Public Comments on Proposed Federal Rules
Here's a look at public comments on proposed Federal Register rules
Featured Stories
Association For Accessible Medicines Urges FDA to Clarify Guidance on Biosimilars
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WASHINGTON, Nov. 20 -- The Association for Accessible Medicines (AAM) has submitted a public comment letter to the Food and Drug Administration (FDA) regarding the draft guidance titled "Safety Labeling Changes - Implementation of Section 505(o)(4) of the FD&C Act." AAM, which represents the interests of manufacturers of generic pharmaceutical products and biosimilars, emphasized the need for FDA to address biosimilars explicitly in the guidance to avoid potential confusion and inefficiencies.
In its letter, AAM highlighted the rapid growth of the generic and biosimilar markets, noting that in
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WASHINGTON, Nov. 20 -- The Association for Accessible Medicines (AAM) has submitted a public comment letter to the Food and Drug Administration (FDA) regarding the draft guidance titled "Safety Labeling Changes - Implementation of Section 505(o)(4) of the FD&C Act." AAM, which represents the interests of manufacturers of generic pharmaceutical products and biosimilars, emphasized the need for FDA to address biosimilars explicitly in the guidance to avoid potential confusion and inefficiencies.
In its letter, AAM highlighted the rapid growth of the generic and biosimilar markets, noting that in2024, these products accounted for 90 percent of all prescriptions filled in the U.S., while only comprising 12 percent of total drug spending. The organization underscored that the draft guidance currently does not provide adequate instructions for biosimilar applicants, a gap that could lead to significant hurdles in compliance and market operations.
One critical point made by AAM is that the SLC Draft Guidance offers no process for biosimilars in the same way it does for generics, leaving manufacturers uncertain about how to comply with any safety labeling changes linked to reference products. AAM argues that if biosimilar manufacturers are expected to follow a multi-applicant procedure indicated by the draft, it would contradict established regulations concerning biosimilars and create complications in safety labeling.
AAM contended that, like generics, biosimilars possess the same safety and efficacy profiles as their reference products and pointed out the risk posed by different safety labeling for a biosimilar compared to its reference product. Such discrepancies could generate confusion among healthcare providers and patients, potentially undermining confidence in biosimilars, which are intended to be affordable alternatives to branded medicines.
Instead, the organization urged the FDA to adopt a more streamlined approach, similar to that of generics. They proposed that once the reference product's labeling is updated, biosimilar manufacturers should be notified, allowing a period of 30 days to submit any necessary labeling changes. AAM asserted that implementing such a system would improve clarity and consistency across the biosimilar landscape, enhancing patient access to these critical medications.
The AAM indicated its desire to continue collaborating with the FDA to foster competition and enhance access to generics and biosimilars, ultimately benefiting American patients. In their letter, the organization expressed optimism for an ongoing dialogue aimed at refining the guidance to better suit the evolving pharmaceutical landscape.
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The letter was signed by:
Giuseppe Randazzo
Senior Vice President
Science and Regulatory Affairs
Association for Accessible Medicines
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2011-D-0164-0020
ASI Urges Treasury Department to Clarify Stablecoin Regulations for Non-Federally Insured Credit Unions
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WASHINGTON, Nov. 20 -- American Share Insurance (ASI), Dublin, Ohio, has submitted a public comment letter to the U.S. Department of the Treasury urging a clear regulatory path for state-chartered, privately insured credit unions concerning the issuance of stablecoins. This call for clarity comes following the recent enactment of the GENIUS Act, aimed at establishing a comprehensive regulatory framework for stablecoin usage across various financial institutions.
Based in Dublin, Ohio, ASI has been providing private deposit insurance for 50 years, protecting the deposits of state-chartered credit
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WASHINGTON, Nov. 20 -- American Share Insurance (ASI), Dublin, Ohio, has submitted a public comment letter to the U.S. Department of the Treasury urging a clear regulatory path for state-chartered, privately insured credit unions concerning the issuance of stablecoins. This call for clarity comes following the recent enactment of the GENIUS Act, aimed at establishing a comprehensive regulatory framework for stablecoin usage across various financial institutions.
Based in Dublin, Ohio, ASI has been providing private deposit insurance for 50 years, protecting the deposits of state-chartered creditunions that choose to operate without federal insurance. The organization emphasizes that these credit unions are adequately licensed and regulated, similar to their federally insured counterparts, and should therefore be considered for a streamlined framework allowing them to issue stablecoins.
