[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Proposed Rules]
[Pages 62634-62651]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21675]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1306, and 1307

[Docket No. DEA-377]
RIN 1117-AB37


Registering Emergency Medical Services Agencies Under the 
Protecting Patient Access to Emergency Medications Act of 2017

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: 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. In addition, the Act allows 
emergency medical services professionals to administer controlled 
substances outside the physical

[[Page 62635]]

presence of a medical director or authorizing medical professional 
pursuant to a valid standing or verbal order. The Drug Enforcement 
Administration proposes to amend its regulations to make them 
consistent with the Act and to otherwise implement its requirements.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before December 4, 2020. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Management 
and Budget (OMB) on or before December 4, 2020.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-377'' on all correspondence, including any 
attachments.
     Electronic Comments: DEA encourages that all comments be 
submitted electronically through the Federal eRulemaking Portal, which 
provides the ability to type short comments directly into the comment 
field on the web page or attach a file for lengthier comments. Please 
go to http://www.regulations.gov and follow the online instructions at 
that site for submitting comments. Upon completion of your submission, 
you will receive a Comment Tracking Number for your comment. Please be 
aware that submitted comments are not instantaneously available for 
public view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted and there is no 
need to resubmit the same comment. Commenters should be aware that the 
electronic Federal Docket Management System will not accept any 
comments after 11:59 p.m. Eastern Time on the last day of the comment 
period.
     Paper Comments: Paper comments that duplicate electronic 
submissions are not necessary. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attn: DEA Federal 
Register Representative/DPW, 8701 Morrissette Drive, Springfield, 
Virginia 22152-2639.
     Paperwork Reduction Act Comments: All comments concerning 
collections of information under the Paperwork Reduction Act must be 
submitted to the Office of Information and Regulatory Affairs, Office 
of Management and Budget, Attention: Desk Officer for DOJ, Washington, 
DC 20503. Please state that your comment refers to RIN 1117-AB37/Docket 
No. DEA-377.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section (DPW), Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA or ``the Administration'') for public inspection 
online at http://www.regulations.gov. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter. The Freedom of Information Act 
applies to all comments received. If you want to submit personal 
identifying information (such as your name, address, etc.) as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place all of the 
personal identifying information you do not want made publicly 
available in the first paragraph of your comment and identify what 
information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at http://www.regulations.gov for easy 
reference.

Outline

I. Background and Purpose
    A. Legal Authority
    B. Purpose
    C. Background
    D. Summary of the Act and Changes to the CSA
II. Summary of Proposed Changes
    A. Definitions
    B. Registration for Emergency Medical Services Agency
    1. Current Regulations for Emergency Medical Services 
Registration
    2. Proposed Regulations for Emergency Medical Services 
Registration
    C. Designated Locations of an Emergency Medical Services Agency
    D. Emergency Medical Services Vehicles
    E. Proposed Recordkeeping Requirements
    1. Records and Inventories
    a. Restocking
    b. Maintenance of Records
    F. Proposed Security Requirements
    1. Security Controls
    a. Storage of Controlled Substances
    b. Delivery
    G. Proposed Administration Requirements
    1. Standing Orders
    2. Verbal Order
III. Regulatory Analyses

I. Background and Purpose

A. Legal Authority

    On November 17, 2017, the ``Protecting Patient Access to Emergency 
Medications Act of 2017,'' Public Law 115-83 (131 Stat. 1267) (``the 
Act''), became law.
    The Act amended a section of the CSA, 21 U.S.C. 823, by adding a 
new subsection, 21 U.S.C. 823(j). This new subsection alters a number 
of CSA requirements ``[f]or the purpose of enabling emergency medical 
services professionals to administer controlled substances in schedule 
II, III, IV, or V to ultimate users receiving emergency medical 
services.'' 21 U.S.C. 823(j)(1). The Act also specifically authorizes 
the Attorney General (and thus the Administrator of DEA by delegation) 
to issue certain regulations to implement the Act. Id. 823(j)(11).

B. Purpose

    The purposes of this proposed rule are twofold. First, this 
proposed rule is to codify in DEA regulations the statutory amendments 
made by the Act. Such proposed changes are merely conforming DEA's 
implementing regulations to statutory amendments of the CSA that have 
already taken effect. Second, this proposed rule amends DEA

[[Page 62636]]

regulations in some ways that do not directly codify the Act's 
amendments. These limited changes are authorized by the CSA, as amended 
by the Act, and seek to implement the Act and effectuate its purposes.

C. Background

    When an individual experiences a medical emergency, his or her 
entry into the healthcare system may not start with the care of a 
physician within a traditional clinical setting, but instead with the 
intervention of emergency medical services (EMS) personnel affiliated 
with a local EMS agency at the incident site. EMS personnel, who 
provide emergency medical services by ground, air, or otherwise, 
respond to 37 million calls annually.\1\ EMS involves the evaluation 
and management of patients with acute traumatic and medical conditions 
in a prehospital environment,\2\ and is an important component of 
medical care, as early medical intervention saves lives and often 
reduces the severity of injury.\3\ The nature of medical intervention 
at the incident site and during transport to the hospital can vary 
widely depending on the severity and type of injury or impairment, and 
may include the administering of controlled substances.\4\
---------------------------------------------------------------------------

    \1\ National EMS Assessment, 2011. The National EMS Assessment, 
led by researchers at the University of North Carolina at Chapel 
Hill, incorporated data from the National Association of State EMS 
Officials 2011 EMS Industry Snapshot: Emergency Medical Services for 
Children Program 2010-2011 report, the 2007 Indian Health Services 
Tribal EMS Pediatric Assessment, and the National EMS Database.
    \2\ FICEMS 2011 National EMS Assessment.
    \3\ Kuehl, Alexander. ``25.'' Prehospital Systems and Medical 
Oversight. Dubuque, IA: Kendall/Hunt Pub., 2002. (``For most 
prehospital medical conditions, patient outcome is assumed to be 
beneficially influenced by early medical intervention, and 
contemporary prehospital care systems are a well-defined practice of 
medicine in the United States.'').
    \4\ A non-exhaustive list of common controlled substance 
pharmaceuticals utilized by EMS include the benzodiazepine class of 
drugs for seizures and sedation as well as morphine (schedule II), 
fentanyl (schedule II), and meperidine (schedule II) for pain 
management.
---------------------------------------------------------------------------

    The delivery of emergency medical care is primarily a local 
function; and, accordingly, a wide variety of organizational structures 
are utilized across the nation. EMS programs may be a part of the local 
municipal government, hospital, or independent government agency, or 
may be contracted by local government with a private entity. Each state 
has a State EMS licensing office that is responsible for the overall 
planning, coordination, and regulation of the State EMS system, as well 
as licensing or certifying EMS providers and ambulances.\5\ These 
agencies are often located within the State health department, but may 
also be found as part of the public safety department or as independent 
agencies.\6\
---------------------------------------------------------------------------

    \5\ http://www.ems.gov.
    \6\ Id.
---------------------------------------------------------------------------

D. Summary of the Act and Changes to the CSA

    The Act established uniform EMS agency requirements for the 
administration of controlled substances while ensuring adequate 
safeguards against theft and diversion. The Act added a new subsection 
to the CSA, 21 U.S.C. 823(j), and in the process redesignated the 
previous subsection (j) as subsection (k). The new 21 U.S.C. 823(j) 
makes a number of notable changes to the CSA. The Act makes five key 
changes.
    First, the Act creates a new registration category under the CSA 
for EMS agencies, directing the Attorney General (and thus the 
Administrator of DEA by delegation) to register such an agency under 
the CSA if the agency submits an application demonstrating that it is 
authorized to conduct emergency medical services under the laws of each 
State in which the agency practices. 21 U.S.C. 823(j)(1)(A). Pursuant 
to 21 U.S.C. 823(j)(1)(B), the Act authorizes the Attorney General to 
deny the application of an EMS agency if registering it would be 
inconsistent with other requirements of 21 U.S.C. 823(j) or with the 
public interest based on the factors of 21 U.S.C. 823(f).
    Second, the Act directs the Attorney General (and thus the 
Administrator) to allow a registered EMS agency to obtain a single 
registration for each State in which the agency administers controlled 
substances, rather than requiring the agency to obtain a separate 
registration for each location at which it operates within that State. 
21 U.S.C. 823(j)(2). The Act also provides that a hospital-based 
emergency medical services agency registered under 21 U.S.C. 823(f) may 
use the registration of the hospital to administer controlled 
substances under 21 U.S.C. 823(j), without requiring the agency to 
acquire a separate registration. 21 U.S.C. 823(j)(3).
    Third, subject to certain restrictions, the Act authorizes EMS 
professionals of a registered EMS agency to administer controlled 
substances in schedule II, III, IV, or V outside the physical presence 
of a medical director or authorizing medical professional in the course 
of providing emergency medical services. 21 U.S.C. 823(j)(4). EMS 
professionals are only allowed to make such administrations if 
authorized by State law and pursuant to standing or verbal orders that 
satisfy a number of statutory conditions. Id.
    Fourth, the Act provides a variety of requirements for how 
registered EMS agencies must deliver controlled substances from 
registered to unregistered locations, store controlled substances, 
restock EMS vehicles at a hospital, maintain records, and otherwise 
conduct their operations. 21 U.S.C. 823(j)(5)-(10).
    Fifth, the Act specifically authorizes the Attorney General (and 
thus the Administrator) to issue regulations regarding the delivery and 
storage of controlled substances by EMS agencies. Id. 823(j)(11).

II. Summary of Proposed Changes

    The Act amended the CSA to add regulatory provisions pertaining to 
the handling of controlled substances by EMS professionals, and the 
majority of this proposed rule merely reiterates those statutory 
requirements. The portion of this proposed rule that goes beyond those 
statutory requirements includes proposed changes to the registration, 
security, recordkeeping, inventory, and administering requirements for 
EMS agencies, which are discussed below.
    Consistent with the Act, DEA is proposing regulations to explicitly 
include EMS agencies handling controlled substances as registrants 
under the CSA,\7\ and to delineate the security, and recordkeeping 
requirements for EMS registrants who store, transport, and administer 
controlled substances. DEA is also proposing regulations that would 
codify, in DEA regulations, the Act's provisions that allow EMS 
personnel to administer controlled substances in schedules II-V outside 
of the physical presence of a medical director or authorizing medical 
professional in the course of providing emergency medical services if 
authorized in the State in which the medical service occurs and 
pursuant to a standing order or verbal order.\8\ In addition, DEA is 
proposing

[[Page 62637]]

regulations that codify the Act's amendments allowing EMS agencies to 
receive controlled substances from hospitals for the purpose of 
restocking EMS vehicles, and allowing EMS agencies and hospitals to 
deliver controlled substances to each other in the event of shortages 
of such substances, public health emergencies, or mass casualty events.
---------------------------------------------------------------------------

    \7\ Consistent with 21 U.S.C. 823(j)(3), DEA is proposing 
regulations that would continue to allow an EMS agency based in a 
hospital that is registered under Sec.  1301.13 to use the 
hospital's registration to administer controlled substances, without 
being separately registered as an EMS agency.
    \8\ 21 U.S.C. 823(j)(13)(M) defines standing order as a written 
medical protocol in which a medical director determines in advance 
the medical criteria that must be met before administering 
controlled substances to individuals in need of emergency medical 
services. 21 U.S.C. 823(j)(13)(N) defines verbal order as an oral 
directive that is given through any method of communication 
including by radio or telephone, directly to an emergency medical 
services professional, to contemporaneously administer a controlled 
substance to individuals in need of emergency medical services 
outside the physical presence of the medical director or authorizing 
medical professional.
---------------------------------------------------------------------------

    In this manner, DEA will bring its regulations into conformity with 
the Act's amendments to the CSA. In particular, DEA's proposed 21 CFR 
1300.06 would add 21 U.S.C. 823(j)(13)'s new definitions of relevant 
terms to DEA regulations. Section 1301.12 would be amended to reflect 
the statutory amendments of 823(j)(2) and 823(j)(5), and Sec.  1301.13 
would be amended to bring it into conformity with 823(j)(1). Proposed 
Sec.  1301.20(a) is adapted directly from the statutory amendment, 
specifically from 823(j)(1)-(3). The proposed provisions of Sec.  
1301.80(a) would add provisions from 823(j)(6). Proposed Sec.  
1304.03(j) is taken from 823(j)(9)(A). Proposed Sec.  1306.07(e) would 
add the provisions of 823(j)(4) and 823(j)(10)(D) to DEA regulations, 
while proposed Sec.  1307.14 would add those of 823(j)(8).
    Not all of the proposed amendments to DEA regulations, however, 
directly codify the Act's statutory amendments in DEA regulations. Some 
of the proposed changes--specifically, Sec. Sec.  1301.20(b), 
1301.80(b), 1304.03(i), 1304.04, 1304.27, 1306.07(f), and 1307.15--
implement the purposes of the Act more broadly, consistent with the 
Administrator's authority to promulgate regulations under 21 U.S.C. 
821, 21 U.S.C. 823(j)(11), and 21 U.S.C. 871(b).

