Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021, 63061-63067 [2021-24921]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices assignment and transfer of Arizona fourth-priority Colorado River water in the amount of 762 acre-feet per year from CVIDD to be divided amongst the Beneficiaries. Amend CVIDD’s Colorado River water delivery contract No. 2–07– 30–W0028 to decrease its Colorado River water entitlement from 8,204.52 to 7,442.52 acre-feet per year. Enter into Colorado River water delivery contracts for Arizona fourth-priority Colorado River water entitlements under contract No. 21–XX–30–W0717 with The Cibola Sportsman’s Club, Inc. for 216 acre-feet per year, contract No. 21–XX–30– W0718 with Alfred F. and Erma Jean Bishop Family Trust for 420 acre-feet per year, and contract No. 21–XX–30– W0719 with Bruce and Lora Cathcart and James and Maria Cathcart for 126 acre-feet per year. 21. City of Needles, BCP, California: Approve a new point of diversion under contract No. 05–XX–30–W0445, as amended, dated March 16, 2007, and contract No. 2–07–30–W0280, as amended, dated July 3, 2002, and revise the necessary exhibits of the abovereferenced contracts to add an additional point of diversion. Columbia-Pacific Northwest—Interior Region 9: Bureau of Reclamation, 1150 North Curtis Road, Suite 100, Boise, Idaho 83706–1234, telephone 208–378– 5344. The Columbia-Pacific Northwest— Interior Region 9 has no updates to report for this quarter. California-Great Basin—Interior Region 10: Bureau of Reclamation, 2800 Cottage Way, Sacramento, California 95825–1898, telephone 916–978–5250. Discontinued contract action: 3. Contractors from the Delta Division, Cross Valley Canal, and West San Joaquin Division; CVP; California: Renewal of 10 interim and long-term water service contracts; water quantities for these contracts total in excess of 148,000 acre-feet. These contract actions will be accomplished through long-term renewal contracts pursuant to Public Law 102–575. Prior to completion of negotiation of long-term renewal contracts, existing interim renewal water service contracts may be renewed through successive interim renewal of contracts. Completed contract actions: 40. Tehama-Colusa Canal Authority, CVP, California: Renewal of OM&R contract. Contract completed on September 28, 2021. 42. Shasta County Water Agency, CVP, California: Proposed partial assignment of 50 acre-feet of the Shasta County Water Agency’s CVP water supply to the City of Shasta Lake for VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 M&I use. Contract completed on August 9, 2021. 43. Friant Water Authority, CVP, California: Negotiation and execution of a repayment contract for Friant Kern Canal Middle Reach Capacity Correction Project. Contract completed on September 23, 2021. Christopher Beardsley, Director, Policy and Programs. [FR Doc. 2021–24762 Filed 11–12–21; 8:45 am] BILLING CODE 4332–90–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–688F] Final Adjusted Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021 Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: This final order establishes the final adjusted 2021 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: This order is effective November 15, 2021. FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 362–3261. SUPPLEMENTARY INFORMATION: SUMMARY: Legal Authority Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas (APQ) for each basic class of controlled substances listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100. Background DEA published the 2021 established APQ for controlled substances in PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 63061 schedules I and II and for the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register on November 30, 2020. 85 FR 76604. DEA is committed to preventing and limiting diversion by enforcing laws and regulations regarding controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, while meeting the legitimate medical, scientific, and export needs of the United States. This notice stated that the Administrator would adjust, as needed, the established APQ in 2021 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2021 proposed adjusted APQ for controlled substances in schedules I and II and AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on September 2, 2021, (86 FR 49346), after consideration of the criteria outlined in that notice. All interested persons were invited to comment on or object to the proposed APQs and AANs on or before October 4, 2021. Comments Received DEA received 27 timely comments in response to the September Federal Register notice from patients, DEAregistered entities, and non-DEA entities. The comments included appreciation of DEA’s response to the increased interest in research using hallucinogenic controlled substances, requests to increase the APQ for additional hallucinogenic controlled substances, requests to increase the APQ for select schedule II controlled substances, concerns regarding the inability to comment to the notice electronically for two weeks, and comments outside the scope of this final order. Issue: Commenters expressed appreciation of DEA’s flexibility in responding to the nationwide public interest in hallucinogenic controlled substances research. DEA Response: DEA acknowledges the expressions of appreciation to changes in the APQ for these controlled substances. The adjustments to select hallucinogenic schedule I controlled substances occurred after DEA received additional schedule I researcher protocols from DEA registered researchers and quota applications from DEA registered manufacturers. Issue: Commenters requested DEA to increase the APQ for Bufotenine, Dimethyltryptamine (DMT), N,NDimethyltryptamine, 5-Methoxy-N,N- E:\FR\FM\15NON1.SGM 15NON1 khammond on DSKJM1Z7X2PROD with NOTICES 63062 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices dimethyltryptamine (5MEODMT), Ibogaine, Ketamine, Lysergic Acid Diethylamide (LSD), 3,4Methylenedioxymethamphetamine (MDMA), Mescaline, Mitragynine, and Psilocybin in response to the nationwide public interest in hallucinogenic controlled substances research. DEA Response: Ketamine is a schedule III controlled substance and therefore is outside of the scope of this final order as DEA only sets APQs for substances controlled in schedules I and II. DEA received additional quota applications for DMT, MDMA, and Psilocybin and considered the timely provided information in those applications for this final order. Regarding the other controlled substances listed, DEA has not received quota applications from DEA-registered manufacturers to support the requested changes in the APQ for these controlled substances. Mitragynine is not a controlled substance and therefore is outside the scope of this final order. Issue: DEA-registered entities requested that the APQ for Methadone, Methadone Intermediate, Methylphenidate Oxycodone (for sale), Phenylacetone, and Thebaine be sufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, for export requirements, and for the establishment and maintenance of reserve stocks. DEA Response: DEA sets APQ in a manner to ensure that the estimated medical, scientific, research, industrial needs of the United States, lawful export requirements, and for the establishment and maintenance of reserve stocks. As discussed in the notice for adjustment, any adjustments to the APQ for a controlled substance are based on factors set forth in 21 CFR 1303.13. In the event of a shortage, the CSA provides a mechanism under which DEA will, in appropriate circumstances, increase quotas to address shortages. 21 U.S.C. 826(h). Under 21 U.S.C. 826(h)(1), after receiving a request to address a shortage, DEA has 30 days to complete review of the request and determine whether adjustments are necessary to address the shortage. If adjustments are necessary, DEA is required to increase the APQ and individual production quotas to alleviate the shortage. Id. If DEA determines adjustments are not necessary, DEA is required to ‘‘provide VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 a written response detailing the basis for the . . . determination.’’ Id. In addition to what Section 826(h)(1) requires, when DEA is notified of an alleged shortage, DEA will confer with the Food and Drug Administration and relevant manufacturers regarding the amount of material in physical inventory, current quota granted, and the estimated legitimate medical need, to determine whether a quota adjustment is necessary to alleviate any quota-related drug shortage. In accordance with 21 CFR 1303.13, DEA considered the comments for Bufotenine, 5-Methoxy-N,Ndimethyltryptamine (5MEODMT), Ibogaine, Lysergic Acid Diethylamide (LSD), Mescaline, Methadone, Methadone Intermediate, Oxycodone (for sale), and Thebaine and the Administrator determined the proposed adjusted 2021 APQs for these substances as published in the Federal Register on September 2, 2021, (86 FR 49346), are sufficient to meet the current 2021 estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and to provide for adequate reserve stock. Issue: Commenters expressed general concerns regarding the inability to submit electronic comments to the notice published on September 2, 2021, for two weeks. Commenters requested an extension of the comment period to allow for additional comments. DEA Response: DEA acknowledges that commenters could not submit electronic comments to the notice for two weeks. However, written comments could be submitted via mail to the address provided in the notice. Written comments that were postmarked on or before October 4, 2021, were considered in this final order. DEA notes that one commenter submitted identical electronic and written comments both of which were timely postmarked, received, and considered for this final order. Out of Scope Comments: DEA received comments on issues outside the scope of this final order. Commenters made several suggestions to the DEA, including: (1) Seeking assistance from indigenous communities to determine the amount of psychedelic substances that would be needed to conduct research; (2) making the United States a signatory to the Nagoya Protocol and the Convention on Biological Diversity; and (3) creating PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 diversified categories for production and research on psilocybin-containing fungi fruiting bodies/sclerotia/liquid culture similar to cannabis (flower), fruiting body extract (akin to cannabis extract), and psilocybin and psilocin separately as purified compounds (akin to delta-9-thc). Regarding this last suggestion, the commenter further suggested that the ‘‘same system should then be replicated in regards to lophophora/mescaline, as well as other plants, fungi and lifeforms, which produce these compounds being used in whole or closer to whole ways.’’ DEA received other comments that were general in nature and raised issues of specific medical illnesses and medical treatments. All of the issues raised are outside of the scope of this final order for 2021 and do not impact the original analysis involved in finalizing the 2021 APQ. Analysis for Final Adjusted 2021 Aggregate Production Quotas and Assessment of Annual Needs In determining the final adjusted 2021 APQ and AAN, DEA considered the above comments relevant to this final order for calendar year 2021, along with the factors set forth in 21 CFR 1303.13 and 21 CFR 1315.13, in accordance with 21 U.S.C. 826(a). DEA has also considered other relevant factors, including the 2020 year-end inventories, initial 2021 manufacturing and import quotas, 2021 export requirements, actual and projected 2021 sales, research and product development requirements, additional applications received, and the extent of any diversion of the controlled substance in the class. Based on all of the above, the Administrator is adjusting the 2021 APQ for the following: 3,4Methylenedioxymethamphetamine (MDMA), 4,4′-Dimethylaminorex, Dimethyltryptamine (DMT), Lisdexamfetamine, Methiopropamine, Psilocybin, Psilocyn, and Phenylacetone. This final order reflects those adjustments. Pursuant to the above, the Administrator hereby finalizes the 2021 APQ for the following schedule I and II controlled substances and the 2021 AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: E:\FR\FM\15NON1.SGM 15NON1 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices 63063 Final adjusted 2021 quotas Basic class (g) khammond on DSKJM1Z7X2PROD with NOTICES Schedule I 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine .................................................................................................................................................. 1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................ 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine .................................................................................................................................. 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................ 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ........................................................................................................................... 1-Benzylpiperazine .............................................................................................................................................................................. 1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................... 2’-fluoro 2-fluorofentanyl ...................................................................................................................................................................... 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) .......................................................................................................................... 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) ....................................................................................................................... 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) ......................................................................................................................... 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ..................................................................................................................... 2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ...................................................................................................................................... 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B; Cimbi-36) ...................... 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ........................................................................................................................ 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C; Cimbi-82) ..................... 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ............................................................................................................................. 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; Cimbi-5) ................................ 2,5-Dimethoxy-4-ethylamphetamine (DOET) ...................................................................................................................................... 2,5-Dimethoxy-4-n-propylthiophenethylamine ..................................................................................................................................... 2,5-Dimethoxyamphetamine (DMA) .................................................................................................................................................... 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) ............................................................................................................... 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ........................................................................................................ 3,4,5-Trimethoxyamphetamine ............................................................................................................................................................ 3,4-Methylenedioxyamphetamine (MDA) ............................................................................................................................................ 3,4-Methylenedioxymethamphetamine (MDMA) ................................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ............................................................................................................................. 3,4-Methylenedioxy-N-methylcathinone (methylone) .......................................................................................................................... 3,4-Methylenedioxypyrovalerone (MDPV) ........................................................................................................................................... 3–FMC; 3-Fluoro-N-methylcathinone .................................................................................................................................................. 3-Methylfentanyl ................................................................................................................................................................................... 3-Methylthiofentanyl ............................................................................................................................................................................. 4′-Methyl acetyl fentanyl ...................................................................................................................................................................... 4,4’-Dimethylaminorex ......................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ................................................................................................................................. 4-Chloro-a-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ............................................................................................................... 