The GENIUS Act, signed into law on July 19, 2025, is designed to permit the issuance of stablecoins by a wide range of financial entities, while ensuring necessary safety and soundness parameters. ASI argues that a clear federal pathway for private insurers should be established, particularly for those credit unions operating under state regulations that do not align with the federal standards introduced by the Act.
A key recommendation in the letter is the interpretation of "State qualified payment stablecoin issuer" to encompass state-chartered credit unions that are privately insured. ASI advocates for an approach that recognizes the diverse landscape of state-chartered credit unions and encourages responsible innovation while maintaining local authority.
The organization underscores the importance of clarity in the oversight expectations for these institutions, ensuring that all credit unions, regardless of size or structure, understand how to engage in the evolving stablecoin market. It acknowledges that while Congress anticipates state legislation on stablecoins, the GENIUS Act stipulates that such state laws should be consistent with its provisions, recognizing variability in state willingness to embrace stablecoin regulation.
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The letter was signed by:
Theresa Mason
Chief Executive Officer
American Mutual Share Insurance Corporation
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2025-0037-0333
Anchorage Digital Submits Public Comment On GENIUS Act Regulations
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WASHINGTON, Nov. 20 -- Anchorage Digital has submitted a public comment letter to the U.S. Department of the Treasury addressing regulations related to the implementation of the Guiding and Establishing National Innovation for U.S. Stablecoins (GENIUS) Act. The organization emphasizes the importance of establishing a regulatory framework that supports the growth and stability of the stablecoin market, which is expected to enhance the existing financial system and facilitate access to financial services.
In the letter, Anchorage Digital outlines its role as a federally chartered digital asset bank
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WASHINGTON, Nov. 20 -- Anchorage Digital has submitted a public comment letter to the U.S. Department of the Treasury addressing regulations related to the implementation of the Guiding and Establishing National Innovation for U.S. Stablecoins (GENIUS) Act. The organization emphasizes the importance of establishing a regulatory framework that supports the growth and stability of the stablecoin market, which is expected to enhance the existing financial system and facilitate access to financial services.
In the letter, Anchorage Digital outlines its role as a federally chartered digital asset bankand the only regulated issuer of stablecoins in the United States. The Bank, a subsidiary of Anchorage, reported a circulating supply of around $1.5 billion in its stablecoin USDtb, which was issued earlier this year. Additionally, it has laid plans for partnerships to introduce new stablecoins in collaboration with leading entities like Tether and Western Union.
Anchorage Digital asserts that the GENIUS Act represents a critical step forward in creating a structured and secure environment for stablecoin issuance. The organization calls for regulators to provide guidance on several key areas, including the management of payment stablecoin reserves, permissible uses of income generated by stablecoins, and investor protection measures relating to custody standards. Anchorage stresses that flexibility in reserve management and clarity on yield definitions will be essential for the progress of white-label stablecoin solutions.
Notably, Anchorage Digital highlights that stablecoins have the potential to transform transactional efficiencies, enabling instantaneous settlements and reduced costs for users. The organization points out that these digital currencies would also contribute to increased demand for U.S. Treasury securities, presenting a strategic advantage in mitigating geopolitical risks associated with foreign holders of debt.
Anchorage Digital's letter underscores a broader vision for the future of financial transactions, especially in terms of accessibility for the unbanked populations. With the projected growth of the stablecoin market, Anchorage argues that adherence to the principles within the GENIUS Act could lead to significant advancements in both domestic and global financial ecosystems.
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The letter was signed by:
Nathan McCauley
Co-Founder and CEO
Anchorage Digital
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Rachel Anderika
Head of Global Operations & Bank COO
Anchorage Digital
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2025-0037-0330
AFL-CIO Transportation Trades Department Urges Denial of Amtrak's Positive Train Control Request
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WASHINGTON, Nov. 20 -- The AFL-CIO Transportation Trades Department (TTD) has issued a public comment letter to the Federal Railroad Administration (FRA) urging the denial of the National Railroad Passenger Corporation's request to amend its Positive Train Control (PTC) system. The request, which seeks approval for extensive outages to enhance the Interoperable Electronic Train Management System (I-ETMS), has raised significant concerns among rail labor advocates.
