📅Notice of Change in National Heart, Lung, and Blood Advisory Council Meeting Schedule
The Department of Health and Human Services announces a change in the meeting schedule of the National Heart, Lung, and Blood Advisory Council. The meeting is partially closed to the public and will occur on June 11, 2025, at the Porter Neuroscience Research Center in Bethesda, MD.
Learn More💰NIH Announces Closed Meetings for Grant Evaluations
The Department of Health and Human Services announces several closed meetings by the National Institutes of Health to evaluate grant applications. These meetings pertain to specific panels focused on scientific research topics, ensuring confidentiality and the protection of sensitive information while facilitating assessments that influence research funding.
Learn More🏥Amended Meeting Notice from the National Heart, Lung, and Blood Institute
The notice provides updates on the rescheduling of the National Heart, Lung, and Blood Advisory Council meeting. It specifies the new start and end times and indicates that the meeting will partially be closed to the public, while referencing a prior publication in the Federal Register.
Learn More📊Request for Public Comments on SRAE Data Collection Initiative
The Administration for Children and Families' (ACF) Office of Planning, Research, and Evaluation (OPRE) requests Office of Management and Budget (OMB) approval for an overarching generic clearance to collect data from programs delivered by Sexual Risk Avoidance Education (SRAE) grant recipients on behalf of the SRAE National Evaluation. The generic mechanism will allow ACF to rapidly respond to research and evaluation opportunities that would not otherwise be feasible under the timelines associated with the Paperwork Reduction Act of 1995. The opportunities may relate to innovative implementation strategies and program components in use by SRAE grant recipients as they arise, and in particular, for youth subpopulations served by grant recipients. The purpose of the data collections submitted under the generic will be to inform ACF programming by building evidence about what innovations work to improve programming and outcomes across the SRAE grant recipients and the youth they serve.
Learn More💊Exclusive Patent License for CNS Therapeutics by NIH
The National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences, institutes of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Psycala Bio, Inc. (Psycala), incorporated in Delaware.
Learn More🚫FDA Issues Final Debarment Order Against Michael Dominic Diaz
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael Dominic Diaz for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Diaz was convicted of one felony count under Federal law. The factual basis supporting Mr. Diaz's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Diaz was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 16, 2024 (30 days after receipt of the notice), Mr. Diaz had not responded. Mr. Diaz's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💊FDA Guidance on Medical Device Submission Feedback Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.
Learn More🏋️Proclamation of National Physical Fitness and Sports Month, 2025
The proclamation by President Trump declares May 2025 as National Physical Fitness and Sports Month, emphasizing the importance of sports and fitness in enhancing health and community well-being. It calls for Americans to actively participate in physical activities and fosters a culture of health, particularly among youth.
Learn More🚫FDA Debars Carlton Mallard for 10 Years from Drug Importation
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Carlton Reico Mallard Jr. for a period of 10 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Mallard was convicted of one felony count under Federal law for introduction into interstate commerce a misbranded drug, with the intent to defraud and mislead, and one felony count of illegal importation of merchandise. The factual bases supporting Mr. Mallard's convictions, as described below, are for conduct relating to the importation into the United States of a drug or controlled substance. Mr. Mallard was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 23, 2025 (30 days after receipt of the notice), Mr. Mallard had not responded. Mr. Mallard's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More💰NIH Grant Review Meetings for Small Businesses in June 2025
The Department of Health and Human Services announces closed meetings where the Center for Scientific Review will evaluate various grant applications. These meetings focus on significant healthcare topics and grant opportunities aimed at advancing research and development in the biomedical field.
Learn More