[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81110-81111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23091]


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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: 60-Day notice.

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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: 
<a href="/cdn-cgi/l/email-protection#430706026d131102032726226d242c35"><span class="__cf_email__" data-cfemail="b0f4f5f19ee0e2f1f0d4d5d19ed7dfc6">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#69210c081d010c1b472c47280a010b080a01290d0c08470e061f"><span class="__cf_email__" data-cfemail="f1b9949085999483dfb4dfb0929993909299b1959490df969e87">[email protected]</span></a>.

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 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 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.

[[Page 81111]]

Overview of This information Collection

    1. Type of Information Collection: New information collection.
    2. The Title of the Form/Collection: Emergency Medical Services 
Recordkeeping and Notice Requirements.
    3. The agency form number, if any, and the applicable component of 
the Department 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 the obligation to respond: Affected Public: (Primary) Business 
or other for-profit.
    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 21,283 Registrants participate in this information collection. The 
time per response is 5 minutes.
    6. An estimate of the total annual burden (in hours) associated 
with the collection: DEA Estimates that this collection takes 92,226 
annual burden hours.
    7. An estimate of the total annual cost burden associated with the 
collection, if applicable: $0.

                                               Total Burden Hours
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                                     Number of                     Total annual      Time per      Total annual
            Activity                respondents      Frequency       responses       response     burden (hours)
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EMS Recordkeeping and Notice....          21,283              52       1,106,716           5 min          92,226
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    Unduplicated Totals.........          21,283  ..............       1,106,716  ..............          92,226
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    If additional information is required contact: Darwin Arceo, 
Department Clearance Officer, United States Department of Justice, 
Justice Management Division, Policy and Planning Staff, Two 
Constitution Square, 145 N Street NE, 4W-218, Washington, DC.

    Dated: October 2, 2024.
Darwin Arceo,
Department Clearance Officer for PRA, U.S. Department of Justice.
[FR Doc. 2024-23091 Filed 10-4-24; 8:45 am]
BILLING CODE 4410-09-P


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