Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 33861 

1See Wholesale Competition in Regions with 

Organized Electric Markets, Order No. 719, 125 

FERC ¶ 61,071, at P 155 (2008), order on reh’g, 

Order No. 719–A, 128 FERC ¶ 61,059, order on 

reh’g, Order No. 719–B, 129 FERC ¶ 61,252 (2009). 

2Participation of Distributed Energy Res. 

Aggregations in Mkts. Operated by Reg’l 

Transmission Orgs. & Indep. Sys. Operators, 175 

FERC ¶ 61,227, at P 26 (2021) (Order). 

3See Participation of Distributed Energy Res. 

Aggregations in Mkts. Operated by Reg’l 

Transmission Orgs. & Indep. Sys. Operators, Order 

No. 2222, 85 FR 67,094 (Oct. 21, 2020), 172 FERC 

¶ 61,247, at P 1 n.1 (2020), corrected, 85 FR 68,450 

(Oct. 29, 2020), order on reh’g, Order No. 2222–A, 

174 FERC ¶ 61,197 (2021) (Danly, Comm’r, 

dissenting) (discussing single resource 

‘‘aggregations’’); 18 CFR 35.28(b)(10) (2020). 

4See Order, 175 FERC ¶ 61,227 at P 27 

(discussing case law on jurisdiction). 

1Participation of Distributed Energy Resource 

Aggregations in Markets Operated by Regional 

Transmission Organizations and Independent 

System Operators, Order No. 2222, 85 FR 67094 

(Oct. 1, 2020), 172 FERC ¶ 61,247 (2020), corrected, 

85 FR 68450 (Oct. 29, 2020), order on reh’g, Order 

No. 2222–A, 174 FERC 61,197 (2021), order on reh’g 

and clarification, Order No. 2222–B, 175 FERC 

¶ 61,227, at P 26 (2021). 

2Order No. 2222–B at P 26. 

3Participation of Aggregators of Retail Demand 

Response Customers in Markets Operated by 

Regional Transmission Organizations and 

Independent System Operators, Notice of Inquiry, 

174 FERC ¶ 61,198 (2021) (NOI); see also Order No. 

2222–B at P 28. 

4Order No. 2222–A (Christie, Comm’r, dissenting 

at PP 1, 3 (emphasis in original) (footnotes omitted) 

(available at https://www.ferc.gov/news-events/ 

news/item-e-1-commissioner-mark-c-christiedissent-regarding-participation-distributed)). 

Accordingly, to ensure consumers can 

realize the full benefits of Order No. 

2222 and the wholesale market services 

demand response resources can provide, 

I urge the Commission to press forward 

to eliminate the Order No. 719 opt-out 

once and for all. 

For these reasons, I respectfully 

concur. 

Neil Chatterjee, 

Commissioner. 

Department of Energy 

Federal Energy Regulatory Commission 

Participation of Distributed Energy 

Resource Aggregations in Markets 

Operated by Regional Transmission 

Organizations and Independent System 

Operators 

Docket No. RM18–9–003 

DANLY, Commissioner, concurring: 

1. I agree with the Commission’s order 

today granting rehearing to extend the 

states’ existing rights to opt-out of 

wholesale demand response programs 1

including demand response resources 

that participate in ‘‘heterogeneous 

distributed energy resource 

aggregations.’’ 2 In other words, states 

can choose to prohibit demand response 

resources within their boundaries from 

participating in multi-state, wholesale 

distributed energy resource programs. 

This order represents the correct 

division of authority between state and 

federal jurisdiction. 

2. I write separately to highlight that 

even if the Commission is correct that 

it has jurisdiction over distributed 

energy resource aggregations—including 

those ‘‘aggregations’’ comprised of a 

single resource 3—the Commission still 

should have chosen not to exercise such 

jurisdiction in Order No. 2222.4 This 

order on rehearing returns authority 

over demand response resources— 

which often are included in distributed 

energy resource aggregations—to the 

states, letting the states choose whether 

demand response resources can 

participate in wholesale distributed 

energy resource aggregations. This 

correctly preserves the traditional 

allocation of authority between the 

individual states and the federal 

government. 

For these reasons, I respectfully 

concur. 

James P. Danly, 

Commissioner. 

Department of Energy 

Federal Energy Regulatory Commission 

Participation of Distributed Energy 

Resource Aggregations in Markets 

Operated by Regional Transmission 

Organizations and Independent System 

Operators 

Docket No. RM18–9–003 

CHRISTIE, Commissioner, concurring 

in part and dissenting in part: 

1. I concur with the first sentence of 

Paragraph 26 and other provisions of the 

order which set ‘‘aside our prior 

decision [in Order No. 2222–A] not to 

extend the Order No. 719 opt-out to 

demand response resources that 

participate in heterogeneous distributed 

energy resource aggregations . . . .’’ 1

2. As the second sentence in 

Paragraph 26 and other provisions in 

today’s order indicate, however, there is 

no decision affirmatively to preserve 

those Order No. 719 opt-out 

provisions; 2 on the contrary, the 

prospect of ultimately removing even 

these opt-out provisions is very much 

alive as a result of the NOI proceeding 

in Docket No. RM21–14–000.3

3. Beyond the parts of this order that 

restore, at least temporarily, those optout provisions, I dissent from the 

remainder of the order, because I would 

have voted against Order No. 2222 had 

I been a member of the Commission at 

that time and I did vote against Order 

No. 2222–A. As I said in my dissent to 

the latter: 

Today the majority . . . sides against 

the consumers who for years to come 

will almost surely pay billions of dollars 

for grid expenditures likely to be ratebased in the name of ‘‘Order 2222 

compliance.’’ 

. . . 

Sadly, instead of making the states, 

municipal and public-power authorities 

and electric co-operatives truly equal 

partners in managing the timing and 

conditions of deployment of behind-themeter DERs in ways that are sensitive to 

local needs and challenges—both 

technical and economic—today’s order 

denies them any meaningful control by 

prohibiting any opt-out or opt-in 

options except in relatively tiny 

circumstances. This order—and its 

predecessor—intentionally seize from 

the states and other authorities their 

historic authority to balance the 

competing interests of deploying new 

technologies while maintaining grid 

reliability and protecting consumers 

from unaffordable costs ....4

4. To ameliorate at least some of the 

damaging effects caused by Order Nos. 

2222 and 2222–A, I would authorize 

states and other RERRAs the right to 

exercise an opt-out from the 

requirements of those orders, if not 

permanently then at least for some 

period of years to enable them better to 

prepare for the impacts on retail 

customers and distribution grids they 

now face. 

For these reasons, I respectfully 

concur in part and dissent in part. 

Mark C. Christie, 

Commissioner. 

[FR Doc. 2021–13442 Filed 6–25–21; 8:45 am] 

BILLING CODE 6717–01–P 

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: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is publishing this 

final rule to revise existing regulations 

for narcotic treatment programs (NTPs) 

to allow the operation of a mobile 


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33862 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

component associated with a DEAregistered NTP to be considered a 

coincident activity permitted under the 

NTP’s registration. Based on these 

revisions, NTP registrants that operate 

or wish to operate mobile components 

(in the State in which the registrant is 

registered) to dispense narcotic drugs in 

schedules II–V at remote location(s) for 

the purpose of maintenance or 

detoxification treatment do not need a 

separate registration for such mobile 

component. This final rule waives 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 this 

rule. 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: This final rule is effective July 

28, 2021. 

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) 776–2265. 

SUPPLEMENTARY INFORMATION: 

Legal Authority and Background 

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 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). The Attorney 

General has delegated this authority to 

the Administrator of the Drug 

Enforcement Administration 

(Administrator of DEA or 

Administrator). Pursuant to this 

authority, DEA is hereby finalizing a 

regulation that would waive the 

requirement of a separate registration for 

narcotic treatment programs (NTPs) that 

utilize mobile components under 

certain conditions. Specifically, under 

this final rule, an NTP is permitted to 

dispense narcotic drugs in schedules II– 

V from a mobile component at 

location(s) remote from, but within the 

same State as, the NTP’s registered 

location, for the purpose of maintenance 

or detoxification treatment. Under this 

final rule, the NTP does not need to 

obtain a separate DEA registration for 

dispensing from the mobile component 

at a separate location as long as it 

complies with the requirements of the 

final rule. Such remote dispensing from 

an NTP’s mobile component is deemed 

under the final rule to be 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 of DEA (Acting 

Administrator) finds that this waiver of 

registration is consistent with the public 

health and safety. 

The final rule also contains additional 

requirements specified in the proposed 

rule to reduce the likelihood of 

diversion. Certain aspects of these 

additional requirements, which were 

raised by the commenters, are addressed 

below in the discussion of the 

comments. In addition, a section-bysection analysis of the final rule is 

provided following the discussion of the 

comments. 

Notice of Proposed Rulemaking 

On February 26, 2020, DEA published 

a notice of proposed rulemaking 

(NPRM) in the Federal Register, which 

provided an opportunity for comment 

on the proposed rule. 85 FR 11008. The 

comment period closed on April 27, 

2020. Through this final rule, DEA is 

responding to these comments and 

finalizing the proposed rule with certain 

modifications discussed below. 

Discussion of Comments 

DEA received a total of 114 comments 

on the NPRM, copies of which are 

available online at www.regulations.gov. 

The commenters included: Researchers, 

practitioners, universities, non-profit 

organizations, addiction treatment 

programs, State and city boards of 

behavioral health and human services, 

associations, manufacturers, a law 

enforcement office, and other individual 

or anonymous commenters. DEA thanks 

all commenters for their thoughtful 

questions and suggestions, and 

appreciates their input during the 

rulemaking process. 

One comment was a general statement 

of support for the rule, with no 

discussion of the proposed regulatory 

changes. Some commenters sought 

clarification of certain provisions in the 

proposed rule or recommended 

additional changes. The majority of 

commenters expressed support for 

various provisions in the proposed rule. 

That said, some commenters offered 

only partial support for the rule, 

agreeing with its general purpose but 

disagreeing with particular provisions; 

some of these commenters offered 

suggestions and proposed amendments 

to the rule that they thought would help 

DEA achieve its purpose. Three 

comments were outside of the scope of 

the rule. One comment—a general 

complaint about the government’s 

COVID–19 response, unrelated to 

DEA—was outside the scope of the 

rulemaking and will therefore not be 

addressed. Another commenter 

suggested lengthening the five-year term 

for nurse anesthetists to treat patients 

with substance use disorder, which is a 

matter beyond the scope of this rule and 

will not be addressed. A third 

commenter suggested future rule 

changes DEA should consider to reduce 

patient access burdens, including: 

Reducing adherence requirements for 

take-home dosing, allowing community 

pharmacies to dispense methadone 

treatment, and allowing physicians 

outside of NTPs to prescribe methadone 

treatment for patients with opioid use 

disorders (OUDs). These issues are 

outside the scope of the rule and will 

not be addressed. 

After a review of the comments, DEA 

noted that there were thirteen main 

issues that commenters raised, and 

many commenters raised multiple 

issues in their comments. Each issue is 

summarized below, along with DEA’s 

responses. DEA has also summarized 

the remainder of the comments that did 

not fit into one of the thirteen main 

issues. 

Expanding the Rule’s Scope Beyond 

Mobile NTPs 

Comment: One commenter 

recommended that the scope of the 

proposed rule be expanded to allow 

mobile components to carry controlled 

substances used for sedation (general 

anesthesia). The commenter stated that 

many specialty doctors (such as oral 

surgeons) work in multiple locations 

each week and are required to obtain 

separate permits (i.e., separate DEA 

registrations) for each office in which 

they operate, and as such, cannot fill in 

for another doctor in the case of an 

emergency. 

DEA Response: DEA understands that 

many specialty doctors (such as oral 

surgeons) may work in multiple 

locations each week and are therefore 

required under 21 U.S.C. 822(e)(1) and 

21 CFR 1301.12(a) to obtain separate 

registrations for each office in which 

they operate, and as such are unable to 

fill in for another doctor in the case of 

an emergency. 


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This CSA requirement of separate 

registrations for each principal place of 

business or professional practice where 

the practitioner dispenses controlled 

substances allows DEA to monitor the 

dispensing of controlled substances. 

This requirement thereby reduces the 

potential for diversion of those 

substances. Accordingly, the CSA only 

authorizes the Administrator (by 

delegation from the Attorney General) to 

issue regulations waiving this 

requirement if he finds doing so to be 

consistent with the public health and 

safety. 21 U.S.C. 822(d). 

As explained in the NPRM and above, 

DEA has concluded that allowing NTPs 

to operate mobile NTPs under the 

conditions specified in this rule is 

consistent with the public health and 

safety. See NPRM, 85 FR 11008, 11010. 

This conclusion, however, only extends 

to mobile NTP components used for 

maintenance and detoxification 

treatment; any other use is beyond the 

scope of this rule. 

In this rulemaking, DEA has not 

considered whether waiving the 

separate registration requirement in any 

other circumstances would be 

consistent with the public health and 

safety, because such a determination 

was not necessary for this rulemaking. 

It is, in other words, beyond the scope 

of this rule. This final rule, therefore, 

does not change the requirement for 

separate registrations at each principal 

place of business or professional 

practice for any other registrants 

(including specialty doctors) that 

dispense controlled substances. To the 

degree interested parties believe that the 

separate registration requirement should 

be waived in other circumstances, they 

may petition DEA to do so by 

regulation. 

Setting a Mileage Limit for Mobile NTP 

Dispensing 

Comments: One commenter suggested 

that the proposed rule clarify the radius 

outside of the ‘‘dispensary’’ (i.e., the 

NTP’s registered location) within which 

the ‘‘dispenser’’ (i.e., the mobile NTP) 

can deliver. Another commenter was 

concerned that the proposed rule 

suggested a mileage limit which might 

not be realistic, especially when applied 

to larger States. The commenter stated 

that there may be value in allowing each 

individual State to set and adjust the 

mileage limit that would be most 

appropriate for mobile NTPs operating 

in their State. Several other commenters 

(discussed in more detail below) 

suggested that DEA allow mobile NTPs 

to operate within a 200-mile radius of 

the NTP’s registered location, even if 

that radius included areas in 

neighboring states. 

DEA Response: DEA will not define 

an exact distance that the mobile 

component can travel from its registered 

location. As further explained below, 

DEA has concluded that mobile NTPs 

must be required to return to their 

registered locations upon the 

completion of their operations each day 

and that such a requirement can be met 

while still increasing access to 

maintenance or detoxification treatment 

in rural and underserved areas. A 

specified mileage limit, however, is not 

necessary to ensure that mobile NTPs 

will return to their registered locations 

daily. NTPs are better positioned than 

DEA to determine how far from their 

registered location the mobile 

components can travel while still 

allowing adequate time to return to their 

registered location at the end of the day, 

especially given that this distance is 

likely to vary between different 

geographic regions given differences in 

roads, traffic, and other conditions. 

Mobile Components Crossing State 

Lines 

Comments: Several organizations, 

practitioners, and non-profit 

organizations; a university policy think 

tank and researcher; and members of the 

general public were opposed to the 

proposed rule’s requirement that mobile 

NTP components only operate in the 

same State as their registered NTP 

location. Multiple commenters voiced 

concern that this requirement would 

hinder the effectiveness of the proposed 

rule in providing services to 

underserved communities. One 

commenter noted that for many rural 

communities, the closest NTP may be 

across state lines. Five commenters 

cited studies that provided statistics on 

the number of NTP patients that 

traveled across state lines to access 

services, and calculated the mean 

driving distance to a methadone clinic 

in five rural states. These studies noted 

that many of these patients lived in 

areas that have been hit hardest by the 

opioid epidemic, and would benefit 

greatly from mobile medication 

delivery. Another commenter provided 

a citation to an article that showed the 

ineffectiveness of limiting mobile NTPs 

to intrastate in rural and underserved 

communities. These commenters urged 

DEA to allow NTPs located in one State 

to provide services to underserved areas 

in neighboring States. Commenters 

suggested that one way of allowing the 

mobile components to cross State lines 

would be to authorize an NTP’s mobile 

component to operate across State lines 

so long as it remains within a 200-mile 

radius of the NTP’s registered location, 

which would increase access to remote 

areas that otherwise might remain 

underserved. Commenters went on to 

say that as long as the NTP abided by 

the applicable State laws and secured 

approval from local DEA field offices, 

the mobile component should be 

allowed to cross State lines. Finally, one 

commenter suggested making 

requirements based on distance and 

population, and creating regulations 

built on collaboration. The commenter 

stated this approach would allow an 

NTP with mobile capabilities in one 

state to collaborate with an NTP that 

seeks to provide those services in a 

different state if the two NTPs share a 

patient base within a certain geographic 

area. 