4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ........................................................... 4F–MDMB–BINACA ............................................................................................................................................................................ 4-Fluoroisobutyryl fentanyl ................................................................................................................................................................... 4–FMC; Flephedrone ........................................................................................................................................................................... 4–MEC; 4-Methyl-N-ethylcathinone ..................................................................................................................................................... 4-Methoxyamphetamine ...................................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (DOM) ...................................................................................................................................... 4-Methylaminorex ................................................................................................................................................................................ 4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................ 4-Methyl-a-ethylaminopentiophenone (4–MEAP) ............................................................................................................................... 4-Methyl-a-pyrrolidinohexiophenone (MPHP) ..................................................................................................................................... 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ............................................................................................................................... 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ......................................................................................................... 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8-homolog) .......................... 5F–CUMYL–PINACA ........................................................................................................................................................................... 5F–EDMB–PINACA ............................................................................................................................................................................. 5F–MDMB–PICA ................................................................................................................................................................................. 5F–AB–PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .......................................... 5F–CUMYL–P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) ................................... 5F–ADB; 5F–MDMB–PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................... 5F–AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) .................................................................. 5F–APINACA; 5F–AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ....................................................... 5-Fluoro-PB–22; 5F–PB–22 ................................................................................................................................................................ 5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol- ...................................................................................................................... 3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .................................................................................................................................. 5-Methoxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine .................................................................................................................................................. 5-Methoxy-N,N-dimethyltryptamine ..................................................................................................................................................... AB–CHMINACA ................................................................................................................................................................................... AB–FUBINACA .................................................................................................................................................................................... VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1 20 30 10 30 30 25 10 15 30 30 30 30 30 100 30 30 25 30 30 25 25 25 30 30 30 55 3,200 40 40 35 25 30 30 30 30 30 25 25 25 30 30 25 25 150 25 25 45 25 25 25 50 40 25 25 25 25 25 30 30 30 20 25 25 25 35 30 50 63064 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices Final adjusted 2021 quotas Basic class khammond on DSKJM1Z7X2PROD with NOTICES (g) AB–PINACA ......................................................................................................................................................................................... ADB–FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ................................. Acetorphine .......................................................................................................................................................................................... Acetyl Fentanyl .................................................................................................................................................................................... Acetyl-alpha-methylfentanyl ................................................................................................................................................................. Acetyldihydrocodeine ........................................................................................................................................................................... Acetylmethadol .................................................................................................................................................................................... Acryl Fentanyl ...................................................................................................................................................................................... ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ..................................................... AH–7921 .............................................................................................................................................................................................. All other tetrahydrocannabinol ............................................................................................................................................................. Allylprodine .......................................................................................................................................................................................... Alphacetylmethadol .............................................................................................................................................................................. alpha-Ethyltryptamine .......................................................................................................................................................................... Alphameprodine ................................................................................................................................................................................... Alphamethadol ..................................................................................................................................................................................... Alphaprodine ........................................................................................................................................................................................ alpha-Methylfentanyl ............................................................................................................................................................................ alpha-Methylthiofentanyl ...................................................................................................................................................................... alpha-Methyltryptamine (AMT) ............................................................................................................................................................ alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. alpha-Pyrrolidinoheptaphenone (PV8) ................................................................................................................................................. alpha-Pyrrolidinohexanophenone (a-PHP) .......................................................................................................................................... alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ Aminorex .............................................................................................................................................................................................. Anileridine ............................................................................................................................................................................................ APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................................................... Benzethidine ........................................................................................................................................................................................ Benzylmorphine ................................................................................................................................................................................... Betacetylmethadol ............................................................................................................................................................................... beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................ beta-Hydroxyfentanyl ........................................................................................................................................................................... beta-Hydroxythiofentanyl ..................................................................................................................................................................... beta-Methyl fentanyl ............................................................................................................................................................................ beta-Phenyl fentanyl ............................................................................................................................................................................ Betameprodine ..................................................................................................................................................................................... Betamethadol ....................................................................................................................................................................................... Betaprodine .......................................................................................................................................................................................... Brorphine ............................................................................................................................................................................................. Bufotenine ............................................................................................................................................................................................ Butylone ............................................................................................................................................................................................... Butyryl fentanyl .................................................................................................................................................................................... Cathinone ............................................................................................................................................................................................. Clonitazene .......................................................................................................................................................................................... Codeine methylbromide ....................................................................................................................................................................... Codeine-N-oxide .................................................................................................................................................................................. Cyclopentyl Fentanyl ........................................................................................................................................................................... Cyclopropyl Fentanyl ........................................................................................................................................................................... Cyprenorphine ..................................................................................................................................................................................... d-9–THC .............................................................................................................................................................................................. Desomorphine ...................................................................................................................................................................................... Dextromoramide .................................................................................................................................................................................. Diapromide ........................................................................................................................................................................................... Diethylthiambutene .............................................................................................................................................................................. Diethyltryptamine ................................................................................................................................................................................. Difenoxin .............................................................................................................................................................................................. Dihydromorphine .................................................................................................................................................................................. Dimenoxadol ........................................................................................................................................................................................ Dimepheptanol ..................................................................................................................................................................................... Dimethylthiambutene ........................................................................................................................................................................... Dimethyltryptamine .............................................................................................................................................................................. Dioxyaphetyl butyrate .......................................................................................................................................................................... Dipipanone ........................................................................................................................................................................................... Drotebanol ........................................................................................................................................................................................... Ethylmethylthiambutene ....................................................................................................................................................................... Etorphine .............................................................................................................................................................................................. Etoxeridine ........................................................................................................................................................................................... Fenethylline .......................................................................................................................................................................................... Fentanyl carbamate ............................................................................................................................................................................. Fentanyl related substances ................................................................................................................................................................ VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1 30 30 25 100 30 30 25 25 50 30 1,000 25 25 25 25 25 25 30 30 25 25 25 25 25 25 20 25 25 30 25 30 30 30 30 30 25 4 25 30 15 25 30 40 25 30 192 30 20 25 384,460 25 25 20 20 25 9,200 753,500 25 25 20 3,200 25 25 25 25 30 25 30 30 