Department of Health and Human Services February 9, 2023 – Federal Register Recent Federal Regulation Documents
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Meeting of the Advisory Committee on Infant and Maternal Mortality (Formerly the Advisory Committee on Infant Mortality)
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Infant and Maternal Mortality (ACIMM or Committee) has scheduled a public meeting. Information about ACIMM and the agenda for this meeting can be found on the ACIMM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.
Meeting of the National Advisory Council for Healthcare Research and Quality
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Announcement of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders Meeting
As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders will hold a meeting on March 14, 2023.
Policy Statement for Biosafety Level 4/Animal Biosafety Level 4 Laboratory Verification; Notice of Availability
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the availability and implementation of the final Biosafety Level 4 (BSL-4)/ Animal BSL-4 (ABSL-4) verification policy. The policy statement assists individuals and entities in verifying that the facility design parameters and operational procedures, including heating, ventilation, and air conditioning (HVAC) systems, in BSL-4 and/or ABSL-4 laboratories are functioning as intended to meet the biosafety sufficiency requirement in the HHS/CDC select agent and toxin regulations.
Determination of Regulatory Review Period for Purposes of Patent Extension; XOSPATA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XOSPATA 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; ERLEADA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ERLEADA 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.
Vaccines and Related Biological Products 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 Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. On March 7, 2023, the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2023-2024 influenza season. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Availability of Four Draft Toxicological Profiles
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comments on drafts of four updated toxicological profiles: Cobalt, Hexachlorocyclohexanes, 1,1,1- Trichloroethane, and Vinyl Chloride.
Prospective Grant of Exclusive Patent License: Novel Therapeutics for the Treatment of Neurodegenerative Disorders
The National Institute of Neurological Disorders and Stroke (``NINDS''), an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive, sublicensable patent license to University College London Business, Ltd. (``UCLB''), incorporated in England and Wales under company registration number 02776963 whose registered office address is University College London, Gower Street, London WC1E 6BT, United Kingdom, for NINDS's rights to the patent applications listed in the Supplementary Information section of this notice. UCLB is the technology transfer company of the University College London (``UCL''), a non-profit research institution located in London, United Kingdom.
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