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 2020, 66014-66023 [2019-26119]

Download as PDF jbell on DSKJLSW7X2PROD with NOTICES 66014 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends). (10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm’s(s’) operations on that product during calendar year 2018 (report quantity data in short tons and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association. (a) The quantity and value (landed, duty-paid but not including antidumping or countervailing duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm’s(s’) imports; (b) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and (c) the quantity and value (f.o.b. U.S. port, including antidumping and/or countervailing duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country. (11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm’s(s’) operations on that product during calendar year 2018 (report quantity data in short tons and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping or countervailing duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association. (a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm’s(s’) production; (b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and VerDate Sep<11>2014 17:10 Nov 29, 2019 Jkt 250001 cleanup, and a typical or representative product mix); and (c) the quantity and value of your firm’s(s’) exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm’s(s’) exports. (12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2013, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries. (13) (Optional) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions. Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.61 of the Commission’s rules. By order of the Commission. Issued: November 25, 2019. Lisa Barton, Secretary to the Commission. [FR Doc. 2019–25941 Filed 11–29–19; 8:45 am] BILLING CODE 7020–02–P PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–508E] 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 2020 Drug Enforcement Administration, Department of Justice. ACTION: Final order. AGENCY: This final order establishes the initial 2020 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: Effective Date: This order is effective December 2, 2019. FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control Division, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, VA 22152, Telephone: (571) 362–3261. 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 schedule 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 Drug Enforcement Administration (DEA) pursuant to 28 CFR 0.100. Background The 2020 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 2020 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. E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices On September 12, 2019, 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 2020’’ was published in the Federal Register. 84 FR 48170. This notice proposed the 2020 aggregate production quotas for each basic class of controlled substance listed in schedules I and II, and the 2020 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 October 15, 2019. jbell on DSKJLSW7X2PROD with NOTICES Comments Received Within the public comment period, DEA received 731 comments from DEA registrants, hospital associations, professional associations, doctors, nurses, health system organizations, State Attorneys General, and others. The comments included concerns about the quota process, concerns that further quota reductions will lead to drug shortages, requests for less interference in the doctor-patient relationship, availability of prescription drugs for chronic pain patients, requests for hearings, requests for increase in specific production quotas, and other comments outside the scope of this notice. DEA received a joint comment from two Senators urging DEA to apply DEA’s new authorities to prevent and limit opioid diversion due to excessively high production levels. Although this comment was received after the close of the comment period, DEA shares the Senators’ concerns and is working to improve its ability to use available databases to better quantify diversion as part of the quota process. Shortages There were non-DEA registered commenters that expressed concerns about the decrease in 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 DEA separate quotas for solid oral controlled substances and injectable controlled substances, and that DEA allow consideration by individual pharmaceutical dosage forms. DEA also received letters from many doctors, nurses, hospital administrators, VerDate Sep<11>2014 17:10 Nov 29, 2019 Jkt 250001 and others in the medical field regarding the proposed quota reduction for fentanyl and other schedule II narcotics. These letters characterized the reductions as ‘‘extremely problematic for American healthcare providers,’’ stating that the reduction for fentanyl and other schedule II narcotics will lead to drug shortages, raise drug prices, lead to hardships on hospitals and surgical facilities, and negatively impact patients. These letters discussed fentanyl’s appearance on the Food and Drug Administration’s (FDA) drug shortage list and that fentanyl is the least diverted among the covered controlled substances. 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 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 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. Pursuant to 21 U.S.C. 826(a)(1), ‘‘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.’’ However, the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub. L. 115–271), provides an exception to that general rule by now giving DEA the authority to establish quotas in terms of pharmaceutical dosage forms if the agency determines that doing so will assist in avoiding the overproduction, shortages, or diversion of a controlled substance. While DEA is now allowed to issue quotas in terms of pharmaceutical dosage form, it is not required to do so. DEA will not be utilizing this authority at the aggregate production quota level, but will be doing so at the individual dosage-form manufacturing level where it will have a greater impact on averting potential shortages. Because quotas set at the individual dosage-form manufacturing level are more directly connected to distributions of current and new FDA-approved drug products, they allow DEA to manage manufacturing quotas to alleviate any potential shortage in a more timely PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 66015 manner than with quotas set at the aggregate production quota level. This is also true because the aggregate production quota is initially established prior to the start of the quota calendar year. Additionally, DEA and FDA can coordinate efforts to prevent or alleviate drug shortages pursuant to 21 U.S.C. 826(h). Such efforts may include adjusting domestic competitors’ quota, completion of FDA approval to increase the number of competitors, and determining a foreign manufacturer that can meet FDA approval. For example, the domestic shortage of injectable hydromorphone that occurred in 2018 was alleviated through the collaboration of FDA and DEA to determine who were the other dosage-form manufacturers with injectable hydromorphone products in the market, whether other dosage-form manufacturers had the capability to increase their production levels to meet legitimate patient need in a timely manner, and when it was determined that the domestic manufacturers could not increase production significantly to meet legitimate patient need, DEA and FDA coordinated their regulatory authority to allow for the limited importation of injectable hydromorphone into the United States. Relevant Information Obtained From the States Pursuant to 21 CFR 1303.11, DEA must consider relevant information from the States when setting the aggregate production quota. Seven State Attorneys General submitted a joint comment expressing concerns about the estimation of diversion for all controlled substances, not accounting for overprescribing, and the consideration of additional information to set quotas. Their concerns are addressed in more detail below. I. Diversion Analysis for All Controlled Substances The seven State Attorneys General commented that DEA should not take different approaches when accounting for diversion for the five covered controlled substances and the remaining controlled substances. In the letter, they discussed the mandates from the SUPPORT Act, as well as the requirements implemented through 21 CFR 1303.11 by the Controlled Substances Quota rule. 83 FR 32784. They expressed that they have similar language and purposes, even though the SUPPORT Act goes a bit further in its mandate by requiring the estimation of diversion for the five covered controlled substances. They pointed out that DEA E:\FR\FM\02DEN1.SGM 02DEN1 66016 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices jbell on DSKJLSW7X2PROD with NOTICES estimated diversion and made straightforward quota reductions by the corresponding quantities, whereas DEA only noted that the databases contained usable information in regards to the remaining controlled substances. DEA did not indicate that diversion estimates were conducted for any other controlled substance, nor did DEA indicate that any corresponding decreases were made for other controlled substances. They commented that if DEA believes they have a sound method for estimating diversion, then it is unreasonable not to apply that method for estimating diversion to all controlled substances. The States also commented that there is a lack of transparency in the setting of quotas. The States believe that DEA needs to explain the logic behind using different approaches in setting quotas. They commented that DEA must include the findings of fact when setting the quota and that transparency is essential in allowing parties to evaluate DEA’s 2020 Proposed Aggregate Production Quota notice. DEA considered various data sources in order to determine the extent of diversion of all controlled substances as is required by the recent amendments to the CSA and changes to DEA’s own regulations. In accordance with factor six in 21 CFR 1303.11(b), DEA formally solicited the Department of Health and Human Services (HHS), U.S. Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the states in August 2018, requesting information including rates of overdose deaths and abuse and overall public health impact related to controlled substances. This information was also considered pursuant to the SUPPORT Act. DEA determined that due to the grouping of drug classes in all of the sources provided, the data could not be used to estimate diversion for the purpose of setting the aggregate production quotas. However, DEA estimated diversion of the covered controlled substances defined in the SUPPORT Act utilizing DEA’s internal data sources. DEA will continue to further define sources that will be useful in analyzing diversion of the remaining controlled substances. II. Methods and Data That Capture Over-Prescribing as Part of its Diversion Analysis The States acknowledged that DEA’s current approach for accounting for diversion is a significant improvement but commented that DEA does not adequately account for over-prescribing. They commented that over-prescribing results when there is overproduction, which allows legitimate prescriptions to VerDate Sep<11>2014 17:10 Nov 29, 2019 Jkt 250001 be diverted. Assuming a controlled substance is validly dispensed for a legitimate medical purpose, both the physician and patient will use their judgement to determine how much medication will be prescribed and how much they will consume. The physician’s decisions may be influenced by recommendations from CDC, FDA, and professional medical organizations that have conducted and/or reviewed clinical studies used to determine prescription guidelines. Patients are ultimately going to decide for themselves how much of the legitimately prescribed medication they will consume. DEA does not control the quantity of a substance prescribed to a patient, and DEA cannot control how much of the prescription a patient decides to consume. DEA also receives assistance in curbing overprescribing from programs in place, such as the President’s Safer Prescribing Plan, which seeks to reduce nationwide opioid prescription fills by one-third. 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. These decreases take into account the combined efforts of DEA, FDA, and CDC enforcing regulations and issuing guidance documents, as well as many states enacting prescription monitoring database programs to stem the opiate/opioid epidemic. There are ample reasons not to pursue the methods suggested by the State Attorneys General, including that the studies on which they relied are limited in scope of procedures and number of hospitals, such that the methodology is insufficient to expand to a national level. As pointed out by the States, ‘‘there is no perfect system of measuring other sources of diversion like overprescription.’’ The States pointed to data from drug takeback programs, but currently that data is not usable for consideration in determining the aggregate production quota. There is no method in place to determine how much of the prescription medications are schedule I or II substances and which controlled substances are being returned. DEA and HHS are working together to consider options for quantifying Take-Back Program data. III. Consideration of Additional Information To Determine Production Quotas The State Attorneys General commented that DEA should expand its PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 sources of data used to set aggregate production quotas. They suggested three steps that DEA should take to gather information to set quotas which are listed below. 1: Improve Usability of the Automated Reports and Consolidated Ordering System (ARCOS) and the Suspicious Order Reporting System (SORS) The State Attorneys General commented that DEA should improve usability of the ARCOS and SORS databases to gather better information on prescribing practices. They also note that DEA did not indicate whether SORS was used and minimally referred to ARCOS not being used because it contained identical information to the Theft Loss Report Database. The States commented that DEA needs to reform its process to upload SORS reports into the SORS database. Further, they commented that overdose data received from States and the CDC should be cross-referenced with ARCOS to provide context that should inform the quotasetting process. SORS was not centralized until its recent launch on October 23, 2019. DEA will need time to sort through the system to determine its utility for aggregate production quota purposes. The submission of a suspicious order alone is not an automatic determination that the order is illicit in nature. Further investigations need to be completed to determine if a transgression has occurred. The differences in reporting frequencies to ARCOS are specified in 21 CFR 1304.33(b). Acquisition and distribution transaction reports must be completed every quarter no later than the 15th day of the month succeeding the quarter for which it is being submitted. In the same section of the CFR, it does mention that a registrant may be given permission to file a report more frequently, but no more than on a monthly basis. The State Attorneys General request to change this regulation is outside of the scope of this final order. 2: Improve Data Collection in Prescription Drug Takeback Programs To Capture the Quantities of Drugs Overprescribed in Particular Areas The State Attorneys General expressed that DEA should expand the National Take Back Program to assist with gathering more precise data on over-prescribing. They noted that the takeback programs do not track the types and quantities of what the public turns in, limiting their value. Currently, DEA and HHS are working together to consider methods that improve data E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices collection and subsequently the usability of data obtained from the TakeBack Program. 3: Consider Medical Best Practices as Part of the Holistic Diversion Analysis The letter submitted by the State Attorneys General also suggested that DEA study the best practices developed by the medical community and state regulators to determine what opioid quantities are ‘‘medically necessary.’’ They expressed that relying exclusively on evidence of illegal activity assumes that any legally-sold controlled substance is a part of the medical and scientific needs of the United States. DEA is responsible for enforcing the provisions of the CSA and DEA regulations that require prescriptions for controlled substances to be issued by a practitioner for a legitimate medical purpose in the usual course of his/her professional practice. However, beyond that context, DEA does not regulate the practice of medicine generally and thus does not have a role in establishing the type of ‘‘best practices’’ to which the commenter refers. jbell on DSKJLSW7X2PROD with NOTICES Pain Management and Medical Associations Letters DEA also received 106 comments that expressed concern that DEA’s proposed reduction of opioids would adversely impact the availability of pain relieving prescription drugs for people with chronic pain. These comments were general in nature, and raised issues of specific medical illnesses and medical treatment, and therefore are outside of the scope of this Final Order. As a result, these comments did not provide new discrete data for consideration, and they do not impact the original analysis involved in establishing the 2020 aggregate production quotas. 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 require doctors to only write prescriptions for legitimate medical needs. Any practitioner issuing an invalid prescription for controlled substances, and any pharmacy knowingly filling such a prescription, would be in violation of the CSA. Hearings Two commenters urged DEA to hold a public hearing to receive feedback from stakeholders. They asked that DEA bring together all stakeholders, allowing VerDate Sep<11>2014 17:10 Nov 29, 2019 Jkt 250001 stakeholders to publicly discuss their concerns. 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 five DEA-registered manufacturers regarding twenty-four different schedule I and II controlled substances. Commenters stated the proposed aggregate production quotas for amphetamine (for sale), fentanyl, hydromorphone, methylphenidate, morphine, noroxymorphone (for conversion), and oxycodone (for sale) 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. Commenters requested the proposed aggregate production quotas for FUB–144, 5F–AB–PINACA, 5F–EDMB–PINACA, 5F–MDMB–PICA, MMB–CHMICA, FUB–AKB48 (FUB– APINACA), 5F–CUMYL–PINACA, 5F– CUMYL–P7AICA, 4–CN–CUMYL– BUTINACA, NM2201, 4-Methyl-alphaethylaminopentiophenone (4–MEAP), N-Ethylhexedrone, 4-Chloro-alphapyrrolidinovalerophenone (4-Chloroalpha-PVP), 4′-Methyl-alphapyrrolidinohexiophenone (MPHP), NEthylpentylone, alphaPyrrolidinohexanophenone (alphaPHP), and alphaPyrrolidinoheptaphenone (PV8), be sufficient for additional quota requests. DEA has considered the comments for specific controlled substances and made adjustments as needed which are described below in the section titled Determination of 2020 Aggregate Production Quotas and Assessment of Annual Needs. DEA received one comment to the proposed established 2020 assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine regarding the difficulty in procuring finished dosageforms of ephedrine. DEA has considered this comment in the section regarding drug shortages of controlled substances. This letter characterized the reductions of controlled substances and ephedrine as ‘‘extremely problematic for American PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 66017 healthcare providers,’’ stating that these reductions will lead to drug shortages, raise drug prices, lead to hardships on hospitals and surgical facilities, and negatively impact patients. DEA is required under the CSA to establish quotas for ephedrine, pseudoephedrine, and phenylpropanolamine 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. Although DEA sets the assessment of annual needs, it is possible that manufacturers’ business practices may lead to a shortage of ephedrine drug products at the consumer level, despite the adequacy of the assessment of annual needs set by DEA. For instance, DEA does not have the authority to dictate when during the calendar year the manufacturer actually utilizes the quota granted to them. Also, DEA cannot dictate how much of the granted quota the manufacturer allocates for use in a single production run. The assessment of annual needs is set by DEA in a manner to include all dosage forms of ephedrine in order to ensure that the estimated medical needs of the United States are met. Additionally, DEA and FDA can coordinate efforts to prevent or alleviate drug shortages. Such efforts may include adjusting competitors’ domestic or import quotas and completion of FDA approval to increase the number of competitors. Out of Scope DEA received 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. DEA also received comments asserting that illicit drug use, and not prescription drug use, is the main factor in the opioid crisis. Although DEA is genuinely concerned with illicit drug use and its involvement in the opioid crisis, the manufacturing of illicit substances is not considered when determining the aggregate production quotas because such illicit manufacturing cannot be tempered by adjusting the aggregate production quotas, therefore it is outside the scope of this final order. All of these out of scope issues do not impact the original analysis involved in establishing the 2020 aggregate production quotas. E:\FR\FM\02DEN1.SGM 02DEN1 66018 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices Determination of 2020 Aggregate Production Quotas and Assessment of Annual Needs In determining the 2020 aggregate production quotas and assessment of annual needs, DEA has taken into consideration the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a), and other relevant factors, including the 2019 manufacturing quotas, current 2019 sales and inventories, anticipated 2020 export requirements, industrial use, additional applications for 2020 quotas, as well as information on research and product development requirements. Based on all of the above, the Administrator is adjusting the 2020 aggregate production quotas for 4Methyl-alpha-ethylaminopentiophenone (4–MEAP), N-Ethylhexedrone, 4-Chloroalpha-pyrrolidinovalerophenone (4Chloro-alpha-PVP), 4’-Methyl-alphapyrrolidinohexiophenone (MPHP), alpha-Pyrrolidinohexanophenone (alpha-PHP), alphaPyrrolidinoheptaphenone (PV8), amphetamine (for sale), oxycodone (for sale), and oxymorphone (for sale). Regarding FUB-144, 5F-AB-PINACA, 5F-EDMB-PINACA, 5F-MDMB-PICA, MMB-CHMICA, FUB-AKB48 (FUB- APINACA), 5F-CUMYL-PINACA, 5FCUMYL-P7AICA, 4-CN-CUMYLBUTINACA, NM2201, NEthylpentylone, fentanyl, hydromorphone, methylphenidate, morphine, noroxymorphone (for conversion), and oxycodone (for sale), DEA has determined the proposed aggregate production quotas and assessment of annual needs are sufficient to provide for the 2020 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. Estimates of Diversion Pursuant to the SUPPORT Act The SUPPORT Act (21 U.S.C. 826(i)(1)(a)) requires that ‘‘in establishing any quota under this section . . ., for [the covered controlled substances], the Attorney General shall estimate the amount of diversion of the [covered controlled substances] that occurs in the United States.’’ To estimate diversion as is required by the SUPPORT Act, DEA aggregated the active pharmaceutical ingredient (API) of each covered controlled substance by metric weight where the data was available in the aforementioned databases. Based on the individual entries into the aforementioned databases, DEA calculated the estimated amount of diversion by multiplying the strength of the API listed for each finished dosage form by the total amount of units reported to estimate the metric weight in kilograms of the controlled substance being diverted. The estimate of diversion for each of the covered controlled substances is reported below. DIVERSION ESTIMATES FOR 2018 (KG) Fentanyl ........................................ Hydrocodone ................................ Hydromorphone ............................ Oxycodone .................................... Oxymorphone ............................... 0.109 24.259 1.219 57.051 1.157 In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2020 aggregate production quotas for the following schedule I and II controlled substances and the 2020 assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: Established 2020 quotas (g) Basic class jbell on DSKJLSW7X2PROD with NOTICES 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 (AM694) ........................................................................................................................... 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 (DMA) .................................................................................................................................................... 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 ............................................................................................................................................................................. VerDate Sep<11>2014 17:10 Nov 29, 2019 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1 20 15 10 30 30 25 10 15 30 30 30 30 100 30 30 25 30 30 25 25 25 30 30 30 55 50 40 40 35 25 30 30 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices Established 2020 quotas (g) jbell on DSKJLSW7X2PROD with NOTICES Basic class 4-Bromo-2,5-dimethoxyamphetamine (DOB) ...................................................................................................................................... 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) .................................................................................................................................. 4-Chloro-a-pyrrolidinovalerophenone (4-chloro-alpha-PVP) ............................................................................................................... 4CN-Cumyl-Butanica, 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-ethylaminopentiophenone (4-MEAP) ................................................................................................................................ 4-Methyl-a-pyrrolidinohexiophenone (MPHP) ..................................................................................................................................... 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) ........................... 5F-CUMYL-PINACA ............................................................................................................................................................................ 5F-EDMB-PINACA ............................................................................................................................................................................... 5F-MDMB-PICA ................................................................................................................................................................................... 5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide ............................................ 5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide) ..................................... 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)-1H-indol-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) .................................. Acetorphine .......................................................................................................................................................................................... Acetyl Fentanyl .................................................................................................................................................................................... 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 ..................................................................................................................................................................................... Alphaprodine ........................................................................................................................................................................................ alpha-Methylfentanyl ............................................................................................................................................................................ alpha-Methylthiofentanyl ...................................................................................................................................................................... alpha-Methyltryptamine (AMT) ............................................................................................................................................................ alpha-Pyrrolidinobutiophenone (a-PBP) .............................................................................................................................................. alpha-Pyrrolidinoheptaphenone (PV8) ................................................................................................................................................. alpha-Pyrrolidinohexanophenone (a-PHP) .......................................................................................................................................... alpha-Pyrrolidinopentiophenone (a-PVP) ............................................................................................................................................ Aminorex .............................................................................................................................................................................................. Anileridine ............................................................................................................................................................................................ APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) ......................................................................................... Benzethidine ........................................................................................................................................................................................ Benzylmorphine ................................................................................................................................................................................... Betacetylmethadol ............................................................................................................................................................................... beta-Hydroxy-3-methylfentanyl ............................................................................................................................................................ beta-Hydroxyfentanyl ........................................................................................................................................................................... beta-Hydroxythiofentanyl ..................................................................................................................................................................... Betameprodine ..................................................................................................................................................................................... Betamethadol ....................................................................................................................................................................................... Betaprodine .......................................................................................................................................................................................... Bufotenine ............................................................................................................................................................................................ Butylone ............................................................................................................................................................................................... Butyryl fentanyl .................................................................................................................................................................................... Cathinone ............................................................................................................................................................................................. Clonitazene .......................................................................................................................................................................................... VerDate Sep<11>2014 18:34 Nov 29, 2019 Jkt 250001 PO 00000 Frm 00055 Fmt 4703 66019 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1 30 25 25 25 30 25 25 150 25 25 45 25 25 25 50 40 25 25 25 25 25 30 30 30 20 25 25 25 25 30 50 30 30 25 100 30 30 25 25 50 30 25 2 25 2 2 25 30 30 25 25 25 25 25 25 20 25 25 30 2 30 30 30 25 4 25 15 25 30 40 25 66020 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices Established 2020 quotas (g) jbell on DSKJLSW7X2PROD with NOTICES Basic class Codeine methylbromide ....................................................................................................................................................................... Codeine-N-oxide .................................................................................................................................................................................. Cyclopentyl Fentanyl ........................................................................................................................................................................... Cyclopropyl Fentanyl ........................................................................................................................................................................... Cyprenorphine ..................................................................................................................................................................................... Desomorphine ...................................................................................................................................................................................... Dextromoramide .................................................................................................................................................................................. Diapromide ........................................................................................................................................................................................... Diethylthiambutene .............................................................................................................................................................................. Diethyltryptamine ................................................................................................................................................................................. Difenoxin .............................................................................................................................................................................................. Dihydromorphine .................................................................................................................................................................................. Dimenoxadol ........................................................................................................................................................................................ Dimepheptanol ..................................................................................................................................................................................... Dimethylthiambutene ........................................................................................................................................................................... Dimethyltryptamine .............................................................................................................................................................................. Dioxyaphetyl butyrate .......................................................................................................................................................................... Dipipanone ........................................................................................................................................................................................... Drotebanol ........................................................................................................................................................................................... Ethylmethylthiambutene ....................................................................................................................................................................... Etorphine .............................................................................................................................................................................................. Fenethylline .......................................................................................................................................................................................... Fentanyl related substances ................................................................................................................................................................ FUB-144 ............................................................................................................................................................................................... FUB-AKB48 ......................................................................................................................................................................................... Furanyl fentanyl ................................................................................................................................................................................... Furethidine ........................................................................................................................................................................................... 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) ............................................................................................................................ Ketobemidone ...................................................................................................................................................................................... Levomoramide ..................................................................................................................................................................................... Levophenacylmorphan ......................................................................................................................................................................... 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) ........................................... MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate ............................. Marihuana ............................................................................................................................................................................................ Mecloqualone ....................................................................................................................................................................................... Mescaline ............................................................................................................................................................................................. Methaqualone ...................................................................................................................................................................................... Methcathinone ..................................................................................................................................................................................... Methyoxyacetyl fentanyl ...................................................................................................................................................................... Methyldesorphine ................................................................................................................................................................................. Methyldihydromorphine ........................................................................................................................................................................ Morpheridine ........................................................................................................................................................................................ Morphine methylbromide ..................................................................................................................................................................... Morphine methylsulfonate .................................................................................................................................................................... Morphine-N-oxide ................................................................................................................................................................................ MT-45 ................................................................................................................................................................................................... Myrophine ............................................................................................................................................................................................ NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate ................................................................................................ N,N-Dimethylamphetamine .................................................................................................................................................................. Naphyrone ........................................................................................................................................................................................... N-Ethyl-1-phenylcyclohexylamine ........................................................................................................................................................ N-Ethyl-3-piperidyl benzilate ................................................................................................................................................................ N-Ethylamphetamine ........................................................................................................................................................................... N-Ethylhexedrone ................................................................................................................................................................................ VerDate Sep<11>2014 18:34 Nov 29, 2019 Jkt 250001 PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1 30 192 30 20 25 25 25 20 20 25 9,200 753,500 25 25 20 50 25 5 25 25 30 30 40 25 25 30 25 25,417,000 45 40 25 30 25 35 45 45 30 30 35 30 30 30 30 25 25 40 30 30 30 25 3,200,000 30 25 60 25 30 5 25 25 5 5 150 30 25 25 25 25 5 10 24 25 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices 66021 Established 2020 quotas (g) Basic class N-Ethylpentylone, ephylone ................................................................................................................................................................. N-Hydroxy-3,4-methylenedioxyamphetamine ...................................................................................................................................... N-Methyl-3-Piperidyl Benzilate ............................................................................................................................................................ Nicocodeine ......................................................................................................................................................................................... Nicomorphine ....................................................................................................................................................................................... Noracymethadol ................................................................................................................................................................................... Norlevorphanol ..................................................................................................................................................................................... Normethadone ..................................................................................................................................................................................... Normorphine ........................................................................................................................................................................................ Norpipanone ........................................................................................................................................................................................ Ocfentanil ............................................................................................................................................................................................. Ortho-fluorofentanyl, 2-fluorofentanyl .................................................................................................................................................. Para-chloroisobutyryl fentanyl ............................................................................................................................................................. Para-fluorofentanyl ............................................................................................................................................................................... Para-fluorobutyryl fentanyl ................................................................................................................................................................... Para-methoxybutyryl fentanyl .............................................................................................................................................................. Parahexyl ............................................................................................................................................................................................. PB-22; QUPIC ..................................................................................................................................................................................... Pentedrone .......................................................................................................................................................................................... Pentylone ............................................................................................................................................................................................. Phenadoxone ....................................................................................................................................................................................... Phenampromide ................................................................................................................................................................................... Phenomorphan .................................................................................................................................................................................... Phenoperidine ...................................................................................................................................................................................... Pholcodine ........................................................................................................................................................................................... Piritramide ............................................................................................................................................................................................ Proheptazine ........................................................................................................................................................................................ Properidine ........................................................................................................................................................................................... Propiram .............................................................................................................................................................................................. Psilocybin ............................................................................................................................................................................................. Psilocyn ................................................................................................................................................................................................ Racemoramide ..................................................................................................................................................................................... 