Search Results for keywords:"Centers for Medicare

The Environmental Protection Agency (EPA) reviewed a petition requesting testing of 54 per- and polyfluoroalkyl substances (PFAS) produced by Chemours Company in North Carolina. The petition, submitted by several health and environmental groups, also asked for a National Academy of Sciences panel to oversee the testing. After considering the information, EPA denied the request, stating that the petition didn't provide enough specific facts to warrant a new rule or order under the Toxic Substances Control Act (TSCA). EPA highlighted ongoing actions and research addressing PFAS risks and noted that some existing projects may already cover the requested testing.

The Federal Transit Administration (FTA) is considering a temporary waiver for the Buy America requirements on battery electric minibuses due to the lack of U.S.-manufactured options that meet these standards. This waiver would allow transit providers to buy these buses despite not meeting local manufacturing rules, as long as certain conditions are met, like having a battery-powered system and specific vehicle size and design features. The FTA seeks public feedback on whether they should implement this waiver or make any changes to it. If the waiver is granted, it will help improve access to zero-emission public transportation for routes with fewer passengers, potentially leading to reduced greenhouse gas emissions.

The National Marine Fisheries Service (NMFS) has published a notice about an Exempted Fishing Permit (EFP) application by Atlantic Capes Fisheries, Inc., in partnership with Rutgers University. This permit, if granted, would allow certain vessels to catch both surfclams and ocean quahogs during the same trip, something normally restricted by current regulations. The aim is to research and develop accurate methods for estimating the number of these species discarded and mixed at sea. Public comments on this proposal must be submitted by April 7, 2025.

The Rural Utilities Service of the USDA has announced that applications are open for the Community Connect Grant Program for Fiscal Year 2025. This program provides approximately $26 million to help construct broadband networks in rural areas lacking such services. Eligible entities like incorporated organizations, state or local governments, and Indian tribes can apply for grants ranging from $100,000 to $5,000,000 to ensure rural communities have access to affordable, high-speed internet. Applications must be submitted online between February 20, 2025, and April 21, 2025.

The Food and Drug Administration (FDA) is inviting industry organizations to participate in selecting nonvoting representatives for the Patient Engagement Advisory Committee, which discusses the use and regulation of medical devices. These nonvoting representatives can be nominated either by the organizations or through self-nomination and should be experienced in fields related to medical devices. Organizations interested in participating must notify the FDA by January 29, 2025, and nominations should be submitted by the same date. The FDA is particularly looking for individuals with expertise in areas like cybersecurity, digital health, patient engagement, and health equity.

The U.S. Environmental Protection Agency (EPA) is proposing amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for the Polyether Polyols (PEPO) Production industry. The proposed changes, under the Clean Air Act (CAA), aim to address harmful emissions of ethylene oxide (EtO) and other hazardous air pollutants to improve air quality and public health. The EPA suggests tighter controls on process vents, storage vessels, equipment leaks, heat exchange systems, and wastewater, and plans to implement fenceline monitoring to measure and manage emissions more effectively. The agency estimates significant reductions in harmful emissions with these new standards.

The National Marine Fisheries Service (NMFS) is considering a request for an Exempted Fishing Permit (EFP) that would allow fishing boats to operate outside the usual fishery regulations. This permit, requested by the Northeast Seafood Coalition in partnership with Massachusetts Division of Marine Fisheries, aims to study the effectiveness of cod protection areas and gather biological data on cod. The project will also help fishermen access underutilized groundfish stocks while ensuring that cod spawning thresholds are not exceeded. Public comments on the proposal are welcome until April 28, 2025.

The Federal Aviation Administration (FAA) has issued a final rule that shifts the compliance deadline for individuals with foreign addresses applying for certain aviation certificates, ratings, or authorizations to designate a U.S. agent for service. Originally set for January 6, 2025, the deadline has been extended to April 2, 2025, to allow the FAA more time to develop their online system for accepting these designations. This change aims to prevent disruptions in issuing these certificates due to the system's development delays. The compliance date for individuals who already hold certain certificates remains unchanged at July 7, 2025.

The Bureau of Land Management (BLM), under the Interior Department, is seeking public comments on the renewal of an information collection under the Paperwork Reduction Act of 1995. This collection is linked to applications for leasing or selling public lands for recreation or public purposes, with an extension request to renew OMB Control Number 1004-0012. The BLM invites comments on several aspects, such as the necessity of the information collected and the estimated burden it imposes, by January 17, 2025. The proposed information collection is crucial for assessing applications from state and local governments, as well as nonprofit organizations, and is estimated to involve 920 burden hours annually.

The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products. This guidance explains how AI can be used to produce credible information or data regarding the safety, effectiveness, or quality of these products. It emphasizes a risk-based assessment framework for AI models and encourages early consultation with the FDA to ensure compliance and credibility. The guidance and its proposed recommendations are open for public comment until April 7, 2025, allowing stakeholders to contribute their views on the outlined framework and engagement options with the FDA.