A. Definitions

    The Act contains a provision, 21 U.S.C. 823(j)(13), defining the 
terms used throughout its other provisions. In order to conform to the 
Act, DEA is proposing to add these new definitions to its regulations 
as part of a new section, 21 CFR 1300.06. This includes defining the 
terms ``authorizing medical professional,'' ``designated location,'' 
``emergency medical services,'' ``emergency medical services agency,'' 
``emergency medical services professional,'' ``emergency medical 
services vehicle,'' ``hospital-based,'' ``medical director,'' ``medical 
oversight,'' ``registered emergency medical services agency,'' 
``registered location,'' ``specific state authority,'' ``standing 
order,'' and ``verbal order.''
    Additionally, the Act contains provisions that allows DEA to issue 
regulations specifying, with regard to the delivery of controlled 
substances under 21 U.S.C. 823(j)(5), the types of locations that may 
be designated. 21 U.S.C. 823(j)(11)(A)(i). In order to conform with the 
Act, DEA has identified this type of location as a ``stationhouse'' and 
is proposing to add the definition of a ``stationhouse'' to its 
regulations as part of 21 CFR 1300.06.

B. Registration for Emergency Medical Services Agencies

1. Current Regulations for EMS Registration
    Pursuant to 21 CFR 1301.12(a), controlled substances may only be 
delivered to, and distributed or dispensed from, a DEA registered 
location. In addition, under the CSA and DEA regulations, a separate 
registration is required for each principal place of business or 
professional practice at one general physical location where controlled 
substances are manufactured, distributed, imported, exported, or 
dispensed by a person. 21 U.S.C. 822(e); 21 CFR1301.12(a).
    Until the passage of the Act, the CSA and its implementing 
regulations did not directly mention EMS. Historically, DEA has not 
specifically registered EMS agencies to procure or dispense controlled 
substances. Instead, generally, EMS vehicles have obtained controlled 
substances for dispensing pursuant to a physician's instructions by 
operating under the registration of a hospital through one of two 
options.
    Under the first option, an EMS vehicle owned and operated by a 
hospital handles controlled substances under the hospital's 
registration.\9\ The EMS vehicle obtains controlled substances from the 
hospital's pharmacy or emergency room, as an extension of the hospital 
pharmacy. Under the second option, an EMS agency is registered under a 
hospital registration by agreement--that is, a private EMS agency 
enters into a formal agreement with a specified hospital to act as the 
hospital's agent. The hospital supplies each EMS vehicle with a 
prepared kit containing controlled substances needed by the EMS agency 
and replenishes the kit as necessary. Many EMS agencies are currently 
using hospital registrations to stock and operate their EMS vehicles at 
those hospitals in this manner.
---------------------------------------------------------------------------

    \9\ EMS agencies' use of this option is now explicitly 
authorized by the Act, 21 U.S.C. 823(j)(3), and DEA is proposing to 
add this option to its regulations as 21 CFR 1301.20(a)(2).
---------------------------------------------------------------------------

2. Proposed Regulations for EMS Registration
    The Act authorized the Attorney General (and thus, by delegation, 
the Administrator) to register EMS agencies, which allowed for a new 
registration category for EMS professionals to administer controlled 
substances in schedule II-V to patients receiving emergency medical 
services. 21 U.S.C. 823(j)(1). The Act thereby effectively amends the 
CSA to add a new category of registrant--an EMS agency--and to require 
DEA to grant registrations to those agencies if certain conditions are 
met. Thus, in conformity with the Act, DEA proposes to amend 21 CFR 
1301.13 and to add 21 CFR 1301.20 to provide for the registration of 
EMS agencies.
    As part of this regulatory change, DEA is proposing to add Sec.  
1301.20(a) to its regulations, which will describe the registration 
requirements for EMS agencies registered under Sec.  1301.13. The 
proposed registration requirements of Sec.  1301.20(a) are taken 
directly from the Act, 21 U.S.C. 823(j)(1)-(3).
    DEA recommends three options to allow EMS agencies to transition 
their registrations, in accordance with the Act. The three options for 
EMS agencies to transition are: (1) Transition immediately on the 
effective date established by DEA; (2) transition at the expiration of 
their current registration; or (3) transition three to six months prior 
to their renewal date. DEA recommends that registrants contact their 
local DEA field office to complete this transition.

C. Designated Location of an Emergency Medical Services Agency

    Many EMS agencies currently utilize what is sometimes termed the 
``hub-and-spoke'' model where the agency has a main or central location 
and several stationhouses managed by the main location. The 
stationhouses are strategically placed throughout a geographical area 
to provide timely responses to emergency medical needs of the residents 
of the area. Under DEA's current registration regulations, if only the 
main location is registered with DEA, the employees of each of the 
individual (unregistered) stationhouses are not allowed to acquire or 
store controlled substances at the unregistered stationhouse.
    To lessen the burden for EMS agencies with several stationhouses in 
a single state, the Act allows EMS agencies to choose the option of a 
single registration in each state where the EMS

[[Page 62638]]

agency operates, 21 U.S.C. 823(j)(2), and DEA proposes to amend its 
regulations accordingly through proposed Sec.  1301.20(a)(1). The Act 
and the proposed regulation still require EMS agencies that operate EMS 
facilities in multiple states to have a separate registration in each 
state where the agency operates, however. In addition, under the Act 
and Sec.  1301.20(a)(2) of these proposed regulations, hospital-based 
EMS agencies are allowed to operate under the registration of a 
hospital to administer controlled substances without being separately 
registered pursuant to 21 U.S.C. 823(j)(3).
    Additionally, the Act amended the CSA to specifically authorize EMS 
agencies to designate specific unregistered locations where controlled 
substances would be delivered and stored, but requires registered EMS 
agencies to provide notice of these locations to the Attorney General 
at least 30 days before delivery. 21 U.S.C. 823(j)(5). DEA proposes to 
bring its regulations into conformity with the Act by adding 21 CFR 
1301.20(b). Consistent with the Attorney General's authority under 21 
U.S.C. 823(j)(11)(A)(ii) to prescribe how EMS agencies provide notice 
of designated locations, that regulation proposes to require 
notification of the name and physical address of the designated 
location through DEA's website, www.DEAdiversion.usdoj.gov. Pursuant to 
proposed Sec.  1301.20(b), an EMS agency still must obtain a DEA 
registration for the registered location at which it receives 
controlled substances from distributers. After an EMS agency has been 
approved for a DEA registration, the EMS agency may identify designated 
locations through DEA's website, www.DEAdiversion.usdoj.gov. An EMS 
agency that has thus identified designated locations may deliver 
controlled substances to that designated location 30 days after 
notification to DEA.
    The Act also authorizes the Attorney General to issue regulations 
specifying the types of locations that may be designated by an EMS 
agency. 21 U.S.C. 823(j)(11)(A)(i). Pursuant to this authority, DEA is 
proposing to include a provision in Sec.  1301.20(b) that would allow 
an EMS agency to label stationhouses as the types of location that 
would be considered a ``designated location'' of the EMS agency. 
Additionally, only agency locations that satisfy the proposed 
regulation's definition of stationhouse (i.e., enclosed structures 
housing EMS agency vehicles within the state of the emergency medical 
services agency's registration, and which are actively and primarily 
being used for emergency response) may be selected as ``designated 
locations'' by EMS agencies that are registered with DEA. Thus, for 
example, a location that serves primarily as a residence (such as a 
house or apartment building) does not meet the proposed definition of a 
stationhouse and may not be selected as a ``designated location'' by an 
EMS agency that is registered with DEA. In contrast, a building that is 
actively serving primarily to house the equipment of a county fire and 
rescue department, for example, is a stationhouse under the proposed 
rule (and thus may be selected as a ``designated location'' by an EMS 
agency that is registered with DEA) regardless of whether such building 
is also used for overnight accommodation by EMS personnel.
    As discussed above, the provisions of proposed Sec.  1301.20(b) 
outline the process by which a stationhouse is ``designated'' under an 
existing EMS agency registration. This notification must occur at least 
30 days prior to the first delivery of controlled substances to the 
unregistered designated location of the agency. Unless an objection is 
raised by DEA, an unregistered location automatically becomes a 
designated location of the agency 30 days after notification of the 
designated location is made to DEA.
    Additionally, parts of proposed Sec.  1301.80 would codify in DEA 
regulations the Act's list of the locations where a registered EMS 
agency may store controlled substances. See 21 U.S.C. 823(j)(6). The 
permissible locations include both the registered and designated 
location(s) of the agency, and inside an EMS vehicle situated at a 
registered location or designated location of the agency. Furthermore, 
the controlled substances may be stored inside any EMS vehicle used by 
the agency that is traveling from or returning to a registered or 
designated location of the agency. Id. These provisions directly 
incorporate the Act and make it clear to registrants that under the 
specified conditions, DEA is allowing the transportation of controlled 
substances between both registered and designated locations of the 
agency.

D. Emergency Medical Services Vehicles

    Both the Act and the proposed definition of emergency services 
vehicles in Sec.  1300.06 define EMS vehicles as ambulances, fire 
apparatus, supervisor trucks, or other vehicles used by an EMS agency 
for the purpose of providing or facilitating emergency medical care and 
transport or transporting controlled substances to and from the 
registered and designated locations. See 21 U.S.C. 823(j)(13)(F). Under 
the control of the consultant practitioner registration or hospital 
registration, controlled substances can be supplied to and stored in an 
EMS vehicle. Proposed Sec.  1301.80 allows a registered EMS agency to 
store controlled substances in an EMS vehicle located at a registered 
location, a designated location, or in an EMS vehicle used by the 
agency that is traveling from, or returning to, a registered or 
designated location of the agency in the course of responding to an 
emergency, or otherwise actively in use by the agency.

E. Proposed Changes to Recordkeeping Requirements

1. Records and Inventories
    The transportation of controlled substances for administration to 
EMS patients presents unique recordkeeping concerns. With regard to 
non-practitioners that transport controlled substances (e.g., 
manufacturers, distributors, exporters, importers), DEA can track the 
movement of the controlled substances through recordkeeping and 
reporting requirements within the two-registrant integrity system. 
Generally, the registrant that transports controlled substances 
maintains a record of, and would report delivery of the controlled 
substances, while the registrant that receives the controlled 
substances must account for the received controlled substances. Every 
registrant is required to maintain complete and accurate records of 
each substance manufactured, imported, received, sold, delivered, 
exported, or disposed of. 21 CFR 1304.21(a). This two-registrant 
integrity system provides an effective means of protection against 
diversion in that the transfer of the controlled substances shall be 
verified by two separate registrants, thus helping to ensure that 
controlled substances are not diverted for illicit use.
    EMS agencies are typically the last registrants to possess 
controlled substances prior to administering to a patient at the scene 
of an emergency. As such, the two-registrant integrity system does not 
exist beyond the transfer to an EMS agency, in the traditional sense of 
registrant recordkeeping. Therefore, 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.

