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 2019, 67348-67354 [2018-28108]

Download as PDF 67348 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices inspection at the Office of the Secretary and on EDIS. The authority for the Commission’s determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission’s Rules of Practice and Procedure (19 CFR part 210). By order of the Commission. Issued: December 20, 2018. Lisa Barton, Secretary to the Commission. [FR Doc. 2018–28175 Filed 12–27–18; 8:45 am] BILLING CODE 7020–02–P JUDICIAL CONFERENCE OF THE UNITED STATES Hearing of the Judicial Conference Advisory Committee on the Federal Rules of Evidence The Advisory Committee on the Federal Rules of Evidence, Judicial Conference of the United States. ACTION: Notice of cancellation of public hearing. AGENCY: The January 18, 2019 public hearing in Washington, DC, on proposed amendments to the Evidence Rules has been canceled. FOR FURTHER INFORMATION CONTACT: Rebecca A. Womeldorf, Rules Committee Secretary, Rules Committee Staff, Administrative Office of the United States Courts, Washington, DC 20544, telephone (202) 502–1820. SUPPLEMENTARY INFORMATION: Announcements for this hearing were previously published in 83 FR 39463 and 83 FR44305. SUMMARY: Dated: December 20, 2018. Rebecca A. Womeldorf, Rules Committee Secretary. [FR Doc. 2018–28160 Filed 12–27–18; 8:45 am] BILLING CODE 2210–55–P DEPARTMENT OF JUSTICE Drug Enforcement Administration amozie on DSK3GDR082PROD with NOTICES1 [Docket No. DEA–488E] 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 2019 Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 This final order establishes the initial 2019 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. DATES: Valid December 28, 2018. FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Regulatory Drafting and Policy Support Section (DPW), Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (202) 598–6812. SUPPLEMENTARY INFORMATION: SUMMARY: 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 2019 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 2019 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 include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes. On August 20, 2018, the DEA published 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 2019’’ in the Federal Register. 83 FR 42164. This notice proposed the 2019 aggregate production quotas for each basic class of controlled substance listed in schedules I and II and the 2019 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All interested PO 00000 Frm 00138 Fmt 4703 Sfmt 4703 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 19, 2018. Comments Received The DEA received 48 comments from professional organizations, patients, associations, universities, Senators, State Attorneys General, a doctor, DEA registered entities, and non-DEA entities. The comments included concerns about the quota process, shortages, prescriptions, diversion, marihuana, requests for a hearing, requests for increase in specific production quotas, and other comments that are outside the scope of the notice. Quota Process There were eight commenters that expressed concerns about the quota process. Some of these commenters requested that the DEA consider information from the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) to determine the aggregate production quota. Other commenters stated that the DEA did not consider the factors contained in the Controlled Substances Quotas Final Rule published on July 16, 2018, 83 FR 32784, to determine the 2019 aggregate production quota. The DEA has obtained and considered relevant information from the FDA. The information the DEA received included the observed and estimated domestic usage of 26 schedule II controlled substances, new drug applications and abbreviated drug application approvals, and clinical trials for schedule I and II controlled substances. Regarding the Final Rule published on July 16, 2018, 83 FR 32784, the DEA amended the factors set forth in 21 CFR 1303.11 to be considered when setting the aggregate production quotas to include the extent of diversion of the controlled substances in each class, and relevant information obtained from the HHS, the FDA, the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the states. The DEA has solicited the states and federal partners to obtain relevant information to be considered when setting the aggregate production quota pursuant to 21 CFR 1303.11 and this information will be considered for the 2019 proposed adjustments to the aggregate production quota. The DEA will continue to solicit information from the states for the 2020 aggregate production quotas and the years to follow. E:\FR\FM\28DEN1.SGM 28DEN1 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices However, the DEA is obligated to issue individual production and procurement quotas sufficiently in advance of the upcoming year to allow manufacturers to prepare for the legitimate needs of the United States. The DEA may not issue individual production and procurement quotas until the aggregate production quotas have been established. As a result of these obligations under the CSA, the DEA was not able to obtain and consider the amended factors set forth in Final Rule, 83 FR 32784, for the purpose of issuing the 2019 proposed aggregate production quota. The DEA has a fluid process for setting quotas which allows the agency to make necessary quota adjustments. The process involves setting the proposed aggregate production quotas for a calendar year, and, following the review of any comments, the issuance of a Final Order to establish the aggregate production quota. Later in the process, the DEA issues a Proposed Adjustment to the aggregate production quota, and following the review of any comments, DEA issues a final order setting the Final Adjusted Aggregate Production Quotas. The DEA will consider the additional information received in the course of preparing proposed amendments and the final 2019 adjusted aggregate production quota. amozie on DSK3GDR082PROD with NOTICES1 Shortages There were 28 commenters that expressed concerns about the decrease in certain aggregate production quotas. These commenters alleged that decreases to the aggregate production quotas have resulted in a shortage of injectable opioid medications and interfere with the treatment of patients. Some of these commenters also suggested that the DEA separate quotas for solid oral controlled substances and injectable controlled substances, and that DEA allow consideration by individual pharmaceutical dosage forms. The DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet legitimate medical, scientific, and export needs of the United States. Although the DEA sets the aggregate production quota, it is possible that manufacturers’ business practices may lead to a shortage of controlled substances at the consumer level, despite the adequacy of the aggregate production quota set by DEA. The aggregate production quotas are set by the DEA in a manner to include both injectable opioids and solid oral opioids in order to ensure that the estimated VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 medical needs of the United States are met. Notably, at the time of the proposed aggregate production quota, 21 U.S.C. 826(a) provided that ‘‘production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.’’ On October 24, 2018, the President signed into law the SUPPORT for Patients and Communities Act of 2018, (Pub. L. 115–271), which now allows but does not require the DEA to grant quotas in terms of dosage forms if the agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance. DEA will be evaluating these issues over time. Furthermore, the DEA and the FDA can coordinate efforts to prevent or alleviate drug shortages pursuant to 21 U.S.C. 826a(2). For example, the asserted domestic shortage of injectable controlled substances was alleviated through the FDA and the DEA collaboration to get specific injectable controlled substances imported into the United States. Transparency Two Senators submitted a joint comment supporting the DEA’s efforts to address the opioid crisis, but expressed concerns that the aggregate production quota for schedule II opioids remains too high. These commenters also requested a transparent explanation of the analysis and specific considerations that the DEA considered when establishing the 2019 quotas for schedule II opioids. The DEA continues to address the opioid crisis through initiatives such as the President’s Safer Prescribing Plan, which seeks to reduce nationwide opioid prescription fills by one-third within three years. The DEA has observed a decline in the number of prescriptions written for schedule II opioids since 2014 and will continue to set aggregate production quotas to meet the medical needs of the United States while combating the opioid crisis. In determining the aggregate production quota, the DEA took into account the data regarding the number of prescriptions that have been issued and an analysis of the factors as then set forth in 21 CFR 1303.11. The specific information that was obtained and considered included an analysis of sales data from databases such as Automation of Reports and Consolidated Orders System (ARCOS) and IQVIA; in addition to FDA forecasts and projections, historical total market sales data, PO 00000 Frm 00139 Fmt 4703 Sfmt 4703 67349 products entering and exiting the market, expected product development, expected exports, inventory data, theft and loss data, and company forecasts. As a result, the final aggregate production quota for several opioids are decreased from the proposed initial 2019 levels. These decreases take into account the combined efforts of the the DEA, the FDA, and the CDC enforcing regulations and issuing guidance documents as well as many states enacting prescription monitoring database programs to stem the opiate/ opioid epidemic. Quotas and Prescriptions Eleven State Attorneys General submitted a joint comment recognizing DEA’s efforts to combat the opioid epidemic and expressed concerns about excessive quotas for opioids. These commenters also expressed concerns about overprescribing and referenced various studies. The referenced material cited in these comments also discuss patients who divert their prescriptions by sharing their prescriptions with others. The DEA continues to address the opioid crisis through laws, regulations, and initiatives such as the Safer Prescribing Plan. The Safer Prescribing Plan seeks to reduce nationwide opioid prescription fills by one-third within three years. The DEA has observed a decline for certain prescriptions written for schedule II opioids since 2014 which can be attributed to federal and state government activities and interventions, including the implementation of Prescription Drug Monitoring Programs, enforcement of current regulations, and guidance documents such as the CDC Guidelines for Prescribing Opioids for Chronic Pain—United States, March 2016. The DEA will continue to address the opioid crisis while ensuring an adequate and uninterrupted supply of controlled substances in order to meet the demand of legitimate medical, scientific, and export needs of the United States. The DEA sets aggregate production quotas in a manner to ensure that all prescriptions that are authorized for legitimate medical purposes can be filled. Prescribers who are authorized to dispense controlled substances are responsible for adhering to the laws and regulations set forth under the CSA, which requires doctors to only write prescriptions for legitimate medical needs. Any practitioner issuing an invalid prescription for controlled substances and any pharmacy filling such a prescription would be in violation of the CSA. E:\FR\FM\28DEN1.SGM 28DEN1 67350 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices Upon review of the studies, DEA has determined that they are insufficient to support a reduction in the aggregate production quotas. The studies have found, with respect to a variety of medical procedures, that physicians prescribe more controlled substances for post-operative pain than the patients utilize. However, the DEA has concluded that while the referenced studies are concerning, they are insufficient to support a determination as to the level of overprescribing that occurs across the range of the medical procedures that are performed each year on a national basis. amozie on DSK3GDR082PROD with NOTICES1 Including Diversion in Quotas Eleven State Attorneys General and three other commenters expressed concerns about DEA’s ability to account for diversion when setting the aggregate production quotas. The factors that DEA considers in setting the aggregate production quotas were amended in a Final Rule published on July 16, 2018, 83 FR 32784, to include the extent of any diversion of the controlled substances in the class, which will strengthen DEA’s ability to reduce the likelihood of the diversion of controlled substances. When setting the established aggregate production quota, the DEA accounted for diversion by analyzing information such as, reports of controlled substance thefts and losses, and seizure data that are captured through internal DEA databases and will continue to do so when setting future aggregate production quotas. The DEA will also consider information obtained from CMS, CDC, FDA, and the states which may include diversion data to be considered for the adjusted aggregate production quota. Marihuana Seven commenters expressed their support for the increase in the production quota of marihuana. Three of those commenters expressed concerns about approval of applications for registration to manufacture (grow) marihuana. The DEA increased the production quota for marihuana based solely on increased usage projections for federally approved research projects. The DEA continues to review applications for registration and registers the number of bulk manufacturers of a controlled substance that is necessary to produce an adequate and uninterrupted supply. Hearings Two commenters urged DEA to hold a public hearing. One of the commenters stated that the DEA should have a VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 hearing to gather stakeholder feedback on how the DEA can help address the opioid epidemic while ensuring an adequate supply of opioids for clinically appropriate care. The second commenter stated that the DEA should hold a hearing to enable stakeholders to express their views about the proposed reductions. Under the DEA regulations, the decision of whether to grant this type of a hearing on the issues raised by the commenters lies solely within the discretion of the Administrator. (21 CFR 1303.11(c) and 21 CFR 1303.13 (c)). I find that neither of the foregoing two requests presented any evidence that would lead me to conclude that a hearing is necessary or warranted. Therefore, I decline to order a hearing on the issues presented by the commenters. Specific Quota for DEA-Registered Manufacturers The DEA received comments from four DEA-registered manufacturers regarding thirty-three different schedule I and II controlled substances. These commenters stated the proposed aggregate production quotas for 3methyl fentanyl, 4–ANPP, acetyl fentanyl, acryl fentanyl, betahydroxythiofentanyl, butyrl fentanyl, carfentanil, cyclopentyl fentanyl, cyclopropyl fentanyl, d-amphetamine (for sale), d,l-amphetamine, difenoxylate (for sale), fentanyl, fentanyl related substances, furanyl fentanyl, gamma hydroxybutyric acid, isobytyryl fentanyl, levorphanol, methoxyacetyl fentanyl, noroxymorphone (for conversion), ocfentanil, opium (powder), oxycodone (for sale), parachloroisobutyryl fentanyl, parafluorofentanyl, para-fluorobutyryl fentanyl, para-methyoxybutyrl fentanyl, remifentanil, sufentanil, tetrahydrofuranyl fentanyl, thebaine, U– 47700, and valeryl fentanyl were potentially 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. The DEA has considered the comments for specific controlled substances and made adjustments as needed which are described below in the section titled Determination of 2019 Aggregate Production Quotas and Assessment of Annual Needs. The DEA did not receive any comments to the proposed established 2019 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine. PO 00000 