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| Tipoffs: Public Comments on Proposed Federal Rules Newsletter for 2026-06-04 ( 78 items ) |
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73 Strings Urges U.S. Department of Labor to Clarify Valuation Standards in Proposed Fiduciary Duty Rule (10)
WASHINGTON, June 3 -- 73 Strings Inc., a valuation technology infrastructure provider based in Cambridge, Massachusetts, submitted a public comment letter to the U.S. Department of Labor's Employee Benefits Security Administration. The letter addresses the agency's proposed rule on fiduciary duties in selecting designated investment alternatives for participant-directed defined contribution (DC) plans, published in the Federal Register on March 31, 2026.
The company, comprised of private-asset valuation practitioners serving institutional inve more ST
Accenture Proposes Clarifications to FDA Draft Guidance on New Approach Methodologies in Drug Development (10)
WASHINGTON, June 3 -- Accenture, New York, a global professional services company, submitted a public comment letter to the U.S. Food and Drug Administration addressing the agency's March 2026 draft guidance titled "General Considerations for the Use of New Approach Methodologies in Drug Development." The letter supports the FDA's direction in promoting new approach methodologies and emphasizes alignment with the agency's April 2025 Roadmap to Reducing Animal Testing.
In the letter, Accenture calls for clearer definitions of three evidentiary more ST
AI-Enabled Optimization of Early-Phase Clinical Trials Faces Architectural Challenges for Real-Time Scaling (10)
WASHINGTON, June 3 -- Scientix.AI Inc., Austin, Texas, has submitted a public comment letter to the U.S. Food and Drug Administration (FDA) addressing the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program under docket number FDA-2026-N-4390. The letter emphasizes critical architectural considerations necessary for the pilot to move beyond a technical demonstration toward a scalable, real-time system usable across the clinical trial ecosystem.
Scientix.AI, led by its founder and CEO, highlights the complex data trans more ST
Alliance for Chemical Distribution Urges IRS to Finalize Superfund Chemical Tax Regulations (10)
WASHINGTON, June 3 -- The Alliance for Chemical Distribution, headquartered in Arlington, Virginia, submitted a public comment letter to the Internal Revenue Service urging the agency to prioritize finalizing regulations under subsections 4661, 4662, 4671, and 4672 concerning the Superfund chemical taxes. The letter was filed in response to the IRS's invitation to contribute recommendations for its 2026-2027 Priority Guidance Plan.
The chemical distribution trade association emphasized that the Superfund chemical tax remains a complex challeng more ST
Alliance for MRNA Medicines Urges FDA to Reject Citizen Petition Challenging COVID-19 Vaccine Approvals (10)
WASHINGTON, June 3 -- The Alliance for mRNA Medicines, Cambridge, Massachusetts, has submitted a public comment letter to the U.S. Food and Drug Administration urging the agency to deny a Citizen Petition filed by Children's Health Defense. The petition questioned the FDA's authorization and licensure of COVID-19 vaccines developed by Moderna Inc. and Pfizer Inc./BioNTech, specifically targeting Emergency Use Authorizations granted in December 2020 and subsequent Biologic License Applications approvals in 2021 and 2022.
In the public comment l more ST
ALPA Opposes NetJets Petition to Extend Pilot Duty Hours Without Fatigue Mitigations (10)
WASHINGTON, June 3 -- The Air Line Pilots Association, International submitted a public comment letter to the Federal Aviation Administration (FAA) opposing NetJets Aviation Inc.'s petition to extend maximum pilot work hours. ALPA, representing over 80,000 pilots across North America, contends that the petition fails to demonstrate an equivalent level of safety required under FAA regulations and lacks necessary fatigue risk mitigation measures.
ALPA highlighted that the FAA convened the Part 135 Aviation Rulemaking Committee (135 ARC) followin more ST
Alpha Holdings Urges IRS to Clarify Education Choice Tax Credit Rules (10)
WASHINGTON, June 3 -- Alpha Holdings Inc., Austin, Texas, submitted a public comment letter to the Internal Revenue Service concerning the implementation of the Education Choice Tax Credit under Internal Revenue Code Section 25F. The letter was filed in response to IRS Notice 2026-23, inviting comments on items to include in the 2026-2027 Priority Guidance Plan. Alpha Holdings, drawing on its experience in educational philanthropy and scholarship administration, outlined three priority recommendations to facilitate effective rollout and adminis more ST
American Bankers Association Urges IRS to Modernize Electronic Payee Statement Rules (10)
WASHINGTON, June 3 -- The American Bankers Association submitted a public comment letter to the Internal Revenue Service urging the agency to modernize and expand electronic furnishing rules for payee statements. The letter responds to Notice 2026-4 issued by the U.S. Department of the Treasury and the IRS, which seeks input on updating regulations that govern electronic delivery of tax-related payee statements under sections 6041-6050AA of the Internal Revenue Code and IRS Publication 1179.
ABA recognized Treasury and the IRS's efforts to sol more ST
American Bar Association Section of Taxation Submits Comprehensive Recommendations to IRS for 2025-2026 Priority Guidance Plan (10)
WASHINGTON, June 3 -- The American Bar Association, Chicago, Illinois, has issued a public comment letter to the Internal Revenue Service outlining its recommendations for inclusion in the 2025-2026 Priority Guidance Plan. The letter addresses a broad range of issues impacting federal tax administration and compliance across multiple specialized committees within the Section.
The Section of Taxation emphasized that its recommendations do not represent the views of the broader American Bar Association but highlight important areas requiring att more ST
American Chemistry Council Raises Concerns Over EPA's Draft Hazard Assessment of Para-Dichlorobenzene (10)
WASHINGTON, June 3 -- The American Chemistry Council submitted a public comment letter to the U.S. Environmental Protection Agency (EPA) addressing the agency's draft Human Health and Environmental Hazard Assessment for para-dichlorobenzene (p-DCB). The letter critiques aspects of the EPA's draft evaluation issued in April 2026 under the Toxic Substances Control Act (TSCA) and prepared for review by the Science Advisory Committee on Chemicals (SACC) scheduled for June 2026.
