Search Results for agency_names:"Justice Department"

S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

Synthcon LLC has applied to be registered as a bulk manufacturer of controlled substances, according to a notice from the Drug Enforcement Administration under the Department of Justice. The company intends to produce these substances for use as reference materials, proficiency tests, and academic research. Interested parties, such as current bulk manufacturers and applicants, are invited to submit comments or objections to this application by April 26, 2021, and may also request a hearing by the same date. Written comments can be sent to the DEA at their address in Springfield, Virginia.

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.

PXI Systems Alliance, Inc. submitted notifications to the Attorney General and the Federal Trade Commission to report changes in its membership as part of a research project under the National Cooperative Research and Production Act of 1993. Five members, including companies from Germany, Japan, Tennessee, and California, have left the group. Despite these changes, PXI Systems plans to continue its work and will update membership changes as needed. The project remains open to new members, and the last notification was made in August 2024.

The Department of Justice has lodged a proposed Consent Decree with a federal court in New Jersey concerning three companies linked to the CPS/Madison Superfund Site. These companies are expected to carry out and help with environmental cleanup efforts that could cost around $14 million. The decree outlines that the U.S. government won't sue the companies for these specific cleanup actions. The public has 30 days to submit comments on this proposal.

Restek Corporation has applied to be registered as a bulk manufacturer of certain controlled substances. The application was submitted to the Drug Enforcement Administration on February 19, 2025, and the company plans to produce synthetic versions of substances like Marihuana and Tetrahydrocannabinols for specific purposes. Interested parties can file comments or objections, or request a hearing on this registration by June 17, 2025. All submissions must be made through the Federal eRulemaking Portal.

The Subcutaneous Drug Development & Delivery Consortium, Inc. has notified the Attorney General and the Federal Trade Commission about changes in its membership as required by law. New members of this research venture include Janssen Research & Development, LLC, Novo Nordisk from Denmark, and Ypsomed AG from Switzerland. This action is part of the ongoing compliance with the National Cooperative Research and Production Act, which limits the damages that antitrust plaintiffs can recover in certain circumstances. The Consortium plans to keep the membership open and continues to update the authorities on its developments.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import these substances solely for clinical trials. Other types of uses or commercial sales are not allowed under this registration. Interested parties can submit comments or objections electronically by April 16, 2025, and can also request a hearing on the application by the same date.

The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), under the Department of Justice, is seeking public comments on a new information collection called the Licensing Questionnaire, using ATF Form 8620.44. This form aims to assess if individuals seeking employment or contracts with ATF, or their immediate family members, have any financial interests in the alcohol, tobacco, firearms, or explosives industries. The agency expects 2,000 respondents annually, with each taking about 5 minutes to complete the form, totaling an estimated public burden of 167 hours. The comment period is open for 30 days, until March 29, 2021.

Sterling Pharma USA LLC has applied to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of controlled substances. This application, filed on February 11, 2025, aims to support the company's internal research and provide substances for pre-clinical trial studies. The public can comment or object to this registration until May 16, 2025, through the Federal eRulemaking Portal.