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Public Comments on Proposed Federal Rules
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Blockchain Association Urges Treasury to Ensure Consistency and Flexibility in State-Level Stablecoin Regulation
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WASHINGTON, June 10 -- The Blockchain Association, a nonprofit organization based in Washington D.C. devoted to promoting innovation in the digital asset space, submitted a public comment letter to the U.S. Department of the Treasury regarding the department's Proposed Rule implementing Section 4(c) of the Guiding and Establishing National Innovation for U.S. Stablecoins Act. The letter addresses broad principles for determining when state-level regulatory frameworks for payment stablecoins can be considered substantially similar to the federal regulatory framework.The Blockchain Association ... Show Full Article WASHINGTON, June 10 -- The Blockchain Association, a nonprofit organization based in Washington D.C. devoted to promoting innovation in the digital asset space, submitted a public comment letter to the U.S. Department of the Treasury regarding the department's Proposed Rule implementing Section 4(c) of the Guiding and Establishing National Innovation for U.S. Stablecoins Act. The letter addresses broad principles for determining when state-level regulatory frameworks for payment stablecoins can be considered substantially similar to the federal regulatory framework. The Blockchain Association(BA), representing over 100 member companies in the blockchain industry, conveyed support for Treasury's efforts to develop clear standards that preserve both a consistent national framework and state-level regulatory roles under the GENIUS Act. The act enables qualified state payment stablecoin issuers (SQPSIs) with under $10 billion in issuance to opt into state supervision if their regulatory framework meets a "substantially similar" standard compared to the federal regime. The primary federal regulators involved include the Board of Governors of the Federal Reserve System, Federal Deposit Insurance Corporation, National Credit Union Administration, and the Office of the Comptroller of the Currency (OCC).
BA emphasized that Treasury's Proposed Rule appropriately balances nationwide consistency with state flexibility in stablecoin regulation, reflecting the dual banking tradition in the United States. The organization's letter urges Treasury to anchor the federal regulatory baseline specifically on the OCC's framework, which is set to become the primary Federal regulator for stablecoin issuers that exceed the $10 billion threshold. This anchoring provides states with a clear benchmark against which to calibrate their regulatory regimes, ensuring uniform requirements are met or exceeded without permitting jurisdiction shopping or cherry-picking components from multiple federal frameworks.
The association recommended that the Treasury clarify that the "federal regulatory framework" encompasses not only the GENIUS Act's statutory text but also the department's regulations, interpretations, and orders, particularly those pertaining to the Bank Secrecy Act and sanctions compliance. This would preserve federal authority in combating illicit activity involving digital assets, as mandated by the act.
A central focus of the letter is the distinction between "uniform requirements" and "state-calibrated requirements" proposed in the Treasury's rule. Uniform requirements consist of core prudential safeguards-such as reserve asset composition and redemption obligations-that must align exactly with the federal framework to maintain nationwide fungibility and consumer confidence. BA opposes any form of balancing or equivalence test that permits deviations from these uniform standards, advocating instead for a strict, section-by-section conformity test.
For state-calibrated requirements, the organization acknowledges the value of regulatory flexibility tailored to local market conditions and supervisory expertise. Such requirements include certain licensing, chartering, and technology-related provisions, which can differ so long as they produce regulatory outcomes that are at least as protective as those under the federal framework. The letter underscores that this authority is bounded and urges the removal or revision of terms implying open-ended state "substantive discretion," which is not supported by the statute.
BA also recommended that Treasury require consistent use of statutory definitions across all state frameworks to prevent regulatory fragmentation. For example, the definition of "payment stablecoin" under the GENIUS Act strictly limits regulated assets to centralized, fully backed tokens and excludes deposits and decentralized stablecoins. Allowing states to reinterpret this definition risks undermining the federal standards and complicating the stablecoin market.
Regarding consumer protection and market-access requirements, the association cautioned against permitting states to impose additional licensing, token approval, or registration conditions on federally supervised payment stablecoin issuers that could conflict with the act's aims. Treasury is urged to assess state regulations holistically to ensure no hidden barriers impede the ability of stablecoin issuers to operate across state lines under federally coordinated supervision.
In its letter, BA advocates for the creation of a passporting mechanism whereby states with SCRC-approved frameworks could allow stablecoin issuers licensed therein to operate in other states without redundant licensing processes. This mutually recognized system would ease entry barriers for smaller entities, stimulate interstate commerce, and encourage states to adopt robust regulatory frameworks that meet approval standards.
The Blockchain Association's comments highlight the importance of preserving the GENIUS Act's goal of fostering responsible innovation in stablecoins through consistent yet adaptable oversight. By endorsing Treasury's Proposed Rule with suggested enhancements, the organization seeks to support the development of a coherent regulatory landscape that ensures stablecoins maintain their stability, liquidity, and consumer protections nationwide while accommodating state-specific considerations.
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The letter was signed by:
Ashok Pinto
Executive Vice President
Legal and Government Relations
The Blockchain Association
1155 F St NW, Suite 300
Washington, DC 20004
contact@theblockchainassociation.org
(202) 503-9613
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2026-0232-0044
California Hospice and Palliative Care Association Urges Caution on Hospice Payment Rule and Data Integrity Concerns
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WASHINGTON, June 10 -- The California Hospice and Palliative Care Association, based in Elk Grove, California, submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing concerns about the proposed FY 2027 Hospice Wage Index and Payment Rate Update, the Hospice Conditions of Participation Updates, and the Hospice Quality Reporting Program Requirements. Offering detailed recommendations, CHAPCA highlighted potential risks related to current payment methodologies, data reliability, and program integrity that may negatively impact legitimate hospice providers and
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WASHINGTON, June 10 -- The California Hospice and Palliative Care Association, based in Elk Grove, California, submitted a public comment letter to the Centers for Medicare & Medicaid Services expressing concerns about the proposed FY 2027 Hospice Wage Index and Payment Rate Update, the Hospice Conditions of Participation Updates, and the Hospice Quality Reporting Program Requirements. Offering detailed recommendations, CHAPCA highlighted potential risks related to current payment methodologies, data reliability, and program integrity that may negatively impact legitimate hospice providers andbeneficiary care.CHAPCA's letter emphasizes the challenging financial pressures facing hospice providers, including rising labor costs, inflation, transportation expenses, pharmaceuticals, and operational overhead. With California experiencing some of the highest labor and living expenses nationally, these factors make the proposed payment update insufficient to meet providers' needs. Unlike hospitals or other healthcare sectors with diversified payer mixes, hospices rely heavily on Medicare reimbursement, exposing them to payment adequacy vulnerabilities if the methodology does not reflect their unique care models.
The association calls on CMS to reassess the FY 2027 hospice payment update using current data on inflation, wages, pharmaceutical prices, and labor markets. They also urge the agency to evaluate the cumulative impact of past forecasting errors and productivity adjustments, noting that hospice care is labor-intensive and largely delivered in community-based settings where productivity gains are structurally limited.
On the hospice wage index front, CHAPCA acknowledges CMS's efforts to implement floor and transition protections but opposes adopting a hospice-specific wage index until cost reports and claims data are thoroughly validated. The letter points out that hospices operate under staffing patterns and labor markets distinct from acute-care hospitals. Additionally, hospices bear considerable travel and transportation burdens not captured by hospital-centric wage indices, particularly in states like California with vast service areas and competitive labor markets.
The association expresses strong reservations about proceeding with a hospice-specific wage index development amid ongoing data integrity challenges. A significant concern is that the current hospice cost report universe includes providers who are terminated, revoked, inactive, or suspected of fraudulent activity. CHAPCA points to rapid provider growth and evidence of program integrity failures in California and other states as a major distortion risk for wage index calculations. The letter recommends CMS conduct extensive program integrity screening, audit a representative sample of cost reports, and exclude data from problematic providers before moving forward.
