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 2017, 47821-47826 [2016-17370]

Download as PDF ehiers on DSK5VPTVN1PROD with NOTICES Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices business proprietary information (‘‘BPI’’) under administrative protective order. BPI referred to during the remand proceedings will be governed, as appropriate, by the administrative protective order issued in the investigations. The Secretary will maintain a service list containing the names and addresses of all persons or their representatives who are parties to the remand proceedings, and the Secretary will maintain a separate list of those authorized to receive BPI under the administrative protective order during the remand proceedings. Written Submissions.—The Commission is not reopening the record and will not accept the submission of new factual information for the record. The Commission will permit the parties to file comments concerning how the Commission could best comply with the Court’s remand instructions. The comments must be based solely on the information in the Commission’s record. The Commission will reject submissions containing additional factual information or arguments pertaining to issues other than those on which the Court has remanded this matter. The deadline for filing comments is August 1, 2016. Comments shall be limited to no more than fifteen (15) double-spaced and single-sided pages of textual material. Parties are advised to consult with the Commission’s Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subpart A (19 CFR part 207) for provisions of general applicability concerning written submissions to the Commission. All written submissions must conform with the provisions of section 201.8 of the Commission’s rules; any submissions that contain BPI must also conform with the requirements of sections 201.6, 207.3, and 207.7 of the Commission’s rules. 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Lisa Barton, Secretary to the Commission. [FR Doc. 2016–17286 Filed 7–21–16; 8:45 am] BILLING CODE 7020–02–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–443N] 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 2017 Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. AGENCY: The Drug Enforcement Administration (DEA) proposes to establish the 2017 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 August 22, 2016. 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 2017 aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, DATES: PO 00000 Frm 00076 Fmt 4703 Sfmt 4703 47821 pseudoephedrine, and phenylpropanolamine. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–443N’’ 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion Control, 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 E:\FR\FM\22JYN1.SGM 22JYN1 47822 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 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 2017 Aggregate Production Quotas and Assessment of Annual Needs The proposed year 2017 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 2017 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 2017 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 phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2017 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 2017 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). During the calendar years 2013–2016, the DEA included an additional 25% of the estimated medical, scientific, and research needs for the United States as part of the amount necessary to ensure the establishment and maintenance of reserve stocks for all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (difenoxin, gamma-hydroxybutyric acid, and tetrahydrocannabinols). Based on interagency discussions beginning in November 2015, and after reviewing all relevant quota applications received, published FDA drug shortage lists, and subsequent reports required under 21 U.S.C. 826a for those calendar years, the Acting Administrator has determined that inclusion of the additional 25% of the estimated medical, scientific, and research needs for the United States is unnecessary. Instead, the Acting Administrator determined that 21 U.S.C. 826(c) and 21 U.S.C. 952(a)(2)(A) provide sufficient ability for the DEA to mitigate adverse public effects should a natural disaster or other unforeseen event result in substantial disruption to the amount of controlled substances available for legitimate public need. As such, DEA proposes to remove the additional 25% from the aggregate production quotas. The resulting proposed established aggregate production quotas reflect these reduced amounts. The Acting Administrator, therefore, proposes to establish the 2017 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 2017 quotas (g) Basic class ehiers on DSK5VPTVN1PROD with NOTICES Schedule I [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201) ................................................................................ 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-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200) ......................................................................................................... 1-Benzylpiperazine ........................................................................................................................................................................ VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 15 10 30 30 15 35 25 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices Proposed 2017 quotas (g) ehiers on DSK5VPTVN1PROD with NOTICES Basic class 1-Butyl-3-(1-naphthoyl)indole (JWH-073) ...................................................................................................................................... 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8) ..................................................................................... 1-Hexyl-3-(1-naphthoyl)indole (JWH-019) ..................................................................................................................................... 1-Methyl-4-phenyl-4-propionoxypiperidine ..................................................................................................................................... 1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678) ................................................................................................................ 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203) ...................................................................................................................... 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) .................................................................................................................. 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398) ...................................................................................................................... 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122) ..................................................................................................................... 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) .............................................................................................................. 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081) ................................................................................................................. 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-FMC; Flephedrone ...................................................................................................................................................................... 4-Methoxyamphetamine ................................................................................................................................................................ 4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................ 4-Methylaminorex .......................................................................................................................................................................... 4-MEC; 4-Methyl-N-ethylcathinone ................................................................................................................................................ 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) ..................... 