July 2023 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 2,158
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Proposed Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these systems. In this proposed rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. This proposed rule also would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. This proposed rule would also establish payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this proposed rule would update and refine requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We also propose to codify provisions of the Consolidated Appropriations Act, 2023, in Community Mental Health Centers Conditions of Participation (CoPs). We propose to revise the personnel qualifications of Mental Health Counselors and add personnel qualifications for Marriage and Family Therapists in the CMHC CoPs. We also seek comment on separate payment under the Inpatient Prospective Payment System (IPPS) for establishing and maintaining access to a buffer stock of essential medicines to foster a more reliable, resilient supply of these medicines. Finally, we propose to address any future revisions to the IPPS Medicare Code Editor (MCE), including any additions or deletions of claims edits, as well as the addition or deletion of ICD-10 diagnosis and procedure codes to the applicable MCE edit code lists, outside of the annual IPPS rulemakings. Additionally, we propose a technical correction to the Rural Emergency Hospital Conditions of Participation.
Federal “Good Neighbor Plan” for the 2015 Ozone National Ambient Air Quality Standards; Response to Judicial Stays of SIP Disapproval Action for Certain States
The Environmental Protection Agency (EPA) is taking interim final action to stay, for emissions sources in Arkansas, Kentucky, Louisiana, Mississippi, Missouri, and Texas only, the effectiveness of the federal implementation plan (FIP) requirements established to address the obligations of these and other states to mitigate interstate air pollution with respect to the 2015 national ambient air quality standards (NAAQS) for ozone (the Good Neighbor Plan). The EPA is also revising certain other regulations to ensure that sources in these states will continue to be subject to previously established requirements to mitigate interstate air pollution with respect to other ozone NAAQS while the Good Neighbor Plan's requirements are stayed. These revisions will also ensure that the stay is limited to requirements for which the EPA does not currently have authority to implement a FIP pending judicial review. The stay and the associated revisions to other regulations are being issued in response to judicial orders that partially stay, pending judicial review, a separate, earlier EPA action which disapproved certain state implementation plan (SIP) revisions submitted by these and other states. Finally, for states for which the Good Neighbor Plan's requirements are not being stayed, the EPA is revising three near-term deadlines that are incorrect as published in the Good Neighbor Plan.
National Center for Health Statistics, ICD-10 Coordination and Maintenance Committee
The Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee. This meeting is open to the public, limited only by the number of audio lines available. Online Registration is required.
Board of Scientific Counselors, National Center for Injury Prevention and Control
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is partially open to the public.
Board of Scientific Counselors, National Center for Health Statistics
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public. Time will be available for public comment.
Solicitation of Nominations for Appointment to CDC's Advisory Committee to the Director Data and Surveillance Workgroup
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisory Committee to the Director Data and Surveillance Workgroup (DSW). The DSW consists of approximately 15 members who are experts in fields associated with public health science and practice; policy development, analysis, and implementation; and surveillance and informatics.
Public Meetings of the National Park Service Alaska Region Subsistence Resource Commission Program
The National Park Service (NPS) is hereby giving notice that the Aniakchak National Monument Subsistence Resource Commission (SRC), the Denali National Park SRC, the Cape Krusenstern National Monument SRC, the Lake Clark National Park SRC, the Kobuk Valley National Park SRC, the Wrangell-St. Elias National Park SRC, and the Gates of the Arctic National Park SRC will meet as indicated below.
Airworthiness Directives; Fokker Services B.V. Airplanes
The FAA is superseding Airworthiness Directive (AD) 2020-09-11 and AD 2022-21-12, which applied to all Fokker Services B.V. Model F28 Mark 0070 and 0100 airplanes. AD 2020-09-11 and AD 2022-21-12 required revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. Since the FAA issued AD 2022-21-12, new or more restrictive tasks and limitations have been introduced. This AD continues to require the actions of AD 2022-21-12, and also requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations; as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Airbus SAS Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Airbus SAS Model A318, A319, A320, and A321 series airplanes. This AD was prompted by reports where the passenger door external handle mechanism was not retrieving its normal, flush position when the door was being closed. This AD requires a one-time cleaning and lubrication of the external door handle mechanism of each affected door, and limits the installation of affected parts, as specified in a European Union Aviation Safety Agency (EASA) AD, which is incorporated by reference. The FAA is issuing this AD to address the unsafe condition on these products.
