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 2018, 63533-63538 [2018-26587]

Download as PDF Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices Accordingly, effective October 18, 2018, the Commission, pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)), instituted countervailing duty investigation Nos. 701–TA–612–613 and antidumping duty investigation Nos. 731–TA–1429– 1430 (Preliminary). Notice of the institution of the Commission’s investigations and of a public conference to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the Federal Register of October 25, 2018 (83 FR 53899). The conference was held in Washington, DC, on November 8, 2018, and all persons who requested the opportunity were permitted to appear in person or by counsel. The Commission made these determinations pursuant to sections 703(a) and 733(a) of the Act (19 U.S.C. 1671b(a) and 1673b(a)). It completed and filed its determinations in these investigations on December 3, 2018. The views of the Commission are contained in USITC Publication 4858 (December 2018), entitled Polyester Textured Yarn from China and India: Investigation Nos. 701–TA–612–613 and 731–TA– 1429–1430 (Preliminary). By order of the Commission. Issued: December 3, 2018. Lisa Barton, Secretary to the Commission. [FR Doc. 2018–26604 Filed 12–7–18; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–471A] 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 2018 Drug Enforcement Administration (DEA), Department of Justice (DOJ). ACTION: Final order. AGENCY: This final order establishes the final adjusted 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. SUMMARY: VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 This order is effective December 10, 2018. FOR FURTHER INFORMATION CONTACT: Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: DATES: Legal Authority Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas 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 The DEA published the 2018 established aggregate production quotas for controlled substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine in the Federal Register on November 8, 2017. 82 FR 51873. The 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, in order to meet the demand of legitimate medical, scientific, and export needs of the United States. This notice stated that the Administrator would adjust, as needed, the established aggregate production quotas in 2018 in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The 2018 proposed adjusted aggregate production quotas for controlled substances in schedules I and II and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine were subsequently published in the Federal Register on August 23, 2018, (83 FR 42690) in consideration of the outlined criteria. All interested persons were invited to comment on or object to the proposed adjusted aggregate production quotas and assessment of annual needs on or before September 24, 2018. Comments Received The DEA received 526 comments from doctors, nurses, veterinarians, nonprofit organizations, associations, PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 63533 patients, caregivers, DEA-registered entities, and non-DEA entities. The comments included concerns about drug shortages, interference with doctorpatient relationships, increase in the production of marihuana, requests for a hearing, requests for increases in specific production quotas, and comments that were outside the scope of this final order. There were 200 commenters that expressed general concerns about the decrease to the production quotas of controlled substances and shortages of controlled substances. There were 27 commenters that expressed general concerns alleging that decreases to the aggregate production quotas interfered with doctor-patient relationships. The DEA sets aggregate production quotas in a manner to ensure that the estimated medical needs of the United States are met. In determining the aggregate production quota, the DEA does take into account the prescriptions that have been issued. The DEA does not interfere with doctor-patient relationships. Doctors who are authorized to dispense controlled substances are responsible for adhering to the laws and regulations set forth under the CSA, which requires doctors to only write prescriptions for a legitimate medical need. The DEA is responsible for enforcing controlled substance laws and regulations. The DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet the demand of legitimate medical, scientific, and export needs of the United States. The decrease or increase in the aggregate production quota for controlled substances is based on factors set forth in 21 CFR 1303.13. In the event of a shortage, the CSA provides a mechanism under which the DEA will, in appropriate circumstances, increase quotas to address shortages. 21 U.S.C. 826(h). When DEA is notified of an alleged shortage, DEA will confer with the FDA 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 factually valid shortage. Four non-DEA registered entities expressed support to increase the production quota of marihuana for research purposes. The DEA increased the production quota for marihuana based solely on increased usage projections for federally approved research projects. Two non-DEA-registered individuals urged DEA to hold a public hearing in connection with their view that reducing quotas will not be effective in E:\FR\FM\10DEN1.SGM 10DEN1 63534 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices preventing the deaths and other harms associated with the opioid crisis in the United States. One of these individuals stated that the purpose of the hearing would be to obtain input from various medical professionals and patients. The second commenter expressed his view that reduction in quotas could lead to the under treatment of pain. Under the DEA regulations, the decision of whether to grant a hearing on the issues raised by the comments lies solely within the discretion of the Administrator. 21 CFR 1303.11(c) and 1303.13(c). I find that neither of the foregoing two comments, or any of the other comments, presented any evidence that would lead me to conclude that a hearing is necessary or warranted. Therefore, I decline to order a hearing on the issues presented by the comments. Five DEA-registered entities submitted comments regarding a total of 30 schedule I and II controlled substances. Comments received proposed that the aggregate production quotas for 3-methylfentanyl, 4–ANPP, acetyl fentanyl, acryl fentanyl, betahydroxythiofentanyl, butyryl fentanyl, carfentanil, cyclopentyl fentanyl, cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), fentanyl, fentanyl related substances, furanyl fentanyl, isobutyryl fentanyl, levorphanol, meperidine, methoxyacetyl fentanyl, noroxymorphone (for conversion), ocfentanil, oripavine, oxymorphone (for conversion), para-chloroisobutyryl fentanyl, para-fluorofentanyl, parafluorobutyryl fentanyl, paramethyoxybutyryl fentanyl, remifentanil, tetrahydrofuranyl fentanyl, U–47700, and valeryl fentanyl were insufficient 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. The DEA received 288 comments which addressed issues that are outside the scope of this final order. The comments were general in nature and raised issues of specific medical illnesses, medical treatments, and medication costs and therefore, are outside of the scope of this Final Order for 2018 and do not impact the original analysis involved in finalizing the 2018 aggregate production quotas. The DEA received no comments from DEA-registered or non-DEA registered entities for previously established values of the 2018 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. Analysis for Final Adjusted 2018 Aggregate Production Quotas and Assessment of Annual Needs In determining the final adjusted 2018 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments that are specifically relevant to this Final Order for calendar year 2018 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), and other relevant factors including the 2017 year-end inventories, initial 2018 manufacturing and import quotas, 2018 export requirements, actual and projected 2018 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 2018 aggregate production quotas for the following: Lower for codeine (for sale), hydrocodone (for sale), morphine (for sale), and oxycodone (for sale) based on the data received since the publication of the 2018 Proposed Revised Aggregate Production Quotas and Assessment of Annual Needs in the Federal Register on August 23, 2018, (83 FR 42690); higher for cyclopentyl fentanyl, fentanyl related substances, methoxyacetyl fentanyl, para-chloroisobutyryl fentanyl, and para-methyoxybutyryl fentanyl due to the publication of their schedule I temporary controlled status; higher for noroxymorphone (for conversion) and oripavine based on their involvement in the synthesis pathway to produce the FDA approved drugs used in the medically assisted treatment of opioid addiction. This final order reflects those adjustments. Regarding 3-methyl fentanyl, 4– ANPP, acetyl fentanyl, acryl fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), fentanyl, furanyl fentanyl, isobutyryl fentanyl, levorphanol, meperidine, ocfentanil, oxymorphone (for conversion), para-fluorofentanyl, parafluorobutyryl fentanyl, remifentanil, tetrahydrofuranyl fentanyl, U–47700, and valeryl fentanyl, the Administrator hereby determines that the proposed adjusted 2018 aggregate production quotas and assessment of annual needs for these substances and list I chemicals as published on August 23, 2018, (83 FR 42690) are sufficient to meet the current 2018 estimated medical, scientific, research, and industrial needs of the United States and to provide for adequate reserve stock. This final order establishes these aggregate production quotas at the same amounts as proposed. Pursuant to the above, the Administrator hereby finalizes the 2018 aggregate production quotas for the following schedule I and II controlled substances and the 2018 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Final revised 2018 quotas (g) Basic class Temporarily Scheduled Substances 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-carboxamide ............................................................................................ 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboxamide ........................................................................ Cyclopropyl Fentanyl ........................................................................................................................................................................... Cyclopentyl fentanyl ............................................................................................................................................................................. Fentanyl related substances ................................................................................................................................................................ Isobutyryl Fentanyl ............................................................................................................................................................................... Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate .................................................................................. Methoxyacetyl fentanyl ........................................................................................................................................................................ N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ...................................................................... Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ................................................................................................................ Ocfentanil ............................................................................................................................................................................................. Ortho-fluorofentanyl ............................................................................................................................................................................. Para-chloroisobutyryl fentanyl ............................................................................................................................................................. Para-fluorobutyryl fentanyl ................................................................................................................................................................... VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 25 25 20 30 40 25 25 30 25 25 25 30 30 25 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices 63535 Final revised 2018 quotas (g) Basic class Para-methoxybutyryl fentanyl .............................................................................................................................................................. Tetrahydrofuranyl fentanyl ................................................................................................................................................................... Valeryl fentanyl .................................................................................................................................................................................... 30 5 25 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 (AM–694) ......................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine ................................................................................................................................................... 1-Benzylpiperazine .............................................................................................................................................................................. 1-Methyl-4-phenyl-4-propionoxypiperidine ........................................................................................................................................... 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 ................................................................................................................................................................ 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-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 4-Bromo-2,5-dimethoxyphenethylamine (2C–B) ................................................................................................................................. 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-α-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-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-UR-144, XLR11 [1-(5-Fluoro-pentyl)-1Hindol-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 .................................................................................................................................................................................... AB–PINACA ......................................................................................................................................................................................... ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .................................. 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 .............................................................................................................................................................................................. Allylprodine .......................................................................................................................................................................................... Alphacetylmethadol .............................................................................................................................................................................. alpha-ethyltryptamine ........................................................................................................................................................................... VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 20 15 10 30 30 15 25 10 30 30 30 30 30 30 30 25 30 30 25 25 25 30 30 30 55 50 40 40 35 25 30 30 30 25 30 25 25 150 25 25 45 25 50 40 30 30 30 20 25 25 25 25 30 50 30 30 100 30 30 2 25 50 30 2 2 25 63536 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices Final revised 2018 quotas (g) Basic class Alphameprodine ................................................................................................................................................................................... Alphamethadol ..................................................................................................................................................................................... alpha-methylfentanyl ............................................................................................................................................................................ alpha-methylthiofentanyl ...................................................................................................................................................................... alpha-methyltryptamine (AMT) ............................................................................................................................................................ alpha-Pyrrolidinobutiophenone (α-PBP) .............................................................................................................................................. alpha-Pyrrolidinopentiophenone (α-PVP) ............................................................................................................................................ Aminorex .............................................................................................................................................................................................. Anileridine ............................................................................................................................................................................................ APINACA, AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ...................................................................................... Benzylmorphine ................................................................................................................................................................................... Betacetylmethadol ............................................................................................................................................................................... beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................ beta-Hydroxyfentanyl ........................................................................................................................................................................... beta-Hydroxythiofentanyl ..................................................................................................................................................................... Betameprodine ..................................................................................................................................................................................... Betamethadol ....................................................................................................................................................................................... Betaprodine .......................................................................................................................................................................................... Bufotenine ............................................................................................................................................................................................ Butylone ............................................................................................................................................................................................... Butyryl fentanyl .................................................................................................................................................................................... Cathinone ............................................................................................................................................................................................. Codeine methylbromide ....................................................................................................................................................................... Codeine-N-oxide .................................................................................................................................................................................. Desomorphine ...................................................................................................................................................................................... Diampromide ........................................................................................................................................................................................ Diethylthiambutene .............................................................................................................................................................................. Diethyltryptamine ................................................................................................................................................................................. Difenoxin .............................................................................................................................................................................................. Dihydromorphine .................................................................................................................................................................................. Dimethyltryptamine .............................................................................................................................................................................. Dipipanone ........................................................................................................................................................................................... Etorphine .............................................................................................................................................................................................. Fenethylline .......................................................................................................................................................................................... Furanyl fentanyl ................................................................................................................................................................................... Gamma-Hydroxybutyric Acid ............................................................................................................................................................... Heroin .................................................................................................................................................................................................. Hydromorphinol .................................................................................................................................................................................... Hydroxypethidine ................................................................................................................................................................................. Ibogaine ............................................................................................................................................................................................... 