2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on a generic clearance to collect information to support communications used by FDA about drug products.

The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.

In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection. FNS seeks OMB approval for the burden associated with SNAP application forms and other document requests that are necessary to effectively administer a large population of retailers, varied in type and scope, and ensure that these retailers remain in compliance with program requirements.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology.'' Physiologic closed-loop control (PCLC) devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during emergency response and medical surge situations. This guidance provides technical considerations for PCLC technology in order to promote development and availability of safe and effective PCLC medical devices.

NMFS proposes to implement allowable catch levels, an overfishing limit, an allowable biological catch, and an annual catch limit for Pacific mackerel in the exclusive economic zone off the U.S. West Coast (California, Oregon, and Washington) for the fishing years (seasons) 2023-2024 and 2024-2025. This proposed rule is made pursuant to the Coastal Pelagic Species Fishery Management Plan. The proposed harvest guideline and annual catch target for the 2023-2024 fishing season are 7,871 metric tons (mt) and 6,871 mt, respectively. The proposed harvest guideline and annual catch target for the 2024-2025 fishing season are 8,943 mt and 7,943 mt, respectively. If the fishery attains the annual catch target in either fishing season, the directed fishery will close, reserving the 1,000-mt difference between the harvest guideline and annual catch target as a set-aside for incidental landings in other Coastal Pelagic Species fisheries and other sources of mortality. This rulemaking is intended to conserve and manage the Pacific mackerel stock off the U.S. West Coast.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).

The purpose of this Federal Register notice is to provide the public with notice that the Secretary of the Department of Veterans Affairs (VA) intends to enter an enhanced-use lease (EUL) of certain assets identified herein on the campus of the Greater Los Angeles Healthcare System-West Los Angeles (GLAHS-WLA).

Restek Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Cambridge Isotope Laboratories, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

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 updates to the currently approved information collection project: ``Medical Expenditures Panel SurveyHousehold and Medical Provider Components.'' In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

The FAA proposes to adopt a new airworthiness directive (AD) for all Rolls-Royce Deutschland Ltd & Co KG (RRD) Model Trent 1000-AE3, Trent 1000-CE3, Trent 1000-D3, Trent 1000-G3, Trent 1000-H3, Trent 1000-J3, Trent 1000-K3, Trent 1000-L3, Trent 1000-M3, Trent 1000-N3, Trent 1000-P3, Trent 1000-Q3, and Trent 1000-R3 engines. This proposed AD was prompted by a determination that certain intervals for visual inspection of the intermediate-pressure stage 8 (IP8) and high-pressure stage 3 (HP3) air transfer tubes and front bearing housing IP8 air feed tubes need to be reduced. This proposed AD would require initial and repetitive visual inspections of the IP8 and HP3 air transfer tubes and front bearing housing IP8 air feed tubes for cracking, damage, or air leakage wear, and replacement, if necessary, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). The FAA is proposing this AD to address the unsafe condition on these products.

The North Pacific Fishery Management Council (Council) Social Science Planning Team (SSPT) will meet October 18, 2023.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension of a currently approved information collection request (ICR).

The New England Fishery Management Council (Council) is scheduling a hybrid meeting of its Scallop Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The U.S. Department of Commerce (Commerce) determines that the company subject to this countervailing duty administrative review of passenger vehicle and light truck tires (PVLT tires) from the Socialist Republic of Vietnam (Vietnam) received countervailable subsidies during the period of review (POR), November 10, 2020, through December 31, 2021.

The U.S. Nuclear Regulatory Commission (NRC) is considering an application for the renewal of Facility Operating License No. NPF-58, which authorizes Energy Harbor Nuclear Corp. (Energy Harbor, the applicant), doing business as Energy Harbor Nuclear Generation LLC, to operate Perry Nuclear Power Plant (PNPP), Unit 1. The renewed license would authorize the applicant to operate PNPP for an additional 20 years beyond the period specified in the current license. The current operating license for PNPP expires on November 7, 2026.

Notice is hereby given that the Hudson River Sloop Clearwater, Incorporated (hereinafter `Clearwater') has applied in due form to renew a permit pursuant to the Endangered Species Act of 1973, as amended (ESA). The renewal permit application is for the incidental take of Atlantic sturgeon (Acipenser oxyrinchus oxyrinchus) and shortnose sturgeon (A. brevirostrum) associated with the otherwise lawful environmental education program conducted on the Hudson River, New York. The education program uses small otter trawls and beach seines to collect fish and invertebrate specimens that are held onboard the vessels for educational purposes. The duration of the proposed permit is 10 years. NMFS is providing this notice in order to allow other agencies and the public an opportunity to review and comment on the application materials. All comments received will become part of the public record and will be available for review.

The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 1 to Regulatory Issue Summary (RIS) 2014-06, ``Consideration of Current Operating Issues and Licensing Actions in License Renewal.'' Revision 1 to RIS 2014-06 provides information to the addressees on how the NRC considers current operating issues in the license renewal review under NRC regulations. This RIS is intended for all holders of operating licenses and combined licenses for nuclear power reactors, except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel. NRC regulations identify the technical information that must be submitted in a license renewal application to enable the NRC staff to make a determination that the license may be renewed. Pursuant to the regulations, an applicant is required to demonstrate that the effects of aging on the functionality of structures and components subject to an aging management review will be adequately managed; the consideration of recent operating experience is an important aspect of that demonstration. In addition, as required by NRC regulations, license renewal applicants need to update their applications with new information related to any current licensing basis changes during the NRC application review that could impact aging management of structures and components.

In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).

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 Guam Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a virtual business meeting via Zoom at 9:30 a.m. ChST on Tuesday, October 17, 2023, (7:30 p.m. ET on Monday, October 16, 2023). The purpose of this meeting is to discuss the comments received at the public forum on August 30th, 2023.