Proposed Adjustments to the 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 2016, 47829-47834 [2016-17371]

Download as PDF Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices ehiers on DSK5VPTVN1PROD with NOTICES Michigan, the State in which he seeks registration. Because he does not meet this prerequisite for obtaining a DEA registration, I will deny his application on this basis. Material Falsification Pursuant to section 304(a)(1), the Attorney General is also authorized to suspend or revoke a registration ‘‘upon a finding that the registrant . . . has materially falsified any application filed pursuant to or required by this subchapter.’’ 21 U.S.C. 824(a)(1). It is well established that the various grounds for revocation or suspension of an existing registration that Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also properly considered in deciding whether to grant or deny an application under section 303. See The Lawsons, Inc., 72 FR 74334, 74337 (2007); Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 (1993). Thus, the allegation that Applicant materially falsified his application is properly considered in this proceeding. See Samuel S. Jackson, 72 FR 23848, 23852 (2007). Moreover, just as materially falsifying an application provides a basis for revoking an existing registration without proof of any other misconduct, see 21 U.S.C. 824(a)(1), it also provides an independent and adequate ground for denying an application. The Lawsons, 72 FR 74338; cf. Bobby Watts, M.D., 58 FR 46995 (1993). Here, the Government’s evidence shows that upon being served with an Order to Show Cause and Immediate Suspension of Registration which alleged that he had prescribed controlled substances in violation of the CSA, Applicant surrendered his registration. GXs 3 & 4. Moreover, on the Voluntary Surrender form, Applicant acknowledged that he was doing so ‘‘[i]n view of my alleged failure to comply with the Federal requirements pertaining to controlled substances.’’ GX 4. Yet days later, Applicant applied for a new registration and provided a ‘‘no’’ answer to the question: ‘‘[h]as the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended, restricted or denied, or is any such action pending?’’ GX 1, at 1, 3. Applicant’s answer was false as he had clearly surrendered his registration for cause. His false answer was also material as ‘‘it ‘ha[d] a natural tendency to influence, or was capable of influencing, the decision of’ the decisionmaking body to which it was addressed.’’ Kungys v. United States, VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 485 U.S. 759, 770 (1988) (quoting Weinstock v. United States, 231 F.2d 699, 701 (D.C. Cir. 1956)) (other citation omitted); see also United States v. Wells, 519 U.S. 482, 489 (1997) (quoting Kungys, 485 U.S. at 770). As the Supreme Court has further explained, ‘‘it has never been the test of materiality that the misrepresentation or concealment would more likely than not have produced an erroneous decision, or even that it would more likely than not have triggered an investigation, but rather, whether the misrepresentation or concealment was predictably capable of affecting, i.e., had a natural tendency to affect, the official decision.’’ Kungys, 485 U.S. at 771. While the evidence must be ‘‘clear, unequivocal, and convincing,’’ the ‘‘ultimate finding of materiality turns on an interpretation of the substantive law.’’ Id. at 772 (int. quotations and citations omitted). Applicant’s false answer to the question of whether he had ever surrendered his federal registration was clearly ‘‘capable of affecting’’ the decision of whether to grant his application. As the evidence shows, Applicant surrendered his registration in response to allegations that he violated the CSA and DEA regulations by prescribing controlled substances that were in schedules for which he lacked authorization, as well as allegations that he issued prescriptions that lacked a legitimate medical purpose. GX 3, at 2 (Sept. 24, 2012 Immediate Suspension Order) (citing 21 U.S.C. 822(b) and 841(a)(1); 21 CFR 1301.12(a) and 1306.04(a)). Notably, under the public interest standard, the Agency is required to consider both the Applicant’s ‘‘experience in dispensing . . . controlled substances’’ and his ‘‘[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.’’ 21 U.S.C. 823(f)(2) & (4). See also Shannon L. Gallentine, D.P.M., 76 FR 45864, 45866 (2011). Thus, notwithstanding that the Agency did not grant his application, his false answer was still material as it was capable of influencing the decision as to whether to grant his application. See United States v. Alemany Rivera, 781 F.2d 229, 234 (1st Cir. 1985) (‘‘It makes no difference that a specific falsification did not exert influence so long as it had the capacity to do so.’’); United States v. Norris, 749 F.2d 1116, 1121 (4th Cir. 1984) (‘‘There is no requirement that the false statement influence or effect the decision making process of a department of the United States Government.’’). Accordingly, I conclude that Applicant materially falsified his September 2012 application PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 47829 for registration. This provides a further reason to deny his pending application. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28 CFR 0.100(b), I order that the application of Mikhayl Soliman, M.D., for a DEA Certificate of Registration as a practitioner, be, and it hereby is, denied. This Order is effective immediately. Dated: July 15, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016–17394 Filed 7–21–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–420P] Proposed Adjustments to the 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 2016 Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. AGENCY: The Drug Enforcement Administration (DEA) proposes to adjust the 2016 aggregate production quotas for several 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 1303.13(c) and 1315.13(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 DATES: E:\FR\FM\22JYN1.SGM 22JYN1 47830 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices ehiers on DSK5VPTVN1PROD with NOTICES Federal Register a final order establishing the 2016 adjusted 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–420P’’ 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 VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 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 and Background 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. The DEA established the 2016 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on October 6, 2015 (80 FR 60400). That notice stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment. PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 Analysis for Proposed Adjusted 2016 Aggregate Production Quotas and Assessment of Annual Needs The DEA proposes to adjust the established 2016 aggregate production quotas and assessment of annual needs for certain schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2016 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. In determining the proposed adjustment, the Acting Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2016 by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical; and (5) other factors affecting medical, scientific, research, and industrial needs in 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. The Acting Administrator also considered updated information obtained from 2015 year-end inventories, 2015 disposition data submitted by quota applicants, E:\FR\FM\22JYN1.SGM 22JYN1 47831 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices estimates of the medical needs of the United States, product development, and other information made available to the DEA after the initial aggregate production quotas and assessment of annual needs had been established. 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 adjusted 2016 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). As described in the previously published notice establishing the 2016 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers, 21 CFR 1303.24, may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substance aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances. The Acting Administrator, therefore, proposes that the year 2016 aggregate production quotas for the two temporarily scheduled substances be established, and to adjust the 2016 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: Established 2016 quotas (g) Basic class Proposed revised 2016 quotas (g) Temporarily Scheduled Substances beta-Hydroxythiofentanyl ................................................................................................................................ Butyryl fentanyl ............................................................................................................................................... N/A N/A 30. 