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Device for Sleep Apnea Testing Based on Mandibular Movement; Classification Into Class II

FDA has classified the device for sleep apnea testing based on mandibular movement into Class II (special controls), codifying the classification at 21 CFR 868.2376. The device is a prescription device intended to aid in evaluation of sleep apnea during sleep in patients suspected of having sleep breathing disorders. This De Novo classification, originally issued to Sunrise SA on January 7, 2022, establishes special controls that, combined with general controls, provide reasonable assurance of safety and effectiveness.

FDA Classifies Alzheimer's Pathology Test as Class II

FDA finalized classification of the Alzheimer's disease pathology assessment test as Class II (special controls), codifying the device type under 21 CFR 866.5840. The classification was applicable May 4, 2022, following De Novo review of Fujirebio Diagnostics' Lumipulse G β-Amyloid Ratio (1-42/1-40) device. Special controls identified in the order will apply to all devices of this generic type.

FDA Classifies Setmelanotide Eligibility Gene Variant Detection System Class II

FDA classified the setmelanotide eligibility gene variant detection system into class II (special controls) under 21 CFR 862.1164. The device is a qualitative in vitro diagnostic intended to detect germline variants within genes to identify patients eligible for setmelanotide treatment. Manufacturers of similar in vitro diagnostic devices should review special controls requirements.

Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia

FDA classified the digital therapy device for amblyopia as Class II with special controls. The device uses dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or improve visual acuity. This action codifies a prior De Novo classification from October 20, 2021, allowing other manufacturers to use this device as a predicate for 510(k) clearance.

Establishment of Class E Airspace; Sparta, KY

The FAA has issued a final rule establishing Class E airspace at Sparta, KY (Gallatin County Airport). The new airspace extends upward from 700 feet above the surface within a 6.5-mile radius of the airport to support new instrument procedures and IFR operations. The rule takes effect at 0901 UTC on July 9, 2026.

NCUA Proposes Streamlined Merger Rules for Credit Unions Converting to Banks

The NCUA Board has proposed amendments to 12 CFR Part 708a, Subpart C, which governs mergers of insured credit unions into banks. The proposal would eliminate certain prescriptive procedural, disclosure, and communication requirements currently imposed on credit unions pursuing such mergers. The intended effect is to reduce regulatory burdens on credit union boards of directors and provide them greater flexibility to exercise business judgment while still ensuring members receive clear and effective disclosures. Public comments are being accepted until June 22, 2026.

NIH WNV Monoclonal Antibodies Available for Licensing

NIAID, a component of the NIH, is making five novel neutralizing human monoclonal antibodies targeting West Nile virus (WNV) available for commercial licensing under 35 U.S.C. 209 and 37 CFR Part 404. The antibodies, which bind the WNV envelope protein, are in pre-clinical stage and are available alone or in combination, with accompanying nucleic acids, vectors, and host cells for production. HHS Reference No. E-200-2024-0 covers U.S. Provisional Patent Application (filed July 31, 2024) and PCT Application No. PCT/US2025/039922 (filed July 30, 2025).

Warning Letter to vapepengood.com for Marketing Unauthorized Nicotine Pouches

The FDA Center for Tobacco Products issued a warning letter to vapepengood.com (Flushing, NY) on April 9, 2026, for marketing unauthorized nicotine pouch products, specifically Icy Blackcurrant XX Strong Nicotine Pouches by Zyn and Zyn Red Fruits Nicotine Pouches, without required premarket authorization under section 910(c)(1)(A)(i) of the FD&C Act. The products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6). The firm must respond within 15 working days describing corrective actions and a compliance plan, and failure to address violations may result in civil money penalties, seizure, and/or injunction.

Steel Concrete Reinforcing Bar From Algeria; Determination

The US International Trade Commission determined that the U.S. steel concrete reinforcing bar (rebar) industry is materially injured by reason of imports of rebar from Algeria sold at less than fair value (LTFV). The investigation (No. 731-TA-1751) was initiated in June 2025 following a petition by the Rebar Trade Action Coalition. The Commission's affirmative determination was filed April 17, 2026, pursuant to Section 735(b) of the Tariff Act of 1930.