The ACC's p-DCB Risk Evaluation Consortium, including industry collabo more ST
American Psychological Association Services Urges Caution on CMS Proposal for Inpatient Psychiatric Facilities Payment System Updates (10)
WASHINGTON, June 3 -- American Psychological Association Services submitted a public comment letter to the Centers for Medicare & Medicaid Services (CMS) addressing the fiscal year 2027 proposed rule on the Inpatient Psychiatric Facilities (IPF) prospective payment system (CMS-1847-P). The letter provides a comprehensive response concerning reimbursement rates, quality measures, and the proposed Patient Assessment Instrument (PAI) tool.
APA Services expressed support for CMS's efforts to increase reimbursement levels for mental health treatmen more ST
Apollo Global Management Supports Labor Department's Proposed Rule to Enhance Retirement Outcomes Through Alternative Investments (10)
WASHINGTON, June 3 -- Apollo Global Management Inc., New York, submitted a public comment letter to the U.S. Department of Labor endorsing the department's proposed rule on fiduciary duties in selecting designated investment alternatives for defined contribution plans. Apollo's letter responds specifically to Request for Input #5 of the rule proposal and provides data-driven insights on the financial benefits of incorporating alternative assets into retirement plans, along with analysis on how fiduciaries can evaluate these complex investment o more ST
AUVSI Urges Bureau of Industry and Security to Modernize Drone Export Controls (10)
WASHINGTON, June 3 -- The Association for Uncrewed Vehicle Systems International (AUVSI), based in Arlington, Virginia, submitted a public comment letter to the U.S. Department of Commerce's Bureau of Industry and Security (BIS) addressing the interim final rule (IFR) designed to streamline export controls for drones. AUVSI supports efforts to strengthen the U.S. uncrewed systems industrial base while maintaining export controls tied to genuine national security risks, emphasizing the need to update controls on widely available dual-use commerc more ST
Awaken Group Supports Labor Department's Proposed Rule on Fiduciary Duties With Technology Platform Clarifications (10)
WASHINGTON, June 3 -- Awaken Group Inc., a New York-based technology platform company, submitted a public comment letter to the U.S. Department of Labor's Employee Benefits Security Administration endorsing the proposed rule on Fiduciary Duties in Selecting Designated Investment Alternatives. The letter emphasizes the role that qualified third-party technology platforms can play in helping plan fiduciaries comply with the rule's safe harbor provisions while maintaining fiduciary responsibility.
Awaken Group, founded in 2025, specializes in pro more ST
Better Markets Urges Withdrawal of DOL Proposal to Shield Fiduciaries From Litigation Over Alternative Investments in 401(k) Plans (10)
WASHINGTON, June 3 -- Better Markets Inc., a Washington D.C.-based non-profit and independent organization advocating for market integrity and investor protections, has submitted a public comment letter to the U.S. Department of Labor (DOL) expressing strong opposition to the agency's proposal to establish a "safe harbor" for fiduciaries selecting alternative investments, including private market assets and cryptocurrencies, for ERISA-covered 401(k) plans.
The letter argues that the Department's proposal, published as Fiduciary Duties in Selec more ST
BioCytics and Carolina BioOncology Institute Propose AI-Enabled Clinical Trial Platform to FDA (10)
WASHINGTON, June 3 -- Carolina BioOncology Institute PLLC, Huntersville, North Carolina, alongside BioCytics Inc., submitted a public comment letter to the U.S. Food and Drug Administration (FDA) outlining a proposal for an AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter details their BioCytics Digitally Integrated Clinical Enterprise (BioDICE) software platform, which incorporates openEHR Electronic Data Capture (openEHR-EDC) standards to facilitate real-time clinical trials (RTCTs) for oncology therapies, emph more ST
BlackRock Provides Comprehensive Feedback on DOL Fiduciary Duties Proposal (10)
WASHINGTON, June 3 -- BlackRock, Inc., New York, submitted a public comment letter to the U.S. Department of Labor's Employee Benefits Security Administration regarding the department's proposed rule titled Fiduciary Duties in Selecting Designated Investment Alternatives (RIN 1210-AC38). The proposal aims to clarify and establish a safe harbor for fiduciaries' duty of prudence under the Employee Retirement Income Security Act of 1974 (ERISA) in connection with selecting designated investment alternatives for participant-directed individual acco more ST
Calico Biosystems Urges on Use of Patient Native Versus Engineered Systems in FDA's New Approach Methodologies Guidance (10)
WASHINGTON, June 3 -- Calico Biosystems, South San Francisco, California, has submitted a public comment letter to the U.S. Food and Drug Administration addressing its draft guidance on new approach methodologies in drug development. The letter emphasizes the need for clearer distinction within the NAM framework between patient native biological systems and engineered in vitro reconstructions, arguing that these different model types present unique considerations for biological relevance, context of use, validation, and regulatory application.
