July 12, 2026
Dear Sir or Madam,
On behalf of the Clinical Immunology Society (CIS) we appreciate the opportunity to submit comments on the proposed revisions to the Regulation for Federal Financial Assistance (OMB-2026-0034). CIS is the leading professional association dedicated to clinicians and scientists specializing in clinical immunology and inborn errors of immunity (primary immunodeficiencies). CIS represents 1,019 physicians, physician-scientists, researchers, advanced practice providers, trainees, and other healthcare professionals committed to improving the diagnosis, treatment, and long-term care of individuals with immune system disorders. Our members practice in academic medical centers, adult and children's hospitals, community-based settings, and research institutions, and also serve in leadership, scientific, and clinical roles within biotechnology and pharmaceutical organizations across the United States and around the world. Many CIS members serve as principal investigators, peer reviewers, study section members, clinical trial investigators, and leaders of federally funded research programs focused on inborn errors of immunity and related immune-mediated diseases.
CIS members care for some of the nation’s most medically vulnerable patients, including infants, children, and adults living with inherited and acquired immune disorders. These conditions often result in life-threatening complications, including severe or recurrent infections, autoimmune disease, immune dysregulation, autoinflammatory disorders, and allergic diseases. For many patients, continued advances in biomedical research and clinical trials are essential to improving survival, reducing disease burden, and enhancing quality of life.
In addition to providing clinical care, CIS members lead and participate in research that is critical to advancing the understanding of immune-mediated diseases, developing innovative therapies, and improving outcomes for individuals with inborn errors of immunity. Through their work as investigators, clinical trial leaders, and physician-scientists, our members help translate scientific discoveries into treatments that directly benefit patients and public health. This has resulted in the characterization of approximately 7% of all rare diseases, multiple FDA-approved targeted therapies, the widespread use of curative bone marrow transplantation for fatal inborn errors of immunity, and pioneering efforts in genetic and cellular therapies.
CIS supports the stated goals of transparency, accountability, appropriate oversight, and responsible stewardship of federal funds. These goals are important to the public, to investigators, and to patients. Our concern is that several provisions, if finalized without clarification or appropriate guardrails, could unintentionally harm biomedical research, rare disease studies, dissemination of findings, and the integrity of NIH-style expert peer review.
For these reasons, CIS respectfully offers the following section-specific comments and requests. Our intent is not to diminish oversight, but rather to ensure that the final rule achieves its intended objectives while allowing federally funded biomedical research to be conducted, reviewed, completed, and disseminated responsibly. We appreciate your consideration of these comments and offer the following recommendations regarding specific provisions.
1. Publication, Conference, and Dissemination Costs (References: §§200.461, 200.432, 200.475; Subpart E §§200.400–200.476)
CIS recognizes the importance of ensuring that federal funds are used appropriately and that publication, travel, and conference costs are reasonable, necessary, and tied to the purpose of the award.
At the same time, dissemination of results is not separate from the research enterprise. For biomedical research, publication fees, open-access charges, data-sharing costs, and presentation of findings at scientific meetings are necessary to ensure that federally funded discoveries reach clinicians, investigators, patients, and the broader public. Dissemination is the mechanism through which the public realizes the benefit of federally funded research. Discoveries that remain unpublished or inaccessible cannot inform clinical practice, future research, or public health decision-making.
The proposed revisions clarify that:
CIS respectfully requests that the final rule clarify that reasonable publication, open-access charges, data repository, and scientific meeting travel costs remain allowable when they are included in an approved budget, are required by the award, or are directly connected to dissemination of federally funded work. We also request that approval of these costs through the approved budget be considered sufficient agency approval, rather than requiring duplicative case-by-case approval after the award has been made.
2. Merit Review and Scientific Peer Review (Reference: §200.205)
CIS agrees that federal award decisions must be transparent, lawful, and accountable. However, in biomedical research, scientific merit review must remain grounded in expert evaluation. Expert scientific peer review has been the cornerstone of federally funded biomedical research for decades and remains the most reliable mechanism for evaluating scientific merit, feasibility, innovation, and potential public health impact. NIH-style peer review is not an administrative formality. It is the mechanism by which scientific rigor, feasibility, innovation, investigator expertise, human-subject protections, and potential impact are evaluated by individuals with relevant subject matter expertise. This is particularly important in rare diseases, where the scientific and clinical context may not be apparent without specialized knowledge.
