October 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (Renewal)'' (EPA ICR No. 2260.05, OMB Control No. 2090-0029) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through June 30, 2021. An Agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The U.S. Department of Energy (DOE) received a petition from the Competitive Enterprise Institute (CEI) to define a new product class under the Energy Policy and Conservation Act, as amended (EPCA), for standard residential dishwashers with a cycle time for the normal cycle of less than one hour from washing through drying. Based upon its evaluation of the petition and careful consideration of the public comments, DOE granted CEI's petition and proposed a dishwasher product class with a cycle time for the normal cycle of less than one hour. In this final rule, DOE establishes a new product class for standard residential dishwashers with a cycle time for the normal cycle of one hour (60 minutes) or less from washing through drying. DOE's decision to establish the new product class is based on its evaluation of CEI's petition, the comments the Department received in response to the petition and the proposed rule to establish the new product class, as well as additional testing and evaluation conducted by the Department. This rulemaking only sets out the basis for the new product class. DOE intends to determine the specific energy and water consumption limits for the product class in a separate rulemaking.

The National Institutes of Health (NIH) is issuing this final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This Policy establishes the requirements of submission of Data Management and Sharing Plans (hereinafter Plans) and compliance with NIH Institute, Center, or Office (ICO)-approved Plans. It also emphasizes the importance of good data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. This Policy applies to research funded or conducted by NIH that results in the generation of scientific data.

This notice announces actions taken by the FHWA that are final. The actions required by applicable Federal environmental laws relate to a proposed highway project, the South Bridge Connector, in Brown County, Wisconsin. Those actions grant approvals for the project.

The Federal Aviation Administration (FAA) announces its findings on the noise compatibility program submitted by the City of Burlington, Vermont under the provisions of Title I of the Aviation Safety and Noise Abatement Act of 1979. These findings are made in recognition of the description of federal and non-federal responsibilities in Senate Report No. 96-52 (1980). On October 14, 2020, the Airports Division Deputy Director approved the Burlington International Airport noise compatibility program. This supersedes the approval issued August 27, 2020. All of the proposed program elements were approved.

This proposed action is taken in response to the United States Court of Appeals for the District of Columbia Circuit's (D.C. Circuit) remand of the Cross-State Air Pollution Rule (CSAPR) Update in Wisconsin v. EPA on September 13, 2019. The CSAPR Update finalized Federal Implementation Plans (FIPs) for 22 states to address their interstate pollution-transport obligations under the Clean Air Act (CAA) for the 2008 ozone National Ambient Air Quality Standards (NAAQS). The D.C. Circuit found that the CSAPR Update, which was published on October 26, 2016, as a partial remedy to address upwind states' obligations prior to the 2018 Moderate area attainment date under the 2008 ozone NAAQS, was unlawful to the extent it allowed those states to continue their significant contributions to downwind ozone problems beyond the statutory dates by which downwind states must demonstrate their attainment of the air quality standards. On the same grounds, the D.C. Circuit also vacated the CSAPR Close-Out in New York v. EPA on October 1, 2019. This proposed rule, if finalized, will resolve 21 states' outstanding interstate ozone transport obligations with respect to the 2008 ozone NAAQS. The U.S. Environmental Protection Agency (EPA) is taking this action under the Clean Air Act section known as the ``good neighbor provision.'' This action proposes to find that for 9 of the 21 states for which the CSAPR Update was found to be only a partial remedy (Alabama, Arkansas, Iowa, Kansas, Mississippi, Missouri, Oklahoma, Texas, and Wisconsin), their projected nitrogen oxides (NOX) emissions in the 2021 ozone season and thereafter do not significantly contribute to a continuing downwind nonattainment and/or maintenance problem, and therefore the states' CSAPR Update FIPs (or the SIPs subsequently approved to replace certain states' CSAPR Update FIPs) fully address their interstate ozone transport obligations with respect to the 2008 ozone NAAQS. This action also proposes to find that for the 12 remaining states (Illinois, Indiana, Kentucky, Louisiana, Maryland, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and West Virginia), their projected 2021 ozone season NOX emissions significantly contribute to downwind states' nonattainment and/or maintenance problems for the 2008 ozone NAAQS. EPA proposes to issue new or amended FIPs for these 12 states to replace their existing CSAPR NOX Ozone Season Group 2 emissions budgets for electricity generating units (EGUs) with revised budgets via a new CSAPR NOX Ozone Season Group 3 Trading Program. EPA is proposing to require implementation of the revised emission budgets beginning with the 2021 ozone season (which runs annually from May 1-September 30). Based on EPA's assessment of remaining air quality issues and additional emission control strategies for EGUs and other emissions sources in other industry sectors (non-EGUs), EPA further proposes that the proposed NOX emission reductions fully eliminate these states' significant contributions to downwind air quality problems for the 2008 ozone NAAQS. EPA also proposes in this action an error correction for its June 2018 approval of Kentucky's good neighbor SIP.

This action proposes special conditions for The Boeing Company (Boeing) Model 787 series airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is pretensioner restraint systems installed on passenger seats. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

On August 7, 2020, the U.S. Food and Drug Administration approved a new drug application for oliceridine, chemically known as N- [(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time} )amine fumarate. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oliceridine in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing oliceridine, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule II of the CSA.

The Pipeline and Hazardous Materials Safety Administration (PHMSA) is amending the requirements of the requalification periods for certain Department of Transportation (DOT) 4-series specification cylinders in non-corrosive gas service in response to a petition for rulemaking submitted by the National Propane Gas Association (NPGA).

Notice is hereby given that the NAETC will meet for two days, virtually.

This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.

NMFS is prohibiting directed fishing for pollock in Statistical Area 620 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the D season allowance of the 2020 total allowable catch of pollock for Statistical Area 620 in the GOA.

The National Park Service is soliciting electronic comments on the significance of properties nominated before October 17, 2020, for listing or related actions in the National Register of Historic Places.

The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice (Notice) of receipt of an application (Application), filed on October 19, 2020, by Driftwood LNG LLC (Driftwood). Driftwood seeks to amend the export term set forth in its current authorization to export liquefied natural gas (LNG) to non-free trade agreement countries, DOE/FE Order No. 4373, to a term ending on December 31, 2050. Driftwood filed the Application under the Natural Gas Act (NGA) and DOE's policy statement entitled, ``Extending Natural Gas Export Authorizations to Non-Free Trade Agreement Countries Through the Year 2050'' (Policy Statement). Protests, motions to intervene, notices of intervention, and written comments on the requested term extension are invited.