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Notice

Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2018

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AGENCY:

Drug Enforcement Administration, Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

The Drug Enforcement Administration (DEA) proposes to establish the 2018 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 6, 2017. 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 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-471N” 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.

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FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

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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 2018 Aggregate Production Quotas and Assessment of Annual Needs

The proposed year 2018 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 2018 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 2018 aggregate production quotas and assessment of annual needs, the Acting Administrator has taken into account the criteria pursuant to 21 U.S.C. 826(a) and in accordance with 21 CFR 1303.11 (aggregate production quotas for controlled substances) and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and Start Printed Page 36831phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2018 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 2018 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).

The Acting Administrator, therefore, proposes to establish the 2018 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 classProposed 2018 quotas
(g)
Schedule I
1-(1-Phenylcyclohexyl)pyrrolidine10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)30
1-[1-(2-Thienyl)cyclohexyl]piperidine15
1-Benzylpiperazine25
1-Methyl-4-phenyl-4-propionoxypiperidine2
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)25
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)25
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)30
2,5-Dimethoxy-4-ethylamphetamine (DOET)25
2,5-Dimethoxy-4-n-propylthiophenethylamine25
2,5-Dimethoxyamphetamine25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)30
3,4,5-Trimethoxyamphetamine25
3,4-Methylenedioxyamphetamine (MDA)55
3,4-Methylenedioxymethamphetamine (MDMA)50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)40
3,4-Methylenedioxy-N-methylcathinone (methylone)40
3,4-Methylenedioxypyrovalerone (MDPV)35
3-FMC; 3-Fluoro-N-methylcathinone25
3-Methylfentanyl30
3-Methylthiofentanyl30
4-Bromo-2,5-dimethoxyamphetamine (DOB)25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25
4-Fluoroisobutyryl fentanyl30
4-FMC; Flephedrone25
4-MEC; 4-Methyl-N-ethylcathinone25
4-Methoxyamphetamine150
4-Methyl-2,5-dimethoxyamphetamine (DOM)25
4-Methylaminorex25
4-Methyl-N-methylcathinone (mephedrone)45
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol50
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)40
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1 H-indazole-3-carboxamido)-3-methylbutanoate)30
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1 H-indazole-3-carboxamide)30
5-Fluoro-PB-22; 5F-PB-2220
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone25
5-Methoxy-3,4-methylenedioxyamphetamine25
5-Methoxy-N,N-diisopropyltryptamine25
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5-Methoxy-N,N-dimethyltryptamine25
AB-CHMINACA30
AB-FUBINACA50
AB-PINACA30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide)30
Acetyl Fentanyl100
Acetyl-alpha-methylfentanyl30
Acetyldihydrocodeine30
Acetylmethadol2
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide)50
AH-792130
Allylprodine2
Alphacetylmethadol2
alpha- Ethyltryptamine25
Alphameprodine2
Alphamethadol2
alpha-Methylfentanyl30
alpha-Methylthiofentanyl30
alpha-Methyltryptamine (AMT)25
alpha-Pyrrolidinobutiophenone (α-PBP)25
alpha-Pyrrolidinopentiophenone (α-PVP)25
Aminorex25
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)25
Benzylmorphine30
Betacetylmethadol2
beta-Hydroxy-3-methylfentanyl30
beta-Hydroxyfentanyl30
beta-Hydroxythiofentanyl30
Betameprodine2
Betamethadol4
Betaprodine2
Bufotenine3
Butylone25
Butyryl fentanyl30
Cathinone24
Codeine methylbromide30
Codeine-N-oxide192
Desomorphine25
Diethyltryptamine25
Difenoxin8,225
Dihydromorphine1,000,160
