August 2022 – Federal Register Recent Federal Regulation Documents

The U.S. Nuclear Regulatory Commission (NRC) is issuing an environmental assessment (EA) prepared under the National Environmental Policy Act of 1969 (NEPA) and NRC's regulations. This EA summarizes the results of the NRC staff's environmental review, which evaluates the potential environmental impacts of granting exemptions from NRC regulations and issuing an associated license amendment in response to a request from the Union Electric Company, doing business as (dba) Ameren Missouri (Ameren, the licensee) for Renewed Facility Operating License NPF-30, for the Callaway Plant, Unit No. 1 (Callaway). Specifically, the licensee is seeking a license amendment and regulatory exemptions that would, if granted, allow the licensee to use both a deterministic and risk-informed approach to address safety issues discussed in Generic Safety Issue (GSI)-191, ``Assessment of Debris Accumulation in PWR [Pressurized Water Reactor] Sump Pump Performance'' and to close Generic Letter (GL) 2004-02, ``Potential Impact of Debris Blockage on Emergency Recirculation During Design Basis Accidents at Pressurized-Water Reactors.'' The NRC staff is issuing a final EA and finding of no significant impact (FONSI) associated with the proposed exemptions.

We, the U.S. Fish and Wildlife Service, have received three separate applications for incidental take permits (ITPs) under the Endangered Species Act from the Michigan Department of Natural Resources (DNR), Minnesota DNR, and Wisconsin DNR. If approved, the permits would authorize incidental take of the Indiana bat, northern long-eared bat, little brown bat, and tricolored bat. The applicants also have jointly submitted the Lake States Forest Management Bat Habitat Conservation Plan (HCP). We make available for public comment the applicants' HCP and announce the availability of a draft environmental assessment, which has been prepared in response to the permit applications in accordance with the requirements of the National Environmental Policy Act. We invite the public and local, State, Tribal, and Federal agencies to comment on these documents.

Notice is hereby given that Ann Zoidis, Cetos Research Organization 51 Kebo Ridge Road, Bar Harbor, ME 04609, has applied in due form for a permit to conduct research on marine mammals.

In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below will be submitted to the Office of Management and Budget (OMB) for review and approval. The ICR describes a new information collection to survey a national sample of law enforcement and its expected burden. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on March 29, 2022. NHTSA received two comments. As explained in this document, neither of the comments necessitates revisions to the information collection or burden estimates.

The U.S. Department of Transportation (DOT or the Department) is issuing a guidance document to inform the public and regulated entities about DOT's interpretation of the terms unfair, deceptive, and practices as it relates to its statutory authority to prohibit unfair or deceptive practices. The Department is taking this action to better define the terms unfair and deceptive in response to an Executive order issued by President Biden on July 9, 2021, on promoting competition in the American economy.

This action establishes United States Area Navigation (RNAV) route T-382 in the vicinity of Hooper Bay, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Measure Dx: A Resource to Identify, Analyze, and Learn from Diagnostic Safety Events.'' This proposed information collection was previously published in the Federal Register on June 15, 2022 and allowed 60 days for public comment. AHRQ did not receive substantive comments from members of the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.

AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. Additional information about the Common Formats can be obtained through AHRQ's PSO website at https://pso.ahrq.gov/common-formats and the PSO Privacy Protection Center's website at https://www.psoppc.org/psoppc_web/ publicpages/commonFormatsOverview. The purpose of this notice is to announce a meeting to discuss implementation of the Common Formats with software developers and other interested parties. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ's technical specifications and implemented, or plan to implement, the Common Formats electronically.

This action proposes to amend five VHF Omnidirectional Range (VOR) Federal airways, and remove five VOR Federal airways. This action supports the FAA's VOR Minimum Operational Network (MON) program.

