2022 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 3,394
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands; Proposed 2023 and 2024 Harvest Specifications for Groundfish
NMFS proposes 2023 and 2024 harvest specifications, apportionments, and prohibited species catch allowances for the groundfish fisheries of the Bering Sea and Aleutian Islands (BSAI) management area. This action is necessary to establish harvest limits for groundfish during the 2023 and 2024 fishing years and to accomplish the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP). The 2023 harvest specifications supersede those previously set in the final 2022 and 2023 harvest specifications, and the 2024 harvest specifications will be superseded in early 2024 when the final 2024 and 2025 harvest specifications are published. The intended effect of this action is to conserve and manage the groundfish resources in the BSAI in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
Single-Entity Treatment of Consolidated Groups for Specific Purposes
This document contains proposed regulations that treat members of a consolidated group as a single United States shareholder in certain cases for purposes of section 951(a)(2)(B) of the Internal Revenue Code (the ``Code''). The proposed regulations affect consolidated groups that own stock of foreign corporations.
Atlantic Highly Migratory Species; Atlantic Bluefin Tuna Fisheries; Closure of the General Category December Fishery for 2022
NMFS closes the General category fishery for large medium and giant (i.e., measuring 73 inches (185 centimeters) curved fork length or greater) Atlantic bluefin tuna (BFT) for the December subquota time period, and thus for the remainder of 2022. This action applies to Atlantic Tunas General category (commercial) permitted vessels and highly migratory species (HMS) Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Fishermen aboard General category permitted vessels and HMS Charter/ Headboat permitted vessels may tag-and-release BFT of all sizes, subject to the requirements of the catch-and-release and tag-and- release programs. On January 1, 2023, the fishery will reopen automatically.
Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
The Food and Drug Administration (FDA) is confirming the effective date of December 14, 2022, for the final rule that appeared in the Federal Register of September 15, 2022. The direct final rule revises the ``small number of animals'' definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. This document confirms the effective date of the direct final rule.
Airworthiness Directives; Airbus SAS Airplanes
The FAA proposes to supersede Airworthiness Directive (AD) 2022-09-11, which applies to certain Airbus SAS Model A350-941 and - 1041 airplanes. AD 2022-09-11 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2022-09-11, the FAA has determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would continue to require the actions in AD 2022-09-11 and require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for all The Boeing Company Model 787-8, 787-9, and 787-10 airplanes. This proposed AD was prompted by reports of a loss of water pressure during flight and water leaks that affected multiple pieces of electronic equipment. This proposed AD would require a detailed visual inspection of all door 1 and door 3 lavatory and galley potable water systems for any missing or incorrectly installed clamshell couplings and applicable on-condition actions. The FAA is proposing this AD to address the unsafe condition on these products.
Determination To Defer Sanctions; California; Yolo-Solano Air Quality Management District
The Environmental Protection Agency (EPA) is making an interim final determination that the California Air Resources Board has submitted a revised rule on behalf of the Yolo-Solano Air Quality Management District (YSAQMD) that corrects a deficiency in its Clean Air Act (CAA or Act) State implementation plan (SIP) provisions concerning reasonably available control technology (RACT) ozone nonattainment requirements for controlling emissions of volatile organic compounds (VOC) from solvent cleaning and degreasing operations. This determination is based on a proposed approval, published elsewhere in this issue of the Federal Register, of YSAQMD's Rule 2.31, which regulates this source category. The effect of this interim final determination is that the imposition of sanctions that was triggered by a prior disapproval by the EPA, is now deferred. If the EPA finalizes its approval of YSAQMD 's submission, relief from these sanctions will become permanent.
Air Plan Approval; California; Yolo-Solano Air Quality Management District
The Environmental Protection Agency (EPA) is proposing an approval of a revision to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California State Implementation Plan (SIP). This revision concerns emissions of volatile organic compounds (VOCs) from solvent cleaning and degreasing operations. We are proposing action on a local rule that regulates these emission sources under the Clean Air Act (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.
