Notice of Proposed Rulemaking

62634

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

TABLE 1—INFORMATION ON PARTICIPATING IN THE PUBLIC MEETINGS AND ON SUBMITTING COMMENTS TO THE PROPOSED
RULE ON REQUIREMENTS FOR ADDITIONAL TRACEABILITY RECORDS FOR CERTAIN FOODS DOCKET
Activity

Date

Electronic address

First public meeting .....

November 6, 2020;
8:30 a.m.–3:30 p.m.
EST.
by October 28, 2020 ..

Webcast information will be sent upon completion of registration.

Webcast will have closed captioning.

https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................

There is no registration fee for the public
meetings. Early registration is recommended.

Advance registration ....
Request to make oral
presentation.

by October 9, 2020 ....

Notice confirming opportunity to make
oral presentation.

by October 16, 2020 ..

Submitting either electronic or written comments.
Second public meeting

Submit comments by
January 21, 2021.

https://www.regulations.gov ............................

November 18, 2020;
9:30 a.m.–4:30 p.m.
EST.
by November 6, 2020

Webcast information will be sent upon completion of registration.

Webcast will have closed captioning.

https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................

There is no registration fee for the public
meetings. Early registration is recommended.

Advance registration ....

An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.

Request to make oral
presentation.

by October 16, 2020 ..

Notice confirming opportunity to make
oral presentation.

by October 23, 2020 ..

Submitting either electronic or written comments.
Third public meeting ....

Submit comments by
January 21, 2021.

https://www.regulations.gov ............................

December 2, 2020;
11:30 a.m.–6:30
p.m. EST.
by November 18, 2020

Webcast information will be sent upon completion of registration.

Webcast will have closed captioning.

https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
https://www.fda.gov/food/news-events-cfsan/
workshops-meetings-webinars-food-and-dietary-supplements.
.........................................................................

There is no registration fee for the public
meetings. Early registration is recommended.

Advance registration ....

jbell on DSKJLSW7X2PROD with PROPOSALS

Other information

Request to make oral
presentation.

by October 26, 2020 ..

Notice confirming opportunity to make
oral presentation.

by November 9, 2020

Submitting either electronic or written comments.

Submit comments by
January 21, 2021.

https://www.regulations.gov ............................

IV. Transcripts

DEPARTMENT OF JUSTICE

Please be advised that as soon as a
transcript is available, it will be
accessible at: https://
www.regulations.gov. You may also
view the transcript at the Dockets
Management Staff (see ADDRESSES).

Drug Enforcement Administration

Dated: September 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21935 Filed 10–2–20; 8:45 am]
BILLING CODE 4164–01–P

[Docket No. DEA–377]
RIN 1117–AB37

Registering Emergency Medical
Services Agencies Under the
Protecting Patient Access to
Emergency Medications Act of 2017
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

PO 00000

Frm 00020

Fmt 4702

Sfmt 4702

An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.

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

SUMMARY:

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

AGENCY:

An Agency representative will confirm the opportunity to make an oral presentation and
will provide the approximate time on the
public meeting agenda to do so.
See ADDRESSES for additional information
on submitting comments.

E:\FR\FM\05OCP1.SGM

05OCP1

jbell on DSKJLSW7X2PROD with PROPOSALS

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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:

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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

PO 00000

Frm 00021

Fmt 4702

Sfmt 4702

62635

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

E:\FR\FM\05OCP1.SGM

05OCP1

62636

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

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.

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

C. Background

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

jbell on DSKJLSW7X2PROD with PROPOSALS

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
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
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.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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

PO 00000

Frm 00022

Fmt 4702

Sfmt 4702

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
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 § 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

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

jbell on DSKJLSW7X2PROD with PROPOSALS

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.
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 § 1301.13 would be
amended to bring it into conformity
with 823(j)(1). Proposed § 1301.20(a) is
adapted directly from the statutory
amendment, specifically from 823(j)(1)–
(3). The proposed provisions of
§ 1301.80(a) would add provisions from
823(j)(6). Proposed § 1304.03(j) is taken
from 823(j)(9)(A). Proposed § 1306.07(e)
would add the provisions of 823(j)(4)
and 823(j)(10)(D) to DEA regulations,
while proposed § 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,
§§ 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
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.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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
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).