30. 15 10 45 45 15 45 25 45 45 45 2 45 45 45 45 45 45 45 30 30 30 30 30 25 no no no no no no no no no no no no no no no no no no no no no no no no 30 25 no change. no change. 30 15 no change. no change. 25 25 25 no change. no change. no change. 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 ......................................................................................................................................... 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 ........................................................................................................................... VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. change. 47832 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices Established 2016 quotas (g) ehiers on DSK5VPTVN1PROD with NOTICES Basic class Proposed revised 2016 quotas (g) 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 C8homolog). 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 ...................................................................................................................................... Betacetylmethadol .......................................................................................................................................... Betameprodine ................................................................................................................................................ Betamethadol .................................................................................................................................................. Betaprodine ..................................................................................................................................................... Bufotenine ....................................................................................................................................................... Butylone .......................................................................................................................................................... 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 ....................................................................................................................................................... VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 30 30 25 55 50 40 50 35 25 2 2 25 25 25 150 25 25 25 45 25 68 53 no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. 50. 40. 25 25 25 25 15 2 2 2 N/A 2 25 2 2 25 25 25 2 2 2 25 25 2 2 2 2 2 4 2 3 25 70 5 305 25 25 11,000 3,000,000 35 5 5 70,250,000 50 2 2 5 40 658,000 no change. no change. no change. no change. no change. no change. no change. no change. 30. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. 30. no change. no change. no change. no change. no change. 2,000,000. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. 47833 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices Established 2016 quotas (g) Basic class Proposed revised 2016 quotas (g) 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 ........................................................................................................................................................... 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 50 50 511,250 2 25 2 25 no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. no change. 25. 25. no change. no change. no change. no change. no change. 5 5 2,950,000 17,750 3 25,125 15,000,000 39,705,000 19 200,000 50,000,000 63,900,000 19 226,375 3 31,250 1,337,500 125,000 3 3 2,300,000 3 235,000 88,500,000 8,250,000 5 4 30 7,125 29,750,000 5,450,000 6 no change. no change. 2,250,000. no change. no change. no change. no change. 45,000,000. no change. no change. no change. no change. no change. no change. no change. 18,750. no change. no change. 5. no change. no change. no change. 177,500. 86,000,000. 7,000,000. no change. no change. 33. no change. 23,750,000. 4,632,500. no change. 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) ........................................................................................................................................... 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 ............................................................................................................................. VerDate Sep<11>2014 15:19 Jul 21, 2016 Jkt 238001 PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 E:\FR\FM\22JYN1.SGM 22JYN1 47834 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices Established 2016 quotas (g) Basic class Proposed revised 2016 quotas (g) Meperidine Intermediate-B ............................................................................................................................. Meperidine Intermediate-C ............................................................................................................................. Metazocine ...................................................................................................................................................... Methadone (for sale) ...................................................................................................................................... Methadone Intermediate ................................................................................................................................. Methamphetamine .......................................................................................................................................... 11 6 19 31,875,000 34,375,000 2,061,375 no no no no no no change. change. change. change. change. change. [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 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 ......................................................................................................................................................... 96,750,000 91,250,000 62,500,000 18,750 17,500,000 1,475,000 112,500 687,500 30,000,000 6,250,000 139,150,000 29,000,000 7,750,000 38,125,000 6 50 3 50 3 3 3,750 215,003 6,255 25,500,000 125,000,000 84,375,000. no change. no change. no change. no change. 625,000. no change. 375,000. no change. 5,000,000. no change. 25,000,000. 6,250,000. no change. no change. no change. no change. no change. 5. no change. no change. no change. no change. no change. no change. 100,000 4,000,000 22,400,000 8,500,000 7,000 224,500,000 50,000. no change. 15,000,000. no change. 40. 200,000,000. 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 2016 aggregate production quotas and assessment of annual needs as needed. ehiers on DSK5VPTVN1PROD with NOTICES Conclusion Dated: July 14, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016–17371 Filed 7–21–16; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE 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 any adjustment of 2016 aggregate production quota for each basic class of controlled substances in schedules I and II and VerDate Sep<11>2014 established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f). 15:19 Jul 21, 2016 Jkt 238001 Notice of Charter Renewal Justice Department. Notice of Charter Renewal of the Executive Advisory Board of the National Domestic Communications Assistance Center. AGENCY: ACTION: PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 In accordance with the provisions of the Federal Advisory Committee Act, title 5, United States Code, Appendix, and title 41 of the U.S. Code of Federal Regulations, section 101–6.1015, notice is hereby given that the Charter of the National Domestic Communications Assistance Center (NDCAC) Executive Advisory Board (EAB) has been renewed. The Charter is on file with the General Services Administration. The Attorney General determined that the NDCAC EAB is in the public interest and is necessary in connection with the performance of duties of the United States Department of Justice. These duties can best be performed through the advice and counsel of this group. The purpose of the EAB is to provide advice and recommendations to the SUMMARY: E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)]
[Notices]
[Pages 47829-47834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17371]