5-Fluoro-UR144, XLR11 ................................................................................................................................................................ 5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................ 5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................ 5-Methoxy-N,N-dimethyltryptamine ............................................................................................................................................... AB-PINACA .................................................................................................................................................................................... Acetyl-alpha-methylfentanyl ........................................................................................................................................................... Acetyldihydrocodeine ..................................................................................................................................................................... Acetylmethadol .............................................................................................................................................................................. AH-7921 ......................................................................................................................................................................................... Allylprodine .................................................................................................................................................................................... alpha-Ethyltryptamine .................................................................................................................................................................... alpha-Methylfentanyl ...................................................................................................................................................................... alpha-Methylthiofentanyl ................................................................................................................................................................ alpha-Methyltryptamine (AMT) ...................................................................................................................................................... alpha-Pyrrolidinobutiophenone (a-PBP) ........................................................................................................................................ alpha-Pyrrolidinopentiophenone (a-PVP) ...................................................................................................................................... Alphacetylmethadol ........................................................................................................................................................................ Alphameprodine ............................................................................................................................................................................. Alphamethadol ............................................................................................................................................................................... Aminorex ........................................................................................................................................................................................ APINCA, AKB48 ............................................................................................................................................................................ Benzylmorphine ............................................................................................................................................................................. beta-Hydroxy-3-methylfentanyl ...................................................................................................................................................... beta-Hydroxyfentanyl ..................................................................................................................................................................... beta-Hydroxythiofentanyl ............................................................................................................................................................... Betacetylmethadol ......................................................................................................................................................................... Betameprodine ............................................................................................................................................................................... VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00078 Fmt 4703 47823 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 45 45 45 2 35 30 30 30 30 30 30 30 30 30 30 30 25 30 25 30 5 25 25 25 30 30 25 55 50 40 40 35 25 2 2 25 25 25 150 25 25 25 45 25 50 40 25 25 25 25 15 2 2 2 30 2 25 2 2 25 25 25 2 2 2 25 25 2 2 2 30 2 2 47824 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices Proposed 2017 quotas (g) Basic class Betamethadol ................................................................................................................................................................................. Betaprodine .................................................................................................................................................................................... Bufotenine ...................................................................................................................................................................................... Butylone ......................................................................................................................................................................................... Butyryl fentanyl .............................................................................................................................................................................. Cathinone ....................................................................................................................................................................................... Codeine methylbromide ................................................................................................................................................................. Codeine-N-oxide ............................................................................................................................................................................ Desomorphine ................................................................................................................................................................................ Diethyltryptamine ........................................................................................................................................................................... Difenoxin ........................................................................................................................................................................................ Dihydromorphine ............................................................................................................................................................................ Dimethyltryptamine ........................................................................................................................................................................ Dipipanone ..................................................................................................................................................................................... Fenethylline .................................................................................................................................................................................... gamma-Hydroxybutyric acid .......................................................................................................................................................... Heroin ............................................................................................................................................................................................ Hydromorphinol .............................................................................................................................................................................. Hydroxypethidine ........................................................................................................................................................................... Ibogaine ......................................................................................................................................................................................... Lysergic acid diethylamide (LSD) .................................................................................................................................................. Marihuana ...................................................................................................................................................................................... Mescaline ....................................................................................................................................................................................... Methaqualone ................................................................................................................................................................................ Methcathinone ............................................................................................................................................................................... Methyldesorphine ........................................................................................................................................................................... Methyldihydromorphine .................................................................................................................................................................. Morphine methylbromide ............................................................................................................................................................... Morphine methylsulfonate .............................................................................................................................................................. Morphine-N-oxide .......................................................................................................................................................................... N,N-Dimethylamphetamine ............................................................................................................................................................ N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA) ............................................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA) .................................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA) .............................. N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl) .............................................................................................. N-Ethyl-1-phenylcyclohexylamine .................................................................................................................................................. N-Ethylamphetamine ..................................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine ................................................................................................................................ Naphyrone ..................................................................................................................................................................................... Noracymethadol ............................................................................................................................................................................. Norlevorphanol ............................................................................................................................................................................... Normethadone ............................................................................................................................................................................... Normorphine .................................................................................................................................................................................. Para-fluorofentanyl ......................................................................................................................................................................... Parahexyl ....................................................................................................................................................................................... Pentedrone .................................................................................................................................................................................... Pentylone ....................................................................................................................................................................................... Phenomorphan .............................................................................................................................................................................. Pholcodine ..................................................................................................................................................................................... Psilocybin ....................................................................................................................................................................................... Psilocyn .......................................................................................................................................................................................... Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22) .................................................................. Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC) .................................................................................................. Tetrahydrocannabinols .................................................................................................................................................................. Thiofentanyl ................................................................................................................................................................................... Tilidine ............................................................................................................................................................................................ Trimeperidine ................................................................................................................................................................................. UR-144 ........................................................................................................................................................................................... 4 2 3 25 30 24 5 305 25 25 8,750 1,566,000 35 5 5 56,200,000 25 2 2 5 10 472,000 25 10 25 5 2 5 5 350 25 50 50 15 100 5 24 24 25 2 52 2 40 5 5 25 25 2 5 30 50 20 20 409,000 2 25 2 25 ehiers on DSK5VPTVN1PROD 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) .......................................................................................................................................................................... VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 4 4 1,000,000 4,200 2 20,100 9,000,000 37,500,000 10 94,000 40,000,000 45,000,000 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 47825 Proposed 2017 quotas (g) Basic class 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 81,100 2 15,000 820,000 90,000 2 2 1,750,000 2 122,000 58,410,000 4,300,000 4 3 10 4,900 19,000,000 3,706,000 5 9 5 15 23,700,000 25,600,000 1,539,100 [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 ........................................................................................................................................................................................ 