Federal Register/Vol. 86, No. 59/Tuesday, March 30, 2021

16558 Federal Register / Vol. 86, No. 59 / Tuesday, March 30, 2021 / Proposed Rules

these 28 registrations represent 22 rule will not have a significant effect on information unless it displays a entities. Some of these entities are likely a substantial number of small entities. currently valid OMB control number. to be large entities. However, since DEA Unfunded Mandates Reform Act of 1995 List of Subjects in 21 CFR Part 1308 does not have information of registrant size and the majority of DEA registrants In accordance with the Unfunded Administrative practice and are small entities or are employed by Mandates Reform Act (UMRA) of 1995, procedure, Drug traffic control, small entities, DEA estimates a 2 U.S.C. 1501 et seq., DEA has Reporting and recordkeeping maximum of 22 entities are small determined and certifies that this action requirements. entities. Therefore, DEA conservatively would not result in any Federal For the reasons set out above, DEA mandate that may result ‘‘in the estimates as many as 22 small entities proposes to amend 21 CFR part 1308 as expenditure by State, local, and tribal are affected by this proposed rule. follows: governments, in the aggregate, or by the A review of the 28 registrations private sector, of $100 million or more PART 1308—SCHEDULES OF indicates that all entities that currently (adjusted annually for inflation) in any CONTROLLED SUBSTANCES handle 5F-EDMB-PINACA, 5F-MDMB- 1 year * * *.’’ Therefore, neither a PICA, FUB-AKB48, 5F-CUMYL-PINACA Small Government Agency Plan nor any ■ 1. The authority citation for part 1308 or FUB-144 also handle other schedule other action is required under UMRA of continues to read as follows: I controlled substances, and have 1995. established and implemented (or Authority: 21 U.S.C. 811, 812, 871(b), maintain) the systems and processes Paperwork Reduction Act of 1995 956(b), unless otherwise noted. required to handle 5F-EDMB-PINACA, This action does not impose a new ■ 2. In § 1308.11, 5F-MDMB-PICA, FUB-AKB48, 5F- collection of information under the ■ a. Add paragraphs (d)(87) through CUMYL-PINACA and FUB-144. Paperwork Reduction Act of 1995. 44 (d)(91); and Therefore, DEA anticipates that this U.S.C. 3501–3521. This action would ■ b. Remove and reserve paragraphs proposed rule will impose minimal or not impose recordkeeping or reporting (h)(37) through (41). no economic impact on any affected requirements on State or local The additions to read as follows: entities; and thus, will not have a governments, individuals, businesses, or significant economic impact on any of organizations. An agency may not § 1308.11 Schedule I. the 22 affected small entities. Therefore, conduct or sponsor, and a person is not * * * * * DEA has concluded that this proposed required to respond to, a collection of (d) * * *

(87) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-EDMB-PINACA) ...... 7036 (88) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA) ...... 7041 (89) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL)) ...... 7047 (90) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25) ... 7083 (91) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (trivial name: FUB-144) ...... 7014

* * * * * MAPA; methyl 3-oxo-2- DATES: Comments must be submitted phenylbutanoate; methyl 2- electronically or postmarked on or D. Christopher Evans, phenylacetoacetate; a-acetyl- before June 1, 2021. Commenters should Acting Administrator. benzeneacetic acid, methyl ester; and be aware that the electronic Federal [FR Doc. 2021–06553 Filed 3–29–21; 8:45 am] CAS Number: 16648–44–5) and its Docket Management System will not BILLING CODE 4410–09–P optical isomers as a list I chemical accept any comments after 11:59 p.m. under the Controlled Substances Act Eastern Time on the last day of the comment period. DEPARTMENT OF JUSTICE (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to ADDRESSES: To ensure proper handling Drug Enforcement Administration illicitly manufacture the schedule II of comments, please reference ‘‘Docket controlled substances phenylacetone No. DEA–678’’ on all electronic and 21 CFR Part 1310 (also known as phenyl-2-propanone or written correspondence, including any P2P), methamphetamine, and attachments. [Docket No. DEA–678] amphetamine and is important to the • Electronic comments: The Drug manufacture of these controlled Enforcement Administration (DEA) Designation of Methyl alpha- substances. If finalized, this action phenylacetoacetate, a Precursor encourages that all comments be would subject handlers of methyl alpha- submitted electronically through the Chemical Used in the Illicit phenylacetoacetate to the chemical Manufacture of Phenylacetone, Federal eRulemaking Portal which regulatory provisions of the CSA and its provides the ability to type short Methamphetamine, and Amphetamine, implementing regulations. This as a List I Chemical comments directly into the comment rulemaking does not establish a field on the web page or attach a file for AGENCY: Drug Enforcement threshold for domestic and international lengthier comments. Please go to http:// Administration, Department of Justice. transactions of methyl alpha- www.regulations.gov and follow the ACTION: Notice of proposed rulemaking. phenylacetoacetate. As such, all online instructions at that site for transactions of chemical mixtures submitting comments. Upon completion SUMMARY: The Drug Enforcement containing methyl alpha- of your submission, you will receive a Administration is proposing the control phenylacetoacetate would be regulated Comment Tracking Number for your of the chemical methyl alpha- at any concentration and would be comment. Please be aware that phenylacetoacetate (also known as subject to control under the CSA. submitted comments are not

