July 28, 2023 – Federal Register Recent Federal Regulation Documents
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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.
Biosimilar User Fee Rates for Fiscal Year 2024
The Food and Drug Administration (FDA, the Agency, or we) is announcing the rates for biosimilar user fees for fiscal year (FY) 2024. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA III directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2023, through September 30, 2024.
Notice of OFAC Sanctions Actions
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons 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; Implementation
HHS exempts certain records in an existing system of records maintained by OCSE within ACF from the accounting, access, and amendment requirements of the Privacy Act. The affected system of records is OCSE Federal Case Registry of Child Support Orders, HHS/ACF/ OCSE, System No. 09-80-0385. Only case files marked with the Family Violence Indicator (FVI) will be exempted, to align with a restriction in section 453(b)(2) of the Social Security Act which prohibits disclosure of case files marked with the FVI to anyone other than a court or agent of a court, to avoid harm to the custodial parent or the child of such parent.
Agency Information Collection Activities; Proposed Collection; Comment Request; Identification, Listing and Rulemaking Petitions (Renewal), EPA ICR No. 1189.32, OMB Control No. 2050-0053
The Environmental Protection Agency (EPA) is planning to submit the information collection request (ICR), Identification, Listing and Rulemaking Petitions (Renewal), EPA ICR No. 1189.32, OMB Control No. 2050-0053 to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described in SUPPLEMENTARY INFORMATION. This is a proposed extension of the ICR, which is currently approved through March 31, 2024. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Fisheries of the Gulf of Mexico and the South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meeting
The SEDAR 79 assessment process of Gulf of Mexico and South Atlantic mutton snapper will consist of a Data Workshop, and a series of assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.
Caribbean Fishery Management Council; Public Meeting
The Caribbean Fishery Management Council (CFMC) will hold its 182nd public hybrid meeting to address the items contained in the tentative agenda included in the SUPPLEMENTARY INFORMATION.
Pacific Fishery Management Council; Public Meetings
The Pacific Fishery Management Council's (Pacific Council) Groundfish Subcommittee of the Scientific and Statistical Committee (SSC) will hold two online meetings to review 2023 groundfish stock assessments. These online meetings are open to the public.
Notice of HUD-Held Multifamily and Healthcare Loan Sale (MHLS 2023-2)
This notice announces HUD's intention to sell one unsubsidized multifamily and nine unsubsidized healthcare mortgage loans, without Federal Housing Administration (FHA) insurance, in a competitive, sealed bid sale on or about August 30, 2023 (MHLS 2023-2 or Loan Sale). This notice also describes generally the bidding process for the sale and certain persons who are ineligible to bid.
Clinical Considerations for Studies of Devices Intended To Treat Opioid Use Disorder; 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 ``Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder.'' Design of clinical studies for devices intended to treat opioid use disorder (OUD) is challenging. This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder (``OUD device studies'') and used to support marketing submissions. These recommendations are applicable to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. This draft guidance is not final nor is it for implementation at this time.
Notice of Intent To Designate as Abandoned Horizon Instruments, Inc., Supplemental Type Certificate No. SA5842NW
This notice announces the FAA's intent to designate Horizon Instruments, Inc., Supplemental Type Certificate (STC) No. SA5842NW as abandoned and make the related engineering data available upon request. The FAA has received a request to provide engineering data concerning this STC. The FAA has been unsuccessful in contacting Horizon Instruments, Inc., concerning the STC. This action is intended to enhance-aviation safety.
Air Plan Approval and Air Quality Designation; KY; Redesignation of the Northern Kentucky Portion of the Cincinnati, OH-KY 2015 8-Hour Ozone Nonattainment Area to Attainment
On September 21, 2022, the Commonwealth of Kentucky, through the Kentucky Energy and Environment Cabinet (Cabinet), Division of Air Quality (DAQ), submitted a request for the Environmental Protection Agency (EPA) to redesignate the Northern Kentucky portion (hereinafter referred to as the ``Northern Kentucky Area'' or ``Area'') of the Cincinnati, Ohio- Kentucky, 2015 8-hour ozone nonattainment area (hereinafter referred to as the ``Cincinnati OH-KY Area'') to attainment for the 2015 8-hour ozone National Ambient Air Quality Standards (NAAQS or standards) and to approve a State Implementation Plan (SIP) revision containing a maintenance plan for the Area. The Cabinet submitted this request and SIP revision through a letter dated September 20, 2022, and supplemented it on November 22, 2022. EPA is proposing to approve the Commonwealth's plan for maintaining attainment of the 2015 8-hour ozone standard in the Northern Kentucky Area, including the motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and volatile organic compounds (VOCs) for the years of 2026 and 2035 for the Area, to incorporate the maintenance plan into the SIP, and to redesignate the Area to attainment for the 2015 8-hour ozone NAAQS. EPA previously approved the redesignation request and maintenance plan for the Ohio portion of the Cincinnati, OH-KY Area. EPA is also notifying the public of the status of EPA's adequacy determination for the MVEBs for the Area.
COBRA Fees to be Adjusted for Inflation in Fiscal Year 2024 CBP Dec. 23-08
This document announces that U.S. Customs and Border Protection (CBP) is adjusting certain customs user fees and corresponding limitations established by the Consolidated Omnibus Budget Reconciliation Act (COBRA) for Fiscal Year 2024 in accordance with the Fixing America's Surface Transportation Act (FAST Act) as implemented by the CBP regulations.
Generic Drug User Fee Rates for Fiscal Year 2024
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2024 rates for GDUFA III fees. These fees are effective on October 1, 2023, and will remain in effect through September 30, 2024.
Airworthiness Directives; Bombardier, Inc., Airplanes
The FAA is adopting a new airworthiness directive (AD) for all Bombardier, Inc., Model BD-100-1A10 airplanes. This AD was prompted by an in-service event where the nose gear door amber caution message displayed on the crew alerting system during the initial climb after gear retraction. This AD requires revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA is issuing this AD to address the unsafe condition on these products.
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