81 FR 47829 - Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016
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 | 47829-47834 | |
| FR Document | 2016-17371 |
[Federal Register Volume 81, Number 141 (Friday, July 22, 2016)] [Notices] [Pages 47829-47834] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17371] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-420P] Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2016 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Notice with request for comments. ----------------------------------------------------------------------- SUMMARY: The Drug Enforcement Administration (DEA) proposes to adjust the 2016 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. DATES: Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(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 [[Page 47830]] Federal Register a final order establishing the 2016 adjusted 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-420P'' 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 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 and Background 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. The DEA established the 2016 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on October 6, 2015 (80 FR 60400). That notice stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment. Analysis for Proposed Adjusted 2016 Aggregate Production Quotas and Assessment of Annual Needs The DEA proposes to adjust the established 2016 aggregate production quotas and assessment of annual needs for certain schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2016 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes. In determining the proposed adjustment, the Acting Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2016 by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical; and (5) other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Acting Administrator finds relevant. These quotas do not include imports of controlled substances for use in industrial processes. The Acting Administrator also considered updated information obtained from 2015 year-end inventories, 2015 disposition data submitted by quota applicants, [[Page 47831]] estimates of the medical needs of the United States, product development, and other information made available to the DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the 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 adjusted 2016 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively). As described in the previously published notice establishing the 2016 aggregate production quotas and assessment of annual needs, the DEA has specifically considered that inventory allowances granted to individual manufacturers, 21 CFR 1303.24, 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. This would be concerning if a natural disaster or other unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need. As such, the DEA has included in all proposed adjusted schedule II controlled substance aggregate production quotas, and certain proposed adjusted schedule I controlled substance aggregate production quotas, an additional 25% of the estimated medical, scientific, and research needs as part of the amount necessary to ensure the establishment and maintenance of reserve stocks. The resulting adjusted established aggregate production quotas will reflect these included amounts. This action will not affect the ability of manufacturers to maintain inventory allowances as specified by regulation. The DEA expects that maintaining this reserve in certain established aggregate production quotas will mitigate adverse public effects if an unforeseen event resulted in substantial disruption to the amount of controlled substances available to provide for legitimate public need, as determined by the DEA. The DEA does not anticipate utilizing the reserve in the absence of these circumstances. The Acting Administrator, therefore, proposes that the year 2016 aggregate production quotas for the two temporarily scheduled substances be established, and to adjust the 2016 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: ------------------------------------------------------------------------ Established 2016 Proposed revised quotas 2016 quotas Basic class ----------------------------------------- (g) (g) ------------------------------------------------------------------------ Temporarily Scheduled Substances ------------------------------------------------------------------------ beta-Hydroxythiofentanyl...... N/A 30. Butyryl fentanyl.............. N/A 30. ------------------------------------------------------------------------ Schedule I ------------------------------------------------------------------------ [1-(5-fluoropentyl)-1H-indazol- 15 no change. 