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) .......................................................................................................................... Lysergic acid diethylamide (LSD) ........................................................................................................................................................ MAB–CHMINACA; ADB–CHMINACA (N-(1-amino-3,3dimethyl-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) .......................................... Marihuana ............................................................................................................................................................................................ Mecloqualone ....................................................................................................................................................................................... Mescaline ............................................................................................................................................................................................. Methaqualone ...................................................................................................................................................................................... Methcathinone ..................................................................................................................................................................................... Methyldesorphine ................................................................................................................................................................................. Methyldihydromorphine ........................................................................................................................................................................ Morphine methylbromide ..................................................................................................................................................................... Morphine methylsulfonate .................................................................................................................................................................... Morphine-N-oxide ................................................................................................................................................................................ N,N-Dimethylamphetamine .................................................................................................................................................................. Naphyrone ........................................................................................................................................................................................... N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................ N-Ethylamphetamine ........................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... Noracymethadol ................................................................................................................................................................................... Norlevorphanol ..................................................................................................................................................................................... VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 2 2 30 30 25 25 25 25 20 25 30 2 30 30 30 2 4 2 3 25 30 24 30 192 25 20 20 25 8,225 1,000,160 50 5 30 30 30 37,130,000 45 40 2 30 35 45 45 30 30 35 30 30 30 40 30 30 30 1,140,216 30 25 60 25 5 2 5 5 150 25 25 5 10 24 24 2 55 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices 63537 Final revised 2018 quotas (g) Basic class Normethadone ..................................................................................................................................................................................... Normorphine ........................................................................................................................................................................................ Para-fluorofentanyl ............................................................................................................................................................................... Parahexyl ............................................................................................................................................................................................. PB–22; QUPIC ..................................................................................................................................................................................... Pentedrone .......................................................................................................................................................................................... Pentylone ............................................................................................................................................................................................. Phenomorphan .................................................................................................................................................................................... Pholcodine ........................................................................................................................................................................................... Psilocybin ............................................................................................................................................................................................. Psilocyn ................................................................................................................................................................................................ SR–18 and RCS–8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ......................................................................................... SR–19 and RCS–4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) ............................................................................................................ Tetrahydrocannabinols ........................................................................................................................................................................ Thiofentanyl ......................................................................................................................................................................................... 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 .............................................................................................................................................................................................. 2 40 25 5 20 25 25 2 5 30 50 45 30 384,460 25 30 25 2 25 30 Schedule II 1-Phenylcyclohexylamine .................................................................................................................................................................... 1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... Alfentanil .............................................................................................................................................................................................. Alphaprodine ........................................................................................................................................................................................ Amobarbital .......................................................................................................................................................................................... Amphetamine (for conversion) ............................................................................................................................................................ Amphetamine (for sale) ....................................................................................................................................................................... Carfentanil ............................................................................................................................................................................................ Cocaine ................................................................................................................................................................................................ Codeine (for conversion) ..................................................................................................................................................................... Codeine (for sale) ................................................................................................................................................................................ Dextropropoxyphene ............................................................................................................................................................................ Dihydrocodeine .................................................................................................................................................................................... Dihydroetorphine .................................................................................................................................................................................. Diphenoxylate (for conversion) ............................................................................................................................................................ Diphenoxylate (for sale) ....................................................................................................................................................................... Ecgonine .............................................................................................................................................................................................. Ethylmorphine ...................................................................................................................................................................................... Etorphine hydrochloride ....................................................................................................................................................................... Fentanyl ............................................................................................................................................................................................... Glutethimide ......................................................................................................................................................................................... Hydrocodone (for conversion) ............................................................................................................................................................. Hydrocodone (for sale) ........................................................................................................................................................................ Hydromorphone ................................................................................................................................................................................... Isomethadone ...................................................................................................................................................................................... Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ Levomethorphan .................................................................................................................................................................................. Levorphanol ......................................................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................................................ Meperidine ........................................................................................................................................................................................... Meperidine Intermediate-A .................................................................................................................................................................. Meperidine Intermediate-B .................................................................................................................................................................. Meperidine Intermediate-C .................................................................................................................................................................. Metazocine ........................................................................................................................................................................................... Methadone (for sale) ........................................................................................................................................................................... Methadone Intermediate ...................................................................................................................................................................... Methamphetamine ............................................................................................................................................................................... 15 25 1,342,000 6,200 2 20,100 12,000,000 39,856,000 20 92,120 13,536,000 36,114,260 35 264,140 2 14,100 770,800 88,134 30 32 1,342,320 2 114,680 43,027,640 4,547,720 30 5 2,200 38,000 19,000,000 1,913,148 30 30 30 15 22,278,000 24,064,000 1,446,754 [846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)] Methylphenidate ................................................................................................................................................................................... Morphine (for conversion) .................................................................................................................................................................... Morphine (for sale) .............................................................................................................................................................................. Nabilone ............................................................................................................................................................................................... Noroxymorphone (for conversion) ....................................................................................................................................................... Noroxymorphone (for sale) .................................................................................................................................................................. Opium (powder) ................................................................................................................................................................................... VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 64,600,000 4,089,000 29,353,676 62,000 17,804.670 376,000 84,600 63538 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices Final revised 2018 quotas (g) Basic class Opium (tincture) ................................................................................................................................................................................... Oripavine .............................................................................................................................................................................................. Oxycodone (for conversion) ................................................................................................................................................................ Oxycodone (for sale) ........................................................................................................................................................................... Oxymorphone (for conversion) ............................................................................................................................................................ Oxymorphone (for sale) ....................................................................................................................................................................... Pentobarbital ........................................................................................................................................................................................ Phenazocine ........................................................................................................................................................................................ Phencyclidine ....................................................................................................................................................................................... Phenmetrazine ..................................................................................................................................................................................... Phenylacetone ..................................................................................................................................................................................... Racemethorphan ................................................................................................................................................................................. Racemorphan ...................................................................................................................................................................................... Remifentanil ......................................................................................................................................................................................... Secobarbital ......................................................................................................................................................................................... Sufentanil ............................................................................................................................................................................................. Tapentadol ........................................................................................................................................................................................... Thebaine .............................................................................................................................................................................................. 564,000 26,629,500 2,453,400 79,596,606 20,962,000 3,137,240 25,850,000 5 35 25 40 5 5 3,000 172,100 1,880 18,388,280 84,600,000 List I Chemicals Ephedrine (for conversion) .................................................................................................................................................................. Ephedrine (for sale) ............................................................................................................................................................................. Phenylpropanolamine (for conversion) ................................................................................................................................................ Phenylpropanolamine (for sale) ........................................................................................................................................................... Pseudoephedrine (for conversion) ...................................................................................................................................................... Pseudoephedrine (for sale) ................................................................................................................................................................. Aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. Dated: December 3, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018–26587 Filed 12–7–18; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Office of Justice Programs [OMB Number 1121–0218] Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change, of a Previously Approved Collection Census of Juveniles in Residential Placement (CJRP) Office of Justice Programs, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Office of Justice Programs, 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. DATES: Comments are encouraged and will be accepted for 60 days until February 8, 2019. SUMMARY: VerDate Sep<11>2014 17:10 Dec 07, 2018 Jkt 247001 If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Benjamin Adams, Social Science Analyst, National Institute of Justice, 810 Seventh Street NW, Washington, DC 20531 (email: benjamin.adams@ usdoj.gov; telephone: 202–616–3687). SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; —Evaluate whether the accuracy of the agency’s estimate of the burden on the proposed collection of information, including the validity of the methodology and assumptions that were used; —Evaluate whether and if so how the quality, utility, and clarity of the information collected can be enhanced; and —Minimize the burden of the collection of information on those who are to FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 47,000 4,136,000 14,100,000 7,990,000 1,000 180,000,000 respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of this information collection: 1. Type of Information Collection: Extension, without change, of a currently approved collection. 2. The Title of the Form/Collection: Census of Juveniles in Residential Placement. 3. The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form number is CJ–14, Office of Justice Programs, United States Department of Justice. 4. Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Federal Government, State, Local or Tribal. Other: Not-for-profit institutions; Business or other for-profit. Abstract: The Census of Juveniles in Residential Placement (CJRP), which is administered biennially, collects information from all secure and nonsecure residential placement facilities that house juvenile offenders, defined as persons younger than age 21 who are held in a residential setting as a result of some contact with the justice system. This encompasses both status offenses and delinquency offenses, and E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)]
[Notices]
[Pages 63533-63538]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26587]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471A]