Another commenter expressed 

concern that NTPs would choose to only 

operate within their own State if (1) 

State methadone authorities hesitated to 

license a mobile component with a 

registered location in another State, or 

(2) States placed more onerous licensing 

processes on mobile components from 

another State. The commenter suggested 

that DEA should not prohibit this at the 

Federal level. The commenter further 

suggested that if States are willing to 

approve mobile components that are 

based in another State to promote access 

for their own citizens, DEA should defer 

to the States and permit mobile NTPs to 

operate in a different State than that of 

the NTP’s registered location if the 

provider can obtain the requisite license 

from the State methadone authority. 

Finally, one organization and an 

anonymous commenter supported the 

requirement that a mobile NTP only 

operate in the same State in which the 

NTP is registered with DEA. The 

organization noted that State regulations 

can vary greatly, and the organization 

was aware of the immediate regulatory 

crisis that would exist if DEA 

promulgated Federal regulations around 

mobile NTPs that permitted the mobile 

NTPs to dispense controlled substances 

in States in which they are not 

registered. The organization expressed 

concern that any potential for conflict 

within the treatment delivery system 

could put patient care in jeopardy and 

foster confusion that may fuel 

additional stigma against an already 

overly stigmatized medical treatment. 

The organization also noted that mobile 

NTPs are governed by State regulations 

in addition to the Federal regulations 

promulgated by DEA and the Substance 

Abuse and Mental Health Services 

Administration (SAMHSA). The 

organization further noted that 

operating a mobile NTP across State 

lines would call into question which 


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State has oversight and how the 

originating State could enforce their 

rules on a mobile NTP that is not 

located within their borders. The 

anonymous commenter also supported 

limiting the mobile NTP to the same 

State in which the NTP is registered, 

stating the restriction would prevent the 

mobile NTP from breaking the laws of 

the surrounding states it would be 

operating in, which might be different 

than the laws of the State in which the 

NTP is registered. 

DEA Response: DEA appreciates the 

concerns raised by commenters that the 

proposed requirement that mobile NTPs 

only operate in the same State as their 

associated NTP’s registered location 

may hinder the effectiveness of the rule 

in providing services to underserved 

communities. The intent of the rule is 

to increase access to these rural and 

underserved communities, while 

ensuring that certain recordkeeping and 

security requirements are met to prevent 

the diversion of controlled substances. 

As stated in the preamble to the 

proposed rule, however, the CSA and 

DEA regulations have always required, 

with limited exceptions, practitioners to 

have separate registrations in each State 

in which they dispense controlled 

substances. See NPRM, 85 FR 11008, 

11010. A practitioner, including an 

NTP, must maintain a DEA registration 

in each State in which it dispenses 

controlled substances because DEA 

registrations are based on State licenses 

to dispense controlled substances. See, 

e.g., Clarification of Registration 

Requirements for Individual 

Practitioners, 71 FR 69478, 69478 (Dec. 

1, 2006). DEA relies on State licensing 

bodies to determine that NTPs are 

qualified to dispense controlled 

substances for detoxification and 

maintenance purposes. State authority 

to conduct these activities only confers 

rights and privileges within the issuing 

State; consequently, a DEA registration 

based on a State license cannot 

authorize controlled substance 

dispensing outside of the State. This 

aspect of the CSA and DEA regulations 

also helps to ensure that each State 

retains the primary authority to regulate 

the practice of medicine within its 

borders. Therefore, DEA can only 

authorize an NTP and, as a coincident 

activity, its mobile component, to 

dispense controlled substances in the 

same State in which its brick-andmortar NTP is registered with DEA to 

dispense controlled substances. 

Restricting a mobile NTP to a 200-mile 

radius of the DEA-registered site would 

not address this requirement, as the 

State authority to operate an NTP is 

limited to the borders of the State, 

regardless of distance. 

DEA also cannot authorize NTPs to 

avoid this requirement by allowing a 

single mobile NTP to partner with 

multiple NTPs with registered locations 

in different States. This rule authorizes 

a registered NTP to operate a mobile 

component away from its registered 

location as a coincident activity of its 

DEA registration, which, as stated 

above, is predicated on state 

authorization. Moreover, this 

arrangement is critical to ensuring that 

a registered NTP maintains effective 

security and recordkeeping oversight of 

its mobile NTP operations to safeguard 

against diversion of the mobile NTP’s 

controlled substances. Allowing 

multiple registered NTPs to share the 

same mobile component would 

diminish any individual location’s 

perceived authority and responsibility 

for the controlled substances contained 

on the mobile NTP. For example, it 

would complicate the NTP’s task of 

reconciling the dispensing logs from 

both the mobile component and the 

NTP’s registered location to ensure that 

only the NTP’s enrolled patients are 

receiving controlled substances. 

Furthermore, the task of recording (and 

investigators’ task of tracing) the 

movement of controlled substances 

received at the NTP’s registered location 

and transferred to the mobile NTP 

components would also be complicated. 

Thus, as reflected in the rule, DEA has 

concluded that each mobile NTP 

component may only operate under the 

DEA registration of a single NTP 

location—and may only operate in the 

State in which that registered NTP is 

licensed. 

Comment: One commenter noted that 

although the proposed rule limited 

mobile components to the same State as 

the existing registration, it did not 

enumerate explicit measures for 

physically monitoring unauthorized 

out-of-State dispensations. The 

commenter stated that a lack of 

monitoring requirements in the 

proposed rule seemingly undermined 

effective DEA enforcement of its 

standards, thus enabling unauthorized 

medical practice to go undetected, and, 

accordingly, impeding States’ rights to 

authorize practitioners. 

DEA Response: The risk of a mobile 

NTP engaging in unauthorized out-ofState dispensing is not appreciably 

greater than any other practitioner 

engaging in such dispensing. Thus, DEA 

has concluded that the various 

regulatory requirements and monitoring 

activities that DEA uses to combat 

unauthorized dispensing in general 

should be adequate to combat any 

unauthorized dispensing by mobile 

NTPs. Moreover, this final rule already 

provides for certain measures designed 

to enhance DEA’s ability to monitor the 

activities of mobile NTPs, such as the 

requirement that NTPs notify their local 

DEA office before using a mobile 

component to dispense controlled 

substances. 

Mobile Components Facilitate 

Expanded Access in Rural Areas 

Comments: A majority of commenters 

voiced support for the proposed rule 

saying that it would expand access to 

treatment for those who needed it. 

Multiple commenters stated that the 

proposed regulation was a step in the 

right direction because it reversed 

outdated regulations that have inhibited 

access to treatment. Several commenters 

stated that the proposed rule would 

greatly improve health outcomes for 

people with substance use disorder 

living in both rural and urban areas. 

These commenters noted that rural or 

geographically remote areas that were 

lacking in opioid replacement 

medication services faced a treatment 

gap because of issues like poverty, lack 

of access to care, and premature deaths; 

these mobile components could bridge 

these gaps, and allow more individuals 

to have access to treatment programs, 

which would help improve the odds of 

long-term recovery. Other commenters 

mentioned that the use of these mobile 

components could have positive 

outcomes outside of treatment for OUD, 

stating they could help with human 

immunodeficiency virus prevention, 

overdoses, and relapses. Other 

commenters also noted how the mobile 

components would allow many 

underrepresented groups like those 

suffering from mobility issues, mental 

health issues, incarceration, and 

homelessness to access treatment. 

Several commenters also stated that 

these mobile components, while 

expanding access, would reduce costs 

because there would not be as great of 

a need to build more brick-and-mortar 

NTPs. 

Two associations, one representing 

NTPs and the other representing the 

interests of individuals in medicationassisted treatment (MAT), noted a 

potential funding source available 

through the U.S. Department of 

Agriculture (USDA). Both associations 

mentioned that the funding is available 

to assist NTPs with the purchase of 

mobile vans, if the NTPs meet USDA 

criteria in serving rural communities as 

defined by a population of 50,000 or 

less. Both associations also stated that 

they would advise NTPs to actively 

pursue this funding, working in 


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1 79 FR 53520 (Sept. 9, 2014). 

coordination with State opioid 

treatment authorities as well as 

SAMHSA and DEA, once the proposed 

rule had been finalized. 

Several commenters also pointed out 

the advantages of allowing practitioners 

to dispense controlled substances at 

multiple locations, as the rule would 

facilitate. One commenter provided her 

personal experiences that she currently 

can only treat patients with opioid 

addiction at the DEA-registered 

location, where the injectable 

buprenorphine is delivered. The 

commenter believed that allowing 

providers to have more than one 

location is essential for good health 

care, because this would greatly 

increase access and treatment options 

for those suffering from opioid 

addiction. 

Finally, several commenters 

mentioned how the current COVID–19 

public health emergency would have 

negative effects on individuals who 

were suffering from OUD, because of 

State-mandated stay-at-home orders, 

social distancing requirements, and 

severe limitations on some of the 

transportation options on which these 

individuals rely. Commenters further 

noted that these negative consequences 

of the public health emergency could 

cause increases in isolation and an 

inability to reach treatment clinics, 

which could result in an increase in 

overdoses or even deaths. These 

commenters said that the use of mobile 

components would ensure that these 

individuals would be able to continue 

treatment. 

DEA Response: As stated in the 

NPRM, DEA concluded that waiving the 

requirement for separate registration for 

mobile NTPs is consistent with the 

public health and safety, as it will 

increase access to treatment for those 

suffering from OUD in rural and 

underserved communities. See NPRM, 

85 FR 11008, 11011. DEA re-affirms that 

position in the final rule. Specifically, 

DEA will waive the requirement of 

separate registration only for an NTP 

operating a mobile component at 

location(s) remote from, but within the 

same State as, the NTP’s registered 

location for the purpose of maintenance 

or detoxification treatment. 

The intent of the rule is to ensure that 

there is greater access to treatment for 

those who are suffering from OUD, and 

who are unable to access treatment 

because of rural or geographic 

limitations, mobility issues, etc. 

Furthermore, DEA has no objection to 

NTPs seeking grants or funding from 

government programs, or partnering 

with other organizations in order to 

defray the costs of purchasing and 

outfitting a mobile component. 

Regarding the COVID–19 public health 

emergency, this is an unprecedented 

event that has resulted in many agencies 

and organizations changing the way 

they operate. As a result of the public 

health emergency, DEA has worked 

closely with SAMHSA to provide 

guidance and support to opioid 

treatment programs to ensure that any 

individual who relies on MAT is able to 

continue treatment without disruption. 

It is DEA’s hope that these mobile NTPs 

will be able to ensure greater access in 

in the future, especially when public 

health emergencies like this arise. 

The Mobile Component Returning to Its 

Registered Location on a Daily Basis 

Comments: Multiple commenters 

expressed concern regarding the 

requirement in proposed 21 CFR 

1301.72(e) to return the mobile 

component and the controlled 

substances on board to the NTP’s 

registered location daily. One 

commenter asserted that the daily return 

trip to prevent diversion is unnecessary 

since the mobile NTPs would be 

required to keep a record of all 

controlled substances removed from the 

safe on any given day. Several other 

commenters were concerned that the 

proposal would reduce the effectiveness 

of the mobile NTPs. Two commenters 

specifically stated this requirement 

would significantly limit the 

geographical reach of the mobile 

component. Multiple commenters 

argued that travel times could 

negatively affect the amount of time the 

component could operate, as many of 

the communities being served by mobile 

NTPs were far from the nearest DEAregistered NTP location. In fact, some 

commenters contended that many of 

these communities were hundreds of 

miles, with some specifying 100 to 200 

miles and some simply stating over one 

hundred miles, from the NTP’s 

registered location. One commenter 

further stated that the time required to 

travel such large distances could deter 

NTPs from offering regular services in 

the most remote areas. The commenter 

indicated that there are communities 

with significant rates of OUD located as 

far as 195 miles from the nearest NTP, 

which would require the mobile 

component to travel six hours round 

trip daily to reach these communities. 

The commenter recommended that DEA 

allow NTPs to enter into DEA-approved 

agreements with local or State law 

enforcement entities closer to the 

remote service area to secure the 

controlled substances in their facility 

while the mobile NTP is not in 

operation. The commenter stated that 

DEA already requires controlled 

substances in the possession of law 

enforcement be stored in a manner 

consistent with DEA’s standard 

procedures for storing illicit controlled 

substances, and referenced DEA’s 

disposal final rule regulation at 21 CFR 

1317.35(c) (Collection by law 

enforcement).1 Accordingly, the 

commenter pointed out that, if a law 

enforcement entity in closer proximity 

to the mobile component’s service area 

than the NTP’s registered location has 

secure storage procedures that meet 

DEA standards, the medications could 

be stored at this location for easier dayto-day access. 

Another commenter expressed 

concerns that the security requirements 

DEA proposed were administratively 

burdensome, and specifically 

mentioned the requirement that the 

mobile component return to the NTP’s 

registered location on a daily basis. The 

commenter stated that this requirement 

would increase the amount of time 

spent traveling, which would result in 

additional wear and tear on the vehicles 

and less time to work with patients who 

need care and rely on the mobile 

component. The commenter thus 

indicated that this requirement would 

detract from the increased access to 

treatment and reduced costs of 

expanded access that this regulation 

aims to achieve. 

Likewise, a number of commenters 

also noted that requiring the mobile 

components to return to the NTP’s 

registered location every day would be 

costly when factoring in staff time, 

travel costs, and the wear and tear on 

the vehicles. Several commenters 

postulated that these expenses could 

easily rival the cost of opening a new 

brick-and-mortar NTP. Two commenters 

estimated the cost for a mobile NTP, 

with at least one nurse and one medical 

assistant, traveling 100 miles round trip, 

six times per week for a year, as 

approaching $62,000. Both commenters 

stated this this amount could be more 

expensive than renting space for a new 

registered NTP location in some areas. 

Several commenters suggested that this 

requirement might hinder the 

effectiveness of the rule, particularly in 

rural areas, due to the extra costs and 

travel time associated with traveling 

back and forth daily. One commenter 

further stated that although DEA 

asserted that the proposed rule would 

benefit rural areas, this assertion was 

incorrect due to the scarcity of 

registered NTP locations near rural 

areas, and the costs that would be 

incurred if a mobile NTP attempted to 


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33866 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

2Substance Abuse and Mental Health Services 

Administration, Medications for Opioid Use 

Disorder. Treatment Improvement Protocol (TIP) 

Series 63, Publication No. PEP20–02–01–006, 

Rockville, MD: Substance Abuse and Mental Health 

Services Administration (2020). 

3Roxane Laboratories, Dolophine hydrochloride 

package insert, Fda.gov/media/76020/download 

(accessed May 10, 2021). 

4Food and Drug Administration, Public health 

advisory: Methadone use for pain control may 

result in death and life-threatening changes in 

breathing and heartbeat, Silver Spring, MD: U.S. 

Department of Health and Human Services, 2006, 

https://www.fda.gov/ForConsumers/Consumer

Updates/ucm12346.htm (accessed May 10, 2021); 

Modesto-Lowe V, Brooks D, Petry N., Methadone 

deaths: Risk factors in pain and addicted 

populations, J Gen Intern Med 25: 305–309 (2010); 

Madden ME, Shapiro SL, The methadone epidemic: 

Methadone-related deaths on the rise in Vermont, 

Am J Forensic Med Pathol. 32(2): 131–135, 2011. 

5McCance-Katz EF. The National Survey on Drug 

Use and Health: 2019. Slide 14. SAMHSA.gov/data/ 

release/2019-national-survey-on-drug-use-andhealth-nsduh-releases (accessed May 10, 2021). 

