The Drug Enforcement Administration is placing the newly approved drug lasmiditan in Schedule V of the Controlled Substances Act, it said in an interim final rule. Effective Jan. 31, lasmiditan, which was granted approval by the Food and Drug Administration in October, is subject to new registration, labeling, recordkeeping, and import and export requirements. DEA is accepting comments on the rule until March 2.
The Drug Enforcement Administration is extending for one more year the temporary listing of cyclopentyl fentanyl, isobutyryl fentanyl, pharmacologist fentanyl, portamento fentanyl, and valeryl fentanyl in schedule I of the Controlled Substances Act, it said. The synthetic opioids, first temporarily listed in 2018 (see 1801310009), will now remain listed in schedule I until Feb. 2, 2021. DEA also issued a proposed rule to permanently list these synthetic opioids in schedule I, with comments due March 2. Substances may only be temporarily listed under the CSA for three years.
The Drug Enforcement Administration is removing the opioid antagonist 6-beta-naltrexol from schedule II of the Controlled Substances Act, it said in a final rule. Effective Jan. 24, DEA is removing “regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle” 6-beta-naltrexol, it said.
The Drug Enforcement Administration placed the neurosteroid brexanolone into Schedule IV of the Controlled Substances Act, it said. The final rule confirms an interim regulation issued in June that subjected brexanolone to new registration, labeling, recordkeeping, and import and export requirements.
The Drug Enforcement Administration permanently placed the synthetic cannabinoids 5F-ADB, 5F-AMB, 5FAPINACA, ADB-FUBINACA, MDMB-CHMICA and MDMB-FUBINACA into Schedule I of the Controlled Substances Act, in a final rule. The substances had already been temporarily listed in Schedule I since 2017 (see 1904050027). The final order takes effect Jan. 24.
The International Trade Commission on Jan. 21 issued Revision 1 to the 2020 Harmonized Tariff Schedule. This latest version includes updates needed to implement the latest set of exclusions from list 3 of Section 301 tariffs on products from China (see 2001020035). The new exclusions are listed in new U.S. Note 20(pp) to subchapter III of chapter 99. New subheading 9903.88.37 is created for products entering under the exclusions, and conforming changes are made to other provisions throughout subchapter III. The exclusions take retroactive effect as of Sept. 24, 2018, the date that the list 3 tariffs took effect.
The International Trade Commission is working to add provisions on the Trade Agreement between the United States and Japan to the Harmonized Tariff Schedule of the U.S., James Holbein, director of the ITC’s Office of Tariff Affairs and Trade Agreements, said in an interview Jan. 7. Technical issues with the ITC’s electronic system for updating the tariff schedule had led to the omission of new General Note 36, as well as provisions in chapter 99, from the 2020 Basic Edition of the HTS, Holbein said. The ITC’s information technology office is currently working to fix those issues, he said.
The International Trade Commission is now reviewing the more than 4,000 petitions received as part of the Miscellaneous Tariff Bill process for temporary duty suspensions, the agency said in an update. The ITC will post the petitions that meet the requirements on a rolling basis on the MTB portal, it said. “The next step in the MTB process is the public comment phase, during which interested parties and the public can review all posted petitions and file comments for Commission consideration,” the ITC said. “The public comment period will open on January 10, 2020, and run through February 24, 2020.” All comments must be filed through the MTB portal, where they will be visible, the agency said.
The Congressional Research Service released a report Jan. 3 on issues and provisions surrounding the state-state dispute settlement mechanism in the U.S.-Mexico-Canada Agreement, including explanations of the consultation, panel establishment and resolution process. The report also includes potential considerations for Congress, including whether it should use USMCA's dispute resolution system as a ”template” for future Trade Promotion Authority legislation.
The Federal Aviation Administration is issuing a proposed rule that would require unmanned aircraft systems to include remote identification systems. The proposal would require that standard UASs broadcast identification and location information directly from the unmanned aircraft, and at the same time transmit that information to a network of remote ID “service suppliers” through an internet connection. For UASs that have a range of no more than 400 feet, a limited ID system would be allowed that would transmit information through the internet only, with no broadcast requirements. The FAA is proposing that all UASs comply with these design and manufacturing requirements within three years of the effective date of the final rule, with limited exceptions. “No UAS could be produced for operation in the United States after two years and no UAS could be operated after three years except in accordance with the requirements of this proposal,” the FAA said. Comments are due March 2.