Department of Health and Human Services March 4, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 27 of 27
Proposed Information Collection Activity; Head Start REACH: Strengthening Outreach, Recruitment, and Engagement Approaches With Families-Mixed Methods Study (New Collection)
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on different approaches that Head Start programs use to recruit, select, and enroll families, and the ways in which such practices reflect programs' community contexts. We are not attempting to recruit a nationally representative sample. Instead, the study will aim to obtain a variety of eligibility, recruitment, selection, enrollment, and attendance (ERSEA) practices and experiences to explore how these practices and experiences intersect with different adversities, demographic characteristics, and community contexts.
National Plan and Provider Enumeration System (NPPES) Data Changes
This notice provides information on changes to data elements that providers are required to submit to the National Plan and Provider Enumeration System (NPPES) to obtain and maintain a National Provider Identifier (NPI). The changes to the required data elements affect the data that is made available to the public from NPPES in downloadable files and in a query-only database on the internet.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOTYKTU
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOTYKTU 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; FYARRO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FYARRO 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; RELYVRIO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RELYVRIO 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; VOXZOGO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VOXZOGO 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; SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for the SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM 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 medical device.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments: Selection of Strain(s) To Be Included in the 2024 to 2025 Formula for COVID-19 Vaccines
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. On May 16, 2024, the Committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Modifications to Performance Standards During Natural Disasters and Other Calamities
OCSS issues this final rule to provide temporary relief to states from certain child support program performance requirements and penalties during natural disasters and other calamities which have a negative impact on state child support program operations. The rule allows OCSS to modify performance measure requirements when natural disasters and other calamities affect, or are expected to affect, the state child support program's ability to achieve performance standards for paternity establishment, support order establishment, and current collections. The rule enables states to avoid the imposition of penalties due to adverse data reliability audit findings during, and after, natural disasters and other calamities, including pandemics and declared public health emergencies.
Partnerships With Faith-Based and Neighborhood Organizations
This final rule amends the regulations of the agencies listed above (the ``Agencies'') to clarify protections for beneficiaries and prospective beneficiaries of federally funded social services and the rights and obligations of organizations providing such services. In accordance with the Executive order of February 14, 2021, Establishment of the White House Office of Faith-Based and Neighborhood Partnerships, this clarification should promote maximum participation by beneficiaries and providers in the Agencies' covered programs and activities and ensure consistency in the implementation of those programs and activities.
Notice of Award of a Sole Source Cooperative Agreement To Fund Uganda National Health Laboratories and Diagnostic Services (NHLDS)
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $10,000,000, for Year 1 funding to NHLDS. The award will strengthen laboratory systems in Uganda by contributing to the attainment of HIV epidemic control and establishing sustainable and integrated systems for quality assured disease diagnostics, monitoring, and surveillance. Funding amounts for years 2-5 will be set at continuation.
Meeting of the Mine Safety and Health Research Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a hybrid meeting, accessible both in person and virtually. It is open to the public and limited only by the space available and the number of web conference lines available. Time will be available for public comment.
Meeting of the Clinical Laboratory Improvement Advisory Committee
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Clinical Laboratory Improvement Advisory Committee (CLIAC). This is a virtual meeting. It is open to the public, limited only by the number of webcast lines available. Time will be available for public comment, and the public is also welcome to submit written comments in advance of the meeting (see the public participation section below).
Meeting of the Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control (CDC) announces a meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, with a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the teleconference (information below). The audio conference line has 150 ports for callers.
Solicitation of Nominations for Appointment to the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the Director (ACD), CDC
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership to the Communications and Public Engagement Workgroup (CPEW) of the Advisory Committee to the Director, CDC. The CPEW workgroup consists of approximately 15 members who are experts in the fields associated with communications, including public relations, health communication, risk communication, communication research, and marketing; community and partner engagement; public health science and practice, including implementation; and behavioral science/behavior change campaigns.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
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