or condition or the action or condition itself.

However, the mere identification of any threat(s) does not necessarily mean that the species meets the statutory definition of an “endangered species” or a “threatened species.” In determining whether a species meets either definition, we must evaluate all identified threats by considering the expected response by the species, and the effects of the threats—in light of those actions and conditions that will ameliorate the threats—on an individual, population, and species level. We evaluate each threat and its expected effects on the species, and then analyze the cumulative effect of all of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species, such as any existing regulatory mechanisms or conservation efforts. The Secretary determines whether the species meets the definition of an “endangered species” or a “threatened species” only after conducting this cumulative analysis and describing the expected effect on the species now and in the foreseeable future.

The Act does not define the term “foreseeable future,” which appears in the statutory definition of “threatened species.” Our implementing regulations at 50 CFR 424.11(d) set forth a framework for evaluating the foreseeable future on a case-by-case basis. The term “foreseeable future” extends only so far into the future as the Services can reasonably determine that both the future threats and the species' responses to those threats are likely. In other words, the foreseeable future is the period of time in which we can make reliable predictions. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions.

It is not always possible or necessary to define the foreseeable future as a particular number of years. Analysis of the foreseeable future uses the best scientific and commercial data available and should consider the timeframes applicable to the relevant threats and to the species' responses to those threats in view of its life-history characteristics. Data that are typically relevant to assessing the species' biological response include species-specific factors such as lifespan, reproductive rates or productivity, certain behaviors, and other demographic factors.

We considered the threats of habitat loss and degradation and collection of the species for the pet trade, along with demographic factors of Egyptian tortoises, and determined that the foreseeable future was approximately 60 years. This timeline for the foreseeable future is based on several factors. The Egyptian tortoise matures slowly, and in the best of conditions has a low reproductive rate. Thus, the species depends on high survival rates and long reproductive lifespans of adults to increase population size (Wilbur and Morin 1988, in Díaz-Paniagua et al. 2001, p. 707). Because of the long generation length (up to 20 years) and slow reproductive rate, demographic responses of the species to the threats that are already ongoing will manifest increasingly over a significant period of time. Additionally, existing studies already document the species' responses to threats over the past three generations or approximately 60 years (Perälä 2005, p. 894; Perälä 2006, p. 61; Rhodin 2020, pers. comm; Rhodin et al. 2017, p. 154; Baha El Din 1994, p. 6; Baha El Din et al. 2003, p. 651). We considered and incorporated the information underlying IUCN's Red List assessment of the species that also takes into account the decline in abundance and range of the species, levels of exploitation, and direct observations by experts (IUCN 2012, unpaginated; Perälä 2005, p. 897; Perälä 2006, p. 65). We found the IUCN's information to be part of the best scientific and commercial information available for this species, and that predictions based on IUCN's information for this species can be reliable over approximately the next 60 years. We also note that IUCN reasonably projects that the species faces a greater-than-80-percent chance of extinction in the wild within the next 60 years.

Therefore, based on the best scientific and commercial data available, we conclude that over a period of 60 years we can make reliable predictions that both the future threats to the species and the species' response to those threats are likely. “Reliable” does not mean “certain”; it means sufficient to provide a reasonable degree of confidence in the prediction. Thus, a prediction is reliable if it is reasonable to depend on it when making decisions. Under this approach, because habitat loss and collection for the pet trade are the primary threats to the Egyptian tortoise currently and into the future, and the species has a slow reproductive rate in the best of conditions that depends on high survival rates and long reproductive lifespans of adults to increase population size, we evaluate how far into the future we can make reliable prediction about habitat loss and collection of the species and the responses of Egyptian tortoises to these threats. In addition to the slow, innate reproductive capacity of Egyptian tortoises, we considered and incorporated the information underlying IUCN's Red List assessment of the species that projects that the species faces a greater-than-80-percent chance of extinction in the wild within the next 60 years, taking into account the decline in abundance and range of the species, levels of exploitation, and direct observations by experts. We found the IUCN's information to be part of the best scientific and commercial information available for this species, and that predictions based on IUCN's information for this species can be reliable over approximately the next 60 years. Therefore, we identified 60 years, or 2080, as the foreseeable future for the threats of habitat loss and collection because that is the period over which we can make reliable predictions as to the future condition of Egyptian tortoises.

