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Notice

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

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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 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.

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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 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:Start Printed Page 36451

Basic classEstablished 2017 quotas (g)Proposed Revised 2017 quotas (g)
Temporarily Scheduled Substances
4-Fluoroisobutyryl fentanylN/A30.
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)N/A30.
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1 H-indazole-3-carboxamido)-3-methylbutanoate)N/A30.
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1 H-indazole-3-carboxamide)N/A30.
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide)N/A30.
MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1 H-indole-3-carboxamido)-3,3-dimethylbutanoate)N/A30.
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1 H-indazole-3-carboxamido)-3,3-dimethylbutanoate)N/A30.
Furanyl fentanylN/A30.
U-47700N/A30.
Schedule I
1-(1-Phenylcyclohexyl)pyrrolidine10no change.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)30no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)30no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine15no change.
1-Benzylpiperazine25no change.
1-Methyl-4-phenyl-4-propionoxypiperidine2no change.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)30no change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)30no change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)30no change.
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P)30no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)30no change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)25no change.
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)30no change.
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)25no change.
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)30no change.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)530.
2,5-Dimethoxy-4-ethylamphetamine (DOET)25no change.
2,5-Dimethoxy-4-n-propylthiophenethylamine25no change.
2,5-Dimethoxyamphetamine25no change.
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)30no change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)30no change.
3,4,5-Trimethoxyamphetamine25no change.
3,4-Methylenedioxyamphetamine (MDA)55no change.
3,4-Methylenedioxymethamphetamine (MDMA)50no change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)40no change.
3,4-Methylenedioxy-N-methylcathinone (methylone)40no change.
3,4-Methylenedioxypyrovalerone (MDPV)35no change.
3-FMC; 3-Fluoro-N-methylcathinone25no change.
3-Methylfentanyl230.
3-Methylthiofentanyl230.
4-Bromo-2,5-dimethoxyamphetamine (DOB)25no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25no change.
4-FMC; Flephedrone25no change.
4-MEC; 4-Methyl-N-ethylcathinone25no change.
4-Methoxyamphetamine150no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)25no change.
4-Methylaminorex25no change.
4-Methyl-N-methylcathinone (mephedrone)45no change.
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)25no change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol50no change.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)40no change.
5-Fluoro-PB-22; 5F-PB-2220no change.
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 H indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone25no change.
5-Methoxy-3,4-methylenedioxyamphetamine25no change.
5-Methoxy-N,N-diisopropyltryptamine25no change.
5-Methoxy-N,N-dimethyltryptamine25no change.
AB-CHMINACA1530.
AB-FUBINACA50no change.
AB-PINACA1530.
Acetyl Fentanyl100no change.
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Acetyl-alpha-methylfentanyl230.
Acetyldihydrocodeine230.
Acetylmethadol2no change.
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide)50no change.
AH-792130no change.
Allylprodine2no change.
Alphacetylmethadol2no change.
alpha- Ethyltryptamine25no change.
Alphameprodine2no change.
Alphamethadol2no change.
alpha-Methylfentanyl230.
alpha-Methylthiofentanyl230.
alpha-Methyltryptamine (AMT)25no change.
alpha-Pyrrolidinobutiophenone (α-PBP)25no change.
alpha-Pyrrolidinopentiophenone (α-PVP)25no change.
Aminorex25no change.
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1 H-indazole-3-carboxamide)25no change.
Benzylmorphine230.
Betacetylmethadol2no change.
beta-Hydroxy-3-methylfentanyl230.
beta-Hydroxyfentanyl230.
beta-Hydroxythiofentanyl30no change.
Betameprodine2no change.
Betamethadol4no change.
Betaprodine2no change.
Bufotenine3no change.
Butylone25no change.
Butyryl fentanyl30no change.
Cathinone24no change.
Codeine methylbromide530.
Codeine-N-oxide305330
Desomorphine25no change.
Diethyltryptamine25no change.
Difenoxin8,750no change.
Dihydromorphine1,566,000no change.
Dimethyltryptamine35no change.
