81 FR 47821 - Proposed 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 2017
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 141 (July 22, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 141 (July 22, 2016)
| Page Range | 47821-47826 | |
| FR Document | 2016-17370 |
[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)] [Notices] [Pages 47821-47826] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17370] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-443N] Proposed 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 2017 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) proposes to establish the 2017 aggregate production quotas for 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 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 Federal Register a final order establishing the 2017 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-443N'' 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. 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. 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 [[Page 47822]] 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 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. Analysis for Proposed 2017 Aggregate Production Quotas and Assessment of Annual Needs The proposed year 2017 aggregate production quotas and assessment of annual needs 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 2017 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 2017 aggregate production quotas and assessment of annual needs, the Acting Administrator has taken into account the criteria pursuant to 21 U.S.C. 826(a) and in accordance with 21 CFR 1303.11 (aggregate production quotas for controlled substances) and 21 CFR 1315.11 (assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA proposes the aggregate production quotas and assessment of annual needs for 2017 by considering: (1) Total net disposal of each 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 each class or chemical as indicated by procurement and import quotas requested in accordance with 21 CFR 1303.12, 1315.32, and 1315.34; and (5) other factors affecting medical, scientific, research, and industrial needs of 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. 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 2017 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). During the calendar years 2013-2016, the DEA included an additional 25% of the estimated medical, scientific, and research needs for the United States as part of the amount necessary to ensure the establishment and maintenance of reserve stocks for all schedule II aggregate production quotas, and certain schedule I aggregate production quotas (difenoxin, gamma-hydroxybutyric acid, and tetrahydrocannabinols). Based on interagency discussions beginning in November 2015, and after reviewing all relevant quota applications received, published FDA drug shortage lists, and subsequent reports required under 21 U.S.C. 826a for those calendar years, the Acting Administrator has determined that inclusion of the additional 25% of the estimated medical, scientific, and research needs for the United States is unnecessary. Instead, the Acting Administrator determined that 21 U.S.C. 826(c) and 21 U.S.C. 952(a)(2)(A) provide sufficient ability for the DEA to mitigate adverse public effects should a natural disaster or other unforeseen event result in substantial disruption to the amount of controlled substances available for legitimate public need. As such, DEA proposes to remove the additional 25% from the aggregate production quotas. The resulting proposed established aggregate production quotas reflect these reduced amounts. The Acting Administrator, therefore, proposes to establish the 2017 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: ------------------------------------------------------------------------ Proposed 2017 Basic class quotas (g) ------------------------------------------------------------------------ Schedule I ------------------------------------------------------------------------ [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1- 15 yl)methanone (THJ-2201)............................. 1-(1-Phenylcyclohexyl)pyrrolidine.................... 10 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201).... 30 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)... 30 1-[1-(2-Thienyl)cyclohexyl]piperidine................ 15 1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH- 35 200)................................................ 1-Benzylpiperazine................................... 25 [[Page 47823]] 1-Butyl-3-(1-naphthoyl)indole (JWH-073).............. 45 1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR- 45 18 and RCS-8)....................................... 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)... 35 1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203).... 30 1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)... 30 1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398).... 30 1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122).... 30 1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) 30 1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081).. 30 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)..... 30 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D).... 30 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N).... 30 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P).. 30 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)............. 30 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2- 25 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36)...................................... 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).... 30 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2- 25 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82)...................................... 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)...... 30 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2- 5 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5)....................................... 2,5-Dimethoxy-4-ethylamphetamine (DOET).............. 25 2,5-Dimethoxy-4-n-propylthiophenethylamine........... 25 2,5-Dimethoxyamphetamine............................. 25 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T- 30 2).................................................. 