Agency for International Development – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration proposes to place the substance eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6- dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2- yl)ethyl]amino]methyl]-2-methoxybenzoic acid), including its salts, isomers, and salts of isomers, into schedule IV of the Controlled Substances Act (CSA). This proposed scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess), or propose to handle eluxadoline.

National Center for Natural Products Research (NIDA MPROJECT), Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants National Center for Natural Products Research (NIDA MPROJECT), Inc. registration as a manufacturer of those controlled substances.

Sigma Aldrich Research Biochemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Sigma Aldrich Research Biochemicals, Inc. registration as a manufacturer of those controlled substances.

Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance.

Actavis Laboratories FL, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Actavis Laboratories FL, Inc., registration as an importer of those controlled substances.

Cambrex Charles City applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cambrex Charles City registration as a manufacturer of those controlled substances.

Johnson Matthey, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc., registration as an importer of those controlled substances.

Johnson Matthey, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as a manufacturer of those controlled substances.

Apertus Pharmaceuticals applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Apertus Pharmaceuticals registration as a manufacturer of those controlled substances.

American Radiolabeled Chemicals, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants American Radiolabeled Chemicals, Inc. registration as a manufacturer of those controlled substances.

Pharmacore applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Pharmacore registration as an importer of this controlled substance.

The Administrator of the Drug Enforcement Administration is issuing this final order to temporarily schedule the synthetic opioid, N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide (acetyl fentanyl), and its optical, positional, and geometric isomers, salts and salts of isomers, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of this opioid substance into 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, import, export, engage in research, or possess), or propose to handle, acetyl fentanyl.

Navinta LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Navinta LLC registration as a manufacturer of those controlled substances.

Siegfried USA, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Siegfried USA, LLC registration as a manufacturer of those controlled substances.

Meda Pharmaceuticals, Inc. applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meda Pharmaceuticals, Inc. registration as an importer of this controlled substance.

The U.S. Agency for International Development (USAID) is implementing a pilot for a Partner Vetting System (PVS) for USAID assistance and acquisition awards. The purpose of the Partner Vetting System is to help mitigate the risk that USAID funds and other resources could inadvertently benefit individuals or entities that are terrorists, supporters of terrorists or affiliated with terrorists, while also minimizing the impact on USAID programs and its implementing partners. This final rule sets out the requirements for the vetting of Federal awards, requirements including award terms for PVS, and applies PVS to a pilot program and any subsequent implementation of PVS that is determined appropriate. It follows publication of a proposed rule and takes into consideration the public comments received.