Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2014, 40186-40189 [2013-16052]

Download as PDF 40186 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 1308.24(a). All other requirements of the CSA and the CFR apply, including, but not limited to, registration as an importer as required by 21 U.S.C. 957. controlled substance will require a new application for exemption pursuant to 21 U.S.C. 811(g)(3)(B) and 21 CFR 1308.23–1308.24. Dated: June 17, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator. Chemical Preparations Containing Newly Controlled Substances The statutory authority for exempt chemical preparations is based on the control status of substances contained within a preparation, the intended administration of a preparation, and the packaged form of a preparation. DEA conducts a case-by-case analysis of each application for exemption to determine whether exemption of a preparation from certain provisions of the CSA is appropriate pursuant to the specified statutory and regulatory requirements. Most exempt chemical preparations have remained effective until the holder of a specific exempt chemical preparation specifically requested that the exemption be terminated. The CSA allows for modifications to the controlled substances schedules to add, remove, or change the schedule of substances thus resulting in periodic modifications to the control status of various substances. 21 U.S.C. 811(a). Since the CSA was enacted in 1970, DEA has on several occasions added to, removed from, or modified the schedules of controlled substances in accordance with the CSA. Such changes may result in the non-compliance of exempt chemical preparations with current statutes or regulations if chemical preparations that have already obtained exempt status contain newly controlled substances. For example, although an exempt chemical preparation may continue to be packaged in the same manner as when it was approved, non-controlled substances in the preparation may become controlled, thus prompting the need for a new application for exemption of the chemical preparation to ensure continued compliance. Other preparations that previously contained no controlled substances may contain newly controlled substances and thus would require an application for exemption. DEA reviews applications for chemical preparation exemptions based on the statutes and regulations that are in place at the time of the application, including the control status of substances included in the preparation. DEA must remain vigilant to ensure that exempt chemical preparations remain consistent with the standards set forth in the CSA and its implementing regulations. As such, DEA reminds the public that any chemical preparation, regardless of whether it was previously exempt, that contains a newly Review of Exemptions Pursuant to 21 U.S.C. 811(g)(3) BILLING CODE 4410–09–P Based on inquiries received from industry, DEA is conducting a comprehensive review of the exempt chemical preparation regulations. DEA’s regulations at 21 CFR 1308.24(a) state that approved chemical preparations are exempt from certain provisions of both Subchapter I and Subchapter II of the CSA: ‘‘The chemical preparations and mixtures approved pursuant to 1308.23 are exempt from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822–823, 825–829, 952–954) and 1301.74 of this chapter, to the extent described in paragraphs (b) to (h) of this section.’’ Pursuant to its regulations, DEA has provided exemptions from the application of section 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 of the Act (21 U.S.C. 822–823, 825–829, 952–954) and 21 CFR 1301.74 since the implementation of the regulations in the early 1970s. Until DEA’s analysis of the exemption regulations is complete, DEA will continue to review and provide exemptions to chemical preparations consistent with the implementing regulations, when warranted. DEA will publish a future notice regarding the outcome of DEA’s review of its regulations with respect to the exemption of chemical preparations. DEPARTMENT OF JUSTICE VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 Opportunity for Comment Pursuant to 21 CFR 1308.23, any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Deputy Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed. Approved Exempt Chemical Preparations Are Posted on DEA’s Web Site A list of all current exemptions, including those listed in this order, is available on DEA’s Web site at http:// www.DEAdiversion.usdoj.gov/ schedules/exempt/exempt_chemlist.pdf. The dates of applications of all current exemptions are posted for easy reference. PO 00000 Frm 00098 Fmt 4703 Sfmt 4703 [FR Doc. 2013–16010 Filed 7–2–13; 8:45 am] Drug Enforcement Administration [Docket No. DEA–378] Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2014 Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice with request for comments. AGENCY: This notice proposes initial year 2014 aggregate production quotas for controlled substances in Schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Electronic comments must be submitted and written comments must be postmarked on or before August 2, 2013. The electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period. ADDRESSES: To ensure proper handling of comments, please reference ‘‘Docket No. DEA–378’’ on all electronic and written correspondence. DEA encourages that all comments be submitted electronically through http:// www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at http:// www.regulations.gov for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive Assistant, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices Springfield, VA 22152, Telephone: (202) 307–7165. SUPPLEMENTARY INFORMATION: emcdonald on DSK67QTVN1PROD with NOTICES Posting of Public Comments All comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in DEA’s public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. 