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine 30 (2C-T-4)............................................ 3,4,5-Trimethoxyamphetamine.......................... 25 3,4-Methylenedioxyamphetamine (MDA).................. 55 3,4-Methylenedioxymethamphetamine (MDMA)............. 50 3,4-Methylenedioxy-N-ethylamphetamine (MDEA)......... 40 3,4-Methylenedioxy-N-methylcathinone (methylone)..... 40 3,4-Methylenedioxypyrovalerone (MDPV)................ 35 3-FMC; 3-Fluoro-N-methylcathinone.................... 25 3-Methylfentanyl..................................... 2 3-Methylthiofentanyl................................. 2 4-Bromo-2,5-dimethoxyamphetamine (DOB)............... 25 4-Bromo-2,5-dimethoxyphenethylamine (2-CB)........... 25 4-FMC; Flephedrone................................... 25 4-Methoxyamphetamine................................. 150 4-Methyl-2,5-dimethoxyamphetamine (DOM).............. 25 4-Methylaminorex..................................... 25 4-MEC; 4-Methyl-N-ethylcathinone..................... 25 4-Methyl-N-methylcathinone (mephedrone).............. 45 4-Methyl-[alpha]-pyrrolidinopropiophenone (4-MePPP).. 25 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3- 50 hydroxycyclohexyl]-phenol........................... 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]- 40 phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 5-Fluoro-UR144, XLR11................................ 25 5-Methoxy-3,4-methylenedioxyamphetamine.............. 25 5-Methoxy-N,N-diisopropyltryptamine.................. 25 5-Methoxy-N,N-dimethyltryptamine..................... 25 AB-PINACA............................................ 15 Acetyl-alpha-methylfentanyl.......................... 2 Acetyldihydrocodeine................................. 2 Acetylmethadol....................................... 2 AH-7921.............................................. 30 Allylprodine......................................... 2 alpha-Ethyltryptamine................................ 25 alpha-Methylfentanyl................................. 2 alpha-Methylthiofentanyl............................. 2 alpha-Methyltryptamine (AMT)......................... 25 alpha-Pyrrolidinobutiophenone ([alpha]-PBP).......... 25 alpha-Pyrrolidinopentiophenone ([alpha]-PVP)......... 25 Alphacetylmethadol................................... 2 Alphameprodine....................................... 2 Alphamethadol........................................ 2 Aminorex............................................. 25 APINCA, AKB48........................................ 25 Benzylmorphine....................................... 2 beta-Hydroxy-3-methylfentanyl........................ 2 beta-Hydroxyfentanyl................................. 2 beta-Hydroxythiofentanyl............................. 30 Betacetylmethadol.................................... 2 Betameprodine........................................ 2 [[Page 47824]] Betamethadol......................................... 4 Betaprodine.......................................... 2 Bufotenine........................................... 3 Butylone............................................. 25 Butyryl fentanyl..................................... 30 Cathinone............................................ 24 Codeine methylbromide................................ 5 Codeine-N-oxide...................................... 305 Desomorphine......................................... 25 Diethyltryptamine.................................... 25 Difenoxin............................................ 8,750 Dihydromorphine...................................... 1,566,000 Dimethyltryptamine................................... 35 Dipipanone........................................... 5 Fenethylline......................................... 5 gamma-Hydroxybutyric acid............................ 56,200,000 Heroin............................................... 25 Hydromorphinol....................................... 2 Hydroxypethidine..................................... 2 Ibogaine............................................. 5 Lysergic acid diethylamide (LSD)..................... 10 Marihuana............................................ 472,000 Mescaline............................................ 25 Methaqualone......................................... 10 Methcathinone........................................ 25 Methyldesorphine..................................... 5 Methyldihydromorphine................................ 2 Morphine methylbromide............................... 5 Morphine methylsulfonate............................. 5 Morphine-N-oxide..................................... 350 N,N-Dimethylamphetamine.............................. 25 N-(1-Amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H- 50 indazole-3-carboxamide (ADB-PINACA)................. N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(4- 50 fluorobenzyl)-1H-indazole-3-carboxamide (AB- FUBINACA)........................................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1- 15 (cyclohexylmethyl)-1H-indazole-3-carboxamide (AB- CHMINACA)........................................... N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 100 (acetyl fentanyl)................................... N-Ethyl-1-phenylcyclohexylamine...................... 5 N-Ethylamphetamine................................... 24 N-Hydroxy-3,4-methylenedioxyamphetamine.............. 24 Naphyrone............................................ 25 Noracymethadol....................................... 2 Norlevorphanol....................................... 52 Normethadone......................................... 2 Normorphine.......................................... 40 Para-fluorofentanyl.................................. 5 Parahexyl............................................ 5 Pentedrone........................................... 25 Pentylone............................................ 25 Phenomorphan......................................... 2 Pholcodine........................................... 5 Psilocybin........................................... 30 Psilocyn............................................. 50 Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3- 20 carboxylate (5-fluoro-PB-22; 5F-PB-22).............. Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB- 20 22; QUPIC).......................................... Tetrahydrocannabinols................................ 