PO 00000

Frm 00023

Fmt 4702

Sfmt 4702

62637

hospital registrations to stock and
operate their EMS vehicles at those
hospitals in this manner.
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 § 1301.20(a) to its
regulations, which will describe the
registration requirements for EMS
agencies registered under § 1301.13. The
proposed registration requirements of
§ 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 ‘‘huband-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

E:\FR\FM\05OCP1.SGM

05OCP1

jbell on DSKJLSW7X2PROD with PROPOSALS

62638

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

agency operates, 21 U.S.C. 823(j)(2), and
DEA proposes to amend its regulations
accordingly through proposed
§ 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 § 1301.20(a)(2) of
these proposed regulations, hospitalbased 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 § 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 § 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

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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 § 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
§ 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 § 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

PO 00000

Frm 00024

Fmt 4702

Sfmt 4702

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 § 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 nonpractitioners 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.

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
DEA proposes § 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 § 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).

jbell on DSKJLSW7X2PROD with PROPOSALS

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 § 1307.14(a) codifies this
allowance in DEA regulations.
b. Maintenance of Records
Under § 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 § 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
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.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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 § 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 § 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 § 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
§ 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

PO 00000

Frm 00025

Fmt 4702

Sfmt 4702

62639

from these requirements. In this specific
instance, under proposed
§ 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 § 1301.75. Although
§ 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
§ 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 § 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
§ 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 . . .

E:\FR\FM\05OCP1.SGM

05OCP1

jbell on DSKJLSW7X2PROD with PROPOSALS

62640

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

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
§ 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
§ 1301.80(i).
The second option in proposed
§ 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. § 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
§ 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 § 1301.80(b) would
provide alternative options for shortterm or long-term storage of controlled
substances that are actively being
transported or stored in a fixed location.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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 § 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 § 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 § 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 § 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
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 § 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.’’

PO 00000

Frm 00026

Fmt 4702

Sfmt 4702

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.
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 § 1300.06
incorporates this definition into DEA
regulations.
The Act and proposed § 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 § 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
§ 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
§ 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 § 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

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
or certification includes the ability to
provide verbal orders. See 21 U.S.C.
823(j)(13)(A).
Under the Act and proposed
§ 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 § 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.

jbell on DSKJLSW7X2PROD with PROPOSALS

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

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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.
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
12 OMB

PO 00000

Circular A–4.

Frm 00027

Fmt 4702

Sfmt 4702

62641

requirements only apply to each new
‘‘significant regulatory action that . . .
imposes costs.’’ Additionally, this
guidance states that ‘‘Generally, ‘onetime’ 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

E:\FR\FM\05OCP1.SGM

05OCP1

62642

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

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.

jbell on DSKJLSW7X2PROD with PROPOSALS

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 feeexempt. 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
Similarly, of the 2,108 fee-exempt
registrations, 411 can be consolidated
into an agency’s existing registration in
the same State, reducing the laborrelated 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 feeexempt registrations with the 395 feepaying 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
13 These existing registrations will be transitioned
to the new ‘‘Emergency Medical Services Agency’’
registration category created by this proposed rule.
14 395 × $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.
15 See approved burden estimates for DEA form
224A within the 1117–0014 Supporting Statement

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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 nongovernmental EMS agencies must pay
the $731 registration fee.
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.
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 × (1 + 0.4577) = $140.79.
16 Under this scenario, the EMS agency must pick
up controlled substances from the practitioner’s
personal place of business.

PO 00000

Frm 00028

Fmt 4702

Sfmt 4702

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
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
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.
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.

E:\FR\FM\05OCP1.SGM

05OCP1

62643

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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
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 feepaying, and 10,807 of which are feeexempt. 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.