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 posted online or made available in the public docket, 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 posted online or made available in the public docket 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 posted online or made available in the public docket, 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. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA’s public docket file. The Freedom of Information Act applies to all comments received. If you wish to inspect the agency’s public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. Background Section 306 of the 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 ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy VerDate Mar<15>2010 17:48 Jul 02, 2013 Jkt 229001 Administrator, pursuant to 28 CFR 0.104. The proposed year 2014 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 2014 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 2014 aggregate production quotas and assessment of annual needs, DEA has taken into account the criteria that DEA is required to consider in accordance with 21 U.S.C. 826(a), 21 CFR 1303.11 (aggregate production quotas for controlled substances), and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate production quotas and assessment of annual needs for 2014 by considering (1) total net disposal of the 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 such class or chemical as indicated by procurement and chemical import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting the medical, scientific, research, and industrial needs in the United States, lawful export requirements, and reserve stocks, as the Deputy Administrator finds relevant. Other factors DEA 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 2014 assessment of annual needs, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294 and 75 FR 79407, respectively). DEA also specifically considered that inventory allowances granted to PO 00000 Frm 00099 Fmt 4703 Sfmt 4703 40187 individual manufacturers 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. See 21 CFR 1303.24. 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, DEA proposes to include in all Schedule II aggregate production quotas, and certain Schedule I aggregate production quotas (gammahydroxybutyric acid and tetrahydrocannabinols), 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 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. 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 DEA. DEA does not anticipate utilizing the reserve in the absence of these circumstances. The Deputy Administrator, therefore, proposes that the year 2014 aggregate production quotas and assessment of annual needs for the following Schedule I and II controlled substances and for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, be established as follows: Basic class—schedule I (1-Pentyl-1H-indol-3yl)(2,2,3,3tetramethylcyclopropyl)methanone (UR–144) ..... [1-(5-fluoro-pentyl)-1H-indol3-yl](2,2,3,3tetramethylcyclopropyl)methanone (XLR11) ........ 1-(1Phenylcyclohexyl)pyrrolidine ........................ 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ....... 1-(5-Fluoropentyl)-3-(2iodobenzoyl)indole (AM694) ............................ 1-[1-(2Thienyl)cyclohexyl]piperidine ....... E:\FR\FM\03JYN1.SGM 03JYN1 Proposed 2014 quotas 15 g 15 g 10 g 45 g 45 g 5g 40188 Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices emcdonald on DSK67QTVN1PROD with NOTICES Basic class—schedule I Proposed 2014 quotas 1-[2-(4-Morpholinyl)ethyl]-3(1-naphthoyl)indole (JWH– 200) ................................... 1-Butyl-3-(1-naphthoyl)indole (JWH–073) ........................ 1-Cyclohexylethyl-3-(2methoxyphenylacetyl)indole (SR–18 and RCS– 8) ....................................... 1-Hexyl-3-(1-naphthoyl)indole (JWH–019) ........................ 1-Methyl-4-phenyl-4propionoxypiperidine ......... 1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) .............................. 1-Pentyl-3-(2chlorophenylacetyl)indole (JWH–203) ........................ 1-Pentyl-3-(2methoxyphenylacetyl)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-(4methoxynaphthoyl)]indole (JWH–081) ........................ 2-(2,5-Dimethoxy-4-(n)propylphenyl)ethanamine (2C–P) ............................... 2-(2,5-Dimethoxy-4ethylphenyl)ethanamine (2C–E) ............................... 2-(2,5-Dimethoxy-4methylphenyl)ethanamine (2C–D) ............................... 2-(2,5-Dimethoxy-4-nitrophenyl)ethanamine (2C–N) 2-(2,5Dimethoxyphenyl)ethanamine (2C–H) ......... 2-(4-Chloro-2,5dimethoxyphenyl)ethanamine (2C–C) ......... 2-(4-Iodo-2,5dimethoxyphenyl)ethanamine (2C–I) .......... 