UC Comment Letters

This comment letter responds to the Environmental Protection Agency’s supplemental proposed rule on “Strengthening Transparency in Regulatory Science.” UC urges EPA to withdraw the proposal, arguing that its expanded data-transparency requirements could exclude rigorous scientific studies from regulatory decision-making, undermine protections for confidential human research data, and give EPA excessive discretion to favor or exclude particular studies rather than relying on the best available science.

This comment letter responds to the National Aeronautics and Space Administration (NASA)'s proposed Reporting Requirements Regarding Findings of Harassment, Sexual Harassment, Other Forms of Harassment, or Sexual Assault. The University of California (UC) supports NASA’s goal of addressing harassment and ensuring oversight of federally funded projects, but recommends revisions to align NASA’s requirements with existing National Science Foundation (NSF) policies, protect privacy and due process, clarify reporting obligations, and reduce administrative burden and confusion created by inconsistent federal agency requirements.

This comment letter requests that NASA extend the comment period for the "New Conflict of Interest and Conflict of Commitment Policy for Recipients of NASA Financial Assistance Awards" by 60 days. NASA's proposed policy was published in the Federal Register on January 30, 2023 and only provided a 30-day comment period.

This comment letter responds to the National Science Foundation (NSF)'s proposed revisions to the Proposal and Award Policies and Procedures Guide (PAPPG). The University of California (UC) generally supports the proposed updates but expresses concern that expanded Current and Pending Support and Biosketch requirements would increase administrative burden, create ambiguity regarding disclosure obligations, and lack consistency with other federal agencies. UC recommends greater federal harmonization, development of a common disclosure system, clearer definitions and accountability standards, and implementation approaches that reduce burden on researchers and institutions.

This comment letter responds to the U.S. National Science Foundation (NSF)'s proposed Guidance on Financial Assistance (GFA), which would replace the current Proposal and Award Policies and Procedures Guide (PAPPG). The University of California (UC) urges NSF not to finalize the draft guidance in its current form, expressing concern that it introduces significant policy changes affecting merit review, international collaboration, research security, publication and data-sharing requirements, indirect cost recovery, award administration, and termination authorities. UC recommends substantial revisions to preserve merit-based funding decisions, support international scientific collaboration, maintain allowable research dissemination costs, protect award stability and institutional flexibilities, reduce administrative burden, and provide a transparent, prospective implementation process.

This comment letter responds to the National Science Foundation’s request for comments on proposed government-wide common disclosure forms for biographical sketches and current and pending support. UC supports standardized forms as a means of reducing administrative burden but recommends limiting agency-specific exceptions, simplifying certification requirements, harmonizing definitions and submission requirements across agencies, and allowing sufficient time and technological support for implementation.

This comment letter responds to the U.S. Department of Agriculture’s interim final rule establishing a domestic hemp production program. UC requests clearer and more flexible requirements for universities conducting hemp research, particularly regarding pre-harvest THC testing, use of DEA-licensed laboratories, negligence standards, disposal requirements, and distinctions between hemp grown for consumption and industrial or research purposes.

This comment letter responds to the Department of Commerce Bureau of Industry and Security (BIS)'s proposed amendments to the Export Administration Regulations originally issued on July 29, 2024. UC supports BIS’s proposed amendments to the Export Administration Regulations as a careful effort to advance national security and foreign policy goals while recognizing the need to protect academic research and collaboration. UC endorses AUECO and COGR recommendations seeking additional exclusions for routine academic activities and clearer definitions of Military-Support End Users and Intelligence End Users to avoid unnecessary disruption to international research while still safeguarding critical technologies.

This comment letter responds to the U.S. Patent and Trademark Office’s request for comments on its National Strategy for Expanding American Innovation. UC supports increasing participation in invention and entrepreneurship and recommends federal support for educational programs, community partnerships and mentoring, improved access to capital, standardized data collection to measure participation and outcomes, and continued support for the Bayh-Dole Act and a strong patent system.

This comment letter responds to NIST’s request for information on rebuilding the Interagency Edison (iEdison) system for reporting federally funded inventions. UC strongly supports modernizing the system and recommends greater consistency in invention-reporting requirements across federal agencies, improved functionality to address outdated and burdensome processes, and continued stakeholder engagement in developing and testing the replacement system.