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instantaneously available for public information that it cannot be effectively its optical isomers, was added to Table view on Regulations.gov. If you have redacted, all or part of that comment I of the 1988 Convention. This letter was received a Comment Tracking Number, may not be made publicly available. prompted by a March 4, 2020, decision your comment has been successfully Comments posted to http:// at the 63rd Session of the United submitted and there is no need to www.regulations.gov may include any Nations Commission on Narcotic Drugs resubmit the same comment. personal identifying information (such (CND) to add MAPA to Table I. As • Paper comments: Paper comments as name, address, and phone number) discussed above, the United States is a that duplicate electronic submissions included in the text of your electronic party to the 1988 Convention, and has are not necessary. Should you wish to submission that is not identified as certain obligations pursuant to Article mail a paper comment, in lieu of an directed above as confidential. 12. By designating MAPA as a list I electronic comment, it should be sent An electronic copy of this proposed chemical, the United States will fulfill via regular or express mail to: Drug rule is available at http:// its obligations under the 1988 Enforcement Administration, Attn: DEA www.regulations.gov for easy reference. Convention. MAPA is used in, and is important to, Federal Register Representative/DPW, Legal Authority 8701 Morrissette Drive, Springfield, the manufacture of the schedule II Virginia 22152. The Controlled Substances Act (CSA) substances phenylacetone (also known gives the Attorney General the authority FOR FURTHER INFORMATION CONTACT: as phenyl-2-propanone, P2P, or benzyl to specify, by regulation, a chemical as methyl ketone), methamphetamine, and Terrence L. Boos, Drug and Chemical a list I chemical. 21 U.S.C. 802(34). The Evaluation, Diversion Control Division, amphetamine. Throughout the 1970s, term ‘‘list I chemical’’ means a chemical methamphetamine was illicitly Drug Enforcement Administration; that is used in manufacturing a Mailing Address: 8701 Morrissette produced in the United States, primarily controlled substance in violation of the with the precursor chemical P2P. In Drive, Springfield, Virginia 22152; CSA and is important to the Telephone: (571) 362–3249. response to the illicit use of P2P, DEA manufacture of the controlled controlled P2P as a schedule II SUPPLEMENTARY INFORMATION: substance. Id. Pursuant to 28 CFR controlled substance in 1980 pursuant Posting of Public Comments 0.100(b), the Attorney General has to the ‘‘immediate precursor’’ provisions delegated his authority to designate list of the CSA, specifically 21 U.S.C. Please note that all comments I chemicals to the Administrator of DEA 811(e).1 Clandestine laboratory received in response to this docket are (Administrator). operators have circumvented this considered part of the public record. The DEA regulations set forth the control by developing a variety of They will, unless reasonable cause is process by which DEA may add a synthetic methods for producing P2P. given, be made available by the Drug chemical as a listed chemical. As set Congress and DEA responded by Enforcement Administration (DEA) for forth in 21 CFR 1310.02(c), the agency placing controls on precursor chemicals public inspection online at http:// may do so by publishing a final rule in used in the illicit production of P2P, www.regulations.gov. Such information the Federal Register following a such as phenylacetic acid (and its salts includes personal identifying published notice of proposed and esters), acetic anhydride, benzyl information (such as your name, rulemaking with at least 30 days for cyanide, benzaldehyde, and address, etc.) voluntarily submitted by public comments. The current list of all nitroethane.23 However, clandestine the commenter. The Freedom of list I chemicals is available in 21 CFR laboratory operators circumvented these Information Act applies to all comments 1310.02(a). controls by using alternative precursors received. If you want to submit personal In addition, the United States is a that avoid the production of P2P: identifying information (such as your party to the 1988 United Nations Ephedrine and pseudoephedrine for the name, address, etc.) as part of your Convention against Illicit Traffic in production of methamphetamine; and comment, but do not want it to be made Narcotic Drugs and Psychotropic phenylpropanolamine for the publicly available, you must include the Substances (1988 Convention), production of amphetamine. This led phrase ‘‘PERSONAL IDENTIFYING December 20, 1988, 1582 U.N.T.S. 95. Congress and DEA to place stringent INFORMATION’’ in the first paragraph Under Article 12 of the 1988 controls on the manufacture, of your comment. You must also place Convention, when the United States distribution, importation, and all of the personal identifying receives notification that a chemical has exportation of ephedrine (its salts, information you do not want made been added to Table I or Table II of the optical isomers, and salts of optical publicly available in the first paragraph 1988 Convention, the United States is isomers), pseudoephedrine, and of your comment and identify what required to take measures it deems phenylpropanolamine (controlled as list information you want redacted. appropriate to monitor the manufacture I chemicals), and pharmaceutical If you want to submit confidential and distribution of that chemical within products containing these chemicals business information as part of your the United States and to prevent its through the Combat Methamphetamine comment, but do not want it to be made diversion. The 1988 Convention also Epidemic Act of 2005 (Title VII of the publicly available, you must include the requires the United States to take other USA PATRIOT Act Improvement and phrase ‘‘CONFIDENTIAL BUSINESS specified measures related to that Reauthorization Act of 2005, Pub. L. INFORMATION’’ in the first paragraph chemical, including measures related to 109–117), the Methamphetamine of your comment. You must also its international trade. Production Prevention Act of 2008 (Pub. prominently identify the confidential Background business information to be redacted 1 44 FR 7182 (Feb. 11, 1980). within the comment. By letter dated May 7, 2020, in 2 On November 18, 1988, the Chemical Diversion Comments containing personal accordance with Article 12, paragraph 6 and Trafficking Act (Subtitle A of Title VI of Pub. identifying information or confidential of the 1988 Convention, the Secretary- L. 100–690) was enacted. business information identified as General of the United Nations informed 3 Under 21 CFR 1310.02(a), benzaldehyde, benzyl cyanide, nitroethane, and phenylacetic acid directed above will be made publicly the United States Government that the (including its salts and esters) are list I chemicals. available in redacted form. If a comment chemical methyl alpha- Under 21 CFR 1310.02(b), acetic anhydride is a list has so much confidential business phenylacetoacetate (MAPA), including II chemical.