more ST
Capital Group Urges Department of Labor to Adjust Liquidity Rules for Target Date Funds (10)
WASHINGTON, June 3 -- The Capital Group Companies, Los Angeles, California submitted a public comment letter to the U.S. Department of Labor's Employee Benefits Security Administration addressing the agency's proposed regulation concerning fiduciary duties in selecting designated investment alternatives under the Employee Retirement Income Security Act of 1974 (ERISA). The letter praised the Department's asset-class-neutral approach that emphasizes evaluating investment options based on expected net-of-fees, risk-adjusted returns and recognized more ST
Carbon Management Alliance Urges Treasury to Provide Legal Certainty for 45Q Tax Credit Amid EPA Subpart RR Repeal (10)
WASHINGTON, June 3 -- The Carbon Management Alliance (CMA), an informal working group based in Houston, Texas, has submitted a public comment letter to the U.S. Department of the Treasury recommending actions to enhance legal certainty for the 45Q tax credit related to carbon sequestration projects. The letter responds to Notice 2026-23, which seeks recommendations for the Treasury's 2026-2027 Priority Guidance Plan. CMA's comments focus on anticipated regulatory changes stemming from the possible repeal by the U.S. Environmental Protection Age more ST
Center for Biological Diversity Urges NOAA to Deny Deep-Seabed Mining Exploration Licenses in Clarion-Clipperton Zone (10)
WASHINGTON, June 3 -- The Center for Biological Diversity submitted a public comment letter urging the National Oceanic and Atmospheric Administration to deny the applications from American Metal Resources LLC, Austin, Texas, and SeaX Inc., St. Petersburg, Florida, for deep-seabed mining exploration licenses in the Clarion-Clipperton Zone, as filed under the Deep Seabed Hard Mineral Resources Act. The letter raises concerns regarding the environmental risks, legal issues, and insufficient data related to the proposed deep-seabed mining activiti more ST
Certara Urges FDA to Focus on Decision Quality in AI-Enabled Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, June 3 -- Certara Inc., a life sciences company headquartered in Radnor, Pennsylvania, submitted a public comment letter to the Food and Drug Administration regarding the agency's proposed pilot program for AI-enabled optimization of early-phase clinical trials. The letter advocates for a pilot design that prioritizes improving the quality and timeliness of development decisions through the integration of AI methods within the existing framework of model-informed drug development (MIDD).
Certara emphasizes that the pilot program sh more ST
CFP Board Urges Revisions to DOL's Proposed Fiduciary Rule on Retirement Investments (10)
WASHINGTON, June 3 -- The Certified Financial Planner Board of Standards submitted a public comment letter to the Employee Benefits Security Administration (EBSA) of the U.S. Department of Labor (DOL) regarding the agency's proposed rule titled Fiduciary Duties in Selecting Designated Investment Alternatives. The CFP Board, which certifies more than 109,000 financial professionals across the United States, expressed strong concerns about the potential impact of the proposed rule on participant protections and fiduciary responsibilities under th more ST
Chamber of Progress Urges Caution in Regulating Startup Transaction Structures (10)
WASHINGTON, June 3 -- The Chamber of Progress, McLean, Virginia, a tech industry coalition committed to progressive societal advancements, submitted a public comment letter to the Federal Trade Commission and the U.S. Department of Justice regarding potential amendments to the Hart-Scott-Rodino premerger notification system. The letter specifically addresses concerns over regulatory proposals targeting "Non-Traditional Transaction Structures" such as acquihires and licensing arrangements in startup acquisitions.
The organization highlighted th more ST
Charles Schwab Addresses Department of Labor on Proposed Fiduciary Duties Regulation (10)
WASHINGTON, June 3 -- Charles Schwab & Co., Westlake, Texas, submitted a public comment letter to the U.S. Department of Labor regarding the agency's proposed regulation on "Fiduciary Duties in Selecting Designated Investment Alternatives." The proposal, released on March 31, 2026, aims to establish a fiduciary safe harbor framework for selecting investments in retirement plans governed by ERISA. Schwab, a prominent retirement services provider managing nearly 35,000 plans and serving approximately 6 million participants, expressed overall supp more ST
Circle Internet Group Urges Uniform Federal Baseline for State Regulation of Stablecoins (10)
WASHINGTON, June 3 -- Circle Internet Group Inc., New York, has submitted a public comment letter to the U.S. Department of the Treasury regarding the agency's proposed rulemaking on establishing broad-based principles to determine whether state-level regulatory regimes for stablecoins are substantially similar to the federal regulatory framework under the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act).
Circle supports the Treasury's effort to set a clear framework ensuring that state regulations align with more ST
CMS Faces Opposition to Proposed Day-4 Interdisciplinary Team Meeting Requirement in Inpatient Rehabilitation Facilities (10)
WASHINGTON, June 3 -- Alta Bates Summit ARU, based in Berkeley California, submitted a public comment letter opposing the U.S. Centers for Medicare & Medicaid Services' (CMS) proposal requiring an initial interdisciplinary team (IDT) meeting by the fourth day of inpatient rehabilitation admissions. Alta Bates Summit ARU expressed concerns that the rule emphasizes timing over care quality without evidence linking earlier meetings to better patient outcomes.
The organization highlighted that interdisciplinary communication in rehabilitation faci more ST
Colorado Cattlemen's Association Highlights Challenges in Wolf Management Program (10)
WASHINGTON, June 3 -- The Colorado Cattlemen's Association, Denver, has submitted a public comment letter to the U.S. Fish and Wildlife Service expressing concerns regarding the proposed information collection activities related to experimental populations under Section 10(j) of the Endangered Species Act. The letter focuses on the operational difficulties faced by Colorado livestock producers due to the state's wolf reintroduction program and urges the agency to address numerous implementation shortcomings.
The CCA emphasizes that wolf manage more ST
Colorado Department of Natural Resources Urges BLM to Reassess Federal Oil and Gas Royalty Rates (10)
WASHINGTON, June 3 -- The Colorado Department of Natural Resources submitted a public comment letter to the U.S. Department of the Interior's Bureau of Land Management (BLM) regarding the proposed Direct Final Rule on oil and gas leasing fees, rentals, and royalties. CODNR emphasizes the importance of considering impacts to wildlife, people, and the environment while addressing the development of federal oil and gas leasing regulations.
