[Federal Register Volume 85, Number 38 (Wednesday, February 26, 2020)]
[Proposed Rules]
[Pages 11008-11020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03627]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, and 1304

[Docket No. DEA-459]
RIN 1117-AB43


Registration Requirements for Narcotic Treatment Programs With 
Mobile Components

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to revise 
the existing regulations for narcotic treatment programs (NTPs) to 
allow a mobile component associated with the registered program to be 
considered a coincident activity. The NTP registrants that operate or 
wish to operate mobile components (in the state that the registrant is 
registered in) to dispense narcotic drugs in schedules II-V at a remote 
location for the purpose of maintenance or detoxification treatment 
would not be required to obtain a separate registration for a mobile 
component. This proposed rule would waive the requirement of a separate 
registration at each principal place of business or professional 
practice where controlled substances are dispensed for those NTPs with 
mobile components that fully comply with the requirements of the 
proposed rule, once finalized. These revisions to the regulations are 
intended to make maintenance or detoxification treatments more widely 
available, while ensuring that safeguards are in place to reduce the 
likelihood of diversion.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before April 27, 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.

ADDRESSES: To ensure proper handling of comments, please reference 
``RIN 1117-AB43/Docket No. DEA-459'' on all correspondence, including 
any attachments.
     Electronic comments: The Drug Enforcement Administration 
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 
http://www.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.
     Paper comments: Paper comments that duplicate the 
electronic submission are not necessary and are discouraged. 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, 
Diversion Control Division; Mailing Address: 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Drug Enforcement 
Administration, Attn: DEA Federal Register Representative/DPW, 
Diversion Control Division; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record. They will, unless reasonable cause is given, be made 
available by the Drug Enforcement Administration (DEA) 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 (FOIA) 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 the 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this notice of proposed rulemaking are available in their entirety 
under the tab ``Supporting Documents'' of the public docket of this 
action at http://www.regulations.gov under FDMS Docket ID: DEA-459 (RIN 
1117-AB43/Docket Number DEA-459) for easy reference.

I. Background and Purpose

A. Legal Authority

    The Controlled Substances Act (CSA) generally provides, with 
certain exceptions, that all persons who are required to register under 
the Act must obtain a separate registration ``at each principal place 
of business or professional practice'' where such persons manufacture, 
distribute, or dispense a controlled substance. 21 U.S.C. 822(e)(1). 
However, the CSA authorizes the Administrator of DEA (by delegation 
from the Attorney General) to issue regulations waiving the requirement 
of registration of certain manufacturers, distributors, or dispensers 
if he finds it consistent with the public health and safety. 21 U.S.C. 
822(d).
    Pursuant to this latter provision, DEA is hereby proposing a 
regulation that would waive the requirement of a separate registration 
for NTPs that

[[Page 11009]]

utilize mobile components. Specifically, under the proposed rule, an 
NTP would be permitted to dispense narcotic drugs in schedules II-V at 
a location remote from, but within the same state as, the NTP's 
registered location, for the purpose of maintenance or detoxification 
treatment. Under this proposed rule, regardless of whether the NTP is 
dispensing narcotic drugs at a remote location on such a regular basis 
that the location would constitute a principal place of business or 
professional practice within the meaning of the CSA (see discussion 
below), the NTP would not need to have a separate registration with DEA 
at that location as long as it complies with the requirements of the 
proposed rule. Such remote dispensing by an NTP would be deemed a 
coincident activity permitted under the NTP's registration. In the 
interest of helping to alleviate the ongoing opioid epidemic in the 
United States, the Acting Administrator finds that this proposed waiver 
of registration is consistent with the public health and safety.

B. Purpose of the Proposed Rule

    The impetuses for this notice of proposed rulemaking (NPRM) are the 
opioid epidemic currently affecting the nation and the desire to design 
additional ways to curtail this epidemic. During 2017, 70,237 deaths 
occurred as a result of drug overdoses, including 47,600 deaths (67.8%) 
that involved an opioid.\1\ Further, annual drug overdose deaths have 
more than tripled since 1999.\2\ From 2015 to 2016, drug overdose 
deaths increased in all drug categories examined by the Centers for 
Disease Control and Prevention; the largest increase occurred among 
deaths involving synthetic opioids other than methadone (synthetic 
opioids), which includes illicitly manufactured fentanyl. Consequently, 
the demand for evidence-based medication-assisted treatment for 
substance use disorders (SUD), including opioid use disorder (OUD), has 
increased over the years, especially for services provided by NTPs; in 
some areas, this has resulted in long waiting lists and high service 
fees. Additionally, in rural and other underserved communities, the 
distance to the nearest NTP or the lack of consistent access to 
transportation may prevent or substantially impede access to these 
critical services.
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    \1\ ``Opioid Overdose.'' Drug Overdose Deaths. June 27, 2019. 
Accessed November 15, 2019. https://www.cdc.gov/drugoverdose/data/statedeaths.html.
    \2\ Scholl L., Seth P., Kariisa M., Wilson N., & Baldwin G., 
Drug and Opioid-Involved Overdose Deaths--United States, 2013-2017, 
67 MMWR Morbidity Mortality Weekly Report 1419-1427 (2019). Accessed 
September 12, 2019. DOI: http://dx.doi.org/10.15585/mmwr.mm675152e1.
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    In April of 2000, DEA, in association with the American Methadone 
Treatment Association (now the American Association for the Treatment 
of Opioid Dependence), developed guidelines for NTPs to follow to 
ensure greater stability in the treatment process by using the same 
standard throughout the United States.\3\ As the nature of the opioid 
epidemic evolves, new methods and guidelines to further increase 
accessibility for persons with OUD also need to evolve. Alternative 
methods, such as mobile components of NTPs, can be used to bring 
treatment to those in rural or other areas where NTPs are not 
accessible, or to allow people who concurrently are unable to travel to 
an NTP to receive care. This has prompted some NTPs to purchase 
vehicles (in this NPRM, the word ``conveyance'' will be used 
interchangeably with ``mobile component'' to describe such vehicles) 
for the purposes of dispensing controlled substances outside of their 
registered location, but within states in which they are registered. 
Under the proposed rule, mobile components of NTPs would not be 
authorized to function as hospitals, long-term care facilities, or 
emergency medical service vehicles, and would not be authorized to 
transport patients.
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    \3\ Drug Enforcement Administration, Narcotic Treatment Programs 
Best Practice Guideline (2000).
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    There are more than 1,700 NTPs registered with DEA, including 
opioid treatment programs, detoxification treatment services that 
utilize methadone, and compounders. Prior to 2007, DEA authorized 
mobile NTPs on an ad hoc basis. Since then, it has placed a moratorium 
on further such authorizations, resulting in a gradual decline in the 
number of mobile NTPs. During the past five years, 19 NTPs have 
operated a mobile component. Currently, eight NTPs operate mobile units 
under those agreements.\4\ The vast majority of authorized mobile NTP 
components complied with the CSA and its implementing regulations. This 
NPRM builds on the existing experience and provides additional 
flexibility for NTPs in operating mobile components subject to the 
regulatory restrictions put into place to prevent the diversion of 
controlled substances. This NPRM is thus aimed at helping to alleviate 
the opioid crisis in the United States by formalizing the requirements 
for operating a mobile NTP and thereby allowing for greater access to 
OUD treatment while maintaining appropriate controls to reduce the 
likelihood of diversion.
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    \4\ Data collected from DEA field offices in June 2019.
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C. Why This Proposed Rule Is Legally Necessary