TABLE 1
EMS agency org type

% of
reported
pop

Reported
pop

Est.
pop

Est. number
of reg*

Current
MLP–AS

MLP–AS
reg
eliminated

Post-rule
MLP–AS

Non-MLP–
AS reg
eliminated

Total
reg
eliminated

Fire-Dep’t-Based ..........
Gov’t Non-Fire .............
Hospital-Based ............
Private Non-Hospital ....
Tribal ............................
Other EMS ** ...............

6,388
3,255
901
3,910
84
978

41.17
20.98
5.81
25.20
0.54
6.30

8,762
4,465
1,236
5,363
115
1,342

7,097
3,617
N/A
3,861
93
966

1,145
960
N/A
1,413
3
0

251
160
N/A
395
0
N/A

894
800
N/A
1,018
3
0

1,414
688
N/A
1,107
22
376

1,665
848
N/A
1,502
22
376

Total ......................

15,516

100

21,283

15,634

3,521

806

2,715

3,607

4,413

Fee
status
Exempt.
Exempt.
N/A.
Paying.
Exempt.
Paying.

jbell on DSKJLSW7X2PROD with PROPOSALS

* 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
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

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-DepartmentBased’’ 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.’’
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.
25 3,809 × $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 × .5 = 1,905 (rounded). (1,905 × $731)/
3 = $464,185.
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 × $731 = $1,084,037. This figure is
divided by three in order to account for the threeyear registration cycle, resulting in $361,358.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

PO 00000

Frm 00029

Fmt 4702

Sfmt 4702

E:\FR\FM\05OCP1.SGM

05OCP1

62644

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

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.
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.

TABLE 2
100% of
registrations
Are transferred

50% of
registrations
are transferred

0% of
registrations
are transferred

Annual Change in Transfer Payments—MLP–AS (Consolidated) ............................
Annual Change in Transfer Payments—EMS not Separately Registered ................
Annual Change in Transfer Payments—EMS Not Separately Registered
(Consolidated) ........................................................................................................

$(96,248)
0

$(96,248)
464,185

$(96,248)
928,126

(361,358)

(180,801)

0

Net Annual Change in Transfer Payments ........................................................

(457,606)

187,163

831,878

Annualized Net Change in Transfer Payments Over 12 Years (Discounted 7%) ....
Annualized Net Change in Transfer Payments Over 12 Years (Discounted 3%) ....

(302,885)
(379,584)

123,864
155,229

550,612
690,043

All figures are rounded.

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
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
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

29 $928,126 (calculated in note 25)¥$96,248 =
$831,878.
30 1,483 × .5 = 742 (rounded). ((742 x $731)/3) +
$96,248 = $277,049.
31 $464,185 (calculated in note 26) ¥$277,049 =
$187,136.
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.
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 feepaying 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.
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.
39 12,919 × 0.5 = 6,460 registrants. $140.79 × 0.15
× 6,460 = $136,426. The result is rounded.
40 (12,919 × 0.5)¥(4,413 × 0.5) = 4,253. $140.79
× 0.08 × 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.

jbell on DSKJLSW7X2PROD with PROPOSALS

Labor Burden of Applications for DEA
Registrations and Renewals

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

PO 00000

Frm 00030

Fmt 4702

Sfmt 4702

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
$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
Table 3 summarizes the estimated net
change in labor burden cost for both

62645

scenarios as a result of this proposed
rule.

TABLE 3
100% of
registrations
are transferred

jbell on DSKJLSW7X2PROD with PROPOSALS

Annualized Net Change in Labor Burden Over 12 Years (Discounted 7%) .............
Annualized Net Change in Labor Burden Over 12 Years (Discounted 3%) .............

$(12,969)
(16,253)

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.

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

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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

PO 00000

Frm 00031

Fmt 4702

Sfmt 4702

50% of
registrations
are transferred
$16,753
18,950

0% of
registrations are
transferred
$42,782
49,879

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.
three registration cycles yields the annualized
present values.

