December 2022 – Federal Register Recent Federal Regulation Documents
Results 551 - 600 of 2,202
M11 Clinical Electronic Structured Harmonised Protocol; International Council for Harmonisation; Draft Guidance for Industry; Draft Template; and Technical Specification; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP),'' and two supplemental documents entitled ``M11 Template,'' and ``M11 Technical Specification.'' The draft guidance, template, and technical specification were prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The draft guidance provides recommendations for a harmonized clinical trial protocol including the organization of standardized content and formatting. The draft template identifies headers, common text, and a set of data fields and terminologies that will be the basis for efficiencies in data exchange. The technical specification recommends the use of an open, non-proprietary standard to enable electronic exchange of clinical protocol information. The intent of the draft guidance and supporting documents is to create an international standard for the content and exchange of clinical trial protocol information facilitating review and assessment by regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders.
Technical Advisory Committee; Request for Nominations
The BLS is soliciting new members for the Technical Advisory Committee (TAC) to address five member terms expiring on April 27, 2023, one current vacancy, and any additional vacancies that may occur on the TAC between the date of publication of this notice and April 27, 2023.
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Land Use Application and Permit
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes to renew an information collection.
Submission of Data by State Educational Agencies; Submission Dates for State Revenue and Expenditure Reports for Fiscal Year 2022, Revisions to Those Reports, and Revisions to Prior Fiscal Year Reports
The Secretary announces dates for State educational agencies (SEAs) to submit expenditure and revenue data and average daily attendance statistics on ED Form 2447 (the National Public Education Financial Survey (NPEFS)) for fiscal year (FY) 2022, revisions to those reports, and revisions to reports for previous fiscal years. The Secretary sets these dates to ensure that data are available to serve as the basis for timely distribution of Federal funds. The U.S. Census Bureau is the data collection agent for this request of the Department of Education's National Center for Education Statistics (NCES). The data will be published by NCES and will be used by the Secretary in the calculation of allocations for FY 2024 appropriated funds.
Processing Claims, Sergeant First Class Heath Robinson Honoring Our Promise To Address Comprehensive Toxics Act of 2022, or the Honoring Our PACT Act of 2022
On August 10, 2022, the President signed the Sergeant First Class Heath Robinson Honoring our Promise to Address Comprehensive Toxics Act of 2022, or the Honoring our PACT Act of 2022 (PACT Act) into law, establishing substantial legislative changes in laws administered by the Department of Veterans Affairs (VA).
Local Government Advisory Committee (LGAC) Meeting
Pursuant to the Federal Advisory Committee Act (FACA), EPA herby provides notice of a meeting for the Local Government Advisory Committee (LGAC) on the date and time described below. This meeting will be open to the public. For information on public attendance and participation, please see the registration information under SUPPLEMENTARY INFORMATION.
Administrative Simplification: Adoption of Standards for Health Care Attachments Transactions and Electronic Signatures, and Modification to Referral Certification and Authorization Transaction Standard
This rule would implement requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, enacted on March 30, 2010collectively, the Affordable Care Act. Specifically, this proposed rule would adopt standards for ``health care attachments'' transactions, which would support both health care claims and prior authorization transactions, and a standard for electronic signatures to be used in conjunction with health care attachments transactions. To better support the use of the proposed standards for attachments transactions with prior authorization transactions, this rule also proposes to adopt a modification to the standard for the referral certification and authorization transaction (X12 278) to move from Version 5010 to Version 6020.
Payments Under State Home Care Agreements for Nursing Home Care
The Department of Veterans Affairs proposes to amend its State home per diem regulation to provide a new formula for calculating the prevailing rate VA would pay a State home that enters into a State home care agreement to provide nursing home care to eligible veterans.
FDIC Official Sign and Advertising Requirements, False Advertising, Misrepresentation of Insured Status, and Misuse of the FDIC's Name or Logo
The Federal Deposit Insurance Corporation (FDIC) is seeking comment on a proposal to modernize the rules governing use of the official FDIC sign and insured depository institutions' (IDIs) advertising statements to reflect how depositors do business with IDIs today, including through digital and mobile channels. The proposed rule also would clarify the FDIC's regulations regarding misrepresentations of deposit insurance coverage by addressing specific scenarios where consumers may be misled as to whether they are doing business with an IDI and whether their funds are protected by deposit insurance. The proposal is intended to enable consumers to better understand when they are doing business with an IDI and when their funds are protected by the FDIC's deposit insurance coverage.
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2024
This proposed rule includes proposed payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation programs, as well as proposed 2024 user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also proposes requirements related to updating standardized plan options and reducing plan choice overload; re-enrollment hierarchy; plan and plan variation marketing name requirements for QHPs; essential community providers (ECPs) and network adequacy; failure to file and reconcile; special enrollment periods (SEPs); the annual household income verification; the deadline for QHP issuers to report enrollment and payment inaccuracies; requirements related to the State Exchange improper payment measurement program; and requirements for agents, brokers, and web-brokers assisting FFE and SBE-FP consumers.