CTA/CQ Plan Amendment No. 1 Extends Processor Hours to 9 p.m. ET Sunday–8 p.m. ET Friday

The SEC published notice and instituted proceedings under Rule 608(b)(2)(i) of Regulation NMS to determine whether to approve or disapprove Amendment No. 1 to the Extended Hours Proposal. The proposal would extend the Consolidated Tape Association and Consolidated Quotation Plan Processor's hours of operation to receive and disseminate quotation and last-sale information from 9:00 p.m. ET Sunday through 8:00 p.m. ET Friday, with a one-hour technical refresh pause Monday through Thursday. Participants that utilize extended hours bear development and operating costs on a proportionate-share basis.

Takes of Marine Mammals Incidental to Francis Scott Key Bridge Rebuild, Baltimore MD

NMFS has received a request from the Federal Highway Administration for two consecutive incidental harassment authorizations to take marine mammals incidental to the Francis Scott Key Bridge Rebuild project in Baltimore, MD. The proposal would authorize Level B harassment take of Tamanend's bottlenose dolphins during pile driving activities. NMFS is requesting public comments on the proposed IHAs and possible 1-year renewals.

Proposed Incidental Harassment Authorizations for Sparrows Point Container Terminal Marine Mammal Take

NMFS has received a request from Tradepoint TiL Terminal, LLC (TTT) for two consecutive incidental harassment authorizations (IHAs) under the Marine Mammal Protection Act to incidentally take Tamanend's bottlenose dolphins (Level B harassment only) during construction of the Sparrows Point Container Terminal in Baltimore County, MD. NMFS is requesting public comments on the proposed IHAs and possible one-time 1-year renewals by May 22, 2026. Neither TTT nor NMFS expect serious injury or mortality to result from the activity.

Hei Siblings Petition NHTSA to Reconsider Seat Belt Warning Delay

Vianey Hei and Elry Hei filed a formal Petition for Reconsideration under 49 C.F.R. § 553.35 challenging NHTSA's April 6, 2026 interim final rule that further delayed implementation of rear-seat seat belt warning systems under FMVSS No. 208. Petitioners argue the delay was unjustified given NHTSA's own safety findings of approximately 50 lives saved and over 500 injuries prevented annually once the requirement is fully implemented. The petition requests NHTSA withdraw the delay or reopen the rulemaking with specific justification for which makes and models require additional time and what quantified cost basis supports the extension beyond NHTSA's own $19.59-per-vehicle estimate.

CFPB Final Rule Bars Disparate Impact Under ECOA Regulation B

The CFPB has finalized amendments to Regulation B (12 CFR Part 1002), implementing the Equal Credit Opportunity Act, removing disparate impact liability under the effects test. The rule further defines what constitutes discouragement of credit applicants and adds prohibitions and conditions for special purpose credit programs (SPCPs). The amendments facilitate compliance by clarifying creditor obligations under ECOA.

USITC Corrects Electric Aircraft 337-TA-1499 Investigation

The U.S. International Trade Commission issued a correction to Investigation No. 337-TA-1499 concerning electric aircraft, power systems for electric aircraft, and components thereof. The correction adds a new paragraph to the Scope of Investigation section specifying that the presiding administrative law judge shall take evidence and hear arguments on public interest factors under 19 U.S.C. 1337(d)(1), (f)(1), and (g)(1). The notice also adds a clarifying statement that the correction does not alter the date of institution of the investigation.

Cboe EDGX Proposes Market-Maker Order Solicitation for Simple Auctions

The SEC published notice of Cboe EDGX Exchange's proposed rule change to amend Rules 21.19 and 21.21, which would permit Market-Makers with appointments in the applicable class to be solicited for Initiating Orders in Simple AIM and Simple SAM Auctions. Currently, Market-Makers are prohibited from being solicited as contra orders in simple auctions, though they may participate in complex auctions. The Exchange argues the change would enhance price improvement opportunities, particularly for retail and smaller customer orders.

ITC Light Devices, No Review, Proceeding Terminated

The U.S. International Trade Commission determined not to review an enforcement initial determination by the presiding administrative law judge finding that Apple's second redesigned products do not infringe the asserted patents. The combined modification and enforcement proceeding (Investigation No. 337-TA-1276) is terminated in its entirety, with the conclusion that the accused products should not be excluded pursuant to the limited exclusion order. The Commission vote took place on April 17, 2026.