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 2018

AGENCY: Drug Enforcement Administration (DEA), Department of Justice 
(DOJ).

ACTION: Final order.

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

SUMMARY: This final order establishes the final adjusted 2018 aggregate 
production quotas for controlled substances in schedules I and II of 
the Controlled Substances Act (CSA) and the assessment of annual needs 
for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: This order is effective December 10, 2018.

FOR FURTHER INFORMATION CONTACT: Regulatory Drafting and Policy Support 
Section (DPW), Diversion Control Division, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone: (202) 598-6812.

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 
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

    The DEA published the 2018 established aggregate production quotas 
for controlled substances in schedules I and II and the assessment of 
annual needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine in the Federal Register on November 8, 2017. 82 FR 
51873. The 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, 
in order to meet the demand of legitimate medical, scientific, and 
export needs of the United States. This notice stated that the 
Administrator would adjust, as needed, the established aggregate 
production quotas in 2018 in accordance with 21 CFR 1303.13 and 21 CFR 
1315.13. The 2018 proposed adjusted aggregate production quotas for 
controlled substances in schedules I and II and assessment of annual 
needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine were subsequently published in the Federal Register 
on August 23, 2018, (83 FR 42690) in consideration of the outlined 
criteria. All interested persons were invited to comment on or object 
to the proposed adjusted aggregate production quotas and assessment of 
annual needs on or before September 24, 2018.

