Overview
Title
Amending Regulations To Require Online Submission of Applications for and Renewals of DEA Registration
Agencies
ELI5 AI
The DEA wants people to apply for or renew their special permission to handle certain drugs, like medicine, using the internet instead of paper forms. They think doing this online will save time and money for everyone, but they haven't checked if everyone has internet to do this.
Summary AI
The Drug Enforcement Administration (DEA) is proposing a new rule to require that all applications and renewals for DEA registration be submitted online. This change will eliminate the current option to submit paper forms, making the process more efficient and cost-effective. The proposal is expected to save money for both the DEA and applicants by reducing errors and the need for corrections, while nearly all current applicants already use the internet for submissions. The rule change also aligns with federal efforts to streamline and modernize regulatory processes.
Abstract
This rule proposes to amend the Drug Enforcement Administration (DEA) regulations to require all initial and renewal applications for DEA registration to be submitted online.
Keywords AI
Sources
AnalysisAI
The document in question is a proposed rule by the Drug Enforcement Administration (DEA), published in the Federal Register, to amend existing regulations. It aims to make it mandatory for all initial and renewal applications for DEA registration to be submitted online, doing away with the option of submitting paper forms. This change is a part of a broader move toward modernizing processes and reducing costs associated with handling physical submissions.
General Summary
The proposed rule by the DEA is primarily concerned with streamlining the process for handling registrations related to controlled substances and chemical handling, by requiring electronic submissions only. This proposal highlights the current trend where the vast majority of applications are already being submitted online, representing over 99% of total submissions in the first quarter of 2020. The DEA argues that moving to an entirely electronic submission process will save costs, reduce errors, and align with federal goals to modernize and improve efficiency in governmental processes.
Significant Issues and Concerns
Several issues and potential concerns arise from the document:
Lack of Detailed Cost-Benefit Analysis: While the benefits of moving to electronic submissions are clear, there is a lack of detailed analysis on potential costs to those who are reliant on paper forms. Although the assumption is that there is broad internet access, the rule does not thoroughly explore the reasons some users may still prefer paper submissions.
Outreach and Preferences: The document does not show evidence of outreach to understand why a small percentage of users choose paper over online submissions. Without engaging this demographic, the decision to eliminate paper forms assumes technological readiness across the board.
Complex Language: The regulatory flexibility analysis is presented in a dense and complex manner, which may pose a challenge for individuals unfamiliar with technical jargon or regulatory processes.
Handling Confidential Information: While the proposal discusses how confidential business and personal information will be handled, there could be more clarity on the redaction process to ensure that the public understands how their sensitive information will be dealt with.
Internet Access Assumptions: The assumption that all applicants have access to the internet, despite preferring paper forms, is not backed by evidence. Some stakeholders may face barriers to technology access that are not addressed in this document.
Impact on the Public
The proposed change could broadly impact many people who interact with the DEA for registration purposes. For most, the impact would be negligible since they already use electronic submissions. However, for the minor percentage still reliant on paper forms, this change could create inconvenience or additional hurdles.
Impact on Specific Stakeholders
Applicants Currently Using Paper Forms: These individuals or entities might face challenges, especially if they lack reliable internet access or are uncomfortable with online processes.
The DEA and Federal Agencies: The move could lead to cost savings for the DEA due to reduced need for processing paper forms and correcting errors. It also supports a move toward fewer regulatory burdens and more streamlined government processes.
Small Businesses: Businesses that have relied on paper submissions might need to invest in ensuring they can meet the new online submission requirements, potentially increasing operational costs, though the DEA argues these will be offset by cost savings.
Overall, while the proposed rule aims to better align with technological advancements and government planning, stakeholders currently using paper forms may require more assistance and assurance of easy transition to electronic submissions to ensure that the benefits can be comprehensively realized.
Financial Assessment
The proposed rulemaking document outlines financial implications related to the amendment of DEA regulations requiring online submission for DEA registration applications. The document emphasizes anticipated cost savings and the economic impact of transitioning from paper to electronic submissions. Here's a detailed commentary focused on these financial aspects.
Cost Savings from Electronic Submissions
The document highlights a projected annual cost saving totaling $52,715. This amount is broken down into savings to applicants, estimated at $2,805, achieved through the elimination of expenses associated with printing paper forms and sending them via regular mail or courier services. Specifically, the savings of $0.63 per form comprises $0.55 for postage and $0.08 for an envelope.
The DEA itself anticipates savings of $49,910 due to reduced production costs associated with no longer needing to print and distribute paper forms. These production savings are derived from eliminating expenses related to materials, postage, and labor involved in handling paper forms. By transitioning to an online system, both applicants and the DEA benefit from increased efficiency and the reduction of processing errors, thus lowering costs.
Implications of Cost References
The DEA estimates suggest the financial advantages of electronic submissions outweigh the costs of maintaining the current dual system. However, there are associated issues. The document notes the modest extent of overall savings, which raises questions about whether these savings justify eliminating paper submissions entirely. Addressing the transition concerns of the estimated 0.7 percent of applicants still using paper forms could ensure an equitable shift to fully digital procedures.
Regulatory Cost Evaluations
Under Executive Orders 12866 and 13771, the DEA classifies this proposed rule as not a "significant regulatory action," indicating that it does not have a major financial impact on the economy—defined as an annual effect of $100 million or more. The anticipated savings allow the proposed rule to qualify as a deregulatory action under Executive Order 13771, reflecting an overall reduction in regulatory costs.
Communicating and Confirming Internet Access
The document assumes that all entities, even those currently using paper forms, have internet access. It references email addresses provided in paper application submissions as indicative of internet capability. However, the actual access levels among these entities are not explicitly confirmed, which could pose a risk if some applicants do not have reliable internet access. This assumption is crucial as the financial savings are predicated on universal access to online systems.
Overall, while the document adeptly outlines the expected financial savings, there are underlying assumptions and trade-offs, particularly regarding how the transition will impact current paper form users. Addressing these issues could further optimize the economic efficiency and inclusivity of the proposed changes.
Issues
• The document extensively discusses cost savings from moving to electronic submissions but does not quantify the potential costs for entities preferring paper submissions, which might still incur some expenses despite internet access.
• It is not clear if DEA conducted outreach to assess the preferences of current paper form users and why they opt for paper over electronic submissions.
• The explanation of the regulatory flexibility analysis could be simplified. The current language is dense and may be difficult for individuals without technical expertise to completely understand.
• Details on how the DEA will handle submissions with confidential business information and personal identifying information are given, but the process for public comments that require redaction may need further clarification to avoid ambiguity.
• The document assumes that all potential users, even those currently submitting paper forms, have internet access without confirming actual access levels among this subset.
• The document highlights only a modest annual cost saving that may not justify the complete elimination of paper submissions without more demonstrable benefits or detailed analysis of efficiency gains.
• Some passages, such as those explaining Executive Orders 13132 and 13175, use technical terms that might be hard for a layperson to understand without background knowledge on these topics.