Frm 00140 Fmt 4703 Sfmt 4703 Out of Scope The DEA received seven comments which addressed issues that are outside the scope of this final order. The comments were general in nature and raised issues of specific medical illnesses, medical treatments, and medication costs and, therefore, are outside of the scope of this Final Order, and do not impact the original analysis involved in establishing the 2019 aggregate production quotas. Determination of 2019 Aggregate Production Quotas and Assessment of Annual Needs In determining the 2019 aggregate production quotas and assessment of annual needs, the DEA has taken into consideration the above comments along with the factors previously set forth in 21 CFR 1303.11 (as described above) and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2018 manufacturing quotas, current 2018 sales and inventories, anticipated 2019 export requirements, industrial use, additional applications for 2019 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is establishing the 2019 aggregate production quotas. These quotas are lower for codeine (for sale), codeine (for conversion), hydrocodone (for sale), morphine (for sale), and oxycodone (for sale); higher for cyclopentyl fentanyl, methoxyacetyl fentanyl, N-ethlypentylone (ephylone), para-methyoxybutyryl fentanyl, and para-chloroisobutyryl fentanyl due to their temporarily controlled status; higher for amphetamine (for conversion) based on increased usage forecasted by the FDA and its use in the treatment of Attention Deficit Hyperactivity Disorder; higher for levorphanol based on manufacturers’ ongoing product development activities necessary for the FDA approval process; and higher for opium powder and sufentanil based on manufacturers’ projected exports. Regarding 3-methylfentanyl, 4–ANPP, acetyl fentanyl, acryl fentanyl, betahydroxythiofentanyl, butyryl fentanyl, carfentanil, cyclopropyl fentanyl, damphetamine (for sale), d,lamphetamine, difenoxylate (for sale), fentanyl, fentanyl related substances, furanyl fentanyl, gamma hydroxybutyric acid, isobutyryl fentanyl, noroxymorphone (for conversion), ocfentanil, para-fluorofentanyl, parafluorobutyrl fentanyyl, remifentanil, tetrahydrofuranyl fentanyl, thebaine, U– 47700, and valeryl fentanyl, the DEA E:\FR\FM\28DEN1.SGM 28DEN1 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2019 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 2019 aggregate production quotas for the 67351 following schedule I and II controlled substances and the 2019 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Established 2019 quotas (g) Basic class amozie on DSK3GDR082PROD with NOTICES1 Schedule I 1-[1-(2-Thienyl)cyclohexyl]pyrrolidine .............................................................................................................................................. 1-(1-Phenylcyclohexyl)pyrrolidine .................................................................................................................................................... 1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine .............................................................................................................................. 1-(5-Fluoropentyl)-3-(1-naphthoyl) indole (AM2201) ....................................................................................................................... 1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole (AM–694) ................................................................................................................... 1-Benzylpiperazine .......................................................................................................................................................................... 1-Methyl-4-phenyl-4-propionoxypiperidine ....................................................................................................................................... 1-[1-(2-Thienyl)cyclohexyl]piperidine ............................................................................................................................................... 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) ....................................................................................................................... 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) .................................................................................................................... 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) ...................................................................................................................... 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P) ............................................................................................................... 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) ................................................................................................................................... 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) ................... 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) .................................................................................................................... 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) .................... 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) .......................................................................................................................... 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) ............................. 2,5-Dimethoxy-4-ethylamphetamine (DOET) .................................................................................................................................. 2,5-Dimethoxy-4-(n)-propylthiophenethylamine ............................................................................................................................... 2,5-Dimethoxyamphetamine ............................................................................................................................................................ 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) ............................................................................................................ 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) ...................................................................................................... 3,4,5-Trimethoxyamphetamine ........................................................................................................................................................ 3,4-Methylenedioxyamphetamine (MDA) ........................................................................................................................................ 3,4-Methylenedioxymethamphetamine (MDMA) ............................................................................................................................. 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) ......................................................................................................................... 3,4-Methylenedioxy-N-methylcathinone (methylone) ...................................................................................................................... 3,4-Methylenedioxypyrovalerone (MDPV) ....................................................................................................................................... 3-FMC; 3-Fluoro-N-methylcathinone ............................................................................................................................................... 3-Methylfentanyl ............................................................................................................................................................................... 3-Methylthiofentanyl ......................................................................................................................................................................... 4-Bromo-2,5-dimethoxyamphetamine (DOB) .................................................................................................................................. 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) .............................................................................................................................. 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboximide ........................................................................................... 4-Fluoroisobutyryl fentanyl ............................................................................................................................................................... 4-FMC; Flephedrone ........................................................................................................................................................................ 4-MEC; 4-Methyl-N-ethylcathinone .................................................................................................................................................. 4-Methoxyamphetamine .................................................................................................................................................................. 4-Methyl-2,5-dimethoxyamphetamine (DOM) .................................................................................................................................. 4-Methylaminorex ............................................................................................................................................................................ 4-Methyl-N-methylcathinone (mephedrone) .................................................................................................................................... 4-Methyl-a-pyrrolidinopropiophenone (4-MePPP) ........................................................................................................................... 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol ..................................................................................................... 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) ....................... N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide .................................................................. 1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide ................................................................... 5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ........................ 5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) ............................................................... 5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) .................................................... 5-Fluoro-PB-22; 5F-PB-22 ............................................................................................................................................................... 5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol- ................................................................................................................... 3-yl](2,2,3,3-tetramethylcyclopropyl)methanone .............................................................................................................................. 5-Methoxy-3,4-methylenedioxyamphetamine .................................................................................................................................. 5-Methoxy-N-N-diisopropyltryptamine ............................................................................................................................................. 5-Methoxy-N-N-dimethyltryptamine ................................................................................................................................................. AB-CHMINACA ................................................................................................................................................................................ AB-FUBINACA ................................................................................................................................................................................. AB-PINACA ...................................................................................................................................................................................... ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) .............................. Acetyl Fentanyl ................................................................................................................................................................................ VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 PO 00000 Frm 00141 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 20 15 10 30 30 25 10 15 30 30 30 30 30 30 30 25 30 30 25 25 25 30 30 30 55 50 40 40 35 25 30 30 30 25 25 30 25 25 150 25 25 45 25 50 40 25 25 30 30 30 20 25 25 25 25 30 50 30 30 100 67352 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices Established 2019 quotas (g) amozie on DSK3GDR082PROD with NOTICES1 Basic class Acetyl-alpha-methylfentanyl ............................................................................................................................................................. Acetyldihydrocodeine ....................................................................................................................................................................... Acetylmethadol ................................................................................................................................................................................ Acryl Fentanyl .................................................................................................................................................................................. ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) .................................................. AH-7921 ........................................................................................................................................................................................... Allylprodine ...................................................................................................................................................................................... Alphacetylmethadol .......................................................................................................................................................................... alpha-Ethyltryptamine ...................................................................................................................................................................... Alphameprodine ............................................................................................................................................................................... Alphamethadol ................................................................................................................................................................................. alpha-Methylfentanyl ........................................................................................................................................................................ alpha-Methylthiofentanyl .................................................................................................................................................................. alpha-Methyltryptamine (AMT) ........................................................................................................................................................ alpha-Pyrrolidinobutiophenone (a-PBP) .......................................................................................................................................... alpha-Pyrrolidinopentiophenone (a-PVP) ........................................................................................................................................ Aminorex .......................................................................................................................................................................................... Anileridine ........................................................................................................................................................................................ APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ................................................................................... Benzylmorphine ............................................................................................................................................................................... Betacetylmethadol ........................................................................................................................................................................... beta-Hydroxy-3-methylfentanyl ........................................................................................................................................................ beta-Hydroxyfentanyl ....................................................................................................................................................................... beta-Hydroxythiofentanyl ................................................................................................................................................................. Betameprodine ................................................................................................................................................................................. Betamethadol ................................................................................................................................................................................... Betaprodine ...................................................................................................................................................................................... Bufotenine ........................................................................................................................................................................................ Butylone ........................................................................................................................................................................................... Butyryl Fentanyl ............................................................................................................................................................................... Cathinone ......................................................................................................................................................................................... Codeine methylbromide ................................................................................................................................................................... Codeine-N-oxide .............................................................................................................................................................................. Cyclopentyl Fentanyl ....................................................................................................................................................................... Cyclopropyl Fentanyl ....................................................................................................................................................................... Desomorphine .................................................................................................................................................................................. Diampromide .................................................................................................................................................................................... Diethylthiambutene .......................................................................................................................................................................... Diethyltryptamine ............................................................................................................................................................................. Difenoxin .......................................................................................................................................................................................... Dihydromorphine .............................................................................................................................................................................. Dimethyltryptamine .......................................................................................................................................................................... Dipipanone ....................................................................................................................................................................................... Etorphine .......................................................................................................................................................................................... Fenethylline ...................................................................................................................................................................................... Fentanyl related substances ............................................................................................................................................................ Furanyl Fentanyl .............................................................................................................................................................................. gamma-Hydroxybutyric acid ............................................................................................................................................................ Heroin .............................................................................................................................................................................................. Hydromorphinol ................................................................................................................................................................................ Hydroxypethidine ............................................................................................................................................................................. Ibogaine ........................................................................................................................................................................................... Isobutyryl Fentanyl ........................................................................................................................................................................... JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) .................................................................................................................. JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) ....................................................................................................................................... JWH-073 (1-Butyl-3-(1-naphthoyl)indole) ........................................................................................................................................ JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl))indole) ................................................................................................................... JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) ....................................................................................................................... JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) ........................................................................................................... JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) ........................................................................................................................ JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) .................................................................................................................... JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) ........................................................................................................................ Lysergic acid diethylamide (LSD) .................................................................................................................................................... MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3carboxamide) ................................................................................................................................................................................ MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) ............. MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) ....................................... Methyl2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................................................................... Marihuana ........................................................................................................................................................................................ Mecloqualone ................................................................................................................................................................................... Mescaline ......................................................................................................................................................................................... Methaqualone .................................................................................................................................................................................. VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 PO 00000 Frm 00142 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 30 30 2 25 50 30 2 2 25 2 2 30 30 25 25 25 25 20 25 30 2 30 30 30 2 4 2 3 25 30 24 30 192 30 20 25 20 20 25 8,225 753,500 50 5 30 30 25 30 33,417,000 45 40 2 30 25 35 45 45 30 30 35 30 30 30 40 30 30 30 25 2,450,000 30 25 60 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices 67353 Established 2019 quotas (g) Basic class Methcathinone ................................................................................................................................................................................. Methoxyacetyl Fentanyl ................................................................................................................................................................... Methyldesorphine ............................................................................................................................................................................. Methyldihydromorphine .................................................................................................................................................................... Morphine methylbromide ................................................................................................................................................................. Morphine methylsulfonate ................................................................................................................................................................ Morphine-N-oxide ............................................................................................................................................................................ Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-carboxylate .............................................................................................................. N,N-Dimethylamphetamine .............................................................................................................................................................. Naphyrone ....................................................................................................................................................................................... N-Ethyl-1-phenylcyclohexylamine .................................................................................................................................................... N-Ethyl-3-piperidyl benzilate ............................................................................................................................................................ N-Ethylamphetamine ....................................................................................................................................................................... N-Ethylpentylone (ephylone) ........................................................................................................................................................... N-Hydroxy-3,4-methylenedioxyamphetamine .................................................................................................................................. Noracymethadol ............................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................................. Normethadone ................................................................................................................................................................................. Normorphine .................................................................................................................................................................................... Ocfentanil ......................................................................................................................................................................................... Ortho-parafluorofentanyl .................................................................................................................................................................. Para-chlorisobutyrl Fentanyl ............................................................................................................................................................ Para-flourobutyryl Fentanyl .............................................................................................................................................................. Para-fluorofentanyl ........................................................................................................................................................................... Para-methoxybutyrl Fentanyl ........................................................................................................................................................... Parahexyl ......................................................................................................................................................................................... PB-22; QUPIC ................................................................................................................................................................................. Pentedrone ...................................................................................................................................................................................... Pentylone ......................................................................................................................................................................................... Phenomorphan ................................................................................................................................................................................ Pholcodine ....................................................................................................................................................................................... Psilocybin ......................................................................................................................................................................................... Psilocyn ............................................................................................................................................................................................ SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) ....................................................................................... SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) .......................................................................................................... Tetrahydrocannabinols .................................................................................................................................................................... Tetrahydrofuranyl fentanyl ............................................................................................................................................................... Thiofentanyl ..................................................................................................................................................................................... THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) ................................................................................ Tilidine .............................................................................................................................................................................................. Trimeperidine ................................................................................................................................................................................... UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .................................................................................. U-47700 ........................................................................................................................................................................................... Valeryl fentanyl ................................................................................................................................................................................ 25 30 5 2 5 5 150 25 25 25 5 10 24 30 24 2 55 2 40 25 30 30 25 25 30 5 20 25 25 2 5 30 50 45 30 384,460 5 25 30 25 2 25 30 25 amozie on DSK3GDR082PROD with NOTICES1 Schedule II 1-Phenylcyclohexylamine ................................................................................................................................................................ 1-Piperidinocyclohexanecarbonitrile ................................................................................................................................................ 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................................... Alfentanil .......................................................................................................................................................................................... Alphaprodine .................................................................................................................................................................................... Amobarbital ...................................................................................................................................................................................... Amphetamine (for conversion) ........................................................................................................................................................ Amphetamine (for sale) ................................................................................................................................................................... Carfentanil ........................................................................................................................................................................................ Cocaine ............................................................................................................................................................................................ Codeine (for conversion) ................................................................................................................................................................. Codeine (for sale) ............................................................................................................................................................................ Dextropropoxyphene ........................................................................................................................................................................ Dihydrocodeine ................................................................................................................................................................................ Dihydroetorphine .............................................................................................................................................................................. Diphenoxylate (for conversion) ........................................................................................................................................................ Diphenoxylate (for sale) ................................................................................................................................................................... Ecgonine .......................................................................................................................................................................................... Ethylmorphine .................................................................................................................................................................................. Etorphine hydrochloride ................................................................................................................................................................... Fentanyl ........................................................................................................................................................................................... Glutethimide ..................................................................................................................................................................................... Hydrocodone (for conversion) ......................................................................................................................................................... Hydrocodone (for sale) .................................................................................................................................................................... Hydromorphone ............................................................................................................................................................................... VerDate Sep<11>2014 18:13 Dec 27, 2018 Jkt 247001 PO 00000 Frm 00143 Fmt 4703 Sfmt 4703 E:\FR\FM\28DEN1.SGM 28DEN1 15 25 1,185,000 6,200 2 20,100 12,700,000 42,400,000 20 92,120 12,900,000 36,114,260 35 238,466 2 14,100 770,800 88,134 30 32 1,185,000 2 5,000 43,027,640 4,071,000 67354 Federal Register / Vol. 83, No. 248 / Friday, December 28, 2018 / Notices Established 2019 quotas (g) Basic class Isomethadone .................................................................................................................................................................................. Levo-alphacetylmethadol (LAAM) .................................................................................................................................................... Levomethorphan .............................................................................................................................................................................. Levorphanol ..................................................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................................ Meperidine ....................................................................................................................................................................................... Meperidine Intermediate-A .............................................................................................................................................................. Meperidine Intermediate-B .............................................................................................................................................................. Meperidine Intermediate-C .............................................................................................................................................................. Metazocine ....................................................................................................................................................................................... Methadone (for sale) ....................................................................................................................................................................... Methadone Intermediate .................................................................................................................................................................. Methamphetamine ........................................................................................................................................................................... 30 5 4,000 38,000 19,000,000 1,580,000 30 30 30 15 22,278,000 24,064,000 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 ............................................................................................................................................................................... Morphine (for conversion) ................................................................................................................................................................ Morphine (for sale) .......................................................................................................................................................................... Nabilone ........................................................................................................................................................................................... Noroxymorphone (for conversion) ................................................................................................................................................... Noroxymorphone (for sale) .............................................................................................................................................................. Opium (powder) ............................................................................................................................................................................... Opium (tincture) ............................................................................................................................................................................... Oripavine .......................................................................................................................................................................................... Oxycodone (for conversion) ............................................................................................................................................................ Oxycodone (for sale) ....................................................................................................................................................................... Oxymorphone (for conversion) ........................................................................................................................................................ Oxymorphone (for sale) ................................................................................................................................................................... Pentobarbital .................................................................................................................................................................................... Phenazocine .................................................................................................................................................................................... Phencyclidine ................................................................................................................................................................................... Phenmetrazine ................................................................................................................................................................................. Phenylacetone ................................................................................................................................................................................. Racemethorphan ............................................................................................................................................................................. Racemorphan .................................................................................................................................................................................. Remifentanil ..................................................................................................................................................................................... Secobarbital ..................................................................................................................................................................................... Sufentanil ......................................................................................................................................................................................... Tapentadol ....................................................................................................................................................................................... Thebaine .......................................................................................................................................................................................... 64,600,000 4,089,000 29,353,676 62,000 19,169,340 376,000 250,000 530,837 28,705,000 2,081,000 79,596,606 24,525,540 2,880,000 25,850,000 5 35 25 40 5 5 3,000 172,100 4,000 18,388,280 84,600,000 List I Chemicals amozie on DSK3GDR082PROD with NOTICES1 Ephedrine (for conversion) .............................................................................................................................................................. Ephedrine (for sale) ......................................................................................................................................................................... Phenylpropanolamine (for conversion) ............................................................................................................................................ Phenylpropanolamine (for sale) ....................................................................................................................................................... Pseudoephedrine (for conversion) .................................................................................................................................................. Pseudoephedrine (for sale) ............................................................................................................................................................. 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 2019 aggregate production quotas and assessment of annual needs as needed. Dated: December 20, 2018. Uttam Dhillon, Acting Administrator. BILLING CODE 4410–09–P 18:13 Dec 27, 2018 Employment and Training Administration Agency Information Collection Activities; Comment Request; Transmittal for Unemployment Insurance Materials ACTION: Notice. The Department of Labor’s (DOL’s), Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct SUMMARY: [FR Doc. 2018–28108 Filed 12–27–18; 8:45 am] VerDate Sep<11>2014 DEPARTMENT OF LABOR Jkt 247001 PO 00000 Frm 00144 Fmt 4703 Sfmt 4703 25 4,136,000 14,100,000 7,990,000 1,000 174,246,000 the information collection request (ICR) titled, ‘‘Transmittal for Unemployment Insurance Materials.’’ This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA). DATES: Consideration will be given to all written comments received by February 26, 2019. ADDRESSES: A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, E:\FR\FM\28DEN1.SGM 28DEN1

