Department of Justice March 2021 – Federal Register Recent Federal Regulation Documents

Patheon Pharmaceuticals Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Assistance, 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.

The Office of Justice Programs, Department of Justice (DOJ), 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.

The Department of Justice (DOJ), Executive Office for Immigration Review (EOIR), 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.

The Department of Justice (DOJ), U.S. Marshals Service (USMS), will submit 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.

The Drug Enforcement Administration proposes placing N-(1-(2- fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamid e (2'- fluoro ortho-fluorofentanyl), N-(1-(4-methylphenethyl)piperidin-4-yl)- N-phenylacetamide (4'-methyl acetyl fentanyl), N-(1-phenethylpiperidin- 4-yl)-N,3-diphenylpropanamide ([beta]'-phenyl fentanyl; 3- phenylpropanoyl fentanyl), N-phenyl-N-(1-(2-phenylpropyl)piperidin-4- yl)propionamide ([beta]-methyl fentanyl), N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)butyramide (ortho-fluorobutyryl fentanyl; 2- fluorobutyryl fentanyl), N-(2-methylphenyl)-N-(1-phenethylpiperidin-4- yl)acetamide (ortho-methyl acetylfentanyl; 2-methyl acetylfentanyl), 2- methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)aceta mide (ortho-methyl methoxyacetylfentanyl), N-(4-methylphenyl)-N-(1- phenethylpiperidin-4-yl)propionamide (para-methylfentanyl; 4- methylfentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide (phenyl fentanyl; benzoyl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylthiophene-2-carboxamide (thiofuranyl fentanyl), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in schedule I of the Controlled Substances Act. These ten specific substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle 2'- fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho- methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para- methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.

Stepan Company has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Acting Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule 1-(1-(1-(4- bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imid azol-2-one (commonly known as brorphine), 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 I of the Controlled Substances Act . This action is based on a finding by the Acting Administrator that the placement of brorphine in schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will be imposed on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle brorphine.

Groff NA Hemplex, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Microgenics Corporation Thermo Fisher Scientific has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.