2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is withdrawing the approval of the new drug application (NDA) for ASACOL (mesalamine) delayed-release tablets, 400 milligrams (mg), held by Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA 92612 (Allergan). Pursuant to FDA's request, Allergan agreed to withdrawal of this application and has waived its opportunity for a hearing.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, ``Reactor Site Criteria.''

The FAA proposes to adopt a new airworthiness directive (AD) for all Gulfstream Aerospace Corporation (Gulfstream) Model GV airplanes. This proposed AD was prompted by notification of corrosion present in floor beam support links. This proposed AD would require inspecting the right butt line 6 floor beam inboard support links and bushings for corrosion. The FAA is proposing this AD to address the unsafe condition on these products.

The FAA is superseding Airworthiness Directive (AD) 2018-16- 05, which applied to certain The Boeing Company Model 757 airplanes. AD 2018-16-05 required repetitive inspections for skin cracking and shim migration at the upper link drag fittings, diagonal brace cracking, and fastener looseness; and applicable on-condition actions. This AD retains the actions required by AD 2018-16-05, reduces the compliance times for certain inspections, and adds repetitive inspections at certain fastener hole locations and applicable on-condition actions. This AD was prompted by reports of bolt rotation in the engine drag fitting joint and fastener heads; an inspection of the fastener holes revealed that cracks were found in the skin. This AD was also prompted by a report of multiple cracks in the drag fitting at fastener holes found during an inspection required by AD 2018-16-05. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is superseding Airworthiness Directive (AD) 2018-14- 02, which applied to certain The Boeing Company Model 777-200, -200LR, -300, and -300ER series airplanes. AD 2018-14-02 required an inspection for foam insulation on the dripshield above the overhead panel support structure and replacement if necessary. For certain airplanes, AD 2018- 14-02 also required replacement of foam insulation on the overhead panel support structure. This AD continues to require the actions in AD 2018-14-02, and, for certain airplanes, this AD requires an inspection of the foam insulation on the overhead panel support structure, and replacement if necessary. This AD was prompted by reports that additional areas of Boeing Material Specification (BMS) 8-39 flexible urethane foam were found on the overhead panel support structure in the flight compartment. The FAA is issuing this AD to address the unsafe condition on these products.

NHTSA is issuing this ANPRM to seek public comment on whether any test procedures for any Federal Motor Vehicle Safety Standards (FMVSS) may be a candidate for replacement, repeal, or modification, for reasons other than for considerations relevant only to automated driving systems (ADS). This document is a continuation of the Agency's efforts to improve the FMVSS and minimize burdens. The Agency takes this action in response to its review of the FMVSS and to public comments solicited by DOT in a 2017 notice on its regulatory reform efforts. The commenters requested that NHTSA amend test procedures for air brakes and occupant crash protection. NHTSA has also identified some possible additional test procedure issues and discusses them in this Notice. In addition, this ANPRM also seeks comments and supporting information relating to any other test procedures which may be a candidate for replacement, repeal or modification, not just those specifically discussed in this Notice.

This action proposes to establish Area Navigation (RNAV) route Q-437 in the northeastern United States in support of the Northeast Corridor Atlantic Coast Route Project (NEC ACR) for improve efficiency of the National Airspace System (NAS) while reducing the dependency on ground based navigational systems.

This action amends VHF Omnidirectional Range (VOR) Federal airways V-53, V-115, and V-140, and Area Navigation (RNAV) T-routes T- 215 and T-323; and removes VOR Federal airway V-339 in the vicinity of Hazard, KY. The Air Traffic Service (ATS) route modifications are necessary due to the planned decommissioning of the VOR portion of the Hazard, KY, VOR/Distance Measuring Equipment (VOR/DME) navigation aid (NAVAID) which provides navigation guidance for portions of the affected ATS routes. The Hazard VOR is being decommissioned as part of the FAA's VOR Minimum Operational Network (MON) program.

