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RESOURCES > Federal Register Notices > Quotas - 2017 > 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 2017

Quotas - 2017

[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Pages 36449-36454]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-16440]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-470P]

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 2017

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice with request for comments.


SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust the 2017 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 5, 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 2017 adjusted 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-470P" 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: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

[[Page 36450]]

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 2017 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 October 5, 2016 (81 FR 69079). 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 2017 Aggregate Production Quotas and Assessment of Annual Needs

The DEA proposes to adjust the established 2017 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 2017 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 2017 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 2016 year-end inventories, 2016 disposition data submitted by quota applicants, 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 2017 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 that the year 2017 aggregate production quotas for the nine temporarily scheduled substances be established, and to adjust the 2017 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:

[[Page 36451]]

Basic Class Established
2017
Quotas
(g)
Proposed
Revised
2017
Quotas
(g)
Temporarily Scheduled Substances
4-Fluoroisobutyryl fentanyl N/A 30
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) N/A 30
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) N/A 30
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) N/A 30
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30
Furanyl fentanyl N/A 30
U-47700 N/A 30
Schedule I
1-(1-Phenylcyclohexyl)pyrrolidine 10 no change
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 no change
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) 25 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) 5 30
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 25 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 2 30
3-Methylthiofentanyl 2 30
4-Bromo-2,5-dimethoxyamphetamine (DOB) 25 no change
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25 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
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 15 30
AB-FUBINACA 50 no change
AB-PINACA 15 30
Acetyl Fentanyl 100 no change
Acetyl-alpha-methylfentanyl 2 30
Acetyldihydrocodeine 2 30
Acetylmethadol 2 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 2 30
alpha-Methylthiofentanyl 2 30
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 2 30
Betacetylmethadol 2 no change
beta-Hydroxy-3-methylfentanyl 2 30
beta-Hydroxyfentanyl 2 30
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 5 30
Codeine-N-oxide 305 330
Desomorphine 25 no change
Diethyltryptamine 25 no change
Difenoxin 8,750 no change
Dihydromorphine 1,566,000 no change
Dimethyltryptamine 35 no change
Dipipanone 5 no change
Etorphine Zero 30
Fenethylline 5 30
gamma-Hydroxybutyric acid 56,200,000 no change
Heroin 25 45
Hydromorphinol 2 no change
Hydroxypethidine 2 no change
Ibogaine 5 30
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) 10 40
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) Zero 30
Marihuana 472,000 no change
Mecloqualone Zero 30
Mescaline 25 no change
Methaqualone 10 60
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 350 no change
N,N-Dimethylamphetamine 25 no change
Naphyrone 25 no change
N-Ethyl-1-phenylcyclohexylamine 5 no change
N-Ethylamphetamine 24 no change
N-Hydroxy-3,4-methylenedioxyamphetamine 24 no change
Noracymethadol 2 no change
Norlevorphanol 52 55
Normethadone 2 no change
Normorphine 40 no change
Para-fluorofentanyl 5 25
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 409,000 no change
Thiofentanyl 2 25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 15 30
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
Schedule II
1-Phenylcyclohexylamine 4 no change
1-Piperidinocyclohexanecarbonitrile 4 no change
4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,750,000 no change
Alfentanil 4,200 no change
Alphaprodine 2 no change
Amobarbital 20,100 no change
Amphetamine (for conversion) 12,000,000 no change
Amphetamine (for sale) 42,400,000 no change
Carfentanil 10 20
Cocaine 103,400 no change
Codeine (for conversion) 40,000,000 no change
Codeine (for sale) 45,000,000 no change
Dextropropoxyphene 15 35
Dihydrocodeine 281,100 422,000
Dihydroetorphine 2 no change
Diphenoxylate (for conversion) 15,000 no change
Diphenoxylate (for sale) 820,000 1,110,000
Ecgonine 99,000 no change
Ethylmorphine 2 30
Etorphine hydrochloride 32 no change
Fentanyl 1,750,000 no change
Glutethimide 2 no change
Hydrocodone (for conversion) 122,000 no change
Hydrocodone (for sale) 58,410,000 no change
Hydromorphone 5,140,800 no change
Isomethadone 4 30
Levo-alphacetylmethadol (LAAM) 3 5
Levomethorphan 10 30
Levorphanol 8,300 12,900
Lisdexamfetamine 19,000,000 no change
Meperidine 3,706,000 no change
Meperidine Intermediate-A 5 no change
Meperidine Intermediate-B 9 30
Meperidine Intermediate-C 5 no change
Metazocine 15 no change
Methadone (for sale) 23,700,000 no change
Methadone Intermediate 25,600,000 no change
Methamphetamine 1,539,100 no change
[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)]
Methylphenidate 73,000,000 no change
Morphine (for conversion) 27,300,000 no change
Morphine (for sale) 41,000,000 no change
Nabilone 19,000 no change
Noroxymorphone (for conversion) 17,700,000 no change
Noroxymorphone (for sale) 400,000 no change
Opium (powder) 90,000 no change
Opium (tincture) 907,200 600,000
Oripavine 22,000,000 22,700,000
Oxycodone (for conversion) 2,610,000 no change
Oxycodone (for sale) 108,510,000 no change
Oxymorphone (for conversion) 22,300,000 no change
Oxymorphone (for sale) 4,200,000 no change
Pentobarbital 27,500,000 no change
Phenazocine 5 no change
Phencyclidine 20 35
Phenmetrazine 2 25
Phenylacetone 20 40
Racemethorphan 2 5
Racemorphan 2 5
Remifentanil 3,000 no change
Secobarbital 172,002 no change
Sufentanil 4,000 no change
Tapentadol 21,000,000 no change
Thebaine 100,000,000 no change
List I Chemicals
Ephedrine (for conversion) 50,000 no change
Ephedrine (for sale) 5,360,000 no change
Phenylpropanolamine (for conversion) 15,000,000 no change
Phenylpropanolamine (for sale) 8,500,000 no change
Pseudoephedrine (for conversion) 40 no change
Pseudoephedrine (for sale) 200,00,000 no change

[[Page 36454]]

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 2017 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 2017 aggregate production quota 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).

Dated: July 27, 2017.

Chuck Rosenberg,
Acting Administrator.

[FR Doc. 2017-16440 Filed 8-3-17; 8:45 am]

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