October 24, 2022 – Federal Register Recent Federal Regulation Documents

Designated Reserve Ratio for 2023
Document Number: 2022-22987
Type: Notice
Date: 2022-10-24
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
Pursuant to the Federal Deposit Insurance Act (FDI Act), the Board of Directors (Board) of the Federal Deposit Insurance Corporation (FDIC) designates that the Designated Reserve Ratio (DRR) for the Deposit Insurance Fund shall remain at 2 percent for 2023. The Board is publishing this notice as required by the FDI Act.
Assessments, Amendments To Incorporate Troubled Debt Restructuring Accounting Standards Update
Document Number: 2022-22986
Type: Rule
Date: 2022-10-24
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
The Federal Deposit Insurance Corporation is adopting a final rule that incorporates updated accounting standards in the risk-based deposit insurance assessment system applicable to all large insured depository institutions (IDIs), including highly complex IDIs. The FDIC calculates deposit insurance assessment rates for large and highly complex IDIs based on supervisory ratings and financial measures, including the underperforming assets ratio and the higher-risk assets ratio, both of which are determined, in part, using restructured loans or troubled debt restructurings (TDRs). The final rule includes modifications to borrowers experiencing financial difficulty, an accounting term recently introduced by the Financial Accounting Standards Board (FASB) to replace TDRs, in the underperforming assets ratio and higher-risk assets ratio for purposes of deposit insurance assessments.
Assessments, Revised Deposit Insurance Assessment Rates
Document Number: 2022-22985
Type: Rule
Date: 2022-10-24
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
The FDIC is adopting a final rule to increase initial base deposit insurance assessment rate schedules by 2 basis points, beginning the first quarterly assessment period of 2023. The increase in the assessment rate schedules will increase the likelihood that the reserve ratio will reach the statutory minimum of 1.35 percent by the statutory deadline of September 30, 2028, consistent with the FDIC's Amended Restoration Plan, and is intended to support growth in the Deposit Insurance Fund (DIF or fund) in progressing toward the FDIC's long-term goal of a 2 percent Designated Reserve Ratio (DRR).
Announcement of Solicitation of Written Comments on Proposed Healthy People 2030 Objectives
Document Number: 2022-22983
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) solicits written comments on an additional objective proposed to be added to Healthy People 2030, and written comments from the public proposing additional new core, developmental, or research objectives to be included in Healthy People 2030. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives will be incorporated on https://health.gov/healthypeople. This updated set will reflect further review and deliberation by federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts.
Federal Economic Statistics Advisory Committee
Document Number: 2022-22982
Type: Notice
Date: 2022-10-24
Agency: Department of Commerce, Bureau of Economic Analysis
The Under Secretary for Economic Affairs requests nominations of individuals to the Federal Economic Statistics Advisory Committee (FESAC or the Committee). The Under Secretary for Economic Affairs, in coordination with the Directors of the Bureau of Economic Analysis and the U.S. Census Bureau, as well as the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics, will consider nominations received in response to this notice, as well as from other sources.
Federal Economic Statistics Advisory Committee Meeting
Document Number: 2022-22981
Type: Notice
Date: 2022-10-24
Agency: Department of Commerce, Bureau of Economic Analysis
The Bureau of Economic Analysis (BEA) is giving notice of a meeting of the Federal Economic Statistics Advisory Committee (FESAC or the Committee). The Committee advises the Under Secretary for Economic Affairs, the Directors of the Bureau of Economic Analysis and the Census Bureau, and the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. An agenda will be accessible prior to the meeting at https://apps.bea.gov/fesac/.
Notice of Public Meeting of the Nebraska Advisory Committee to the U.S. Commission on Civil Rights
Document Number: 2022-22980
Type: Notice
Date: 2022-10-24
Agency: 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 Nebraska Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold two (2) meetings on Thursday, November 10, 2022 at 4:00 p.m.- 5:00 p.m. Central Time and Tuesday, December 13, 2022 at 4:00 p.m.-5:00 p.m. Central Time. The purpose for the meetings is to discuss the proposal for their project on the effects of the pandemic on education in the state.
Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities September 2022
Document Number: 2022-22979
Type: Proposed Rule
Date: 2022-10-24
Agency: Environmental Protection Agency
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.
