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RESOURCES > Federal Register Notices > Quotas - 2018 > 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

Quotas - 2018

[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42690-42696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:

Basic Class Established
2018
Quotas
(g)
Proposed
Revised
2018
Quotas
(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-36) 30 no change
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-82) 25 no change
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
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
4-Methyl-N-methylcathinone (mephedrone) 45 no change
4-Methyl-α-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-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25 no change
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 (α-PBP) 25 no change
alpha-Pyrrolidinopentiophenone (α-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
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
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-indazole-3-carboxamide) 30 no change
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 30 no change
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
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
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 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).

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Dated: August 17, 2018.

Uttam Dhillon,
Acting Administrator.

[FR Doc. 2018-18265 Filed 8-22-18; 8:45 am]

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