Notice2024-29121
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
December 12, 2024
Issuing agencies
Justice Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 239 (Thursday, December 12, 2024)</title>
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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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<a href="/cdn-cgi/l/email-protection#420607036c121003022627236c252d34"><span class="__cf_email__" data-cfemail="3b7f7e7a156b697a7b5f5e5a155c544d">[email protected]</span></a> or <a href="/cdn-cgi/l/email-protection#0c44696d7864697e2249224d6f646e6d6f644c68696d226b637a"><span class="__cf_email__" data-cfemail="01496460756964732f442f40626963606269416564602f666e77">[email protected]</span></a>.
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 <a href="http://www.reginfo.gov/public/do/">www.reginfo.gov/public/do/</a>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 <a href="http://www.reginfo.gov">www.reginfo.gov</a>. 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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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.