40 results for "15 U.S.C. 45"
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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.
NSCC Order Approving New Transaction Reporting Capability
The SEC approved NSCC's proposed rule change SR-NSCC-2026-004 to create MPID Transaction Reporting, a new service allowing NSCC members to receive UTC trade capture output for their NSCC-cleared activities by using their MPID to designate trade data. The receiving member must be authorized by the disclosing member through their established clearing relationship. No public comments were received during the comment period.
NMFS Closes South Atlantic Gag Recreational Fishing August 2
NMFS implements a temporary rule closing the recreational gag fishery in South Atlantic Federal waters effective August 2, 2026, through January 1, 2027. The closure results from 2025 recreational landings of 187,751 lb exceeding the annual catch limit of 176,665 lb by 11,086 lb. During the closure, bag and possession limits for gag are zero.
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.
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.
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.
USCIS Extends Notice Period 60 Days
U.S. Citizenship and Immigration Services (USCIS) has extended a notice period by 60 days. The document, filed on regulations.gov under docket USCIS-2013-0002-0042, references a PDF attachment containing the full extension details. The specific notice period affected and the regulatory context are contained within the PDF, which is not included in this record.
G-1055 Form Posted by USCIS
USCIS posted the G-1055 form (Application to Replace Permanent Resident Card) to regulations.gov under docket USCIS-2010-0008. The form is available as a downloadable PDF attachment. No regulatory amendments or new compliance obligations are described in this posting.
USCIS Certificate Non-Existence Extension, Comments Due June 22
DHS/USCIS invites public comment on a proposed extension of OMB Control Number 1615-0156, covering Form G-1566 (Request for a Certificate of Non-Existence). The form is used by individuals to request USCIS verify whether immigration records exist for a named subject. Estimated annual respondents: 1,000 paper filers and 1,000 electronic filers, with a combined annual hour burden of 912 hours and total annual cost burden of $61,000. Comments are accepted for 60 days.
USCIS Fee Waiver Extension, Comments Due June 22
DHS/USCIS is seeking public comments through June 22, 2026 on extending the currently approved Form I-912 (Request for Fee Waiver) collection under OMB Control Number 1615-0116. The collection allows applicants to demonstrate inability to pay immigration fees. Estimated annual respondents: 602,528 with 653,435 hours burden and $2,009,461 cost burden.
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.
NMFS Finalizes 21 Marine Mammal Stock Assessment Reports Under MMPA
NMFS has finalized 21 marine mammal stock assessment reports (SARs) under Section 117 of the Marine Mammal Protection Act (MMPA), covering the 2018-2022 period for Alaska, Atlantic, Gulf of America, and Pacific regions. The revisions primarily update human-caused mortality and serious injury (M/SI) estimates and abundance estimates for affected stocks. NMFS responded to public comments from the Marine Mammal Commission and Center for Biological Diversity, addressing concerns about lost fishing gear, plastic pollution, and alternative data collection methods.
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.
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.
Priority Mail Express Priority Mail USPS Ground Advantage Negotiated Service Agreements
The United States Postal Service gives notice of filing 12 requests with the Postal Regulatory Commission to add domestic shipping services contracts to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List. The filings cover Priority Mail and USPS Ground Advantage products under MC and K docket numbers ranging from MC2026-202 through MC2026-216. Documents are available at www.prc.gov.
PRC Notices USPS Competitive Product List Filings for Comment
The Postal Regulatory Commission published a notice on April 22, 2026, informing the public of USPS filings to add competitive negotiated service agreements to the Competitive product list. Two dockets are noticed: MC2026-209/K2026-208 (Priority Mail Express International, Priority Mail International & First-Class Package International Service Contract 111) and MC2026-216/K2026-214 (Fulfillment Standardized Distinct Product PM-GA Contract 966). Comments on the public proceeding are due April 27, 2026.
Summer EBT Benefit Levels Adjusted for 2026
USDA has published the 2026 Summer EBT benefit levels for children, effective January 1 through December 31, 2026. The contiguous 48 states and District of Columbia maintain the 2025 rate of $40 per month ($120 total summer), as the Thrifty Food Plan cost change of 0.49 percent rounds down to no change. Alaska, Hawaii, and U.S. Territories receive increased benefits reflecting higher food costs in those areas.
