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Federal Register / Vol. 85, No. 170 / Tuesday, September 1, 2020 / Notices 54407

operate), normal operating levels (hours DEPARTMENT OF JUSTICE www.regulations.gov and follow the per week/weeks per year), time for online instructions at that site for downtime, maintenance, repair, and Enforcement Administration submitting comments. Upon completion cleanup, and a typical or representative [Docket No. DEA–688P] of your submission, you will receive a product mix); and Comment Tracking Number for your comment. Please be aware that (c) the quantity and value of your Proposed Aggregate Production submitted comments are not firm’s(s’) exports to the United States of Quotas for Schedule I and II Controlled Substances and Assessment of instantaneously available for public Subject Merchandise and, if known, an Annual Needs for the List I Chemicals view on Regulations.gov. If you have estimate of the percentage of total Ephedrine, Pseudoephedrine, and received a Comment Tracking Number, exports to the United States of Subject Phenylpropanolamine for 2021 your comment has been successfully Merchandise from the Subject Country submitted, and there is no need to accounted for by your firm’s(s’) exports. AGENCY: Drug Enforcement resubmit the same comment. Paper (12) Identify significant changes, if Administration, Department of Justice. comments that duplicate electronic any, in the supply and demand ACTION: Notice with request for submissions are not necessary and are conditions or business cycle for the comments. discouraged. Should you wish to mail a paper comment in lieu of an electronic Domestic Like Product that have SUMMARY: The Drug Enforcement comment, it should be sent via regular occurred in the United States or in the Administration (DEA) proposes to or express mail to: Drug Enforcement market for the Subject Merchandise in establish the 2021 aggregate production Administration, Attention: DEA Federal the Subject Country since the Order quotas for controlled substances in Register Representative/DPW, 8701 Date, and significant changes, if any, schedules I and II of the Controlled Morrissette Drive, Springfield, Virginia that are likely to occur within a Substances Act (CSA) and assessment of 22152. reasonably foreseeable time. Supply annual needs for the list I chemicals conditions to consider include ephedrine, pseudoephedrine, and FOR FURTHER INFORMATION CONTACT: technology; production methods; phenylpropanolamine. Scott A. Brinks, Diversion Control development efforts; ability to increase DATES: Interested persons may file Division, Drug Enforcement production (including the shift of written comments on this notice in Administration; Mailing Address: 8701 production facilities used for other accordance with 21 CFR 1303.11(c) and Morrissette Drive, Springfield, Virginia products and the use, cost, or 1315.11(d). Electronic comments must 22152, Telephone: (571) 362–3261. availability of major inputs into be submitted, and written comments SUPPLEMENTARY INFORMATION: production); and factors related to the must be postmarked, on or before Posting of Public Comments ability to shift supply among different October 1, 2020. Commenters should be national markets (including barriers to aware that the electronic Federal Docket Please note that all comments importation in foreign markets or Management System will not accept received in response to this docket are changes in market demand abroad). comments after 11:59 p.m. Eastern Time considered part of the public record. Demand conditions to consider include on the last day of the comment period. They will, unless reasonable cause is end uses and applications; the existence Based on comments received in given, be made available by the Drug and availability of substitute products; response to this notice, the Enforcement Administration (DEA) for and the level of competition among the Administrator may hold a public public inspection online at http:// Domestic Like Product produced in the hearing on one or more issues raised. In www.regulations.gov. Such information United States, Subject Merchandise the event the Administrator decides in includes personal identifying produced in the Subject Country, and his sole discretion to hold such a information (such as your name, such merchandise from other countries. hearing, the Administrator will publish address, etc.) voluntarily submitted by a notice of any such hearing in the the commenter. (13) (OPTIONAL) A statement of Federal Register. After consideration of The Freedom of Information Act whether you agree with the above any comments or objections, or after a (FOIA) applies to all comments definitions of the Domestic Like Product hearing, if one is held, the received. If you want to submit personal and Domestic Industry; if you disagree Administrator will publish in the identifying information (such as your with either or both of these definitions, Federal Register a final order name, address, etc.) as part of your please explain why and provide establishing the 2021 aggregate comment, but do not want it to be made alternative definitions. production quotas for schedule I and II publicly available, you must include the Authority: This proceeding is being controlled substances, and an phrase ‘‘PERSONAL IDENTIFYING conducted under authority of Title VII of the assessment of annual needs for the list INFORMATION’’ in the first paragraph Tariff Act of 1930; this notice is published I chemicals ephedrine, of your comment. You must also place pursuant to § 207.61 of the Commission’s pseudoephedrine, and all the personal identifying information rules. phenylpropanolamine. you do not want made publicly By order of the Commission. ADDRESSES: To ensure proper handling available in the first paragraph of your Issued: August 21, 2020. of comments, please reference ‘‘Docket comment and identify what information you want redacted. Lisa Barton, No. DEA–688P’’ on all correspondence, including any attachments. DEA If you want to submit confidential Secretary to the Commission. encourages that all comments be business information as part of your [FR Doc. 2020–18774 Filed 8–31–20; 8:45 am] submitted electronically through the comment, but do not want it to be made BILLING CODE 7020–02–P Federal eRulemaking Portal, which publicly available, you must include the provides the ability to type short phrase ‘‘CONFIDENTIAL BUSINESS comments directly into the comment INFORMATION’’ in the first paragraph field on the web page or attach a file for of your comment. You must also lengthier comments. Please go to http:// prominently identify confidential