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 ................................................................................................................................................................... Thebacon ............................................................................................................................................................................................. Thiafentanil .......................................................................................................................................................................................... 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 .................................................................................................................................................................................... 30 24 30 25 25 25 55 25 40 25 25 30 30 25 25 30 5 20 25 25 25 25 25 25 5 25 25 25 25 30 50 25 45 30 384,460 15 25 25 25 30 25 25 25 30 25 jbell on DSKJLSW7X2PROD with NOTICES Schedule II 1-Phenylcyclohexylamine .................................................................................................................................................................... 1-Piperidinocyclohexanecarbonitrile .................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ......................................................................................................................................... Alfentanil .............................................................................................................................................................................................. Alphaprodine ........................................................................................................................................................................................ Amobarbital .......................................................................................................................................................................................... Amphetamine (for conversion) ............................................................................................................................................................ Amphetamine (for sale) ....................................................................................................................................................................... Bezitramide .......................................................................................................................................................................................... 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) ............................................................................................................................................................. VerDate Sep<11>2014 18:34 Nov 29, 2019 Jkt 250001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\02DEN1.SGM 02DEN1 15 25 813,005 3,260 2 20,100 14,137,578 47,000,000 25 20 82,127 3,225,000 30,731,558 35 156,713 2 14,100 770,800 88,134 30 32 813,005 25 1,250 66022 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices Established 2020 quotas (g) Basic class Hydrocodone (for sale) ........................................................................................................................................................................ Hydromorphone ................................................................................................................................................................................... Isomethadone ...................................................................................................................................................................................... Levo-alphacetylmethadol (LAAM) ........................................................................................................................................................ Levomethorphan .................................................................................................................................................................................. Levorphanol ......................................................................................................................................................................................... Lisdexamfetamine ................................................................................................................................................................................ Meperidine ........................................................................................................................................................................................... Meperidine Intermediate-A .................................................................................................................................................................. Meperidine Intermediate-B .................................................................................................................................................................. Meperidine Intermediate-C .................................................................................................................................................................. Metazocine ........................................................................................................................................................................................... Methadone (for sale) ........................................................................................................................................................................... Methadone Intermediate ...................................................................................................................................................................... Methamphetamine ............................................................................................................................................................................... 34,836,854 3,054,479 30 5 30 38,000 21,000,000 1,463,873 30 30 30 15 22,278,000 24,064,000 1,213,603 [678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 505,231 grams for methamphetamine mostly for conversion to a schedule III product; and 29,494 grams for methamphetamine (for sale)] Methylphenidate ................................................................................................................................................................................... Metopon ............................................................................................................................................................................................... Moramide-intermediate ........................................................................................................................................................................ 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 ..................................................................................................................................................................................... Piminodine ........................................................................................................................................................................................... Racemethorphan ................................................................................................................................................................................. Racemorphan ...................................................................................................................................................................................... Remifentanil ......................................................................................................................................................................................... Secobarbital ......................................................................................................................................................................................... Sufentanil ............................................................................................................................................................................................. Tapentadol ........................................................................................................................................................................................... Thebaine .............................................................................................................................................................................................. 57,438,334 25 25 4,089,000 29,353,655 62,000 19,169,340 376,000 250,000 530,837 28,705,000 914,010 67,593,983 24,525,540 829,051 25,850,000 25 35 25 40 25 5 5 3,000 172,100 4,000 13,447,541 70,829,235 List I Chemicals jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:34 Nov 29, 2019 Jkt 250001 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Administrator may adjust the 2020 aggregate production quotas and assessment of annual needs as needed. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 25 4,136,000 14,100,000 7,990,000 1,000 174,246,000 Dated: November 27, 2019. Uttam Dhillon, Acting Administrator. [FR Doc. 2019-26119 Filed 11–29–19; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\02DEN1.SGM 02DEN1 Federal Register / Vol. 84, No. 231 / Monday, December 2, 2019 / Notices information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. DEPARTMENT OF JUSTICE [OMB Number 1121–0311] Agency Information Collection Activities; Proposed eCollection eComments Requested; Reinstatement, With Change, of Previously Approved Collection: National Inmate Survey in Prisons (NIS–4P) Bureau of Justice Statistics, Department of Justice. ACTION: 60-Day notice. AGENCY: The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. DATES: Comments are encouraged and will be accepted for 60 days until January 31, 2020. FOR FURTHER INFORMATION CONTACT: If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Amy Lauger, Supervisory Statistician, Institutional Research and Special Projects Unit, Bureau of Justice Statistics, 810 Seventh Street NW, Washington, DC 20531 (email: Amy.Lauger@ojp.usdoj.gov; telephone: 202–307–0711). SUPPLEMENTARY INFORMATION: Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points: —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility; —Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether, and if so how, the quality, utility, and clarity of the jbell on DSKJLSW7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:34 Nov 29, 2019 Jkt 250001 Overview of this information collection: 1 Type of Information Collection: Reinstatement, with change, of a previously approved collection. 2 The Title of the Form/Collection: National Inmate Survey in Prisons (NIS– 4P). 3 The agency form number, if any, and the applicable component of the Department sponsoring the collection: There is no agency form number at this time. The applicable component within the Department of Justice is the Bureau of Justice Statistics, in the Office of Justice Programs. 4 Affected public who will be asked or required to respond, as well as a brief abstract: Respondents will primarily be State, Local, or Tribal Government entities. The work under this clearance will be used to produce estimates for the incidence and prevalence of sexual victimization within correctional facilities as required under the Prison Rape Elimination Act of 2003 (Pub. L. 108–79). The Bureau of Justice Statistics uses this information in published reports and for the U.S. Congress, Executive Office of the President, practitioners, researchers, students, the media, and others interested in criminal justice statistics. In 2003, the Prison Rape Elimination Act (PREA or the Act) was signed into law. The Act requires BJS to ‘‘carry out, for each calendar year, a comprehensive statistical review and analysis of the incidence and effects of prison rape.’’ The Act further instructs BJS to collect survey data: ‘‘. . . the Bureau shall . . . use surveys and other statistical studies of current and former inmates . . .’’ To implement the Act, BJS developed the National Prison Rape Statistics Program (NPRS), which includes four separate data collection efforts: The Survey on Sexual Violence (SSV), the National Inmate Survey (NIS), the National Survey of Youth in Custody (NSYC), and the National Former Prisoner Survey (NFPS). The NIS PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 66023 collects information on sexual victimization self-reported by inmates held in adult correctional facilities, both prisons and jails. The NIS has been conducted three times, in 2007 (NIS–1), in 2008–09 (NIS–2), and in 2011–12 (NIS–3). Each iteration of NIS was conducted in at least one facility in all 50 states and the District of Columbia. In each iteration of the survey, inmates completed the survey using an audio computer-assisted self-interview (ACASI), whereby they heard questions and instructions via headphones and responded to the survey items via a touch-screen interface. The collection requested in this notice is the fourth iteration of the National Inmate Survey. For NIS–4, administration of the survey in prisons will take place separately from survey administration in jails. This collection request is specific to conducting the survey in adult prison facilities. The survey instrument for the NIS–4 in Prisons is slightly modified from the previous iterations. The main difference is the addition of a new set of incidentspecific questions administered to respondents who affirmatively indicate they were sexually victimized at some point in the previous 12 months while housed in their current prison facility. These incident-specific questions will provide information to the public on the nature of sexual victimization in prisons, such as where incidents occurred within the facility, the relationship between the victim and the alleged perpetrator(s), and whether the victim suffered any injuries as a result of the incident, among other incident characteristics. 5 An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: Prior to data collection commencing in 2020, BJS will coordinate the logistics of NIS–4 survey administration with staff at state, local, and tribal correction facilities. Because the administration of this survey in jails is not included in this request, the overall number of burden hours is lower than in the last request approved in 2010 (the jail survey will be submitted under a new OMB number). It is estimated that 150 facility respondents will devote 180 minutes of time to this coordination effort. During data collection in 2020, 77,000 state, local, and tribal adult inmates held in prisons E:\FR\FM\02DEN1.SGM 02DEN1