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.
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.
Andrew Gonzalez Indirect Auto Lending Disclosure Petition
The FTC received a petition for rulemaking from Andrew Gonzalez requesting to mandate disclosures regarding indirect auto lending. The Commission has opened a public comment period, with comments due by May 21, 2026. After the comment period closes, the FTC may grant or deny the petition in whole or in part, or determine the petition is insufficient to warrant commencement of a rulemaking proceeding.
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.
NYSE Proposes Rule Enabling Tokenized Securities Trading
The New York Stock Exchange filed a proposed rule change with the SEC to adopt Rule 7.50 and amend Rules 1.1, 7.36, 7.37, and 7.41 to enable the trading of securities in tokenized form during a DTC Pilot Program. Exchange member organizations eligible to participate in the DTC Pilot Program may trade tokenized versions of eligible equity securities and exchange-traded products, subject to the same conditions and restrictions approved in a prior Nasdaq rule change. The SEC is soliciting comments from interested persons.
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).
Amino Acids and Exercise in FSHD (NCT07543016)
NIH registered clinical trial NCT07543016, evaluating whether amino acid supplementation combined with a structured diet and exercise program improves body composition and physical performance in individuals with facioscapulohumeral muscular dystrophy (FSHD). The study also compares responses between FSHD patients and age- and sex-matched healthy controls. Conditions include FSH Muscular Dystrophy and Muscular Dystrophy; interventions include Essential Amino Acids Supplementation, Exercise, Diet, and Placebo Control.
Stillwater Capital ITP Application, Alabama Beach Mouse, Baldwin County, Alabama
The U.S. Fish and Wildlife Service announces receipt of an application from Stillwater Capital Assets LLC for a 50-year Incidental Take Permit under Section 10(a)(1)(B) of the Endangered Species Act. The permit would authorize incidental take of the federally threatened Alabama beach mouse (Peromyscus polionotus ammobates) during construction of a single-family home at 11068 Mobile Street West, Gulf Shores, Alabama, affecting 0.05 acres of occupied habitat. The Service requests public comment on the application, including the proposed Habitat Conservation Plan and the Service's preliminary determination that the action may qualify for a categorical exclusion under NEPA.
USCIS Requests Comments on Application for Civil Surgeon Designation Extension
DHS/USCIS has published a 60-day notice under the Paperwork Reduction Act inviting public comments on extending OMB Control Number 1615-0114 for Form I-910, the Application for Civil Surgeon Designation. The collection applies to physicians seeking civil surgeon designation for immigration medical examinations. USCIS estimates 470 annual respondents with a total hour burden of 940 hours and a cost burden of $24,205. Comments are accepted through June 22, 2026.
USCIS Extends I-910 Supporting Document Period 60 Days
USCIS has extended the period for providing supporting documents for Form I-910 to 60 days. Form I-910 is used to apply for a travel document or temporary evidence of lawful permanent resident status.
USCIS G-1055 Supporting Material, Apr 20
USCIS posted supporting material for Form G-1055 (Immigration Fees) to its Regulations.gov docket (USCIS-2013-0002). The filing provides administrative documentation associated with the agency's fee-calculation form but does not itself establish new filing requirements or compliance obligations.
I-912 Fee Waiver Supporting Material, Apr 21
USCIS posted supporting material for Form I-912 (Fee Waiver Request) to the public docket on April 21. The document, filed under docket USCIS-2010-0008, is accessible as a PDF download via regulations.gov. No new obligations, deadlines, or policy changes are stated.
I-912 Fee Waiver Supporting Material
USCIS has filed supporting material to the I-912 Fee Waiver rulemaking docket (USCIS-2010-0008). The document is a PDF attachment containing supporting information related to fee waiver requests under Form I-912. No substantive regulatory text is visible in the source.
Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
NIH's ClinicalTrials.gov registered observational study NCT07541690, an examination of phenotypic and genotypic mechanisms of antibiotic resistance in multi-drug resistant Klebsiella Pneumoniae. The study will analyze 70 urine, pus, and sputum samples using culture, biochemical testing, antimicrobial susceptibility profiling, and PCR-based gene detection for biofilm formation and efflux pump activity. No compliance obligations are created by this registry entry.
Cardiac Arrest Resuscitation Patent, US12609190B2
The USPTO granted patent US12609190B2 on April 21, 2026 to inventors Tamara Aliza Freeman and Michelle Alyssa Freeman. The patent covers cardiac arrest resuscitation methods and equipment including a manual or automatic Pocket Crash Cart that attaches to patients via IV or OS for quick emergency medication administration. The patent also covers software for mirroring defibrillator and AED displays and transmitting patient information to medical professionals via internet for expert advice in hard-to-reach locations.
Screen Time Before Sleep and Posture Disorders NCT07541963
NIH registered NCT07541963, an observational study examining whether pre-sleep screen exposure contributes to poor posture, musculoskeletal problems, and balance deficits. The study assesses forward head posture, rounded shoulders, and neuromuscular performance related to screen use before sleep.
Ottobock Prosthetic Foot Component Patent, EP3914195A1 Granted
Ottobock SE & Co. KGaA has been granted European Patent EP3914195A1 for a prosthetic foot component, published April 15, 2026 by the European Patent Office. The patent covers the technical design and functionality of the prosthetic device, with inventors including Martin Pusch and designated coverage across all EU member states and extension states.
Rajanikanth et al v. Edlow et al
The United States District Court for the Northern District of California docketed Rajanikanth et al v. Edlow et al (Case No. 5:26-cv-00660-EKL), a civil case concerning other immigration actions filed by private plaintiffs against Joseph B. Edlow and USCIS. Judge Eumi K. Lee is assigned to the San Jose Division. The most recent filing dated April 21, 2026 is a reply brief in support of a motion to dismiss filed by the defendants.
Squat Depth Effects on Muscle Activation and Jump Performance
This registry entry documents a randomized crossover study registered with ClinicalTrials.gov (NCT07543237) examining how different squat depths affect lower extremity muscle activation and jump performance in healthy sports science students.
Optrell Mapping Catheter Papillary Muscle Ventricular Arrhythmia NCT07541092
NIH ClinicalTrials.gov posted an observational study (NCT07541092) evaluating the Optrellâ„¢ mapping catheter with TRUEref technology for mapping ventricular arrhythmias originating from the papillary muscles. The study will assess the catheter's ability to achieve simultaneous multi-bipole contact and use intracardiac echocardiography for optimal positioning. No compliance obligations or regulatory deadlines are associated with this study registration.
International Federated Wearable Motor Monitoring in Young Children With Spinal Muscular Atrophy: Active-NBS Study
NIH registered NCT07543003, an international observational study evaluating wearable-derived remote motor monitoring in young children with spinal muscular atrophy (SMA). The study will recruit up to 60 SMA patients and 30 healthy controls over a maximum of 30 months using the Syde and MAIJU wearable devices worn at home, without additional hospital visits. The federated data model enables collaborative sites across the UK and internationally to collect harmonised motor development data.
Balance & Respiratory Muscle Strength in Healthy Adults
The NIH registered a new observational study (NCT07541950) examining the acute effects of balance exercises on balance performance in healthy individuals aged 18-25. The single-blind pre-test/post-test study will assess participants using the Single Leg Stance Test before and after an 8-10 minute balance exercise program including single-leg stance, eyes-closed balance, and unstable surface training.
Respiratory Physiotherapy and PMR After Cardiac Surgery Randomized Controlled Trial
NIH ClinicalTrials.gov registered a randomized controlled trial (NCT07542691) evaluating respiratory physiotherapy combined with progressive muscle relaxation exercises in 116 cardiac surgery patients. The intervention group will receive 30 minutes of combined therapy daily for three consecutive days in addition to routine postoperative care, while the control group receives routine care only. Outcome measures include dyspnea, anxiety, hemodynamic parameters, and delirium symptoms.
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