Notice of Proposed Order and Request for Comment on an Application for a Capital Comparability Determination Submitted on Behalf of Nonbank Swap Dealers Subject to Regulation by the Mexican Comision Nacional Bancaria y de Valores
The Commodity Futures Trading Commission (``Commission'' or ``CFTC'') is soliciting public comment on a joint request submitted by Morgan Stanley Mexico, Casa de Bolsa, S.A. de C.V., Goldman Sachs Mexico, Casa de Bolsa, S.A. de C.V., and Casa de Bolsa Finamex, S.A. de C.V. requesting that the Commission determine that the capital and financial reporting laws and regulations of Mexico applicable to CFTC- registered swap dealers organized and domiciled in Mexico, and licensed with the Mexican Banking and Securities Commission (Comision Nacional Bancaria y de Valores) as broker-dealers (casa de bolsa), provide a sufficient basis for an affirmative finding of comparability with respect to the Commission's swap dealer capital and financial reporting requirements adopted under the Commodity Exchange Act. The Commission also is soliciting public comment on a proposed order providing for the conditional availability of substituted compliance in connection with the application.
General Schedule Locality Pay Areas; Correction
This document corrects the preamble to a final rule published in the Federal Register of December 5, 2022, regarding General Schedule Locality Pay Areas. This correction clarifies the effective date of the rule.
General Services Administration Acquisition Regulation (GSAR); Clarify Commercial Products and Services Contract Terms and Conditions
The General Services Administration (GSA) is issuing a final rule amending the General Services Administration Acquisition Regulation (GSAR) to make technical amendments to GSAR clause 552.212-4 regarding commercial items and its prescribing section. This GSAR clause is a deviation to FAR clause 52.212-4. These technical amendments update obsolete references, correct typographical errors, and make minor editorial changes to improve clarity of GSA's deviation to FAR clause 52.212-4.
Endangered and Threatened Wildlife and Plants; Endangered Status for the Dolphin and Union Caribou
We, the U.S. Fish and Wildlife Service (Service or USFWS), determine endangered status under the Endangered Species Act of 1973 (Act), as amended, for the Dolphin and Union caribou (Rangifer tarandus groenlandicus x peary), a distinct population segment (DPS) of the barren-ground caribou (Rangifer tarandus groenlandicus). After reviewing new survey information received during the public comment period that identified significant decline in the population during a recent 4-year period, we have reevaluated the status of the DPS. Our reassessment concluded that the species is in danger of extinction now. Therefore, we are listing this DPS as endangered under the Act. Listing this DPS as endangered also means that the proposed rule under section 4(d) of the Act will not be finalized or put in place. Rather, the prohibitions under section 9(a)(1) of the Act and our implementing regulations for endangered wildlife will apply to all Dolphin and Union caribou specimens. The Dolphin and Union caribou is native only to Canada.
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program
This proposed rule would place new requirements on Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs) to improve the electronic exchange of healthcare data and streamline processes related to prior authorization, while continuing CMS' drive toward interoperability in the healthcare market. This proposed rule would also add a new measure for eligible hospitals and critical access hospitals (CAHs) under the Medicare Promoting Interoperability Program and for Merit-based Incentive Payment System (MIPS) eligible clinicians under the Promoting Interoperability performance category of MIPS. These policies taken together would play a key role in reducing overall payer and provider burden and improving patient access to health information.
Small Business Development Centers
This rule proposes revisions to Small Business Development Centers Program (the SBDC Program or the Program) regulations to align with current policy and guidance from the U.S. Small Business Administration (SBA or the Agency) and to incorporate updates to uniform administrative requirements, cost principles, and audit requirements for Federal awards (Uniform Guidance). This proposed rule also includes policy and procedural changes identified by the Agency as necessary to preserve the integrity and legislative intent of the Program.
Airworthiness Directives; Dassault Aviation Airplanes
The FAA proposes to supersede Airworthiness Directive (AD) 2021-09-12, which applies to certain Dassault Aviation Model FALCON 7X airplanes. AD 2021-09-12 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2021-09- 12, the FAA has determined that new or more restrictive airworthiness limitations are necessary. This proposed AD would continue to require the actions in AD 2021-09-12 and require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive airworthiness limitations, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.
