December 11, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Department of Defense is publishing the unclassified text of an arms sales notification.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Department of Defense is publishing the unclassified text of an arms sales notification.

In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing a new information collection.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Food and Drug Administration (FDA) is correcting a notice entitled ``Qualification Process for Drug Development Tools; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability of a final guidance for industry and FDA staff that met the 21st Century Cures Act's requirement to issue guidance on this qualification process and elaborated on the new qualification process and transparency requirements and discusses the taxonomy for biomarkers and other drug development tools. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0001, abstracted below that we will submit to OMB for an extension in compliance with the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves air carriers maintaining an accounting system for the passenger civil aviation security service fees collected and reporting this information to TSA on a quarterly basis, as well as retaining the data used for these reports for three fiscal years.

The following remote public hearing on proposed amendments to the Federal Rules of Appellate Procedure has been canceled: Appellate Rules Hearing on January 4, 2021.

FHWA, on behalf of TxDOT, is issuing this notice to advise the public that an EIS will be prepared for a proposed transportation project to construct an eight-lane freeway along the United States (US) Highway 380 corridor from Coit Road in Prosper (west of McKinney) to Farm-to-Market Road (FM) 1827 (east of McKinney), in Collin County, Texas.

HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.

The Notice of Realty Action (NORA) announces the Bureau of Land Management (BLM) proposes to patent 154.694 acres of public land in Sevier County, Utah, to Sevier County for the expansion of the Sevier County landfill.

Office of Natural Resources Revenue (ONRR) regulations provide two types of accounting and auditing relief for Federal onshore or Outer Continental Shelf lease production from marginal properties. Each year, ONRR provides a list of qualifying marginal Federal oil and gas properties to States that receive a portion of Federal royalties from those properties. Each State then decides whether to participate in relief, and if so, whether to allow one or both relief options. For calendar year 2020, ONRR provides this notice of the affected States' decision regarding whether relief should be allowed and, if so, which type of relief will be allowed.

The Department of Veterans Affairs (VA), Office of Construction and Facilities Management, is seeking nominations of qualified candidates to be considered for appointment to the Advisory Committee on Structural Safety of Department Facilities (``the Committee'').

As authorized under the provisions of the Federal Land Policy and Management Act of 1976, as amended, notice is hereby given that temporary closures and temporary restrictions of activities will be in effect on public lands administered by the Lake Havasu Field Office, Bureau of Land Management (BLM), to minimize the risk of potential collisions with spectators and racers during the annual Best In The Desert (BITD) off-highway vehicle (OHV) race events, Parker 250 and Parker 425, authorized under a Special Recreation Permit (SRP).

Mercuria Energy America, LLC. (Applicant or MEA) has applied for authorization to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.

The Food and Drug Administration (FDA or Agency) is announcing the availability of three device-specific final guidance documents for the Safety and Performance Based Pathwayspecifically, ``Spinal Plating SystemsPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' ``Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff,'' and ``Magnetic Resonance (MR) Receive-only CoilPerformance Criteria for Safety and Performance Based Pathway; Guidance for Industry and Food and Drug Administration Staff.'' The device-specific guidances identified in this notice were developed in accordance with the final guidance entitled ``Safety and Performance Based Pathway.''

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement with change of a previously approved collection.

This action amends Class E surface airspace and Class E airspace extending upward from 700 feet above the surface in Dubois, PA, due to the decommissioning of the Clarion Very High Frequency Omnidirectional Range Tactical Air Navigational System (VORTAC) and cancellation of the associated instrument approach procedure at Dubois Regional Airport. This action also updates the name of the airport, as well as the name and geographic coordinates of Penn Highlands Healthcare-Dubois Heliport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.