The SSA report documents the results of our comprehensive biological review of the best scientific and commercial data available regarding the status of the species, including an assessment of the potential threats to the species. The SSA report does not represent a decision by the Service on whether the species should be listed as an endangered or threatened species under the Act. However, it does provide the scientific basis that informs our regulatory decisions, which involve the further application of standards within the Act and its implementing regulations and policies. The following is a summary of the key results and conclusions from the SSA report; the full SSA report can be found at Docket FWS-HQ-ES-2020-0114 on https://www.regulations.gov. As noted above, the proposed rule includes more detail than this final rule, but that does not imply a change between the proposed and final rules.

To assess Egyptian tortoise's viability, we used the three conservation biology principles of resiliency, redundancy, and representation (Shaffer and Stein 2000, pp. 306-310). Briefly, resiliency supports the ability of the species to withstand environmental and demographic stochasticity (for example, wet or dry, warm or cold years), redundancy supports the ability of the species to withstand catastrophic events (for example, droughts, large pollution events), and representation supports the ability of the species to adapt over time to long-term changes in the environment (for example, climate change). In general, the more resilient and redundant a species is and the more representation it has, the more likely it is to sustain populations over time, even under changing environmental conditions. Using these principles, we identified the species' ecological requirements for survival and reproduction at the individual, population, and species levels, and described the beneficial and risk factors influencing the species' viability.

The SSA process can be categorized into three sequential stages. During the first stage, we evaluated the individual species' life-history needs. The next stage involved an assessment of the historical and current condition of the species' demographics and habitat characteristics, including an explanation of how the species arrived at its current condition. The final stage of the SSA involved making predictions about the species' responses to positive and negative environmental and anthropogenic influences. Throughout all of these stages, we used the best available information to characterize viability as the ability of a species to sustain populations in the wild over time. We use this information to inform our regulatory decision.

In this discussion, we review the biological condition of the species and its resources, and the threats that influence the species' current and future condition, in order to assess the species' overall viability and the risks to that viability.

Egyptian tortoises face similar threats to their viability throughout their range, although the magnitude may vary among Libya, Egypt, and Israel. The primary threats to the species are loss of habitat and collection of the species for the pet trade (Service 2022, pp. 30-39). Because Egyptian tortoises need areas of sandy dunes to more solidified sands with plant cover from bushes and small shrubs and annual plants to eat, habitat destruction throughout the range of the species caused by human activities is the major factor limiting suitable habitat necessary for the species' survival. Habitat loss may also occur because of changing environmental conditions from climate change. Protected areas, national parks, and nature reserves offer some suitable habitat and protection for the Egyptian tortoise. However, even the habitat in these areas is degraded and is also used for pastoral livestock grazing, which competes with Egyptian tortoise for vegetation (Attum et al. 2007b, entire; Baha El Din et al. 2003, p. 653; Attum et al. 2013, p. 74). Because of the land-use changes and habitat loss, the populations in each country have no connectivity across international borders, including the populations in North Sinai, Egypt, and in Israel that are both on the east side of the Nile and are relatively close in proximity.

Egyptian tortoises were heavily collected from Egypt through much of the first half of the 20th century for sale as pets (Baha El Din 1994, p. 25). The mass collection of the species for the pet trade was recognized as early as 1933 (Flower 1933, p. 746) and continued until the late 1970s, by which time the species' population was extirpated from large parts of the North Coast of Egypt. Currently, the only populations in Egypt are very small and managed by locals in the Zaranik Protected Area in North Sinai. Commercial collection of the species is not currently a factor at this location. However, collection for the pet trade is the biggest threat to the species in Libya, which has the largest remaining population of the species. Collection of Egyptian tortoises is minimal in Israel. Bedouins use shells from dead tortoises and do not collect live tortoises, but some poaching by agricultural workers does occur, which has been reduced through increased outreach and enforcement by Israel Nature and Parks Authority (INPA 2021, p. 4).

