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The Department of Health and Human Services and the Food and Drug Administration (FDA) are proposing to permanently waive certain premarket notification requirements for specific medical devices. This action follows temporary waivers provided during the COVID-19 pandemic to make medical devices more accessible. The proposal includes making seven class I devices and 84 class II devices permanently exempt from the 510(k) premarket notification requirement, which typically involves a costly and time-consuming process. The public is invited to comment on the proposed exemptions and suggest improvements to the regulatory system concerning medical devices.

The Administration for Native Americans under the Administration for Children and Families is seeking public comments on their request to extend the Ongoing Progress Report and Objective Work Plan for another three years, until September 30, 2026. This extension involves changes only to the report itself. Comments must be submitted by February 18, 2025, to have full effect. This request, which is part of efforts to monitor and evaluate grants effectively, involves collecting information to assess the performance and progress of projects funded by the administration.

The Food and Drug Administration (FDA) has announced a reorganization of its Center for Drug Evaluation and Research (CDER), specifically within the Office of Surveillance and Epidemiology (OSE) and the Office of New Drugs (OND). This reorganization aims to enhance their ability to support the FDA's mission by improving drug safety and management, addressing drug development for rare diseases, opioids, and other critical areas. The changes include creating several new offices and divisions to streamline operations and respond to legislative requirements. This structure was approved by the Secretary of Health and Human Services and is detailed in the FDA's Staff Manual Guide available online.

The Food and Drug Administration (FDA) has announced the release of a final guidance document titled "Mouse Embryo Assay for Assisted Reproduction Technology Devices." This guidance provides recommendations on conducting the mouse embryo assay (MEA), which is used to evaluate the potential for embryotoxicity of devices that come into contact with gametes and/or embryos. The FDA has revised the guidance based on public comments and has made several technical clarifications. The document emphasizes that following FDA guidelines is not mandatory and alternative approaches are acceptable if they meet relevant requirements.

The Administration for Children and Families, part of the U.S. Department of Health and Human Services, is seeking public comments on extending and updating the Low Income Home Energy Assistance Program (LIHEAP) Performance Measures. This involves continuing the current data collection until June 2025 and introducing changes starting July 2025. These changes aim to collect more detailed data on the impact of federal funds and improve survey tools. The general public, especially those interested in the program, can submit their comments by January 31, 2025.

The document is an amendment issued by the Acting Secretary of the Department of Health and Human Services under the Public Readiness and Emergency Preparedness Act. This amendment expands the list of people who can prescribe, dispense, and administer COVID-19 countermeasures by including federal employees, contractors, and volunteers. These individuals will receive liability protection as they assist in the national COVID-19 vaccination program. The amendment also ensures that any conflicting state laws are preempted to allow a quicker and more extensive rollout of COVID-19 vaccinations.

The National Institute on Alcohol Abuse and Alcoholism is holding a closed meeting on March 5, 2025. The meeting will take place from 10:00 a.m. to 5:00 p.m. and will be conducted virtually. Participants will review and evaluate grant applications, which involve discussions that may reveal confidential information or personal details. This confidentiality aligns with federal rules to protect trade secrets and personal privacy.

The Food and Drug Administration (FDA) is extending the period for public comments on a concept paper titled "Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed." Originally, the comment period was set to end on April 12, 2021, but it has been extended by 60 days to June 11, 2021, to give people more time to share their thoughts. The concept paper was published on January 11, 2021, and this extension is in response to requests for more time to provide comprehensive feedback. Interested parties can submit their comments electronically or in written form by the new deadline.

The Centers for Medicare & Medicaid Services (CMS), part of the Department of Health and Human Services (HHS), issued a notice about a new information collection related to PACE Medicaid Capitation Rate Setting. The notice is looking for public comments on the proposed collection methods, which aim to assist states in setting PACE rates for elderly care programs integrating Medicare and Medicaid services. This process involves obtaining feedback on minimizing the burden of information collection and improving the clarity and utility of the collected data. Comments must be submitted by December 20, 2024, through options like electronic submission at regulations.gov or via mail.

The U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) are seeking public feedback on the Scientific Report prepared by the 2025 Dietary Guidelines Advisory Committee. Individuals are encouraged to submit written comments online or by mail within 60 days after the report is made available, with specific instructions on submissions provided on the respective government websites. Additionally, the public can register to give virtual oral comments on January 16, 2025, with pre-registration required. These oral presentations can be either live or pre-recorded, aimed at addressing the scientific findings and recommendations within the report.