Search Results for agency_names:"Justice Department"

The Indigenous Peyote Conservation Initiative has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances, specifically Peyote plants. They aim to use the imported Peyote for research, analysis, and conservation efforts related to South Texas Cacti. Public comments or objections to this application can be submitted until March 1, 2021, and requests for a hearing must also be made by then. The DEA will grant the registration only if the applicant's activities comply with authorized guidelines, and it does not include commercial importation of finished drug forms.

Myonex LLC has submitted an application to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. The company plans to import these substances in dosage forms specifically for use in clinical trials, research, and analytical work, but not for commercial sales. Interested parties, including manufacturers or other applicants, are invited to submit comments or objections to this application by May 19, 2025, and they also have the option to request a hearing. No commercial activities involving the finished dosage forms are allowed under this registration.

In January 2025, the Drug Enforcement Administration and the Department of Health and Human Services published new rules about expanding telemedicine practices. These rules were supposed to take effect on February 18, 2025, but have been delayed to March 21, 2025. This delay aligns with a Presidential order for a "Regulatory Freeze Pending Review," allowing more time for feedback on the rules. The rules allow certain medical professionals to prescribe medications via telemedicine, even without an initial in-person visit, under specific conditions. Public comments about this delay are encouraged, focusing on potential policy, legal, and factual issues.

The Department of Justice's National Institute of Justice is seeking public comments on a new study called the “National Study of Interpersonal Violence Experienced by Young Adults.” This study aims to understand interpersonal violence experienced by young adults, both in college and not, by surveying 17,000 individuals aged 18-24 over six years. The study explores various types of violence, including intimate partner violence and stalking, and aims to help identify protective factors and improve support services for victims. Public comments are encouraged until March 6, 2025, to provide feedback on the necessity and effectiveness of this information collection.

Promega Corporation has applied to the Drug Enforcement Administration to register as a bulk manufacturer of certain controlled substances. This notice invites comments or objections to the proposed registration by May 27, 2025. Comments must be submitted electronically through the Federal eRulemaking Portal at regulations.gov. The substances will be manufactured as Active Pharmaceutical Ingredients for sale to customers, with no other uses authorized.

Veranova, L.P. has applied to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances. These substances include Coca Leaves, raw Opium, Poppy Straw Concentrate, Thebaine, Noroxymorphone, and Fentanyl. The company intends to use these materials to manufacture active pharmaceutical ingredients and reference standards for testing purposes. The DEA invites public comments or objections by March 17, 2025, and requests for a hearing must be sent to the designated DEA addresses.

The Drug Enforcement Administration (DEA) has decided to revoke the Certificate of Registration for Dr. Henry-Norbert O. Ndekwe after finding that he no longer has a valid medical license to practice in Oklahoma, where he is registered to handle controlled substances. The DEA issued an Order to Show Cause because Dr. Ndekwe's state medical license expired, and he did not request a hearing to contest the findings. Therefore, the DEA concluded that he is not eligible to maintain his registration to dispense controlled substances. This decision will take effect on May 16, 2025, and any pending applications by Dr. Ndekwe to renew or modify his registration are also denied.

The Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) has filed notifications regarding changes in its membership with the Attorney General and the Federal Trade Commission. This was done under the National Cooperative Research and Production Act of 1993, which helps limit the damages antitrust plaintiffs can recover under certain conditions. Several new companies and organizations have joined the consortium, but no other changes have been made to its membership or planned activities. The consortium intends to continue updating its membership changes as they occur.

Cedarburg Pharmaceuticals has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of controlled substances. The company plans to produce synthetic Tetrahydrocannabinols (THC) as an active pharmaceutical ingredient for distribution. Interested parties, including current manufacturers or applicants, can submit comments or request a hearing regarding this application by March 15, 2021. The DEA is handling correspondence related to this application.

The Pistoia Alliance, Inc. has informed the U.S. authorities about changes in its membership following the National Cooperative Research and Production Act of 1993. As of November 15, 2024, new members joining the group include companies from the UK, US, and Switzerland, while others from Germany and the US have left. These notifications aim to maintain the group's protection under the Act, which limits antitrust lawsuit recoveries. Membership in the group remains open, and additional updates will be filed to record future changes.