    As indicated above, the CSA generally requires all persons who 
dispense controlled substances--including NTPs--to be registered at 
each ``principal place of business or professional practice'' where 
they dispense controlled substances. This requirement is reiterated in 
DEA regulations. 21 CFR 1301.12. While the CSA and DEA regulations do 
not define the term ``principal place of business or professional 
practice,'' in one case, a federal court looked to 21 CFR 1301.12(b)(3) 
in evaluating this question and focused on whether the practitioner 
``regularly engaged in the dispensing or administering of controlled 
substances'' at a particular location as determinative of whether a 
separate registration is required at such location. United States v. 
Clinical Leasing, 930 F.3d 394, 395-396 (5th Cir. 1991). That court 
stated: ``If a physician intends to dispense controlled substances from 
a particular location several times a week or month, he must first 
[obtain] a separate registration for the location.'' Id. In another 
case (a DEA administrative proceeding), the agency explained that where 
a practitioner travels to numerous locations to administer controlled 
substances on an ``as-needed and random basis'' and under other 
circumstances that were not indicative of maintaining a principal place 
of professional practice at such locations, the practitioner was not 
required to be separately registered at such locations. Jeffrey J. 
Becker, DDS, 77 FR 72387, 72388 (Dec. 5, 2012).
    It is not necessary for purposes of this proposed rule to attempt 
to define precisely the meaning of the term ``principal place of 
business or professional practice'' or to attempt to examine the 
various scenarios in which that term might apply to a mobile NTP. It is 
sufficient to note that there may be circumstances in which a mobile 
NTP would operate in such a manner that it would be considered to have 
a ``principal place of business or professional practice'' at one or 
more consistent remote locations and, therefore, would need to obtain a 
separate registration at such remote locations under 21 U.S.C. 
822(e)(1). Because DEA has concluded that it is consistent with the 
public health and safety to allow mobile NTPs to operate without 
obtaining such separate registrations at remote locations, the agency 
is hereby proposing to waive this requirement through the promulgation

[[Page 11010]]

of the proposed rule. See 21 U.S.C. 822(d). DEA is proposing that the 
regulations would be amended to specify that operating a mobile NTP 
will be a coincident activity of a registered NTP.
    It should be noted that DEA has always required, with limited 
exceptions, practitioners to have separate registrations in each state 
in which they dispense controlled substances. See, e.g., Clarification 
of Registration Requirements for Individual Practitioners, 71 FR 69478, 
69478 (Dec. 1, 2006) (explaining that a practitioner must maintain a 
DEA registration for each state in which he or she dispenses controlled 
substances because DEA registrations are based on state licenses to 
dispense controlled substances). Thus, under the proposed rule, a 
mobile NTP would be able to only dispense controlled substances in 
states in which the NTP is registered with DEA to dispense controlled 
substances.

D. Why the Proposed Waiver of Registration Is Consistent With the 
Public Health and Safety

    As indicated, the CSA allows DEA to issue a regulation waiving the 
requirement of registration for certain categories of registrants where 
the Administrator finds it consistent with the public health and 
safety. For the reasons discussed above, DEA concludes that allowing 
for the use of mobile NTPs under the conditions specified in this 
proposed rule would increase access to OUD treatment, which will be 
beneficial to the public health and safety. This conclusion is further 
supported by DEA's belief that under the conditions specified in the 
proposed rule, there would be minimal risk of diversion. DEA bases this 
view about the minimal diversion risk on historical information 
gathered from mobile components that have operated or are currently 
operating.
    A review of theft and loss reports from 2005 to 2017 shows that 
NTPs did not distinguish thefts and losses occurring at the registered 
location from those occurring at mobile facilities. There was only one 
report that concluded theft or loss occurred at a mobile NTP. However, 
this mobile NTP is no longer operational as the registrant voluntarily 
surrendered DEA registration. Furthermore, since 2017, there have not 
been any additional mobile NTP reports of thefts or losses of 
controlled substances submitted to DEA.

E. Summary of Costs and Benefits

    DEA conducted an analysis of the costs and benefits of this 
proposed rule, and concludes that its promulgation will result in a net 
cost savings between $1,297,670 and $1,482,272 over a five-year period. 
This proposed rule would enable NTPs to expand their treatment 
availability to patients via mobile units rather than being limited to 
registering and opening additional brick-and-mortar locations only. 
DEA's comparative analysis shows that the cost of operating a mobile 
unit is less than the cost of operating a physical location, yielding 
the aforementioned savings. A complete discussion of the costs and 
benefits of this proposed rule can be found in the Regulatory Analyses 
below.

II. Scope of the Proposed Rule

    This proposed rule describes under what circumstances mobile 
components of NTPs would be able to transport and dispense controlled 
substances away from their registered locations within the same state 
as the registered NTP. The rule also sets forth proposed requirements 
for security, recordkeeping, reporting, and inventory for those mobile 
components that wish to transport controlled substances away from a 
registered location for dispensing at a mobile NTP.
    It is important to note that these mobile components would not be 
permitted to share or transfer controlled substances from one mobile 
component to another while deployed outside of the registered location. 
Nor would mobile components be permitted to act as reverse 
distributors.\5\ Likewise, stationary NTPs with mobile components would 
not be allowed to modify their registrations to authorize their mobile 
components to act as collectors \6\ under 21 CFR 1301.51 and 1317.40. 
Finally, as stated above, these proposed mobile components of NTPs 
would not be authorized to function as hospitals, long-term care 
facilities, or emergency medical service vehicles, and may not 
transport patients.
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    \5\ 21 CFR 1300.01 defines a reverse distributor as a person 
registered with the Administration as a reverse distributor. To 
reverse distribute means to acquire controlled substances from 
another registrant or law enforcement for the purpose of: (1) Return 
to the registered manufacturer or another registrant authorized by 
the manufacturer to accept returns on the manufacturer's behalf; or 
(2) destruction.
    \6\ 21 CFR 1300.01 defines collector as a registered 
manufacturer, distributor, reverse distributor, narcotic treatment 
program, hospital/clinic with an on-site pharmacy, or retail 
pharmacy that is authorized to receive a controlled substance for 
the purpose of destruction from an ultimate user, a person lawfully 
entitled to dispose of an ultimate user decedent's property, or a 
long-term care facility on behalf of an ultimate user that resides 
or has resided at that facility.
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A. Part 1300: Definitions

    In section 1300.01, DEA is proposing to add a definition for mobile 
narcotic treatment programs (mobile NTPs). This definition reflects 
that a mobile NTP is a motor vehicle that serves as a mobile component 
of an NTP, which engages in maintenance and/or detoxification treatment 
with narcotic drugs in schedules II-V, at a location remote from, but 
within the same state as, the registered NTP, and which operates under 
the registration of the NTP. Because the proposed mobile NTP definition 
references a motor vehicle, DEA also proposes to separately define 
``motor vehicle'' as a vehicle propelled under its own motive power and 
lawfully used on public streets, roads, or highways with more than 
three wheels in contact with the ground; a motor vehicle does not 
include a trailer in this context. Therefore, under DEA's proposed 
rule, a trailer could not serve as a mobile NTP.

B. Part 1301: Registration of Manufacturers, Distributors, and 
Dispensers of Controlled Substances

    DEA regulations have always required that all registrants maintain 
effective security to guard against theft and diversion of controlled 
substances. See 21 CFR 1301.71-77. The need for such security applies 
equally in the mobile NTP context. Thus, this NPRM contains provisions 
(described below) that would require NTPs to secure controlled 
substances while operating a mobile component away from the registered 
location.
    Also, as indicated, DEA proposes to revise section 1301.13 to make 
operating a mobile component of an NTP a coincident activity of an 
existing NTP registration, provided the NTP has obtained prior approval 
from the local DEA office. DEA intends to lessen the regulatory burden 
on NTPs by waiving the separate DEA registration requirement, as 
discussed above, and allowing them to operate a mobile component of an 
NTP in the same state as the registered NTP, under its existing 
registration. As a result, the mobile component of an NTP would not 
have to apply for a separate registration, as it would be considered 
coincident activity. Furthermore, DEA proposes to specify in the 
regulations that the records generated during the operations of a 
mobile component of an NTP shall be maintained at the location of the 
registered NTP, rather than requiring such records to be stored at the 
location of the mobile component. This is discussed in part 1304 of the 
proposed