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business information to be redacted aggregate production quotas for 2021 by in the United States, lawful export within the comment. considering the following seven factors: requirements, and the establishment Comments containing personal (1) Total net disposal of the class by and maintenance of reserve stocks, as identifying information or confidential all manufacturers during the current the Administrator finds relevant, business information identified and and 2 preceding years; including changes in the currently located as directed above will generally (2) Trends in the national rate of net accepted medical use in treatment with be made available in redacted form. If a disposal of the class; the chemicals or the substances which comment contains so much confidential (3) Total actual (or estimated) are manufactured from them, the business information or personal inventories of the class and of all economic and physical availability of identifying information that it cannot be substances manufactured from the class, raw materials for use in manufacturing effectively redacted, all or part of that and trends in inventory accumulation; and for inventory purposes, yield and comment may not be made publicly (4) Projected demand for such class as stability problems, potential disruptions available. Comments posted to http:// indicated by procurement quotas to production (including possible labor www.regulations.gov may include any requested pursuant to § 1303.12; strikes), and recent unforeseen personal identifying information (such (5) The extent of any diversion of the emergencies such as floods and fires. 21 as name, address, and phone number) controlled substance in the class; CFR 1315.11(b). included in the text of your electronic (6) Relevant information obtained As may be noted, the five assessment submission that is not identified as from the Department of Health and of annual needs factors considered are directed above as confidential. Human Services (HHS), including from similar, but not identical, to five of the An electronic copy of this document the Food and Drug Administration seven factors considered in determining is available at http:// (FDA), the Centers for Disease Control the aggregate production quotas. In www.regulations.gov for easy reference. and Prevention (CDC), and the Centers determining the proposed 2021 for Medicare and Medicaid Services Legal Authority assessment of annual needs, DEA used (CMS), and relevant information the calculation methodology previously Section 306 of the CSA (21 U.S.C. obtained from the states; and described in the 2010 and 2011 826) requires the Attorney General to (7) Other factors affecting medical, assessment of annual needs (74 FR establish aggregate production quotas scientific, research, and industrial needs 60294, Nov. 20, 2009, and 75 FR 79407, for each basic class of controlled in the United States and lawful export Dec. 20, 2010, respectively). substance listed in schedules I and II, requirements, as the Administrator finds Information From the Food and Drug and for the list I chemicals ephedrine, relevant, including changes in the Administration pseudoephedrine, and currently accepted medical use in phenylpropanolamine. The Attorney treatment with the class or the In accordance with part 1303 of Title General has delegated this function to substances which are manufactured 21, of the CFR, 21 U.S.C. 826, and 42 the Administrator of the DEA pursuant from it, the economic and physical U.S.C. 242, HHS continues to provide to 28 CFR 0.100. availability of raw materials for use in DEA with estimates of the quantities of Analysis for Proposed 2021 Aggregate manufacturing and for inventory select schedule I and II controlled Production Quotas and Assessment of purposes, yield and stability problems, substances and three list I chemicals Annual Needs potential disruptions to production that will be required to meet the (including possible labor strikes), and legitimate medical domestic needs of The proposed 2021 aggregate recent unforeseen emergencies such as the United States for a given calendar production quotas and assessment of floods and fires. year. The FDA is responsible for annual needs represent those quantities providing these estimates and of schedule I and II controlled Assessment of Annual Needs predictions of legitimate medical needs substances, and the list I chemicals In similar fashion, in determining the to DEA. FDA provides DEA with its ephedrine, pseudoephedrine, and proposed 2021 assessment of annual predicted estimates of medical usage for phenylpropanolamine, to be needs for the list I chemicals ephedrine, selected controlled substances based on manufactured in the United States (U.S.) pseudoephedrine, and information available to them at a in 2021 to provide for the estimated phenylpropanolamine, the Acting specific point in time to meet statutory medical, scientific, research, and Administrator has taken into account requirements. FDA’s predicted levels of industrial needs of the United States, the criteria of 21 U.S.C. 826(a) and 21 medical need for the United States was lawful export requirements, and the CFR 1315.11 and considered the five expected to decline on average 36.52 establishment and maintenance of following factors: percent for calendar year 2021. These reserve stocks. These quotas include (1) Total net disposal of the chemical declines were expected to occur across imports of ephedrine, pseudoephedrine, by all manufacturers and importers a variety of schedule II and phenylpropanolamine, but do not during the current and 2 preceding including , , include imports of controlled years; , , and substances for use in industrial (2) Trends in the national rate of net . However, FDA’s predicted processes. disposal of each chemical; level of medical need for the United Aggregate Production Quotas (3) Total actual (or estimated) States was calculated by FDA at the inventories of the chemical and of all beginning of the Coronavirus Disease In determining the proposed 2021 substances manufactured from the 2019 (COVID–19) pandemic and, aggregate production quotas, the Acting chemical, and trends in inventory therefore, did not take into account Administrator has taken into account accumulation; changes in usage that are necessary to the criteria of 21 U.S.C. 826(a) and 21 treat patients who require schedule II 1 (4) Projected demand for each CFR 1303.11. The DEA proposes the chemical as indicated by procurement controlled substances. DEA has and import quotas requested pursuant to considered both the potential for 1 Two additional aggregate production quotas factors were added when DEA published the Final § 1315.32; and diversion as well as the anticipated Rule ‘‘Controlled Substances Quotas’’ in the (5) Other factors affecting medical, increase in demand for opioids used to Federal Register, 83 FR 32784, on July 16, 2018. scientific, research, and industrial needs treat patients with COVID–19 in the

