Listing of Approved Drug Products Containing Dronabinol in Schedule III
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to modify the listing of the Marinol[supreg] formulation in schedule III so that certain generic drug products are also included in that listing. Several products are currently the subject of Abbreviated New Drug Applications (ANDAs) under review by the U.S. Food and Drug Administration (FDA). Each product is a generic formulation of Marinol[supreg] and contains dronabinol, the (-) isomer of delta-9- (trans)-tetrahydrocannabinol (THC), which is a schedule I controlled substance. Due to variations in formulation, these generic Marinol[supreg] products do not meet the specific conditions specified in the current schedule III listing. This proposed action expands the schedule III listing to include formulations having naturally-derived dronabinol and products encapsulated in hard gelatin capsules. This would have the effect of transferring the FDA-approved versions of such generic Marinol[supreg] products from schedule I to schedule III.
Schedules of Controlled Substances: Placement of Propofol Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance propofol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and on an evaluation of the relevant data by DEA. If finalized, this action would impose the regulatory controls and criminal sanctions of schedule IV on those who handle propofol and products containing propofol.
Privacy Act of 1974; System of Records
Pursuant to the Privacy Act of 1974 (5 U.S.C. 552a), the Federal Bureau of Investigation (FBI), Department of Justice, proposes to modify an existing system of records entitled ``Data Integration and Visualization System,'' JUSTICE/FBI-021, which describes the Data Integration and Visualization System (DIVS), to revise the System Location section to clarify locations where the records may be directly accessed and by whom the records may be directly accessed. A new sentence has been added at the end of the System Location section to reflect this information. This system notice was last published on August 31, 2010 (75 FR 53342).
Nondiscrimination on the Basis of Disability in State and Local Government Services, Public Accommodations and in Commercial Facilities; Hearings
On July 26, 2010, the Department of Justice (Department) published four Advanced Notices of Proposed Rulemaking (ANPRMs) in the Federal Register to amend regulations issued under the Americans with Disabilities Act (ADA). These four ANPRMs include: Nondiscrimination on the Basis of Disability; Accessibility of Web Information and Services of State and Local Government Entities and Public Accommodations; Nondiscrimination on the Basis of Disability in State and Local Government Services; Accessibility of Next Generation 9-1-1; Nondiscrimination on the Basis of Disability; Movie Captioning and Video Description; and Nondiscrimination on the Basis of Disability by State and Local Governments and Places of Public Accommodation; Equipment and Furniture. To provide an opportunity for interested persons to express their views directly to Department officials, the Department will hold three public hearings on the ANPRMs.