Voglio sapere a riguardo di…

Federal Register / Vol. 86, No. 112 / Monday, June 14, 2021 / Rules and Regulations Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This 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 The Acting Administrator, in accordance with the Regulatory Flexibility Act RFA, 5 U.S.C. 601602, has reviewed this final rule and by approving it certifies that it will not have a significant economic impact on a substantial number of small entities.
On August 31, 2018, DEA published an order to temporarily place Nethylpentylone in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. On August 27, 2020, DEA published a temporary scheduling order extending the temporary scheduling of Nethylpentylone for up to one year pursuant to 21 U.S.C. 811h2.
Accordingly, all entities that currently handle or plan to handle Nethylpentylone have already been required to establish and implement the systems and processes required to specifically handle N-ethylpentylone.
There are currently 31 unique registrations authorized to handle Nethylpentylone specifically, as well as a number of registered analytical labs that are authorized to handle schedule I
controlled substances generally. Some of these entities are likely to be large entities. However, since DEA does not have information of registrant size and the majority of DEA registrants are small entities or are employed by small entities, DEA estimates a maximum of 26 entities are small entities. Therefore, DEA conservatively estimates as many as 26 small entities are affected by this rule.
A review of the 31 registrations indicates that all entities that currently
handle N-ethylpentylone also handle other schedule I controlled substances, and thus they have established and implemented or maintain the systems and processes required to handle Nethylpentylone as a schedule I
substance. Therefore, DEA anticipates that this rule will impose minimal or no economic impact on any affected entities, and, thus, will not have a significant economic impact on any of the 26 affected small entities. Therefore, DEA has concluded that this rule will not have a significant economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
UMRA
In accordance with UMRA of 1995, 2
U.S.C. 1501 et seq., DEA has determined and certifies that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any 1 year . Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
Determination To Make Rule Effective Immediately As indicated above, this rule finalizes the schedule I control status of Nethylpentylone that has already been in effect since the publication of an order in the Federal Register amending 21
CFR 1308.11h to temporarily place Nethylpentylone in schedule I of the CSA
pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. 83 FR
44474. The August 2018 order was effective on the date of publication, and was based on findings by the thenActing Administrator that the temporary scheduling of N-ethylpentylone was necessary to avoid an imminent hazard to the public safety pursuant to 21
U.S.C. 811h1. Because this rule finalizes the control status of Nethylpentylone that has already been in effect for over two and half years, it does not alter the legal obligations of any person who handles this substance.

Rather, it merely makes permanent the current scheduling status and corresponding legal obligations.
Therefore, DEA is making the rule effective on the date of publication in the Federal Register, as any delay in the effective date is unnecessary and would be contrary to the public interest.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44
U.S.C. 35013521. This action would not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
Congressional Review Act CRA
This rule is not a major rule as defined by the CRA, 5 U.S.C. 804.
However, pursuant to the CRA, DEA is submitting a copy of this final rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR
part 1308 is amended as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for part 1308
continues to read as follows:

Authority: 21 U.S.C. 811, 812, 871b, 956b, unless otherwise noted.

2. In 1308.11:
a. Add paragraph d86; and b. Remove and reserve paragraph h36.
The addition reads as follows:

1308.11

Schedule I.

d

86 N-ethylpentylone Other names: ephylone, 1-1,3-benzodioxol-5-yl-2-ethylaminopentan-1-one

lotter on DSK11XQN23PROD with RULES1

D. Christopher Evans, Acting Administrator.
FR Doc. 202112261 Filed 61121; 8:45 am BILLING CODE 441009P

VerDate Sep<11>2014

16:08 Jun 11, 2021

Jkt 253001

PO 00000

Frm 00003

Fmt 4700

Sfmt 9990

31429

E:FRFM14JNR1.SGM

14JNR1

7543