[[Page 11011]]

rule, which is titled Records and Reports of Registrants.
    DEA is proposing to revise section 1301.72 to ensure controlled 
substances in a mobile component of an NTP are protected against theft 
and diversion. To achieve this end, DEA is proposing that the security 
requirements under 21 CFR 1301.72(a)(1) and 21 CFR 1301.72(d) become 
applicable to the mobile components of an NTP. The storage area for 
controlled substances in a mobile component of a NTP must not be 
accessible from outside the vehicle. The proposed requirement to secure 
the controlled substances in a securely locked safe in the conveyance 
will assist in adequately securing the controlled substances. Since 
small quantities of controlled substances will be present in the mobile 
component, DEA is proposing that the safe used by these mobile 
components have safeguards against forced entry, lock manipulation, and 
radiological attacks. The safe must also be bolted or cemented to the 
floor or wall in such a way that it cannot be readily moved. DEA is 
also proposing that the safe be equipped with an alarm system that 
transmits a signal directly to a central protection company or a local 
or State police agency which has a legal duty to respond, or a 24-hour 
control station operated by the registrant, or such other protection as 
the Administrator may approve if there is an attempted unauthorized 
entry into the safe.
    Upon completion of the operation of the conveyance on a given day, 
the conveyance would need to be immediately returned to the registered 
location, and all controlled substances removed from the conveyance and 
secured within the registered location. If the mobile component is 
disabled for any reason (mechanical failure, accident, fire, etc.), the 
registrant would be required to have a protocol in place to ensure that 
the controlled substances on the conveyance are secure and accounted 
for. If the conveyance is taken to an automotive repair shop, all 
controlled substances would need to be removed and secured at the 
registered location.
    Under the proposed rule, registrants would not be required to 
obtain a separate registration for conveyances (mobile components) 
utilized by the registrant to transport controlled substances away from 
registered locations for dispensing within the same state at 
unregistered locations. Vehicles must possess valid county/city and 
state information (e.g., a vehicle information number (VIN) or license 
plate number) on file in the fixed NTP. Registrants will also be 
required to provide proper city/county and state licensing and 
registration to DEA at the time of inspection and prior to transporting 
controlled substances away from their registered location.
    DEA takes this opportunity to remind authorized persons 
transporting controlled substances to dispense at an unregistered 
location that the DEA-approved conveyance they utilize to transport 
these controlled substances is a controlled premise subject to 
administrative inspection pursuant to 21 U.S.C. 880. The CSA includes 
in its definition of controlled premises ``conveyances, where persons 
registered under [21 U.S.C. 823] (or exempt from registration under [21 
U.S.C. 822(d)] or by regulation of the Attorney General) . . . may 
lawfully hold . . . distribute, dispense, administer, or otherwise 
dispose of controlled substances.'' 21 U.S.C. 880(a)(2). Included 
within this section's scope of inspection for controlled premises, the 
CSA grants DEA inspectors the right, ``[e]xcept as may otherwise be 
indicated in an applicable inspection warrant . . . to inspect, within 
reasonable limits and in a reasonable manner, controlled premises and 
all pertinent equipment, finished and unfinished drugs . . . and other 
substances or materials, containers, and labeling found therein.'' 21 
U.S.C. 880(b)(3).
    DEA is aware that state and federal security requirements for 
controlled substances may vary. However, it is the responsibility of 
the registrant to be aware of these requirements and follow both state 
and federal regulations, or whichever has the stricter requirements. 
Registrants and practitioners should continue to consult with their 
State Opioid Treatment Authority or equivalent office to ensure 
compliance, as referenced in DEA April 2000 Narcotic Treatment Program 
Best Practice Guide.
    DEA is proposing to revise 21 CFR 1301.74 to include mobile 
components of DEA-registered NTPs, since the existing regulations do 
not contain such a provision. As described in the proposed revisions to 
section 1301.74, personnel who are authorized to dispense controlled 
substances for narcotic treatment must ensure proper security measures 
and patient dosage. For example, DEA is proposing that persons enrolled 
in any NTP, including those who received treatment at a mobile NTP, 
would be required to wait in an area that is physically separated from 
the narcotic storage and dispensing area by a physical entrance such as 
a door or other entryway.
    Under the proposed revisions, the distribution and delivery of 
narcotic drugs in schedules II-V to mobile NTPs would only be permitted 
by the registrant at the registrant's registered location. Persons who 
are permitted to deliver narcotic drugs in schedules II-V to mobile 
NTPs will not be able to: Receive narcotic drugs in schedules II-V from 
other mobile NTPs or any other entity; deliver narcotic drugs in 
schedules II-V to other mobile NTPs or any other entity; or conduct 
reverse distribution of controlled substances on a mobile NTP. Any 
controlled substances being transported for disposal from the 
dispensing location of the mobile component shall be secured and 
disposed of in compliance with part 1317 and all other applicable 
federal, state, tribal, and local laws and regulations.
    Finally, the proposed physical security controls of mobile 
components would need to be implemented by the NTP pursuant to 21 CFR 
1301.72 and 1301.74. In the event of a security breach in which 
controlled substances are lost or stolen, the registrant must determine 
the significance of the loss and look to the theft and loss reporting 
requirements in 21 CFR 1301.74(c).

C. Part 1304: Records and Reports of Registrants

    Under the proposed rule, the recordkeeping requirements of 21 CFR 
1304 would apply to mobile components of NTPs. DEA is proposing 
revisions to sections 1304.04 and 1304.24 to include mobile components. 
As with brick and mortar NTPs, the records of the mobile components 
would be stored at the registered location of the NTP in a manner that 
meets all applicable security and confidentiality requirements, and 
must be readily retrievable.
    Currently 21 CFR 1304.24(b) requires that a brick and mortar NTP 
maintain the records, required by 21 CFR 1304.24(a), in a dispensing 
log at the NTP site. It is understood that this log is in paper form. 
As an alternative to maintaining a paper dispensing log, DEA is 
proposing that an NTP or its mobile component may also use an 
automated/computerized data processing system for the storage and 
retrieval of the program's dispensing records, if a number of 
conditions are met: The automated system maintains the same information 
required in 21 CFR 1304.24(a) for paper records; the automated system 
has the capability of producing a hard copy printout of the program's 
dispensing records; the NTP or its mobile component prints a hard copy 
of each day's dispensing log, which is then initialed appropriately by 
each person who dispensed medication

[[Page 11012]]

to the program's patients; and the automated system is approved by 
DEA.\7\
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    \7\ This is not a new alternative. DEA has previously informed 
NTPs that they could use an automated/computerized data processing 
system meeting these requirements for the storage and retrieval of 
their dispensing records. See Narcotic Treatment Programs Best 
Practice Guideline (April 2000), https://www.deadiversion.usdoj.gov/pubs/manuals/narcotic/narcotic.pdf pp. 14, 20, and 21.
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    DEA also is proposing that the NTP's computer software program be 
required to be capable of producing accurate summary reports for the 
brick and mortar location and its mobile component, for any time-frame 
selected by DEA personnel during an investigation. Further, if these 
summary reports are maintained in hard copy form, DEA proposes that 
they should be kept in a systematically organized file located at the 
registered site of the NTP. Additionally, DEA is also proposing that 
the NTP or its mobile component be required to maintain an off-site 
back-up of all computer generated program information.
    Finally, DEA is proposing that NTPs be required to retain all 
records for the brick and mortar NTP as well as the mobile component 
two years from the date of execution. This time period is the same 
period as that required by 21 CFR 1304.04(a). However, because some 
states require that records be retained for longer than two years, the 
NTP should contact its State Opioid Treatment Authority for information 
about state requirements.