Dimethyltryptamine35
Dipipanone5
Etorphine30
Fenethylline30
Furanyl fentanyl30
gamma-Hydroxybutyric acid37,130,000
Heroin45
Hydromorphinol40
Hydroxypethidine2
Ibogaine30
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)35
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)45
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)45
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)30
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)30
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)35
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)30
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)30
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)30
Lysergic acid diethylamide (LSD)40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide)30
MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1 H-indole-3-carboxamido)-3,3-dimethylbutanoate)30
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1 H-indazole-3-carboxamido)-3,3-dimethylbutanoate)30
Marihuana443,680
Mecloqualone30
Mescaline25
Methaqualone60
Methcathinone25
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Methyldesorphine5
Methyldihydromorphine2
Morphine methylbromide5
Morphine methylsulfonate5
Morphine-N-oxide150
N,N-Dimethylamphetamine25
Naphyrone25
N-Ethyl-1-phenylcyclohexylamine5
N-Ethylamphetamine24
N-Hydroxy-3,4-methylenedioxyamphetamine24
Noracymethadol2
Norlevorphanol55
Normethadone2
Normorphine40
Para-fluorofentanyl25
Parahexyl5
PB-22; QUPIC20
Pentedrone25
Pentylone25
Phenomorphan2
Pholcodine5
Psilocybin30
Psilocyn50
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)45
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)30
Tetrahydrocannabinols384,460
Thiofentanyl25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)30
Tilidine25
Trimeperidine2
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone25
U-4770030
Schedule II
1-Phenylcyclohexylamine4
1-Piperidinocyclohexanecarbonitrile4
4-Anilino-N-phenethyl-4-piperidine (ANPP)1,342,320
Alfentanil2,538
Alphaprodine2
Amobarbital18,894
Amphetamine (for conversion)11,280,000
Amphetamine (for sale)39,856,000
Carfentanil20
Cocaine92,120
Codeine (for conversion)15,040,000
Codeine (for sale)40,015,800
Dextropropoxyphene35
Dihydrocodeine264,140
Dihydroetorphine2
Diphenoxylate (for conversion)14,100
Diphenoxylate (for sale)770,800
Ecgonine88,134
Ethylmorphine30
Etorphine hydrochloride32
Fentanyl1,342,320
Glutethimide2
Hydrocodone (for conversion)114,680
Hydrocodone (for sale)50,348,280
Hydromorphone4,547,720
Isomethadone30
Levo-alphacetylmethadol (LAAM)5
Levomethorphan30
Levorphanol12,126
Lisdexamfetamine17,869,000
Meperidine2,717,540
Meperidine Intermediate—A5
Meperidine Intermediate—B30
Meperidine Intermediate—C5
Metazocine15
Methadone (for sale)22,278,000
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Methadone Intermediate24,064,000
Methamphetamine1,446,754
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]
Methylphenidate60,724,000
Morphine (for conversion)4,089,000
Morphine (for sale)33,958,440
Nabilone17,860
Noroxymorphone (for conversion)14,044,540
Noroxymorphone (for sale)376,000
Opium (powder)84,600
Opium (tincture)564,000
Oripavine24,534,000
Oxycodone (for conversion)2,453,400
Oxycodone (for sale)95,692,000
Oxymorphone (for conversion)20,962,000
Oxymorphone (for sale)3,395,280
Pentobarbital25,850,000
Phenazocine5
Phencyclidine35
Phenmetrazine25
Phenylacetone40
Racemethorphan5
Racemorphan5
Remifentanil2,820
Secobarbital161,682
Sufentanil1,880
Tapentadol18,388,280
Thebaine94,000,000
List I Chemicals
Ephedrine (for conversion)47,000
Ephedrine (for sale)4,136,000
Phenylpropanolamine (for conversion)14,100,000
Phenylpropanolamine (for sale)7,990,000
Pseudoephedrine (for conversion)40
Pseudoephedrine (for sale)169,200,000

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 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 the 2018 aggregate production quota for controlled substances in schedules I and II and establishing an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.11(c) and 1315.11(f).

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Dated: July 27, 2017.

Chuck Rosenberg,

Acting Administrator.

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[FR Doc. 2017-16439 Filed 8-4-17; 8:45 am]

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