2023 – Federal Register Recent Federal Regulation Documents
Results 901 - 950 of 28,124
Notice of Inventory Completion: Sam Noble Oklahoma Museum of Natural History, University of Oklahoma, Norman, OK
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Sam Noble Oklahoma Museum of Natural History, University of Oklahoma (SNOMNH) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from McCurtain County, OK.
Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that MEPHYTON (phytonadione) tablets, 5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of calcium formate as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. This action is in response to a food additive petition filed by LANXESS Corp.
License Renewal Application; Pacific Gas and Electric Company; Diablo Canyon Nuclear Power Plant, Units 1 and 2
The U.S. Nuclear Regulatory Commission (NRC) found acceptable for docketing and is considering an application for the renewal of Facility Operating License Nos. DPR-80 and DPR-82, which authorize Pacific Gas and Electric Company (PG&E, the applicant) to operate Diablo Canyon Nuclear Power Plant (DCPP), Units 1 and 2. The current operating licenses for DCPP expire as follows: Unit 1 on November 2, 2024, and Unit 2 on August 26, 2025. If renewed, the renewed licenses would authorize the applicant to operate DCPP for an additional 20 years beyond the period specified in each of the current licenses.
Jeremy Walenty: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jeremy Walenty for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Walenty was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. Walenty's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Walenty was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of October 15, 2023 (30 days after receipt of the notice), Mr. Walenty had not responded. Mr. Walenty's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
James Funaro: Final Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring James Funaro for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Funaro was convicted of one felony count under Federal law for conspiracy to launder money. The factual basis supporting Mr. Funaro's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Funaro was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of October 11, 2023 (30 days after receipt of the notice), Mr. Funaro had not responded. Mr. Funaro's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
The Food and Drug Administration (FDA or the Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices, 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 ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' FDA is issuing this draft guidance to clarify how FDA evaluates real- world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance proposes expanded recommendations to the 2017 guidance entitled ``Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices.'' This draft guidance is not final nor is it for implementation at this time.
Notice of OFAC Sanctions Actions
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more 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.
Notice of OFAC Sanctions Actions
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more 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.
Privacy Act of 1974; System of Records
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-1 Grievance Records. This System of Records Notice (SORN) is being modified to align with new formatting requirements, published by the Office of Management and Budget, and to ensure appropriate Privacy Act coverage of business processes and Privacy Act information. 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). Language throughout the SORN has been updated to align with applicable Federal privacy laws, policies, procedures, and best practices.
De Minimis Error Safe Harbor Exceptions to Penalties for Failure To File Correct Information Returns or Furnish Correct Payee Statements
This document contains final regulations implementing statutory safe harbor rules that protect persons required to file information returns or to furnish payee statements from penalties under the Internal Revenue Code (Code) for failure to file correct information returns or furnish correct payee statements. The statutory safe harbor rules treat information returns and payee statements with erroneous dollar amounts as correct returns or statements for certain penalty purposes if the errors are de minimis in dollar amount. The final regulations also prescribe the time and manner in which a payee may elect not to have the statutory safe harbor rules apply. In addition, these final regulations update dollar amounts, definitions, and references in existing regulations relating to information return and payee statement penalties to reflect various statutory amendments to the Code that are not accounted for in the existing regulations. Finally, the final regulations provide rules relating to the reporting of basis of securities by brokers as this reporting relates to the de minimis error safe harbor rules. The final regulations affect persons required to either file information returns or to furnish payee statements (filers) and the recipients of payee statements (payees).
National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision
The Manual on Uniform Traffic Control Devices for Streets and Highways (MUTCD) (also referred to as ``the Manual'') is incorporated by reference within our regulations, approved by FHWA, and recognized as the national standard for traffic control devices used on all public roads, bikeways, or private roads open to public travel. The purpose of this final rule is to revise Standard, Guidance, Option provisions, and supporting information, relating to the traffic control devices in all parts of the MUTCD to improve safety for all road users by promoting uniformity, and to incorporate new provisions that reflect technological advances in traffic control device application. The MUTCD, with these changes incorporated, is being designated as the 11th Edition of the MUTCD.
Removals From the Unverified List
The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by removing four persons, all under the destination of People's Republic of China (China), from the UVL because BIS was able to verify their bona fides.
Privacy Act System of Records
The Federal Communications Commission (FCC, Commission, or Agency) proposes to modify an existing system of records, FCC/OS-1, Electronic Comment Filing System (ECFS), subject to the Privacy Act of 1974, as amended. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the agency. The Commission uses this system to handle and process public comments related to FCC rulemakings and other proceedings. This modification makes various necessary changes to the Categories of Records and identifies a new FCC point of contact.
