Comment from Susan Swain

Dear OMB. I write because I am extraordinarily concerned that the proposed OMB-2026-0034 Regulation for Federal Financial Assistance if imposed will cripple science and allow dismantle the highly successful scientific research enterprise that has made huge advances in healthcare possible and has spurred multiple highly successful industries and companies. I am a professor at U Mass Medical School who has been doing research in Immunology for over 50 years. I have over 250 publications, cited over 38,000 times in the peer-reviewed publication of other scientists. I Directed a free-standing Research Institute for 13 years and have been a professor at UCSD and U Mass Medical School. I strongly believe that the US has led the world in biomedical research and the improved health that it has supported both because of the large investment wise leaders have put into it and the thoughtful and strategic way the administration and funding of grants has been structured. The kingpin of this system is peer review which ensures that panels of fellow scientists who have the expertise relevant to each the proposal for funding, evaluate the merit of the proposals. They meet and discuss proposals in their area of expertise and then the whole panel scores each grant. The average score is by far the major factor in the decision to fund a project. Only a fraction of highly meritorious grants, almost always in the top quartile of those reviewed, are currently funded. Science succeeds because scientists are passionate about what they do, and they are successful in biomedical research only if they can make discoveries that improve our understanding of the complex science of how the body works. The rules in the OMB proposal under consideration would severely undermine basic and applied scientific research. Here are some of the most deleterious.: [200.205] This will allow political appointees, not scientists to determine what grants are funded by requiring pre-issuance review of grants to assure they demonstrably advance the Presidents policy priorities. As part of this, the rule explicitly states the results of peer review of grant proposals are advisory and are not ministerially ratified, routinely deferred or otherwise treated as de facto binding. Mention is made of the important of Gold Standard Science-but no definition of this is given. Together these would ensure that politics not science decided what individuals and institutions receive funds. This would degrade the scientific enterprise. [200.340] states that active grants can be terminated at any time for any reason if they are inconsistent with program goals or priorities. Science is done by a group of people, often with different expertise, working together who are recruited when a grant is funded. If a grant is terminated mid-stream, those people lose their jobs and soon no one will want to work in research. The effort and resources and money spent are squandered. Other rules further restrict research by prohibiting Gender research [200.300], preventing funds being used for scientific collaboration with international colleagues [200.220] and for restricting funds for attendance to scientific meetings [200.432]. professional society membership and subscriptions to academic journals [200,454], and costs of publishing research [200,461]. Progress in science depends on the scientists collaborating with peers, learning things relevant to their research at meetings and of course encouraging publication of scientific findings. There is even a rule [200.204] that allows agency heads to exempt some grant competitions from public notice. Each of these rules inserts political appointees into the funding process and would greatly impede the conduct of groundbreaking science. In my studies we have analyzed what is needed to make strong, long-lived protective immunity and are next trying to apply that to vaccines for no pathological viruses. We also are studying what we have discovered is the unique immune system of aged animals and are analyzing how to induce immunity to novel pathogens in the aged. These studies can teach us how to prepare for future pandemics. Implementation of the rules above would make these endeavors almost impossible and would discourage brilliant young scientists from becoming researchers. Please, save American biomedical science reject the entire OMB-2026-0034