Agencies

[Federal Register Volume 83, Number 248 (Friday, December 28, 2018)]
[Notices]
[Pages 67348-67354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-28108]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-488E]


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 2019

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This final order establishes the initial 2019 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.

DATES: Valid December 28, 2018.

FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Regulatory Drafting 
and Policy Support Section (DPW), 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 2019 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 
2019 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 include imports of ephedrine, pseudoephedrine, and 
phenylpropanolamine, but do not include imports of controlled 
substances for use in industrial processes.
    On August 20, 2018, the DEA published 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 2019'' in the Federal 
Register. 83 FR 42164. This notice proposed the 2019 aggregate 
production quotas for each basic class of controlled substance listed 
in schedules I and II and the 2019 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 19, 2018.

Comments Received

    The DEA received 48 comments from professional organizations, 
patients, associations, universities, Senators, State Attorneys 
General, a doctor, DEA registered entities, and non-DEA entities. The 
comments included concerns about the quota process, shortages, 
prescriptions, diversion, marihuana, requests for a hearing, requests 
for increase in specific production quotas, and other comments that are 
outside the scope of the notice.

Quota Process

    There were eight commenters that expressed concerns about the quota 
process. Some of these commenters requested that the DEA consider 
information from the Department of Health and Human Services (HHS) and 
the Food and Drug Administration (FDA) to determine the aggregate 
production quota. Other commenters stated that the DEA did not consider 
the factors contained in the Controlled Substances Quotas Final Rule 
published on July 16, 2018, 83 FR 32784, to determine the 2019 
aggregate production quota.
    The DEA has obtained and considered relevant information from the 
FDA. The information the DEA received included the observed and 
estimated domestic usage of 26 schedule II controlled substances, new 
drug applications and abbreviated drug application approvals, and 
clinical trials for schedule I and II controlled substances.
    Regarding the Final Rule published on July 16, 2018, 83 FR 32784, 
the DEA amended the factors set forth in 21 CFR 1303.11 to be 
considered when setting the aggregate production quotas to include the 
extent of diversion of the controlled substances in each class, and 
relevant information obtained from the HHS, the FDA, the Centers for 
Disease Control and Prevention (CDC), the Centers for Medicare and 
Medicaid Services (CMS), and the states.
    The DEA has solicited the states and federal partners to obtain 
relevant information to be considered when setting the aggregate 
production quota pursuant to 21 CFR 1303.11 and this information will 
be considered for the 2019 proposed adjustments to the aggregate 
production quota. The DEA will continue to solicit information from the 
states for the 2020 aggregate production quotas and the years to 
follow.

