December 4, 2020 – Federal Register Recent Federal Regulation Documents

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden related to the information reporting by passport applicants.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Requesting FDA Feedback on Combination Products.'' The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics. These interactions can occur through application-based mechanisms, such as the pre-submission process used in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) and the formal meetings used in the Center for Drug Evaluation and Research (CDER) and CBER, or through Combination Product Agreement Meetings (CPAMs), as appropriate.

The Food and Drug Administration (FDA) is announcing the revocations of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Manufacturers of Protective Barrier Enclosures and Other Stakeholders for certain protective barrier enclosures (``PBE Authorization'') and to Manufacturers of Infusion Pumps and Infusion Pump Accessories and Other Stakeholders for certain infusion pumps and infusion pump accessories (``Infusion Pump Authorization''). FDA revoked the PBE Authorization on August 20, 2020, and the Infusion Pump Authorization on September 21, 2020, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection provisions for calorie labeling of articles of food in vending machines and nutrition labeling of standard menu items in restaurants and similar retail food establishments.

As authorized by the John D. Dingell, Jr. Conservation, Management, and Recreation Act, the National Park Service announces that the Secretary of the Interior (Secretary) has established, in the State of Mississippi, Medgar and Myrlie Evers Home National Monument (National Monument) as a unit of the National Park System. This National Monument is established to preserve, protect, and interpret for the benefit of present and future generations resources associated with the pivotal roles of Medgar and Myrlie Evers in the American Civil Rights Movement.

The Food and Drug Administration (FDA or Agency) is correcting a notice entitled ``Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Amendments; Guidance for Industry; Availability'' that appeared in the Federal Register of November 25, 2020. The document announced the availability for a guidance for industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section. This document corrects that error.

This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.

The Coconino and Tonto National Forests, located in Arizona, have prepared a Comprehensive River Management Plan (CRMP) for the Fossil Creek Wild and Scenic River. Significant programmatic forest plan amendments to the Coconino and Tonto National Forests land management plans, to incorporate management direction from the CRMP have also been prepared for the Fossil Creek Wild and Scenic River. Because the project includes two separate decisions, this notice initiates two separate but concurrent pre-decisional objection filing periods. Objections to the proposed CRMP must be filed within 45 days of the publication date of this notice and objections to the proposed amendments to the land management plans must be filed withn 60 days of the publication date of this notice. The accompanying Final Environmental Impact Statement and draft Record of Decision describe the actions and analyze the effects of site specific activities associated with the CRMP and the forest plan amendments.

Notice is hereby given that the U.S. International Trade Commission has determined to grant a joint motion terminating the investigation as to Comcast Corporation, Comcast Cable Communications, LLC, Comcast Cable Communications Management, LLC, and Comcast Holdings Corporation (collectively, ``Comcast''), all of Philadelphia, Pennsylvania, based on a settlement agreement. The investigation is terminated.

The Economic Development Administration (EDA) has received petitions for certification of eligibility to apply for Trade Adjustment Assistance from the firms listed below. Accordingly, EDA has initiated investigations to determine whether increased imports into the United States of articles like or directly competitive with those produced by each of the firms contributed importantly to the total or partial separation of the firms' workers, or threat thereof, and to a decrease in sales or production of each petitioning firm.

NMFS reviewed the Alaska, Atlantic, and Pacific regional marine mammal stock assessment reports (SARs) in accordance with the Marine Mammal Protection Act (MMPA). SARs for marine mammals in the Alaska, Atlantic, and Pacific regions were revised according to new information. NMFS solicits public comments on the draft 2020 SARs. NMFS is also requesting new information for strategic stocks that were not updated in 2020.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Ely District (EYDO), Nevada, has prepared a Draft Environmental Impact Statement (EIS) for the Robinson Mine Plan of Operations Amendment project and by this notice is announcing its availability.

