FR 2025-05034

Summary of the Document

The document is a notice from the Drug Enforcement Administration (DEA), part of the Department of Justice, about the extension of a previously approved information collection effort. This initiative involves collecting data via DEA Forms 225, 225a, and 225b, which pertain to the registration of businesses and individuals who handle controlled substances. The registration process aims to ensure compliance with the Controlled Substances Act, maintain oversight, and prevent the diversion of these substances. The DEA is inviting public comments on the necessity and efficiency of this collection process. The comment period is open until May 27, 2025.

Significant Issues or Concerns

There are several areas within the document that might present challenges or require further clarification. First, while the document states that the total annual cost burden associated with this data collection is $0, it does not offer a detailed explanation for this lack of cost, which might confuse stakeholders. Additionally, the document employs technical language that might be complex for the general public, particularly around the evaluation of the information's accuracy and minimizing the burden on those responding. Clarifying these points in simpler language could enhance understanding and accessibility.

Another area of potential concern is the contact information provided for further inquiries, which includes two different email addresses without clear guidelines on which address to use for specific types of questions. This could lead to confusion among those seeking additional information. Furthermore, the document identifies different categories of affected public, such as "Business or other for-profit" and "Not-for-Profit institutions," but could further explain their roles and responsibilities within this information collection framework.

Impact on the Public

Broadly, the document's proposed extension of information collection could impact various stakeholders, especially those involved in the handling of controlled substances. By soliciting public comments, the DEA seeks to ensure that the process remains efficient and not unduly burdensome, reflecting public needs and considerations in the registration process. For the general public, maintaining a robust registration system helps safeguard against the misuse of controlled substances, which is vital for public safety.

Impact on Specific Stakeholders

For businesses, especially those for-profit entities dealing with pharmaceutical manufacturing and distribution, compliance with DEA registration requirements is crucial. This notice, by seeking public engagement, could offer these stakeholders an opportunity to influence how the registration process is structured and possibly streamline their obligations. Not-for-profit organizations, along with governmental entities, might have different interactions with the registration process, with each group assessing how the data collection drives compliance or impacts operational efficiency.

By participating in the comment process, various stakeholders can help shape a system that balances regulatory oversight with operational practicality, ensuring that those handling controlled substances do so within a framework that preserves public safety and minimizes administrative burdens.

The document in question primarily revolves around a proposed information collection by the Drug Enforcement Administration (DEA), specifically focusing on the applications and renewals related to handling controlled substances. Notably, there is a particular reference to the financial implications associated with this process.

Summary of Financial References

Within the document, it is stated that “An estimate of the total annual cost burden associated with the collection, if applicable: $0.” This indicates that, according to the DEA, there are no direct financial costs imposed on the registrants participating in this information collection process.

Analysis of Financial Implications

Given that the annual cost burden is estimated at $0, it suggests that the DEA does not anticipate any direct expenses for the entities involved in filling out the necessary forms, such as DEA Forms 225, 225a, and 225b. This absence of expenses could imply that the processes involved in these forms, such as application submission and data management by the DEA, are designed to be cost-free for the businesses and individuals required to comply.

Relation to Identified Issues

One of the issues highlighted in the document is the lack of detailed explanation regarding why there is no cost associated with this collection. This could lead to confusion or skepticism among the respondents as it might not align with their expectations or experiences regarding typical bureaucratic processes, which often include some form of administrative cost or fee.

Furthermore, while the financial cost is noted as $0, there remains the non-financial burden of time required for completion. For instance, completing the forms requires varying amounts of time, from 10 minutes for a renewal (DEA Form 225a) to 1 hour for a chain renewal (DEA Form 225b). Although no financial expenditure is reported, these time estimations suggest a significant investment of effort and resources, which may indirectly translate into a financial consideration for businesses relying on productivity and operational efficiency.

In summary, while the document states no financial cost burden, a more detailed explanation of what offsets potential administrative costs or how the process remains financially neutral would benefit the stakeholders involved. This transparency could lead to a better understanding and smoother compliance with DEA regulations by the affected parties.