Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration places the substance 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 (eluxadoline), including its salts, isomers, and salts of isomers, into schedule IV 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 action imposes 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.

The Drug Enforcement Administration is amending the table of Excluded Nonnarcotic Products to update the company name for the drug product Nasal Decongestant Inhaler/Vapor Inhaler (containing 50 milligrams levmetamfetamine) to Aphena Pharma SolutionsNew York, LLC. This over-the-counter, nonnarcotic drug product is excluded from the provisions of the Controlled Substances Act.

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

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

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

This final order establishes the final adjusted 2015 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC.

Pursuant to Public Law 106-503, the National Earthquake Prediction Evaluation Council (NEPEC) will hold its next meeting at the Southern Methodist University in Dallas, Texas. The Committee is comprised of members from academia, industry, and State government. The Committee shall advise the Director of the U.S. Geological Survey (USGS) on matters relating to the USGS's participation in the National Earthquake Hazards Reduction Program. At the meeting, the Council will receive briefings and updates on: The USGS's strategic plan for operational earthquake forecasting and outcomes of a user-needs workshop on that subject held in March 2015; on USGS work to calculate the probability of future earthquakes in areas of the U.S. subject to induced seismicity; on the estimation of aftershock probabilities and on new modeled estimates of earthquake likelihood along the Wasatch fault zone by a technical working group; and on development of a plan for rapid communication of earthquake information in the Cascadia region. The NEPEC will review USGS procedures for calculating and communicating aftershock probabilities following large earthquakes in areas outside of California and the application of these procedures following the M7.8 Gorkha, Nepal earthquake of April 2015. The council will also finalize a statement for public release summarizing the proper procedures for posing and testing earthquake predictions and forecasts. Meetings of the National Earthquake Prediction Evaluation Council are open to the public. A draft meeting agenda is available upon request from the Executive Secretary on request (contact information below). In order to ensure sufficient seating and hand-outs, it is requested that visitors pre-register by September 13. Members of the public wishing to make a statement to the Council should provide notice of that intention by August 26 so that time may be allotted in the agenda. A meeting summary will be posted by September 30 to the committee Web site: https://earthquake.usgs.gov/aboutus/nepec/.

Pursuant to Public Law 106-503, the National Earthquake Prediction Evaluation Council (NEPEC) will hold its next meeting at the Southern Methodist University in Dallas, Texas. The Committee is comprised of members from academia, industry, and State government. The Committee shall advise the Director of the U.S. Geological Survey (USGS) on matters relating to the USGS's participation in the National Earthquake Hazards Reduction Program. At the meeting, the Council will receive briefings and updates on: The USGS's strategic plan for operational earthquake forecasting and outcomes of a user-needs workshop on that subject held in March 2015; on USGS work to calculate the probability of future earthquakes in areas of the U.S. subject to induced seismicity; on the estimation of aftershock probabilities and on new modeled estimates of earthquake likelihood along the Wasatch fault zone by a technical working group; and on development of a plan for rapid communication of earthquake information in the Cascadia region. The NEPEC will review USGS procedures for calculating and communicating aftershock probabilities following large earthquakes in areas outside of California and the application of these procedures following the M7.8 Gorkha, Nepal earthquake of April 2015. The council will also finalize a statement for public release summarizing the proper procedures for posing and testing earthquake predictions and forecasts. Meetings of the National Earthquake Prediction Evaluation Council are open to the public. A draft meeting agenda is available upon request from the Executive Secretary on request (contact information below). In order to ensure sufficient seating and hand-outs, it is requested that visitors pre-register by September 13. Members of the public wishing to make a statement to the Council should provide notice of that intention by August 26 so that time may be allotted in the agenda. A meeting summary will be posted by September 30 to the committee Web site: https://earthquake.usgs.gov/aboutus/nepec/.

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

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

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