DHS Data Privacy and Integrity Advisory Committee
The DHS Data Privacy and Integrity Advisory Committee will meet on Tuesday, November 7, 2023, via virtual conference. The meeting will be open to the public.
Procurement List; Deletions
This action deletes a product from the Procurement List that was furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Agency Information Collection Activities; Proposed Collection; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
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.
Endangered and Threatened Wildlife and Plants; Establishment of a Nonessential Experimental Population of Grizzly Bear in the North Cascades Ecosystem, Washington State
We, the U.S. Fish and Wildlife Service (USFWS or Service), propose to establish a nonessential experimental population (NEP) of the grizzly bear (Ursus arctos horribilis) within the U.S. portion of the North Cascades Ecosystem (NCE) in the State of Washington under section 10(j) of the Endangered Species Act of 1973, as amended (Act or ESA). Establishment of this NEP is intended to support reintroduction and recovery of grizzly bears within the NCE and provide the prohibitions and exceptions under the Act necessary and appropriate to conserve the species within a defined NEP area. The proposed NEP area includes most of the State of Washington except for an area in northeastern Washington that encompasses the Selkirk Ecosystem Grizzly Bear Recovery Zone. The best available data indicate that reintroduction of the grizzly bear to the NCE, within the NEP area, is biologically feasible and will promote the conservation of the species. We are seeking comments on this proposed section 10(j) rule.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Formaldehyde Standard
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.
Efforts by Certain Foreign Countries To Eliminate the Worst Forms of Child Labor; Identify Child Labor, Forced Labor, and Forced or Indentured Child Labor in the Production of Goods in Foreign Countries; and Share Business Practices To Reduce the Likelihood of Forced Labor or Child Labor in the Production of Goods
This notice is a request for information and/or comment on three reports issued by the Bureau of International Labor Affairs (ILAB) regarding child labor and forced labor in certain foreign countries. Relevant information submitted by the public will be used by the Department of Labor (DOL) in preparing its ongoing reporting as required under Congressional mandates and a Presidential directive.
Agency Information Collection Activities: Supplemental Nutrition Assistance Program (SNAP) Retailer Applications
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.
Technical Considerations for Medical Devices With Physiologic Closed-Loop Control Technology; Guidance for Industry and Food and Drug Administration Staff; Availability
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.
Advisory Committee on Supply Chain Competitiveness: Notice of Public Meeting
This notice sets forth the schedule and proposed topics of discussion for the upcoming public meeting of the Advisory Committee on Supply Chain Competitiveness (Committee).
Fisheries Off West Coast States; Coastal Pelagic Species Fisheries; Biennial Specifications; 2023-2024 and 2024-2025 Specifications for Pacific Mackerel
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.
Application for Authorization To Export Electric Energy; CWP Energy, Inc.
CWP Energy, Inc. (the Applicant or CWP Energy) has applied for authorization to transmit electric energy from the United States to Mexico pursuant to the Federal Power Act.
Antimicrobial Susceptibility Test System Devices-Updating Breakpoints in Device Labeling; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Antimicrobial Susceptibility Test (AST) System DevicesUpdating Breakpoints in Device Labeling.'' This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria website (STIC website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.
Enhanced-Use Lease of U.S. Department of Veterans Affairs Real Property for the Development of Permanent Supportive Housing at the Greater Los Angeles Healthcare System, West Los Angeles, California Campus
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).
Electronic Submission Template for Medical Device De Novo Requests; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Electronic Submission Template for Medical Device De Novo Requests.'' FDA is issuing this draft guidance to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This draft guidance, when finalized, is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guidance submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process. This draft guidance is not final nor is it for implementation at this time.
Importer of Controlled Substances Application: Restek Corporation
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.
Importer of Controlled Substances Application: Curia Wisconsin, Inc.
Curia Wisconsin, 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.
Importer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc.
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.
Bulk Manufacturer of Controlled Substances Application: Restek Corporation
Restek Corporation has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.
Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG Engines
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.
Pacific Fishery Management Council; Public Meetings
The Pacific Fishery Management Council (Pacific Council) and its advisory bodies will meet November 1-8, 2023 in Garden Grove, California and via webinar. The Council meeting will be live streamed with the opportunity to provide public comment remotely.
North Pacific Fishery Management Council; Public Meeting
The North Pacific Fishery Management Council (Council) Social Science Planning Team (SSPT) will meet October 18, 2023.
New Postal Products
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meetings
The South Atlantic Fishery Management Council (Council) will hold a joint meeting of its Citizen Science Operations Committee and Citizen Science Projects Advisory Committee via webinar October 27, 2023.
New England Fishery Management Council; Public Meeting
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.
New England Fishery Management Council; Public Meeting
The New England Fishery Management Council (Council) is scheduling a hybrid meeting of its Scallop Advisory Panel 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.
Sam Rayburn Dam Rate Schedule
The Administrator, Southwestern Power Administration (Southwestern), has approved and placed into effect Rate Order No. SWPA-82, which provides a temporary extension of Southwestern's current Sam Rayburn Dam rate schedule (SRD-15) through September 30, 2024, unless superseded.
Passenger Vehicle and Light Truck Tires From the Socialist Republic of Vietnam: Final Results of Countervailing Duty Administrative Review; 2020-2021
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.
Integrated System Rate Schedules
The Administrator, Southwestern Power Administration (Southwestern), has approved and placed into effect Rate Order No. SWPA-81, which provides a temporary extension of Southwestern's current Integrated System rate schedules (P-13B, NFTS-13A, and EE-13) through September 30, 2024, unless superseded.
Energy Harbor Corp.; Energy Harbor Generation LLC; Energy Harbor Nuclear Corp.; Perry Nuclear Power Plant, Unit 1
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.
Miscellaneous and General Requirements
The Federal Labor Relations Authority (FLRA) is proposing to amend its regulations to specify that, if parties wish to file documents with the FLRA's Office of Case Intake and Publication (CIP) in person, then they must schedule an appointment at least one business day in advance. The proposed amendments also specify that electronically filed (eFiled) documents must be filed by ``11:59 p.m.,'' rather than ``midnight,'' on the due date, and make other minor technical and formatting changes.
Endangered Species; File No. 27686
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recalls
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.
Recommencement in Reporting Requirements for the Federal Cigarette Labeling and Advertising Act (FCLAA) and Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
On April 27, 2020, the Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), published a notice in the Federal Register announcing an extension of the deadline for annual reporting of data submitted for cigarettes and smokeless tobacco products, respectively, under the Federal Cigarette Labeling and Advertising Act (FCLAA) and the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA). CDC announced this extension due to the public health response to the COVID-19 pandemic. CDC has since re-evaluated this extension and determined that data submissions can recommence. Required ingredient reports and nicotine analysis reports must be submitted to CDC on or before March 31, 2024.
Consideration of Current Operating Issues and Licensing Actions in License Renewal
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.
Safety Zone; La Quinta and Corpus Christi Shipping Channel, Ingleside, TX
The Coast Guard is establishing a temporary, moving safety zone for all navigable waters of the La Quinta and Corpus Christi Shipping Channel between gated pair lights 11 and 12 to the sea buoy. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards arising from the towing of the rig NFE PIONEER II. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Sector Corpus Christi, or a designated representative.