Agencies

[Federal Register Volume 84, Number 231 (Monday, December 2, 2019)]
[Notices]
[Pages 66014-66023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26119]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-508E]


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 2020

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final order.

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SUMMARY: This final order establishes the initial 2020 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: Effective Date: This order is effective December 2, 2019.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration, 8701 Morrissette Drive, 
Springfield, VA 22152, Telephone: (571) 362-3261.

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 schedule 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 Drug Enforcement Administration (DEA) 
pursuant to 28 CFR 0.100.

Background

    The 2020 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 
2020 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.

[[Page 66015]]

    On September 12, 2019, 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 2020'' was published in 
the Federal Register. 84 FR 48170. This notice proposed the 2020 
aggregate production quotas for each basic class of controlled 
substance listed in schedules I and II, and the 2020 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 October 15, 2019.

Comments Received

    Within the public comment period, DEA received 731 comments from 
DEA registrants, hospital associations, professional associations, 
doctors, nurses, health system organizations, State Attorneys General, 
and others. The comments included concerns about the quota process, 
concerns that further quota reductions will lead to drug shortages, 
requests for less interference in the doctor-patient relationship, 
availability of prescription drugs for chronic pain patients, requests 
for hearings, requests for increase in specific production quotas, and 
other comments outside the scope of this notice. DEA received a joint 
comment from two Senators urging DEA to apply DEA's new authorities to 
prevent and limit opioid diversion due to excessively high production 
levels. Although this comment was received after the close of the 
comment period, DEA shares the Senators' concerns and is working to 
improve its ability to use available databases to better quantify 
diversion as part of the quota process.

Shortages

    There were non-DEA registered commenters that expressed concerns 
about the decrease in 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 DEA 
separate quotas for solid oral controlled substances and injectable 
controlled substances, and that DEA allow consideration by individual 
pharmaceutical dosage forms.
    DEA also received letters from many doctors, nurses, hospital 
administrators, and others in the medical field regarding the proposed 
quota reduction for fentanyl and other schedule II narcotics. These 
letters characterized the reductions as ``extremely problematic for 
American healthcare providers,'' stating that the reduction for 
fentanyl and other schedule II narcotics will lead to drug shortages, 
raise drug prices, lead to hardships on hospitals and surgical 
facilities, and negatively impact patients. These letters discussed 
fentanyl's appearance on the Food and Drug Administration's (FDA) drug 
shortage list and that fentanyl is the least diverted among the covered 
controlled substances.
    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 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 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.
    Pursuant to 21 U.S.C. 826(a)(1), ``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.'' However, the 
Substance Use-Disorder Prevention that Promotes Opioid Recovery 
Treatment for Patients and Communities Act of 2018 (SUPPORT Act), (Pub. 
L. 115-271), provides an exception to that general rule by now giving 
DEA the authority to establish quotas in terms of pharmaceutical dosage 
forms if the agency determines that doing so will assist in avoiding 
the overproduction, shortages, or diversion of a controlled substance. 
While DEA is now allowed to issue quotas in terms of pharmaceutical 
dosage form, it is not required to do so. DEA will not be utilizing 
this authority at the aggregate production quota level, but will be 
doing so at the individual dosage-form manufacturing level where it 
will have a greater impact on averting potential shortages. Because 
quotas set at the individual dosage-form manufacturing level are more 
directly connected to distributions of current and new FDA-approved 
drug products, they allow DEA to manage manufacturing quotas to 
alleviate any potential shortage in a more timely manner than with 
quotas set at the aggregate production quota level. This is also true 
because the aggregate production quota is initially established prior 
to the start of the quota calendar year.
    Additionally, DEA and FDA can coordinate efforts to prevent or 
alleviate drug shortages pursuant to 21 U.S.C. 826(h). Such efforts may 
include adjusting domestic competitors' quota, completion of FDA 
approval to increase the number of competitors, and determining a 
foreign manufacturer that can meet FDA approval. For example, the 
domestic shortage of injectable hydromorphone that occurred in 2018 was 
alleviated through the collaboration of FDA and DEA to determine who 
were the other dosage-form manufacturers with injectable hydromorphone 
products in the market, whether other dosage-form manufacturers had the 
capability to increase their production levels to meet legitimate 
patient need in a timely manner, and when it was determined that the 
domestic manufacturers could not increase production significantly to 
meet legitimate patient need, DEA and FDA coordinated their regulatory 
authority to allow for the limited importation of injectable 
hydromorphone into the United States.

Relevant Information Obtained From the States

    Pursuant to 21 CFR 1303.11, DEA must consider relevant information 
from the States when setting the aggregate production quota. Seven 
State Attorneys General submitted a joint comment expressing concerns 
about the estimation of diversion for all controlled substances, not 
accounting for over-prescribing, and the consideration of additional 
information to set quotas. Their concerns are addressed in more detail 
below.