600 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices 63065 Final adjusted 2021 quotas Basic class khammond on DSKJM1Z7X2PROD with NOTICES (g) FUB–144 .............................................................................................................................................................................................. FUB–AKB48 ......................................................................................................................................................................................... FUB–AMB, MMB-Fubinaca, AMB-Fubinaca ....................................................................................................................................... Furanyl fentanyl ................................................................................................................................................................................... Furethidine ........................................................................................................................................................................................... gamma-Hydroxybutyric acid ................................................................................................................................................................ Heroin .................................................................................................................................................................................................. Hydromorphinol .................................................................................................................................................................................... Hydroxypethidine ................................................................................................................................................................................. Ibogaine ............................................................................................................................................................................................... Isobutyryl Fentanyl ............................................................................................................................................................................... JWH–018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) ..................................................................................................................... JWH–019 (1-Hexyl-3-(1-naphthoyl)indole) .......................................................................................................................................... JWH–073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................................... JWH–081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ...................................................................................................................... JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) .......................................................................................................................... JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) .............................................................................................................. JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ........................................................................................................................... JWH–250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ....................................................................................................................... JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ........................................................................................................................... Ketobemidone ...................................................................................................................................................................................... Levomoramide ..................................................................................................................................................................................... Levophenacylmorphan ......................................................................................................................................................................... Lysergic acid diethylamide (LSD) ........................................................................................................................................................ MAB–CHMINACA; ADB–CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3carboxamide) .................................................................................................................................................................................... MDMB–CHMICA; MMB–CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............... MDMB–FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) .......................................... MMB–CHMICA-(AMB–CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................ Marihuana ............................................................................................................................................................................................ Marihuana extract ................................................................................................................................................................................ Mecloqualone ....................................................................................................................................................................................... Mescaline ............................................................................................................................................................................................. Methaqualone ...................................................................................................................................................................................... Methcathinone ..................................................................................................................................................................................... Methiopropamine ................................................................................................................................................................................. Methyoxyacetyl fentanyl ...................................................................................................................................................................... Methyldesorphine ................................................................................................................................................................................. Methyldihydromorphine ........................................................................................................................................................................ Morpheridine ........................................................................................................................................................................................ Morphine methylbromide ..................................................................................................................................................................... Morphine methylsulfonate .................................................................................................................................................................... Morphine-N-oxide ................................................................................................................................................................................ MT–45 .................................................................................................................................................................................................. Myrophine ............................................................................................................................................................................................ NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ................................................................................................ N,N-Dimethylamphetamine .................................................................................................................................................................. Naphyrone ........................................................................................................................................................................................... N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................ N-Ethylamphetamine ........................................................................................................................................................................... N-Ethylhexedrone ................................................................................................................................................................................ N-Ethylpentylone, ephylone ................................................................................................................................................................. N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... N-Methyl-3-Piperidyl Benzilate ............................................................................................................................................................ Nicocodeine ......................................................................................................................................................................................... Nicomorphine ....................................................................................................................................................................................... Noracymethadol ................................................................................................................................................................................... Norlevorphanol ..................................................................................................................................................................................... Normethadone ..................................................................................................................................................................................... Normorphine ........................................................................................................................................................................................ Norpipanone ........................................................................................................................................................................................ Ocfentanil ............................................................................................................................................................................................. Ortho-fluorofentanyl, 2-fluorofentanyl .................................................................................................................................................. ortho-Fluoroacryl fentanyl .................................................................................................................................................................... ortho-Fluorobutyryl fentanyl ................................................................................................................................................................. ortho-Fluoroisobutyryl fentanyl ............................................................................................................................................................ ortho-Methyl acetylfentanyl .................................................................................................................................................................. ortho-Methyl methoxyacetyl fentanyl ................................................................................................................................................... Para-chloroisobutyryl fentanyl ............................................................................................................................................................. VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 PO 00000 Frm 00082 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1 25 25 25 30 25 29,417,000 45 40 25 30 25 35 45 45 30 30 35 30 30 30 30 25 25 40 30 30 30 25 2,000,000 500,000 30 25 60 25 30 30 5 25 25 5 5 150 30 25 25 25 25 25 10 24 25 30 24 30 25 25 25 2,550 25 40 25 25 30 30 30 30 30 30 30 63066 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices Final adjusted 2021 quotas Basic class (g) Para-fluorofentanyl ............................................................................................................................................................................... Para-fluorobutyryl fentanyl ................................................................................................................................................................... para-Fluoro furanyl fentanyl ................................................................................................................................................................. para-Methylfentanyl ............................................................................................................................................................................. Para-methoxybutyryl fentanyl .............................................................................................................................................................. Parahexyl ............................................................................................................................................................................................. PB–22; QUPIC ..................................................................................................................................................................................... Pentedrone .......................................................................................................................................................................................... Pentylone ............................................................................................................................................................................................. Phenadoxone ....................................................................................................................................................................................... Phenampromide ................................................................................................................................................................................... Phenomorphan .................................................................................................................................................................................... Phenoperidine ...................................................................................................................................................................................... Phenyl fentanyl .................................................................................................................................................................................... Pholcodine ........................................................................................................................................................................................... Piritramide ............................................................................................................................................................................................ Proheptazine ........................................................................................................................................................................................ Properidine ........................................................................................................................................................................................... Propiram .............................................................................................................................................................................................. Psilocybin ............................................................................................................................................................................................. Psilocyn ................................................................................................................................................................................................ Racemoramide ..................................................................................................................................................................................... SR–18 and RCS–8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ......................................................................................... SR–19 and RCS–4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ............................................................................................................ Tetrahydrofuranyl fentanyl ................................................................................................................................................................... Thebacon ............................................................................................................................................................................................. Thiafentanil .......................................................................................................................................................................................... Thiofentanyl ......................................................................................................................................................................................... Thiofuranyl fentanyl ............................................................................................................................................................................. THJ–2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) .................................................................................... Tilidine .................................................................................................................................................................................................. Trimeperidine ....................................................................................................................................................................................... UR–144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ..................................................................................... U–47700 .............................................................................................................................................................................................. Valeryl fentanyl .................................................................................................................................................................................... 