73,000,000 27,300,000 41,000,000 15,000 17,700,000 400,000 90,000 300,000 20,000,000 2,610,000 108,510,000 22,300,000 4,200,000 27,500,000 5 20 2 20 2 2 3,000 172,002 4,000 21,000,000 100,000,000 List I Chemicals ehiers on DSK5VPTVN1PROD with NOTICES Ephedrine (for conversion) ............................................................................................................................................................ Ephedrine (for sale) ....................................................................................................................................................................... Phenylpropanolamine (for conversion) .......................................................................................................................................... Phenylpropanolamine (for sale) ..................................................................................................................................................... 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 VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2017 aggregate production quotas and assessment of annual needs as needed. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 50,000 4,100,000 15,000,000 8,500,000 200,000,000 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 E:\FR\FM\22JYN1.SGM 22JYN1 47826 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 2017 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 14, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016–17370 Filed 7–21–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ehiers on DSK5VPTVN1PROD with NOTICES Mikhayl Soliman, M.D.: Decision and Order On March 27, 2015, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Mikhayl Soliman, M.D. (hereinafter, Applicant), of both Wayne, Michigan and Los Angeles, California. The Show Cause Order proposed the denial of Applicant’s applications for DEA Certificates of Registration in the States of Michigan and California on multiple grounds. GX 7, at 1. First, the Show Cause Order alleged that Applicant had previously been registered to handle controlled substances in only Schedule III and IIIN, at the registered address of 3152 South Wayne Road, Wayne, Michigan. Id. The Show Cause Order alleged that on September 14, 2012, Applicant was issued an Order to Show Cause and Immediate Suspension of Registration and that he subsequently voluntarily surrendered his registration. The Show Cause Order alleged that on September 24, 2012, Applicant applied for a new DEA practitioner’s registration at his previous registered location in Wayne, Michigan, and that on October 2, 2012, he applied for a new practitioner’s registration at a proposed location in Los Angeles, California. Id. The Order then alleged that on both applications, Applicant had failed to disclose that he had voluntarily surrendered his registration and had materially falsified both applications. Id. at 1–2 (citing 21 U.S.C. 843(a)(4)(A)). Second, the Show Cause Order alleged that as a result of actions taken by the medical boards of California and Michigan, Applicant is ‘‘without authority to practice in the States . . . in which [he] applied for’’ DEA registrations. Id. at 2. Specifically, the Show Cause Order alleged that on January 15, 2014, the Michigan Board of Medicine issued a Consent Order which VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 found that he ‘‘had prescribed controlled substances . . . in a manner which demonstrated negligence, incompetence, and a lack of good moral character’’ and that he ‘‘prescribed, gave away or administered drugs for other than lawful diagnostic or therapeutic purposes.’’ Id. The Order also alleged that the Michigan Board had suspended his medical license for six months and one day and required that he petition the Board for reinstatement; the Order then alleged that Applicant’s Michigan medical license remains suspended. Id. The Order further alleged that based on the Michigan Board’s findings, the Medical Board of California revoked his California license effective October 10, 2014. Id. Finally, the Show Cause Order alleged that on May 16, 2012, DEA Investigators had seized 323 patient files which Applicant had discarded in the trash at his residence, and that the files showed that Applicant had prescribed both hydrocodone (then a Schedule III controlled substance) and alprazolam (a Schedule IV drug) ‘‘to the majority of these patients.’’ Id. The Order then alleged that DEA Investigators obtained information from the Michigan Automated Prescriptions System which showed that ‘‘between January 1, 2007 and August 20, 1012, [Applicant] prescribed at least 19,409 dosage units of [s]chedule II [drugs], 725,760 dosage units of [s]chedule IV [drugs], and 246,397 dosage units of [s]chedule V [drugs], without the registered authority to do so.’’ Id.1 Thereafter, the Government attempted to serve the Show Cause Order by FedEx delivered to the proposed business address Applicant used when he applied for a registration in Los Angeles. GX 9, at 1. The Government did not, however, require a signature. Id. at 1–2. Moreover, the Government does not point to any precedent of either the courts or this Agency which allows for the use of FedEx to serve a charging document or complaint (as opposed to post-service filings) on a person.2 Thus, this attempt was deemed inadequate to accomplish service. The Government also noted that it emailed a lawyer who was representing Applicant ‘‘in a pending criminal matter’’ and asked him if he could 1 The Show Cause Order also notified Applicant of his right to either request a hearing on the allegations of the Order to Show Cause or to submit a written statement while waiving his right to a hearing, the procedure for electing either option, and the consequence of failing to elect either option. GX 7, at 3. 2 Nor am I aware of any rules of procedure which allow for a charging document or complaint to be served in this manner. PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 confirm Applicant’s current address or accept service on Applicant’s behalf. GX 10. The lawyer, however, did not respond. Request for Final Agency Action, at 3. Moreover, according to the Government, a Supervisory Diversion Investigator phoned the attorney and asked for Applicant’s address in order to serve the Show Cause Order. Id. According to the Government, while the attorney stated that he would contact the Government’s counsel, he did not.3 Id. The Government then mailed the Show Cause Order by certified mail, return receipt requested, addressed to Applicant at his proposed business address in Wayne, Michigan. GX 11, 12, and 13. Several weeks later the mailing was returned unclaimed, with the Post Office indicating that it was ‘‘unable to forward’’ the mailing. GX 13. The Government did not, however, send the Show Cause Order to Applicant by First Class Mail. See Jones v. Flowers, 547 U.S. 220 (2006). Subsequently, the Government submitted a Request for Final Agency Action along with the Investigative File. Upon review of the record, I found that service was inadequate and directed that the Request for Final Agency Action be returned. On November 9, 2015, the Government again mailed the Show Cause Order by certified mail, return receipt requested, addressed to Applicant at his proposed registered location. Here again, several weeks later the mailing was returned by the Post Office as undeliverable. GX 18. Also on November 9, 2015, the same day the Government had re-mailed the Show Cause Order, it emailed the Order to Applicant at the email address he had provided to the Agency on his applications. According to an affidavit submitted by the Government, it ‘‘did not receive any bounce-back email or other indication that the email . . . was undeliverable or otherwise not received.’’ GX 19. Upon re-submission of its Request for Final Agency Action, the Government advised that on September 24, 2015, Applicant was found guilty in the United States District Court for the Eastern District of Michigan on multiple counts of health care fraud and aiding and abetting the unlawful distribution of controlled substances. Request for Final Agency Action, at 4; see also GX 15, at 5). The Government further advised that on October 5, 2015, 3 Given that Applicant had been criminally charged and released on bond, the Pre-Trial Services Office would likely have been a more fruitful source for obtaining his residence address. E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47821-47826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17370]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-443N]