Amtrak's request proposes regular quarterly and biannual outages for I-ETMS upgrades through December 2030. TTD, which represents 40
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WASHINGTON, Nov. 20 -- The AFL-CIO Transportation Trades Department (TTD) has issued a public comment letter to the Federal Railroad Administration (FRA) urging the denial of the National Railroad Passenger Corporation's request to amend its Positive Train Control (PTC) system. The request, which seeks approval for extensive outages to enhance the Interoperable Electronic Train Management System (I-ETMS), has raised significant concerns among rail labor advocates.
Amtrak's request proposes regular quarterly and biannual outages for I-ETMS upgrades through December 2030. TTD, which represents 40affiliated unions that include conductors and locomotive engineers, asserts that a five-year approval period for such outages is excessively long and could undermine rail safety. The organization emphasized the importance of public engagement in the approval process, arguing that the potential material modifications to Amtrak's PTC system necessitate thorough review and feedback opportunities.
According to TTD, the FRA's recent publication of a notice on October 3, 2025, was not sufficient to meet the requirements outlined under 49 CFR 236.1021(e), which mandates public comment opportunities for material changes in train control systems. The agency contends that the community deserves the chance to assess and provide insights into requested outages each time Amtrak's system undergoes necessary updates.
The letter highlights concerns that blanket approvals can lead to a troubling precedent, suggesting that the agency must retain its commitment to ensure both the safety of railroad operations and the public's right to be involved in the processes that affect their safety. TTD believes that approving I-ETMS outages on an ongoing basis without adequate scrutiny compromises essential regulatory standards and public trust.
The organization has aligned with comments from affiliated unions, including the Brotherhood of Locomotive Engineers and Trainmen and the Transportation Division of the International Association of Sheet Metal, Air, Rail, and Transportation Workers. Together, they advocate for a more responsible approach to approving changes that could affect the safety and reliability of railroad operations.
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The letter was signed by:
Greg Regan
President
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Read full text of letter here: https://www.regulations.gov/comment/FRA-2010-0029-0269
Advocates for Highway & Auto Safety Warns FMCSA Against Splitting Truck Driver Rest Periods
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WASHINGTON, Nov. 20 -- Advocates for Highway and Auto Safety has submitted a public comment letter to the U.S. Department of Transportation expressing concerns regarding the Federal Motor Carrier Safety Administration's (FMCSA) proposed pilot program that would allow commercial motor vehicle (CMV) drivers to split their sleeper berth rest periods. The organization highlights alarming statistics on truck-related fatalities and injuries, urging the FMCSA to reconsider the implications of altering existing sleeper berth requirements.
The statistics are staggering. In 2023 alone, approximately 5,472
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WASHINGTON, Nov. 20 -- Advocates for Highway and Auto Safety has submitted a public comment letter to the U.S. Department of Transportation expressing concerns regarding the Federal Motor Carrier Safety Administration's (FMCSA) proposed pilot program that would allow commercial motor vehicle (CMV) drivers to split their sleeper berth rest periods. The organization highlights alarming statistics on truck-related fatalities and injuries, urging the FMCSA to reconsider the implications of altering existing sleeper berth requirements.
The statistics are staggering. In 2023 alone, approximately 5,472individuals lost their lives, and over 153,000 were injured in crashes that involved large trucks. Critics argue these numbers underscore the ongoing risks associated with trucking, which is already considered one of the most dangerous occupations in the U.S. As the letter points out, the growing fatalities are not just numbers; they represent the tragic ripple effects on families and communities nationwide.
Advocates emphasized that fatigue remains a critical factor in truck safety. Citing findings from the National Transportation Safety Board, the group pointed to a direct correlation between driver fatigue and the frequency of truck-related accidents. Alarmingly, a significant portion of commercial drivers reported feeling drowsy while on the road, which suggests that fatigue management is crucial in enhancing roadway safety.
The organization argues that the proposed pilot program, which would potentially weaken requirements for minimum sleep duration, is fundamentally flawed and could exacerbate existing safety issues. Advocates assert that research consistently shows that adequate sleep is vital for safe driving, and evidence from past FMCSA rulings supports this position. The push towards allowing shorter sleeper periods is seen as a dangerous departure from established protocols regarding driver rest and recovery.
Moreover, the Advocates highlighted concerns about the integrity of the studies cited by the FMCSA in justifying the pilot program. Many of these studies conducted laboratory-based research on a limited demographic, raising questions about their applicability to the broader population of CMV drivers who often face unique health challenges.
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The letter was signed by:
Shaun Kildare, Ph.D.