3-yl](naphthalen-1- yl)methanone (THJ-2201). 1-(1- 10 no change. Phenylcyclohexyl)pyrrolidine. 1-(5-Fluoropentyl)-3-(1- 45 no change. naphthoyl)indole (AM2201). 1-(5-Fluoropentyl)-3-(2- 45 no change. iodobenzoyl)indole (AM694). 1-[1-(2- 15 no change. Thienyl)cyclohexyl]piperidine. 1-[2-(4-Morpholinyl)ethyl]-3- 45 no change. (1-naphthoyl)indole (JWH-200). 1-Benzylpiperazine............ 25 no change. 1-Butyl-3-(1-naphthoyl)indole 45 no change. (JWH-073). 1-Cyclohexylethyl-3-(2- 45 no change. methoxyphenylacetyl)indole (SR-18 and RCS-8). 1-Hexyl-3-(1-naphthoyl)indole 45 no change. (JWH-019). 1-Methyl-4-phenyl-4- 2 no change. propionoxypiperidine. 1-Pentyl-3-(1-naphthoyl)indole 45 no change. (JWH-018 and AM678). 1-Pentyl-3-(2- 45 no change. chlorophenylacetyl)indole (JWH-203). 1-Pentyl-3-(2- 45 no change. methoxyphenylacetyl)indole (JWH-250). 1-Pentyl-3-(4-chloro-1- 45 no change. naphthoyl)indole (JWH-398). 1-Pentyl-3-(4-methyl-1- 45 no change. naphthoyl)indole (JWH-122). 1-Pentyl-3-[(4-methoxy)- 45 no change. benzoyl]indole (SR-19, RCS-4). 1-Pentyl-3-[1-(4- 45 no change. methoxynaphthoyl)]indole (JWH- 081). 2-(2,5-Dimethoxy-4- 30 no change. ethylphenyl)ethanamine (2C-E). 2-(2,5-Dimethoxy-4- 30 no change. methylphenyl)ethanamine (2C- D). 2-(2,5-Dimethoxy-4-nitro- 30 no change. phenyl)ethanamine (2C-N). 2-(2,5-Dimethoxy-4-n- 30 no change. propylphenyl)ethanamine (2C- P). 2-(2,5- 30 no change. Dimethoxyphenyl)ethanamine (2C-H). 2-(4-Bromo-2,5- 25 no change. dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi- 36). 2-(4-Chloro-2,5- 30 no change. dimethoxyphenyl)ethanamine (2C-C). 2-(4-Chloro-2,5- 25 no change. dimethoxyphenyl)-N-(2- methoxybenzyl)ethanamine (25C- NBOMe; 2C-C-NBOMe; 25C; Cimbi- 82). 2-(4-Iodo-2,5- 30 no change. dimethoxyphenyl)ethanamine (2C-I). 2-(4-Iodo-2,5-dimethoxyphenyl)- 15 no change. N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5). 2,5-Dimethoxy-4- 25 no change. ethylamphetamine (DOET). 2,5-Dimethoxy-4-n- 25 no change. propylthiophenethylamine. 2,5-Dimethoxyamphetamine...... 25 no change. [[Page 47832]] 2-[4-(Ethylthio)-2,5- 30 no change. dimethoxyphenyl]ethanamine (2C-T-2). 2-[4-(Isopropylthio)-2,5- 30 no change. dimethoxyphenyl]ethanamine (2C-T-4). 3,4,5-Trimethoxyamphetamine... 25 no change. 3,4-Methylenedioxyamphetamine 55 no change. (MDA). 3,4- 50 no change. Methylenedioxymethamphetamine (MDMA). 3,4-Methylenedioxy-N- 40 no change. ethylamphetamine (MDEA). 3,4-Methylenedioxy-N- 50 no change. methylcathinone (methylone). 3,4-Methylenedioxypyrovalerone 35 no change. (MDPV). 3-FMC; 3-Fluoro-N- 25 no change. methylcathinone. 3-Methylfentanyl.............. 2 no change. 3-Methylthiofentanyl.......... 2 no change. 4-Bromo-2,5- 25 no change. dimethoxyamphetamine (DOB). 4-Bromo-2,5- 25 no change. dimethoxyphenethylamine (2- CB). 4-FMC; Flephedrone............ 25 no change. 4-Methoxyamphetamine.......... 150 no change. 4-Methyl-2,5- 25 no change. dimethoxyamphetamine (DOM). 4-Methylaminorex.............. 25 no change. 4-MEC; 4-Methyl-N- 25 no change. ethylcathinone. 4-Methyl-N-methylcathinone 45 no change. (mephedrone). 4-Methyl-[alpha]- 25 no change. pyrrolidinopropiophenone (4- MePPP). 5-(1,1-Dimethylheptyl)-2- 68 50. [(1R,3S)-3-hydroxycyclohexyl]- phenol. 5-(1,1-Dimethyloctyl)-2- 53 40. [(1R,3S)-3-hydroxycyclohexyl]- phenol (cannabicyclohexanol or CP-47,497 C8-homolog). 5-Fluoro-UR144, XLR11......... 25 no change. 5-Methoxy-3,4- 25 no change. methylenedioxyamphetamine. 5-Methoxy-N,N- 25 no change. diisopropyltryptamine. 5-Methoxy-N,N- 25 no change. dimethyltryptamine. AB-PINACA..................... 15 no change. Acetyl-alpha-methylfentanyl... 2 no change. Acetyldihydrocodeine.......... 2 no change. Acetylmethadol................ 2 no change. AH-7921....................... N/A 30. Allylprodine.................. 2 no change. alpha-Ethyltryptamine......... 25 no change. alpha-Methylfentanyl.......... 2 no change. alpha-Methylthiofentanyl...... 2 no change. alpha-Methyltryptamine (AMT).. 25 no change. alpha-Pyrrolidinobutiophenone 25 no change. ([alpha]-PBP). alpha-Pyrrolidinopentiophenone 25 no change. ([alpha]-PVP). Alphacetylmethadol............ 2 no change. Alphameprodine................ 2 no change. Alphamethadol................. 2 no change. Aminorex...................... 25 no change. APINCA, AKB48................. 25 no change. Benzylmorphine................ 2 no change. beta-Hydroxy-3-methylfentanyl. 2 no change. beta-Hydroxyfentanyl.......... 2 no change. Betacetylmethadol............. 2 no change. Betameprodine................. 2 no change. Betamethadol.................. 4 no change. Betaprodine................... 