Common Alloy Aluminum Sheet From Germany: Notice of Initiation of Changed Circumstances Review, and Consideration of Revocation, in Part, of the Antidumping Duty Order
Based on a request from Eastman Kodak Company (Kodak), the U.S. Department of Commerce (Commerce) is initiating a changed circumstances review to consider the possible revocation, in part, of the antidumping duty (AD) order on common alloy aluminum sheet (CAAS) from Germany with respect to certain lithographic-grade aluminum sheet.
Notice of Public Meeting of the Commonwealth of the Northern Mariana Islands Advisory Committee to the U.S. Commission on Civil Rights
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 Commonwealth of the Northern Mariana Islands Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a briefing at 9:00 a.m. ChST on Friday, September 1, 2023, (7:00 p.m. ET on Thursday, August 31, 2023) in Pod Y-10 at the Northern Marianas College (Finasisu Lane, Saipan, Northern Mariana Islands 96950). The purpose of the meeting is to hear testimony on the accessibility and quality of healthcare in the CNMI judicial system.
Notice of Public Meeting of the Guam Advisory Committee to the U.S. Commission on Civil Rights
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 business meeting at 9:00 a.m. ChST on Wednesday, August 30, 2023, (7:00 p.m. ET on Tuesday, August 29, 2023) in the Anthony Leon Guerrero Multipurpose Room at the University of Guam (32 University Drive, Mangilao, Guam 96913). The purpose of the meeting is to collect input from members of the public on potential civil rights topics of study for the Committee's investigation.
Monosodium Glutamate From the Republic of Indonesia: Preliminary Results of Antidumping Duty Administrative Review; 2021-2022
The U.S. Department of Commerce (Commerce) preliminarily determines that sales of monosodium glutamate (MSG) from the Republic of Indonesia (Indonesia) have been made below normal value during the period of review (POR), November 1, 2021, through October 31, 2022. We invite interested parties to comment on these preliminary results.
Prestressed Concrete Steel Wire Strand From Mexico: Initiation of Circumvention Inquiry on the Antidumping Duty Order
In response to a request from Insteel Wire Products Company, Sumiden Wire Products Corporation, and Wire Mesh Corp. (collectively, the requestors), the U.S. Department of Commerce (Commerce) is initiating a country-wide circumvention inquiry to determine whether imports of certain high carbon steel (HCS) wire from Mexico that are assembled or completed into prestressed concrete steel wire strand (PC strand) in the United States, are circumventing the antidumping duty order on PC strand from Mexico.
Meeting of the Substance Abuse and Mental Health Services Administration National Advisory Council
Notice is hereby given for the meeting on August 31, 2023, of the Substance Abuse and Mental Health Services Administration National Advisory Council (SAMHSA NAC). The meeting is open to the public and can also be accessed virtually. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https:// www.samhsa.gov/about-us/advisory-councils/meetings. The meeting will include, but not be limited to, remarks from the Assistant Secretary for Mental Health and Substance Use; consideration and approval of the meeting minutes of April 27, 2023; updates and follow up from the SAMHSA NAC meeting of April 27, 2023; recap of the joint meetings of the councils (JNAC) and Lessons Learned; presentations and council discussions on the following topics: Kids Online Health and Safety; Technical Assistance and Training Strategy, and Strategic Plan Updates; and a general council discussion and public comments.
Joint Meeting of the National Advisory Councils
Notice is hereby given of the combined (joint) meeting on August 30, 2023, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) four National Advisory Councils: the SAMHSA National Advisory Council (NAC), the Center for Mental Health Services NAC, the Center for Substance Abuse Prevention NAC, the Center for Substance Abuse Treatment NAC; and the two SAMHSA Advisory Committees: Advisory Committee for Women's Services (ACWS) and the Tribal Technical Advisory Committee (TTAC).
Administrative Declaration of an Economic Injury Disaster for the State of Colorado
This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Colorado dated 07/25/2023. Incident: Colorado Highway 133 Sinkhole and Road Closure. Incident Period: 05/02/2023 through 06/19/2023.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for AmeriCorps Application Questions
In accordance with the Paperwork Reduction Act of 1995, the Corporation for National and Community Service (operating as AmeriCorps) is proposing to renew an information collection.
Prescription Drug User Fee Rates for Fiscal Year 2024
The Food and Drug Administration (FDA, Agency, or we) is announcing the rates for prescription drug user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2022 (PDUFA VII), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2024.
Outsourcing Facility Fee Rates for Fiscal Year 2024
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 rates for the establishment and reinspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a reinspection fee for each reinspection of an outsourcing facility. This document establishes the FY 2024 rates for the small business establishment fee ($6,196), the non-small business establishment fee ($20,036), and the reinspection fee ($18,588) for outsourcing facilities; provides information on how the fees for FY 2024 were determined; and describes the payment procedures outsourcing facilities should follow.
