To Whom It May Concern:

I respectfully submit this comment in opposition to the proposed fast-track regulation mandating that all centers maintain stock epinephrine auto-injectors on the premises. While the intent of this proposal—to enhance emergency preparedness for allergic reactions—is commendable, the expedited regulatory process and the current structure of the proposal raise several substantive concerns.

1. Procedural Concerns

The decision to advance this measure through a fast-track procedure is deeply concerning. This process limits the opportunity for thorough stakeholder consultation and public comment. Regulations with medical, financial, and legal implications should be developed through a full and transparent rulemaking process to ensure that the voices of affected providers, healthcare professionals, and the public are adequately heard.

2. Financial and Logistical Burdens

The proposal does not appear to account for the economic impact on centers, particularly smaller or non-profit operations. The cost of purchasing and regularly replacing epinephrine auto-injectors—given their short shelf life—represents a recurring expense that many facilities are not equipped to absorb. Additionally, maintaining compliance would require administrative oversight, training, and proper storage conditions, all of which add to operational demands without corresponding financial support.

3. Training, Liability, and Legal Clarity

The proposed regulation also raises significant liability concerns. The act of administering epinephrine is inherently medical in nature and carries both legal and ethical responsibilities. Absent clear statutory immunity or comprehensive training requirements, staff members may be placed in untenable positions during emergencies. The regulation must include explicit guidance regarding training standards, documentation procedures, and legal protections for individuals acting in good faith.

4. Need for a Deliberative Process

Given these considerations, it would be prudent for the agency to withdraw or delay this proposal and instead pursue a more deliberative rulemaking process. Such an approach would allow for careful evaluation of costs, benefits, and implementation challenges, ensuring that any final regulation promotes safety without imposing undue hardship or risk on the institutions expected to comply.

In summary, while I support the underlying goal of improving emergency readiness, the proposed fast-track rule in its current form is premature and insufficiently developed. A more inclusive, data-driven, and transparent process would better serve both public safety and regulatory fairness.

Thank you for your consideration of these comments.