2 no change. Bufotenine.................... 3 no change. Butylone...................... 25 no change. Cathinone..................... 70 30. Codeine methylbromide......... 5 no change. Codeine-N-oxide............... 305 no change. Desomorphine.................. 25 no change. Diethyltryptamine............. 25 no change. Difenoxin..................... 11,000 no change. Dihydromorphine............... 3,000,000 2,000,000. Dimethyltryptamine............ 35 no change. Dipipanone.................... 5 no change. Fenethylline.................. 5 no change. gamma-Hydroxybutyric acid..... 70,250,000 no change. Heroin........................ 50 no change. Hydromorphinol................ 2 no change. Hydroxypethidine.............. 2 no change. Ibogaine...................... 5 no change. Lysergic acid diethylamide 40 no change. (LSD). Marihuana..................... 658,000 no change. [[Page 47833]] Mescaline..................... 25 no change. Methaqualone.................. 10 no change. Methcathinone................. 25 no change. Methyldesorphine.............. 5 no change. Methyldihydromorphine......... 2 no change. Morphine methylbromide........ 5 no change. Morphine methylsulfonate...... 5 no change. Morphine-N-oxide.............. 350 no change. N,N-Dimethylamphetamine....... 25 no change. N-(1-Amino-3,3-dimethyl-1- 50 no change. oxobutan-2-yl)-1-pentyl-1H- indazole-3-carboxamide (ADB- PINACA). N-(1-Amino-3-methyl-1-oxobutan- 50 no change. 2-yl)-1-(4-fluorobenzyl)-1H- indazole-3-carboxamide (AB- FUBINACA). N-(1-Amino-3-methyl-1-oxobutan- 15 no change. 2-yl)-1-(cyclohexylmethyl)-1H- indazole-3-carboxamide (AB- CHMINACA). N-(1-phenethylpiperidin-4-yl)- 100 no change. N-phenylacetamide (acetyl fentanyl). N-Ethyl-1- 5 no change. phenylcyclohexylamine. N-Ethylamphetamine............ 24 no change. N-Hydroxy-3,4- 24 no change. methylenedioxyamphetamine. Naphyrone..................... 25 no change. Noracymethadol................ 2 no change. Norlevorphanol................ 52 no change. Normethadone.................. 2 no change. Normorphine................... 40 no change. Para-fluorofentanyl........... 5 no change. Parahexyl..................... 5 no change. Pentedrone.................... 25 no change. Pentylone..................... 25 no change. Phenomorphan.................. 2 no change. Pholcodine.................... 5 no change. Psilocybin.................... 30 no change. Psilocyn...................... 50 no change. Quinolin-8-yl 1-(5- 50 25. fluoropentyl)-1H-indole-3- carboxylate (5-fluoro-PB-22; 5F-PB-22). Quinolin-8-yl 1-pentyl-1H- 50 25. indole-3-carboxylate (PB-22; QUPIC). Tetrahydrocannabinols......... 511,250 no change. Thiofentanyl.................. 2 no change. Tilidine...................... 25 no change. Trimeperidine................. 2 no change. UR-144........................ 25 no change. ------------------------------------------------------------------------ Schedule II ------------------------------------------------------------------------ 1-Phenylcyclohexylamine....... 5 no change. 1- 5 no change. Piperidinocyclohexanecarbonit rile. 4-Anilino-N-phenethyl-4- 2,950,000 2,250,000. piperidine (ANPP). Alfentanil.................... 17,750 no change. Alphaprodine.................. 3 no change. Amobarbital................... 25,125 no change. Amphetamine (for conversion).. 15,000,000 no change. Amphetamine (for sale)........ 39,705,000 45,000,000. Carfentanil................... 19 no change. Cocaine....................... 200,000 no change. Codeine (for conversion)...... 50,000,000 no change. Codeine (for sale)............ 63,900,000 no change. Dextropropoxyphene............ 19 no change. Dihydrocodeine................ 226,375 no change. Dihydroetorphine.............. 3 no change. Diphenoxylate (for conversion) 31,250 18,750. Diphenoxylate (for sale)...... 1,337,500 no change. Ecgonine...................... 125,000 no change. Ethylmorphine................. 3 5. Etorphine hydrochloride....... 3 no change. Fentanyl...................... 2,300,000 no change. Glutethimide.................. 3 no change. Hydrocodone (for conversion).. 235,000 177,500. Hydrocodone (for sale)........ 88,500,000 86,000,000. Hydromorphone................. 8,250,000 7,000,000. Isomethadone.................. 5 no change. Levo-alphacetylmethadol (LAAM) 4 no change. Levomethorphan................ 30 33. Levorphanol................... 7,125 no change. Lisdexamfetamine.............. 29,750,000 23,750,000. Meperidine.................... 5,450,000 4,632,500. Meperidine Intermediate-A..... 6 no change. [[Page 47834]] Meperidine Intermediate-B..... 11 no change. Meperidine Intermediate-C..... 6 no change. Metazocine.................... 19 no change. Methadone (for sale).......... 