December 6, 2022 – Federal Register Recent Federal Regulation Documents

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A318 series airplanes; Model A319 series airplanes; Model A320-211, -212, -214, -216, -231, -232, -233, -251N, - 252N, -253N, -271N, -272N, and -273N airplanes; and Model A321 series airplanes. This proposed AD was prompted by a report that certain overheat detection system (OHDS) sensing elements installed at certain positions might not properly detect thermal bleed leak events due to a quality escape during the manufacturing process. This proposed AD would require a one-time detailed inspection of each affected part installed at an affected position and, depending on the findings, replacement; and would prohibit the installation of affected parts at affected positions, 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.

This action revokes Colored Federal airway Amber 6 (A-6) due to the planned decommissioning of the St Marys, AK (SMA), Non- Directional Beacon (NDB) in the vicinity of St. Mary's, AK.

The Environmental Protection Agency (EPA) is correcting a final rule that appeared in Federal Register on Monday, November 28, 2022, which finalized updates to the list of North American Industry Classification System (NAICS) codes subject to reporting under the Toxics Release Inventory (TRI) to reflect the Office of Management and Budget (OMB) 2022 NAICS code revision. This document corrects an error in an amendatory instruction that appeared in the regulatory text portion of the final rule.

The FAA proposes to supersede Airworthiness Directive (AD) 2021-20-09, which applies to certain ATRGIE Avions de Transport R[eacute]gional Model ATR72 airplanes. AD 2021-20-09 requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2021-20-09, the FAA has determined that new or more restrictive tasks and airworthiness limitations are necessary. This proposed AD would continue to require the actions in AD 2021-20-09 and require revising the existing maintenance or inspection program, as applicable, to incorporate additional new or more restrictive tasks and 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.

The FAA proposes to supersede Airworthiness Directive (AD) 2021-08-19, which applies to all The Boeing Company Model 787-8, -9, and -10 airplanes. AD 2021-08-19 requires repetitive general visual inspections for disengaged or damaged decompression panels of the bilge barriers located in the forward and aft cargo compartments, reinstallation of disengaged but undamaged panels, and replacement of damaged panels. Since the FAA issued AD 2021-08-19, new procedures for changing or replacing the bilge barrier assembly in the forward cargo compartment have been developed. This proposed AD would retain the requirements of AD 2021-08-19 and require changing or replacing the bilge barrier assembly in the forward and aft cargo compartments, which would terminate the repetitive inspections. The FAA is proposing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer.'' This guidance provides recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for programmed cell death receptor-1 (PD-1) or programmed cell death-ligand 1 (PD-L1) blocking antibodies. This guidance is based on accumulated scientific and regulatory experience for PD-1 and PD-L1 drugs, and as such, does not address development of alternative dosing regimens for other drugs or biologics, changes in route of administration, or novel formulations of previously approved PD-1/PD-L1 products. This guidance finalizes the draft guidance of the same title issued on August 26, 2021.

The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of chlorinated isocyanurates (chlorinated isos) from the People's Republic of China (China) during the period of review (POR), January 1, 2020, through December 31, 2020. Interested parties are invited to comment on these preliminary results.

This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Washington dated 11/30/2022. Incident: Bolt Creek Wildfire. Incident Period: 09/10/2022 through 10/21/2022.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials.'' The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection'' issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

The Commission is recognizing a recent filing by the Postal Service of its intent to establish new service standards for USPS Connect Local Mail and proposing corresponding revisions to its Service Performance Measurement (SPM) Plan for Market Dominant products. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The National Science Foundation published a notice in the Federal Register concerning a meeting of the National Artificial Intelligence Research Resource Task Force. The meeting scheduled for Wednesday, December 7, 2022, at 1 p.m. (ET) is cancelled. The notice is in the Federal Register of Tuesday, November 1, 2022, in FR Doc. 2022- 23733, in the third column of page 65829.

This action revokes the Colored Federal airway Red 1 (R-1) in the vicinity of King Salmon, AK, due to the airway no longer being used by pilots as the overlaying United States Area Navigation (RNAV) route T-230 provides better navigation capability with a lower minimum enroute altitude (MEA).

This action revokes Colored Federal airways Blue 7 (B-7) and Green 9 (G-9) in the vicinity of Bethel, AK, due to the planned decommissioning of the Oscarville, AK (OSE), Non-Directional Beacon (NDB).

This action revokes Colored Federal airway Amber 4 (A-4) in the vicinity of Anaktuvuk Pass, AK, due to the pending decommissioning of the Anaktuvuk Pass, AK (AKP), Non-Directional Beacon (NDB).

The Energy Policy and Conservation Act, as amended (``EPCA''), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including circulator pumps. In this notice of proposed rulemaking (``NOPR''), DOE proposes energy conservation standards for circulator pumps, and also announces a public meeting to receive comment on these proposed standards and associated analyses and results.

The Agriculture Improvement Act of 2018 (2018 Farm Bill) amended several sections of the Rural Electrification Act of 1936 (RE Act) that are carried out by the Electric Program at the USDARural Utilities Service (RUS). Section 6501 extends refinancing authority to RUS for loans made or guaranteed by the Secretary. Section 6503 ended the Cushion of Credit Payment Program. Section 6505 made several changes to the loan guarantee program authorized under section 313A of the RE Act. Section 6507 permits RUS to include provisions for cybersecurity and grid security improvements.

The Federal Energy Regulatory Commission (Commission) proposes to direct the North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization (ERO), to develop new or modified Reliability Standards that address the following reliability gaps related to inverter-based resources (IBR): data sharing; model validation; planning and operational studies; and performance requirements. Further, the Commission proposes to direct NERC to submit to the Commission a compliance filing within 90 days of the effective date of the final rule in this proceeding that includes a detailed, comprehensive standards development and implementation plan to ensure all new or modified Reliability Standards necessary to address the IBR-related reliability gaps identified in the final rule are submitted to the Commission within 36 months of Commission approval of the plan.