Department of Health and Human Services August 14, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee as a medical device panel is to provide advice and recommendations to FDA. In addition, the Committee will meet to discuss and provide advice to FDA on in vitro diagnostic devices used in pandemic preparedness and response to satisfy, in part, a requirement under the Food and Drug Omnibus Reform Act of 2022 (FDORA). The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Request for Letters of Interest (LOI) for NCI-ComboMATCH Laboratories
The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) has developed a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principle of this initiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence.
Statement of Organization, Functions, and Delegations of Authority
The Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST) has modified its organizational structure.
Submission for OMB Review; Replication of Recovery and Reunification Interventions for Families-Impact Study (New Collection)
The Administration for Children and Families (ACF) is proposing a data collection activity as part of the Replication of Recovery and Reunification Interventions for Families-Impact Study (R3- Impact). The R3-Impact Study aims to satisfy the legislative requirements called for by the 2018 SUPPORT for Patients and Communities Act by replicating and testing the efficacy of two recovery coaching interventions for families engaged in the child welfare system due to parental substance use disorders.
Agency Information Collection Request; 60-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Fees for Cruise Ship Operational Sanitation, Construction, and Renovation Inspections
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces fees for vessel sanitation, construction, and renovation inspections for fiscal year (FY) 2024. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every passenger cruise vessel that has a foreign itinerary involving a U.S. port and carries 13 or more passengers is subject to twice-yearly unannounced operational sanitation inspections and, when necessary, reinspection. Cruise vessel design and equipment must meet VSP's sanitary design criteria standards and routine operational inspection requirements. Cruise vessel owners or shipyards that build or renovate cruise vessels can request construction or renovation inspections of new or renovated vessels before their first or next operational inspection.
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