2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for ``manual surgical instrument for general use'' and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is issuing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also amending the existing classification for ``manual surgical instrument for general use'' to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.

The Coast Guard will enforce special local regulations for the Roar Offshore on October 8 and 9, 2021, to provide for the safety of life on navigable waterways during this event. The regulation for recurring marine events within Sector St. Petersburg identifies the regulated area for this event in Fort Myers Beach, FL. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any designated representative.

The Corps of Engineers (Corps) is amending its regulations to establish a danger zone in the Pacific Ocean adjacent to the Mason Live-Fire Training Range Complex at Marine Corps Base, Camp Blaz on the north coast of Guam. The danger zone is located entirely within the Pacific Ocean, comprising 3,660 acres and extending approximately 2.8 miles into the ocean from the high tide line. Establishment of the danger zone will intermittently prohibit vessels from lingering in the danger zone when the range is in active use in order to ensure public safety.

NIST is issuing a final rule to amend the regulations governing the Hollings Manufacturing Extension Partnership (MEP) program to reflect the current requirements for publishing Notices of Funding Opportunities (NOFOs) for the establishment and operation of MEP Centers, consistent with the current MEP authorizing statute and Department of Commerce (Department or DOC) policy.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Umlaut Engineering GmbH (previously P3 Engineering GmbH) HAFEX (Halon-free) hand-held P3HAFEX fire extinguishers (fire extinguishers). This proposed AD was prompted by reports of a quality control issue on certain fire extinguishers, where the spindle geometries of the fire extinguishers were found to be out of tolerance. This proposed AD would require removing affected fire extinguishers from service. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to adopt a new airworthiness directive (AD) for certain Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This proposed AD results from 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 describes the unsafe condition as insufficient performance of the fuel drain system that could lead to fire and damage of the airplane. This proposed AD would require modifying the fuel drain pipe routing and installing a drain mast. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA proposes to adopt a new airworthiness directive (AD) for certain General Electric Company (GE) CF34-8C and CF34-8E model turbofan engines. This proposed AD was prompted by a report of a quality escape during the manufacturing of a high-pressure turbine (HPT) rotor stage 1 disk. This proposed AD would require removing the HPT rotor stage 1 disk from service and replacing the HPT rotor stage 1 disk with a part eligible for installation. The FAA is proposing this AD to the unsafe condition on these products.

This action proposes to amend United Stated Area Navigation (RNAV) route T-227 in the vicinity of Fairbanks, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.

The Department of Veterans Affairs (VA) is amending its adjudication and loan guaranty regulations regarding eligibility and assistance for certain veterans and members of the Armed Forces in acquiring specially adapted housing assistance. The amendments are necessary to implement certain provisions of the Ryan Kules and Paul Benne Specially Adaptive Housing Improvement Act of 2019.

This interim final rule applies when, during emergencies such the current COVID-19 pandemic, Federal funding is available to assist tenants with nonpayment of rent and tenants facing eviction for nonpayment of rent in public housing and properties with project-based rental assistance (PBRA) (for purposes of this rule, PBRA includes projects in the following programs: Section 8, Section 8 Moderate Rehabilitation, Section 202/162 Project Assistance Contract, Section 202 Project Rental Assistance Contract (PRAC), Section 811 PRAC, Section 236 Rental Housing Assistance Program and Rent Supplement) need sufficient time and information to seek and receive such emergency rent relief. This interim final rule will allow the Secretary, upon making the requisite findings and providing the requisite notice, to require housing providers participating in those programs to provide tenants facing eviction for non-payment of rent with notification of and information about the opportunity to secure emergency funding and additional time to secure such funding prior to eviction.

The FAA is adopting a new airworthiness directive (AD) for AERO Sp. z o.o. (AERO) Model AT-3R100 airplanes with an ELPROP 3-1-1P propeller. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as cracks in the propeller hub. The FAA is issuing this AD to address the unsafe condition on these products.

The Securities and Exchange Commission (``Commission'') is adopting amendments to Volumes I and II of the Electronic Data Gathering, Analysis, and Retrieval system (``EDGAR'') Filer Manual (``Filer Manual'') and related rules and forms. The EDGAR system was upgraded on September 20, 2021.

The Council on Environmental Quality (CEQ) is proposing to modify certain aspects of its regulations for implementing the procedural provisions of the National Environmental Policy Act (NEPA) to generally restore regulatory provisions that were in effect for decades before being modified in 2020. CEQ proposes these changes in order to better align the provisions with CEQ's extensive experience implementing NEPA, in particular its perspective on how NEPA can best inform agency decision making, as well as longstanding Federal agency experience and practice, NEPA's statutory text and purpose, including making decisions informed by science, and case law interpreting NEPA's requirements. The proposed rule would restore provisions addressing the purpose and need of a proposed action, agency NEPA procedures for implementing CEQ's NEPA regulations, and the definition of ``effects.'' CEQ invites comments on the proposed revisions.

The U.S. Nuclear Regulatory Commission (NRC) is confirming the effective date of October 26, 2021, for the direct final rule that was published in the Federal Register on August 12, 2021. The direct final rule amended the TN Americas LLC, NUHOMS[supreg] EOS Dry Spent Fuel Storage System listing in the ``List of approved spent fuel storage casks'' to include Amendment No. 2 to Certificate of Compliance No. 1042. Amendment No. 2 revises the certificate of compliance to add a dry shielded canister for storage, add new heat load zone configurations, and make other changes to the storage system. Amendment No. 2 also changes the certificate of compliance and technical specifications, and updates the final safety analysis report for consistency and clarity.

