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

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

American Radiolabeled Chem has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), 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 proposed information collection (IC) is also being published to obtain comments from the public and affected agencies.

Notice is hereby given pursuant to section 708 of the Defense Production Act of 1950 (``DPA'') for the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Devices to Respond to COVID-19 (``Medical Devices Plan of Action''), the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Medical Gases to Respond to COVID-19 (``Medical Gases Plan of Action''), the Plan of Action to Establish a National Strategy for the Manufacture, Allocation and Distribution of Diagnostic Test Kits and other Testing Components to Respond to COVID-19 (``Diagnostic Test Kits Plan of Action''), and the Plan of Action to Establish a National Strategy for the Manufacture, Allocation, and Distribution of Drug Products, Drug Substances, and Associated Medical Devices to Respond to COVID-19 (``Drug Products Plan of Action'') proposed by the Federal Emergency Management Agency (``FEMA''), that the Acting Assistant Attorney General finds for each that the purposes of section 708(c)(1) of the DPA may not reasonably be achieved through a plan of action having less anticompetitive effects or without any plan of action. Given these findings, the Medical Devices Plan of Action, the Medical Gases Plan of Action, the Diagnostic Test Kits Plan of Action, and the Drug Products Plan of Action may become effective following the publication of this notice. Given these findings, the Medical Devices Plan of Action, the Medical Gases Plan of Action, the Diagnostic Test Kits Plan of Action, and the Drug Products Plan of Action may become effective following the publication of this notice.

The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995.

The Department of Justice (``Department'') proposes amending Bureau of Alcohol, Tobacco, Firearms, and Explosives (``ATF'') regulations to provide new regulatory definitions of ``firearm frame or receiver'' and ``frame or receiver'' because the current regulations fail to capture the full meaning of those terms. The Department also proposes amending ATF's definitions of ``firearm'' and ``gunsmith'' to clarify the meaning of those terms, and to provide definitions of terms such as ``complete weapon,'' ``complete muffler or silencer device,'' ``privately made firearm,'' and ``readily'' for purposes of clarity given advancements in firearms technology. Further, the Department proposes amendments to ATF's regulations on marking and recordkeeping that are necessary to implement these new or amended definitions.

Lipomed 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.

Experic LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

The Bureau of Justice Statistics, 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, Office on Violence Against Women (OVW) 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 the Chief Information Officer, Department of Justice, is 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.

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

On March 2, 2021, the United States Food and Drug Administration approved a new drug application for AZSTARYS capsules for oral use, a combination drug product containing serdexmethylphenidate chloride and dexmethylphenidate hydrochloride, for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age or older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place serdexmethylphenidate and its salts in schedule IV of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act, thereby facilitating the commercial distribution of AZSTARYS as a lawful controlled substance.

The U.S. Marshals Service (USMS), Department of Justice (DOJ), 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 (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.