83 FR 42690 - 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 2018
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 164 (August 23, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 164 (August 23, 2018)
| Page Range | 42690-42696 | |
| FR Document | 2018-18265 |
[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)] [Notices] [Pages 42690-42696] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18265] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-471P] 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 2018 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust the 2018 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 September 24, 2018. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2018 adjusted aggregate [[Page 42691]] 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-471P'' on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. FOR FURTHER INFORMATION CONTACT: Thomas D. Sonnen, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598- 6812. SUPPLEMENTARY INFORMATION: Posting of Public Comments Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential. An electronic copy of this document is available at http://www.regulations.gov for easy reference. Legal Authority 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 2018 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 November 8, 2017 (82 FR 51873). 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 2018 Aggregate Production Quotas and Assessment of Annual Needs The DEA proposes to adjust the established 2018 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 2018 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 2018 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 2017 year-end inventories, 2017 disposition data submitted by quota applicants, [[Page 42692]] 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 2018 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). The Acting Administrator, therefore, proposes to adjust the 2018 aggregate production quotas for certain schedule I and II controlled substances and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: ------------------------------------------------------------------------ Established Basic class 2018 quotas Proposed revised 2018 (g) quotas (g) ------------------------------------------------------------------------ Temporarily Scheduled Substances ------------------------------------------------------------------------ 1-(4-Cyanobutyl)-N-(2- N/A 25. phenylpropan-2-yl)-1H-indazole- 3-carboximide. 1-(5-Fluoropentyl)-N-(2- N/A 25. phenylpropan-2-yl)-1H- pyrrolo[2,3-b]pyridine- 3carboximide. Cyclopropyl Fentanyl............ N/A 20. Fentanyl related substances..... N/A 25. Isobutyryl Fentanyl............. N/A 25. Methyl-2-(1-(cyclohexylmethyl)- N/A 25. 1H-indole-3-carboxamido)-3- methylbutanoate. N-(1-Amino-3-methyl-1-oxobutan-2- N/A 25. yl)-1-(5-fluoropentyl)-1H- indazole-3-carboxamide. Naphthalen-1-yl 1-(5- N/A 25. fluorpentyl)-1H-indole-3- carboxylate. Ocfentanil...................... N/A 25. Para-flourobutyryl fentanyl..... N/A 25. Tetrahydrofuranyl fentanyl...... N/A 5. Valeryl fentanyl................ N/A 25. ------------------------------------------------------------------------ Schedule I ------------------------------------------------------------------------ 1-[1-(2- Zero 20. Thienyl)cyclohexyl]pyrrolidine. 1-(1- 10 15. Phenylcyclohexyl)pyrrolidine. 1-(2-Phenylethyl)-4-phenyl-4- zero 10. acetoxypiperidine. 1-(5-Fluoropentyl)-3-(1- 30 no change. naphthoyl)indole (AM2201). 1-(5-Fluoropentyl)-3-(2- 30 no change. iodobenzoyl)indole (AM694). 1-[1-(2- 15 no change. Thienyl)cyclohexyl]piperidine. 1-Benzylpiperazine.............. 25 no change. 1-Methyl-4-phenyl-4- 2 10. propionoxypiperidine. 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-dimethoxyphenyl)- 30 no change. 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-dimethoxyphenyl)- 25 no change. 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)-N- 30 no change. (2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5). 2,5-Dimethoxy-4-ethylamphetamine 25 no change. (DOET). 2,5-Dimethoxy-4-n- 25 no change. propylthiophenethylamine. 2,5-Dimethoxyamphetamine........ 25 no change. 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..... 30 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- 40 no change. methylcathinone (methylone). 3,4-Methylenedioxypyrovalerone 35 no change. (MDPV). 3-FMC; 3-Fluoro-N- 25 no change. methylcathinone. 3-Methylfentanyl................ 30 no change. 3-Methylthiofentanyl............ 30 no change. 4-Bromo-2,5-dimethoxyamphetamine 30 no change. (DOB). 4-Bromo-2,5- 25 no change. dimethoxyphenethylamine (2-CB). 4-Fluoroisobutyryl fentanyl..... 30 no change. 4-FMC; Flephedrone.............. 25 no change. 4-MEC; 4-Methyl-N-ethylcathinone 25 no change. 4-Methoxyamphetamine............ 150 no change. 4-Methyl-2,5- 25 no change. dimethoxyamphetamine (DOM). 4-Methylaminorex................ 25 no change. [[Page 42693]] 4-Methyl-N-methylcathinone 45 no change. (mephedrone). 4-Methyl-[alpha]- 25 no change. pyrrolidinopropiophenone (4- MePPP). 5-(1,1-Dimethylheptyl)-2- 50 no change. [(1R,3S)-3-hydroxycyclohexyl]- phenol. 5-(1,1-Dimethyloctyl)-2-[(1R,3S)- 40 no change. 3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP- 47,497 C8-homolog). 5F-ADB; 5F-MDMB-PINACA (methyl 2- 30 no change. (1-(5-fluoropentyl)-1H-indazole- 3-carboxamido)-3,3- dimethylbutanoate). 5F-AMB (methyl 2-(1-(5- 30 no change. fluoropentyl)-1H-indazole-3- carboxamido)-3-methylbutanoate). 5F-APINACA; 5F-AKB48 (N- 30 no change. (adamantan-1-yl)-1-(5- fluoropentyl)-1H-indazole-3- carboxamide). 