2,5-Dimethoxy-4ethylamphetamine (DOET) 2,5-Dimethoxy-4-npropylthiophenethylamine 2,5-Dimethoxyamphetamine 2-[4-(Ethylthio)-2,5dimethoxyphenyl]ethanamine (2C–T–2) ..... 2-[4-(Isopropylthio)-2,5dimethoxyphenyl]ethanamine (2C–T–4) ..... 3,4,5Trimethoxyamphetamine ... 3,4Methylenedioxyamphetamine (MDA) .......................... 3,4Methylenedioxymethamphetamine (MDMA) ............... 3,4-Methylenedioxy-Nethylamphetamine (MDEA) VerDate Mar<15>2010 17:48 Jul 02, 2013 45 g 45 g 45 g 45 g 2g 45 g 45 g 45 g 45 g 45 g 45 g 45 g 30 g 30 g 30 g 30 g 30 g 30 g 30 g 25 g 25 g 25 g 30 g 30 g 25 g 55 g 50 g 40 g Jkt 229001 Basic class—schedule I 3,4-Methylenedioxy-Nmethylcathinone (methylone) ....................... 3,4Methylenedioxypyrovalerone (MDPV) ........................ 3-Methylfentanyl ................... 3-Methylthiofentanyl .............. 4-Bromo-2,5dimethoxyamphetamine (DOB) ................................ 4-Bromo-2,5dimethoxyphenethylamine (2–CB) ............................... 4-Methoxyamphetamine ....... 4-Methyl-2,5dimethoxyamphetamine (DOM) ............................... 4-Methylaminorex ................. 4-Methyl-N-methylcathinone (mephedrone) .................... 5-(1,1-Dimethylheptyl)-2[(1R,3S)-3hydroxycyclohexyl]-phenol 5-(1,1-Dimethyloctyl)-2[(1R,3S)-3hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47, 497 C8-homolog) 5-Methoxy-3,4methylenedioxyamphetamine ..................................... 5-Methoxy-N,Ndiisopropyltryptamine ........ 5-Methoxy-N,Ndimethyltryptamine ............ Acetyl-alpha-methylfentanyl .. Acetyldihydrocodeine ............ Acetylmethadol ..................... Allylprodine ........................... Alphacetylmethadol .............. Alpha-ethyltryptamine ........... Alphameprodine .................... Alphamethadol ...................... Alpha-methylfentanyl ............ Alpha-methylthiofentanyl ...... Alpha-methyltryptamine (AMT) ................................ Aminorex ............................... Benzylmorphine .................... Betacetylmethadol ................ Beta-hydroxy-3methylfentanyl ................... Beta-hydroxyfentanyl ............ Betameprodine ..................... Betaprodine .......................... Bufotenine ............................. Cathinone ............................. Codeine Methylbromide ........ Codeine-N-oxide ................... Desomorphine ...................... Diethyltryptamine .................. Difenoxin ............................... Dihydromorphine .................. Dimethyltryptamine ............... Dipipanone ............................ Fenethylline .......................... Gamma-hydroxybutyric acid Heroin ................................... Hydromorphinol .................... Hydroxypethidine .................. Ibogaine ................................ PO 00000 Frm 00100 Fmt 4703 Sfmt 4703 Proposed 2014 quotas Basic class—schedule I 50 g 35 g 2g 2g 25 g 25 g 100 g 25 g 25 g 45 g 68 g 53 g 25 g 25 g 25 2 2 2 2 2 25 2 2 2 2 g g g g g g g g g g g 25 25 2 2 g g g g 2g 2g 2g 2g 3g 26 g 5g 200 g 5g 25 g 50 g 3,300,000 g 25 g 5g 5g 70,250,000 g 25 g 2g 2g 5g Lysergic acid diethylamide (LSD) ................................. Marihuana ............................. Mescaline .............................. Methaqualone ....................... Methcathinone ...................... Methyldihydromorphine ........ Morphine Methylbromide ...... Morphine Methylsulfonate .... Morphine-N-oxide ................. N-(1-adamantyl)-1-pentyl-1Hindazole-3-carboxamide (AKB48) ............................. N-Benzylpiperazine ............... N,N-Dimethylamphetamine ... N-Ethyl-1phenylcyclohexylamine ..... N-Ethylamphetamine ............ N-Hydroxy-3,4methylenedioxyamphetamine ..................................... Noracymethadol .................... Norlevorphanol ..................... Normethadone ...................... Normorphine ......................... Para-fluorofentanyl ............... Parahexyl .............................. Phenomorphan ..................... Pholcodine ............................ Properidine ........................... Psilocybin .............................. Psilocyn ................................ Tetrahydrocannabinols ......... Thiofentanyl .......................... Tilidine .................................. Trimeperidine ........................ Basic class—schedule II 1-Phenylcyclohexylamine ..... 1Piperdinocyclohexanecarbonitrile (PCC) .................... 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 ..................... Diphenoxylate ....................... Ecgonine ............................... Ethylmorphine ....................... Fentanyl ................................ Glutethimide .......................... Hydrocodone (for sale) ......... Hydromorphone .................... Isomethadone ....................... Levo-alphacetylmethadol (LAAM) .............................. Levomethorphan ................... Levorphanol .......................... Lisdexamfetamine ................. Meperidine ............................ Meperidine Intermediate-A ... E:\FR\FM\03JYN1.SGM 03JYN1 Proposed 2014 quotas 30 21,000 25 10 25 2 5 5 175 g g g g g g g g g 15 g 25 g 25 g 5g 24 g 24 2 52 2 18 2 5 2 2 2 30 30 491,000 2 10 2 g g g g g g g g g g g g g g g g Proposed 2014 quotas 3g 3g 2,687,500 17,625 3 9 g g g g 18,375,000 49,000,000 6 240,000 68,750,000 46,125,000 19 100,750 750,000 127,500 3 2,108,750 3 99,625,000 5,968,750 5 g g g g g g g g g g g g g g g g 4 6 2,000 23,750,000 6,250,000 6 g g g g g g Federal Register / Vol. 78, No. 128 / Wednesday, July 3, 2013 / Notices Basic class—schedule II Proposed 2014 quotas Meperidine Intermediate-B ... Meperidine Intermediate-C ... Metazocine ........................... Methadone (for sale) ............ Methadone Intermediate ....... Methamphetamine ................ 11 6 6 31,875,000 38,875,000 3,911,375 g g g g g g [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,600,000 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 .................. Remifentanil .......................... Secobarbital .......................... Sufentanil .............................. Tapentadol ............................ Thebaine ............................... Basic class—list I chemicals 96,750,000 91,250,000 62,500,000 30,375 g g g g 12,250,000 1,262,500 112,500 625,000 22,750,000 9,250,000 149,375,000 g g g g g g g Dated: June 27, 2013. Thomas M. Harrigan, Deputy Administrator. 17,250,000 7,750,000 35,000,000 6 6 3 29,980,050 3 3,750 215,003 6,255 17,500,000 145,000,000 g g g g g g g g g g g g g DEPARTMENT OF JUSTICE Proposed 2014 quotas [FR Doc. 2013–16052 Filed 7–2–13; 8:45 am] BILLING CODE 4410–09–P Office of Juvenile Justice and Delinquency Prevention [OMB Number 1121–0219] Agency Information Collection Activities; Proposed Collection; Comments Requested: Juvenile Residential Facility Census (Extension, Without Change, of a Currently Approved Collection) ACTION: 60 Day Notice. The Department of Justice (DOJ), Office of Justice Programs, Office of Juvenile Justice and Delinquency Prevention, will be submitting the 25,700,000 g following information collection request 5,300,000 g to the Office of Management and Budget (OMB) for review and approval in 5,000 g accordance with the Paperwork 156,000,000 g Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and The Deputy Administrator further affected agencies. Comments are proposes that aggregate production encouraged and will be accepted for quotas for all other Schedule I and II ‘‘sixty days’’ until September 3, 2013. controlled substances included in 21 CFR 1308.11 and 1308.12 be established This process is conducted in accordance at zero. Pursuant to 21 CFR 1303.13 and with 5 CFR 1320.10. If you have comments especially on 21 CFR 1315.13, upon consideration of the estimated public burden or the relevant factors, the Deputy associated response time, suggestions, Administrator may adjust the 2014 or need a copy of the proposed aggregate production quotas and information collection instrument with assessment of annual needs as needed. instructions or additional information, Comments please contact Brecht Donoghue, (202) Pursuant to 21 CFR 1303.11 and 21 305–1270, Office of Juvenile Justice and CFR 1315.11, any interested person may Delinquency Prevention, Office of submit written comments on or Justice Programs, U.S. Department of Ephedrine (for conversion) ... Ephedrine (for sale) .............. Phenylpropanolamine (for conversion) ........................ Phenylpropanolamine (for sale) .................................. Pseudoephedrine (for conversion) ............................. Pseudoephedrine (for sale) .. emcdonald on DSK67QTVN1PROD with NOTICES objections to these proposed determinations. Based on comments received in response to this Notice, the Deputy Administrator may hold a public hearing on one or more issues raised. In the event the Deputy Administrator decides in his sole discretion to hold such a hearing, the Deputy Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments and after a hearing, if one is held, the Deputy Administrator will publish in the Federal Register a Final Order establishing the 2014 aggregate production quota for each basic class of controlled substance and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. VerDate Mar<15>2010 17:48 Jul 02, 2013 15,100,000 g 2,900,000 g Jkt 229001 PO 00000 Frm 00101 Fmt 4703 Sfmt 4703 40189 Justice, 810 Seventh Street NW., Washington, DC 20531. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Enhance the quality, utility, and clarity of the information to be collected; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. Overview of This Information Collection Back to Top (1) Type of information collection: Extension, without change, of a currently approved collection. (2) The title of the form/collection: Juvenile Residential Facility Census. (3) The agency form number, if any, and the applicable component of the Department sponsoring the collection: The form number is CJ–15, Office of Juvenile Justice and Delinquency Prevention, United States Department of Justice. (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Federal Government, State, Local or Tribal. Other: Not-forprofit institutions; Business or other forprofit. (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond/reply: It is estimated that 2,545 respondents will complete a 2-hour questionnaire. (6) An estimate of the total public burden (in hours) associated with the collection: Approximately 5,090 hours. If additional information is required, contact: Jerri Murray, Department Clearance Officer, U.S. Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3W–1407B, Washington, DC 20530. E:\FR\FM\03JYN1.SGM 03JYN1