Small Business Size Standards: Adjustment of Alternative Size Standard for SBA's 7(a) and CDC/504 Loan Programs for Inflation; and Surety Bond Limits: Adjustments for Inflation
The U.S. Small Business Administration (SBA or Agency) proposes to amend its Small Business Size Regulations to increase the alternative size standard for its 7(a) Business and Certified Development Company (CDC/504) Loan Programs (collectively ``Business Loan Programs'') by 34.46% to account for inflation that has occurred since the size standard's establishment in 2010. The inflation adjustment would increase the size standard's level for tangible net worth to $20 million and for net income to $6.5 million. SBA also is adjusting for inflation the applicable statutory limits for contract size under the Surety Bond Guarantee (SBG) Program. The adjustment would increase the contract limit to $9 million and to $14 million for Federal contracts if a Federal contracting officer certifies that such a guarantee is necessary.
Shore Leave for Professional Mariners of the National Oceanic and Atmospheric Administration
On December 23, 2022, the President signed into law the James M. Inhofe National Defense Authorization Act for Fiscal Year 2023 (FY 2023 NDAA). Pursuant to the FY 2023 NDAA, this final rule establishes shore leave regulations for NOAA's professional mariners and authorizes payment of the difference between a NOAA professional mariner's temporary and permanent rates of pay for annual leave accrued while temporarily promoted. This final rule also makes clerical amendments to create a new subchapter specific to NOAA Marine and Aviation Operations.
Procedures for Disclosure of Records Pursuant to the Freedom of Information Act
This final rule amends the Office of the Director of National Intelligence's (ODNI) rules implementing the Freedom of Information Act (FOIA).
Revision of the Form LM-10 Employer Report
The Office of Labor-Management Standards (OLMS) of the Department of Labor (Department) is revising the Form LM-10 Employer Report upon review of the comments received in response to its September 13, 2022 notice of proposed form revision. Under section 203 of the Labor-Management Reporting and Disclosure Act of 1959 (LMRDA or the Act), employers must file a Form LM-10 Employer Report with the Department to disclose certain payments, expenditures, agreements, and arrangements. Under the revision, the Department adds a checkbox to the Form LM-10 report requiring certain reporting entities to indicate whether such entities were Federal contractors or subcontractors in their prior fiscal year, and two lines for entry of filers' Unique Entity Identifier and Federal contracting agency or agencies, if applicable.
Carbon Tetrachloride (CTC); Regulation Under the Toxic Substances Control Act (TSCA)
The Environmental Protection Agency (EPA) is proposing to address the unreasonable risk of injury to human health presented by carbon tetrachloride (CTC) under its conditions of use as documented in EPA's 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride pursuant to the Toxic Substances Control Act (TSCA). CTC is a volatile, organic compound that is primarily used as a feedstock (i.e., processed as a reactant) in the making of products such as refrigerants, aerosol propellants, and foam-blowing agents. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk. EPA determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and dermal exposures and liver toxicity from chronic inhalation, chronic dermal, and acute dermal exposures in the workplace. To address the identified unreasonable risk, EPA is proposing under TSCA to establish workplace safety requirements for most conditions of use, including the condition of use related to the making of low Global Warming Potential (GWP) hydrofluoroolefins (HFOs), prohibit the manufacture (including import), processing, distribution in commerce, and industrial/commercial use of CTC for conditions of use where information indicates use of CTC has already been phased out, and establish recordkeeping and downstream notification requirements. The use of CTC in low GWP HFOs is particularly important in the Agency's efforts to support the American Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, which was ratified on October 26, 2022.
Energy Conservation Program: Energy Conservation Standards for Consumer Water Heaters
The Energy Policy and Conservation Act, as amended (``EPCA''), prescribes energy conservation standards for various consumer products and certain commercial and industrial equipment, including consumer water heaters. EPCA also requires the U.S. Department of Energy (``DOE'' or ``the Department'') to periodically determine whether more- stringent standards would be technologically feasible and economically justified, and would result in significant energy savings. In this notice of proposed rulemaking (``NOPR''), DOE proposes amended energy conservation standards for consumer water heaters, and also announces a public meeting to receive comments on these proposed standards and associated analyses and results.