5-Fluoro-PB-22; 5F-PB-22........ 20 no change. 5-Fluoro-UR144, XLR11 ([1-(5- 25 no change. fluoro-pentyl)-1Hindol-. 3-yl](2,2,3,3- tetramethylcyclopropyl)methanon e. 5-Methoxy-3,4- 25 no change. methylenedioxyamphetamine. 5-Methoxy-N,N- 25 no change. diisopropyltryptamine. 5-Methoxy-N,N-dimethyltryptamine 25 no change. AB-CHMINACA..................... 30 no change. AB-FUBINACA..................... 50 no change. AB-PINACA....................... 30 no change. ADB-FUBINACA (N-(1-amino-3,3- 30 no change. dimethyl-1-oxobutan-2-yl)-1-(4- fluorobenzyl)-1H-indazole-3- carboxamide). Acetyl Fentanyl................. 100 no change. Acetyl-alpha-methylfentanyl..... 30 no change. Acetyldihydrocodeine............ 30 no change. Acetylmethadol.................. 2 no change. Acryl Fentanyl.................. 25 no change. ADB-PINACA (N-(1-amino-3,3- 50 no change. dimethyl-1-oxobutan-2-yl)-1- pentyl-1H-indazole-3- carboxamide). AH-7921......................... 30 no change. Allylprodine.................... 2 no change. Alphacetylmethadol.............. 2 no change. alpha-Ethyltryptamine........... 25 no change. Alphameprodine.................. 2 no change. Alphamethadol................... 2 no change. alpha-Methylfentanyl............ 30 no change. alpha-Methylthiofentanyl........ 30 no change. alpha-Methyltryptamine (AMT).... 25 no change. alpha-Pyrrolidinobutiophenone 25 no change. ([alpha]-PBP). alpha-Pyrrolidinopentiophenone 25 no change. ([alpha]-PVP). Aminorex........................ 25 no change. APINCA, AKB48 (N-(1-adamantyl)-1- 25 no change. pentyl-1H-indazole-3- carboxamide). Benzylmorphine.................. 30 no change. Betacetylmethadol............... 2 no change. beta-Hydroxy-3-methylfentanyl... 30 no change. beta-Hydroxyfentanyl............ 30 no change. beta-Hydroxythiofentanyl........ 30 no change. Betameprodine................... 2 no change. Betamethadol.................... 4 no change. Betaprodine..................... 2 no change. Bufotenine...................... 3 no change. Butylone........................ 25 no change. Butyryl fentanyl................ 30 no change. Cathinone....................... 24 no change. Codeine methylbromide........... 30 no change. Codeine-N-oxide................. 192 no change. Desomorphine.................... 25 no change. Diapromide...................... Zero 20. Diethylthiambutene.............. Zero 20. Diethyltryptamine............... 25 no change. Difenoxin....................... 8,225 no change. Dihydromorphine................. 1,000,160 no change. Dimethyltryptamine.............. 35 50. Dipipanone...................... 5 no change. Etorphine....................... 30 no change. Fenethylline.................... 30 no change. Furanyl fentanyl................ 30 no change. gamma-Hydroxybutyric acid....... 37,130,000 no change. Heroin.......................... 45 no change. Hydromorphinol.................. 40 no change. Hydroxypethidine................ 2 no change. Ibogaine........................ 30 no change. JWH-018 and AM678 (1-Pentyl-3-(1- 35 no change. naphthoyl)indole). JWH-019 (1-Hexyl-3-(1- 45 no change. naphthoyl)indole). JWH-073 (1-Butyl-3-(1- 45 no change. naphthoyl)indole). JWH-081 (1-Pentyl-3-[1-(4- 30 no change. methoxynaphthoyl)]indole). JWH-122 (1-Pentyl-3-(4-methyl-1- 30 no change. naphthoyl)indole). [[Page 42694]] JWH-200 (1-[2-(4- 35 no change. Morpholinyl)ethyl]-3-(1- naphthoyl)indole). JWH-203 (1-Pentyl-3-(2- 30 no change. chlorophenylacetyl)indole). JWH-250 (1-Pentyl-3-(2- 30 no change. methoxyphenylacetyl)indole). JWH-398 (1-Pentyl-3-(4-chloro-1- 30 no change. naphthoyl)indole). Lysergic acid diethylamide (LSD) 40 no change. MAB-CHMINACA; ADB-CHMINACA (N-(1- 30 no change. amino-3,3-dimethyl-1-oxobutan-2- yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide). MDMB-CHMICA; MMB-CHMINACA(methyl 30 no change. 2-(1-(cyclohexylmethyl)-1H- indole-3-carboxamido)-3,3- dimethylbutanoate). MDMB-FUBINACA (methyl 2-(1-(4- 30 no change. fluorobenzyl)-1H-indazole-3- carboxamido)-3,3- dimethylbutanoate). Marihuana....................... 443,680 1,140,216. Mecloqualone.................... 30 no change. Mescaline....................... 25 no change. Methaqualone.................... 60 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................ 150 no change. N,N-Dimethylamphetamine......... 25 no change. Naphyrone....................... 25 no change. N-Ethyl-1-phenylcyclohexylamine. 5 no change. N-Ethyl-3-piperidyl benzilate... Zero 10. N-Ethylamphetamine.............. 24 no change. N-Hydroxy-3,4- 24 no change. methylenedioxyamphetamine. Noracymethadol.................. 2 no change. Norlevorphanol.................. 55 no change. Normethadone.................... 2 no change. Normorphine..................... 40 no change. Para-fluorofentanyl............. 25 no change. Parahexyl....................... 5 no change. PB-22; QUPIC.................... 20 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. SR-18 and RCS-8 (1- 45 no change. Cyclohexylethyl-3-(2- methoxyphenylacetyl)indole). SR-19 and RCS-4 (1-Pentyl-3-[(4- 30 no change. methoxy)-benzoyl]indole). Tetrahydrocannabinols........... 384,460 no change. Thiofentanyl.................... 25 no change. THJ-2201 ( [1-(5-fluoropentyl)- 30 no change. 1H-indazol-3-yl](naphthalen-1- yl)methanone). Tilidine........................ 25 no change. Trimeperidine................... 2 no change. UR-144 (1-pentyl-1H-indol-3- 25 no change. yl)(2,2,3,3- tetramethylcyclopropyl)methanon e. U-47700......................... 30 no change. ------------------------------------------------------------------------ Schedule II ------------------------------------------------------------------------ 1-Phenylcyclohexylamine......... 