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A330-200, -300, -800, and -900 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. This proposed AD was prompted by reports that the instructions on the doghouse door lock placard are unclear and incomplete. This proposed AD would require replacing the placard with an improved instruction placard, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference. This proposed AD would also prohibit the installation of affected parts under certain conditions. The FAA is proposing this AD to address the unsafe condition on these products.

This action proposes to amend United States Area Navigation (RNAV) route T-267 in the vicinity of Nome, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.

We, the U.S. Fish and Wildlife Service (Service), propose to list Eriogonum tiehmii (hereafter Tiehm's buckwheat), a plant species native to Nevada in the United States, as endangered under the Endangered Species Act of 1973, as amended (Act). If we finalize this rule as proposed, it would add this species to the List of Endangered and Threatened Plants and extend the Act's protections to the species.

The Environmental Protection Agency (EPA) is proposing to amend the Environmental Protection Agency Acquisition Regulation (EPAAR) to address common Commercial Supplier Agreement terms that are inconsistent with or create ambiguity with Federal Law, to create a new subpart for class deviations, and to update clause Fixed Rates for ServicesIndefinite Delivery/Indefinite Quantity Contract.

This document sets forth interim final rules implementing certain provisions of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021. These interim final rules implement provisions of the No Surprises Act that provide for a Federal independent dispute resolution (IDR) (Federal IDR) process to permit group health plans and health insurance issuers offering group or individual health insurance coverage and nonparticipating providers, facilities, and providers of air ambulance services to determine the out-of-network rate for items and services that are emergency services, nonemergency services furnished by nonparticipating providers at participating facilities, and air ambulance services furnished by nonparticipating providers of air ambulance services, under certain circumstances. The Department of Health and Human Services (HHS), the Department of Labor (DOL), and the Department of the Treasury (collectively, the Departments) are issuing these interim final rules with largely parallel provisions that apply to group health plans and health insurance issuers offering group or individual health insurance coverage and certified IDR entities, providers, facilities, and providers of air ambulance services. In addition to the interim final rules issued jointly by the Departments, this document also includes interim final rules issued by the Office of Personnel Management (OPM) to clarify how certain No Surprises Act provisions apply to health benefits plans offered by carriers under the Federal Employees Health Benefits (FEHB) Act. In addition to the interim final rules issued jointly by the Departments and OPM, this document includes interim final rules issued by HHS that address good faith estimates of health care items and services for uninsured or self-pay individuals and the associated patient-provider dispute resolution process. The HHS-only interim final rules apply to selected dispute resolution (SDR) entities, providers, facilities, and providers of air ambulance services.

DoD, GSA, and NASA are proposing to amend the Federal Acquisition Regulation (FAR) to implement the final rule published by the Small Business Administration implementing a section of the Carl Levin and Howard P. ``Buck'' McKeon National Defense Authorization Act for Fiscal Year (FY) 2015.

The FAA is adopting a new airworthiness directive (AD) for MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL-600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by reports and a design review indicating that there could be possible corrosion on the main landing gear (MLG) outer cylinder at the interface with the gland nut on the shock strut installation and on the forward and aft trunnion pins in the MLG dressed shock strut assembly. This AD requires detailed inspections for corrosion on the MLG outer cylinder assemblies, certain MLG dressed shock strut assemblies, and the MLG outer cylinder at the gland nut threads, thread relief groove, and chamfer; a detailed inspection for the presence of corrosion-inhibiting compound (CIC) on the MLG forward and aft trunnion pins and grease adapter assemblies; applicable corrective actions; application of primer, paint, and CIC as applicable; re-identification of certain part numbers; and marking of the MOD STATUS field of the nameplate of certain parts. The FAA is issuing this AD to address the unsafe condition on these products.

This action contains a correction to the final rule published on September 15, 2021, setting forth the Concrete Masonry Products Research, Education, and Promotion Order, as authorized by the Concrete Masonry Products Research, Education, and Promotion Act of 2018, which establishes a Concrete Masonry Products Board (Board) composed of industry members appointed by the Secretary of Commerce (Secretary) to develop and implement programs of research, education, and promotion in the concrete masonry products industry. This action corrects email contact information found in the previously published rule.

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus SAS Model A300 series airplanes; Airbus SAS Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus SAS Model A310 series airplanes. This proposed AD was prompted by reports of incorrect installation of the fire shut- off valves (FSOV) actuator, which was found to rotate around its pivot axis. This proposed AD would require a one-time detailed inspection of the FSOV actuator for rotation around its pivot axis, and replacement if necessary, 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 Commission is acknowledging a recent filing requesting the Commission initiate a rulemaking proceeding to consider changes to analytical principles relating to periodic reports (Proposal Six). This document informs the public of the filing, invites public comment, and takes other administrative steps.

This interim final rule revises regulations to delay implementation of the Electronic Monitoring (EM) Program for the West Coast Groundfish Trawl Rationalization Program. This action will delay implementation of the EM program until at least January 1, 2024. This change will provide additional time for industry and prospective service providers to prepare for implementation. The change is expected to strengthen Pacific Fishery Management Council and industry support for the EM program and may increase participation when the EM program is implemented.