409,000 Thiofentanyl......................................... 2 Tilidine............................................. 25 Trimeperidine........................................ 2 UR-144............................................... 25 ------------------------------------------------------------------------ Schedule II ------------------------------------------------------------------------ 1-Phenylcyclohexylamine.............................. 4 1-Piperidinocyclohexanecarbonitrile.................. 4 4-Anilino-N-phenethyl-4-piperidine (ANPP)............ 1,000,000 Alfentanil........................................... 4,200 Alphaprodine......................................... 2 Amobarbital.......................................... 20,100 Amphetamine (for conversion)......................... 9,000,000 Amphetamine (for sale)............................... 37,500,000 Carfentanil.......................................... 10 Cocaine.............................................. 94,000 Codeine (for conversion)............................. 40,000,000 Codeine (for sale)................................... 45,000,000 [[Page 47825]] Dextropropoxyphene................................... 15 Dihydrocodeine....................................... 81,100 Dihydroetorphine..................................... 2 Diphenoxylate (for conversion)....................... 15,000 Diphenoxylate (for sale)............................. 820,000 Ecgonine............................................. 90,000 Ethylmorphine........................................ 2 Etorphine hydrochloride.............................. 2 Fentanyl............................................. 1,750,000 Glutethimide......................................... 2 Hydrocodone (for conversion)......................... 122,000 Hydrocodone (for sale)............................... 58,410,000 Hydromorphone........................................ 4,300,000 Isomethadone......................................... 4 Levo-alphacetylmethadol (LAAM)....................... 3 Levomethorphan....................................... 10 Levorphanol.......................................... 4,900 Lisdexamfetamine..................................... 19,000,000 Meperidine........................................... 3,706,000 Meperidine Intermediate-A............................ 5 Meperidine Intermediate-B............................ 9 Meperidine Intermediate-C............................ 5 Metazocine........................................... 15 Methadone (for sale)................................. 23,700,000 Methadone Intermediate............................... 25,600,000 Methamphetamine...................................... 1,539,100 ------------------------------------------------------------------------ [900,000 grams of levo-desoxyephedrine for use in a non-controlled, non- prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)] ------------------------------------------------------------------------ Methylphenidate...................................... 73,000,000 Morphine (for conversion)............................ 27,300,000 Morphine (for sale).................................. 41,000,000 Nabilone............................................. 15,000 Noroxymorphone (for conversion)...................... 17,700,000 Noroxymorphone (for sale)............................ 400,000 Opium (powder)....................................... 90,000 Opium (tincture)..................................... 300,000 Oripavine............................................ 20,000,000 Oxycodone (for conversion)........................... 2,610,000 Oxycodone (for sale)................................. 108,510,000 Oxymorphone (for conversion)......................... 22,300,000 Oxymorphone (for sale)............................... 4,200,000 Pentobarbital........................................ 27,500,000 Phenazocine.......................................... 5 Phencyclidine........................................ 20 Phenmetrazine........................................ 2 Phenylacetone........................................ 20 Racemethorphan....................................... 2 Racemorphan.......................................... 2 Remifentanil......................................... 3,000 Secobarbital......................................... 172,002 Sufentanil........................................... 4,000 Tapentadol........................................... 21,000,000 Thebaine............................................. 100,000,000 ------------------------------------------------------------------------ List I Chemicals ------------------------------------------------------------------------ Ephedrine (for conversion)........................... 50,000 Ephedrine (for sale)................................. 4,100,000 Phenylpropanolamine (for conversion)................. 15,000,000 Phenylpropanolamine (for sale)....................... 8,500,000 Pseudoephedrine (for sale)........................... 200,000,000 ------------------------------------------------------------------------ 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 2017 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 the [[Page 47826]] 2017 aggregate production quota for controlled substances in schedules I and II and establishing an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.11(c) and 1315.11(f). Dated: July 14, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-17370 Filed 7-21-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 47821
business proprietary information and a certificate of service must be pseudoephedrine, and
(‘‘BPI’’) under administrative protective timely filed. The Secretary will not phenylpropanolamine.
order. BPI referred to during the remand accept a document for filing without a ADDRESSES: To ensure proper handling
proceedings will be governed, as certificate of service. of comments, please reference ‘‘Docket
appropriate, by the administrative By order of the Commission. No. DEA–443N’’ on all correspondence,
protective order issued in the Issued: July 18, 2016. including any attachments. The Drug
investigations. The Secretary will Enforcement Administration encourages
Lisa Barton,
maintain a service list containing the that all comments be submitted
names and addresses of all persons or Secretary to the Commission.