Regulatory Analyses

Summary of Costs and Benefits

    DEA examined each of the provisions of the proposed rule to 
estimate its economic impact. DEA's analytic approach focuses on 
comparing the costs and/or cost-savings of a ``no action'' baseline 
regulatory environment with the costs and/or cost-savings of the 
regulatory environment that would result from the promulgation of this 
proposed rule. This is the standard analytic framework codified in the 
OMB Circular A-4, published on September 17, 2003. This proposed rule 
is an enabling rule designed to expand access to medication-assisted 
treatment (MAT) offered by NTPs in underserved communities. Previously, 
DEA had only authorized mobile NTPs on an ad hoc basis, and had placed 
a moratorium on further such authorizations in 2007. Thus, DEA compared 
the costs of delivering MAT services in a baseline regulatory 
environment in which no new mobile NTPs are authorized, to the costs of 
delivering an equivalent level of MAT services in the proposed 
regulatory environment in which a registered NTP may begin to operate a 
mobile component as a coincident activity. This analysis, detailed 
below, finds that this proposed rule will result in a cost savings for 
DEA registered NTPs in the form of reduced startup, labor, and 
operating costs of MAT services delivered via a mobile component. DEA 
also recognizes that this proposed rule is likely to result in benefits 
in the form of economic burden reductions (health care costs, criminal 
justice costs, and lost productivity costs), as access to treatment for 
underserved communities is expected to expand. However, DEA does not 
have a good basis to estimate the totality of this benefit with any 
accuracy since data on the number of patients treated via existing 
mobile components are not available. Thus, while these benefits are not 
quantified, DEA expects that this proposed rule will result in a net 
benefit to society.
    MAT has been shown to be an effective opioid treatment option--a 
2014 meta-analysis concluded that MAT has significantly increased 
treatment retention and decreased illicit opioid use.\8\ While it is 
estimated that 2 million Americans have an OUD involving medications, 
and another 526,000 had an OUD involving heroin, in 2018, only 19.7% of 
Americans with an OUD received any specialty treatment.\9\ A review of 
private insurance data found that, following an opioid-related 
hospitalization, fewer than 11% of covered patients received MAT in 
combination with psychosocial services. An additional 6% received MAT 
without psychosocial services, and 43% received psychosocial services 
only.\10\ As of 2016, over 90% of NTPs were located in urban areas, 
forcing rural patients to travel great distances to receive their doses 
of medication.\11\ Some rural patients report that the burden of 
traveling daily to receive their medication effectively prevents them 
from working,\12\ further increasing the risk that they will 
discontinue treatment.\13\
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    \8\ Thomas C.P., Fullerton C.A., Kim M., et al. Medication-
Assisted Treatment with Buprenorphine: Assessing the Evidence. 
Psychiatry Serv. 2014;65(2):158-170. doi:10.1176/appi.ps.201300256.
    \9\ Substance Abuse and Mental Health Services Administration. 
(2019). Key substance use and mental health indicators in the United 
States: Results from the 2018 National Survey on Drug Use and Health 
(HHS Publication No. PEP19-5068, NSDUH Series H-54). Rockville, MD: 
Center for Behavioral Health Statistics and Quality, Substance Abuse 
and Mental Health Services Administration.
    \10\ Ali, M.M., Mutter, R. (2016). The CBHSQ Report: Patients 
Who Are Privately Insured Receive Limited Follow-up Services After 
Opioid-Related Hospitalizations. Rockville, MD: Substance Abuse and 
Mental Health Services Administration, Center for Behavioral Health 
Statistics and Quality. Retrieved by ONDCP on August 18, 2017 at 
http://www.samhsa.gov/data/sites/default/files/report_2117/ShortReport-2117.pdf.
    \11\ Leonardson J., Gale J.A. Distribution of Substance Abuse 
Treatment Facilities Across the Rural--Urban Continuum. 2016. 
https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf.
    \12\ Sigmon S.C. Access to Treatment for Opioid Dependence in 
Rural America: Challenges and Future Directions. JAMA Psychiatry. 
2014;71(4):359-360. doi:10.1001/jamapsychiatry.2013.4450.
    \13\ Leonardson J., Gale J.A. Distribution of Substance Abuse 
Treatment Facilities Across the Rural--Urban Continuum. 2016. 
https://muskie.usm.maine.edu/Publications/rural/pb35bSubstAbuseTreatmentFacilities.pdf.
---------------------------------------------------------------------------

    Because DEA is not currently authorizing new mobile NTPs, for an 
NTP registrant to provide MAT services to patient populations with 
little or no access to an NTP, the registrant would be required to 
register and open another brick-and-mortar location in the underserved 
geographic area. The many fixed capital and operating expenses 
associated with the startup and ongoing operation of a new facility 
discourage providers from doing this. For example, registrants would be 
required to obtain another NTP registration at $244 per year and incur 
the cost of renting additional office space, and ensuring that the new 
location meets DEA requirements, that it is appropriately licensed by 
the state, and that it is accredited by an accrediting organization 
approved by the Substance Abuse and Mental Health Services 
Administration (SAMHSA). Additionally, opening a new location would 
entail additional staffing and facilities costs. Under the proposed 
regulatory environment, registrants would be able to operate a mobile 
component as a coincident activity of their existing facility, 
foregoing the expenses of a brick-and-mortar expansion in favor of the 
comparatively lower cost of operating a mobile component.
    DEA believes it is reasonable to assume that in any given 
geographic region, the fixed capital expenses of opening a new brick-
and-mortar location (most significantly office rent) will always exceed 
the capital expenses of operating a mobile component (most 
significantly the purchase price of a conveyance to be converted to a 
mobile NTP). These major capital expenses are discussed and compared in 
detail in the following paragraph; however, it is important to first 
set boundaries for this analysis by discussing what costs will not be 
included and why. DEA assumes that two significant expenses are the 
same for both activities, and therefore, are excluded from the 
analysis: The

[[Page 11013]]

labor required to dispense narcotic drugs in schedules II-V, and the 
cost to outfit an NTP office or mobile conveyance with sufficient 
medical and office equipment. Labor costs are considered to be equal 
for both activities as the proposed rule does not change the 
requirements for the types of personnel that are authorized to dispense 
controlled substances. Whether an NTP expands via a brick-and-mortar 
location or mobile component, DEA assumes that the registrant would 
need to expand the quantity and type of labor required to dispense 
narcotic drugs in schedules II-V, at the same rate for both. However, 
it is likely that brick and mortar locations would be required to 
employ a medical administrative assistant to handle records management, 
billing, and reception; functions that a mobile component of an 
existing NTP would outsource to the labor provided by the parent brick 
and mortar NTP. DEA assumes that a new brick and mortar NTP requires 
one medical assistant, and calculates that the total annual 
compensation for this medical assistant to be $48,994.\14\
---------------------------------------------------------------------------

    \14\ The total annual cost of compensation is based on the 
median annual wage for Occupation Code 31-9092 Medical Assistants 
($33,610). May 2018 National Occupational Employment and Wage 
Estimates, United States, BUREAU OF LABOR STATISTICS, https://www.bls.gov/oes/current/oes_nat.htm#31-9092 (last visited November 
11, 2019). Average benefits for employees in private industry is 
31.4% 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 11, 
2019). The 31.4% of total compensation equates to 45.8% (31.4% / 
68.6%) load on wages and salaries. $33,610 x (1 + 0.4577) = 
$48,994.17.
---------------------------------------------------------------------------

    DEA also recognizes that there are startup costs that will be the 
same for both activities. This includes the purchase of medical 
equipment and basic office supplies, and the installation of a section 
1301.72(a)(1)(iii)-compliant alarm system. Such startup costs are 
accordingly also omitted from this analysis. Whether MAT services are 
being rendered via a mobile conveyance or traditional office 
environment, the same type and quantity of labor, medical equipment, 
and security equipment is assumed needed to deliver the same amount of 
treatment while adhering to DEA regulations.
    According to the National Association of Realtors, the average 
annual price per square foot for office space throughout the United 
States was $46 in the first quarter of 2017.\15\ Based on DEA's 
knowledge of registrant operations, NTPs require a minimum of 1,000 
square feet of office space, which equates to a conservative estimate 
of yearly rent for NTPs of $46,000. Assuming the NTP agrees to a five-
year lease, the present value of the cost of five years of office rent 
is $188,609.08 at a 7% discount rate and $210,666.53 at a 3% discount 
rate. In comparison, commercial vehicles suitable for service as a 
mobile NTP range in price from $30,000 to $40,000.\16\ Furthermore, the 
proposed rule would not require an NTP to obtain a separate 
registration for the mobile component at a cost of $244 per year, which 
is a cost that a new brick-and-mortar location would be forced to 
incur. The present value of registration costs per registrant over a 
five-year period is $1,000.45 at a 7% discount rate and $1,117.45 at a 
3% discount rate.
---------------------------------------------------------------------------

    \15\ ``2017 Q1 Commercial Real Estate Market Survey.'' 
www.nar.realtor, 2017, www.nar.realtor/research-and-statistics/
research-reports/commercial-real-estate-market-survey/2017-q1-
commercial-real-estate-market-survey.
    \16\ Price range gathered by searching commercialtrucktrader.com 
for class 1, 2, and 3 light duty box trucks and class 4, 5, and 6 
medium duty box trucks. These vehicle classes were used based on 
DEA's knowledge of the types of vehicles currently used by 
registrants for mobile components.
---------------------------------------------------------------------------