Comments Received

    The DEA received 526 comments from doctors, nurses, veterinarians, 
nonprofit organizations, associations, patients, caregivers, DEA-
registered entities, and non-DEA entities. The comments included 
concerns about drug shortages, interference with doctor-patient 
relationships, increase in the production of marihuana, requests for a 
hearing, requests for increases in specific production quotas, and 
comments that were outside the scope of this final order.
    There were 200 commenters that expressed general concerns about the 
decrease to the production quotas of controlled substances and 
shortages of controlled substances. There were 27 commenters that 
expressed general concerns alleging that decreases to the aggregate 
production quotas interfered with doctor-patient relationships. The DEA 
sets aggregate production quotas in a manner to ensure that the 
estimated medical needs of the United States are met. In determining 
the aggregate production quota, the DEA does take into account the 
prescriptions that have been issued. The DEA does not interfere with 
doctor-patient relationships. Doctors who are authorized to dispense 
controlled substances are responsible for adhering to the laws and 
regulations set forth under the CSA, which requires doctors to only 
write prescriptions for a legitimate medical need. The DEA is 
responsible for enforcing controlled substance laws and regulations. 
The DEA is committed to ensuring an adequate and uninterrupted supply 
of controlled substances in order to meet the demand of legitimate 
medical, scientific, and export needs of the United States. The 
decrease or increase in the aggregate production quota for controlled 
substances is based on factors set forth in 21 CFR 1303.13. In the 
event of a shortage, the CSA provides a mechanism under which the DEA 
will, in appropriate circumstances, increase quotas to address 
shortages. 21 U.S.C. 826(h). When DEA is notified of an alleged 
shortage, DEA will confer with the FDA 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 factually 
valid shortage.
    Four non-DEA registered entities expressed support to increase the 
production quota of marihuana for research purposes. The DEA increased 
the production quota for marihuana based solely on increased usage 
projections for federally approved research projects.
    Two non-DEA-registered individuals urged DEA to hold a public 
hearing in connection with their view that reducing quotas will not be 
effective in

[[Page 63534]]

preventing the deaths and other harms associated with the opioid crisis 
in the United States. One of these individuals stated that the purpose 
of the hearing would be to obtain input from various medical 
professionals and patients. The second commenter expressed his view 
that reduction in quotas could lead to the under treatment of pain. 
Under the DEA regulations, the decision of whether to grant a hearing 
on the issues raised by the comments lies solely within the discretion 
of the Administrator. 21 CFR 1303.11(c) and 1303.13(c). I find that 
neither of the foregoing two comments, or any of the other comments, 
presented any evidence that would lead me to conclude that a hearing is 
necessary or warranted. Therefore, I decline to order a hearing on the 
issues presented by the comments.
    Five DEA-registered entities submitted comments regarding a total 
of 30 schedule I and II controlled substances. Comments received 
proposed that the aggregate production quotas for 3-methylfentanyl, 4-
ANPP, acetyl fentanyl, acryl fentanyl, beta-hydroxythiofentanyl, 
butyryl fentanyl, carfentanil, cyclopentyl fentanyl, cyclopropyl 
fentanyl, d-amphetamine (for conversion), diphenoxylate (for sale), 
fentanyl, fentanyl related substances, furanyl fentanyl, isobutyryl 
fentanyl, levorphanol, meperidine, methoxyacetyl fentanyl, 
noroxymorphone (for conversion), ocfentanil, oripavine, oxymorphone 
(for conversion), para-chloroisobutyryl fentanyl, para-fluorofentanyl, 
para-fluorobutyryl fentanyl, para-methyoxybutyryl fentanyl, 
remifentanil, tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl 
were insufficient 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.
    The DEA received 288 comments which addressed issues that are 
outside the scope of this final order. The comments were general in 
nature and raised issues of specific medical illnesses, medical 
treatments, and medication costs and therefore, are outside of the 
scope of this Final Order for 2018 and do not impact the original 
analysis involved in finalizing the 2018 aggregate production quotas.
    The DEA received no comments from DEA-registered or non-DEA 
registered entities for previously established values of the 2018 
assessment of annual needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine.

Analysis for Final Adjusted 2018 Aggregate Production Quotas and 
Assessment of Annual Needs