[[Page 67349]]

    However, the DEA is obligated to issue individual production and 
procurement quotas sufficiently in advance of the upcoming year to 
allow manufacturers to prepare for the legitimate needs of the United 
States. The DEA may not issue individual production and procurement 
quotas until the aggregate production quotas have been established. As 
a result of these obligations under the CSA, the DEA was not able to 
obtain and consider the amended factors set forth in Final Rule, 83 FR 
32784, for the purpose of issuing the 2019 proposed aggregate 
production quota.
    The DEA has a fluid process for setting quotas which allows the 
agency to make necessary quota adjustments. The process involves 
setting the proposed aggregate production quotas for a calendar year, 
and, following the review of any comments, the issuance of a Final 
Order to establish the aggregate production quota. Later in the 
process, the DEA issues a Proposed Adjustment to the aggregate 
production quota, and following the review of any comments, DEA issues 
a final order setting the Final Adjusted Aggregate Production Quotas. 
The DEA will consider the additional information received in the course 
of preparing proposed amendments and the final 2019 adjusted aggregate 
production quota.
Shortages
    There were 28 commenters that expressed concerns about the decrease 
in certain aggregate production quotas. These commenters alleged that 
decreases to the aggregate production quotas have resulted in a 
shortage of injectable opioid medications and interfere with the 
treatment of patients. Some of these commenters also suggested that the 
DEA separate quotas for solid oral controlled substances and injectable 
controlled substances, and that DEA allow consideration by individual 
pharmaceutical dosage forms.
    The DEA is committed to ensuring an adequate and uninterrupted 
supply of controlled substances in order to meet legitimate medical, 
scientific, and export needs of the United States. Although the DEA 
sets the aggregate production quota, it is possible that manufacturers' 
business practices may lead to a shortage of controlled substances at 
the consumer level, despite the adequacy of the aggregate production 
quota set by DEA. The aggregate production quotas are set by the DEA in 
a manner to include both injectable opioids and solid oral opioids in 
order to ensure that the estimated medical needs of the United States 
are met.
    Notably, at the time of the proposed aggregate production quota, 21 
U.S.C. 826(a) provided that ``production quotas shall be established in 
terms of quantities of each basic class of controlled substance and not 
in terms of individual pharmaceutical dosage forms prepared from or 
containing such a controlled substance.'' On October 24, 2018, the 
President signed into law the SUPPORT for Patients and Communities Act 
of 2018, (Pub. L. 115-271), which now allows but does not require the 
DEA to grant quotas in terms of dosage forms if the agency determines 
that doing so will assist in avoiding the overproduction, shortages, or 
diversion of a controlled substance. DEA will be evaluating these 
issues over time.
    Furthermore, the DEA and the FDA can coordinate efforts to prevent 
or alleviate drug shortages pursuant to 21 U.S.C. 826a(2). For example, 
the asserted domestic shortage of injectable controlled substances was 
alleviated through the FDA and the DEA collaboration to get specific 
injectable controlled substances imported into the United States.
Transparency
    Two Senators submitted a joint comment supporting the DEA's efforts 
to address the opioid crisis, but expressed concerns that the aggregate 
production quota for schedule II opioids remains too high. These 
commenters also requested a transparent explanation of the analysis and 
specific considerations that the DEA considered when establishing the 
2019 quotas for schedule II opioids.
    The DEA continues to address the opioid crisis through initiatives 
such as the President's Safer Prescribing Plan, which seeks to reduce 
nationwide opioid prescription fills by one-third within three years. 
The DEA has observed a decline in the number of prescriptions written 
for schedule II opioids since 2014 and will continue to set aggregate 
production quotas to meet the medical needs of the United States while 
combating the opioid crisis.
    In determining the aggregate production quota, the DEA took into 
account the data regarding the number of prescriptions that have been 
issued and an analysis of the factors as then set forth in 21 CFR 
1303.11. The specific information that was obtained and considered 
included an analysis of sales data from databases such as Automation of 
Reports and Consolidated Orders System (ARCOS) and IQVIA; in addition 
to FDA forecasts and projections, historical total market sales data, 
products entering and exiting the market, expected product development, 
expected exports, inventory data, theft and loss data, and company 
forecasts. As a result, the final aggregate production quota for 
several opioids are decreased from the proposed initial 2019 levels. 
These decreases take into account the combined efforts of the the DEA, 
the FDA, and the CDC enforcing regulations and issuing guidance 
documents as well as many states enacting prescription monitoring 
database programs to stem the opiate/opioid epidemic.
Quotas and Prescriptions
    Eleven State Attorneys General submitted a joint comment 
recognizing DEA's efforts to combat the opioid epidemic and expressed 
concerns about excessive quotas for opioids. These commenters also 
expressed concerns about overprescribing and referenced various 
studies. The referenced material cited in these comments also discuss 
patients who divert their prescriptions by sharing their prescriptions 
with others.
    The DEA continues to address the opioid crisis through laws, 
regulations, and initiatives such as the Safer Prescribing Plan. The 
Safer Prescribing Plan seeks to reduce nationwide opioid prescription 
fills by one-third within three years. The DEA has observed a decline 
for certain prescriptions written for schedule II opioids since 2014 
which can be attributed to federal and state government activities and 
interventions, including the implementation of Prescription Drug 
Monitoring Programs, enforcement of current regulations, and guidance 
documents such as the CDC Guidelines for Prescribing Opioids for 
Chronic Pain--United States, March 2016. The DEA will continue to 
address the opioid crisis while ensuring an adequate and uninterrupted 
supply of controlled substances in order to meet the demand of 
legitimate medical, scientific, and export needs of the United States.
    The DEA sets aggregate production quotas in a manner to ensure that 
all prescriptions that are authorized for legitimate medical purposes 
can be filled. Prescribers who are authorized to dispense controlled 
substances are responsible for adhering to the laws and regulations set 
forth under the CSA, which requires doctors to only write prescriptions 
for legitimate medical needs. Any practitioner issuing an invalid 
prescription for controlled substances and any pharmacy filling such a 
prescription would be in violation of the CSA.

[[Page 67350]]

