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Federal Register/Vol. 85, No. 230/Monday, November 30, 2020 76604 Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices notifications disclosing all changes in Act on September 18, 2020 (85 FR DEPARTMENT OF JUSTICE membership. 58390). Drug Enforcement Administration On September 10, 2018, CONFERS Suzanne Morris, [Docket No. DEA–688E] filed its original notification pursuant to Chief, Premerger and Division Statistics, Section 6(a) of the Act. The Department Antitrust Division. Established Aggregate Production of Justice published a notice in the [FR Doc. 2020–26362 Filed 11–27–20; 8:45 am] Federal Register pursuant to Section Quotas for Schedule I and II Controlled BILLING CODE P Substances and Assessment of 6(b) of the Act on October 19, 2018 (83 Annual Needs for the List I Chemicals FR 53106). Ephedrine, Pseudoephedrine, and The last notification was filed with DEPARTMENT OF JUSTICE Phenylpropanolamine for 2021 the Department on May 1, 2020. A notice was published in the Federal Antitrust Division AGENCY: Drug Enforcement Register pursuant to Section 6(b) of the Administration, Department of Justice. Act on May 28, 2020 (85 FR 32049). Notice Pursuant to the National ACTION: Final order. Cooperative Research and Production Suzanne Morris, Act of 1993—Cooperative Research SUMMARY: This final order establishes Chief, Premerger and Division Statistics, Group on AC2AT–II the initial 2021 aggregate production Antitrust Division. quotas for controlled substances in [FR Doc. 2020–26358 Filed 11–27–20; 8:45 am] Notice is hereby given that, on schedules I and II of the Controlled Substances Act and the assessment of BILLING CODE 4410–11–P November 19, 2020, pursuant to Section 6(a) of the National Cooperative annual needs for the list I chemicals Research and Production Act of 1993, ephedrine, pseudoephedrine, and DEPARTMENT OF JUSTICE 15 U.S.C. 4301 et seq. (‘‘the Act’’), phenylpropanolamine. Southwest Research Institute— DATES: Applicable Date: Applicable Antitrust Division Cooperative Research Group on November 30, 2020. Advanced Combustion Catalyst and FOR FURTHER INFORMATION CONTACT: Notice Pursuant to the National Aftertreatment Technologies—II Scott A. Brinks, Diversion Control Cooperative Research and Production (‘‘AC2AT–II’’) has filed written Division, Drug Enforcement Act of 1993—Dynamic Spectrum notifications simultaneously with the Administration, 8701 Morrissette Drive, Alliance, Inc. Attorney General and the Federal Trade Springfield, VA 22152, Telephone: (571) Commission disclosing changes in its 362–3261. Notice is hereby given that, on membership. The notifications were November 23, 2020, pursuant to Section SUPPLEMENTARY INFORMATION: filed for the purpose of extending the 6(a) of the National Cooperative Act’s provisions limiting the recovery of I. Legal Authority Research and Production Act of 1993, antitrust plaintiffs to actual damages Section 306 of the Controlled 15 U.S.C. 4301 et seq. (‘‘the Act’’), under specified circumstances. Substances Act (CSA) (21 U.S.C. 826) Dynamic Spectrum Alliance, Inc. Specifically, Denso Corporation requires the Attorney General to (‘‘DSA’’) has filed written notifications ‘‘Client’’, Aichi-ken, JAPAN, has establish aggregate production quotas simultaneously with the Attorney withdrawn as a party to this venture. No for each basic class of controlled General and the Federal Trade other changes have been made in either substance listed in schedule I and II and Commission disclosing changes in its the membership or planned activity of assessment of annual needs for the list membership. The notifications were the group research project. Membership I chemicals ephedrine, filed for the purpose of extending the in this group research project remains pseudoephedrine, and Act’s provisions limiting the recovery of open, and AC2AT–II intends to file phenylpropanolamine. The Attorney antitrust plaintiffs to actual damages General has delegated this function to additional written notifications under specified circumstances. the Administrator of the Drug disclosing all changes in membership. Specifically, The University of York, Enforcement Administration (DEA) Heslington, UNITED KINGDOM; On February 6, 2019, AC2AT–II filed pursuant to 28 CFR 0.100. its original notification pursuant to Amazon, Sunnyvale, CA; and Google, II. Background Mountain View, CA have been added as Section 6(a) of the Act. The Department parties to this venture. of Justice published a notice in the The 2021 aggregate production quotas Federal Register pursuant to Section (APQ) and assessment of annual needs No other changes have been made in 6(b) of the Act on February 28, 2019 (84 (AAN) represent those quantities of either the membership or planned FR 6821). schedule I and II