    There are also several operating expenses that are unique to a 
mobile conveyance that should be factored into this analysis. The first 
is the cost of the narcotic safe and associated installation costs. DEA 
recognizes that while both a mobile conveyance and a traditional NTP 
office require a safe, the confined space of a mobile conveyance likely 
requires some amount of customization in the installation process in 
order to meet the requirements of 21 CFR 1301.72(a)(1). To account for 
this unique installation cost, DEA doubled the highest quoted price of 
the safe \17\ and attributed that full amount to the mobile conveyance, 
while attributing only the purchase price of the safe to the cost of a 
brick-and-mortar NTP. The second set of costs unique to the operation 
of a mobile component are maintenance and transportation expenses such 
as fuel, repair, insurance, permits, licenses, tires, tolls, and driver 
wages and benefits. The American Transportation Research Institute 
estimates that the average marginal cost per mile of operating a 
straight truck in 2016 (the most recent year in which this figure was 
updated) was $1.63. This figure is inclusive of all previously listed 
expenses.\18\ Based on DEA's knowledge of the operations of existing 
mobile NTPs, DEA estimates that a mobile NTP operating under the 
proposed rule would travel no greater than 5,000 miles per year 
(roughly 100 miles per week). This equates to an annual transportation 
and maintenance expense of $8,150.00 per year. DEA requests input 
concerning these assumptions especially in light of the needs for this 
service in rural locations where clients may be located far from one 
another.
---------------------------------------------------------------------------

    \17\ Quotes for safes meeting DEA's regulatory specifications 
were sourced online from three leading manufacturers: Healthcare 
Logistics, Medicus Health and Harloff. The highest price quoted was 
$899.00. Doubling the price to account for installation yields a 
total cost of $1,798.00.
    \18\ Hooper, Alan, and Dan Murray. An Analysis of the 
Operational Costs of Trucking: 2017 Update. ATRI, American 
Transportation Research Institute, 2017, atri-online.org/wp-content/uploads/2017/10/ATRI-Operational-Costs-of-Trucking-2017-10-2017.pdf.
---------------------------------------------------------------------------

    Comparing the present value of the costs associated with operating 
a mobile NTP over a five-year period with the present value of the 
costs associated with opening a brick-and-mortar NTP over a five-year 
period yields a net present value of cost savings between $318,855 (at 
a 7% discount rate) and $359,131 (at a 3% discount rate) for the 
operation of a mobile NTP. The comparison of costs between the baseline 
and proposed regulatory environment are summarized in the tables below:
BILLING CODE 4410-09-P

[[Page 11014]]

[GRAPHIC] [TIFF OMITTED] TP26FE20.007

BILLING CODE 4410-09-C
    DEA does not have a systematic method for estimating how many NTP 
registrants that are currently deterred or prevented from opening 
additional brick-and-mortar sites due to costs might take advantage of 
this enabling rule to begin operating a mobile NTP. DEA also recognizes 
that, because of their fixed locations, brick-and-mortar sites are more 
limited in the geographic area they can reasonably serve than are 
mobile units. DEA conservatively estimates, however, that this number 
would at least equal the number of NTP registrants that operated mobile 
components at some point in the previous five years under ad hoc 
agreements with DEA field offices. There have been 19 such NTP 
registrants, and there are currently eight with mobile components still 
in operation. Therefore, DEA considers it a reasonable assumption that 
at least 11 additional NTP registrants would begin operating a mobile 
NTP after the promulgation of this rule, bringing the total number of 
mobile NTPs to at least the previous total of 19. This yields a total 
cost savings for all of those NTPs over a five-year period of 
$3,507,405 \20\ (at a 7% discount rate) to $3,950,441 \21\ (at a 3% 
discount rate).
---------------------------------------------------------------------------

    \19\ The cost of a safe is a one-time expense incurred in the 
first year of operation.
    \20\ The proposed regulatory environment yields a five-year cost 
savings (discounted at 7%) of $318,855 over the current regulatory 
environment. $318,855 x 11 = $3,507,405.
    \21\ The proposed regulatory environment yields a five-year cost 
savings (discounted at 3%) of $359,131 over the current regulatory 
environment. $359,131 x 11 = $3,950,441.
---------------------------------------------------------------------------

    For the reasons outlined in the comparative analysis discussed 
above, DEA concludes that moving from the baseline regulatory 
environment to the regulatory environment of the proposed rule results 
in a cost reduction for NTP registrants that wish to expand their 
services to new geographic areas, and will spur an increase in the 
number of mobile NTPs. Therefore, this proposed rule is a deregulatory 
action that will result in a net cost savings between $3,507,405 and 
$3,950,441.

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 12866, 13563, and 13771. Executive Order 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). Executive Order 13563 is 
supplemental to and reaffirms the principles, structures, and 
definitions governing regulatory review established in Executive Order 
12866. DEA expects that this proposed rule will not have an annual 
effect on the economy of $100 million or more in at least one year and 
therefore is not an economically significant regulatory action. DEA 
examined each of the provisions of the proposed rule to estimate its 
economic impact, comparing the costs and/or cost-savings of a ``no 
action'' baseline regulatory environment with the costs and/or cost-
savings of the regulatory environment that would result from the 
promulgation of this proposed rule. This proposed rule is an enabling 
rule designed to expand the supply of medication-assisted treatment 
(MAT) providers, and DEA currently has only authorized mobile NTPs on 
an ad hoc basis, with a present moratorium on further such 
authorizations. Thus, DEA compared the costs of delivering MAT

[[Page 11015]]

services in a baseline regulatory environment in which no new mobile 
NTPs are authorized, to the costs of delivering an equivalent level of 
MAT services in the proposed regulatory environment in which a 
registered NTP may begin to operate a mobile component as a coincident 
activity, subject to the provisions of this proposed rule. DEA's 
analysis, summarized in the preceding section, finds that this proposed 
rule will result in a net cost-savings between $3,507,405 and 
$3,950,441, and is therefore below the $100 million threshold.
    For a number of years, DEA has allowed registered NTPs to utilize 
mobile units as part of their programs through special arrangements 
with local DEA field offices. The use of these mobile units was in 
response to the opioid epidemic that is currently affecting the nation. 
With the number of deaths attributed to overdoses increasing, the 
demand for access to medication-assisted treatment increased. In many 
areas, this has resulted in long wait lists and high service fees for 
services provided by NTPs. Alternative guidelines and methods were 
sought to increase accessibility to treatment for people with SUD 
including OUD, especially in rural areas or areas where NTPs are not 
accessible, or to allow those who have health conditions that prevent 
them from traveling long distances to receive maintenance or 
detoxification treatment. Mobile units associated with the registered 
NTP were seen as an alternative because they increased accessibility to 
treatment in the areas that needed it.
    This NPRM builds on the existing experience and provides additional 
flexibility for NTPs in operating mobile units, subject to regulatory 
restrictions put into place to prevent the diversion of controlled 
substances. DEA is proposing to revise 21 CFR 1301.13 to make operating 
a mobile component of an NTP a coincident activity of an existing NTP 
registration, and intends to lessen the regulatory burden on NTPs by 
waiving the separate DEA registration requirement. These mobile units 
would be required to maintain effective security to guard against theft 
and diversion of controlled substances in accordance with 21 CFR 
1301.72. The mobile NTPs would also be subject to the recordkeeping 
requirements in 21 CFR 1304.04 and 1304.24. Many of the current mobile 
units are already following these regulatory requirements. This 
proposed rule, once finalized, will ensure that these regulatory 
requirements can be enforced consistently over any current or future 
NTP wishing to operate a mobile unit.
    Thus, this proposed rule, once promulgated, would enable any NTP 
registered with DEA to engage in an activity that was previously 
authorized through special arrangements with DEA field offices. 
Furthermore, DEA's purpose for allowing registered NTPs to operate a 
mobile unit as a coincident activity is to expand the availability of 
MAT in accordance with the priorities outlined in The President's 
Commission on Combating Drug Addiction and The Opioid Crisis, published 
on November 1, 2017.
    The Office of Information and Regulatory Affairs (OIRA) has 
determined that the proposed rule is a ``significant regulatory 
action'' under Executive Order 12866. Accordingly, this rule has been 
reviewed by OIRA.
    Executive Order 13771 was issued on January 30, 2017, and published 
in the Federal Register on February 3, 2017. 82 FR 9339. Section 2(a) 
of Executive Order 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 Executive Order 13771 requires that the new incremental 
costs associated with new regulations, to the extent permitted by law, 
be offset by the elimination of existing costs associated with at least 
two prior regulations. Guidance from OMB, issued on April 5, 2017, 
explains that the above requirements only apply to each new 
``significant regulatory action that . . . . imposes costs.'' Although 
this proposed rule is a significant regulatory action under Executive 
Order 12866, this proposed rule is expected to be an Executive Order 
13771 ``deregulatory action,'' as defined by OMB--that is, a regulatory 
action with total costs less than zero. The result of DEA's analysis 
shows that moving from the baseline regulatory environment to the 
regulatory environment of the proposed rule results in a cost reduction 
for NTP registrants that wish to serve new geographic areas, and will 
increase the number of mobile NTP units. Therefore, this proposed rule 
is expected to be a deregulatory action that will result in a net cost 
savings between $3,507,405 and $3,950,441.