Dan Gibbs, Executive Director, raised concerns about the current federal royalty rate, which is set at a min more ST
Conference of Boston Teaching Hospitals Opposes Department of Labor Wage Rule Impacting Visa Holders (10)
WASHINGTON, June 3 -- The Conference of Boston Teaching Hospitals, Massachusetts, submitted a public comment letter to the U.S. Department of Labor concerning the proposed rule which aims to improve wage protections for the temporary and permanent employment of certain foreign nationals in the U.S. COBTH represents 12 member nonprofit academic medical centers in Boston employing immigrant workers under H-1B and Permanent Labor Certification visa programs.
COBTH expressed deep concern that the proposed wage increases for prevailing wage levels more ST
Cost Analysis Shows Vadadustat Lowers Hospitalization Costs Compared to Darbepoetin Alfa in Dialysis-Dependent CKD Patients (10)
WASHINGTON, June 3 -- Akebia Therapeutics Inc., Cambridge, Massachusetts, submitted a public comment letter to the U.S. Department of Health & Human Services presenting a cost comparison analysis of hospitalizations for dialysis-dependent chronic kidney disease (DD-CKD) patients treated with vadadustat versus darbepoetin alfa (DA). The analysis is based on hospitalization data derived from the INNO VATE clinical trials and Medicare inpatient cost information.
Vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, was evalua more ST
Cynergy Wellness Urges Enhancements to FMCSA Drug and Alcohol Clearinghouse (10)
WASHINGTON, June 3 -- Cynergy Wellness Inc., a Kansas City, Missouri-based nationally licensed physician practice and provider of Medical Review Officer services, submitted a public comment letter to the U.S. Department of Transportation's Federal Motor Carrier Safety Administration (FMCSA). The company detailed recommendations aimed at improving the FMCSA Drug and Alcohol Clearinghouse information collection process.
Cynergy Wellness supported comments from the National Drug and Alcohol Screening Association and proposed expanded access for Q more ST
Endangered Small Credit Union Defense Supports NCUA's Proposed Rule With Recommendations for Implementation (10)
WASHINGTON, June 3 -- The Endangered Small Credit Union Defense, Kennewick, Washington state, a nonprofit advocacy group representing small credit unions under $500 million in assets, submitted a public comment letter to the National Credit Union Administration supporting the agency's proposed rule to modernize Anti-Money Laundering and Countering the Financing of Terrorism program requirements.
ESCUD described the burdens small credit unions face from regulatory practices that do not fully recognize their low-risk, relationship-based operatio more ST
Engine Urges Labor Department to Reconsider Wage Proposal Impacting Startup Talent Access (10)
WASHINGTON, June 3 -- Engine, a nonprofit technology policy and advocacy organization that represents thousands of high-technology startups across the nation, submitted a public comment letter to the U.S. Department of Labor concerning the agency's proposed rule revision to prevailing wage calculations for H-1B and related visa programs. The organization warns that the proposal could increase labor costs for startups, reduce access to specialized foreign talent, and ultimately harm U.S. competitiveness in emerging technology sectors such as art more ST
Environmental Groups Urge NOAA to Halt Proposed Increases in Atlantic Shark Fishing Mortality (10)
WASHINGTON, June 3 -- The Center for Biological Diversity, Tucson, Arizona, and Earthjustice, headquartered in San Francisco, California, submitted a public comment letter to the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS) expressing strong opposition to the agency's proposed revisions to commercial Atlantic blacknose and recreational Atlantic shark fisheries management measures. The groups contend that the proposed rule, intended to increase management flexibility and optimize commercial an more ST
ESQlabs Submits Detailed Public Comment Letter to FDA on Draft Guidance for New Approach Methodologies in Drug Development (10)
WASHINGTON, June 3 -- ESQlabs GmbH, Saterland, Germany, a contract research organization specializing in computational and in vitro approaches to drug development, has submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's draft guidance titled "General Considerations for the Use of New Approach Methodologies in Drug Development." The letter offers comprehensive feedback aimed at refining the FDA's framework for integrating new approach methodologies that reduce animal testing and support regulatory de more ST
Federated Hermes Supports Department of Labor's Proposed Rule to Reduce Litigation Risk and Expand Alternative Investments in 401(k) Plans (10)
WASHINGTON, June 3 -- Federated Hermes, a Boston, Massachusetts-based global investment management firm, submitted a public comment letter to the U.S. Department of Labor concerning its proposed rule on fiduciary duties in selecting designated investment alternatives (DIAs) for participant-directed individual account plans. The letter applauds the Department's efforts to create a clear, process-based framework intended to expand access to alternative assets such as private equity, private credit, real estate, and infrastructure within defined c more ST
Fidelity Investments Urges IRS to Default to Electronic Delivery of Payee Statements (10)
WASHINGTON, June 3 -- Fidelity Investments, Boston, Massachusetts, submitted a public comment letter to the Internal Revenue Service urging the agency to modernize the electronic furnishing requirements for payee statements. Fidelity emphasized the importance of defaulting to electronic communication for tax forms and underscored the need for regulations that reflect the digital-first interactions between brokers and customers.
In its letter, Fidelity highlighted that brokerage customers, in both traditional and digital asset arenas, primarily more ST
FlowVest Inc. Supports Department of Labor Proposed Rule on Fiduciary Duties for Alternative Investments (10)
WASHINGTON, June 3 -- FlowVest Inc., a marketplace platform headquartered in Tonawanda, New York, has submitted a public comment letter to the U.S. Department of Labor Employee Benefits Security Administration (EBSA) expressing support for the Proposed Rule on Fiduciary Duties in Selecting Designated Investment Alternatives. This rule, published on March 31, 2026, is aligned with Executive Order 14330, which aims to democratize access to alternative assets for 401(k) investors.
