Proposed 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, 36830-36834 [2017-16439]

Download as PDF 36830 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–471N] Proposed 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, Department of Justice. ACTION: Notice with request for comments. AGENCY: The Drug Enforcement Administration (DEA) proposes to establish the 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. SUMMARY: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before September 6, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2018 aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–471N’’ on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page mstockstill on DSK30JT082PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http:// www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ‘‘PERSONAL IDENTIFYING INFORMATION’’ in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ‘‘CONFIDENTIAL BUSINESS INFORMATION’’ in the first paragraph of your comment. You must also prominently identify confidential PO 00000 Frm 00103 Fmt 4703 Sfmt 4703 business information to be redacted within the comment. Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http:// www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document is available at http:// www.regulations.gov for easy reference. 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 substance 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 DEA pursuant to 28 CFR 0.100. Analysis for Proposed 2018 Aggregate Production Quotas and Assessment of Annual Needs The proposed year 2018 aggregate production quotas and assessment of annual needs represent those quantities of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2018 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes. In determining the proposed 2018 aggregate production quotas and assessment of annual needs, the Acting Administrator has taken into account the criteria pursuant to 21 U.S.C. 826(a) and in accordance with 21 CFR 1303.11 (aggregate production quotas for controlled substances) and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and E:\FR\FM\07AUN1.SGM 07AUN1 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2018 by considering: (1) Total net disposal of each class or chemical by all manufacturers and chemical importers during the current and two preceding years; (2) trends in the national rate of net disposal of the class or chemical; (3) total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation; (4) projected demand for each class or chemical as indicated by procurement and import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Acting Administrator finds relevant. These quotas do not include imports of controlled substances for use in industrial processes. Other factors the Acting Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the 36831 proposed 2018 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). The Acting Administrator, therefore, proposes to establish the 2018 aggregate production quotas for certain schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Proposed 2018 quotas Basic class (g) mstockstill on DSK30JT082PROD with NOTICES Schedule I 1-(1-Phenylcyclohexyl)pyrrolidine ........................................................................................................................................................ 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ............................................................................................................................ 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ........................................................................................................................... 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 (2-CB) .................................................................................................................................. 4-Fluoroisobutyryl fentanyl ................................................................................................................................................................... 4-FMC; Flephedrone ............................................................................................................................................................................ 4-MEC; 4-Methyl-N-ethylcathinone ...................................................................................................................................................... 4-Methoxyamphetamine ...................................................................................................................................................................... 4-Methyl-2,5-dimethoxyamphetamine (DOM) ...................................................................................................................................... 4-Methylaminorex ................................................................................................................................................................................ 4-Methyl-N-methylcathinone (mephedrone) ........................................................................................................................................ 4-Methyl-a-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-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ............................................ 5-Methoxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... 5-Methoxy-N,N-diisopropyltryptamine .................................................................................................................................................. VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00104 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 10 30 30 15 25 2 30 30 30 30 30 25 30 25 30 30 25 25 25 30 30 25 55 50 40 40 35 25 30 30 25 25 30 25 25 150 25 25 45 25 50 40 30 30 30 20 25 25 25 36832 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices Proposed 2018 quotas Basic class mstockstill on DSK30JT082PROD with NOTICES (g) 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 .................................................................................................................................................................................... ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) ...................................................... AH-7921 ............................................................................................................................................................................................... Allylprodine .......................................................................................................................................................................................... Alphacetylmethadol .............................................................................................................................................................................. alpha-Ethyltryptamine .......................................................................................................................................................................... Alphameprodine ................................................................................................................................................................................... Alphamethadol ..................................................................................................................................................................................... alpha-Methylfentanyl ............................................................................................................................................................................ alpha-Methylthiofentanyl ...................................................................................................................................................................... alpha-Methyltryptamine (AMT) ............................................................................................................................................................ alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ Aminorex .............................................................................................................................................................................................. APINCA, 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 ...................................................................................................................................................................................... 