Safety Zone; GM New Years Eve Fireworks, Detroit River, Detroit, MI
The Coast Guard is establishing a temporary safety zone for certain navigable waters within the Detroit River, Detroit, MI. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards during a fireworks event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Detroit.
Airworthiness Directives; Airbus SAS Airplanes
The FAA proposes to supersede Airworthiness Directive (AD) 2019-18-07, which applies to certain Airbus SAS Model A319-111, -112, - 113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, - 131, -211, -212, -213, -231, and -232 airplanes. AD 2019-18-07 requires repetitive rototest inspections of the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, including doing all applicable related investigative actions and repair if necessary. AD 2019-18-07 also adds actions (modification) for certain airplanes. Since the FAA issued AD 2019-18-07, it was determined that certain airplanes need to do additional work. This proposed AD would continue to require the actions in AD 2019-18-07 and would require additional work for certain airplanes, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A350-941 and -1041 airplanes. This proposed AD was prompted by a determination that the surface protection is missing between certain aluminum brackets and the struts to which they are attached in the flight deck air distribution system. This proposed AD would require applying surface protection to the affected aluminum brackets and struts, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). This proposed AD would also prohibit modifying an airplane using certain service information. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; Gulfstream Aerospace LP (Type Certificate Previously Held by Israel Aircraft Industries, Ltd.) Airplanes
The FAA is revising a notice of proposed rulemaking (NPRM) that would have applied to certain Gulfstream Aerospace LP Model Gulfstream 200 airplanes. This action revises the NPRM by adding Model Galaxy airplanes to the applicability. The FAA is proposing this airworthiness directive (AD) to address the unsafe condition on these products. Since these actions would impose an additional burden over those in the NPRM, the FAA is requesting comments on this SNPRM.
Post Office Box Refund
The Postal Service is proposing to amend Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM[supreg]) to clarify the refund policy for customers who qualified for a Group ``E'' (free) Post Office BoxTM.
Modification of Class D Airspace and Class E Airspace; Bozeman Yellowstone International Airport, MT; Correction
The FAA is correcting a final rule that appeared in the Federal Register on November 16, 2022. The Final Rule incorrectly listed the effective date as 0901 UTC, December 29, 2022. This action corrects the effective date to 0901 UTC, February 23, 2023.
Airworthiness Directives; DG Flugzeugbau GmbH and Schempp-Hirth Flugzeugbau GmbH Gliders
The FAA proposes to supersede Airworthiness Directive (AD) 2015-09-04 R1, which applies to DG Flugzeugbau GmbH Model DG-1000T gliders equipped with a Solo Kleinmotoren GmbH (currently Solo Vertriebs-und Entwicklungs-GmbH) (Solo) Model 2350 C engine. AD 2015- 09-04 R1 prohibits operation of the engine and requires performing a magnetic particle or dye penetrant inspection of the propeller shaft and reporting the results of the inspection to Solo. This proposed AD is prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as occurrences of rupture of the eccentric axle on Solo Model 2350 C engines (installed on DG Flugzeugbau GmbH Model DG- 1000T gliders in the United States) and an occurrence on a Solo Model 2350 D engine (installed on Schempp-Hirth Flugzeugbau GmbH (Schempp- Hirth) Model Duo Discus T gliders in the United States). This proposed AD would require repetitive replacement of the eccentric axle, would add the Schempp-Hirth Model Duo Discus T gliders to the applicability, and would retain from AD 2015-09-04 R1 the option of operating the glider with the engine non-operative instead of replacing the eccentric axle. The FAA is proposing this AD to address the unsafe condition on these products.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation; Correction
This document corrects typographical errors in the final rule that appeared in the August 10, 2022, Federal Register as well as an additional typographical error in a related correcting amendment that appeared in the November 4, 2022 Federal Register. The final rule was entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation''.
