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

33883

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
Narcotic Treatment Program ..

873

9

1.07% Not Substantial

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. 35013521. 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.

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Congressional Review Act
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

3. The authority citation for part 1301
continues to read as follows:

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

2. In 1300.01b, add in alphabetical order the definitions of Mobile Narcotic Treatment Program and Motor vehicle to read as follows:

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
1300.01 Definitions relating to controlled substances.

vii Narcotic Treatment Program including compounder.

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Renewal363a

Narcotic Drugs in Schedules IIV.

4 For any narcotic treatment program NTP intending to operate a mobile NTP, the registrant must notify
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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
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Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871b, 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

4. In 1301.13, revise paragraph e1vii, and add paragraph e4 to read as follows:

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

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 IIV, 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 1301.13e 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 1300DEFINITIONS

b

Not significant.

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

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:

Economic impact of compliance
1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature;
coincident activities.

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May operate one or more mobile narcotic treatment programs as defined under 1300.01b, provided approval has been obtained under 1301.13e4.

the mobile NTP. The mobile NTP may only operate in the same State in which the NTP is registered.

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