Skip to Content

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 2014

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble Start Printed Page 33780

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

The Drug Enforcement Administration proposes to adjust the 2014 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 1303.11(c) and 1315.11(d). Electronic comments must be submitted, and written comments must be postmarked, on or before July 14, 2014. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after midnight Eastern Time on the last day of the comment period.

ADDRESSES:

To ensure proper handling of comments, please reference “Docket No. DEA-378” on all electronic and written correspondence. The DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov. Paper comments that duplicate electronic submissions are not necessary. Should you, however, wish to submit written comments via regular or express mail, they should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Ruth A. Carter, Office of Diversion Control, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

All comments received are considered part of the public record and will be made available 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 the confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form.

An electronic copy of this document is available at http://www.regulations.gov for easy reference. If you wish to personally inspect the comments and materials received or the supporting documentation the DEA used in preparing the proposed action, these materials will be available for public inspection by appointment. To arrange a viewing, please see the “For Further Information Contact” paragraph above.

Legal Authority

Section 306 of the Controlled Substances Act (CSA), 21 U.S.C. 826, requires the Attorney General to determine the total quantity and 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. This responsibility has been delegated to the Administrator of the DEA pursuant to 28 CFR 0.100(b). The Administrator, in turn, has redelegated that authority to the Deputy Administrator, pursuant to 28 CFR pt. 0 subpt. R, App.

The DEA published the established aggregate production quotas for schedule I and II controlled substances and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2014 in the Federal Register (78 FR 55099) on September 9, 2013. 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 2014 Aggregate Production Quotas and Assessment of Annual Needs

The DEA proposes to adjust the established 2014 aggregate production quotas for certain schedule I and II controlled substances to be manufactured in the United States in 2014 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. The DEA also proposes to adjust the established 2014 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured in and imported to the United States in 2014 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.

In proposing the adjustment, the DEA has taken into account the criteria that the DEA is required to consider in accordance with 21 CFR 1303.13 and 21 CFR 1315.13. The DEA determines whether to propose an adjustment of the aggregate production quotas for basic classes of schedule I and II controlled substances and assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine 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 Start Printed Page 33781importation, 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 Deputy Administrator finds relevant.

