FR 2024-29122

The document under review is a call for public feedback from the Department of Justice's Drug Enforcement Administration (DEA) regarding a proposed update to their registration process. This update primarily concerns the inclusion of emergency medical services (EMS) agencies in the handling of controlled substances under the Controlled Substances Act. To this end, the DEA seeks to amend existing forms (DEA Forms 224 and 224A) to enable EMS agencies to register and manage such substances legally and efficiently.

General Summary

The DEA intends to revise their current data collection methods to better accommodate EMS agencies. These changes are prompted by legal requirements under the Protecting Patient Access to Emergency Medications Act of 2017. The update aims to simplify the process for EMS agencies to obtain and use controlled substances in emergencies, in compliance with state laws. The public comment period, open for 30 days, invites opinions on the necessity and practicality of these changes, as well as their impact on the affected parties.

Significant Issues and Concerns

Several notable issues surface upon examination of the document:

1. Lack of Detail on Costs: The document states a "Total Estimated Annual Other Costs Burden" of $0, potentially overlooking indirect or unforeseen expenses that might be relevant to EMS agencies or other stakeholders.

2. Complex Language: The language used is heavily bureaucratic and filled with legal jargon, which might be inaccessible to individuals without a background in law or government procedures. This complexity could deter meaningful public participation or misunderstanding of the proposal's implications.

3. Methodology Transparency: There is no detailed explanation of how the "Estimated Time per Respondent" was calculated. Clarifying this would assist in assessing the accuracy and feasibility of the proposed changes.

4. Undefined Changes: While the document references the Protecting Patient Access to Emergency Medications Act of 2017, it fails to delineate how exactly this impacts the current process versus the proposed updates. This omission might leave stakeholders uncertain about new requirements.

Public Impact

Broadly, this document and its proposed revisions could significantly affect various segments of the population. For general citizens, particularly those reliant on EMS services, these changes could ensure more effective and timely access to emergency medical drugs when needed, enhancing public health outcomes.

Impact on Specific Stakeholders

Emergency Medical Services (EMS) Agencies:
The proposal allows EMS agencies to streamline their operations regarding controlled substances. By registering as a singular entity per state, they may reduce administrative burdens and permit EMS personnel greater autonomy when delivering necessary medications during emergencies.

Businesses and Non-profits:
Entities involved in controlled substance operations could experience changes in their registration processes, affecting administrative responsibilities and potentially operational costs if details on indirect spending are not fully anticipated.

Governmental Agencies:
Entities at various governmental levels, from federal to tribal, may need to adjust their oversight and processing structures to align with the revised DEA forms and protocols, potentially impacting resources and staffing.

In summary, while the DEA's initiative to revise data collection forms is a step towards accommodating EMS agencies better, clarity, simplicity, and comprehensive cost evaluation are areas needing attention. Solidity in these areas will ensure that the changes are both beneficial and practical for the involved stakeholders.

The document from the Federal Register primarily addresses revisions in the application process for registration related to the handling of controlled substances by entities. While financial allocations or specific spending amounts are not the document's focus, there is a mention of "$0" regarding the "Total Estimated Annual Other Costs Burden."

Financial Summary

The document specifies that the Total Estimated Annual Other Costs Burden is $0. This suggests that the proposed changes to the registration process, including revisions to the DEA Forms 224 and 224A, do not anticipate incurring any additional costs beyond those already accounted for within existing structures or budgets. The lack of financial burden implies that the changes are streamlined into current operating procedures without necessitating new funding.

Relevant Issues and Considerations

One of the identified issues is the lack of detail regarding any associated costs. The document notes "$0" for additional cost burdens but does not provide a detailed breakdown, leaving room for speculation on whether unexpected or indirect costs might arise. This omission could be significant for parties attempting to evaluate the financial implications of complying with the new registration requirements.

The use of technical and bureaucratic language throughout the document could hinder understanding, particularly in relation to the financial reference to "$0". Simplifying this language might help businesses and other entities better assess how the changes could affect them financially.

Moreover, while the document estimates the time burden on respondents, it lacks an explicit explanation of how these time evaluations were calculated and whether they factor into the cost assessment. Understanding these calculations could further illuminate whether the "$0" estimate accurately captures the true cost of compliance.

In summary, the document's financial reference lacks granularity, which may leave affected parties uncertain about potential unknown costs. Clarifying these aspects and simplifying the language could aid in better understanding the financial impact of the proposed information collection changes.