CHAPCA also critiques the proposed Service and Spending Variation Index (SSVI), designed to identify hospice providers with unusual patterns potentially indicative of fraud or waste. The association highlights methodological flaws in the SSVI, such as its reliance on annual claim snapshots that fail to capture longitudinal beneficiary enrollment patterns and complex fraud indicators like serial reenrollments and provider cycling. According to CHAPCA, the SSVI may normalize fraud-heavy market behaviors rather than isolate them due to its inability to follow beneficiaries over time or adequately separate adverse-status providers from compliant ones.
Furthermore, the letter raises concerns about the SSVI attributing non-hospice Medicare spending-such as durable medical equipment and laboratory services-to hospices, even though hospices do not control or adjudicate those bills. Publicly scoring hospices for spending they cannot influence could mislead the public and unfairly damage provider reputations. CHAPCA recommends terminating the SSVI's public implementation, removing existing public files until disclosure and methodology concerns are resolved, and maintaining separate internal fraud analytics for enforcement purposes.
Regarding administrative proposals, CHAPCA opposes requiring hospices to give all Medicare beneficiaries an election statement addendum at admission, citing risks of confusing or incomplete information that could cause patient anxiety. Instead, they recommend providing the addendum only upon beneficiary request after clinical assessment. The association asserts that unaddressed non-hospice spending during hospice elections stems from Medicare processing system limitations rather than documentation requirements and urges CMS to improve oversight and claims processing for unrelated services.
On telehealth face-to-face eligibility, CHAPCA appreciates statutory changes but calls for CMS to release clear, uniform guidance on practitioner enrollment, billing codes, and enforcement timelines prior to initiating audits or denials. The group stresses the importance of a reasonable good-faith compliance period to prevent penalizing providers over technical issues.
CHAPCA also questions the proposed Hospice Quality Reporting Program icon indicating non-compliance, warning it could mislead patients and families by confusing reporting status with clinical quality. They advocate delaying icon implementation until reporting stabilizes and ensuring public reporting tools undergo beneficiary testing and provide clear, plain-language explanations.
The association supports expanding access to community-based palliative care distinct from the Medicare hospice benefit. They recommend exploring dedicated payment pathways that facilitate interdisciplinary symptom management, care coordination, and caregiver support while maintaining hospice benefit integrity. Expanding telehealth access for seriously ill beneficiaries is also encouraged.
In an extended analysis attached to their letter, CHAPCA details significant data integrity concerns found in hospice cost report filings. Between fiscal years 2016 and 2024, total hospice cost reports increased by about 68 percent, with certified hospice filings nearly doubling. A considerable percentage of these reports come from states with noted program integrity problems, especially California, Arizona, Nevada, and Texas, which combined accounted for over half of filings by 2024. The presence of terminated and non-compliant providers' data in the cost report universe threatens to distort any hospice-specific wage index constructed from these reports.
Drawing on lessons from home health payment policy, where reliance on data from fraud-affected providers led to nationwide payment challenges, CHAPCA urges CMS not to repeat such errors in hospice. They recommend comprehensive data validation, stakeholder engagement, and impact analysis before adopting new payment methodologies.
The letter also touches on Medical Aid in Dying (MAID), advising CMS to maintain clear distinctions between hospice care and direct MAID participation. The association supports continued hospice care for beneficiaries who inquire about or pursue MAID under state law, while complying with federal funding restrictions.
CHAPCA concludes by reiterating support for strengthening hospice program integrity and beneficiary protections but cautions that policy tools and payment systems must be built on reliable data. They emphasize the need to recognize the differences between legitimate providers serving patients faithfully and those with questionable operational practices that disrupt Medicare hospice benefits. The organization looks forward to ongoing collaboration with CMS to ensure policies maintain access to quality end-of-life care while addressing program integrity challenges.
Contact information for CHAPCA, including its Elk Grove headquarters and leadership, was provided in the letter, reflecting the association's commitment to representing California's hospice and palliative care providers in federal policy discussions.
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The letter was signed by:
Sheila Clark
President and CEO
California Hospice and Palliative Care Association
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Read full text of letter here: https://www.regulations.gov/comment/CMS-2026-1156-0180
BioinvestGPT Proposes Patient-Data-Free AI Tool Class for FDA Early-Phase Clinical Trial Pilot Program
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WASHINGTON, June 10 -- BioinvestGPT ApS, a Copenhagen, Denmark-based company, submitted a public comment letter to the Food and Drug Administration outlining a proposal for an artificial intelligence tool class designed to optimize early-phase clinical trials. The letter concerns the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program and specifically responds to the agency's requests for information on pilot program design, implementation, evaluation metrics, and success criteria.BioinvestGPT introduced its proprietary technology, BeatSoC Virtual Clinical Trials (BVCT), as a ... Show Full Article WASHINGTON, June 10 -- BioinvestGPT ApS, a Copenhagen, Denmark-based company, submitted a public comment letter to the Food and Drug Administration outlining a proposal for an artificial intelligence tool class designed to optimize early-phase clinical trials. The letter concerns the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program and specifically responds to the agency's requests for information on pilot program design, implementation, evaluation metrics, and success criteria. BioinvestGPT introduced its proprietary technology, BeatSoC Virtual Clinical Trials (BVCT), as areference implementation of a patient-data-free, first-in-human-blinded mechanistic prediction tool capable of estimating registrational-endpoint clinical benefits for candidate drugs compared to standard-of-care treatments. The company urges the FDA to consider this tool class as a candidate within the pilot program, emphasizing that BVCT is not proposed as a regulatory gatekeeper but rather as a decision-support mechanism to aid Phase 1 to Phase 2 transition discussions between sponsors and the agency.
According to BioinvestGPT, BVCT generates predictions based purely on molecular structure and registered trial design parameters without inputting any patient-level data or first-in-human data for the drug asset. This approach reportedly alleviates concerns about patient privacy, intellectual property leaks, and data residence issues, making it well-suited for regulatory pilot evaluation. The company offered assurances that outputs from BVCT would not be used in isolation to approve, place on hold, or terminate drug programs, thereby maintaining existing regulatory review frameworks.
The public comment letter highlighted evidence from BioinvestGPT's operational history dating back to August 2022, involving 1,431 prospectively issued and cryptographically time-stamped predictions across multiple phases of clinical development. The tool demonstrated positive predictive values (PPV) of 96.9% on Phase 1 entry predictions-a key subgroup corresponding to the earliest human dosing stage-with overall cohort-wide PPV of 89.6% and negative predictive value (NPV) of 98.6%. These metrics, BioinvestGPT noted, substantially exceed historical industry baselines and reflect consistency across therapeutic areas including oncology, rare diseases, metabolic, and neurological indications.
BioinvestGPT proposed an 18-month pilot duration divided into an initial 6-month qualification phase exposing the tool class to independent validation, followed by 12 months of prospective operational evaluation. Central to the proposal is incorporating independent, FDA-selected academic biostatistics groups to conduct blinded re-adjudications of predictions before any operational deployment in Phase 1 trials. This step is intended to ensure that the agency bases decisions on independently verified performance rather than relying on company-derived claims.
The letter elaborated on a four-party collaboration model encompassing the FDA as regulator and evaluator, an FDA-selected clinical trial sponsor, the AI tool provider (such as BioinvestGPT), and an FDA-nominated academic adjudicator. Such a structure prioritizes sponsor confidentiality, maintains agency impartiality, and enables transparent scientific knowledge sharing via publicly accessible deposits and periodic pilot reports formatted according to established reporting standards including TRIPOD+AI and MI-CLAIM.