25 25 30 30 30 5 20 25 25 25 25 25 25 30 5 25 25 25 25 6,000 3,500 25 45 30 15 25 25 25 30 30 25 25 25 30 25 khammond on DSKJM1Z7X2PROD with NOTICES Schedule II 1-Phenylcyclohexylamine .................................................................................................................................................................... 1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... Alfentanil .............................................................................................................................................................................................. Alphaprodine ........................................................................................................................................................................................ Amobarbital .......................................................................................................................................................................................... Bezitramide .......................................................................................................................................................................................... Carfentanil ............................................................................................................................................................................................ Cocaine ................................................................................................................................................................................................ Codeine (for conversion) ..................................................................................................................................................................... Codeine (for sale) ................................................................................................................................................................................ D-amphetamine (for sale) .................................................................................................................................................................... D,l-amphetamine .................................................................................................................................................................................. D-amphetamine (for conversion) ......................................................................................................................................................... Dextropropoxyphene ............................................................................................................................................................................ Dihydrocodeine .................................................................................................................................................................................... Dihydroetorphine .................................................................................................................................................................................. Diphenoxylate (for conversion) ............................................................................................................................................................ Diphenoxylate (for sale) ....................................................................................................................................................................... Ecgonine .............................................................................................................................................................................................. Ethylmorphine ...................................................................................................................................................................................... Etorphine hydrochloride ....................................................................................................................................................................... Fentanyl ............................................................................................................................................................................................... Glutethimide ......................................................................................................................................................................................... Hydrocodone (for conversion) ............................................................................................................................................................. Hydrocodone (for sale) ........................................................................................................................................................................ Hydromorphone ................................................................................................................................................................................... Isomethadone ...................................................................................................................................................................................... L-amphetamine .................................................................................................................................................................................... Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ Levomethorphan .................................................................................................................................................................................. Levorphanol ......................................................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................................................ VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\15NON1.SGM 15NON1 15 25 937,758 3,260 25 20,100 25 20 68,576 1,612,500 27,616,684 21,200,000 21,200,000 16,068,789 35 156,713 25 14,100 770,800 68,576 30 32 731,452 25 1,250 30,821,224 2,743,101 30 30 25 30 26,495 22,500,000 Federal Register / Vol. 86, No. 217 / Monday, November 15, 2021 / Notices 63067 Final adjusted 2021 quotas Basic class (g) L-methamphetamine ............................................................................................................................................................................ Meperidine ........................................................................................................................................................................................... Meperidine Intermediate-A .................................................................................................................................................................. Meperidine Intermediate-B .................................................................................................................................................................. Meperidine Intermediate-C .................................................................................................................................................................. Metazocine ........................................................................................................................................................................................... Methadone (for sale) ........................................................................................................................................................................... Methadone Intermediate ...................................................................................................................................................................... Methamphetamine ............................................................................................................................................................................... D-methamphetamine (for conversion) ................................................................................................................................................. D-methamphetamine (for sale) ............................................................................................................................................................ Methylphenidate (for conversion) ........................................................................................................................................................ Methylphenidate (for sale) ................................................................................................................................................................... Metopon ............................................................................................................................................................................................... Moramide-intermediate ........................................................................................................................................................................ Morphine (for conversion) .................................................................................................................................................................... Morphine (for sale) .............................................................................................................................................................................. Nabilone ............................................................................................................................................................................................... Norfentanyl ........................................................................................................................................................................................... Noroxymorphone (for conversion) ....................................................................................................................................................... Noroxymorphone (for sale) .................................................................................................................................................................. Oliceridine ............................................................................................................................................................................................ Opium (powder) ................................................................................................................................................................................... Opium (tincture) ................................................................................................................................................................................... Oripavine .............................................................................................................................................................................................. Oxycodone (for conversion) ................................................................................................................................................................ Oxycodone (for sale) ........................................................................................................................................................................... Oxymorphone (for conversion) ............................................................................................................................................................ Oxymorphone (for sale) ....................................................................................................................................................................... Pentobarbital ........................................................................................................................................................................................ Phenazocine ........................................................................................................................................................................................ Phencyclidine ....................................................................................................................................................................................... Phenmetrazine ..................................................................................................................................................................................... Phenylacetone ..................................................................................................................................................................................... Piminodine ........................................................................................................................................................................................... Racemethorphan ................................................................................................................................................................................. Racemorphan ...................................................................................................................................................................................... Remifentanil ......................................................................................................................................................................................... Secobarbital ......................................................................................................................................................................................... Sufentanil ............................................................................................................................................................................................. Tapentadol ........................................................................................................................................................................................... Thebaine .............................................................................................................................................................................................. 587,229 856,695 30 30 30 15 25,619,700 27,673,600 50 485,020 40,000 15,300,000 57,438,334 25 25 3,376,696 26,505,995 62,000 25 22,044,741 376,000 22,500 250,000 530,837 33,010,750 620,887 57,110,032 28,204,371 563,174 30,766,670 25 35 25 6,100,000 25 5 5 3,000 172,100 4,000 13,447,541 57,137,944 List I Chemicals Ephedrine (for conversion) .................................................................................................................................................................. Ephedrine (for sale) ............................................................................................................................................................................. Phenylpropanolamine (for conversion) ................................................................................................................................................ Phenylpropanolamine (for sale) ........................................................................................................................................................... Pseudoephedrine (for conversion) ...................................................................................................................................................... Pseudoephedrine (for sale) ................................................................................................................................................................. khammond on DSKJM1Z7X2PROD with NOTICES The Administrator further proposes that APQ for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. Anne Milgram, Administrator. [FR Doc. 2021–24921 Filed 11–10–21; 4:15 pm] BILLING CODE 4410–09–P [OMB Number 1117–0034] Agency Information Collection Activities; Proposed eCollection, eComments Requested; Revision of a Currently Approved Collection; The National Forensic Laboratory Information System Collection of Analysis Data Drug Enforcement Administration, Department of Justice. ACTION: 30-Day Notice. AGENCY: VerDate Sep<11>2014 16:42 Nov 12, 2021 Jkt 256001 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the Federal Register at 86 FR 47523 on August 25, 2021, allowing for a 60 day comment period. No comments were received. SUMMARY: DEPARTMENT OF JUSTICE 100 4,136,000 14,878,320 16,690,000 1,000 174,246,000 E:\FR\FM\15NON1.SGM 15NON1

