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 Department of Justice Drug Enforcement Administration [Docket No. DEA-488P]
 AGENCY: Drug Enforcement Administration, Department of Justice.
 ACTION: Notice with request for comments.
 SUMMARY: The Drug Enforcement Administration (DEA) proposes to establish the 2019 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
 DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before September 19, 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 2019 aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
 ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-488P” 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 Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the DEA pursuant to 28 CFR 0.100. Analysis for Proposed 2019 Aggregate Production Quotas and Assessment of Annual Needs The proposed year 2019 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 2019 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 2019 aggregate production quotas and assessment of annual needs, the Acting Administrator has taken into account the criteria in 21 U.S.C. 826(a) and factors set forth in 21 CFR 1303.11 (aggregate production quotas for controlled substances) and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and 
                    ( print page 42165)
                    phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2019 by considering: (1) Total net disposal of each class or chemical by all manufacturers and chemical importers during the current and two preceding years; (2) trends in the national rate of net disposal of the class or chemical; (3) total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation; (4) projected demand for each class or chemical as indicated by procurement and import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Acting Administrator finds relevant. These quotas do not include imports of controlled substances for use in industrial processes. Other factors the Acting Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the proposed 2019 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). On July 16, 2018, DEA published a final rule regarding controlled substances quotas with an effective date of August 15, 2018 (“Controlled Substances Quotas Final Rule”). 83 FR 32784. The Controlled Substances Quotas Final Rule added two factors for DEA to consider when setting aggregate production quotas and assessments of annual needs. These additional factors are: (1) The extent of any diversion of the controlled substance in the class; and (2) relevant information obtained from the Department of Health and Human Services, including from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services, and relevant information obtained from the states. The proposed aggregate quotas for 2019 in this notice were determined with consideration of the factors in effect prior to the effective date of the Controlled Substances Quotas Final Rule. The Acting Administrator, therefore, proposes to establish the 2019 aggregate production quotas for certain schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Basic class
Proposed 2019 quotas(g)**Schedule I**1-[1-(2-Thienyl)cyclohexyl]pyrrolidine
201-(1-Phenylcyclohexyl)pyrrolidine
151-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine
101-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)
301-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)
301-Benzylpiperazine
251-Methyl-4-phenyl-4-propionoxypiperidine
101-[1-(2-Thienyl)cyclohexyl]piperidine
152-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)
302-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)
302-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)
302-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)
302-(2,5-Dimethoxyphenyl)ethanamine (2C-H)
302-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)
302-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)
302-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)
252-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)
302-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)
302,5-Dimethoxy-4-ethylamphetamine (DOET)
252,5-Dimethoxy-4-n-propylthiophenethylamine
252,5-Dimethoxyamphetamine
252-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)
302-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)
303,4,5-Trimethoxyamphetamine
303,4-Methylenedioxyamphetamine (MDA)
553,4-Methylenedioxymethamphetamine (MDMA)
503,4-Methylenedioxy-N-ethylamphetamine (MDEA)
403,4-Methylenedioxy-N-methylcathinone (methylone)
403,4-Methylenedioxypyrovalerone (MDPV)
353-FMC; 3-Fluoro-N-methylcathinone
253-Methylfentanyl
303-Methylthiofentanyl
304-Bromo-2,5-dimethoxyamphetamine (DOB)
304-Bromo-2,5-dimethoxyphenethylamine (2-CB)
251-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide
254-Fluoroisobutyryl fentanyl
304-FMC; Flephedrone
254-MEC; 4-Methyl-N-ethylcathinone
254-Methoxyamphetamine
1504-Methyl-2,5-dimethoxyamphetamine (DOM)
25( print page 42166)4-Methylaminorex
254-Methyl-N-methylcathinone (mephedrone)
454-Methyl-α-pyrrolidinopropiophenone (4-MePPP)
255-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol
505-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)
40N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide
251-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3carboximide
255F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)
305F-AMB (methyl 2-(1-(5-fluoropentyl)-1
                            *H*
                            -indazole-3-carboxamido)-3-methylbutanoate)
305F-APINACA; 5F-AKB48 (
                            *N*
                            -(adamantan-1-yl)-1-(5-fluoropentyl)-1
                            *H*
                            -indazole-3-carboxamide)
305-Fluoro-PB-22; 5F-PB-22
205-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1
                            *H*
                            indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone
255-Methoxy-3,4-methylenedioxyamphetamine
255-Methoxy-N,N-diisopropyltryptamine
255-Methoxy-N,N-dimethyltryptamine
25AB-CHMINACA
30AB-FUBINACA
50AB-PINACA
30ADB-FUBINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1
                            *H*
                            -indazole-3-carboxamide)
30Acetyl Fentanyl
100Acetyl-
                            *alpha*
                            -methylfentanyl
