2012-19052. Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Proposed Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2013

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

This notice proposes initial year 2013 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

DATES:

Electronic comments must be submitted and written comments must be postmarked on or before September 4, 2012. 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-365” on all electronic and written correspondence. DEA encourages that all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov Web site for easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to http://www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT:

John W. Partridge, Chief, Liaison and Policy Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: [phone].

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received are considered part of the public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

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 posted online or made available in the public docket, 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 posted online or made available in the public docket 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 posted online or made available in the public docket, 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. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket.

Personal identifying information and confidential business information identified and located as set forth above will be redacted, and the comment, in redacted form, will be posted online and placed in the DEA's public docket file. Please note that the Freedom of Information Act applies to all comments received. If you wish to inspect the agency's public docket file in person by appointment, please see the For Further Information Contact paragraph.

Background

Section 306 of the 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 ephedrine, pseudoephedrine, and phenylpropanolamine. This responsibility has been delegated to the Administrator of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated this function to the Deputy Administrator, pursuant to 28 CFR 0.104.

The proposed year 2013 aggregate production quotas represent those quantities of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2013 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. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine but do not include imports of controlled substances for use in industrial processes.

In determining the proposed 2013 aggregate production quotas and assessment of annual needs, DEA has taken into account the criteria that DEA is required to consider in accordance with 21 U.S.C. 826(a), 21 CFR 1303.11 (aggregate production quotas for controlled substances), and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). DEA proposes the aggregate production quotas and assessment of annual needs for 2013 by considering (1) total net disposal of the class or chemical by all manufacturers and chemical importers during the current and two preceding years; (2) trends in the national rate of net disposal of the class or chemical; (3) total actual (or estimated) inventories of the class or chemical and of all substances manufactured from the class or chemical, and trends in inventory accumulation; (4) projected demand for such class or chemical as indicated by procurement and chemical import quotas requested pursuant to 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting the medical, scientific, research, and industrial needs in the United States, lawful export requirements, and reserve stocks, as the Deputy Administrator finds relevant. Other factors 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 2013 assessment of annual needs, DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294 and 75 FR 79407, respectively).

DEA also 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, DEA proposes to include in all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (gamma-hydroxybutyric acid and tetrahydrocannabinols), 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 established aggregate production quota will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public affects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by DEA. DEA does not anticipate utilizing the reserve in the absence of these circumstances.

The Deputy Administrator, therefore, proposes that the year 2013 aggregate production quotas and assessment of annual needs for the following schedule I and II controlled substances and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, be established as follows:

	Proposed 2013 quotas g
Basic Class—Schedule I
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201)	45
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)	45
1-[1-(2-Thienyl)cyclohexyl]piperidine	5
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)	45
1-Butyl-3-(1-naphthoyl)indole (JWH-073)	45
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)	45
1-Hexyl-3-(1-naphthoyl)indole (JWH-019)	45
1-Methyl-4-phenyl-4-propionoxypiperidine	2
1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)	45
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)	45
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)	45
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)	45
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)	45
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)	45
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)	45
2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)	15
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)	15
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)	15
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)	15
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)	15
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)	15
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)	15
2,5-Dimethoxy-4-ethylamphetamine (DOET)	12
2,5-Dimethoxy-4-n-propylthiophenethylamine	12
2,5-Dimethoxyamphetamine	12
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)	15
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)	15
3-Methylfentanyl	2
3-Methylthiofentanyl	2
3,4-Methylenedioxyamphetamine (MDA)	30
3,4-Methylenedioxy-N-methylcathinone (methylone)	15
3,4-Methylenedioxy-N-ethylamphetamine (MDEA)	24
3,4-Methylenedioxymethamphetamine (MDMA)	35
3,4-Methylenedioxypyrovalerone (MDPV)	15
3,4,5-Trimethoxyamphetamine	12
4-Bromo-2,5-dimethoxyamphetamine (DOB)	12
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)	12
4-Methoxyamphetamine	88
4-Methylaminorex	12
4-Methyl-2,5-dimethoxyamphetamine (DOM)	12
4-Methyl-N-methylcathinone (mephedrone)	15
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol	68
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47, 497 C8-homolog)	53
5-Methoxy-3,4-methylenedioxyamphetamine	12
5-Methoxy-N,N-diisopropyltryptamine	12
5-Methoxy-N,N-dimethyltryptamine	10
Acetyl-alpha-methylfentanyl	2
Acetyldihydrocodeine	2
Acetylmethadol	2
Allylprodine	2
Alphacetylmethadol	2
Alpha-ethyltryptamine	12
Alphameprodine	2
Alphamethadol	2
Alpha-methylfentanyl	2
Alpha-methylthiofentanyl	2
Alpha-methyltryptamine (AMT)	12
Aminorex	12
Benzylmorphine	2
Betacetylmethadol	2
Beta-hydroxy-3-methylfentanyl	2
Beta-hydroxyfentanyl	2
Betameprodine	2
Betamethadol	2
Betaprodine	2
Bufotenine	3
Cathinone	12
Codeine-N-oxide	602
Desomorphine	5
Diethyltryptamine	12
Difenoxin	50
Dihydromorphine	3,300,000
Dimethyltryptamine	18
Gamma-hydroxybutyric acid	46,250,000
Heroin	25
Hydromorphinol	54
Hydroxypethidine	2
Ibogaine	5
Lysergic acid diethylamide (LSD)	30
Marihuana	21,000
Mescaline	13
Methaqualone	10
Methcathinone	14
Methyldihydromorphine	2
Morphine-N-oxide	655
N-Benzylpiperazine	12
N,N-Dimethylamphetamine	12
N-Ethylamphetamine	12
N-Hydroxy-3,4-methylenedioxyamphetamine	12
Noracymethadol	2
Norlevorphanol	52
Normethadone	2
Normorphine	18
Para-fluorofentanyl	2
Phenomorphan	2
Pholcodine	2
Properidine	2
Psilocybin	2
Psilocyn	4
Tetrahydrocannabinols	491,000
Thiofentanyl	2
Tilidine	10
Trimeperidine	2
Basic Class—Schedule II
1-Phenylcyclohexylamine	3
1-Piperdinocyclohexanecarbonitrile	21
4-Anilino-N-phenethyl-4-piperidine (ANPP)	2,250,000
Alfentanil	38,250
Alphaprodine	3
Amobarbital	9
Amphetamine (for conversion)	18,375,000
Amphetamine (for sale)	38,000,000
Carfentanil	6
Cocaine	240,000
Codeine (for conversion)	81,250,000
Codeine (for sale)	49,506,250
Dextropropoxyphene	19
Dihydrocodeine	250,000
Diphenoxylate	750,000
Ecgonine	127,500
Ethylmorphine	3
Fentanyl	2,108,750
Glutethimide	3
Hydrocodone (for sale)	78,750,000
Hydromorphone	4,535,000
Isomethadone	5
Levo-alphacetylmethadol (LAAM)	4
Levomethorphan	6
Levorphanol	4,500
Lisdexamfetamine	19,250,000
Meperidine	6,875,000
Meperidine Intermediate-A	6
Meperidine Intermediate-B	11
Meperidine Intermediate-C	6
Metazocine	6
Methadone (for sale)	25,000,000
Methadone Intermediate	32,500,000
Methamphetamine	3,912,500
[962,500 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 2,888,750 grams for methamphetamine mostly for conversion to a schedule III product; and 61,250 grams for methamphetamine (for sale)]
Methylphenidate	72,250,000
Morphine (for conversion)	103,750,000
Morphine (for sale)	51,250,000
Nabilone	25,628
Noroxymorphone (for conversion)	9,000,000
Noroxymorphone (for sale)	508,750
Opium (powder)	91,250
Opium (tincture)	1,287,500
Oripavine	22,750,000
Oxycodone (for conversion)	10,250,000
Oxycodone (for sale)	123,375,000
Oxymorphone (for conversion)	16,000,000
Oxymorphone (for sale)	6,875,000
Pentobarbital	42,500,000
Phenazocine	6
Phencyclidine	30
Phenmetrazine	3
Phenylacetone	20,000,000
Racemethorphan	3
Remifentanil	2,500
Secobarbital	215,003
Sufentanil	6,250
Tapentadol	13,500,000
Thebaine	145,000,000
Basic Class—List I Chemicals
Ephedrine (for conversion)	12,000,000
Ephedrine (for sale)	3,200,000
Phenylpropanolamine (for conversion)	25,700,000
Phenylpropanolamine (for sale)	4,400,000
Pseudoephedrine (for sale)	185,000,000

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 be established 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 2013 aggregate production quotas and assessment of annual needs as needed.

Comments

Pursuant to 21 CFR 1303.11 and 21 CFR 1315.11, 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. In the event the Deputy Administrator decides in his sole discretion to hold such a hearing, the Deputy Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments and after a hearing, if one is held, the Deputy Administrator will publish in the Federal Register a final order establishing the 2013 aggregate production quota for each basic class of controlled substance and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Dated: July 31, 2012.

Thomas M. Harrigan,

Deputy Administrator.