controlled substances activity of the group research project. and the list I chemicals ephedrine, Membership in this group research Suzanne Morris, pseudoephedrine, and project remains open, and DSA intends Chief, Premerger and Division Statistics, phenylpropanolamine that may be to file additional written notifications Antitrust Division. manufactured in the United States in disclosing all changes in membership. [FR Doc. 2020–26361 Filed 11–27–20; 8:45 am] 2021 to provide for the estimated On September 1, 2020, DSA filed its BILLING CODE 4410–11–P medical, scientific, research, industrial original notification pursuant to Section needs of the United States, lawful 6(a) of the Act. The Department of export requirements, and the Justice published a notice in the Federal establishment and maintenance of Register pursuant to Section 6(b) of the reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled VerDate Sep<11>2014 20:03 Nov 27, 2020 Jkt 253001 PO 00000 Frm 00091 Fmt 4703 Sfmt 4703 E:\FR\FM\30NON1.SGM 30NON1 TKELLEY on DSKBCP9HB2PROD with NOTICES Federal Register / Vol. 85, No. 230 / Monday, November 30, 2020 / Notices 76605 substances for use in industrial APQ. These commenters alleged that quotas for specific dosage forms; processes. decreases to the APQ have resulted in however, DEA cannot demand that the On September 1, 2020, a notice titled a shortage of injectable opioid manufacturer utilize the quota ‘‘Proposed Aggregate Production Quotas medications and interfere with the immediately, nor does it have the for Schedule I and II Controlled treatment of patients. Some of these authority to demand immediate Substances and Assessment of Annual commenters also suggested that DEA production of dosage forms. Needs for the List I Chemicals separate quotas for solid oral controlled DEA and the Food and Drug Ephedrine, Pseudoephedrine, and substances and injectable controlled Administration (FDA) are required to Phenylpropanolamine for 2021’’ substances, and urged DEA to utilize its coordinate efforts to prevent or alleviate (hereinafter ‘‘Proposed 2021 APQ’’) was discretionary authority under the drug shortages pursuant to 21 U.S.C. published in the Federal Register. 85 FR Substance Use-Disorder Prevention that 826(h) and maintain a collaborative 54407. This notice proposed the 2021 Promotes Opioid Recovery and working relationship. In addition, DEA APQ for each basic class of controlled Treatment Act (SUPPORT Act),1 to and FDA have worked collaboratively. substance listed in schedules I and II establish APQ in terms of For example, in 2016 the domestic and the 2021 AAN for the list I pharmaceutical dosage form for all shortage of injectable controlled chemicals ephedrine, pseudoephedrine, schedule II controlled substances. substances was alleviated by the and phenylpropanolamine. All DEA Response: DEA is committed to importation of certain injectable interested persons were invited to ensuring an adequate and uninterrupted controlled substances coordinated by comment on or object to the proposed supply of controlled substances in order the collaborated effort of FDA and DEA. APQ and the proposed AAN on or to meet the legitimate medical, The alleviation of this drug shortage did before October 1, 2020. scientific, and export needs of the not require an adjustment to the APQ. United States. DEA sets APQ in a Again in 2020, when hospitals informed III. Comments Received manner to provide for all dispensings DEA that there was a domestic shortage Within the public comment period, authorized for legitimate medical of injectable controlled substances due DEA received 294 comments from DEA purposes, and in turn, the APQ take into to the Coronavirus Disease of 2019 registrants, hospital associations, consideration both injectable opioids (COVID–19) health emergency, DEA professional associations, doctors, and solid oral opioids to meet the collaborated with FDA to increase the nurses, health system organizations, estimated medical needs of the United appropriate APQ and individual quotas State Attorneys General, and others. The States. The SUPPORT Act allows, but to allow for increased manufacturing of comments included concerns over drug does not require, DEA to grant quotas in the specific drug products. shortages due to further quota terms of dosage forms if the agency B. Pain Management Association Letters reductions from doctors and nurses, determines that doing so will assist in patients, and various health groups and avoiding the overproduction, shortages, Issue: DEA received comments that hospital affiliations; requests for less or diversion of a controlled substance. expressed concern that DEA’s proposed interference in the doctor-patient DEA believes that incorporating all reduction of opioids
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