Proposed Collection; Comment Request; Extension: Rule 201 and Rule 200(g) of Regulation SHO
Document Number: 2022-22977
Type: Notice
Date: 2022-10-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request; Extension: Rule 18f-1 and Form N-18f-1
Document Number: 2022-22976
Type: Notice
Date: 2022-10-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Proposed Collection; Comment Request; Extension: Rule 602
Document Number: 2022-22975
Type: Notice
Date: 2022-10-24
Agency: Securities and Exchange Commission, Agencies and Commissions
CHAMPVA Coverage of Audio-Only Telehealth, Mental Health Services, and Cost Sharing for Certain Contraceptive Services and Contraceptive Products Approved, Cleared, or Granted by FDA
Document Number: 2022-22905
Type: Proposed Rule
Date: 2022-10-24
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA) proposes amending its medical regulations regarding Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) coverage. This rulemaking would align with the Department of Defense for benefits administered through TRICARE and more closely align with requirements of other Federal programs. This rulemaking would remove the exclusion from CHAMPVA coverage for audio-only telehealth. In addition, we propose removing limitations on outpatient mental health visits as well as removing cost sharing requirements for certain contraceptive services and contraceptive products approved, cleared, or granted by the U.S. Food and Drug Administration (FDA).
Notice of Availability of the Proposed Notice of Sale for Gulf of Mexico Outer Continental Shelf Region-Wide Oil and Gas Lease Sale 259
Document Number: 2022-22886
Type: Notice
Date: 2022-10-24
Agency: Department of the Interior, Bureau of Ocean Energy Management
The Bureau of Ocean Energy Management (BOEM) announces the availability of the Proposed Notice of Sale (NOS) for the proposed Gulf of Mexico (GOM) Region-wide Outer Continental Shelf (OCS) Oil and Gas Lease Sale 259 (GOM Lease Sale 259). GOM Lease Sale 259 is required to be held by the Inflation Reduction Act of 2022. BOEM is publishing this notice pursuant to its regulatory authority. Regarding oil and gas leasing on the OCS, the Secretary of the Interior, pursuant to section 19 of the Outer Continental Shelf Lands Act, provides governors of affected states and the executive of any affected local government the opportunity to review and comment on the Proposed NOS. The Proposed NOS describes the proposed size, timing, and location of the sale, including lease stipulations, terms and conditions, minimum bids, royalty rates, and rental rates.
Airworthiness Directives; Vulcanair S.p.A. Airplanes
Document Number: 2022-22703
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for all Vulcanair S.p.A. Model P.68, P.68B, P.68C, P.68C-TC, P.68 ``Observer,'' P.68TC ``Observer,'' P.68 ``Observer 2,'' and P.68R airplanes. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as corrosion causing failure of the upper rudder hinge. This AD requires repetitively inspecting the upper and lower rudder hinges for corrosion, cracking, and damage, and depending on the inspection results, taking corrective action. The FAA is issuing this AD to address the unsafe condition on these products.
Airworthiness Directives; Bell Textron Canada Limited Helicopters
Document Number: 2022-22593
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
The FAA is adopting a new airworthiness directive (AD) for certain Bell Textron Canada Limited Model 429 helicopters. This AD was prompted by reports of failed rivets between the tailboom skin and the tail rotor (TR) gearbox support assembly. This AD requires visually inspecting the external surface of the TR gearbox support assembly, borescope inspecting or visually inspecting the inside of the tailboom for certain conditions, and performing a tactile inspection. Depending on the results of the inspections, this AD requires removing certain rivets from service or repairing gaps in accordance with an approved method. This AD also requires repeating these inspections within certain intervals. The FAA is issuing this AD to address the unsafe condition on these products.
Establishment of Class D Airspace; Chicago/Romeoville, IL
Document Number: 2022-22498
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
This action establishes Class D airspace at Chicago/ Romeoville, IL. This action supports the establishment of an air traffic control tower at Lewis University Airport, Chicago/Romeoville, IL.
Establishment of United States Area Navigation (RNAV) Route T-371; Kodiak, AK
Document Number: 2022-22497
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
This action establishes RNAV route T-371 in the vicinity of Kodiak, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska.
Amendment of United States Area Navigation (RNAV) Route T-269; Yakutat, AK
Document Number: 2022-22496
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
This action amends United States Area Navigation (RNAV) route T-269 in the vicinity of Yakutat, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska.
Amendment of United States Area Navigation (RNAV) Route T-266; Juneau, AK
Document Number: 2022-22411
Type: Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
This action amends United States Area Navigation (RNAV) route T-266 in the vicinity of Juneau, AK, in support of a large and comprehensive T-route modernization project for the state of Alaska.
