Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; Application for Registration and Application for Registration Renewal; DEA Forms 224, 224A, 81109-81110 [2024-23027]

Download as PDF Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices U.S.C. appendix 3; or (ii) by U.S. Government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3 This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission’s Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)). By order of the Commission. Issued: October 1, 2024. Lisa Barton, Secretary to the Commission. [FR Doc. 2024–23039 Filed 10–4–24; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE [OMB Number 1117–0014] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Previously Approved Collection; Application for Registration and Application for Registration Renewal; DEA Forms 224, 224A Drug Enforcement Administration, Department of Justice. ACTION: 60-Day notice. AGENCY: 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 lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: 2 All contract personnel will sign appropriate nondisclosure agreements. 3 Electronic Document Information System (EDIS): https://edis.usitc.gov. VerDate Sep<11>2014 17:11 Oct 04, 2024 Jkt 262001 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: 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 that manufacture, distribute, dispense, conduct research with, import, or export any controlled substance to obtain a registration issued by the Attorney General. DEA would be revising the proposed information collection instruments as statutorily mandated by the Protecting Patient Access to Emergency Medications Act of 2017. DEA would be creating a new business activity and adding it to forms DEA–224 and DEA–224A to allow Emergency Medical Services agencies to register as such, if authorized by state law. This new business activity would allow EMS agencies to obtain a DEA registration that will permit EMS agencies to deliver controlled substances to their designated locations without obtaining a separate registration as a Distributor. This registration would allow EMS personnel to administer PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 81109 controlled substances outside the physical presence of a medical director or authorizing medical professional in the course of providing emergency medical services. Upon issuance of an EMS agency registration, the EMS agency should use the online system to identify all of the locations it intends to designate under the EMS agencies’ DEA registration. This proposed collection would also allow EMS agencies to choose the option of a single registration in each state where the EMS agency operates. If the agency operates EMS facilities in multiple states, the agency must have a separate registration in each state where the agency operates. Overview of This Information Collection 1. Type of Information Collection: Revision of a currently approved collection. 2. The Title of the Form/Collection: Application for Registration and Application for Registration Renewal. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: DEA Forms: 224, 224A. 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. Affected public (Other): Not-for-profit institutions; Federal, State, local, and tribal governments. 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 146,285 registrants participate in this information collection for DEA Form 224, and 524,196 registrants for DEA form 224A. The time per response is 20 minutes for DEA Form 224, and 10 minutes for DEA Form 224A. 6. An estimate of the total annual burden (in hours) associated with the collection: DEA estimates that this collection takes 48,762 annual burden hours for DEA Form 224 and 87,366 annual burden hours for DEA Form 224A. 7. An estimate of the total annual cost burden associated with the collection, if applicable: $0. E:\FR\FM\07OCN1.SGM 07OCN1 81110 Federal Register / Vol. 89, No. 194 / Monday, October 7, 2024 / Notices TOTAL BURDEN HOURS Number of respondents Activity Time per response (hours) Total annual burden (hours) DEA—224 ....................................................... DEA—224A ..................................................... 146,285 524,196 ........................ ........................ 0.33 hours (20 minutes) ................................. 0.17 hours (10 minutes) ................................. 48,762 87,366 Unduplicated Totals ................................. 670,481 ........................ ......................................................................... 136,366 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 20530. Dated: October 1, 2024. Darwin Arceo, Department Clearance Officer for PRA, U.S. Department of Justice. [FR Doc. 2024–23027 Filed 10–4–24; 8:45 am] BILLING CODE 4410–09–P 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 Drug Enforcement Administration, Department of Justice. ACTION: 60-Day notice. AGENCY: 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: DEA.PRA@ dea.gov or Heather.E.Achbach@dea.gov. SUMMARY: lotter on DSK11XQN23PROD with NOTICES1 Total annual responses VerDate Sep<11>2014 17:11 Oct 04, 2024 Jkt 262001 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 SUPPLEMENTARY INFORMATION: PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 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. E:\FR\FM\07OCN1.SGM 07OCN1

Agencies

[Federal Register Volume 89, Number 194 (Monday, October 7, 2024)]
[Notices]
[Pages 81109-81110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23027]


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DEPARTMENT OF JUSTICE

[OMB Number 1117-0014]


Agency Information Collection Activities; Proposed eCollection 
eComments Requested; Revision of a Previously Approved Collection; 
Application for Registration and Application for Registration Renewal; 
DEA Forms 224, 224A

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: 60-Day notice.

-----------------------------------------------------------------------

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: 
[email protected] or [email protected].

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 that manufacture, distribute, dispense, conduct 
research with, import, or export any controlled substance to obtain a 
registration issued by the Attorney General. DEA would be revising the 
proposed information collection instruments as statutorily mandated by 
the Protecting Patient Access to Emergency Medications Act of 2017. DEA 
would be creating a new business activity and adding it to forms DEA-
224 and DEA-224A to allow Emergency Medical Services agencies to 
register as such, if authorized by state law. This new business 
activity would allow EMS agencies to obtain a DEA registration that 
will permit EMS agencies to deliver controlled substances to their 
designated locations without obtaining a separate registration as a 
Distributor. This registration would allow EMS personnel to administer 
controlled substances outside the physical presence of a medical 
director or authorizing medical professional in the course of providing 
emergency medical services. Upon issuance of an EMS agency 
registration, the EMS agency should use the online system to identify 
all of the locations it intends to designate under the EMS agencies' 
DEA registration. This proposed collection would also allow EMS 
agencies to choose the option of a single registration in each state 
where the EMS agency operates. If the agency operates EMS facilities in 
multiple states, the agency must have a separate registration in each 
state where the agency operates.

Overview of This Information Collection

    1. Type of Information Collection: Revision of a currently approved 
collection.
    2. The Title of the Form/Collection: Application for Registration 
and Application for Registration Renewal.
    3. The agency form number, if any, and the applicable component of 
the Department sponsoring the collection: DEA Forms: 224, 224A. 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.
    Affected public (Other): Not-for-profit institutions; Federal, 
State, local, and tribal governments.
    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 146,285 registrants participate in this information collection for 
DEA Form 224, and 524,196 registrants for DEA form 224A. The time per 
response is 20 minutes for DEA Form 224, and 10 minutes for DEA Form 
224A.
    6. An estimate of the total annual burden (in hours) associated 
with the collection: DEA estimates that this collection takes 48,762 
annual burden hours for DEA Form 224 and 87,366 annual burden hours for 
DEA Form 224A.
    7. An estimate of the total annual cost burden associated with the 
collection, if applicable: $0.

[[Page 81110]]



                                               Total Burden Hours
----------------------------------------------------------------------------------------------------------------
                                           Number of     Total annual       Time per response      Total annual
               Activity                   respondents      responses             (hours)          burden (hours)
----------------------------------------------------------------------------------------------------------------
DEA--224..............................         146,285  ..............  0.33 hours (20 minutes).          48,762
DEA--224A.............................         524,196  ..............  0.17 hours (10 minutes).          87,366
                                       -------------------------------------------------------------------------
    Unduplicated Totals...............         670,481  ..............  ........................         136,366
----------------------------------------------------------------------------------------------------------------

    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 20530.

    Dated: October 1, 2024.
Darwin Arceo,
Department Clearance Officer for PRA, U.S. Department of Justice.
[FR Doc. 2024-23027 Filed 10-4-24; 8:45 am]
BILLING CODE 4410-09-P


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