Agency Information Collection Activities: Comment Request; Awardee Reporting Requirements for the Established Program To Stimulate Competitive Research (EPSCoR) Research Infrastructure Improvement Programs
The National Science Foundation (NSF) has submitted the following information collection requirement to OMB for review and clearance under the Paperwork Reduction Act of 1995. This is the second notice for public comment; the first was published in the Federal Register, and no comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice.
Submission to the Office of Management and Budget for Review and Approval; Underground Mining Permit Applications-Minimum Requirements for Reclamation and Operation Plan
In accordance with the Paperwork Reduction Act of 1995, we, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are proposing to renew an information collection.
Air Plan Approval; Wyoming; Interstate Transport of Air Pollution for the 2015 8-Hour Ozone National Ambient Air Quality Standards
The Environmental Protection Agency (EPA) is finalizing approval of the portion of a Wyoming State Implementation Plan (SIP) submission addressing interstate transport for the 2015 8-hour ozone national ambient air quality standards (NAAQS). The ``good neighbor'' or ``interstate transport'' provision requires that each state's SIP contain adequate provisions to prohibit emissions from within the state from significantly contributing to nonattainment or interfering with maintenance of the NAAQS in other states. This requirement is part of the broader set of ``infrastructure'' requirements, which are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the Clean Air Act (CAA).
Amendment of Class E Airspace; Danville, IL
This action proposes to amend the Class E airspace at Danville, IL. The FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Danville very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operating Network (MON) Program. The name and geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database. This action will bring the airspace into compliance with FAA orders to support instrument flight rule (IFR) operations.
Amendment of Class D and Class E Airspace; Anderson, IN
This action proposes to amend the Class D and Class E airspace at Anderson, IN. The FAA is proposing this action as the result of an airspace review conducted due to the decommissioning of the Muncie very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operating Network (MON) Program. The name of the airport would also be updated to coincide with the FAA's aeronautical database. This action will bring the airspace into compliance with FAA orders to support instrument flight rule (IFR) operations.
Publication of Burma Sanctions Regulations Web General Licenses 3 and 4
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing two general licenses (GLs) issued pursuant to the Burma Sanctions Regulations: GLs 3 and 4, each of which was previously made available on OFAC's website.
Publication of Syria-Related Sanctions Regulations Web General Licenses 1, 2, and 3
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing three general licenses (GLs) issued pursuant to the Syria-Related Sanctions Regulations: GLs 1, 2, and 3, each of which were previously made available on OFAC's website.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is superseding Airworthiness Directive (AD) 2019-12- 07, which applied to all Airbus SAS Model A318-111, -112, -121, and - 122 airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. AD 2019-12-07 required replacement of both main landing gear (MLG) shock absorbers, an identification of affected MLG sliding tubes; inspection of affected chromium plates and sliding tube axles for damage; and replacement of the sliding tube if necessary. AD 2019- 12-07 also required repetitive inspections of affected MLG sliding tubes for cracking, replacement of cracked MLG sliding tubes, and eventual replacement of each affected MLG sliding tube. This AD continues to require the actions specified in AD 2019-12-07 and requires repetitive inspections of additional MLG sliding tubes, replacement if necessary, and eventual replacement of the additional MLG sliding tubes. This AD also extends the repetitive inspection interval. This AD also prohibits the installation of affected parts under certain conditions. This AD was prompted by the FAA's determination that additional MLG sliding tubes are affected by the unsafe condition and that the repetitive inspection interval may be extended. The FAA is issuing this AD to address the unsafe condition on these products.
Registration and Listing of Cosmetic Product Facilities and Products; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Registration and Listing of Cosmetic Product Facilities and Products.'' The guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This guidance also includes a new draft section, Appendix B, for comment purposes only, that describes frequently asked questions and answers about cosmetic product facility registrations and product listing submissions. Aside from that section, this guidance finalizes the draft guidance that was published on August 8, 2023.
Designation of Three Entities Contributing to Ballistic Missile Proliferation
Pursuant to the authority in the Executive Order, ``Blocking Property of Weapons of Mass Destruction Proliferators and Their Supporters,'' and delegated authority, the Under Secretary of State for Arms Control and International Security, in consultation with the Secretary of the Treasury and the Attorney General, has determined that General Technology Limited, Beijing Luo Luo Technology Development Co Ltd, and Changzhou Utek Composite Company Ltd, engaged, or attempted to engage, in activities or transactions that have materially contributed to, or pose a risk of materially contributing to, the proliferation of weapons of mass destruction or their means of delivery (including missiles capable of delivering such weapons), including any efforts to manufacture, acquire, possess, develop, transport, transfer or use such items, by Pakistan.