CIS is concerned that language emphasizing that peer review is advisory, without additional guardrails, could be interpreted in a way that weakens confidence in merit-based funding decisions. The concern is not that agencies should lack oversight. Rather, the concern is that scientific merit should not be displaced by non-scientific considerations or by disagreement with the scientific conclusions of qualified reviewers.
The proposed revisions to §200.205 explicitly:
CIS respectfully requests that the final rule clarify that expert peer review remains the primary basis for evaluating scientific merit for biomedical research awards. When an agency departs from peer-review recommendations, the basis for that departure should be documented, tied to clear statutory, regulatory, budgetary, or programmatic criteria, and should not be based solely on viewpoint, perceived controversy, or disagreement with the scientific conclusions of qualified peer reviewers.
3. Termination Authority Changes in Conditions, and Research Continuity (References: §§200.340, 200.208)
CIS understands that agencies must retain the ability to terminate or modify awards when there is noncompliance, misuse of funds, loss of eligibility, or other legally appropriate reasons. Appropriate termination authority is part of responsible oversight.
However, biomedical research often requires multi-year planning, longitudinal follow-up, biospecimen collection, clinical trial infrastructure, and sustained patient engagement. In rare disease research, enrolled participants may have no alternative study or therapeutic option. In rare disease studies, participants may travel substantial distances to enroll, contribute irreplaceable biospecimens, or undergo years of follow-up. Abrupt termination may compromise participant safety, scientific validity, and the public investment already made in the project.
Mid-cycle termination or major changes in award conditions, if based only on evolving priorities and without transition protections, can result in loss of irreplaceable data, disruption of clinical trials, and harm to participants who volunteered in good faith.
The proposed revisions:
CIS respectfully requests that the final rule include guardrails for mid-cycle termination or major post-award changes in conditions. These should include written notice, a clear statement of reasons, an opportunity to respond or cure when appropriate, protection for patient safety and ethical obligations, allowance of reasonable wind-down and closeout costs, and transition planning for human-subjects research and ongoing clinical trials.
For biomedical and rare disease research, CIS also requests clarification that an award should not be terminated solely because agency priorities change after the award has been peer reviewed, approved, and initiated, absent a defined legal, compliance, safety, or funding basis.
4. Monitoring, Subrecipient Oversight, and Administrative Burden
(References: §§200.329, 200.332, 200.208)
CIS supports accountability and appropriate monitoring of federal awards. Responsible monitoring protects patients, institutions, investigators, and the public.
At the same time, monitoring requirements should be risk-based, proportional, and not duplicative of existing institutional, sponsor, IRB, human-subjects, conflict-of-interest, and financial compliance systems. Clinician-scientists already balance patient care, research operations, regulatory requirements, and institutional oversight. Excessive or duplicative reporting can divert time and resources away from the research itself without improving accountability.
The proposed rule expands:
CIS respectfully requests that the final rule clarify that enhanced monitoring should be based on objective, documented risk factors, such as prior noncompliance, audit findings, financial management concerns, or performance issues.
CIS also requests that agencies avoid duplicative reporting when recipients already have established institutional controls, IRB oversight, subrecipient monitoring systems, and audit mechanisms. Where possible, agencies should allow reliance on existing institutional documentation and harmonized reporting formats.
Conclusion
Taken together, the provisions discussed above could unintentionally create uncertainty for biomedical investigators and institutions if they are implemented without clarification. The impact would be especially significant in fields such as clinical immunology, where research depends on collaboration, specialized peer review, long-term follow-up, national and international networks, and rapid dissemination of findings.
The Clinical Immunology Society respectfully urges OMB to adjust the proposed provisions, particularly:
-
§200.461, §200.432, §200.475 (publication and dissemination costs), to maintain provision of reasonable publication, open-access, data-sharing, and scientific meeting costs when included in an approved budget, required by the award, or directly tied to dissemination of federally funded work
-
§200.205 (merit and peer review), to preserve expert peer review as the primary basis for scientific merit decisions in biomedical research, with documentation required when agencies depart from peer-review recommendations
-
§200.340 and related sections (termination authority and funding stability), to include guardrails and transition protections for mid-cycle termination or major post-award changes, especially for human-subjects research and clinical trials
-
§§200.329–200.332 (monitoring and administrative burden), to ensure monitoring and reporting requirements are risk-based, proportional, objective, and not duplicative of existing institutional and federal compliance systems
CIS appreciates the opportunity to provide these comments and stands ready to work with OMB and federal research agencies to ensure that accountability measures strengthen—rather than inadvertently impede—the conduct of high-quality biomedical research that advances patient care and public health.
Respectfully,
Clinical Immunology Society