Drug Enforcement Administration March 2017 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With or Without Change, of a Previously Approved Collection Drug Questionnaire (DEA-341)
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), 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.
Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II
On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed 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 FDA-approved products of oral solutions containing dronabinol in schedule II of the CSA.
Importer of Controlled Substances Registration
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of various classes of schedule I or II controlled substances.
Schedules of Controlled Substances: Temporary Placement of 4-Fluoroisobutyryl Fentanyl Into Schedule I
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to issue a temporary order to schedule the synthetic opioid, N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide (4-fluoroisobutyryl fentanyl or para-fluoroisobutyryl fentanyl), 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 synthetic opioid into Schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. When it is issued, the temporary scheduling order will impose the administrative, civil, and criminal sanctions and regulatory controls applicable to Schedule I controlled substances under the Controlled Substances Act on the manufacture, distribution, reverse distribution, possession, importation, exportation, research, and conduct of instructional activities, and chemical analysis of this synthetic opioid.
Bulk Manufacturer of Controlled Substances Registration
Registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as bulk manufacturers of various classes of controlled substances.
Program To Hire Special Assistant United States Attorneys in Targeted Federal Judicial Districts Utilizing Diversion Control Fee Account Funds
The Drug Enforcement Administration (DEA) is proposing a rule that would expand and enhance the enforcement component of the Diversion Control Program (DCP) as previously outlined in the December 30, 1996, Federal Register document ``Registration and Reregistration Application Fees,'' hereinafter referred to as the 1996 Rule. The 1996 Rule specified six types of investigations involving the diversion of controlled substances, which could be pursued by the DCP utilizing funding from the Diversion Control Fee Account (DCFA). Those investigations included the theft or robbery of pharmaceutical controlled substances, the acquisition of pharmaceutical controlled substances through fraud or deceit, and other illegal diversion activities. The 1996 Rule also authorized the continued use and expansion by the DCP of Tactical Diversion Squads (TDSs), defined as, ``enforcement teams consisting of Federal, state, and local law enforcement personnel fully dedicated to the investigation and prosecution of persons involved in the diversion of controlled substances.''
Schedules of Controlled Substances: Placement of Brivaracetam Into Schedule V
This final rule adopts without change an interim final rule with request for comments published in the Federal Register on May 12, 2016. The Drug Enforcement Administration is placing the substance brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts) into schedule V of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act, as revised by the Improving Regulatory Transparency for New Medical Therapies Act which was signed into law on November 25, 2015.
Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones Into Schedule I
With the issuance of this final rule, the Drug Enforcement Administration places 10 synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alpha- pyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone ([alpha]-PVP); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB e); 2-(methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone, bk-MBDP); 4-fluoro-N-methylcathinone (4-FMC, flephedrone); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2-(pyrrolidin- 1-yl)pentan-1-one (naphyrone); alpha-pyrrolidinobutiophenone ([alpha]- PBP) and their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This rule continues the imposition of the 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 4- MEC, 4-MePPP, [alpha]-PVP, butylone, pentedrone, pentylone, 4-FMC, 3- FMC, naphyrone, or [alpha]-PBP.
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