In terms of pilot evaluation metrics, BioinvestGPT recommended assessing trial efficiency through timelines from IND clearance to patient dosing and from Phase 1 dosing to Phase 2 initiation, alongside examining decision quality using joint performance profiles including PPV, NPV, sensitivity, specificity, and F1-score. They also emphasized the importance of comparing AI-supported decisions against concurrent non-AI sponsor decisions and historical approval likelihood baselines. The impact of the tool on participant safety and data integrity was addressed, pointing out that while the tool itself does not directly accelerate safety signal detection, it helps contextualize observed Phase 1 safety profiles by offering mechanistically anticipated adverse event predictions.
The company asserted alignment with the National Institute of Standards and Technology (NIST) AI Risk Management Framework principles, describing BVCT as valid, reliable, safe, secure, resilient, accountable, transparent, explainable, privacy-enhanced, and bias-managed. The patient-data-free design contributes to eliminating significant data-breach vectors and protecting patient confidentiality.
BioinvestGPT further noted that the tool class has demonstrated commercial readiness through engagement with a top 20 global pharmaceutical company and a prominent institutional asset manager, who have integrated BVCT within their internal decision-support workflows. Nonetheless, the company stressed that the FDA's independent re-adjudication process and pilot evaluation are essential to objectively confirm the tool's operational fitness.
Recognizing limitations inherent in mechanistic candidate-prediction tools, the submitters identified six structural failure modes for consideration during pilot deployment, including incomplete public knowledge of mechanisms, variabilities in disease biology characterization, rapidly changing standards of care, unmodeled adherence or formulation factors, endpoints driven by non-biological considerations, and non-stationarity in therapeutic context.
The letter concluded by underlining the high uncertainty and limited information available in early-phase trials, making this phase particularly amenable to mechanistically validated AI decision-support tools. BioinvestGPT offered to make its extensive data sets, codebase, and blinded pilot samples available to the agency under requested conditions and expressed readiness to participate in the pilot under cooperative research agreements or similar frameworks. They also indicated willingness to brief FDA offices such as the Center for Drug Evaluation and Research's Office of Computational Science and the Office of the Commissioner's Deputy Chief Medical Officer.
The submission stands as a comprehensive proposal for integrating transparent, auditable AI tools into early drug development regulatory decision-making, advocating a prudent pathway for verification, collaboration, and learning with the potential to increase Phase 1 to Phase 2 trial decision quality and efficiency. The FDA's responses to these comments may influence the shaping of how AI technologies contribute to the regulatory evaluation landscape for experimental therapeutics.
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Idonae Lovetrue (Siyi Liu)
Co-founder & Co-CEO
Strategy, Operations, BD
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Bragi Lovetrue (Zhipan Ren)
Co-founder & Co-CEO
Science & Technology
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2026-N-4390-0112
Anti-Fraud Coalition Urges FinCEN to Strengthen Proposed Whistleblower Rule for Greater Protection and Incentives
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WASHINGTON, June 10 -- The Anti-Fraud Coalition, a public interest nonprofit based in Washington, D.C., submitted a public comment letter to the U.S. Department of the Treasury Financial Crimes Enforcement Network addressing the agency's proposed rule on whistleblower incentives and protections. The proposal, issued pursuant to provisions of the Anti-Money Laundering Act of 2020 and related statutes, seeks to establish a whistleblower program to encourage individuals to report violations of significant financial crime statutes including the Bank Secrecy Act, International Emergency Economic Powers
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WASHINGTON, June 10 -- The Anti-Fraud Coalition, a public interest nonprofit based in Washington, D.C., submitted a public comment letter to the U.S. Department of the Treasury Financial Crimes Enforcement Network addressing the agency's proposed rule on whistleblower incentives and protections. The proposal, issued pursuant to provisions of the Anti-Money Laundering Act of 2020 and related statutes, seeks to establish a whistleblower program to encourage individuals to report violations of significant financial crime statutes including the Bank Secrecy Act, International Emergency Economic PowersAct, Trading With the Enemy Act, and the Foreign Narcotics Kingpin Designation Act.The Anti-Fraud Coalition (TAF Coalition), which has decades of experience advising whistleblowers and contributing to whistleblower program development, expresses overall support for the rule but highlights critical areas needing revision to ensure whistleblowers are properly incentivized, adequately protected, and fairly awarded in alignment with Congressional intent.
Notable positive elements identified by the organization include the proposed $15 million threshold to qualify for a presumptive 30% award and provisions giving whistleblowers flexibility to have their tip recognized as original information even when the data comes from multiple sources, reinforcing the program's usability and cooperation with internal compliance processes.
However, the Coalition warns that several policy decisions could undermine the program's effectiveness. One key concern is the exclusion of monies recovered through bankruptcy proceedings from the definition of "monetary sanctions," a measure which risks penalizing whistleblowers in cases where companies fail due to their own misconduct. This exclusion could discourage reports from critical sectors such as fintech startups, where financial fragility is common. The Coalition recommends amending definitions to explicitly include bankruptcy recoveries to align FinCEN's program with successful elements of other whistleblower statutes like the False Claims Act.
The letter also critiques the proposal's exclusion of funds sent to the U.S. Victims of State Sponsored Terrorism Fund (USVSSTF) from whistleblower awards. The Coalition argues this directly contradicts the program's goals by disincentivizing reporting in high-priority areas such as terror financing and Iran sanctions violations. They advocate including such funds to maximize victim compensation and whistleblower motivation.
TAF Coalition expresses further concern about provisions potentially rendering whistleblowers ineligible for awards if the information was obtained through means violating criminal law, such as unauthorized recordings. Given the complex legal landscape for consent to recordings across jurisdictions, this could unfairly disqualify essential tips. The Coalition recommends removal of these disqualifications, emphasizing that other established programs offer protections for such whistleblowers.
Another contested rule would disqualify whistleblowers convicted of any criminal violation "related to" the covered action, with no differentiation by degree of culpability or relevance. The Coalition advises narrowing this rule to avoid deterring valuable insiders who may have minor or tangential involvement but can provide critical information.
The Coalition also objects to proposed discretion allowing FinCEN to pay whistleblower awards below the statutory minimum of 10% if another agency makes a related payment, which they assert violates the statutory mandate and precedent set by recent Supreme Court rulings.
A particularly troubling provision permits sharing whistleblower information with witnesses, defendants, or even the whistleblower's employer without sufficient confidentiality safeguards. The Coalition highlights that confidentiality and anonymity form the foundation of successful whistleblower programs, especially given known retaliation risks, and calls for strong legal protections to maintain whistleblower confidence.
Additional comments provided include suggestions to replace vague requirements that whistleblower submissions be "complete" with a more workable standard that they do not omit information making the report misleading. The Coalition proposes removing overly broad subjective criteria that could punish whistleblowers for technical missteps or incomplete knowledge.
TAF Coalition criticizes the proposal's requirement that whistleblowers who first report internally must bring the same information to FinCEN "within a reasonable time," arguing the ambiguity likely deters internal reporting. A specific 120-day timeframe is suggested to promote clarity.
The organization also recommends removing or modifying the 120-day waiting period imposed on internal audit and compliance personnel before they can submit information to the government, noting that companies frequently retaliate during such periods and early reporting exceptions for imminent harm or cover-ups should be allowed.
In addition to detailed critiques summarized above, the Coalition associates itself with similar concerns raised by the National Whistleblower Center and other commenters. It underscores the need for more robust protections for international whistleblowers, mechanisms permitting direct reporting to the Department of Justice, and assurance of timely award payments without undue delays.
TAF Coalition advises FinCEN to improve the clarity and administration of the rule by including explicit presumptions that opening an investigation satisfies causation standards for whistleblower awards and to revise language in key provisions regarding definitions, eligibility, and confidentiality protections. The letter also emphasizes the importance of resolving timing issues related to award submissions and appeals to prevent delays in compensation.
