2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is proposing to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately proposing to require the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device. FDA is publishing this proposed rule based, in part, on the recommendations of the Orthopaedic and Rehabilitation Devices Panel, regarding the classification of spinal spheres for use in intervertebral fusion procedures.

The United States Patent and Trademark Office (USPTO) is proposing to implement electronic patent issuance. Under the proposed change, the USPTO would issue patents electronically through its patent document viewing systems (i.e., Patent Center and Patent Application Image Retrieval (PAIR)). Patents would no longer be issued on paper, and as a result, they would no longer be mailed to the correspondence address of record as part of the patent issuance process. The elimination of these steps would allow issued patents to be available weeks sooner in electronic form, and the patentee would be able to view and print the complete issued patent via the USPTO's patent document viewing systems immediately upon issue. Patentees would continue to have the option of ordering an unlimited number of paper presentation copies and certified copies of patents.

This document notifies the public as required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) that the EPA Administrator has forwarded to the Secretary of the United States Department of Agriculture (USDA) a draft regulatory document concerning ``Pesticides; Certification of Pesticide Applicators; Extension to Expiration Date of Certification Plans (RIN 2070-AL00).'' The draft regulatory document is not available to the public until after it has been signed and made available by EPA.

This document corrects a typographic error that appeared in the final rule published in the Federal Register on November 8, 2021 entitled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model.''

This regulation establishes an exemption from the requirement of a tolerance for residues of Trichoderma harzianum strain T-78 in or on all food commodities when used in accordance with label directions and good agricultural practices. Symborg, Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Trichoderma harzianum strain T-78 under FFDCA when used in accordance with this exemption.

The FAA is adopting a new airworthiness directive (AD) for certain General Electric Company (GE) CF34-8C and CF34-8E model turbofan engines. This AD was prompted by an in-flight shutdown of an engine and subsequent investigation by the manufacturer that revealed a broken variable geometry (VG) actuator rod end caused by corrosion and seizure of the rod end bearing. This AD requires performing an inspection of the master compressor VG actuator and slave compressor VG actuator and, depending on the results of the inspection, replacement of the part with a part eligible for installation. This AD also requires reporting the results of the inspection to GE. The FAA previously sent an emergency AD to all known U.S. owners and operators of these GE CF34-8C and CF34-8E model turbofan engines and is now issuing this AD to address the unsafe condition on these products.

This action corrects an error in the calculation of the post- transfer quota for the State of North Carolina that published in the Federal Register on November 26, 2021.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus Helicopters Deutschland GmbH Model EC135P1, EC135P2, EC135P2+, EC135P3, EC135T1, EC135T2, EC135T2+, and EC135T3 helicopters. This AD was prompted by reduced life limits being established for certain part-numbered tail rotor (TR) blades. This AD requires determining the total hours time-in-service (TIS) of certain part- numbered TR blades, establishing a life limit for certain part-numbered TR blades, removing from service any TR blade that has reached or exceeded its life limit, creating a component history card, re- identifying certain part-numbered TR blades, and removing any TR blade from service before reaching its retirement life. This AD also prohibits installing certain TR blades on certain model helicopters. The FAA is issuing this AD to address the unsafe condition on these products.

The Postal Service published a final notice in the Federal Register, on November 30, 2021, regarding the revisions to Mailing Standards of the United States Postal Service, International Mail Manual (IMM[supreg]), to reflect the prices, product features, and classification changes to Competitive Services and other minor changes, as established by the Governors of the Postal Service effective January 9, 2022. That document contained an error in the Certificate of Mailing Individual Pieces chart in that it incorrectly listed the firm mailing sheet (PS Form 3665), per piece (minimum 3) First-Class Mail International only with the price for all other qualifying classes of mail. There is no price change to First Class Mail International only. This document serves to correct the error by replacing First Class Mail International only to reflect all other qualifying classes of mail.

The Environmental Protection Agency (EPA) is proposing to deny all undecided/pending small refinery exemption petitions under the Renewable Fuel Standard program currently before the agency. EPA is providing an opportunity for the public to comment on our proposed denial of these petitions.

This notice announces a fact-finding informal airspace meeting regarding a plan to modify the Class C Airspace at Nashville International Airport, TN (KBNA). 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.

This action proposes to modify VHF Omnidirectional Range (VOR) Federal airways V-7, V-9, and V-11. This action is necessary due to the planned decommissioning of the Dyersburg, TN, (DYR); Malden, MO, (MAW); and the Muscle Shoals, AL, (MSL), VOR and Tactical Air Navigation (VORTAC) facilities, under the FAA's VOR Minimum Operational Network (MON) program, which provide navigation guidance for segments of the routes.