Notice is hereby given that NMFS has received one permit application submitted by FISHBIO Environmental, LLC. (FISHBIO) to enhance the propagation and survival of species listed under the Endangered Species Act (ESA) of 1973, as amended, for a 5 year period. This document serves to notify the public of the availability of the renewal permit application for review and comment, prior to a decision by NMFS whether to issue the permit application may be viewed online at: https://apps.nmfs.noaa.gov/preview/preview_open_for_comment.c fm.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``Modigliani Up Close'' at The Barnes Foundation, Philadelphia, Pennsylvania, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ZYNTEGLO (betibeglogene autotemcel), manufactured by bluebird bio, Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E11A Pediatric Extrapolation.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development. The draft guidance also discusses study designs and statistical methodologies, including modeling and simulation, that can be utilized to develop and implement a pediatric extrapolation approach. The draft guidance is intended to provide recommendations for the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic PotentialQuestions and Answers.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance contains revised questions and answers (Q&As) for the ICH guidance for industry ``E14 Clinical Evaluation of the QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs'' and new Q&As for the ICH guidance for industry ``S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals'' that provide recommendations on considerations for an integrated risk assessment combining nonclinical and clinical datain particular, at later stages of drug development when clinical data are available. The guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making. This guidance finalizes the draft guidance of the same title issued in September 2020.

The Coast Guard is establishing a safety zone near Ship Rock, Catalina Island, in support of the Ocean Cup Pacific Rum Run. This action is necessary to protect the area near Ship Rock, Catalina Island, public vessels, and the high-speed vessels participating in the event. This regulation would prohibit vessels from entering into, transiting through, or remaining within the designated area during the enforcement period unless specifically authorized by the Captain of the Port, Los AngelesLong Beach, or his designated representative.

The Commission publishes in the Federal Register any settlement that it provisionally accepts under the Consumer Product Safety Act. Published below is a provisionally accepted Settlement Agreement with Segway Powersports, Inc., containing a civil penalty in the amount of $5 million, with all but $1.25 million suspended, subject to the terms and conditions of the Settlement Agreement.

This document grants in full the General Motors, LLC's (GM) petition for exemption from the Federal Motor Vehicle Theft Prevention Standard (theft prevention standard) for its Buick Envision line beginning in model year (MY) 2023. The petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of the theft prevention standard.

The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft regulatory guide (DG), DG-1401, ``Maintenance, Testing, and Replacement of Vented Lead Acid Storage Batteries for Production and Utilization Facilities''. This DG is the proposed Revision 4 to Regulatory Guide (RG) 1.129. RG 1.129 describes methods that are acceptable to the NRC staff pertaining to the maintenance, testing, and replacement of vented lead acid storage batteries in production and utilization facilities.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition ``Edward Hopper's New York'' at the Whitney Museum of American Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the Federal Register.

Notice is hereby given that NOAA is establishing a national marine sanctuary advisory council for the Wisconsin Shipwreck Coast National Marine Sanctuary, which was designated on August 16, 2021. The council will provide advice and recommendations to ONMS regarding the sanctuary management plan and will serve as liaisons between the sanctuary and constituents and community groups. ONMS is adding the new council to the list of established national marine sanctuary advisory councils. ONMS solicits applications to fill council seats on an as needed basis and is seeking applicants for seats on the Wisconsin Shipwreck Coast National Marine Sanctuary Advisory Council. This notice contains web page links and contact information for the Wisconsin Shipwreck Coast National Marine Sanctuary and application materials to apply for the newly established advisory council.

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 interagency Trade Policy Staff Committee (TPSC) invites interested persons to submit written comments to assist the Office of the United States Trade Representative (USTR) in the preparation of its annual report to the Congress on China's compliance with the commitments made in connection with its accession to the World Trade Organization (WTO). Due to the COVID-19 situation, the TPSC will foster public participation via written questions and written responses relating to the written comments received by the TPSC rather than an in-person hearing. This notice includes the schedule for submission of comments, questions and responses.

These amended special conditions are issued for the Airbus Model A330-243 series airplane, as modified by TC Inter-Informatics A.S. (TC Inter-Informatics). 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 single-occupant, oblique, B/E Aerospace Super Diamond seats, equipped with inflatable lap belts. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These 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.

In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection FERC-577 (Natural Gas Facilities: Environmental Review and Compliance).