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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 2016

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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 2016 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 August 22, 2016. 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 Start Printed Page 47830 Federal Register a final order establishing the 2016 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-420P” 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/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

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FOR FURTHER INFORMATION CONTACT:

Michael J. Lewis, Office of Diversion Control, 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 2016 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 6, 2015 (80 FR 60400). 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 2016 Aggregate Production Quotas and Assessment of Annual Needs

The DEA proposes to adjust the established 2016 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 2016 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 2016 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 2015 year-end inventories, 2015 disposition data submitted by quota applicants, Start Printed Page 47831estimates 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 2016 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).

As described in the previously published notice establishing the 2016 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers, 21 CFR 1303.24, may not always result in the availability of sufficient quantities to maintain an adequate reserve stock pursuant to 21 U.S.C. 826(a), as intended. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substance aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances.

The Acting Administrator, therefore, proposes that the year 2016 aggregate production quotas for the two temporarily scheduled substances be established, and to adjust the 2016 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 classEstablished 2016 quotasProposed revised 2016 quotas
(g)(g)
Temporarily Scheduled Substances
beta-HydroxythiofentanylN/A30.
Butyryl fentanylN/A30.
Schedule I
[1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)15no change.
1-(1-Phenylcyclohexyl)pyrrolidine10no change.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)45no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)45no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine15no change.
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)45no change.
1-Benzylpiperazine25no change.
1-Butyl-3-(1-naphthoyl)indole (JWH-073)45no change.
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)45no change.
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)45no change.
1-Methyl-4-phenyl-4-propionoxypiperidine2no change.
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)45no change.
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)45no change.
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)45no change.
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)45no change.
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)45no change.
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)45no change.
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)45no 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)15no change.
2,5-Dimethoxy-4-ethylamphetamine (DOET)25no change.
2,5-Dimethoxy-4-n-propylthiophenethylamine25no change.
2,5-Dimethoxyamphetamine25no change.
Start Printed Page 47832
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)50no change.
3,4-Methylenedioxypyrovalerone (MDPV)35no change.
3-FMC; 3-Fluoro-N-methylcathinone25no change.
3-Methylfentanyl2no change.
3-Methylthiofentanyl2no change.
4-Bromo-2,5-dimethoxyamphetamine (DOB)25no change.
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)25no change.
4-FMC; Flephedrone25no change.
4-Methoxyamphetamine150no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)25no change.
4-Methylaminorex25no change.
4-MEC; 4-Methyl-N-ethylcathinone25no 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]-phenol6850.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)5340.
5-Fluoro-UR144, XLR1125no change.
5-Methoxy-3,4-methylenedioxyamphetamine25no change.
5-Methoxy-N,N-diisopropyltryptamine25no change.
5-Methoxy-N,N-dimethyltryptamine25no change.
AB-PINACA15no change.
Acetyl-alpha-methylfentanyl2no change.
Acetyldihydrocodeine2no change.
Acetylmethadol2no change.
AH-7921N/A30.
Allylprodine2no change.
alpha- Ethyltryptamine25no change.
alpha-Methylfentanyl2no change.
alpha-Methylthiofentanyl2no change.
alpha-Methyltryptamine (AMT)25no change.
alpha-Pyrrolidinobutiophenone (α-PBP)25no change.
alpha-Pyrrolidinopentiophenone (α-PVP)25no change.
Alphacetylmethadol2no change.
Alphameprodine2no change.
Alphamethadol2no change.
Aminorex25no change.