This comment letter responds to the Department of Defense’s interim rule implementing new cybersecurity assessment and certification requirements for federal contractors. UC supports strengthened cybersecurity protections but requests clearer guidance on how the requirements apply to fundamental research, greater transparency regarding assessment levels, and confirmation that compliance costs are allowable as direct costs on DoD awards.

This comment letter responds to the Education Department (ED)'s request for comments on the collection of information required under Section 117 of the Higher Education Act (HEA)(20 §U.S.C. 1011f), as published in the Federal Register on December 27, 2022. UC is concerned that ED significantly underestimates the burden of HEA Section 117 foreign gift and contract reporting, noting that the PEBC portal’s manual-entry process is cumbersome, repetitive, and far more time-consuming than the agency’s estimate. UC recommends allowing single-file uploads, reducing repetitive screens and manual data entry, auto-populating institutional fields, improving review and correction features, expanding institutional access to submitted data, and aligning login requirements with the six-month reporting cycle.

This comment letter responds to the U.S. Department of Education’s proposed information collection requirements for reporting foreign gifts and contracts under Section 117 of the Higher Education Act. UC supports transparency regarding foreign relationships but argues that the proposed requirements exceed the statute, impose substantial administrative burdens, and raise privacy and confidentiality concerns, particularly regarding submission of complete agreements, information about individual donors, and reporting of foreign-affiliated entities.

This comment letter responds to the U.S. Department of Education’s proposed revisions to the Education Department General Administrative Regulations (EDGAR). UC supports the Department of Education's goals of updating regulations to better align them with other Departmental regulations and procedures. However, several provisions within the proposed rule raise concerns and have significant implications for extramural funding,sponsored programs, institutional cost recovery, multi-year awards, compliance,subrecipients, and award stability.

This comment letter responds to DOE's proposed "Financial Assistance Regulations-Conflict of Interest and Conflict of Commitment Policy Requirements", published on June 18, 2024. UC appreciates DOE’s effort to strengthen research integrity but urges DOE to align its final conflict-of-interest policy with the longstanding PHS COI regulations, preferably by finalizing the existing DOE Interim Policy with targeted changes rather than creating divergent requirements. UC specifically recommends removing conflict-of-commitment requirements from the COI policy, using existing biographical sketch/current and pending support disclosures for COC information, adopting PHS-style definitions and thresholds, shifting reporting to before expenditure of funds, clarifying disclosure obligations, and allowing one year for implementation.

This comment letter responds to the National Institutes of Health’s request for information on developing consent language for the future use and sharing of research data and biospecimens. UC recommends that NIH provide flexible guidance rather than standardized sample language, clarify how the proposal relates to broad consent requirements, avoid a default opt-out approach to future sharing, and address the varying federal, state, and local laws governing informed consent and research privacy.

This comment letter responds to the FDA’s Final Order expanding the list of tropical diseases eligible for the Tropical Disease Priority Review Voucher (PRV) Program. UC supports the announced additions but urges FDA to also include coccidioidomycosis (Valley Fever), arguing that it meets the program’s eligibility criteria and that PRV incentives could encourage development of urgently needed diagnostics, treatments, vaccines, and cures.

This comment letter responds to the National Institutes of Health’s request for information on research interests and barriers related to studying the health effects of cannabis and its constituents. UC calls for increased and broader research funding, a streamlined federal regulatory framework, improved access to cannabis products representative of those actually used by the public, and coordinated federal resources, infrastructure, training, and regulatory support to expand cannabis research.

This comment letter responds the DOJ's proposed rule on provisions pertaining to preventing access to U.S. sensitive personal data and government-related data by countries of concern or covered persons. UC supports DOJ’s goal of protecting sensitive personal and government-related data, but urges the agency to avoid impairing academic research, especially by adding an exemption for covered data transactions in non-federally funded research. UC also endorses COGR’s recommendations for clearer definitions, more detailed compliance guidance, practical tools, and sufficient implementation time so universities can comply consistently without undermining global research collaboration.

