Federal Register - June 22, 2021
Versione di testo Cosa è?Dateas è un sito indipendente non affiliato a entità governative. La fonte dei documenti PDF che pubblichiamo qui è l'entità governativa indicata in ciascuno di essi. Le versioni in testo sono trascrizioni che realizziamo per facilitare l'accesso e la ricerca di informazioni, ma possono contenere errori o non essere complete.
Source: Federal Register
32634
Federal Register / Vol. 86, No. 117 / Tuesday, June 22, 2021 / Rules and Regulations
qualify for placement in a schedule other than schedule I see 21 U.S.C.
812b25.
Pursuant to 5 U.S.C. 553b3B, DEA
finds that notice and comment rulemaking is unnecessary and that good cause exists to dispense with these procedures. The addition of a separate listing 4FMDMBBINACA and its DEA
controlled substances code number in the list of schedule I substances in 21
CFR 1308.11d makes no substantive difference in the status of this drug as a schedule I controlled substance, but instead is a minor or merely technical amendment in which the public is not particularly interested. National Nutritional Foods Assn v. Kennedy, 572
F.2d 377, 385 2d Cir. 1978 quoting S.
Rep. No. 79752, at 200 1945. See also Utility Solid Waste Activities Group v.
E.P.A., 236 F.3d 749, 755 D.C. Cir.
2001 the unnecessary prong is confined to those situations in which the administrative rule is a routine determination, insignificant in nature and impact, and inconsequential to the industry and public int. quotations and citation omitted. This rule is a technical amendment to 21 CFR
1308.11d as it is insignificant in nature and impact, and inconsequential to the industry and public. Therefore, publishing a notice of proposed rulemaking and soliciting public comment are unnecessary.
In addition, because 4FMDMB
BINACA is already subject to domestic control under schedule I as a positional isomer of 5FAMB and no additional requirements are being imposed through this action, DEA finds good cause exists to make this rule effective immediately upon publication in accordance with 5
U.S.C. 553d3. DEA is concerned that delaying the effective date of this rule potentially could cause confusion regarding the regulatory status of 4F
MDMBBINACA. 4FMDMBBINACA
is currently controlled as a schedule I
controlled substance, and this level of control does not change with this rulemaking.
lotter on DSK11XQN23PROD with RULES1
Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review This regulation has been drafted and reviewed in accordance with the principles of Executive Orders E.O.
12866 and 13563. This rule is not a
significant regulatory action under E.O.
12866. 4FMDMBBINACA already is a controlled substance in the United States under schedule I, as it is a positional isomer of a schedule I
hallucinogen, 5FAMB. In this final rule, DEA is merely making an administrative change by amending its regulations to separately list 4F
MDMBBINACA in schedule I and to assign the DEA controlled substances code number 7043 to the substance. A
separate listing for 4FMDMBBINACA
and its DEA controlled substances code number will not alter the status of 4F
MDMBBINACA as a schedule I
controlled substance. Accordingly, this rule has not been reviewed by the Office of Management and Budget OMB.
Executive Order 12988, Civil Justice Reform This regulation meets the applicable standards set forth in sections 3a and 3b2 of E.O. 12988 to eliminate drafting errors and ambiguity, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
Executive Order 13132, Federalism This rulemaking does not have federalism implications warranting the application of E.O. 13132. The 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 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 Regulatory Flexibility Act RFA
5 U.S.C. 601612 applies to rules that are subject to notice and comment under section 553b of the APA or other laws. As noted in the above section regarding the applicability of the APA, DEA determined that there was good cause to exempt this final rule from
notice and comment. Consequently, the RFA does not apply.
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 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.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act UMRA of 1995, 2 U.S.C. 1532, DEA has determined that this action would not result in any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more adjusted annually for inflation in any 1 year. Therefore, neither a Small Government Agency Plan nor any other action is required under UMRA of 1995.
Congressional Review Act This rule is not a major rule as defined by the Congressional Review Act CRA, 5 U.S.C. 804. However, pursuant to the CRA, DEA is submitting a copy of this 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, DEA
amends 21 CFR part 1308 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. Amend 1308.11 by adding paragraph d87 to read as follows:
1308.11
Schedule I.
d
87 methyl 2-1-4-fluorobutyl-1H-indazole-3-carboxamido-3,3-dimethylbutanoate 4FMDMBBINACA, 4FMDMB
BUTINACA
VerDate Sep<11>2014
18:13 Jun 21, 2021
Jkt 253001
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
E:FRFM22JNR1.SGM
22JNR1
7043