In its letter, FlowVest outlined the design of its planned investm more ST
Gun Owners of America Urges ATF to Limit Firearm Records Retention to Protect Privacy and Second Amendment Rights (10)
WASHINGTON, June 3 -- Gun Owners of America Inc., a Springfield, Virginia-based gun rights organization, submitted a public comment letter to the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) within the U.S. Department of Justice opposing the agency's proposed rulemaking on firearm records retention periods. The letter voiced strong opposition to the ATF's consideration of extending retention of firearms transaction records to 20 or 30 years, emphasizing legal, constitutional, privacy, and national security concerns.
The ATF publis more ST
Hackensack Riverkeeper Urges EPA for Enforceable Actions on Drinking Water Contaminants (10)
WASHINGTON, June 3 -- Hackensack Riverkeeper Inc., New Jersey, submitted a public comment letter to the U.S. Environmental Protection Agency (EPA) regarding the agency's Draft Drinking Water Contaminant Candidate List 6 (CCL 6). The nonprofit organization expressed concern that although the EPA acknowledges the presence and hazards of contaminants such as microplastics and per- and polyfluoroalkyl substances (PFAS), the agency's current approach lacks enforceable protections to safeguard public health.
The letter highlights that PFAS, termed " more ST
Heritage Foundation Urges Sunsetting and Deregulation of Head Start Program (10)
WASHINGTON, June 3 -- The Heritage Foundation submitted a public comment letter to the Administration for Children and Families (ACF), urging federal officials to sunset the Head Start program and convert it into Education Savings Accounts (ESAs) for preschool families. The letter expressed support for ACF's recent proposed rulemaking titled "Restoring Flexibility to Support Head Start Program Access," published on May 12, 2026, which aims to reduce regulatory burdens and increase local program flexibility.
Madison Marino Doan, Policy Analyst, more ST
Humane World Urges FDA to Strengthen Adoption of Non-Animal Testing Methodologies in Drug Development (10)
WASHINGTON, June 3 -- Humane World for Animals and Humane World Action Fund submitted a public comment letter to the U.S. Food and Drug Administration addressing the agency's draft guidance titled "General Considerations for the Use of New Approach Methodologies" (Docket No. FDA-2025-D-6131). The organizations expressed support for the FDA's intent to reduce animal testing and promote the integration of new approach methodologies in drug development and regulatory submissions. They emphasized the importance of clarifying regulatory pathways and more ST
Impact of New Tariffs on Small Fabricators in the Countertop Industry (10)
WASHINGTON, June, 3 -- America's Granite Inc., Rockville, MD, expressed concerns in a public comment letter to the U.S. International Trade Commission regarding newly imposed tariffs on imported quartz raw materials.
The company warned that these tariffs will raise production costs for small countertop fabricators, which rely heavily on imported quartz slabs to manufacture finished products domestically.
According to the letter, higher material costs will force price increases, potentially reducing demand from homeowners, builders, and develo more ST
Institute for Policy Integrity Challenges BLM's Reduction of Federal Oil and Gas Royalty Rates (10)
WASHINGTON, June 3 -- The Institute for Policy Integrity at New York University School of Law, has submitted a public comment letter to the U.S. Bureau of Land Management (BLM), expressing strong concerns over the agency's direct final rule to revise oil and gas leasing regulations by lowering the federal royalty rate on onshore production from 16.67% to 12.5%. The letter critiques the BLM's regulatory change, which implements provisions of the One Big Beautiful Bill Act (OBBB), and challenges BLM's interpretation of its discretion and the expe more ST
International Center for Law & Economics Urges Targeted Changes to Premerger Notification Form (10)
WASHINGTON, June 3 -- The International Center for Law and Economics, Portland, Oregon, submitted a public comment letter to the Federal Trade Commission and U.S. Department of Justice Antitrust Division regarding proposed improvements to the Hart-Scott-Rodino premerger notification form. ICLE provided a comprehensive analysis focused on balancing the disclosure requirements' antitrust value against their associated compliance costs.
ICLE emphasized the legal baseline established by a recent federal court vacating the updated 2025 HSR form due more ST
Johnson & Johnson Urges Exclusion of Two Multiple Myeloma Therapies From Skilled Nursing Facility Billing (10)
WASHINGTON, June 3 -- Johnson & Johnson Services has submitted a public comment letter to the Centers for Medicare & Medicaid Services (CMS) regarding the agency's proposed updates to the Medicare Program's prospective payment system and consolidated billing for skilled nursing facilities (SNFs) for federal fiscal year 2027. The letter recommends adding two multiple myeloma therapies, TECVAYLI(R) and TALVEY(R), to the list of drugs excluded from SNF consolidated billing.
