Federal Register Redux: 2024-09-23

Overview of Today’s Federal Register

Federal Register Excerpts (September 23, 2024): A Detailed Table of Contents

Part 1: Legal Notices and Proposed Rules

I. Food and Drug Administration (FDA)

1. A. NoticesAdvancing Smoking Cessation: Outlines priorities for the FDA and National Institutes of Health (NIH) concerning smoking cessation. (77521-77523)

2. Patent Extension Regulatory Review Period: Symdeko: Discusses the patent extension for the cystic fibrosis drug Symdeko. (77520-77521)

3. Withdrawal of Approval of Drug Application: Progynon Associates: Announces the withdrawal of approval for Oreton (testosterone) and Winstroid (stanozolol) due to failure to submit required reports. (77515)

4. B. Proposed RulesRequirements Related to the Mental Health Parity and...: This section focuses on proposed changes to mental health parity regulations. (Incomplete excerpt)

5. Part 866—Immunology and Microbiology Devices: This section introduces an amendment to part 866 of Title 21 of the Code of Federal Regulations, specifically focusing on quantitative cytomegalovirus nucleic acid tests for transplant patient management. (Incomplete excerpt)

II. Department of Homeland Security (DHS)

1. A. U.S. Coast GuardSafety Zone; MassDOT Kernwood Avenue Bridge, Danvers River, Salem and Beverly, MA: This section announces a temporary safety zone around the MassDOT Kernwood Avenue Bridge during repair work, outlining the zone's location, duration, and enforcement periods. (Incomplete excerpt)

2. Regulated Navigation Areas and Limited Access Areas: This section proposes an amendment to part 165 of Title 33 of the Code of Federal Regulations related to regulated navigation areas and limited access areas. (Incomplete excerpt)

III. Department of Commerce

1. A. National Oceanic and Atmospheric Administration (NOAA)Fisheries of the Exclusive Economic Zone Off Alaska: This section implements a temporary rule prohibiting directed fishing for Pacific ocean perch in the Central Aleutian district to prevent exceeding the 2024 total allowable catch. (Incomplete excerpt)

IV. Department of Transportation (DOT)

1. A. Federal Aviation Administration (FAA)Airworthiness Directives; Piper Aircraft, Inc. Airplanes: This section proposes a new airworthiness directive superseding a previous one to address fatigue cracks in Piper aircraft, outlining required inspections and modifications. (Incomplete excerpt)

V. Environmental Protection Agency (EPA)

• A. Air Quality State Plan Approval; South Coast Air Quality Management District and Mojave Desert Air Quality Management District; Negative Declarations; Oil and Natural Gas Production and Processing; California: This section concerns the approval of California's negative declarations for the Oil and Natural Gas CTG for the 2008 and 2015 ozone NAAQS. (Incomplete excerpt)

VI. Foreign-Trade Zones Board

1. A. NoticesProposed Production Activity: Lists proposed production activities for various companies in different foreign-trade zones. (Incomplete excerpt)

VII. International Trade Administration

1. A. NoticesCertain Softwood Lumber Products From Canada: Provides an update on the antidumping duty investigation of certain softwood lumber from Canada. (Incomplete excerpt)

VIII. Department of Commerce

1. A. National Oceanic and Atmospheric Administration (NOAA)Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico: This section announces the issuance of a Letter of Authorization (LOA) to LLOG Exploration Offshore, LLC for the incidental take of marine mammals during geophysical surveys in the Gulf of Mexico. It summarizes the request, analysis, and authorization for the activity. (Incomplete excerpt)

2. Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to Marine Site Characterization Surveys off New York and New Jersey in the New York Bight: This section announces the renewal of an incidental harassment authorization for the take of marine mammals during marine site characterization surveys off the coasts of New York and New Jersey. It details the authorization process, survey information, mitigation measures, and environmental impact considerations. (Incomplete excerpt)

IX. Department of Defense (DoD)

1. A. Office of the SecretaryTransmittal No. 23-28: Announces a proposed arms sale to Latvia, including a Naval Strike Missile Coastal Defense System and related equipment, outlining its purpose and estimated cost. (Incomplete excerpt)

2. Transmittal No. 23-30: Arms Sales Notification: Notifies of arms sales to the United Kingdom, specifying that all items have been cleared for release and export. (Incomplete excerpt)

3. B. Office of the Under Secretary of Defense for Intelligence and SecurityDocket ID: DoD-2024-OS-0056: This section details proposed modifications to the DoD's Privacy Act System of Records Notice (SORN) for "Defense Incident-Based Reporting System (DIBRS)," focusing on data sharing and system management updates. (Incomplete excerpt)