[[Page 62639]]

    DEA proposes Sec.  1304.03(i) to 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. Because states have differing requirements for 
the ability to handle controlled substances, maintaining records of 
employees authorized to handle controlled substances will help DEA 
identify the source of any diversion occurring at EMS agencies.
    Proposed Sec.  1304.03(i) is not based directly on the text of the 
Act, but instead on DEA's general authority under the CSA to prevent 
diversion of controlled substances by requiring registrants to maintain 
records. See 21 U.S.C. 823(j)(12)(B) (nothing in the Act is to be 
construed to limit the authority of the Attorney General to take 
measures to prevent diversion).
a. Restocking
    Following an emergency response where controlled substances were 
administered, EMS personnel may not have enough time to return to their 
stationhouse to restock their EMS vehicle with controlled substances. 
Depending on the circumstances, the stationhouse may be a considerable 
distance from the hospital where the EMS personnel brought a patient, 
or the volume of emergencies may be so great that the ambulance does 
not have time to return to the stationhouse. Rural EMS systems in the 
United States may face transport distances of 20 to 100 miles to the 
nearest hospital.\10\ Thus, the Act allows non hospital-based EMS 
agencies to receive controlled substances from a hospital for the 
purpose of restocking an EMS vehicle following an emergency response. 
21 U.S.C. 823(j)(8). DEA's proposed Sec.  1307.14(a) codifies this 
allowance in DEA regulations.
---------------------------------------------------------------------------

    \10\ Williamson, H.A., Jr. (2001). Emergency Care. In J.P. 
Geyman, T.E. Norris & L.G. Hart (Eds.), Textbook of Rural Medicine 
(pp. 93-102). New York: The McGraw-Hill Companies, Inc.
---------------------------------------------------------------------------

b. Maintenance of Records
    Under Sec.  1304.04(a), 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. Under this proposed rule, DEA 
would require maintenance of records of deliveries of controlled 
substances between all locations of the agency. Following the Act, 21 
U.S.C. 823(j)(9)(B)(ii), DEA also proposes in Sec.  1304.04(a)(5) to 
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.
    Because EMS agencies have a unique registration that differs from 
other types of registrants, DEA is also proposing to add a new section 
to its regulations that describes the additional recordkeeping 
requirements applicable to EMS agencies. Consistent with the Act's 
amendments to the CSA, 21 U.S.C. 823(j)(9), proposed Sec.  1304.27(a) 
would require an EMS agency to maintain records for each controlled 
substance administered or disposed of in the course of providing 
emergency medical services. Under proposed Sec.  1304.27(a), any EMS 
personnel who disposes of or administers controlled substances to a 
patient in the course of providing emergency medical care must 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). EMS personnel do not have independent 
authority to administer controlled substances; therefore, more 
stringent recordkeeping requirements are necessary when allowing 
administration of controlled substances without direct oversight.
    DEA proposes in Sec.  1304.27(b)(3) 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. In the event of theft 
or loss of controlled substances, registrants must report such 
occurrence in accordance with the theft and loss reporting requirements 
of 21 CFR part 1304.
    Finally, under 21 U.S.C. 823(j)(8)(c) of the Act, designated 
locations of an EMS agency must notify the registered location of their 
EMS agency within 72 hours of receiving controlled substances from a 
hospital for the purpose of restocking an EMS vehicle following an 
emergency response. DEA's proposed Sec.  1304.27(c) would codify this 
requirement in DEA regulations. However, EMS agencies that operate 
under a hospital-based registration and receive restock of controlled 
substances from the hospital under which the agency is operating would 
be exempt from these requirements. In this specific instance, under 
proposed Sec.  1307.14(a)(2), hospitals would already have a record of 
the controlled substances that the hospital delivered to the EMS agency 
operating under that hospital's registration. As such, it would be 
duplicative to require that EMS agency to obtain a receipt of those 
controlled substances because the EMS agency would be reporting receipt 
of the controlled substances back to the hospital that issued the 
controlled substances in the first place.

F. Proposed Changes for Security Requirements

1. Security Controls
    Every DEA registrant must follow certain security requirements to 
prevent the theft or loss of controlled substances, and the Act 
authorizes the Attorney General to issue regulations specifying the 
manner in which controlled substances must be stored by EMS agencies. 
21 U.S.C. 823(j)(11)(B). Pursuant to this authorization, DEA proposes 
to implement physical security requirements for EMS agencies similar to 
those already established for practitioners in Sec.  1301.75. Although 
Sec.  1301.75 addresses general physical security controls for 
practitioners, EMS agencies have some unique security concerns that 
require additional security controls as discussed below.
a. Storage of Controlled Substances
    Pursuant to its authorization under the Act to issue regulations 
regarding EMS agencies' storage of controlled substances, DEA proposes 
to add Sec.  1301.80 to address additional security concerns for EMS 
agencies. First, although designated locations of EMS agencies are not 
individually registered, they are allowed to store controlled 
substances in certain secured locations. Proposed Sec.  1301.80(a)(1) 
through (4) specifies the locations within an EMS agency where 
controlled substances may be stored, and implements the Act's allowance 
in 21 U.S.C. 823(j)(6) of storage at EMS registered locations, at 
designated locations, inside of EMS vehicles stationed at registered or 
designated locations, and inside of EMS vehicles that are actively in 
use by the agency.
    In addition, DEA proposes to add Sec.  1301.80(b) to allow two 
options for storage components in which EMS agencies may store 
controlled substances. This change is not taken directly from the Act's 
statutory amendments to the CSA, but instead implements the Act's 
authorization to the Attorney General to ``specify . . .

[[Page 62640]]

the manner in which [controlled] substances must be stored at 
registered and designated locations, including in EMS vehicles.'' 21 
U.S.C. 823(j)(11)(B).
    The first option in proposed Sec.  1301.80(b)(1) would allow for an 
EMS agency to store controlled substances in a securely locked, 
substantially constructed cabinet or safe that cannot be readily 
removed. This storage component must be located at a secured location, 
as stated in proposed Sec.  1301.80(i).
    The second option in proposed Sec.  1301.80(b)(2) would allow an 
EMS agency to store controlled substances in an automated dispensing 
system (ADS) machine, under specific conditions. An ADS is ``a 
mechanical system that performs operations or activities, other than 
compounding or administration, relative to the storage, packaging, 
counting, labeling, and dispensing of medications, and which collects, 
controls, and maintains all transactions in information.'' 21 CFR 
1300.01. Currently, DEA regulations permit retail pharmacies to install 
and operate ADS machines at long-term care facilities as a way of 
preventing the accumulation of surplus controlled substances at those 
facilities. See id. Sec.  1301.27. At an EMS agency registered or 
designated location, an ADS machine effectively would serve as a 
controlled substance storage locker with advanced capabilities and 
would provide a mechanism for storing stocks of controlled substances 
before they are secured in emergency vehicles as well as for monitoring 
the dissemination of those substances.
    The proposed conditions in Sec.  1301.80(b)(2) under which an EMS 
agency could use an ADS machine to store controlled substances include 
the following: (1) The ADS machine must be located at an EMS agency 
registered location or designated location; (2) the EMS agency cannot 
permit any entity other than the registered EMS agency to install and 
operate the ADS machine; (3) the ADS machine cannot be used to directly 
dispense controlled substances to an ultimate user; and (4) EMS agency 
must operate the ADS machine in compliance with requirements of State 
law. It is necessary that access to the ADS machine be limited to 
employees of the EMS agency in order to account for and monitor 
dissemination of controlled substances.
    In sum, proposed Sec.  1301.80(b) would provide alternative options 
for short-term or long-term storage of controlled substances that are 
actively being transported or stored in a fixed location.
b. Delivery
    As discussed in Section C, the Act allows for controlled substances 
to be delivered between a registered location and a designated location 
of an EMS agency. 21 U.S.C. 823(j)(5). Also, pursuant to its 
authorization to issue regulations regarding the delivery of controlled 
substances under 21 U.S.C. 823(j)(11), DEA proposes that medical 
directors determine who accepts deliveries of controlled substances 
because medical directors provide oversight for EMS agencies. 
Specifically, proposed Sec.  1301.80(c) would require that the delivery 
of controlled substances at a registered or designated location be 
accepted by a medical director of the agency or a person designated in 
writing by the medical director. For record keeping purposes of the 
delivery of controlled substances, proposed Sec.  1304.27(b)(3) would 
require the medical director of the agency or designated person 
accepting the controlled substances to provide their signature, title, 
date received, quantity, and any additional information required. The 
proposed regulations specify the requirements that would be set forth 
regarding the delivery of controlled substances for emergency medical 
services.

G. Proposed Administration Requirements

    DEA proposes to add Sec.  1306.07(e), which implements 21 U.S.C. 
823(j)(4) in DEA regulations, allowing EMS professionals of registered 
EMS agencies to administer controlled substances outside the physical 
presence of a medical director or authorizing medical professional in 
the course of providing emergency medical services.\11\ Medical 
directors and EMS professionals authorized to administer controlled 
substances under their State license may administer controlled 
substances in the course of providing emergency medical services. 
However, under 21 U.S.C. 823(j)(4) and proposed Sec.  1306.07(e), an 
EMS professional who is outside the physical presence of a medical 
director or authorizing medical professional must not only have 
authority from their EMS agency to administer controlled substances, 
but such administration must also be pursuant to a proper standing or 
verbal order issued and adopted by one or more medical directors of the 
agency, as discussed below.
---------------------------------------------------------------------------

    \11\ Currently, the regulations in 21 CFR part 1306 relate 
primarily to prescriptions, and thus 21 CFR 1306.01 states part 
1306's scope as generally consisting of ``[r]ules governing the 
issuance, filling and filing of prescriptions pursuant to . . . 21 
U.S.C. 829.'' Because DEA is proposing to add provisions related to 
the administration of controlled substances by EMS agencies to part 
1306, DEA is also proposing to amend Sec.  1306.01 to broaden part 
1306's stated scope to ``the process and procedures for dispensing, 
by way of prescribing and administering controlled substances to 
ultimate users.''
---------------------------------------------------------------------------

1. Standing Orders
    Many agencies have given their EMS personnel the autonomy to 
administer controlled substances in the event of an emergency by 
establishing what is commonly known as a standing order. The Act 
defines a standing order as a written medical protocol in which a 
medical director determines in advance the medical criteria that must 
be met before administering controlled substances to individuals in 
need of emergency medical services. 21 U.S.C. 823(j)(13)(M). DEA's 
proposed Sec.  1300.06 incorporates this definition into DEA 
regulations.
    The Act and proposed Sec.  1306.07(e) would allow standing orders 
to be used by EMS professionals. Under both the Act and the proposed 
regulation, such EMS professionals must be authorized by their 
individual State to administer controlled substances. See 21 U.S.C. 
823(j)(4). Standing orders that are developed by a state authority may 
be issued and adopted by the medical director of an EMS agency. Under 
the Act and proposed Sec.  1306.07(e), only the medical director of an 
EMS agency is given the authority to issue and adopt a standing order. 
See 21 U.S.C. 823(j)(4). Also, under both the Act and proposed Sec.  
1306.07(e), the EMS agency is required to maintain a record of the 
standing orders issued and adopted by a medical director at the 
registered location of the agency. 21 U.S.C. 823(j)(10)(D).
2. Verbal Orders
    In the absence of standing orders, EMS personnel may receive a 
verbal order. Under the Act and proposed Sec.  1300.06, a verbal order 
is an oral directive through any method of communication including by 
radio or telephone, directly to an EMS professional, to 
contemporaneously administer a controlled substance to individuals in 
need of emergency medical services outside the physical presence of the 
medical director or authorizing medical professional. See 21 U.S.C. 
823(j)(13)(N). The Act and proposed Sec.  1300.06 define ``authorizing 
medical professional'' as an emergency or other physician, or other 
medical professional (including an advanced practice registered nurse 
or physician assistant) who is registered under 21 U.S.C. 823, who is 
acting within the scope of the registration, and whose scope of 
practice under a State license

[[Page 62641]]

or certification includes the ability to provide verbal orders. See 21 
U.S.C. 823(j)(13)(A).
    Under the Act and proposed Sec.  1306.07(e), an EMS professional 
may administer directly a controlled substance in schedules II-V 
outside of the presence of a practitioner in the course of providing 
emergency medical services if the administration is authorized by State 
law and is pursuant to a verbal order that is issued in accordance with 
the policy of the agency. Such authorization must be provided by a 
medical director or authorizing medical professional in response to a 
request by the EMS professional with respect to a specific patient, 
either in the case of a mass casualty incident, or to ensure the proper 
care and treatment of a specific patient. Under proposed Sec.  1307.15 
and consistent with the Act under 21 U.S.C. 823(j)(4)(B), EMS agencies 
must contact the Special Agent in Charge (SAC) for the area or DEA 
Headquarters Diversion Control Division for approval of shortages, 
public health emergencies, or mass casualty events.