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table of proposed 2021 aggregate • Theft Loss Report database (SUPPORT Act), Public Law 115–271, production quotas listed below as is comprised of DEA registrant reported mandates that DEA, in consultation required pursuant to 21 CFR entries documenting diversion with HHS, determine reliable rates of 1303.11(b)(7). consisting of employee theft, break-ins, overdose deaths, , and overall With regard to certain schedule II armed robberies, and material lost in public health impact as factors for the (, transit; purpose of estimating diversion for each • , and Statistical Management Analysis & of the following five covered controlled lisdexamfetamine) that are widely used Reporting Tools System (SMARTS) substances: Fentanyl, hydrocodone, to treat patients with attention deficit database comprised of laboratory drug hydromorphone, , and hyperactivity disorder (ADHD), FDA submissions from data and drug . The SUPPORT Act predicted a 0.5 percent decline in purchases made by DEA task force further mandates that DEA ‘‘make domestic medical use. DEA noted that groups, tactical diversion squads, appropriate quota reductions, as although usage is not forecasted to have enforcement groups, and High Intensity determined by the [Administrator], from a significant increase in demand, FDA Drug Trafficking Area (HIDTA) task the quota the [Administrator] would raised concerns over receiving a large force groups; have otherwise established had such • System to Retrieve Information on volume of drug shortage notifications diversion not been considered.’’ 2 21 from patients for these medications as Drug Evidence (STRIDE) database U.S.C. 826(i)(1). well as multiple recalls for out-of- comprised of material seized by specification lots of specific ADHD numerous law enforcement groups In accordance with this mandate, DEA medications. DEA did consider FDA’s across the country including the Federal requested information from several concerns when calculating the aggregate Bureau of Investigation (FBI) field reliable sources. In February 2020, DEA production quota for these substances. offices; DEA field offices; U.S. met with representatives from FDA, While FDA’s predicted estimate of usage Immigration and Customs Enforcement CDC, and CMS to discuss sharing remains stable, DEA has observed (ICE) offices; Bureau of , relevant data that each agency increases in the number of quota , Firearms and Explosives (ATF) maintains. For example, the CDC applications for product development offices; and metropolitan police maintains information regarding efforts as well as exports for medical use departments. unintentional overdose deaths and CMS for these controlled substances, and has The data was categorized by basic maintains data regarding prescriptions proposed increases in these APQs to drug class and the amount of active for controlled substances filled under meet these demands. However, DEA is pharmaceutical ingredient (API) in the the Medicare Part D program. Following closely monitoring trends in licit dosage form was delineated with an that meeting, DEA requested use as DEA has grown appropriate metric for use in proposing information on overdose deaths, increasingly concerned over the misuse aggregate production quota values (i.e., overprescribing, and the public health of prescription stimulants among young weight). Because of the factor required impact of these categories from each of adults and the demand for by 21 CFR 1303.11(b)(6), DEA formally these federal partners. here in the U.S. solicited HHS components CDC and For the factors listed in 21 CFR CMS, in February 2020, requesting Overdose Death Data Provided by the 1303.11(b)(3) and (4), DEA registered information including rates of overdose Centers for Disease Control and manufacturers of controlled substances deaths and abuse and overall public Prevention in schedules I and II provided the health impact related to schedule II information by submitting their controlled substances, including the In May 2020, the CDC provided DEA individual data to several DEA database covered controlled substances. In April with data from their National Vital systems used for reporting inventory, 2020, DEA formally solicited the states Statistics System Mortality files for 2015 distribution, manufacturing, and regarding information that would be through 2017, which provided estimated quota requirements to meet helpful to DEA in estimating the amount numerical, crude, and age-adjusted rates sales forecasts for each class of of diversion, including PDMP data for of deaths involving the controlled substance as required by the covered controlled substances. This covered controlled substances regulations. See 21 CFR 1303.12, information is considered pursuant to aggregated by public health regions of 1303.22, and part 1304. Factor the SUPPORT Act discussed below. The the United States. The CDC noted that 1303.11(b)(5) requires DEA to consider Acting Administrator considered the if the death involved more than one the extent of diversion of controlled effects of the COVID–19 pandemic controlled substance, the death was substances. The estimates of diversion pursuant to 21 CFR 1303.11(b)(7) as counted in all involved substances. as required by the SUPPORT Act are discussed under Information from the Further, CDC informed DEA that discussed later in the document. FDA section. calendar year 2018 data would not be Diversion is defined as all distribution, available until the fall of 2020. The dispensing, or other use of controlled Estimates of Diversion Pursuant to the number of overdose deaths in which the substances for other than a legitimate Substance Use-Disorder Prevention That covered controlled substance was medical purpose. In order to consider Promotes Recovery and identified, as provided by the CDC, is the extent of diversion, Federal, state, Treatment for Patients and provided in Table 1 below. With respect and local law enforcement and Communities Act to fentanyl, the data includes the registrant reports of diversion of The Substance Use-Disorder covered controlled substance fentanyl controlled substances from 2019 were Prevention that Promotes Opioid and all known fentanyl analogues, extracted from several DEA supported Recovery and Treatment for Patients which are not covered controlled databases. The databases used include: and Communities Act of 2018 substances under the SUPPORT Act.

2 On October 23, 2019, DEA published a proposal amendments to the CSA made by the SUPPORT SUPPORT Act, and DEA is therefore obligated to to amend its quota regulations. 84 FR 56712. When Act. However, the statutory requirements stated adhere to them in issuing these adjusted aggregate finalized, the regulations will implement the above became effective upon enactment of the production quotas.

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TABLE 1: OVERDOSE DEATHS OF COVERED CONTROLLED SUBSTANCES, 2015–2017

Trend (percent 2015 2016 2017 change from 2015 to 2017)

Fentanyl and its Analogues ... 8,251 ...... 18,335 ...... 27,299 ...... 231 Hydrocodone ...... 3,051 ...... 3,199 ...... 3,072 ...... 1 Hydromorphone ...... 793 ...... 743 ...... 786 ...... ¥1 Oxycodone ...... 5,792 ...... 6,199 ...... 6,053 ...... 5 Oxymorphone ...... 1,006 ...... 1,077 ...... 900 ...... ¥11