[FR Doc. 2016–17286 Filed 7–21–16; 8:45 am]
electronically through the Federal
their representatives who are parties to eRulemaking Portal which provides the
the remand proceedings, and the BILLING CODE 7020–02–P
ability to type short comments directly
Secretary will maintain a separate list of into the comment field on the Web page
those authorized to receive BPI under or attach a file for lengthier comments.
the administrative protective order DEPARTMENT OF JUSTICE Please go to http://www.regulations.gov
during the remand proceedings. and follow the online instructions at
Written Submissions.—The Drug Enforcement Administration that site for submitting comments. Upon
Commission is not reopening the record completion of your submission you will
and will not accept the submission of [Docket No. DEA–443N]
receive a Comment Tracking Number for
new factual information for the record. your comment. Please be aware that
Proposed Aggregate Production
The Commission will permit the parties submitted comments are not
Quotas for Schedule I and II Controlled
to file comments concerning how the instantaneously available for public
Substances and Assessment of
Commission could best comply with the view on Regulations.gov. If you have
Court’s remand instructions. Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and received a Comment Tracking Number,
The comments must be based solely
Phenylpropanolamine for 2017 your comment has been successfully
on the information in the Commission’s
submitted and there is no need to
record. The Commission will reject AGENCY: Drug Enforcement resubmit the same comment. Paper
submissions containing additional Administration, Department of Justice. comments that duplicate electronic
factual information or arguments
ACTION: Notice with request for submissions are not necessary and are
pertaining to issues other than those on
comments. discouraged. Should you wish to mail a
which the Court has remanded this
paper comment in lieu of an electronic
matter. The deadline for filing SUMMARY: The Drug Enforcement comment, it should be sent via regular
comments is August 1, 2016. Comments Administration (DEA) proposes to or express mail to: Drug Enforcement
shall be limited to no more than fifteen establish the 2017 aggregate production Administration, Attention: DEA Federal
(15) double-spaced and single-sided quotas for controlled substances in Register Representative/ODW, 8701
pages of textual material. schedules I and II of the Controlled
Parties are advised to consult with the Morrissette Drive, Springfield, Virginia
Substances Act and assessment of 22152.
Commission’s Rules of Practice and annual needs for the list I chemicals
Procedure, part 201, subparts A through FOR FURTHER INFORMATION CONTACT:
ephedrine, pseudoephedrine, and
E (19 CFR part 201), and part 207, phenylpropanolamine. Michael J. Lewis, Office of Diversion
subpart A (19 CFR part 207) for Control, Drug Enforcement
provisions of general applicability DATES: Interested persons may file Administration; Mailing Address: 8701
concerning written submissions to the written comments on this notice in Morrissette Drive, Springfield, Virginia
Commission. All written submissions accordance with 21 CFR 1303.11(c) and 22152, Telephone: (202) 598–6812.
must conform with the provisions of 1315.11(d). Electronic comments must SUPPLEMENTARY INFORMATION:
section 201.8 of the Commission’s rules; be submitted, and written comments
any submissions that contain BPI must must be postmarked, on or before Posting of Public Comments
also conform with the requirements of August 22, 2016. Commenters should be Please note that all comments
sections 201.6, 207.3, and 207.7 of the aware that the electronic Federal Docket received in response to this docket are
Commission’s rules. The Commission’s Management System will not accept considered part of the public record.
