COLUMBIA, Md.—The Foundation Fighting Blindness, a driving force in the global development of treatments and cures for blinding diseases, is urging the Office of Management and Budget (OMB) to withdraw its proposed rule (docket OMB-2026-0034) titled Regulation for Federal Financial Assistance. In its announcement, the foundation said the proposed rule would “fundamentally alter the long-standing framework governing federal financial assistance in ways that would undermine the biomedical research enterprise, create substantial uncertainty for research institutions and patient organizations, and jeopardize the public-private partnerships that have driven decades of medical innovation.”
The rule was published on May 29, 2026, and proposes a major rewrite of 2 CFR Part 200 (the uniform guidance) governing U.S. federal grants and cooperative agreements, with a targeted effective date of October 1, 2026. It received tens of thousands of comments during the public comment period which ended on July 13.
“Over 50 years of strategic investments, we have helped advance numerous scientific discoveries from the laboratory into clinical development, including research that ultimately contributed to the first FDA-approved gene therapy for an inherited disease,” the foundation said. “Our mission depends upon a strong partnership among private philanthropy, academic institutions, biotechnology companies, and federal research agencies.
“For patients living with blinding inherited retinal diseases and dry AMD—many of whom have no approved treatment and face irreversible vision loss—predictability in the federal research system directly affects whether promising therapies reach patients,” the foundation said.
As written, The Foundation Fighting Blindness said the proposed rule would implement the following changes:
- Upend merit-based scientific review by authorizing additional political review of awards that have already undergone rigorous scientific evaluation and the ability to change agency priorities after completing the peer-review process.
- Allow for ad-hoc termination of awards, permitting agencies to terminate discretionary awards when they decide that doing so serves agency priorities or the national interest, instead of terminating awards based on scientific performance or recipient compliance.
- Weaken public-private research partnerships that drive rare disease research by introducing uncertainty into federal funding. Rare disease research typically has limited commercial incentives and instead relies on private investments, which in turn look to federal funding for certainty.
- Put congressional funding for research at odds with presidential policy. It is unclear what happens when presidential priorities are not aligned with the funding Congress has already appropriated for disease-specific research programs.
“Because these changes will ultimately hurt patients awaiting new treatments to slow down or reverse vision loss, we respectfully urge OMB to preserve scientific peer review as the primary basis for awarding biomedical research grants,” the foundation said.
The proposed revisions represent some of the most significant changes to the federal grants framework in many years and would affect nearly every recipient of federal financial assistance, according to the foundation. The revisions would impact universities, non-profits, patient advocacy organizations, research institutions, and federal agencies, and have the potential to disrupt ongoing clinical research involving patients and delay development of therapies for rare diseases where only a handful of research programs may exist, the foundation argued.
The foundation goes on to say that patients with inherited retinal diseases and dry AMD depend on a stable, predictable, and scientifically driven federal research enterprise, and because of that, Foundation Fighting Blindness is requesting that the OMB withdraw the proposed rule and, if additional reforms are deemed necessary, engage stakeholders through a new rulemaking process that preserves merit-based scientific review, respects congressional intent, and strengthens—not weakens—the research ecosystem that is essential to delivering new therapies to patients.
To read the foundation’s full comments to OMB, click here.