31,875,000 no change. Methadone Intermediate........ 34,375,000 no change. Methamphetamine............... 2,061,375 no change. ------------------------------------------------------------------------ [1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)] ------------------------------------------------------------------------ Methylphenidate............... 96,750,000 84,375,000. Morphine (for conversion)..... 91,250,000 no change. Morphine (for sale)........... 62,500,000 no change. Nabilone...................... 18,750 no change. Noroxymorphone (for 17,500,000 no change. conversion). Noroxymorphone (for sale)..... 1,475,000 625,000. Opium (powder)................ 112,500 no change. Opium (tincture).............. 687,500 375,000. Oripavine..................... 30,000,000 no change. Oxycodone (for conversion).... 6,250,000 5,000,000. Oxycodone (for sale).......... 139,150,000 no change. Oxymorphone (for conversion).. 29,000,000 25,000,000. Oxymorphone (for sale)........ 7,750,000 6,250,000. Pentobarbital................. 38,125,000 no change. Phenazocine................... 6 no change. Phencyclidine................. 50 no change. Phenmetrazine................. 3 no change. Phenylacetone................. 50 no change. Racemethorphan................ 3 5. Racemorphan................... 3 no change. Remifentanil.................. 3,750 no change. Secobarbital.................. 215,003 no change. Sufentanil.................... 6,255 no change. Tapentadol.................... 25,500,000 no change. Thebaine...................... 125,000,000 no change. ------------------------------------------------------------------------ List I Chemicals ------------------------------------------------------------------------ Ephedrine (for conversion).... 100,000 50,000. Ephedrine (for sale).......... 4,000,000 no change. Phenylpropanolamine (for 22,400,000 15,000,000. conversion). Phenylpropanolamine (for sale) 8,500,000 no change. Pseudoephedrine (for 7,000 40. conversion). Pseudoephedrine (for sale).... 224,500,000 200,000,000. ------------------------------------------------------------------------ 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 2016 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 any adjustment of 2016 aggregate production quota for each basic class of controlled substances in schedules I and II and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f). Dated: July 14, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-17371 Filed 7-21-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices 47829
Michigan, the State in which he seeks 485 U.S. 759, 770 (1988) (quoting for registration. This provides a further
registration. Because he does not meet Weinstock v. United States, 231 F.2d reason to deny his pending application.
this prerequisite for obtaining a DEA 699, 701 (D.C. Cir. 1956)) (other citation
Order
registration, I will deny his application omitted); see also United States v. Wells,
on this basis. 519 U.S. 482, 489 (1997) (quoting Pursuant to the authority vested in me
Kungys, 485 U.S. at 770). As the by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
Material Falsification I order that the application of Mikhayl
Supreme Court has further explained,
Pursuant to section 304(a)(1), the ‘‘it has never been the test of materiality Soliman, M.D., for a DEA Certificate of
Attorney General is also authorized to that the misrepresentation or Registration as a practitioner, be, and it
suspend or revoke a registration ‘‘upon concealment would more likely than not hereby is, denied. This Order is effective
a finding that the registrant . . . has have produced an erroneous decision, immediately.
materially falsified any application filed or even that it would more likely than Dated: July 15, 2016.
pursuant to or required by this not have triggered an investigation, but Chuck Rosenberg,
subchapter.’’ 21 U.S.C. 824(a)(1). It is rather, whether the misrepresentation or
well established that the various Acting Administrator.
concealment was predictably capable of
grounds for revocation or suspension of [FR Doc. 2016–17394 Filed 7–21–16; 8:45 am]
affecting, i.e., had a natural tendency to
an existing registration that Congress affect, the official decision.’’ Kungys, BILLING CODE 4410–09–P
enumerated in section 304(a), 21 U.S.C. 485 U.S. at 771. While the evidence
824(a), are also properly considered in must be ‘‘clear, unequivocal, and
deciding whether to grant or deny an convincing,’’ the ‘‘ultimate finding of DEPARTMENT OF JUSTICE
application under section 303. See The materiality turns on an interpretation of
Lawsons, Inc., 72 FR 74334, 74337 Drug Enforcement Administration
the substantive law.’’ Id. at 772 (int.
