I am writing to express my opposition to the proposed fast-track regulation that would require centers to keep stock epinephrine injectors on site. While I fully support efforts to ensure the safety of individuals with severe allergies, the proposed rule raises several concerns that should be carefully addressed before implementation.

To begin with, the fast-track process limits public input and thoughtful consideration. Regulations with medical, financial, and legal implications should not be rushed. Decisions about emergency medical requirements deserve thorough analysis and opportunities for those directly affected to provide meaningful feedback.

Additionally, the financial and operational burden on centers—particularly smaller facilities—cannot be overlooked. Auto-injectors are expensive, have short shelf lives, and must be replaced regularly. Without funding assistance or reimbursement provisions, this mandate would create an additional strain on already tight budgets.

There are also significant liability and training issues. Administering epinephrine requires proper instruction and confidence. The regulation does not appear to outline clear standards for staff training or legal protection for individuals who administer the medication in good faith. These gaps could discourage compliance or create unnecessary legal risks.

Finally, while the goal of protecting public health is commendable, rushing a regulation of this nature is counterproductive. A more deliberate process—one that includes educators, healthcare providers, and center administrators—would result in a more balanced and effective policy.

For these reasons, I urge the agency to pause the fast-track approval and engage in a full rulemaking process that prioritizes both safety and practicality. Ensuring readiness for emergencies is essential, but it must be done through a thoughtful and well-supported approach.

Respectfully,