This comment letter responds to the Drug Enforcement Agency (DEA)'s Notice of Proposed Rulemaking "Schedules of Controlled Substances: Rescheduling of Marijuana", published in the Federal Register on May 21, 2024. UC supports DEA’s proposal to move marijuana, marijuana extracts, and naturally derived delta-9-THC from schedule I to schedule III as a step toward reducing research barriers, but argues that rescheduling alone will not let researchers study the real-world cannabis products available in state-regulated markets. UC urges DEA to allow universities to access state-legal cannabis products and fresh plant material for research, classify naturally and synthetically derived delta-9-THC consistently, assess THC isomers and derivatives through the eight-factor analysis, and issue updated guidance explaining the regulatory requirements for cannabis research.

This comment letter responds to the Drug Enforcement Agency (DEA)'s Advanced Notice of Proposed Rulemaking on Controlled Substance Destruction Alternatives to Incinceration, issued on October 31, 2023. UC explains that it currently uses reverse distributors to destroy controlled substances used in research and clinical care, but that limited reverse-distributor capacity can force institutions to store expired or unusable substances longer than intended. UC asks DEA to allow or clarify that controlled substances purchased or used for research or clinical care may be rendered non-retrievable on-site, including through hardening agents or activated carbon under documented chain-of-custody, two-witness handling, and DEA Form 41 recordkeeping procedures.

This comment letter responds to the Office of Management and Budget (OMB)'s Proposed Rule to revise sections of 2 CFR, Subtitle A, Chapters I and II (the Uniform Guidance). UC expresses support for OMB’s burden-reducing changes but said the rule still leaves uncertainty and unrecovered costs around indirect-cost rates, agency IDC limits, outdated caps, DS-2 reporting, COI scope, and subaward rules. UC recommends clearer language, stronger enforcement of negotiated IDC rates, eliminating or updating outdated requirements, clarifying procurement COI, and preserving administrative flexibility.

This comment letter responds to the Office of Management and Budget (OMB)'s request for information on proposed revisions to 2 CFR, Subtitle A, Chapters I and II (Uniform Guidance). UC endorses COGR’s comments and recommends that OMB reduce administrative burden under 2 CFR by eliminating the DS-2 requirement, raising the subaward MTDC cap from $25,000 to $75,000 with regular reevaluation, and reconsidering the 26% cap on administrative F&A costs. UC also asks OMB to clarify that negotiated indirect cost rates must be accepted unless limited by statute or regulation, specify that § 200.112 concerns procurement-related conflicts rather than research COI, and rewrite subrecipient indirect-cost-rate rules in plain English so pass-through entities and subrecipients have clear, workable options.

This comment letter requests that OMB extend the comment period for the proposed revisions to 2 CFR, Subtitle A, Chapters I and II (Uniform Guidance) by 60 days. OMB's proposed revisions to the Uniform Guidance was published in the Federal Register on February 9, 2023 and only provided a 30-day comment period.

This comment letter responds to the Office of Science and Technology Policy (OSTP)'s Request for Information on Accelerating the American Scientific Enterprise. The University of California (UC) strongly supports policies that strengthen U.S. research competitiveness and recommends stable and predictable federal research funding, preservation of the Bayh-Dole Act, strong intellectual property protections, expanded technology transfer and commercialization programs, streamlined research administration, and sustained investments in scientific talent, infrastructure, and regional innovation ecosystems to accelerate the translation of research into societal and economic benefits.

This comment letter responds to the Office of Science and Technology Policy’s request for information on public access to peer-reviewed publications, data, and code resulting from federally funded research. UC strongly recommends a zero-day embargo for federally funded peer-reviewed manuscripts, standardized data-sharing requirements across federal agencies, and continued federal support for open-access publishing and long-term research data management costs.

This comment letter responds to the Office of Science and Technology Policy (OSTP)'s RFI on proposed changes to Dual Use Research of Concern (DURC) and Potential Pandemic Pathogen Care and Oversight (P3CO) policies. UC supports updating DURC and P3CO oversight but warns that a broad risk-based framework could overburden institutions, dilute attention from the highest-risk research, and slow important biomedical, surveillance, vaccine, and in silico work. UC recommends maintaining a clear list-based approach, combining related biosafety programs where efficient, giving federal agencies a larger role in risk assessment, preserving rapid-response pathways, and providing detailed guidance, training, examples, decision trees, and agency contacts for institutions.

