January 24, 2023 – Federal Register Recent Federal Regulation Documents

The Securities and Exchange Commission (``Commission'') is adopting amendments to Volumes I and II of the Electronic Data Gathering, Analysis, and Retrieval system (``EDGAR'') Filer Manual (``Filer Manual'') and related rules and forms. EDGAR Releases 22.4 and 22.4.1 will be deployed in the EDGAR system on December 19, 2022, and January 3, 2023, respectively.

The Food and Drug Administration (FDA or Agency) is publishing this notification in light of the recent decision by the U.S. Court of Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra. The Catalyst decision addressed the orphan-drug exclusivity provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Orphan Drug Act and subsequent amendments, and concluded that FDA's approval of Jacobus Pharmaceutical Company's (Jacobus's) drug (the drug at issue in the litigation) must be set aside. Consistent with the court's decision, FDA has set aside its approval of Jacobus's drug. This notification announces that, at this time, while complying with the court's order in Catalyst, FDA intends to continue to apply its regulations tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved to matters beyond the scope of that order.

The FAA is adopting a new airworthiness directive (AD) for all Gulfstream Aerospace Corporation (Gulfstream) Model GV and GV-SP airplanes. This AD was prompted by the omission of a life limit in the airworthiness limitations section (ALS) of the maintenance manual for a certain main landing gear (MLG) trunnion pin. This AD requires revising the ALS of the existing instructions for continued airworthiness (ICA) or inspection program for the airplane to establish a life limit for the affected MLG trunnion pin. The FAA is issuing this AD to address the unsafe condition on these products.

We, the U.S. Fish and Wildlife Service (Service), propose to designate critical habitat for the sickle darter (Percina williamsi) under the Endangered Species Act of 1973 (Act), as amended. In total, approximately 104 river miles (168 river kilometers) in Bledsoe, Blount, Morgan, and Roane Counties, Tennessee, and Scott, Smyth, and Washington Counties, Virginia, fall within the boundaries of the proposed critical habitat designation. If we finalize this rule as proposed, it would extend the Act's protections to this species' critical habitat. We also announce the availability of a draft economic analysis of the proposed designation of critical habitat for the sickle darter.

FMCSA announces its decision to renew exemptions for nine individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.

The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Significant New Alternatives Policy (SNAP) Program (Renewal)'' (EPA ICR No. 1596.11, OMB Control No. 2060-0226) 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 August 31, 2023. 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 Environmental Protection Agency (EPA) is proposing to approve revisions to the Iowa State Implementation Plan (SIP) and the Operating Permit Program for the State of Iowa. The revisions require the electronic submittal of air emissions reporting, construction permit applications, and Title V permit applications, and make administrative updates. These revisions do not impact the stringency of the SIP or have an adverse effect on air quality. The EPA's proposed approval of this rule revision is being done in accordance with the requirements of the Clean Air Act (CAA).

The Environmental Protection Agency (EPA) is finalizing a program to further reduce air pollution, including ozone and particulate matter (PM), from heavy-duty engines and vehicles across the United States. The final program includes new emission standards that are significantly more stringent and that cover a wider range of heavy-duty engine operating conditions compared to today's standards; further, the final program requires these more stringent emissions standards to be met for a longer period of when these engines operate on the road. Heavy-duty vehicles and engines are important contributors to concentrations of ozone and particulate matter and their resulting threat to public health, which includes premature death, respiratory illness (including childhood asthma), cardiovascular problems, and other adverse health impacts. The final rulemaking promulgates new numeric standards and changes key provisions of the existing heavy-duty emission control program, including the test procedures, regulatory useful life, emission-related warranty, and other requirements. Together, the provisions in the final rule will further reduce the air quality impacts of heavy-duty engines across a range of operating conditions and over a longer period of the operational life of heavy- duty engines. The requirements in the final rule will lower emissions of NOX and other air pollutants (PM, hydrocarbons (HC), carbon monoxide (CO), and air toxics) beginning no later than model year 2027. We are also finalizing limited amendments to the regulations that implement our air pollutant emission standards for other sectors (e.g., light-duty vehicles, marine diesel engines, locomotives, and various other types of nonroad engines, vehicles, and equipment).

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Bryn Mawr College intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice. The cultural items were removed from the Northwest Coast.

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 2022 SARs. NMFS is also requesting new information for strategic stocks that were not updated in 2022.

In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.

The NMFS will convene a peer-review of the Gulf of Mexico (GOM) Atlantis ecosystem model, in support of ecosystem-based fishery management in the Gulf of Mexico (GOM) large marine ecosystem. The purpose of the meeting is to facilitate a formal peer-review of the GOM Atlantis ecosystem model, to evaluate the model performance characteristics and to identify any appropriate EBFM applications in the southeast region that the GOM Atlantis model could be used to simulate. The external and independent peer review will be conducted by the Center for Independent Experts (CIE), which is a NOAA-supported, formal scientific peer-review process for evaluating scientific information to ensure quality and credibility. The public is invited to attend the presentations and discussions between the CIE review panel and the scientists who have participated in the development and internal, peer-review of the GOM Atlantis model.

The U.S. Nuclear Regulatory Commission (NRC) has recently submitted a request for renewal of an existing collection of information to the Office of Management and Budget (OMB) for review. The information collection is entitled, 10 CFR part 11, ``Criteria and Procedures for Determining Eligibility for Access to or Control Over Special Nuclear Material.''

The Food and Drug Administration (FDA) is announcing the renewal of the Technical Electronic Product Radiation Safety Standards Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Technical Electronic Product Radiation Safety Standards Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until December 24, 2024.

In accordance with the Federal Advisory Committee Act, the National Aeronautics and Space Administration announces a forthcoming meeting of the Aerospace Safety Advisory Panel (ASAP).

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This is a Notice of the Presidential declaration of a major disaster for the State of California (FEMA-4683-DR), dated 01/14/2023. Incident: Severe Winter Storms, Flooding, Landslides, and Mudslides. Incident Period: 12/27/2022 and continuing.