Airworthiness Directives; GE Aviation Czech s.r.o. (Type Certificate Previously Held by WALTER Engines a.s., Walter a.s., and MOTORLET a.s.) Turboprop Engines
Document Number: 2022-22399
Type: Proposed Rule
Date: 2022-10-24
Agency: Federal Aviation Administration, Department of Transportation
The FAA proposes to adopt a new airworthiness directive (AD) for all GE Aviation Czech s.r.o. (GEAC) H75-100, H75-200, H80, H80-100, H80-200, H85-100, and H85-200 model turboprop engines. This proposed AD was prompted by the manufacturer revising the airworthiness limitations section (ALS) of the existing engine maintenance manual (EMM) to introduce updated coefficients for the calculation of the cyclic life and safe life for the main shaft. This proposed AD would require revising the ALS of the existing EMM and the operator's existing approved maintenance or inspection program, as applicable, to incorporate the updated coefficients and recalculate the cycles accumulated on critical parts. The FAA is proposing this AD to address the unsafe condition on these products.
Air Plan Approval; TN; Updates to References to Appendix W Modeling Guideline
Document Number: 2022-22357
Type: Rule
Date: 2022-10-24
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of Tennessee on April 9, 2021. Specifically, EPA is approving updates to the incorporation by reference of Federal guidelines on air quality modeling in the Tennessee SIP. EPA is also converting the previous conditional approval regarding infrastructure SIP prevention of significant deterioration (PSD) elements for the 2015 ozone national ambient air quality standards (NAAQS) for Tennessee to a full approval. EPA is approving this revision pursuant to the Clean Air Act (CAA or Act).
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Application for Free Training for Civics and Citizenship Teachers of Adults; Civics and Citizenship Toolkit
Document Number: 2022-23079
Type: Notice
Date: 2022-10-24
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Agency Information Collection Extension
Document Number: 2022-23077
Type: Notice
Date: 2022-10-24
Agency: Department of Energy, U.s. Energy Information Administration
EIA submitted an information collection request for extension as required by the Paperwork Reduction Act of 1995. The information collection requests a three-year extension with changes to its Form EIA-846, ``Manufacturing Energy Consumption Survey'' (MECS), OMB Control Number 1905-0169. The proposed collection will collect data from the U.S. manufacturing sector on energy consumption basic energy consumption and expenditures, shipments of energy offsite, end use consumption, building characteristics, participation in energy management programs, technologies, and fuel switching capacity.
Business Standards Council Review of Travel, Relocation, and Transportation (TRT) Federal Integrated Business Framework Business Standards: Request For Public Comment
Document Number: 2022-23076
Type: Notice
Date: 2022-10-24
Agency: General Services Administration, Agencies and Commissions
This notice informs the public of the opportunity to provide input on the proposed travel and expense management business standards that have been created in support of Federal shared services. This is the first set of TRT standards being developed and input will be used in formulation of business standards for Federal travel.
Privacy Act of 1974; Systems of Records
Document Number: 2022-23075
Type: Notice
Date: 2022-10-24
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Pursuant to the Privacy Act of 1974 and Office of Management and Budget (OMB) Circular No. A-108, to ensure the system of records notices remain accurate, the U.S. Nuclear Regulatory Commission (NRC) staff reviews each notice on a periodic basis. As a result of this systematic review, the NRC is republishing 13 of its system of records notices and has made various revisions to ensure that the NRC's notices remain clear, accurate, and up to date. Four of the system noticesNRC 5, Grants Management System, NRC 8, Employee Disciplinary Actions, Appeals, Grievances, and Complaints Records, NRC 11, Reasonable Accommodations Records, and NRC 23, Case Management SystemIndices, Files, and Associated Records are subject to a 30-day comment period. The revisions to these systems, with the exception of the modifications to routines uses for the NRC 5 and NRC 8 systems, are in effect upon this publication. The NRC 5 and NRC 8 routine use modifications will go into effect 30 days after this publication. The remaining systems revisions are minor corrective and administrative changes that do not meet the threshold criteria established by OMB for either a new or altered system of records. The minor modifications include updating authorities, narrowing the scope of one system notice, renaming two systems for clarity, and various other minor updates, in accordance with OMB Circular A-108. Additional details are provided in the SUPPLEMENTARY INFORMATION section of this document.
Cost-of-Living Increase and Other Determinations for 2023
Document Number: 2022-23073
Type: Notice
Date: 2022-10-24
Agency: Social Security Administration, Agencies and Commissions
Under title II of the Social Security Act (Act), there will be an 8.7 percent cost-of-living increase in Social Security benefits effective December 2022. In addition, the national average wage index for 2021 is $60,575.07. The cost-of-living increase and national average wage index affect other program parameters as described below.