Agencies

[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Notices]
[Pages 40186-40189]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-16052]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-378]


Proposed Aggregate Production Quotas for Schedule I and II 
Controlled Substances and Proposed Assessment of Annual Needs for the 
List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine 
for 2014

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

ACTION: Notice with request for comments.

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

SUMMARY: This notice proposes initial year 2014 aggregate production 
quotas for controlled substances in Schedules I and II of the 
Controlled Substances Act (CSA) and assessment of annual needs for the 
List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before August 2, 2013. The electronic Federal 
Docket Management System will not accept comments after midnight 
Eastern Time on the last day of the comment period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-378'' on all electronic and written correspondence. 
DEA encourages that all comments be submitted electronically through 
http://www.regulations.gov using the electronic comment form provided 
on that site. An electronic copy of this document is also available at 
http://www.regulations.gov for easy reference. Paper comments that 
duplicate the electronic submission are not necessary as all comments 
submitted to www.regulations.gov will be posted for public review and 
are part of the official docket record. Written comments submitted via 
regular or express mail should be sent to the Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODL, 
8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Executive 
Assistant, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive,

[[Page 40187]]

Springfield, VA 22152, Telephone: (202) 307-7165.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    All comments received are considered part of the public record and 
made available for public inspection online at http://www.regulations.gov and in DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    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 posted online or made available in the public docket, 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 posted online or made available 
in the public docket 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 posted online or made available 
in the public docket, 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. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. The Freedom of Information Act applies to 
all comments received. If you wish to inspect the agency's public 
docket file in person by appointment, please see the For Further 
Information Contact paragraph.