Highlighting the potential risk of frivolous or low-quality submissions fueled by the advent of artificial intelligence tools, the Coalition supports including rules to bar submissions with bad faith omissions or falsehoods but stresses that whistleblowers must have the opportunity to correct or withdraw submissions before sanctions are imposed.
Concluding, the Anti-Fraud Coalition acknowledges FinCEN's efforts and expresses eagerness to collaborate with the agency to finalize a whistleblower program that upholds Congressional goals, safeguards whistleblowers, and enhances enforcement against financial crimes.
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The letter was signed by:
Jacklyn DeMar
President & CEO, The Anti-Fraud Coalition
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Read full text of letter here: https://www.regulations.gov/comment/FINCEN-2026-0067-0078
Andreessen Horowitz Urges Uniformity in Treasury Stablecoin Regulatory Framework
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WASHINGTON, June 10 -- Andreessen Horowitz, a venture capital firm based in Menlo Park, California, submitted a public comment letter to the U.S. Department of the Treasury addressing the agency's proposed rulemaking on the GENIUS Act's framework for determining when a state-level stablecoin regulatory regime is substantially similar to the federal regulatory framework. The letter emphasizes the importance of regulatory clarity, uniform definitions, and close federal-state coordination to support digital asset innovation while preventing a fragmented stablecoin market.The Treasury's proposal, ... Show Full Article WASHINGTON, June 10 -- Andreessen Horowitz, a venture capital firm based in Menlo Park, California, submitted a public comment letter to the U.S. Department of the Treasury addressing the agency's proposed rulemaking on the GENIUS Act's framework for determining when a state-level stablecoin regulatory regime is substantially similar to the federal regulatory framework. The letter emphasizes the importance of regulatory clarity, uniform definitions, and close federal-state coordination to support digital asset innovation while preventing a fragmented stablecoin market. The Treasury's proposal,issued in April 2026, aims to implement Section 4(c) of the Guiding and Establishing National Innovation for U.S. Stablecoins (GENIUS) Act by establishing broad-based principles to evaluate if states' regulatory regimes align closely with federal standards. a16z, which manages over $100 billion across multiple funds including nearly $10 billion dedicated to crypto investments, engaged extensively with the digital asset ecosystem and underscored the critical nature of this proposal. The firm's investments include regulated stablecoin issuers and infrastructure providers reliant on blockchain technology to develop internet-based financial protocols.
In its public comment letter, a16z highlights that stablecoins have become foundational financial infrastructure for internet and international payments. It advocates for a uniform regulatory framework to enable stablecoins issued under state licenses to operate nationwide under single-state primary supervision. This approach aims to avoid the multi-state licensing complexities that have historically burdened money transmission businesses and to maintain a level playing field between federally and state-regulated eligible issuers.
Key points from a16z's response include the recommendation that all GENIUS Act definitions, not just select "uniform requirements," be standardized at the federal and state levels to ensure substantial similarity. The letter argues against granting states broad or substantive discretion to diverge on regulatory definitions or core requirements. Instead, states should have authority only over areas Congress explicitly carved out in Section 7 of the Act, such as chartering, licensing, consumer protection, and supervision tailored to qualified payment stablecoin issuers.
The letter further supports including all relevant federal regulations and final rules, such as those recently proposed by the Federal Deposit Insurance Corporation (FDIC), within the "federal regulatory framework." This comprehensive approach would promote consistent treatment across regulators and preclude discrepancies like allowing pass-through deposit insurance on payment stablecoins in some jurisdictions but not others, which could undermine fungibility and market stability.
a16z stresses the importance of fungibility and interoperability for stablecoins to function effectively as a national payment and settlement instrument. The firm recommends that Treasury's final rule strictly requires state regimes to mirror federal prudential standards and prohibits states from imposing conflicting requirements that could fragment the market or create arbitrage opportunities. It also requests that the Treasury avoid reliance on imprecise metrics such as numerical scoring to assess substantial similarity, instead advocating for clear, section-by-section evaluations requiring full alignment with federal standards on substantive matters.
The public comment letter critiques Treasury's proposal to designate certain Section 4(a) provisions as "state-calibrated" with wide latitude for state discretion. a16z maintains that these provisions should be uniform requirements subject to minimal deviation, except for nonsubstantive procedural differences. Examples discussed include limitations on the payment of interest or yield on stablecoins and mandates regarding reserve assets, capitalization, liquidity, and activity restrictions. Any material deviation from federal requirements risks inconsistent consumer protection and threatens the viability of a national stablecoin framework.
Additionally, a16z recommends clearer definitions for a "state-level regulatory regime" to encompass all enforceable statutes, rules, and guidance that effectively regulate permitted payment stablecoin issuers (PPSIs), including broader statutes like digital asset licensing and money transmission laws. The firm urges that states be allowed to submit multiple regulatory regimes for certification and that the Treasury clarify how states with multiple overlapping regulatory frameworks should be treated by the Stablecoin Certification Review Committee (SCRC).
Regarding interstate operations, the letter supports Treasury clarifying the preemption of host state regulatory requirements under Section 7(f) of the GENIUS Act. a16z encourages the agency to confirm that PPSIs licensed in one certified state should not be subject to duplicative or inconsistent requirements in host states, fostering a truly national market. This recommendation aligns with Congressional intent to prevent a fragmented licensing system reminiscent of traditional money transmission regulations, which impose significant operational burdens.
The firm also calls for Treasury to coordinate closely with other federal payment stablecoin regulators, including the FDIC and federal banking agencies, to maintain a coherent and durable federal regulatory framework that can adapt to innovation while preserving core uniform standards.
a16z concludes by providing a detailed review and markup of the Proposal's Appendix A, categorizing which GENIUS Act provisions should be uniform versus state-calibrated. The submission urges Treasury to finalize a rulemaking that promotes clarity, operational simplicity, and regulatory consistency to support the stablecoin ecosystem's growth as a vital component of America's digital financial infrastructure.
The letter from a16z represents a comprehensive stakeholder perspective advocating for regulatory harmonization during a pivotal period in U.S. stablecoin regulation. Its recommendations seek to balance state authority with overarching federal standards to ensure safe, efficient, and interoperable payment stablecoins that can serve consumers and businesses nationally.
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The letter was signed by:
Miles Jennings, Head of Policy & General Counsel
Michele R. Korver, Head of Regulatory
Jai Ramaswamy, Chief Legal Officer
Scott Walker, Chief Compliance Officer
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2026-0232-0028
Amneal Pharmaceuticals Provides Detailed Recommendations for FDA Scale-up and Post-Approval Changes Guidance Revision
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WASHINGTON, June 10 -- Amneal Pharmaceuticals LLC, a Bridgewater, New Jersey-based affordable medicines company, has submitted a public comment letter to the Food and Drug Administration addressing the agency's solicitation for feedback on guidance related to scale-up and post-approval changes for pharmaceutical dosage forms. The letter provides in-depth suggestions aimed at modernizing and refining the FDA's existing SUPAC guidance to better align with contemporary scientific knowledge, risk-based regulatory approaches, and industry practices.Amneal, a leading U.S.-based manufacturer of generic ... Show Full Article WASHINGTON, June 10 -- Amneal Pharmaceuticals LLC, a Bridgewater, New Jersey-based affordable medicines company, has submitted a public comment letter to the Food and Drug Administration addressing the agency's solicitation for feedback on guidance related to scale-up and post-approval changes for pharmaceutical dosage forms. The letter provides in-depth suggestions aimed at modernizing and refining the FDA's existing SUPAC guidance to better align with contemporary scientific knowledge, risk-based regulatory approaches, and industry practices. Amneal, a leading U.S.-based manufacturer of genericand specialty pharmaceuticals with a global network of production facilities, emphasized the foundational role of SUPAC guidance in drug product development, regulatory approval, and ongoing post-approval management. The company acknowledged the agency's ongoing commitment to ensuring these guidance reflect current technical considerations and risk assessment strategies. Drawing from its extensive experience in developing and manufacturing more than 500 approved pharmaceutical products including oral solids, injectables, inhalation, topical, and complex formulations, Amneal outlined both commendations and specific recommendations for improvement in the public comment letter addressed to the FDA's Dockets Management Staff.
