Search Results for agency_names:"Health and Human Services Department"

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 Department of Health and Human Services (HHS) has proposed new rules to revise health insurance standards under the Patient Protection and Affordable Care Act. These changes focus on improving the integrity of insurance marketplaces, especially concerning eligibility and enrollment systems. Key revisions include stricter policies on past-due premium payments and a proposal to exclude Deferred Action for Childhood Arrivals (DACA) recipients from health coverage through marketplaces. Additionally, the proposal aims to strengthen oversight on agents and brokers to prevent improper enrollments, which are believed to have cost taxpayers billions of dollars in recent years.

The Centers for Disease Control and Prevention (CDC), part of the Department of Health and Human Services, is awarding around $20 million to the World Health Organization (WHO), with the total expected funding to reach approximately $100 million over five years. This funding will help CDC and WHO work together to improve the world's ability to detect, respond to, and prevent infectious diseases. The focus is on building infrastructure and preparing for disease outbreaks, using WHO's global network to support these efforts. The award period is from September 2025 to September 2030.

The U.S. Department of Health and Human Services has issued a final rule revising the Adoption and Foster Care Analysis and Reporting System (AFCARS). This rule mandates that state Title IV-E agencies collect and report more detailed data related to the Indian Child Welfare Act (ICWA) for children in foster care. The aim is to better understand the experiences and outcomes for American Indian/Alaska Native (AI/AN) children and to improve culturally responsive care. States are given a three-year timeframe to implement these changes, which will take effect on October 1, 2028.

The Department of Health and Human Services (HHS) is establishing a new system of records to maintain child abuse and neglect investigation records for the Office of Refugee Resettlement's Unaccompanied Children Bureau. The rule exempts this system from certain Privacy Act requirements, like disclosure and access rights, to protect the integrity of investigations and secure sensitive information. HHS explains that these exemptions are necessary to prevent interference with investigations, safeguard the identities of children and informants, and maintain the effectiveness of investigative techniques. The rule will be effective by February 6, 2025, unless adverse comments are received by January 22, 2025.

This document from the Centers for Medicare & Medicaid Services (CMS) corrects technical and typographical mistakes in a previous rule published in November 2024. It involves Medicare and Medicaid Programs, particularly regarding payment systems, quality reporting programs, and various health policies. The corrections ensure accurate implementation of payment methodologies without changing any policy decisions made in the original rule, with the goal of making sure health providers receive correct payments promptly. As these are minor technical fixes, CMS has skipped the usual public notice and comment stages to enable quick implementation.

The Food and Drug Administration (FDA) has set January 1, 2024, as the uniform compliance date for food labeling regulations that were published between January 1, 2021, and December 31, 2022. This means any new food labeling rules released during this timeframe must be followed by the start of 2024 to reduce the economic impact of labeling changes on the food industry. The FDA states that while these regulations don't immediately introduce new costs, they allow businesses time to adjust their labeling practices. The rule also specifies that special circumstances may justify a different compliance date, which will be detailed as needed.

The Substance Abuse and Mental Health Services Administration (SAMHSA), part of the Department of Health and Human Services, announced additional funding for five grant recipients from the FY 2020 National Consumer and Consumer Supporter Technical Assistance Centers initiative. The extra funding totals $1,806,000, allowing each recipient to receive up to $361,200. This funding will extend their projects by 12 months, until March 30, 2026, enabling them to continue supporting mental health services for adults with serious mental illness. These funds are only available to the original grant recipients who demonstrate satisfactory applications and budgets.

The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

The Food and Drug Administration (FDA) is proposing a new rule to set a maximum nicotine level in cigarettes and other combusted tobacco products. This measure aims to decrease the addictiveness of these products, making it easier for people who want to quit to do so, and to prevent youth from becoming addicted. The rule is expected to benefit public health by reducing the number of individuals who start smoking or continue smoking over time. The proposal could potentially improve health outcomes by reducing the overall harmful effects of tobacco addiction.