Home Mortgage Disclosure (Regulation C); Judicial Vacatur of Coverage Threshold for Closed-End Mortgage Loans
In April 2020, the Consumer Financial Protection Bureau (Bureau or CFPB) issued a final rule (2020 HMDA Rule) to amend Regulation C to increase the threshold for reporting data about closed- end mortgage loans. The 2020 HMDA Rule increased the closed-end mortgage loan reporting threshold from 25 loans to 100 loans in each of the two preceding calendar years, effective July 1, 2020. On September 23, 2022, the United States District Court for the District of Columbia vacated the 2020 HMDA Rule as to the increased loan-volume reporting threshold for closed-end mortgage loans. As a result of the September 23, 2022 order, the threshold for reporting data about closed-end mortgage loans is 25, the threshold established by the 2015 HMDA Rule. Accordingly, this technical amendment updates the Code of Federal Regulations to reflect the closed-end mortgage loan reporting threshold of 25 mortgage loans in each of the two preceding calendar years.
Protected Critical Infrastructure Information: Technical Amendments
This final rule amends the Protected Critical Infrastructure Information regulations to provide non-substantive technical, organizational, and conforming updates that are intended to improve the accuracy of these provisions. This action is editorial in nature and does not impose any new regulatory requirements on affected parties.
Clean Energy for New Federal Buildings and Major Renovations of Federal Buildings
The Department of Energy (``DOE'') is publishing a supplemental notice of proposed rulemaking (``SNOPR'') to establish revised energy performance standards for the construction of new Federal buildings, including commercial buildings, multi-family high- rise residential buildings, and low-rise residential buildings per the Energy Conservation and Production Act (``ECPA''), as amended by the Energy Independence and Security Act (``EISA'') of 2007. This document presents an updated proposal with a new focus that accounts for the needs of Federal agencies and the goals of President Biden's Administration and responds to comments received on prior notice of proposed rulemaking (``NOPR'') and SNOPR documents. Consistent with the requirements of ECPA and EISA, this document presents revised Federal building energy performance standards that would require reductions in Federal agencies' on-site use of fossil fuels (which include coal, petroleum, natural gas, oil shales, bitumens, tar sands, and heavy oils) consistent with the targets of ECPA and EISA and provides processes by which agencies can petition DOE for the downward adjustment of said targets for buildings.
Strengthening the Section 184 Indian Home Loan Guarantee Program
This proposed rule would revise the regulations governing the Section 184 Indian Home Loan Guarantee Program (``Section 184 Program'') to fiscally strengthen the program by clarifying rules for Lenders, Tribes, and Borrowers. As the program has experienced an increase in demand, it now requires an update to the implementing regulations to minimize potential risk and increase program participation by financial institutions. This proposed rule strives to modernize and enhance the Section 184 Program by adding participation and eligibility requirements for Lenders and other financial institutions. This proposed rule would also clarify the rules governing Tribal participation in the program, establish underwriting requirements, specify rules on the closing and endorsement process, establish stronger and clearer servicing requirements, establish program rules governing claims submitted by Servicers and paid by HUD, and add standards governing monitoring, reporting, sanctions and appeals. This rule would add new definitions and make statutory conforming amendments, including the categorical exclusion of the Section 184 program in HUD's environmental review regulations. Ultimately, the changes made by this proposed rule would promote program sustainability, increase Borrower protections, and provide clarity for new and existing Lenders who participate in the program.
Technical Amendments to Commission Rules
To conform with current Federal Register requirements of structuring statutory authority citations within the Code of Federal Regulations (``CFR''), the Securities and Exchange Commission (``Commission'') is adopting technical amendments to its regulations regarding organization; conduct and ethics; and information and requests. The technical amendments move the citations of statutory authority for the regulations from the subpart level to the part level and amend related citations to remove duplicative statutory citations at the subpart level.
International Product Change-International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add an International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
International Product Change-International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add an International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
International Product Change-International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add an International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
International Product Change-International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service With Reseller Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add an International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service with Reseller contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
International Product Change-International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service With Reseller Agreement
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add an International Priority Airmail, Commercial ePacket, Priority Mail Express International, Priority Mail International & First-Class Package International Service with Reseller contract to the list of Negotiated Service Agreements in the Competitive Product List in the Mail Classification Schedule.
Addition of General Licenses for the Official Business of the United States Government and Certain International Organizations and Entities and Updates to the 50 Percent Rule Interpretive in OFAC Sanctions Regulations
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending its regulations in multiple sanctions programs to add, amend, or update general licenses authorizing official business of the United States government and official business of certain international organizations and entities, and update an interpretation explaining that the property and interests in property of an entity are blocked if one or more blocked persons own, whether individually or in the aggregate, directly or indirectly, a 50 percent or greater interest in the entity. Additionally, OFAC is updating the authority citation of several CFR parts to consolidate or shorten citations to conform to Federal Register requirements.