6National Drug Intelligence Center. Methadone 

diversion, abuse and misuse: Deaths increasing at 

alarming rate. Justice.gov/archive/ndic/pubs25/ 

25930/index.htm#Diversion (2007) (accessed May 

10, 2021); Wright N, D’Agnone O, Krajci P, et al. 

Addressing misuse and diversion of opioid 

substitution medication: Guidance based on 

systematic evidence review and real-world 

experience. J Public Health. 38 (3): e368–e374, 

2016. 

7For example, an average dose range for an 

individual on methadone maintenance is 60–120 

mg daily, which would be multiplied by the 

number of individuals for whom the mobile NTP 

conveyance carries doses. See SAMSHA TIP 63, 

supra note 2. 

travel to a rural area each day from an 

urban area. 

Many commenters suggested that DEA 

allow these mobile components to stay 

in the field for longer periods of time. 

The commenters indicated that costs 

would be reduced significantly and 

there would be more time for providing 

care to patients, thus making the mobile 

components more effective, if the 

components were allowed to return to 

the registered location less frequently. 

The majority of commenters proposed 

only requiring the mobile NTPs to 

return to the registered location once a 

week, while another commenter 

suggested a 72-hour turnaround time, 

and another commenter simply 

requested that the mobile NTP be 

allowed to remain in the field for 

‘‘multiple days.’’ One of the commenters 

who suggested returning once a week, 

alternatively recommended the mobile 

NTPs not be required to return more 

frequently than every other day. 

Another commenter stated that DEA 

should not specify when the mobile 

component must return or, as an 

alternative, suggested that DEA should 

consider increasing the intervals 

between returns and only requiring 

weekly returns. 

Most commenters believed that 

requiring the mobile components to 

return to the registered location less 

frequently would increase access to 

treatment while still maintaining 

appropriate safeguards against potential 

theft and diversion. Indeed, several 

commenters asserted that these longer 

turnaround times were feasible given 

that DEA was proposing to apply 

existing security protocols to mobile 

components. One commenter similarly 

stated that the security measures 

required by the proposed rule were 

adequate to prevent diversion while the 

mobile component is in the field. 

However, one commenter suggested that 

if the mobile components are allowed to 

stay in the field for longer periods of 

time, additional security measures 

should be taken. The commenter 

suggested requiring an armed guard 

outside the mobile component or 

requiring the mobile component to be 

locked in a secure, fenced-in location. 

Finally, one commenter stated that in 

the absence of evidence of abuse, DEA 

should not require the mobile 

component to return to the registered 

NTP location daily or store the 

controlled substances in the registered 

location at the end of each day. The 

commenter stated that the proposed rule 

includes multiple safety measures and 

procedures that are adequate to protect 

controlled substances, which the 

commenter felt acted as a significant 

check against theft and diversion. The 

commenter further contended that it is 

not clear that moving the mobile 

component back to the registered 

location and removing the controlled 

substances daily decreases the risk of 

diversion. Furthermore, the commenter 

asserted that DEA does not provide 

evidence or reasoning to explain how 

these requirements reduce the risk of 

diversion. The commenter insisted that 

pending the development of better 

information regarding the risks of 

diversion, DEA should not specify when 

the mobile component must return to 

the NTP’s registered location. 

DEA Response: DEA appreciates 

commenters’ concerns over the 

proposed requirement that the mobile 

component and the controlled 

substances it carries return to the NTP’s 

registered location daily. As stated 

before, the intent of the rule is to ensure 

that more individuals have access to 

treatment despite geographical 

limitations. The need to ensure that 

individuals in these remote locations 

can access the care that they need has 

to be balanced against security and 

recordkeeping requirements to ensure 

that the controlled substances on board 

the mobile component are not diverted 

for illicit use. 

Several concerns drive DEA’s 

conclusion that, upon the completion of 

their daily operations, mobile NTPs 

generally must return to their registered 

locations and secure all controlled 

substances within their registered 

location. 

The first and most important concern 

is the danger associated with controlled 

substances that mobile NTPs will be 

carrying, should those substances be 

diverted. Of course, mobile NTPs will 

primarily be storing and distributing 

methadone, and methadone is an 

extremely dangerous drug if abused. 

More specifically, methadone is a potent 

schedule II opioid with a relatively long 

elimination half-life of 8–59 hours with 

an average of 24 hours depending on the 

individual.2 As such, methadone can 

accumulate in an individual’s body if 

taken more frequently than prescribed 

or in doses that exceed an individual’s 

tolerance for the medication.3

Methadone has been associated with 

adverse events and opioid overdose 

deaths in those lacking experience with 

the drug as well as in experienced users 

who overuse the drug or combine it 

with other illicit drugs or with other 

prescribed medications that have 

adverse drug-drug interactions with 

methadone.4

Methadone is also a demonstrated 

diversion risk.5 It has significant street 

value, and its misuse and abuse has 

been documented.6 And mobile NTPs, 

especially if they were allowed to 

remain away from their registered 

locations for multiple days, are likely to 

be carrying methadone in substantial 

quantities, enough to be of great street 

value and to impose a significant risk to 

an entire community should a fully 

stocked mobile NTP have its methadone 

diverted.7

So long as methadone remains in a 

mobile component, it is at an elevated 

risk of theft both because the mobile 

conveyance itself could be stolen, and 

because security measures in a mobile 

NTP will generally be less robust than 

those at the NTP’s registered location. 

This risk is manageable when the 

mobile NTP is in operation and thus 

secured by staff to guard against theft. 

However, the risk becomes unwieldy— 

especially given that dangers posed by 

such quantities of methadone—when 

the mobile NTP is not in use and is 

unattended, generally at night, and the 

likelihood of theft is greater. Thus, by 

requiring NTPs to secure their 

controlled substances within their 

registered NTP location after operation 

each day, DEA decreases the risk that 

those controlled substances will be 

stolen—and thereby decreases the risk 


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8 DEA appreciates commenters’ suggestions that 

the risk of theft or diversion of controlled 

substances left in a mobile NTP overnight could be 

mitigated by increasing the security requirements 

for mobile NTPs. While such measures could 

reduce the danger of theft or diversion somewhat, 

they would not suffice to overcome the inherent 

enhanced dangers of leaving controlled substances 

in an unmanned conveyance overnight at an 

unregistered location. And such enhanced security 

measures would do nothing to address the 

reduction in the registered NTP’s ability to monitor 

the mobile component’s dispensing that would 

result if mobile NTPs were not required to return 

to their registered NTP location nightly. 

9The CSA requirements governing the dispensing 

of buprenorphine are set forth in 21 U.S.C. 

823(g)(2). 

that the communities served by mobile 

NTPs will be harmed by diverted 

methadone. 

Requiring the mobile NTP and its 

controlled substances to return to the 

registered location of the NTP also 

reduces the likelihood that controlled 

substances will be lost or mishandled. 

Requiring an NTP’s mobile component 

to return nightly better enables the NTP 

to monitor its mobile component’s 

dispensing, and thus become more 

readily aware of any problems—such as 

the ‘‘double-dipping’’ discussed below 

(under Recordkeeping Requirements for 

Mobile Components)—or other 

discrepancies that may signal that the 

mobile NTP’s controlled substances are 

being diverted or otherwise improperly 

dispensed.8 For similar reasons, DEA 

will not allow NTPs to enter into 

agreements with local or State law 

enforcement entities closer to the 

remote service area to secure the 

controlled substances in their facility 

while the mobile NTP is not in 

operation. Even assuming that these law 

enforcement entities are equipped to 

securely store the controlled substances, 

the regular transfer of these substances 

back and forth between mobile NTPs 

and the law enforcement entities would 

inhibit the NTP’s (and ultimately DEA’s) 

ability to monitor the controlled 

substances and unnecessarily create 

opportunities for the substances to be 

stolen, mislaid, or otherwise 

mishandled. 

Additionally, allowing mobile NTPs 

to remain in operation for multiple days 

without returning to their registered 

locations not only presents an elevated 

risk of diversion, there are alternative 

options that make it generally 

unnecessary. For example, nothing in 

this rule impacts the ability of an NTP 

to register at an additional physical 

location. Thus, if an NTP wishes to treat 

patients with methadone at a remote 

correctional facility or similar rural 

location, that NTP could simply register 

a physical location in the area to which 

to return its mobile component and 

where to secure its controlled 

substances. Indeed, a correctional 

facility can itself register with DEA as 

an NTP. While some correctional 

facilities have obtained an NTP 

registration, DEA wishes to emphasize 

this option for those who may be 

unaware of it. Moreover, many OUD 

patients may be successfully treated 

with alternative medications such as 

buprenorphine or naltrexone. 

Buprenorphine is a schedule III narcotic 

drug approved by the U.S. Food and 

Drug Administration (FDA) for the 

treatment of OUD, and, as such, may be 

dispensed for such purpose without the 

dispenser being registered as an NTP.9

Naltrexone is a non-controlled 

substance and, as such, may be 

dispensed without a DEA registration. 

Accordingly, OUD treatment involving 

the use of either buprenorphine or 

naltrexone does not require the use of a 

mobile NTP. 

In sum, DEA has concluded, for the 

reasons stated above, that it is necessary 

and appropriate to maintain in the final 

rule the requirement that a mobile NTP 

return to its registered location each 

day. However, in view of the comments 

DEA received on this issue, DEA wishes 

to emphasize that it has decided to add 

to the text of the final rule a provision 

that expressly allows NTPs to apply for 

an exception to this requirement. The 

process for applying for such an 

exception will be as set forth in 21 CFR 

1307.03, which allows any person to 

apply for an exception to any provision 

of the DEA regulations. As with all 

applications for an exception to any 

provision of the regulations submitted 

pursuant to section 1307.03, each 

application for an exception to the 

requirement that a mobile NTP return 

each day will be evaluated by DEA on 

a case-by-case basis in determining 

whether the applicant has demonstrated 

exceptional circumstances that warrant 

a waiver of the regulation. In making 

this determination, DEA will consider 

the applicant’s security and 

recordkeeping as well as other factors 

relevant to determining whether 

effective controls against diversion will 

be maintained. DEA is revising 21 CFR 

1301.72(e) (from that proposed in the 

NPRM) to reflect this change to the 

regulatory text. 

In addition, DEA will continue to 

evaluate the risk of diversion that might 

result from eliminating, in some 

circumstances, the requirement that a 

mobile NTP return to its registered 

location each day. DEA will closely 

monitor applications seeking an 

exception to that requirement. One year 

after this rule is finalized, DEA will 

review whether additional rulemaking 

is necessary to improve access to 

treatment via mobile NTPs. In 

conducting its review, DEA will consult 

with the Department of Health and 

Human Services (HHS) and the Office of 

National Drug Control Policy (ONDCP). 

If the volume and nature of such 

applications and an evaluation of the 

associated risk of diversion warrant it, 

DEA will further amend the regulations 

to allow mobile NTPs to be excepted 

from this requirement—without having 

to apply for an exception—under certain 

specified circumstances. If DEA 

determines that such additional 

amendment to the regulations is 

warranted, it will initiate a separate 

rulemaking proceeding to do so in 

accordance with the Administrative 

Procedure Act (APA). 

Security Requirements for Mobile 

Components 

Comments: Several commenters 

addressed the security requirements that 

were detailed in the proposed rule. Two 

commenters, who recommended a 72- 

hour return instead of the proposed 

same day return requirement for mobile 

NTPs (see discussion above), suggested 

that the final rule add additional 

security requirements during this 72- 

hour time frame. The commenters 

suggested either utilizing armed security 

guards outside the mobile component, 

or locking the mobile component in a 

secure fenced-in location and using, 

possibly, unarmed (rather than armed) 

security guards. One commenter 

believed such security measures would 

not present any additional diversion 

issues and noted that DEA 

acknowledged thefts from mobile NTPs 

in the past had not been an issue. 

One commenter pointed out the 

known criminal activity risks associated 

with having controlled substances on 

site, such as theft, and noted that ‘‘brickand-mortar’’ NTPs often protect their 

employees and patients through various 

security measures. The commenter 

provided two examples of these 

measures: (1) A panic button that, when 

activated, triggers law enforcement to 

immediately respond, and (2) the local 

law enforcement knows the existence 

and whereabouts of an NTP and, 

therefore, can respond quickly and 

efficiently to an emergency. In contrast, 

the commenter stated that the proposed 

rule fails to mention whether mobile 

NTPs must take any explicit security 

measures to protect their employees and 

patients, including installing panic 

buttons, or making local law 

enforcement aware of the mobile NTPs’ 

exact locations at any given moment, 

including during travel. The commenter 


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33868 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

requested that the final rule more fully 

address how mobile NTPs will 

implement such security measures to 

improve the safety of their employees 

and patients. 

DEA Response: DEA appreciates the 

concerns expressed regarding the 

security requirements for mobile NTPs. 

DEA regulations have always required 

that all registrants maintain effective 

security to guard against theft and 

diversion of controlled substances. See, 

e.g., 21 CFR 1301.71(a). The need for 

such security applies equally to mobile 

NTPs. Thus, under this final rule, the 

security requirements of 21 CFR 

1301.72(e) and 1301.74(j)–(n) apply to 

the mobile components of NTPs to 

ensure this need for security is met. 

Of course, under certain 

circumstances, mobile NTPs may need 

additional security measures beyond 

those specifically required by DEA 

regulations to effectively protect against 

theft or diversion of controlled 

substances. Because the need for such 

measures is circumstance-specific, DEA 

is not including them in the final rule, 

but rather will rely on local DEA 

personnel, NTPs themselves, and any 

other relevant laws and regulations to 

determine what additional measures, if 

any, are necessary. In particular, DEA 

will leave the decision on whether 

armed or unarmed security personnel 

will be utilized by the mobile 

component while it is away from its 

registered location to the NTP, as there 

are many factors that should be 

considered when making this decision. 

For example, the NTP may want to 

consider the location to which the 

mobile components will be traveling, 

the cost of security personnel, and 

whether or not these security personnel 

would fit in to any standard operating 

procedures used by the NTP. Thus, DEA 

will not mandate that armed or unarmed 

security personnel be utilized by these 

mobile components. 

The proposed rule stated in proposed 

21 CFR 1301.72(e) that the mobile 

component must be returned to the 

registered location on a daily basis. See 

NPRM, 85 FR 11008, 11011, 11019. DEA 

appreciates that some registered NTP 

locations might not have enough room 

to park the mobile component 

overnight; therefore parking the mobile 

component in a secure fenced-in 

location would be permissible, as long 

as all DEA security requirements are 

met, the controlled substances are 

removed from the mobile component at 

the end of the day, and the local DEA 

office is notified of the location where 

the mobile component will be parked 

overnight. 

For similar reasons, DEA will leave 

the decision on what safety measures 

the NTP would like to take to ensure the 

safety of the mobile component’s staff 

and patients to the NTP and any 

relevant government bodies outside of 

DEA. There are many factors like the 

location of the NTP, the number of 

patients it treats, cost, etc., which would 

affect the NTP’s decision when deciding 

which safety measures would ensure 

patient and staff safety. Aside from DEA 

security requirements, there are other 

Federal, State, local, and tribal laws 

these NTPs must take into consideration 

when making their decision. Thus, 

because the appropriate safety measures 

for a mobile NTP will vary based on 

circumstances and legal requirements, 

DEA will not attempt to specify 

additional safety requirements for NTPs 

as part of this rule. If such requirements 

are necessary, other Federal, State, local, 

and tribal authorities can create them. 

Comment: One commenter stated that 

the proposed rule was silent on what 

would happen to the medication if the 

mobile NTP breaks down, and 

recommended that DEA include a 

requirement for a standard operation 

procedure or contingency plan if the 

vehicle breaks down while en route to 

the communities where services are 

provided remotely, and if the mobile 

NTP is out of service for an extended 

period due to repairs. The commenter 

suggested that at a minimum, the 

standard operating procedure needs to 

include plans for dosing patients in the 

following circumstances: (1) If the 

mobile NTP breaks down while en route 

to the community, and (2) when the 

mobile NTP is out of service for an 

extended period due to repairs. The 

commenter expressed concern that if 

these plans are not in place, patients 

may encounter barriers to receiving 

their medication in an alternative 

manner (e.g., transportation and costs to 

reach a registered NTP location, waivers 

by NTP for patients to have ‘‘take home’’ 

privileges for the medication) and be 

put at increased risk for overdose. The 

commenter also noted possible 

limitations in the responsiveness of a 

mobile NTP’s security system, reliant on 

Wi-Fi capability, when the mobile NTP 

has weak or no access to Wi-Fi while in 

rural communities and is not near the 

registered NTP location. 

