September 25, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 124
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
The Food and Drug Administration (FDA, the Agency, or we) is proposing to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative HBV antibody assays and quantitative assays that detect anti-HBs (antibodies to HBV surface antigen (HBsAg)), and quantitative HBV nucleic acid-based assays, all of which are postamendments class III devices, into class II (general controls and special controls), subject to premarket notification. FDA is also proposing three new device classification regulations along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for each device.
Determination of Regulatory Review Period for Purposes of Patent Extension; FRUZAQLA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FRUZAQLA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELUCIREM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ELUCIREM 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.
Live Biotherapeutic Products To Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency), the Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (collectively, we) are announcing a public workshop entitled "Live Biotherapeutic Products to Prevent Necrotizing Enterocolitis in Very Low Birth Weight Infants." The purpose of the public workshop is to exchange information with the medical and scientific community about the regulatory and scientific issues associated with use of live biotherapeutic products to prevent necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
Agency Information Collection Activities; Extension; Application for Identification Card (CBP Form 3078)
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) 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 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Commercial Driver's License: Oregon Department of Transportation; Application for Exemption
FMCSA announces its decision to grant a five-year exemption to the Oregon Department of Transportation (Oregon) from the commercial driver's license (CDL) rules concerning acceptable proof of citizenship or lawful permanent residency for citizens of Freely Associated States (FAS) who reside in Oregon and wish to obtain a CDL or commercial learner's permit (CLP). The FAS are the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. The U.S. Department of Homeland Security (DHS) allows States to issue full- term REAL ID licenses and ID cards to citizens of the FAS. The exemption allows Oregon to accept from citizens of the FAS a valid, unexpired passport issued by a FAS and an Arrival/Departure Record, meaning an I-94 or I-94A form, as proof of lawful entry into the United States, and issue standard CLPs and CDLs, rather than non-domiciled CLPs and CDLs, to these individuals. FMCSA concludes that granting the exemption, subject to the terms and conditions set forth below, is likely to achieve a level of safety equivalent to or greater than the level of safety that would be obtained absent the exemption.
Gato Negro Permitium Dos, S.A.P.I. de C.V.; Application for Long-Term Authorization To Re-Export U.S.-Sourced Natural Gas in the Form of Liquefied Natural Gas From Mexico to Non-Free Trade Agreement Countries
The Office of Fossil Energy and Carbon Management (FECM) of the Department of Energy (DOE) gives notice (Notice) of receipt of an application (Application), filed on August 21, 2024, by Gato Negro Permitium Dos, S.A.P.I. de C.V. (Gato Dos). As relevant here, Gato Dos requests long-term authorization to re-export U.S.-sourced natural gas in the form of liquefied natural gas (LNG) to non-free trade agreement countries in a volume equivalent to 0.556 billion cubic feet per day (Bcf/d). Gato Dos seeks to re-export this LNG by vessel from the Gato Negro Manzanillo LNG Plant (Manzanillo Plant), under development in the State of Colima, Mexico. Gato Dos filed the Application under the Natural Gas Act (NGA).
General Directive 24-1: Required Actions Regarding Assaults on Transit Workers
The Federal Transit Administration (FTA) is issuing a General Directive to address the significant and continuing national-level safety risk related to assaults on transit workers. The General Directive requires each transit agency subject to FTA's Public Transportation Agency Safety Plans (PTASP) Final Rule to conduct a safety risk assessment, identify safety risk mitigations or strategies, and provide information to FTA on how it is assessing, mitigating, and monitoring the safety risk associated with assaults on transit workers. Each transit agency serving a large urbanized area must involve the joint labor-management Safety Committee when identifying safety risk mitigations.
60-Day Notice of Proposed Information Collection: Civil Rights Compliance Requirements; OMB Control No.: 0575-0018
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Housing Service (RHS), the Rural Business- Cooperative Service (RBS), and Rural Utilities Service (RUS) intention to request an extension for a currently approved information collection in support of compliance with Civil Rights laws.