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

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-420P]


Proposed Adjustments to the 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 2016

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.

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

SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust 
the 2016 aggregate production quotas for several 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 1303.13(c) and 1315.13(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

[[Page 47830]]

Federal Register a final order establishing the 2016 adjusted 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-420P'' 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 
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 and Background

    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.
    The DEA established the 2016 aggregate production quotas for 
substances in schedules I and II and the assessment of annual needs for 
the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine on October 6, 2015 (80 FR 60400). That notice 
stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all 
aggregate production quotas and assessments of annual need are subject 
to adjustment.

Analysis for Proposed Adjusted 2016 Aggregate Production Quotas and 
Assessment of Annual Needs

    The DEA proposes to adjust the established 2016 aggregate 
production quotas and assessment of annual needs for certain schedule I 
and II controlled substances, and the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine, to be manufactured in the 
United States in 2016 to provide for the estimated medical, scientific, 
research, and industrial needs of the United States, for lawful export 
requirements, and for the establishment and maintenance of reserve 
stocks. These quotas do not include imports of controlled substances 
for use in industrial processes.
    In determining the proposed adjustment, the Acting Administrator 
has taken into account the criteria in accordance with 21 CFR 1303.13 
(adjustment of aggregate production quotas for controlled substances) 
and 21 CFR 1315.13 (adjustment of the assessment of annual needs for 
ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA 
determined whether to propose an adjustment of the aggregate production 
quotas and assessment of annual needs for 2016 by considering: (1) 
Changes in the demand for that class or chemical, changes in the 
national rate of net disposal of the class or chemical, and changes in 
the rate of net disposal of the class or chemical by registrants 
holding individual manufacturing quotas for the class; (2) whether any 
increased demand for that class or chemical, the national and/or 
individual rates of net disposal of that class or chemical are 
temporary, short term, or long term; (3) whether any increased demand 
for that class or chemical can be met through existing inventories, 
increased individual manufacturing quotas, or increased importation, 
without increasing the aggregate production quota; (4) whether any 
decreased demand for that class or chemical will result in excessive 
inventory accumulation by all persons registered to handle that class 
or chemical; and (5) other factors affecting medical, scientific, 
research, and industrial needs in 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.
    The Acting Administrator also considered updated information 
obtained from 2015 year-end inventories, 2015 disposition data 
submitted by quota applicants,

