Comments on: OMB Proposed Revisions to Uniform Guidance

Dear Director Vought:

The Ad Hoc Group for Medical Research, a coalition of nearly 600 organizations representing patients, scientists, health professionals, academic and research institutions, educators, and industry supporting funding for the National Institutes of Health (NIH), appreciates the opportunity to comment on the proposed revisions to the Uniform Guidance.

Medical research depends on a federal funding system that is rigorous, transparent, predictable, and stable. Scientific research frequently spans many years, relies on highly specialized personnel and infrastructure, and often requires sustained collaboration among institutions. We are therefore particularly concerned that several provisions of the proposed rule could unintentionally slow the timely issuance of federal awards, reduce the stability of awarded funding, and undermine the continuity that is essential for successful medical research. Although we recognize the Administration’s interest in strengthening stewardship and oversight of federal funds, we urge OMB to ensure that these objectives are achieved without disrupting the efficient operation of the nation’s medical research enterprise.

Proposed § 200.205 (Pre-Issuance Review). We are concerned that the addition of a new pre-issuance review by senior political appointees for all discretionary awards will substantially lengthen the time between scientific peer review and award issuance. The proposed rule provides that peer review recommendations would remain advisory and would be subject to an additional level of review before awards are finalized. Scientists already have experienced delays over the past two fiscal years due, at least in part, to the implementation of the new review processes which are being codified and expanded in this proposal.

Medical research operates on carefully coordinated timelines. Delays in award issuance interrupt hiring, delay the purchase of specialized equipment and supplies, postpone the initiation of clinical studies, and create uncertainty for trainees, early-career investigators, and research staff. Research institutions often must make staffing and infrastructure decisions based on anticipated award dates, while patients awaiting enrollment in clinical studies may experience delays in access to promising new interventions. Even relatively modest administrative delays can slow the pace of scientific discovery and postpone the development of new diagnostics, treatments, and preventive strategies.

Proposed § 200.206 and 200.208 (Risk Assessment and Award Conditions). We support appropriate stewardship of federal resources and recognize the importance of risk-based oversight. However, expanding pre-award risk assessments and authorizing agencies to add or modify award conditions throughout the period of performance may substantially increase administrative review before awards can be issued while introducing additional uncertainty for recipients after awards are made.

The medical research enterprise already operates under extensive scientific, financial, and regulatory oversight. Additional layers of review that are not accompanied by defined timelines risk slowing awards without providing commensurate benefits. We encourage OMB to ensure that any expanded risk assessment processes are narrowly tailored, applied consistently, and implemented in a manner that does not unnecessarily delay funding decisions for applicants with demonstrated records of responsible stewardship.

Proposed § 200.202 and 200.204 (Multi-Year Awards). We appreciate the proposal’s recognition that multi-year awards can reduce administrative burden in appropriate circumstances. In medical research, however, there is no one-size-fits-all approach to award duration. The appropriate funding mechanism depends on the scientific objectives, stage of research, and programmatic needs of the funding opportunity. Some projects—such as large clinical studies, longitudinal cohort research, and infrastructure investments—may benefit from multi-year funding commitments. Other programs, including investigator-initiated research, pilot projects, rapidly evolving scientific fields, and programs intended to support a broad and diverse portfolio of investigators, may be better served through more traditional funding approaches.

Accordingly, we encourage OMB to preserve agency flexibility to determine when multi-year awards are appropriate rather than creating an expectation that they become the default approach across federal research programs.

We are also concerned that the proposal does not address implementation considerations associated with expanding the use of multi-year awards. Because agencies operate under finite annual appropriations, an abrupt transition to funding a substantially larger share of awards on a multi-year basis could temporarily consume a greater proportion of available resources, resulting in a significant reduction in the number of new competing awards made during the transition period. Such an outcome would be particularly harmful to early-career investigators, new research ideas, and emerging areas of science, all of which depend on a healthy pipeline of new awards each year.

If OMB elects to encourage broader use of multi-year awards, we recommend that agencies retain discretion to determine where such awards are scientifically appropriate and develop implementation plans that avoid unintended disruptions to the annual cadence of new research funding.

Proposed § 200.340-200.343 (Suspension and Termination Authority). We are concerned that the proposed expansion of agency authority to suspend or terminate discretionary awards—including when an award is determined not to effectuate program goals, agency priorities, or the national interest “as they exist at the time of the termination”—creates significant uncertainty for long-term medical research. The proposal also would authorize temporary suspensions, require only a brief summary of the reasons for discretionary terminations, and provide limited procedural opportunities for recipients to respond before funding is discontinued.

Medical research differs from many other federally funded activities because it often cannot simply be paused and resumed without significant scientific and financial consequences. Research involving clinical trial participants, longitudinal patient cohorts, animal models, specialized laboratory resources, or time-sensitive experiments may suffer irreversible losses if funding is unexpectedly suspended or terminated. Interruptions can delay the development of new diagnostics and treatments, waste taxpayer investments that have already been made, and discourage institutions from making the substantial commitments necessary to recruit personnel, purchase equipment, and build research capacity.

Importantly, broad discretionary suspension and termination authority also undermines the proposal’s movement toward multi-year awards. The value of multi-year funding lies in the confidence it provides investigators that they can responsibly undertake complex scientific projects over several years. If recipients cannot reasonably rely on the continuity of awarded funding, the practical benefits of multi-year awards are substantially diminished, and institutions may become less willing to make the long-term investments that such awards are intended to support.

We respectfully recommend that OMB preserve appropriate agency authority to address fraud, waste, abuse, and recipient noncompliance while narrowing the circumstances under which otherwise compliant discretionary awards may be suspended or terminated. At a minimum, OMB should establish clear, objective standards governing discretionary terminations, provide meaningful notice and an opportunity for recipient response before termination whenever practicable, and recognize the unique operational and scientific consequences that funding interruptions can have for medical research.

Proposed Effective Date. We note that the preamble proposes to finalize this proposed rule with an effective date of October 1, 2026, which would allow OMB less than four months to review the submitted comments, consider potential revisions, and draft and publish the final text. Given the volume of comments to date and scope of the proposal, we are concerned that even with the assistance of technological tools, the condensed timeline would inhibit OMB’s ability to give appropriate consideration to the feedback it receives. Moreover, once the rule is finalized, agencies and stakeholders similarly would have little time to implement necessary changes before the rule is effective. It is unclear what benefit there is to rushing implementation of a proposal as sweeping as this rule, but rather hasty implementation runs substantial risk of further disrupting and destabilizing the medical research enterprise after an already volatile period for scientists and patients alike.

The United States has built the world’s leading medical research enterprise through a federal funding system that combines rigorous scientific merit review with predictable, stable funding mechanisms that enable investigators to pursue ambitious, long-term scientific exploration. We respectfully urge OMB to withdraw the proposed rule until it can be comprehensively modified to preserve these strengths by minimizing unnecessary delays in award issuance, reinforcing the stability needed for long-term research investments, and ensuring that awarded projects can proceed with the continuity necessary to deliver scientific advances that improve the health of patients and communities.

Thank you for considering these comments.

Sincerely,

The Ad Hoc Group for Medical Research