February 13, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development.'' This guidance is intended to provide a framework for considering whether and what type of long-term neurologic, sensory, and/or developmental evaluations could be useful in supporting a determination of safety of a regulated product for use in neonates, and which domains of assessment may be most pertinent. Although short-term safety evaluations may be acceptable for adults or other populations, such short-term evaluations may not identify important adverse events in the neonatal population, as latent effects may follow early-life exposures and drug treatment during the neonatal period coincides with a time of critical growth and physiologic development. Consideration of these potential long-term neurologic, sensory, and development effects in the neonatal population early in a drug development program will help ensure a safer product.

In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico, notification is hereby given that a Letter of Authorization (LOA) has been issued to Shell Offshore Inc. (Shell) for the take of marine mammals incidental to geophysical survey activity in the Gulf of Mexico.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 2 of Regulatory Guide (RG) 1.156, ``Qualification of Connection Assemblies for Production and Utilization Facilities.'' This revised guide was updated to endorse ``Institute of Electrical and Electronics Engineers'' Std. 572-2019 to provide the latest technical information on approaches to satisfy the qualification requirements for connection assemblies. This includes guidance that when used in conjunction with the guidance in RG 1.89, ``Environmental Qualification of Certain Electric Equipment Important to Safety for Nuclear Power Plants,'' provides an acceptable method of demonstrating compliance with the NRC regulations pertaining to the environmental qualification of connectors, terminations, and environmental seals in combination with cables or wires as assemblies for service in production and utilization facilities to ensure that the connection assemblies can perform their safety functions. Further, the revised guide modifies the title of the RG to include other nuclear facilities, as discussed in the RG Section A, under Applicability.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection OMB 1140-0110 (Initial Suitability RequestATF 3252.4) is being revised due to minor material changes to the form, such as conversion of data fields from narrative format to question format.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Guide (RG) 5.71, ``Cyber Security Programs for Nuclear Power Reactors.'' Revision 1 incorporates references to industry guidance on identifying and protecting critical digital assets for safety-related, important to safety, balance of plant, and emergency preparedness equipment. It also clarifies guidance on defense-in-depth for cyber security and includes updated text based on the latest National Institute of Standards and Technology (NIST) and International Atomic Energy Agency (IAEA) cyber security guidance. Specifically, this revision clarifies issues identified from cyber security inspections, insights gained through the Security Frequently Asked Questions (SFAQ) process, documented cyber security attacks, new technologies, and new regulations. This revision also considers the changes in the most recent revision to the NIST Special Publications (SP) 800-53, upon which Revision 0 of Regulatory Guide (RG) 5.71, ``Cyber Security Programs for Nuclear Facilities'' was based.

The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics (BJS), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Department of Justice (DOJ), Justice Management Division, Office of Attorney Recruitment and Management (OARM), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Compact Wallets and Components Thereof, DN 3668; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS) announces the renewal of the charter of the Healthcare Infection Control Practices Advisory Committee (HICPAC).

In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person listed in the addresses section below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

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 that the Pennsylvania Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a Zoom meeting on Friday February 24, 2023 from 12:00 p.m.-1:00 p.m. Eastern time. The purpose of the meeting is for the Committee to discuss a partial draft of its upcoming report on fair housing.

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, that the Virginia Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a series of business meetings via web conference. The purpose of the meetings is to review, discuss, and revise the draft report on police oversight and accountability in Virginia.

This document provides the public with notice that, on February 3, 2023, Union Pacific Railroad (UP) submitted a request for amendment (RFA) to its FRA-approved Positive Train Control Safety Plan (PTCSP). FRA is publishing this notice and inviting public comment on the railroad's RFA to its PTCSP.

The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. OFAC is also publishing the names of one or more persons that have been removed from the SDN List.

The Department of Health and Human Services (HHS or ``the Department'') is issuing this supplemental notice of proposed rulemaking (SNPRM) to solicit public comment on its proposal to remove provisions authorized under the Controlled Substances Act (CSA), as amended by the Drug Addiction Treatment Act of 2000 (DATA-2000). These changes are as a result of amendments made in the Consolidated Appropriations Act, 2023, which was enacted on December 29, 2022. Among other things, section 1262(a)(1) of this Act amended the CSA by eliminating the requirement that practitioners obtain a waiver to prescribe certain schedule III-V medications for the treatment of opioid use disorder (OUD).