Notice with request for comments.
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.
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.
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: (202) 307-4654.
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.
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
|Basic Class—Schedule I|
|1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR-18 and RCS-8)||45|
|1-Pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)||45|
|1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4)||45|
|5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47, 497 C8-homolog)||53|
|Lysergic acid diethylamide (LSD)||30|
|Basic Class—Schedule II|
|Amphetamine (for conversion)||18,375,000|
|Amphetamine (for sale)||38,000,000|
|Codeine (for conversion)||81,250,000|
|Codeine (for sale)||49,506,250|
|Hydrocodone (for sale)||78,750,000|
|Methadone (for sale)||25,000,000|
|[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)]|
|Morphine (for conversion)||103,750,000|
|Morphine (for sale)||51,250,000|
|Noroxymorphone (for conversion)||9,000,000|
|Noroxymorphone (for sale)||508,750|
|Oxycodone (for conversion)||10,250,000|
|Oxycodone (for sale)||123,375,000|
|Oxymorphone (for conversion)||16,000,000|
|Oxymorphone (for sale)||6,875,000|
|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.
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,
[FR Doc. 2012-19052 Filed 8-2-12; 8:45 am]
BILLING CODE 4410-09-P