E:\FR\FM\05OCP1.SGM

05OCP1

62646

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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.
These three types of entities are
affected by at least one of the following
four quantifiable impacts of the
proposed rule: registration fees,

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

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 feeexempt 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.

TABLE 4—PROVISIONS OF PROPOSED RULE
Registration fees
Affected
entities
Hospital-based EMS .........
Private EMS ......................
Government EMS ..............

Records & Security

Impact
per entity 43

N/A
3,809
N/A

Affected
entities

N/A
218
N/A

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

DEA form 224

Impact
per entity

1,236
4,827
10,807

Affected
entities
$0
0
0

Impact
per entity 44

N/A
3,809
9,110

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

DEA form 224A

N/A
21
21

Affected
entities

Impact
per entity 45

N/A
3,809
9,110

N/A
4
4

smallest entities. The table below
summarizes the results.

jbell on DSKJLSW7X2PROD with PROPOSALS

TABLE 5
NAICS code description

622110 ...........
621910 ...........

General Medical and Surgical Hospitals
Ambulance Services ................................

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.
43 The impact per entity of registration fees is
calculated by dividing the net annual change in

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

Number of
smallest
affected
entities

Number of
affected
entities

NAICS code

1,236
16,239

20
373

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.

PO 00000

Frm 00032

Fmt 4702

Sfmt 4702

Average
revenue per
smallest
entity
$190,600
44,150

Annual
impact per
entity
($)
$0
243

Impact
% of
revenue
0.00%
0.55%

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.

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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.

jbell on DSKJLSW7X2PROD with PROPOSALS

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

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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

PO 00000

Frm 00033

Fmt 4702

Sfmt 4702

62647

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 RegistrationDEA 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 § 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

E:\FR\FM\05OCP1.SGM

05OCP1

62648

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

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.

jbell on DSKJLSW7X2PROD with PROPOSALS

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.

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

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
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).
■

2. Add § 1300.06 to read as follows:

§ 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 firebased and hospital-based agencies),

PO 00000

Frm 00034

Fmt 4702

Sfmt 4702

non-governmental (including hospitalbased agencies), private, or volunteerbased;
(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

E:\FR\FM\05OCP1.SGM

05OCP1

62649

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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

*

*

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

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.

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

■

§ 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.
■ 5. In § 1301.13:
■ a. Revise paragraph (d);
■ b. Redesignate rows (e)(1)(v) through
(x) as rows (e)(1)(vi) through (xi); and
■ c. Add new row (e)(1)(v).
DEA
Application
forms

§ 1301.20 Registration for emergency
medical services agencies.

(a) An emergency medical services
agency shall be issued a registration
under § 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.

23:47 Oct 02, 2020

Jkt 253001

*

Frm 00035

Fmt 4702

Coincident
activities
allowed

*
731

*

Sfmt 4702

Registration
period
(years)

Application fee
($)

(2) If a hospital where an emergency
medical services agency is based is
registered under § 1301.13, the agency
may use the registration of the hospital
to administer controlled substances in
accordance with § 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

PO 00000

*
*
*
*
(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) * * *

*
*
New—224 .............................
Renewal—224a ....................

*

*
*
*
*
■ 6. Add § 1301.20 under undesignated
heading ‘‘Registration’’ to read as
follows:

jbell on DSKJLSW7X2PROD with PROPOSALS

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

*
*
Schedules II–V .........................

*

VerDate Sep<11>2014

The revision and addition read as
follows:

Controlled
substances

Business activity

*
(v) Emergency Medical
Services Agency.

presence of the medical director or
authorizing medical professional.

*
3

*

*

and physical address of the designated
location online at
www.DEAdiversion.usdoj.gov.
§ § 1301.78 and 1301.79
Reserved]

[Added and

7. Add and reserve §§ 1301.78 and
1301.79 under undesignated heading
‘‘Security Requirements’’;
■ 8. Add § 1301.80 under undesignated
heading ‘‘Security Requirements’’ to
read as follows:
■

§ 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 § 1301.20;
(3) In an emergency medical services
vehicle situated at a registered location
or designated location of the agency; or

E:\FR\FM\05OCP1.SGM

05OCP1

62650

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules

(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
§ 1301.80(a)(1) through (4); or
(2) An automated dispensing machine
as defined in § 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
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.