The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant K & L Trucking, Inc.'s (K & L) application for a limited 5-year exemption to allow the company to secure large metal coils to its trailers using a cargo securement system that differs from that required by the Federal Motor Carrier Safety Regulations (FMCSRs). The Agency has determined that granting the exemption would likely achieve a level of safety equivalent to or greater than the level of safety provided by the regulation.

We, the U.S. Fish and Wildlife Service, have received an application from six wholly owned subsidiaries of EDP Renewables North America LLC collectively known as Meadow Lake Group (applicant) for an incidental take permit (ITP) under the Endangered Species Act, for its Meadow Lake Wind Resource Area wind project. If approved, the ITP would be for a 29-year period and would authorize the incidental take of the Indiana bat and the northern long-eared bat. The applicant has prepared a habitat conservation plan (HCP) that describes the actions and measures that the applicant would implement to avoid, minimize, and mitigate incidental take of the species. We also announce the availability of a draft environmental assessment (DEA), which has been prepared in response to the permit application in accordance with the requirements of the National Environmental Policy Act. We request public comment on the application and associated documents.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of California (FEMA- 4569-DR), dated 11/25/2020. Incident: Wildfires. Incident Period: 09/04/2020 through 11/17/2020.

Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (``ID'') (Order No. 14) of the presiding administrative law judge (``ALJ'') granting a motion to intervene filed by non-party Signify North America Corp. (``Signify'').

The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. Currently, the IRS is soliciting comments concerning the burden related to the guidance under sections 897, 1445, and 6109 to require use of Taxpayer Identifying Numbers on submission under the section 897 and 1445.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a teleconference meeting of the Hawai[revaps]i Advisory Committee (Committee) to the Commission will be held from 10 a.m. to 11:30 a.m. on Wednesday, December 16, 2020 (Hawaiian Time). The purpose of the meeting will be to debrief their web hearings on COVID-19 and its impact on Pacific Islander communities.

In accordance with the National Environmental Policy Act of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM), Anchorage Field Office, Anchorage, Alaska, prepared a Proposed Resource Management Plan (RMP)/Final Environmental Impact Statement (EIS) for the Bering Sea- Western Interior region of Alaska and by this notice is announcing its availability.

In this rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by making corrections to address errors that were inadvertently introduced with the September 11, 2020, Federal Register publication of ``Wassenaar Arrangement 2018 Plenary Decisions Implementation; and Other Revisions Related to National Security Controls (Final Rule)''.

In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Humboldt River Field Office, Winnemucca, Nevada, as the lead agency, has prepared the Thacker Pass Lithium Mine Project Final Environmental Impact Statement (EIS), for the proposed Lithium Mine Project Proposed Plans of Operations and Reclamation Plan Permit Applications (the Project) in Humboldt County, Nevada, and by this notice announces the availability of the FEIS. In accordance with the Bald and Golden Eagle Protection Act (Eagle Act), the Fish and Wildlife Service (FWS) is a cooperating agency with the BLM on the development of this FEIS and has used it to analyze the potential impacts of approving LNC's request for an incidental take permit for golden eagles. FWS has evaluated the LNC's Eagle Conservation Plan (ECP), which describes their request for incidental take of eagles and a 5-year incidental take permit for golden eagles under the Eagle Act.

This proposed rule sets forth payment parameters and provisions related to the risk adjustment program; cost-sharing parameters and cost-sharing reductions; and user fees for Federally- facilitated Exchanges and State-based Exchanges on the Federal platform. It includes proposed changes related to special enrollment periods; Navigator program standards; direct enrollment entities; the administrative appeals processes with respect to health insurance issuers and non-federal governmental group health plans; the medical loss ratio program; acceptance of payments by issuers of individual market Qualified Health Plans; and other related topics. It proposes clarifications to the regulation imposing network adequacy standards with regard to Qualified Health Plans that do not use provider networks. It proposes changes to the regulation requiring the reporting of certain prescription drug information by qualified health plans or their pharmacy benefit managers. It also proposes a new direct enrollment option for Federally-facilitated Exchanges and State Exchanges. This proposed rule also proposes changes related to section 1332 State Innovation Waivers.