The letter highlights two SUPAC guidance as particularly beneficial to industry: the 1995 guidance on Immediate-Release Solid Oral Dosage Forms and the 2014 Manufacturing Equipment Addendum. Amneal requested expanded guidance on ingredient components such as flavors and colorants, as well as updates to reflect current manufacturing equipment technologies. It suggested revisions to better clarify change categories for Chemistry, Manufacturing, and Controls (CMC) submissions and called for closer alignment with the FDA's current supplement categories, including Prior Approval Supplements, Changes Being Effected Supplements, and Annual Reports.
Amneal identified challenges arising from fixed batch size ranges and outdated equipment classifications that hinder a flexible, risk-based evaluation of changes. The company requested clearer decision frameworks for assessing whether manufacturing changes are major, moderate, or minor, noting that current guidance sometimes produce uncertainty when an equipment design changes without affecting the operating principle or product quality.
The letter further discussed inconsistencies and overlaps among various FDA guidance that complicate regulatory submissions, pointing out discrepancies between the SUPAC guidance and other related guidance such as the Changes to an Approved NDA and ANDA (CANA) guidance, particularly regarding scale changes and equipment modifications. Amneal advocated consolidating SUPAC guidance into a unified document with dosage form-specific modules, complemented by integration of modern lifecycle management concepts from ICH guidelines, including ICH Q9 on quality risk management and ICH Q12 on pharmaceutical quality systems.
Specific recommendations by dosage form included updates to immediate-release and modified-release oral solids guidance to incorporate mechanistic understanding of drug release and leverage process capability indices, reducing unnecessary dissolution and bioequivalence studies. For nonsterile semisolid dosage forms, Amneal encouraged risk-based approaches incorporating modern physicochemical characterization to avoid excessive in vitro and in vivo testing. The letter also urged recognition of complex generics with advanced formulations that require multidimensional characterization beyond traditional sameness criteria.
Amneal proposed adding new topics to the SUPAC guidance to cover transdermal products, nasal dosage forms, peptides, and other complex or combination products. It highlighted gaps in current guidance relating to device-related changes and product categories insufficiently addressed, recommending FDA develop risk-based principles tailored to these emerging pharmaceutical technologies.
Overall, Amneal's submission stressed the necessity for the FDA to modernize SUPAC guidance by embedding science-driven, risk-based principles that support efficient post-approval change management without compromising product quality or patient safety. The letter urged the agency to update equipment classifications and testing expectations to reflect current industrial practice and evolving technologies. It also recommended enhancing clarity through decision trees, examples, and clear cross-referencing of guidance documents to reduce regulatory burden and enhance predictability for industry stakeholders.
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The letter was signed by:
Pavan Kumar
Vice President, Global Regulatory Affairs
Amneal Pharmaceuticals LLC
Email: pkumar@amneal.com
Telephone: (631) 759-0982
Fax: (631) 527-3523
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2026-N-0809-0032
American Pilots' Association Recommends Changes to North Atlantic Right Whale Vessel Speed Rule
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WASHINGTON, June 10 -- The American Pilots' Association, headquartered in Washington D.C., has submitted a public comment letter to the National Marine Fisheries Service regarding the agency's Advanced Notice of Proposed Rulemaking for amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule. APA, representing over 1,300 state-licensed pilots including all East Coast pilot groups, provided extensive recommendations aiming to balance endangered whale conservation with maritime safety and operational efficiency.The APA, established in 1884 and serving pilots who navigate more than ... Show Full Article WASHINGTON, June 10 -- The American Pilots' Association, headquartered in Washington D.C., has submitted a public comment letter to the National Marine Fisheries Service regarding the agency's Advanced Notice of Proposed Rulemaking for amendments to the North Atlantic Right Whale Vessel Strike Reduction Rule. APA, representing over 1,300 state-licensed pilots including all East Coast pilot groups, provided extensive recommendations aiming to balance endangered whale conservation with maritime safety and operational efficiency. The APA, established in 1884 and serving pilots who navigate more than90 percent of large ocean-going vessels in U.S. waters, emphasized pilots' crucial role in ensuring safe navigation and protecting the marine environment. Their comments focused on the proposal to replace current seasonal vessel speed restrictions with alternative management approaches that leverage advanced technology for whale detection and strike avoidance. The association highlighted the importance of maintaining clear navigational safety protocols that do not inadvertently increase risks to life or commerce.
Among the core recommendations APA proposed is the establishment of a grant program to equip vessels, including pilot boats, with visual and acoustic technologies that can detect the presence of NARWs and other protected marine mammals. The association suggested regular workshops focused on whale detection, monitoring, and strike avoidance technologies involving stakeholders from government, academia, technology firms, and the maritime community. They further recommended NMFS deploy monitoring systems such as sonobuoys and seabed sensors in east-west arrays along the East Coast to provide real-time whale location data. The use of autonomous surface and underwater drones was also suggested as a tool for enhanced monitoring utilizing artificial intelligence and thermal imaging.
APA advocates for the adoption of dynamic speed zones (DSZs) informed by real-time monitoring data to replace broad seasonal speed restrictions. These DSZs could allow speed regulation tailored to actual whale presence, potentially reducing undue economic burden on the maritime industry while maintaining or improving whale safety.
Notably, APA urged NMFS to exempt pilot boats from the NARW speed restrictions entirely. The association cited safety of life at sea concerns, pointing out that pilot transfer operations between pilot boats and large vessels are inherently dangerous and often require speeds exceeding current speed limits. Arbitrary speed caps on pilot boats, APA argued, could compromise the precision and safety of these maneuvers. Additionally, APA noted that no pilot boats have ever been recorded striking a North Atlantic right whale, underscoring their proficiency in avoiding marine mammals.
The letter also called for excluding deep draft vessels restricted by draft limitations and operating within Federal Navigation Channels (FNCs) and pilot boarding areas from the NARW VSRR. These channels, maintained by the U.S. Army Corps of Engineers, are vital narrow waterways where large vessels require freedom to maneuver at speeds often exceeding 10 knots to safely counter lateral forces from currents and winds. APA explained the technique of "crabbing," where increased vessel speed is necessary to maintain safe course in restricted channels, and underscored that speed constraints in these environments heighten navigational risk. APA referenced prior statements from the Cruise Lines International Association indicating large vessels need minimum speeds higher than 10 knots to navigate safely in such settings.
Emphasizing that pilot boarding areas are locations of elevated personnel risk, APA highlighted the critical role of precise speed control during pilot transfers offshore, noting that reduced speeds increase relative motion and the riskiness of transfers. The association maintained that exemptions for pilot boats and operational flexibility for deep draft vessels within FNCs and boarding grounds are essential for safety and should be codified explicitly in the rule amendments.
APA also addressed the use and enforcement of the existing navigation safety deviation clause within the NARW VSRR. The association proposed clear codification of FNCs and pilot boarding areas as locations where the safety deviation clause applies automatically. Furthermore, APA recommended that vessels utilizing deviations submit ship log documentation to NMFS within 30 days to provide necessary context for enforcement. They called for the agency to issue notices of proposed violation and allow for 30-day responses before proceeding with penalties, advising that negligent violations be treated as civil, not criminal offenses. APA also opposed the use of Automatic Identification System (AIS) data for enforcement purposes, reasoning that AIS was designed to enhance navigation safety, not as a monitoring tool, and has accuracy limitations that could lead to unjust penalties. Additionally, they expressed concerns over privacy and commercial sensitivities related to public AIS data.