Fentanyl and its analogues are the quota setting year (2021). However, this aggregate production quotas. As such, substances that continue to be the information continues to serve as an DEA sent a letter to each state attorney opioids involved in the vast majority of important reminder of the persistent general soliciting information that overdose deaths in the United States, role that controlled prescription opioids would be helpful in estimating the increasing by 231 percent from 2015 play in our Nation’s opioid epidemic. amount of diversion for the five covered 3 through 2017. However, based on the Data From the Centers for Medicare and controlled substances identified in the data presented to DEA by the CDC, Medicaid Services SUPPORT Act. In that letter, DEA which did not differentiate between licit indicated that it was specifically In further consultation with HHS, fentanyl and illicit fentanyl and its interested in obtaining information from analogues, as well as analyzed seizure DEA was advised that the Centers for Medicare and Medicaid Services (CMS) each state’s data from law enforcement activities, may have information related to Monitoring Program (PDMP) or any DEA believes that the vast majority of diversion, such as reliable rates of analysis of prescription data that would deaths involving fentanyl were not from overprescribing (doctor shopping and assist DEA in estimating diversion of products that were lawfully being prescribed significantly more covered controlled substances and manufactured and distributed pursuant medicine than is medically necessary). setting appropriate quotas in to the CSA but were from unlawfully DEA was informed by CMS that CMS compliance with the SUPPORT Act. manufactured and distributed fentanyl had reviewed their internal databases DEA requested the data be provided to and fentanyl related substances. The and does not have the ability to the agency by June 1, 2020, in order to information from the CDC also systematically distinguish between provide the agency with adequate time demonstrates a relatively stable number appropriate and inappropriate to analyze the data and determine a of overdose deaths involving prescriptions without investigations. methodology for inclusion in diversion oxycodone, hydrocodone, and While CMS was unable to generate a estimates to be considered in proposing hydromorphone. Overdose deaths report, DEA will attempt to solicit the APQ values for the 2021 calendar year. involving oxymorphone show an 11 raw data from CMS to determine percent decline during this period. Twenty states and U.S. territories overprescribing rates based on CDC acknowledged receipt of DEA’s Whereas DEA is required to consider prescription guidance for schedule II rates in overdose deaths pursuant to correspondence and nine of those states substances and DEA’s own parameters provided DEA with de-identified changes made by the SUPPORT Act, for doctor shopping. DEA has concluded that this data on aggregated PDMP data. The list of states overdose deaths for 2015 through 2017 Information From States’ Attorneys and territories responding to DEA’s cannot be reliably utilized to estimate General request for data is listed in Table 2. the amount of diversion for the five DEA also obtains information from covered controlled substances for the the states to be considered in setting the

TABLE 2—STATES/TERRITORIES THAT RESPONDED TO DEA’S DATA REQUEST

State/territory Acknowledged letter Submitted PDMP data

1. Connecticut ...... X ...... 2. Delaware ...... X ...... 3. District of Columbia ...... X ...... 4. Florida ...... X ...... X 5. Guam ...... X ...... X 6. Illinois ...... X ...... 7. Louisiana ...... X ...... X 8. Maine ...... X ...... 9. Massachusetts ...... X ...... 10. Michigan ...... X ...... 11. Missouri ...... X ...... 12. Montana ...... X ...... 13. New Hampshire ...... X ...... 14. Ohio ...... X ...... X

3 According to the CDC, there were an estimated time of this publication, the CDC has released CDC’s current mortality data may be found at: 47,506 unintentional overdose deaths involving a unintentional overdose statistics for 2018 and https://www.cdc.gov/drugoverdose/data/ natural, semi-synthetic or synthetic opioid in 2017. provisional estimates for 2019; however, deaths index.html. More than half (57 percent) involved fentanyl and involving each of the five covered substances are substances chemically similar to fentanyl. At the not available for those years. Information about

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TABLE 2—STATES/TERRITORIES THAT RESPONDED TO DEA’S DATA REQUEST—Continued

State/territory Acknowledged letter Submitted PDMP data

15. Oklahoma ...... X ...... X 16. Oregon ...... X ...... 17. South Dakota ...... X ...... X 18. Texas ...... X ...... X 19. West Virginia ...... X ...... X 20. Wyoming ...... X ...... X