According to Johnson & Johnson, TECVAYLI(R) (teclistamab-cqyv) and TALVEY more ST
KLINiSOL Inc. Proposes AI Pilot Program Enhancements to FDA for Early-Phase Clinical Trials (10)
WASHINGTON, June 3 -- KLINiSOL Inc., Middle Village, New York, has submitted a public comment letter to the U.S. Food and Drug Administration (FDA) regarding the agency's Request for Information on the Artificial Intelligence-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). The clinical research organization, specializing in integrated clinical trial operating platforms, provided detailed recommendations aimed at improving the design, implementation, and evaluation of AI systems used in early-phase more ST
LeadingAge Raises Concerns Over DOL Proposed Wage Rule Impact on Care Providers (10)
WASHINGTON, June 3 -- LeadingAge, a nonprofit organization representing over 5,300 aging services providers, submitted a public comment letter to the U.S. Department of Labor regarding the agency's proposed rule entitled "Improving Wage Protections for the Temporary and Permanent Employment of Certain Foreign Nationals in the United States." The organization expressed support for the department's aim to promote fair wages and protect U.S. workers but highlighted challenges posed by the methodology used to set prevailing wages under the proposed more ST
Legal Firm Supports ATF Proposal to Remove CLEO Notification Requirement Under National Firearms Act (10)
WASHINGTON, June 3 -- Jonathan S. Goldstein of Goldstein Law Partners, Green Lane, Pennsylvania, submitted a public comment letter to the Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF) endorsing the agency's proposed rule to eliminate the requirement that applicants to make or transfer firearms under the National Firearms Act (NFA) forward a copy of their application to their local chief law enforcement officer (CLEO). The letter argues that the CLEO notification requirement lacks statutory foundation and has failed to deliver meani more ST
LSTA Supports DOL Proposal On Fiduciary Duties Enhancing Access To Alternative Assets In Retirement Plans (10)
WASHINGTON, June 3 -- The Loan Syndications and Trading Association Inc., New York, submitted a public comment letter to the U.S. Department of Labor (DOL) endorsing the agency's proposed regulation aimed at clarifying fiduciary duties under the Employee Retirement Income Security Act of 1974 (ERISA) in selecting designated investment alternatives for participant-directed employee benefit plans. The LSTA strongly supports the initiative as a measure to reduce regulatory hindrances and litigation risks that have limited access for American worke more ST
Luminator Technology Group Supports FMCSA Exemption for Camera-Based Mirror Systems (10)
WASHINGTON, June 3 -- Luminator Technology Group, Plano, Texas, submitted a public comment letter to the Federal Motor Carrier Safety Administration supporting ROSHO Automotive Solutions' application for an exemption from 49 CFR 393.80(a). The exemption would permit the use of camera-based mirror systems as alternatives to traditional rear-vision mirrors on commercial motor vehicles.
The letter highlighted FMCSA's prior exemption of Stoneridge's MirrorEye camera-monitor system, which demonstrated an expanded field of view, elimination of blind more ST
Madison Community Foundation Urges IRS for Clarifications on Donor Advised Funds and Charitable Activity Guidelines (10)
WASHINGTON, June 3 -- The Madison Community Foundation, Wisconsin, a philanthropic organization serving the Greater Madison area, has submitted a public comment letter to the Internal Revenue Service and U.S. Department of the Treasury regarding the agencies' 2026-2027 Priority Guidance Plan. The letter outlines concerns about several regulatory proposals that impact community foundations, particularly focusing on donor advised funds, economic development activities as charitable, and political campaign activity restrictions for section 501(c)( more ST
McKinsey & Company Provides Comprehensive Input to FDA on AI-Enabled Early-Phase Clinical Trials Pilot Program (10)
WASHINGTON, June 3 -- McKinsey & Company Inc., a global life sciences advisory firm, has submitted a detailed public comment letter to the U.S. Food and Drug Administration (FDA) regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Drawing on extensive expertise in AI deployment across clinical trial functions, McKinsey outlined recommendations for pilot design, implementation, evaluation metrics, and governance aimed at advancing the safe and effective integration of AI to improve early-phase drug develo more ST
Missouri Hospital Association Urges CMS To Address Medicare Payment Shortfalls and Implement Outlier Cap for Psychiatric Facility Reimbursement (10)
WASHINGTON, June 3 -- The Missouri Hospital Association, a Jefferson City, Missouri-based organization representing 135 member hospitals, has submitted a public comment letter to the Centers for Medicare & Medicaid Services regarding the proposed FY 2027 updates to the Medicare Inpatient Psychiatric Facility Prospective Payment System (IPF PPS). The letter addresses financial pressures on hospitals, adequacy of the market basket update, proposed outlier payment caps, wage index methodology, and challenges posed by Medicare Advantage plans.
The more ST
MyDirectives Highlights Critical Importance of Accessible Advance Care Planning in Skilled Nursing Facilities (10)
WASHINGTON, June 3 -- MyDirectives Inc., a Richardson, Texas-based healthcare technology company, submitted a public comment letter to the Centers for Medicare & Medicaid Services (CMS) addressing CMS-1843-P, a Request for Information regarding advance care planning (ACP) quality measure concepts for the Skilled Nursing Facility Quality Reporting Program (SNF QRP). The company emphasized that ACP should be treated as continuous, interoperable healthcare infrastructure rather than a one-time administrative task.
In their letter to CMS, MyDirect more ST
NASAA Urges Stronger Safeguards in DOL Proposed Rule on Fiduciary Duties for Retirement Plan Investments (10)
WASHINGTON, June 3 -- The North American Securities Administrators Association submitted a public comment letter to the U.S. Department of Labor Employee Benefits Security Administration (EBSA) regarding the agency's proposed rulemaking to clarify fiduciary duties under the Employee Retirement Income Security Act of 1974 (ERISA). The rulemaking aims to establish a process-based safe harbor related to selecting designated investment alternatives (DIAs) for participant-directed defined contribution plans.
NASAA, an investor protection organizati more ST
National Turkey Federation Urges USDA to Retain Multi-Factor Establishment Size Framework (10)
WASHINGTON, June 3 -- The National Turkey Federation submitted a public comment letter to the U.S. Department of Agriculture Food Safety and Inspection Service regarding the agency's advance notice of proposed rulemaking titled "Revising Establishment Size Definitions." Representing more than 95 percent of U.S. turkey production, NTF stressed the importance of maintaining a classification system that incorporates workforce size, production volume, and other operational factors to ensure accurate regulatory impact assessments.