DEA Response: DEA has concluded 

that it is unnecessary for this rule to 

require NTPs to create a contingency 

plan for dosing patients served by the 

mobile NTP if the mobile NTP breaks 

down or is placed out of service. NTPs 

may well decide that such plans are 

appropriate, and other laws, regulations, 

or governing bodies may require them. 

The requirements DEA is imposing in 

this rule, however, are appropriately 

focused on DEA’s duty under the CSA 

to protect against the diversion of 

controlled substances. Thus, DEA is 

requiring a contingency plan for 

safeguarding the mobile NTP’s 

controlled substances if it breaks down. 

In the proposed rule, DEA stated that if 

the mobile component was 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. DEA went on to state that 

if the conveyance is taken to an 

automotive repair shop, all controlled 

substances would need to be removed 

and secured at the registered location. 

However, other than those security 

requirements, DEA will not specify 

what should be included in the NTP’s 

standard operating procedures, or what 

plans NTPs should implement regarding 

dosing patients while the mobile 

component is out of service. Such 

matters are beyond the scope of this 

rule, and properly within the judgment 

of the NTP and any relevant regulatory 

bodies outside of DEA. 

Comment: Another commenter noted 

that the proposed amendment to DEA 

regulations at 21 CFR 1301.74(l) would 

provide DEA discretion to require 

additional security measures for mobile 

NTPs based on certain factors. The 

commenter acknowledged that DEA 

currently has this discretion for NTPs 

but could not locate any DEA guidance 

on how DEA utilizes the listed factors 

to determine if an NTP applying for 

registration warrants additional security 

measures. The commenter stated that 

this proposed provision similarly did 

not provide any information regarding 

how DEA would use these factors to 

evaluate security measures for mobile 

components, nor did DEA provide a 

single example of the security measures 

it might require for such a component 

if the factors were relevant. 

As a result, the commenter believed 

this provision to not be clear or 

transparent and could lead to DEA field 

offices unevenly or arbitrarily applying 

the regulations. The commenter further 

stated that a registered NTP considering 

starting a mobile NTP would likely have 

to reach out to the local DEA field office 

early in the planning phase which could 

result in delays getting the mobile 

component up and running. Therefore, 

the commenter recommended that DEA 

not finalize this proposed provision, or 

at the very minimum, that DEA provide 

clarity in the final rule preamble 

regarding the factors and additional 

security measures. 


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10The Narcotic Treatment Programs Best 

Practices Guideline, developed by DEA in 

collaboration with the American Methadone 

Treatment Association (now the American 

Association for the Treatment of Opioid 

Dependence), provided assistance in understanding 

the provisions of the CSA and in the 

implementation of the regulations as they apply to 

dosage reconciliation practices in NTPs. DEA 

rescinded the guideline after publication of the 

NPRM, but the recommendations it contained 

continue to represent best practices for NTP 

operation. 

Another commenter noted that 

current regulations provide DEA 

discretion to prescribe security 

requirements to the NTP based on 

certain factors. However, this 

commenter stated that it would seem 

practically impossible for DEA to fully 

exercise its discretion under 21 CFR 

1301.73(l) and effectively set security 

standards for mobile components, given 

the changing locations of mobile 

components when contrasted with 

registered NTP locations. 

DEA Response: Under the final rule, 

DEA will review the security systems 

used on these mobile components and 

make a determination on which security 

systems meet DEA requirements on a 

case-by-case basis before approving the 

operation of a mobile NTP. DEA 

appreciates the concern that such caseby-case evaluation of mobile NTPs’ 

security systems may lead to delays and 

differences in enforcement between 

local DEA offices. As it is DEA’s intent 

to ensure that there are no delays or 

unfairness in getting mobile 

components up and running, DEA will 

endeavor to prevent such problems from 

occurring. 

DEA, however, cannot forego case-bycase determinations, even if they 

inevitably bring some risk of delay or 

enforcement discrepancies. As 

discussed above, although this final rule 

and DEA regulations more broadly 

articulate basic security requirements, 

they cannot account for all security 

situations. Some situations may require 

additional security measures for a 

mobile NTP to be able to adequately 

guard against loss through theft or other 

forms of diversion. Attempting to 

account for all such scenarios in 

advance through regulation is 

ineffective and may impose unnecessary 

restrictions on other mobile NTPs. DEA 

can best ensure that mobile NTPs 

provide adequate security by enabling 

local DEA offices to conduct case-bycase evaluations as appropriate. That 

said, DEA is slightly modifying the 

proposed regulatory language describing 

how these case-by-case evaluations are 

conducted in this final rule to clarify 

that DEA, not any other entity, applies 

the factors. 

DEA has concluded that mobile NTPs’ 

changing locations will not compromise 

its ability to make such assessments. 

DEA already evaluates the security 

arrangements provided by a wide range 

of registrants under many different 

circumstances. Although mobile NTPs 

do present some unique challenges, 

DEA is confident that it can work with 

mobile NTPs to ensure that they operate 

securely. 

Comment: Finally, one commenter 

stated that DEA’s security requirements 

in 21 CFR 1301.72 through 1301.76 are 

extremely outdated and currently put all 

registered NTPs, as well all DEA 

registrants, at high risk for diversion, 

and that this risk would extend to 

mobile NTPs. In particular, this 

commenter claimed that, in today’s 

environment, the controls outlined in 21 

CFR 1301.75(a) and (b) are inconsistent 

with those in 21 CFR 1301.71(a), and 

stated that securing controlled 

substances consistent with DEA’s nonpractitioner requirements in 21 CFR 

1301.72(a) can potentially reduce crime 

by 75–85 percent. This commenter 

encouraged DEA to strengthen and 

enhance the schedule I–V physical 

security requirements for all registrants 

consistent with 21 CFR 1301.72(a), by 

utilizing currently available market 

technologies. 

DEA Response: DEA appreciates this 

comment suggesting in general terms 

that it broadly update the security 

requirements of its regulations to better 

reflect currently available security 

technologies. DEA recognizes that 

technologies change, but has concluded 

that the security regulations in this rule 

adequately protect against theft and 

diversion in the use of mobile NTPs 

given current technologies. The sort of 

broader changes to DEA security 

regulations suggested by the commenter 

are beyond the scope of this rule. 

Recordkeeping Requirements for 

Mobile Components 

Comments: One commenter stated 

that they did not see a reason why all 

of the records mobile components 

would be required to keep could not be 

electronically logged in on a daily basis, 

while still being in compliance with the 

proposed amendment to 21 CFR part 

1304. Another commenter noted that the 

proposed rule allows mobile NTPs to 

maintain electronic dispensing logs; 

however, the mobile NTP would still 

need to print out a hard copy of such 

log daily with the dispenser of each 

dose initialing each relevant entry. The 

commenter advocated for allowing these 

dispensers to use digital signatures in 

these logs because the processes for 

digital signatures are readily available 

and widely used, and using digital 

signatures would reduce unnecessary 

paperwork for physicians. In addition, 

the commenter stated that DEA should 

not require pre-approval of the mobile 

NTP’s electronic recordkeeping system 

for the dispensing log because this 

could create unnecessary delays in the 

transition to electronic recordkeeping. 

Further, if DEA permits digital 

signatures in the final rule, the 

commenter requested that DEA clarify 

that DEA’s approval of an electronic 

recordkeeping system for a registered 

NTP location will be sufficient for the 

mobile component. 

DEA Response: DEA recognizes the 

concerns expressed by commenters 

regarding the use of electronic 

dispensing logs. In the proposed rule, 

DEA proposed an alternative to 

maintaining a paper dispensing log, 

stating 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 were met. The 

requirement that the NTP or its mobile 

component print 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, is one of the 

conditions that must be met. This 

requirement, along with the others 

specified in section 1304.24(b)(1), is 

based on recommendations in the 

Narcotic Treatment Programs Best 

Practice Guideline (April 2000).10

Furthermore, DEA emphasizes that the 

rule is not adding additional 

recordkeeping requirements to NTPs. 

The rule is instead simply applying 

already-existing recordkeeping 

requirements of 21 CFR part 1304 to 

mobile NTPs, as well as providing NTPs 

and their mobile components the option 

of using a computerized data processing 

system, instead of a paper dispensing 

log. DEA believes the recordkeeping 

requirements in this rule are necessary 

to ensure accountability and prevent 

diversion. Thus, DEA generally agrees 

that electronic logging of dispensing 

records is appropriate. These electronic 

records, however, will still have to be 

logged on a daily basis, and must 

comply with the requirements in 21 

CFR part 1304. Finally, requiring the 

NTP employee who dispensed the 

medication to review and initial the 

hard copy of the dispensing log at the 

end of each day is important for 

maintaining accurate records and 

ensuring accountability. 

DEA also notes the commenter’s 

concerns about the requirement that 


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DEA must pre-approve any electronic 

recordkeeping system used in lieu of a 

paper dispensing log. Prior to granting 

a registration to an NTP and its mobile 

component, under § 1301.13(e)(4) of this 

rule, the local DEA field office must 

evaluate all of the mobile components’ 

procedures and processes to determine 

if they provide effective controls against 

diversion. If the electronic 

recordkeeping system meets all of the 

recordkeeping and security 

requirements under the CSA, DEA will 

approve the system; this will be done on 

a case-by-case basis. If a registered NTP 

has an electronic recordkeeping system 

that is approved by DEA, this does not 

necessarily mean the same system will 

be as useful on the mobile component; 

this is why the electronic recordkeeping 

system on the mobile component must 

be evaluated separately. 

Comment: One commenter expressed 

concern that under the proposed rule, it 

appeared that patients could engage in 

‘‘double-dipping’’ by receiving 

treatment at a mobile NTP in the 

morning, and then at a registered NTP 

location later in the day, for example. 

The commenter stated that under the 

proposed revisions to 21 CFR 1304.24 

there is a requirement that NTPs must 

maintain records of patient information 

including the dosage consumed, but no 

requirement that the records be 

maintained in real-time, potentially 

allowing such ‘‘double-dipping’’ to 

occur before an NTP could compare 

dispensing logs and discover it. 

Therefore, to decrease the likelihood of 

patient overdoses, the commenter 

recommended that the final rule require 

all mobile NTPs to record doses in real 

time. 

DEA Response: NTPs have protocols 

in place to ensure that their patients 

cannot engage in ‘‘double-dipping’’ by 

receiving treatment at a mobile 

component in the morning, and then at 

a registered NTP location later in the 

day; the use of paper or electronic logs 

should not have a major impact on these 

protocols. Moreover, regardless of 

whether NTPs have such a protocol in 

place, ordinary diligence by NTPs, 

including periodic comparisons 

between the dispensing logs of a mobile 

NTP and its registered NTP, should 

readily reveal any individuals who are 

engaged in such ‘‘double-dipping’’ and 

enable NTPs to take steps to prevent 

them from doing so in the future. 

Although the use of ‘‘real-time’’ 

electronic dispensing logs might allow 

an NTP to uncover such ‘‘doubledipping’’ more quickly, DEA has 

concluded that requiring the use of 

technology could be burdensome and is 

not necessary to prevent ‘‘doubledipping’’ from becoming a significant 

source of diversion or significant risk of 

overdose among patients. Thus, DEA 

has concluded that NTPs should 

generally be capable of guarding against 

‘‘double-dipping’’ without further 

regulation. Every NTP has protocols in 

place to ensure that their patients 

receive the correct dose, and to ensure 

that the records containing this 

information are correct and up-to-date. 

As stated earlier, DEA has concluded 

that the use of technology could be 

burdensome, which goes against the 

purpose of this rulemaking. For these 

reasons, DEA will not require all mobile 

components to record doses in real time; 

however, if a mobile NTP chooses to do 

so, that would be permitted. 

Advantages of Serving Multiple 

Locations 

Comments: One commenter stated 

that the proposed rule was ambiguous 

on whether the mobile component 

could park at a location, dispense 

medication, and then move to another 

location or locations for further 

dispensing. The commenter suggested 

that DEA revise the proposed rule to 

explicitly allow mobile treatment 

components to serve multiple locations 

in a single day, because this would 

enable opioid treatment providers to 

help patients residing in skilled 

nursing/long term nursing facilities to 

receive their medication for opioid use 

disorder. The commenter did not 

provide any specific information on 

how this would help. 

DEA Response: DEA will leave the 

decision of whether a mobile 

component serves multiple locations in 

a single day to the NTP. For a mobile 

component in a more urban area, 

multiple stops might be more feasible, 

in comparison to a mobile component 

that would be serving a more remote 

area. As long as these mobile 

components follow all applicable 

Federal, State, local, and tribal laws, 

DEA will permit the mobile component 

to serve multiple locations. Although 

the proposed rule was not intended to 

limit mobile NTPs to serving a single 

location, DEA recognizes that references 

in the proposed regulatory text to 

mobile NTPs serving ‘‘a location’’ or ‘‘a 

dispensing location’’ in proposed 21 

CFR 1300.01(b) and 1301.72(e) may 

have been confusing. Thus, in this final 

rule, DEA has revised these sections to 

clarify that a mobile NTP may serve 

multiple remote locations. 

The Use of Past/Current Mobile 

Components 

Comments: Several commenters noted 

that mobile components have not only 

been used in the past, but some States 

are currently using them, and they have 

had a positive impact on the 

communities they operate in. One 

commenter stated that Minnesota 

benefited from a mobile methadone unit 

that operated approximately 15 years 

ago, because it increased compliance 

with dosing and provided services to 

geographically remote patients, allowing 

for better supervision, and faster 

stabilization of both dose and behavior. 

Another commenter said many NTPs 

already operate mobile components and 

these revisions will allow more 

flexibility, allowing even more NTPs to 

provide treatment via mobile 

components. A commenter who worked 

at a treatment program mentioned that 

their organization operated a mobile 

Suboxone program, and stated that it 

benefitted the community because the 

number of overdoses had been greatly 

reduced, and larger numbers of people 

were able to initiate treatment who 

would not otherwise have been able to 

without such access. 

Finally, two commenters mentioned 

the use of mobile components in 

emergency situations, such as during 

Hurricanes Katrina and Sandy. One of 

these commenters mentioned how 

mobile methadone components are an 

important part of the broad continuum 

of care for individuals with OUD, and 

stated these mobile components 

provided essential treatment services 

during Hurricane Katrina. However, the 

other commenter noted that mobile 

components had been largely 

unavailable to providers responding to 

emergency situations. That commenter 

mentioned that during Hurricane Sandy 

in 2012, affected NTPs employed 

strategies such as alternative 

transportation, take-home dosing, and 

guest dosing at nearby programs (i.e., 

temporary dosing at another NTP) to 

ensure continued access to treatment, 

and stated that these actions had 

varying degrees of execution and 

success. The commenter went on to say 

that mobile NTPs were considered as an 

option for reaching patients when 

facilities were destroyed, but one unit 

was being repaired at the time and the 

other was not able to operate because 

there was not a functioning registered 

NTP location to store the methadone. 

DEA Response: DEA appreciates the 

information provided by the 

commenters. As stated previously, the 

intent of this rule is to ensure that there 

is greater access to treatment for those 

who are suffering from OUD, and are 

unable to access treatment because of 

rural or geographic limitations, mobility 

issues, etc. The revised regulations will 

allow NTPs the option to use mobile 


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components during emergency 

situations such as those described by 

the two commenters, as long as all 

applicable, Federal, State, local, and 

tribal laws are followed when operating 

these mobile components. As discussed 

in the NPRM, prior to this rule, DEA 

only authorized mobile NTPs on an ad 

hoc basis and had placed a moratorium 

on new authorizations in 2007. See 85 

FR 11008, 11009. This rule will allow 

the use of mobile NTPs to be expanded 

more extensively, more consistently, 

and with greater protections against 

theft and diversion than was possible 

before. 