The data that DEA received varied in production quota values. DEA Proposed its form and content and was ultimately calculated the estimated amount of Basic class 2021 determined to be inapplicable at the diversion by multiplying the strength of quotas national level. the API listed for each finished dosage (g) Data from PDMPs can be evaluated to form by the total amount of units 1-(1- identify common diversion schemes reported to estimate the metric weight Phenylcyclohexyl)pyrrolidine 15 such as ‘‘doctor shopping,’’ a scheme in in kilograms of the controlled substance 1-(2-Phenylethyl)-4-phenyl-4- which a patient obtains controlled being diverted. The estimate of acetoxypiperidine ...... 10 substances from multiple treatment diversion for each of the covered 1-(5-Fluoropentyl)-3-(1-naph- providers without the providers controlled substances is reported below: thoyl)indole (AM2201) ...... 30 knowing of the other prescriptions. In 1-(5-Fluoropentyl)-3-(2- addition, information from PDMPs can TABLE 3—ESTIMATE OF DIVERSION iodobenzoyl)indole (AM694) 30 assist in identifying ‘‘red flags’’ that FOR COVERED CONTROLLED SUB- 1-Benzylpiperazine ...... 25 1-Methyl-4-phenyl-4- could be evidence of diversion and STANCES. misuse of covered controlled propionoxypiperidine ...... 10 1-[1-(2- substances, such as: Over-prescribing; Diversion Estimates for 2019 (kg) patients traveling long distances or Thienyl)cyclohexyl]piperidine 15 2-(2,5-Dimethoxy-4- across state lines to have prescriptions Fentanyl ...... 0.090 ethylphenyl)ethanamine (2C- filled; early refills; and dangerous drug Hydrocodone ...... 30.294 E) ...... 30 Hydromorphone ...... 1.424 combinations such as the ‘‘holy trinity,’’ 2-(2,5-Dimethoxy-4- Oxycodone ...... 60.959 a cocktail of consisting of an methylphenyl)ethanamine Oxymorphone ...... 1.311 opioid, a , and a (2C-D) ...... 30 commonly prescribed 2-(2,5-Dimethoxy-4-nitro- such as , which when In accordance with the SUPPORT Act, phenyl)ethanamine (2C-N) .... 30 misused in combination, can be lethal. after estimating the amount of diversion 2-(2,5-Dimethoxy-4-(n)- DEA has determined that analysis of for the foregoing five controlled propylphenyl)ethanamine raw data from state PDMPs on these five substances, DEA made adjustments to (2C-P) ...... 30 covered substances is essential for DEA the individual aggregate production 2-(2,5- quotas for each covered controlled Dimethoxyphenyl)ethanamine to effectively estimate diversion of the (2C-H) ...... 100 covered controlled substances pursuant substance by the corresponding quantities listed in the table. 2-(4-Bromo-2,5- to the SUPPORT Act. DEA is currently dimethoxyphenyl)-N-(2-me- exploring additional means to obtain In determining the proposed 2021 thoxybenzyl)ethanamine PDMP data so that it may fulfill this assessment of annual needs, the DEA (25B-NBOMe; 2C-B-NBOMe; statutory obligation while protecting the used the calculation methodology 25B; Cimbi-36) ...... 30 privacy of patients who obtain such previously described in the 2010 and 2-(4-Chloro-2,5- prescriptions. 2011 assessment of annual needs (74 FR dimethoxyphenyl)ethanamine 60294, Nov. 20, 2009, and 75 FR 79407, (2C-C) ...... 30 DEA Law Enforcement Data Dec. 20, 2010, respectively). 2-(4-Chloro-2,5- dimethoxyphenyl)-N-(2-me- DEA extracted data from its Drug The Acting Administrator, therefore, Theft and Loss, Statistical Management thoxybenzyl)ethanamine proposes to establish the 2021 aggregate (25C-NBOMe; 2C-C-NBOMe; Analysis & Reporting Tools System production quotas for certain schedule I 25C; Cimbi-82) ...... 25 (SMARTS) and System to Retrieve and II controlled substances and 2-(4-Iodo-2,5- Information on Drug Evidence (STRIDE) assessment of annual needs for the list dimethoxyphenyl)ethanamine databases, and aggregated the quantity I chemicals ephedrine, (2C-I) ...... 30 of active pharmaceutical ingredient pseudoephedrine, and 2-(4-Iodo-2,5-dimethoxyphenyl)- (API) of each covered controlled phenylpropanolamine, expressed in N-(2-methoxy- substance by metric weight where the grams of anhydrous acid or base, as benzyl)ethanamine (25I- data was available. From the databases, follows: NBOMe; 2C-I-NBOMe; 25I; DEA gathered data involving employee Cimbi-5) ...... 30 2,5-Dimethoxy-4- theft, break-ins, armed robberies, and Proposed ethylamphetamine (DOET) ... 25 material lost in transit. DEA also used 2021 Basic class 2,5-Dimethoxy-4-(n)- seizure data by law enforcement quotas (g) propylthiophenethylamine ..... 25 nationwide. This data was categorized 2,5-Dimethoxyamphetamine by basic drug class and the amount of Schedule I (DMA) ...... 25 API in the dosage form was delineated 2-(4-Ethylthio-2,5- with an appropriate metric for use in 1-[1-(2- dimethoxyphenyl)ethanamine proposing the adjusted aggregate Thienyl)cyclohexyl]pyrrolidine 20 (2C-T-2) ...... 30

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Proposed Proposed Proposed 2021 2021 2021 Basic class quotas Basic class quotas Basic class quotas (g) (g) (g)