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L. 110–415), and the Combat suppliers.8 Clandestine laboratory and totaled more than 10.5 metric tons. Methamphetamine Act of 2010 (Pub. L. operators currently use MAPA to All incidents reported in PICS occurred 111–268).4 The international manufacture P2P, which they then in Europe, or involved shipments of community soon took similar measures. convert to methamphetamine and MAPA destined for countries in Europe. With the growing problem of illicit amphetamine. DEA has determined that MAPA is drug production, the issue of precursor MAPA now readily available from commercial chemical control has gained global chemical suppliers and has identified attention. International controls on MAPA is known as methyl alpha- seven potential suppliers in China, five precursors were first established under phenylacetoacetate; methyl 3-oxo-2- potential suppliers in the United States, Article 12 of the 1988 Convention, phenylbutanoate; methyl 2- three potential suppliers in the United which established two categories of phenylacetoacetate; a-acetyl- Kingdom, and one potential supplier controlled illicit drug precursor benzeneacetic acid, methyl ester; and each in France, Hong Kong, and Latvia. substances: Table I and Table II.5 CAS Number: 16648–44–5. MAPA first DEA is concerned about the ease with International efforts to prevent the illicit emerged in late 2017 with the which MAPA serves as a precursor production of amphetamine-type Netherlands reporting seizures totaling chemical for illicit controlled substance 9 stimulants (including amphetamine and nearly 490 kg on Form D. Belgium production and with the international methamphetamine), and international followed in 2018 with reports through trafficking in this chemical. The control of precursors, have since made the Precursors Incident Communication international community shares this significant progress. Two international System (PICS) of more than 550 kg of concern. The INCB found ‘‘that MAPA 10 entities have played a crucial role in MAPA seized. China was reported as is frequently used in the illicit this effort: The CND and the the alleged origin for all of the incidents manufacture of amphetamine-type International Narcotics Control Board in the Netherlands or Belgium where stimulants, namely amphetamine, and (INCB). The CND meets annually to the origin was provided. The INCB that the volume and extent of the illicit consider and adopt a range of decisions reported an increase in the frequency of manufacture of amphetamine-type and resolutions related to international seizures and amounts seized reported stimulants pose serious public health or 11 drug control treaties, including the 1988 through PICS since November 2018. social problems so as to warrant MAPA is a close chemical relative of Convention. The INCB is an international action.’’ 13 Based in part on precursors controlled under the 1988 independent, quasi-judicial expert body the findings of the INCB, and as noted Convention (e.g., APAAN and APAA) for the implementation of the above, the CND has added MAPA to and the timing of its emergence suggests international drug control treaties, Table I of the 1988 Convention. it is trafficked to circumvent these including the 1988 Convention. Therefore, DEA is proposing the recent precursor controls. The INCB In response to domestic and designation of MAPA as a list I notes that MAPA does not have any international controls on amphetamine chemical. and methamphetamine precursors, legitimate use.12 DEA has not identified clandestine laboratory operators have any known legitimate use for MAPA, Proposed Designation of MAPA and Its continued to explore alternate methods other than in small amounts for Optical Isomers as a List I Chemical of making these illicit drugs, including research, development, and laboratory For the reasons discussed above, the developing techniques to manufacture analytical purposes. Due to the lack of Acting Administrator of DEA finds that their own precursors and diverting other industrial uses of MAPA, the chemical MAPA is used in the manufacture of precursors to produce these precursors. has not been widely available from controlled substances (i.e., schedule II The INCB reported the emergence of legitimate chemical suppliers. Since late substances P2P, methamphetamine, and MAPA in late 2017, noting its use as a 2017, however, there have been large amphetamine) in violation of the CSA 6 precursor for the production of P2P. international seizures of MAPA, and is important to the manufacture of The emergence and increase in primarily in Europe, which suggest these controlled substances. Laboratory encounters of MAPA are linked to there is a ready supply of MAPA from operators are using MAPA as the increased scrutiny over other P2P international chemical manufacturers. precursor material for the illicit precursors, such as alpha- The only use for a large quantity of manufacture of P2P, methamphetamine, 7 phenylacetoacetamide (APAA). MAPA of which DEA is aware is as a and amphetamine. Therefore, the Acting Although MAPA does not have any primary precursor for conversion to Administrator proposes the designation legitimate use and it has not been P2P, and subsequent conversion to of MAPA as a list I chemical. widely traded through legitimate amphetamine or methamphetamine. If finalized, handlers of MAPA would Between late 2017, and May 7, 2019, channels, it is advertised by online become subject to the chemical the INCB noted 29 incidents from PICS regulatory provisions of the CSA, 4 DEA implemented the Combat where MAPA was seized. The amount including 21 CFR parts 1309, 1310, Methamphetamine Epidemic Act of 2005, the of MAPA seized in individual incidents 1313, and 1316. Since 1 gram of MAPA Methamphetamine Production Prevention Act of ranged from 500 grams to 2 metric tons, 2008, and the Combat Methamphetamine could make approximately 1 gram of Enhancement Act of 2010 in a series of interim and methamphetamine hydrochloride, final rules. 72 FR 17401 (Apr. 9, 2007), 72 FR 28601 8 Id. (May 22, 2007), 73 FR 73549 (Dec. 3, 2008), 73 FR 9 Member countries use Form D to report to INCB which is equivalent to approximately 79318 (Dec. 29, 2008), 75 FR 4973 (Feb. 1, 2010), annual information on substances frequently used 200 tablets containing 5 milligrams of 75 FR 10168 (Mar. 5, 2010), 75 FR 38915 (Jul. 7, in the illicit manufacture of narcotic drugs and methamphetamine hydrochloride, this 2010), 76 FR 20518 (Apr. 13, 2011), and 76 FR psychotropic substances. action does not propose the 74696 (Dec. 1, 2011). 10 The Precursors Incident Communication establishment of a threshold for 5 Table I and Table II are annexed to the System or PICS is a worldwide, real-time, on-line Convention. tool for communication and information sharing domestic and import transactions of 6 Statement by Mr. Cornelis de Joncheere, between national authorities on precursor incidents MAPA in accordance with the President, International Narcotics Control Board, to include seizures, stopped shipments, diversion Reconvened sixty-second session of the and diversion attempts, illicit laboratories and 13 Notification from the President of the INCB to Commission on Narcotic Drugs, 13 December 2019, associated equipment. the Chair of the CND on its sixty-third session at 1. 11 Id. concerning the scheduling of MAPA under the 1988 7 Id. 12 Id. Convention, Nov. 12, 2019, at 1.