4 15. 1- 4 25. Piperidinocyclohexanecarbonitri le. 4-Anilino-N-phenethyl-4- 1,342,320 no change. piperidine (ANPP). Alfentanil...................... 6,200 no change. Alphaprodine.................... 2 no change. Amobarbital..................... 20,100 no change. Amphetamine (for conversion).... 11,280,000 12,700,000. Amphetamine (for sale).......... 39,856,000 no change. Anileridine..................... Zero 20. Carfentanil..................... 20 no change. Cocaine......................... 92,120 no change. Codeine (for conversion)........ 15,040,000 12,900,000. Codeine (for sale).............. 40,015,000 no change. Dextropropoxyphene.............. 35 no change. Dihydrocodeine.................. 264,140 no change. Dihydroetorphine................ 2 no change. Diphenoxylate (for conversion).. 14,100 no change. Diphenoxylate (for sale)........ 770,800 no change. Ecgonine........................ 88,134 no change. Ethylmorphine................... 30 no change. [[Page 42695]] Etorphine hydrochloride......... 32 no change. Fentanyl........................ 1,342,320 no change. Glutethimide.................... 2 no change. Hydrocodone (for conversion).... 114,680 no change. Hydrocodone (for sale).......... 50,348,280 44,710,000. Hydromorphone................... 4,547,720 no change. Isomethadone.................... 30 no change. Levo-alphacetylmethadol (LAAM).. 5 no change. Levomethorphan.................. 30 2,200. Levorphanol..................... 12,126 38,000. Lisdexamfetamine................ 17,869,000 19,000,000. Meperidine...................... 2,717,540 1,913,148. Meperidine Intermediate-A....... 5 30. Meperidine Intermediate-B....... 30 no change. Meperidine Intermediate-C....... 5 30. Metazocine...................... 15 no change. Methadone (for sale)............ 22,278,000 no change. Methadone Intermediate.......... 24,064,000 no change. Methamphetamine................. 1,446,754 no change. ------------------------------------------------------------------------ [846,000 grams of levo-desoxyephedrine for use in a non-controlled, non- prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)] ------------------------------------------------------------------------ Methylphenidate................. 64,600,000 no change. Morphine (for conversion)....... 4,089,000 no change. Morphine (for sale)............. 33,958,440 31,456,000. Nabilone........................ 31,000 62,000. Noroxymorphone (for conversion). 14,044,540 16,440,000. Noroxymorphone (for sale)....... 376,000 no change. Opium (powder).................. 84,600 no change. Opium (tincture)................ 564,000 no change. Oripavine....................... 24,534,000 no change. Oxycodone (for conversion)...... 2,453,400 no change. Oxycodone (for sale)............ 95,692,000 85,578,000. Oxymorphone (for conversion).... 20,962,000 no change. Oxymorphone (for sale).......... 3,395,280 3,137,240. Pentobarbital................... 25,850,000 no change. Phenazocine..................... 5 no change. Phencyclidine................... 35 no change. Phenmetrazine................... 25 no change. Phenylacetone................... 40 no change. Racemethorphan.................. 5 no change. Racemorphan..................... 5 no change. Remifentanil.................... 2,820 3,000. Secobarbital.................... 161,682 172,100. Sufentanil...................... 1,880 no change. Tapentadol...................... 18,388,280 no change. Thebaine........................ 94,000,000 86,200,000. ------------------------------------------------------------------------ List I Chemicals ------------------------------------------------------------------------ Ephedrine (for conversion)...... 47,000 no change. Ephedrine (for sale)............ 4,136,000 no change. Phenylpropanolamine (for 14,100,000 no change. conversion). Phenylpropanolamine (for sale).. 7,990,000 no change. Pseudoephedrine (for conversion) 40 1,000. Pseudoephedrine (for sale)...... 180,000,000 no change. ------------------------------------------------------------------------ The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2018 aggregate production quotas and assessment of annual needs as needed. Conclusion After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the Federal Register a final order establishing any adjustment of 2018 aggregate production quotas 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). [[Page 42696]] Dated: August 17, 2018. Uttam Dhillon, Acting Administrator. [FR Doc. 2018-18265 Filed 8-22-18; 8:45 am] BILLING CODE 4410-09-P
![42690 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
INTERNATIONAL TRADE named as respondents Sony Corporation The authority for the Commission’s
COMMISSION of Tokyo, Japan, Sony Corporation of determination is contained in section
America of New York, New York, and 337 of the Tariff Act of 1930, as
[Investigation No. 337–TA–1012 Sony Electronics Inc. of San Diego, amended (19 U.S.C. 1337), and in Part
(Consolidated Modification and 210 of the Commission’s Rules of
California (collectively, ‘‘the Sony
Enforcement Proceeding)]
respondents’’). The Office of Unfair Practice and Procedure (19 CFR part
Certain Magnetic Data Storage Tapes Import Investigations (‘‘OUII’’) was also 210).
and Cartridges Containing the Same named as a party to the investigation. By order of the Commission.
Notice of Institution of Modification On March 8, 2018, the Commission Issued: August 17, 2018.
Proceeding found a section 337 violation as to the Lisa Barton,
’891 patent and issued a limited Secretary to the Commission.