2-(4-(Isopropylthio)-2,5- 5F-CUMYL-P7AICA; (1-(5- ...... 25 dimethoxyphenyl)ethanamine fluoropentyl)-N-(2- ...... 30 (2C-T-4) ...... 30 phenylpropan-2-yl)-1H- ...... 25 3,4,5-Trimethoxyamphetamine 30 pyrrolo[2,3-b]pyridine-3- Beta-Hydroxy-3-methylfentanyl 30 3,4- carboximide) ...... 25 Beta-Hydroxyfentanyl ...... 30 Methylenedioxyamphetamine 5F-ADB; 5F-MDMB-PINACA Beta-Hydroxythiofentanyl ...... 30 (MDA) ...... 55 (methyl 2-(1-(5-fluoropentyl)- Betameprodine ...... 25 3,4- 1H-indazole-3-carboxamido)- ...... 4 Methylenedioxymethamphet- 3,3-dimethylbutanoate) ...... 30 Betaprodine ...... 25 amine (MDMA) ...... 50 5F-AMB (methyl 2-(1-(5- Bufotenine ...... 15 3,4-Methylenedioxy-N- fluoropentyl)-1H-indazole-3- Butylone ...... 25 ethylamphetamine (MDEA) ... 40 carboxamido)-3- Butyryl fentanyl ...... 30 Cathinone ...... 40 3,4-Methylenedioxy-N- methylbutanoate) ...... 30 ...... 25 methylcathinone (methylone) 40 5F-APINACA; 5F-AKB48 (N- Codeine methylbromide ...... 30 3,4- (adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3- Codeine-N-oxide ...... 192 Methylenedioxypyrovalerone Cyclopentyl Fentanyl ...... 30 (MDPV) ...... 35 carboxamide) ...... 30 5-Fluoro-PB-22; 5F-PB-22 ...... 20 Cyclopropyl Fentanyl ...... 20 3-Fluoro-N-methylcathinone (3- 5-Fluoro-UR144, XLR11 ([1-(5- ...... 25 FMC) ...... 25 fluoro-pentyl)-1H-indol-3- Delta 9-THC ...... 384,460 3-Methylfentanyl ...... 30 yl](2,2,3,3- ...... 25 3-Methylthiofentanyl ...... 30 tetramethylcyclopropy- ...... 25 4-Bromo-2,5- l)methanone ...... 25 ...... 20 dimethoxyamphetamine 5-Methoxy-3,4- ...... 20 (DOB) ...... 30 methylenedioxyamphetamine 25 Diethyltryptamine ...... 25 4-Bromo-2,5- 5-Methoxy-N,N- ...... 9,200 dimethoxyphenethylamine (2- diisopropyltryptamine ...... 25 ...... 753,500 CB) ...... 25 5-Methoxy-N,N- ...... 25 4-Chloro-alpha- dimethyltryptamine ...... 25 ...... 25 pyrrolidinovalerophenone (4- AB-CHMINACA ...... 30 ...... 20 chloro-alpha-PVP) ...... 25 AB-FUBINACA ...... 50 Dimethyltryptamine ...... 50 1-(4-Cyanobutyl)-N-(2- AB-PINACA ...... 30 ...... 25 phenylpropan-2-yl)-1 H-inda- ADB-FUBINACA (N-(1-amino- ...... 25 zole-3-carboximide (4CN- 3,3-dimethyl-1-oxobutan-2- ...... 25 Cumyl-Butinaca) ...... 25 yl)-1-(4-fluorobenzyl)-1H-in- ...... 25 4-Fluoroisobutyryl fentanyl ...... 30 dazole-3-carboxamide) ...... 30 ...... 30 4-Fluoro-N-methylcathinone (4- ...... 25 ...... 25 FMC; Flephedrone) ...... 25 Acetyl Fentanyl ...... 100 Fenethylline ...... 30 4-Methyl-N-ethylcathinone (4- Acetyl-alpha-methylfentanyl ...... 30 Fentanyl related substances .... 600 MEC) ...... 25 ...... 30 FUB-144 ...... 25 4-Methoxyamphetamine ...... 150 ...... 25 FUB-AKB48 ...... 25 4-Methyl-2,5- Acryl Fentanyl ...... 25 FUB-AMB, MMB-Fubinaca, dimethoxyamphetamine ADB-PINACA (N-(1-amino-3,3- AMB-Fubinaca ...... 25 (DOM) ...... 25 dimethyl-1-oxobutan-2-yl)-1- Furanyl fentanyl ...... 30 ...... 25 4-Methylaminorex ...... 25 pentyl-1H-indazole-3- carboxamide) ...... 50 Gamma Hydroxybutyric Acid .... 25,417,000 4-Methyl-N-methylcathinone AH-7921 ...... 30 ...... 45 () ...... 45 All other .. 1,000 ...... 40 4-Methyl-alpha- ...... 25 ...... 25 ethylaminopentiophenone (4- ...... 25 ...... 30 MEAP) ...... 25 Alpha-Ethyltryptamine ...... 25 Isobutyryl Fentanyl ...... 25 4-Methyl-alpha- Alphameprodine ...... 25 JWH-018 and AM678 (1- pyrrolidinohexiophenone ...... 25 Pentyl-3-(1-naphthoyl)indole) 35 (MPHP) ...... 25 Alphaprodine ...... 25 JWH-019 (1-Hexyl-3-(1-naph- 4-Methyl-alpha- Alpha-Methylfentanyl ...... 30 thoyl)indole) ...... 45 pyrrolidinopropiophenone (4- Alpha-Methylthiofentanyl ...... 30 JWH-073 (1-Butyl-3-(1-naph- MePPP) ...... 25 Alpha-Methyltryptamine (AMT) 25 thoyl)indole) ...... 45 5-(1,1-Dimethylheptyl)-2- Alpha-Pyrrolidinobutiophenone JWH-081 (1-Pentyl-3-(1-(4- [(1R,3S)-3- (a-PBP) ...... 25 methoxynaphthoyl)indole) ..... 30 hydroxycyclohexyl-phenol ..... 50 Alpha-Pyrrolidinoheptaphenone JWH-122 (1-Pentyl-3-(4-methyl- 5-(1,1-Dimethyloctyl)-2- (PV8) ...... 25 1-naphthoyl)indole) ...... 30 [(1R,3S)3-hydroxycyclohexyl- Alpha- JWH-200 (1-[2-(4- phenol (cannabicyclohexanol Pyrrolidinohexanophenone Morpholinyl)ethyl]-3-(1-naph- or CP-47,497 C8-homolog) ... 40 (a-PHP) ...... 25 thoyl)indole) ...... 35 5F-CUMYL-PINACA ...... 25 Alpha-Pyrrolidinopentiophenone JWH-203 (1-Pentyl-3-(2- 5F-EDMB-PINACA ...... 25 (a-PVP) ...... 25 chlorophenylacetyl)indole) .... 30 5F-MDMB-PICA ...... 25 Aminorex ...... 25 JWH-250 (1-Pentyl-3-(2- 5F-AB-PINACA; N-(1-amino-3- ...... 20 methoxyphenylacetyl)indole) 30 methyl-1-oxobutan-2-yl)-1-(5- APINACA, AKB48 (N-(1- JWH-398 (1-Pentyl-3-(4-chloro- fluoropentyl)-1H-indazole-3- adamantyl)-1-pentyl-1H-inda- 1-naphthoyl)indole) ...... 30 carboxamide ...... 25 zole-3-carboxamide) ...... 25 ...... 30

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Proposed Proposed Proposed 2021 2021 2021 Basic class quotas Basic class quotas Basic class quotas (g) (g) (g)