I. Diversion Analysis for All Controlled Substances

    The seven State Attorneys General commented that DEA should not 
take different approaches when accounting for diversion for the five 
covered controlled substances and the remaining controlled substances. 
In the letter, they discussed the mandates from the SUPPORT Act, as 
well as the requirements implemented through 21 CFR 1303.11 by the 
Controlled Substances Quota rule. 83 FR 32784. They expressed that they 
have similar language and purposes, even though the SUPPORT Act goes a 
bit further in its mandate by requiring the estimation of diversion for 
the five covered controlled substances. They pointed out that DEA

[[Page 66016]]

estimated diversion and made straightforward quota reductions by the 
corresponding quantities, whereas DEA only noted that the databases 
contained usable information in regards to the remaining controlled 
substances. DEA did not indicate that diversion estimates were 
conducted for any other controlled substance, nor did DEA indicate that 
any corresponding decreases were made for other controlled substances. 
They commented that if DEA believes they have a sound method for 
estimating diversion, then it is unreasonable not to apply that method 
for estimating diversion to all controlled substances.
    The States also commented that there is a lack of transparency in 
the setting of quotas. The States believe that DEA needs to explain the 
logic behind using different approaches in setting quotas. They 
commented that DEA must include the findings of fact when setting the 
quota and that transparency is essential in allowing parties to 
evaluate DEA's 2020 Proposed Aggregate Production Quota notice.
    DEA considered various data sources in order to determine the 
extent of diversion of all controlled substances as is required by the 
recent amendments to the CSA and changes to DEA's own regulations. In 
accordance with factor six in 21 CFR 1303.11(b), DEA formally solicited 
the Department of Health and Human Services (HHS), U.S. Centers for 
Disease Control and Prevention (CDC), the Centers for Medicare and 
Medicaid Services (CMS), and the states in August 2018, requesting 
information including rates of overdose deaths and abuse and overall 
public health impact related to controlled substances. This information 
was also considered pursuant to the SUPPORT Act. DEA determined that 
due to the grouping of drug classes in all of the sources provided, the 
data could not be used to estimate diversion for the purpose of setting 
the aggregate production quotas. However, DEA estimated diversion of 
the covered controlled substances defined in the SUPPORT Act utilizing 
DEA's internal data sources. DEA will continue to further define 
sources that will be useful in analyzing diversion of the remaining 
controlled substances.

II. Methods and Data That Capture Over-Prescribing as Part of its 
Diversion Analysis

    The States acknowledged that DEA's current approach for accounting 
for diversion is a significant improvement but commented that DEA does 
not adequately account for over-prescribing. They commented that over-
prescribing results when there is overproduction, which allows 
legitimate prescriptions to be diverted. Assuming a controlled 
substance is validly dispensed for a legitimate medical purpose, both 
the physician and patient will use their judgement to determine how 
much medication will be prescribed and how much they will consume. The 
physician's decisions may be influenced by recommendations from CDC, 
FDA, and professional medical organizations that have conducted and/or 
reviewed clinical studies used to determine prescription guidelines. 
Patients are ultimately going to decide for themselves how much of the 
legitimately prescribed medication they will consume. DEA does not 
control the quantity of a substance prescribed to a patient, and DEA 
cannot control how much of the prescription a patient decides to 
consume. DEA also receives assistance in curbing overprescribing from 
programs in place, such as the President's Safer Prescribing Plan, 
which seeks to reduce nationwide opioid prescription fills by one-
third. 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. These decreases take into 
account the combined efforts of DEA, FDA, and CDC enforcing regulations 
and issuing guidance documents, as well as many states enacting 
prescription monitoring database programs to stem the opiate/opioid 
epidemic.
    There are ample reasons not to pursue the methods suggested by the 
State Attorneys General, including that the studies on which they 
relied are limited in scope of procedures and number of hospitals, such 
that the methodology is insufficient to expand to a national level.
    As pointed out by the States, ``there is no perfect system of 
measuring other sources of diversion like over-prescription.'' The 
States pointed to data from drug takeback programs, but currently that 
data is not usable for consideration in determining the aggregate 
production quota. There is no method in place to determine how much of 
the prescription medications are schedule I or II substances and which 
controlled substances are being returned. DEA and HHS are working 
together to consider options for quantifying Take-Back Program data.

III. Consideration of Additional Information To Determine Production 
Quotas

    The State Attorneys General commented that DEA should expand its 
sources of data used to set aggregate production quotas. They suggested 
three steps that DEA should take to gather information to set quotas 
which are listed below.

1: Improve Usability of the Automated Reports and Consolidated Ordering 
System (ARCOS) and the Suspicious Order Reporting System (SORS)

    The State Attorneys General commented that DEA should improve 
usability of the ARCOS and SORS databases to gather better information 
on prescribing practices. They also note that DEA did not indicate 
whether SORS was used and minimally referred to ARCOS not being used 
because it contained identical information to the Theft Loss Report 
Database. The States commented that DEA needs to reform its process to 
upload SORS reports into the SORS database. Further, they commented 
that overdose data received from States and the CDC should be cross-
referenced with ARCOS to provide context that should inform the quota-
setting process.
    SORS was not centralized until its recent launch on October 23, 
2019. DEA will need time to sort through the system to determine its 
utility for aggregate production quota purposes. The submission of a 
suspicious order alone is not an automatic determination that the order 
is illicit in nature. Further investigations need to be completed to 
determine if a transgression has occurred.
    The differences in reporting frequencies to ARCOS are specified in 
21 CFR 1304.33(b). Acquisition and distribution transaction reports 
must be completed every quarter no later than the 15th day of the month 
succeeding the quarter for which it is being submitted. In the same 
section of the CFR, it does mention that a registrant may be given 
permission to file a report more frequently, but no more than on a 
monthly basis. The State Attorneys General request to change this 
regulation is outside of the scope of this final order.

2: Improve Data Collection in Prescription Drug Takeback Programs To 
Capture the Quantities of Drugs Overprescribed in Particular Areas

    The State Attorneys General expressed that DEA should expand the 
National Take Back Program to assist with gathering more precise data 
on over-prescribing. They noted that the takeback programs do not track 
the types and quantities of what the public turns in, limiting their 
value. Currently, DEA and HHS are working together to consider methods 
that improve data

[[Page 66017]]

collection and subsequently the usability of data obtained from the 
Take-Back Program.

3: Consider Medical Best Practices as Part of the Holistic Diversion 
Analysis

    The letter submitted by the State Attorneys General also suggested 
that DEA study the best practices developed by the medical community 
and state regulators to determine what opioid quantities are 
``medically necessary.'' They expressed that relying exclusively on 
evidence of illegal activity assumes that any legally-sold controlled 
substance is a part of the medical and scientific needs of the United 
States.
    DEA is responsible for enforcing the provisions of the CSA and DEA 
regulations that require prescriptions for controlled substances to be 
issued by a practitioner for a legitimate medical purpose in the usual 
course of his/her professional practice. However, beyond that context, 
DEA does not regulate the practice of medicine generally and thus does 
not have a role in establishing the type of ``best practices'' to which 
the commenter refers.

Pain Management and Medical Associations Letters

    DEA also received 106 comments that expressed concern that DEA's 
proposed reduction of opioids would adversely impact the availability 
of pain relieving prescription drugs for people with chronic pain. 
These comments were general in nature, and raised issues of specific 
medical illnesses and medical treatment, and therefore are outside of 
the scope of this Final Order. As a result, these comments did not 
provide new discrete data for consideration, and they do not impact the 
original analysis involved in establishing the 2020 aggregate 
production quotas.
    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 require doctors to only write prescriptions 
for legitimate medical needs. Any practitioner issuing an invalid 
prescription for controlled substances, and any pharmacy knowingly 
filling such a prescription, would be in violation of the CSA.