(2007); Anthony D. Funches, 64 FR quotations and citations omitted). [Docket No. DEA–420P]
14267, 14268 (1999); Alan R. Applicant’s false answer to the
Schankman, 63 FR 45260 (1998); Kuen question of whether he had ever Proposed Adjustments to the
H. Chen, 58 FR 65401, 65402 (1993). surrendered his federal registration was Aggregate Production Quotas for
Thus, the allegation that Applicant clearly ‘‘capable of affecting’’ the Schedule I and II Controlled
materially falsified his application is decision of whether to grant his Substances and Assessment of
properly considered in this proceeding. application. As the evidence shows, Annual Needs for the List I Chemicals
See Samuel S. Jackson, 72 FR 23848, Applicant surrendered his registration Ephedrine, Pseudoephedrine, and
23852 (2007). Moreover, just as in response to allegations that he Phenylpropanolamine for 2016
materially falsifying an application violated the CSA and DEA regulations
provides a basis for revoking an existing AGENCY: Drug Enforcement
by prescribing controlled substances Administration, Department of Justice.
registration without proof of any other that were in schedules for which he
misconduct, see 21 U.S.C. 824(a)(1), it ACTION: Notice with request for
lacked authorization, as well as
also provides an independent and allegations that he issued prescriptions comments.
adequate ground for denying an that lacked a legitimate medical SUMMARY: The Drug Enforcement
application. The Lawsons, 72 FR 74338; purpose. GX 3, at 2 (Sept. 24, 2012 Administration (DEA) proposes to
cf. Bobby Watts, M.D., 58 FR 46995 Immediate Suspension Order) (citing 21 adjust the 2016 aggregate production
(1993). U.S.C. 822(b) and 841(a)(1); 21 CFR
Here, the Government’s evidence quotas for several controlled substances
1301.12(a) and 1306.04(a)). Notably, in schedules I and II of the Controlled
shows that upon being served with an under the public interest standard, the
Order to Show Cause and Immediate Substances Act and assessment of
Agency is required to consider both the annual needs for the list I chemicals
Suspension of Registration which Applicant’s ‘‘experience in dispensing
alleged that he had prescribed ephedrine, pseudoephedrine, and
. . . controlled substances’’ and his phenylpropanolamine.
controlled substances in violation of the ‘‘[c]ompliance with applicable State,
CSA, Applicant surrendered his Federal, or local laws relating to DATES: Interested persons may file
registration. GXs 3 & 4. Moreover, on the controlled substances.’’ 21 U.S.C. written comments on this notice in
Voluntary Surrender form, Applicant 823(f)(2) & (4). See also Shannon L. accordance with 21 CFR 1303.13(c) and
acknowledged that he was doing so Gallentine, D.P.M., 76 FR 45864, 45866 1315.13(d). Electronic comments must
‘‘[i]n view of my alleged failure to (2011). be submitted, and written comments
comply with the Federal requirements Thus, notwithstanding that the must be postmarked, on or before
pertaining to controlled substances.’’ GX Agency did not grant his application, August 22, 2016. Commenters should be
4. Yet days later, Applicant applied for his false answer was still material as it aware that the electronic Federal Docket
a new registration and provided a ‘‘no’’ was capable of influencing the decision Management System will not accept
answer to the question: ‘‘[h]as the as to whether to grant his application. comments after 11:59 p.m. Eastern Time
applicant ever surrendered (for cause) or See United States v. Alemany Rivera, on the last day of the comment period.
had a federal controlled substance 781 F.2d 229, 234 (1st Cir. 1985) (‘‘It Based on comments received in
registration revoked, suspended, makes no difference that a specific response to this notice, the
restricted or denied, or is any such falsification did not exert influence so Administrator may hold a public
action pending?’’ GX 1, at 1, 3. long as it had the capacity to do so.’’); hearing on one or more issues raised. In
Applicant’s answer was false as he United States v. Norris, 749 F.2d 1116, the event the Administrator decides in
ehiers on DSK5VPTVN1PROD with NOTICES
had clearly surrendered his registration 1121 (4th Cir. 1984) (‘‘There is no his sole discretion to hold such a
for cause. His false answer was also requirement that the false statement hearing, the Administrator will publish
material as ‘‘it ‘ha[d] a natural tendency influence or effect the decision making a notice of any such hearing in the
to influence, or was capable of process of a department of the United Federal Register. After consideration of
influencing, the decision of’ the States Government.’’). Accordingly, I any comments or objections, or after a
decisionmaking body to which it was conclude that Applicant materially hearing, if one is held, the
addressed.’’ Kungys v. United States, falsified his September 2012 application Administrator will publish in the
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methanone (THJ–2201) ................................................ 15 no change.
