Search Results for keywords:"Additive Manufacturing

The Environmental Protection Agency (EPA) is reviewing the National Emission Standards for Hazardous Air Pollutants related to brick and clay manufacturing to determine if the regulations should be changed or kept the same. This review is part of a process required by the Regulatory Flexibility Act, which ensures that rules do not unfairly impact small businesses. The EPA is asking for public comments on the rules, especially about how they could be improved or if there are issues with them overlapping with other laws. People can submit their comments until May 30, 2025.

The Food and Drug Administration (FDA) has released a final guidance document for the pharmaceutical industry called the "Advanced Manufacturing Technologies Designation Program." This program aims to encourage the adoption of advanced manufacturing technologies (AMTs) that can enhance drug quality and production efficiency. The guidance outlines eligibility criteria, submission processes, and benefits for obtaining an AMT designation, which supports the development of crucial drugs. Additionally, it finalizes a draft from December 2023 and reaffirms FDA's commitment to improving drug manufacturing processes.

Patheon API Manufacturing, Inc. has applied to the Drug Enforcement Administration (DEA) to become a registered bulk manufacturer of certain controlled substances. The company intends to produce these substances as Active Pharmaceutical Ingredients (APIs) for its customers, specifically focusing on synthetic tetrahydrocannabinols. The public, including existing manufacturers and applicants, may submit comments or request a hearing on this application by April 20, 2021.

The Office of Management and Budget (OMB) has issued a request for information (RFI) to improve the domestic manufacturing of semiconductors for commercial information technology products. They are seeking feedback from the public on how to strengthen America's semiconductor supply chain by relying on domestic sources and reducing dependency on foreign production. The agency aims to gather insights on various strategies, including dual sourcing and industrial mobilization, to enhance national and economic security. Responses to the RFI will inform potential government actions to support U.S. semiconductor manufacturing and are due by March 17, 2025.

Pharmaron Manufacturing Services (US) LLC has applied to be registered as an importer of certain controlled substances. The Drug Enforcement Administration (DEA) announced this application and is inviting comments and requests for hearings from other registered bulk manufacturers and applicants until April 25, 2025. The company aims to use the imported substances for analytical purposes and production processes but is not authorized for commercial sale of finished dosage forms. The submission of comments should be done electronically through the Federal eRulemaking Portal.

Pharmaron Manufacturing Services (US), LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to allow the company to produce materials for clinical trials. Interested parties can submit comments or request a hearing on the application by May 27, 2025, via the Federal eRulemaking Portal. The application was officially filed on February 11, 2025, and no other activities related to these substances are authorized beyond clinical trial production.

The Bureau of Industry and Security (BIS) is hosting a virtual public briefing on December 5, 2024, to discuss two new rules posted for public inspection. These rules involve changes to controls on advanced computing and semiconductor items, as well as updates to the Entity List, which includes entities from countries like China and Japan that are considered contrary to U.S. national security interests. The public can register online to attend the briefing and learn more about these regulatory updates.

The Foreign-Trade Zones (FTZ) Board has approved an application to establish Subzone 102G for True Manufacturing Co., Inc., in O'Fallon and Mexico, Missouri. This decision was made on January 7, 2025, following the submission of an application by the St. Louis County Port Authority, which is the grantee of FTZ 102. The application was reviewed and found to meet the necessary criteria, and the new subzone will be subject to FTZ 102's 2,000-acre activation limit. The application process included a public comment period announced in the Federal Register on November 26, 2024.

The document is about a notice filed by the Integrated Photonics Institute for Manufacturing Innovation, also known as AIM Photonics, which is under the American Institute for Manufacturing Integrated Photonics. On December 6, 2024, they informed the Attorney General and the Federal Trade Commission about changes in their membership, adding two new Canadian members: the Canadian Photonics Fabrication Centre in Ottawa and Dream Photonics, Inc. in Vancouver. This notice extends the provisions of the National Cooperative Research and Production Act, which limits the recovery of antitrust plaintiffs to actual damages under certain conditions. Membership in AIM Photonics remains open, and they plan to disclose further changes in the future.

The American Institute for Manufacturing Integrated Photonics (AIM Photonics) has submitted a notice under a specific U.S. law to update its membership, adding the Universal Thin Film Lab Corporation and the Regents of the University of California Irvine to their group. This notice, filed as required by the National Cooperative Research and Production Act, helps limit the recovery of damages in antitrust lawsuits to actual damages for certain cases. AIM Photonics remains open to new members and will continue to update its membership list as changes occur. This latest filing was made to the Department of Justice and published in the Federal Register.