The Costs and Benefits Associated With 

Mobile Components 

Comments: Many commenters 

believed that this proposed rule would 

give providers a lower cost option for 

reaching patients where it may not be 

otherwise financially feasible to 

establish a new registered NTP location. 

Several commenters stated that the 

proposed rule would reduce the costs 

for NTPs wanting to expand their 

geographic reach and increase the 

treatment they are able to provide. 

Several commenters pointed to benefits 

that would result from the use of these 

mobile components that might not be 

quantifiable. Multiple commenters 

stated that the proposed rule would save 

many lives, as well as improve the 

health and well-being of patients 

receiving treatment, and allow these 

patients to live productive and 

satisfying lives. One commenter 

mentioned that the use of mobile NTPs 

could start saving thousands of lives 

and decrease illicit opioid use. 

Other commenters mentioned the 

savings that would be realized by 

allowing the mobile components to 

register only once. One commenter 

estimated savings between $1,270,670 

and $1,482,272 would be possible over 

five years ‘‘simply because operating out 

of the mobile unit would allow more 

treatments to be dispensed and 

operating over multiple locations would 

bring in more revenue.’’ However, the 

commenter did not explain the basis for 

this estimate. 

Conversely, one State behavioral 

health agency expressed general 

concerns about the startup costs 

associated with operating a mobile 

component, and stated that some NTPs 

may find this expense to be a barrier to 

establishing a mobile component. The 

commenter further indicated that as a 

result, some NTPs may desire to partner 

with agencies who already own wellequipped mobile components. The 

commenter recommended that DEA 

explicitly indicate whether it will allow 

a registered NTP to partner with an 

organization who owns a mobile NTP 

(e.g., hospital or health center). 

As discussed in detail above, many 

commenters were opposed to requiring 

the mobile component to return to the 

NTP’s registered location on a daily 

basis; the costs of the daily round trips 

were chief among the issues raised 

when voicing their concerns. These 

commenters generally believed that the 

costs associated with traveling to and 

from the communities served by mobile 

NTPs (e.g., staff time, travel costs, wear 

and tear on vehicles, etc.) could easily 

rival the cost of opening a new 

registered NTP location, especially 

when the communities are 100 to 200 

miles away, as noted by some 

commenters. Two commenters gave an 

example of a mobile NTP with at least 

one nurse and one medical assistant 

traveling 100 miles round trip six times 

per week for a year and estimated the 

yearly cost, based on the proposed rule’s 

estimated per mile operating cost, 

would be close to $62,000. Similarly, 

another commenter remarked that in the 

summary and benefits section of the 

proposed rule’s preamble, the mileage 

used to estimate operating costs for a 

mobile NTP, no more than 5,000 miles 

per year (100 miles per week), was 

rather low, especially for rural areas in 

some States. 

Three commenters also detailed other 

expenses that might result from 

operating the mobile component. One 

commenter stated that while the 

proposed rule provided potential 

safeguards addressing security, theft, 

and misuse, the rule did not discuss in 

its cost-benefit analysis the intangible 

costs associated with detecting any 

violation of either operating the mobile 

component as a treatment center or any 

of the rule’s other prohibitions. 

However, the commenter did not detail 

any specific cost numbers for these 

intangible costs. One commenter 

expressed concerns that the costs 

associated with paying an entire team of 

healthcare professionals for their travel 

time would likely be expensive and 

possibly even cost prohibitive, 

particularly if mobile NTPs will provide 

the same interdisciplinary services 

offered at registered NTP locations. This 

commenter further stated that the 

proposed rule failed to address these 

costs. Another commenter also 

mentioned the small, extra expense of 

hiring security personnel to protect the 

mobile NTP, which the commenter 

recommended if the regulations would 

no longer require the mobile NTPs to 

return to the DEA-registered location at 

the end of each day. 

Finally, a commenter expressed great 

appreciation that the proposed rule’s 

economic analysis qualitatively 

described benefits and cost-savings that 

cannot be quantified, including reduced 

health care costs, criminal justice costs, 

and lost productivity costs that will be 

reduced as a result of increased access 

to treatment. However, the commenter 

stated that this analysis omitted other 

important unquantifiable benefits, such 

as improved quality of life and 

improved dignity for patients who can 

access treatment. The commenter stated 

that the major benefit of this proposed 

rule is its expected effect on the cost to 

treat each patient with OUD and the 

number of patients who have access to 

such treatment (i.e., a decrease in costs 

and an increase in patients), noting that 

this will improve the quality of life and 

dignity for patients who can access this 

critical treatment. Therefore, the 

commenter suggested that DEA should 

revise its economic analysis and 

acknowledge these benefits in the final 

rule. In addition, this commenter stated 

that DEA should clarify in the final rule 

that the benefit-cost analysis framework 

applied in the proposed rule shows that 

a reduction in the marginal cost of 

treating patients for OUD could expand 

output, which would be a social benefit. 

The commenter explained that the 

analysis conducted by DEA in the 

proposed rule assumes that NTPs are 

currently incurring costs to expand 

treatment access by opening additional 

registered NTP locations. However, the 

commenter further noted that if DEA’s 

assumption is not true, and NTPs are 

not currently incurring costs to expand 

registered NTP locations, then under 

this rule, NTPs might actually incur 

more costs, the costs associated with 

operating a mobile NTP. 

DEA Response: DEA appreciates the 

support from commenters agreeing with 

the agency’s assessment that this rule 

will provide a less costly avenue for 

NTP’s to expand operations and treat 

more patients compared with opening a 

new registered NTP location. As stated 

earlier, the intent of the proposed rule 

is to ensure that treatment is made more 

widely available to those who need it. 

Although not readily quantifiable, 

saving lives, preventing overdoses, and 

ensuring patients receiving treatment 

are able to live productive lives help 

further the purpose in the proposed and 

final rule. Regarding one commenter’s 

view that DEA has not accounted for a 

potential increase in costs to the agency 

related to monitoring the security and 

recordkeeping of mobile components, 

DEA anticipates that its field offices will 

conduct any necessary security reviews 


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as a part of their routine NTP inspection 

workload, thus there will be no 

additional costs to DEA. 

DEA’s estimation of operating costs 

for a mobile NTP represents the average 

costs for an NTP choosing to operate a 

mobile component. As one commenter 

noted, in certain rural locations 

throughout the United States, these 

operating costs may be higher than the 

average costs presented in the regulatory 

analysis because NTPs may choose to 

travel further distances on a more 

frequent basis in order to reach patients 

in particularly remote areas. These 

operating costs may even surpass the 

costs associated with opening another 

registered location. Delivering treatment 

to patients in very remote locations will 

always carry higher transaction costs 

than delivering treatment to patients in 

readily accessible locations such as 

urban or suburban centers. Absent this 

rule, however, treating patients in these 

remote areas would likely require 

opening not just one more registered 

location, but many. DEA is confident 

that the operating costs of a single 

mobile NTP servicing a wide geographic 

area will always be less than those of 

multiple additional registered NTP 

locations that would be required to treat 

the patients dispersed throughout the 

same area. 

Additionally, DEA recognizes that 

some mobile components may indeed 

travel greater distances than the 100 

miles per week estimated in the 

proposed rule. However, DEA considers 

this mileage estimate to be a reasonable 

average of the weekly distance any 

particular mobile component might 

travel to treat patients, especially when 

factoring in mobile components that 

will operate in more densely-packed 

urban and suburban settings. As another 

commenter noted, operating a mobile 

component may also result in higher 

cost savings than what is presented in 

the regulatory analysis due to the 

possible increased volume of patients 

treated by a mobile component. Again, 

DEA’s analysis represents average cost 

savings when comparing the operation 

of a mobile NTP with a registered 

location, and therefore, this is factored 

into the agency’s conclusions below. 

Regarding one commenter’s challenge 

that the labor costs for the healthcare 

professionals needed to staff a mobile 

component would likely be prohibitive, 

DEA assumes that the labor required to 

provide MAT services are the same in 

a mobile component and a registered 

NTP setting. Therefore, any particular 

NTP would incur those labor costs 

when choosing to expand operations, 

whether via starting a mobile 

component or opening an additional 

registered NTP location. 

DEA agrees with the commenter 

stating that this rule is likely to result 

in an increase in quality of life and 

personal dignity for previously 

untreated patients who are able to 

receive care from a mobile NTP. DEA 

believes that these benefits are already 

discussed in the regulatory analysis 

below, and no further expansion is 

necessary. 

DEA also agrees with the commenter’s 

summation that the framework for the 

analysis presented in the regulatory 

impact analysis of this rule is a marginal 

cost framework, i.e., a comparison of the 

incremental costs incurred by NTPs 

choosing to expand operations under 

the baseline regulatory environment vs. 

under the rule’s regulatory environment. 

DEA does not see any benefit to the 

public in explaining this fact further in 

the regulatory impact analysis. 

The Ability of the Mobile Component 

To Operate as an Emergency Medical 

Services Vehicle or Hospital 

Comments: Several commenters noted 

that DEA did not address the specific 

services the mobile component could 

and could not provide to those 

individuals who utilize it. Many of 

these commenters also provided 

suggestions for the services they 

believed the mobile components should 

provide. One commenter suggested that 

DEA allow the mobile component to 

operate as an emergency medical 

services (EMS) vehicle or a hospital. 

The commenter stated that by not 

allowing the vehicles to operate as an 

EMS vehicle (e.g., to transport patients) 

or a hospital, there was a risk to the 

communities being served by the mobile 

component, because many of the rural 

areas might not have local hospitals or 

only have access to hospitals that are 

overcrowded and underfunded. The 

commenter also noted that some 

community members utilizing the 

mobile component may mistakenly 

assume that the mobile component is 

able to treat overdose victims or try to 

seek emergency treatment at a mobile 

component instead of an EMS vehicle or 

a hospital. 

One commenter suggested that DEA 

revise the proposed amendment, 21 CFR 

1301.13(4)(ii), to state explicitly that 

mobile NTPs are allowed to conduct the 

necessary medical and psychosocial 

services required to induct and maintain 

MAT/medications for opioid use 

disorder (MOUD); to utilize a Qualified 

Service Organization Agreement 

(QSOA) with an entity or entities that 

can provide these services; and to 

provide counseling services 

electronically (e.g., telehealth) by 

qualified providers. The commenter also 

mentioned that allowing these services, 

which would have to be consistent with 

applicable State and Federal law, would 

decrease the risk of discontinuity of 

care, which could cause the patient to 

relapse and/overdose. 

Another commenter noted that the 

proposed rule did not include guidance 

on ancillary requirements for NTP 

patients such as toxicology and 

serology, and stated that the NTP 

registrant should be required to indicate 

whether physical examinations, 

toxicology testing, and serology testing 

would be conducted in the mobile NTP 

or at the registered NTP location. The 

commenter also asked if the mobile NTP 

could conduct these services, and if not, 

recommended that the rule include 

clear guidance as to where these 

services could be provided or if these 

services could be conducted in 

coordination with a partner, like a 

hospital. 

Finally, another commenter suggested 

that the final rule should expressly state 

that services such as infectious disease 

screenings and harm reduction 

interventions are available in mobile 

NTPs just as they are at the registered 

NTP locations. As these mobile NTP 

components are to operate as 

‘‘coincident,’’ or equivalent, to the 

registered NTP location, the commenter 

suggested, a mobile NTP should provide 

most or all of the same supplemental 

services that are logistically possible. 

The commenter stated further that the 

exclusion of such language could be 

interpreted as prohibiting these critical 

public health interventions that are 

essential to addressing disparate rates of 

sexually transmitted and other 

infectious diseases among persons with 

substance use disorder, especially those 

who inject drugs. 

DEA Response: DEA appreciates 

commenters’ concerns about those 

individuals in rural communities being 

served by the mobile component not 

having local hospitals or access to 

hospitals that are overcrowded or 

underfunded. However, as stated in the 

NPRM, the mobile components will not 

be configured in a way to allow them to 

serve as an EMS vehicle or hospital, and 

will not have the necessary equipment 

or supplies on board to function as 

such. See NPRM, 85 FR 11008, 11010. 

In the preamble of the proposed rule, 

DEA stated it was proposing to waive 

the requirement of a separate 

registration for NTPs that utilize mobile 

components, and that specifically, an 

NTP would be permitted to dispense 

narcotic drugs in schedules II–V at 

location(s) remote from, but within the 


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same State as, the NTP’s registered 

location, for the purpose of maintenance 

or detoxification treatment. See NPRM, 

85 FR 11008, 11009. DEA did not 

include guidance on ancillary 

requirements for NTP patients such as 

toxicology and serology, infectious 

disease screenings, and harm reduction 

interventions, because if and how such 

services are provided is outside the 

scope of DEA’s authority. Although 

nothing in the rule prohibits a mobile 

NTP from providing such services, (if 

they can be provided in a manner 

consistent with the rule and other laws), 

it is similarly outside the scope of DEA’s 

authority to explicitly permit mobile 

NTPs to conduct the medical and 

psychosocial services required to induct 

and maintain MAT/MOUD, to utilize a 

QSOA with an entity or entities that can 

provide these services, and to provide 

counseling services electronically by 

qualified providers. Further, the 

registered NTP should decide whether 

its mobile component will offer these 

services based on the needs of the 

community they are servicing, staffing, 

financial impact to the NTP, etc. As long 

as the NTP follows all applicable, 

Federal, State, local, and tribal laws, 

DEA knows of no reason, at this time, 

why these activities would be 

prohibited. 

The Mobile Component Servicing 

Correctional Facilities 

Comments: Approximately 20 

commenters addressed the benefits of 

mobile components servicing 

incarcerated individuals with OUD. All 

of these commenters asserted that this 

rule would help in the treatment of 

incarcerated individuals. Commenters 

posited that the proposed revisions 

might allow NTPs to bring their mobile 

components to correctional facilities, as 

these facilities might have logistical 

difficulties arranging the transport of 

inmates to NTPs. One commenter 

recommended that DEA collaborate 

with NTPs and other Federal agencies to 

maximize opportunities to increase the 

use of mobile methadone to increase 

treatment access for these vulnerable 

populations. Several commenters 

similarly suggested that NTPs partner 

with law enforcement and State opioid 

treatment authorities to expand access 

to the services provided by the mobile 

component to correctional facilities. An 

organization representing individuals in 

medication-assisted recovery from OUD 

declared that it would encourage its 

members to advocate for the use of 

mobile components in these facilities 

with their State opioid treatment 

authorities and local law enforcement 

agencies. 

Some commenters noted that existing 

mobile NTPs have proven to be helpful 

in providing treatment for incarcerated 

individuals; however, no specific 

examples were provided. Another 

commenter, a non-profit organization, 

gave an example where mobile NTPs in 

Atlantic County, New Jersey provide 

medication (methadone, buprenorphine, 

and naltrexone) and counseling to 

inmates onsite, and link those being 

released from correctional facilities to 

community-based NTPs. The non-profit 

also stated that one NTP that shared that 

its mobile NTP had treated more than 

1,000 inmates in more than two years, 

and that these inmates subsequently had 

a lower recidivism rate compared to the 

general correctional facility population. 

Other commenters cited studies that 

showed how access to MAT services 

would decrease the rates of recidivism 

and post-release mortality as patients 

successfully transition from the 

correctional environment into an 

outpatient treatment setting. Two 

commenters both referenced data from a 

study in Rhode Island; the commenters 

reported that the data showed that 

offering MAT during incarceration and 

upon release resulted in a 60 percent 

decrease in overdose mortality among 

people who were recently incarcerated. 

One of the commenters described the 

study as ‘‘recent,’’ but neither provided 

a specific citation for the study. 

Finally, a pharmaceutical 

manufacturer sought clarity for itself, 

and its treatment provider customers, on 

whether NTPs operating a mobile 

component as described in the proposed 

rule would be allowed to regularly use 

the mobile component to transport and 

provide NTP services, including 

methadone treatment, to inmates 

housed in correctional facilities. The 

manufacturer believed the plain 

language of the proposed rule’s legal 

authority, as well as the proposed 

changes to 21 CFR 1301.13(e)(4), 

authorize a properly registered NTP 

operating a mobile component to 

dispense narcotic drugs for addiction 

treatment to inmates at a correctional 

facility. 

