Department of Health and Human Services September 6, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Determination of Regulatory Review Period for Purposes of Patent Extension; YCANTH
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YCANTH and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; STEGLUJAN
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for STEGLUJAN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; STEGLATRO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for STEGLATRO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; SEGLUROMET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SEGLUROMET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
The Food and Drug Administration (FDA or we) is classifying the hemodialyzer with expanded solute removal profile into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemodialyzer with expanded solute removal profile's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
Meeting of the Community Preventive Services Task Force (CPSTF)
The Centers for Disease Control and Prevention, within the Department of Health and Human Services, announces the next meeting of the Community Preventive Services Task Force (CPSTF) on October 16-17, 2024.
Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle; Guidance for Industry, Food and Drug Administration Staff and Other Interested Parties; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle." This draft guidance explains the principal concepts that sponsors and other interested parties should consider when choosing to collect and submit patient preference information (PPI). The knowledge gleaned from the use of PPI could be used across the total product life cycle, including for review in investigational device exemption (IDE) applications, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, De Novo classification requests, or premarket notifications (510(k)s). This draft guidance also discusses FDA's inclusion of PPI in its decision summaries and provides recommendations for the inclusion of such information in device labeling for certain devices. This draft guidance is not final nor is it for implementation at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collections applicable to the Pharmaceutical Distribution Supply Chain, provided for in Subchapter H of Federal Food, Drug, and Cosmetic Act (FD&C Act).
Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-New Drug Application 215244 for Elamipretide Hydrochloride Injection
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection; Comment Request; Correction
The SAMHSA published a document in the Federal Register of August 15, 2024, concerning request for comments on specifications for comments on a new SAMHSA data collection titled "SAMHSA Unified Client-level Performance Reporting Tool (SUPRT)". The document was missing a website to view the proposed draft tool. This correction includes the web address.
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