This comment letter responds to a Senate Health, Education, Labor and Pensions (HELP) Committee letter, dated September 29, 2023, that seeks input on modernizing the NIH. UC urged Congress to modernize NIH carefully by preserving peer-driven, broad-based scientific participation while avoiding sweeping mandates that could disrupt the biomedical research enterprise. UC recommended incremental, piloted reforms that support early-career scientists, reduce administrative burden, reform IDeA eligibility, protect full F&A cost recovery, improve clinical-trial diversity, strengthen research workforce diversity, and maintain essential research methods where no adequate alternatives exist.

This comment letter responds to the California Department of Cannabis Control’s proposed regulations governing research funding under the state’s Medicinal and Adult-Use Commercial Cannabis Regulations. UC recommends aligning the program with standard research administration practices by requiring peer review, providing feedback to unsuccessful applicants, using the California Model Agreement for UC and CSU awards, clarifying records-retention and personnel requirements, and leveraging UC’s existing grantmaking expertise.

This comment letter responds to the California Institute of Regenerative Medicine (CIRM)'s Second Notice of Proposed Regulation Amendments concerning the revised CIRM Intellectual Property (IP) Policy. The University of California (UC) expresses appreciation that CIRM addressed many concerns raised in UC’s earlier comments, but recommends several additional clarifications to improve the policy’s implementation, including narrowing and clarifying the definition of collaborators, correcting inconsistencies in publication-related materials provisions, aligning public-access requirements with NIH standards, facilitating material-transfer requests, and clarifying appeal procedures under CIRM’s march-in rights framework. UC’s recommendations are intended to promote research collaboration, technology transfer, and practical compliance with the policy.

This comment letter responds to the California Institute for Regenerative Medicine (CIRM)'s proposed adoption of Section 100505 (CIRM Award Management Policy). The University of California (UC) generally supports the proposed policy but recommends revisions to ensure facilities and indirect cost reimbursement accurately reflects the true costs of conducting research, simplify implementation timelines for existing awards, clarify liability and indemnification provisions, and provide more practical requirements for returning unobligated funds, in order to promote fair, efficient, and sustainable research administration.

This comment letter responds to AAALAC International's proposed revisions to their position statement on "The Attending Veterinarian and Veterinary Care". UC generally supports AAALAC’s proposed revisions to the position statement, but recommends retaining language that makes surgical training/qualification and classification of major versus minor surgeries a shared responsibility of the IACUC and veterinary staff. UC also objects to using the undefined phrase “standards of veterinary practice,” urges AAALAC to reference regulatory expectations instead, and recommends adding clearer language on AV communication mechanisms, part-time AV oversight limits, and the AV’s role in animal husbandry. The content of this letter was submitted through a comment portal and did not require a signature.

This comment letter responds to SMART IRB's proposed revisions to their Reliance Agreement 3.0. UC asks SMART IRB to preserve continuity for existing studies under prior reliance-agreement versions, clarify confusing withdrawal/reporting language, and allow flexibility for non-federally regulated research through agreed-upon commensurate protections rather than defaulting rigidly to SMART IRB SOPs or the Common Rule. UC also raises several deal-breaker legal and operational concerns, including overly broad liability and indemnification language, burdensome or unclear QA/QI and reporting obligations, lack of flexibility for DOE-managed labs, and governing-law/venue provisions that could complicate participation.

This comment letter responds to the General Services Administration (GSA)'s Information Collection on the Federal Funding Accountability and Transparency Act Sub-Award Reporting System Registration Requirements for Prime Grant Awardees (FFATA reporting requirements) published in the Federal Register on February 29, 2024. UC acknowledges that FFATA subaward reporting is statutorily required, but says GSA’s estimated annual burden of 30 minutes per respondent is a major underestimate because UC submits reports monthly and campuses spend roughly 18 to 30 hours per report, or about 200 to 360 hours per year. UC recommends improving FSRS guidance and technical support, resolving recurring system errors, reducing duplicative data entry, carrying forward unchanged information for existing subawards, and limiting required FSRS fields to those actually required by FFATA.