1-(1-Phenylcyclohexyl)pyrrolidine ................................................................................................................... 10 no change.
1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ....................................................................................... 45 no change.
1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) ...................................................................................... 45 no change.
1-[1-(2-Thienyl)cyclohexyl]piperidine .............................................................................................................. 15 no change.
1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH–200) ......................................................................... 45 no change.
1-Benzylpiperazine ......................................................................................................................................... 25 no change.
1-Butyl-3-(1-naphthoyl)indole (JWH–073) ...................................................................................................... 45 no change.
1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole (SR–18 and RCS–8) .................................................... 45 no change.
1-Hexyl-3-(1-naphthoyl)indole (JWH–019) ..................................................................................................... 45 no change.
1-Methyl-4-phenyl-4-propionoxypiperidine ...................................................................................................... 2 no change.
1-Pentyl-3-(1-naphthoyl)indole (JWH–018 and AM678) ................................................................................ 45 no change.
1-Pentyl-3-(2-chlorophenylacetyl)indole (JWH–203) ...................................................................................... 45 no change.
1-Pentyl-3-(2-methoxyphenylacetyl)indole (JWH–250) .................................................................................. 45 no change.
1-Pentyl-3-(4-chloro-1-naphthoyl)indole (JWH–398) ...................................................................................... 45 no change.
1-Pentyl-3-(4-methyl-1-naphthoyl)indole (JWH–122) ..................................................................................... 45 no change.
1-Pentyl-3-[(4-methoxy)-benzoyl]indole (SR–19, RCS–4) .............................................................................. 45 no change.
1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH–081) ................................................................................. 45 no change.
2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C–E) ..................................................................................... 30 no change.
2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C–D) .................................................................................. 30 no change.
2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C–N) .................................................................................... 30 no change.
2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C–P) ................................................................................ 30 no change.
2-(2,5-Dimethoxyphenyl)ethanamine (2C–H) ................................................................................................. 30 no change.
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B–NBOMe; 2C–B–NBOMe; 25B; 25 no change.
Cimbi-36).
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C–C) ................................................................................... 30 no change.
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C–NBOMe; 2C–C–NBOMe; 25C; 25 no change.
ehiers on DSK5VPTVN1PROD with NOTICES
Cimbi-82).
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C–I) ........................................................................................ 30 no change.
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I–NBOMe; 2C–I–NBOMe; 25I; 15 no change.
Cimbi-5).
2,5-Dimethoxy-4-ethylamphetamine (DOET) ................................................................................................. 25 no change.
2,5-Dimethoxy-4-n-propylthiophenethylamine ................................................................................................ 25 no change.
2,5-Dimethoxyamphetamine ........................................................................................................................... 25 no change.
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![47832 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Established Proposed
2016 revised 2016
Basic class quotas quotas
(g) (g)
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–2) .......................................................................... 30 no change.
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C–T–4) ................................................................... 30 no change.
3,4,5-Trimethoxyamphetamine ....................................................................................................................... 25 no change.
3,4-Methylenedioxyamphetamine (MDA) ....................................................................................................... 55 no change.
3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................ 50 no change.
3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ........................................................................................ 40 no change.
3,4-Methylenedioxy-N-methylcathinone (methylone) ..................................................................................... 50 no change.
3,4-Methylenedioxypyrovalerone (MDPV) ...................................................................................................... 35 no change.
3–FMC; 3-Fluoro-N-methylcathinone ............................................................................................................. 25 no change.
3-Methylfentanyl .............................................................................................................................................. 2 no change.
3-Methylthiofentanyl ........................................................................................................................................ 2 no change.
4-Bromo-2,5-dimethoxyamphetamine (DOB) ................................................................................................. 25 no change.
4-Bromo-2,5-dimethoxyphenethylamine (2–CB) ............................................................................................ 25 no change.
4–FMC; Flephedrone ...................................................................................................................................... 25 no change.
4-Methoxyamphetamine ................................................................................................................................. 150 no change.