Executive Order 12988, Civil Justice Reform

    This proposed rule 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, establish clear 
legal standards, and reduce burden.

Executive Order 13132, Federalism

    This proposed rule 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 on 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 substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
government and Indian tribes.

Regulatory Flexibility Act

    In accordance with the Regulatory Flexibility Act (RFA), DEA 
evaluated the impact of this rule on small entities. DEA's evaluation 
of economic impact by size category indicates that the rule will not, 
if promulgated, have a significant economic impact on a substantial 
number of these small entities.
    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.

Description and Estimate of the Number of Small Entities

    To determine the proposed rule's effect on small entities, DEA must 
first calculate the total number of affected entities. To do this, DEA 
must determine the total number of NTP entities in the United States, 
as those are the entities that are able to take advantage of this 
enabling rule.
    DEA begins with the number of relevant DEA registrations--that is, 
NTP registrations. The number of NTP entities differs from the number 
of NTP registrations, however, because NTP entities often hold more 
than one DEA registration, such as where a registrant handles 
controlled substances at

[[Page 11016]]

multiple locations, requiring the entity to hold registrations for each 
of these locations. DEA does not, in the general course of business, 
collect or otherwise maintain information regarding associated or 
parent organizations holding multiple registrations. Therefore, to 
derive the total number of NTP entities from the number of NTP 
registrations, DEA needs to develop a relationship, or ratio, between 
the total number of NTP registrations and the number of entities 
possessing those registrations.
    To do so, DEA first determined the North American Industry 
Classification System (NAICS) \22\ classification codes that most 
closely represent the affected business activity--namely, NTP activity. 
The business activity and its corresponding representative NAICS codes 
are listed in the table below.
---------------------------------------------------------------------------

    \22\ The North American Industry Classification System (NAICS) 
is the standard used by the Federal statistical agencies in 
classifying business establishments for the purpose of collecting, 
analyzing, and publishing statistical data related to the U.S. 
business economy. https://www.census.gov/eos/www/naics/ (last 
accessed: 1/10/2019).

            Business Activity and Representative NAICS Codes
------------------------------------------------------------------------
         Business activity                       NAICS codes
------------------------------------------------------------------------
Narcotic Treatment Program........  622210--Psychiatric and Substance
                                     Abuse Hospitals.
                                    621420--Outpatient Mental Health and
                                     Substance Abuse Centers.
------------------------------------------------------------------------

    DEA then gathered economic data for those codes using the U.S. 
Census Bureau, Statistics of U.S. Businesses (SUSB). Specifically, DEA 
used the SUSB data to determine the number of ``firms'' and the number 
of ``establishments'' in the United States that correspond to each 
relevant NAICS code. (For the purposes of this analysis, the term 
``firm'' as defined in the SUSB is used interchangeably with ``entity'' 
as defined in the RFA.) From this, DEA calculated a firm-to-
establishment ratio--i.e., the average number of organizations for each 
establishment engaged in these activities. DEA calculated this ratio to 
be 0.53, as listed in the table below. In other words, each 
organization engaged in activities covered by these NAICS codes 
operated, on average, slightly fewer than two establishments.

                                    Firm-to-Establishment Ratio by NAICS Code
----------------------------------------------------------------------------------------------------------------
                                                                                                    Firm to
                       NAICS code                         Number of firms       Number of        establishment
                                                                              establishments         ratio
----------------------------------------------------------------------------------------------------------------
Total Narcotic Treatment Program.......................              5,889             11,109               0.53
                                                        --------------------------------------------------------
622210--Psychiatric and Substance Abuse Hospitals......                417                635                .66
621420--Outpatient Mental Health and Substance Abuse                 5,472             10,474                .52
 Centers...............................................
----------------------------------------------------------------------------------------------------------------
Source: SUSB.\23\ (Accessed 5/1/2017)

    Because an entity generally must obtain a separate registration 
``at each principal place of business or professional practice'' where 
it manufactures, distributes, or dispenses a controlled substance, see 
21 U.S.C. 822(e)(1), the number of NTP establishments should be roughly 
equivalent to the number of DEA registrations for NTPs. Thus, DEA 
applied the calculated firm-to-establishment ratio of 0.53 to the 1,605 
NTP registrations in DEA's database to estimate the number of NTP 
entities, resulting in an estimate of 851 NTP entities in the United 
States. The table below summarizes this calculation.
---------------------------------------------------------------------------

    \23\ Data for NAICS codes related to NTPs are based on the 2014 
SUSB Annual Datasets by Establishment Industry, December 2016. SUSB 
annual or static data includes: Number of firms, number of 
establishments, employment, and annual payroll for most U.S. 
business establishments. The data are tabulated by geographic area, 
industry, and employment size of the enterprise. The industry 
classification is based on 2012 North American Industry 
Classification System (NAICS) codes.

                                     Number of Entities by Business Activity
----------------------------------------------------------------------------------------------------------------
                                                             Number of          Entity to
          Business activity               NAICS code       registrations/     establishment        Number of
                                                           establishment          ratio             entities
----------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program..........     622210, 621420              1,605               0.53                851
                                                        --------------------------------------------------------
    Grand Total.....................  .................              1,605  .................                851
----------------------------------------------------------------------------------------------------------------

    Thus, based on these calculations, DEA estimates that 851 entities 
could currently make use of the proposed rule, including the eight NTP 
entities that currently operate mobile NTP components. Of these, DEA 
estimates that at least an additional 11 entities will choose to 
operate a mobile NTP as a coincident activity in response to the 
proposed rule, matching the previous total of 19 mobile NTPs that were 
in operation over the previous five years. Because the proposed rule is 
an enabling rule and thus does not affect entities that choose not to 
change their behavior in response to it, only NTP entities that choose 
to establish mobile NTP units would be affected by the rule. Therefore, 
DEA estimates that 1.29% (11 of 851) of total NTP entities in the

[[Page 11017]]

United States would be affected by this proposed rule.
    To estimate the number of NTP entities that are small entities for 
RFA purposes, DEA used a process similar to that used to estimate the 
total number of NTP entities. As described above, U.S. Small Business 
Administration (SBA) \24\ size standards--based on the number of 
employees or annual receipts, depending on the industry--determine what 
constitutes a ``small entity'' under the RFA. The SBA has established 
these size standards for business activities corresponding to each 
NAICS code. The SBA size standards for each of the NAICS codes that 
best correspond to NTPs are listed below: Firms below this SBA size 
standard (based on annual receipts for these codes) are small firms--
and thus small entities under the RFA.
---------------------------------------------------------------------------

    \24\ The SBA is an independent agency of the Federal Government 
to aid, counsel, assist, and protect the interests of small business 
concerns, to preserve free competitive enterprise, and to maintain 
and strengthen the overall economy of the nation. https://www.sba.gov/about-sba (last accessed: 1/10/2019).