[[Page 47831]]

estimates of the medical needs of the United States, product 
development, and other information made available to the DEA after the 
initial aggregate production quotas and assessment of annual needs had 
been established. 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 adjusted 2016 assessment of annual needs, the 
DEA used the calculation methodology previously described in the 2010 
and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 
2009, and 75 FR 79407, Dec. 20, 2010, respectively).
    As described in the previously published notice establishing the 
2016 aggregate production quotas and assessment of annual needs, the 
DEA has specifically considered that inventory allowances granted to 
individual manufacturers, 21 CFR 1303.24, may not always result in the 
availability of sufficient quantities to maintain an adequate reserve 
stock pursuant to 21 U.S.C. 826(a), as intended. This would be 
concerning if a natural disaster or other unforeseen event resulted in 
substantial disruption to the amount of controlled substances available 
to provide for legitimate public need. As such, the DEA has included in 
all proposed adjusted schedule II controlled substance aggregate 
production quotas, and certain proposed adjusted schedule I controlled 
substance aggregate production quotas, an additional 25% of the 
estimated medical, scientific, and research needs as part of the amount 
necessary to ensure the establishment and maintenance of reserve 
stocks. The resulting adjusted established aggregate production quotas 
will reflect these included amounts. This action will not affect the 
ability of manufacturers to maintain inventory allowances as specified 
by regulation. The DEA expects that maintaining this reserve in certain 
established aggregate production quotas will mitigate adverse public 
effects if an unforeseen event resulted in substantial disruption to 
the amount of controlled substances available to provide for legitimate 
public need, as determined by the DEA. The DEA does not anticipate 
utilizing the reserve in the absence of these circumstances.
    The Acting Administrator, therefore, proposes that the year 2016 
aggregate production quotas for the two temporarily scheduled 
substances be established, and to adjust the 2016 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:

------------------------------------------------------------------------
                                Established  2016    Proposed  revised
                                      quotas            2016  quotas
          Basic class          -----------------------------------------
                                       (g)                  (g)
------------------------------------------------------------------------
                    Temporarily Scheduled Substances
------------------------------------------------------------------------
beta-Hydroxythiofentanyl......                N/A  30.
Butyryl fentanyl..............                N/A  30.
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
[1-(5-fluoropentyl)-1H-indazol-                15  no change.
 3-yl](naphthalen-1-
 yl)methanone (THJ-2201).
1-(1-                                          10  no change.
 Phenylcyclohexyl)pyrrolidine.
1-(5-Fluoropentyl)-3-(1-                       45  no change.
 naphthoyl)indole (AM2201).
1-(5-Fluoropentyl)-3-(2-                       45  no change.
 iodobenzoyl)indole (AM694).
1-[1-(2-                                       15  no change.
 Thienyl)cyclohexyl]piperidine.
1-[2-(4-Morpholinyl)ethyl]-3-                  45  no change.
 (1-naphthoyl)indole (JWH-200).
1-Benzylpiperazine............                 25  no change.
1-Butyl-3-(1-naphthoyl)indole                  45  no change.
 (JWH-073).
1-Cyclohexylethyl-3-(2-                        45  no change.
 methoxyphenylacetyl)indole
 (SR-18 and RCS-8).
1-Hexyl-3-(1-naphthoyl)indole                  45  no change.
 (JWH-019).
1-Methyl-4-phenyl-4-                            2  no change.
 propionoxypiperidine.
1-Pentyl-3-(1-naphthoyl)indole                 45  no change.
 (JWH-018 and AM678).
1-Pentyl-3-(2-                                 45  no change.
 chlorophenylacetyl)indole
 (JWH-203).
1-Pentyl-3-(2-                                 45  no change.
 methoxyphenylacetyl)indole
 (JWH-250).
1-Pentyl-3-(4-chloro-1-                        45  no change.
 naphthoyl)indole (JWH-398).
1-Pentyl-3-(4-methyl-1-                        45  no change.
 naphthoyl)indole (JWH-122).
1-Pentyl-3-[(4-methoxy)-                       45  no change.
 benzoyl]indole (SR-19, RCS-4).
1-Pentyl-3-[1-(4-                              45  no change.
 methoxynaphthoyl)]indole (JWH-
 081).
2-(2,5-Dimethoxy-4-                            30  no change.
 ethylphenyl)ethanamine (2C-E).
2-(2,5-Dimethoxy-4-                            30  no change.
 methylphenyl)ethanamine (2C-
 D).
2-(2,5-Dimethoxy-4-nitro-                      30  no change.
 phenyl)ethanamine (2C-N).
2-(2,5-Dimethoxy-4-n-                          30  no change.
 propylphenyl)ethanamine (2C-
 P).
2-(2,5-                                        30  no change.
 Dimethoxyphenyl)ethanamine
 (2C-H).
2-(4-Bromo-2,5-                                25  no change.
 dimethoxyphenyl)-N-(2-
 methoxybenzyl)ethanamine (25B-
 NBOMe; 2C-B-NBOMe; 25B; Cimbi-
 36).
2-(4-Chloro-2,5-                               30  no change.
 dimethoxyphenyl)ethanamine
 (2C-C).
2-(4-Chloro-2,5-                               25  no change.
 dimethoxyphenyl)-N-(2-
 methoxybenzyl)ethanamine (25C-
 NBOMe; 2C-C-NBOMe; 25C; Cimbi-
 82).
2-(4-Iodo-2,5-                                 30  no change.
 dimethoxyphenyl)ethanamine
 (2C-I).
2-(4-Iodo-2,5-dimethoxyphenyl)-                15  no change.
 N-(2-methoxybenzyl)ethanamine
 (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5).
2,5-Dimethoxy-4-                               25  no change.
 ethylamphetamine (DOET).
2,5-Dimethoxy-4-n-                             25  no change.
 propylthiophenethylamine.
2,5-Dimethoxyamphetamine......                 25  no change.

[[Page 47832]]