30Acetyldihydrocodeine
30Acetylmethadol
2Acryl Fentanyl
25ADB-PINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1
                            *H*
                            -indazole-3-carboxamide)
50AH-7921
30Allylprodine
2Alphacetylmethadol
2*alpha-*
                            Ethyltryptamine
25Alphameprodine
2Alphamethadol
2*alpha*
                            -Methylfentanyl
30*alpha*
                            -Methylthiofentanyl
30*alpha*
                            -Methyltryptamine (AMT)
25*alpha*
                            -Pyrrolidinobutiophenone (α-PBP)
25*alpha*
                            -Pyrrolidinopentiophenone (α-PVP)
25Aminorex
25Anileridine
20APINCA, AKB48 (
                            *N*
                            -(1-adamantyl)-1-pentyl-1
                            *H*
                            -indazole-3-carboxamide)
25Benzylmorphine
30Betacetylmethadol
2*beta*
                            -Hydroxy-3-methylfentanyl
30*beta*
                            -Hydroxyfentanyl
30*beta*
                            -Hydroxythiofentanyl
30Betameprodine
2Betamethadol
4Betaprodine
2Bufotenine
3Butylone
25Butyryl fentanyl
30Cathinone
24Codeine methylbromide
30Codeine-N-oxide
192Cyclopropyl Fentanyl
20Desomorphine
25Diapromide
20Diethylthiambutene
20Diethyltryptamine
25Difenoxin
8,225Dihydromorphine
753,500Dimethyltryptamine
50Dipipanone
5Etorphine
30Fenethylline
30Fentanyl related substances
25Furanyl fentanyl
30*gamma*
                            -Hydroxybutyric acid
33,417,000Heroin
45Hydromorphinol
40Hydroxypethidine
2Ibogaine
30( print page 42167)Isobutyryl Fentanyl
25JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)
35JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)
45JWH-073 (1-Butyl-3-(1-naphthoyl)indole)
45JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)
30JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)
30JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)
35JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)
30JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)
30JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)
30Lysergic acid diethylamide (LSD)
40MAB-CHMINACA; ADB-CHMINACA (
                            *N*
                            -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1
                            *H*
                            -indazole-3-carboxamide)
30MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1
                            *H*
                            -indole-3-carboxamido)-3,3-dimethylbutanoate)
30MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1
                            *H*
                            -indazole-3-carboxamido)-3,3-dimethylbutanoate)
30Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate
25Marihuana
2,450,000Mecloqualone
30Mescaline
25Methaqualone
60Methcathinone
25Methyldesorphine
5Methyldihydromorphine
2Morphine methylbromide
5Morphine methylsulfonate
5Morphine-N-oxide
150Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate
25*N,N*
                            -Dimethylamphetamine
25Naphyrone
25*N*
                            -Ethyl-1-phenylcyclohexylamine
5*N*
                            -Ethyl-3-piperidyl benzilate
10*N*
                            -Ethylamphetamine
24*N*
                            -Hydroxy-3,4-methylenedioxyamphetamine
24Noracymethadol
2Norlevorphanol
55Normethadone
2Normorphine
40Ocfentanil
25Para-fluorofentanyl
25Para-flourobutyryl fentanyl
25Parahexyl
5PB-22; QUPIC
20Pentedrone
25Pentylone
25Phenomorphan
2Pholcodine
5Psilocybin
30Psilocyn
50SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)
45SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)
30Tetrahydrocannabinols
384,460Tetrahydrofuranyl fentanyl
5Thiofentanyl
25THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)
30Tilidine
25Trimeperidine
2UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone
25U-47700
30Valeryl fentanyl
25**Schedule II**1-Phenylcyclohexylamine
151-Piperidinocyclohexanecarbonitrile
254-Anilino-N-phenethyl-4-piperidine (ANPP)
1,185,000Alfentanil
6,200Alphaprodine
2Amobarbital
20,100Amphetamine (for conversion)
12,000,000Amphetamine (for sale)
42,400,000Carfentanil
20( print page 42168)Cocaine
92,120Codeine (for conversion)
13,536,000Codeine (for sale)
40,015,800Dextropropoxyphene
35Dihydrocodeine
238,466Dihydroetorphine
2Diphenoxylate (for conversion)
14,100Diphenoxylate (for sale)
770,800Ecgonine
88,134Ethylmorphine
30Etorphine hydrochloride
32Fentanyl
1,185,000Glutethimide
2Hydrocodone (for conversion)
5,000Hydrocodone (for sale)
44,710,000Hydromorphone
4,071,000Isomethadone
30Levo-alphacetylmethadol (LAAM)
5Levomethorphan
4,000Levorphanol
34,000Lisdexamfetamine
19,000,000Meperidine
1,580,000Meperidine Intermediate-A
30Meperidine Intermediate-B
30Meperidine Intermediate-C
30Metazocine
15Methadone (for sale)
22,278,000Methadone Intermediate
24,064,000Methamphetamine
1,446,754**[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
64,600,000Morphine (for conversion)
4,089,000Morphine (for sale)
31,456,000Nabilone
62,000Noroxymorphone (for conversion)
19,169,340Noroxymorphone (for sale)
376,000Opium (powder)
84,600Opium (tincture)
530,837Oripavine
28,705,000Oxycodone (for conversion)
2,081,000Oxycodone (for sale)
85,578,000Oxymorphone (for conversion)
24,525,540Oxymorphone (for sale)
2,880,000Pentobarbital
25,850,000Phenazocine
5Phencyclidine
35Phenmetrazine
25Phenylacetone
40Racemethorphan
5Racemorphan
5Remifentanil
3,000Secobarbital
172,100Sufentanil
1,880Tapentadol
18,388,280Thebaine
84,600,000**List I Chemicals**Ephedrine (for conversion)
25Ephedrine (for sale)
4,136,000Phenylpropanolamine (for conversion)
14,100,000Phenylpropanolamine (for sale)
7,990,000Pseudoephedrine (for conversion)
1,000Pseudoephedrine (for sale)
174,246,000
 
 
 The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2019 aggregate production quotas and assessment of annual needs as needed. Conclusion After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the 
                    **Federal Register**
                     a final order establishing the 2019 aggregate production quotas for controlled substances in schedules I and II and establishing an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.11(c) and 1315.11(f). Dated: August 14, 2018. Uttam Dhillon, Acting Administrator.


[FR Doc. 2018-17893 Filed 8-17-18; 8:45 am] BILLING CODE 4410-09-P