Levomoramide ...... 25 ...... 25 L-methamphetamine ...... 587,229 ...... 25 ...... 25 Levo-alphacetylmethadol Lysergic acid diethylamide ...... 25 (LAAM) ...... 25 (LSD) ...... 40 ...... 5 ...... 30 MAB-CHMINACA; ADB- ...... 25 ...... 26,495 CHMINACA (N-(1-amino-3,3- ...... 25 Lisdexamfetamine ...... 21,000,000 dimethyl-1-oxobutan-2-yl)-1- ...... 25 Meperidine ...... 856,695 (cyclohexylmethyl)-1H-inda- ...... 25 Meperidine Intermediate-A ...... 30 zole-3-carboxamide) ...... 30 Psilocybin ...... 30 Meperidine Intermediate-B ...... 30 MDMB-CHMICA; MMB- Psilocyn ...... 50 Meperidine Intermediate-C ...... 30 CHMINACA(methyl 2-(1- ...... 25 ...... 15 (cyclohexylmethyl)-1H-indole- SR-18 and RCS-8 (1- (for sale) ...... 25,619,700 3-carboxamido)-3,3- Cyclohexylethyl-3-(2- Methadone Intermediate ...... 27,673,600 dimethylbutanoate) ...... 30 methoxyphenylacetyl)indole) 45 Methylphenidate ...... 57,438,334 MDMB-FUBINACA (methyl 2- SR-19 and RCS-4 (1-Pentyl-3- ...... 25 (1-(4-fluorobenzyl)-1H-inda- [(4-methoxy)-benzoyl]indole) 30 Moramide-intermediate ...... 25 zole-3-carboxamido)-3,3- Tetrahydrofuranyl fentanyl ...... 15 Morphine (for conversion) ...... 3,376,696 dimethylbutanoate) ...... 30 ...... 25 Morphine (for sale) ...... 27,784,062 MMB-CHMICA (AMB- ...... 25 ...... 62,000 CHMICA); Methyl-2-(1- ...... 25 Norfentanyl ...... 25 (cyclohexylmethyl)-1H-indole- THJ-2201 ( [1-(5-fluoropentyl)- (for conver- 3-carboxamido)-3- 1H-indazol-3-yl](naphthalen- sion) ...... 22,044,741 methylbutanoate ...... 25 1-yl)methanone) ...... 30 Noroxymorphone (for sale) ...... 376,000 Marihuana ...... 1,500,000 ...... 25 (powder) ...... 250,000 Marihuana extract ...... 200,000 ...... 25 Opium (tincture) ...... 530,837 Mecloqualone ...... 30 UR-144 (1-pentyl-1H-indol-3- ...... 33,010,750 Mescaline ...... 25 yl)(2,2,3,3- Oxycodone (for conversion) ..... 620,887 Methaqualone ...... 60 tetramethylcyclopropy- Oxycodone (for sale) ...... 57,110,032 Methcathinone ...... 25 l)methanone ...... 25 Oxymorphone (for conversion) 28,204,371 Methoxyacetyl fentanyl ...... 30 U-47700 ...... 30 Oxymorphone (for sale) ...... 563,174 ...... 5 Valeryl fentanyl ...... 25 Pentobarbital ...... 25,850,000 ...... 25 ...... 25 ...... 25 Schedule II ...... 35 ...... 5 Phenmetrazine ...... 25 Morphine methylsulfonate ...... 5 1-Phenylcyclohexylamine ...... 15 Phenylacetone ...... 40 Morphine-N-oxide ...... 150 1- ...... 25 MT-45 ...... 30 Piperidinocyclohexanecarbo- Racemethorphan ...... 5 ...... 25 nitrile ...... 25 ...... 5 NM2201; Naphthalen-1-yl 1-(5- 4-Anilino-N-phenethyl-4-piper- ...... 3,000 fluoropentyl)-1H-indole-3- idine (ANPP) ...... 666,249 Secobarbital ...... 172,100 carboxylate ...... 25 ...... 3,260 ...... 4,000 N,N-Dimethylamphetamine ...... 25 Alphaprodine ...... 25 ...... 13,447,541 Naphyrone ...... 25 Amobarbital ...... 20,100 ...... 57,137,944 N-Ethyl-1- ...... 25 phenylcyclohexylamine ...... 25 ...... 20 List I Chemicals N-Ethyl-3-piperidyl benzilate ..... 10 ...... 68,576 N-Ethylamphetamine ...... 24 Codeine (for conversion) ...... 1,612,500 Ephedrine (for conversion) ...... 100 N-Ethylhexedrone ...... 25 Codeine (for sale) ...... 27,616,684 Ephedrine (for sale) ...... 4,136,000 N-Ethylpentylone, ephylone ...... 30 D-amphetamine (for sale) ...... 21,200,000 Phenylpropanolamine (for con- N-Hydroxy-3,4- D-amphetamine (for conver- version) ...... 14,878,320 Phenylpropanolamine (for sale) 16,690,000 methylenedioxyamphetamine 24 sion) ...... 14,137,578 Pseudoephedrine (for conver- N-Methyl-3-Piperidyl Benzilate 30 D-methamphetamine (for con- sion) ...... 1,000 ...... 25 version) ...... 485,02 Pseudoephedrine (for sale) ...... 174,246,000 ...... 25 D-methamphetamine (for sale) 25,491 ...... 25 D,L-amphetamine ...... 21,200,000 ...... 55 D,L-methamphetamine ...... 50 The Acting Administrator further ...... 25 ...... 35 proposes that aggregate production ...... 40 ...... 156,713 quotas for all other schedule I and II ...... 25 ...... 25 controlled substances included in 21 ...... 25 (for conversion) 14,100 CFR 1308.11 and 1308.12 remain at Ortho-fluorofentanyl, 2- Diphenoxylate (for sale) ...... 770,800 zero. fluorofentanyl ...... 30 Ecgonine ...... 68,576 Para-chloroisobutyryl fentanyl .. 30 ...... 30 Adjustments to the Aggregate Para-fluorofentanyl ...... 25 Etorphine hydrochloride ...... 32 Production Quotas During the COVID– Para-fluorobutyryl fentanyl ...... 25 Fentanyl ...... 666,249 19 Public Health Emergency Para-methoxybutyryl fentanyl ... 30 ...... 25 Parahexyl ...... 5 Hydrocodone (for conversion) .. 1,250 The establishment (and adjustment) of PB-22; QUPIC ...... 20 Hydrocodone (for sale) ...... 30,821,224 the aggregate production quotas for Pentedrone ...... 25 Hydromorphone ...... 2,827,940 schedule I and II substances is a critical Pentylone ...... 25 ...... 30 component of DEA’s response to the ...... 25 L-amphetamine ...... 30 threat posed by the ongoing COVID–19