 
2-[4-(Ethylthio)-2,5-                          30  no change.
 dimethoxyphenyl]ethanamine
 (2C-T-2).
2-[4-(Isopropylthio)-2,5-                      30  no change.
 dimethoxyphenyl]ethanamine
 (2C-T-4).
3,4,5-Trimethoxyamphetamine...                 25  no change.
3,4-Methylenedioxyamphetamine                  55  no change.
 (MDA).
3,4-                                           50  no change.
 Methylenedioxymethamphetamine
 (MDMA).
3,4-Methylenedioxy-N-                          40  no change.
 ethylamphetamine (MDEA).
3,4-Methylenedioxy-N-                          50  no change.
 methylcathinone (methylone).
3,4-Methylenedioxypyrovalerone                 35  no change.
 (MDPV).
3-FMC; 3-Fluoro-N-                             25  no change.
 methylcathinone.
3-Methylfentanyl..............                  2  no change.
3-Methylthiofentanyl..........                  2  no change.
4-Bromo-2,5-                                   25  no change.
 dimethoxyamphetamine (DOB).
4-Bromo-2,5-                                   25  no change.
 dimethoxyphenethylamine (2-
 CB).
4-FMC; Flephedrone............                 25  no change.
4-Methoxyamphetamine..........                150  no change.
4-Methyl-2,5-                                  25  no change.
 dimethoxyamphetamine (DOM).
4-Methylaminorex..............                 25  no change.
4-MEC; 4-Methyl-N-                             25  no change.
 ethylcathinone.
4-Methyl-N-methylcathinone                     45  no change.
 (mephedrone).
4-Methyl-[alpha]-                              25  no change.
 pyrrolidinopropiophenone (4-
 MePPP).
5-(1,1-Dimethylheptyl)-2-                      68  50.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol.
5-(1,1-Dimethyloctyl)-2-                       53  40.
 [(1R,3S)-3-hydroxycyclohexyl]-
 phenol (cannabicyclohexanol
 or CP-47,497 C8-homolog).
5-Fluoro-UR144, XLR11.........                 25  no change.
5-Methoxy-3,4-                                 25  no change.
 methylenedioxyamphetamine.
5-Methoxy-N,N-                                 25  no change.
 diisopropyltryptamine.
5-Methoxy-N,N-                                 25  no change.
 dimethyltryptamine.
AB-PINACA.....................                 15  no change.
Acetyl-alpha-methylfentanyl...                  2  no change.
Acetyldihydrocodeine..........                  2  no change.
Acetylmethadol................                  2  no change.
AH-7921.......................                N/A  30.
Allylprodine..................                  2  no change.
alpha-Ethyltryptamine.........                 25  no change.
alpha-Methylfentanyl..........                  2  no change.
alpha-Methylthiofentanyl......                  2  no change.
alpha-Methyltryptamine (AMT)..                 25  no change.
alpha-Pyrrolidinobutiophenone                  25  no change.
 ([alpha]-PBP).
alpha-Pyrrolidinopentiophenone                 25  no change.
 ([alpha]-PVP).
Alphacetylmethadol............                  2  no change.
Alphameprodine................                  2  no change.
Alphamethadol.................                  2  no change.
Aminorex......................                 25  no change.
APINCA, AKB48.................                 25  no change.
Benzylmorphine................                  2  no change.
beta-Hydroxy-3-methylfentanyl.                  2  no change.
beta-Hydroxyfentanyl..........                  2  no change.
Betacetylmethadol.............                  2  no change.
Betameprodine.................                  2  no change.
Betamethadol..................                  4  no change.
Betaprodine...................                  2  no change.
Bufotenine....................                  3  no change.
Butylone......................                 25  no change.
Cathinone.....................                 70  30.
Codeine methylbromide.........                  5  no change.
Codeine-N-oxide...............                305  no change.
Desomorphine..................                 25  no change.
Diethyltryptamine.............                 25  no change.
Difenoxin.....................             11,000  no change.
Dihydromorphine...............          3,000,000  2,000,000.
Dimethyltryptamine............                 35  no change.
Dipipanone....................                  5  no change.
Fenethylline..................                  5  no change.
gamma-Hydroxybutyric acid.....         70,250,000  no change.
Heroin........................                 50  no change.
Hydromorphinol................                  2  no change.
Hydroxypethidine..............                  2  no change.
Ibogaine......................                  5  no change.
Lysergic acid diethylamide                     40  no change.
 (LSD).
Marihuana.....................            658,000  no change.

[[Page 47833]]

 
Mescaline.....................                 25  no change.
Methaqualone..................                 10  no change.
Methcathinone.................                 25  no change.
Methyldesorphine..............                  5  no change.
Methyldihydromorphine.........                  2  no change.
Morphine methylbromide........                  5  no change.
Morphine methylsulfonate......                  5  no change.
Morphine-N-oxide..............                350  no change.
N,N-Dimethylamphetamine.......                 25  no change.
N-(1-Amino-3,3-dimethyl-1-                     50  no change.
 oxobutan-2-yl)-1-pentyl-1H-
 indazole-3-carboxamide (ADB-
 PINACA).
N-(1-Amino-3-methyl-1-oxobutan-                50  no change.
 2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide (AB-
 FUBINACA).
N-(1-Amino-3-methyl-1-oxobutan-                15  no change.
 2-yl)-1-(cyclohexylmethyl)-1H-
 indazole-3-carboxamide (AB-
 CHMINACA).
N-(1-phenethylpiperidin-4-yl)-                100  no change.
 N-phenylacetamide (acetyl
 fentanyl).
N-Ethyl-1-                                      5  no change.
 phenylcyclohexylamine.
N-Ethylamphetamine............                 24  no change.
N-Hydroxy-3,4-                                 24  no change.
 methylenedioxyamphetamine.
Naphyrone.....................                 25  no change.
Noracymethadol................                  2  no change.
Norlevorphanol................                 52  no change.
Normethadone..................                  2  no change.
Normorphine...................                 40  no change.
Para-fluorofentanyl...........                  5  no change.
Parahexyl.....................                  5  no change.
Pentedrone....................                 25  no change.
Pentylone.....................                 25  no change.
Phenomorphan..................                  2  no change.
Pholcodine....................                  5  no change.
Psilocybin....................                 30  no change.
Psilocyn......................                 50  no change.
Quinolin-8-yl 1-(5-                            50  25.
 fluoropentyl)-1H-indole-3-
 carboxylate (5-fluoro-PB-22;
 5F-PB-22).
Quinolin-8-yl 1-pentyl-1H-                     50  25.
 indole-3-carboxylate (PB-22;
 QUPIC).
Tetrahydrocannabinols.........            511,250  no change.
Thiofentanyl..................                  2  no change.
Tilidine......................                 25  no change.
Trimeperidine.................                  2  no change.
UR-144........................                 25  no change.
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine.......                  5  no change.
1-                                              5  no change.
 Piperidinocyclohexanecarbonit
 rile.
4-Anilino-N-phenethyl-4-                2,950,000  2,250,000.
 piperidine (ANPP).
Alfentanil....................             17,750  no change.
Alphaprodine..................                  3  no change.
Amobarbital...................             25,125  no change.
Amphetamine (for conversion)..         15,000,000  no change.
Amphetamine (for sale)........         39,705,000  45,000,000.
Carfentanil...................                 19  no change.
Cocaine.......................            200,000  no change.
Codeine (for conversion)......         50,000,000  no change.
Codeine (for sale)............         63,900,000  no change.
Dextropropoxyphene............                 19  no change.
Dihydrocodeine................            226,375  no change.
Dihydroetorphine..............                  3  no change.
Diphenoxylate (for conversion)             31,250  18,750.
Diphenoxylate (for sale)......          1,337,500  no change.
Ecgonine......................            125,000  no change.
Ethylmorphine.................                  3  5.
Etorphine hydrochloride.......                  3  no change.
Fentanyl......................          2,300,000  no change.
Glutethimide..................                  3  no change.
Hydrocodone (for conversion)..            235,000  177,500.
Hydrocodone (for sale)........         88,500,000  86,000,000.
Hydromorphone.................          8,250,000  7,000,000.
Isomethadone..................                  5  no change.
Levo-alphacetylmethadol (LAAM)                  4  no change.
Levomethorphan................                 30  33.
Levorphanol...................              7,125  no change.
Lisdexamfetamine..............         29,750,000  23,750,000.
Meperidine....................          5,450,000  4,632,500.
Meperidine Intermediate-A.....                  6  no change.