The association questioned the effectiveness of the existing 10-knot speed restriction, noting that NMFS itself acknowledged in its 2022 rulemaking that a direct causal link between speed reduction and right whale mortality decline has not been established. APA highlighted the agency's reliance on a dated 2007 study to justify the 10-knot threshold and called for continued research and independent economic impact assessments, noting that the Endangered Species Act requires consideration of economic effects from protective regulations.
Recognizing the importance of timely and reliable information dissemination, APA urged increased governmental commitment to real-time outreach to mariners regarding whale sightings and locations, enabled by advances in detection technologies. They stressed that this critical communication role should remain a supervised government function rather than be delegated to unsupervised private entities.
The letter concluded with APA reaffirming its longstanding commitment to collaborate with NMFS and other federal entities in advancing solutions that protect the North Atlantic right whale while ensuring maritime safety and the efficient flow of commerce. APA expressed hope that their recommendations would be seriously considered in the ongoing rulemaking process and invited further discussion with agency staff.
Through its input, the American Pilots' Association sought to balance the regulatory environment to reduce unnecessary burdens on pilots and operators while preserving protections for one of the ocean's most endangered species. Their detailed insights emphasize the complex interplay between environmental protection and the practical realities of navigation in critical U.S. waterways.
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The letter was signed by:
Clayton L. Diamond
Executive Director-General Counsel
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Read full text of letter here: https://www.regulations.gov/comment/NOAA-NMFS-2026-0364-24922
American Academy of Neurology Advocates for Drug Repurposing to Address Unmet Neurological Needs
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WASHINGTON, June 10 -- The American Academy of Neurology, headquartered in Minneapolis, Minnesota, submitted a public comment letter to the Food and Drug Administration addressing the agency's request for information on drug repurposing to meet unmet medical needs. The AAN emphasized the importance of prioritizing chronic neurological conditions, neurodegenerative diseases, and rare neurological disorders in the FDA's drug repurposing efforts.The organization highlighted that neurological diseases affect half of the United States population and that drug repurposing could expedite finding adjunctive ... Show Full Article WASHINGTON, June 10 -- The American Academy of Neurology, headquartered in Minneapolis, Minnesota, submitted a public comment letter to the Food and Drug Administration addressing the agency's request for information on drug repurposing to meet unmet medical needs. The AAN emphasized the importance of prioritizing chronic neurological conditions, neurodegenerative diseases, and rare neurological disorders in the FDA's drug repurposing efforts. The organization highlighted that neurological diseases affect half of the United States population and that drug repurposing could expedite finding adjunctiveor disease-modifying therapies benefiting conditions such as epilepsy, multiple sclerosis, Alzheimer's disease, Parkinson's disease, and rare disorders like Batten disease. It noted that leveraging established safety profiles and pharmacokinetics of existing medications may accelerate discovery of treatments that modify disease progression, particularly for conditions with high failure rates in new drug development.
The AAN also encouraged the agency to consider neuroinflammatory and pain disorders as priorities, given the unmet treatment needs and existing analgesic properties observed in some FDA-approved drugs. Additionally, pediatric neurological disorders were identified as an area that could benefit from repurposing due to the frequent reliance on off-label medication usage in children, who are underrepresented in clinical trials.
To assist identification of promising candidates, the academy recommended that the FDA utilize federated electronic health record databases and apply artificial intelligence-driven network medicine to correlate drug mechanisms with genetic and phenotypic data. The use of master protocols such as basket trials that target shared pathological mechanisms was also advocated to streamline clinical validation.
The primary barriers cited included high regulatory compliance costs, limited financial incentives for drug sponsors, and challenges arising from widespread off-label use without formal indications. The AAN urged the FDA and federal partners to create specialized regulatory pathways for academic and nonprofit sponsors and called for alignment with the Centers for Medicare & Medicaid Services to improve insurance coverage for repurposed treatments.
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2026-N-4492-0136
7T World Urges to Maintain Strong Federal Floor in State Stablecoin Regulatory Similarity Standards
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WASHINGTON, June 10 -- 7T World LLC, a strategic advisory and compliance technology firm headquartered in Kalispell, Montana, submitted a public comment letter to the U.S. Department of the Treasury regarding the agency's notice of proposed rulemaking on the GENIUS Act's broad-based principles for determining whether state-level regulatory regimes for payment stablecoins are substantially similar to the Federal regulatory framework. The GENIUS Act, enacted in 2025, establishes a regulatory regime governing payment stablecoin issuers, including State-qualified issuers, with the Treasury overseeing
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WASHINGTON, June 10 -- 7T World LLC, a strategic advisory and compliance technology firm headquartered in Kalispell, Montana, submitted a public comment letter to the U.S. Department of the Treasury regarding the agency's notice of proposed rulemaking on the GENIUS Act's broad-based principles for determining whether state-level regulatory regimes for payment stablecoins are substantially similar to the Federal regulatory framework. The GENIUS Act, enacted in 2025, establishes a regulatory regime governing payment stablecoin issuers, including State-qualified issuers, with the Treasury overseeingthe definition of "substantial similarity" to the Federal framework.7T World's comment letter engages in detail with the Treasury's proposed rules in 12 CFR Chapter XV, Parts 1520 and 1521, outlining key aspects the firm considers vital to preserve both regulatory coherence and operational safety for community banks, credit unions, and consumers interacting with stablecoins. The firm emphasizes its independent practitioner perspective, highlighting operational risk control and compliance challenges observed in regulated financial institutions and cross-border payments businesses, which complement the issuer-side feedback Treasury typically receives.
Central to 7T World's position is the firm's endorsement of Treasury's proposed standard that State regulatory regimes must "meet or exceed" the Federal floor standards described in Section 4(a) of the GENIUS Act, thereby producing regulatory outcomes "at least as stringent and protective" as the Federal framework. The firm warns that a permissive "substantially similar" standard allowing State regimes below the Federal floor would create incoherent standards resulting in conflict between certifying States and the Stablecoin Certification Review Committee, which must unanimously approve State certifications only if those regimes meet or exceed Federal requirements. This standard, 7T World argues, ensures a uniform and examinable baseline that protects community financial institutions relying on payment stablecoins as counterparties and facilitators for underbanked customers.
Further, the letter insists that the crucial federal Bank Secrecy Act/Anti-Money Laundering (BSA/AML) and sanctions rules, which apply to all payment stablecoin issuers directly via Treasury's Financial Crimes Enforcement Network (FinCEN) and the Office of Foreign Assets Control (OFAC), must be enforced at the State level with no narrowing of scope. 7T World strongly advocates that State regimes not only require written BSA/AML and sanctions programs but also mandate operational testing of their efficacy on a risk-based basis. This approach mirrors the Federal emphasis on independent testing programs and transaction-monitoring reviews detailed in the FFIEC examination manual, rather than mere documentary compliance. The firm cites enforcement failures at the federal level resulting from static monitoring systems and stresses examination regimes must detect not only documentation adequacy but real-world operational performance.
On the subject of examination and enforcement authority, 7T World concurs with Treasury that States must have unconditional and practical authority to examine payment stablecoin issuers. Examination rights conditioned on the issuer's consent or request would undermine effective supervision and fail the substantial similarity test. The comment recommends Treasury explicitly state in its preamble that State regulatory regimes must ensure examination and enforcement powers are exercisable in fact as well as in form, while recognizing that staffing and funding decisions rest with the States outside this substantial similarity inquiry.
