Securities Exchange Act of 1934; CFR Correction

Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Rules and Regulations 18987 Country Entity License requirement License review policy Federal Register citation

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RUSSIA * * * * * * Aviatech Supply Ltd., a.k.a., the fol￾lowing two aliases: -Aviatech; and -Aviatechexport Ltd. 630123, Aeroport St. Build.1A, 3rd Floor, Novosibirsk, Russia. For all items subject to the EAR. (See § 744.11 of the EAR) Presumption of denial ...... 88 FR [INSERT FR PAGE NUMBER] 3/30/2023 Aviazapchast PLC, 48, Ivana Franko Street, Moscow, 121351, Russia. For all items subject to the EAR. (See § 744.11 of the EAR) Presumption of denial ...... 88 FR [INSERT FR PAGE NUMBER ] 3/30/2023.

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Thea D. Rozman Kendler, Assistant Secretary for Export Administration. [FR Doc. 2023–06663 Filed 3–28–23; 4:15 pm] BILLING CODE 3510–33–P SECURITIES AND EXCHANGE COMMISSION 17 CFR Part 240 General Rules and Regulations, Securities Exchange Act of 1934 CFR Correction This rule is being published by the Office of the Federal Register to correct an editorial or technical error that appeared in the most recent annual revision of the Code of Federal Regulations. ■ In Title 17 of the Code of Federal Regulations, Part 240, revised as of April 1, 2022, in section 240.13e–100, reinstate the paragraphs at the end of the section following ‘‘Item 16. Exhibits’’ to read as follows: § 240.13e–100 Schedule 13E–3, Transaction statement under section 13(e) of the Securities Exchange Act of 1934 and Rule 13e–3 (§ 240.13e–3) thereunder.

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Signature. After due inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct. lllllllllllllllllllll (Signature) lllllllllllllllllllll (Name and title) lllllllllllllllllllll (Date) Instruction to Signature: The statement must be signed by the filing person or that person’s authorized representative. If the statement is signed on behalf of a person by an authorized representative (other than an executive officer of a corporation or general partner of a partnership), evidence of the representative’s authority to sign on behalf of the person must be filed with the statement. The name and any title of each person who signs the statement must be typed or printed beneath the signature. See § 240.12b–11 with respect to signature requirements. [FR Doc. 2023–06701 Filed 3–29–23; 8:45 am] BILLING CODE 0099–10–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 888 [Docket No. FDA–2021–N–0310] RIN 0910–AI32 Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify 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 premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. DATES: This rule is effective May 1, 2023. ADDRESSES: For access to the docket to read background documents or comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this final rule, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Constance Soves, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993–0002, 301–796–6951, Constance.Soves@fda.hhs.gov. SUPPLEMENTARY INFORMATION: 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 VerDate Sep<11>2014 15:57 Mar 29, 2023 Jkt 259001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\30MRR1.SGM 30MRR1 lotter on DSK11XQN23PROD with RULES1