Background

    Section 306 of the 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 ephedrine, 
pseudoephedrine, and phenylpropanolamine. This responsibility has been 
delegated to the Administrator of the DEA by 28 CFR 0.100. The 
Administrator, in turn, has redelegated this function to the Deputy 
Administrator, pursuant to 28 CFR 0.104.
    The proposed year 2014 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 2014 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 2014 aggregate production quotas and 
assessment of annual needs, DEA has taken into account the criteria 
that DEA is required to consider in accordance with 21 U.S.C. 826(a), 
21 CFR 1303.11 (aggregate production quotas for controlled substances), 
and 21 CFR 1315.11 (assessment of annual needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate 
production quotas and assessment of annual needs for 2014 by 
considering (1) total net disposal of the 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 such class or chemical as indicated by procurement and chemical 
import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and 
1315.34; and (5) other factors affecting the medical, scientific, 
research, and industrial needs in the United States, lawful export 
requirements, and reserve stocks, as the Deputy Administrator finds 
relevant. Other factors DEA 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 2014 assessment of annual needs, DEA used the calculation 
methodology previously described in the 2010 and 2011 assessment of 
annual needs (74 FR 60294 and 75 FR 79407, respectively).
    DEA also specifically considered that inventory allowances granted 
to individual manufacturers 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. See 21 CFR 1303.24. 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, DEA proposes to include 
in all Schedule II aggregate production quotas, and certain Schedule I 
aggregate production quotas (gamma-hydroxybutyric acid and 
tetrahydrocannabinols), 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 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. 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 DEA. DEA does not anticipate utilizing 
the reserve in the absence of these circumstances.
    The Deputy Administrator, therefore, proposes that the year 2014 
aggregate production quotas and assessment of annual needs for the 
following Schedule I and II controlled substances and for the List I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, be established as 
follows:

------------------------------------------------------------------------
                                                           Proposed 2014
                 Basic class--schedule I                      quotas
------------------------------------------------------------------------
(1-Pentyl-1H-indol-3-yl)(2,2,3,3-                                   15 g
 tetramethylcyclopropyl)methanone (UR-144)..............
[1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-                        15 g
 tetramethylcyclopropyl)methanone (XLR11)...............
1-(1-Phenylcyclohexyl)pyrrolidine.......................            10 g
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).......            45 g
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)......            45 g
1-[1-(2-Thienyl)cyclohexyl]piperidine...................             5 g

[[Page 40188]]

