Rules and Regulations. Final order

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BILLING CODE 7020-02-P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-471F] Established 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 2018 AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final order. SUMMARY: This final order establishes the initial 2018 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

APPLICABLE DATE: Applicable November 8, 2017. FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone:

(202)598-6812. SUPPLEMENTARY INFORMATION: 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. Background The 2018 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 that may be manufactured in the United States in 2018 to provide for the estimated medical, scientific, research, 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. On August 7, 2017, a notice titled “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 2018” was published in the **Federal Register** . 82 FR 36830. This notice proposed the 2018 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2018 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All interested persons were invited to comment on or object to the proposed aggregate production quotas and the proposed assessment of annual needs on or before September 6, 2017. Comments Received Within the public comment period, the DEA received seventeen comments from three DEA-registered manufacturers regarding sixteen different schedule I and II controlled substances and one comment from a DEA-registered manufacturer regarding the proposed assessment of annual needs for the list I chemical phenylpropanolamine (for conversion). Commenters stated the proposed aggregate production quotas for 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, methylphenidate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, as well as the proposed assessment of annual needs for phenylpropanolamine (for conversion), were insufficient to provide for the estimated medical, scientific, research, and industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. These comments were considered in setting the final 2018 Aggregate Production Quotas as discussed below. In addition to these seventeen comments, the DEA received one comment from a DEA-registered manufacturer seeking clarification on whether DEA considers manufacturing at outsourcing facilities when determining the Aggregate Production Quotas. The DEA notes that it is the responsibility of all DEA-registered dosage form manufacturers to submit quota applications by April 1, in order for their individual business practices to be considered when the DEA proposes the Aggregate Production Quota for the following year. 21 CFR 1303.12(b). These quota applications and comments with discrete data regarding the quantities of the basic classes of schedule I or II controlled substances received during the comment period for the proposed Aggregate Production Quotas are taken into consideration before establishing the values presented in this Final Order. This DEA-registered manufacturer provided no quantitative data supporting the position that the proposed quota for 2018 will adversely impact outsourcing facilities for DEA to consider. The DEA also received one hundred five comments that expressed concern that DEA's proposed reduction of opioids by twenty percent would adversely impact the availability of pain relieving prescription drugs for people with chronic pain. These comments were general in nature, and raised issues of specific medical illnesses and medical treatment, and therefore are outside of the scope of this Final Order for 2018. As a result, these one hundred and six comments did not provide new discrete data for consideration, and do not impact the original analysis involved in establishing the 2018 aggregate production quotas. Determination of 2018 Aggregate Production Quotas and Assessment of Annual Needs In determining the 2018 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2017 manufacturing quotas, current 2017 sales and inventories, anticipated 2018 export requirements, industrial use, additional applications for 2018 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is adjusting the 2018 aggregate production quotas for 2-(4-bromo-2,5-dimethoxyphenyl)-n-(2-methoxybenzyl) ethanamine, 3,4,5-trimethoxy amphetamine, 4-bromo-2,5-dimethoxy-amphetamine, acryl fentanyl, alfentanil, amobarbital, methylphenidate, and nabilone, are warranted. Adjustment to the proposed assessment of annual needs for pseudoephedrine (for sale) was also determined to be warranted. This final order reflects those adjustments. Regarding 4-anilino-n-phenethyl-4-piperadine (ANPP), amphetamine (for conversion), codeine (for sale), diphenoxylate, fentanyl, gamma hydroxybutyric acid, hydrocodone (for sale), lisdexamfetamine, methadone, methadone-intermediate, morphine (for conversion), morphine (for sale), oxycodone (for sale), oxymorphone (for sale), sufentanil, and phenylpropanolamine (for conversion), the DEA has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2018 estimated medical, scientific, research, industrial needs of the United States, export requirements, and the establishment and maintenance of reserve stocks. This final order establishes these aggregate production quotas and assessment of annual needs at the same amounts as proposed. In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2018 aggregate production quotas for the following schedule I and II controlled substances and the 2018 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Basic class 2018 Established quotas