AGENCY: U.S. International Trade exclusion order (‘‘LEO’’) and cease and
Commission. [FR Doc. 2018–18155 Filed 8–22–18; 8:45 am]
desist orders (‘‘CDOs’’) to each of the
BILLING CODE 7020–02–P
ACTION: Notice. Sony respondents. 83 FR 11245–47
(March 14, 2018). The LEO generally
SUMMARY: Notice is hereby given that prohibits the Sony respondents from
the U.S. International Trade importing certain magnetic data storage DEPARTMENT OF JUSTICE
Commission has determined to institute tapes and cartridges containing the same
a modification proceeding relating to Drug Enforcement Administration
that infringe the ’891 patent, with
the March 8, 2018 limited exclusion certain exceptions related to service and [Docket No. DEA–471P]
order and cease and desist orders issued repair and verification testing. The
in the above-referenced investigation. CDOs prohibit the Sony respondents Proposed Adjustments to the
FOR FURTHER INFORMATION CONTACT: from importing, selling, marketing, Aggregate Production Quotas for
Megan M. Valentine, Office of the advertising, distributing, transferring Schedule I and II Controlled
General Counsel, U.S. International (except for exportation) certain magnetic Substances and Assessment of
Trade Commission, 500 E Street SW, data storage tapes and cartridges Annual Needs for the List I Chemicals
Washington, DC 20436, telephone (202) containing the same that infringe the Ephedrine, Pseudoephedrine, and
708–2301. Copies of non-confidential ’891 patent, and soliciting United States Phenylpropanolamine for 2018
documents filed in connection with this agents or distributors for these activities. AGENCY: Drug Enforcement
investigation are or will be available for On May 9, 2018, Fujifilm filed a Administration, Department of Justice.
inspection during official business complaint requesting that the ACTION: Notice with request for
hours (8:45 a.m. to 5:15 p.m.) in the Commission institute a formal comments.
Office of the Secretary, U.S. enforcement proceeding under
International Trade Commission, 500 E Commission Rule 210.75 to investigate SUMMARY: The Drug Enforcement
Street SW, Washington, DC 20436, alleged violation of the CDOs by the Administration (DEA) proposes to
telephone (202) 205–2000. General Sony Respondents, as well as Sony adjust the 2018 aggregate production
information concerning the Commission Storage Media Solutions Corporation, quotas for several controlled substances
may also be obtained by accessing its Sony Storage Media Manufacturing in schedules I and II of the Controlled
internet server at https://www.usitc.gov. Corporation, Sony DADC US Inc., and Substances Act and assessment of
The public record for this investigation Sony Latin America Inc. (collectively, annual needs for the list I chemicals
may be viewed on the Commission’s ‘‘Sony’’). On June 13, 2018, the ephedrine, pseudoephedrine, and
electronic docket (EDIS) at https:// Commission instituted the enforcement phenylpropanolamine.
edis.usitc.gov. Hearing-impaired proceeding. 83 FR 27626–27 (June 13, DATES: Interested persons may file
persons are advised that information on 2018). OUII was also named as a party written comments on this notice in
this matter can be obtained by in the enforcement proceeding. accordance with 21 CFR 1303.13(c) and
contacting the Commission’s TDD On July 23, 2018, Sony filed a request 1315.13(d). Electronic comments must
terminal on (202) 205–1810. for an advisory opinion and a petition be submitted, and written comments
SUPPLEMENTARY INFORMATION: The for modification of the remedial orders must be postmarked, on or before
Commission instituted the original to clarify that certain of its redesigned September 24, 2018. Commenters
investigation on July 1, 2016, based on tape products are outside the scope of should be aware that the electronic
a complaint filed by Fujifilm the remedial orders. On August 2, 2018, Federal Docket Management System
Corporation of Tokyo, Japan, and Fujifilm filed a response, opposing both will not accept comments after 11:59
Fujifilm Recording Media U.S.A., Inc. of Sony’s request and petition. p.m. Eastern Time on the last day of the
Bedford, Massachusetts (collectively, Having examined the request and comment period.
‘‘Fujifilm’’). 81 FR 43243–44 (July 1, petition, as well as the supporting Based on comments received in
2016). Pertinent to this action, the documents, the Commission has response to this notice, the
complaint alleged violations of section determined to institute a modification Administrator may hold a public
337 of the Tariff Act of 1930, as proceeding, pursuant to Commission hearing on one or more issues raised. In
amended, 19 U.S.C. 1337 (‘‘section Rule 210.76(b) (19 CFR. 210.76(b)), to the event the Administrator decides in
337’’), in the sale for importation, determine whether the LEO and CDOs his sole discretion to hold such a
importation, and sale within the United issued in the underlying investigation hearing, the Administrator will publish
daltland on DSKBBV9HB2PROD with NOTICES
States after importation of certain should be modified to exclude certain of a notice of any such hearing in the
magnetic data storage tapes and Sony’s redesigned tape products. The Federal Register. After consideration of
cartridges containing the same by reason Commission has further determined to any comments or objections, or after a
of infringement of, inter alia, claims 1, delegate the modification proceeding to hearing, if one is held, the
4–9, 11 and 14 of U.S. Patent No. the presiding administrative law judge Administrator will publish in the
6,641,891 (‘‘the ’891 patent’’). The and to consolidate that proceeding with Federal Register a final order
Commission’s Notice of Investigation the ongoing enforcement proceeding. establishing the 2018 adjusted aggregate
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![42692 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
estimates of the medical needs of the both bulk and finished dosage form The Acting Administrator, therefore,
United States, product development, manufacturers, and other pertinent proposes to adjust the 2018 aggregate
and other information made available to information. In determining the production quotas for certain schedule I
the DEA after the initial aggregate proposed adjusted 2018 assessment of and II controlled substances and the
production quotas and assessment of annual needs, the DEA used the assessment of annual needs for the list
annual needs had been established. calculation methodology previously I chemicals ephedrine,
Other factors the Acting Administrator described in the 2010 and 2011 pseudoephedrine, and
considered in calculating the aggregate established assessment of annual needs phenylpropanolamine, expressed in
production quotas, but not the (74 FR 60294, Nov. 20, 2009, and 75 FR grams of anhydrous acid or base, as
assessment of annual needs, include
79407, Dec. 20, 2010, respectively). follows:
product development requirements of
Proposed
Established revised 2018
Basic class 2018 quotas quotas
(g) (g)
Temporarily Scheduled Substances
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide .................................................................. N/A 25.