Hearings

    Two commenters urged DEA to hold a public hearing to receive 
feedback from stakeholders. They asked that DEA bring together all 
stakeholders, allowing stakeholders to publicly discuss their concerns.
    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 five DEA-registered manufacturers 
regarding twenty-four different schedule I and II controlled 
substances. Commenters stated the proposed aggregate production quotas 
for amphetamine (for sale), fentanyl, hydromorphone, methylphenidate, 
morphine, noroxymorphone (for conversion), and oxycodone (for sale) 
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. 
Commenters requested the proposed aggregate production quotas for FUB-
144, 5F-AB-PINACA, 5F-EDMB-PINACA, 5F-MDMB-PICA, MMB-CHMICA, FUB-AKB48 
(FUB-APINACA), 5F-CUMYL-PINACA, 5F-CUMYL-P7AICA, 4-CN-CUMYL-BUTINACA, 
NM2201, 4-Methyl-alpha-ethylaminopentiophenone (4-MEAP), N-
Ethylhexedrone, 4-Chloro-alpha-pyrrolidinovalerophenone (4-Chloro-
alpha-PVP), 4'-Methyl-alpha-pyrrolidinohexiophenone (MPHP), N-
Ethylpentylone, alpha-Pyrrolidinohexanophenone (alpha-PHP), and alpha-
Pyrrolidinoheptaphenone (PV8), be sufficient for additional quota 
requests.
    DEA has considered the comments for specific controlled substances 
and made adjustments as needed which are described below in the section 
titled Determination of 2020 Aggregate Production Quotas and Assessment 
of Annual Needs. DEA received one comment to the proposed established 
2020 assessment of annual needs for ephedrine, pseudoephedrine, and 
phenylpropanolamine regarding the difficulty in procuring finished 
dosage-forms of ephedrine. DEA has considered this comment in the 
section regarding drug shortages of controlled substances. This letter 
characterized the reductions of controlled substances and ephedrine as 
``extremely problematic for American healthcare providers,'' stating 
that these reductions will lead to drug shortages, raise drug prices, 
lead to hardships on hospitals and surgical facilities, and negatively 
impact patients.
    DEA is required under the CSA to establish quotas for ephedrine, 
pseudoephedrine, and phenylpropanolamine 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. Although DEA sets the assessment of 
annual needs, it is possible that manufacturers' business practices may 
lead to a shortage of ephedrine drug products at the consumer level, 
despite the adequacy of the assessment of annual needs set by DEA. For 
instance, DEA does not have the authority to dictate when during the 
calendar year the manufacturer actually utilizes the quota granted to 
them. Also, DEA cannot dictate how much of the granted quota the 
manufacturer allocates for use in a single production run. The 
assessment of annual needs is set by DEA in a manner to include all 
dosage forms of ephedrine in order to ensure that the estimated medical 
needs of the United States are met.
    Additionally, DEA and FDA can coordinate efforts to prevent or 
alleviate drug shortages. Such efforts may include adjusting 
competitors' domestic or import quotas and completion of FDA approval 
to increase the number of competitors.

Out of Scope

    DEA received 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. DEA also received comments asserting that illicit drug use, and 
not prescription drug use, is the main factor in the opioid crisis. 
Although DEA is genuinely concerned with illicit drug use and its 
involvement in the opioid crisis, the manufacturing of illicit 
substances is not considered when determining the aggregate production 
quotas because such illicit manufacturing cannot be tempered by 
adjusting the aggregate production quotas, therefore it is outside the 
scope of this final order.
    All of these out of scope issues do not impact the original 
analysis involved in establishing the 2020 aggregate production quotas.

[[Page 66018]]

Determination of 2020 Aggregate Production Quotas and Assessment of 
Annual Needs

    In determining the 2020 aggregate production quotas and assessment 
of annual needs, DEA has taken into consideration the above comments 
along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, 
in accordance with 21 U.S.C. 826(a), and other relevant factors, 
including the 2019 manufacturing quotas, current 2019 sales and 
inventories, anticipated 2020 export requirements, industrial use, 
additional applications for 2020 quotas, as well as information on 
research and product development requirements. Based on all of the 
above, the Administrator is adjusting the 2020 aggregate production 
quotas for 4-Methyl-alpha-ethylaminopentiophenone (4-MEAP), N-
Ethylhexedrone, 4-Chloro-alpha-pyrrolidinovalerophenone (4-Chloro-
alpha-PVP), 4'-Methyl-alpha-pyrrolidinohexiophenone (MPHP), alpha-
Pyrrolidinohexanophenone (alpha-PHP), alpha-Pyrrolidinoheptaphenone 
(PV8), amphetamine (for sale), oxycodone (for sale), and oxymorphone 
(for sale).
    Regarding FUB-144, 5F-AB-PINACA, 5F-EDMB-PINACA, 5F-MDMB-PICA, MMB-
CHMICA, FUB-AKB48 (FUB-APINACA), 5F-CUMYL-PINACA, 5F-CUMYL-P7AICA, 4-
CN-CUMYL-BUTINACA, NM2201, N-Ethylpentylone, fentanyl, hydromorphone, 
methylphenidate, morphine, noroxymorphone (for conversion), and 
oxycodone (for sale), DEA has determined the proposed aggregate 
production quotas and assessment of annual needs are sufficient to 
provide for the 2020 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.

Estimates of Diversion Pursuant to the SUPPORT Act

    The SUPPORT Act (21 U.S.C. 826(i)(1)(a)) requires that ``in 
establishing any quota under this section . . ., for [the covered 
controlled substances], the Attorney General shall estimate the amount 
of diversion of the [covered controlled substances] that occurs in the 
United States.'' To estimate diversion as is required by the SUPPORT 
Act, DEA aggregated the active pharmaceutical ingredient (API) of each 
covered controlled substance by metric weight where the data was 
available in the aforementioned databases. Based on the individual 
entries into the aforementioned databases, DEA calculated the estimated 
amount of diversion by multiplying the strength of the API listed for 
each finished dosage form by the total amount of units reported to 
estimate the metric weight in kilograms of the controlled substance 
being diverted. The estimate of diversion for each of the covered 
controlled substances is reported below.

                    Diversion Estimates for 2018 (kg)
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Fentanyl.....................................................      0.109
Hydrocodone..................................................     24.259
Hydromorphone................................................      1.219
Oxycodone....................................................     57.051
Oxymorphone..................................................      1.157
------------------------------------------------------------------------

    In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 
1315.11, the Administrator hereby establishes the 2020 aggregate 
production quotas for the following schedule I and II controlled 
substances and the 2020 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                          2020 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 (AM694)......              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)................             100
2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-                                 30
 methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B;
 Cimbi-36)..............................................
2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C).......              30
2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-                                25
 methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C;
 Cimbi-82)..............................................
2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I).........              30
2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-                                  30
 methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I;
 Cimbi-5)...............................................
2,5-Dimethoxy-4-ethylamphetamine (DOET).................              25
2,5-Dimethoxy-4-n-propylthiophenethylamine..............              25
2,5-Dimethoxyamphetamine (DMA)..........................              25
2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)              30
2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-              30
 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

[[Page 66019]]