NTF emphasized th more ST
Netsmart Technologies Urges Caution on Medicare Skilled Nursing Facility Payment and Reporting Proposals (10)
WASHINGTON, June 3 -- Netsmart Technologies Inc., Overland Park, Kansas, submitted a public comment letter to the U.S. Department of Health and Human Services (HHS) Center for Medicare and Medicaid Services (CMS) regarding the Fiscal Year 2027 Skilled Nursing Facility Prospective Payment System (SNF PPS) proposed rule. Netsmart, a supplier of clinical and management information systems supporting post-acute and behavioral health care providers nationwide, offered detailed feedback on a range of issues including data submission deadlines, all-pa more ST
Nevada Legal Services Opposes HUD Rule Changes on Housing Protections (10)
WASHINGTON, June 3 -- Nevada Legal Services, Inc., based in Las Vegas, Nevada, has submitted a public comment letter to the U.S. Department of Housing and Urban Development (HUD) opposing proposed amendments to the HOME Investment Partnerships Program. The letter responds to HUD's Notice of Proposed Rulemaking titled "Establishing Flexibility for Implementation of Work Requirements and Term Limits," urging the agency to withdraw these policy changes.
As a statewide civil legal aid organization dedicated to supporting low-income residents, Neva more ST
Orbital Advisors Supports Regulatory Clarity on Remote Sensing for Pipeline Patrols (10)
WASHINGTON, June 3 -- Orbital Advisors Inc. submitted a public comment letter to the Pipeline and Hazardous Materials Safety Administration advocating for clearer regulatory language regarding the use of innovative remote sensing technologies in pipeline right-of-way patrols. The letter responds to PHMSA's proposed rulemaking that would explicitly include satellite imagery and unmanned aerial systems as acceptable patrol methods, provided they meet prescribed quality expectations.
Orbital Advisors emphasized that pipeline operators should reta more ST
Pathway for Immigrant Workers Urges Department of Labor to Reconsider Proposed Wage Rule for EB-3 Visa Category (10)
WASHINGTON, June 3 -- Pathway for Immigrant Workers, Cambridge, Massachusetts, has submitted a public comment letter to the U.S. Department of Labor opposing the agency's proposed rule concerning prevailing wages for foreign nationals employed in the United States under various visa programs. The non-profit cautions that the proposed method of setting uniform wage percentiles for the EB-3 visa category risks detaching wage requirements from actual market conditions, potentially rendering the EB-3 program largely unusable for employers and immig more ST
Premier Inc. Urges FDA to Advance AI Pilot Program for Early-Phase Clinical Trials With Focus on Safeguards and Inclusivity (10)
WASHINGTON, June 3 -- Premier Inc., a Charlotte, North Carolina-based healthcare improvement company, submitted a public comment letter to the U.S. Food and Drug Administration (FDA) in response to the agency's Request for Information (RFI) regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. Premier expressed support for the FDA's initiative to leverage artificial intelligence (AI) to enhance the efficiency, quality, and inclusiveness of early clinical trials, emphasizing that AI technologies, when responsibly de more ST
Prudential Financial Endorses Asset-Neutral Fiduciary Rule by U.S. Department of Labor (10)
WASHINGTON, June 3 -- Prudential Financial, Newark, New Jersey, submitted a public comment letter to the U.S. Department of Labor regarding the agency's Notice of Proposed Rulemaking on Fiduciary Duties in Selecting Designated Investment Alternatives. Prudential, a leader in financial services specializing in retirement, asset management, and insurance solutions, offered its views on the proposed regulations under the Employee Retirement Income Security Act (ERISA).
In the letter, Prudential endorsed the Department's asset-neutral approach, wh more ST
Renaissance Charitable Foundation Urges IRS to Withdraw Proposed Donor-Advised Fund Regulations (10)
WASHINGTON, June 3 -- The Renaissance Charitable Foundation Inc., Indianapolis, Indiana, has submitted a public comment letter to the Internal Revenue Service urging withdrawal of Treasury's Proposed Regulations concerning definitions and distributions of donor-advised funds for the 2025-2026 Priority Guidance Plan. The foundation criticized the proposed rules as exceeding statutory authority and imposing undue costs on private entities without corresponding public benefits.
The foundation's letter argues that the proposed regulations unlawful more ST
Results for America Submits Detailed Input on Treasury's SIPPRA Program Review (10)
WASHINGTON, June 3 -- Results for America, headquartered in Washington, D.C., has submitted a public comment letter to the U.S. Department of the Treasury concerning the draft Fiscal Year 2026 Social Impact Partnerships to Pay for Results Act Notice of Funding Availability. RFA's comments provide targeted recommendations aimed at enhancing the program's outcome valuation methodologies, application processes, evaluation designs, and outcome prioritization in the department's third funding round.
In its feedback to the Office of Economic Policy more ST
Securities Industry & Financial Markets Association Urges Treasury and IRS to Repeal and Amend Multiple Tax Regulations Citing Excessive Compliance Burdens (10)
WASHINGTON, June 3 -- The Securities Industry and Financial Markets Association, New York, submitted a public comment letter to the U.S. Department of the Treasury and Internal Revenue Service recommending numerous reforms, repeals, and withdrawals of existing and proposed tax regulations. The letter expressed concerns over the compliance complexities and operational costs the regulations impose, which SIFMA asserts outweigh any corresponding public benefits.
SIFMA, representing broker-dealers, investment banks, and asset managers with nearly more ST
Skyline Tile & Marble Opposes ITC Quartz Tariff Ruling (10)
WASHINGTON, June 3 -- Skyline Tile & Marble, Inc., based in Woodinville, WA, submitted a public comment letter to the U.S. International Trade Commission (ITC) opposing its ruling favoring the Quartz Manufacturing Association of America.
The company warned that increased tariffs on imported quartz would raise costs, harm nearly 10,000 U.S. fabrication shops, and threaten jobs in this price-sensitive industry.