III. Regulatory Analyses

    As explained above, DEA is issuing this proposed rule to amend its 
regulations in order to make them consistent with the changes made to 
the CSA by the ``Protecting Patient Access to Emergency Medications Act 
of 2017,'' and to otherwise implement the Act's requirements. DEA 
conducted an analysis of the statutory and regulatory changes of this 
proposed rule, the results of which are discussed below.

Executive Orders 12866 (Regulatory Planning and Review), 13563 
(Improving Regulation and Regulatory Review), and 13771 (Reducing 
Regulation and Controlling Regulatory Costs)

    This proposed rule was developed in accordance with the principles 
of Executive Orders (E.O.) 12866, 13563, and 13771. E.O. 12866 directs 
agencies to assess all costs and benefits of available regulatory 
alternatives and, if regulation is necessary, to select regulatory 
approaches that maximize net benefits (including potential economic, 
environmental, public health, and safety effects; distributive impacts; 
and equity). E.O. 13563 is supplemental to and reaffirms the 
principles, structures, and definitions governing regulatory review as 
established in E.O. 12866. E.O. 12866 classifies a ``significant 
regulatory action,'' requiring review by the Office of Management and 
Budget (OMB), as any regulatory action that is likely to result in a 
rule that may: (1) Have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy; a sector of 
the economy; productivity; competition; jobs; the environment; public 
health or safety; or State, local, or tribal governments or 
communities; (2) create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs, or the rights and obligations of recipients thereof; or (4) 
raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in the Executive 
Order.
    DEA expects that the annual economic impact of this proposed rule, 
in the form of changes in transfers, to range from a decrease of 
$302,885 to an increase of $550,612 at a 7 percent discount rate; or 
from a decrease of $379,584 to an increase of $690,043 at a 3 percent 
discount rate. Fees paid to DEA are considered transfer payments and 
not costs.\12\ Annual changes in labor burden costs as a result of this 
proposed rule are expected to range from a decrease of $12,696 to an 
increase of $42,782 at a 7 percent discount rate; or from decrease of 
$16,253 to an increase of $49,879 at a 3 percent discount rate. 
Therefore, this proposed rule is not an economically significant 
regulatory action. The analysis of transfers, cost savings, and 
benefits is below. The economic, interagency, budgetary, legal, and 
policy implications of this proposed rule have been examined, and while 
the proposed rule is not economically significant, it has been 
determined that it is a significant regulatory action under E.O. 12866. 
Accordingly, this rule has been submitted to OMB for review.
---------------------------------------------------------------------------

    \12\ OMB Circular A-4.
---------------------------------------------------------------------------

    E.O. 13771, titled ``Reducing Regulation and Controlling Regulatory 
Costs,'' was issued on January 30, 2017, and published in the Federal 
Register on February 3, 2017. 82 FR 9339. Section 2(a) of E.O. 13771 
requires an agency, unless prohibited by law, to identify at least two 
existing regulations to be repealed when the agency publicly proposes 
for notice and comment or otherwise promulgates a new regulation. In 
furtherance of this requirement, section 2(c) of E.O. 13771 requires 
that the new incremental costs associated with new regulations, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations. Guidance from OMB, 
issued on April 5, 2017, explains that the above requirements only 
apply to each new ``significant regulatory action that . . . imposes 
costs.'' Additionally, this guidance states that ``Generally, `one-
time' regulatory actions (i.e., those actions that are not periodic in 
nature) that expand consumption and/or production options would qualify 
as E.O. 13771 deregulatory actions.'' While DEA has determined that 
this proposed rulemaking is a ``significant regulatory action,'' DEA 
anticipates that it will be classified as an enabling rule by OMB 
because it allows EMS agencies to consolidate many registrations in the 
same State under a single registration, and EMS personnel to administer 
controlled substances in schedules II-V pursuant to a standing or 
verbal order, which was previously not authorized. Therefore, this 
proposed rule is not expected to be an E.O. 13771 regulatory action.
Analysis of the Proposed Rule's Economic Impact
    DEA analyzed the impact of the following provisions of the proposed 
rule: Allowing EMS agencies to register under the CSA with a single 
registration for each State in which an agency operates, along with the 
proposed security and recordkeeping requirements for such a registrant; 
allowing EMS personnel to administer controlled substances in schedules 
II-V outside the presence of a medical director or authorizing medical 
professional when authorized in the State and pursuant to a standing or 
verbal order; and allowing EMS agencies and hospitals to transfer 
controlled substances between each other in order to restock EMS 
vehicles or to deliver controlled substances in the event of shortages, 
public health emergencies, or mass casualty events. Additionally, this 
proposed rule is incorporating into regulation several new terms 
defined in the Act.
    Benefits of the proposed rule are expected to be generated by 
reducing regulatory uncertainty among EMS agencies and personnel 
regarding the administration, transfer, and disposal of controlled 
substances, and these benefits will be discussed qualitatively. By 
allowing EMS registrants to consolidate multiple registrations into a 
single registration for each State in which they currently operate, 
there will be a resulting reduction in transfer payments for current 
registrants. The proposed rule may also result in an increase in 
transfer payments for EMS agencies that are currently not separately 
registered. The expected net change in transfer payments is quantified 
below. There are also labor

[[Page 62642]]

burden costs associated with obtaining a DEA registration for any EMS 
agencies that must become separately registered after this rule is 
promulgated. These costs or cost savings are discussed and quantified 
below. DEA expects the recordkeeping and security requirements of this 
proposed rule to have no impact, as they are codifications of existing 
practice among EMS agencies. Finally, the newly defined terms being 
incorporated into regulation by this proposed rule will have no impact 
on regulated entities.
Registrations for Emergency Medical Services Agencies
    While this proposed rule is allowing for a new registration 
category for EMS agencies that handle controlled substances, many EMS 
agencies have already obtained separate DEA registrations as ``Mid-
level Practitioner--Ambulance Service'' (MLP-AS).\13\ As of November 
2019, there were 3,521 MLP-AS registrants, 1,413 of which are private 
sector entities that pay a registration fee of $731 every three years. 
The remaining 2,108 are governmental entities that are fee-exempt. DEA 
reviewed its registration database and determined that 395 of the 1,413 
fee-paying registrations are held by EMS agencies with other existing 
registrations in the same State. Because the proposed rule allows EMS 
agencies to obtain a single registration for each State in which they 
operate, these 395 registrations can be consolidated under other 
existing registrations, reducing the total amount of registration fees 
collected by DEA. The resulting annual reduction in transfer payments 
from registrants to DEA amounts to $96,248.\14\
---------------------------------------------------------------------------

    \13\ These existing registrations will be transitioned to the 
new ``Emergency Medical Services Agency'' registration category 
created by this proposed rule.
    \14\ 395 x $731 = $288,745. Dividing this figure by three to 
account for the three-year registration cycle, and rounding to the 
nearest whole dollar gives $96,248.
---------------------------------------------------------------------------

    Similarly, of the 2,108 fee-exempt registrations, 411 can be 
consolidated into an agency's existing registration in the same State, 
reducing the labor-related paperwork burden for these agencies, as they 
no longer need to complete multiple registration renewal applications 
for the same State every three years. Combining the 411 fee-exempt 
registrations with the 395 fee-paying registrations results in a total 
of 806 registration renewal applications that are eliminated. The 
resulting annual cost savings generated from this reduction in labor 
burden is $3,026.\15\
---------------------------------------------------------------------------

    \15\ See approved burden estimates for DEA form 224A within the 
1117-0014 Supporting Statement https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005. This labor burden estimate 
is derived by multiplying the loaded hourly wage for physicians 
($140.79) by the hour burden per electronic DEA form 224A (0.08), by 
the estimated number of forms (806). The product ($9,078.14) is then 
divided by three in order to account for the three-year registration 
renewal period, and rounded to the nearest whole dollar. The loaded 
hourly wage of $140.79 is based on the median hourly wages for 
Occupation Code 29-1069 Physicians and Surgeons, All Other ($96.58). 
May 2018 National Occupational Employment and Wage Estimates, United 
States, Bureau of Labor Statistics, https://www.bls.gov/oes/current/oes_nat.htm#29-1069 (last visited November, 2019). Average benefits 
for employees are 31.4 percent of total compensation. Employer Costs 
for Employee Compensation--June, 2019, Bureau of Labor Statistics, 
https://www.bls.gov/news.release/pdf/ecec.pdf (last visited 
November, 2019). The 31.4 percent of total compensation equates to a 
45.77 percent (31.4/68.6) load on wages and salaries. $96.58 x (1 + 
0.4577) = $140.79.
---------------------------------------------------------------------------

    DEA assumes that all other EMS agencies not registered as MLP-AS 
currently operate under the registration of another DEA registrant in 
one of two ways: A DEA registered practitioner, typically a licensed 
physician, serves as the medical director of the EMS agency; or for EMS 
agencies operated by hospitals, the agency will utilize that hospital's 
registration. In the latter case, hospital-based EMS agencies can 
continue to operate under the registration of their hospital after 
promulgation of this proposed rule. In the former case, practitioners 
who serve as the medical director of an EMS agency may utilize a single 
registration for their personal place of business and EMS agency 
locations,\16\ or they may hold practitioner registrations separate 
from their personal place of business registration for each EMS agency 
location that they oversee. Because this proposed rule allows a medical 
director holding multiple registrations to transfer those existing 
registrations directly to one EMS agency, EMS agencies operating under 
this arrangement will not need a new registration. However, for EMS 
agencies currently operating under their medical director's registered 
personal place of business, a new EMS agency registration for each 
state in which they operate will be required. Additionally, affected 
non-governmental EMS agencies must pay the $731 registration fee.
---------------------------------------------------------------------------

    \16\ Under this scenario, the EMS agency must pick up controlled 
substances from the practitioner's personal place of business.
---------------------------------------------------------------------------

    Accurately measuring how many EMS agencies fall into the two 
aforementioned categories is not possible using DEA registration data, 
because DEA has not historically collected data on how many 
practitioners hold multiple registrations for the purposes of serving 
as the medical director of an EMS agency. Therefore, DEA chose to 
estimate how many new registrations will be required by considering the 
entire range of possible scenarios, and calculated the outcome if 
either 0 percent, 50 percent, or 100 percent of EMS agencies will 
receive a transferred practitioner registration from their medical 
director. While DEA cannot accurately assess the likelihood of each of 
these scenarios given the lack of available data, DEA considers the 50 
percent scenario to be the most plausible of the three estimates 
because it is the mid-point of the upper and lower bounds.
    In order to calculate the range of impacted entities, DEA must 
first estimate the total population of EMS agencies active in the 
United States. Because DEA registration data are insufficient for these 
purposes, DEA used the latest data available from the National Highway 
Traffic Safety Administration's (NHTSA) Office of EMS. According to an 
NHTSA research note published in 2014,\17\ there are an estimated 
21,283 governmental and non-governmental EMS agency locations 
throughout the United States. The 21,283 figure is NHTSA's estimation 
of the total population using data gathered from 49 of 50 States.\18\
---------------------------------------------------------------------------

    \17\ https://www.ems.gov/pdf/812041-Natl_EMS_Assessment_2011.pdf. The comprehensive national assessment 
that this research note is based on, the first of its kind, has not 
been updated since 2011. Prior to this national assessment, data on 
the number and type of EMS agencies operating throughout the United 
States was fragmented and considered to be inaccurate. Therefore, 
DEA considers this is the most accurate data regarding EMS agency 
demographics available.
    \18\ CA data were not available.
---------------------------------------------------------------------------

    DEA then analyzed its registration database to match current MLP-AS 
registrants with the corresponding EMS organizational types defined in 
the NHTSA research note.\19\ Because the survey data used by NHTSA to 
develop these organizational types did not include California (CA), 
Illinois (IL), Washington (WA), or Virginia (VA), the total number of 
EMS agency locations categorized by type amounts to 15,516 instead of 
the total 21,283 estimated EMS agency locations throughout the United 
States. DEA assumes that the distribution of EMS agencies by