Handbook on E-Filing, available on the comments after 11:59 p.m. Eastern Time They will, unless reasonable cause is
Commission’s Web site at http:// on the last day of the comment period. given, be made available by the Drug
edis.usitc.gov, elaborates upon the Based on comments received in Enforcement Administration (DEA) for
Commission’s rules with respect to response to this notice, the public inspection online at http://
electronic filing. Administrator may hold a public www.regulations.gov. Such information
Additional written submissions to the hearing on one or more issues raised. In includes personal identifying
Commission, including requests the event the Administrator decides in information (such as your name,
pursuant to section 201.12 of the his sole discretion to hold such a address, etc.) voluntarily submitted by
Commission’s rules, shall not be hearing, the Administrator will publish the commenter.
accepted unless good cause is shown for a notice of any such hearing in the The Freedom of Information Act
accepting such submissions or unless Federal Register. After consideration of (FOIA) applies to all comments
the submission is pursuant to a specific any comments or objections, or after a received. If you want to submit personal
request by a Commissioner or hearing, if one is held, the identifying information (such as your
ehiers on DSK5VPTVN1PROD with NOTICES
Commission staff. Administrator will publish in the name, address, etc.) as part of your
In accordance with sections 201.16(c) Federal Register a final order comment, but do not want it to be made
and 207.3 of the Commission’s rules, establishing the 2017 aggregate publicly available, you must include the
each document filed by a party to the production quotas for schedule I and II phrase ‘‘PERSONAL IDENTIFYING
investigation must be served on all other controlled substances, and an INFORMATION’’ in the first paragraph
parties to the investigation (as identified assessment of annual needs for the list of your comment. You must also place
by either the public or BPI service list), I chemicals ephedrine, all the personal identifying information
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methanone (THJ-2201) ................................................................................ 15
1-(1-Phenylcyclohexyl)pyrrolidine .................................................................................................................................................. 10
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...................................................................................................................... 30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ..................................................................................................................... 30
1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................................. 15
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200) ......................................................................................................... 35
1-Benzylpiperazine ........................................................................................................................................................................ 25
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Proposed 2017
Basic class quotas (g)
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) ................................................................................................................ 35
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH-203) ...................................................................................................................... 30
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250) .................................................................................................................. 30
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398) ...................................................................................................................... 30
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122) ..................................................................................................................... 30
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19, RCS-4) .............................................................................................................. 30
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081) ................................................................................................................. 30
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ..................................................................................................................... 30
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) .................................................................................................................. 30
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) .................................................................................................................... 30
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) ................................................................................................................ 30
2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ................................................................................................................................. 30
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) .................. 25
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) .................................................................................................................. 30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) .................. 25
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) ........................................................................................................................ 30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ............................ 5
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................................................ 25
2,5-Dimethoxy-4-n-propylthiophenethylamine ............................................................................................................................... 25
2,5-Dimethoxyamphetamine .......................................................................................................................................................... 25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) .......................................................................................................... 30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) .................................................................................................... 30
3,4,5-Trimethoxyamphetamine ...................................................................................................................................................... 25
3,4-Methylenedioxyamphetamine (MDA) ...................................................................................................................................... 55
3,4-Methylenedioxymethamphetamine (MDMA) ........................................................................................................................... 50
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ....................................................................................................................... 40
3,4-Methylenedioxy-N-methylcathinone (methylone) .................................................................................................................... 40
3,4-Methylenedioxypyrovalerone (MDPV) ..................................................................................................................................... 35
3-FMC; 3-Fluoro-N-methylcathinone ............................................................................................................................................. 25
3-Methylfentanyl ............................................................................................................................................................................. 2
3-Methylthiofentanyl ....................................................................................................................................................................... 2
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................................................ 25
4-Bromo-2,5-dimethoxyphenethylamine (2-CB) ............................................................................................................................ 25
4-FMC; Flephedrone ...................................................................................................................................................................... 25
4-Methoxyamphetamine ................................................................................................................................................................ 150
4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................................................ 25
4-Methylaminorex .......................................................................................................................................................................... 25
4-MEC; 4-Methyl-N-ethylcathinone ................................................................................................................................................ 25
4-Methyl-N-methylcathinone (mephedrone) .................................................................................................................................. 45