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 2017

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration (DEA) proposes to 
establish the 2017 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 August 22, 2016. 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 2017 
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-443N'' 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/ODW, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, 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

[[Page 47822]]

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 2017 Aggregate Production Quotas and Assessment 
of Annual Needs

    The proposed year 2017 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 2017 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 2017 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 phenylpropanolamine). The DEA proposes 
the aggregate production quotas and assessment of annual needs for 2017 
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 2017 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).
    During the calendar years 2013-2016, the DEA included an additional 
25% of the estimated medical, scientific, and research needs for the 
United States as part of the amount necessary to ensure the 
establishment and maintenance of reserve stocks for all schedule II 
aggregate production quotas, and certain schedule I aggregate 
production quotas (difenoxin, gamma-hydroxybutyric acid, and 
tetrahydrocannabinols). Based on interagency discussions beginning in 
November 2015, and after reviewing all relevant quota applications 
received, published FDA drug shortage lists, and subsequent reports 
required under 21 U.S.C. 826a for those calendar years, the Acting 
Administrator has determined that inclusion of the additional 25% of 
the estimated medical, scientific, and research needs for the United 
States is unnecessary. Instead, the Acting Administrator determined 
that 21 U.S.C. 826(c) and 21 U.S.C. 952(a)(2)(A) provide sufficient 
ability for the DEA to mitigate adverse public effects should a natural 
disaster or other unforeseen event result in substantial disruption to 
the amount of controlled substances available for legitimate public 
need. As such, DEA proposes to remove the additional 25% from the 
aggregate production quotas. The resulting proposed established 
aggregate production quotas reflect these reduced amounts.
    The Acting Administrator, therefore, proposes to establish the 2017 
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 2017
                     Basic class                           quotas (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-                    15
 yl)methanone (THJ-2201).............................
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-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-                35
 200)................................................
1-Benzylpiperazine...................................                 25

[[Page 47823]]

