1 Billing Code 4410 - 09 - P DEPARTMENT OF JUSTICE Drug Enforcement Administration

[DEA # 390 P ] Controlled Substances: 2014 Proposed Aggregate Production Quota for Four T emporarily Controlled Synthetic Cannabinoids AGENCY: Drug Enforcement Administration (DEA), Department of Justice. ACTION: Notice of a proposed 2014 aggregate production quota for four synthetic cannabinoids . SUMMARY: Four synthetic cannabinoids : quinolin - 8 - yl 1 - pentyl - 1 H - indole - 3 - carboxylate (PB - 22; QUPIC); quinolin - 8 - yl 1 - (5 - fluoropentyl) - 1 H - indole - 3 - carboxylate (5 - fluoro - PB - 22; 5F PB - 22); N

- (1 - amino - 3 - methyl - 1 - oxobutan - 2 - yl) - 1 - (4 - fluorobenzyl) - 1 H - indazole - 3 - carboxamide (AB - FUBINACA); and N - (1 - amino - 3,3 - dimeth yl - 1 - oxobutan - 2 - yl) - 1 - pentyl - 1 H - indazole - 3 - carboxamide (ADB - PINACA) were temporarily placed in s chedule I of the Controlled Substance s Act (CSA) by a final order published by the DEA on February 10, 2014 ( 79 FR 7577 ). This means that any manufacturer that wishes to manufacture PB - 22, 5F - PB - 22, AB FUBINACA, or ADB - PINACA after February 10, 2014, must be registered with the DEA and have obtained a manufacturing quota for PB - 22, 5F - PB - 22, AB - FUBINACA, or ADB - PINACA pursuant to 21 CFR part 1303. The DEA can not issue individual manufacturing quotas for PB - 22, 5F - PB - 22, AB FUBINACA, or ADB - PINACA unless and until it establishes an aggregate production quota. Therefore, t his notice propose s a 2014 aggregate production quota for PB - 22, 5F - PB - 22, AB FUBINACA, an d ADB - PINACA .2

DATE S : Comments or objections should be received on or before [INSERT 30 DAYS FROM DATE OF PUBLICATION] . ADDRESSES: To ensure proper handling of comments, plea se reference “ Docket No. DEA - 390P ” on all electronic and written correspondence. The DEA encourages that all comments be submitted electronically through www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at www.regulations.gov fo r easy reference. Paper comments that duplicate the electronic submission are not necessary as all comments submitted to www.regulations.gov will be posted for public review and are part of the official docket record. Written comments submitted via regul ar or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Re presentative/ODW , 8701 Morrissette Drive, Springfield, V irginia 22152. FOR FURTHER INFORMATION CONTACT: Ruth A. Carter, Office of Diversion Contro l, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone : (202) 598 - 6812 . SUPPLEMENTARY INFORMATION: Posting of Public Comments The Freedom of Information Act applies to all comments received. All comments received are considered part of the public record and made available for public inspection online at 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 made3

available in the public docket, you m ust 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 y our 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 “ CONFID ENTIAL 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 effe ctively 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 commen t, in redacted form, will be posted online and placed in the DEA's public docket file. If you wish to inspect the DEA 's public docket file in person by appointment, please see the For Further Information Contact paragraph. Background Section 306 of the CS A (21 U.S.C. 826) requires that the Attorney General establish aggregate production quotas for each basic class of controlled substance listed in s chedules I and II each year. This responsibility has been delegated to the Administrator of the DEA by 28 CF R 0.100 . The Administrator, in turn, has redelegated this function to the Deputy Administrator , pursuant to 28 CF R 0.104.4 The DEA established the 2014 aggregate production quotas for substances in schedules I and II on September 9, 2013 (78 FR 55099). Subsequently, o n January 10, 2014 , the DEA published in the Federal Register a notice of intent to temporarily place four synthetic cannabinoids : quinolin - 8 - yl 1 - pentyl - 1 H - indole - 3 - carboxylate (PB - 22; QUPIC); quinolin - 8 - yl 1 - (5 - fluoropentyl) - 1 H

- indole - 3 - c arboxylate (5 - fluoro - PB - 22; 5F - PB - 22); N - (1 - amino - 3 - methyl 1 - oxobutan - 2 - yl) - 1 - (4 - fluorobenzyl) - 1 H - indazole - 3 - carboxamide (AB - FUBINACA); and N - (1 - amino - 3,3 - dimethyl - 1 - oxobutan - 2 - yl) - 1 - pentyl - 1 H - indazole - 3 - carboxamide (ADB - PINACA) in schedule I of the CSA (7 9 FR 1776). On February 10, 2014 , the DEA published in the Federal Register a final order to temporarily place these four synthetic cannabinoids in schedule I of the CSA (7 9 FR 7577 ) , making all regulations pertaining to schedule I controlled substances applicable to the manufacture of these four synthetic cannabinoids , including the establishment of an aggregate production quota pursuant to 21 CFR 1303.11 . PB - 22, 5F - PB - 22, AB - FUBINAC A, and ADB - PINACA were non - controlled substances when the a ggregate production quotas for s chedule I and II substances were established, therefore , no aggregate production quotas for PB - 22, 5F - PB - 22, AB FUBINACA, and ADB - PINACA were established at that tim e . In determining the 2014 aggregate production quotas of these four cannabinoids , the Deputy Administrator considered the following factors in accordance with 21 U.S.C. 826(a) and 21 CFR 1303.11: (1) T otal estimated net disposal of each substance by al l manufacturers; (2) estimated trends in the national rate of net disposal; (3) total estimated inventories of the basic class and of all substances manufactured from the class; (4) projected demand for each class as indicated by procurement quotas request ed pursuant to 21 CFR 1303.12; and (5) other factors affecting medical, scientific, research, and industrial needs of the United States and lawful export requirements, as the Deputy5

Administrator finds relevant. These quotas do not include imports of contr olled substances for use in industrial processes. The Deputy Administrator, therefore, proposes that the year 2014 aggregate production quotas for the following temporarily controlled s chedule I controlled substances, expressed in grams of anhydrous acid o r base, be established as follows:

Basic Class

– Schedule I Proposed 2014 Quota N - (1 - amino - 3,3 - dimethyl - 1 - oxobutan - 2 - yl) - 1 - pentyl - 1 H - indazole 3 - carboxamide ( ADB - PINACA ) 15 g N - (1 - amino - 3 - methyl - 1 - oxobutan - 2 - yl) - 1 - (4 - fluorobenzyl) - 1H indazole - 3 - carboxamide ( AB - FUBINACA ) 15 g quinolin - 8 - yl 1 - (5 - fluoropentyl) - 1H - indole - 3 - carboxylate ( 5 - fluoro - PB - 22; 5F - PB - 22 ) 15 g quinolin - 8 - yl 1 - pentyl - 1H - indole - 3 - carboxylate ( PB - 22; QUPIC ) 15 g Comments Pursuant to 21 CFR 1303.11 , any interested person may submit written comments on or objections to these proposed determinations. Based on comments received in response to this n otice, the Deputy Administrator may hold a public hearing on one or more issues raised. In the event the Depu ty 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 Adminis trator will publish in the Federal Register a f inal o rder establishing the 2014 aggregate production quota for PB - 22, 5F - PB - 22, AB - FUBINACA, and ADB - PINACA .

___________________________ ______________________________ Dated: February 28, 2014 Thomas M. Harrigan Deputy Administrator