 
4-Bromo-2,5-dimethoxyamphetamine (DOB)..................              30
4-Bromo-2,5-dimethoxyphenethylamine (2-CB)..............              25
4-Chloro-[alpha]-pyrrolidinovalerophenone (4-chloro-                  25
 alpha-PVP).............................................
4CN-Cumyl-Butanica, 1-(4-Cyanobutyl)-N-(2-phenylpropan-2-             25
 yl)-1H-indazole-3-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]-ethylaminopentiophenone (4-MEAP).......              25
4-Methyl-[alpha]-pyrrolidinohexiophenone (MPHP).........              25
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)...
5F-CUMYL-PINACA.........................................              25
5F-EDMB-PINACA..........................................              25
5F-MDMB-PICA............................................              25
5F-AB-PINACA; N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-              25
 fluoropentyl)-1H-indazole-3-carboxamide................
5F-CUMYL-P7AICA; (1-(5-fluoropentyl)-N-(2-phenylpropan-2-             25
 yl)-1H-pyrrolo[2,3-b]pyridine-3-carboximide)...........
5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-              30
 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)-1H-indol-3-               25
 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)-1-             30
 (4-fluorobenzyl)-1H-indazole-3-carboxamide)............
Acetorphine.............................................              25
Acetyl Fentanyl.........................................             100
Acetyl-alpha-methylfentanyl.............................              30
Acetyldihydrocodeine....................................              30
Acetylmethadol..........................................              25
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............................................              25
Alphacetylmethadol......................................               2
alpha-Ethyltryptamine...................................              25
Alphameprodine..........................................               2
Alphamethadol...........................................               2
Alphaprodine............................................              25
alpha-Methylfentanyl....................................              30
alpha-Methylthiofentanyl................................              30
alpha-Methyltryptamine (AMT)............................              25
alpha-Pyrrolidinobutiophenone ([alpha]-PBP).............              25
alpha-Pyrrolidinoheptaphenone (PV8).....................              25
alpha-Pyrrolidinohexanophenone ([alpha]-PHP)............              25
alpha-Pyrrolidinopentiophenone ([alpha]-PVP)............              25
Aminorex................................................              25
Anileridine.............................................              20
APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-                25
 carboxamide)...........................................
Benzethidine............................................              25
Benzylmorphine..........................................              30
Betacetylmethadol.......................................               2
beta-Hydroxy-3-methylfentanyl...........................              30
beta-Hydroxyfentanyl....................................              30
beta-Hydroxythiofentanyl................................              30
Betameprodine...........................................              25
Betamethadol............................................               4
Betaprodine.............................................              25
Bufotenine..............................................              15
Butylone................................................              25
Butyryl fentanyl........................................              30
Cathinone...............................................              40
Clonitazene.............................................              25

[[Page 66020]]

 
Codeine methylbromide...................................              30
Codeine-N-oxide.........................................             192
Cyclopentyl Fentanyl....................................              30
Cyclopropyl Fentanyl....................................              20
Cyprenorphine...........................................              25
Desomorphine............................................              25
Dextromoramide..........................................              25
Diapromide..............................................              20
Diethylthiambutene......................................              20
Diethyltryptamine.......................................              25
Difenoxin...............................................           9,200
Dihydromorphine.........................................         753,500
Dimenoxadol.............................................              25
Dimepheptanol...........................................              25
Dimethylthiambutene.....................................              20
Dimethyltryptamine......................................              50
Dioxyaphetyl butyrate...................................              25
Dipipanone..............................................               5
Drotebanol..............................................              25
Ethylmethylthiambutene..................................              25
Etorphine...............................................              30
Fenethylline............................................              30
Fentanyl related substances.............................              40
FUB-144.................................................              25
FUB-AKB48...............................................              25
Furanyl fentanyl........................................              30
Furethidine.............................................              25
gamma-Hydroxybutyric acid...............................      25,417,000
Heroin..................................................              45
Hydromorphinol..........................................              40
Hydroxypethidine........................................              25
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
Ketobemidone............................................              30
Levomoramide............................................              25
Levophenacylmorphan.....................................              25
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-(cyclohexylmethyl)-             30
 1H-indole-3-carboxamido)-3,3-dimethylbutanoate)........
MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-              30
 3-carboxamido)-3,3-dimethylbutanoate)..................
MMB-CHMICA-(AMB-CHMICA); Methyl-2-(1-(cyclohexylmethyl)-              25
 1H-indole-3-carboxamido)-3-methylbutanoate.............
Marihuana...............................................       3,200,000
Mecloqualone............................................              30
Mescaline...............................................              25
Methaqualone............................................              60
Methcathinone...........................................              25
Methyoxyacetyl fentanyl.................................              30
Methyldesorphine........................................               5
Methyldihydromorphine...................................              25
Morpheridine............................................              25
Morphine methylbromide..................................               5
Morphine methylsulfonate................................               5
Morphine-N-oxide........................................             150
MT-45...................................................              30
Myrophine...............................................              25
NM2201; Naphthalen-1-yl 1-(5-fluoropentyl)-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-Ethylhexedrone........................................              25

[[Page 66021]]

 
N-Ethylpentylone, ephylone..............................              30
N-Hydroxy-3,4-methylenedioxyamphetamine.................              24
N-Methyl-3-Piperidyl Benzilate..........................              30
Nicocodeine.............................................              25
Nicomorphine............................................              25
Noracymethadol..........................................              25
Norlevorphanol..........................................              55
Normethadone............................................              25
Normorphine.............................................              40
Norpipanone.............................................              25
Ocfentanil..............................................              25
Ortho-fluorofentanyl, 2-fluorofentanyl..................              30
Para-chloroisobutyryl fentanyl..........................              30
Para-fluorofentanyl.....................................              25
Para-fluorobutyryl fentanyl.............................              25
Para-methoxybutyryl fentanyl............................              30
Parahexyl...............................................               5
PB-22; QUPIC............................................              20
Pentedrone..............................................              25
Pentylone...............................................              25
Phenadoxone.............................................              25
Phenampromide...........................................              25
Phenomorphan............................................              25
Phenoperidine...........................................              25
Pholcodine..............................................               5
Piritramide.............................................              25
Proheptazine............................................              25
Properidine.............................................              25
Propiram................................................              25
Psilocybin..............................................              30
Psilocyn................................................              50
Racemoramide............................................              25
SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-                              45
 methoxyphenylacetyl)indole)............................
SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole)              30
Tetrahydrocannabinols...................................         384,460
Tetrahydrofuranyl fentanyl..............................              15
Thebacon................................................              25
Thiafentanil............................................              25
Thiofentanyl............................................              25
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-                           30
 yl](naphthalen-1-yl)methanone).........................
Tilidine................................................              25
Trimeperidine...........................................              25
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)...............         813,005
Alfentanil..............................................           3,260
Alphaprodine............................................               2
Amobarbital.............................................          20,100
Amphetamine (for conversion)............................      14,137,578
Amphetamine (for sale)..................................      47,000,000
Bezitramide.............................................              25
Carfentanil.............................................              20
Cocaine.................................................          82,127
Codeine (for conversion)................................       3,225,000
Codeine (for sale)......................................      30,731,558
Dextropropoxyphene......................................              35
Dihydrocodeine..........................................         156,713
Dihydroetorphine........................................               2
Diphenoxylate (for conversion)..........................          14,100
Diphenoxylate (for sale)................................         770,800
Ecgonine................................................          88,134
Ethylmorphine...........................................              30
Etorphine hydrochloride.................................              32
Fentanyl................................................         813,005
Glutethimide............................................              25
Hydrocodone (for conversion)............................           1,250

[[Page 66022]]

 
Hydrocodone (for sale)..................................      34,836,854
Hydromorphone...........................................       3,054,479
Isomethadone............................................              30
Levo-alphacetylmethadol (LAAM)..........................               5
Levomethorphan..........................................              30
Levorphanol.............................................          38,000
Lisdexamfetamine........................................      21,000,000
Meperidine..............................................       1,463,873
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.........................................       1,213,603
------------------------------------------------------------------------
[678,878 grams of levo-desoxyephedrine for use in a non-controlled, non-
   prescription product; 505,231 grams for methamphetamine mostly for
       conversion to a schedule III product; and 29,494 grams for
                       methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate.........................................      57,438,334
Metopon.................................................              25
Moramide-intermediate...................................              25
Morphine (for conversion)...............................       4,089,000
Morphine (for sale).....................................      29,353,655
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)..............................         914,010
Oxycodone (for sale)....................................      67,593,983
Oxymorphone (for conversion)............................      24,525,540
Oxymorphone (for sale)..................................         829,051
Pentobarbital...........................................      25,850,000
Phenazocine.............................................              25
Phencyclidine...........................................              35
Phenmetrazine...........................................              25
Phenylacetone...........................................              40
Piminodine..............................................              25
Racemethorphan..........................................               5
Racemorphan.............................................               5
Remifentanil............................................           3,000
Secobarbital............................................         172,100
Sufentanil..............................................           4,000
Tapentadol..............................................      13,447,541
Thebaine................................................      70,829,235
------------------------------------------------------------------------
                            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 2020 aggregate production quotas and 
assessment of annual needs as needed.

    Dated: November 27, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-26119 Filed 11-29-19; 8:45 am]
BILLING CODE 4410-09-P