 
1-Butyl-3-(1-naphthoyl)indole (JWH-073)..............                 45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-                45
 18 and RCS-8).......................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)..............                 45
1-Methyl-4-phenyl-4-propionoxypiperidine.............                  2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)...                 35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)....                 30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)...                 30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)....                 30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)....                 30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)                 30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)..                 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E).....                 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)....                 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)....                 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)..                 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H).............                 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-                                   5
 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-                30
 2)..................................................
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine                   30
 (2C-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.....................................                  2
3-Methylthiofentanyl.................................                  2
4-Bromo-2,5-dimethoxyamphetamine (DOB)...............                 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)...........                 25
4-FMC; Flephedrone...................................                 25
4-Methoxyamphetamine.................................                150
4-Methyl-2,5-dimethoxyamphetamine (DOM)..............                 25
4-Methylaminorex.....................................                 25
4-MEC; 4-Methyl-N-ethylcathinone.....................                 25
4-Methyl-N-methylcathinone (mephedrone)..............                 45
4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP)..                 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-                                  50
 hydroxycyclohexyl]-phenol...........................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
5-Fluoro-UR144, XLR11................................                 25
5-Methoxy-3,4-methylenedioxyamphetamine..............                 25
5-Methoxy-N,N-diisopropyltryptamine..................                 25
5-Methoxy-N,N-dimethyltryptamine.....................                 25
AB-PINACA............................................                 15
Acetyl-alpha-methylfentanyl..........................                  2
Acetyldihydrocodeine.................................                  2
Acetylmethadol.......................................                  2
AH-7921..............................................                 30
Allylprodine.........................................                  2
alpha-Ethyltryptamine................................                 25
alpha-Methylfentanyl.................................                  2
alpha-Methylthiofentanyl.............................                  2
alpha-Methyltryptamine (AMT).........................                 25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP)..........                 25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP).........                 25
Alphacetylmethadol...................................                  2
Alphameprodine.......................................                  2
Alphamethadol........................................                  2
Aminorex.............................................                 25
APINCA, AKB48........................................                 25
Benzylmorphine.......................................                  2
beta-Hydroxy-3-methylfentanyl........................                  2
beta-Hydroxyfentanyl.................................                  2
beta-Hydroxythiofentanyl.............................                 30
Betacetylmethadol....................................                  2
Betameprodine........................................                  2

[[Page 47824]]

 
Betamethadol.........................................                  4
Betaprodine..........................................                  2
Bufotenine...........................................                  3
Butylone.............................................                 25
Butyryl fentanyl.....................................                 30
Cathinone............................................                 24
Codeine methylbromide................................                  5
Codeine-N-oxide......................................                305
Desomorphine.........................................                 25
Diethyltryptamine....................................                 25
Difenoxin............................................              8,750
Dihydromorphine......................................          1,566,000
Dimethyltryptamine...................................                 35
Dipipanone...........................................                  5
Fenethylline.........................................                  5
gamma-Hydroxybutyric acid............................         56,200,000
Heroin...............................................                 25
Hydromorphinol.......................................                  2
Hydroxypethidine.....................................                  2
Ibogaine.............................................                  5
Lysergic acid diethylamide (LSD).....................                 10
Marihuana............................................            472,000
Mescaline............................................                 25
Methaqualone.........................................                 10
Methcathinone........................................                 25
Methyldesorphine.....................................                  5
Methyldihydromorphine................................                  2
Morphine methylbromide...............................                  5
Morphine methylsulfonate.............................                  5
Morphine-N-oxide.....................................                350
N,N-Dimethylamphetamine..............................                 25
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-                 50
 indazole-3-carboxamide (ADB-PINACA).................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-                            50
 fluorobenzyl)-1H-indazole-3-carboxamide (AB-
 FUBINACA)...........................................
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-                               15
 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-
 CHMINACA)...........................................
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide                      100
 (acetyl fentanyl)...................................
N-Ethyl-1-phenylcyclohexylamine......................                  5
N-Ethylamphetamine...................................                 24
N-Hydroxy-3,4-methylenedioxyamphetamine..............                 24
Naphyrone............................................                 25
Noracymethadol.......................................                  2
Norlevorphanol.......................................                 52
Normethadone.........................................                  2
Normorphine..........................................                 40
Para-fluorofentanyl..................................                  5
Parahexyl............................................                  5
Pentedrone...........................................                 25
Pentylone............................................                 25
Phenomorphan.........................................                  2
Pholcodine...........................................                  5
Psilocybin...........................................                 30
Psilocyn.............................................                 50
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-                         20
 carboxylate (5-fluoro-PB-22; 5F-PB-22)..............
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-                   20
 22; QUPIC)..........................................
Tetrahydrocannabinols................................            409,000
Thiofentanyl.........................................                  2
Tilidine.............................................                 25
Trimeperidine........................................                  2
UR-144...............................................                 25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine..............................                  4
1-Piperidinocyclohexanecarbonitrile..................                  4
4-Anilino-N-phenethyl-4-piperidine (ANPP)............          1,000,000
Alfentanil...........................................              4,200
Alphaprodine.........................................                  2
Amobarbital..........................................             20,100
Amphetamine (for conversion).........................          9,000,000
Amphetamine (for sale)...............................         37,500,000
Carfentanil..........................................                 10
Cocaine..............................................             94,000
Codeine (for conversion).............................         40,000,000
Codeine (for sale)...................................         45,000,000