    Upon review of the studies, DEA has determined that they are 
insufficient to support a reduction in the aggregate production quotas. 
The studies have found, with respect to a variety of medical 
procedures, that physicians prescribe more controlled substances for 
post-operative pain than the patients utilize. However, the DEA has 
concluded that while the referenced studies are concerning, they are 
insufficient to support a determination as to the level of 
overprescribing that occurs across the range of the medical procedures 
that are performed each year on a national basis.
Including Diversion in Quotas
    Eleven State Attorneys General and three other commenters expressed 
concerns about DEA's ability to account for diversion when setting the 
aggregate production quotas.
    The factors that DEA considers in setting the aggregate production 
quotas were amended in a Final Rule published on July 16, 2018, 83 FR 
32784, to include the extent of any diversion of the controlled 
substances in the class, which will strengthen DEA's ability to reduce 
the likelihood of the diversion of controlled substances. When setting 
the established aggregate production quota, the DEA accounted for 
diversion by analyzing information such as, reports of controlled 
substance thefts and losses, and seizure data that are captured through 
internal DEA databases and will continue to do so when setting future 
aggregate production quotas. The DEA will also consider information 
obtained from CMS, CDC, FDA, and the states which may include diversion 
data to be considered for the adjusted aggregate production quota.
Marihuana
    Seven commenters expressed their support for the increase in the 
production quota of marihuana. Three of those commenters expressed 
concerns about approval of applications for registration to manufacture 
(grow) marihuana. The DEA increased the production quota for marihuana 
based solely on increased usage projections for federally approved 
research projects. The DEA continues to review applications for 
registration and registers the number of bulk manufacturers of a 
controlled substance that is necessary to produce an adequate and 
uninterrupted supply.
Hearings
    Two commenters urged DEA to hold a public hearing. One of the 
commenters stated that the DEA should have a hearing to gather 
stakeholder feedback on how the DEA can help address the opioid 
epidemic while ensuring an adequate supply of opioids for clinically 
appropriate care. The second commenter stated that the DEA should hold 
a hearing to enable stakeholders to express their views about the 
proposed reductions.
    Under the DEA regulations, the decision of whether to grant this 
type of a hearing on the issues raised by the commenters lies solely 
within the discretion of the Administrator. (21 CFR 1303.11(c) and 21 
CFR 1303.13 (c)). I find that neither of the foregoing two requests 
presented any evidence that would lead me to conclude that a hearing is 
necessary or warranted. Therefore, I decline to order a hearing on the 
issues presented by the commenters.
Specific Quota for DEA-Registered Manufacturers
    The DEA received comments from four DEA-registered manufacturers 
regarding thirty-three different schedule I and II controlled 
substances. These commenters stated the proposed aggregate production 
quotas for 3-methyl fentanyl, 4-ANPP, acetyl fentanyl, acryl fentanyl, 
beta-hydroxythiofentanyl, butyrl fentanyl, carfentanil, cyclopentyl 
fentanyl, cyclopropyl fentanyl, d-amphetamine (for sale), d,l-
amphetamine, difenoxylate (for sale), fentanyl, fentanyl related 
substances, furanyl fentanyl, gamma hydroxybutyric acid, isobytyryl 
fentanyl, levorphanol, methoxyacetyl fentanyl, noroxymorphone (for 
conversion), ocfentanil, opium (powder), oxycodone (for sale), para-
chloroisobutyryl fentanyl, para-fluorofentanyl, para-fluorobutyryl 
fentanyl, para-methyoxybutyrl fentanyl, remifentanil, sufentanil, 
tetrahydrofuranyl fentanyl, thebaine, U-47700, and valeryl fentanyl 
were potentially 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.
    The DEA has considered the comments for specific controlled 
substances and made adjustments as needed which are described below in 
the section titled Determination of 2019 Aggregate Production Quotas 
and Assessment of Annual Needs. The DEA did not receive any comments to 
the proposed established 2019 assessment of annual needs for ephedrine, 
pseudoephedrine, and phenylpropanolamine.
Out of Scope
    The DEA received seven comments which addressed issues that are 
outside the scope of this final order. The comments were general in 
nature and raised issues of specific medical illnesses, medical 
treatments, and medication costs and, therefore, are outside of the 
scope of this Final Order, and do not impact the original analysis 
involved in establishing the 2019 aggregate production quotas.

Determination of 2019 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2019 aggregate production quotas and assessment 
of annual needs, the DEA has taken into consideration the above 
comments along with the factors previously set forth in 21 CFR 1303.11 
(as described above) and 21 CFR 1315.11, in accordance with 21 U.S.C. 
826(a), and other relevant factors, including the 2018 manufacturing 
quotas, current 2018 sales and inventories, anticipated 2019 export 
requirements, industrial use, additional applications for 2019 quotas, 
as well as information on research and product development 
requirements.
    Based on all of the above, the Administrator is establishing the 
2019 aggregate production quotas. These quotas are lower for codeine 
(for sale), codeine (for conversion), hydrocodone (for sale), morphine 
(for sale), and oxycodone (for sale); higher for cyclopentyl fentanyl, 
methoxyacetyl fentanyl, N-ethlypentylone (ephylone), para-
methyoxybutyryl fentanyl, and para-chloroisobutyryl fentanyl due to 
their temporarily controlled status; higher for amphetamine (for 
conversion) based on increased usage forecasted by the FDA and its use 
in the treatment of Attention Deficit Hyperactivity Disorder; higher 
for levorphanol based on manufacturers' ongoing product development 
activities necessary for the FDA approval process; and higher for opium 
powder and sufentanil based on manufacturers' projected exports.
    Regarding 3-methylfentanyl, 4-ANPP, acetyl fentanyl, acryl 
fentanyl, beta-hydroxythiofentanyl, butyryl fentanyl, carfentanil, 
cyclopropyl fentanyl, d-amphetamine (for sale), d,l-amphetamine, 
difenoxylate (for sale), fentanyl, fentanyl related substances, furanyl 
fentanyl, gamma hydroxybutyric acid, isobutyryl fentanyl, 
noroxymorphone (for conversion), ocfentanil, para-fluorofentanyl, para-
fluorobutyrl fentanyyl, remifentanil, tetrahydrofuranyl fentanyl, 
thebaine, U-47700, and valeryl fentanyl, the DEA

[[Page 67351]]

has determined the proposed aggregate production quotas and assessment 
of annual needs are sufficient to provide for the 2019 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 2019 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2019 assessment of annual needs for the list I 
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 
expressed in grams of anhydrous acid or base, as follows:

------------------------------------------------------------------------
                                                           Established
                      Basic class                       2019 quotas  (g)
------------------------------------------------------------------------
                               Schedule I
------------------------------------------------------------------------
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine................                20
1-(1-Phenylcyclohexyl)pyrrolidine.....................                15
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine........                10
1-(5-Fluoropentyl)-3-(1-naphthoyl) indole (AM2201)....                30
1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole (AM-694)..                30
1-Benzylpiperazine....................................                25
1-Methyl-4-phenyl-4-propionoxypiperidine..............                10
1-[1-(2-Thienyl)cyclohexyl]piperidine.................                15
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)                   30
 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-methoxybenzyl)                    30
 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...........................                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
1-(4-Cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-               25
 carboximide..........................................
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-[alpha]-pyrrolidinopropiophenone (4-MePPP)...                25
5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-               50
 phenol...............................................
5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-                40
 phenol (cannabicyclohexanol or CP-47,497 C8-homolog).
N-(1-Amino-3-methyl-1-oxobutan-2-yl)-1-(5-                            25
 fluoropentyl)-1H-indazole-3-carboxamide..............
1-(5-Fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-                        25
 pyrrolo[2,3-b]pyridine-3-carboxamide.................
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-                 30
 1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)....
5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-                   30
 carboxamido)-3-methylbutanoate)......................
5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-                        30
 fluoropentyl)-1H-indazole-3-carboxamide).............
5-Fluoro-PB-22; 5F-PB-22..............................                20
5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-..                25
3-yl](2,2,3,3-tetramethylcyclopropyl)methanone........
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)-               30
 1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)........
Acetyl Fentanyl.......................................               100