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ......................................................................................................................... 25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ................................................................................................... 50
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ..................... 40
5-Fluoro-UR144, XLR11 ................................................................................................................................................................ 25
5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................................................ 25
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................................................ 25
5-Methoxy-N,N-dimethyltryptamine ............................................................................................................................................... 25
AB-PINACA .................................................................................................................................................................................... 15
Acetyl-alpha-methylfentanyl ........................................................................................................................................................... 2
Acetyldihydrocodeine ..................................................................................................................................................................... 2
Acetylmethadol .............................................................................................................................................................................. 2
AH-7921 ......................................................................................................................................................................................... 30
Allylprodine .................................................................................................................................................................................... 2
alpha-Ethyltryptamine .................................................................................................................................................................... 25
alpha-Methylfentanyl ...................................................................................................................................................................... 2
alpha-Methylthiofentanyl ................................................................................................................................................................ 2
alpha-Methyltryptamine (AMT) ...................................................................................................................................................... 25
alpha-Pyrrolidinobutiophenone (a-PBP) ........................................................................................................................................ 25
alpha-Pyrrolidinopentiophenone (a-PVP) ...................................................................................................................................... 25
Alphacetylmethadol ........................................................................................................................................................................ 2
Alphameprodine ............................................................................................................................................................................. 2
Alphamethadol ............................................................................................................................................................................... 2
Aminorex ........................................................................................................................................................................................ 25
ehiers on DSK5VPTVN1PROD with NOTICES
APINCA, AKB48 ............................................................................................................................................................................ 25
Benzylmorphine ............................................................................................................................................................................. 2
beta-Hydroxy-3-methylfentanyl ...................................................................................................................................................... 2
beta-Hydroxyfentanyl ..................................................................................................................................................................... 2
beta-Hydroxythiofentanyl ............................................................................................................................................................... 30
Betacetylmethadol ......................................................................................................................................................................... 2
Betameprodine ............................................................................................................................................................................... 2
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![Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 47825
Proposed 2017
Basic class quotas (g)
Dextropropoxyphene ...................................................................................................................................................................... 15
Dihydrocodeine .............................................................................................................................................................................. 81,100
Dihydroetorphine ............................................................................................................................................................................ 2
Diphenoxylate (for conversion) ...................................................................................................................................................... 15,000
Diphenoxylate (for sale) ................................................................................................................................................................. 820,000
Ecgonine ........................................................................................................................................................................................ 90,000
Ethylmorphine ................................................................................................................................................................................ 2
Etorphine hydrochloride ................................................................................................................................................................. 2
Fentanyl ......................................................................................................................................................................................... 1,750,000
Glutethimide ................................................................................................................................................................................... 2
Hydrocodone (for conversion) ....................................................................................................................................................... 122,000
Hydrocodone (for sale) .................................................................................................................................................................. 58,410,000
Hydromorphone ............................................................................................................................................................................. 4,300,000
Isomethadone ................................................................................................................................................................................ 4
Levo-alphacetylmethadol (LAAM) .................................................................................................................................................. 3
Levomethorphan ............................................................................................................................................................................ 10
Levorphanol ................................................................................................................................................................................... 4,900
Lisdexamfetamine .......................................................................................................................................................................... 19,000,000
Meperidine ..................................................................................................................................................................................... 3,706,000
Meperidine Intermediate-A ............................................................................................................................................................ 5
Meperidine Intermediate-B ............................................................................................................................................................ 9
Meperidine Intermediate-C ............................................................................................................................................................ 5
Metazocine ..................................................................................................................................................................................... 15
