December 5, 2022 – Federal Register Recent Federal Regulation Documents

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.

The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the September 1, 2024, expiration date.

The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Eastern Kern Air Pollution Control District (EKAPCD or ``the District'') portion of the California State Implementation Plan (SIP). In this action, we are approving one rule submitted by the EKAPCD, governing the issuance of permits for stationary sources, focusing on the preconstruction review and permitting of major sources and major modifications under part D of title I of the Clean Air Act (CAA or ``the Act'').

The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Statistical Approaches to Establishing Bioequivalence.'' This draft guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. When finalized, this guidance will replace FDA's 2001 guidance for industry of the same name.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.'' For purposes of implementing the Generic Drug User Fee Amendments of 2022 (GDUFA III), the Pre-Submission Facility Correspondence (PFC) process was revised as part of the performance goals and program enhancements agreed to by FDA and industry, as described in the GDUFA Reauthorization Performance Goals and Program Enhancements, Fiscal Years 2023 through 2027 (GDUFA III commitment letter). FDA assesses facility information submitted in a PFC to inform the Agency's decision regarding the need for facility inspections that support assessment of the abbreviated new drug application (ANDA). A complete and accurate PFC allows the Agency to begin the facility assessment process in advance of the planned ANDA submission for priority ANDAs, allowing the Agency more time to make preapproval inspection decisions. A PFC meeting the conditions outlined in the revised draft guidance will qualify the ANDA for a shorter, 8- month priority review goal. This revised draft guidance describes the content, timing, and assessment of a complete and accurate PFC for purposes of GDUFA III. Additionally, this revised draft guidance provides information on the Agency's rationale for and current approach to assessing a PFC and replaces the previous draft guidance for industry, ``ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence),'' issued in November 2017.

The U.S. Department of Commerce (Commerce) determines that Metalco S.A. (Metalco), the sole company subject to the 2020-2021 administrative review of the antidumping duty order on corrosion- resistant steel products from the People's Republic of China (China), is part of the China-wide entity because it did not demonstrate its eligibility for a separate rate. The period of review (POR) is July 1, 2020, through June 30, 2021.

The U.S. Department of Commerce (Commerce) has received requests to conduct administrative reviews of various antidumping duty (AD) and countervailing duty (CVD) orders with October anniversary dates. In accordance with Commerce's regulations, we are initiating those administrative reviews.

The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning a revision to a regulatory reporting requirement for national banks and federal savings associations titled, ``Company-Run Annual Stress Test Reporting Template and Documentation for Covered Institutions with Total Consolidated Assets of $250 Billion or More under the Dodd-Frank Wall Street Reform and Consumer Protection Act.''

The National Archives and Records Administration (NARA) publishes notice of certain Federal agency requests for records disposition authority (records schedules). We publish notice in the Federal Register and on regulations.gov for records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on such records schedules.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) proposes to renew an information collection.

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.