Quagen Pharmaceuticals LLC Importer Application for Diphenoxylate

The DEA published a notice that Quagen Pharmaceuticals LLC applied on March 4, 2026 to be registered as an importer of Diphenoxylate (Schedule II controlled substance, Drug Code 9170). Comments and objections may be submitted through May 18, 2026. The company plans to import the controlled substance for distribution to its customers.

CDRH Grants Variance to University of Texas at Austin

FDA CDRH issued a variance approval to The University of Texas at Austin on April 22, 2026, granting an exception to standard medical device regulatory requirements under the referenced variance proceeding. The variance allows UT Austin to conduct specified activities that would otherwise require separate FDA authorization under 21 CFR Part 812. The approval is documented under docket FDA-2026-V-3707 and is effective upon issuance.

Final Rule: Pesticide Tolerance Actions for Six Active Ingredients Under Registration Review

EPA is finalizing tolerance actions for six pesticide active ingredients—hydrogen cyanide, 1-naphthaleneacetic acid, carboxin, ethofumesate, thiobencarb, and propylene oxide—under registration review conducted pursuant to FIFRA. The final rule establishes modifications to tolerance levels codified at 40 CFR 180.130, 180.155, 180.301, 180.345, 180.401, and 180.491. Affected parties include crop producers (NAICS 111), animal producers (NAICS 112), food manufacturers (NAICS 311), and pesticide manufacturers (NAICS 32532). Objections and hearing requests must be received on or before June 22, 2026 in accordance with 40 CFR part 178.

State Department Corrects Consular Fee for Certificate of Loss of Nationality

The Department of State issued a correcting amendment to 22 CFR Part 22, fixing an erroneous paragraph designation in amendatory instruction 2 of a March 13, 2026 final rule. The correction revises the fee schedule entry for administrative processing of a Certificate of Loss of Nationality. The corrected fee amount is $450, effective April 16, 2026, applicable as of April 13, 2026.

Annual Fee Schedule Update Government Lands Hydropower Licensees FY 2026

FERC's Executive Director has issued the annual update to the fee schedule in 18 CFR Part 11, Appendix A, listing per-acre rental fees by county for use of government lands by hydropower licensees. The updated fees apply from October 1, 2025 through September 30, 2026 (FY 2026). The rule is effective April 21, 2026.

Eaglelionton Int'l Trading Co Inc FSVP Warning Letter Brooklyn NY

FDA issued a Warning Letter to Eaglelionton Int'l Trading Co Inc, a Brooklyn-based food importer, following an FSVP inspection conducted January 29 through February 12, 2026, and a prior inspection from May 1-17, 2023. The firm was found to be non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, specifically for failing to develop, maintain, and follow an FSVP for any imported foods including coconut milk and canned products from identified foreign suppliers. FDA has not received a response to the Form FDA 483a issued on February 12, 2026. The importer must respond in writing within 15 working days with documentation of corrective actions.

Rollins Inc.; Proposed Consent Order for Non-Compete Agreements

The FTC has accepted for public comment a consent agreement with Rollins, Inc. settling charges that the company engaged in unfair methods of competition by entering into and enforcing non-compete agreements with employees in violation of Section 5 of the FTC Act. The proposed Decision and Order would require Rollins to remedy anticompetitive effects from its post-employment covenants not to compete. Comments will be accepted through May 22, 2026.

Deerpath Funding Advantage IV, LP Exemption Request Under SBIA Section 312

The SBA published a notice on April 22, 2026 seeking public comment on Deerpath Funding Advantage IV, LP's request for an exemption under Section 312 of the Small Business Investment Act and 13 CFR 107.730 for a proposed securities transaction. The firm seeks to purchase securities of a portfolio concern from non-SBIC Deerpath Capital funds, which are classified as Associates under common control, constituting a conflict of interest requiring SBA's prior written exemption.