 
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-              45 g
 200)...................................................
1-Butyl-3-(1-naphthoyl)indole (JWH-073).................            45 g
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18            45 g
 and RCS-8).............................................
1-Hexyl-3-(1-naphthoyl)indole (JWH-019).................            45 g
1-Methyl-4-phenyl-4-propionoxypiperidine................             2 g
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)......            45 g
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).......            45 g
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)......            45 g
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398).......            45 g
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122).......            45 g
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)...            45 g
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).....            45 g
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)...            30 g
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)........            30 g
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).......            30 g
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).......            30 g
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)................            30 g
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).......            30 g
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).........            30 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).................            25 g
2,5-Dimethoxy-4-n-propylthiophenethylamine..............            25 g
2,5-Dimethoxyamphetamine................................            25 g
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)            30 g
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-            30 g
 T-4)...................................................
3,4,5-Trimethoxyamphetamine.............................            25 g
3,4-Methylenedioxyamphetamine (MDA).....................            55 g
3,4-Methylenedioxymethamphetamine (MDMA)................            50 g
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)............            40 g
3,4-Methylenedioxy-N-methylcathinone (methylone)........            50 g
3,4-Methylenedioxypyrovalerone (MDPV)...................            35 g
3-Methylfentanyl........................................             2 g
3-Methylthiofentanyl....................................             2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................            25 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............            25 g
4-Methoxyamphetamine....................................           100 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).................            25 g
4-Methylaminorex........................................            25 g
4-Methyl-N-methylcathinone (mephedrone).................            45 g
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-             68 g
 phenol.................................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-              53 g
 phenol (cannabicyclohexanol or CP-47, 497 C8-homolog)..
5-Methoxy-3,4-methylenedioxyamphetamine.................            25 g
5-Methoxy-N,N-diisopropyltryptamine.....................            25 g
5-Methoxy-N,N-dimethyltryptamine........................            25 g
Acetyl-alpha-methylfentanyl.............................             2 g
Acetyldihydrocodeine....................................             2 g
Acetylmethadol..........................................             2 g
Allylprodine............................................             2 g
Alphacetylmethadol......................................             2 g
Alpha-ethyltryptamine...................................            25 g
Alphameprodine..........................................             2 g
Alphamethadol...........................................             2 g
Alpha-methylfentanyl....................................             2 g
Alpha-methylthiofentanyl................................             2 g
Alpha-methyltryptamine (AMT)............................            25 g
Aminorex................................................            25 g
Benzylmorphine..........................................             2 g
Betacetylmethadol.......................................             2 g
Beta-hydroxy-3-methylfentanyl...........................             2 g
Beta-hydroxyfentanyl....................................             2 g
Betameprodine...........................................             2 g
Betaprodine.............................................             2 g
Bufotenine..............................................             3 g
Cathinone...............................................            26 g
Codeine Methylbromide...................................             5 g
Codeine-N-oxide.........................................           200 g
Desomorphine............................................             5 g
Diethyltryptamine.......................................            25 g
Difenoxin...............................................            50 g
Dihydromorphine.........................................     3,300,000 g
Dimethyltryptamine......................................            25 g
Dipipanone..............................................              5g
Fenethylline............................................             5 g
Gamma-hydroxybutyric acid...............................    70,250,000 g
Heroin..................................................            25 g
Hydromorphinol..........................................             2 g
Hydroxypethidine........................................             2 g
Ibogaine................................................             5 g
Lysergic acid diethylamide (LSD)........................            30 g
Marihuana...............................................        21,000 g
Mescaline...............................................            25 g
Methaqualone............................................            10 g
Methcathinone...........................................            25 g
Methyldihydromorphine...................................             2 g
Morphine Methylbromide..................................             5 g
Morphine Methylsulfonate................................             5 g
Morphine-N-oxide........................................           175 g
N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide                  15 g
 (AKB48)................................................
N-Benzylpiperazine......................................            25 g
N,N-Dimethylamphetamine.................................            25 g
N-Ethyl-1-phenylcyclohexylamine.........................             5 g
N-Ethylamphetamine......................................            24 g
N-Hydroxy-3,4-methylenedioxyamphetamine.................            24 g
Noracymethadol..........................................             2 g
Norlevorphanol..........................................            52 g
Normethadone............................................             2 g
Normorphine.............................................            18 g
Para-fluorofentanyl.....................................             2 g
Parahexyl...............................................             5 g
Phenomorphan............................................             2 g
Pholcodine..............................................             2 g
Properidine.............................................             2 g
Psilocybin..............................................            30 g
Psilocyn................................................            30 g
Tetrahydrocannabinols...................................       491,000 g
Thiofentanyl............................................             2 g
Tilidine................................................            10 g
Trimeperidine...........................................             2 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                           Proposed 2014
                Basic class--schedule II                      quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine.................................             3 g
1-Piperdinocyclohexanecarbonitrile (PCC)................             3 g
4-Anilino-N-phenethyl-4-piperidine (ANPP)...............     2,687,500 g
Alfentanil..............................................        17,625 g
Alphaprodine............................................             3 g
Amobarbital.............................................             9 g
Amphetamine (for conversion)............................    18,375,000 g
Amphetamine (for sale)..................................    49,000,000 g
Carfentanil.............................................             6 g
Cocaine.................................................       240,000 g
Codeine (for conversion)................................    68,750,000 g
Codeine (for sale)......................................    46,125,000 g
Dextropropoxyphene......................................            19 g
Dihydrocodeine..........................................       100,750 g
Diphenoxylate...........................................       750,000 g
Ecgonine................................................       127,500 g
Ethylmorphine...........................................             3 g
Fentanyl................................................     2,108,750 g
Glutethimide............................................             3 g
Hydrocodone (for sale)..................................    99,625,000 g
Hydromorphone...........................................     5,968,750 g
Isomethadone............................................             5 g
Levo-alphacetylmethadol (LAAM)..........................             4 g
Levomethorphan..........................................             6 g
Levorphanol.............................................         2,000 g
Lisdexamfetamine........................................    23,750,000 g
Meperidine..............................................     6,250,000 g
Meperidine Intermediate-A...............................             6 g