Determination of Overfishing or an Overfished Condition
This action serves as a notice that NMFS, on behalf of the Secretary of Commerce (Secretary), has found that Western Atlantic sailfish is now overfished and the Pribilof Islands blue king crab remains overfished. NMFS, on behalf of the Secretary, is required to provide this notice whenever it determines that a stock or stock complex is subject to overfishing, overfished, or approaching an overfished condition.
Transboundary Management Guidance Committee and Steering Committee Meetings
This notice provides the proposed schedule and agenda of the October 1-2, 2024, Transboundary Management Guidance Committee (TMGC) and U.S./Canada Transboundary Resources Steering Committee meetings. The members will meet and discuss concerns regarding transboundary resources outlined in the SUPPLEMENTARY INFORMATION section below.
Notice of Public Meeting of the Invasive Species Advisory Committee
Pursuant to the provisions of the Federal Advisory Committee Act, notice is hereby given that a meeting of the Invasive Species Advisory Committee (ISAC) will meet as indicated below.
Expanded Burial Benefits
The Department of Veterans Affairs (VA) amends its adjudication regulations pertaining to burial benefits to conform to statutory changes enacted by the Johnny Isakson and David P. Roe, M.D. Veterans Health Care and Benefits Improvement Act of 2020 and the Burial Equity for Guards and Reserves Act of the Consolidated Appropriations Act, 2022. The conforming regulatory changes implement an expansion of the transportation benefit and provision of a single payment rate for non-service-connected burial allowances regardless of the location of a qualifying Veteran's death and coincide with the effective date for the statutory amendments (January 5, 2023). The conforming regulatory changes also implement the extension of the VA plot or interment allowance to Tribal organizations for interment of eligible Veterans on trust land owned by, or held in trust for, the Tribal organization and coincide with the effective date for the statutory amendments (March 15, 2022). VA also provides additional clarifying changes to its burial benefits regulations.
Call for Nominations for the Geologic Mapping Advisory Committee
The U.S. Department of the Interior (Department) is seeking nominations for qualified persons to serve as members of the Geologic Mapping Advisory Committee (Committee).
Determination of Regulatory Review Period for Purposes of Patent Extension; ZAVZPRET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZAVZPRET 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.
Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2025
The Drug Enforcement Administration (DEA) proposes to establish the 2025 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
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.
Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2024
The Drug Enforcement Administration proposes to adjust the 2024 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act. Additionally, as DEA announced in an April 29, 2024 letter to DEA-registered manufacturers, procurement quotas for commercial manufacturing of a schedule II controlled substance will be calculated on a semi-annual basis, except for injectable drug products containing schedule II controlled substances, which will be calculated on an annual basis.
Agency Information Collection Activities; Comment Request; Private School Universe Survey (PSS) 2025-26 and 2027-28 Data Collections, and 2027-28 PSS Frame Development Activities
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Agency Information Collection Activity Under OMB Review: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to approve a request for an extension without change to an existing information collection: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.
Determination of Regulatory Review Period for Purposes of Patent Extension; DAYBUE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYBUE 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.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Drug Use Statement
The Drug Enforcement Administration, Department of Justice (DOJ), 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.
USAID Injury/Illness Collection Form per the USAID Occupational Safety & Health (OHS) Program
In accordance with the Information Collection Review procedures of the Paperwork Reduction Act of 1995 (PRA), the United States Agency for International Development (USAID), is announcing that it has submitted a request to the Office of Management and Budget (OMB) for approval to collect information via Google Forms as per the USAID Occupational Safety & Health (OHS) program. This collection is mandated by the Occupational Safety and Health Administration under the OSH act of 1970 and Federal regulations.
Agency Information Collection Activities; Extension; Declaration of the Ultimate Consignee That Articles Were Exported for Temporary Scientific or Educational Purposes
The Department of Homeland Security, U.S. Customs and Border Protection (CBP) 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 (PRA). The information collection is published in the Federal Register to obtain comments from the public and affected agencies.
Exchange of Coin
This final rule removes Treasury regulations relating to the exchange of bent, partial, fused, and mixed coins. The removal will end the exchange program for bent and partial coin.
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.
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