December 23, 2020 – Federal Register Recent Federal Regulation Documents

This final rule implements an Executive Order requiring entities funded under section 330(e) of the Public Health Service Act (PHS Act or the Act), whether by receiving a federal award or a subaward, and that also participate in the 340B Drug Pricing Program (340B Program) must establish practices to provide access to insulin and injectable epinephrine to low-income health center patients at the price the health center purchased these two drugs through the 340B Program. The Executive Order supports the improved access to these life-saving medications by low-income individuals who do not have access to affordable insulin and injectable epinephrine due to either lack of insurance or high cost sharing requirements.

This document denies the request to extend the comment period on the U.S. Department of Transportation (DOT) notice of proposed rulemaking (NPRM) on Procedures for Considering Environmental Impacts. This NPRM contains the Department's procedures implementing the National Environmental Policy Act and outlines the Department's internal policies and procedures for environmental reviews of DOT's actions. The NPRM was published in the Federal Register on November 23, 2020.

On July 9, 2020, DHS and DOJ (collectively, ``the Departments'') published a notice of proposed rulemaking (``NPRM'') clarifying that the danger to the security of the United States statutory bar to eligibility for asylum and withholding of removal may encompass emergency public health concerns. This final rule responds to comments received in response to the NPRM and reflects (and in some instances, modifies) intervening changes made to the regulatory framework by Procedures for Asylum and Withholding of Removal; Credible Fear and Reasonable Fear Review, published December 11, 2020 (``Global Asylum Final Rule''). Namely, it amends existing regulations to clarify that in certain circumstances there are ``reasonable grounds for regarding [an] alien as a danger to the security of the United States'' or ``reasonable grounds to believe that [an] alien is a danger to the security of the United States'' based on emergency public health concerns generated by a communicable disease, making the alien ineligible to be granted asylum in the United States under section 208 of the Immigration and Nationality Act (``INA'') or the protection of withholding of removal under the INA (``statutory withholding of removal'') or subsequent regulations (because of the threat of torture). The final rule further allows DHS to exercise its prosecutorial discretion regarding how to process individuals subject to expedited removal who are determined to be ineligible for asylum and withholding of removal in the United States because they are subject to the danger to the security of the United States. Finally, the rule modifies the process in expedited removal proceedings for screening aliens for potential eligibility for deferral of removal (who are ineligible for withholding of removal as subject to the danger to the security of the United States bar).

The Bureau of Consumer Financial Protection (Bureau) is issuing this final rule amending an appendix for Regulation V, which implements the Fair Credit Reporting Act (FCRA). The Bureau is required to calculate annually the dollar amount of the maximum allowable charge for disclosures by a consumer reporting agency to a consumer pursuant to FCRA section 609; this final rule establishes the maximum allowable charge for the 2021 calendar year.

The FAA is adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-100-1A10 airplanes. This AD was prompted by a report that corrosion was found on the shock strut cylinders during unscheduled maintenance of the nose landing gear (NLG). This AD requires a modification of the NLG shock strut cylinder. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA is adopting a new airworthiness directive (AD) for certain Airbus SAS Model A300 F4-605R airplanes and Model A310-324 airplanes. This AD was prompted by a report that certain emergency locator transmitter (ELT) lithium batteries lack protection against current injection. This AD requires modification of the airplane circuit connecting the ELT battery, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.

NMFS is adjusting the 2021 total allowable catch (TAC) amounts for the Gulf of Alaska (GOA) pollock and Pacific cod fishery. This action is necessary because NMFS has determined these TACs are incorrectly specified, and will ensure the GOA pollock and Pacific cod TACs are the appropriate amount based on the best available scientific information for pollock and Pacific cod in the GOA. This action is consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.

NMFS is transferring 19.5 metric tons (mt) of Atlantic bluefin tuna (BFT) from the 28.9-mt General category December 2021 subquota to the January through March 2021 subquota period. This action is based on consideration of the regulatory determination criteria regarding inseason adjustments and applies to Atlantic tunas General category (commercial) permitted vessels and Atlantic Highly Migratory Species (HMS) Charter/Headboat category vessels with a commercial sale endorsement when fishing commercially for BFT.

