The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for QUVIVIQ and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

On Friday, September 13, 2024, the Human Resources and Administration/Operations, Security, and Preparedness, Department of Veterans Affairs (VA), published a notice in the Federal Register announcing an opportunity for public comment on the proposed collection Human Resources and Administration/Operations, Security, and Preparedness (VA Form 0730b). This notice was published in error; therefore, this document corrects that error by withdrawing this FR notice.

Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibition "The Arts of Korea" at The Art Institute of Chicago, in Chicago, Illinois; 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, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a virtual business meeting of the Arizona Advisory Committee (Committee) to the U.S. Commission on Civil Rights will convene via ZoomGov on Monday, October 21, 2024, from 12:30 p.m.2 p.m. Arizona time. The purpose of the meeting is to review drafts of their report examining the racial and/or ethnic disparities in access to pediatric health care.

The U.S. Department of Commerce (Commerce) preliminarily determines that melamine from Qatar is not being, or is not likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2023, through December 31, 2023. Interested parties are invited to comment on this preliminary determination.

The U.S. Department of Commerce (Commerce) preliminarily determines that melamine from Japan is being, or is likely to be, sold in the United States at less than fair value (LTFV). The period of investigation (POI) is January 1, 2023, through December 31, 2023. Interested parties are invited to comment on this preliminary determination.

The Food and Drug Administration (FDA) is withdrawing approval of four new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for the identified NDAs.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Advancing Smoking Cessation: FDA and NIH Priorities." Jointly convened by FDA and the National Institutes of Health (NIH), this public meeting will address the need for novel smoking cessation products to help individuals of all ages, including underserved and vulnerable populations, stop smoking. The overall goal of the meeting is to stimulate novel product development to reduce rates of smoking and related chronic illnesses. The meeting format will include presentations and panel discussions.

The Food and Drug Administration (FDA, 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 Food and Drug Administration (FDA or Agency) is announcing year three of the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP). This program facilitates the expedited CMC development of products under an investigational new drug application (IND) based on the anticipated clinical benefit of earlier patient access to the products. FDA has implemented this pilot program to assist with CMC readiness for products regulated by both the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) that have accelerated clinical development timelines. To accelerate CMC development and facilitate CMC readiness, the pilot features increased communication between FDA and sponsors and explores the use of science- and risk-based regulatory approaches, as applicable. This notice outlines the eligibility criteria and process for submitting a request to participate in the pilot.

In accordance with the Privacy Act of 1974, the Office of the Secretary of Defense (OSD) is modifying a current system of records titled, Defense Civilian Human Resource Management System (DCHRMS), DHRA 23 DoD. The records within this system are used to provide human resource information and system support for the DoD civilian workforce worldwide that manages the HR processing and reporting, including position, compensation and benefits, and performance management, as well as create efficiencies in Human Capital Management. This system of records notice (SORN) is being updated to cover compensation records and administrative appeals relating to claims filed under the Helping American Victims Afflicted by Neurological Attacks Act (HAVANA). This SORN modification expands the Category of Individuals section to cover current and former DoD employees, and dependents of current or former employees who on or after January 1, 2016, experienced a qualifying brain injury. Additionally, the DoD is modifying the Routine Use section to allow additional sharing outside of DoD. Lastly, the DoD is also modifying various other sections within the SORN to improve clarity or update information that has changed.

The Environmental Protection Agency (EPA) is requesting comment on an application from Jaguar Land Rover North America, LLC ("JLR") for off-cycle carbon dioxide (CO2) credits under EPA's light-duty vehicle greenhouse gas emissions standards. "Off- cycle" emission reductions can be achieved by employing technologies that result in real-world benefits, but where that benefit is not adequately captured on the test procedures used by manufacturers to demonstrate compliance with emission standards. EPA's light-duty vehicle greenhouse gas program acknowledges these benefits by giving automobile manufacturers several options for generating "off-cycle" CO2 credits. Under the regulations, a manufacturer may apply for CO2 credits for off-cycle technologies that result in off-cycle benefits. In these cases, a manufacturer must provide EPA with a proposed methodology for determining the real-world off-cycle benefit. JLR submitted their application describing a methodology for determining off-cycle credits from the technology described in their application. Pursuant to applicable regulations, EPA is making this off-cycle credit calculation methodology available for public comment.

In compliance with the Paperwork Reduction Act (PRA), this document announces the availability of and solicits public comment on the following Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): "Pesticide Environmental Stewardship Program Annual Measures Reporting," identified by EPA ICR No. 2415.05 and OMB Control No. 2070-0188. This ICR represents a renewal of an existing ICR that is currently approved through July 31, 2025. Before submitting the ICR to OMB for review and approval under the PRA, EPA is soliciting comments on specific aspects of the information collection that is summarized in this document. The ICR and accompanying material are available in the docket for public review and comment.

Winnebago Industries, Inc., (Winnebago or petitioner), has determined that certain model year (MY) 2013-2023 Winnebago motorhomes do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 108, Lamps, Reflective Devices, and Associated Equipment. Winnebago filed a noncompliance report dated November 11, 2022, and amended the report on December 2, 2022, and May 17, 2023. Winnebago petitioned NHTSA on December 2, 2022, and amended the petition on May 17, 2023, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This document announces the denial of Winnebago's petition.

The DoD is publishing the unclassified text of an arms sales notification.

As required by the Privacy Act of 1974 and the Office of Management and Budget (OMB) Circulars A-108 and A-130, the Department of Energy (DOE or the Department) is publishing notice of a modification to an existing Privacy Act system of records. DOE proposes to amend System of Records DOE-10 Energy Employees Occupational Illness Compensation Program Act Files. This System of Records Notice (SORN) is being modified to align with new formatting requirements, published by OMB, and to ensure appropriate Privacy Act coverage of business processes and Privacy Act information. This notice also incorporates into the "Routine Uses" section changes required by amendments to The Energy Employees Occupational Illness Compensation Program Act (EEOICPA). While there are no substantive changes to the "Categories of Individuals" or "Categories of Records" sections covered by this SORN, substantive changes have been made to the "System Locations," "Routine Uses," and "Administrative, Technical and Physical Safeguards" sections to provide greater transparency. Changes to "Routine Uses" include new provisions related to responding to breaches of information held under a Privacy Act SORN as required by OMB's Memorandum M-17-12, "Preparing for and Responding to a Breach of Personally Identifiable Information" (January 3, 2017). Changes to routine uses pertaining to EEOICPA have been modified to remove two categories of obsolete users due to the 2004 amendments that repealed the use of physician panels. Three routine uses have been consolidated into one to reduce redundancy. Language throughout the SORN has been updated to align with applicable Federal privacy laws, policies, procedures, and best practices.