Search Results for keywords:"Centers for Medicare

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Search Results: keywords:"Centers for Medicare

  • Type:Notice
    Citation:86 FR 4085
    Reading Time:about 8 minutes

    The Food and Drug Administration (FDA) announced a new date for the previously canceled public meeting on "Patient-Focused Drug Development for Vitiligo," now scheduled for March 8, 2021, in a virtual format. This meeting aims to gather patient input on how vitiligo affects their daily lives, their views on current treatment options, and how they decide on treatments. Participants can submit comments electronically or by mail until May 10, 2021, using the docket number FDA-2020-N-0255. The FDA seeks to understand patient perspectives to improve understanding and treatment approaches for vitiligo.

    Simple Explanation

    The FDA wants to hear from people with a skin condition called vitiligo to learn how it affects their lives and what they think about treatments, and they’ve set up an online meeting on March 8, 2021, where people can share their thoughts.

  • Type:Notice
    Citation:86 FR 6343
    Reading Time:about a minute or two

    The Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have issued a notice about two requests for proposals that were initially published on September 24, 2020. These proposals involve the reimportation of insulin and the personal importation of prescription drugs. The notice updates these proposals to include revised versions in the Federal Register. Responses to the proposals can be submitted via email and will be reviewed on a rolling basis.

    Simple Explanation

    The government wants to know if people have ideas about how we can bring insulin and other medicines from another country back into our own country. They're asking for suggestions, but they need to explain better who can send those ideas and how they will pick the best ones.

  • Type:Notice
    Citation:89 FR 106515
    Reading Time:about 7 minutes

    The Food and Drug Administration (FDA) announced the release of final guidance titled "E11A Pediatric Extrapolation," prepared with the International Council for Harmonisation. This guidance aims to streamline pediatric drug development, focusing on strategies like safety extrapolation and statistical methodologies to ensure safe, effective medicines for children. It replaces a draft guidance from August 2022 and includes updates to study designs and modeling approaches. The public can comment on this guidance, which is accessible through FDA's regulations website.

    Simple Explanation

    The FDA, which makes sure medicines are safe, has shared new instructions to help make medicines for kids. They have worked with an international group to make the process faster and safer, using special math tools to predict outcomes.

  • Type:Notice
    Citation:86 FR 11563
    Reading Time:about 4 minutes

    The U.S. Nuclear Regulatory Commission (NRC) has issued a new Regulatory Guide (RG) 1.237, titled "Guidance for Changes During Construction for Nuclear Power Plants Being Constructed Under a Combined License Referencing a Certified Design Under 10 CFR part 52." This guide provides an approved process for making design changes to structures, systems, and components of nuclear plants under construction. The document also mentions that it does not impose mandatory compliance on licensees and would not constitute a backfit or forward fit. The guide is accessible online alongside related documents for public review.

    Simple Explanation

    The U.S. Nuclear Regulatory Commission has made a new guide to help people who build nuclear power plants know how to safely change their designs as they build. It's not mandatory to follow these rules, but they show a good way to do it if you choose to.

  • Type:Notice
    Citation:86 FR 8160
    Reading Time:about 27 minutes

    The Rural Business-Cooperative Service under the USDA has issued a notice inviting applications for grants under the Rural Business Development Grant (RBDG) Program for the fiscal year 2021. These grants aim to promote economic development and job creation in rural areas by funding business opportunity and enterprise projects. Applications must be submitted by March 31, 2021, to the appropriate USDA Rural Development State Office. Eligibility is limited to public bodies, government entities, Indian Tribes, or nonprofit entities primarily serving rural areas, with strict requirements and a competitive selection process based on specific criteria.

    Simple Explanation

    The USDA is offering money to help grow businesses in the countryside. People like local governments, tribes, and nonprofits can ask for this money, but they must follow specific rules and apply by a certain date.

  • Type:Notice
    Citation:86 FR 11572
    Reading Time:about 78 minutes

    The U.S. Department of Transportation has announced a Notice of Funding Opportunity for the Infrastructure for Rebuilding America (INFRA) program for fiscal year 2021. This program provides federal financial assistance to important transportation projects, focusing on enhancing highway and freight infrastructure of national or regional importance. Key objectives for project selection include promoting economic growth, addressing climate change, advancing racial equity, and encouraging innovation. The deadline for submitting applications through the Grants.gov platform is March 19, 2021.

    Simple Explanation

    The government is offering money to help build and improve roads and highways, and they want projects that can make a big difference in people's lives. People have to apply by telling the government about their projects, but some might find it hard to understand all the rules or get enough money to match what the government gives.

  • Type:Notice
    Citation:89 FR 104226
    Reading Time:about 15 minutes

    The Office of Management and Budget (OMB) is asking for public comments on a draft report that offers initial guidance for classifying environmental-economic statistics. This effort, led by an interagency group of experts, aims to create a framework for including environmental data in national economic accounts, such as measuring assets like land, water, and forests. The goal is to develop consistent statistical categories that align with national and international standards. The feedback from this request will help shape future guidelines, with final guidance expected in 2028.

    Simple Explanation

    The government is asking people to share their thoughts on new ideas about how to count nature, like trees and water, when they talk about money. They want to make sure everyone understands and agrees on how to do this by the year 2028.

  • Type:Notice
    Citation:89 FR 100539
    Reading Time:about 2 minutes

    The Department of Labor (DOL) is seeking public feedback on an information collection request related to authorizing the release of medical information for Black Lung Benefits. The Office of Workers' Compensation Programs (OWCP) has submitted this request to the Office of Management and Budget (OMB) as part of their review process. The public is encouraged to comment by January 13, 2025, focusing on the necessity, accuracy, and potential improvements for the collection process. This request involves gathering consent from individuals to use their medical evidence in support of Black Lung claims, impacting around 5,990 respondents annually.

    Simple Explanation

    The Department of Labor wants to hear what people think about sharing medical information for helping with Black Lung Benefits claims. They want to make sure they're collecting the right information and making it easy for everyone involved.

  • Type:Notice
    Citation:90 FR 9802
    Reading Time:about 2 minutes

    The Internal Revenue Service (IRS) is seeking public comments on the Information Returns (IR) application for a Transmitter Control Code (TCC), as part of its effort to reduce paperwork and respondent burden. This application is for those intending to file Information Returns electronically using the FIRE System and will replace the obsolete Form 4419. Comments are invited by April 21, 2025, on various aspects of the information collection, such as its necessity and ways to improve its utility and clarity. Approved applicants will receive a 5-digit code to identify the business transmitting electronic returns.

    Simple Explanation

    The IRS wants people to share their thoughts on a new code that helps them send tax forms online, and they're getting rid of an old form that used to do this. They hope this new code will make it simpler to show which business is sending tax forms, and want to know if it can be made even clearer and better.

  • Type:Notice
    Citation:89 FR 106728
    Reading Time:about 3 minutes

    The Federal Highway Administration (FHWA), part of the Department of Transportation, is seeking public comments on a new information collection related to the National Scenic Byway Program (NSBP). This program aims to recognize and enhance roads across the United States, offering grants to State Departments of Transportation and federally recognized Indian Tribes. Comments are invited on the necessity and accuracy of this information collection, as well as any suggestions to improve it or reduce the burden on applicants. The deadline for submitting comments is January 29, 2025.

    Simple Explanation

    The Federal Highway Administration is asking people for their thoughts on a new plan to help make special roads prettier and more fun to drive on, and they want these thoughts by the end of January 2025. They also gave a lot of money to help fix these roads, and they're trying to make sure they do it in a fair way.