    In determining the final adjusted 2018 aggregate production quotas 
and assessment of annual needs, the DEA has taken into consideration 
the above comments that are specifically relevant to this Final Order 
for calendar year 2018 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), and 
other relevant factors including the 2017 year-end inventories, initial 
2018 manufacturing and import quotas, 2018 export requirements, actual 
and projected 2018 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 2018 aggregate production 
quotas for the following: Lower for codeine (for sale), hydrocodone 
(for sale), morphine (for sale), and oxycodone (for sale) based on the 
data received since the publication of the 2018 Proposed Revised 
Aggregate Production Quotas and Assessment of Annual Needs in the 
Federal Register on August 23, 2018, (83 FR 42690); higher for 
cyclopentyl fentanyl, fentanyl related substances, methoxyacetyl 
fentanyl, para-chloroisobutyryl fentanyl, and para-methyoxybutyryl 
fentanyl due to the publication of their schedule I temporary 
controlled status; higher for noroxymorphone (for conversion) and 
oripavine based on their involvement in the synthesis pathway to 
produce the FDA approved drugs used in the medically assisted treatment 
of opioid addiction. This final order reflects those adjustments.
    Regarding 3-methyl fentanyl, 4-ANPP, acetyl fentanyl, acryl 
fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, 
cyclopropyl fentanyl, d-amphetamine (for conversion), diphenoxylate 
(for sale), fentanyl, furanyl fentanyl, isobutyryl fentanyl, 
levorphanol, meperidine, ocfentanil, oxymorphone (for conversion), 
para-fluorofentanyl, para-fluorobutyryl fentanyl, remifentanil, 
tetrahydrofuranyl fentanyl, U-47700, and valeryl fentanyl, the 
Administrator hereby determines that the proposed adjusted 2018 
aggregate production quotas and assessment of annual needs for these 
substances and list I chemicals as published on August 23, 2018, (83 FR 
42690) are sufficient to meet the current 2018 estimated medical, 
scientific, research, and industrial needs of the United States and to 
provide for adequate reserve stock. This final order establishes these 
aggregate production quotas at the same amounts as proposed.
    Pursuant to the above, the Administrator hereby finalizes the 2018 
aggregate production quotas for the following schedule I and II 
controlled substances and the 2018 assessment of annual needs for the 
list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                           Final revised
                       Basic class                          2018 quotas
                                                                (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1 H-indazole-3-              25
 carboxamide............................................
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-                        25
 pyrrolo[2,3-b]pyridine-3carboxamide....................
Cyclopropyl Fentanyl....................................              20
Cyclopentyl fentanyl....................................              30
Fentanyl related substances.............................              40
Isobutyryl Fentanyl.....................................              25
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-              25
 3-methylbutanoate......................................
Methoxyacetyl fentanyl..................................              30
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-              25
 1H-indazole-3-carboxamide..............................
Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-                       25
 carboxylate............................................
Ocfentanil..............................................              25
Ortho-fluorofentanyl....................................              30
Para-chloroisobutyryl fentanyl..........................              30
Para-fluorobutyryl fentanyl.............................              25

[[Page 63535]]

 
Para-methoxybutyryl fentanyl............................              30
Tetrahydrofuranyl fentanyl..............................               5
Valeryl fentanyl........................................              25
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine..................              20
1-(1-Phenylcyclohexyl)pyrrolidine.......................              15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine..........              10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......              30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM-694).....              30
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................              10
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)...............              30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)                   30
 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-methoxybenzyl)                  25
 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-methoxybenzyl)                    30
 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................................              25
2-(4-Ethylthio-2,5-dimethoxyphenyl)ethanamine (2C-T-2)..              30
2-(4-Isopropylthio)-2,5-dimethoxyphenyl)ethanamine (2C-T-             30
 4).....................................................
3,4,5-Trimethoxyamphetamine.............................              30
3,4-Methylenedioxyamphetamine (MDA).....................              55
3,4-Methylenedioxymethamphetamine (MDMA)................              50
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-Bromo-2,5-dimethoxyamphetamine (DOB)..................              30
4-Bromo-2,5-dimethoxyphenethylamine (2C-B)..............              25
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]-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-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-UR-144, XLR11 [1-(5-Fluoro-pentyl)-1Hindol-3-                25
 yl](2,2,3,3-tetramethylcyclopropyl)methanone...........
5-Methoxy-3,4-methylenedioxyamphetamine.................              25
5-Methoxy-N,N-diisopropyltryptamine.....................              25
5-Methoxy-N-N-dimethyltryptamine........................              25
AB-CHMINACA.............................................              30
AB-FUBINACA.............................................              50
AB-PINACA...............................................              30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetyl Fentanyl.........................................             100
Acetyl-alpha-methylfentanyl.............................              30
Acetyldihydrocodeine....................................              30
Acetylmethadol..........................................               2
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
Allylprodine............................................               2
Alphacetylmethadol......................................               2
alpha-ethyltryptamine...................................              25

[[Page 63536]]