4. C. Office of the SecretaryTransmittal No. 23-34: Details a proposed arms sale to Norway for C-130J aircraft sustainment and associated services, covering its scope, cost, and justification. (Incomplete excerpt)

5. Transmittal No. 23-0D: Reports an enhancement of technology or capability in a previous arms sale to Romania involving AH-64D Apache Longbow Block III Attack Helicopters, specifically the addition of Common Missile Warning Systems. (Incomplete excerpt)

6. Privacy Act of 1974; System of Records Notice: This section proposes changes to the system of records notice for the "Defense Incident-Based Reporting System (DIBRS)," addressing data sharing, system management, and data collection updates. (Incomplete excerpt)

Part 2: Rules and Regulations

I. Department of Energy (DOE)

1. A. National Nuclear Security AdministrationDefense Nuclear Facilities Safety and Security Board: Provides contact information for various Department of Energy sites. (77504)

II. Environmental Protection Agency (EPA)

• A. Air Quality State Plan Approval; South Coast Air Quality Management District and Mojave Desert Air Quality Management District; Negative Declarations; Oil and Natural Gas Production and Processing; California (Continued from Part 1): Continues the discussion of California's negative declarations for the Oil and Natural Gas CTG for the 2008 and 2015 ozone NAAQS. (Incomplete excerpt)

III. Federal Maritime Commission

1. A. Ocean Transportation Intermediary Licensing—Non-Vessel Operating Common Carriers; CorrectionCorrects a previous document regarding licensing requirements for non-vessel operating common carriers in ocean transportation. (77511)

IV. Department of the Treasury

1. A. Internal Revenue ServiceOff-Cycle Credit Application: Details an off-cycle greenhouse gas (GHG) credit application from Jaguar Land Rover (JLR) for using a 48 Volt efficient motor-generator and a 48 volt/12 volt DC/DC converter in their vehicles. (Incomplete excerpt)

V. Federal Reserve System

1. A. Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesAnnounces the application of Security Midwest Bancorp, Inc. to become a bank holding company through the acquisition of Security Bank, S.B. in Springfield, Illinois. (77513)

VI. Department of Health and Human Services (HHS)

1. A. Food and Drug AdministrationPatent Extension; Symdeko: Announces the patent term restoration for Symdeko (tezacaftor/ivacaftor) for the treatment of cystic fibrosis, outlining the regulatory review period and patent information. (77520)

2. B. National Institutes of HealthBasic Mechanisms and Therapeutic Targets of Aging and Age-Related Diseases: This notice requests applications for the "Basic Mechanisms and Therapeutic Targets of Aging and Age-Related Diseases," outlining research priorities, eligibility, and funding opportunities. (77521)

VII. Department of the Interior

1. A. Fish and Wildlife ServiceNotice of Intent To Prepare an Environmental Impact Statement for the Proposed Rat Eradication Project on Four Islands in the Alaska Maritime National Wildlife Refuge, Alaska: This section announces the intent to prepare an environmental impact statement for eradicating non-native rats from four islands in the Alaska Maritime National Wildlife Refuge. It outlines the project, alternatives, cooperating agencies, and public comment procedures. (Incomplete excerpt)

VIII. Bureau of Land Management

1. A. Notice of Officially Filed Plats of Survey: ArizonaLists recently filed survey plats in Arizona, specifying their location, date of acceptance, and purpose. (77540)

IX. Securities and Exchange Commission

1. A. Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To Amend FINRA Rule 3240 (Borrowing From and Lending to Customers)This section details the SEC's approval of FINRA's proposed rule change to amend Rule 3240 regarding borrowing and lending between registered persons and customers. It outlines the rule's background, purpose, amendments, comment summaries, and the SEC's analysis and justification for approval. (Incomplete excerpt)

X. Department of Transportation

1. A. Federal Motor Carrier Safety AdministrationParts and Accessories Necessary for Safe Operation; Application for an Exemption From Encore Flooring & Building Products, USDOT #2329419: This section announces the FMCSA's decision to grant an exemption to Encore Flooring & Building Products. This exemption permits the use of an Intellistop module, which modifies brake lamp behavior for enhanced safety. The document summarizes the application, public comments, and the agency's rationale for granting the exemption. (Incomplete excerpt)

XI. Departments of Labor, the Treasury, and Health and Human Services

1. A. Patient Protection and Affordable Care Act; Health Insurance Portability and Accountability Act; Mental Health Parity and Addiction Equity Act ImplementationThis section details the final rules implementing the Mental Health Parity and Addiction Equity Act (MHPAEA). It covers definitions related to mental health and substance use disorder benefits, non-quantitative treatment limitations, comparative analyses, and severability clauses. The document outlines the rulemaking process, stakeholder input, and the agencies' rationale for the final rules. (Incomplete excerpt)