DEA Response: As stated before, the 

intent of this rule is to increase access 

to maintenance or detoxification 

treatment to those individuals who need 

it. As many of the commenters 

indicated, incarcerated individuals are a 

group who would greatly benefit from 

mobile NTPs servicing correctional 

facilities. The current use of mobile 

components by some NTPs in states 

such as New Jersey and Rhode Island, 

coupled with research presented by 

several commenters demonstrating 

lower recidivism rates as a result of 

treatment received while incarcerated, 

show that these mobile components are 

beneficial. Therefore, to avoid any 

possible confusion, in this final rule, 

DEA is adding an additional provision 

to 21 CFR 1301.13(e)(4) to clarify that 

NTPs may operate mobile components 

at correctional facilities where 

otherwise permitted by law. DEA would 

like to remind NTP registrants that they 

must follow all applicable, Federal, 

State, local, and tribal laws when 

operating these mobile components at 

correctional facilities. 

Promulgation of Telemedicine Special 

Registration Regulation and Related 

Issues 

Comments: Several commenters 

expressed concerns regarding the status 

of the telemedicine special registration 

that Congress mandated DEA implement 

by October 2019 in the Substance UseDisorder Prevention that Promotes 

Opioid Recovery and Treatment for 

Patients and Communities Act 

(SUPPORT Act), Public Law 115–271, 

sec. 3232, 132 Stat. 3894, 3950 (2018). 

One commenter mentioned that while 

this proposed rule was a step in the 

right direction, it falls short of the 

special registration for telemedicine, 

which would help more people who 

struggle to find access to buprenorphine 

providers. One commenter similarly 

noted that the proposed rule was an 

important step in expanding access to 

care for those with OUDs; this 

commenter, along with the others, also 

urged DEA to promulgate regulations 

implementing the telemedicine special 

registration as quickly as possible. 

DEA Response: Although these 

comments regarding telemedicine 

special registration are beyond the scope 

of this rule, DEA understands 

commenters’ frustration with the delay. 

DEA intends to promulgate regulations 

for the telemedicine special registration 

in the near future. 

Comment: One commenter suggested 

that the definition of mobile NTPs be 

expanded to include mobile internetbased health applications. 

DEA Response: In this final rule, DEA 

will not expand the definition of mobile 

NTPs to include mobile internet healthbased applications. The dispensing of 

controlled substances through internet 

applications raises risks and other 

issues quite different than those raised 

by dispensing through a mobile 

conveyance. Thus, such internet 

dispensing is beyond the scope of this 

rule, but will be considered in the 

context of the aforementioned special 

telemedicine registration rulemaking. 


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11Substance Abuse and Mental Health Services 

Administration. (2020). Treatment Improvement 

Protocol (TIP) 63: Medications for Opioid Use 

Disorder (HHS Publication No. PEP20–02–01–006). 

https://store.samhsa.gov/SMA18-5063FULLDOC 

(last accessed: 9/2/2020). 

Other Comments 

Comments: One commenter discussed 

how some State treatment agencies have 

already experienced staffing shortages 

or may in the future, and how it is also 

possible for an agency to suffer full 

closure due to the COVID–19 public 

health emergency. The commenter 

stated that both the lack of treatment 

facilities and staffing shortages would 

negatively impact an agency’s ability to 

admit clients into treatment, and that 

this will become more apparent due to 

the predicted increase in admissions 

following the public health emergency. 

Another commenter mentioned that 

DEA, SAMHSA, State regulators, and 

NTPs have taken steps to ensure 

continued access to treatment by 

changing dosing schedules to limit faceto-face contact, facilitating access to 

telehealth, and allowing home delivery 

of medications for OUD treatment to 

quarantined patients to prevent the 

spread of COVID–19. Finally, one 

commenter stated that due to the 

ongoing public health crisis, DEA 

should follow a tiered approach and 

immediately begin approving mobile 

components while devoting resources to 

finalizing this rule. The commenter 

further stated that DEA used its 

authority granted by 21 U.S.C. 822(d) to 

approve mobile components on an ad 

hoc basis prior to 2007, and thus there 

is no legal constraint on DEA to finalize 

this rule before beginning to approve 

mobile components on an ad hoc basis. 

Several commenters expressed 

concern that SAMHSA’s current 

requirement of daily dosing at the 

initiation of methadone treatment 

would limit the reach of newly 

operationalized mobile components to 

just one region/one community, given 

that a mobile component would have to 

repeatedly return to the same location(s) 

each day to provide daily methadone 

doses to newly initiated patients. To 

expand access to treatment, the 

commenters urged DEA to work with 

SAMHSA to revise regulations 

restricting take-home medications. Four 

commenters also suggested that DEA 

should work with SAMHSA to allow 

NTP providers to prescribe medications 

to be filled at community pharmacies 

and to allow non-NTP providers to 

prescribe methadone. 

DEA Response: DEA has worked 

closely with SAMHSA during the 

COVID–19 public health emergency to 

provide guidance and support to NTPs 

to ensure that any individual who relies 

on MAT is able to continue treatment 

without disruption. It is DEA’s intent 

that mobile NTP components will be 

able to help agencies facing lack of 

treatment facilities and staffing 

shortages resulting from COVID–19 or 

any other public health or 

environmental emergency that impacts 

NTP access. DEA will continue to work 

with SAMHSA and its other partners 

after this public health emergency has 

ended to ensure that those suffering 

from OUD face fewer barriers to 

treatment. 

DEA is using its discretion to approve 

mobile components under the authority 

granted to it by the CSA. 21 U.S.C. 

822(d). Any NTP that wishes to use a 

mobile component for maintenance or 

detoxification treatment will be able to 

start the approval process once the final 

rule has been published to ensure that 

all interested NTPs would be subject to 

the same requirements. 

Comments: Two commenters noted 

that the proposed rule does not 

reference mobile NTPs’ need to adhere 

to Health Insurance Portability and 

Accountability Act (HIPAA)/privacy 

requirements. These commenters 

assumed that these same requirements 

applied to mobile NTPs but advised 

DEA to clarify this matter in the final 

rule to prevent misinterpretation. One of 

these commenters advised DEA to 

include a reference to ‘‘best practice’’ 

standards as defined by SAMHSA in 

TIP 63: Medications for Opioid Use 

Disorder.11 The commenter also 

recommended that DEA work closely 

with SAMHSA to develop a companion 

document to accompany the new 

requirements related to the 

administration of an NTP. 

DEA Response: Regarding the 

commenters seeking clarity regarding 

HIPAA/privacy requirements for the 

mobile NTPs, DEA proposed requiring 

the records of the mobile components to 

be stored at the registered location of the 

NTP in a manner that meets all 

applicable security and confidentiality 

requirements. See NPRM, 85 FR 11008, 

11010–12 (proposed 21 CFR 1304.24(b)). 

These same requirements will apply in 

the final rule. NTPs already have 

protocols in place to protect patient 

information to ensure that they are in 

compliance with all Federal, State, 

local, or tribal requirements; the final 

rule is supplementary to these existing 

protocols. NTPs also have protocols and 

procedures in place to ensure that they 

are in compliance with all Federal, 

State, local, and tribal laws dealing with 

patient care, and best practices; 

therefore, DEA will not include a 

reference to ‘‘best practice’’ standards as 

defined by SAMHSA in TIP 63: 

Medications for Opioid Use Disorder. In 

sum, DEA does not anticipate any 

significant differences in how NTPs 

protect the privacy of patients served by 

registered NTPs and those served by 

their mobile components. 

Comment: One commenter noted that 

it is also important to be clear that 

adding new mobile components does 

not imply that treatment standards 

would be different or less stringent than 

those of registered NTPs. The 

commenter suggested that in order to 

ensure high quality treatment, the rule 

provide additional information about 

clinical requirements and the States’ 

role in that area, leaving less room for 

problems as new mobile NTPs become 

operational. Two commenters also 

noted that the proposed rule focused 

exclusively on the operational aspects of 

administering a methadone clinic, but 

did not address any counseling 

activities that are required for NTPs. 

One commenter stated that DEA should 

extend the regulations to require mobile 

components to have minimum 

treatment standards and use a 

multifaceted approach (e.g., counseling, 

recovery network, mandatory number of 

treatment visits per month for each 

patient). 

One commenter recommended that 

the rule acknowledges that States may 

have additional requirements for NTPs 

beyond the Federal regulations. The 

commenter also inquired if all 

requirements that apply to a registered 

NTP location apply to a mobile 

component. The commenter expressed 

concern that without explicit guidance, 

it could lead to a misinterpretation of 

NTP requirements. The commenter also 

recommended adding language to the 

proposed regulation to clarify the 

expectation that a mobile NTP will 

provide services beyond the 

administration of the medication, such 

as counseling. 

DEA Response: Under the rule, 

mobile NTPs are part of their DEAregistered NTP locations: Their 

dispensing of controlled substances 

through their mobile components is 

now a coincident activity allowed under 

their NTP’s DEA registration. Thus, 

except where otherwise provided for by 

this rule or other laws or regulations, 

mobile NTPs are subject to the same 

standards as the NTPs of which they are 

a part. 

DEA’s NTP regulations seek to 

minimize diversion or abuse of the 

controlled substances dispensed by 

NTPs, but DEA does not establish 

broader treatment standards for NTPs. 

Thus, to the degree commenters wish 


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12 85 FR 44710 (July 24, 2020). 

the government to clarify treatment 

standards specific to the mobile 

components of NTPs, they should 

contact the government entities that 

establish and enforce those standards. 

Comment: One commenter stated that 

in the final rule DEA should consider 

clarifying that the ability of mobile vans 

to convey injectable and implantable 

buprenorphine products that are 

administered to patients will not be 

restricted. The commenter also 

requested that DEA consider clarifying 

in the final rule’s preamble section ‘‘the 

role of ‘Hospital/Clinic’ as ‘nonpractitioner’ registrants to provide 

buprenorphine products for the 

treatment of [OUD] in accordance with 

21 CFR 1301.28.’’ 

DEA Response: The purpose of this 

rule is to waive the requirement of a 

separate registration for NTPs that 

utilize mobile components and to allow 

an NTP to dispense narcotic drugs in 

schedules II–V at location(s) remote 

from, but within the same State as, the 

NTP’s registered location, for the 

purpose of maintenance or 

detoxification treatment. The registered 

NTP, not DEA, should decide which 

narcotic drugs should be dispensed to 

its patients, both at the registered 

location and on the mobile component, 

in accordance with each individual 

patient’s medical needs as determined 

by a medical professional authorized to 

make such a determination. Nothing in 

this final rule prevents a mobile NTP 

from providing the same treatment as 

would be available at the registered NTP 

location, as long as the mobile NTPs 

follow all applicable Federal, State, 

local, and tribal laws. 

DEA regulations in 21 CFR 1301.28 

include provisions for exemption from 

separate registration requirements for 

individual practitioners dispensing or 

prescribing schedule III–V narcotic 

controlled drugs approved by FDA for 

maintenance or detoxification treatment 

provided they meet certain conditions, 

including being a ‘‘qualifying 

physician’’ or ‘‘qualifying other 

practitioner,’’ as defined in 21 U.S.C. 

823(g)(2)(G)(ii) or (g)(2)(G)(iv), 

respectively. Thus, the request to clarify 

the role of Hospital/Clinic in accordance 

with 21 CFR 1301.28 is beyond the 

scope of this final rule. 

Comment: Another commenter noted 

that the proposed rule does not include 

guidance on parking guidelines for the 

mobile component, and suggested that 

the NTP should be required to establish 

a standard operating procedure or 

obtain linkage agreements with 

organizations (e.g., hospitals or 

programs operating needle exchange 

programs) where the vehicle will be 

parked. The commenter stated the 

linkage agreements must include the 

mobile component’s days/date and 

hours of operation, and that without 

these agreements, there may be 

complaints and issues for local law 

enforcement agencies or community 

leaders. 

DEA Response: Regarding the 

commenter’s parking concerns for the 

mobile NTP, DEA appreciates the 

potential issues; however, DEA will not 

provide any guidance in this final rule. 

The NTP is responsible for establishing 

a protocol for parking, and to determine 

the appropriate organizations that might 

assist with parking. What constitutes an 

appropriate parking location for a 

mobile NTP will vary significantly from 

area to area based on local conditions 

and laws. Dictating what must be 

included in any agreements is thus 

outside the scope of this rulemaking and 

will not be addressed. DEA would like 

to remind NTP registrants of their 

obligations under any applicable 

Federal, State, or local laws when it 

comes to operating these mobile 

components. 

Comment: One commenter suggested 

that DEA not require NTPs to get preapproval from the local DEA field office 

before operating a mobile component; 

rather, DEA should only require 

registered NTPs to notify the local DEA 

field office that they will begin 

operating a mobile component. The 

commenter stated that this will prevent 

a situation where a registered NTP 

seeking to expand access with a mobile 

component will be required to wait for 

approval, missing out on critical days 

and weeks that could be spent providing 

access to patients. The commenter 

argued that other conditions in the 

proposed rule, combined with DEA’s 

regular inspections, are sufficient to 

ensure diversion is not occurring at 

mobile components, especially since the 

NTPs that are already registered will be 

familiar with DEA diversion regulations 

and capable of complying with the 

conditions for mobile components. The 

commenter also suggested that in the 

preamble to the final rule, DEA should 

commit to conducting a retrospective 

review and collecting data to assess the 

impact of the rule on treatment 

accessibility and the risk of diversion. 

The commenter stated that if this final 

rule succeeds at expanding treatment for 

opioid use disorder to patients while 

simultaneously minimizing diversion 

risks, DEA should further expand the 

program. 

DEA Response: DEA will not change 

the requirement that NTPs obtain preapproval from the local DEA field office 

before operating a mobile component. 

DEA appreciates the commenters’ 

concern about how possible delays in 

the approval process could have 

negative effects on those individuals 

who need access to treatment. Preapproval from the local DEA field office 

is part of the registration process for the 

mobile component; without it, the NTP 

will not be permitted to operate the 

mobile component under the 

requirements set forth by this final rule. 

DEA continually reviews the 

programs that fall under its regulatory 

authority; if it determines that 

adjustments are required to ensure 

compliance or to ensure that the rule’s 

effect is more successful, the 

appropriate action will be taken. 

Section-by-Section Analysis of the Final 

Rule 

DEA is finalizing the proposed rule 

with certain modifications to 21 CFR 

1300.01, 1301.13, and 1301.72. In brief, 

this rule slightly revises the mobile NTP 

definition at § 1300.01(b) from that 

proposed. The definition is revised to 

clarify that it is the operation of the 

mobile NTP (i.e., administering 

maintenance and/or detoxification 

treatment from the mobile component) 

that is the coincident activity, not the 

vehicle itself. The application fee in 

§ 1301.13(e)(1)(vii), in the table, is 

revised to reflect the new registration 

fee schedule that became effective on 

October 1, 2020.12

Also, this rule revises the proposed 

new § 1301.13(e)(4) by adding a third 

subparagraph (iii) to clarify that a 

mobile NTP may operate at a location or 

locations, including correctional 

facilities, away from, but within the 

same State as, the NTP’s registered 

location. Previously, the proposed rule 

was silent as to correctional facilities. 

Relatedly, in several places, references 

in the proposed rule to the remote 

‘‘location’’ where the mobile NTP 

operates are replaced with references to 

the mobile NTP’s ‘‘location or 

locations’’ to clarify that a mobile NTP 

can operate at more than one remote 

location under appropriate 

circumstances. 

This rule revises the proposed new 

§ 1301.72(e) to allow the mobile 

component to be parked at the 

registered location or any secure, 

fenced-in area when the mobile 

component is not in use. Prior to 

parking the conveyance at a secure, 

fenced-in location, all controlled 

substances must be removed from the 

conveyance and returned to the 

registered location and, the local DEA 

office must be notified of the location of 


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33876 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

the secure, fenced-in area. The proposed 

new paragraph did not previously 

address this security condition. 