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-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3carboxamide) .................................................................................................................................................................................... MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............... MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ........................................... Marihuana ............................................................................................................................................................................................ Mecloqualone ....................................................................................................................................................................................... Mescaline ............................................................................................................................................................................................. Methaqualone ...................................................................................................................................................................................... Methcathinone ..................................................................................................................................................................................... VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00105 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 25 30 50 30 30 100 30 30 2 50 30 2 2 25 2 2 30 30 25 25 25 25 25 30 2 30 30 30 2 4 2 3 25 30 24 30 192 25 25 8,225 1,000,160 35 5 30 30 30 37,130,000 45 40 2 30 35 45 45 30 30 35 30 30 30 40 30 30 30 443,680 30 25 60 25 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices 36833 Proposed 2018 quotas Basic class (g) Methyldesorphine ................................................................................................................................................................................. Methyldihydromorphine ........................................................................................................................................................................ Morphine methylbromide ..................................................................................................................................................................... Morphine methylsulfonate .................................................................................................................................................................... Morphine-N-oxide ................................................................................................................................................................................ N,N-Dimethylamphetamine .................................................................................................................................................................. Naphyrone ........................................................................................................................................................................................... N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ N-Ethylamphetamine ........................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... Noracymethadol ................................................................................................................................................................................... Norlevorphanol ..................................................................................................................................................................................... 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 ............................................................................................................................................................................................... 5 2 5 5 150 25 25 5 24 24 2 55 2 40 25 5 20 25 25 2 5 30 50 45 30 384,460 25 30 25 2 25 30 mstockstill on DSK30JT082PROD with NOTICES 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) ........................................................................................................................................................................... VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 PO 00000 Frm 00106 Fmt 4703 Sfmt 4703 E:\FR\FM\07AUN1.SGM 07AUN1 4 4 1,342,320 2,538 2 18,894 11,280,000 39,856,000 20 92,120 15,040,000 40,015,800 35 264,140 2 14,100 770,800 88,134 30 32 1,342,320 2 114,680 50,348,280 4,547,720 30 5 30 12,126 17,869,000 2,717,540 5 30 5 15 22,278,000 36834 Federal Register / Vol. 82, No. 150 / Monday, August 7, 2017 / Notices Proposed 2018 quotas Basic class (g) Methadone Intermediate ...................................................................................................................................................................... Methamphetamine ............................................................................................................................................................................... 24,064,000 1,446,754 [900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)] Methylphenidate ................................................................................................................................................................................... Morphine (for conversion) .................................................................................................................................................................... Morphine (for sale) .............................................................................................................................................................................. Nabilone ............................................................................................................................................................................................... Noroxymorphone (for conversion) ....................................................................................................................................................... Noroxymorphone (for sale) .................................................................................................................................................................. Opium (powder) ................................................................................................................................................................................... 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 .............................................................................................................................................................................................. 60,724,000 4,089,000 33,958,440 17,860 14,044,540 376,000 84,600 564,000 24,534,000 2,453,400 95,692,000 20,962,000 3,395,280 25,850,000 5 35 25 40 5 5 2,820 161,682 1,880 18,388,280 94,000,000 List I Chemicals Ephedrine (for conversion) .................................................................................................................................................................. Ephedrine (for sale) ............................................................................................................................................................................. Phenylpropanolamine (for conversion) ................................................................................................................................................ Phenylpropanolamine (for sale) ........................................................................................................................................................... Pseudoephedrine (for conversion) ...................................................................................................................................................... Pseudoephedrine (for sale) ................................................................................................................................................................. The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2018 aggregate production quotas and assessment of annual needs as needed. mstockstill on DSK30JT082PROD with NOTICES Conclusion After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the Federal Register a final order establishing the 2018 aggregate production quota for controlled substances in schedules I and II and establishing an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.11(c) and 1315.11(f). VerDate Sep<11>2014 18:14 Aug 04, 2017 Jkt 241001 Dated: July 27, 2017. Chuck Rosenberg, Acting Administrator. [FR Doc. 2017–16439 Filed 8–4–17; 8:45 am] BILLING CODE 4410–09–P 47,000 4,136,000 14,100,000 7,990,000 40 169,200,000 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. DEPARTMENT OF JUSTICE Comments are encouraged and will be accepted for 60 days until October 6, 2017. [OMB Number 1110–0051] FOR FURTHER INFORMATION CONTACT: DATES: Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Final Disposition Report (R–84) Criminal Justice Information Services Division, Federal Bureau of Investigation, Department of Justice. ACTION: 60-day notice. AGENCY: Department of Justice (DOJ), Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the SUMMARY: PO 00000 Frm 00107 Fmt 4703 Sfmt 4703 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 Gerry Lynn Brovey, Supervisory Information Liaison Specialist, FBI, CJIS, Resources Management Section, Administrative Unit, Module C–2, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306 (facsimile: 304–625– 5093) or email glbrovey@ic.fbi.gov. Written comments and/or suggestions E:\FR\FM\07AUN1.SGM 07AUN1

Agencies

[Federal Register Volume 82, Number 150 (Monday, August 7, 2017)]
[Notices]
[Pages 36830-36834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16439]



[[Page 36830]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-471N]


Proposed 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, Department of Justice.