Senior Director of Research
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Peter Kurdock
General Counsel
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Read full text of letter here: https://www.regulations.gov/comment/FMCSA-2025-0193-0045
AbbVie Submits Comments on FDA Patient-Focused Drug Development Workshop
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WASHINGTON, Nov. 20 -- AbbVie, Rockville, Maryland, has submitted a public comment letter to the Food and Drug Administration (FDA) regarding the agency's initiative on Patient-Focused Drug Development, specifically addressing the draft version of a new evidence dossier template aimed at enhancing the submission of Clinical Outcome Assessments (COAs). AbbVie praised the FDA for creating a platform that encourages discussions on the methodological challenges associated with patient experience data to improve regulatory decision-making processes.
In its letter, AbbVie acknowledged the FDA's efforts
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WASHINGTON, Nov. 20 -- AbbVie, Rockville, Maryland, has submitted a public comment letter to the Food and Drug Administration (FDA) regarding the agency's initiative on Patient-Focused Drug Development, specifically addressing the draft version of a new evidence dossier template aimed at enhancing the submission of Clinical Outcome Assessments (COAs). AbbVie praised the FDA for creating a platform that encourages discussions on the methodological challenges associated with patient experience data to improve regulatory decision-making processes.
In its letter, AbbVie acknowledged the FDA's effortsto streamline the submission process while highlighting some key areas for improvement. The company noted that while the draft template is not a regulatory requirement, clarity regarding flexibility in submissions would significantly benefit sponsors. AbbVie expressed concerns that the proposed changes to the organizational structure of evidence dossiers could disrupt established processes, requiring extensive internal training and coordination. The organization emphasized that a more efficient bridging approach might help maintain consistency while allowing for meaningful engagement in the evidentiary process.
AbbVie further stated that the success of the proposed dossier template relies heavily on leveraging established terminology and evidence types. Given the prevalence of terms like content validity and psychometric validation in the industry, the organization recommended that the FDA enhance the proposed structure with explicit connections to these familiar concepts. This alignment is anticipated to mitigate potential confusion and operational hurdles, ensuring that the methods historically employed for COA endpoint development remain clear.
In addition to its comments on the rationale table, AbbVie encouraged the FDA to retain a format consistent with previous guidelines from 2009, advocating for minimal disruption to existing formats. The organization argued that this approach would promote a better understanding of the evidence and methods utilized by both sponsors and FDA reviewers, facilitating an efficient evaluation process.
AbbVie concluded its letter by calling for greater clarity regarding best practices for structuring COA dossiers, particularly when multiple endpoints are involved. The company's suggestions aim to assist the FDA in fostering consistent and accurate submissions, ultimately improving the trial landscape for patient treatments.
The submission marks AbbVie's continued commitment to collaborating with regulatory bodies in advancing patient experience data methodology and enhancing outcomes in drug development.
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The letter was signed by:
Robyn Carson
Vice President, Patient-Centered Outcomes Research & HEOR Aesthetics
AbbVie
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Katie McCarthy
Head US/Canada Regulatory Policy & Intelligence
AbbVie
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Read full text of letter here: https://www.regulations.gov/comment/FDA-2025-N-2368-0026
a16z Advocates for Clarity on GENIUS Act Regulations
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WASHINGTON, Nov. 20 -- Andreessen Horowitz, known as a16z, has submitted a public comment letter to the U.S. Department of the Treasury expressing key concerns regarding the implementation of regulations surrounding the Guiding and Establishing National Innovation for U.S. Stablecoins Act, or the GENIUS Act. This communication highlights the firm's commitment to fostering clarity and innovation in the payment stablecoin sector while ensuring consumer protection and financial stability.
In the letter, a16z emphasizes the critical need for clear definitions within the regulatory framework established
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WASHINGTON, Nov. 20 -- Andreessen Horowitz, known as a16z, has submitted a public comment letter to the U.S. Department of the Treasury expressing key concerns regarding the implementation of regulations surrounding the Guiding and Establishing National Innovation for U.S. Stablecoins Act, or the GENIUS Act. This communication highlights the firm's commitment to fostering clarity and innovation in the payment stablecoin sector while ensuring consumer protection and financial stability.
In the letter, a16z emphasizes the critical need for clear definitions within the regulatory framework establishedby the GENIUS Act. The firm delineates the distinction between "payment stablecoins" and "decentralized stablecoins," arguing that the latter should not be subject to the same regulatory requirements meant for payment stablecoins, as they do not have a centralized issuer or associated risks. This clarification is necessary to encourage responsible innovation and prevent confusion in the marketplace.
