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###### Department of Justice

          - [OMB Number 1117-0060]

# AGENCY:

Drug Enforcement Administration, Department of Justice.

# ACTION:

30-Day notice.

# SUMMARY:

The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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 30 days until January 13, 2025.

# FOR FURTHER INFORMATION CONTACT:

                        If you have 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:

                    This proposed information collection was previously published in the                     **Federal Register**                     on October 7, 2024, at 89 FR 81110, allowing for a 60-day comment period.                

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 agency, 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;

—Enhance the quality, utility, and clarity of the information to be collected; and/or

                    —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.                

                    Written comments and recommendations for this information collection should be submitted within 30 days of the publication of this notice on the following website                     *www.reginfo.gov/​public/​do/​*                    PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function and entering either the title of the information collection or the OMB Control Number 1117-0060. This information collection request may be viewed at                     *www.reginfo.gov.*                     Follow the instructions to view Department of Justice, information collections currently under review by OMB.                

DOJ seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOJ notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.

## Overview of This Information Collection

                    1.                     *Type of Information Collection:*                     New Information Collection.                

                    2.                     *Title of the Form/Collection:*                     Emergency Medical Services Recordkeeping and Notice Requirements.                

                    3.                     *Agency form number, if any, and the applicable component of the Department of Justice sponsoring the collection:*                     No form number is associated with this collection. 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 a brief abstract:*                     Affected public (Primary): Business or other for-profit.                

*Affected public (Other):*                     Not-for-profit institutions; Federal, State, Local, and tribal governments.                

*Abstract:*                     The Controlled Substances Act (CSA) (21 U.S.C. 801-971) requires all persons who handle controlled substances to obtain a registration from the Attorney General. 21 U.S.C. 822, 823, 831, 957, and 958. The “Protecting Patient Access to Emergency Medications Act of 2017,” (hereafter the “Act”) which became law on November 17, 2017, amended the Controlled Substances Act to allow for a new registration category for emergency medical services agencies that handle controlled substances. It also established standards for registering emergency medical services agencies, and set forth new requirements for delivery, storage, and recordkeeping related to their handling of controlled substances.                

With this proposed collection, DEA is proposing recordkeeping regulations for EMS agencies to incorporate the Act's CSA amendments regarding recordkeeping, and to ensure an accurate accounting of the controlled substances outside the two-registrant integrity system.

                    The Act require EMS agencies to maintain records of the EMS personnel whose State license or certification gives them the ability to administer controlled substances, in compliance with their State laws. Under 21 U.S.C 827(b), controlled substance records for all DEA registrants are required to be maintained for at least two years from the date of such inventory or records. Following the Act, 21 U.S.C. 823(k)(9)(B)(ii), DEA would require that records be maintained, whether electronically or otherwise, at each registered and                           ( print page 100538)                        designated location of the agency where the controlled substances involved are received, administered, or otherwise disposed of.                

                    Consistent with the Act's amendments to the CSA, 21 U.S.C. 823(k)(9), DEA would require an EMS agency to maintain records for each controlled substance administered or disposed of in the course of providing emergency medical services. In addition, any EMS personnel who disposes of or administers controlled substances to a patient in the course of providing emergency medical care would have to record the name of the controlled substance(s) and detailed information about the circumstances surrounding the administration of the controlled substance(s) (                    *e.g.,*                     name of the substance, date dispensed, identification of the patient).                

Additionally, in accordance with 21 U.S.C 821(k)(9)(b), that an EMS agency must maintain records of controlled substances delivered between registered and designated locations of the agency (except agencies restocking at the hospital under which the EMS agency is operating, because the hospital is required to keep records of such restocking). These records, for example, should include the name of the controlled substance(s), finished form, number of units in the commercial container, date delivered, and the address of the EMS agency location where the controlled substances were delivered.

                    5.                     *Obligation to Respond:*                     Voluntary.                

                    6.                     *Total Estimated Number of Respondents:*                     21,283.                

                    7.                     *Estimated Time per Respondent:*                     5 minutes.                

                    8.                     *Frequency:*                     52 per year.                

                    9.                     *Total Estimated Annual Time Burden:*                     92,226 hours.                

                    10.                     *Total Estimated Annual Other Costs Burden:*                     $0.                

If additional information is required, contact: Darwin Arceo, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Two Constitution Square, 145 N Street NE, 4W-218 Washington, DC 20530.

Dated: December 6, 2024.

Darwin Arceo,

Department Clearance Officer for PRA, U.S. Department of Justice. 

[FR Doc. 2024-29121 Filed 12-11-24; 8:45 am]

BILLING CODE 4410-09-P