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

■

§ 1304.03 Persons required to keep
records and file reports.

jbell on DSKJLSW7X2PROD with PROPOSALS

*

*
*
*
*
(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 § 1304.27, of all
controlled substances that are received,
administered, or otherwise disposed of
pursuant to the agency’s registration.
■ 11. In § 1304.04, revise paragraph (a)
introductory text and add paragraphs
(a)(4) and (5) to read as follows:

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

§ 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.
*
*
*
*
*
■ 12. Add § 1304.27 to read as follows:
§ 1304.27 Additional recordkeeping
requirements applicable to emergency
medical services agencies.

(a) Each emergency medical services
agency registered pursuant to § 1301.20
of this chapter (including a hospitalbased emergency medical services
agency using a hospital registration
under § 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
§ 1301.20 of this chapter must maintain
records with all of the following
information:

PO 00000

Frm 00036

Fmt 4702

Sfmt 4702

(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 3milliliter 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 3milliliter 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 3milliliter 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

E:\FR\FM\05OCP1.SGM

05OCP1

Federal Register / Vol. 85, No. 193 / Monday, October 5, 2020 / Proposed Rules
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 3milliliter 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.

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 § 1304.13 of
this chapter.

notifies the registered location of the
agency within 72 hours of the vehicle
receiving the controlled substances.
■ 18. Add § 1307.15 under undesignated
heading ‘‘Special Exceptions for
Manufacture and Distribution of
Controlled Substances’’ to read as
follows:

PART 1307—MISCELLANEOUS

Coast Guard

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

33 CFR Part 127

■

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

§ 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

DEPARTMENT OF HOMELAND
SECURITY

[Docket No. USCG–2019–0444]
RIN 1625–AC52

Operational Risk Assessments for
Waterfront Facilities Handling
Liquefied Natural Gas as Fuel, and
Updates to Industry Standards

■

17. Add § 1307.14 under undesignated
heading ‘‘Special Exceptions for
Manufacture and Distribution of
Controlled Substances’’ to read as
follows:

ACTION:

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

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

PART 1306—PRESCRIPTIONS
13. The authority citation for part
1306 is revised to read as follows:

14. Revise § 1306.01 to read as
follows:

■

§ 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.
■ 15. Amend § 1306.07 by adding
paragraphs (e) and (f) to read as follows:
jbell on DSKJLSW7X2PROD with PROPOSALS

62651

§ 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

VerDate Sep<11>2014

23:47 Oct 02, 2020

Jkt 253001

■

(a) Notwithstanding the definition of
registered location in § 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 § 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 § 1304.27(b)
of this chapter;
(2) The hospital maintains a record of
such delivery to the agency in
accordance with § 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

PO 00000

Frm 00037

Fmt 4702

Sfmt 4702

Coast Guard, DHS.
Notice of proposed rulemaking.

AGENCY:

The Coast Guard proposes to
amend its regulations concerning
waterfront facilities handling liquefied
natural gas (LNG) and liquefied
hazardous gas (LHG). The proposed rule
would make the following three
changes. First, the proposed rule would
revise the Coast Guard’s existing
regulations to allow waterfront facilities
handling LNG as fuel to conduct an
operational risk assessment instead of a
waterway suitability assessment (WSA)
without first obtaining Captain of the
Port approval. Second, the proposed
rule would revise existing regulations to
update incorporated technical standards
to reflect the most recent published
editions. Third, for waterfront facilities
handling LNG that must comply with
the WSA requirements, the proposed
rule would require these facilities to
provide information to the Coast Guard
regarding the nation of registry for
vessels transporting natural gas that are

SUMMARY:

E:\FR\FM\05OCP1.SGM

05OCP1