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provisions of 21 CFR 1310.04(g). publishing a final rule in the Federal Upon publication of a final rule, any Therefore, DEA is proposing that all Register, if DEA determines that: (1) The person manufacturing, distributing, MAPA transactions, regardless of size, mixture is formulated in such a way that importing, or exporting MAPA or a would be regulated transactions as it cannot be easily used in the illicit chemical mixture containing MAPA defined in 21 CFR 1300.02(b). As such, production of a controlled substance, would become subject to the registration if finalized, all MAPA transactions and (2) the listed chemical or chemicals requirement under the CSA. DEA would be subject to recordkeeping, cannot be readily recovered. recognizes, however, that it is not reporting, import and export controls, Requirements for Handling List I possible for persons who are subject to and other CSA chemical regulatory Chemicals the registration requirements to requirements. In addition, each immediately complete and submit an regulated bulk manufacturer must If finalized as proposed, the application for registration and for DEA submit manufacturing, inventory, and designation of MAPA as a list I chemical to immediately issue registrations for use data on an annual basis, in would subject handlers (manufacturers, those activities. Therefore, to allow any accordance with 21 CFR 1310.05(d). distributors, importers, and exporters) continued legitimate commerce in and proposed handlers to all of the Chemical Mixtures of MAPA MAPA, DEA is proposing to establish in regulatory controls and administrative, 21 CFR 1310.09 a temporary exemption This rulemaking also proposes that civil, and criminal sanctions applicable from the registration requirement for chemical mixtures containing MAPA to the manufacture, distribution, persons desiring to engage in activities would not be exempt from regulatory importing, and exporting of a list I with MAPA, provided that DEA receives requirements at any concentration, chemical. Upon publication of a final a properly completed application for unless a manufacturer submits to DEA rule, persons potentially handling registration on or before 30 days after an application for exemption of such MAPA, including regulated chemical publication of a final rule implementing chemical mixture, DEA accepts the mixtures containing MAPA, would be regulations regarding MAPA. The application for filing, and DEA exempts required to comply with the following temporary exemption for such persons the chemical mixture in accordance list I chemical regulations: would remain in effect until DEA takes with 21 CFR 1310.13 (Exemption of 1. Registration. Any person who final action on their application for chemical mixtures by application). handles (manufactures, distributes, registration or application for exemption Since 1 gram of MAPA could make imports, or exports), or proposes to of a chemical mixture. approximately 1 gram of engage in such handling of, MAPA or a methamphetamine hydrochloride, chemical mixture containing MAPA The temporary exemption would which is equivalent to approximately must obtain a registration pursuant to 21 apply solely to the registration 200 tablets containing 5 milligrams of U.S.C. 822, 823, 957, and 958. requirement; all other chemical control methamphetamine hydrochloride, Regulations describing registration for requirements, including recordkeeping regulation of chemical mixtures list I chemical handlers are set forth in and reporting, would become effective containing any amount of MAPA is 21 CFR part 1309. DEA regulations on the effective date of the final rule. necessary to prevent the illicit require separate registrations for Therefore, all transactions of MAPA and extraction, isolation, and use of MAPA. manufacturing, distributing, importing, chemical mixtures containing MAPA Therefore, all chemical mixtures and exporting of MAPA.15 Further, a would be regulated while an application containing any quantity of MAPA separate registration is required for each for registration or exemption is pending. would be subject to control under the principal place of business at one This is necessary because a delay in CSA, unless a manufacturer of MAPA is general physical location where list I regulating these transactions could granted an exemption by the application chemicals are manufactured, result in increased diversion of process in accordance with 21 CFR distributed, imported, or exported by a chemicals desirable to drug traffickers. 1310.13. This rulemaking proposes the person.16 Additionally, the temporary modification of the ‘‘Table of DEA notes that under the CSA, exemption for registration does not Concentration Limits’’ in 21 CFR ‘‘warehousemen’’ are not required to suspend applicable Federal criminal 1310.12(c) to reflect the fact that register and may lawfully possess list I laws relating to MAPA, nor does it chemical mixtures containing any chemicals, if the possession of those supersede State or local laws or amount of MAPA are subject to CSA chemicals is in the usual course of regulations. All handlers of MAPA must 17 chemical control provisions. business or employment. Under DEA comply with applicable State and local implementing regulations, the Application Process for Exemption of requirements in addition to the CSA warehouse in question must receive the Chemical Mixtures regulatory controls. list I chemical from a DEA registrant DEA has implemented an application and shall only distribute the list I 2. Records and Reports. Every DEA process to exempt certain chemical chemical back to the DEA registrant and registrant would be required to maintain mixtures from the requirements of the registered location from which it was records and submit reports to DEA with CSA and its implementing received.18 A warehouse that distributes respect to MAPA pursuant to 21 U.S.C. regulations.14 Manufacturers may list I chemicals to persons other than the 830(a) and (b)(1) and (2) and in submit an application for exemption for registrant and registered location from accordance with 21 CFR 1310.04 and those mixtures that do not meet the which they were obtained is conducting 1310.05. Pursuant to 21 CFR 1310.04, a criteria set forth in 21 CFR 1310.12(d) distribution activities and is required to record must be made and maintained for for an automatic exemption. Pursuant to register as such. two years after the date of a transaction 21 CFR 1310.13(a), DEA may grant an involving a listed chemical, provided exemption of a chemical mixture, by 15 21 CFR 1309.21. the transaction is a regulated 16 21 CFR 1309.23(a). See also 21 U.S.C. 822(e)(1) transaction. 14 21 CFR 1310.13 specifies that this chemical with separate registration requirements pertaining Each regulated bulk manufacturer of a to manufacturing or distributing a list I chemical. mixture is a chemical mixture consisting of two or listed chemical would be required to more chemical components, at least one of which 17 21 U.S.C. 822(c)(2) and 21 U.S.C. 957(b)(1)(B). is a list I or list II chemical. 18 See 21 CFR 1309.23(b)(1). submit manufacturing, inventory, and