Agencies

[Federal Register Volume 86, Number 217 (Monday, November 15, 2021)]
[Notices]
[Pages 63061-63067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24921]


=======================================================================
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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-688F]


Final Adjusted Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Assessment of Annual Needs for the List I 
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2021

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This final order establishes the final adjusted 2021 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This order is effective November 15, 2021.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Legal Authority

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) 
requires the Attorney General to establish aggregate production quotas 
(APQ) for each basic class of controlled substances listed in schedules 
I and II and for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. The Attorney General has delegated this function 
to the Administrator of the Drug Enforcement Administration (DEA) 
pursuant to 28 CFR 0.100.

Background

    DEA published the 2021 established APQ for controlled substances in 
schedules I and II and for the assessment of annual needs (AAN) for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in 
the Federal Register on November 30, 2020. 85 FR 76604. DEA is 
committed to preventing and limiting diversion by enforcing laws and 
regulations regarding controlled substances and the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, while meeting the 
legitimate medical, scientific, and export needs of the United States. 
This notice stated that the Administrator would adjust, as needed, the 
established APQ in 2021 in accordance with 21 CFR 1303.13 and 21 CFR 
1315.13.
    The 2021 proposed adjusted APQ for controlled substances in 
schedules I and II and AAN for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine were subsequently published in 
the Federal Register on September 2, 2021, (86 FR 49346), after 
consideration of the criteria outlined in that notice. All interested 
persons were invited to comment on or object to the proposed APQs and 
AANs on or before October 4, 2021.