ACTION: Notice with request for comments.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
establish the 2018 aggregate production quotas for controlled 
substances in schedules I and II of the Controlled Substances Act and 
assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine.

DATES: Interested persons may file written comments on this notice in 
accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments 
must be submitted, and written comments must be postmarked, on or 
before September 6, 2017. Commenters should be aware that the 
electronic Federal Docket Management System will not accept comments 
after 11:59 p.m. Eastern Time on the last day of the comment period.
    Based on comments received in response to this notice, the 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Administrator decides in his sole discretion to hold 
such a hearing, the Administrator will publish a notice of any such 
hearing in the Federal Register. After consideration of any comments or 
objections, or after a hearing, if one is held, the Administrator will 
publish in the Federal Register a final order establishing the 2018 
aggregate production quotas for schedule I and II controlled 
substances, and an assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-471N'' on all correspondence, including any 
attachments. The Drug Enforcement Administration encourages that all 
comments be submitted electronically through the Federal eRulemaking 
Portal which provides the ability to type short comments directly into 
the comment field on the Web page or attach a file for lengthier 
comments. Please go to http://www.regulations.gov and follow the online 
instructions at that site for submitting comments. Upon completion of 
your submission you will receive a Comment Tracking Number for your 
comment. Please be aware that submitted comments are not 
instantaneously available for public view on Regulations.gov. If you 
have received a Comment Tracking Number, your comment has been 
successfully submitted and there is no need to resubmit the same 
comment. Paper comments that duplicate electronic submissions are not 
necessary and are discouraged. Should you wish to mail a paper comment 
in lieu of an electronic comment, it should be sent via regular or 
express mail to: Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/DRW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying 
information (such as your name, address, etc.) voluntarily submitted by 
the commenter.
    The Freedom of Information Act (FOIA) applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all the personal identifying information 
you do not want made publicly available in the first paragraph of your 
comment and identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information or 
confidential business information identified and located as directed 
above will generally be made available in redacted form. If a comment 
contains so much confidential business information or personal 
identifying information that it cannot be effectively redacted, all or 
part of that comment may not be made publicly available. Comments 
posted to http://www.regulations.gov may include any personal 
identifying information (such as name, address, and phone number) 
included in the text of your electronic submission that is not 
identified as directed above as confidential.
    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

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 substance 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 DEA pursuant to 28 CFR 0.100.

Analysis for Proposed 2018 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2018 aggregate production quotas and assessment 
of annual needs represent those quantities of schedule I and II 
controlled substances, and the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine, to be manufactured in the 
United States in 2018 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, lawful export 
requirements, and the establishment and maintenance of reserve stocks. 
These quotas include imports of ephedrine, pseudoephedrine, and 
phenylpropanolamine, but do not include imports of controlled 
substances for use in industrial processes.
    In determining the proposed 2018 aggregate production quotas and 
assessment of annual needs, the Acting Administrator has taken into 
account the criteria pursuant to 21 U.S.C. 826(a) and in accordance 
with 21 CFR 1303.11 (aggregate production quotas for controlled 
substances) and 21 CFR 1315.11 (assessment of annual needs for 
ephedrine, pseudoephedrine, and

[[Page 36831]]