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use data on an annual basis.19 Existing Regulatory Analyses MAPA to P2P in the United States, if it takes place at all, is limited to small, standard industry reports containing the Executive Orders 12866 (Regulatory gram quantities. Therefore, DEA required information would be Planning and Review) and 13563 concludes the vast majority of, if not all, acceptable, provided the information is (Improving Regulation and Regulatory MAPA is used for the manufacturing of separate or readily retrievable from the Review) report. illicit P2P, methamphetamine, and This proposed rule was developed in amphetamine. The CSA and its implementing accordance with the principles of DEA cannot rule out the possibility regulations require that each regulated Executive Orders (E.O.) 12866 and that minimal quantities of MAPA are person must report to DEA any 13563. E.O. 12866 directs agencies to used for the manufacturing of legitimate regulated transaction involving an assess all costs and benefits of available P2P. However, if there are any extraordinary quantity of a listed regulatory alternatives and, if regulation quantities of MAPA used for the chemical, an uncommon method of is necessary, to select regulatory manufacturing of legitimate P2P, the payment or delivery, or any other approaches that maximize net benefits quantities are believed to be minimal. circumstance that the regulated person (including potential economic, DEA welcomes any public comment on believes may indicate that the listed environmental, public health, and safety these quantities and their economic chemical will be used in violation of effects; distributive impacts; and significance. equity). E.O. 13563 is supplemental to subchapter I of the CSA. In addition, DEA evaluated the costs and benefits and reaffirms the principles, structures, regulated persons must report any of this proposed action. proposed regulated transaction with a and definitions governing regulatory person whose description or other review as established in E.O. 12866. Costs E.O. 12866 classifies a ‘‘significant identifying characteristics DEA has regulatory action,’’ requiring review by DEA believes the market for MAPA previously furnished to the regulated the Office of Management and Budget for the legitimate manufacturing of person, any unusual or excessive loss or (OMB) as any regulatory action that is pharmaceutical amphetamine or disappearance of a listed chemical likely to result in a rule that may: (1) methamphetamine is minimal. As stated under the control of the regulated Have an annual effect on the economy above, the only use for MAPA of which person, and any in-transit loss in which of $100 million or more or adversely DEA is aware is as a chemical the regulated person is the supplier.20 affect in a material way the economy, a intermediate for the manufacture of P2P, 3. Importation and Exportation. All sector of the economy, productivity, methamphetamine, and amphetamine. Any manufacturer, distributor, importer, importation and exportation of MAPA competition, jobs, the environment, or exporter of MAPA for the production would need to be in compliance with 21 public health or safety, or State, local, or tribal governments or communities; of legitimate P2P, methamphetamine, U.S.C. 957, 958, and 971 and in and amphetamine, if they exist at all, accordance with 21 CFR part 1313. (2) create a serious inconsistency or otherwise interfere with an action taken would incur costs if this proposed rule 4. Security. All applicants and or planned by another agency; (3) were finalized. The primary costs registrants would be required to provide materially alter the budgetary impact of associated with this proposed rule effective controls against theft and entitlements, grants, user fees, or loan would be the annual registration fees for diversion of list I chemicals in programs or the rights and obligations of manufacturers ($3,699) and for accordance with 21 CFR 1309.71– recipients thereof; or (4) raise novel distributors, importers, and exporters 1309.73. legal or policy issues arising out of legal ($1,850). However, any manufacturer 5. Administrative Inspection. Places, mandates, the President’s priorities, or that uses MAPA for legitimate P2P, methamphetamine, and amphetamine including factories, warehouses, or the principles set forth in the E.O. DEA production would already be registered other establishments and conveyances, has determined that this proposed rule is not a ‘‘significant regulatory action’’ with DEA and have all security and where registrants or other regulated other handling processes established persons may lawfully hold, under E.O. 12866, section 3(f). If finalized as proposed, MAPA would because of the controls already in place manufacture, distribute, or otherwise be subject to all of the regulatory on P2P, methamphetamine, and dispose of a list I chemical or where controls and administrative, civil, and amphetamine, resulting in minimal cost records relating to those activities are criminal sanctions applicable to the to those entities. As there are different maintained, are controlled premises as manufacture, distribution, importing, forms of handling the scheduled defined in 21 U.S.C. 880(a) and 21 CFR and exporting of list I chemicals. MAPA substances versus the list I chemical 1316.02(c). The CSA allows for is used in, and is important to, the illicit (distribution of P2P, methamphetamine, administrative inspections of these manufacture of the schedule II- and amphetamine versus exporting controlled premises as provided in 21 controlled substances P2P, MAPA), this could require a separate CFR part 1316, subpart A.21 methamphetamine, and amphetamine. registration for the different handling of 6. Liability. Any activity involving DEA has searched information in the the substances. If an entity is already MAPA not authorized by, or in violation public domain for any legitimate uses of registered to handle, manufacture, of, the CSA would be unlawful, and this chemical. Other than the small import, or export a scheduled substance, would subject the person to amounts for research, development, and the entity would not need an additional administrative, civil, and/or criminal laboratory analytical purposes, DEA has registration for the list I chemical, not documented any industrial use for provided it is handling the list I action. MAPA except for it being a chemical chemical in the same manner that it is intermediate in the production of the registered for with the scheduled schedule II substances P2P, substance, or as a coincident activity methamphetamine, and amphetamine. permitted by § 1309.21. Even with the 19 21 CFR 1310.05(d). Based on the review of established possibility of these additional 20 21 U.S.C. 830(b) and 21 CFR 1310.05(a) and (b). aggregate production quota for P2P (40 registrations, DEA believes that the cost 21 21 U.S.C. 880. grams for 2019), legal conversion of would be minimal.