Comments Received

    DEA received 27 timely comments in response to the September 
Federal Register notice from patients, DEA-registered entities, and 
non-DEA entities. The comments included appreciation of DEA's response 
to the increased interest in research using hallucinogenic controlled 
substances, requests to increase the APQ for additional hallucinogenic 
controlled substances, requests to increase the APQ for select schedule 
II controlled substances, concerns regarding the inability to comment 
to the notice electronically for two weeks, and comments outside the 
scope of this final order.
    Issue: Commenters expressed appreciation of DEA's flexibility in 
responding to the nationwide public interest in hallucinogenic 
controlled substances research.
    DEA Response: DEA acknowledges the expressions of appreciation to 
changes in the APQ for these controlled substances. The adjustments to 
select hallucinogenic schedule I controlled substances occurred after 
DEA received additional schedule I researcher protocols from DEA 
registered researchers and quota applications from DEA registered 
manufacturers.
    Issue: Commenters requested DEA to increase the APQ for Bufotenine, 
Dimethyltryptamine (DMT), N,N-Dimethyltryptamine, 5-Methoxy-N,N-

[[Page 63062]]

dimethyltryptamine (5MEODMT), Ibogaine, Ketamine, Lysergic Acid 
Diethylamide (LSD), 3,4-Methylenedioxymethamphetamine (MDMA), 
Mescaline, Mitragynine, and Psilocybin in response to the nationwide 
public interest in hallucinogenic controlled substances research.
    DEA Response: Ketamine is a schedule III controlled substance and 
therefore is outside of the scope of this final order as DEA only sets 
APQs for substances controlled in schedules I and II. DEA received 
additional quota applications for DMT, MDMA, and Psilocybin and 
considered the timely provided information in those applications for 
this final order. Regarding the other controlled substances listed, DEA 
has not received quota applications from DEA-registered manufacturers 
to support the requested changes in the APQ for these controlled 
substances. Mitragynine is not a controlled substance and therefore is 
outside the scope of this final order.
    Issue: DEA-registered entities requested that the APQ for 
Methadone, Methadone Intermediate, Methylphenidate Oxycodone (for 
sale), Phenylacetone, and Thebaine be sufficient to provide for the 
estimated medical, scientific, research, and industrial needs of the 
United States, for export requirements, and for the establishment and 
maintenance of reserve stocks.
    DEA Response: DEA sets APQ in a manner to ensure that the estimated 
medical, scientific, research, industrial needs of the United States, 
lawful export requirements, and for the establishment and maintenance 
of reserve stocks. As discussed in the notice for adjustment, any 
adjustments to the APQ for a controlled substance are based on factors 
set forth in 21 CFR 1303.13. In the event of a shortage, the CSA 
provides a mechanism under which DEA will, in appropriate 
circumstances, increase quotas to address shortages. 21 U.S.C. 826(h). 
Under 21 U.S.C. 826(h)(1), after receiving a request to address a 
shortage, DEA has 30 days to complete review of the request and 
determine whether adjustments are necessary to address the shortage. If 
adjustments are necessary, DEA is required to increase the APQ and 
individual production quotas to alleviate the shortage. Id. If DEA 
determines adjustments are not necessary, DEA is required to ``provide 
a written response detailing the basis for the . . . determination.'' 
Id. In addition to what Section 826(h)(1) requires, when DEA is 
notified of an alleged shortage, DEA will confer with the Food and Drug 
Administration and relevant manufacturers regarding the amount of 
material in physical inventory, current quota granted, and the 
estimated legitimate medical need, to determine whether a quota 
adjustment is necessary to alleviate any quota-related drug shortage.
    In accordance with 21 CFR 1303.13, DEA considered the comments for 
Bufotenine, 5-Methoxy-N,N-dimethyltryptamine (5MEODMT), Ibogaine, 
Lysergic Acid Diethylamide (LSD), Mescaline, Methadone, Methadone 
Intermediate, Oxycodone (for sale), and Thebaine and the Administrator 
determined the proposed adjusted 2021 APQs for these substances as 
published in the Federal Register on September 2, 2021, (86 FR 49346), 
are sufficient to meet the current 2021 estimated medical, scientific, 
research, and industrial needs of the United States, lawful export 
requirements, and to provide for adequate reserve stock.
    Issue: Commenters expressed general concerns regarding the 
inability to submit electronic comments to the notice published on 
September 2, 2021, for two weeks. Commenters requested an extension of 
the comment period to allow for additional comments.
    DEA Response: DEA acknowledges that commenters could not submit 
electronic comments to the notice for two weeks. However, written 
comments could be submitted via mail to the address provided in the 
notice. Written comments that were postmarked on or before October 4, 
2021, were considered in this final order. DEA notes that one commenter 
submitted identical electronic and written comments both of which were 
timely postmarked, received, and considered for this final order.
    Out of Scope Comments: DEA received comments on issues outside the 
scope of this final order. Commenters made several suggestions to the 
DEA, including: (1) Seeking assistance from indigenous communities to 
determine the amount of psychedelic substances that would be needed to 
conduct research; (2) making the United States a signatory to the 
Nagoya Protocol and the Convention on Biological Diversity; and (3) 
creating diversified categories for production and research on 
psilocybin-containing fungi fruiting bodies/sclerotia/liquid culture 
similar to cannabis (flower), fruiting body extract (akin to cannabis 
extract), and psilocybin and psilocin separately as purified compounds 
(akin to delta-9-thc). Regarding this last suggestion, the commenter 
further suggested that the ``same system should then be replicated in 
regards to lophophora/mescaline, as well as other plants, fungi and 
lifeforms, which produce these compounds being used in whole or closer 
to whole ways.''
    DEA received other comments that were general in nature and raised 
issues of specific medical illnesses and medical treatments. All of the 
issues raised are outside of the scope of this final order for 2021 and 
do not impact the original analysis involved in finalizing the 2021 
APQ.

