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AGENCY:
Drug Enforcement Administration, Department of Justice.
ACTION:
60-Day notice.
SUMMARY:
The Drug Enforcement Administration (DEA), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
DATES:
Comments are encouraged and will be accepted for 60 days until December 6, 2024.
FOR FURTHER INFORMATION CONTACT:
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Heather E. Achbach, Regulatory Drafting and Policy Support Section, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 776-3882; Email: DEA.PRA@dea.gov or Heather.E.Achbach@dea.gov.
SUPPLEMENTARY INFORMATION:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility;
—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and
—Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Abstract: The Controlled Substances Act (CSA) (21 U.S.C. 801-971) requires all persons that manufacture, distribute, dispense, conduct research with, import, or export any controlled substance to obtain a registration issued by the Attorney General. DEA would be revising the proposed information collection instruments as statutorily mandated by the Protecting Patient Access to Emergency Medications Act of 2017. DEA would be creating a new business activity and adding it to forms DEA-224 and DEA-224A to allow Emergency Medical Services agencies to register as such, if authorized by state law. This new business activity would allow EMS agencies to obtain a DEA registration that will permit EMS agencies to deliver controlled substances to their designated locations without obtaining a separate registration as a Distributor. This registration would allow EMS personnel to administer controlled substances outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services. Upon issuance of an EMS agency registration, the EMS agency should use the online system to identify all of the locations it intends to designate under the EMS agencies' DEA registration. This proposed collection would also allow EMS agencies to choose the option of a single registration in each state where the EMS agency operates. If the agency operates EMS facilities in multiple states, the agency must have a separate registration in each state where the agency operates.
Overview of This Information Collection
1. Type of Information Collection: Revision of a currently approved collection.
2. The Title of the Form/Collection: Application for Registration and Application for Registration Renewal.
3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: DEA Forms: 224, 224A. The applicable component within the Department of Justice is the Drug Enforcement Administration, Diversion Control Division.
4. Affected public who will be asked or required to respond, as well as the obligation to respond: Affected Public: (Primary) Business or other for-profit.
Affected public (Other): Not-for-profit institutions; Federal, State, local, and tribal governments.
5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The DEA estimates that 146,285 registrants participate in this information collection for DEA Form 224, and 524,196 registrants for DEA form 224A. The time per response is 20 minutes for DEA Form 224, and 10 minutes for DEA Form 224A.
6. An estimate of the total annual burden (in hours) associated with the collection: DEA estimates that this collection takes 48,762 annual burden hours for DEA Form 224 and 87,366 annual burden hours for DEA Form 224A.
7. An estimate of the total annual cost burden associated with the collection, if applicable: $0.
Total Burden Hours
| Activity | Number of respondents | Total annual responses | Time per response (hours) | Total annual burden (hours) |
|---|---|---|---|---|
| DEA—224 | 146,285 | 0.33 hours (20 minutes) | 48,762 | |
| DEA—224A | 524,196 | 0.17 hours (10 minutes) | 87,366 | |
| Unduplicated Totals | 670,481 | 136,366 |