🚫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💰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🎓HRSA Call for Comments on Scholarships for Disadvantaged Students Program
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More📊Insights on SAMHSA's Training and Technical Assistance Program
The Substance Abuse and Mental Health Services Administration (SAMHSA) announces a collection of information related to its Training and Technical Assistance (TTA) programs, focusing on performance monitoring and participant feedback. This data will support continuous improvement of TTA events and contribute to the development of knowledge dissemination activities within the behavioral health sector.
Learn More🏥Expanded Eligibility for WTC Health Program Responders Announced
On September 11, 2024, CDC published in the Federal Register an interim final rule with request for comment to update existing regulations governing the WTC Health Program to align with statutory changes. The interim final rule expanded eligibility criteria for enrollment of new Pentagon and Shanksville responders, capped at 500 new members, and made various conforming amendments to the WTC Health Program regulations. In this final rule, CDC responds to public comment and finalizes the revisions to the regulation.
Learn More🏥Comments Requested
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, requests approval from the Office of Management and Budget (OMB) and invites public comments on the proposed information collection, including proposed changes. The request consists of several forms that will allow the Unaccompanied Alien Children Bureau (UAC Bureau) to continue conducting statutorily mandated assessments of unaccompanied alien children (UAC--also referred to as "child" or "children") in ORR care and custody as well as their sponsors. These assessments allow ORR to understand the status and needs of the child and their potential sponsor; assessment findings inform all decisions concerning the child's care while in ORR custody and eventual reunification with a sponsor.
Learn More📊OMB Review Request for National Youth in Transition Database
The Administration for Children and Families (ACF) is requesting a three-year extension of the National Youth in Transition Database (NYTD) Services and Youth Outcomes Survey (OMB#: 0970-0340, expiration date 05/31/2025). There are no changes requested to the form.
Learn More🏥Public Comments Invitation on Incident Reporting for Unaccompanied Minors
The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is inviting public comments on the proposed information collection, including proposed changes. The request consists of several forms that will allow the Unaccompanied Alien Children Bureau (UAC Bureau) to ensure that serious issues are elevated to ORR and that all incidents and the response to such incidents are documented and resolved in a way that protects the interests of children.
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