[[Page 62643]]

organizational type in CA, IL, WA, and VA broadly matches the national 
distribution. Therefore, DEA adjusted for this missing data by 
calculating the percent of the total for each organizational type for 
the 46 reporting States and applied those percentages to the estimated 
21,283 EMS agencies in the entire United States.\20\ DEA was then able 
to categorize current MLP-AS registrants as Fire-Department-Based, 
Governmental Non-Fire-Based, Private Non-Hospital, or Tribal, according 
to their registration name.\21\
---------------------------------------------------------------------------

    \19\ The NHTSA research note breaks down the demographics of EMS 
agencies into the following organizational types: ``Fire-Department-
Based,'' ``Governmental Non-Fire-Based,'' ``Hospital-Based,'' 
``Private Non-Hospital,'' ``Tribal,'' ``Other EMS Agency,'' and 
``Emergency Medical Dispatch.'' The ``Other EMS Agency'' 
organizational type is not defined in the research note or national 
assessment survey on which the research note is based; however, for 
the purposes of this analysis, DEA considers this category to be 
made up of private sector entities. The ``Emergency Medical 
Dispatch'' category is excluded from this analysis because dispatch 
agencies will not be required to obtain a DEA registration.
    \20\ For example, of the 15,516 EMS agency locations reported to 
NHTSA by organizational type, 6,388 were Fire-Department-Based. 
6,388 is 41.17 percent % of 15,516. 41.17 percent of 21,283 is 
8,762. This calculation is repeated for each organizational type and 
the results are reported in the ``Est. Pop'' column of Table 1.
    \21\ In order to classify EMS agencies currently registered as 
MLP-AS as either ``Fire-Department-Based'' or ``Governmental Non-
Fire-Based,'' DEA filtered all fee-exempt MLP-AS registrants into 
two groups based on whether their registration name contained the 
word ``fire.''
---------------------------------------------------------------------------

    It is reasonable to assume that a portion of these estimated EMS 
agencies not separately registered operate multiple locations in the 
same State. The NHTSA research note states that EMS agencies are 
``licensed in each State to provide service to a specific location or 
service area. EMS service areas can be very large, as in a geopolitical 
boundary, such as a county, city or municipality, or as small as the 
local service area of a single EMS agency station.'' This definition 
suggests that the 21,283 total EMS agencies estimated by NHTSA includes 
EMS agencies operating multiple stations in the same State. Because 
only one registration is required for multiple ``agencies,'' as defined 
by NHTSA, DEA must adjust its calculation of the number of EMS agencies 
not separately registered to account for this.
    In order to estimate how many EMS agencies not separately 
registered operate more than one location in a State, DEA used the 
existing MLP-AS registrant category as a model. It is reasonable to 
assume that the characteristics of the population of EMS agencies 
registered as MLP-AS are broadly representative of the characteristics 
of the population of EMS agencies that are not separately registered. 
As discussed previously, the fee-paying MLP-AS registrant category 
contains 1,413 registrations that can be consolidated into 1,018 
registrations. Similarly, the fee-exempt category contains 2,108 
registrations that can be consolidated into 1,697 registrations. DEA 
used these figures to calculate a State-level ``agency-to-location'' 
ratio of 0.72 for fee-paying registrants,\22\ and 0.81 for fee-exempt 
registrants.\23\ These ratios are then applied to the estimated 6,705 
private-sector and 13,342 governmental EMS agency locations not 
separately registered with DEA, respectively, to determine the expected 
total number of EMS agencies that require separate registrations as a 
result of this proposed rule.\24\ This calculation yields an estimated 
total of 15,634 EMS agencies that will be separately registered, 4,827 
of which are fee-paying, and 10,807 of which are fee-exempt. Removing 
the 1,018 fee-paying and 1,697 fee-exempt MLP-AS registrants from these 
respective totals yields an estimated 3,809 fee-paying and 9,110 fee-
exempt EMS agencies that must obtain a separate registration after this 
rule is promulgated. These calculations are summarized in table 1 
below.
---------------------------------------------------------------------------

    \22\ 1,018/1,413 = 0.72.
    \23\ 1,697/2,108 = 0.81.
    \24\ An ``agency-to-location'' ratio is not applied to the 
estimated 1,236 hospital-based EMS agencies, beacuse this proposed 
rule does not impact their registration status.

                                                                                             Table 1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  % of                                                                    Non-MLP-AS
              EMS agency org type                  Reported     reported    Est.  pop   Est. number   Current  MLP-AS  reg   Post-rule       reg       Total  reg           Fee  status
                                                     pop          pop                     of reg*     MLP-AS    eliminated     MLP-AS     eliminated   eliminated
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Fire-Dep't-Based...............................        6,388        41.17        8,762        7,097     1,145          251          894        1,414        1,665  Exempt.
Gov't Non-Fire.................................        3,255        20.98        4,465        3,617       960          160          800          688          848  Exempt.
Hospital-Based.................................          901         5.81        1,236          N/A       N/A          N/A          N/A          N/A          N/A  N/A.
Private Non-Hospital...........................        3,910        25.20        5,363        3,861     1,413          395        1,018        1,107        1,502  Paying.
Tribal.........................................           84         0.54          115           93         3            0            3           22           22  Exempt.
Other EMS **...................................          978         6.30        1,342          966         0          N/A            0          376          376  Paying.
                                                ------------------------------------------------------------------------------------------------------------------------------------------------
    Total......................................       15,516          100       21,283       15,634     3,521          806        2,715        3,607        4,413  .............................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
* Figures in this column are calculated by multiplying the corresponding row of the Est. Pop column by either the fee-paying ``Agency-to-Location'' ratio of 0.72 or the fee-exempt ``Agency-to-
  Location'' ratio of 0.81, depending on each registrant's fee status reported in the Fee Status column.
** Category not defined in the 2011 National Assessment; assumed to be private-sector entities.

    As discussed previously, DEA's methodology for estimating the 
number of new EMS agency registrations must account for situations in 
which a practitioner is currently using a single DEA registration to 
serve as the medical director of multiple EMS agency locations. Because 
DEA does not have the ability to identify how many EMS agencies are 
currently operating in this manner, DEA chose to calculate a range of 
between 0 percent and 100 percent of EMS agencies that may have a DEA 
registration transferred from a practitioner. If 100 percent of the 
estimated 3,809 fee-paying EMS agencies not separately registered are 
currently operating under a practitioner registration that will be 
transferred from their medical director, there will be no increase in 
fees (transfer payments) from these future registrants to DEA. If 0 
percent of these 3,809 fee-paying EMS agencies operate under a 
practitioner registration that can be transferred from their medical 
director, there will be an increase in fees (transfer payments) of 
$928,126 to DEA on an annual basis.\25\ Likewise, calculations for the 
50 percent scenario yield an estimated increase in fees (transfer 
payments) of $464,185.\26\
---------------------------------------------------------------------------

    \25\ 3,809 x $731 = 2,784,379. This figure is divided by three 
in order to account for the three-year registration cycle, resulting 
in $928,126 (figure is rounded).
    \26\ 3,809 x .5 = 1,905 (rounded). (1,905 x $731)/3 = $464,185.
---------------------------------------------------------------------------

    Similarly, if 100 percent of the estimated 1,483 \27\ fee-paying 
registrations able to be consolidated currently operate under a 
practitioner that is using a single DEA registration to serve as the 
medical director of an EMS, there will be an annual reduction in 
transfer payments of $361,358.\28\ This transfer payment reduction is 
combined with the previously calculated reduction in transfers of 
$96,248 from the 806 MLP-AS registrations that will be consolidated, 
resulting in a total

[[Page 62644]]

reduction in transfers of $457,606. However, if 0 percent of agencies 
are operating in this manner, only the 806 MLP-AS consolidated 
registrations are relevant, resulting in a net increase in transfer 
payments of $831,878.\29\ Calculations for the 50 percent scenario 
yield an estimated reduction in fees (transfer payments) of 
$277,049.\30\ This results in a net increase of $187,136 for the 
midpoint scenario.\31\ Therefore, DEA estimates the annual net change 
in transfer payments as a result of this proposed rule will range 
between a decrease of $457,606 and an increase of $831,878, with the 
midpoint of these estimates resulting in an increase of $187,136.
---------------------------------------------------------------------------

    \27\ Sum of the ``Private Non-Hospital'' and ``Other EMS'' rows 
of the Non-MLP-AS Registrations Eliminated column of Table 1. 1,107 
+ 376 = 1,483.
    \28\ 1,483 x $731 = $1,084,037. This figure is divided by three 
in order to account for the three-year registration cycle, resulting 
in $361,358.
    \29\ $928,126 (calculated in note 25)-$96,248 = $831,878.
    \30\ 1,483 x .5 = 742 (rounded). ((742 x $731)/3) + $96,248 = 
$277,049.
    \31\ $464,185 (calculated in note 26) -$277,049 = $187,136.
---------------------------------------------------------------------------

    For the respective 0 percent, 50 percent, and 100 percent 
scenarios, DEA converted the estimated annual change in transfer 
payments calculated above into annualized present values at a 7 percent 
discount rate and a 3 percent discount rate over 12 years, or three 
registration cycles.\32\ The results of this analysis are summarized 
below in Table 2.
---------------------------------------------------------------------------

    \32\ The present value of $(457,606) over 12 years equals 
$(3,634,620.91) at 7 percent and $(4,555,011.95) at 3 percent. The 
present value of $831,878 over 12 years equals $6,607,305.99 at 7 
percent and $8,280,516.93 at 3 percent. The present value of 
$187,136 over 12 years equals $1,486,362.54 at 7 percent and 
$1,862,752.49 at 3 percent. Dividing these respective results by 12 
to account for three registration cycles yields the annualized net 
change in transfer payments found in Table 2.

                                                     Table 2
----------------------------------------------------------------------------------------------------------------
                                                              100% of             50% of             0% of
                                                         registrations Are  registrations are  registrations are
                                                            transferred        transferred        transferred
----------------------------------------------------------------------------------------------------------------
Annual Change in Transfer Payments--MLP-AS                       $(96,248)          $(96,248)          $(96,248)
 (Consolidated)........................................
Annual Change in Transfer Payments--EMS not Separately                   0            464,185            928,126
 Registered............................................
Annual Change in Transfer Payments--EMS Not Separately           (361,358)          (180,801)                  0
 Registered (Consolidated).............................
                                                        --------------------------------------------------------
    Net Annual Change in Transfer Payments.............          (457,606)            187,163            831,878
----------------------------------------------------------------------------------------------------------------
Annualized Net Change in Transfer Payments Over 12               (302,885)            123,864            550,612
 Years (Discounted 7%).................................
Annualized Net Change in Transfer Payments Over 12               (379,584)            155,229            690,043
 Years (Discounted 3%).................................
----------------------------------------------------------------------------------------------------------------
All figures are rounded.