                                               SBA Size Standards
----------------------------------------------------------------------------------------------------------------
                                                                            Size standards ($    Size standards
               NAICS codes                           Description                million in         (number of
                                                                             annual receipts)      employees)
----------------------------------------------------------------------------------------------------------------
622210..................................  Psychiatric and Substance Abuse                38.5  .................
                                           Hospitals.
621420..................................  Outpatient Mental Health and                     15  .................
                                           Substance Abuse Centers.
----------------------------------------------------------------------------------------------------------------
Source: SBA, February 26, 2016. (Accessed 5/1/2017)

    DEA used SUSB data to estimate the number of small firms for each 
of these NAICS codes. In 2012, the last year for which the SUSB has 
published the necessary receipts data,\25\ 180 of 411 (43.78%) firms 
within code 622210 fell below the SBA size standard and thus were small 
firms.\26\ 4,369 of 4,987 (87.61%) firms within code 621420 fell below 
the standard. DEA assumes that these percentages of small firms for 
each code have remained constant in recent years. DEA then applied 
these percentages to the updated totals found in the 2014 SUSB Annual 
Datasets by Establishment Industry, resulting in approximately 183 
firms (43.78% of the total 417) within code 622210 and 4,794 firms 
(87.61% of the total 5,472) within code 621420 classified as small 
firms. Combining these values indicates that, for these codes, 4,977 of 
5,889 firms, or 84.51%, are small firms. Thus, since these are the 
NAICS codes that most closely correspond to NTP entities, DEA estimates 
that 84.51% of NTP entities are small firms. As described above, DEA 
has concluded that there are roughly 851 total NTP entities in the 
United States. Accordingly, DEA estimates that 719 (84.51%) of the 
total 851 NTP entities are small entities. The analysis is summarized 
in the table below.
---------------------------------------------------------------------------

    \25\ SUSB receipts data are available only for Economic Census 
years (years ending in 2 and 7). Thus, DEA used SUSB data from 2012, 
the most recent available annual receipt data.
    \26\ SUSB data gives the number of firms for each NAICS code 
within a series of ranges of annual receipts. Thus, to determine the 
number of firms falling below the SBA size standard, DEA added 
together the number of firms in each range falling completely below 
the SBA standard. Because the SBA size standard for code 622210 
falls within the middle of a range, DEA's calculations may slightly 
underestimate the number of small firms for this code.

                                            Summary of Registration, Establishment, Entity, and Small Entity
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of          Entity to
                    Business activity                        registrations/     establishment        Number of        Percent small     Number of small
                                                             establishments         ratio             entities           entities           entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program...............................              1,605               0.53                851              84.51                719
Percent Small Entity.....................................  .................  .................  .................  .................             84.51%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In consultation with the SBA's Office of Advocacy, DEA has adopted 
the SBA standard that the amount of small entities affected by a 
proposed rule is ``substantial'' if 30% or more of the relevant group 
of small entities will be affected by the rule. As described in the 
Summary of Costs and Benefits section, this proposed rule is an 
enabling rule and a deregulatory action resulting in a total cost 
savings of at least $3,507,405 over a five-year period. The proposed 
rule allows NTP registrants another option for expanding the reach of 
their services, if they so choose, without requiring that current or 
future NTP registrants change their business practices or incur any 
costs. DEA estimates that only an additional 11 entities will choose to 
operate a mobile NTP as a coincident activity in response to the 
proposed rule. Because the proposed rule is an enabling rule and thus 
does not affect entities that do not change their behavior in response 
to it, only these 11 NTP entities and the 8 NTPs currently operating 
units under ad hoc agreements are affected by the rule. Therefore, DEA 
estimates that 2.23% (19 of 851) of total NTP entities in the United 
States are affected by this proposed rule. DEA estimates that 11 NTPs 
not already operating a mobile NTP (or 1.29% of all NTPs) will choose 
to operate a mobile unit. DEA has no reason to conclude that the 
percentage of small NTP entities that begin operating mobile components 
in response to the rule will differ from the percentage of total NTPs 
(11 of 851, or 1.29%), especially since most NTP entities are small. 
Thus, DEA estimates that 1.29% (9 of the 719 \27\) of small NTP 
entities will choose to begin operating a mobile NTP as a coincident 
activity in response to the rule.
---------------------------------------------------------------------------

    \27\ 0.0129 x 719 = 9.2751. Rounding down to the nearest whole 
number yields 9.
---------------------------------------------------------------------------

Estimating Impact on Small Entities

    The 9 affected small entities are estimated to realize the same 
cost savings as other affected entities, as calculated above: Between 
$318,855 (at a 7% discount rate) and $359,131 (at a 3% discount rate) 
per entity over a five-

[[Page 11018]]

year period. DEA generally considers impacts that are greater than 3% 
of yearly revenue to be a ``significant economic impact'' on an entity, 
and recognizes that this amount of cost savings rises above that 
threshold for those small entities. However, since the percent of 
affected small entities is less than 30% (1.29%), this proposed rule 
does not impact a substantial number of small entities. Therefore, this 
proposed rule does not rise to the level of certification as 
economically significant.
    The table below summarizes the analysis.

                                               Summary of Analysis
----------------------------------------------------------------------------------------------------------------
                                   Estimated number   Estimated number
        Business activity         of small entities  of affected small  Percentage of small   Economic impact of
                                   (establishments)       entities        entities affected       compliance
----------------------------------------------------------------------------------------------------------------
Narcotic Treatment Program......                719                  9  1.29 (Not            Not significant.
                                                                         Substantial).
----------------------------------------------------------------------------------------------------------------

    DEA examined the economic impact of the proposed rule for each 
affected industry for various size ranges. Based on the analysis above, 
and because of these facts, DEA certifies this proposed 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 annually for 
inflation) in any 1 year.'' Therefore, neither a Small Government 
Agency Plan nor any other action is required under UMRA of 1995.

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information 
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose new recordkeeping or reporting 
requirements on State or local governments, individuals, businesses, or 
organizations. Although the proposed rule revises certain recordkeeping 
and reporting provisions to explicitly apply them to mobile NTPs, these 
provisions already apply to NTPs in general and thus do not impose any 
new collection of information requirement.

List of Subjects

21 CFR Part 1300

    Chemicals, traffic control.

21 CFR Part 1301

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

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

    For the reasons stated in the preamble, DEA proposes to amend 21 
CFR parts 1300, 1301, and 1304 as follows:

PART 1300--DEFINITIONS

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

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

0
2. In Sec.  1300.01(b), add in alphabetical order the definition of 
``Mobile Narcotic Treatment Program'' and ``Motor vehicle'' to read as 
follows:


Sec.  1300.01  Definitions relating to controlled substances.

* * * * *
    (b) * * *
    Mobile Narcotic Treatment Program means a motor vehicle, as defined 
in this section, that serves as a mobile component (conveyance) that is 
operating under the registration of a narcotic treatment program, and 
engages in maintenance and/or detoxification treatment with narcotic 
drugs in schedules II-V, at a location remote from, but within the same 
State as, its registered location. Operating a mobile narcotic 
treatment program is a coincident activity of an existing narcotic 
treatment program listed in 21 CFR 1301.13(e).
    Motor vehicle means a vehicle propelled under its own motive power 
and lawfully used on public streets, roads, or highways with more than 
three wheels in contact with the ground. This term does not include a 
trailer.
* * * * *

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

0
3. The authority citation for part 1301 continues 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 unless otherwise noted.