phenylpropanolamine). The DEA proposes the aggregate production quotas 
and assessment of annual needs for 2018 by considering: (1) Total net 
disposal of each class or chemical by all manufacturers and chemical 
importers during the current and two preceding years; (2) trends in the 
national rate of net disposal of the class or chemical; (3) total 
actual (or estimated) inventories of the class or chemical and of all 
substances manufactured from the class or chemical, and trends in 
inventory accumulation; (4) projected demand for each class or chemical 
as indicated by procurement and import quotas requested in accordance 
with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors 
affecting medical, scientific, research, and industrial needs of the 
United States and lawful export requirements, as the Acting 
Administrator finds relevant. These quotas do not include imports of 
controlled substances for use in industrial processes.
    Other factors the Acting Administrator considered in calculating 
the aggregate production quotas, but not the assessment of annual 
needs, include product development requirements of both bulk and 
finished dosage form manufacturers, and other pertinent information. In 
determining the proposed 2018 assessment of annual needs, the DEA used 
the calculation methodology previously described in the 2010 and 2011 
assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 
79407, Dec. 20, 2010, respectively).
    The Acting Administrator, therefore, proposes to establish the 2018 
aggregate production quotas for certain schedule I and II controlled 
substances and assessment of annual needs for the list I chemicals 
ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams 
of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                           Proposed 2018
                                                              quotas
                       Basic class                       ---------------
                                                                (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-(1-Phenylcyclohexyl)pyrrolidine.......................              10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......              30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)......              30
1-[1-(2-Thienyl)cyclohexyl]piperidine...................              15
1-Benzylpiperazine......................................              25
1-Methyl-4-phenyl-4-propionoxypiperidine................               2
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-                                 25
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).......              30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).........              30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET).................              25
2,5-Dimethoxy-4-n-propylthiophenethylamine..............              25
2,5-Dimethoxyamphetamine................................              25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)              30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 T-4)...................................................
3,4,5-Trimethoxyamphetamine.............................              25
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)..................              25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............              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-UR144, 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

[[Page 36832]]

 
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
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
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
APINCA, 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
Diethyltryptamine.......................................              25
Difenoxin...............................................           8,225
Dihydromorphine.........................................       1,000,160
Dimethyltryptamine......................................              35
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-3,3-dimethyl-1-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide)...........................................
MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-                               30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate).....................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
Marihuana...............................................         443,680
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25

[[Page 36833]]

 
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-Ethylamphetamine......................................              24
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
Noracymethadol..........................................               2
Norlevorphanol..........................................              55
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.................................               4
1-Piperidinocyclohexanecarbonitrile.....................               4
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............       1,342,320
Alfentanil..............................................           2,538
Alphaprodine............................................               2
Amobarbital.............................................          18,894
Amphetamine (for conversion)............................      11,280,000
Amphetamine (for sale)..................................      39,856,000
Carfentanil.............................................              20
Cocaine.................................................          92,120
Codeine (for conversion)................................      15,040,000
Codeine (for sale)......................................      40,015,800
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)..................................      50,348,280
Hydromorphone...........................................       4,547,720
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................              30
Levorphanol.............................................          12,126
Lisdexamfetamine........................................      17,869,000
Meperidine..............................................       2,717,540
Meperidine Intermediate--A..............................               5
Meperidine Intermediate--B..............................              30
Meperidine Intermediate--C..............................               5
Metazocine..............................................              15
Methadone (for sale)....................................      22,278,000

[[Page 36834]]

 
Methadone Intermediate..................................      24,064,000
Methamphetamine.........................................       1,446,754
------------------------------------------------------------------------
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
 prescription product; 600,000 grams for methamphetamine mostly for
 conversion to a schedule III product; and 39,100 grams for
 methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.........................................      60,724,000
Morphine (for conversion)...............................       4,089,000
Morphine (for sale).....................................      33,958,440
Nabilone................................................          17,860
Noroxymorphone (for conversion).........................      14,044,540
Noroxymorphone (for sale)...............................         376,000
Opium (powder)..........................................          84,600
Opium (tincture)........................................         564,000
Oripavine...............................................      24,534,000
Oxycodone (for conversion)..............................       2,453,400
Oxycodone (for sale)....................................      95,692,000
Oxymorphone (for conversion)............................      20,962,000
Oxymorphone (for sale)..................................       3,395,280
Pentobarbital...........................................      25,850,000
Phenazocine.............................................               5
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................              40
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           2,820
Secobarbital............................................         161,682
Sufentanil..............................................           1,880
Tapentadol..............................................      18,388,280
Thebaine................................................      94,000,000
------------------------------------------------------------------------
                            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)........................              40
Pseudoephedrine (for sale)..............................     169,200,000
------------------------------------------------------------------------

    The Acting Administrator further proposes that aggregate production 
quotas for all other schedule I and II controlled substances included 
in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 
1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, 
the Acting Administrator may adjust the 2018 aggregate production 
quotas and assessment of annual needs as needed.

Conclusion

    After consideration of any comments or objections, or after a 
hearing, if one is held, the Acting Administrator will issue and 
publish in the Federal Register a final order establishing the 2018 
aggregate production quota for controlled substances in schedules I and 
II and establishing an assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 
1303.11(c) and 1315.11(f).

    Dated: July 27, 2017.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2017-16439 Filed 8-4-17; 8:45 am]
 BILLING CODE 4410-09-P