This final rule does not change the 

proposed new requirement in 

§ 1301.72(e), that upon completion of 

the operation of the mobile NTP 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. However, this rule adds a 

provision in § 1301.72(e) that expressly 

allows NTPs to apply for an exception 

to this requirement, following the 

process set forth in 21 CFR 1307.03, 

which allows any person to apply for an 

exception to any provision of the DEA 

regulations. In addition, the revised 

§ 1301.72(e) specifically provides that 

the application must include certain 

other information, and that DEA will 

evaluate each application on a case-bycase basis to determine whether the 

applicant has demonstrated exceptional 

circumstances that warrant a waiver of 

the daily return requirement. 

Finally, this rule makes a variety of 

minor changes in capitalization, 

abbreviation, word choice, and grammar 

throughout the regulatory text, but these 

are not intended as substantive 

revisions. For example, whereas the 

proposed text used both ‘‘narcotic 

treatment program’’ and ‘‘NTP,’’ the 

revised text more consistently uses 

‘‘NTP’’ throughout. Similarly, proposed 

new § 1301.74(j) and (l) referred to an 

NTP ‘‘physician,’’ whereas the revised 

text uses the more general term 

‘‘practitioner.’’ 

Below are summaries of provisions 

contained in the final rule. 

Part 1300: Definitions 

In section 1300.01, DEA adds a 

definition for a mobile NTP. This 

definition reflects that a mobile NTP is 

an NTP operating from a motor vehicle 

that serves as a mobile component of the 

NTP. As such, a mobile NTP engages in 

maintenance and/or detoxification 

treatment with narcotic drugs in 

schedules II–V, at a location or locations 

remote from, but within the same State 

as, the registered NTP, and operates 

under the registration of the NTP. 

Because the mobile NTP definition 

references a motor vehicle, DEA also 

separately defines ‘‘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, a trailer could not serve as a 

mobile NTP. 

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 final rule 

contains provisions (described below) 

that require NTPs to secure controlled 

substances while operating a mobile 

component away from the registered 

location. 

In this final rule, DEA revises 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 reduce 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 a registered NTP 

will not have to apply for a separate 

registration, as its operation is 

considered coincident activity. In 

addition, DEA specifies in the 

regulations that the records generated 

during the operations of a mobile 

component of an NTP shall be 

maintained at the NTP’s registered 

location, rather than requiring such 

records to be stored in the mobile 

component. Section 1301.13 is also 

revised to explicitly state that registered 

NTPs may operate mobile components 

at correctional facilities where 

otherwise permitted by law. 

DEA revises section 1301.72 to ensure 

controlled substances in a mobile 

component of an NTP are protected 

against theft and diversion. To achieve 

this end, the security requirements 

under 21 CFR 1301.72(a)(1) and 21 CFR 

1301.72(d) apply to the mobile 

component of an NTP. The storage area 

for controlled substances in a mobile 

component of an NTP must not be 

accessible from outside the vehicle. The 

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 requiring 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 requiring 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 mobile NTP on a given day, the 

conveyance will need to immediately 

return to the registered location, and all 

controlled substances removed from the 

conveyance and secured within the 

registered location. After the controlled 

substances have been removed, the 

conveyance may be parked until its next 

use at the registered location or any 

secure, fenced-in area, once the local 

DEA office has been notified of the 

location of this secure, fenced-in area. If 

the mobile component is disabled for 

any reason (mechanical failure, 

accident, fire, etc.), the registrant will 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 will need to be 

removed and secured at the registered 

location. 

NTPs will 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 at the NTP’s 

registered location. NTPs are also 

required to provide State and local 

licensing and registration 

documentation to DEA at the time of 

inspection and prior to transporting 

controlled substances away from their 

registered location. 

Regarding the requirement for the 

mobile NTP to return daily to the 

registered location, and to store its 

controlled substances at the registered 

location, DEA revises 21 CFR 1301.72(e) 

to expressly allow the NTP to apply for 

an exception to this requirement, 

following the process set forth in 21 

CFR 1307.03. In addition, the revised 

§ 1301.72(e) specifically provides that 

the application must include the 

proposed alternate return period, 

enhanced security measures, and any 

other factors the applicant wishes the 

Administrator to consider. DEA will 

evaluate each application on a case-bycase basis to determine whether the 


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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 33877 

13Thomas CP, Fullerton CA, 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. 

14Substance 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. 

applicant has demonstrated exceptional 

circumstances that warrant a waiver of 

the daily return requirement. DEA will 

consider the applicant’s security and 

recordkeeping as well as other factors 

relevant to determining whether 

effective controls against diversion will 

be maintained. 

DEA revises 21 CFR 1301.74 to 

include mobile components of DEAregistered NTPs, since the existing 

regulations do not contain such a 

provision. As described in the 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 

now requiring that persons enrolled in 

any NTP, including those who receive 

treatment at a mobile NTP, 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. 

Mobile NTPs may only be stocked 

with narcotic drugs in schedules II–V 

from the registered NTP location. 

Personnel designated to transfer 

narcotic drugs in schedules II–V from 

the registered location to mobile NTPs 

are not 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 to the registered NTP 

location for disposal from the 

dispensing location(s) of the mobile 

component shall be secured and 

disposed of in compliance with 21 CFR 

part 1317 and all other applicable 

Federal, State, tribal, and local laws and 

regulations. 

Finally, the physical security controls 

of mobile components will 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 comply with 

the theft and significant loss reporting 

requirements in 21 CFR 1301.74(c). 

Part 1304: Records and Reports of 

Registrants 

Under the final rule, the 

recordkeeping requirements of 21 CFR 

part 1304 apply to mobile components 

of NTPs. DEA revises sections 1304.04 

and 1304.24 to include mobile 

components. As with registered NTP 

locations, the records of the mobile 

components will 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. 

21 CFR 1304.24(b) requires that an 

NTP maintain the records, required by 

21 CFR 1304.24(a), in a dispensing log 

at the registered location. It is 

understood that this log is in paper 

form. As an alternative to maintaining a 

paper dispensing log, DEA is permitting 

an NTP or its mobile component to also 

use an automated/computerized data 

processing system for the storage and 

retrieval of its 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 daily dispensing log, 

which is then initialed appropriately by 

each practitioner who dispensed 

medication to the NTP’s patients; and 

the automated system is approved by 

DEA. 

The NTP’s computer software 

program must be capable of producing 

accurate summary dispensing reports 

for the registered NTP location and its 

mobile component, for any time-frame 

selected by DEA personnel during an 

investigation. Further, if summary 

reports are maintained in hard copy 

form, they should be stored in a 

systematically organized file at the 

registered location of the NTP. 

Additionally, a back-up of all computer 

generated records of dispensing by the 

NTP and its mobile component is 

required to be maintained off-site. 

Finally, NTPs are required to retain 

all records for the registered NTP 

location as well as any mobile 

components for 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 final 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 final rule. This is 

the standard analytic framework 

codified in the Office of Management 

and Budget (OMB) Circular A–4, 

published on September 17, 2003. This 

final rule is an enabling rule designed 

to expand access to 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 final rule’s regulatory 

environment, in which a registered NTP 

may begin to operate a mobile 

component as a coincident activity, if 

authorized by DEA. This analysis, 

detailed below, finds that this final rule 

will result in a cost savings for DEAregistered NTPs in the form of reduced 

startup, labor, and operating costs of 

MAT services delivered via a mobile 

component. DEA also recognizes that 

this final rule is likely to result in 

benefits in the form of economic burden 

reductions (healthcare 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 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 final 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.13 While SAMHSA estimated that 2 

million Americans have an OUD 

involving medications, and another 

526,000 had an OUD involving heroin, 

in 2018, only 19.7 percent of Americans 

with an OUD received any specialty 

treatment.14 A review of private 

insurance data collected from 2010 to 

2014 found that, following an opioidrelated hospitalization, fewer than 11 

percent of covered patients received 


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15Ali, 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. 

16Leonardson J, Gale JA. Distribution of 

Substance Abuse Treatment Facilities Across the 

Rural—Urban Continuum. 2016. https://

muskie.usm.maine.edu/Publications/rural/ 

pb35bSubstAbuseTreatmentFacilities.pdf. 

17Sigmon SC. 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. 

18Leonardson J, Gale JA. Distribution of 

Substance Abuse Treatment Facilities Across the 

Rural—Urban Continuum. 2016. https://

muskie.usm.maine.edu/Publications/rural/ 

pb35bSubstAbuseTreatmentFacilities.pdf. 

19The 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 

× (1 + 0.4577) = $48,994.17. 

20 ‘‘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. 

21Price 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 NTP registrants for mobile 

components. 

22Quotes 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. 

MAT in combination with psychosocial 

services. An additional 6 percent 

received MAT without psychosocial 

services, and 43 percent received 

psychosocial services only.15 As of 

2016, over 90 percent of NTPs were 

located in urban areas, forcing rural 

patients to travel great distances to 

receive their doses of medication.16

According to research published in 

2014, some rural patients reported that 

the burden of traveling daily to receive 

their medication effectively prevents 

them from working,17 further increasing 

the risk that they will discontinue 

treatment.18

Without this rule permitting 

registered NTPs to operate mobile 

components as coincident activity, an 

NTP wishing to provide MAT services 

to patient populations with little or no 

access to an NTP would be required to 

register and open another NTP 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 $296 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 

SAMHSA. Additionally, opening a new 

location would entail additional staffing 

and facilities costs. Under the final 

rule’s regulatory provisions, registrants 

are able to operate a mobile component 

as a coincident activity of their existing 

registered location, foregoing the 

expenses of opening and operating a 

new registered location, 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 registered 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 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 final rule does 

not change the requirements for the 

personnel that are authorized to 

dispense controlled substances. 

Whether an NTP expands via a new 

registered location or a 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 registered 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 

associated registered NTP. DEA assumes 

that a new registered NTP location 

requires one medical assistant, and 

calculates the total annual 

compensation for this medical assistant 

to be $48,994.19

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 an alarm system 

compliant with 21 CFR 1301.72(a)(iii). 

Such startup costs are accordingly also 

omitted from this analysis. Whether 

MAT services are being rendered via a 

mobile NTP or the traditional office 

environment, the same type and 

quantity of labor, medical equipment, 

and security equipment is assumed 

necessary 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 (the most recent year in 

which this figure was updated).20 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 percent discount rate and 

$210,666.53 at a 3 percent discount rate. 

In comparison, commercial vehicles 

suitable for service as a mobile NTP 

range in price from $30,000 to 

$40,000.21 Furthermore, the final rule 

does not require an NTP to obtain a 

separate registration for the mobile 

component at a cost of $296 per year, 

which is a cost that a new registered 

NTP location would incur. The present 

value of registration costs per registrant 

over a five-year period is $1,213.66 at a 

7 percent discount rate and $1,355.59 at 

a 3 percent discount rate. 

There are also several operating 

expenses that are unique to a mobile 

component 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 component and a traditional 

NTP office require a safe, the confined 

space of a mobile component 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 22

and attributed that full amount to the 


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23Hooper, 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. 

24 $1.63 per mile × 5,000 miles per year = $8,150. 

25The cost of a safe is a one-time expense 

incurred in the first year of operation. 

26The final rule’s regulatory environment yields 

a five-year cost savings (discounted at 7%) of 

$318,855 over the current regulatory environment. 

$319,069 × 11 = $3,509,759. 

27The final rule’s regulatory environment yields 

a five-year cost savings (discounted at 3%) of 

$359,131 over the current regulatory environment. 

$359,369 × 11 = $3,953,059. 

mobile component, while attributing 

only the purchase price of the safe to the 

cost of a stationary 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.23 Based on DEA’s knowledge 

of the operations of existing mobile 

NTPs, DEA estimates that a mobile NTP 

operating under the final rule will travel 

an average of 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.24

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 an additional NTP 

location over a five-year period yields a 

net present value of cost savings 

between $319,069 (at a 7 percent 

discount rate) and $359,369 (at a 3 

percent 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: 

BASELINE REGULATORY ENVIRONMENT—TOTAL COSTS FOR ADDITIONAL NTP LOCATIONS * 

Office rent per year .............................................................. $46,000.00 

Cost of safe 25 ...................................................................... 899.00 

Labor Cost ........................................................................... 48,994.00 

Registration fee .................................................................... 296.00 

NPV 3% Year 1 Year 2 Year 3 Year 4 Year 5 

$437,274 .............................................................................. $96,189.00 $95,290.00 $95,290.00 $95,290.00 $95,290.00 

NPV 7% Year 1 Year 2 Year 3 Year 4 Year 5 

$391,549 .............................................................................. $96,189.00 $95,290.00 $95,290.00 $95,290.00 $95,290.00 

* All figures rounded to the nearest whole dollar. 

FINAL RULE’S REGULATORY ENVIRONMENT—TOTAL MOBILE NTP COSTS * 

Vehicle purchase price ........................................................ $40,000.00 

Cost to install DEA compliant safe ...................................... 1,798.00 

Maintenance cost per year .................................................. 8,150.00 

NPV 3% Year 1 Year 2 Year 3 Year 4 Year 5 

$77,905 ................................................................................ $49,948.00 $8,150.00 $8,150.00 $8,150.00 $8,150.00 

NPV 7% Year 1 Year 2 Year 3 Year 4 Year 5 

$72,480 ................................................................................ $49,948.00 $8,150.00 $8,150.00 $8,150.00 $8,150.00 

* All figures rounded to the nearest whole dollar. 

DEA does not have a systematic 

method for estimating how many NTP 

registrants that are currently deterred or 

prevented from opening additional NTP 

locations 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, registered NTPs are more 

limited in their geographic service area 

than a mobile NTP would be. 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 nineteen such NTP 

registrants, and there are currently eight 

with mobile components still in 

operation. Therefore, DEA considers it a 

reasonable assumption that at least 

eleven additional NTP registrants will 

begin operating a mobile NTP after this 

final rule is published, bringing the total 

number of mobile NTPs to at least the 

previous total of nineteen. This yields a 

total cost savings for all of those NTPs 

over a five-year period of $3,509,759 26

(at a 7 percent discount rate) to 

$3,953,059 27 (at a 3 percent discount 

rate). 

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 final 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 final rule 

is a deregulatory action that will result 

in a net cost savings between $3,509,759 

and $3,953,059. 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

This final rule was developed in 

accordance with the principles of 

Executive Orders (E.O.) 12866 and 

13563. E.O. 12866 directs agencies to 


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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 established in E.O. 12866. DEA 

expects that this final 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 

final rule to estimate its economic 

impact, comparing the costs and/or costsavings of a ‘‘no action’’ baseline 

regulatory environment with the costs 

and/or cost-savings of the regulatory 

environment that will result from this 

final rule. This final rule is an enabling 

rule designed to expand the supply of 

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 

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 final rule’s regulatory 

environment in which a registered NTP 

may begin to operate a mobile 

component as a coincident activity, 

subject to the provisions of this final 

rule. DEA’s analysis, summarized in the 

preceding section, finds that this final 

rule will result in a net cost-savings 

between $3,509,759 and $3,953,059, and 

is therefore below the $100 million 

threshold. 

For a number of years, DEA has 

allowed registered NTPs to utilize 

mobile components as part of their 

programs through special arrangements 

with local DEA field offices. The use of 

these mobile components 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 substance use disorder, 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 

components associated with the 

registered NTP were seen as an 

alternative because they increased 

accessibility to treatment in the areas 

that needed it. 

This final rule builds on the existing 

experience and provides additional 

flexibility for NTPs in operating mobile 

components, subject to regulatory 

restrictions put into place to prevent the 

diversion of controlled substances. DEA 

is revising 21 CFR 1301.13 to make 

operating a mobile component of an 

NTP a coincident activity of an existing 

NTP registration, and this provision will 

reduce the regulatory burden on NTPs 

by waiving the separate DEA 

registration requirement. These mobile 

NTPs are required to maintain effective 

security to guard against theft and 

diversion of controlled substances in 

accordance with 21 CFR 1301.72. The 

mobile NTPs are also subject to the 

recordkeeping requirements in 21 CFR 

1304.04 and 1304.24. Many of the 

current mobile NTPs are already 

following these regulatory requirements. 