Notice of Request for Approval of a New Information Collection
Document Number: 2022-23072
Type: Notice
Date: 2022-10-24
Agency: Department of Agriculture
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Office of the Chief Information Security OfficerInformation Security CenterChief Privacy Office to request approval for a new information collection for an electronic Request and/or Consent for Privacy Records.
30-Day Notice of Proposed Information Collection: Petition To Classify Special Immigrant Under INA 203(b)(4) as an Employee or Former Employee of the U.S. Government Abroad, or the Surviving Spouse or Child of an Employee of the U.S. Government Abroad
Document Number: 2022-23070
Type: Notice
Date: 2022-10-24
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
V and S Railway, LLC-Abandonment Exemption-in Franklin County, Mo.
Document Number: 2022-23069
Type: Notice
Date: 2022-10-24
Agency: Surface Transportation Board, Department of Transportation
National Cancer Institute; Notice of Closed Meetings
Document Number: 2022-23068
Type: Notice
Date: 2022-10-24
Agency: Department of Health and Human Services, National Institutes of Health
Solicitation of Nominations for Appointment to the Advisory Committee on Breast Cancer in Young Women (ACBCYW)
Document Number: 2022-23011
Type: Notice
Date: 2022-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the ACBCYW. The ACBCYW consists of 15 experts in fields associated with breast cancer, disease prevention, early detection, diagnosis, public health, social marketing, genetic screening and counseling, treatment, rehabilitation, palliative care, and survivorship in young women, or in related disciplines with a specific focus on young women.
Preparations for the 43rd Session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals
Document Number: 2022-23010
Type: Notice
Date: 2022-10-24
Agency: Department of Labor, Occupational Safety and Health Administration
This notice is to advise interested persons that OSHA will conduct a virtual public meeting in advance of the 43rd session of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals (UNSCEGHS) to be held as a hybrid (in-person and virtual) meeting December 7-9, 2022, in Geneva, Switzerland. OSHA, along with the U.S. Interagency Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Coordinating Group, plans to consider the comments and information gathered at this public meeting when developing the U.S. Government positions for the UNSCEGHS meeting. This meeting will occur jointly with the Department of Transportation (DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA), to discuss proposals in preparation for the 61st session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCETDG), to be held as a hybrid meeting November 28-December 6, 2022.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Training Provider Eligibility Collection
Document Number: 2022-23009
Type: Notice
Date: 2022-10-24
Agency: Department of Labor
The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
Proposed Extension of Information Collection; Slope and Shaft Sinking Plans, 30 CFR 77.1900 (Pertains to Surface Work Areas of Underground Coal Mines)
Document Number: 2022-23008
Type: Notice
Date: 2022-10-24
Agency: Department of Labor, Mine Safety and Health Administration
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Slope and Shaft Sinking Plans, 30 CFR 77.1900 (pertains to surface work areas of underground coal mines).
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH); Notice of Charter Renewal
Document Number: 2022-23007
Type: Notice
Date: 2022-10-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through February 3, 2023.
Proposed Extension of Information Collection; Program To Prevent Smoking in Hazardous Areas of Underground Coal Mines
Document Number: 2022-23006
Type: Notice
Date: 2022-10-24
Agency: Department of Labor, Mine Safety and Health Administration
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for the Program to Prevent Smoking in Hazardous Areas of Underground Coal Mines.
Petition for Modification of Application of Existing Mandatory Safety Standards
Document Number: 2022-23005
Type: Notice
Date: 2022-10-24
Agency: Department of Labor, Mine Safety and Health Administration
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
Petition for Modification of Application of Existing Mandatory Safety Standards
Document Number: 2022-23004
Type: Notice
Date: 2022-10-24
Agency: Department of Labor, Mine Safety and Health Administration
This notice is a summary of a petition for modification submitted to the Mine Safety and Health Administration (MSHA) by the party listed below.
Resolution-Related Resource Requirements for Large Banking Organizations
Document Number: 2022-23003
Type: Proposed Rule
Date: 2022-10-24
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions, Federal Reserve System
The Board of Governors of the Federal Reserve System (Board) and Federal Deposit Insurance Corporation (FDIC) (together, the agencies) are publishing for public comment this advance notice of proposed rulemaking (ANPR) to solicit public input regarding whether an extra layer of loss-absorbing capacity could improve optionality in resolving a large banking organization or its insured depository institution, and the costs and benefits of such a requirement. This may, among other things, address financial stability by limiting contagion risk through the reduction in the likelihood of uninsured depositors suffering loss, and keep various resolution options open for the FDIC to resolve a firm in a way that minimizes the long term risk to financial stability and preserves optionality. The agencies are seeking comment on all aspects of the ANPR from all interested parties and also request commenters to identify other issues that the Board and FDIC should consider.