4-Methyl-2,5-dimethoxyamphetamine (DOM) ................................................................................................. 25 no change.
4-Methylaminorex ........................................................................................................................................... 25 no change.
4–MEC; 4-Methyl-N-ethylcathinone ................................................................................................................ 25 no change.
4-Methyl-N-methylcathinone (mephedrone) ................................................................................................... 45 no change.
4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) .......................................................................................... 25 no change.
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol .................................................................... 68 50.
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP–47,497 C8- 53 40.
homolog).
5-Fluoro-UR144, XLR11 ................................................................................................................................. 25 no change.
5-Methoxy-3,4-methylenedioxyamphetamine ................................................................................................. 25 no change.
5-Methoxy-N,N-diisopropyltryptamine ............................................................................................................. 25 no change.
5-Methoxy-N,N-dimethyltryptamine ................................................................................................................ 25 no change.
AB–PINACA .................................................................................................................................................... 15 no change.
Acetyl-alpha-methylfentanyl ............................................................................................................................ 2 no change.
Acetyldihydrocodeine ...................................................................................................................................... 2 no change.
Acetylmethadol ............................................................................................................................................... 2 no change.
AH–7921 ......................................................................................................................................................... N/A 30.
Allylprodine ..................................................................................................................................................... 2 no change.
alpha-Ethyltryptamine ..................................................................................................................................... 25 no change.
alpha-Methylfentanyl ....................................................................................................................................... 2 no change.
alpha-Methylthiofentanyl ................................................................................................................................. 2 no change.
alpha-Methyltryptamine (AMT) ....................................................................................................................... 25 no change.
alpha-Pyrrolidinobutiophenone (a-PBP) ......................................................................................................... 25 no change.
alpha-Pyrrolidinopentiophenone (a-PVP) ....................................................................................................... 25 no change.
Alphacetylmethadol ......................................................................................................................................... 2 no change.
Alphameprodine .............................................................................................................................................. 2 no change.
Alphamethadol ................................................................................................................................................ 2 no change.
Aminorex ......................................................................................................................................................... 25 no change.
APINCA, AKB48 ............................................................................................................................................. 25 no change.
Benzylmorphine .............................................................................................................................................. 2 no change.
beta-Hydroxy-3-methylfentanyl ....................................................................................................................... 2 no change.
beta-Hydroxyfentanyl ...................................................................................................................................... 2 no change.
Betacetylmethadol .......................................................................................................................................... 2 no change.
Betameprodine ................................................................................................................................................ 2 no change.
Betamethadol .................................................................................................................................................. 4 no change.
Betaprodine ..................................................................................................................................................... 2 no change.
Bufotenine ....................................................................................................................................................... 3 no change.
Butylone .......................................................................................................................................................... 25 no change.
Cathinone ........................................................................................................................................................ 70 30.
Codeine methylbromide .................................................................................................................................. 5 no change.
Codeine-N-oxide ............................................................................................................................................. 305 no change.
Desomorphine ................................................................................................................................................. 25 no change.
Diethyltryptamine ............................................................................................................................................ 25 no change.
Difenoxin ......................................................................................................................................................... 11,000 no change.
Dihydromorphine ............................................................................................................................................. 3,000,000 2,000,000.
Dimethyltryptamine ......................................................................................................................................... 35 no change.
Dipipanone ...................................................................................................................................................... 5 no change.
Fenethylline ..................................................................................................................................................... 5 no change.
ehiers on DSK5VPTVN1PROD with NOTICES
gamma-Hydroxybutyric acid ........................................................................................................................... 70,250,000 no change.
Heroin ............................................................................................................................................................. 50 no change.
Hydromorphinol ............................................................................................................................................... 2 no change.
Hydroxypethidine ............................................................................................................................................ 2 no change.
Ibogaine .......................................................................................................................................................... 5 no change.
Lysergic acid diethylamide (LSD) ................................................................................................................... 40 no change.
Marihuana ....................................................................................................................................................... 658,000 no change.
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![47834 Federal Register / Vol. 81, No. 141 / Friday, July 22, 2016 / Notices
Established Proposed
2016 revised 2016
Basic class quotas quotas
(g) (g)
Meperidine Intermediate-B ............................................................................................................................. 11 no change.
Meperidine Intermediate-C ............................................................................................................................. 6 no change.
Metazocine ...................................................................................................................................................... 19 no change.
Methadone (for sale) ...................................................................................................................................... 31,875,000 no change.
Methadone Intermediate ................................................................................................................................. 34,375,000 no change.
Methamphetamine .......................................................................................................................................... 2,061,375 no change.