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide ............................................. N/A 25.
Cyclopropyl Fentanyl ............................................................................................................................................... N/A 20.
Fentanyl related substances ................................................................................................................................... N/A 25.
Isobutyryl Fentanyl .................................................................................................................................................. N/A 25.
Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ...................................................... N/A 25.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .......................................... N/A 25.
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate ..................................................................................... N/A 25.
Ocfentanil ................................................................................................................................................................ N/A 25.
Para-flourobutyryl fentanyl ....................................................................................................................................... N/A 25.
Tetrahydrofuranyl fentanyl ....................................................................................................................................... N/A 5.
Valeryl fentanyl ........................................................................................................................................................ N/A 25.
Schedule I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine ...................................................................................................................... Zero 20.
1-(1-Phenylcyclohexyl)pyrrolidine ............................................................................................................................ 10 15.
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine ...................................................................................................... zero 10.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ................................................................................................ 30 no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) .............................................................................................. 30 no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine ....................................................................................................................... 15 no change.
1-Benzylpiperazine .................................................................................................................................................. 25 no change.
1-Methyl-4-phenyl-4-propionoxypiperidine .............................................................................................................. 2 10.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ............................................................................................... 30 no change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) ............................................................................................ 30 no change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) .............................................................................................. 30 no change.
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) ......................................................................................... 30 no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ........................................................................................................... 30 no change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi- 30 no change.
36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) ............................................................................................ 30 no change.
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi- 25 no change.
82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) ................................................................................................. 30 no change.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ...... 30 no change.
2,5-Dimethoxy-4-ethylamphetamine (DOET) .......................................................................................................... 25 no change.
2,5-Dimethoxy-4-n-propylthiophenethylamine ......................................................................................................... 25 no change.
2,5-Dimethoxyamphetamine .................................................................................................................................... 25 no change.
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) .................................................................................... 30 no change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) .............................................................................. 30 no change.
3,4,5-Trimethoxyamphetamine ................................................................................................................................ 30 no change.
3,4-Methylenedioxyamphetamine (MDA) ................................................................................................................ 55 no change.
3,4-Methylenedioxymethamphetamine (MDMA) ..................................................................................................... 50 no change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ................................................................................................. 40 no change.
3,4-Methylenedioxy-N-methylcathinone (methylone) .............................................................................................. 40 no change.
3,4-Methylenedioxypyrovalerone (MDPV) ............................................................................................................... 35 no change.
3-FMC; 3-Fluoro-N-methylcathinone ....................................................................................................................... 25 no change.
3-Methylfentanyl ...................................................................................................................................................... 30 no change.
3-Methylthiofentanyl ................................................................................................................................................ 30 no change.
daltland on DSKBBV9HB2PROD with NOTICES
4-Bromo-2,5-dimethoxyamphetamine (DOB) .......................................................................................................... 30 no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ...................................................................................................... 25 no change.
4-Fluoroisobutyryl fentanyl ...................................................................................................................................... 30 no change.
4-FMC; Flephedrone ............................................................................................................................................... 25 no change.
4-MEC; 4-Methyl-N-ethylcathinone ......................................................................................................................... 25 no change.
4-Methoxyamphetamine .......................................................................................................................................... 150 no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM) ......................................................................................................... 25 no change.
4-Methylaminorex .................................................................................................................................................... 25 no change.
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![Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42693
Proposed
Established revised 2018
Basic class 2018 quotas quotas
(g) (g)
4-Methyl-N-methylcathinone (mephedrone) ............................................................................................................ 45 no change.
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ................................................................................................... 25 no change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ............................................................................. 50 no change.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 40 no change.
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 no change.
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ....................................... 30 no change.
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) ............................ 30 no change.
5-Fluoro-PB-22; 5F-PB-22 ....................................................................................................................................... 20 no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol- ........................................................................................... 25 no change.
3-yl](2,2,3,3-tetramethylcyclopropyl)methanone ......................................................................................................
5-Methoxy-3,4-methylenedioxyamphetamine .......................................................................................................... 25 no change.
5-Methoxy-N,N-diisopropyltryptamine ..................................................................................................................... 25 no change.
5-Methoxy-N,N-dimethyltryptamine ......................................................................................................................... 25 no change.
AB-CHMINACA ....................................................................................................................................................... 30 no change.
AB-FUBINACA ........................................................................................................................................................ 50 no change.
AB-PINACA ............................................................................................................................................................. 30 no change.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) ..... 30 no change.
Acetyl Fentanyl ........................................................................................................................................................ 100 no change.
Acetyl-alpha-methylfentanyl ..................................................................................................................................... 30 no change.
Acetyldihydrocodeine .............................................................................................................................................. 30 no change.
Acetylmethadol ........................................................................................................................................................ 2 no change.
Acryl Fentanyl .......................................................................................................................................................... 25 no change.
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .......................... 50 no change.
AH-7921 .................................................................................................................................................................. 30 no change.
Allylprodine .............................................................................................................................................................. 2 no change.
Alphacetylmethadol ................................................................................................................................................. 2 no change.
alpha-Ethyltryptamine .............................................................................................................................................. 25 no change.
Alphameprodine ...................................................................................................................................................... 2 no change.
Alphamethadol ......................................................................................................................................................... 2 no change.
alpha-Methylfentanyl ............................................................................................................................................... 30 no change.
alpha-Methylthiofentanyl .......................................................................................................................................... 30 no change.
alpha-Methyltryptamine (AMT) ................................................................................................................................ 25 no change.
alpha-Pyrrolidinobutiophenone (a-PBP) .................................................................................................................. 25 no change.
alpha-Pyrrolidinopentiophenone (a-PVP) ................................................................................................................ 25 no change.