Hazardous Materials: Enhanced Safety Provisions for Lithium Batteries Transported by Aircraft (FAA Reauthorization Act of 2018)
This final rule revises the Hazardous Materials Regulations for lithium cells and batteries transported by aircraft and is consistent with the previously published Interim Final Rule, which responded to congressional mandates; prohibited the transport of lithium ion cells and batteries as cargo on passenger aircraft; required lithium ion cells and batteries to be shipped at not more than a 30 percent state of charge aboard cargo-only aircraft when not packed with or contained in equipment; and limited the use of alternative provisions for smaller lithium cell or battery shipments to one package per consignment. In response to comments, this final rule provides editorial amendments and modification of certain provisions including marking requirements, requests for an extension on the compliance date, and exception for lithium cells or batteries used for medical devices with approval by the Associate Administrator.
Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants: Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review
On August 12, 2020, the U.S. Environmental Protection Agency (EPA) published the final risk and technology review (RTR) for the Miscellaneous Organic Chemical Manufacturing NESHAP (2020 MON final rule) pursuant to Clean Air Act (CAA). Subsequently, the EPA received and granted petitions for reconsideration on two issues, specifically, on the use of the EPA's IRIS value for ethylene oxide in assessing cancer risk for the source category, and the use of the Texas Commission on Environmental Quality's (TCEQ's) risk value for ethylene oxide as an alternative risk value to the EPA's IRIS value for purposes of evaluating risk as part of the CAA residual risk review. On February 4, 2022, the EPA proposed the Reconsideration of the 2020 National Emission Standards for Hazardous Air Pollutants (NESHAP): Miscellaneous Organic Chemical Manufacturing Residual Risk and Technology Review to address these two issues and request public comment. This action finalizes the EPA's decision to use the IRIS value for ethylene oxide in the risk assessment for the 2020 MON final rule and our decision to reject the use of the TCEQ's risk value for ethylene oxide as an alternative risk value to the EPA's IRIS value. As such, in this final action, EPA is making no changes to the risk assessment or related regulatory text for the miscellaneous organic chemical manufacturing source category.
Miscellaneous and General Requirements
The Federal Labor Relations Authority (FLRA or Authority) seeks public comments on a proposed revision to its regulations and a proposed rescission of its general statement of policy or guidance (policy statement) in Office of Personnel Management (OPM), 71 FLRA 571 (2020) (Member Abbott concurring; then-Member DuBester dissenting). The proposed revision and rescission concern the intervals at which Federal employees may revoke their voluntary, written assignments of payroll deductions for the payment of regular and periodic dues allotted to their exclusive representative. Specifically, in addition to rescinding OPM, the Authority proposes either revising its regulation entitled ``Revocation of Assignments'' to provide that dues revocations may be processed only at one-year intervals, or, alternatively, rescinding that regulation in its entirety. The Authority seeks comments on these proposals.
Determination That ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ZYBAN (Bupropion Hydrochloride) Tablets, Extended Release, 150 Milligrams, was 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.
Occupational Exposure to Noise Standard (29 CFR 1910.95) Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
OSHA solicits public comments concerning the proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Occupational Exposure to Noise Standard.
Records Schedules; Availability and Request for Comments
The National Archives and Records Administration (NARA) publishes notice of certain Federal agency requests for records disposition authority (records schedules). We publish notice in the Federal Register and on regulations.gov for records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on such records schedules.
Notice of Availability and Request for Comment: “Study of Debris Penetration of Recreational Off-Highway Vehicle (ROV) Proof-of-Concept (POC) Floorboard Guards”
The U.S. Consumer Product Safety Commission (Commission or CPSC) is announcing the availability of, and seeking comment on, a report from SEA, Ltd. (SEA), ``Study of Debris Penetration of Recreational Off-Highway Vehicle (ROV) Proof-of-Concept (POC) Floorboard Guards'' (SEA Technical Report). This report is related to CPSC's notice of proposed rulemaking (NPR) regarding off-highway vehicle debris penetration hazards. CPSC contracted with SEA to perform debris penetration tests on POC floorboard guards per the test methods described in the NPR. The SEA Technical Report also evaluates an alternative test method for debris penetration that is proposed in two draft voluntary standards. The SEA testing evaluates the effectiveness of the test methods in addressing the debris penetration hazard and the feasibility of the proposed requirements in the NPR.
Addition of General Licenses to OFAC Sanctions Regulations for Certain Transactions of Nongovernmental Organizations and Related to Agricultural Commodities, Medicine, Medical Devices, Replacement Parts and Components, or Software Updates for Medical Devices
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending its regulations in multiple sanctions programs to add general licenses authorizing certain transactions of nongovernmental organizations and certain transactions related to the provision of agricultural commodities, medicine, medical devices, replacement parts and components, or software updates.
Notice of Extensions for Reinstated Product Exclusions: China's Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation
In prior Federal Register notices, the U.S. Trade Representative modified the actions being taken in the section 301 investigation of China's acts, policies, and practices related to technology transfer, intellectual property, and innovation by excluding certain products from additional duties. The U.S. Trade Representative subsequently extended 549 of these exclusions. In 2022, following public notice and comment, the U.S. Trade Representative determined to reinstate 352 of these exclusions. These reinstated exclusions are scheduled to expire on December 31, 2022. This notice announces the U.S. Trade Representative's determination to extend the reinstated exclusions for an additional nine months.
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