Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Human West Nile Virus Vaccine Meeting and Request for Information
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is announcing a meeting and opportunity to comment on a human West Nile virus (WNV) vaccine. The primary purpose of the meeting is to inform critical next steps toward the deployment of a human WNV vaccine.
Medicare Program; Announcement of the Re-Approval of COLA Under the Clinical Laboratory Improvement Amendments of 1988
This notice announces the application of COLA for re-approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the following specialty and subspecialty areas under CLIA: Microbiology, including Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology; Diagnostic Immunology, including Syphilis Serology, and General Immunology; Chemistry, including Routine Chemistry, Toxicology, and Endocrinology; Hematology, including routine hematology and coagulation; Immunohematology, including ABO Group, D (Rho) typing, Unexpected Antibody Detection, Compatibility Testing, and Antibody Identification; Pathology, including Histopathology, Oral Pathology, and Cytology. We have determined that COLA meets or exceeds the applicable CLIA requirements. We are announcing the re-approval and grant COLA deeming authority for a period of 6 years.
Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees.
Request for Information: Nomination and Evidence-Based Review Process of the Advisory Committee on Heritable Disorders in Newborns and Children
At the request of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee), HRSA is requesting input from the public on the process used by the Committee for nomination and evidence-based review of conditions that are considered for inclusion in the Recommended Uniform Screening Panel (RUSP). As an entity that advises the Secretary of Health and Human Services (Secretary) based on evidence-based information, ACHDNC periodically considers and evaluates its processes. During the November 2023 meeting, ACHDNC hosted listening sessions to learn more from stakeholders regarding their views on the process used by ACHDNC for nomination and evidence-based review of conditions. In support of this work, HRSA is seeking public input on a series of questions that will help inform the nomination and review processes.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction
This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, ``Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories'' (referred to hereafter as the ``December 2023 final rule'').
Agency Information Collection Request. 30-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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Real Cost Monthly Implementation Assessment
The Food and Drug Administration (FDA 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.
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.
Key Information and Facilitating Understanding in Informed Consent; Draft Guidance for Sponsors, Investigators, and Institutional Review Boards; Availability
The Office for Human Research Protections, Office of the Assistant Secretary for Health (OHRP), and the Food and Drug Administration (FDA) are announcing the availability of a draft guidance entitled ``Key Information and Facilitating Understanding in Informed Consent.'' This draft guidance provides recommendations related to two provisions of the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule) by the U.S. Department of Health and Human Services (HHS) and identical provisions in FDA's proposed rule ``Protection of Human Subjects and Institutional Review Boards.'' FDA's proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protections and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Common Rule, in accordance with the 21st Century Cures Act (Cures Act). The guidance addresses the provisions of the revised Common Rule that require informed consent to begin with key information about the research and to present information in a way that facilitates understanding and identical provisions in FDA's proposed rule.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 061'' (Recognition List Number: 061), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Clinical Pharmacology Considerations for Antibody-Drug Conjugates; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Clinical Pharmacology Considerations for Antibody-Drug Conjugates,'' which provides recommendations for the development of antibody-drug conjugates (ADCs). Specifically, this guidance addresses the FDA's current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection and adjustment, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug- drug interactions (DDIs) for ADCs with a cytotoxic small-molecule drug or payload. Currently, there are no final FDA guidances outlining the clinical pharmacology considerations for ADCs. This guidance finalizes the draft guidance of the same title issued on February 8, 2022.
Notice of Award of a Sole Source Cooperative Agreement To Fund Ministry of Health (MOH)-AIDS Control Program
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $15,000,000, for Year 1 funding to MOHAIDS Control Program. The award will support achievement of HIV epidemic control in Uganda by supporting the MOH to develop and disseminate key national policies and guidelines, increase technical capacity, ensure quality of health services, improve data quality and utilization, and provide leadership and direction to all partners engaged in the epidemic response. Funding amounts for years 2-5 will be set at continuation.
Government Owned Inventions Available 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.
Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF)
This final rule makes regulatory changes to the Child Care and Development Fund (CCDF). These changes lower child care costs for families participating in CCDF, improve the program's child care provider payment rates and practices, and simplify enrollment in the child care subsidy program. The final rule also includes technical and other changes to improve clarity and program implementation.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP, the full meeting agenda, and instructions for linking to public access will be posted on the SACHRP website at https://www.hhs.gov/ohrp/sachrp- committee/meetings/.
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