Aminorex ................................................................................................................................................................. 25 no change.
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ............................................................. 25 no change.
Benzylmorphine ....................................................................................................................................................... 30 no change.
Betacetylmethadol ................................................................................................................................................... 2 no change.
beta-Hydroxy-3-methylfentanyl ................................................................................................................................ 30 no change.
beta-Hydroxyfentanyl ............................................................................................................................................... 30 no change.
beta-Hydroxythiofentanyl ......................................................................................................................................... 30 no change.
Betameprodine ........................................................................................................................................................ 2 no change.
Betamethadol .......................................................................................................................................................... 4 no change.
Betaprodine ............................................................................................................................................................. 2 no change.
Bufotenine ............................................................................................................................................................... 3 no change.
Butylone ................................................................................................................................................................... 25 no change.
Butyryl fentanyl ........................................................................................................................................................ 30 no change.
Cathinone ................................................................................................................................................................ 24 no change.
Codeine methylbromide ........................................................................................................................................... 30 no change.
Codeine-N-oxide ...................................................................................................................................................... 192 no change.
Desomorphine ......................................................................................................................................................... 25 no change.
Diapromide .............................................................................................................................................................. Zero 20.
Diethylthiambutene .................................................................................................................................................. Zero 20.
Diethyltryptamine ..................................................................................................................................................... 25 no change.
Difenoxin .................................................................................................................................................................. 8,225 no change.
Dihydromorphine ..................................................................................................................................................... 1,000,160 no change.
Dimethyltryptamine .................................................................................................................................................. 35 50.
Dipipanone .............................................................................................................................................................. 5 no change.
Etorphine ................................................................................................................................................................. 30 no change.
Fenethylline ............................................................................................................................................................. 30 no change.
Furanyl fentanyl ....................................................................................................................................................... 30 no change.
gamma-Hydroxybutyric acid .................................................................................................................................... 37,130,000 no change.
Heroin ...................................................................................................................................................................... 45 no change.
daltland on DSKBBV9HB2PROD with NOTICES
Hydromorphinol ....................................................................................................................................................... 40 no change.
Hydroxypethidine ..................................................................................................................................................... 2 no change.
Ibogaine ................................................................................................................................................................... 30 no change.
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .......................................................................................... 35 no change.
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ............................................................................................................... 45 no change.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ................................................................................................................ 45 no change.
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) ........................................................................................... 30 no change.
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ............................................................................................... 30 no change.
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![42694 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Proposed
Established revised 2018
Basic class 2018 quotas quotas
(g) (g)
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ................................................................................... 35 no change.
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ................................................................................................ 30 no change.
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) ............................................................................................ 30 no change.
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ................................................................................................ 30 no change.
Lysergic acid diethylamide (LSD) ............................................................................................................................ 40 no change.
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-inda- 30 no change.
zole-3-carboxamide).
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3- 30 no change.
dimethylbutanoate).
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ............... 30 no change.
Marihuana ................................................................................................................................................................ 443,680 1,140,216.
Mecloqualone .......................................................................................................................................................... 30 no change.
Mescaline ................................................................................................................................................................ 25 no change.
Methaqualone .......................................................................................................................................................... 60 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 .................................................................................................................................................... 150 no change.
N,N-Dimethylamphetamine ...................................................................................................................................... 25 no change.
Naphyrone ............................................................................................................................................................... 25 no change.
N-Ethyl-1-phenylcyclohexylamine ............................................................................................................................ 5 no change.
N-Ethyl-3-piperidyl benzilate .................................................................................................................................... Zero 10.
N-Ethylamphetamine ............................................................................................................................................... 24 no change.
N-Hydroxy-3,4-methylenedioxyamphetamine .......................................................................................................... 24 no change.
Noracymethadol ...................................................................................................................................................... 2 no change.
Norlevorphanol ........................................................................................................................................................ 55 no change.
Normethadone ......................................................................................................................................................... 2 no change.
Normorphine ............................................................................................................................................................ 40 no change.
Para-fluorofentanyl .................................................................................................................................................. 25 no change.
Parahexyl ................................................................................................................................................................. 5 no change.
PB-22; QUPIC ......................................................................................................................................................... 20 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.
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) .............................................................. 45 no change.
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) .................................................................................. 30 no change.
Tetrahydrocannabinols ............................................................................................................................................ 384,460 no change.
Thiofentanyl ............................................................................................................................................................. 25 no change.
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ........................................................ 30 no change.
Tilidine ..................................................................................................................................................................... 25 no change.
Trimeperidine ........................................................................................................................................................... 2 no change.
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .......................................................... 25 no change.
U-47700 ................................................................................................................................................................... 30 no change.
Schedule II
1-Phenylcyclohexylamine ........................................................................................................................................ 4 15.
1-Piperidinocyclohexanecarbonitrile ........................................................................................................................ 4 25.
4-Anilino-N-phenethyl-4-piperidine (ANPP) ............................................................................................................. 1,342,320 no change.
Alfentanil .................................................................................................................................................................. 6,200 no change.
Alphaprodine ........................................................................................................................................................... 2 no change.
Amobarbital ............................................................................................................................................................. 20,100 no change.
Amphetamine (for conversion) ................................................................................................................................ 11,280,000 12,700,000.
Amphetamine (for sale) ........................................................................................................................................... 39,856,000 no change.
Anileridine ................................................................................................................................................................ Zero 20.
Carfentanil ............................................................................................................................................................... 20 no change.
Cocaine ................................................................................................................................................................... 92,120 no change.
Codeine (for conversion) ......................................................................................................................................... 15,040,000 12,900,000.
daltland on DSKBBV9HB2PROD with NOTICES
Codeine (for sale) .................................................................................................................................................... 40,015,000 no change.
