Notice2024-23091
Agency Information Collection Activities; Proposed eCollection eComments Requested; New Information Collection Request; Emergency Medical Services Recordkeeping and Notice Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2024
Issuing agencies
Justice Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 194 (Monday, October 7, 2024)</title>
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[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81110-81111]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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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