The letter draws attention to the continuing nature of substantial similarity as a condition, not simply a one-time certification event. 7T World recommends Treasury anchor the test within the statutory recertification process and solicit comments on how to address scenarios where a State's regime falls below the Federal floor after certification. The firm underscores the need for appropriate notice, cure periods, and orderly transition plans to manage risks to multiple issuers and market stability, avoiding run-risk triggered by sudden regulatory reversals.
Regarding the composition of the Federal regulatory framework that serves as the benchmark for comparison, 7T World supports Treasury's approach to include not only statute but also OCC-issued regulations and interpretations published in the Federal Register, supplemented by Treasury and Federal Reserve Board materials on BSA/AML and sanctions. The firm urges Treasury to assess substantial similarity based on the Federal framework as it exists at the time of certification or recertification to avoid a continuously moving baseline that would frustrate compliance. State calibration within this framework, particularly tailored capital and governance requirements, should be respected as legitimate provided it satisfies the "at least as stringent and protective" standard.
Consumer protection is highlighted as a key dimension, particularly around required disclosures about redemption policies, associated fees, and the uninsured nature of payment stablecoin balances. 7T World calls on Treasury to mandate uniform, clear, and conspicuous disclosures aligned with the Federal standard, given the disproportionate use of these instruments by underbanked and lower-income customers served by community financial institutions. Consistency between State stablecoin disclosure rules and bank-side disclosure expectations is urged through Treasury's coordination with Federal banking regulators.
On procedural flexibility, the firm supports the Treasury's allowance for State deviations on non-substantive format and procedure matters, such as data file formats for reserve-composition reports, recognizing practical State infrastructure differences. However, 7T World cautions against misclassifying substantive elements such as report content, asset categorization, valuation methods, reporting frequency, and assurance standards as mere procedures. These substantive elements must be uniform to preserve the integrity and comparability of examination findings across jurisdictions and against the Federal baseline.
7T World makes clear it does not take positions on issuer-specific prudential thresholds or capital requirements under the State-calibrated rules, acknowledging these are better addressed by issuers, prudential regulators, and market participants. Rather, the firm's focus remains on ensuring the broad-based principles produce genuine, enforceable equivalence that protects all stakeholders effectively.
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The letter was signed by:
Mark Graves
Chief Executive Officer
7T World LLC
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2026-0232-0054
Association for Accessible Medicines Urges Modernization of FDA Scale-Up and Post-approval Changes Guidance
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WASHINGTON, June 10 -- The Association for Accessible Medicines, headquartered in Arlington, Virginia, submitted a public comment letter to the Food and Drug Administration addressing the agency's solicitation of comments on the "Recommendations on Scale-Up and Post-approval Changes Guidance for Industry." The letter highlights the need to modernize and harmonize these guidance to better align with current risk-based approaches, advances in manufacturing technology, and international regulatory frameworks.The AAM represents manufacturers of generic pharmaceutical products and biosimilars, active ... Show Full Article WASHINGTON, June 10 -- The Association for Accessible Medicines, headquartered in Arlington, Virginia, submitted a public comment letter to the Food and Drug Administration addressing the agency's solicitation of comments on the "Recommendations on Scale-Up and Post-approval Changes Guidance for Industry." The letter highlights the need to modernize and harmonize these guidance to better align with current risk-based approaches, advances in manufacturing technology, and international regulatory frameworks. The AAM represents manufacturers of generic pharmaceutical products and biosimilars, activepharmaceutical ingredient producers, and industry suppliers. Generic and biosimilar medicines account for over 90 percent of U.S. prescriptions but represent a small portion of total drug spending. The association's letter underscores the critical role the Chemistry, Manufacturing, and Controls (CMC) section of an Abbreviated New Drug Application (ANDA) plays in the FDA's approval process by demonstrating equivalence to FDA-approved Reference Listed Drugs (RLDs).
The SUPAC guidance, originally developed in the 1990s by the FDA's Center for Drug Evaluation and Research (CDER) to facilitate regulatory flexibility for post-approval changes, remain a foundational resource for industry. These guidance provide frameworks for manufacturing changes such as scale-up, process modifications, and equipment adjustments without requiring FDA pre-approval in many cases. They aim to reduce regulatory burden, avoid production delays, and safeguard patient access to medicines.
However, the AAM contends that these guidance have evolved into a confusing patchwork that lacks clarity and consistency. While five specific SUPAC guidance are currently under FDA review for updates, the association advises that several other relevant guidance related to post-approval changes are not mentioned in the Federal Register notice. The letter cites overlaps, inconsistencies, and outdated recommendations among guidance, notably between SUPAC and others such as the 2014 Annual Reports Guidance and Changes to Approved NDA or ANDA documents.
The AAM recommends consolidating all SUPAC-related guidance into a single, structured framework that clearly defines reporting categories, conditions for changes, required documentation, and illustrative examples. This framework should incorporate principles from newer international standards, such as the International Council for Harmonisation's Q8 through Q12 guidance, and align with FDA's own draft guidance on implementation considerations of ICH Q12. Such harmonization is expected to enhance regulatory predictability, reduce unnecessary conversions from less to more stringent reporting categories, and facilitate efficient post-approval change management.
The letter urges FDA to reevaluate the existing SUPAC numerical limits and ranges, which the AAM describes as outdated and overly restrictive, arguing for a more flexible, risk-based approach that emphasizes justification and maintenance of critical quality attributes over prescriptive thresholds. Recommendations include expanding recognized excipient functions and acceptable ranges, incorporating modern manufacturing techniques such as continuous manufacturing and process analytical technology, and allowing scientific rationales to inform change assessments.
Addressing specific challenges, the letter highlights confusion in interpreting SUPAC guidance and identifies areas where guidance overlap or conflict, impeding effective evaluation and reporting of changes. The AAM calls for removal or revision of sections that are no longer relevant and encourages FDA to clarify expectations through updated examples, emphasizing that such examples should be non-exhaustive and accompanied by rationales to guide informed industry decision-making.
Responding to FDA's query on potential new topics for inclusion, the AAM points out gaps in the current guidance related to complex generics, combination products with device components, transdermal products, sterile products including long-acting injectables, oral and nasal solutions, suspensions, and inhalation products. The letter notes that manufacturers have had to apply SUPAC principles in the absence of product-specific guidance, sometimes resulting in inconsistent requirements such as unnecessary bioequivalence data demands.
Further areas recommended for expanded guidance include new dosage strengths, alternative active pharmaceutical ingredient suppliers, novel excipients for parenterals and ophthalmics, dose proportionality in combination products, evolving packaging materials and stability considerations, lifecycle modernization of analytical methods, and the regulatory impact of digital quality systems such as electronic batch records, digital twins, and artificial intelligence-assisted controls.
The association calls for clearer policies regarding site transfers, noting that SUPAC currently treats many inter-site transfers as major changes unless the sites are "identical." Given advances in standardized equipment and global manufacturing practices, AAM suggests reevaluating this approach in line with established conditions principles articulated in ICH Q12.
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The letter was signed by:
Giuseppe Randazzo
Senior Vice President
Association for Accessible Medicines
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2026-N-0809-0022
Artanis Capital Urges FEMA to Adopt Redeployable Emergency Housing Standards
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WASHINGTON, June 10 -- Artanis Capital LLC, headquartered in Minneapolis, Minnesota, submitted a public comment letter to the Federal Emergency Management Agency regarding the FEMA Review Council's Final Report on disaster housing. The letter criticizes the report for neglecting to address critical standards for structuring, procuring, and managing emergency housing assets, particularly the need for redeployable units that can be utilized across multiple disaster cycles.The letter highlights the current inefficiency of FEMA's Manufactured Housing Unit (MHU) program, which involves purchasing ... Show Full Article WASHINGTON, June 10 -- Artanis Capital LLC, headquartered in Minneapolis, Minnesota, submitted a public comment letter to the Federal Emergency Management Agency regarding the FEMA Review Council's Final Report on disaster housing. The letter criticizes the report for neglecting to address critical standards for structuring, procuring, and managing emergency housing assets, particularly the need for redeployable units that can be utilized across multiple disaster cycles. The letter highlights the current inefficiency of FEMA's Manufactured Housing Unit (MHU) program, which involves purchasingtravel trailers at an average cost of up to $150,000 per unit but auctioning them off for less than $20,000 after relatively short use. This model incurs massive taxpayer losses and creates a cycle of procurement and disposal without lasting value. Moreover, FEMA's current approach does not account for the social fallout from inadequate housing post-disaster, such as high homelessness rates and increased strain on public health and social services. Artanis Capital contends that the Council's report fails to transform this situation by focusing merely on expediting funds rather than improving the type of housing assets purchased.
