Search Results for keywords:"Health and Human Services"

The Food and Drug Administration (FDA) is releasing draft guidance on studying sex differences in the clinical evaluation of medical products. This guidance aims to improve the representation of females in clinical trials and provide recommendations for analyzing sex-specific data. It highlights the importance of understanding different responses to treatments based on sex to improve safety and effectiveness. The public is encouraged to submit comments on this draft guidance by April 7, 2025.

The Administration for Community Living (ACL), part of the Department of Health and Human Services, has submitted a proposal for a new information collection to the Office of Management and Budget. This proposal involves a survey called the APS Practice Survey, aimed at understanding the practices of Adult Protective Services (APS) programs across the U.S. and its territories. The survey seeks to identify innovative practices and challenges within APS programs, providing baseline data to aid research and enhance service delivery. Public comments on this collection are welcomed until March 29, 2021.

The Food and Drug Administration (FDA) is seeking public comments on a proposal to gather information related to the use of public human genetic variant databases. These databases are used to support the clinical validity of genetic and genomic-based tests. The FDA is considering extending their guidelines and processes for recognizing these databases as trustworthy sources of scientific evidence. The deadline for submitting comments is March 26, 2021, and interested parties can access the collection of information online and share their feedback.

The National Institute on Aging announced a closed meeting to review and evaluate grant applications related to the Dominantly Inherited Alzheimer Network. This meeting, scheduled for February 10, 2025, from 12:00 p.m. to 5:00 p.m., will be held virtually. The meeting is closed to protect confidential information and personal privacy. Joshua Jin-Hyouk Park, Ph.D., is the contact person for this meeting, and it will adhere to specific sections of the U.S. Code to ensure confidentiality.

The Food and Drug Administration (FDA) announced that certain drug products, including Bentyl Preservative Free (Dicyclomine Hydrochloride) Injection, 10 Milligrams/Milliliters, have not been taken off the market for safety or effectiveness issues. This means that generic versions of these drugs can still be approved by the FDA and sold, as long as they follow the necessary legal and regulatory guidelines. The drugs will be listed in the "Discontinued Drug Product List" in the Orange Book because they are no longer being sold, but not for reasons related to safety or effectiveness.

The Department of Health and Human Services (HHS) finalized a rule to modify the Vaccine Injury Table, which relates to the National Vaccine Injury Compensation Program (VICP). This new rule removes Shoulder Injury Related to Vaccine Administration (SIRVA) and vasovagal syncope from the list of injuries eligible for compensation under the VICP. Some members of the public opposed the change, expressing concerns about safety and potential impacts on liability for vaccine administrators. However, HHS argued that these injuries are often due to improper administration techniques rather than the content of the vaccines themselves, and stated that this change aims to ensure that funds are directed to injuries directly caused by vaccines.

The Department of Health and Human Services (HHS) is amending a regulation concerning the care of unaccompanied alien children (UACs). This interim final rule removes a previous provision that prohibited the sharing of immigration status information of potential sponsors with law enforcement. The change is necessary because the provision conflicted with federal law, which requires no restriction on sharing immigration status information with the Immigration and Naturalization Service. The rule is effective immediately, and public comments are invited until May 27, 2025.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is announcing a meeting for the Center for Substance Abuse Prevention National Advisory Council on February 24, 2021. The meeting, which will be held online and is open to the public, will discuss substance use prevention priorities and update on the Center's program developments. Interested individuals can present their views in writing or orally and are encouraged to register in advance on SAMHSA's website. Contact information for further inquiries or special accommodations is provided within the notice.

The Administration for Community Living (ACL) has submitted a proposal to the Office of Management and Budget (OMB) for the collection of information required under the Paperwork Reduction Act. This involves gathering data on the Independent Living Services Program Performance Report, which helps improve independent living services in various U.S. regions, including states, territories, and commonwealths. The ACL uses this data to ensure compliance with federal regulations and to identify training needs for organizations involved. The public can submit comments on this proposal until March 29, 2021.

The final rule from the Department of Health and Human Services (HHS) and the Treasury Department provides new guidelines for implementing the Patient Protection and Affordable Care Act (PPACA). It includes plans for reducing user fees for issuers using federal platforms in 2022 and introduces a new direct enrollment option allowing states more flexibility in how they facilitate health insurance plans through private entities. Additionally, the rule seeks to ensure that State Innovation Waivers can be more predictable by codifying policies into regulations, offering states more room for innovation while ensuring the availability of affordable health coverage. The rule clarifies that plans without provider networks are exempt from network adequacy certification while maintaining their other requirements.