(g)Temporarily Scheduled Substances Acryl fentanyl 25 Schedule I 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-Benzylpiperazine 25 1-Methyl-4-phenyl-4-propionoxypiperidine 2 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) 30 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) 30 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 30 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 30 3-Methylthiofentanyl 30 4-Bromo-2,5-dimethoxyamphetamine

(DOB)30 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25 4-Fluoroisobutyryl fentanyl 30 4-FMC; Flephedrone 25 4-MEC; 4-Methyl-N-ethylcathinone 25 4-Methoxyamphetamine 150 4-Methyl-2,5-dimethoxyamphetamine

(DOM)25 4-Methylaminorex 25 4-Methyl-N-methylcathinone (mephedrone) 45 4-Methyl-α-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 5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 5F-AMB (methyl 2-(1-(5-fluoropentyl)-1 *H* -indazole-3-carboxamido)-3-methylbutanoate) 30 5F-APINACA; 5F-AKB48 ( *N* -(adamantan-1-yl)-1-(5-fluoropentyl)-1 *H* -indazole-3-carboxamide) 30 5-Fluoro-PB-22; 5F-PB-22 20 5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1 *H* indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25 5-Methoxy-3,4-methylenedioxyamphetamine 25 5-Methoxy-N,N-diisopropyltryptamine 25 5-Methoxy-N,N-dimethyltryptamine 25 AB-CHMINACA 30 AB-FUBINACA 50 AB-PINACA 30 ADB-FUBINACA ( *N* -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1 *H* -indazole-3-carboxamide) 30 Acetyl Fentanyl 100 Acetyl- *alpha* -methylfentanyl 30 Acetyldihydrocodeine 30 Acetylmethadol 2 Acryl Fentanyl 25 ADB-PINACA ( *N* -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1 *H* -indazole-3-carboxamide) 50 AH-7921 30 Allylprodine 2 Alphacetylmethadol 2 *alpha-* Ethyltryptamine 25 Alphameprodine 2 Alphamethadol 2 *alpha* -Methylfentanyl 30 *alpha* -Methylthiofentanyl 30 *alpha* -Methyltryptamine

(AMT)25 *alpha* -Pyrrolidinobutiophenone (α-PBP) 25 *alpha* -Pyrrolidinopentiophenone (α-PVP) 25 Aminorex 25 APINCA, AKB48 ( *N* -(1-adamantyl)-1-pentyl-1 *H* -indazole-3-carboxamide) 25 Benzylmorphine 30 Betacetylmethadol 2 *beta* -Hydroxy-3-methylfentanyl 30 *beta* -Hydroxyfentanyl 30 *beta* -Hydroxythiofentanyl 30 Betameprodine 2 Betamethadol 4 Betaprodine 2 Bufotenine 3 Butylone 25 Butyryl fentanyl 30 Cathinone 24 Codeine methylbromide 30 Codeine-N-oxide 192 Desomorphine 25 Diethyltryptamine 25 Difenoxin 8,225 Dihydromorphine 1,000,160 Dimethyltryptamine 35 Dipipanone 5 Etorphine 30 Fenethylline 30 Furanyl fentanyl 30 *gamma* -Hydroxybutyric acid 37,130,000 Heroin 45 Hydromorphinol 40 Hydroxypethidine 2 Ibogaine 30 JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) 35 JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) 45 JWH-073 (1-Butyl-3-(1-naphthoyl)indole) 45 JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) 30 JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) 30 JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) 35 JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) 30 JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) 30 JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) 30 Lysergic acid diethylamide