[[Page 47825]]

 
Dextropropoxyphene...................................                 15
Dihydrocodeine.......................................             81,100
Dihydroetorphine.....................................                  2
Diphenoxylate (for conversion).......................             15,000
Diphenoxylate (for sale).............................            820,000
Ecgonine.............................................             90,000
Ethylmorphine........................................                  2
Etorphine hydrochloride..............................                  2
Fentanyl.............................................          1,750,000
Glutethimide.........................................                  2
Hydrocodone (for conversion).........................            122,000
Hydrocodone (for sale)...............................         58,410,000
Hydromorphone........................................          4,300,000
Isomethadone.........................................                  4
Levo-alphacetylmethadol (LAAM).......................                  3
Levomethorphan.......................................                 10
Levorphanol..........................................              4,900
Lisdexamfetamine.....................................         19,000,000
Meperidine...........................................          3,706,000
Meperidine Intermediate-A............................                  5
Meperidine Intermediate-B............................                  9
Meperidine Intermediate-C............................                  5
Metazocine...........................................                 15
Methadone (for sale).................................         23,700,000
Methadone Intermediate...............................         25,600,000
Methamphetamine......................................          1,539,100
------------------------------------------------------------------------
[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......................................         73,000,000
Morphine (for conversion)............................         27,300,000
Morphine (for sale)..................................         41,000,000
Nabilone.............................................             15,000
Noroxymorphone (for conversion)......................         17,700,000
Noroxymorphone (for sale)............................            400,000
Opium (powder).......................................             90,000
Opium (tincture).....................................            300,000
Oripavine............................................         20,000,000
Oxycodone (for conversion)...........................          2,610,000
Oxycodone (for sale).................................        108,510,000
Oxymorphone (for conversion).........................         22,300,000
Oxymorphone (for sale)...............................          4,200,000
Pentobarbital........................................         27,500,000
Phenazocine..........................................                  5
Phencyclidine........................................                 20
Phenmetrazine........................................                  2
Phenylacetone........................................                 20
Racemethorphan.......................................                  2
Racemorphan..........................................                  2
Remifentanil.........................................              3,000
Secobarbital.........................................            172,002
Sufentanil...........................................              4,000
Tapentadol...........................................         21,000,000
Thebaine.............................................        100,000,000
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)...........................             50,000
Ephedrine (for sale).................................          4,100,000
Phenylpropanolamine (for conversion).................         15,000,000
Phenylpropanolamine (for sale).......................          8,500,000
Pseudoephedrine (for sale)...........................        200,000,000
------------------------------------------------------------------------

    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 2017 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

[[Page 47826]]

2017 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 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17370 Filed 7-21-16; 8:45 am]
 BILLING CODE 4410-09-P