New Message Format for the Fedwire® Funds Service
Document Number: 2022-23002
Type: Notice
Date: 2022-10-24
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors of the Federal Reserve System (Board) is announcing that the Federal Reserve Banks (Reserve Banks) will adopt the ISO[supreg] 20022 message format for the Fedwire[supreg] Funds Service on a single day, March 10, 2025. The Board is also announcing a revised testing strategy, backout strategy, and other details concerning the implementation of the ISO 20022 message format for the Fedwire Funds Service.
Surface Transportation Security Advisory Committee (STSAC) Meeting
Document Number: 2022-23023
Type: Notice
Date: 2022-10-24
Agency: Department of Homeland Security, Transportation Security Administration
The Transportation Security Administration (TSA) will hold a meeting of the Surface Transportation Security Advisory Committee (STSAC) on November 17, 2022. Members of the STSAC will meet in person at the TSA Headquarters. A link to virtually participate in the meeting will be available to members of the public as discussed below under SUPPLEMENTARY INFORMATION/Public Participation. An agenda for the meeting can also be found under SUPPLEMENTARY INFORMATION.
2021 Quarterly Listings; Safety Zones, Security Zones, and Special Local Regulations AGENCY: Coast Guard, Department of Homeland Security (DHS).
Document Number: 2022-23022
Type: Rule
Date: 2022-10-24
Agency: Coast Guard, Department of Homeland Security
This document provides notification of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This document lists temporary safety zones, security zones, and special local regulations, all of limited duration and for which timely publication in the Federal Register was not possible. This document also announces notifications of enforcement for existing reoccurring regulations that we issued but were unable to be published before the enforcement period ended.
Wisconsin Central, Ltd.-Petition for Declaratory Order-Interchange With Soo Line Railroad Company
Document Number: 2022-23021
Type: Notice
Date: 2022-10-24
Agency: Surface Transportation Board, Department of Transportation
Volkswagen Group of America, Inc., Denial of Petition for Decision of Inconsequential Noncompliance
Document Number: 2022-23020
Type: Notice
Date: 2022-10-24
Agency: National Highway Traffic Safety Administration, Department of Transportation
Volkswagen Group of America, Inc., (``Volkswagen'') has determined that certain model year (MY) 2019-2020 Volkswagen and Audi motor vehicles do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 138, Tire Pressure Monitoring Systems. Volkswagen filed a noncompliance report dated May 6, 2020, and later amended it on May 15, 2020. Volkswagen subsequently petitioned NHTSA on May 20, 2020, and later amended the petition on June 8, 2020, for a decision that the subject noncompliance is inconsequential as it relates to motor vehicle safety. This document announces and explains the denial of Volkswagen's petition.
In Vitro Permeation Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2022-23018
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``In Vitro Permeation Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance document provides recommendations for in vitro permeation test (IVPT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products by providing recommendations for IVPT studies, which can be used to support a demonstration that two topical products are bioequivalent.
In Vitro Release Test Studies for Topical Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry; Availability
Document Number: 2022-23017
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``In Vitro Release Test Studies for Topical Products Submitted in ANDAs.'' This draft guidance provides recommendations for in vitro release test (IVRT) studies for locally acting liquid-based and/or other semisolid topical products. This draft guidance is intended to assist applicants who are submitting abbreviated new drug applications (ANDAs) for such products, by providing recommendations for IVRT studies, which can be used to support a demonstration that two topical products are bioequivalent.
Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications; Draft Guidance for Industry, Availability
Document Number: 2022-23016
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs.'' This draft guidance is intended to assist applicants who submit abbreviated new drug applications (ANDAs) for liquid-based and/or other semisolid products applied to the skin, including integumentary and mucosal (e.g., vaginal) membranes (referred to as ``topical products''). This draft guidance document provides recommendations for physicochemical and structural (collectively, ``Q3'') characterizations that can be used to identify the dosage form of a proposed generic (test) topical product, and to describe properties of the drug product that may be critical to its performance (to support a demonstration of bioequivalence (BE)).
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2022-23015
Type: Notice
Date: 2022-10-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances for developing topical products applied to the skin, as well as integumentary and mucosal (e.g., vaginal) membranes. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
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