APINCA, AKB4825no change.
Benzylmorphine2no change.
beta-Hydroxy-3-methylfentanyl2no change.
beta-Hydroxyfentanyl2no change.
Betacetylmethadol2no change.
Betameprodine2no change.
Betamethadol4no change.
Betaprodine2no change.
Bufotenine3no change.
Butylone25no change.
Cathinone7030.
Codeine methylbromide5no change.
Codeine-N-oxide305no change.
Desomorphine25no change.
Diethyltryptamine25no change.
Difenoxin11,000no change.
Dihydromorphine3,000,0002,000,000.
Dimethyltryptamine35no change.
Dipipanone5no change.
Fenethylline5no change.
gamma-Hydroxybutyric acid70,250,000no change.
Heroin50no change.
Hydromorphinol2no change.
Hydroxypethidine2no change.
Ibogaine5no change.
Lysergic acid diethylamide (LSD)40no change.
Marihuana658,000no change.
Start Printed Page 47833
Mescaline25no change.
Methaqualone10no change.
Methcathinone25no change.
Methyldesorphine5no change.
Methyldihydromorphine2no change.
Morphine methylbromide5no change.
Morphine methylsulfonate5no change.
Morphine-N-oxide350no change.
N,N-Dimethylamphetamine25no change.
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)50no change.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)50no change.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)15no change.
N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl)100no change.
N-Ethyl-1-phenylcyclohexylamine5no change.
N-Ethylamphetamine24no change.
N-Hydroxy-3,4-methylenedioxyamphetamine24no change.
Naphyrone25no change.
Noracymethadol2no change.
Norlevorphanol52no change.
Normethadone2no change.
Normorphine40no change.
Para-fluorofentanyl5no change.
Parahexyl5no change.
Pentedrone25no change.
Pentylone25no change.
Phenomorphan2no change.
Pholcodine5no change.
Psilocybin30no change.
Psilocyn50no change.
Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)5025.
Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)5025.
Tetrahydrocannabinols511,250no change.
Thiofentanyl2no change.
Tilidine25no change.
Trimeperidine2no change.
UR-14425no change.
Schedule II
1-Phenylcyclohexylamine5no change.
1-Piperidinocyclohexanecarbonitrile5no change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)2,950,0002,250,000.
Alfentanil17,750no change.
Alphaprodine3no change.
Amobarbital25,125no change.
Amphetamine (for conversion)15,000,000no change.
Amphetamine (for sale)39,705,00045,000,000.
Carfentanil19no change.
Cocaine200,000no change.
Codeine (for conversion)50,000,000no change.
Codeine (for sale)63,900,000no change.
Dextropropoxyphene19no change.
Dihydrocodeine226,375no change.
Dihydroetorphine3no change.
Diphenoxylate (for conversion)31,25018,750.
Diphenoxylate (for sale)1,337,500no change.
Ecgonine125,000no change.
Ethylmorphine35.
Etorphine hydrochloride3no change.
Fentanyl2,300,000no change.
Glutethimide3no change.
Hydrocodone (for conversion)235,000177,500.
Hydrocodone (for sale)88,500,00086,000,000.
Hydromorphone8,250,0007,000,000.
Isomethadone5no change.
Levo-alphacetylmethadol (LAAM)4no change.
Levomethorphan3033.
Levorphanol7,125no change.
Lisdexamfetamine29,750,00023,750,000.
Meperidine5,450,0004,632,500.
Meperidine Intermediate-A6no change.
Start Printed Page 47834
Meperidine Intermediate-B11no change.
Meperidine Intermediate-C6no change.
Metazocine19no change.
Methadone (for sale)31,875,000no change.
Methadone Intermediate34,375,000no change.
Methamphetamine2,061,375no change.
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate96,750,00084,375,000.
Morphine (for conversion)91,250,000no change.
Morphine (for sale)62,500,000no change.
Nabilone18,750no change.
Noroxymorphone (for conversion)17,500,000no change.
Noroxymorphone (for sale)1,475,000625,000.
Opium (powder)112,500no change.
Opium (tincture)687,500375,000.
Oripavine30,000,000no change.
Oxycodone (for conversion)6,250,0005,000,000.
Oxycodone (for sale)139,150,000no change.
Oxymorphone (for conversion)29,000,00025,000,000.
Oxymorphone (for sale)7,750,0006,250,000.
Pentobarbital38,125,000no change.
Phenazocine6no change.
Phencyclidine50no change.
Phenmetrazine3no change.
Phenylacetone50no change.
Racemethorphan35.
Racemorphan3no change.
Remifentanil3,750no change.
Secobarbital215,003no change.
Sufentanil6,255no change.
Tapentadol25,500,000no change.
Thebaine125,000,000no change.
List I Chemicals
Ephedrine (for conversion)100,00050,000.
Ephedrine (for sale)4,000,000no change.
Phenylpropanolamine (for conversion)22,400,00015,000,000.
Phenylpropanolamine (for sale)8,500,000no change.
Pseudoephedrine (for conversion)7,00040.
Pseudoephedrine (for sale)224,500,000200,000,000.

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 2016 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 2016 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).

Start Signature

Dated: July 14, 2016.

Chuck Rosenberg,

Acting Administrator.

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[FR Doc. 2016-17371 Filed 7-21-16; 8:45 am]

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