Voglio sapere a riguardo di…

14713

Federal Register / Vol. 86, No. 51 / Thursday, March 18, 2021 / Proposed Rules Management and Budget OMB
pursuant to section 3d1 of Executive Order E.O. 12866 and the principles reaffirmed in E.O. 13563.
Executive Order 12988, Civil Justice Reform This proposed regulation meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988
to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism This proposed rulemaking does not have federalism implications warranting the application of E.O. 13132. The proposed rule does not have substantial direct effects on the States, on the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal Governments This proposed rule does not have tribal implications warranting the application of 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.

jbell on DSKJLSW7X2PROD with PROPOSALS

Regulatory Flexibility Act The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601602, has reviewed this proposed rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities.
On February 6, 2018, DEA published an order to temporarily place fentanylrelated substances, as defined in the order, in schedule I of the CSA pursuant to the temporary scheduling provisions of 21 U.S.C. 811h. DEA estimates that all entities handling or planning to handle fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and para-

fluoro furanyl fentanyl have already established and implemented the systems and processes required to handle these substances which meet the definition of fentanyl-related substances.
There are currently 90 unique registrations authorized to specifically handle the fentanyl-related substances as a class, which include fentanyl carbamate, ortho fluoroacryl fentanyl, ortho-fluoroisobutyryl fentanyl, and para-fluoro furanyl fentanyl, 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 79 entities are small entities. Therefore, DEA conservatively estimates as many as 79 small entities are affected by this proposed rule.
A review of the 90 registrations indicates that all entities that currently handle fentanyl-related substances, including fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl, also handle other schedule I controlled substances, and have established and implemented or maintain the systems and processes required to handle fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl. Therefore, DEA
anticipates that this proposed 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 79 affected small entities.
Therefore, DEA has concluded that this proposed rule will not have a significant effect 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 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 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 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.
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, DEA
proposes to amend 21 CFR part 1308 as follows:
PART 1308SCHEDULES OF
CONTROLLED SUBSTANCES
1. The authority citation for 21 CFR
part 1308 continues to read as follows:

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

2. In 1308.11:
a. Redesignate paragraphs b70, 71, and 75 as paragraphs b74, 75, and 76, respectively.
b. Add paragraph b73;
c. Redesignate paragraphs b64
through 69 as paragraphs b67
through 72;
d. Add new paragraph b66;
e. Redesignate paragraphs b61
through 63 as paragraphs b63
through 65;
f. Add new paragraph b62;
g. Redesignate paragraphs b39
through 60 as paragraphs b40
through 61; and h. Add new paragraph b39.
The additions read as follows:

1308.11

Schedule I.

b

39 Fentanyl carbamate ethyl 1-phenethylpiperidin-4-ylphenylcarbamate

9851

62 ortho-Fluoroacryl fentanyl N-2-fluorophenyl-N-1-phenethylpiperidin-4-ylacrylamide

9852

66 ortho-Fluoroisobutyryl fentanyl N-2-fluorophenyl-N-1-phenethylpiperidin-4-ylisobutyramide

9853

73 para-Fluoro furanyl fentanyl N-4-fluorophenyl-N-1-phenethylpiperidin-4-ylfuran-2-carboxamide

9854

VerDate Sep<11>2014

16:14 Mar 17, 2021

Jkt 253001

PO 00000

Frm 00019

Fmt 4702

Sfmt 4702

E:FRFM18MRP1.SGM

18MRP1