[[Page 40189]]

 
Meperidine Intermediate-B...............................            11 g
Meperidine Intermediate-C...............................             6 g
Metazocine..............................................             6 g
Methadone (for sale)....................................    31,875,000 g
Methadone Intermediate..................................    38,875,000 g
Methamphetamine.........................................     3,911,375 g
------------------------------------------------------------------------
  [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled,
non-prescription product; 2,600,000 grams for methamphetamine mostly for
       conversion to a schedule III product; and 61,375 grams for
                      methamphetamine (for sale)].
------------------------------------------------------------------------
 
Methylphenidate.........................................    96,750,000 g
Morphine (for conversion)...............................    91,250,000 g
Morphine (for sale).....................................    62,500,000 g
Nabilone................................................        30,375 g
Noroxymorphone (for conversion).........................    12,250,000 g
Noroxymorphone (for sale)...............................     1,262,500 g
Opium (powder)..........................................       112,500 g
Opium (tincture)........................................       625,000 g
Oripavine...............................................    22,750,000 g
Oxycodone (for conversion)..............................     9,250,000 g
Oxycodone (for sale)....................................   149,375,000 g
Oxymorphone (for conversion)............................    17,250,000 g
Oxymorphone (for sale)..................................     7,750,000 g
Pentobarbital...........................................    35,000,000 g
Phenazocine.............................................             6 g
Phencyclidine...........................................             6 g
Phenmetrazine...........................................             3 g
Phenylacetone...........................................    29,980,050 g
Racemethorphan..........................................             3 g
Remifentanil............................................         3,750 g
Secobarbital............................................       215,003 g
Sufentanil..............................................         6,255 g
Tapentadol..............................................    17,500,000 g
Thebaine................................................   145,000,000 g
------------------------------------------------------------------------


------------------------------------------------------------------------
                                                           Proposed 2014
              Basic class--list I chemicals                   quotas
------------------------------------------------------------------------
Ephedrine (for conversion)..............................    15,100,000 g
Ephedrine (for sale)....................................     2,900,000 g
Phenylpropanolamine (for conversion)....................    25,700,000 g
Phenylpropanolamine (for sale)..........................     5,300,000 g
Pseudoephedrine (for conversion)........................         5,000 g
Pseudoephedrine (for sale)..............................   156,000,000 g
------------------------------------------------------------------------

    The Deputy 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 be established at zero. Pursuant to 21 
CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant 
factors, the Deputy Administrator may adjust the 2014 aggregate 
production quotas and assessment of annual needs as needed.

Comments

    Pursuant to 21 CFR 1303.11 and 21 CFR 1315.11, any interested 
person may submit written comments on or objections to these proposed 
determinations. Based on comments received in response to this Notice, 
the Deputy Administrator may hold a public hearing on one or more 
issues raised. In the event the Deputy Administrator decides in his 
sole discretion to hold such a hearing, the Deputy Administrator will 
publish a notice of any such hearing in the Federal Register. After 
consideration of any comments and after a hearing, if one is held, the 
Deputy Administrator will publish in the Federal Register a Final Order 
establishing the 2014 aggregate production quota for each basic class 
of controlled substance and assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

    Dated: June 27, 2013.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2013-16052 Filed 7-2-13; 8:45 am]
BILLING CODE 4410-09-P