Derivatives Clearing Organizations Recovery and Orderly Wind-Down Plans; Information for Resolution Planning
The Commodity Futures Trading Commission (Commission or CFTC) is proposing amendments to certain regulations applicable to systemically important derivatives clearing organizations (SIDCOs) and derivatives clearing organizations (DCOs) that elect to be subject to the provisions in the Commission's regulations (Subpart C DCOs). These proposed amendments would, among other things, address certain risk management obligations, modify definitions, and codify existing staff guidance. The Commission is also proposing to amend certain regulations to require DCOs that are not designated as systemically important, and which have not elected to be covered by our regulations, to submit orderly Wind-Down plans. In addition, the Commission is proposing to make conforming amendments to certain provisions, revise the Subpart C Election Form and Form DCO, and remove stale provisions.
Airworthiness Directives; ATR-GIE Avions de Transport Régional Airplanes
The FAA proposes to supersede Airworthiness Directive (AD) 2021-10-20, which applies to certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 and ATR72-212A airplanes. AD 2021-10-20 requires revising the existing aircraft flight manual (AFM) and applicable corresponding operational procedures to update a systems limitation, limiting dispatch with certain equipment inoperative, performing an operational test of a certain contactor and an electrical test of a certain battery toggle switch, and performing corrective actions if necessary. Since the FAA issued AD 2021-10-20, new procedures for modifying the wiring and replacing the battery toggle switch have been developed that would terminate the AD requirements. This proposed AD would continue to require certain actions in AD 2021- 10-20, and would require modifying the battery toggle switch wiring and replacing the battery toggle switch, and would revise the applicability to include additional airplanes, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). This proposed AD would also prohibit the installation of affected parts. The FAA is proposing this AD to address the unsafe condition on these products.
Airworthiness Directives; MHI RJ Aviation ULC (Type Certificate Previously Held by Bombardier, Inc.) Airplanes
The FAA proposes to adopt a new airworthiness directive (AD) for all MHI RJ Aviation ULC Model CL-600-2B19 (Regional Jet Series 100 & 440), CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2C11 (Regional Jet Series 550), CL-600-2D15 (Regional Jet Series 705), CL- 600-2D24 (Regional Jet Series 900), and CL-600-2E25 (Regional Jet Series 1000) airplanes. This proposed AD was prompted by reports of power control unit (PCU) rod end fractures due to pitting corrosion, and a determination that new or more restrictive airworthiness limitations are necessary. This proposed AD would, for certain airplanes, require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. This proposed AD would also require accomplishing certain aircraft maintenance manual (AMM) tasks and corrective actions following short-term or long-term storage. The FAA is proposing this AD to address the unsafe condition on these products.
Agency Information Collection Activities; Revision of a Currently Approved Collection: Suspicious/Criminal Activity Tip Reporting
In accordance with the Paperwork Reduction Act (PRA) of 1995 the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance. This information collection was previously published in the Federal Register on November 1, 2021, allowing for a 60-day comment period. ICE received four comments. The purpose of this notice is to allow an additional 30 days for public comments.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico
In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico (GOM), notification is hereby given that a Letter of Authorization (LOA) has been issued to Chevron USA, Inc., (Chevron) for the take of marine mammals incidental to geophysical survey activity in the GOM.
Agency Information Collection Activities; Comment Request; Veterans Upward Bound (VUB) Program Annual Performance Report
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Aerotest Operations, Inc.; Aerotest Radiography and Research Reactor
The U.S. Nuclear Regulatory Commission (NRC) has received a decommissioning plan from Aerotest Operations, Inc. for the Aerotest Radiography and Research Reactor, located in Contra Costa County, California. The license authorizes the possession only of the reactor and fuel, but not use or operation of the permanently shutdown facility. Aerotest Operations, Inc. is requesting NRC review and approval of a proposed decommissioning plan. If approved, the NRC would amend the Aerotest Radiography and Research Reactor license to reference the NRC approved decommissioning plan. Additionally, the NRC would add a license condition requiring the licensee to submit more detailed information on remaining dismantlement and remediation activities, as well as the final status survey plan, for NRC review and approval prior to conducting final status surveys for license termination.
Implementation of the Dr. Kate Hendricks Thomas Supporting Expanded Review for Veterans in Combat Environments (SERVICE) Act
The Department of Veterans Affairs (VA) is publishing this notice to inform the public about how it is implementing the SERVICE Act.
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2024
The Food and Drug Administration (FDA or Agency) is announcing the fiscal year (FY) 2024 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA).
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2024
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2024 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies that are applying to be directly accredited by FDA.
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2024
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2024 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) that is authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). This fee is effective on August 1, 2023 and will remain in effect through September 30, 2024.
Medical Device User Fee Rates for Fiscal Year 2024
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2024, which apply from October 1, 2023, through September 30, 2024, and provides information on how the fees for FY 2024 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
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