Proposed Modification of Class E Airspace; Visalia Municipal Airport, Visalia, CA
This action proposes to modify the Class E airspace designated as a surface area and modify the Class E airspace extending upward from 700 feet above the surface at Visalia Municipal Airport, Visalia, CA. This proposal would add and remove extensions of the Class E airspace extending from 700 feet above the surface at the airport. Additionally, this action proposes several administrative amendments to update the airport's existing Class E airspace legal descriptions. These actions will support the safety and management of instrument flight rules (IFR) operations at the airport.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Resources of the Gulf of Mexico; Partial Holdback of Commercial Quota for Gag in the Gulf of Mexico
NMFS issues this temporary rule to withhold a portion of the commercial allocation of gag for the 2023 fishing year in anticipation of an upcoming rulemaking that would amend the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) by implementing interim measures to reduce overfishing of gag. These interim measures would, in part, reduce the commercial sector annual catch limit (ACL) and quota. This temporary rule will withhold the distribution of gag individual fishing quota (IFQ) allocation on January 1, 2023, to shareholders in the Groupers and Tilefishes IFQ (GT-IFQ) program in the amount equal to the anticipated reduction in the commercial quota.
Amendment and Establishment of Area Navigation (RNAV) Routes; Eastern United States
This action amends three low altitude Area Navigation (RNAV) routes (T-routes) and establishes five T-routes in support of the VHF Omnidirectional Range (VOR) Minimum Operational Network (MON) Program. The purpose is to enhance the efficiency of the National Airspace System (NAS) by transitioning from ground-based navigation aids to a satellite-based navigation system.
General Provisions; Revised List of Migratory Birds
We, the U.S. Fish and Wildlife Service (Service), propose to revise the List of Birds protected by the Migratory Bird Treaty Act (MBTA) by both adding and removing species. Reasons for the changes to the list include adding species based on new taxonomy and new evidence of natural occurrence in the United States or U.S. territories, removing species no longer known to occur within the United States or U.S. territories, and changing names to conform to accepted use. The net increase of 13 species (16 added and three removed) would bring the total number of species protected by the MBTA to 1,106. We also propose to revise the scientific name of a species subject to specific migratory-bird-permit regulations and to revise corresponding entries for several migratory bird species that are also listed on the List of Endangered and Threatened Wildlife under the Endangered Species Act to reflect currently accepted taxonomy and nomenclature. We regulate the taking, possession, transportation, sale, purchase, barter, exportation, and importation of migratory birds. An accurate and up-to-date list of species protected by the MBTA is essential for public notification, regulatory, and law- enforcement purposes. These revisions would also ensure consistency in the use of common and scientific names across Service regulations.
Advanced Methods To Target and Eliminate Unlawful Robocalls, Call Authentication Trust Anchor
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the Commission's Sixth Report and Order and Fifth Report and Order (Order) gateway provider rules. This document is consistent with the Order, which stated that the Commission would publish a document in the Federal Register announcing the compliance dates of those rules, and to cause those rules to be revised accordingly.
Federal Records Management: Managing Electronic Records, Including Electronic Messages
We are amending our regulations on creating and maintaining Federal records to explicitly include record-keeping requirements for electronic records. On January 1, 2021, the Federal Records Act was amended. It now requires the Archivist of the United States to promulgate regulations governing Federal agency preservation of electronic messages that are determined to be records. We are amending our regulations to define electronic messages and to expressly state records management requirements for electronic records, including electronic messages.
Air Plan Approval; Alaska; Updates to Materials Incorporated by Reference
The Environmental Protection Agency (EPA) is updating the materials that are incorporated by reference into the Alaska State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by Alaska and approved by the EPA. In this action, the EPA is also notifying the public of corrections to typographical errors, and minor formatting changes to the incorporation by reference tables. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration and the EPA Regional Office.