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DEA has identified five domestic minimal. Therefore, any potential cost limited to small, gram quantities. suppliers of MAPA, only one of which as a result of this regulation is minimal. Therefore, DEA believes the vast is registered with DEA to handle list I Executive Order 12988, Civil Justice majority, if not all, of MAPA is used for chemicals. It is difficult to estimate the Reform the illicit manufacturing of P2P, quantity of MAPA these suppliers methamphetamine, and amphetamine. distribute. Chemical distributors often This proposed regulation meets the The primary costs associated with this have items in their catalog while not applicable standards set forth in proposed rule are the annual actually having any material level of sections 3(a) and 3(b)(2) of E.O. 12988 registration fees ($3,699 for sales. If this proposed rule is finalized, to eliminate drafting errors and manufacturers and $1,850 for ambiguity, minimize litigation, provide suppliers for the legitimate use of distributors, importers, and exporters). a clear legal standard for affected MAPA, if any, are expected to choose Additionally, any manufacturer that conduct, and promote simplification the least-cost option, and stop selling uses MAPA for legitimate P2P, and burden reduction. the minimal quantities of MAPA, rather methamphetamine, and amphetamine than incur the registration cost. Because Executive Order 13132, Federalism production would already be registered DEA believes the quantities of MAPA This proposed rulemaking does not with DEA and have all security and supplied for the legitimate other handling processes in place, manufacturing of P2P, have federalism implications warranting resulting in minimal cost. methamphetamine, and amphetamine the application of E.O. 13132. The are minimal, DEA estimates that the cost proposed rule does not have substantial DEA has identified five domestic of foregone sales is minimal; and thus, direct effects on the States, on the suppliers of MAPA, only one of which the cost of this proposed rule is relationship between the national is registered with DEA to handle list I minimal. DEA welcomes any public government and the States, or the chemicals. Based on Small Business comment regarding this estimate. distribution of power and Administration (SBA) size standards for responsibilities among the various This analysis excludes consideration chemical distributors and Statistics of levels of government. of any economic impact to those U.S. Business data, each of the five businesses that facilitate the Executive Order 13175, Consultation suppliers are small entities because manufacture and distribution of MAPA and Coordination With Indian Tribal their revenues are below SBA’s $150 for the production of manufacturing Governments million threshold. It is difficult to illicit P2P, methamphetamine, and This proposed rule does not have estimate the quantity of MAPA these amphetamine. As a law enforcement tribal implications warranting the suppliers distribute. Chemical organization and as a matter of application of E.O. 13175. It does not distributors often have items in their principle, DEA believes considering the have substantial direct effects on one or catalog while not actually having any economic utility of facilitating the more Indian tribes, on the relationship material level of sales. Based on the manufacture of illicit P2P, between the Federal Government and review of established aggregate methamphetamine, and amphetamine Indian tribes, or on the distribution of production quota for P2P (40 grams for would be improper. power and responsibilities between the 2019), legal conversion of MAPA to P2P Benefits Federal Government and Indian tribes. in the United States is limited to small, gram quantities. DEA believes any Regulatory Flexibility Act Controlling MAPA is expected to quantity of sales of MAPA from these prevent, curtail, and limit the unlawful The Acting Administrator, in distributors for legitimate P2P manufacture and distribution of the accordance with the Regulatory manufacturing is minimal. Therefore, controlled substances P2P, Flexibility Act (RFA),22 has reviewed DEA estimates the cost of this proposed methamphetamine, and amphetamine. this proposed rule and by approving it rule on any affected small entity is As a list I chemical, handling of MAPA certifies that it will not have a minimal. DEA welcomes any public would require registration with DEA, significant economic impact on a comment regarding this estimate. Based various controls, and monitoring as substantial number of small entities. As on these factors, DEA projects that this required by the CSA. This proposed rule discussed above, if finalized as proposed rule, if promulgated, will not is also expected to assist in preventing proposed, MAPA would be subject to all result in a significant economic impact the possible theft or diversion of MAPA of the regulatory controls and on a substantial number of small from any legitimate firms. DEA also administrative, civil, and criminal entities. believes control is necessary to prevent sanctions applicable to the manufacture, unscrupulous chemists from distribution, importation, and Unfunded Mandates Reform Act of 1995 synthesizing MAPA and selling it (as an exportation of list I chemicals. MAPA is unregulated material) through the used in, and is important to, the illicit On the basis of information contained internet and other channels, to manufacture of the schedule II- in the RFA section above, DEA has individuals who may wish to acquire an controlled substances P2P, determined and certifies pursuant to the unregulated chemical intermediate for methamphetamine, and amphetamine. Unfunded Mandates Reform Act of 1995 the purpose of manufacturing illicit DEA has not identified any legitimate (UMRA), 2 U.S.C. 1501 et seq., that this P2P, methamphetamine, and industrial use for MAPA, other than its action would not result in any Federal amphetamine. role as a chemical intermediate in the mandate that may result ‘‘in the In summary, DEA conducted a production of P2P, methamphetamine, expenditure by State, local, and tribal qualitative analysis of costs and and amphetamine. Based on the review governments, in the aggregate, or by the benefits. DEA believes this proposed of established aggregate production private sector, of $100,000,000 or more action, if finalized, will minimize the quota for P2P, 40 grams for 2019, legal (adjusted annually for inflation) in any diversion of MAPA. DEA believes the conversion of MAPA to P2P in the 1 year * * *.’’ Therefore, neither a market for MAPA for the legitimate United States, if it takes place at all, is Small Government Agency Plan nor any manufacturing of P2P, other action is required under methamphetamine, and amphetamine is 22 5 U.S.C. 601–612. provisions of UMRA.