Dipipanone5no change.
EtorphineZero30.
Fenethylline530.
gamma-Hydroxybutyric acid56,200,000no change.
Heroin2545.
Hydromorphinol2no change.
Hydroxypethidine2no change.
Ibogaine530.
JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole)35no change.
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole)45no change.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole)45no change.
JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole)30no change.
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole)30no change.
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)35no change.
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole)30no change.
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole)30no change.
JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole)30no change.
Lysergic acid diethylamide (LSD)1040.
MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 H-indazole-3-carboxamide)Zero30.
Marihuana472,000no change.
MecloqualoneZero30.
Mescaline25no change.
Methaqualone1060.
Methcathinone25no change.
Methyldesorphine5no change.
Methyldihydromorphine2no change.
Morphine methylbromide5no change.
Morphine methylsulfonate5no change.
Morphine-N-oxide350no change.
N,N-Dimethylamphetamine25no change.
Naphyrone25no change.
N-Ethyl-1-phenylcyclohexylamine5no change.
N-Ethylamphetamine24no change.
N-Hydroxy-3,4-methylenedioxyamphetamine24no change.
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Noracymethadol2no change.
Norlevorphanol5255.
Normethadone2no change.
Normorphine40no change.
Para-fluorofentanyl525.
Parahexyl5no change.
PB-22; QUPIC20no change.
Pentedrone25no change.
Pentylone25no change.
Phenomorphan2no change.
Pholcodine5no change.
Psilocybin30no change.
Psilocyn50no change.
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole)45no change.
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)30no change.
Tetrahydrocannabinols409,000no change.
Thiofentanyl225.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone)1530.
Tilidine25no change.
Trimeperidine2no change.
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone25no change.
Schedule II
1-Phenylcyclohexylamine4no change.
1-Piperidinocyclohexanecarbonitrile4no change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)1,750,000no change.
Alfentanil4,200no change.
Alphaprodine2no change.
Amobarbital20,100no change.
Amphetamine (for conversion)12,000,000no change.
Amphetamine (for sale)42,400,000no change.
Carfentanil1020.
Cocaine103,400no change.
Codeine (for conversion)40,000,000no change.
Codeine (for sale)45,000,000no change.
Dextropropoxyphene1535.
Dihydrocodeine281,100422,000.
Dihydroetorphine2no change.
Diphenoxylate (for conversion)15,000no change.
Diphenoxylate (for sale)820,0001,110,000.
Ecgonine99,000no change.
Ethylmorphine230.
Etorphine hydrochloride32no change.
Fentanyl1,750,000no change.
Glutethimide2no change.
Hydrocodone (for conversion)122,000no change.
Hydrocodone (for sale)58,410,000no change.
Hydromorphone5,140,800no change.
Isomethadone430.
Levo-alphacetylmethadol (LAAM)35.
Levomethorphan1030.
Levorphanol8,30012,900.
Lisdexamfetamine19,000,000no change.
Meperidine3,706,000no change.
Meperidine Intermediate-A5no change.
Meperidine Intermediate-B930.
Meperidine Intermediate-C5no change.
Metazocine15no change.
Methadone (for sale)23,700,000no change.
Methadone Intermediate25,600,000no change.
Methamphetamine1,539,100no 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)].
Methylphenidate73,000,000no change.
Morphine (for conversion)27,300,000no change.
Morphine (for sale)41,000,000no change.
Nabilone19,000no change.
Noroxymorphone (for conversion)17,700,000no change.
Noroxymorphone (for sale)400,000no change.
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Opium (powder)90,000no change.
Opium (tincture)907,200600,000.
Oripavine22,000,00022,700,000.
Oxycodone (for conversion)2,610,000no change.
Oxycodone (for sale)108,510,000no change.
Oxymorphone (for conversion)22,300,000no change.
Oxymorphone (for sale)4,200,000no change.
Pentobarbital27,500,000no change.
Phenazocine5no change.
Phencyclidine2035.
Phenmetrazine225.
Phenylacetone2040.
Racemethorphan25.
Racemorphan25.
Remifentanil3,000no change.
Secobarbital172,002no change.
Sufentanil4,000no change.
Tapentadol21,000,000no change.
Thebaine100,000,000no change.
List I Chemicals
Ephedrine (for conversion)50,000no change.
Ephedrine (for sale)5,360,000no change.
Phenylpropanolamine (for conversion)15,000,000no change.
Phenylpropanolamine (for sale)8,500,000no change.
Pseudoephedrine (for conversion)40no change.
Pseudoephedrine (for sale)200,00,000no 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 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).

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Dated: July 27, 2017.

Chuck Rosenberg,

Acting Administrator.

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

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