0
4. In Sec.  1301.13, revise paragraph (e)(1)(vii) in the table, and add 
paragraph (e)(4) to read as follows:


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

* * * * *
    (e) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Application    Registration
          Business activity              Controlled substances     DEA application forms       fee ($)     period (years)  Coincident activities allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(vii) Narcotic Treatment Program       Narcotic Drugs in         New-363, Renewal-363a...             244               1  May operate one or more
 (including compounder).                Schedules II-V.                                                                     mobile narcotic treatment
                                                                                                                            programs as defined under
                                                                                                                            Sec.   1300.01(b), provided
                                                                                                                            approval has been obtained
                                                                                                                            under Sec.   1301.13(e)(4).
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    (4) For any narcotic treatment program intending to operate a 
mobile narcotic treatment program, the registrant must notify the local 
DEA

[[Page 11019]]

office, in writing, its intent to do so, and the narcotic treatment 
program must receive explicit written approval from the local DEA 
office prior to operating the mobile narcotic treatment program. The 
mobile narcotic treatment program may only operate in the same State in 
which the narcotic treatment program is registered.
    (i) Registrants are not required to obtain a separate registration 
for conveyances (mobile components) utilized by the registrant to 
transport controlled substances away from registered locations for 
dispensing at unregistered locations as part of a mobile narcotic 
treatment program. Vehicles must possess valid county/city and state 
information (e.g., a vehicle identification number (VIN) or license 
plate number) on file at the registered location of the fixed narcotic 
treatment program. Registrants are also required to provide proper 
city/county and state licensing and registration to DEA at the time of 
inspection, and prior to transporting controlled substances away from 
their registered location.
    (ii) A mobile narcotic treatment program is not permitted to 
reverse distribute, share, or transfer controlled substances from one 
mobile component to another mobile component while deployed outside of 
the registered location. Stationary narcotic treatment programs with 
mobile components are not allowed to modify their registrations to 
authorize their mobile components to act as collectors under 21 CFR 
1301.51 and 1317.40. These mobile components of narcotic treatment 
programs may not function as hospitals, long-term care facilities, or 
emergency medical service vehicles, and will not transport patients.
* * * * *
0
5. In Sec.  1301.72, revise the section heading and add paragraph (e) 
to read as follows:


Sec.  1301.72  Physical security controls for non-practitioners; 
narcotic treatment programs and compounders for narcotic treatment 
programs; mobile narcotic treatment programs; storage areas.

* * * * *
    (e) Mobile Narcotic Treatment Programs. For any conveyance operated 
as a mobile narcotic treatment program (NTP), a securely locked safe 
must be installed and used to store narcotic drugs in schedules II-V 
for the purpose of maintenance or detoxification treatment, when not 
located at the registrant's registered location. The safe must conform 
to the requirements set forth in paragraph (a)(1) of this section. The 
mobile component must also be equipped with an alarm system that 
conforms to the requirements set forth paragraph (a)(1)(iii) of this 
section. The storage area of the mobile component must conform to the 
accessibility requirements in paragraph (d) of this section. The 
storage area for controlled substances in a mobile component of an NTP 
must not be accessible from outside of the vehicle. The person 
transporting the controlled substances on behalf of the mobile NTP is 
required to retain control over the controlled substances when 
transferring controlled substances between the registered location and 
the conveyance, from the conveyance to the dispensing location, and 
when dispensing at the dispensing location. At all other times during 
transportation, all controlled substances must be properly secured in 
the safe. Upon completion of the operation of the conveyance on a given 
day, the conveyance must be immediately returned to the registered 
location, and all controlled substances must be removed from the 
conveyance and secured within the registered location. All registrants 
of NTPs with mobile components shall be required to establish a 
standard operating procedure to ensure, if the mobile component becomes 
inoperable (mechanical failure, accidents, fire, etc.), that the 
controlled substances on the inoperable conveyance are accounted for, 
removed from the inoperable conveyance, and secured at the registered 
location.
* * * * *
0
6. In Sec.  1301.74:
0
a. Revise the section heading;
0
b. Revise paragraphs (j) through (l);
0
c. Redesignate paragraph (m) as paragraph (o).
0
d. Add new paragraphs (m) and (n); and
    The revisions and additions are to read as follows:


Sec.  1301.74  Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs; 
mobile narcotic treatment programs.

* * * * *
    (j) Persons enrolled in any narcotic treatment program, including 
those receiving treatment at a mobile narcotic treatment program, will 
be required to wait in an area that is physically separated from the 
narcotic storage and dispensing area by a physical entrance such as a 
door or other entryway. Patients will need to wait outside of a mobile 
NTP if that unit does not have seating or a reception area that is 
separated from the narcotic storage and dispensing area. This 
requirement will be enforced by the program physician and employees.
    (k) All narcotic treatment programs, including mobile narcotic 
treatment programs, must comply with standards established by the 
Secretary of Health and Human Services (after consultation with the 
Administration) respecting the quantities of narcotic drugs which may 
be provided to persons enrolled in a narcotic treatment program or 
mobile narcotic treatment program, for unsupervised use (e.g., take 
home or non-directly observed therapy).
    (l) DEA may exercise discretion regarding the degree of security 
required in narcotic treatment programs, including mobile narcotic 
treatment programs, based on such factors as the location of a program, 
the number of patients enrolled in a program and the number of 
physicians, staff members and security guards. Personnel that are 
authorized to dispense controlled substances for narcotic treatment 
must ensure proper security measures and patient dosage. Similarly, 
such factors will be taken into consideration when evaluating existing 
security or requiring new security at a narcotic treatment program or 
mobile narcotic treatment program.
    (m) Any controlled substances being transported for disposal from 
the dispensing location of a mobile narcotic treatment program shall be 
secured and disposed of in compliance with part 1317, and all other 
applicable federal, state, tribal, and local laws and regulations.
    (n) A conveyance used as part of a mobile NTP may only be supplied 
with narcotic drugs by the registered NTP that operates such 
conveyance. Persons permitted to dispense controlled substances to 
mobile NTPs shall not:
    (1) Receive controlled substances from other mobile NTPs or any 
other entity;
    (2) Deliver controlled substances to other mobile NTPs or any other 
entity; or
    (3) Conduct reverse distribution of controlled substances on a 
mobile NTP.
* * * * *

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
7. The authority citation for part 1304 continues to read as follows:

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


Sec.  1304.04  [Amended]

0
8. In Sec.  1304.04, amend paragraph (f) by adding ``mobile narcotic 
treatment program,'' after ``exporter,''.
0
9. In Sec.  1304.24, revise the section heading and paragraphs (a) and 
(b) to read as follows:

[[Page 11020]]

Sec.  1304.24  Records for maintenance treatment programs, mobile 
narcotic treatment programs, and detoxification treatment programs.

    (a) Each person registered or authorized (by Sec.  1301.22 of this 
chapter) to maintain and/or detoxify controlled substance users in a 
narcotic treatment program, including a mobile narcotic treatment 
program, shall maintain records with the following information for each 
narcotic controlled substance:
    (1) Name of substance;
    (2) Strength of substance;
    (3) Dosage form;
    (4) Date dispensed;
    (5) Adequate identification of patient (consumer);
    (6) Amount consumed;
    (7) Amount and dosage form taken home by patient; and
    (8) Dispenser's initials.
    (b) The records required by paragraph (a) of this section will be 
maintained in a dispensing log at the NTP site, or in the case of a 
mobile NTP, at the registered site of the NTP, and will be maintained 
in compliance with Sec.  1304.22 without reference to Sec.  1304.03.
    (1) As an alternative to maintaining a paper dispensing log, an NTP 
or its mobile component may also use an automated/computerized data 
processing system for the storage and retrieval of the program's 
dispensing records, if the following conditions are met:
    (i) The automated system maintains the information required in 
paragraph (a);
    (ii) The automated system has the capability of producing a hard 
copy printout of the program's dispensing records;
    (iii) The NTP or its mobile component prints a hard copy of each 
day's dispensing log, which is then initialed appropriately by each 
person who dispensed medication to the program's patients;
    (iv) The automated system is approved by DEA;
    (v) The NTP or its mobile component maintains an off-site back-up 
of all computer generated program information; and
    (vi) The automated system is capable of producing accurate summary 
reports for both the registered site of the NTP and any mobile 
component, for any time-frame selected by DEA personnel during an 
investigation. If these summary reports are maintained in hard copy 
form, they must be kept in a systematically organized file located at 
the registered site of the NTP.
    (2) The NTP must retain all records for the NTP as well as any 
mobile component two years from the date of execution, in accordance 
with Sec.  1304.04(a). However, if the State in which the NTP is 
located requires that records be retained longer than two years, the 
NTP should contact its State Opioid Treatment Authority for information 
about state requirements.
* * * * *

    Date: February 14, 2020.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2020-03627 Filed 2-25-20; 8:45 am]
BILLING CODE 4410-09-P