PBGC Requests Extension of OMB Approval for Multiemployer Plan Information Collections, Comments Close May 22

PBGC has requested that OMB extend approval for seven collections of information in its multiemployer plan regulations under ERISA for three years. OMB approvals currently expire May 31, 2026. The notice, a PRA extension request for existing information collections (29 CFR Parts 4203, 4204, 4207, 4208, 4211, 4213, and 4221), solicits public comment; no comments were received on PBGC's advance January 12, 2026 notice (91 FR 1217). The seven OMB control numbers (1212-0021, 1212-0023, 1212-0035, 1212-0039, 1212-0044, 1212-0053, 1212-0066) cover withdrawal liability determinations, abatement rules, and allocation of unfunded vested benefits. Estimated annual burdens range from 0.5 hours (partial withdrawal abatement) to 1,050 hours (asset-sale variances), with cost estimates from $1,000 to $702,000 per collection annually.

OMB Review Comment Request, Multiemployer Plan Regulations

PBGC is requesting OMB to extend approval for three years (until May 31, 2029) of seven collections of information under the Paperwork Reduction Act related to multiemployer plan regulations under ERISA. The collections cover special withdrawal liability rules (29 CFR Part 4203), variances for sale of assets (29 CFR Part 4204), complete withdrawal liability abatement (29 CFR Part 4207), and partial withdrawal liability abatement (29 CFR Part 4208). Estimated annual burden across all collections is approximately 1,054.5 hours and $718,000. The comment period closes May 22, 2026.

Sky-Spray LLC Requests Extension of Agricultural Drone Exemption No. 22701

Sky-Spray LLC has filed a petition with the FAA requesting renewal of Exemption No. 22701, which authorizes commercial agricultural services using unmanned aircraft systems weighing more than 55 pounds. The petition seeks continued exemption from multiple provisions of 14 CFR Parts 61, 91, and 137, as well as authority under 49 U.S.C. § 44807. The exemption covers pilot certification requirements, aircraft airworthiness standards, flight rules, and agricultural aircraft operations rules.

CMS-R-185 Deeming Authority and CLIA Exemption PRA Notice

CMS published a 60-day Paperwork Reduction Act notice inviting public comment on two information collection packages related to the Clinical Laboratory Improvement Amendments (CLIA) program. The first package (CMS-R-26, OMB Control No. 0938-0612) is a revision covering CLIA laboratory regulations including personnel and histocompatibility requirements, with 49,626 respondents and 14,514,802 total annual hours. The second package (CMS-R-185) is an extension covering the granting and withdrawal of deeming authority for private nonprofit accreditation organizations and CLIA exemptions for state laboratory programs under 42 CFR part 493. Comments must be received by June 22, 2026.

Rural Development Loan Servicing Information Collection Revision, OMB 0570-0015

The Rural Business-Cooperative Service (RBCS) is requesting public comments on a revision to a currently approved information collection (OMB No. 0570-0015) supporting Rural Development Loan Servicing for the Intermediary Relending Program. The collection covers loan servicing and liquidating activities under Subpart R of 7 CFR part 1951, involving both the IRP and Rural Microentrepreneur Assistance Program. RBCS estimates 500 respondents with 4 responses each, totaling 8,000 annual burden hours at 4 hours per response. Comments must be received by June 22, 2026, after which the collection will be submitted to OMB for approval.

NCUA Proposes Amending Credit Union-to-Bank Merger Regulations

The NCUA Board is proposing to amend 12 CFR part 708a, subpart C to streamline merger requirements for insured credit unions converting to banks. The proposal would eliminate the definition of "clear and conspicuous" formatting requirements (currently mandating bold type and minimum 12-point font), remove the requirement to publish pre-board-vote notice in a general circulation newspaper in favor of a member home banking landing page notice, and revise due diligence reporting requirements for merger partner location and negotiation description. The Board is accepting public comments through June 22, 2026. Credit unions considering bank mergers and financial institutions advising on such transactions should monitor this rulemaking, as it could materially alter the procedural and disclosure landscape for charter conversions.

