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Federal Register / Vol. 86, No. 88 / Monday, May 10, 2021 / Rules and Regulations 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 the distribution of power and responsibilities among the various levels of government.

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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 RFA
The Acting Administrator, in accordance with the RFA,12 has reviewed this rule, and by approving, it certifies that it will not have a significant economic impact on a substantial number of small entities.
As discussed above, PMK glycidate, PMK glycidic acid, and APAA will now become subject to all of the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, importation, and exportation of list I chemicals. PMK
glycidate and PMK glycidic acid are closely related in chemical structure to precursors of MDMA and other ecstasy-type substances. APAA is a precursor of amphetamine and methamphetamine. All three chemicals are highly suitable for the illicit manufacture of precursors listed in Table I of the 1988 Convention 3,4methylenedioxyphenyl-2-propanone 3,4-MDP-2-P and 1-phenyl-2propanone P-2-P. DEA has not identified any legitimate industrial use for PMK glycidate, PMK glycidic acid, or APAA, other than as intermediary chemicals in the production of amphetamine, methamphetamine, and MDMA or other ecstasy-type substances. Therefore, DEA believes the vast majority, if not all, of PMK
glycidate, PMK glycidic acid, and APAA
is used for the illicit manufacturing of amphetamine, methamphetamine, and MDMA or other ecstasy-type substances. The primary costs associated with this rule are the annual 12 5

U.S.C. 601612.

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registration fees $3,047 for manufacturers and $1,523 for distributors, importers, and exporters, but only if they are not already registered to handle any list I chemicals.
DEA has identified ten domestic suppliers of one or more of the chemicals, PMK glycidate, PMK glycidic acid, and APAA; nine of these suppliers are currently not registered with DEA to handle list I chemicals. All nine nonregistered domestic suppliers are affected, and all nine 94.5 percent, based on Small Business Administration size standard for chemical distributors and Statistics of U.S. Businesses data are estimated to be small entities. The quantity of these three chemicals distributed by these suppliers is unknown. It is common for chemical distributors to have items on their catalog while not actually having any material level of sales. Based on the discussion above, DEA believes any quantity of sales from these distributors for legitimate pharmaceutical purposes is minimal. DEA did not receive any comments to the contrary in response to the NPRM. DEA estimates 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 the UMRA, 2
U.S.C. 1501 et seq., DEA has determined and certifies that this rule 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 the UMRA.
Paperwork Reduction Act The action does not impose a new collection of information requirement under the Paperwork Reduction Act, 44
U.S.C. 35013521. This action will 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 This final 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 final rule to both Houses
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of Congress and to the Comptroller General.
List of Subjects 21 CFR Part 1310
Administrative practice and procedure, Drug traffic control, Exports, Imports, Reporting and recordkeeping requirements.
Accordingly, for the reasons set forth in the preamble, DEA amends 21 CFR
part 1310 as follows:
PART 1310RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES;
IMPORTATION AND EXPORTATION OF
CERTAIN MACHINES
1. The authority citation for part 1310
continues to read as follows:

Authority: 21 U.S.C. 802, 827h, 830, 871b, 890.

2. In 1310.02, add paragraphs a34
through 36 to read as follows:

1310.02

Substances covered.

a
34 3,4-MDP-2-P methyl glycidate PMK glycidate and its optical and geometric isomers 8535
35 3,4-MDP-2-P methyl glycidic acid PMK glycidic acid and its salts, optical and geometric isomers, and salts of isomers 8525
36 Alpha-phenylacetoacetamide APAA and its optical isomers 8515

3. In 1310.04:
a. Redesignate paragraphs g1vii through xiii as paragraphs g1x through xvi, respectively;
b. Redesignate paragraphs g1i through vi as paragraphs g1ii through vii, respectively; and c. Add new paragraphs g1i, viii, and ix.
The additions read as follows:
1310.04

Maintenance of records.

g
1
i Alpha-phenylacetoacetamide APAA and its optical isomers

viii 3,4-MDP-2-P methyl glycidate PMK glycidate and its optical and geometric isomers ix 3,4-MDP-2-P methyl glycidic acid PMK glycidic acid and its salts, optical and geometric isomers, and salts of isomers

4. In 1310.09, add paragraph q to read as follows:

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10MYR1