Artanis urges FEMA to adopt specific standards ensuring that federally funded emergency housing units are engineered for relocation, built with modular construction, compliant with Build America, Buy America standards, and have an expected lifespan spanning multiple deployments. This approach would transform emergency housing into a durable government asset rather than a disposable commodity. The letter also recommends the creation of a government-owned emergency housing fleet, either federally or state-held, to facilitate rapid deployment and redeployment with support from private operators engaged to maintain the units between disaster events.
The company's proposal advocates for models mirroring the Emergency Management Assistance Compact (EMAC) structure, whereby states can leverage a fleet of redeployable housing units and share resources across jurisdictions through established mutual aid frameworks. This system would replace costly, one-time purchases with an efficient inventory managed on government balance sheets to preserve residual value for taxpayers.
Further recommendations focus on reducing administrative overhead by streamlining procurement processes, allowing states to access pre-established federal supplier relationships, and authorizing emergency acquisitions compliant with current regulations. Artanis emphasizes the importance of integrating housing provision with all federal individual assistance programs, consolidating eligibility and intake processes around housing to increase program effectiveness and improve survivor outcomes.
At the core of their critique is the statement from FEMA Secretary Mullin during the Council's final meeting, where he defined emergency housing as units that are reusable and relocatable across multiple disasters. Artanis Capital frames this directive as a design specification shaping the future of emergency housing procurement, which the current report fails to incorporate explicitly into its recommendations or legislative proposals.
Artanis Emergency Communities offers a ready-made platform that aligns with these specifications, featuring rapidly deployable steel-frame units built in compliance with domestic manufacturing standards. Their communities are equipped with full utilities, internet, and furnishings, designed for quick installation, hurricane resilience, and multiple redeployments without material damage. The company also emphasizes community-scale deployment, which includes onsite case management, security, and support services to create holistic disaster recovery environments.
By moving away from single-use travel trailers to reusable emergency housing assets, Artanis Capital asserts that FEMA and its partners can vastly improve efficiency, reduce taxpayer losses, and address the housing needs of disaster survivors more effectively. The company stands ready to pilot these redeployable housing solutions with state emergency management agencies in accordance with the Secretary's vision and the FEMA Review Council's overall framework.
The commentary concludes by calling on Washington to move swiftly to end the cycle of disposable trailer housing, ensuring that administrative records, presidential communications, legislation, and regulations reflect the necessary standards for reusable emergency housing platforms. Artanis Capital and Artanis Emergency Communities position themselves as prepared leaders in delivering the future of disaster housing.
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Read full text of letter here: https://www.regulations.gov/comment/DHS-2026-0067-0117
Artanis Capital Criticizes FEMA Report Over Omission of Reusable Disaster Housing Standards
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WASHINGTON, June 10 -- Artanis Capital LLC, a Minneapolis, Minnesota-based emergency housing innovator, issued a public comment letter to the Federal Emergency Management Agency expressing concerns about the FEMA Review Council's Final Report on emergency housing reform. Artanis Capital highlighted an omission: the absence of federally mandated standards for emergency housing assets that would make them reusable and redeployable across multiple disaster events.The Review Council's Final Report presents ten recommendations addressing major structural reforms, including changes to disaster declaration ... Show Full Article WASHINGTON, June 10 -- Artanis Capital LLC, a Minneapolis, Minnesota-based emergency housing innovator, issued a public comment letter to the Federal Emergency Management Agency expressing concerns about the FEMA Review Council's Final Report on emergency housing reform. Artanis Capital highlighted an omission: the absence of federally mandated standards for emergency housing assets that would make them reusable and redeployable across multiple disaster events. The Review Council's Final Report presents ten recommendations addressing major structural reforms, including changes to disaster declarationthresholds, streamlining public assistance programs, reducing administrative costs, and shifting emergency shelter responsibilities to state, tribal, and territorial (STT) governments. However, according to Artanis Capital, the report stops short of defining how the emergency housing units themselves should be designed, managed, and procured to support these reforms effectively.
Under the proposed Consolidated Individual Relief framework (FAIR), disaster survivors would receive direct cash assistance, and temporary shelter responsibilities would transfer to STTs who could access one-time federal funding to provide emergency housing. Artanis Capital criticizes this approach for lacking any accompanying standards or frameworks that ensure these assets are durable government resources rather than single-use, disposable units. Without establishing minimum redeployability standards, states might continue purchasing costly travel trailers and mobile homes that rapidly depreciate and are often auctioned at a fraction of their original cost, perpetuating wasteful cycles.
The company cites FEMA's Manufactured Housing Unit (MHU) program as a prime example of procurement inefficiency. MHUs can cost about $150,000 each to purchase, transport, and install, but typically sell for around $18,000 or less at government auctions after minimal use. The overall loss to taxpayers, compounded across thousands of units deployed after disasters, runs into the billions. These units, designed for single-event deployment with an 18-month program cap, contribute to high rates of homelessness post-recovery due to inadequate permanent housing options.
Artanis Capital urges FEMA to adopt deployable housing standards that align with Secretary of Homeland Security's directive for emergency housing units to be reusable, relocatable, and redeployable from one disaster to the next. This directive, issued during the Council's May 7 meeting, specifies that units must be engineered for lift, transport, and reinstallation without material degradation. They should also be constructed modularly, comply with Build America, Buy America requirements, and have a documented useful life spanning multiple deployments.
The letter recommends establishing a government-owned fleet of emergency housing assets with flexible jurisdictional title. Two models are proposed: a federal fleet pre-positioned in regional staging facilities and available for task-order mobilization, and a state-held fleet integrated with the Emergency Management Assistance Compact (EMAC) mutual aid system enabling cross-state deployments. Private operators would manage logistics and maintenance under contract, but the assets would remain government property, preserving residual value rather than being discarded.
Further, Artanis Capital requests that administrative cost reduction efforts extend specifically to housing procurement cycles. By maintaining a standing, government-owned redeployable housing fleet procured under long-term performance contracts, the recurring overhead of repeated acquisitions after each disaster would be eliminated.
The letter also recommends simplifying federal aid access by consolidating all Individual Assistance programs' entry points into a single intake platform anchored by housing provision. This would reduce administrative hurdles and enable survivors to receive coordinated assistance more efficiently.
Artanis Capital's own emergency housing platform aligns with these recommendations. Their turnkey community-scale solutions feature steel-frame units rapidly deployable within days, fully furnished with kitchens, HVAC, internet, and designed to resist hazards like hurricanes and fires. Units are structured for government asset retention and can be redeployed across multiple disaster cycles without significant wear.
Artanis Capital concludes that while the FEMA Review Council's Final Report marks important progress, its failure to incorporate redeployable asset standards risks perpetuating the inefficiencies and social failures of the existing disposable housing model. The firm calls on federal officials to embed these standards in implementing regulations and legislative language to ensure disaster housing reforms translate into sustainable, cost-effective solutions for survivors and taxpayers alike.
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Read full text of letter here: https://www.regulations.gov/comment/DHS-2026-0067-0119