 
Alphameprodine..........................................               2
Alphamethadol...........................................               2
alpha-methylfentanyl....................................              30
alpha-methylthiofentanyl................................              30
alpha-methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Aminorex................................................              25
Anileridine.............................................              20
APINACA, AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-               25
 carboxamide)...........................................
Benzylmorphine..........................................              30
Betacetylmethadol.......................................               2
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30
Betameprodine...........................................               2
Betamethadol............................................               4
Betaprodine.............................................               2
Bufotenine..............................................               3
Butylone................................................              25
Butyryl fentanyl........................................              30
Cathinone...............................................              24
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Desomorphine............................................              25
Diampromide.............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           8,225
Dihydromorphine.........................................       1,000,160
Dimethyltryptamine......................................              50
Dipipanone..............................................               5
Etorphine...............................................              30
Fenethylline............................................              30
Furanyl fentanyl........................................              30
Gamma-Hydroxybutyric Acid...............................      37,130,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................               2
Ibogaine................................................              30
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
Lysergic acid diethylamide (LSD)........................              40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3dimethyl-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)..................
Marihuana...............................................       1,140,216
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methyldesorphine........................................               5
Methyldihydromorphine...................................               2
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
N,N-Dimethylamphetamine.................................              25
Naphyrone...............................................              25
N-Ethyl-1-phenylcyclohexylamine.........................               5
N-Ethyl-3-piperidyl benzilate...........................              10
N-Ethylamphetamine......................................              24
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
Noracymethadol..........................................               2
Norlevorphanol..........................................              55

[[Page 63537]]

 
Normethadone............................................               2
Normorphine.............................................              40
Para-fluorofentanyl.....................................              25
Parahexyl...............................................               5
PB-22; QUPIC............................................              20
Pentedrone..............................................              25
Pentylone...............................................              25
Phenomorphan............................................               2
Pholcodine..............................................               5
Psilocybin..............................................              30
Psilocyn................................................              50
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
Tetrahydrocannabinols...................................         384,460
Thiofentanyl............................................              25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-                           30
 yl](naphthalen-1-yl) methanone)........................
Tilidine................................................              25
Trimeperidine...........................................               2
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl) methanone......................
U-47700.................................................              30
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................              15
1-Piperidinocyclohexanecarbonitrile.....................              25
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       1,342,000
Alfentanil..............................................           6,200
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      12,000,000
Amphetamine (for sale)..................................      39,856,000
Carfentanil.............................................              20
Cocaine.................................................          92,120
Codeine (for conversion)................................      13,536,000
Codeine (for sale)......................................      36,114,260
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         264,140
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          88,134
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................       1,342,320
Glutethimide............................................               2
Hydrocodone (for conversion)............................         114,680
Hydrocodone (for sale)..................................      43,027,640
Hydromorphone...........................................       4,547,720
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................           2,200
Levorphanol.............................................          38,000
Lisdexamfetamine........................................      19,000,000
Meperidine..............................................       1,913,148
Meperidine Intermediate-A...............................              30
Meperidine Intermediate-B...............................              30
Meperidine Intermediate-C...............................              30
Metazocine..............................................              15
Methadone (for sale)....................................      22,278,000
Methadone Intermediate..................................      24,064,000
Methamphetamine.........................................       1,446,754
------------------------------------------------------------------------
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
   prescription product; 564,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 36,754 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.........................................      64,600,000
Morphine (for conversion)...............................       4,089,000
Morphine (for sale).....................................      29,353,676
Nabilone................................................          62,000
Noroxymorphone (for conversion).........................      17,804.670
Noroxymorphone (for sale)...............................         376,000
Opium (powder)..........................................          84,600

[[Page 63538]]

 
Opium (tincture)........................................         564,000
Oripavine...............................................      26,629,500
Oxycodone (for conversion)..............................       2,453,400
Oxycodone (for sale)....................................      79,596,606
Oxymorphone (for conversion)............................      20,962,000
Oxymorphone (for sale)..................................       3,137,240
Pentobarbital...........................................      25,850,000
Phenazocine.............................................               5
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................              40
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           3,000
Secobarbital............................................         172,100
Sufentanil..............................................           1,880
Tapentadol..............................................      18,388,280
Thebaine................................................      84,600,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)..............................          47,000
Ephedrine (for sale)....................................       4,136,000
Phenylpropanolamine (for conversion)....................      14,100,000
Phenylpropanolamine (for sale)..........................       7,990,000
Pseudoephedrine (for conversion)........................           1,000
Pseudoephedrine (for sale)..............................     180,000,000
------------------------------------------------------------------------

    Aggregate production quotas for all other schedule I and II 
controlled substances included in 21 CFR 1308.11 and 1308.12 remain at 
zero.

    Dated: December 3, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-26587 Filed 12-7-18; 8:45 am]
 BILLING CODE 4410-09-P