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2020-10-30
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Schedules of Controlled Substances: Placement of Oliceridine in Schedule II
Rules and Regulations
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United States
Department of Justice
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United States Government Agency or Subagency
United States
Drug Enforcement Administration
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org
United States Government Agency or Subagency
On August 7, 2020, the U.S. Food and Drug Administration approved a new drug application for oliceridine, chemically known as N- [(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time} )amine fumarate. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oliceridine in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing oliceridine, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule II of the CSA.
85 FR 68749
https://www.govinfo.gov/app/details/FR-2020-10-30/2020-22762
2020-22762
fr30oc20-6
4410-09-P
Docket No. DEA-715
https://www.govinfo.gov/app/details/FR-2020-10-30/2020-22762
https://www.govinfo.gov/content/pkg/FR-2020-10-30/html/2020-22762.htm
https://www.govinfo.gov/content/pkg/FR-2020-10-30/pdf/2020-22762.pdf
Administrative Practice and Procedure
Drug Traffic Control
Reporting and Recordkeeping Requirements
5 p.
68749
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85 FR 68749
Code of Federal Regulations
Title 21 Part 1308
21 CFR Part 1308
Schedules of Controlled Substances: Placement of Oliceridine in Schedule II; Federal Register Vol. 85, Issue
RULE
2020-22762
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
2020-10-30
Docket No. DEA-715
4410-09-P
2020-22762
Interim final rule, with request for comments.
On August 7, 2020, the U.S. Food and Drug Administration approved a new drug application for oliceridine, chemically known as N- [(3-methoxythiophen-2-yl)methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl{time} )amine fumarate. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place oliceridine in schedule II of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing oliceridine, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers and salts is possible, in schedule II of the CSA.
The effective date of this rulemaking is October 30, 2020. Interested persons may file written comments on this rulemaking in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before November 30, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
Scott A. Brinks, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug
Administrative Practice and Procedure
Drug Traffic Control
Reporting and Recordkeeping Requirements
Schedules of Controlled Substances:
Placement of Oliceridine in Schedule II,
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Regulations.gov
Federal Register
Vol. 85, no. 211
Office of the Federal Register, National Archives and Records Administration
2020-10-30
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https://www.govinfo.gov/app/details/FR-2020-10-30
https://www.govinfo.gov/content/pkg/FR-2020-10-30/pdf/FR-2020-10-30.pdf
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