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Paperwork Reduction Act List of Subjects in 21 CFR Part 1310 PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS This proposed action does not impose Administrative practice and AND CERTAIN MACHINES; a new collection of information procedure, Drug traffic control, Exports, IMPORTATION AND EXPORTATION OF requirement under the Paperwork Imports, Reporting and recordkeeping CERTAIN MACHINES Reduction Act, 44 U.S.C. 3501–3521. requirements. This proposed action would not impose ■ 1. The authority citation for 21 CFR Accordingly, for the reasons set forth recordkeeping or reporting requirements part 1310 continues to read as follows: in the preamble, DEA proposes to on State or local governments, further amend 21 CFR part 1310, as Authority: 21 U.S.C. 802, 827(h), 830, individuals, businesses, or proposed to be amended at 85 FR 82984 871(b), 890. organizations. An agency may not (December 21, 2020) as follows: ■ 2. In § 1310.02, add paragraph (a)(37) conduct or sponsor, and a person is not to read as follows: required to respond to, a collection of information unless it displays a § 1310.02 Substances covered. currently valid OMB control number. * * * * * (a) * * *

(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers ...... 8795

* * * * * phenylbutanoate) and its optical isomers whose application for ■ 3. In § 1310.04: isomers, including regulated chemical exemption is subsequently denied by ■ a. Redesignate paragraphs (g)(1)(x) mixtures pursuant to § 1310.12, is DEA must obtain a registration with through (xvi) as paragraphs (g)(1)(xi) temporarily exempted from the DEA. A temporary exemption from the through (xvii), respectively; and registration requirement, provided that registration requirement would also be ■ b. Add new paragraph (g)(1)(x). DEA receives a properly completed provided for those persons whose The addition reads as follows: application for registration or application for exemption is denied, § 1310.04 Maintenance of records. application for exemption for a provided that DEA receives a properly chemical mixture containing regulated * * * * * completed application for registration (g) * * * forms of MAPA pursuant to § 1310.13 on or before 30 days following the date (1) * * * on or before 30 days after the of official DEA notification that the (x) methyl alpha-phenylacetoacetate publication of a rule finalizing this application for exemption has been (MAPA; methyl 3-oxo-2- action. The exemption would remain in denied. The temporary exemption for phenylbutanoate) and its optical effect for each person who has made such persons would remain in effect isomers. such application until the until DEA takes final action on their * * * * * Administration has approved or denied registration application. that application. This exemption applies ■ 4. In § 1310.09, add paragraph (r) to ■ 5. In § 1310.12, in the Table of read as follows: only to registration; all other chemical control requirements set forth in the Act Concentration Limits under List I § 1310.09 Temporary exemption from and parts 1309, 1310, 1313, and 1316 of Chemicals in paragraph (c), add an entry registration. this chapter remain in full force and for methyl alpha-phenylacetoacetate * * * * * effect. (MAPA; methyl 3-oxo-2- (r)(1) Each person required under 21 (2) Any person who manufactures, phenylbutanoate) in alphabetical order U.S.C. 822 and 957 to obtain a distributes, imports, or exports a to read as follows: registration to manufacture, distribute, chemical mixture containing regulated § 1310.12 Exempt chemical mixtures. import, or export regulated forms of forms of methyl alpha- methyl alpha-phenylacetoacetate phenylacetoacetate (MAPA; methyl 3- * * * * * (MAPA; methyl 3-oxo-2- oxo-2-phenylbutanoate) and its optical (c) * * *

TABLE OF CONCENTRATION LIMITS

DEA chemical code No. Concentration Special conditions

List I Chemicals

******* methyl alpha-phenylacetoacetate (MAPA; 8795 Not exempt at any concentration ... Chemical mixtures containing any amount methyl 3-oxo-2-phenylbutanoate) and its of MAPA and its optical isomers are not optical isomers. exempt.