Trench Safety: Slope Shore Shield Methods

OSHA's trench safety guidance emphasizes three protective methods—sloping or benching trench walls, shoring with supports, or shielding with trench boxes—to prevent cave-ins, the leading cause of worker fatalities in excavation work. The guidance instructs employers to ensure safe entry and exit, keep materials away from trench edges, monitor for standing water and atmospheric hazards, and verify proper inspection before any worker enters a trench. Applicable standards include 29 CFR 1926.650, 29 CFR 1926.651, and 29 CFR 1926.652.

NCUA Proposes Streamlined Credit Union-to-Bank Merger Framework

Fox Rothschild LLP analyzes NCUA's April 22, 2026 proposed rule to modernize 12 CFR Part 708a, Subpart C, which governs federally insured credit union-to-bank mergers. The proposal would streamline procedural requirements, including replacing newspaper publication mandates with digital posting on member home banking pages, removing the "clear and conspicuous" format specifications in § 708a.301, eliminating the board negotiation narrative requirement in § 708a.304(d), removing boxed-text formatting rules in § 708a.305(e)(2), and deleting non-binding voting guidelines in § 708a.312 entirely. The comment period runs 60 days under docket NCUA-2026-0982, with NCUA specifically requesting input on whether the Supervisory Committee should play a supplemental role in merger reviews.

DOL Proposes Fiduciary Safe Harbor for 401(k) Alternative Investments

On March 30, 2026, the U.S. Department of Labor released a proposed regulation creating a process-based safe harbor for plan fiduciaries selecting designated investment alternatives, including alternative assets, in 401(k) and other individual account plans under ERISA. The proposal responds to Executive Order 14330 (August 7, 2025) and aims to reduce litigation risk and regulatory burdens that have historically discouraged fiduciaries from offering alternative investments. The proposed safe harbor requires fiduciaries to consider six factors: performance, fees, liquidity, valuation, performance benchmarks, and complexity. Public comments are due June 1, 2026, with publication in the Federal Register on March 31, 2026.

B. Braun Medical Inc. Urgent Correction for Hemodialysis Bloodlines

B. Braun Medical Inc. issued an urgent medical device correction for specific hemodialysis bloodlines due to the potential formation of air bubbles. The FDA is issuing an Early Alert to notify the public and advise healthcare providers to use alternate equipment or follow specific mitigation steps if the affected devices must be used.

Control of Hazardous Energy (Lockout/Tagout) - 29 CFR 1910.147

OSHA's lockout/tagout standard (29 CFR 1910.147) establishes minimum performance requirements for controlling hazardous energy during servicing and maintenance of machines and equipment. The standard protects employees from unexpected energization, startup, or release of stored energy that could cause injury. The regulation applies to general industry employers whose employees perform servicing or maintenance on machines with hazardous energy sources.

Airworthiness Directive for Bombardier Challenger Jets

The FAA issued Airworthiness Directive FAA-2025-1732 for all Bombardier Challenger CL-600 series aircraft models (600, 601, 601-3A, 601-3R, and 604 variants) requiring replacement of nosewheel steering rudder pedal potentiometer universal coupling setscrews. The AD also mandates revising existing maintenance or inspection programs to incorporate new life limits for these setscrews. This AD is effective May 8, 2026.

Airbus H160-B ELRS Container Assembly Replacement Required

The FAA issued Airworthiness Directive AD 2026-07-09 requiring replacement of the Emergency Locator Transmitter (ELRS) container assembly on Airbus H160-B helicopters. The AD, effective May 11, 2026, addresses potential safety issues with the current ELRS container configuration. Operators of affected H160-B helicopters must comply with the replacement requirements within the specified compliance periods.

FDA CBER Issues Untitled Letters for Violations

The FDA's Center for Biologics Evaluation and Research (CBER) issues untitled letters to regulated industries for violations that do not meet the threshold for a Warning Letter. These letters address issues found in advertising and promotional labeling, bioresearch monitoring, and internet surveillance.

Medline Industries LP - Quality System Regulation Violations Warning Letter

FDA issued a Warning Letter to Medline Industries, LP (NAMIC Division) citing Quality System Regulation violations under 21 CFR Part 820. The inspection conducted December 1-12, 2025 identified CAPA procedure failures involving NAMIC Angiographic Control Syringes that generated 221 complaints and 177 MDRs, including documented cases of air embolism patient harm and biohazard exposure to clinicians.