Dextropropoxyphene ............................................................................................................................................... 35 no change.
Dihydrocodeine ........................................................................................................................................................ 264,140 no change.
Dihydroetorphine ..................................................................................................................................................... 2 no change.
Diphenoxylate (for conversion) ................................................................................................................................ 14,100 no change.
Diphenoxylate (for sale) .......................................................................................................................................... 770,800 no change.
Ecgonine .................................................................................................................................................................. 88,134 no change.
Ethylmorphine .......................................................................................................................................................... 30 no change.
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![Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices 42695
Proposed
Established revised 2018
Basic class 2018 quotas quotas
(g) (g)
Etorphine hydrochloride .......................................................................................................................................... 32 no change.
Fentanyl ................................................................................................................................................................... 1,342,320 no change.
Glutethimide ............................................................................................................................................................ 2 no change.
Hydrocodone (for conversion) ................................................................................................................................. 114,680 no change.
Hydrocodone (for sale) ............................................................................................................................................ 50,348,280 44,710,000.
Hydromorphone ....................................................................................................................................................... 4,547,720 no change.
Isomethadone .......................................................................................................................................................... 30 no change.
Levo-alphacetylmethadol (LAAM) ........................................................................................................................... 5 no change.
Levomethorphan ...................................................................................................................................................... 30 2,200.
Levorphanol ............................................................................................................................................................. 12,126 38,000.
Lisdexamfetamine ................................................................................................................................................... 17,869,000 19,000,000.
Meperidine ............................................................................................................................................................... 2,717,540 1,913,148.
Meperidine Intermediate-A ...................................................................................................................................... 5 30.
Meperidine Intermediate-B ...................................................................................................................................... 30 no change.
Meperidine Intermediate-C ...................................................................................................................................... 5 30.
Metazocine .............................................................................................................................................................. 15 no change.
Methadone (for sale) ............................................................................................................................................... 22,278,000 no change.
Methadone Intermediate ......................................................................................................................................... 24,064,000 no change.
Methamphetamine ................................................................................................................................................... 1,446,754 no change.
[846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)]
Methylphenidate ...................................................................................................................................................... 64,600,000 no change.
Morphine (for conversion) ....................................................................................................................................... 4,089,000 no change.
Morphine (for sale) .................................................................................................................................................. 33,958,440 31,456,000.
Nabilone .................................................................................................................................................................. 31,000 62,000.
Noroxymorphone (for conversion) ........................................................................................................................... 14,044,540 16,440,000.
Noroxymorphone (for sale) ...................................................................................................................................... 376,000 no change.
Opium (powder) ....................................................................................................................................................... 84,600 no change.
Opium (tincture) ....................................................................................................................................................... 564,000 no change.
Oripavine ................................................................................................................................................................. 24,534,000 no change.
Oxycodone (for conversion) .................................................................................................................................... 2,453,400 no change.
Oxycodone (for sale) ............................................................................................................................................... 95,692,000 85,578,000.
Oxymorphone (for conversion) ................................................................................................................................ 20,962,000 no change.
Oxymorphone (for sale) ........................................................................................................................................... 3,395,280 3,137,240.
Pentobarbital ........................................................................................................................................................... 25,850,000 no change.
Phenazocine ............................................................................................................................................................ 5 no change.
Phencyclidine .......................................................................................................................................................... 35 no change.
Phenmetrazine ........................................................................................................................................................ 25 no change.
Phenylacetone ......................................................................................................................................................... 40 no change.
Racemethorphan ..................................................................................................................................................... 5 no change.
Racemorphan .......................................................................................................................................................... 5 no change.
Remifentanil ............................................................................................................................................................. 2,820 3,000.
Secobarbital ............................................................................................................................................................. 161,682 172,100.
Sufentanil ................................................................................................................................................................. 1,880 no change.
Tapentadol ............................................................................................................................................................... 18,388,280 no change.
Thebaine .................................................................................................................................................................. 94,000,000 86,200,000.
List I Chemicals
Ephedrine (for conversion) ...................................................................................................................................... 47,000 no change.
Ephedrine (for sale) ................................................................................................................................................. 4,136,000 no change.
Phenylpropanolamine (for conversion) .................................................................................................................... 14,100,000 no change.
Phenylpropanolamine (for sale) .............................................................................................................................. 7,990,000 no change.
Pseudoephedrine (for conversion) .......................................................................................................................... 40 1,000.
Pseudoephedrine (for sale) ..................................................................................................................................... 180,000,000 no change.
The Acting Administrator further 2018 aggregate production quotas and quotas for each basic class of controlled
proposes that aggregate production assessment of annual needs as needed. substances in schedules I and II and
quotas for all other schedule I and II established assessment of annual needs
Conclusion
daltland on DSKBBV9HB2PROD with NOTICES
controlled substances included in 21 for the list I chemicals ephedrine,
CFR 1308.11 and 1308.12 remain at After consideration of any comments pseudoephedrine, and
zero. In accordance with 21 CFR or objections, or after a hearing, if one phenylpropanolamine, 21 CFR
1303.13 and 21 CFR 1315.13, upon is held, the Acting Administrator will 1303.13(c) and 1315.13(f).
consideration of the relevant factors, the issue and publish in the Federal
Acting Administrator may adjust the Register a final order establishing any
adjustment of 2018 aggregate production
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![42696 Federal Register / Vol. 83, No. 164 / Thursday, August 23, 2018 / Notices
Dated: August 17, 2018. DEPARTMENT OF JUSTICE Administration (DEA) as importers of
Uttam Dhillon, various classes of schedule I or II
Acting Administrator. Drug Enforcement Administration controlled substances.
[FR Doc. 2018–18265 Filed 8–22–18; 8:45 am] [Docket No. DEA–392] SUPPLEMENTARY INFORMATION: The
BILLING CODE 4410–09–P companies listed below applied to be
Importer of Controlled Substances registered as importers of various basic
Registration classes of controlled substances.