The Environmental Protection Agency (EPA) is proposing to approve revisions, under the Clean Air Act (CAA or ``Act''), to portions of the Arizona, California, and Nevada State Implementation Plans (SIPs) regarding emissions statements (ES) requirements for the 2015 ozone national ambient air quality standards (NAAQS). We are also proposing to approve ES certifications (``certifications'') adopted by various California air districts that existing SIP-approved rules are adequate to meet the ES requirements for the 2015 ozone NAAQS. In addition, we are proposing that the following Arizona, California, and Nevada nonattainment areas (NAAs) meet the ES requirements for the 2015 ozone NAAQS: Phoenix-Mesa, Yuma, Amador County, Butte County, Imperial County, Los Angeles-San Bernardino Counties (West Mojave Desert), Los Angeles-South Coast Air Basin, Nevada County (Western part), Riverside County (Coachella Valley), Sacramento Metro, San Diego County, San Francisco Bay Area, San Joaquin Valley, San Luis Obispo (Eastern part), Sutter Buttes, Tuolumne County, Ventura County, and Las Vegas. We are also proposing to approve that two NAAs meet requirements for prior ozone NAAQS. Finally, we are proposing that Maricopa County Air Quality District (MCAQD) Rule 100, section 503, which we proposed for approval into the SIP on February 23, 2021, meets the ES requirements for the 2015 ozone NAAQS. We are taking comments on this proposal and plan to follow with a final action.

The FAA proposes to amend two Jet Routes; extend one high altitude RNAV Q-route; amend four VHF Omnidirectional Range (VOR) Federal airways; remove one VOR Federal airway; and remove one Domestic Low Altitude Reporting Point, in the vicinity of Fort Dodge, IA. This action is necessary due to the planned decommissioning of the VOR portion of the Fort Dodge, IA, VOR/Tactical Air Navigation (VORTAC), which provides navigation guidance to portions of the affected Air Traffic Service (ATS) routes. The Fort Dodge VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (VOR MON) program. Although the Fort Dodge VOR is being decommissioned, the FAA plans to retain the collocated Distance Measuring Equipment (DME) and Tactical Air Navigation (TACAN) portions of the navigational aid.

The Department of Justice's National Security Division (NSD) anticipates issuing a Notice of Proposed Rulemaking (NPRM) that would amend or otherwise clarify the scope of certain exemptions, update various definitions, and make other modernizing changes to the Attorney General's Foreign Agents Registration Act (FARA) implementing regulations. The Department is issuing this Advanced Notice of Public Rulemaking (ANPRM) to solicit suggestions for any potential amendments to, or clarifications of, the current FARA implementing regulations.

This action proposes to amend United States Area Navigation (RNAV) route T-229 in the vicinity of Point Hope, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.

This action proposes to amend three jet routes and remove four jet routes in the eastern United States. This action supports the VHF Omnidirectional Range (VOR) Minimum Operational Network (MON) program to improve the efficiency of the National Airspace System (NAS) and reduce dependency on ground-based navigational systems.

This action proposes to amend United States Area Navigation (RNAV) route T-233 in the vicinity of Kotzebue, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.

This document corrects a typographical error in the final rules portion of a Federal Register document published on September 14, 2021.

This final rule removes the DoD regulation which is outdated, contains internal guidance for admissions to the School of Medicine, Uniformed Services University of the Health Sciences, reiterates statutory requirements, and is otherwise subject to the military function exemption to rulemaking.

The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

NMFS issues regulations to modify recordkeeping and reporting requirements to remove pot gear tag requirements in the sablefish Individual Fishing Quota (IFQ) fishery in the Gulf of Alaska (GOA) and remove requirements to obtain and submit a notary certification on various programs' application forms. This action is intended to reduce administrative burden on the regulated fishing industry and the National Marine Fisheries Service (NMFS). This action promotes the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act, or MSA), the Halibut Act, fishery management plans (FMPs), and other applicable laws.

This rule amends the regulations for Dairy Margin Coverage (DMC) to allow supplemental DMC payments to participating eligible dairy operations. DMC provides dairy producers with risk management coverage that pays producers when the difference between the price of milk and the cost of feed (the margin) falls below a certain level. Eligible dairy operations with less than 5 million pounds of established production history may enroll supplemental pounds based upon a formula using 2019 actual milk marketings. Supplemental DMC coverage is applicable to calendar years 2021, 2022, and 2023. Participating dairy operations with supplemental production may receive supplemental payments in addition to payments based on their established production history. In addition, the rule amends the alfalfa hay calculation used in determining the average feed cost and actual dairy production margin. To end prolonged months of milk indemnity payments, the rule amends the regulations for Dairy Indemnity Payment Program (DIPP) to indemnify affected farmers for depopulating and permanently removing cows after discovery of chemical residues affecting the commercial marketing of milk for the applicable farm and likely affecting the marketability of cows for a lengthy duration. The rule also implements a new Oriental Fruit Fly (OFF) Program as authorized in the Consolidated Appropriations Act, 2019. In addition, the rule updates the existing Marketing Assistance Loans (MAL) and Loan Deficiency Payments (LDP) loan rates to be consistent with the Agriculture Improvement Act of 2018 (the 2018 Farm Bill); the loan rates were already changed administratively because the loan rate changes were self-enacting. This rule also amends the Conservation Reserve Program (CRP) regulations to remove two discretionary requirements.

This action proposes to amend United States Area Navigation (RNAV) route T-235 in the vicinity of Atqasuk, AK in support of a large and comprehensive T-route modernization project for the state of Alaska.