[[Page 67352]]

 
Acetyl-alpha-methylfentanyl...........................                30
Acetyldihydrocodeine..................................                30
Acetylmethadol........................................                 2
Acryl Fentanyl........................................                25
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-               50
 pentyl-1H-indazole-3-carboxamide)....................
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 ([alpha]-PBP)...........                25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)..........                25
Aminorex..............................................                25
Anileridine...........................................                20
APINACA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-               25
 carboxamide).........................................
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
Cyclopentyl Fentanyl..................................                30
Cyclopropyl Fentanyl..................................                20
Desomorphine..........................................                25
Diampromide...........................................                20
Diethylthiambutene....................................                20
Diethyltryptamine.....................................                25
Difenoxin.............................................             8,225
Dihydromorphine.......................................           753,500
Dimethyltryptamine....................................                50
Dipipanone............................................                 5
Etorphine.............................................                30
Fenethylline..........................................                30
Fentanyl related substances...........................                25
Furanyl Fentanyl......................................                30
gamma-Hydroxybutyric acid.............................        33,417,000
Heroin................................................                45
Hydromorphinol........................................                40
Hydroxypethidine......................................                 2
Ibogaine..............................................                30
Isobutyryl Fentanyl...................................                25
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-                             35
 naphthoyl)indole)....................................
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-                30
 oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
 carboxamide).........................................
MDMB-CHMICA; MMB-CHMINACA(methyl 2-(1-                                30
 (cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-
 dimethylbutanoate)...................................
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-                       30
 indazole-3-carboxamido)-3,3-dimethylbutanoate).......
Methyl2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-               25
 3-methylbutanoate....................................
Marihuana.............................................         2,450,000
Mecloqualone..........................................                30
Mescaline.............................................                25
Methaqualone..........................................                60

[[Page 67353]]

 
Methcathinone.........................................                25
Methoxyacetyl Fentanyl................................                30
Methyldesorphine......................................                 5
Methyldihydromorphine.................................                 2
Morphine methylbromide................................                 5
Morphine methylsulfonate..............................                 5
Morphine-N-oxide......................................               150
Naphthalen-1-yl 1-(5-fluorpentyl)-1H-indole-3-                        25
 carboxylate..........................................
N,N-Dimethylamphetamine...............................                25
Naphyrone.............................................                25
N-Ethyl-1-phenylcyclohexylamine.......................                 5
N-Ethyl-3-piperidyl benzilate.........................                10
N-Ethylamphetamine....................................                24
N-Ethylpentylone (ephylone)...........................                30
N-Hydroxy-3,4-methylenedioxyamphetamine...............                24
Noracymethadol........................................                 2
Norlevorphanol........................................                55
Normethadone..........................................                 2
Normorphine...........................................                40
Ocfentanil............................................                25
Ortho-parafluorofentanyl..............................                30
Para-chlorisobutyrl Fentanyl..........................                30
Para-flourobutyryl Fentanyl...........................                25
Para-fluorofentanyl...................................                25
Para-methoxybutyrl Fentanyl...........................                30
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-                              45
 methoxyphenylacetyl)indole)..........................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-                             30
 benzoyl]indole)......................................
Tetrahydrocannabinols.................................           384,460
Tetrahydrofuranyl fentanyl............................                 5
Thiofentanyl..........................................                25
THJ-2201 ( [1-(5-fluoropentyl)-1H-indazol-3-                          30
 yl](naphthalen-1-yl)methanone).......................
Tilidine..............................................                25
Trimeperidine.........................................                 2
UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-                              25
 tetramethylcyclopropyl)methanone.....................
U-47700...............................................                30
Valeryl fentanyl......................................                25
------------------------------------------------------------------------
                               Schedule II
------------------------------------------------------------------------
1-Phenylcyclohexylamine...............................                15
1-Piperidinocyclohexanecarbonitrile...................                25
4-Anilino-N-phenethyl-4-piperidine (ANPP).............         1,185,000
Alfentanil............................................             6,200
Alphaprodine..........................................                 2
Amobarbital...........................................            20,100
Amphetamine (for conversion)..........................        12,700,000
Amphetamine (for sale)................................        42,400,000
Carfentanil...........................................                20
Cocaine...............................................            92,120
Codeine (for conversion)..............................        12,900,000
Codeine (for sale)....................................        36,114,260
Dextropropoxyphene....................................                35
Dihydrocodeine........................................           238,466
Dihydroetorphine......................................                 2
Diphenoxylate (for conversion)........................            14,100
Diphenoxylate (for sale)..............................           770,800
Ecgonine..............................................            88,134
Ethylmorphine.........................................                30
Etorphine hydrochloride...............................                32
Fentanyl..............................................         1,185,000
Glutethimide..........................................                 2
Hydrocodone (for conversion)..........................             5,000
Hydrocodone (for sale)................................        43,027,640
Hydromorphone.........................................         4,071,000

[[Page 67354]]

 
Isomethadone..........................................                30
Levo-alphacetylmethadol (LAAM)........................                 5
Levomethorphan........................................             4,000
Levorphanol...........................................            38,000
Lisdexamfetamine......................................        19,000,000
Meperidine............................................         1,580,000
Meperidine Intermediate-A.............................                30
Meperidine Intermediate-B.............................                30
Meperidine Intermediate-C.............................                30
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)...................................        29,353,676
Nabilone..............................................            62,000
Noroxymorphone (for conversion).......................        19,169,340
Noroxymorphone (for sale).............................           376,000
Opium (powder)........................................           250,000
Opium (tincture)......................................           530,837
Oripavine.............................................        28,705,000
Oxycodone (for conversion)............................         2,081,000
Oxycodone (for sale)..................................        79,596,606
Oxymorphone (for conversion)..........................        24,525,540
Oxymorphone (for sale)................................         2,880,000
Pentobarbital.........................................        25,850,000
Phenazocine...........................................                 5
Phencyclidine.........................................                35
Phenmetrazine.........................................                25
Phenylacetone.........................................                40
Racemethorphan........................................                 5
Racemorphan...........................................                 5
Remifentanil..........................................             3,000
Secobarbital..........................................           172,100
Sufentanil............................................             4,000
Tapentadol............................................        18,388,280
Thebaine..............................................        84,600,000
------------------------------------------------------------------------
List I Chemicals
------------------------------------------------------------------------
Ephedrine (for conversion)............................                25
Ephedrine (for sale)..................................         4,136,000
Phenylpropanolamine (for conversion)..................        14,100,000
Phenylpropanolamine (for sale)........................         7,990,000
Pseudoephedrine (for conversion)......................             1,000
Pseudoephedrine (for sale)............................       174,246,000
------------------------------------------------------------------------

    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 2019 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: December 20, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-28108 Filed 12-27-18; 8:45 am]
 BILLING CODE 4410-09-P