Labor Burden of Applications for DEA Registrations and Renewals
    As detailed previously, of the estimated 4,827 fee-paying EMS 
agency locations and 10,807 fee-exempt EMS agency locations not 
separately registered, only 3,809 and 9,110 (a total of 12,919) will 
require separate registrations after the promulgation of this proposed 
rule, respectively. If 100 percent of these 12,919 EMS agencies will 
have an existing practitioner registration transferred from their 
medical director, there will be a decrease in labor burden of 
$16,568,\33\ due to the estimated 4,413 \34\ unnecessary registration 
renewal applications that can be consolidated under one registration in 
a state. The previously calculated annual cost savings of $3,026 (see 
note 15) from the consolidation of existing MLP-AS registrants is added 
to this total, resulting in an annual total labor burden reduction of 
$19,594. DEA converted the $19,594 decrease in labor burden into an 
annualized present value of $12,969 at a 7 percent discount rate and 
$16,253 at a 3 percent discount rate over three registration cycles, or 
12 years.\35\
---------------------------------------------------------------------------

    \33\ See approved burden estimates for DEA form 224A within the 
1117-0014 Supporting Statement https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005. This labor burden estimate 
is derived by multiplying the loaded hourly wage for physicians 
($140.79) by the hour burden per electronic DEA form 224A (0.08), by 
the estimated number of forms (4,413). The product ($49,704.50) is 
then divided by three in order to account for the three-year 
registration renewal period.
    \34\ As calculated previously, there are 395 fee-paying and 411 
fee-exempt MLP-AS registrations that will be consolidated under a 
single registration in a State. Of the EMS agencies that are not 
separately registered, an estimated 3,607 can be consolidated under 
a single registration in a State. Combining 806 with 3,607 results 
in 4,413.
    \35\ The present value of $19,594 over 12 years equals 
$195,038.75 at 3 percent and $155,629 at 7 percent. Dividing these 
results by 12 to account for three registration cycles yields the 
annualized present values.
---------------------------------------------------------------------------

    However, if 0 percent of these 12,919 EMS agencies will have an 
existing practitioner registration transferred from their medical 
director, there will be a one-time increase in labor burden of $272,830 
\36\ due to the initial registration application paperwork for 12,919 
registrants, and a triennial labor burden increase of $136,431,\37\ due 
to 12,919 registration renewals every three years. DEA converted the 
one-time burden of $272,830 and the triennial burden of $136,431 into 
an annualized present value of $42,782 at a 7 percent discount rate and 
$49,879 at a 3 percent discount rate over three registrations cycles, 
or 12 years.\38\
---------------------------------------------------------------------------

    \36\ See approved burden estimates for DEA form 224 within the 
1117-0014 Supporting Statement https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005. This labor burden estimate 
is derived by multiplying the loaded hourly wage for physicians 
($140.79) by the hour burden per electronic DEA form 224 (0.15), by 
the estimated number of forms (12,919). The result is rounded.
    \37\ See approved burden estimates for DEA form 224A within the 
1117-0014 Supporting Statement https://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201903-1117-005. This labor burden estimate 
is derived by multiplying the loaded hourly wage for physicians 
($140.79) by the hour burden per electronic DEA form 224A (0.08), by 
the estimated number of forms (12,919), resulting in $145,509.28. 
This figure is reduced by $9,078 to account for the triennial cost 
savings from the consolidation of existing MLP-AS registrants 
calculated in note 15, resulting in $136,431.
    \38\ The present value of $272,830 in year 1 and $136,431 in 
years 4, 7, and 10 equal $598,549.04 at 3 percent and $513,380.84 at 
7 percent discount rates. Dividing these results by 12 to account 
for three registration cycles yields the annualized present values.
---------------------------------------------------------------------------

    Finally, under the 50 percent scenario, there will be a one-time 
increase in labor burden of $136,426 \39\ due to the initial 
registration application paperwork for 6,460 registrants, and a 
triennial labor burden increase of $38,824,\40\ due to 4,253 
registration renewals every three years. DEA converted the one-time 
burden of

[[Page 62645]]

$136,426 and the triennial burden of $38,824 into an annualized present 
value of $16,753 at a 7 percent discount rate and $18,950 at a 3 
percent discount rate over three registration cycles, or 12 years.\41\
---------------------------------------------------------------------------

    \39\ 12,919 x 0.5 = 6,460 registrants. $140.79 x 0.15 x 6,460 = 
$136,426. The result is rounded.
    \40\ (12,919 x 0.5)-(4,413 x 0.5) = 4,253. $140.79 x 0.08 x 
4,253 = $47,902 (rounded). This figure is reduced by $9,078 to 
account for the triennial cost savings from the consolidation of 
existing MLP-AS registrants calculated in note 15, resulting in 
$38,824.
    \41\ The present value of $136,426 in year 1 and $38,824 in 
years 4, 7, and 10 equal $227,403.22 at 3 percent and $201,033.37 at 
7 percent discount rates. Dividing these results by 12 to account 
for three registration cycles yields the annualized present values.
---------------------------------------------------------------------------

    Table 3 summarizes the estimated net change in labor burden cost 
for both scenarios as a result of this proposed rule.

                                                     Table 3
----------------------------------------------------------------------------------------------------------------
                                                              100% of             50% of             0% of
                                                           registrations      registrations    registrations are
                                                          are transferred    are transferred      transferred
----------------------------------------------------------------------------------------------------------------
Annualized Net Change in Labor Burden Over 12 Years              $(12,969)            $16,753            $42,782
 (Discounted 7%).......................................
Annualized Net Change in Labor Burden Over 12 Years               (16,253)             18,950             49,879
 (Discounted 3%).......................................
----------------------------------------------------------------------------------------------------------------

Security and Recordkeeping Requirements
    Because some EMS agencies are currently registered under the 
practitioner business activity as MLP-AS, this proposed rule adopts 
similar physical security controls for EMS agencies as practitioners. 
EMS agencies will be authorized to store controlled substances at EMS 
registered locations and designated locations inside of a securely 
locked, substantially constructed cabinet or safe that cannot be 
readily removed or an automated dispensing system; inside EMS vehicles 
stationed at registered or designated locations; and inside EMS 
vehicles that are actively in use by the agency. DEA expects currently 
unregistered EMS agencies to be operating in a similar manner as 
registered MLP-AS, and such EMS agencies are already in compliance with 
the minimum physical security requirements outlined above. Therefore, 
DEA expects the physical security requirements of this proposed rule to 
be a codification of existing practice that will impose no costs.
    The recordkeeping provisions of this proposed rule require EMS 
agencies to record the details of any administration, disposal, 
acquisition, distribution, or delivery of controlled substances and 
make these records readily retrievable. DEA believes that EMS agencies 
are already collecting and storing these records as a normal course of 
their business operations, and therefore these recordkeeping 
requirements will have no economic impact on EMS registrants. 
Designated EMS locations with vehicles that restock controlled 
substances at a hospital after an emergency event or receive controlled 
substances from another designated location must also notify the 
registered location of the EMS agency within 72 hours. Because 
designated EMS locations have 72 hours to notify registered locations, 
and because designated and registered locations are likely to 
communicate on a more frequent basis during their normal course of 
business, DEA does not expect these events to require any additional 
communication between designated and registered locations. Therefore, 
this provision will also have no economic impact on EMS registrants. 
DEA requests comment on the impact of this proposed rule's 
recordkeeping requirements.
Reducing Regulatory Uncertainty
    Prior to the CSA amendments of the ``Protecting Patient Access to 
Emergency Medications Act of 2017,'' the CSA did not explicitly explain 
exactly how its rules governing the administration, disposal, delivery, 
acquisition, and distribution of controlled substances applied to EMS 
agencies. Most adhered to rules governing mid-level practitioners in 
the absence of regulation that addressed the unique circumstances of 
EMS operations, and advocacy groups frequently highlighted their 
concerns regarding the need for regulations to specifically address EMS 
operations.
    With the Act, and this proposed rule codifying the resulting CSA 
amendments into DEA regulation, EMS registrants have clear rules that 
direct their behavior regarding controlled substances. DEA expects 
there to be benefits resulting from this reduction in regulatory 
uncertainty, especially the explicit authorization of standing and 
verbal orders, by allowing EMS vehicles to restock their supply of 
controlled substances at hospitals following an emergency, and by 
allowing EMS vehicles and hospitals to transfer controlled substances 
between each other in the event of a shortage, public health emergency, 
or mass casualty event. DEA does not have a method to quantify the 
impact of these reductions in regulatory uncertainty; however, DEA 
believes the regulatory clarity provided by this proposed rule will 
result in a benefit to EMS agencies, EMS professionals, and the public. 
Furthermore, due to the Act and proposed rule's authorization of 
standing and verbal orders afforded to EMS personnel which was 
previously not authorized, DEA considers this rule to be an enabling 
rule for the purposes of E.O. 13771.

Executive Order 12988, Civil Justice Reform

    The proposed regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform, to eliminate ambiguity, minimize litigation, provide a clear 
legal standard for affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The proposed rule does not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This proposed rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have direct effects 
on one or more Indian tribes via Indian Health Services.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving 
it, certifies that it will not have a significant economic impact on a 
substantial number of small entities. This proposed rule will have no 
bearing in reference to costs associated with registration fees.

[[Page 62646]]

All fees will be substantially the same irrespective of status, as 
there is no distinction in fee, when an applicant requests registration 
or modification for an EMS agency.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities unless it can certify that the rule will not have a 
significant impact on a substantial number of small entities. For 
purposes of the RFA, small entities include small businesses, nonprofit 
organizations, and small governmental jurisdictions. DEA evaluated the 
impact of this rule on small entities, and discussions of its findings 
are below.
    As discussed in the above economic analysis of the proposed rule, 
because DEA is not able to identify how many EMS agencies currently 
operate under the practitioner registration of their medical director, 
DEA chose to assess the impact of this proposed rule by considering the 
full range of possible scenarios. Thus, DEA considered the impact of 
the proposed rule if 0 percent, 50 percent, or 100 percent of EMS 
agencies receive an existing DEA registration from a practitioner. For 
the purposes of this analysis, DEA conservatively assumes that 0 
percent of EMS agencies will have a DEA registration transferred from a 
practitioner because this is the scenario with the largest possible 
economic impact on affected entities, including small entities.
    There are three types of EMS agencies that are affected by this 
proposed rule: hospital-based, private, and governmental. Of these 
types, some agencies currently hold their own DEA registrations while 
others operate under the registration of another DEA registrant. As 
detailed previously, DEA estimated that 3,809 private EMS agencies and 
9,110 governmental EMS agencies are currently not separately registered 
with DEA, while 1,018 private EMS agencies and 1,697 governmental EMS 
agencies are currently registered with DEA. Additionally there are an 
estimated total of 1,236 hospital entities \42\ that are affected by 
this proposed rule. DEA assumes all EMS agencies are affected in some 
way by this proposed rule, therefore, this proposed rule is expected to 
affect a substantial number of small entities.
---------------------------------------------------------------------------

    \42\ DEA does not have the ability to identify how many hospital 
registrants operate an EMS agency under the hospital's registration. 
However, DEA used NHTSA's national EMS assessment data to estimate 
the total number of hospital-based EMS agencies to be 1,236 (see 
Table 1). Therefore, DEA considers 1,236 hospital entities to be 
affected by this proposed rule.
---------------------------------------------------------------------------

    These three types of entities are affected by at least one of the 
following four quantifiable impacts of the proposed rule: registration 
fees, recordkeeping and security requirements, the labor burden of 
obtaining a DEA registration, and the labor burden of renewing a DEA 
registration. Only the 4,827 private EMS agencies are affected by 
registration fees. Governmental EMS agencies are fee-exempt and 
hospital-based agencies can continue to operate under their hospital's 
registration. All three types of entities, whether separately 
registered or not, are affected by the security and recordkeeping 
requirements of the proposed rule. However, there is no impact because 
these entities are expected to already be in compliance with these 
requirements. Both the estimated 3,809 private agencies and 9,110 
governmental agencies not separately registered must incur the labor 
burden of registering and renewing their registration with DEA every 
three years. Hospital-based agencies already incur this labor burden, 
and this proposed rule will have no further impact on these entities. 
The following table summarizes the estimated impact of the provisions 
of the proposed rule for each type of EMS agency.
---------------------------------------------------------------------------

    \43\ The impact per entity of registration fees is calculated by 
dividing the net annual change in transfer payments for the 0 
percent range in Table 2 ($831,878) by the number of affected 
private entities (3,809). The final figure is rounded to the nearest 
whole dollar.
    \44\ The impact per entity of the labor burden for DEA form 224 
is found by dividing the total labor burden for DEA form 224 
calculated in note 36 ($272,830) by the number of affected entities 
(12,919). The final figure is rounded to the nearest whole dollar.
    \45\ The impact per entity of the labor burden for DEA form 224A 
is found by first dividing the triennial labor burden for DEA form 
224A calculated in note 37 ($145,509) by three to account for the 
three year registration cycle. This annualized labor burden 
($48,503) is then divided by the number of affected entities 
(12,919). The final figure is rounded to the nearest whole dollar.

                                                                              Table 4--Provisions of Proposed Rule
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         Registration fees              Records & Security                 DEA form 224                    DEA form 224A
                                                                 -------------------------------------------------------------------------------------------------------------------------------
                                                                     Affected       Impact  per      Affected       Impact  per      Affected       Impact  per      Affected       Impact  per
                                                                     entities       entity \43\      entities         entity         entities       entity \44\      entities       entity \45\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Hospital-based EMS..............................................             N/A             N/A           1,236              $0             N/A             N/A             N/A             N/A
Private EMS.....................................................           3,809             218           4,827               0           3,809              21           3,809               4
Government EMS..................................................             N/A             N/A          10,807               0           9,110              21           9,110               4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    DEA compared the combined annual economic impact per entity of the 
proposed rule with the annual revenue of the smallest of small entities 
in each affected industry sector. For each of the affected industry 
sectors, the annual increase was not more than 0.6 percent of average 
annual revenue for the smallest entities. The table below summarizes 
the results.