*******

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* * * * * FEDERAL COMMUNICATIONS submit two additional copies for each COMMISSION additional docket or rulemaking D. Christopher Evans, number. Filings can be sent by Acting Administrator. 47 CFR Parts 10 and 11 commercial overnight courier, or by [FR Doc. 2021–05346 Filed 3–29–21; 8:45 am] [PS Docket Nos. 15–94 and 15–91; FCC 21– first-class or overnight U.S. Postal BILLING CODE 4410–09–P 36; FRS 17864] Service mail. All filings must be addressed to the Commission’s Emergency Alert System, Wireless Secretary, Office of the Secretary, Emergency Alerts; National Defense ENVIRONMENTAL PROTECTION Federal Communications Commission. Authorization Act for Fiscal Year 2021, AGENCY Commercial overnight mail (other than Delivering Alerts Via the Internet, U.S. Postal Service Express Mail and 40 CFR PART 52 Including Through Streaming Services Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD AGENCY: Federal Communications [EPA–R05–OAR–2020–0559; FRL–10022– Commission. 20701. U.S. Postal Service first-class, 19–Region 5] Express, and Priority mail must be ACTION: Proposed rule and inquiry. addressed to 45 L Street NE, Air Plan Approval; Ohio; Ohio NSR SUMMARY: In this document, the Washington, DC 20554. Permit Timing Commission, takes actions • People with Disabilities: Contact the implementing section 9201 of the FCC to request reasonable AGENCY: Environmental Protection accommodations (accessible format Agency (EPA). National Defense Authorization Act for Fiscal Year 2021, exploring documents, sign language interpreters, ACTION: Proposed rule; re-opening of opportunities to improve the way the CART, etc.) by email: [email protected] public comment period. public receives emergency alerts from or phone: 202–418–0530 or TTY: 202– 418–0432. SUMMARY: the nation’s Emergency Alert System The Environmental Protection For detailed instructions for Agency (EPA) is re-opening the (EAS) and Wireless Emergency Alerts System (WEA) on their mobile phones, submitting comments and additional comment period for a proposed rule information on the rulemaking process, published February 11, 2021. On televisions, and radios. We propose rules to ensure that more people receive see the SUPPLEMENTARY INFORMATION February 11, 2021, EPA proposed to section of this document. approve, under the Clean Air Act, an relevant emergency alerts, to enable Ohio rule that would allow for the EAS and WEA participants to report FOR FURTHER INFORMATION CONTACT: extension of an installation permit false alerts when they occur, and to Regarding the notice of proposed which is the subject of an appeal by a improve the way states plan for rulemaking, Christopher Fedeli, party other than the owner or operator emergency alerts. In addition, we Attorney Advisor, Public Safety and of the air contaminant source. In initiate an inquiry to examine the Homeland Security Bureau at 202–418– response to requests from members of feasibility of updating the EAS to enable 1514 or [email protected]; the public, EPA is re-opening the or improve alerts to consumers provided regarding the notice of inquiry, James comment period for an additional 30 through the internet, including through Wiley, Attorney-Advisor, Public Safety days. streaming services, and from radio and and Homeland Security Bureau, television stations, cable systems, Cybersecurity and Communications DATES: Comments must be received on satellite radio and television providers, Reliability Division at (202) 418–1678 or or before April 29, 2021. and wireline video providers that [email protected]. ADDRESSES: Submit comments, currently participate in EAS. As SUPPLEMENTARY INFORMATION: This is a identified by Docket ID No. EPA–R05– directed by Congress, after the summary of the Commission’s Notice of OAR–2020–0559, to: Genevieve Damico, conclusion of this inquiry the Proposed Rulemaking and Notice of Chief, Air Permits Section, Air Programs Commission will submit a report on its Inquiry, FCC 21–36, in PS Docket Nos. Branch (AR–18J), U.S. Environmental findings and conclusions to specified 15–94 and 15–91, adopted on March 17, Protection Agency, Region 5, 77 West Committees of the U.S. Senate and 2021 and released on March 19, 2021. Jackson Boulevard, Chicago, Illinois House of Representatives. The full text of this document is 60604, [email protected]. DATES: Comments on the Notice of available at https://docs.fcc.gov/public/ Additional instructions regarding how Proposed Rulemaking are due on or attachments/FCC-21-36A1.pdf. to submit a comment can be found in before April 20, 2021, and reply Pursuant to §§ 1.415 and 1.419 of the the notice of proposed rulemaking comments are due on or before May 4, Commission’s rules, 47 CFR 1.415, published February 11, 2021 (86 FR 2021. Comments on the Notice of 1.419, interested parties may file 9039). Inquiry are due on or before May 14, comments and reply comments on or FOR FURTHER INFORMATION CONTACT: Mari 2021, and reply comments are due on or before the dates indicated on the first Gonza´lez, Environmental Engineer, Air before June 14, 2021. page of this document. Comments may Permits Section, Air Programs Branch ADDRESSES: You may submit comments, be filed using the Commission’s (AR–18J), Environmental Protection identified by PS Docket Nos. 15–94 and Electronic Comment Filing System Agency, Region 5, 77 West Jackson 15–91, by any of the following methods: (ECFS). See Electronic Filing of Boulevard, Chicago, Illinois 60604, • Federal Communications Documents in Rulemaking Proceedings, (312) 886–6175, Gonzalez.Mari@ Commission’s website: http:// 63 FR 24121 (1998). • epa.gov. apps.fcc.gov/ecfs/. Follow the Electronic Filers: Comments may be instructions for submitting comments. filed electronically using the internet by Dated: March 24, 2021. • Mail: Parties who choose to file by accessing the ECFS: http://apps.fcc.gov/ Cheryl Newton, paper must file an original and one copy ecfs/. Acting Regional Administrator, Region 5. of each filing. If more than one docket • Paper Filers: Parties who choose to [FR Doc. 2021–06449 Filed 3–29–21; 8:45 am] or rulemaking number appears in the file by paper must file an original and BILLING CODE 6560–50–P caption of this proceeding, filers must one copy of each filing.

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