Egyptian tortoises are highly sensitive to thermal stress, particularly increased temperature. Therefore, any marginal increase caused by climatic change would be limiting to their survival in the wild (Baha El Din 2020, pers. comm.). This impact has been observed first-hand in captive populations near Cairo, Egypt (only 100 kilometers (62 miles) south of the natural range) (Baha El Din 2020, pers. comm.). Tortoises aestivate under shrubs in the summer when the temperature is highest, food availability is least, and the warming is projected to be the most intense. However, tortoises are more active during the winter and spring when the mean temperatures are approximately 15 to 25 degrees Celsius (°C) (59 to 77 degrees Fahrenheit (°F)). Temperature is projected to rise moderately during the winter and may not reach levels that are directly detrimental to the tortoise.

The Egyptian tortoise is afforded some protection based on existing regulations in each of the range countries. These regulations have had varying success protecting the species' habitat from destruction and the species from collection for the pet trade. As discussed in further detail below, the inclusion of the Egyptian tortoise in Appendix I of CITES in 1995 was an important action for the conservation of the species, considering the decreasing population numbers and the amount of trade occurring up through the 1980s. However, despite its status in Appendix I of CITES, the best available information indicates that Egyptian tortoises are illegally traded internationally. The collection pressure from this illegal trade continues to harm the species, though at a reduced level that was previously attributed to the legal commercial trade while the species was in Appendix II of CITES (CITES Trade Database 2020; Theile et al. 2004, p. iii; Stengel et al. 2011, pp. 10-11, 19).

The Egyptian tortoise's viability is influenced by its resiliency, adaptive capacity (representation), and redundancy. Resiliency for the Egyptian tortoise is measured by population size, distribution, and health throughout its range. Population size, quality of habitat where the species occurs (taking into account anthropogenic effects), whether a population is in a protected area, and the collection pressure of a population all influence the resiliency of the Egyptian tortoise. Overall, the Egyptian tortoise has remained relatively stable since 2005 (see table above). The species occurs in fragmented populations with moderate resiliency because there are multiple populations, some of which are partially in protected areas, and ongoing habitat degradation and collection pressure. The Egyptian tortoise resides in representative habitats on both sides of the Nile River, which provides the species with its resource needs and some ecological diversity in habitat west and east of the river. The existence of multiple, resilient populations reduces the likelihood that any single catastrophic event could affect one or more of the populations simultaneously. We have not identified any catastrophic events that would affect the Egyptian tortoise across its entire range.

We projected the resiliency, representation, and redundancy of the Egyptian tortoise under two plausible future scenarios: (1) a status quo scenario in which human-caused impacts and tortoise population responses continue as the current trends indicate; and (2) a reduced-collection scenario in which the collection of Egyptian tortoises for the pet trade from Libya decreases as a result of Libyan authorities enacting regulations that improve enforcement and reduce the collection of the species. However, reducing collection in Libya is uncertain given the ongoing collection of Egyptian tortoises and geopolitical instability in the country. The two scenarios do not include variance or change in the rate of habitat loss caused by human activities such as development, agriculture and grazing, and military activities. The habitat is highly degraded and continues to decline throughout the range of the species. Additionally, we recognize the effects of climate change in the future but do not differentiate between representative concentration pathway (RCP) 4.5 and RCP 8.5 in the future scenarios because we could not distinguish between RCPs 4.5 and 8.5 at which temperature or timeframe the Egyptian tortoise would show signs of stress. Habitat loss and collection for the pet trade will have a more immediate and pronounced effect on the species and its habitat suitability. Therefore, we focused the future condition on habitat loss and collection pressure because of human activities.