                                                                         Table 5
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of        Average
                                                                             Number of       smallest       revenue per    Annual impact    Impact % of
              NAICS code                     NAICS code description          affected        affected        smallest     per entity ($)      revenue
                                                                             entities        entities         entity
--------------------------------------------------------------------------------------------------------------------------------------------------------
622110...............................  General Medical and Surgical                1,236              20        $190,600              $0           0.00%
                                        Hospitals.
621910...............................  Ambulance Services...............          16,239             373          44,150             243           0.55%
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 62647]]

    While this rule affects a substantial number of small entities, 
because the economic impact for the smallest entities is not 
significant, the proposed rule will not have a significant impact on 
small entities as a whole. In summary, DEA's evaluation of economic 
impact by size category indicates that the rule, if promulgated, will 
not have a significant economic impact on a substantial number of small 
entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., DEA has determined that this action would not 
result in any Federal mandate that may result ``in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted for inflation) in any 
one year.'' Therefore, neither a Small Government Agency Plan nor any 
other action is required under URMA of 1995.

Paperwork Reduction Act of 1995

    Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501 et seq.), DEA has identified the following 
collections of information related to this proposed rule and has 
submitted this collection request to the OMB for review and approval. 
This proposed rule would update DEA's regulations to provide for 
registration of EMS agencies and to require EMS agencies to maintain 
certain records and provide notice to DEA in certain circumstances. A 
person is not required to respond to a collection of information unless 
it displays a valid OMB control number. Copies of existing information 
collections approved by OMB may be obtained at http://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Proposed Rule
    1. Title: Emergency Medical Services Recordkeeping and Notice 
Requirements.
    OMB Control Number: 1117-New.
    Form Number: N/A.
    DEA is proposing to create a new collection of information by 
establishing new recordkeeping and notice requirements for EMS 
agencies.
    For each EMS professional employed by a registered EMS agency, the 
agency would be required to maintain those documents, as required by 
the State in which the professional practices, which describe the 
conditions and extent of the professional's authorization to dispense 
or administer controlled substances, and must make such documents 
available for inspection and copying by authorized employees of the 
Administration.
    EMS agencies would also be required to maintain records of all 
controlled substances received, administered, or otherwise disposed of. 
Such records would be maintained, whether electronically or otherwise, 
at each registered and designated location of the agency where such 
controlled substances are received, administered, or otherwise disposed 
of.
    For each dose of controlled substances administered or disposed of 
in the course of providing emergency medical services, these records 
must include: (1) The name of the substance; (2) the finished form of 
the substance; (3) the date the substance was administered or disposed 
of; (4) identification of the patient, if applicable; (5) amount 
administered; (6) the initials of the person who administered the 
substance; (7) the initials of the medical director or authorizing 
medical professional issuing the standing or verbal order; (8) the 
amount disposed of, if applicable; (9) the manner disposed of; and (10) 
the initials of the person who disposed of the substance and of one 
witness to the disposal.
    For controlled substances acquired from or distributed to another 
registrant, the records must include: (1) The name of the substance; 
(2) the finished form of the substance; (3) the number of units or 
volume of finished form in each commercial container; (4) the number of 
units or volume of finished form and commercial containers transferred; 
(5) the date of the transfer; (6) name, address, and registration 
number of the person to or from whom the substance was transferred; and 
(7) the name and title of the person in receipt of the transferred 
substance.
    For deliveries of controlled substances between a designated 
location and a registered location--except hospital-based agencies 
restocking at the hospital under which the agency is operating--the 
records must include: (1) The name of the substance; (2) the finished 
form of the substance; (3) the number of units or volume of finished 
form in each commercial container; (4) the number of units or volume of 
finished form and commercial containers transferred; (5) the date of 
the transfer; (6) the name and address of the designated location to 
which the substance is delivered; and (7) the name and title of the 
person in receipt of the transferred substance.
    For destruction of a controlled substance (e.g., expired 
inventory), the records must include: (1) The name of the substance; 
(2) the finished form of the substance; (3) the number of units or 
volume of finished form in each commercial container; (4) the number of 
units or volume of finished form and commercial containers destroyed; 
(5) the date of the destruction; (6) the name, address, and 
registration number of the person to whom the substance was 
distributed, if applicable; and (7) the name and title of the person 
destroying the substance.
    Additionally, designated locations of EMS agencies would be 
required to notify their registered locations within 72 hours of any 
receipt of controlled substances in the following circumstances: (1) An 
EMS vehicle primarily situated at the designated location acquires 
controlled substances from a hospital while restocking following an 
emergency response; or (2) a designated location receives controlled 
substances from another designated location of the same EMS agency.
    DEA does not have a good basis to estimate the number of 
respondents and burden related to this collection of information, 
because there is no available data regarding the administration, 
receipt, delivery, acquisition or distribution, and disposal of 
controlled substances specific to the operation of EMS agencies. 
Therefore, DEA submits the following estimated number of respondents 
and burden associated with this collection of information and will 
update this estimate with data when the collection is renewed:
    Number of respondents: 21,283.
    Frequency of response: average of 52 per year.
    Number of responses: average of 1,106,716 per year.
    Burden per response: .0833 hour.
    Total annual hour burden: 92,226 hours.
    Figures are rounded.
    2. Title: Application for Registration-DEA 224, Application for 
Registration Renewal-DEA 224A.
    OMB Control Number: 1117-0014.
    Form Numbers: DEA-224, DEA-224A.
    DEA is proposing to modify an existing collection of information by 
establishing new registration rules for EMS agencies.
    Under proposed Sec.  1301.13, EMS agencies, if authorized by state 
law, may register as a new type of business activity. A new ``EMS 
Agency'' business activity will be added to the application for 
registration and application for registration renewal forms to allow 
EMS agencies to obtain a DEA registration that will permit EMS agencies 
to deliver controlled substances to their

[[Page 62648]]

designated locations without obtaining a separate registration as a 
Distributor. This registration will 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.
    To lessen the burden for EMS agencies with several stationhouses in 
a single state, DEA proposes to 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.
    DEA estimates the following number of respondents and burden 
associated with this collection of information:
    Number of respondents: 621,472.
    Frequency of response: 1 per year.
    Number of responses: 621,472 per year.
    Burden per response: 0.10 hour.
    Total annual hour burden: 65,943 hours.
    Figures are rounded.
B. Request for Comments Regarding the Proposed Collections of 
Information
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collections of information are 
encouraged. Consistent with 44 U.S.C. 3506(c)(2), DEA solicits comment 
on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of DEA.
     The accuracy of DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington, 
DC 20503. Please state that your comments refer to RIN 1117-AB37/Docket 
No. DEA-377.
    All comments must be submitted to OMB on or before November 4, 
2020. The final rule will respond to any OMB or public comments on the 
information collection requirements contained in this proposal.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1306

    Drug traffic control, Prescription drugs.

21 CFR Part 1307

    Drug traffic control.

    For the reasons stated in the preamble, the Drug Enforcement 
Administration proposes to amend 21 CFR parts 1300, 1301, 1304, 1306, 
and 1307 as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

0
2. Add Sec.  1300.06 to read as follows:


Sec.  1300.06  Definitions relating to emergency medical services 
agencies.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802).
    (b) As used in parts 1301, 1304, 1306, and 1307 of this chapter, 
the following terms shall have the meanings specified:
    (1) Authorizing medical professional means an emergency or other 
physician, or other medical professional (including an advanced 
practice registered nurse or physician assistant)--
    (i) Who is registered under 21 U.S.C. 823;
    (ii) Who is acting within the scope of the registration; and
    (iii) Whose scope of practice under a State license or 
certification includes the ability to provide verbal orders.
    (2) Designated location means a location designated by an emergency 
medical services agency under 21 U.S.C. 823(j)(5).
    (3) Emergency medical services means emergency medical response and 
emergency mobile medical services provided outside of a fixed medical 
facility.
    (4) Emergency medical services agency means an organization 
providing emergency medical services, including such an organization 
that--
    (i) Is governmental (including fire-based and hospital-based 
agencies), non-governmental (including hospital-based agencies), 
private, or volunteer-based;
    (ii) Provides emergency medical services by ground, air, or 
otherwise; and
    (iii) Is authorized by the State in which the organization is 
providing such services to provide emergency medical care, including 
the administering of controlled substances, to members of the general 
public on an emergency basis.
    (5) Emergency medical services professional means a health care 
professional (including a nurse, paramedic, or emergency medical 
technician) licensed or certified by the State in which the 
professional practices and credentialed by a medical director of the 
respective emergency medical services agency to provide emergency 
medical services within the scope of the professional's State license 
or certification.
    (6) Emergency medical services vehicle means an ambulance, fire 
apparatus, supervisor truck, or other vehicle used by an emergency 
medical services agency for the purpose of providing or facilitating 
emergency medical care and transport or transporting controlled 
substances to and from the registered and designated locations.
    (7) Hospital-based means, with respect to an emergency medical 
services agency, owned or operated by a hospital.
    (8) Medical director means a physician who is registered under 21 
U.S.C. 823(f) and provides medical oversight to an emergency medical 
services agency.
    (9) Medical oversight means supervision of the provision of medical 
care by an emergency medical services agency.
    (10) Registered emergency services agency means--
    (i) An emergency medical services agency that is registered under 
21 U.S.C. 823(j); or
    (ii) A hospital-based emergency medical services agency that is 
covered by the registration of the hospital.
    (11) Registered location means, for purposes of emergency medical 
services, a location that appears on a DEA certificate of registration 
issued to an emergency medical services agency, which shall be where 
the agency receives controlled substances from distributors.
    (12) Specific State authority means a governmental agency or other 
such authority, including a regional oversight and coordinating body, 
that, pursuant to State law or regulation, develops

[[Page 62649]]

clinical protocols regarding the delivery of emergency medical services 
in the geographic jurisdiction of such agency or authority within the 
State that may be adopted by medical directors.
    (13) Standing order means a written medical protocol in which a 
medical director determines in advance the medical criteria that must 
be met before administering controlled substances to individuals in 
need of emergency medical services.
    (14) Stationhouse means an enclosed structure that houses one or 
more emergency medical services agency vehicles within a State in which 
that emergency medical services agency is registered, and that is 
actively and primarily being used for emergency response by that 
emergency medical services agency.
    (15) Verbal order means an oral directive that is given through any 
method of communication including by radio or telephone, directly to an 
emergency medical services professional, to contemporaneously 
administer a controlled substance to individuals in need of emergency 
medical services outside the physical presence of the medical director 
or authorizing medical professional.

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
3. The authority citation for part 1301 is revised to read as follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965.

0
4. In Sec.  1301.12, add paragraph (b)(5) to read as follows:


Sec.  1301.12   Separate registrations for separate locations.

* * * * *
    (b) * * *
    (5) A designated location that is identified to the Administration 
by a registered emergency medical services agency at least 30 days 
prior to first delivering controlled substances to that unregistered 
location.
0
5. In Sec.  1301.13:
0
a. Revise paragraph (d);
0
b. Redesignate rows (e)(1)(v) through (x) as rows (e)(1)(vi) through 
(xi); and
0
c. Add new row (e)(1)(v).
    The revision and addition read as follows:


Sec.  1301.13   Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (d) At the time a retail pharmacy, hospital/clinic, practitioner, 
emergency medical services agency or teaching institution is first 
registered, that business activity shall be assigned to one of twelve 
groups, which correspond to the months of the year. The expiration date 
of the registrations of all registrants within any group will be the 
last day of the month designated for that group. In assigning any of 
the above business activities to a group, the Administration may select 
a group the expiration date of which is not less than 28 months nor 
more than 39 months from the date such business activity was 
registered. After the initial registration period, the registration 
expires 36 months from the initial expiration date.
    (e) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              Application fee    Registration     Coincident activities
           Business activity              Controlled substances      DEA Application forms          ($)         period (years)           allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(v) Emergency Medical Services Agency.  Schedules II-V...........  New--224................                731               3
                                                                   Renewal--224a...........
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
0
6. Add Sec.  1301.20 under undesignated heading ``Registration'' to 
read as follows:


Sec.  1301.20  Registration for emergency medical services agencies.