Skyline Tile & Marble emphasized that American-produced quartz is already more expensive and that tariffs could push builders to altern more ST
SPARK Institute Urges Strong Support and Refinements for Department of Labor's Investment Selection Proposal (10)
WASHINGTON, June 3 -- The SPARK Institute, representing retirement plan service providers, submitted a public comment letter to the U.S. Department of Labor's Employee Benefits Security Administration expressing robust support for the agency's proposed regulations on fiduciary duties in selecting designated investment alternatives. The proposal, known as RIN 1210-AC38, addresses key fiduciary responsibilities under the Employee Retirement Income Security Act of 1974 (ERISA). The SPARK Institute's letter highlights the proposal's strengths while more ST
Turing Provides Comprehensive Input on FDA AI-Enabled Clinical Trials Pilot Program (10)
WASHINGTON, June 3 -- Turing Enterprises Inc., a San Francisco, California-based AI infrastructure firm, recently submitted a public comment letter to the U.S. Food and Drug Administration concerning the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program. The letter offers extensive recommendations and insights aimed at enhancing the pilot's capacity to produce regulatory-grade evidence for AI use in early-phase drug development.
Turing, operating as an AI infrastructure and evaluation provider rather than a clinical more ST
U.N. Federal Credit Unio Calls on NCUA to Modernize Investment Regulations and Expand Permissible Investments (10)
WASHINGTON, June 3 -- The United Nations Federal Credit Union, headquartered in Long Island City, New York, submitted a public comment letter to the National Credit Union Administration urging updates to the agency's Investment and Deposit Activities Rule. UNFCU highlighted the need to modernize outdated documentation requirements and expand the list of permissible investments to better support federally insured credit unions.
UNFCU pointed out that the current rule's mandate for obtaining individual confirmation statements from each broker-de more ST
U.S. Black Chambers Calls for Inclusive Policies to Support Black-Owned Business Mergers and Acquisitions (10)
WASHINGTON, June 3 -- The U.S. Black Chambers Inc. submitted a public comment letter to the Federal Trade Commission and the U.S. Department of Justice in response to their request for information regarding Hart-Scott-Rodino premerger notification and related merger review policies. Representing 175 affiliate chambers of commerce and over 365,000 Black-owned businesses nationwide, USBC emphasized the need for merger policies that recognize the unique challenges faced by micro-businesses, particularly Black-owned firms, in the mergers and acquis more ST
U.S. Hispanic Business Council Calls for Evidence-Based Approach to Premerger Notification Improvements (10)
WASHINGTON, June 3 -- The U.S. Hispanic Business Council, representing America's 4.5 million Hispanic-owned businesses, submitted a public comment letter to the Federal Trade Commission and U.S. Department of Justice Antitrust Division regarding proposals to improve the premerger notification and report form under the Hart-Scott-Rodino Act. The letter urged the FTC and DOJ to demonstrate sufficient evidence showing that the recent Updated Form, which increased reporting requirements, has effectively enhanced antitrust reviews without imposing e more ST
University of Minnesota Associate Director of Scholar Hoffman Raises Concerns Over Department of Labor's Proposed H-1B Prevailing Wage Rule (10)
WASHINGTON, June 3 -- Molly Hoffman, associate director of scholar advising at the University of Minnesota, Minneapolis, submitted a public comment letter to the U.S. Department of Labor arguing that proposed changes to prevailing wage calculations for H-1B and related visa programs could create wage distortions and harm employers facing workforce shortages.
The commenter criticized the blanket approach taken by the Department of Labor (DOL) in adjusting wage level percentiles across all occupations, asserting that the proposed uniform wage in more ST
University of Pennsylvania Urges ICE to Modify Wage Rule Impacting Postdoctoral Researchers (10)
WASHINGTON, June 3 -- The University of Pennsylvania, Philadelphia, submitted a public comment letter to Immigration and Customs Enforcement addressing concerns about the U.S. Department of Labor's Notice of Proposed Rulemaking titled "Improving Wage Protections for the Temporary and Permanent Employment of Certain Foreign Nationals in the United States." The letter cautions that the NPRM's proposed prevailing wage changes could adversely affect research capabilities by limiting entry-level postdoctoral researchers, many of whom are foreign nat more ST
Vanguard Group Urges Federal Agencies Not to Narrow Investment Exemption in Premerger Notification Rules (10)
WASHINGTON, June 3 -- The Vanguard Group Inc., Malvern, Pennsylvania, submitted a public comment letter to the Federal Trade Commission and the U.S. Department of Justice Antitrust Division regarding a request for comments on possible improvements to the premerger notification and report form under the Hart-Scott-Rodino Antitrust Improvements Act. Vanguard expressed concerns about proposals to alter the "solely-for-the-purpose-of-investment" exemption, warning that changes could impose significant costs on investors and disrupt ordinary investm more ST
Voya Financial Supports Department of Labor Proposed Fiduciary Rule With Recommendations for Clarification (10)
WASHINGTON, June 3 -- Voya Financial, Inc., New York, has submitted a public comment letter to the U.S. Department of Labor regarding the agency's proposed rule entitled Fiduciary Duties in Selecting Designated Investment Alternatives (RIN 1210-AC38). As a leading provider of recordkeeping and related services for defined contribution plans, Voya Financial expresses strong support for the proposed rule while offering recommendations for certain clarifications and adjustments.
The letter praises the Department for providing clear, practical gui more ST
Zealic Health Emphasizes Continuous Compliance Framework in FDA AI Clinical Trials Pilot Program (10)
WASHINGTON, June 3 -- Zealic Health Inc., a clinical trial technology innovator based in Raleigh, North Carolina, submitted a public comment letter to the U.S. Food and Drug Administration regarding the agency's AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390). The company conveyed strong support for the FDA's leadership in modernizing clinical trial execution through artificial intelligence and stressed the need for a comprehensive, real-time approach to clinical trial operations.
Zealic Health more ST
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