Department of Health and Human Services December 18, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
The National Institutes of Health Public Access Policy
The 2024 National Institutes of Health (NIH) Public Access Policy implements additional steps to accelerate free public access to scholarly publications resulting from the research that NIH supports, building upon NIH's long history of providing public access to research results.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group (IRG) Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.
Determination of Regulatory Review Period for Purposes of Patent Extension; BYLVAY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BYLVAY 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOHONOS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOHONOS 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.
Fiscal Year 2025 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "FY 2025 Generic Drug Science and Research Initiatives Workshop." The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of interested partiesindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its fiscal year (FY) 2026 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Advanced Manufacturing Technologies Designation Program
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
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