Analysis for Final Adjusted 2021 Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the final adjusted 2021 APQ and AAN, DEA considered 
the above comments relevant to this final order for calendar year 2021, 
along with the factors set forth in 21 CFR 1303.13 and 21 CFR 1315.13, 
in accordance with 21 U.S.C. 826(a). DEA has also considered other 
relevant factors, including the 2020 year-end inventories, initial 2021 
manufacturing and import quotas, 2021 export requirements, actual and 
projected 2021 sales, research and product development requirements, 
additional applications received, and the extent of any diversion of 
the controlled substance in the class. Based on all of the above, the 
Administrator is adjusting the 2021 APQ for the following: 3,4-
Methylenedioxymethamphetamine (MDMA), 4,4'-Dimethylaminorex, 
Dimethyltryptamine (DMT), Lisdexamfetamine, Methiopropamine, 
Psilocybin, Psilocyn, and Phenylacetone. This final order reflects 
those adjustments.
    Pursuant to the above, the Administrator hereby finalizes the 2021 
APQ for the following schedule I and II controlled substances and the 
2021 AAN for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, expressed in grams of anhydrous acid or base, as 
follows:

[[Page 63063]]



------------------------------------------------------------------------
                                                          Final adjusted
                                                            2021 quotas
                       Basic class                       ---------------
                                                                (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine..................              20
1-(1-Phenylcyclohexyl)pyrrolidine.......................              30
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine..........              10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......              30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)......              30
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................              10
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
2'-fluoro 2-fluorofentanyl..............................              30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........              30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).......              30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).......              30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).....              30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................             100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).......              30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).........              30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET).................              25
2,5-Dimethoxy-4-n-propylthiophenethylamine..............              25
2,5-Dimethoxyamphetamine (DMA)..........................              25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)              30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 T-4)...................................................
3,4,5-Trimethoxyamphetamine.............................              30
3,4-Methylenedioxyamphetamine (MDA).....................              55
3,4-Methylenedioxymethamphetamine (MDMA)................           3,200
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............              40
3,4-Methylenedioxy-N-methylcathinone (methylone)........              40
3,4-Methylenedioxypyrovalerone (MDPV)...................              35
3-FMC; 3-Fluoro-N-methylcathinone.......................              25
3-Methylfentanyl........................................              30
3-Methylthiofentanyl....................................              30
4'-Methyl acetyl fentanyl...............................              30
4,4'-Dimethylaminorex...................................              30
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................              30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............              25
4-Chloro-[alpha]-pyrrolidinovalerophenone (4-chloro-                  25
 alpha-PVP).............................................
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-             25
 yl)-1H-indazole-3-carboximide..........................
4F-MDMB-BINACA..........................................              30
4-Fluoroisobutyryl fentanyl.............................              30
4-FMC; Flephedrone......................................              25
4-MEC; 4-Methyl-N-ethylcathinone........................              25
4-Methoxyamphetamine....................................             150
4-Methyl-2,5-dimethoxyamphetamine (DOM).................              25
4-Methylaminorex........................................              25
4-Methyl-N-methylcathinone (mephedrone).................              45
4-Methyl-[alpha]-ethylaminopentiophenone (4-MEAP).......              25
4-Methyl-[alpha]-pyrrolidinohexiophenone (MPHP).........              25
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).....              25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)...
5F-CUMYL-PINACA.........................................              25
5F-EDMB-PINACA..........................................              25
5F-MDMB-PICA............................................              25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-              25
 fluoropentyl)-1H-indazole-3-carboxamide................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-             25
 yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)...........
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              30
 indazole-3-carboxamido)-3,3-dimethylbutanoate).........
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate)........................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide)...............
5-Fluoro-PB-22; 5F-PB-22................................              20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1H-indol-...              25
3-yl](2,2,3,3-tetramethylcyclopropyl)methanone..........
5-Methoxy-3,4-methylenedioxyamphetamine.................              25
5-Methoxy-N,N-diisopropyltryptamine.....................              25
5-Methoxy-N,N-dimethyltryptamine........................              35
AB-CHMINACA.............................................              30
AB-FUBINACA.............................................              50

[[Page 63064]]

 
AB-PINACA...............................................              30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetorphine.............................................              25
Acetyl Fentanyl.........................................             100
Acetyl-alpha-methylfentanyl.............................              30
Acetyldihydrocodeine....................................              30
Acetylmethadol..........................................              25
Acryl Fentanyl..........................................              25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide)......................
AH-7921.................................................              30
All other tetrahydrocannabinol..........................           1,000
Allylprodine............................................              25
Alphacetylmethadol......................................              25
alpha-Ethyltryptamine...................................              25
Alphameprodine..........................................              25
Alphamethadol...........................................              25
Alphaprodine............................................              25
alpha-Methylfentanyl....................................              30
alpha-Methylthiofentanyl................................              30
alpha-Methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinoheptaphenone (PV8).....................              25
alpha-Pyrrolidinohexanophenone ([alpha]-PHP)............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Aminorex................................................              25
Anileridine.............................................              20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)...........................................
Benzethidine............................................              25
Benzylmorphine..........................................              30
Betacetylmethadol.......................................              25
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30
beta-Methyl fentanyl....................................              30
beta-Phenyl fentanyl....................................              30
Betameprodine...........................................              25
Betamethadol............................................               4
Betaprodine.............................................              25
Brorphine...............................................              30
Bufotenine..............................................              15
Butylone................................................              25
Butyryl fentanyl........................................              30
Cathinone...............................................              40
Clonitazene.............................................              25
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Cyclopentyl Fentanyl....................................              30
Cyclopropyl Fentanyl....................................              20
Cyprenorphine...........................................              25
d-9-THC.................................................         384,460
Desomorphine............................................              25
Dextromoramide..........................................              25
Diapromide..............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           9,200
Dihydromorphine.........................................         753,500
Dimenoxadol.............................................              25
Dimepheptanol...........................................              25
Dimethylthiambutene.....................................              20
Dimethyltryptamine......................................           3,200
Dioxyaphetyl butyrate...................................              25
Dipipanone..............................................              25
Drotebanol..............................................              25
Ethylmethylthiambutene..................................              25
Etorphine...............................................              30
Etoxeridine.............................................              25
Fenethylline............................................              30
Fentanyl carbamate......................................              30
Fentanyl related substances.............................             600

[[Page 63065]]

