OMB Proposed Regulation MB-2026-0034-0001
The American Academy of Allergy, Asthma & Immunology (AAAAI) represents thousands of allergist / immunologists, researchers, and scientific experts dedicated to advancing the treatment and prevention of allergic and immunologic diseases. We care for individuals with asthma, hay fever, sinusitis, eczema, food allergy, drug allergy, anaphylaxis, hives, and immunodeficiencies. Collectively, these disorders are a leading cause of chronic disease in America, affecting an estimated 50 million Americans, and causing substantial morbidity, mortality (asthma, anaphylaxis), and loss of productivity. As such, the U.S. annual healthcare costs of asthma are $82 billion, food allergy $25 billion and hay fever $3-4 billion. Additionally, allergic and immunologic diseases directly limit eligibility for military service, contributing to recruiting shortfalls and reducing military readiness. While robust clinical studies have demonstrated that investments in allergy and immunology therapies improve the health of Americans across the life span and reduce healthcare costs, our ability to treat and prevent allergic disease depends on high-quality research. We submitted public comments on the proposed revisions to the Guidance for Federal Financial Assistance published in the Federal Register on july 10, 2026.
OMB proposal authorizes political priorities over science and public benefit.
On May 29, the Office of Management and Budget (OMB) released a 412 page proposed regulation that would replace the existing framework for the approval and management of federal grants across more than 40 regulatory agencies, including the National Institutes of Health. Agency-level discretion and scientific peer review would be replaced by centralized political appointees aligning funding decisions with administration priorities. Grant recipients would not be able to use federal support for publication-related costs or to participate in conferences to present their research. International collaboration would be replaced by “domestic-first” intention, with any international engagement requiring additional approval.
The administration has announced that it intends to implement this regulation on October 1, 2026.
Key concerns
• Political appointee oversight (§200.205):
o Senior political appointees have oversight over all funds and review grant proposals for whether they fit the priorities of the then-current administration.
o Applications will be judged against the current administration’s Executive Order definition of “Gold Standard Science.”
o Preference is to be given to institutions with lower indirect costs.
o Scientific and merit-based review is only advisory, and senior appointees could not defer to recommendations of others.
• Termination authority [§200.340]: Awards could be terminated at any time senior political appointees determine awards do not advance program goals, the national interest, or administrative priorities at the time of termination.
• Preference for funding multi-year awards [§200.202(f)]: There is considerable concern that this could significantly reduce opportunities for young career researchers.
• Publication-related costs prohibited [§200.461]
• Conference attendance prohibited [§200.432]: Costs for attending conferences is prohibited unless specifically approved in the initial terms and conditions of the award.
• Journal subscriptions and professional memberships prohibited [§200.454]: Specific prior written approval would be required for professional memberships, and costs for professional periodicals are not allowed.
• Removes patient engagement (§200.202). Removes regulatory language that urges agencies to encourage applicants to engage members of the community who would benefit from the program in its design.
What’s Next and how you can help
The open comment period on this rule has colsed but Congress can impact the timeline and trajectory for this radical change in federal administrative procedure. A large volume of carefully considered comments will signal to members of Congress that a more cautious approach is necessary. If the law is challenged in litigation, the courts will consider whether OMB sufficiently considered and responded to comments submitted, although a severability clause in the regulation would allow the remainder of it to stand even if certain sections are overturned by the courts.
Contact your members of Congress to share your concerns. You can expect your members of Congress to ask if you submitted comments, and there is great potential influence in sharing with them the comments you have submitted.
Ask Congress to suspend implementation of this proposal
We continue to hear from researchers and practicing allergist/immunologists about their serious concerns about this proposal, including:
• Potential immediate discontinuation of patient treatment in ongoing clinical trials, some with life threatening consequences
• Discontinuation of drug and therapy research regardless of status or progress to date
• Patient access to specialty care diminished by institutional destabilization of medical centers
• Elimination of ongoing support resulting in destruction of millions of dollars in research investment
• Career disruption undermining the pipeline of developing researchers for a decade or more
For more information, visit this organizational discussion guide prepared by the AAAAI’s expert consultant, Hart Health Strategies.
7/15/2026