This action amends the Class E airspace extending upward from 700 feet above the surface at Warroad International Memorial Airport, Warroad, MN. This action is the result of an airspace review caused by the decommissioning of the Baudette VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program. The name and geographic coordinates of the airport are also being updated to coincide with the FAA's aeronautical database.

In this final rule, the U.S. Department of Commerce (Commerce) adopts the Aluminum Import Monitoring and Analysis (AIM) system by promulgating new regulations that establish a website for the AIM system that consists of an online aluminum import license application platform and public AIM monitor; require importers, customs brokers or their agents to apply for and obtain an import license for each entry of certain aluminum products into the United States through the AIM system website; require license applicants to identify, among other requirements, the country or countries where the largest and the second largest volume of primary aluminum used in the manufacture of the imported aluminum product was smelted (subject to certain exceptions) and the country where the aluminum product was most recently cast; allow for the public release of certain import license data on an aggregate basis, as appropriate, on the public AIM monitor; and apply the license requirement to all imports of basic aluminum products. Further, Commerce is adopting the aluminum import license application form in accordance with the Paperwork Reduction Act (PRA). Lastly, Commerce is notifying parties that, after the AIM system is in place, Commerce will seek additional comment from parties on potential improvements or changes to the system in a subsequent notice.

This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.

The Board and the FDIC (collectively, the Agencies) are amending their Community Reinvestment Act (CRA) regulations to adjust the asset-size thresholds used to define ``small bank'' and ``intermediate small bank.'' As required by the CRA regulations, the adjustment to the threshold amount is based on the annual percentage change in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W).

In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) by adding a new `Military End User' (MEU) List that includes the first tranche of entities. The U.S. Government has determined that these entities are `military end users' for purposes of the `military end user' control in the EAR that applies to specified items for exports, reexports, or transfers (in-country) to the People's Republic of China (China), Russia, and Venezuela when such items are destined for a `military end user.' The existing `military end-use' and `military end user' controls under the EAR, including BIS's authority to inform the public of a license requirement for an item due to an unacceptable risk of diversion to a `military end user' via amendment to the EAR, are essential for protecting U.S. national security interests. The addition of the new MEU List via amendment to the EAR and this first tranche of entities is also responsive to requests received from the public. This final rule will add one hundred and two `military end users' to the MEU List consisting of fifty-seven under China and forty-five under Russia. However, the establishment of the MEU List does not imply that other parties, not included on the list, are not subject to the `military end-use' and `military end user' controls under the EAR.

This rule establishes processes that the Environmental Protection Agency (EPA) will be required to undertake in promulgating regulations under the Clean Air Act (CAA) to ensure that information regarding the benefits and costs of regulatory decisions is provided and considered in a consistent and transparent manner. The EPA is establishing procedural requirements governing the preparation, development, presentation, and consideration of benefit-cost analyses (BCA), including risk assessments used in the BCA, for significant rulemakings conducted under the CAA. Together, these requirements will help ensure that the EPA implements its statutory obligations under the CAA, and describes its work in implementing those obligations, in a way that is consistent and transparent.

The Environmental Protection Agency (EPA) is promulgating this final rule to adjust the level of the maximum (and minimum) statutory civil monetary penalty amounts under the statutes the EPA administers. This action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (``the 2015 Act''). The 2015 Act prescribes a formula for annually adjusting the statutory maximum (and minimum) amount of civil monetary penalties to reflect inflation, maintain the deterrent effect of statutory civil monetary penalties, and promote compliance with the law. The rule does not establish specific civil monetary penalty amounts the EPA may seek in particular cases, as appropriate given the facts of particular cases and applicable agency penalty policies. The EPA's civil penalty policies, which guide enforcement personnel on how to exercise the EPA's discretion within statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator's good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and a violator's ability to pay.