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[Federal Register Volume 89, Number 239 (Thursday, December 12, 2024)]
[Notices]
[Pages 100537-100538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-29121]

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DEPARTMENT OF JUSTICE

[OMB Number 1117-0060]

Agency Information Collection Activities; Proposed eCollection 
eComments Requested; New Information Collection Request; Emergency 
Medical Services Recordkeeping and Notice Requirements

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: 30-Day notice.

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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: 
[email protected] or [email protected].

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

[[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
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