Methadone (for sale) ..................................................................................................................................................................... 23,700,000
Methadone Intermediate ................................................................................................................................................................ 25,600,000
Methamphetamine ......................................................................................................................................................................... 1,539,100
[900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]
Methylphenidate ............................................................................................................................................................................. 73,000,000
Morphine (for conversion) .............................................................................................................................................................. 27,300,000
Morphine (for sale) ........................................................................................................................................................................ 41,000,000
Nabilone ......................................................................................................................................................................................... 15,000
Noroxymorphone (for conversion) ................................................................................................................................................. 17,700,000
Noroxymorphone (for sale) ............................................................................................................................................................ 400,000
Opium (powder) ............................................................................................................................................................................. 90,000
Opium (tincture) ............................................................................................................................................................................. 300,000
Oripavine ........................................................................................................................................................................................ 20,000,000
Oxycodone (for conversion) .......................................................................................................................................................... 2,610,000
Oxycodone (for sale) ..................................................................................................................................................................... 108,510,000
Oxymorphone (for conversion) ...................................................................................................................................................... 22,300,000
Oxymorphone (for sale) ................................................................................................................................................................. 4,200,000
Pentobarbital .................................................................................................................................................................................. 27,500,000
Phenazocine .................................................................................................................................................................................. 5
Phencyclidine ................................................................................................................................................................................. 20
Phenmetrazine ............................................................................................................................................................................... 2
Phenylacetone ............................................................................................................................................................................... 20
Racemethorphan ........................................................................................................................................................................... 2
Racemorphan ................................................................................................................................................................................ 2
Remifentanil ................................................................................................................................................................................... 3,000
Secobarbital ................................................................................................................................................................................... 172,002
Sufentanil ....................................................................................................................................................................................... 4,000
Tapentadol ..................................................................................................................................................................................... 21,000,000
Thebaine ........................................................................................................................................................................................ 100,000,000
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................................................ 50,000
Ephedrine (for sale) ....................................................................................................................................................................... 4,100,000
Phenylpropanolamine (for conversion) .......................................................................................................................................... 15,000,000
Phenylpropanolamine (for sale) ..................................................................................................................................................... 8,500,000
Pseudoephedrine (for sale) ........................................................................................................................................................... 200,000,000
ehiers on DSK5VPTVN1PROD with NOTICES
The Acting Administrator further 1303.13 and 21 CFR 1315.13, upon Conclusion
proposes that aggregate production consideration of the relevant factors, the
After consideration of any comments
quotas for all other schedule I and II Acting Administrator may adjust the
or objections, or after a hearing, if one
controlled substances included in 21 2017 aggregate production quotas and
is held, the Acting Administrator will
CFR 1308.11 and 1308.12 remain at assessment of annual needs as needed. issue and publish in the Federal
zero. In accordance with 21 CFR Register a final order establishing the
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![47826 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
2017 aggregate production quota for found that he ‘‘had prescribed confirm Applicant’s current address or
controlled substances in schedules I and controlled substances . . . in a manner accept service on Applicant’s behalf. GX
II and establishing an assessment of which demonstrated negligence, 10. The lawyer, however, did not
annual needs for the list I chemicals incompetence, and a lack of good moral respond. Request for Final Agency
ephedrine, pseudoephedrine, and character’’ and that he ‘‘prescribed, gave Action, at 3. Moreover, according to the
phenylpropanolamine, 21 CFR away or administered drugs for other Government, a Supervisory Diversion
1303.11(c) and 1315.11(f). than lawful diagnostic or therapeutic Investigator phoned the attorney and
Dated: July 14, 2016. purposes.’’ Id. The Order also alleged asked for Applicant’s address in order to
Chuck Rosenberg, that the Michigan Board had suspended serve the Show Cause Order. Id.
Acting Administrator. his medical license for six months and According to the Government, while the
one day and required that he petition attorney stated that he would contact
[FR Doc. 2016–17370 Filed 7–21–16; 8:45 am]
the Board for reinstatement; the Order the Government’s counsel, he did not.3
BILLING CODE 4410–09–P
then alleged that Applicant’s Michigan Id.
medical license remains suspended. Id. The Government then mailed the
DEPARTMENT OF JUSTICE The Order further alleged that based on Show Cause Order by certified mail,
the Michigan Board’s findings, the return receipt requested, addressed to
Drug Enforcement Administration Medical Board of California revoked his Applicant at his proposed business
California license effective October 10, address in Wayne, Michigan. GX 11, 12,
Mikhayl Soliman, M.D.: Decision and 2014. Id. and 13. Several weeks later the mailing
Order Finally, the Show Cause Order alleged was returned unclaimed, with the Post
that on May 16, 2012, DEA Investigators Office indicating that it was ‘‘unable to
On March 27, 2015, the Deputy
had seized 323 patient files which forward’’ the mailing. GX 13. The
Assistant Administrator, Office of
Applicant had discarded in the trash at Government did not, however, send the
Diversion Control, Drug Enforcement
his residence, and that the files showed Show Cause Order to Applicant by First
Administration, issued an Order to
that Applicant had prescribed both Class Mail. See Jones v. Flowers, 547
Show Cause to Mikhayl Soliman, M.D.
hydrocodone (then a Schedule III U.S. 220 (2006).
(hereinafter, Applicant), of both Wayne,
controlled substance) and alprazolam (a Subsequently, the Government
Michigan and Los Angeles, California.