The DEA also considered updated information obtained from 2013 year-end inventories, 2013 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 DEA 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 2014 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 2014 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers 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. See 21 CFR 1303.24. 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 Deputy Administrator, therefore, proposes to adjust the 2014 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 classPreviously established 2014 quotas (g)Proposed adjusted 2014 quotas (g)
Schedule I
(1-Pentyl-1 H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)15No change.
[1-(5-Fluoro-pentyl)-1 H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (XLR11)15No change.
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone)15No change.
1-(1,3-Benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone)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-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-n-propylphenyl)ethanamine (2C-P)30No 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-Dimethoxyphenyl)ethanamine (2C-H)30No change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)15No 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)15No 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-(Methylamino)-1-phenylpentan-1-one (pentedrone)15No change.
2,5-Dimethoxy-4-ethylamphetamine (DOET)25No change.
2,5-Dimethoxy-4-n-propylthiophenethylamine25No change.
Start Printed Page 33782
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)50No change.
3,4-Methylenedioxypyrovalerone (MDPV)35No change.
3-Fluoro-N-methylcathinone (3-FMC)15No 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-Fluoro-N-methylcathinone (4-FMC)15No change.
4-Methoxyamphetamine100No change.
4-Methyl-2,5-dimethoxyamphetamine (DOM)25No change.
4-Methylaminorex25No change.
4-Methyl-N-ethylcathinone (4-MEC)15No change.
4-Methyl-N-methylcathinone (mephedrone)45No change.
4-Methyl-α-pyrrolidinopropiophenone (4-MePPP)15No change.
5-(1,1-Dimethylheptyl)-2-[(1 R, 3 S)-3-hydroxycyclohexyl]-phenol68No change.
5-(1,1-Dimethyloctyl)-2-[(1 R, 3 S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)53No change.
5-Methoxy-3,4-methylenedioxyamphetamine25No change.
5-Methoxy-N,N-diisopropyltryptamine25No change.
5-Methoxy-N,N-dimethyltryptamine25No change.
Acetyl-alpha-methylfentanyl2No change.
Acetyldihydrocodeine2No change.
Acetylmethadol2No change.
Allylprodine2No change.
Alphacetylmethadol2No change.
alpha-Ethyltryptamine25No change.
Alphameprodine2No change.
Alphamethadol2No change.
alpha-Methylfentanyl2No change.
alpha-Methylthiofentanyl2No change.
alpha-Methyltryptamine (AMT)25No change.
alpha-Pyrrolidinobutiophenone (α-PBP)15No change.
alpha-Pyrrolidinopentiophenone (α-PVP)15No change.
Aminorex25No change.
Benzylmorphine2No change.
Betacetylmethadol2No change.
beta-Hydroxy-3-methylfentanyl2No change.
beta-Hydroxyfentanyl2No change.
Betameprodine2No change.
Betaprodine2No change.
Bufotenine3No change.
Cathinone70No change.
Codeine methylbromide5No change.
Codeine-N-oxide200No change.
Desomorphine5No change.
Diethyltryptamine25No change.
Difenoxin50No change.
Dihydromorphine3,990,000No change.
Dimethyltryptamine35No change.
Dipipanone5No change.
Fenethylline5No change.
gamma-Hydroxybutyric acid70,250,000No change.
Heroin25No change.
Hydromorphinol2No change.
Hydroxypethidine2No change.
Ibogaine5No change.
Lysergic acid diethylamide (LSD)35No change.
Marihuana650,000No change.
Mescaline25No change.
Methaqualone10No change.
Methcathinone25No change.
Methyldesorphine2No change.
Methyldihydromorphine2No change.
Morphine methylbromide5No change.
Start Printed Page 33783
Morphine methylsulfonate5No change.
Morphine-N-oxide175No change.
N-(1-Adamantyl)-1-pentyl-1 H-indazole-3-carboxamide (AKB48)15No change.
N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 H-indazole-3-carboxamide (ADB-PINACA)15No change.
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 H-indazole-3-carboxamide (AB-FUBINACA)15No change.
N,N-Dimethylamphetamine25No change.
Naphthylpyrovalerone (naphyrone)15No change.
N-Benzylpiperazine25No change.
N-Ethyl-1-phenylcyclohexylamine5No change.
N-Ethylamphetamine24No change.
N-Hydroxy-3,4-methylenedioxyamphetamine24No change.
Noracymethadol2No change.
Norlevorphanol52No change.
Normethadone2No change.
Normorphine18No change.
para-Fluorofentanyl2No change.
Parahexyl5No change.
Phenomorphan2No change.
Pholcodine2No change.
Properidine2No change.
Psilocybin3040
Psilocyn3050
Quinolin-8-yl 1-(5-fluoropentyl)-1 H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)15No change.
Quinolin-8-yl 1-pentyl-1 H-indole-3-carboxylate (PB-22; QUPIC)15No change.
Tetrahydrocannabinols491,000No change.
Thiofentanyl2No change.
Tilidine10No change.
Trimeperidine2No change.
Schedule II
1-Phenylcyclohexylamine3No change.
1-Piperidinocyclohexanecarbonitrile3No change.
4-Anilino-N-phenethyl-4-piperidine (ANPP)2,687,500No change.
Alfentanil17,625No change.
Alphaprodine3No change.
Amobarbital9No change.
Amphetamine (for conversion)18,375,000No change.
Amphetamine (for sale)49,000,000No change.
Carfentanil19No change.
Cocaine240,000No change.
Codeine (for conversion)68,750,000No change.
Codeine (for sale)46,125,000No change.
Dextropropoxyphene19No change.
Dihydrocodeine100,750No change.
Diphenoxylate750,0001,288,750
Ecgonine144,000174,375
Ethylmorphine3No change.
Fentanyl2,108,750No change.
Glutethimide3No change.
Hydrocodone (for conversion)0137,500
Hydrocodone (for sale)99,625,000No change.
Hydromorphone6,750,000No change.
Isomethadone5No change.
Levo-alphacetylmethadol (LAAM)4No change.
Levomethorphan195No change.
Levorphanol2,0004,625
Lisdexamfetamine23,750,000No change.
Meperidine6,250,000No change.
Meperidine Intermediate-A6No change.
Meperidine Intermediate-B11No change.
Meperidine Intermediate-C6No change.
Metazocine19No change.
Methadone (for sale)31,875,000No change.
Methadone Intermediate38,875,000No change.
Methamphetamine2,811,375No change.
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 1,500,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate96,750,000No change.
Morphine (for conversion)91,250,000No change.
Start Printed Page 33784
Morphine (for sale)62,500,000No change.
Nabilone30,375No change.
Noroxymorphone (for conversion)17,500,000No change.
Noroxymorphone (for sale)1,262,500No change.
Opium (powder)112,500No change.
Opium (tincture)625,000No change.
Oripavine22,750,00027,625,000
Oxycodone (for conversion)9,250,000No change.
Oxycodone (for sale)149,375,000No change.
Oxymorphone (for conversion)25,000,000No change.
Oxymorphone (for sale)7,750,000No change.
Pentobarbital35,000,000No change.
Phenazocine6No change.
Phencyclidine19No change.
Phenmetrazine3No change.
Phenylacetone67,000,00045,750,000
Racemethorphan3No change.
Remifentanil3,7505,875
Secobarbital215,003No change.
Sufentanil6,255No change.
Tapentadol17,500,000No change.
Thebaine145,000,000No change.
List I Chemicals
Ephedrine (for conversion)1,000,000No change.
Ephedrine (for sale)3,000,000No change.
Phenylpropanolamine (for conversion)44,800,000No change.
Phenylpropanolamine (for sale)5,300,000No change.
Pseudoephedrine (for conversion)5,000No change.
Pseudoephedrine (for sale)192,000,000224,500,000

The Deputy 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. Pursuant to 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Deputy Administrator may adjust the 2014 aggregate production quotas and assessment of annual needs as needed.

Comments

Pursuant to 21 CFR 1303.11(c) and 1315.11(d), any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this notice, the Deputy Administrator may hold a public hearing on one or more issues raised. 21 CFR 1303.11(c) and 1515.11(e). In the event the Deputy Administrator decides to hold such a hearing, the Deputy Administrator will publish a notice of the hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Deputy Administrator will issue and publish in the Federal Register a final order establishing any adjustment of 2014 aggregate production quota for each basic class of controlled substance and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. 21 CFR 1303.11(c) and 1315.11(f).

Start Signature

Dated: June 4, 2014.

Thomas M. Harrigan,

Deputy Administrator.

End Signature End Supplemental Information

[FR Doc. 2014-13804 Filed 6-11-14; 8:45 am]

BILLING CODE 4410-09-P