22 results for "40 CFR Part 63"

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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).

Routine Notice Intellectual Property
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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.

Priority review Rule Consumer Finance
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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.

Priority review Consultation Banking
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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.

Priority review Rule Medical Devices
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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.

Priority review Rule Medical Devices
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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.

Priority review Rule Medical Devices
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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.

Priority review Rule Medical Devices
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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.

Routine Rule Aviation
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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.

Priority review Notice International Trade
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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.

Priority review Rule Agriculture
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NIH/NIAID Offers West Nile Virus Neutralizing Antibodies for Licensing

NIAID announces availability for licensing of seven new fully human monoclonal antibodies (AIS-196, AIS-204, AIS-259, AIS-260, AIS-261, AIS-262, and AIS-265) that neutralize West Nile virus by targeting its envelope protein. The antibodies demonstrated strong virus-blocking activity in laboratory studies and protective effects in mouse models. Licensing inquiries should directed to Brian Bailey at 240-669-5128 or bbailey@mail.nih.gov, referencing HHS Reference No. E-021-2026-0.

Routine Notice Intellectual Property
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CMS Requests Comment on CLIA Information Collections by June 22

The Centers for Medicare & Medicaid Services published a Federal Register notice announcing a 60-day comment period under the Paperwork Reduction Act for two Clinical Laboratory Improvement Amendments (CLIA) information collections. The first item is a revision of CLIA Regulations (OMB Control No. 0938-0612) covering quality assessment, fees, histocompatibility, and personnel requirements, with approximately 49,626 respondents and 14,514,802 total annual hours. The second item is an extension of the collection on granting and withdrawal of deeming authority for private nonprofit accreditation organizations and CLIA exemption under state laboratory programs. Comments are due June 22, 2026.

Routine Notice Healthcare
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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.

Routine Notice Intellectual Property
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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.

Routine Notice Pensions & Retirement
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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.

Routine Notice Securities
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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.

Priority review Consultation Securities
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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.

Routine Rule Energy
FDA Warning Letters
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FDA Warns Shopcalismokes.com Over Unauthorized Zyn Nicotine Pouches

The FDA Center for Tobacco Products issued a Warning Letter to shopcalismokes.com (Farmington Hills, MI) on April 10, 2026, for selling two unauthorized Zyn nicotine pouch products—Zyn Pouches Slim Cool Skittle 15mg and Zyn Pouches Slim Fizzy Cola 15mg—in the U.S. market without required premarket authorization under Section 910 of the FD&C Act. FDA determined the products are adulterated under Section 902(6)(A) and misbranded under Section 903(a)(6). The firm has 15 working days from receipt to submit a written response describing corrective actions, including dates of discontinued sales and a compliance plan. Failure to comply may result in civil money penalties, seizure, and/or injunction.

Priority review Enforcement Tobacco
FR: State Department
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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.

Routine Rule Immigration
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NESHAP Technology Review: Crude Oil and Natural Gas Production and Natural Gas Transmission and Storage Facilities

The EPA is proposing a technology review of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Crude Oil and Natural Gas Production Facilities and Natural Gas Transmission and Storage Facilities under Clean Air Act section 112(d)(6). The Agency is not proposing revisions to current emission standards. The EPA is proposing new standards for methanol from regulated emission points and presenting two alternative approaches for previously unregulated emission points, including acid gas removal units, transport vessel loading operations, storage vessels, and natural gas-driven process controllers and pumps. Comments are due by June 22, 2026.

Priority review Consultation Environmental Protection
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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.

Priority review Consultation Environmental Protection
FDA Warning Letters
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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.

Priority review Enforcement Food Safety

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