This final rule ensures that these 

regulatory requirements can be enforced 

consistently over any current or future 

NTP wishing to operate a mobile NTP. 

Thus, this final rule will 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 component 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. 

While the findings of the regulatory 

impact analysis of this final rule support 

the conclusion that this rulemaking is 

not economically significant, the Office 

of Information and Regulatory Affairs 

(OIRA) has nonetheless determined that 

the final rule is a ‘‘significant regulatory 

action’’ under E.O. 12866, section 3(f). 

Accordingly, this rule has been 

reviewed by OIRA. 

Executive Order 12988, Civil Justice 

Reform 

This final rule meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988, Civil Justice 

Reform, to eliminate ambiguity, 

minimize litigation, establish clear legal 

standards, and reduce burden. 

Executive Order 13132, Federalism 

This final rule does not have 

federalism implications warranting the 

application of E.O. 13132. The final 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 final rule does not have tribal 

implications warranting the application 

of E.O. 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 final rule on small 

entities. DEA’s evaluation of economic 

impact by size category indicates that 

the final rule will not 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 final 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 

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 


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28The 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: 

September 1, 2020). 

29 Data for NAICS codes related to NTPs are based 

on the 2017 SUSB Annual Datasets by 

Establishment Industry, last revised on July 16, 

2020. 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 NAICS codes. 

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) 28 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. 

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 0.56, 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

NAICS code Number of firms Number of 

establishments 

Firm to 

establishment 

ratio 

Total Narcotic Treatment Program ............................................................................ 6,919 12,449 0.56 

622210—Psychiatric and Substance Abuse Hospitals ............................................. 396 623 .64 

621420—Outpatient Mental Health and Substance Abuse Centers ......................... 6,523 11,826 .55 

Source: SUSB.29 (Accessed 9/8/2020). 

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-toestablishment ratio of 0.56 to the 1,832 

NTP registrations in DEA’s database to 

estimate the number of NTP entities, 

resulting in an estimate of 1,026 NTP 

entities in the United States. The table 

below summarizes this calculation. 

NUMBER OF ENTITIES BY BUSINESS ACTIVITY

Business activity NAICS code 

Number of 

registrations/ 

establishment 

Entity to 

establishment 

ratio 

Number of 

entities 

Narcotic Treatment Program ............................................................... 622210 

621420 

1,832 0.56 1,026 

Grand Total ................................................................................... ........................ 1,832 .............................. 1,026 

Thus, based on these calculations, 

DEA estimates that 1,026 entities could 

currently operate a mobile NTP, 

including the eight NTP entities that 

currently operate mobile NTP 

components. Of these, DEA estimates 

that at least an additional eleven entities 

will choose to operate a mobile NTP as 

a coincident activity in response to the 

final rule, matching the previous total of 

nineteen mobile NTPs that were in 

operation over the previous five years. 

Because the final 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 

will be affected by the rule. Therefore, 

DEA estimates that 1.07 percent (11 of 

1,026) of total NTP entities in the 

United States will be affected by this 

final 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, 


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30The 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: 9/8/2020). 

31SUSB 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. 

32SUSB 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. 

33 0.0107 × 873 = 9.3411. Rounding down to the 

nearest whole number yields 9. 

U.S. Small Business Administration 

(SBA) 30 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. 

SBA SIZE STANDARDS

NAICS codes Description 

Size 

standards 

($ million in 

annual 

receipts) 

Size 

standards 

(number of 

employees) 

622210 ............................................. Psychiatric and Substance Abuse Hospitals ............................................ 41.5 ........................

621420 ............................................. Outpatient Mental Health and Substance Abuse Centers ........................ 16.5 ........................

Source: SBA, August 19, 2019. (Accessed 9/8/20120). 

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,31 180 of 411 

(43.78%) firms within code 622210 fell 

below the SBA size standard and thus 

were small firms.32 4,369 of 4,987 (87.61 

percent) 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 2017 SUSB Annual Datasets by 

Establishment Industry, resulting in 

approximately 173 firms (43.78 percent 

of the total 396) within code 622210 and 

5,714 firms (87.61 percent of the total 

6,523) within code 621420 classified as 

small firms. Combining these values 

indicates that, for these codes, 5,887 of 

6,919 firms, or 85.1 percent, are small 

firms. Thus, since these are the NAICS 

codes that most closely correspond to 

NTP entities, DEA estimates that 85.1 

percent of NTP entities are small firms. 

As described above, DEA has concluded 

that there are roughly 1,026 total NTP 

entities in the United States. 

Accordingly, DEA estimates that 873 

(85.1 percent) of the total 1,026 NTP 

entities are small entities. The analysis 

is summarized in the table below. 

SUMMARY OF REGISTRATION, ESTABLISHMENT, ENTITY, AND SMALL ENTITY

Business activity 

Number of 

registrations/ 

establishments 

Entity to 

establishment 

ratio 

Number of 

entities 

Percent small 

entities 

Number of 

small entities 

Narcotic Treatment Program ................................... 1,832 0.56 1,026 85.1 873 

Percent Small Entity ................................................ .............................. .............................. ........................ ........................ 85.1% 

In consultation with the SBA’s Office 

of Advocacy, DEA has adopted the SBA 

standard that the amount of small 

entities affected by a final 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 final rule is an enabling rule and a 

deregulatory action resulting in a total 

cost savings of at least $3,509,759 over 

a five-year period. The final 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 eleven entities will choose to 

operate a mobile NTP as a coincident 

activity in response to the final rule. 

Because the final 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 1.85 

percent (19 of 1,026) of total NTP 

entities in the United States are affected 

by this final rule. DEA estimates that 11 

NTPs not already operating a mobile 

NTP (or 1.07 percent of all NTPs) will 

choose to operate a mobile NTP. 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 1,026, or 

1.07 percent), especially since most NTP 

entities are small. Thus, DEA estimates 

that 1.07 percent (9 of the 873 33) of 

small NTP entities will choose to begin 

operating a mobile NTP as a coincident 

activity in response to the rule. 

Estimating Impact on Small Entities 

The nine affected small entities are 

estimated to realize the same cost 

savings as other affected entities, as 

calculated above: Between $319,069 (at 

a 7 percent discount rate) and $359,369 

(at a 3 percent discount rate) per entity 

over a five-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. 


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Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 33883 

However, since the percentage of 

affected small entities is less than 30 

percent (1.07 percent), this final rule 

does not impact a substantial number of 

small entities. Therefore, this final rule 

does not rise to the level of certification 

as economically significant. 

The table below summarizes the 

analysis. 

SUMMARY OF ANALYSIS

Business activity 

Estimated number 

of small entities 

(Establishments) 

Estimated number 

of affected 

small entities 

Percentage of small entities affected Economic impact 

of compliance 

Narcotic Treatment Program .. 873 9 1.07% (Not Substantial) ...................................... Not significant. 

DEA examined the economic impact 

of the final rule for each affected 

industry for various size ranges. Based 

on the analysis above, and because of 

these facts, DEA certifies this final rule 

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 will 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 million 

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 

will not impose new recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. Although the final 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. 

Congressional Review Act 

This final rule is not a major rule as 

defined by the Congressional Review 

Act (CRA), 5 U.S.C. 804. This final rule 

will not result in an annual effect on the 

economy of $100 million or more; a 

major increase in costs or prices; or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. Accordingly, this final 

rule is not subject to the reporting 

requirements under the CRA. 

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 amends 21 CFR parts 

1300, 1301, and 1304 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. In § 1300.01(b), add in alphabetical 

order the definitions of ‘‘Mobile 

Narcotic Treatment Program’’ and 

‘‘Motor vehicle’’ to read as follows: 

§ 1300.01 Definitions relating to controlled 

substances. 

* * * * * 

(b) * * * 

Mobile Narcotic Treatment Program 

means a narcotic treatment program 

(NTP) operating from a motor vehicle, as 

defined in this section, that serves as a 

mobile component (conveyance) and is 

operating under the registration of the 

NTP, and engages in maintenance and/ 

or detoxification treatment with narcotic 

drugs in schedules II–V, at a location or 

locations remote from, but within the 

same State as, its registered location. 

Operating a mobile NTP is a coincident 

activity of an existing NTP, as listed in 

§ 1301.13(e) of this chapter. 

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 

■ 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. 

■ 4. In § 1301.13, revise paragraph 

(e)(1)(vii), and add paragraph (e)(4) to 

read as follows: 

§ 1301.13 Application for registration; time 

for application; expiration date; registration 

for independent activities; application 

forms, fees, contents and signature; 

coincident activities. 

* * * * * 

(e) * * * 

(1) * * * 

(vii) Narcotic Treatment Program (including 

compounder).

Narcotic Drugs in 

Schedules II–V.

New–363 ..................

Renewal–363a .........

296 1 May operate one or more mobile narcotic 

treatment programs as defined under 

§ 1300.01(b), provided approval has 

been obtained under § 1301.13(e)(4). 

* * * * * 

(4) For any narcotic treatment 

program (NTP) intending to operate a 

mobile NTP, the registrant must notify 

the local DEA office, in writing, of its 

intent to do so, and the NTP must 

receive explicit written approval from 

the local DEA office prior to operating 

the mobile NTP. The mobile NTP may 

only operate in the same State in which 

the NTP is registered. 


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33884 Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 

(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 NTP. Vehicles must possess 

valid county/city and State information 

(e.g., a vehicle information number 

(license plate number) on file at the 

registered location of the NTP. 

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 NTP is not permitted to 

reverse distribute, share, or transfer 

controlled substances from one mobile 

component to another mobile 

component while deployed away from 

the registered location. NTPs 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. Mobile components of NTPs 

may not function as hospitals, long-term 

care facilities, or emergency medical 

service vehicles, and will not transport 

patients. 

(iii) A mobile NTP may operate at any 

remote location or locations within the 

same State as its registered location, 

including correctional facilities, so long 

as doing so is otherwise consistent with 

applicable Federal, State, tribal, and 

local laws and regulations, and so long 

as the local DEA office, when notified 

pursuant to this section, does not 

otherwise direct. 

* * * * * 

■ 5. In § 1301.72, revise the section 

heading and add paragraph (e) to read 

as follows: 

§ 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. (1) For any conveyance 

operated as a mobile narcotic treatment 

program (NTP), a 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 

in 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. 

Personnel transporting the controlled 

substances on behalf of the mobile NTP 

are required to retain control over all 

controlled substances when transferring 

them between the registered location 

and the conveyance, while en route to 

and from the dispensing location or 

locations, and when dispensing at the 

dispensing location or locations. At all 

other times during transportation, all 

controlled substances must be properly 

secured in the safe. Upon completion of 

the operation of the mobile NTP 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. After the conveyance has 

returned to the registered location and 

the controlled substances have been 

removed, the conveyance may be parked 

until its next use at the registered 

location or any secure, fenced-in area, 

once the local DEA office has been 

notified of the location of this secure, 

fenced-in area. All 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 all controlled 

substances on the inoperable 

conveyance are accounted for, removed 

from the inoperable conveyance, and 

secured at the registered location. 

(2) With regard to the requirement of 

paragraph (e)(1) of this section, that 

upon completion of the operation of the 

mobile NTP 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, 

an NTP may apply for an exception to 

this requirement as provided in this 

paragraph. The application for such an 

exception must be submitted in 

accordance with § 1307.03 of this 

chapter and must include the proposed 

alternate return period, enhanced 

security measures, and any other factors 

the applicant wishes the Administrator 

to consider. The Administrator may 

grant such an exception in his 

discretion and will evaluate each 

application on a case-by-case basis in 

determining whether the applicant has 

demonstrated exceptional 

circumstances that warrant the 

exception. In making this 

determination, the Administrator will 

consider the applicant’s security and 

recordkeeping as well as any other 

factors he deems relevant to 

determining whether effective controls 

against diversion will be maintained. 

■ 6. In § 1301.74: 

■ a. Revise the section heading; 

■ b. Revise paragraphs (j) through (l); 

■ c. Redesignate paragraph (m) as 

paragraph (o); and 

■ d. Add new paragraphs (m) and (n). 

The revisions and additions read as 

follows: 

§ 1301.74 Other security controls for nonpractitioners; narcotic treatment programs 

and compounders for narcotic treatment 

programs; mobile narcotic treatment 

programs. 

* * * * * 

(j) Persons enrolled in any narcotic 

treatment program (NTP), including 

those receiving treatment at a mobile 

NTP, 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 must wait 

outside of a mobile NTP component if 

that conveyance 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 practitioner and NTP 

employees. 

(k) All NTPs, including mobile NTPs, 

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 

NTP or mobile NTP for unsupervised 

use (e.g., take home or non-directly 

observed therapy). 

(l) DEA may exercise discretion 

regarding the degree of security required 

in NTPs, including mobile NTPs, based 

on such factors as the location of a 

program, the number of patients 

enrolled in a program, and the number 

of practitioners, 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, DEA will 

consider such factors when evaluating 

existing security or requiring new 

security at a narcotic treatment program 

or mobile NTP. 

(m) Any controlled substances being 

transported for disposal from the 

dispensing location of a mobile NTP 

shall be secured and disposed of in 

compliance with part 1317, and all 

other applicable Federal, State, tribal, 

and local laws and regulations. 


khammond on DSKJM1Z7X2PROD with RULES
Federal Register / Vol. 86, No. 121 / Monday, June 28, 2021 / Rules and Regulations 33885 

(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 

■ 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. 

§ 1304.04 [Amended] 

■ 8. In § 1304.04, amend paragraph (f) 

introductory text by adding ‘‘mobile 

narcotic treatment program,’’ after 

‘‘exporter’’. 

■ 9. In § 1304.24, revise the section 

heading and paragraphs (a) and (b) to 

read as follows: 

§ 1304.24 Records for maintenance 

treatment programs, mobile narcotic 

treatment programs, and detoxification 

treatment programs. 

(a) Each person registered or 

authorized (by § 1301.22 of this chapter) 

to maintain and/or detoxify controlled 

substance users in a narcotic treatment 

program (NTP), including a mobile NTP, 

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 

§ 1304.22 without reference to 

§ 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 

§ 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. 

* * * * * 

D. Christopher Evans, 

Acting Administrator. 

[FR Doc. 2021–13519 Filed 6–25–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 45 

[Docket ID: DOD–2021–OS–0047] 

RIN 0790–AL22 

Medical Malpractice Claims by 

Members of the Uniformed Services; 

Correction 

AGENCY: Department of Defense (DoD) 

Office of General Counsel, DoD. 

ACTION: Interim final rule; correction. 

SUMMARY: The Department of Defense is 

correcting an interim final rule that 

appeared in the Federal Register on 

June 17, 2021. The interim final rule 

implements requirements of the 

National Defense Authorization Act 

(NDAA) for Fiscal Year 2020 permitting 

members of the uniformed services or 

their authorized representatives to file 

claims for personal injury or death 

caused by a Department of Defense 

(DoD) health care providers in certain 

military medical treatment facilities. 

Because Federal courts do not have 

jurisdiction to consider these claims, 

DoD is issued this rule to provide 

uniform standards and procedures for 

considering and processing these 

actions. 

DATES: This correction is effective on 

July 19, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Toppings, 571–372–0485. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2021–12815, appearing at 86 FR 32194– 

32215 in the Federal Register on 

Thursday, June 17, 2021, the following 

correction is made: 

§ 45.11 [Corrected] 

■ 1. On page 32213, in the third column, 

line 47 from the top, in § 45.11, the 

second paragraph (g)(5) and paragraphs 

(g)(6) and (7) that follow are 

redesignated as (g)(6) through (8). 

Dated: June 22, 2021. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2021–13632 Filed 6–25–21; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2020–0694] 

RIN 1625–AA09 

Drawbridge Operation Regulation; Gulf 

Intracoastal Waterway, Madeira Beach, 

FL 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is changing 

the operating schedule that governs the 

Welch Causeway (SR 699) Bridge, Gulf 

Intracoastal Waterway mile 122.8, at 

Madeira Beach, Florida. This change 

will place the drawbridge on a daily 

operating schedule to alleviate vehicle 

congestion due to on demand bridge 

openings and balance the needs of all 

modes of transportation due to the 


khammond on DSKJM1Z7X2PROD with RULES