We project rangewide habitat degradation into the future under Scenario 1, and collection pressure continuing on the same trajectory as current conditions. Human population and development pressure are higher in North Coast, Egypt, and in Israel than in Libya and North Sinai, Egypt. Thus, we would not expect as much habitat loss from development in Libya and North Sinai. However, because collection pressure is higher in Libya, we anticipate that the population in Libya will be substantially reduced. Populations in Libya (one population across three regions), North Sinai, Egypt (one small population made up of five very small subpopulations), and Israel (one population in the Negev Desert) would decrease and become more fragmented, and we conclude that the resiliency of the species will decrease from moderate to low-to-moderate within the foreseeable future because of ongoing habitat degradation and collection pressure. A decreasing population of Egyptian tortoise residing in increasingly degraded habitat reduces the species' ability to sustain populations in the event of stochastic variation. We project that the population in Libya would be substantially reduced because of ongoing collection, but would still occur within the three regions in Libya at much smaller population sizes. The tortoise populations in North Sinai, Egypt, and the Negev Desert in Israel would remain, but would decrease. Therefore, the species will continue to occupy the same areas as it currently occupies. The Egyptian tortoise would occur in each country, west and east of the Nile River, and maintain some ecological diversity between the populations. Thus, representation would likely be similar to current conditions. However, representative habitat types in which the species occurs would continue to be much fewer than they were historically, and would continue to decline. We have not identified any catastrophic events that would affect Egyptian tortoises across its entire range. Therefore, the species would have redundancy to withstand catastrophic events.

Similar to Scenario 1, we project that rangewide habitat degradation will continue in the future, but under Scenario 2, the collection pressure in Libya will be reduced. Libyan authorities and local academics had been seeking to end collection and exportation of Egyptian tortoise from Libya. However, we acknowledge that with the ongoing collection of the species and geopolitical instability in Libya, implementing conservation measures to reduce collection for the pet trade is uncertain. Nonetheless, if collection is reduced, the population in Libya would not decline at the current trajectory, and at a minimum, the Libyan population of Egyptian tortoises would decline at a slower rate compared to current conditions. However, this population would have low-to-moderate resiliency within the foreseeable future because the habitat will continue to be degraded, the population is not in a protected area, and even if conservation measures are implemented, we conclude some collection for the pet trade will continue. The populations in North Sinai, Egypt, and the Negev Desert in Israel would experience a decrease in resiliency in the foreseeable future as described under Scenario 1.

Because the populations in Libya, in North Sinai, Egypt, and in Israel would remain, the Egyptian tortoise would occur in each country, west and east of the Nile River, and represent the same ecological diversity and habitats between the populations as current conditions, although at decreasing levels in each population. Similar to Scenario 1, the species would occupy the same areas as it currently occupies, which are fewer than the species historically occupied, and suitable habitat will continue to decline. Because we have not identified any catastrophic event that would affect the species throughout its range, the species will have redundancy to withstand catastrophic events.

We note that, by using the SSA framework to guide our analysis of the scientific information documented in the SSA report, we have not only analyzed individual effects on the species, but we have also analyzed their potential cumulative effects. We incorporate the cumulative effects into our SSA analysis when we characterize the current and future condition of the species. To assess the current and future condition of the species, we undertake an iterative analysis that encompasses and incorporates the threats individually and then accumulates and evaluates the effects of all the factors that may be influencing the species, including threats and conservation efforts. Because the SSA framework considers not just the presence of the factors, but to what degree they collectively influence risk to the entire species, our assessment integrates the cumulative effects of the factors and replaces a standalone cumulative-effects analysis.

Need for Correction

NMFS published the reallocation of pollock on March 23, 2023 (88 FR 17403). The document contains incorrect amounts of pollock remaining for the Aleutian Islands subarea total allowable catch (TAC) and the Aleut Corporation's A and B season directed fishing allowance. Aleutian Islands subarea TAC is corrected from 19,000 to 4,500. Aleut Corporation is corrected from 2,100 to 2,000 for column “2023 A season” and from (100) to n/a for column “2023 B season”. NMFS is republishing the table in its entirety with the correct numbers. These corrections will not affect the fishing operations. These corrections are necessary to provide the correct information about the amount of the pollock remaining for the Aleutian Islands subarea TAC and the Aleut Corporation A and B season directed fishing allowance and eliminate potential confusion by fishery participants.

In the Federal Register of March 23, 2023 (88 FR 17403), in FR Doc. 2023-06021, on page 17404, Table 4 is corrected to read as follows:

The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This action corrects an error that attributed the total amount of pollock remaining for the Aleutian Islands subarea TAC (4,500 metric tons (mt)) and the Aleut Corporation (2,000 mt). This correction does not change operating practices in the fisheries. Corrections should be made as soon as possible to avoid confusion for participants in the fisheries.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.