2022 – Federal Register Recent Federal Regulation Documents

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 This guidance finalizes the draft guidance of the same title issued on August 26, 2021.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 The guidance revises the draft guidance for industry entitled ``E19 Optimisation of Safety Data Collection'' issued in June 2019.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.

Section 110(h) of the Clean Air Act (CAA), as amended in 1990, requires EPA to assemble the requirements of the federally-enforceable State Implementation Plans (SIPs) in each State and to provide notification in the Federal Register of the availability of such documents every three years. This document fulfills the three-year requirement of making these SIP compilations for each State available to the public. This document also addresses EPA's obligation under a consent decree which required EPA to assemble and publish online the SIP rules that have been approved by EPA as of August 31, 2022.

The U.S. Environmental Protection Agency (EPA) is proposing revisions to the Federal Clean Water Act (CWA) water quality standards (WQS) regulation to clarify and prescribe how WQS must protect aquatic and aquatic-dependent resources reserved to tribes through treaties, statutes, executive orders, or other sources of Federal law, where applicable.

The Environmental Protection Agency (EPA) is proposing to add per- and polyfluoroalkyl substances (PFAS) subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA) to the list of Lower Thresholds for Chemicals of Special Concern (chemicals of special concern). These PFAS already have a lower reporting threshold of 100 pounds. The addition of these PFAS to the list of chemicals of special concern will cause such PFAS to be subject to the same reporting requirements as other chemicals of special concern (i.e., it would eliminate the use of the de minimis exemption and the option to use Form A and would limit the use of range reporting for PFAS). Removing the availability of these burden-reduction reporting options will result in a more complete picture of the releases and waste management quantities for these PFAS. In addition, EPA is proposing to remove the availability of the de minimis exemption for purposes of the Supplier Notification Requirements for all chemicals on the list of chemicals of special concern. This change will help ensure that purchasers of mixtures and trade name products containing such chemicals are informed of their presence in mixtures and products they purchase.

The Bureau of Indian Affairs (BIA) seeks input on changes to its regulations governing the discretionary acquisition of land into trust for the benefit of tribal governments and individual Indians. Since these regulations were first promulgated in 1980, the BIA has developed extensive experience in the fee-to-trust acquisition process. Relying on that experience and input from tribal governments and individual Indians, this proposed rule seeks to make the land into trust process more efficient, simpler, and less expensive to support restoration of tribal homelands.

The Environmental Protection Agency (EPA) is proposing to partially approve and partially disapprove the Arizona state implementation plan (SIP) as meeting the requirements of sections 110(a)(1) and 110(a)(2) of the Clean Air Act (CAA) for the implementation, maintenance, and enforcement of the 2015 ozone national ambient air quality standards (NAAQS or ``standards''). Section 110(a)(1) requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by the EPA, and that the EPA act on such SIPs. We refer to such SIPs as ``infrastructure'' SIPs because they are intended to address basic structural SIP requirements for new or revised NAAQS including, but not limited to, legal authority, regulatory structure, resources, permit programs, monitoring, and modeling necessary to assure attainment and maintenance of the standards. In addition to our proposed partial approval and partial disapproval of Arizona's infrastructure SIP, the EPA is proposing to approve rules in the Arizona Revised Statutes and Pima County Code related to public availability of emissions reports into the Arizona SIP. Lastly, the EPA is proposing to reclassify regions in Arizona with respect to episode plans for ozone under 40 CFR 51.150. The EPA is seeking public comments on this proposed action and will accept comments from the public on this proposal for the next 30 days.

The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A321-251N, A321-251NX, A321-252N, A321-252NX, A321- 253N, and A321-253NX airplanes. This AD was prompted by a stress analysis on the engine structure that indicated that the fail-safe lug may not be able to sustain, during one inspection interval as currently specified in an airworthiness limitations item, the loads deriving from the engagement of the secondary load path within that inspection interval for the aft engine mount system. This AD requires repetitive detailed inspections of the aft engine mount and secondary load path clearance fail-safe pin and replacement of the engine if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-700-2A12 airplanes. This AD was prompted by the investigation of erroneous radio altimeter data that was displayed on an in-service airplane. It was revealed that certain radio altimeter coaxial cables used by the radio altimeter systems, in the aft fuselage equipment bay, were damaged. This AD requires replacing affected radio altimeter coaxial cables. The FAA is issuing this AD to address the unsafe condition on these products.

This action modifies the Class D surface area, and establishes Class E airspace extending upward from 700 feet above the surface at Butts AAF (Fort Carson) Airport, CO. Additionally, this action makes administrative changes to update the airport's existing Class D legal description. These actions will support the safety and management of instrument flight rules (IFR) and visual flight rules (VFR) operations at the airport.

The Commission is recognizing a recent filing by the Postal Service that it has entered into the Inbound Competitive Multi-Service Agreement with a foreign postal operator. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Rural Business-Cooperative Service (Agency), an agency of the United States Department of Agriculture (USDA), announces that it is accepting fiscal year (FY) 2023 applications for the Agriculture Innovation Demonstration Center (AIC) program. In FY 2023, the program has $8,005,621 available for grant funding. The purpose of this program is to establish and operate Agriculture Innovation Centers (Centers) that provide technical and business development assistance to Agricultural Producers seeking to engage in developing and marketing of Value-Added Agricultural Products. This program supports Rural Development's (RD) mission of improving the quality of life for rural Americans and commitment to directing resources to those who most need them.

The Corps of Engineers is proposing to establish three danger zones in the waters of Carr Creek and Whitehall Bay in the vicinity of the Naval Support Activity Annapolis. The establishment of the proposed danger zone in Carr Creek is necessary to enable safe operation of the United States Naval Academy firing range and to reflect the routine and periodic usage of the firing range for training sailors, midshipmen, and law enforcement personnel. The establishment of the two proposed danger zones in Whitehall Bay is necessary to enable the safe operation of the United States Naval Academy firing range and to reflect irregular and infrequent usage of the range for training sailors, midshipmen, and law enforcement personnel. The firing range faces Carr Creek and, during times of operation, may present a danger to vessels located in the areas of the proposed danger zones.