Comment from Kathryn Whitehead

[200.202(e), 200.220] To Whom it May Concern: I am a professor of chemical engineering and biomedical engineering. My research develops lipid nanoparticle delivery systems for RNA therapeutics, and I am the recipient of a Canada Impact+ Research Chair in Translational Drug Delivery, which will bring me to the University of British Columbia in 2027 to collaborate with Canadian colleagues who helped originate this field. I am writing in my personal capacity to oppose the proposed restrictions in sections 200.202(e) and 200.220, which would impose new barriers on international research collaboration funded by federal grants. Lipid nanoparticle delivery is a direct example of why these barriers would be counterproductive. The technology underlying the mRNA COVID vaccines was built over decades through collaboration between American and Canadian researchers, refined further with European partners, and deployed at a scale that saved millions of lives. That work depended on the ability to share data, travel for joint experiments, and fund collaborators across borders without waiting for a political appointee to approve each exchange. Under the domestic-first restraint in 200.202(e), federally funded research with international components would require statutory authorization or senior political approval, adding delay to exactly the kind of collaboration that made rapid vaccine development possible. This restriction will personally affect my own federally funded research as I transition part of my lab's work to a joint U.S.-Canada footprint. Sharing data, coordinating experiments, and supporting collaborators across the border are not incidental to this work. They are how the science gets done. Section 200.220's broad definition of "covered foreign country," left to agency interpretation, also creates uncertainty for researchers who are trying in good faith to determine whether a given international partnership requires special approval, which will chill collaboration even in cases where no national security concern exists. Scientific progress, particularly in a field like RNA delivery that spans immunology, materials science, and clinical medicine, has never respected national borders and should not now be forced to. I urge OMB to withdraw the proposed changes to sections 200.202(e) and 200.220.