💉Notice of CDC Meeting on Vaccination Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. Time will be available for public comment.
Learn More💊FY 2025 Facility Fee Rates for OTC Monograph Drugs Announced
The Food and Drug Administration (FDA, the Agency, or we) is announcing the over-the-counter (OTC) monograph drug facility (MDF) fee rates under the OTC monograph drug user fee program (OMUFA) for fiscal year (FY) 2025. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess and collect user fees from qualifying manufacturers of OTC monograph drugs and submitters of OTC monograph order requests (OMORs). This notice publishes the OMUFA facility fee rates for FY 2025.
Learn More🧠NIH Notice
The Department of Health and Human Services announces closed meetings by the National Institute of Neurological Disorders and Stroke to review and evaluate grant applications. These meetings will address cooperative agreements and support research related to neurological disorders, emphasizing the importance of confidentiality during the discussions.
Learn More🏥NIH Meeting on Grant Applications for Child Health Funding
The notice announces a closed meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, where grant applications will be reviewed and evaluated. Discussions are confidential to protect sensitive information related to trade secrets and personal data.
Learn More💰NIH Notice of Closed Meeting for Grant Applications Review
This notice announces a closed meeting by the National Center for Complementary and Integrative Health, focusing on the review of cooperative agreement applications related to pain care in health care systems. The meeting aims to evaluate funding opportunities that may significantly impact business stakeholders in the health sector.
Learn More💰Notice of Closed Meeting for NIH Grant Applications Review
The Department of Health and Human Services announces a closed meeting of the National Institute of Allergy and Infectious Diseases' Special Emphasis Panel. The agenda includes the review of grant applications related to clinical trial planning and implementation. Meeting proceedings are confidential to protect sensitive information related to the applications.
Learn More🏥Proposed Rule for Marketplace Integrity Under the ACA
This proposed rule would revise standards relating to past-due premium payments; exclude Deferred Action for Childhood Arrivals recipients from the definition of "lawfully present"; the evidentiary standard HHS uses to assess an agent's, broker's, or web-broker's potential noncompliance; failure to file and reconcile; income eligibility verifications for premium tax credits and cost-sharing reductions; annual eligibility redetermination; the automatic reenrollment hierarchy; the annual open enrollment period; special enrollment periods; de minimis thresholds for the actuarial value for plans subject to essential health benefits (EHB) requirements and for income-based cost-sharing reduction plan variations; and the premium adjustment percentage methodology; and prohibit issuers of coverage subject to EHB requirements from providing coverage for sex-trait modification as an EHB.
Learn More⚖️FDA Denies Hearing and Issues Permanent Debarment for Garmendia
The Food and Drug Administration (FDA or Agency) is denying a request for a hearing submitted by Bernardo Garmendia, also known as Bernardo Germendia, (Garmendia) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Garmendia from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Garmendia was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. FDA provided notice to Garmendia of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Garmendia submitted a request for hearing but failed to file with the Agency information and analyses sufficient to create a basis for a hearing.
Learn More💊Meridian Medical Technologies Seeks Importer Registration for Controlled Substances
Meridian Medical Technologies, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊VA Updates Tiered Pharmacy Copayments for 2025
This Department of Veterans Affairs (VA) notice updates the information on Tier 1 medications.
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