Removal of Obsolete Procedures and Requirements Related to F, J, and M Nonimmigrants
The Department of Homeland Security (DHS) is amending its regulations to update information that is no longer accurate since the creation of the Student and Exchange Visitor Information System (SEVIS). DHS is updating obsolete or unnecessary information because SEVIS, a Web-based system that DHS uses to collect and maintain current and ongoing information on Student and Exchange Visitor Program (SEVP)- certified schools, F-1 and M-1 nonimmigrant students, and J-1 Exchange Visitor Program participants and their sponsors, has replaced older paper-based processes. In addition, DHS is making technical changes to correct typographical errors, update references and citations, and make other needed changes to reflect the transfer of responsibilities to DHS from the Department of Justice (DOJ). Further, this rule removes language requiring original signatures on Form I-17, Petition for Approval of School for Attendance by Nonimmigrant Student or successor form, and clarifies language about the requirement of an original signature on Form I-20, Certificate of Eligibility for Nonimmigrant Student Status or successor form. This rulemaking introduces no substantive changes, does not raise existing costs; and places no additional burden on F, J, and M nonimmigrants, or on sponsoring academic institutions and programs.
Safety Zone; Marina Del Rey New Year's Eve Fireworks Display, Marina Del Rey, California
The Coast Guard is establishing a temporary safety zone near the South Jetty on Ballona Creek, Marina Del Rey, CA, for the duration of the fireworks display on December 31, 2022. This temporary safety zone is necessary to provide for the safety of the waterway users to keep them clear of potential harmful debris within the fall out zone during the fireworks display within Marina Del Rey, CA. Entry of persons or vessels into this temporary safety zone is prohibited unless specifically authorized by the Captain of the Port Sector Los Angeles Long Beach, or their designated representative.
Amendment of United States Area Navigation (RNAV) Route T-266; Juneau, AK
This action corrects a final rule published by the FAA in the Federal Register on October 24, 2022, that amends Area Navigation (RNAV) route T-266 in support of a large and comprehensive T-route modernization project for the state of Alaska. In the T-266 description in the final rule, the order of the listed route points was reversed in error. This action makes editorial corrections to list the T-266 route points to match the route data forms and the FAA National Airspace System Resource (NASR) database information.
Airworthiness Directives; General Electric Company Turbofan Engines
The FAA is adopting a new airworthiness directive (AD) for certain General Electric Company (GE) GE90-90B, GE90-94B, GE90-110B1, and GE90-115B model turbofan engines. This AD was prompted by a manufacturer investigation that revealed that certain high-pressure turbine (HPT) stage 1 disks, HPT stage 2 disks, and stages 7-9 compressor rotor spools were manufactured from powder metal material suspected to contain iron inclusion. This AD requires the replacement of the affected HPT stage 1 disks, HPT stage 2 disks, and stages 7-9 compressor rotor spools. The FAA is issuing this AD to address the unsafe condition on these products.
Candidate Salaries
After considering comments received in response to its May 3, 2021, Notification of Availability, the Federal Election Commission seeks comments on proposed changes to its regulations regarding the use of campaign funds by a candidate's principal campaign committee to pay compensation to the candidate. The Notification of Availability was published in response to a Petition for Rulemaking filed by a former candidate for the United States House of Representatives. The Commission has made no final decision on the issues presented in this rulemaking.
Amendment of Class D Airspace and Class E Airspace, East Hampton and Montauk, NY
This action amends Class D airspace, Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface for East Hampton Town Airport, East Hampton, NY, by updating the airport name. In addition, this action makes an editorial change, removing the reference to Block Island, R.I., and East Hampton from the Class E airspace description of Montauk Airport, Montauk, NY, and updates the airport's geographic coordinates. This action does not change the airspace boundaries or operating requirements of either airport.
Airman Certification Standards and Practical Test Standards for Airmen; Incorporation by Reference
The FAA proposes to revise certain regulations governing airman certification. Specifically, the FAA Airman Certification Standards and Practical Test Standards are currently utilized as the testing standard for practical tests and proficiency checks for persons seeking or holding an airman certificate or rating. The FAA proposes to incorporate these Airman Certification Standards and Practical Test Standards by reference into the certification requirements for pilots, flight instructors, flight engineers, aircraft dispatchers, and parachute riggers.
