Drug Enforcement Administration August 2016 – Federal Register Recent Federal Regulation Documents

Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I
Document Number: 2016-20803
Type: Proposed Rule
Date: 2016-08-31
Agency: Drug Enforcement Administration, Department of Justice
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine, which are the main active constituents of the plant kratom, 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 these opioids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety. Any final 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, possession, importation, and exportation of, and research and conduct of instructional activities of these opioids.
Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension of a Currently Approved Collection: National Drug Threat Survey
Document Number: 2016-20785
Type: Notice
Date: 2016-08-30
Agency: Drug Enforcement Administration, Department of Justice
The Department of Justice (DOJ), Drug Enforcement Administration, 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 Thiafentanil Into Schedule II
Document Number: 2016-20463
Type: Rule
Date: 2016-08-26
Agency: Drug Enforcement Administration, Department of Justice
The Drug Enforcement Administration is placing the substance thiafentanil (4-(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2- (thienyl)ethyl]piperidine), including its isomers, esters, ethers, salts and salts of isomers, esters and ethers as possible, into schedule II 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.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals
Document Number: 2016-20241
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-20238
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Cerilliant Corporation
Document Number: 2016-20237
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Akorn, Inc.
Document Number: 2016-20236
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Noramco, Inc.
Document Number: 2016-20235
Type: Notice
Date: 2016-08-24
Agency: Drug Enforcement Administration, Department of Justice
Lawrence E. Stewart, M.D.; Decision and Order
Document Number: 2016-19595
Type: Notice
Date: 2016-08-17
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Stepan Company
Document Number: 2016-19592
Type: Notice
Date: 2016-08-17
Agency: Drug Enforcement Administration, Department of Justice
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Document Number: 2016-19449
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: ALMAC Clinical Services Incorp (ACSI)
Document Number: 2016-19439
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Actavis Laboratories FL., Inc.
Document Number: 2016-19438
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances Application: Bellwyck Clinical Services
Document Number: 2016-19437
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
Importer of Controlled Substances Application: AMRI Rensselaer, Inc.
Document Number: 2016-19436
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
Importer of Controlled Substances Application: Cody Laboratories, Inc.
Document Number: 2016-19435
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Document Number: 2016-19434
Type: Notice
Date: 2016-08-16
Agency: Drug Enforcement Administration, Department of Justice
Registered bulk manufacturers of the affected basic class, and applicants therefor, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 15, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 15, 2016.
Statement of Principles on Industrial Hemp
Document Number: 2016-19146
Type: Notice
Date: 2016-08-12
Agency: Department of Agriculture, Drug Enforcement Administration, Department of Justice, Food and Drug Administration, Department of Health and Human Services, Office of the Secretary
The U.S. Department of Agriculture, in consultation with the U.S. Drug Enforcement Administration and the U.S. Food and Drug Administration, has developed a Statement of Principles on Industrial Hemp to inform the public how Federal law applies to activities associated with industrial hemp that is grown and cultivated in accordance with Section 7606 of the Agricultural Act of 2014. The purpose of this notice is to set forth the statement in its entirety.
Denial of Petition To Initiate Proceedings To Reschedule Marijuana
Document Number: 2016-17960
Type: Proposed Rule
Date: 2016-08-12
Agency: Drug Enforcement Administration, Department of Justice
By letter dated July 19, 2016 the Drug Enforcement Administration (DEA) denied a petition to initiate rulemaking proceedings to reschedule marijuana. Because the DEA believes that this matter is of particular interest to members of the public, the agency is publishing below the letter sent to the petitioner which denied the petition, along with the supporting documentation that was attached to the letter.
Applications To Become Registered Under the Controlled Substances Act To Manufacture Marijuana To Supply Researchers in the United States
Document Number: 2016-17955
Type: Rule
Date: 2016-08-12
Agency: Drug Enforcement Administration, Department of Justice
To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States. This policy statement explains how DEA will evaluate applications for such registration consistent with the CSA and the obligations of the United States under the applicable international drug control treaty.
Denial of Petition To Initiate Proceedings To Reschedule Marijuana
Document Number: 2016-17954
Type: Proposed Rule
Date: 2016-08-12
Agency: Drug Enforcement Administration, Department of Justice
By letter dated July 19, 2016 the Drug Enforcement Administration (DEA) denied a petition to initiate rulemaking proceedings to reschedule marijuana. Because the DEA believes that this matter is of particular interest to members of the public, the agency is publishing below the letter sent to the petitioner which denied the petition, along with the supporting documentation that was attached to the letter.
Importer of Controlled Substances Registration
Document Number: 2016-18922
Type: Notice
Date: 2016-08-10
Agency: Drug Enforcement Administration, Department of Justice
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.
Bulk Manufacturer of Controlled Substances Registration
Document Number: 2016-18921
Type: Notice
Date: 2016-08-10
Agency: Drug Enforcement Administration, Department of Justice
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.
Alaaeldin A. Babiker, M.D.; Decision and Order
Document Number: 2016-18278
Type: Notice
Date: 2016-08-02
Agency: Drug Enforcement Administration, Department of Justice