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public health emergency declared by the phenylpropanolamine, 21 CFR No. DEA–508A2’’ on all Secretary of Health and Human Services 1303.11(c) and 1315.11(f). correspondence, including any (HHS) on January 31, 2020, effective attachments. DEA encourages that all Timothy J. Shea, January 27, 2020, and as has been comments be submitted electronically Acting Administrator. renewed in accordance with section through the Federal eRulemaking Portal, 319(a)(2) of the Public Health Service [FR Doc. 2020–19285 Filed 8–31–20; 8:45 am] which provides the ability to type short Act (PHS Act) (42 U.S.C. 247d(a)(2)). On BILLING CODE P comments directly into the comment April 10, 2020, DEA increased the 2020 field on the web page or to attach a file for lengthier comments. Please go to aggregate production quotas for certain DEPARTMENT OF JUSTICE schedule II controlled substances and http://www.regulations.gov and follow list I chemicals after concluding that Drug Enforcement Administration the online instructions at that site for this action was necessary to ensure that submitting comments. Upon completion [Docket No. DEA–508A2] there would be no supply disruptions of your submission, you will receive a Comment Tracking Number for your for these substances for ventilated Proposed Adjustments to the 4 comment. Please be aware that patients with this infectious disease. Aggregate Production Quotas for submitted comments are not Despite this public health emergency, Schedule I and II Controlled instantaneously available for public DEA remains focused on the challenges Substances and Assessment of view on Regulations.gov. If you have presented by opioid addiction and its Annual Needs for the List I Chemicals effect on the health and wellbeing of the Ephedrine, Pseudoephedrine, and received a Comment Tracking Number, millions of Americans and their families Phenylpropanolamine for 2020 your comment has been successfully who have become dependent upon or submitted and there is no need to AGENCY: addicted to them. The potential for Drug Enforcement resubmit the same comment. Paper addiction and misuse exists in every Administration, Department of Justice. comments that duplicate electronic submissions are not necessary and are community and remains a pressing ACTION: Notice with request for discouraged. Should you wish to mail a health issue with significant social and comments. paper comment in lieu of an electronic economic implications. SUMMARY: The Drug Enforcement comment, it should be sent via regular These proposed 2021 quotas reflect Administration proposes to adjust the or express mail to: Drug Enforcement the quantity that DEA believes is 2020 aggregate production quotas for Administration, Attention: DEA Federal necessary to meet the estimated several controlled substances in Register Representative/DRW, 8701 medical, scientific, research, and schedules I and II of the Controlled Morrissette Drive, Springfield, Virginia industrial needs of the United States, to Substances Act and assessment of 22152. include any increase in demand for annual needs for the list I chemicals certain controlled substances used to ephedrine, pseudoephedrine, and FOR FURTHER INFORMATION CONTACT: treat patients with COVID–19. DEA phenylpropanolamine. Scott A. Brinks, Regulatory Drafting and remains committed to conducting DATES: Interested persons may file Policy Support Section, Diversion continuous surveillance on the supply written comments on this notice in Control Division, Drug Enforcement of schedule II controlled substances and accordance with 21 CFR 1303.13(c) and Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia list I chemicals necessary to treat 1315.13(d). Electronic comments must 22152, Telephone: (571) 362–3261. patients with COVID–19, and, pursuant be submitted, and written comments to his authority, the Acting must be postmarked, on or before SUPPLEMENTARY INFORMATION: October 1, 2020. Commenters should be Administrator will move swiftly and Posting of Public Comments decisively to increase any 2021 aware that the electronic Federal Docket aggregate production quota that he Management System will not accept Please note that all comments determines is necessary to address an comments after 11:59 p.m. Eastern Time received in response to this docket are unforeseen increase in demand, should on the last day of the comment period. considered part of the public record. that occur. Based on comments received in They will, unless reasonable cause is response to this notice, the given, be made available by the Drug In accordance with 21 CFR 1303.13 Administrator may hold a public Enforcement Administration (DEA) for and 1315.13, upon consideration of the hearing on one or more issues raised. In public inspection online at http:// relevant factors, the Acting the event the Administrator decides in www.regulations.gov. Such information Administrator may adjust the 2021 his sole discretion to hold such a includes personal identifying aggregate production quotas and hearing, the Administrator will publish information (such as your name, assessment of annual needs as needed. a notice of any such hearing in the address, etc.) voluntarily submitted by Conclusion Federal Register. After consideration of the commenter. any comments or objections, or after a The Freedom of Information Act After consideration of any comments hearing, if one is held, the applies to all comments received. If you or objections, or after a hearing, if one Administrator will publish in the want to submit personal identifying is held, the Acting Administrator will Federal Register a final order information (such as your name, issue and publish in the Federal establishing the 2020 adjusted aggregate address, etc.) as part of your comment, Register a final order establishing the production quotas for schedule I and II but do not want it to be made publicly 2021 aggregate production quotas for controlled substances, and an adjusted available, you must include the phrase controlled substances in schedule I and assessment of annual needs for the list ‘‘PERSONAL IDENTIFYING II and establishing an assessment of I chemicals ephedrine, INFORMATION’’ in the first paragraph annual needs for the list I chemicals pseudoephedrine, and of your comment. You must also place ephedrine, pseudoephedrine, and phenylpropanolamine. all the personal identifying information ADDRESSES: To ensure proper handling you do not want made publicly 4 85 FR 20302 (April 10, 2020). of comments, please reference ‘‘Docket available in the first paragraph of your

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