Urgent and High-Impact Items in the Federal Register Excerpts

While the sources don't explicitly categorize items as "Urgent" or "High-Impact," certain regulations suggest urgency due to safety concerns or have a potentially broad impact on specific industries or stakeholders. Here are some examples:

• Boeing 737 Runway Prohibition Due to Software Errors [1, 2]: The FAA's final rule prohibiting specific runway selections for Boeing 737s equipped with particular software versions is a high-impact item due to its direct implications for aviation safety. The rule stems from reported display electronic unit software errors during instrument approaches, highlighting a potentially dangerous situation requiring immediate action.

• Piper Aircraft Inspection and Reporting Mandate [3-6]: The FAA's proposed rule, focusing on the inspection of Piper aircraft for potential fatigue cracks in wing spars, is another high-impact item related to aviation safety. The rule mandates inspecting critical bolt holes for anomalies that could develop into fatigue cracks, emphasizing the urgency of addressing these potential weaknesses. The mandatory reporting of inspection results to both Piper and the FAA further underscores the significance of monitoring and mitigating this safety concern.

• Mental Health Parity Act Regulations [7-78]: The extensive regulations related to the Mental Health Parity and Addiction Equity Act (MHPAEA) represent high-impact items with significant implications for health insurance plans and issuers. These rules aim to ensure parity between mental health and substance use disorder benefits and medical/surgical benefits. Key elements include:

• Stringent Data Collection and Analysis Requirements [50, 52, 54, 56, 59, 61, 62, 67, 77]: Plans and issuers are now mandated to collect and evaluate substantial data to demonstrate that their non-quantitative treatment limitations (NQTLs) for mental health and substance use disorder benefits are not more restrictive than those for medical/surgical benefits. This involves analyzing factors like claims denials, network adequacy, and reimbursement rates.

• Demonstrating "Meaningful Benefits" and Addressing Disparities [47, 48, 61, 64]: Plans must provide "meaningful benefits" for mental health conditions and substance use disorders, addressing concerns about minimal coverage compared to medical/surgical benefits.

• Prohibition on Discriminatory Practices [7, 12, 44, 46, 51, 61, 71, 79]: The regulations explicitly prohibit using discriminatory factors or evidentiary standards when designing or applying NQTLs. This aims to prevent practices that systematically disadvantage access to mental health or substance use disorder care.

These MHPAEA regulations signal a significant shift in how mental health and substance use disorder benefits are regulated and will require substantial effort from plans and issuers to demonstrate compliance. The phased applicability dates, with some provisions taking effect in 2026, highlight the complexity of these changes.

It's important to note that while these items stand out, other regulations within the sources, such as those related to international trade or USAID data management, may also have significant but less immediately apparent impacts on specific industries or stakeholders.

Obscure Regulations in the Federal Register

Here are some examples of regulations from the provided excerpts of the Federal Register that an average American might find obscure:

• Rules for Runway Selection Based on Airplane Software: The Federal Aviation Administration (FAA) issued a final rule that supersedes a previous directive regarding the Boeing Company Model 737 series airplanes. The rule prohibits the selection of certain runways for airplanes equipped with specific software due to reports of display electronic unit (DEU) software errors that occurred when airplanes used an instrument approach to land on a particular runway. [1]

• Reporting Requirements for Aircraft Inspection Results: In addition to requiring specific inspections of Piper aircraft, the FAA mandates that inspection results be reported to both Piper and the FAA if cracks are discovered during any inspection. [2]

• Data Management Plans for USAID Recipients: The U.S. Agency for International Development (USAID) will require grant and cooperative agreement recipients to submit information under new Standard Provisions, including detailed Activity Monitoring, Evaluation, and Learning Plans (AMELPs) and Data Management Plans (DMPs) for the digital information they provide to USAID. [3, 4]

• Accreditation Scheme for Conformity Assessment Program: The FDA is announcing updates to the Accreditation Scheme for Conformity Assessment (ASCA) Program. This program allows accredited organizations to conduct conformity assessments for medical devices in the United States. The updates impact medical device manufacturers, accreditation bodies, testing laboratories, and FDA staff. [5]

These regulations highlight the breadth and specificity of regulations found within the Federal Register. While they may not directly affect the everyday lives of most Americans, they illustrate the complexities of governing various industries and ensuring safety and compliance.