The venture capital firm asserts that without precise definitions, the advance notice of proposed rulemaking (ANPRM) may inadvertently create inconsistencies in how various regulators approach the GENIUS Act's implementation. This includes potential overlaps in regulatory responsibilities, which could stifle innovation and mislead the entities involved in the stablecoin ecosystem.
Further, the letter highlights the importance of a level playing field among payment stablecoin issuers, noting that competition must be supported by clear and consistent regulatory guidelines. a16z argues that any deviation or ambiguity in the rules can lead to unequal regulatory burdens on different types of issuers, ultimately affecting the industry's dynamics and consumer choice.
The firm also raises concerns about anti-money laundering (AML) and compliance obligations that could hinder the growth of stablecoins. a16z recommends that regulators clarify that obligations apply primarily to the issuance of stablecoins, rather than to transaction activity in secondary markets where issuers lack control over user transactions.
In light of its observations, a16z emphasizes the significance of working collaboratively with Treasury to establish clear definitions and regulations that align with the legislative intent of the GENIUS Act. By fostering a regulatory environment conducive to innovation, a16z believes the U.S. can bolster its position as a leader in digital finance while reinforcing the U.S. dollar's status as the world's reserve currency.
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The letter was signed by:
Miles Jennings, Head of Policy & General Counsel, a16z crypto
Michele R. Korver, Head of Regulatory, a16z crypto
Jai Ramaswamy, Chief Legal Officer, a16z
Scott Walker, Chief Compliance Officer, a16z
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2025-0037-0308
1Money Co. Raises Concerns Over Proposed Stablecoin Regulations
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WASHINGTON, Nov. 20 -- 1Money Co., New York, submitted a public comment letter to the U.S. Department of the Treasury expressing concerns over the implementation of the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act). The letter highlights the need for a balanced approach in the regulatory framework to foster innovation while ensuring consumer protection.
In the letter, 1Money emphasizes its commitment to revolutionizing the financial landscape through its stablecoin payment system. The company seeks to build an infrastructure that prioritizes rapid transactions
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WASHINGTON, Nov. 20 -- 1Money Co., New York, submitted a public comment letter to the U.S. Department of the Treasury expressing concerns over the implementation of the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act). The letter highlights the need for a balanced approach in the regulatory framework to foster innovation while ensuring consumer protection.
In the letter, 1Money emphasizes its commitment to revolutionizing the financial landscape through its stablecoin payment system. The company seeks to build an infrastructure that prioritizes rapid transactionsand low fees while complying with necessary regulations. It hopes the final rules stemming from the GENIUS Act will provide clear regulatory pathways for both established financial entities and emerging, innovative firms.
1Money points out that ensuring a streamlined federal licensing process is vital for lesser-known players in the stablecoin market, arguing that a one-size-fits-all regulatory approach could inadvertently favor larger institutions and create entry barriers for smaller innovators. It urges Treasury to implement a tiered licensing framework that accommodates different scales of issuers, thereby preserving competitive innovation.
Another concern raised is the necessity for dual regulatory pathways that allow state regulations to work in tandem with federal frameworks. The company notes that flexibility within the licensing system is crucial for fostering innovation in diverse state contexts, asserting that well-designed state frameworks can complement federal oversight while preserving local expertise.
The letter also calls for vigilant consumer protection measures, specifically advocating for consistent redemption rights for stablecoin users. It urges that users should have the ability to convert their stablecoins back into fiat currency without incurring excessive fees or facing delays. 1Money believes that clear redemption standards will maintain consumer trust and enhance market stability.
Furthermore, 1Money discusses its hopes for the regulations to align with international best practices, suggesting that the U.S. should avoid overly stringent requirements that may poise American issuers against their foreign counterparts. The firm advocates for a regulatory environment that encourages growth, providing consumers with more choices in the digital currency space.
In conclusion, 1Money expresses its appreciation for the Treasury's initiative to seek public input on the GENIUS Act and hopes its recommendations will lead to balanced rulemaking that supports innovation while safeguarding consumer rights and market integrity. The collaborative feedback process is viewed as essential for shaping a future where payment stablecoins can thrive within a secure and well-regulated framework.
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The letter was signed by:
Christopher Lalan
Chief Legal Officer
1Money Co.
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Read full text of letter here: https://www.regulations.gov/comment/TREAS-DO-2025-0037-0342
