Search Results for keywords:"Centers for Medicare

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Search Results: keywords:"Centers for Medicare

  • Type:Notice
    Citation:90 FR 1157
    Reading Time:about 10 minutes

    The Food and Drug Administration (FDA) has released draft guidance for the industry on using Artificial Intelligence (AI) to aid in regulatory decisions for drugs and biological products.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.

    Simple Explanation

    The FDA wants to help people use smart computers to check if medicines are safe and work well. They are telling people how to do this and are asking everyone to share their thoughts until April 2025.

  • Type:Proposed Rule
    Citation:90 FR 5808
    Reading Time:about 2 minutes

    The Department of Transportation has withdrawn a proposed rule that was meant to update its National Environmental Policy Act (NEPA) procedures. The original proposal, introduced in 2020, aimed to revise existing procedures for considering environmental impacts, but these changes were never finalized. This decision comes following updates to the NEPA statute in the Fiscal Responsibility Act of 2023 and improved management practices in environmental reviews. The department plans to issue any new revisions for public review and comment before finalization.

    Simple Explanation

    The Department of Transportation decided not to change some rules about how they think about nature when making plans, because they need to make sure these rules fit with new laws and updates they got recently. They will take more time to get it right and will ask people what they think before making any final changes.

  • Type:Notice
    Citation:86 FR 10615
    Reading Time:about 2 minutes

    Norfolk Southern Corporation (NS) has submitted a petition to the Federal Railroad Administration (FRA) to waive certain rules related to train control systems on a section of their railway. They want permission to use locomotives equipped with positive train control (PTC) but not cab signal systems in specific areas. The public is encouraged to submit comments regarding this petition, and the government will consider all communications received by April 8, 2021. Comments will be made available online for public review.

    Simple Explanation

    Norfolk Southern, a train company, is asking for special permission to use certain train safety systems differently on their tracks, and people have until April 8, 2021, to say what they think about this request.

  • Type:Notice
    Citation:90 FR 4836
    Reading Time:about 2 minutes

    The Federal Railroad Administration (FRA) received a petition from the Salt Lake City Department of Public Services and the City of North Salt Lake, asking for a temporary waiver from certain safety regulations about railroad crossings. They want a two-year waiver to install new safety devices at two crossings in the Woods Cross Quiet Zone, as these crossings have had no accidents since 1979. Interested parties can send their comments online, which the FRA will consider before making a final decision. Comments should be submitted by March 17, 2025, although later ones might still be reviewed if feasible.

    Simple Explanation

    The cities want special permission to try out new train crossing safety gear for two years, and people can say what they think about it online.

  • Type:Rule
    Citation:86 FR 4728
    Reading Time:about 4 hours

    The final regulations from the Treasury Department and the IRS provide guidelines for claiming tax credits under section 45Q of the Internal Revenue Code, which encourages carbon oxide sequestration. They clarify how the capture, storage, and utilization of carbon oxide must be conducted and verified to qualify for credits. The regulations also define key terms, explain the process for credit recapture if captured carbon oxide leaks, and specify the documentation and reporting requirements necessary for compliance. The aim is to foster innovation and investment in technologies that reduce carbon emissions and assist in capturing carbon oxide effectively.

    Simple Explanation

    The document is like a rulebook that explains how companies can get rewards, called tax credits, for capturing and storing a special gas that helps the planet stay cool. It tells companies what they need to do to make sure they do this properly and how to prove it.

  • Type:Rule
    Citation:86 FR 2527
    Reading Time:about 4 minutes

    The Board of Governors of the Federal Reserve System has issued a final rule to adjust the amounts of civil money penalties to account for inflation as mandated by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. These adjustments are based on the change in the Consumer Price Index and are applied to penalties assessed on or after January 13, 2021, for violations occurring on or after November 2, 2015. The rule bypasses the usual requirements for public notice and commentary due to provisions in the 2015 Act, and it does not involve any collection of information that would necessitate paperwork under the Paperwork Reduction Act.

    Simple Explanation

    The people in charge of the United States' money rules decided to change some fines to keep up with changing prices, kind of like when candy costs more over time. They based the new amounts on how prices have changed since 2015, but they didn't tell everyone exactly how much the fines are in this document.

  • Type:Notice
    Citation:86 FR 9993
    Reading Time:about 2 minutes

    Norfolk Southern Corporation has requested a waiver from the Federal Railroad Administration (FRA) to operate trains without specific cab signal system equipment on a section of the Port Road Line in Pennsylvania. They wish to use locomotives equipped with a different technology called positive train control (PTC) in this area, covering up to 39.7 miles. The public can view the petition online and submit comments until April 5, 2021. The FRA is currently not planning a public hearing but will consider requests if provided reasons for holding one.

    Simple Explanation

    Norfolk Southern wants permission to run trains in Pennsylvania without some special equipment and instead use a different technology to help guide the trains. People can say what they think about this until early April, but the details aren't super clear on why they want this change or how it might affect everyone.

  • Type:Presidential Document
    Citation:90 FR 8767
    Reading Time:about 4 minutes

    The Executive Order titled "The Iron Dome for America" outlines a policy for the United States to strengthen its defense against advanced missile threats, including ballistic, hypersonic, and cruise missiles. It directs the Secretary of Defense to develop a comprehensive missile defense plan and accelerate the deployment of necessary technologies, ensuring the protection of the U.S. homeland and its critical infrastructure. Additionally, the order calls for increased cooperation with allies on missile defense initiatives and mandates periodic assessments of strategic threats. This directive emphasizes peace through strength and aims to maintain a secure second-strike capability for the United States.

    Simple Explanation

    The President wants to build a special shield for America to keep it safe from very fast and sneaky missiles, and they ask the people in charge of the military to make this shield quickly, even though it might cost a lot and they haven't figured out all the details yet.

  • Type:Notice
    Citation:86 FR 1118
    Reading Time:about 3 minutes

    The Bureau of Indian Education (BIE) is holding an online meeting for the Advisory Board for Exceptional Children to comply with the Individuals with Disabilities Education Act of 2004 (IDEA) for Indian children with disabilities. The meeting will occur on January 27-28, 2021, and is open to the public, with several updates and public commenting sessions scheduled. Due to the COVID-19 pandemic, all activity will be conducted online, and details for joining the meeting or submitting public comments are provided.

    Simple Explanation

    The Bureau of Indian Education is having an online get-together to talk about how to help kids with special needs and make sure they have what they need to learn. Because of COVID-19, they're doing it online to keep everyone safe.

  • Type:Notice
    Citation:86 FR 5199
    Reading Time:about 2 minutes

    The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services is requesting public comments on extending current data collection activities for the Chafee Foster Care Program, which helps young adults transition to adulthood. This involves interviews, focus groups, and data collection to evaluate the program's effectiveness. The ACF is asking for feedback on the necessity, utility, and efficiency of the proposed data collection methods and encourages suggestions to minimize the burden on respondents. Comments should be submitted within 60 days of publication to ensure they are considered in evaluating the program's readiness for further assessment.

    Simple Explanation

    The Administration for Children and Families wants more time to ask young people leaving foster care about how they’re doing, using interviews and group discussions to see if their program is helpful. They're inviting people to suggest easier ways to gather this info without taking too much time.