Schedule IV drug) ‘‘to the majority of submitted a Request for Final Agency
The Show Cause Order proposed the
these patients.’’ Id. The Order then Action along with the Investigative File.
denial of Applicant’s applications for
alleged that DEA Investigators obtained Upon review of the record, I found that
DEA Certificates of Registration in the
information from the Michigan service was inadequate and directed
States of Michigan and California on
Automated Prescriptions System which that the Request for Final Agency
multiple grounds. GX 7, at 1.
First, the Show Cause Order alleged showed that ‘‘between January 1, 2007 Action be returned.
and August 20, 1012, [Applicant] On November 9, 2015, the
that Applicant had previously been
prescribed at least 19,409 dosage units Government again mailed the Show
registered to handle controlled
of [s]chedule II [drugs], 725,760 dosage Cause Order by certified mail, return
substances in only Schedule III and IIIN,
units of [s]chedule IV [drugs], and receipt requested, addressed to
at the registered address of 3152 South
246,397 dosage units of [s]chedule V Applicant at his proposed registered
Wayne Road, Wayne, Michigan. Id. The
[drugs], without the registered authority location. Here again, several weeks later
Show Cause Order alleged that on
to do so.’’ Id.1 the mailing was returned by the Post
September 14, 2012, Applicant was
Thereafter, the Government attempted Office as undeliverable. GX 18.
issued an Order to Show Cause and
to serve the Show Cause Order by FedEx Also on November 9, 2015, the same
Immediate Suspension of Registration
delivered to the proposed business day the Government had re-mailed the
and that he subsequently voluntarily
address Applicant used when he Show Cause Order, it emailed the Order
surrendered his registration.
The Show Cause Order alleged that on applied for a registration in Los Angeles. to Applicant at the email address he had
September 24, 2012, Applicant applied GX 9, at 1. The Government did not, provided to the Agency on his
for a new DEA practitioner’s registration however, require a signature. Id. at 1–2. applications. According to an affidavit
at his previous registered location in Moreover, the Government does not submitted by the Government, it ‘‘did
Wayne, Michigan, and that on October point to any precedent of either the not receive any bounce-back email or
2, 2012, he applied for a new courts or this Agency which allows for other indication that the email . . . was
practitioner’s registration at a proposed the use of FedEx to serve a charging undeliverable or otherwise not
location in Los Angeles, California. Id. document or complaint (as opposed to received.’’ GX 19.
The Order then alleged that on both post-service filings) on a person.2 Thus, Upon re-submission of its Request for
applications, Applicant had failed to this attempt was deemed inadequate to Final Agency Action, the Government
disclose that he had voluntarily accomplish service. advised that on September 24, 2015,
surrendered his registration and had The Government also noted that it Applicant was found guilty in the
materially falsified both applications. emailed a lawyer who was representing United States District Court for the
Id. at 1–2 (citing 21 U.S.C. 843(a)(4)(A)). Applicant ‘‘in a pending criminal Eastern District of Michigan on multiple
Second, the Show Cause Order matter’’ and asked him if he could counts of health care fraud and aiding
alleged that as a result of actions taken and abetting the unlawful distribution
by the medical boards of California and
1 The Show Cause Order also notified Applicant of controlled substances. Request for
of his right to either request a hearing on the Final Agency Action, at 4; see also GX
ehiers on DSK5VPTVN1PROD with NOTICES
Michigan, Applicant is ‘‘without allegations of the Order to Show Cause or to submit
authority to practice in the States . . . a written statement while waiving his right to a
15, at 5). The Government further
in which [he] applied for’’ DEA hearing, the procedure for electing either option, advised that on October 5, 2015,
registrations. Id. at 2. Specifically, the and the consequence of failing to elect either
option. GX 7, at 3. 3 Given that Applicant had been criminally
Show Cause Order alleged that on 2 Nor am I aware of any rules of procedure which charged and released on bond, the Pre-Trial
January 15, 2014, the Michigan Board of allow for a charging document or complaint to be Services Office would likely have been a more
Medicine issued a Consent Order which served in this manner. fruitful source for obtaining his residence address.
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Document Created: 2016-07-22 02:38:22
Document Modified: 2016-07-22 02:38:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice with request for comments. | |
| 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 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. | |
| Contact | Michael J. Lewis, Office of Diversion | |
| FR Citation | 81 FR 47821 |
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