[1,250,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 750,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 61,375 grams for methamphetamine (for sale)]
Methylphenidate .............................................................................................................................................. 96,750,000 84,375,000.
Morphine (for conversion) ............................................................................................................................... 91,250,000 no change.
Morphine (for sale) ......................................................................................................................................... 62,500,000 no change.
Nabilone .......................................................................................................................................................... 18,750 no change.
Noroxymorphone (for conversion) .................................................................................................................. 17,500,000 no change.
Noroxymorphone (for sale) ............................................................................................................................. 1,475,000 625,000.
Opium (powder) .............................................................................................................................................. 112,500 no change.
Opium (tincture) .............................................................................................................................................. 687,500 375,000.
Oripavine ......................................................................................................................................................... 30,000,000 no change.
Oxycodone (for conversion) ........................................................................................................................... 6,250,000 5,000,000.
Oxycodone (for sale) ...................................................................................................................................... 139,150,000 no change.
Oxymorphone (for conversion) ....................................................................................................................... 29,000,000 25,000,000.
Oxymorphone (for sale) .................................................................................................................................. 7,750,000 6,250,000.
Pentobarbital ................................................................................................................................................... 38,125,000 no change.
Phenazocine ................................................................................................................................................... 6 no change.
Phencyclidine .................................................................................................................................................. 50 no change.
Phenmetrazine ................................................................................................................................................ 3 no change.
Phenylacetone ................................................................................................................................................ 50 no change.
Racemethorphan ............................................................................................................................................ 3 5.
Racemorphan ................................................................................................................................................. 3 no change.
Remifentanil .................................................................................................................................................... 3,750 no change.
Secobarbital .................................................................................................................................................... 215,003 no change.
Sufentanil ........................................................................................................................................................ 6,255 no change.
Tapentadol ...................................................................................................................................................... 25,500,000 no change.
Thebaine ......................................................................................................................................................... 125,000,000 no change.
List I Chemicals
Ephedrine (for conversion) ............................................................................................................................. 100,000 50,000.
Ephedrine (for sale) ........................................................................................................................................ 4,000,000 no change.
Phenylpropanolamine (for conversion) ........................................................................................................... 22,400,000 15,000,000.
Phenylpropanolamine (for sale) ...................................................................................................................... 8,500,000 no change.
Pseudoephedrine (for conversion) ................................................................................................................. 7,000 40.
Pseudoephedrine (for sale) ............................................................................................................................ 224,500,000 200,000,000.
The Acting Administrator further established assessment of annual needs SUMMARY: In accordance with the
proposes that aggregate production for the list I chemicals ephedrine, provisions of the Federal Advisory
quotas for all other schedule I and II pseudoephedrine, and Committee Act, title 5, United States
controlled substances included in 21 phenylpropanolamine, 21 CFR Code, Appendix, and title 41 of the U.S.
CFR 1308.11 and 1308.12 remain at 1303.13(c) and 1315.13(f). Code of Federal Regulations, section
zero. In accordance with 21 CFR Dated: July 14, 2016. 101–6.1015, notice is hereby given that
1303.13 and 21 CFR 1315.13, upon Chuck Rosenberg, the Charter of the National Domestic
consideration of the relevant factors, the Acting Administrator.
Communications Assistance Center
Acting Administrator may adjust the (NDCAC) Executive Advisory Board
[FR Doc. 2016–17371 Filed 7–21–16; 8:45 am]
2016 aggregate production quotas and (EAB) has been renewed. The Charter is
BILLING CODE 4410–09–P
assessment of annual needs as needed. on file with the General Services
Administration. The Attorney General
Conclusion determined that the NDCAC EAB is in
DEPARTMENT OF JUSTICE
After consideration of any comments the public interest and is necessary in
connection with the performance of
ehiers on DSK5VPTVN1PROD with NOTICES
or objections, or after a hearing, if one Notice of Charter Renewal
is held, the Acting Administrator will duties of the United States Department
AGENCY: Justice Department. of Justice. These duties can best be
issue and publish in the Federal
ACTION: Notice of Charter Renewal of the performed through the advice and
Register a final order establishing any
Executive Advisory Board of the counsel of this group.
adjustment of 2016 aggregate production
National Domestic Communications
quota for each basic class of controlled The purpose of the EAB is to provide
Assistance Center.
substances in schedules I and II and advice and recommendations to the
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Document Created: 2016-07-22 02:38:24
Document Modified: 2016-07-22 02:38:24
| 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 1303.13(c) and 1315.13(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 47829 |
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