ACTION: Notice of registration. Information on previously published
notices is listed in the table below. No
SUMMARY: Registrants listed below have comments or objections were submitted
applied for and been granted and no requests for hearing were
registration by the Drug Enforcement submitted for these notices.
Company FR docket Published
Fisher Clinical Services, Inc .......................................................................................... 83 FR 28663 ...................... June 20, 2018.
Unither Manufacturing LLC ............................................................................................ 83 FR 29136 ...................... June 22, 2018.
The Drug Enforcement ‘‘no state authority to handle controlled notified Registrant of his right to submit
Administration (DEA) has considered substances’’ in the State of Oklahoma, a corrective action plan. Id. at 2–3
the factors in 21 U.S.C. 823, 952(a) and the State in which he is registered with (citing 21 U.S.C. 824(c)(2)(C)).
958(a) and determined that the the DEA. Order to Show Cause, According to an Affidavit of Service
registration of the listed registrants to Government Exhibit (GX) 2, at 1, 2 filed in this matter, on October 30, 2017,
import the applicable basic classes of (citing 21 U.S.C. 824(a)(3)). For the same personnel from DEA’s Office of Chief
schedule I or II controlled substances is reason, the Order also proposed the Counsel, Diversion and Regulatory
consistent with the public interest and denial of any of Registrant’s Litigation Section, attempted to serve
with United States obligations under ‘‘applications for renewal or the Show Cause Order on the Registrant
international treaties, conventions, or modification of such registration and by regular first class mail addressed to
protocols in effect on May 1, 1971. The any applications for any other DEA the Registrant at his registered address.
DEA investigated each company’s registrations.’’ Id. at 1. GX 6. The Government represents that
maintenance of effective controls With respect to the Agency’s its mailing was not returned as
against diversion by inspecting and jurisdiction, the Show Cause Order undeliverable. Id. On January 10, 2018,
testing each company’s physical alleged that Registrant is the holder of the Government submitted a Request for
security systems, verifying each Certificate of Registration No. Final Agency Action (RFAA)
company’s compliance with state and BR7006085, pursuant to which he is representing that Registrant did not
local laws, and reviewing each authorized to dispense controlled request a hearing and ‘‘ha[d] not filed
company’s background and history. substances as a practitioner in schedules any written statement in lieu of a
Therefore, pursuant to 21 U.S.C. II through V, at the registered address of hearing’’ within 30 days of service and
952(a) and 958(a), and in accordance 8596 E. 101st, Ste. B, Tulsa, Oklahoma. seeking a final order revoking his
with 21 CFR 1301.34, the DEA has Id. The Order also alleged that this registration. GX 7, at 2.
granted a registration as an importer for registration does not expire until April On February 6, 2018, the then-Acting
schedule I or II controlled substances to 30, 2018. Id. Administrator issued an Order noting
the above listed companies. As the substantive ground for the that the Government’s effort at service
proceeding, the Show Cause Order in this case was ‘‘a departure from the
Dated: August 17, 2018.
alleged that ‘‘on September 21, 2017, the Agency’s traditional practice.’’ GX 8.
John J. Martin,
Oklahoma State Board of Osteopathic The Order further noted that ‘‘the
Assistant Administrator. Examiners cancelled [Registrant’s] Government cites to no authority
[FR Doc. 2018–18266 Filed 8–22–18; 8:45 am] osteopathic medical license’’ and his establishing that a sole effort of mailing
BILLING CODE 4410–09–P ‘‘Oklahoma Bureau of Narcotics and by first class mail (with no evidence of
Dangerous Drugs registration is delivery to the address) is sufficient to
inactive.’’ Id. at 1–2. The Show Cause provide constitutionally adequate
DEPARTMENT OF JUSTICE Order thus alleged that Registrant is service for initiating a proceeding under
‘‘currently without authority to practice the Due Process Clause.’’ Id. As a result,
Drug Enforcement Administration
medicine or handle controlled the then-Acting Administrator directed
Greg N. Rampey, D.O.; Dismissal of substances in the State of Oklahoma, the the Government to either address why
Proceedings [S]tate in which [he is] registered with its effort was consistent with the Due
the DEA,’’ and that, as a consequence, Process Clause or to engage in
On October 27, 2017, the Acting ‘‘DEA must revoke’’ his registration. Id. additional reasonable efforts to serve
Assistant Administrator, Diversion at 2. Registrant. Id.
Control Division, Drug Enforcement The Show Cause Order notified On March 29, 2018, my office
daltland on DSKBBV9HB2PROD with NOTICES
Administration (DEA), issued an Order Registrant of (1) his right to request a received the Government’s Second
to Show Cause to Greg N. Rampey, D.O. hearing on the allegations or to submit Request for Final Agency Action
(Registrant), of Tulsa, Oklahoma. The a written statement in lieu of a hearing, (SRFAA) describing a Diversion
Show Cause Order proposed the (2) the procedure for electing either Investigator’s additional attempts to
revocation of Registrant’s DEA option, and (3) the consequence for serve the Show Cause Order and again
Certificate of Registration No. failing to elect either option. Id. (citing seeking a final order revoking
BR7006085 on the ground that he has 21 CFR 1301.43). The Order also Registrant’s registration. SRFAA, at 2.
VerDate Sep<11>2014 19:43 Aug 22, 2018 Jkt 244001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\23AUN1.SGM 23AUN1](https://thefederalregister.org/doc/83_FR_42854/page/7.svg)
Document Created: 2018-08-23 00:34:24
Document Modified: 2018-08-23 00:34:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with request for comments. | |
| 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 September 24, 2018. 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. | |
| Contact | Thomas D. Sonnen, Diversion Control | |
| FR Citation | 83 FR 42690 |
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