(LSD)40 MAB-CHMINACA; ADB-CHMINACA ( *N* -(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1 *H* -indazole-3-carboxamide) 30 MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1 *H* -indole-3-carboxamido)-3,3-dimethylbutanoate) 30 MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1 *H* -indazole-3-carboxamido)-3,3-dimethylbutanoate) 30 Marihuana 443,680 Mecloqualone 30 Mescaline 25 Methaqualone 60 Methcathinone 25 Methyldesorphine 5 Methyldihydromorphine 2 Morphine methylbromide 5 Morphine methylsulfonate 5 Morphine-N-oxide 150 *N,N* -Dimethylamphetamine 25 Naphyrone 25 *N* -Ethyl-1-phenylcyclohexylamine 5 *N* -Ethylamphetamine 24 *N* -Hydroxy-3,4-methylenedioxyamphetamine 24 Noracymethadol 2 Norlevorphanol 55 Normethadone 2 Normorphine 40 Para-fluorofentanyl 25 Parahexyl 5 PB-22; QUPIC 20 Pentedrone 25 Pentylone 25 Phenomorphan 2 Pholcodine 5 Psilocybin 30 Psilocyn 50 SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) 45 SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30 Tetrahydrocannabinols 384,460 Thiofentanyl 25 THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 30 Tilidine 25 Trimeperidine 2 UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25 U-47700 30 Schedule II 1-Phenylcyclohexylamine 4 1-Piperidinocyclohexanecarbonitrile 4 4-Anilino-N-phenethyl-4-piperidine

(ANPP)1,342,320 Alfentanil 6,200 Alphaprodine 2 Amobarbital 20,100 Amphetamine (for conversion) 11,280,000 Amphetamine (for sale) 39,856,000 Carfentanil 20 Cocaine 92,120 Codeine (for conversion) 15,040,000 Codeine (for sale) 40,015,800 Dextropropoxyphene 35 Dihydrocodeine 264,140 Dihydroetorphine 2 Diphenoxylate (for conversion) 14,100 Diphenoxylate (for sale) 770,800 Ecgonine 88,134 Ethylmorphine 30 Etorphine hydrochloride 32 Fentanyl 1,342,320 Glutethimide 2 Hydrocodone (for conversion) 114,680 Hydrocodone (for sale) 50,348,280 Hydromorphone 4,547,720 Isomethadone 30 Levo-alphacetylmethadol

(LAAM)5 Levomethorphan 30 Levorphanol 12,126 Lisdexamfetamine 17,869,000 Meperidine 2,717,540 Meperidine Intermediate-A 5 Meperidine Intermediate-B 30 Meperidine Intermediate-C 5 Metazocine 15 Methadone (for sale) 22,278,000 Methadone Intermediate 24,064,000 Methamphetamine 1,446,754 [846,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 564,000 grams for methamphetamine mostly for conversion to a schedule III product; and 36,754 grams for methamphetamine (for sale)] Methylphenidate 64,600,000 Morphine (for conversion) 4,089,000 Morphine (for sale) 33,958,440 Nabilone 31,000 Noroxymorphone (for conversion) 14,044,540 Noroxymorphone (for sale) 376,000 Opium (powder) 84,600 Opium (tincture) 564,000 Oripavine 24,534,000 Oxycodone (for conversion) 2,453,400 Oxycodone (for sale) 95,692,000 Oxymorphone (for conversion) 20,962,000 Oxymorphone (for sale) 3,395,280 Pentobarbital 25,850,000 Phenazocine 5 Phencyclidine 35 Phenmetrazine 25 Phenylacetone 40 Racemethorphan 5 Racemorphan 5 Remifentanil 2,820 Secobarbital 161,682 Sufentanil 1,880 Tapentadol 18,388,280 Thebaine 94,000,000 List I Chemicals Ephedrine (for conversion) 47,000 Ephedrine (for sale) 4,136,000 Phenylpropanolamine (for conversion) 14,100,000 Phenylpropanolamine (for sale) 7,990,000 Pseudoephedrine (for conversion) 40 Pseudoephedrine (for sale) 180,000,000 The Administrator also establishes aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2018 aggregate production quotas and assessment of annual needs as needed. Dated: November 1, 2017. Robert W. Patterson, Acting Administrator. [FR Doc. 2017-24306 Filed 11-7-17; 8:45 am]

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