Amendment and Revocation of Multiple Air Traffic Service (ATS) Routes; Establishment of Area Navigation (RNAV) Route; and Revocation of the Pawnee City, NE, Low Altitude Reporting Point in the Vicinity of Pawnee City, NE
This action amends Jet Route J-64, VHF Omnidirectional Range (VOR) Federal airways V-50, V-71, V-216, and V-307, and Area Navigation (RNAV) route T-286; establishes RNAV route T-468; and revokes J-130, J- 192, V-553, and the Pawnee City, NE, low altitude reporting point. The FAA is taking this action due to the planned decommissioning of the VOR portion of the Pawnee City, NE, VOR/Tactical Air Navigation (VORTAC) navigational aid (NAVAID). The Pawnee City VOR is being decommissioned in support of the FAA's VOR Minimum Operational Network (MON) program.
Safety Zone; Military Ocean Terminal Concord Safety Zone, Suisun Bay, Military Ocean Terminal Concord, CA
The Coast Guard will enforce the safety zone in the navigable waters of Suisun Bay, off Concord, CA, in support of explosive on- loading to Military Ocean Terminal Concord (MOTCO) from December 11, 2022, through December 15, 2022. This safety zone is necessary to protect personnel, vessels, and the marine environment from potential explosion within the explosive arc. The safety zone is open to all persons and vessels for transitory use, but vessel operators desiring to anchor or otherwise loiter within the safety zone must obtain the permission of the Captain of the Port San Francisco or a designated representative. All persons and vessels operating within the safety zone must comply with all directions given to them by the Captain of the Port San Francisco or a designated representative.
Airworthiness Directives; BAE Systems (Operations) Limited Airplanes
The FAA is superseding Airworthiness Directive (AD) 2005-06- 14, which applied to certain British Aerospace Model BAe 146 and Model Avro 146-RJ series airplanes. AD 2005-06-14 required repetitive inspections for cracking of the outer links on the main landing gear (MLG) side stays, and corrective actions if necessary. AD 2005-06-14 also provided an optional terminating action for the repetitive inspections. Since the FAA issued AD 2005-06-14, there has been a report of additional cracking on a MLG side stay on which the terminating action has been done. This AD continues to require the actions specified in AD 2005-06-14 and requires new repetitive inspections for cracking of the MLG side stay outer link and replacement if necessary as specified in a United Kingdom (U.K.) Civil Aviation Authority (CAA) (U.K. CAA) AD, which is incorporated by reference. This AD also prohibits the installation of affected parts under certain conditions. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus Canada Limited Partnership (Type Certificate Previously Held by C Series Aircraft Limited Partnership (CSALP); Bombardier, Inc.) Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Airbus Canada Limited Partnership Model BD-500-1A10 and BD-500-1A11 airplanes. The FAA previously sent this AD as an emergency AD to all known U.S. owners and operators of these airplanes. This AD was prompted by reports of the autopilot/autothrottle system design resulting in inadvertent engagement of the autopilot when the flightcrew was attempting to engage the autothrottle late into the take-off phase or when attempting to re-engage the autothrottle during takeoff after uncommanded disconnect. This AD requires revising the Limitations section of the existing airplane flight manual (AFM) by revising the title of the existing autopilot AFM limitation, include a new warning prior to the existing autopilot engagement limitations, and include a new limitation prohibiting selecting or reselecting autothrottle during takeoff after thrust levers are advanced to the takeoff setting after the existing autopilot engagement limitations. The FAA is issuing this AD to address the unsafe condition on these products.
Proposed Amendment of V-171 in the Vicinity of Roseau, MN
This action proposes to amend VHF Omnidirectional Range (VOR) Federal airway V-171 in the vicinity of Roseau, MN. The amendment is due to the planned decommissioning of the VOR portion of the Roseau, MN (ROX), VOR/Distance Measuring Equipment (VOR/DME) navigational aid (NAVAID) which provides navigation guidance for portions of the affected airway. The Roseau VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.