[[Page 47834]]

 
Meperidine Intermediate-B.....                 11  no change.
Meperidine Intermediate-C.....                  6  no change.
Metazocine....................                 19  no change.
Methadone (for sale)..........         31,875,000  no change.
Methadone Intermediate........         34,375,000  no change.
Methamphetamine...............          2,061,375  no change.
------------------------------------------------------------------------
  [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
 non-prescription product; 750,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 61,375 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate...............         96,750,000  84,375,000.
Morphine (for conversion).....         91,250,000  no change.
Morphine (for sale)...........         62,500,000  no change.
Nabilone......................             18,750  no change.
Noroxymorphone (for                    17,500,000  no change.
 conversion).
Noroxymorphone (for sale).....          1,475,000  625,000.
Opium (powder)................            112,500  no change.
Opium (tincture)..............            687,500  375,000.
Oripavine.....................         30,000,000  no change.
Oxycodone (for conversion)....          6,250,000  5,000,000.
Oxycodone (for sale)..........        139,150,000  no change.
Oxymorphone (for conversion)..         29,000,000  25,000,000.
Oxymorphone (for sale)........          7,750,000  6,250,000.
Pentobarbital.................         38,125,000  no change.
Phenazocine...................                  6  no change.
Phencyclidine.................                 50  no change.
Phenmetrazine.................                  3  no change.
Phenylacetone.................                 50  no change.
Racemethorphan................                  3  5.
Racemorphan...................                  3  no change.
Remifentanil..................              3,750  no change.
Secobarbital..................            215,003  no change.
Sufentanil....................              6,255  no change.
Tapentadol....................         25,500,000  no change.
Thebaine......................        125,000,000  no change.
------------------------------------------------------------------------
                            List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)....            100,000  50,000.
Ephedrine (for sale)..........          4,000,000  no change.
Phenylpropanolamine (for               22,400,000  15,000,000.
 conversion).
Phenylpropanolamine (for sale)          8,500,000  no change.
Pseudoephedrine (for                        7,000  40.
 conversion).
Pseudoephedrine (for sale)....        224,500,000  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 2016 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 any 
adjustment of 2016 aggregate production quota for each basic class of 
controlled substances in schedules I and II and established assessment 
of annual needs for the list I chemicals ephedrine, pseudoephedrine, 
and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).

    Dated: July 14, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-17371 Filed 7-21-16; 8:45 am]
 BILLING CODE 4410-09-P