Search Results for keywords:"Additive Manufacturing

The Food and Drug Administration (FDA) announced the user fee rates for fiscal year 2025 under the Over-the-Counter (OTC) Monograph Drug User Fee Program. This program allows the FDA to collect fees from manufacturers of OTC monograph drugs, which do not require a new drug application. For FY 2025, the fee for facilities manufacturing these drugs is set at $37,556 for monograph drug facilities and $25,037 for contract manufacturing organizations. These fees help the FDA cover the costs associated with regulating OTC monograph drugs.

The Department of Health and Human Services has issued a notice clarifying that businesses that started producing hand sanitizers during the COVID-19 pandemic are not required to pay certain facility fees under the Food, Drug, and Cosmetic Act. These businesses, many of which normally produce alcoholic beverages, were allowed to make hand sanitizers due to a temporary policy by the FDA to address shortages. The Department emphasizes that imposing such fees would be inconsistent with the intent of the CARES Act and clarifies that these businesses are not considered drug manufacturing facilities under the law, unless they also engage in producing other over-the-counter drugs.

The Department of Commerce, through the Economic Development Administration (EDA), has issued a notice requesting public comment on a revised information collection concerning the Tech Hubs initiative. This initiative aims to enhance U.S. economic and national security by promoting regional innovation and competitiveness. The revised information collection will help ensure that investments in designated Tech Hubs are data-driven and accountable. Public comments are sought to evaluate the necessity, efficiency, and burden of this data collection to improve its effectiveness.

The Environmental Protection Agency (EPA) has finalized a rule under the Toxic Substances Control Act to address health and environmental risks posed by decabromodiphenyl ether (decaBDE), a persistent, bioaccumulative, and toxic chemical. The rule prohibits the manufacture, processing, and distribution of decaBDE and products containing decaBDE, with some exceptions, aiming to significantly reduce exposure to the chemical. To comply, recordkeeping is required for those involved with decaBDE, except in cases involving recycling, where no new decaBDE is added. The restrictions will help to protect human health and the environment by decreasing the presence and exposure risks associated with decaBDE.

The Environmental Protection Agency (EPA) has finalized a rule to address health risks from carbon tetrachloride (CTC) under the Toxic Substances Control Act (TSCA). This rule will establish workplace safety requirements and prohibit certain manufacturing and commercial uses of CTC where evidence shows these uses have ceased. It also introduces recordkeeping and notification responsibilities. The rule supports broader environmental goals, like those in the American Innovation and Manufacturing Act and the Kigali Amendment, aimed at reducing substances harmful to the ozone layer.

The Department of Commerce, through the Census Bureau, is seeking public feedback on its plan to continue the Quarterly Financial Report (QFR) program. This program collects data on the financial status of U.S. corporations, targeting those in manufacturing, mining, and several other sectors. The collected information is crucial for economic analysis and requires the involvement of businesses with significant assets. Comments on the proposed information collection, which aims to minimize the burden on respondents, can be submitted until March 26, 2021.

The Census Bureau, part of the Commerce Department, is inviting public comments on the Manufacturers' Unfilled Orders Survey, as part of their efforts under the Paperwork Reduction Act of 1995. This notice allows for 60 days of public commentary before the information collection request is submitted for approval. The survey collects important data to benchmark the monthly Manufacturers' Shipments, Inventories, and Orders Survey, aiding in the analysis of business conditions. The information from this survey helps refine economic insights used by various governmental and business entities. Public comments help evaluate the survey's necessity, accuracy, and potential improvements while aiming to reduce the reporting burden.

The Environmental Protection Agency (EPA) has issued a final rule under the Toxic Substances Control Act (TSCA) to regulate hexachlorobutadiene (HCBD), a chemical deemed persistent, bioaccumulative, and toxic. This rule prohibits almost all manufacturing, processing, and distribution of HCBD and products containing it, except when HCBD is unintentionally produced as a byproduct in the creation of chlorinated solvents and when distributed for incineration as waste fuel. The rule aims to significantly reduce exposure to HCBD to protect human health and the environment, and it becomes effective on March 8, 2021.

The Environmental Protection Agency (EPA) is issuing a final rule under the Toxic Substances Control Act (TSCA) to limit the use of pentachlorothiophenol (PCTP), a chemical identified as persistent, bioaccumulative, and toxic. The rule prohibits manufacturing, processing, and distributing PCTP and PCTP-containing products if the concentration exceeds 1% by weight. This restriction aims to lower the availability and exposure of PCTP, thereby reducing the potential risks to human health and the environment. By enforcing these limits, the EPA encourages the use of safer alternatives and reduces environmental and human exposure to PCTP.

The America First Trade Policy memorandum outlines a plan by the President to prioritize American economic and national security interests in trade policy. It directs various government officials to investigate and address issues like unfair trade practices, large trade deficits, and currency manipulation. The memo also emphasizes reviewing trade relations with China, exploring tariff adjustments, and examining the effectiveness of existing U.S. export controls. The goal is to enhance the United States' industrial and technological strengths, protect workers, and ensure fair trade practices with global partners.