Air Quality Implementation Plans; California; San Diego County; 2008 and 2015 8-Hour Ozone Nonattainment Area Requirements
The Environmental Protection Agency (EPA) is proposing to approve portions of two state implementation plan (SIP) revisions submitted by the State of California to meet Clean Air Act requirements for the 2008 8-hour ozone national ambient air quality standards (NAAQS or ``standards'') and the 2015 8-hour ozone NAAQS in the San Diego County ozone nonattainment area (``San Diego County area'' or ``area''). The first SIP revision, ``2020 Plan for Attaining the National Ambient Air Quality Standards for Ozone in San Diego County'' (``2020 San Diego County Ozone SIP'' or ``2020 Plan''), addresses most of the SIP requirements for the area. The second SIP revision, referred to as the ``Smog Check Certification,'' supplements the motor vehicle inspection and maintenance program portion of the 2020 Plan. The EPA is proposing to approve the 2020 Plan, and the San Diego County portion of the Smog Check Certification, as meeting all the applicable ozone nonattainment area requirements for the 2008 and 2015 8-hour ozone NAAQS addressed by the plan except for the emissions statement requirement that the EPA previously found to have been met and the contingency measure requirements, for which the EPA is deferring action.
Airworthiness Directives; Bombardier, Inc., Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for certain Bombardier, Inc., Model BD-100-1A10 airplanes. This proposed AD was prompted by a determination that new or more restrictive maintenance tasks are necessary. This proposed AD would require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive maintenance tasks. The FAA is proposing this AD to address the unsafe condition on these products.
Notice of Intent To Repatriate Cultural Items: The University of Kansas, Lawrence, KS
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Kansas intends to repatriate a certain cultural item that meets the definition of a sacred object and that has a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice. The cultural item was removed from Sonora, Mexico.
Notice of Inventory Completion: Grand Rapids Public Museum, Grand Rapids, MI
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Grand Rapids Public Museum has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Lee County, FL.
Notice of Inventory Completion: Grand Rapids Public Museum, Grand Rapids, MI
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Grand Rapids Public Museum, Michigan has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from San Joaquin County, CA.
Notice of Inventory Completion: Binghamton University, State University of New York, Binghamton, NY
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Binghamton University, State University of New York (SUNY Binghamton) has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice. The human remains were removed from Tioga County, NY.
Senior Policy Operating Group's Procurement and Supply Chains Committee Outreach Session
GSA is providing notice of a public meeting on behalf of the Chief Acquisition Officers Council (CAOC) and the Senior Policy Operating Group's (SPOG) Procurement and Supply Chains Committee to build understanding and awareness about the anti-human trafficking requirements of the Federal Acquisition Regulation (FAR), share information about U.S. government tools and reporting to assist with compliance, and to discuss actions the Federal Government can take to achieve more effective implementation.
Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities (November 2023)
This document announces the Agency's receipt of an initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Notice of Inventory Completion: American Museum of Natural History, New York, NY
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the American Museum of Natural History (AMNH) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Nassau and Queens Counties, NY.
Notice of Inventory Completion: American Museum of Natural History, New York, NY
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the American Museum of Natural History (AMNH) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Queens County, NY.
Notice of Inventory Completion: American Museum of Natural History, New York, NY
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the American Museum of Natural History (AMNH) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Snohomish County, WA.
Notice of Inventory Completion: University of Nevada, Las Vegas, Las Vegas, NV
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the University of Nevada, Las Vegas has completed an inventory of human remains and associated funerary objects and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any Indian Tribe. The human remains and associated funerary objects were removed from unknown locations.
Notice of Inventory Completion: San Jose State University, San Jose, CA
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), San Jose State University (SJSU) has completed an inventory of human remains and associated funerary objects and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any federally recognized Indian Tribe. The human remains and associated funerary objects were removed from the Ryan Mound (CA-ALA-329) of Newark/ Fremont, Alameda County, CA.
Notice of Inventory Completion Amendment: California State University, Los Angeles, Los Angeles, CA
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), California State University, Los Angeles has amended a Notice of Inventory Completion published in the Federal Register on August 28, 2023. This notice amends the number of associated funerary objects in a collection removed from Clark County, NV.
Notice of Inventory Completion: South Carolina Institute of Archaeology and Anthropology, University of South Carolina, Columbia, SC
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the South Carolina Institute of Archaeology and Anthropology (SCIAA) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from Pickens County, SC.
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