The FAA is adopting a new airworthiness directive (AD) for all Pratt & Whitney Division (PW) PW4164, PW4164-1D, PW4168, PW4168-1D, PW4168A, PW4168A-1D, and PW4170 model turbofan engines with a certain outer combustion chamber assembly and 3rd stage low-pressure turbine (LPT) duct segments installed. This AD was prompted by reports of damaged or failed 3rd stage LPT duct segments on PW engines with the Talon IIB outer combustion chamber assembly configuration installed. This AD requires removing and replacing certain 3rd stage LPT duct segments. The FAA is issuing this AD to address the unsafe condition on these products.

The U.S. Nuclear Regulatory Commission (NRC) published a draft document entitled ``Implementation of Quality Assurance Criteria and 10 CFR 50.59 for Nuclear Power Plant Components Produced Using Advanced Manufacturing Technologies'' for public comments in the Federal Register on November 30, 2020. The document addresses the application of quality assurance (QA) criteria and NRC's requirements in its regulations regarding, ``Changes, tests and experiments,'' to the implementation of Advanced Manufacturing Technologies (AMT)-fabricated components in U.S. nuclear power plants. This notice withdraws the November 30, 2020, notice in its entirety and reissues the notice to include additional explanatory information, extend the comment period to 60 days, and correct the Agencywide Documents Access and Management System (ADAMS) accession number for the draft document.

The U.S. Department of Transportation (Department or DOT) is issuing a final rule to amend the Department's Air Carrier Access Act (ACAA) regulation on the transport of service animals by air. This final rule is intended to ensure that our air transportation system is safe for the traveling public and accessible to individuals with disabilities.

The Bureau of Consumer Financial Protection (Bureau) is issuing this advisory opinion to clarify that loan products that refinance or consolidate a consumer's pre-existing Federal, or Federal and private, education loans meet the definition of ``private education loan'' in the Truth in Lending Act and Regulation Z and are subject to the disclosure and consumer protection requirements in subpart F of Regulation Z. This advisory opinion is an interpretive rule under the Administrative Procedure Act.

The OCC, the Board, and the Bureau are finalizing amendments to the official interpretations for their regulations that implement section 129H of the Truth in Lending Act (TILA). Section 129H of TILA establishes special appraisal requirements for ``higher-risk mortgages,'' termed ``higher-priced mortgage loans'' or ``HPMLs'' in the agencies' regulations. The OCC, the Board, the Bureau, the Federal Deposit Insurance Corporation (FDIC), the National Credit Union Administration (NCUA), and the Federal Housing Finance Agency (FHFA) (collectively, the Agencies) jointly issued final rules implementing these requirements, effective January 18, 2014. The Agencies' rules exempted, among other loan types, transactions of $25,000 or less, and required that this loan amount be adjusted annually based on any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the OCC, the Board, and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage increase in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the CPI-W in effect as of June 1, 2020, the exemption threshold will remain at $27,200, effective January 1, 2021.

The Board and the Bureau are publishing final rules amending the official interpretations and commentary for the agencies' regulations that implement the Truth in Lending Act (TILA). The Dodd- Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended TILA by requiring that the dollar threshold for exempt consumer credit transactions be adjusted annually by the annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). If there is no annual percentage increase in the CPI-W, the Board and the Bureau will not adjust this exemption threshold from the prior year. However, in years following a year in which the exemption threshold was not adjusted, the threshold is calculated by applying the annual percentage change in the CPI-W to the dollar amount that would have resulted, after rounding, if the decreases and any subsequent increases in the CPI-W had been taken into account. Based on the annual percentage increase in the CPI-W as of June 1, 2020, the exemption threshold will remain at $58,300 effective January 1, 2021. Because the Dodd-Frank Act also requires similar adjustments in the Consumer Leasing Act's threshold for exempt consumer leases, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Consumer Leasing Act elsewhere in this issue of the Federal Register.

This rule streamlines and increases flexibility in the FAA's commercial space launch and reentry regulations, and removes obsolete requirements. It consolidates and revises multiple regulatory parts and applies a single set of licensing and safety regulations across several types of operations and vehicles. The rule describes the requirements to obtain a vehicle operator license, the safety requirements, and the terms and conditions of a vehicle operator license.