 
FUB-144.................................................              25
FUB-AKB48...............................................              25
FUB-AMB, MMB-Fubinaca, AMB-Fubinaca.....................              25
Furanyl fentanyl........................................              30
Furethidine.............................................              25
gamma-Hydroxybutyric acid...............................      29,417,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................              25
Ibogaine................................................              30
Isobutyryl Fentanyl.....................................              25
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)......              35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).................              45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).................              45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole).....              30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole).......              30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-                             35
 naphthoyl)indole)......................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole).......              30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)......              30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole).......              30
Ketobemidone............................................              30
Levomoramide............................................              25
Levophenacylmorphan.....................................              25
Lysergic acid diethylamide (LSD)........................              40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-             30
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-              25
 1H-indole-3-carboxamido)-3-methylbutanoate.............
Marihuana...............................................       2,000,000
Marihuana extract.......................................         500,000
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methiopropamine.........................................              30
Methyoxyacetyl fentanyl.................................              30
Methyldesorphine........................................               5
Methyldihydromorphine...................................              25
Morpheridine............................................              25
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
MT-45...................................................              30
Myrophine...............................................              25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-               25
 carboxylate............................................
N,N-Dimethylamphetamine.................................              25
Naphyrone...............................................              25
N-Ethyl-1-phenylcyclohexylamine.........................              25
N-Ethyl-3-piperidyl benzilate...........................              10
N-Ethylamphetamine......................................              24
N-Ethylhexedrone........................................              25
N-Ethylpentylone, ephylone..............................              30
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
N-Methyl-3-Piperidyl Benzilate..........................              30
Nicocodeine.............................................              25
Nicomorphine............................................              25
Noracymethadol..........................................              25
Norlevorphanol..........................................           2,550
Normethadone............................................              25
Normorphine.............................................              40
Norpipanone.............................................              25
Ocfentanil..............................................              25
Ortho-fluorofentanyl, 2-fluorofentanyl..................              30
ortho-Fluoroacryl fentanyl..............................              30
ortho-Fluorobutyryl fentanyl............................              30
ortho-Fluoroisobutyryl fentanyl.........................              30
ortho-Methyl acetylfentanyl.............................              30
ortho-Methyl methoxyacetyl fentanyl.....................              30
Para-chloroisobutyryl fentanyl..........................              30

[[Page 63066]]

 
Para-fluorofentanyl.....................................              25
Para-fluorobutyryl fentanyl.............................              25
para-Fluoro furanyl fentanyl............................              30
para-Methylfentanyl.....................................              30
Para-methoxybutyryl fentanyl............................              30
Parahexyl...............................................               5
PB-22; QUPIC............................................              20
Pentedrone..............................................              25
Pentylone...............................................              25
Phenadoxone.............................................              25
Phenampromide...........................................              25
Phenomorphan............................................              25
Phenoperidine...........................................              25
Phenyl fentanyl.........................................              30
Pholcodine..............................................               5
Piritramide.............................................              25
Proheptazine............................................              25
Properidine.............................................              25
Propiram................................................              25
Psilocybin..............................................           6,000
Psilocyn................................................           3,500
Racemoramide............................................              25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)              30
Tetrahydrofuranyl fentanyl..............................              15
Thebacon................................................              25
Thiafentanil............................................              25
Thiofentanyl............................................              25
Thiofuranyl fentanyl....................................              30
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone).........................
Tilidine................................................              25
Trimeperidine...........................................              25
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone.......................
U-47700.................................................              30
Valeryl fentanyl........................................              25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              15
1-Piperidinocyclohexanecarbonitrile.....................              25
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............         937,758
Alfentanil..............................................           3,260
Alphaprodine............................................              25
Amobarbital.............................................          20,100
Bezitramide.............................................              25
Carfentanil.............................................              20
Cocaine.................................................          68,576
Codeine (for conversion)................................       1,612,500
Codeine (for sale)......................................      27,616,684
D-amphetamine (for sale)................................      21,200,000
D,l-amphetamine.........................................      21,200,000
D-amphetamine (for conversion)..........................      16,068,789
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         156,713
Dihydroetorphine........................................              25
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          68,576
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................         731,452
Glutethimide............................................              25
Hydrocodone (for conversion)............................           1,250
Hydrocodone (for sale)..................................      30,821,224
Hydromorphone...........................................       2,743,101
Isomethadone............................................              30
L-amphetamine...........................................              30
Levo-alphacetylmethadol (LAAM)..........................              25
Levomethorphan..........................................              30
Levorphanol.............................................          26,495
Lisdexamfetamine........................................      22,500,000

[[Page 63067]]

 
L-methamphetamine.......................................         587,229
Meperidine..............................................         856,695
Meperidine Intermediate-A...............................              30
Meperidine Intermediate-B...............................              30
Meperidine Intermediate-C...............................              30
Metazocine..............................................              15
Methadone (for sale)....................................      25,619,700
Methadone Intermediate..................................      27,673,600
Methamphetamine.........................................              50
D-methamphetamine (for conversion)......................         485,020
D-methamphetamine (for sale)............................          40,000
Methylphenidate (for conversion)........................      15,300,000
Methylphenidate (for sale)..............................      57,438,334
Metopon.................................................              25
Moramide-intermediate...................................              25
Morphine (for conversion)...............................       3,376,696
Morphine (for sale).....................................      26,505,995
Nabilone................................................          62,000
Norfentanyl.............................................              25
Noroxymorphone (for conversion).........................      22,044,741
Noroxymorphone (for sale)...............................         376,000
Oliceridine.............................................          22,500
Opium (powder)..........................................         250,000
Opium (tincture)........................................         530,837
Oripavine...............................................      33,010,750
Oxycodone (for conversion)..............................         620,887
Oxycodone (for sale)....................................      57,110,032
Oxymorphone (for conversion)............................      28,204,371
Oxymorphone (for sale)..................................         563,174
Pentobarbital...........................................      30,766,670
Phenazocine.............................................              25
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................       6,100,000
Piminodine..............................................              25
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           3,000
Secobarbital............................................         172,100
Sufentanil..............................................           4,000
Tapentadol..............................................      13,447,541
Thebaine................................................      57,137,944
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................             100
Ephedrine (for sale)....................................       4,136,000
Phenylpropanolamine (for conversion)....................      14,878,320
Phenylpropanolamine (for sale)..........................      16,690,000
Pseudoephedrine (for conversion)........................           1,000
Pseudoephedrine (for sale)..............................     174,246,000
------------------------------------------------------------------------

    The Administrator further proposes that APQ for all other schedule 
I and II controlled substances included in 21 CFR 1308.11 and 1308.12 
remain at zero.

Anne Milgram,
Administrator.
[FR Doc. 2021-24921 Filed 11-10-21; 4:15 pm]
BILLING CODE 4410-09-P
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