Reopening of Comment Period for Share Repurchase Disclosure Modernization
The Securities and Exchange Commission (``Commission'') is reopening the comment period for its proposal, Share Repurchase Disclosure Modernization, Exchange Act Release No. 34-93783 (Dec. 15, 2021) (``Proposing Release''). The Commission proposed amendments to modernize and improve disclosure about repurchases of an issuer's equity securities that are registered under the Securities Exchange Act of 1934. Specifically, the proposed amendments would require an issuer to provide more timely disclosure on a new Form SR regarding purchases of its equity securities for each day that it, or an affiliated purchaser, makes a share repurchase. The proposed amendments would also enhance the existing periodic disclosure requirements about these purchases. The Commission subsequently reopened the comment period for the Proposing Release in Resubmission of Comments and Reopening of Comment Periods for Several Rulemaking Releases Due to a Technological Error in Receiving Certain Comments, Exchange Act Release No. 34-96005 (Oct. 7, 2022). In addition, after the proposed amendments were published for public comment, an excise tax on share repurchases was signed into law. A staff memorandum was added to the public comment file on December 7, 2022 to analyze the impact of the new excise tax on the potential economic effects of the proposed amendments. The Commission is reopening the comment period to allow interested persons the opportunity to analyze and comment on the additional analysis.
Proposed Modification of Class C Airspace at Luis Munoz Marin International Airport, San Juan, PR; Informal Airspace Meeting
This notice announces a fact-finding informal airspace meeting regarding a plan to modify the Class C Airspace at Luis Munoz Marin International Airport (TJSJ), San Juan, PR. The meeting will be a virtual format via the Zoom platform. The purpose of the meeting is to solicit aeronautical comments on the proposal's effects on local aviation operations. All comments received during the meeting, and the subsequent comment period, will be considered prior to the issuance of a notice of proposed rulemaking.
Extension of Public Comment Period for Amendment 123 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP); Bering Sea and Aleutian Islands Halibut Abundance-Based Management of Amendment 80 Prohibited Species Catch Limit
On November 9, 2022, the National Marine Fisheries Service published a Notice of Availability and request for comments on Amendment 123 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP), but inadvertently did not include the supporting Amendment text. With this notice, NMFS is extending the public comment period by 60 days to February 7, 2023, to afford the public with additional time to provide comments on Amendment 123.
Investigational New Drug Application Annual Reporting
The Food and Drug Administration (FDA, the Agency, or we) is proposing to replace its current annual reporting requirement for investigational new drug applications (INDs) with a new requirement: the annual FDA development safety update report (FDA DSUR). The proposed annual FDA DSUR is intended to be consistent with the format and content of the DSUR that is supported by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which is described in FDA's ICH guidance for industry entitled ``E2F Development Safety Update Report'' (E2F DSUR) (August 2011). The proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.
Investigational New Drug Applications; Exemptions for Clinical Investigations To Evaluate a Drug Use of a Product Lawfully Marketed as a Conventional Food, Dietary Supplement, or Cosmetic
The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations on investigational new drug applications (INDs) to exempt from the IND requirements certain clinical investigations of lawfully marketed foods for human consumption (including both conventional foods and dietary supplements) and cosmetics when the product is to be studied to evaluate its use as a drug. Under the proposal, clinical studies to evaluate a drug use of such products would not have to be conducted under an IND when, among other things, the study is not intended to support a drug development plan or a labeling change that would cause the lawfully marketed product to become an unlawfully marketed drug, and the study does not present a potential for significant risk to the health, safety, or welfare of subjects. Though exempt from the IND requirements, such investigations would still be subject to other regulations designed to protect the rights and safety of subjects, including requirements for informed consent and review by institutional review boards (IRBs). By exempting from the IND requirements certain clinical investigations of products lawfully marketed as a food or cosmetic, the proposed provisions are intended to reduce the regulatory burden of conducting such studies while retaining protections for human subjects.
Multi-Family Housing Simple Transfer Pilot Program
The Rural Housing Service (RHS or the Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), is announcing the implementation of a pilot program for simple transfers of USDA Section 515 Rural Rental Housing properties. The Agency's intention is to evaluate the existing regulations and remove regulatory barriers to reduce application requirements for certain types of transfers, resulting in lower transaction-related costs for applicants and improved processing times.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
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