    (a) An emergency medical services agency shall be issued a 
registration under Sec.  1301.13 if the agency submits an application 
demonstrating it is authorized to conduct such activity under the laws 
of each State in which the agency practices, unless the Administration 
determines that the issuance of such a registration would be 
inconsistent with the requirements of 21 U.S.C. 823(j) or the public 
interest based on the factors listed in 21 U.S.C. 823(f).
    (1) An agency has the option of requesting a single registration in 
each State where the agency administers controlled substances in lieu 
of a separate registration for each location of the agency within a 
State.
    (2) If a hospital where an emergency medical services agency is 
based is registered under Sec.  1301.13, the agency may use the 
registration of the hospital to administer controlled substances in 
accordance with Sec.  1306.07(e) of this chapter, without being 
separately registered as an emergency medical services agency.
    (b) A registered emergency medical services agency may deliver 
controlled substances from a registered location of the agency to an 
unregistered location of the agency only if the agency designates the 
type of unregistered location as a stationhouse for such delivery; and 
notifies the Administration at least 30 days prior to the first 
delivery of controlled substances to the unregistered location. The 
delivery of controlled substances by a registered emergency medical 
services agency pursuant to this section shall not be treated as 
distribution. To notify the Administration, the emergency medical 
services agency must submit the name and physical address of the 
designated location online at www.DEAdiversion.usdoj.gov.


Sec.  Sec.  1301.78 and 1301.79  [Added and Reserved]

0
7. Add and reserve Sec. Sec.  1301.78 and 1301.79 under undesignated 
heading ``Security Requirements'';
0
8. Add Sec.  1301.80 under undesignated heading ``Security 
Requirements'' to read as follows:


Sec.  1301.80   Security controls for emergency medical services 
agencies.

    (a) A registered emergency medical services agency may store 
controlled substances at any of the following secured locations:
    (1) A registered location of the agency;
    (2) A designated location of the agency 30 days following 
notification to DEA in accordance with Sec.  1301.20;
    (3) In an emergency medical services vehicle situated at a 
registered location or designated location of the agency; or

[[Page 62650]]

    (4) In an emergency medical services vehicle used by the agency 
that is traveling from, or returning to, a registered location or 
designated location of the agency in the course of responding to an 
emergency, or otherwise actively in use by the agency.
    (b) A registered emergency medical services agency may store 
controlled substances in a storage component that is identified as:
    (1) A securely locked, substantially constructed cabinet or safe 
that cannot be readily removed; which is located at a secured location 
specified in Sec.  1301.80(a)(1) through (4); or
    (2) An automated dispensing machine as defined in Sec.  1300.01; 
which is
    (i) Located at a secured location specified in 1301.80(a)(1) and 
(2);
    (ii) Installed and operated by the emergency medical services 
agency;
    (iii) Not used to directly dispense controlled substances to an 
ultimate user; and is
    (iv) In compliance with the requirements of State law.

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
9. The authority citation for part 1304 is revised to read as follows:

    Authority:  21 U.S.C. 821, 823(j), 827, 831, 871(b), 958(e)-(g), 
and 965, unless otherwise noted.

0
10. In Sec.  1304.03, add paragraphs (i) and (j) to read as follows:


Sec.  1304.03   Persons required to keep records and file reports.

* * * * *
    (i) For each emergency medical services professional employed by a 
registered emergency services agency, the registered agency must 
maintain in a readily retrievable manner those documents (as required 
by the State in which an emergency medical services professional 
practices), which describe the conditions and extent of the 
professional's authorization to dispense controlled substances, and 
must make such documents available for inspection and copying by 
authorized employees of the Administration. Examples of such 
documentation include protocols, practice guidelines, or practice 
agreements.
    (j) A registered emergency medical services agency shall maintain 
records, as described in Sec.  1304.27, of all controlled substances 
that are received, administered, or otherwise disposed of pursuant to 
the agency's registration.
0
11. In Sec.  1304.04, revise paragraph (a) introductory text and add 
paragraphs (a)(4) and (5) to read as follows:


Sec.  1304.04   Maintenance of records and inventories.

    (a) Except as provided in paragraphs (a)(1) and (2) of this 
section, every inventory and other record required to be kept under 
this part must be kept by the registrant, and be available for 
inspection and copying by authorized employees of the Administration, 
for at least 2 years from the date of such inventory or record.
* * * * *
    (4) Records shall include records of deliveries of controlled 
substances between all locations of the agency.
    (5) Records shall 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.
* * * * *
0
12. Add Sec.  1304.27 to read as follows:


Sec.  1304.27   Additional recordkeeping requirements applicable to 
emergency medical services agencies.

    (a) Each emergency medical services agency registered pursuant to 
Sec.  1301.20 of this chapter (including a hospital-based emergency 
medical services agency using a hospital registration under Sec.  
1301.20(a)(2) of this chapter) must maintain records for each dose of 
controlled substances administered or disposed of in the course of 
providing emergency medical services. The following information shall 
be included in each record:
    (1) Name of the substance;
    (2) Finished form of the substance (e.g., 10-milligram tablet or 
10-milligram concentration per fluid ounce or milliliter);
    (3) Date administered or disposed of;
    (4) Identification of the patient (consumer), if applicable;
    (5) Amount administered;
    (6) Initials of the person who administered the controlled 
substance;
    (7) Initials of the medical director or authorizing medical 
professional issuing the standing or verbal order;
    (8) Whether a standing or verbal order was issued and adopted;
    (9) Amount disposed of, if applicable;
    (10) Manner disposed of; and
    (11) Initials of person who disposed and witness to disposal.
    (b) For each acquisition of a controlled substance from another 
registrant, or each distribution of a controlled substance to another 
registrant, each emergency medical services agency registered pursuant 
to Sec.  1301.20 of this chapter must maintain records with all of the 
following information:
    (1) For each acquisition of a controlled substance from another 
registrant:
    (i) Name of the substance;
    (ii) Finished form of the substance (e.g., 10-milligram tablet or 
10-milligram concentration per fluid ounce or milliliter);
    (iii) Number of units or volume of finished form in each commercial 
container;
    (iv) Number of commercial containers acquired (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (v) Date of the acquisition;
    (vi) Name, address, and registration number of the person from whom 
the substance was acquired; and
    (vii) Name and title of the person acquiring the controlled 
substance.
    (2) For each distribution of a controlled substance to another 
registrant:
    (i) Name of the substance;
    (ii) Finished form of the substance (e.g., 10-milligram tablet or 
10-milligram concentration per fluid ounce or milliliter);
    (iii) Number of units or volume of finished form in each commercial 
container (e.g., 100-tablet bottle or 3-milliliter vial);
    (iv) Number of commercial containers distributed;
    (v) Date of the distribution;
    (vi) Name, address, and registration number of the person to whom 
the substance was distributed; and
    (vii) Name and title of the person in receipt of the distributed 
controlled substances.
    (3) For each delivery of controlled substances between a designated 
location and a registered location:
    (i) Name of the substance;
    (ii) Finished form of the substance (e.g., 10-milligram tablet or 
10-milligram concentration per fluid ounce or milliliter);
    (iii) Number of units or volume of finished form in each commercial 
container (e.g., 100-tablet bottle or 3-milliliter vial);
    (iv) Number of units or volume of finished form in each commercial 
container and number of commercial containers delivered (e.g., 100-
tablet bottle or 3-milliliter vial);
    (v) Date of the delivery;
    (vi) Name and address of the designated location to which the 
substance is delivered; and
    (vii) Name and title of the person in receipt of the controlled 
substances.
    (4) For destruction of a controlled substance:
    (i) Name of the substance;
    (ii) Finished form of the substance (e.g., 10-milligram tablet or 
10-milligram

[[Page 62651]]

concentration per fluid ounce or milliliter);
    (iii) Number of units or volume of finished form in each commercial 
container (e.g., 100-tablet bottle or 3-milliliter vial);
    (iv) Number of units or volume of finished form in each commercial 
container and number of commercial containers destroyed (e.g., 100-
tablet bottle or 3-milliliter vial);
    (v) Date of the destruction;
    (vi) Manner of disposal of the substance, if applicable;
    (vii) Name, address, and registration number of the person to whom 
the substance was distributed, if applicable; and
    (viii) Name and title of the person destroying the controlled 
substance.
    (c) A designated location of an emergency medical services agency 
that receives controlled substances must notify the agency's registered 
location within 72 hours of receipt of the controlled substances, in 
the following circumstances:
    (1) An emergency medical services vehicle primarily situated at a 
designated location of the emergency medical services agency acquires 
controlled substances from a hospital while restocking following an 
emergency response;
    (2) The designated location of the emergency medical services 
agency receives controlled substances from another designated location 
of the same agency.

PART 1306--PRESCRIPTIONS

0
13. The authority citation for part 1306 is revised to read as follows:

    Authority: 21 U.S.C. 821, 823(j), 829, 831, 871(b), unless 
otherwise noted.

0
14. Revise Sec.  1306.01 to read as follows:


Sec.  1306.01   Scope of part 1306.

    This part sets forth the process and procedures for dispensing, by 
way of prescribing and administering controlled substances to ultimate 
users. The purpose of such procedures is to provide safe and efficient 
methods for dispensing controlled substances while providing effective 
controls against diversion.
0
15. Amend Sec.  1306.07 by adding paragraphs (e) and (f) to read as 
follows:


Sec.  1306.07  Administering or dispensing of narcotic drugs.

* * * * *
    (e) An emergency medical services professional of a registered 
emergency medical services agency may administer directly (but not 
prescribe) controlled substances in schedules II-V outside the physical 
presence of a medical director or authorizing medical professional in 
the course of providing emergency medical services if the 
administration is authorized by law of the State in which it occurs; 
and is pursuant to:
    (1) A standing order that is issued and adopted by one or more 
medical directors of the agency, including any such order that may be 
developed by a specific State's authority; or
    (2) A verbal order that is:
    (i) Issued in accordance with a policy of the agency; and
    (ii) Provided by a medical director or an authorizing medical 
professional in response to a request by the emergency medical services 
professional with respect to a specific patient --
    (A) In the case of a mass casualty incident; or
    (B) To ensure the proper care and treatment of a specific patient.
    (f) An emergency medical services agency shall maintain, at a 
registered location of the agency, a record of the standing or verbal 
orders issued or adopted in accordance with Sec.  1304.13 of this 
chapter.

PART 1307--MISCELLANEOUS

0
16. The authority citation for part 1307 is revised to read as follows:

    Authority: 21 U.S.C. 821, 822(d), 823(j), 871(b), unless 
otherwise noted.

0
17. Add Sec.  1307.14 under undesignated heading ``Special Exceptions 
for Manufacture and Distribution of Controlled Substances'' to read as 
follows:


Sec.  1307.14   Delivery of controlled substances to designated 
locations of emergency medical services agencies.

    (a) Notwithstanding the definition of registered location in Sec.  
1300.06 of this chapter, a registered emergency medical services agency 
may receive controlled substances from a hospital for purposes of 
restocking an emergency medical services vehicle following an emergency 
response, and without being subject to the requirements of Sec.  
1305.03 of this chapter, provided all of the following criteria are 
met:
    (1) The registered or designated location of the agency operating 
the vehicle maintains the record of such receipt in accordance with 
Sec.  1304.27(b) of this chapter;
    (2) The hospital maintains a record of such delivery to the agency 
in accordance with Sec.  1304.22(c) of this chapter; and
    (3) If the vehicle is primarily situated at a designated location 
of an emergency medical services agency, such location notifies the 
registered location of the agency within 72 hours of the vehicle 
receiving the controlled substances.
0
18. Add Sec.  1307.15 under undesignated heading ``Special Exceptions 
for Manufacture and Distribution of Controlled Substances'' to read as 
follows:


Sec.  1307.15   Delivery of controlled substances in emergency 
situations.

    (a) Hospitals and emergency medical services agencies' registered 
locations, and designated locations may deliver controlled substances 
to each other, with written approval from the Special Agent in Charge 
of DEA for the area or DEA Headquarters, in the event of:
    (1) Shortages of such substances;
    (2) A public health emergency; or
    (3) A mass casualty event.

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-21675 Filed 10-2-20; 8:45 am]
BILLING CODE 4410-09-P