Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
Results 401 - 600 of 65,881
Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.'' The guidance focuses on frequently asked questions about the new dietary ingredient notification submission and review process. The guidance is intended to help manufacturers and distributors of new dietary ingredients and dietary supplements prepare and submit new dietary ingredient notifications to FDA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Data To Support Drug Product Communications as Used by the Food and Drug Administration
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; Application for Food and Drug Administration Approval to Market a New Drug
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.
Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677-004, is available in the docket identified by the number in the heading of this document.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types
The Food and Drug Administration (FDA or Agency) 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 ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Restaurant and Retail Foodservice Facility Types.''
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/.
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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine and Oral Fluid Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) using Urine and the laboratories currently certified to meet the standards of the Mandatory Guidelines using Oral Fluid.
Determination of Regulatory Review Period for Purposes of Patent Extension; INQOVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INQOVI 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; ONGENTYS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ONGENTYS 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; KLISYRI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KLISYRI 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; ISTURISA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ISTURISA 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 patents which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; LEQVIO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LEQVIO 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; PREVNAR-20
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PREVNAR-20 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; XERAVA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XERAVA 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; NULIBRY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NULIBRY 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.
Proposed Information Collection Activity; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance and Review Process (Office of Management and Budget #: 0970-0568)
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance (TA) and Review Process, (OMB #0970-0568, expiration 4/30/ 2024) and all approved information collections under this generic. There are no changes requested to the terms of the umbrella generic or to the currently approved information collections.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADUHELM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADUHELM 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 biological product.
Meeting of the Advisory Board on Radiation and Worker Health, Subcommittee for Procedure Reviews, National Institute for Occupational Safety and Health
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Determination of Regulatory Review Period for Purposes of Patent Extension; SOGROYA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOGROYA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EVKEEZA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVKEEZA 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; AMPLATZER AMULET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AMPLATZER AMULET 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 patents which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; VEKLURY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VEKLURY 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; GEMTESA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GEMTESA 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; OPDUALAG
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OPDUALAG 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 biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMCEVI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CAMCEVI 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; EVRYSDI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVRYSDI 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.
Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; TEMBEXA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TEMBEXA 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; EPI-SENSE GUIDED COAGULATION SYSTEM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPI-SENSE GUIDED COAGULATION SYSTEM 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 patents which claim that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPHNELO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPHNELO 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 biological product.
Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) announce the following meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment).
Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; BREXAFEMME
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BREXAFEMME 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.
Timothy Baxter; Final Order Announcing Termination Date of Debarment
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) announcing that the debarment of Timothy Baxter will terminate on October 26, 2025.
Determination of Regulatory Review Period for Purposes of Patent Extension; CAMZYOS
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CAMZYOS 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form 3601a
The Food and Drug Administration (FDA or Agency) 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 extension of this information collection.
Determination of Regulatory Review Period for Purposes of Patent Extension; VONJO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONJO 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; MOUNJARO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOUNJARO 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; RECORLEV
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECORLEV 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Export Certificates for Food and Drug Administration Regulated Products
The Food and Drug Administration (FDA, the 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.
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.
National Vaccine Injury Compensation Program; List of Petitions Received
HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; of the Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042)
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed extension to Performance Data for State Grants for Assistive Technology Program Annual Progress Report (OMB Control Number 0985-0042).
Submission for Office of Management and Budget Review; Tribal Child Support Enforcement Direct Funding Requests: (Office of Management and Budget #0970-0218)
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF) is requesting to extend approval of revisions to an approved information collection the Tribal Child Support Enforcement Direct Funding Requests (Office of Management and Budget (OMB) #0970-0218). These revisions were approved under an emergency approval for 6-months and included a new requirement for Tribes or Tribal organizations to provide that charging fees and recovering costs will not be permitted.
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Emerging Infections Program (EIP). EIP is a population-based surveillance activity conducted via active, laboratory case finding that is used for detecting, identifying, and monitoring emerging pathogens.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Project Confianza to Identify Medical Mistrust Drivers among Hispanic/Latino Gay, Bisexual, and Other Men Who Have Sex With Men (HLMSM). The data collection is designed to identify the root causes of medical mistrust and opportunities to implement interventions that can make HIV-related services trusted and acceptable for HLMSM to increase access to, and utilization of, HIV prevention and care services, as well as contribute toward achieving Ending the HIV Epidemic in the U.S. (EHE) goals and National HIV Strategic Plan health disparities goals.
Determination of Regulatory Review Period for Purposes of Patent Extension; Rybrevant
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Rybrevant 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 biological product.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program Core Medical Services Waiver Form, OMB No. 0906-0065-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Proposed Updates for Developing, Implementing, and Evaluating Infection Control Programs for Viral Hemorrhagic Fevers, Andes Virus, and Nipah Virus: Appendix A
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on Draft Proposed Updates for Viral hemorrhagic fevers, Andes virus, and Nipah virus: Appendix A (``Draft Updates: Appendix A''). The updated recommendations in the Draft Updates: Appendix A are intended for use by frontline healthcare personnel, as well as infection control personnel and other persons responsible for developing, implementing, and evaluating infection control programs for healthcare settings across the continuum of care.
Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Cytomegalovirus and Parvovirus B19 Sections and Draft Source Control Definition
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), announces the opening of a docket to obtain comment on the Draft Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Cytomegalovirus and Parvovirus B19 Sections (``Draft Guideline: Cytomegalovirus and Parvovirus B19 Sections''), and on the accompanying Draft ``Source Control'' Definition adapted for Infection Control in Healthcare Personnel to be in the ``Terminology'' Appendix. The updated recommendations in the Draft Guideline: Cytomegalovirus and Parvovirus B19 Sections are intended for use by the leaders and staff of Occupational Health Services (OHS), as further provided herein. These updated recommendations will help facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) who have been exposed or infected and may be contagious to others in the workplace.
User Fees; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending its regulations to update a link regarding user fee disputes. This technical amendment is non-substantive.
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.
Proposed Information Collection Activity; Family Violence Prevention and Services Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions (Office of Management and Budget #0970-0280)
The Family Violence Prevention and Services Act (FVPSA) program within the Office of Family Violence Prevention and Services (OFVPS) plans to extend data collection for the Family Violence Prevention and Services Grants to States; Native American Tribes and Alaskan Native Villages; and State Domestic Violence Coalitions (Office of Management and Budget (OMB) #0970-0280; Expiration Date: May 31, 2024). Minor changes are proposed to the existing information collection.
Advisory Commission on Childhood Vaccines Meeting; Correction
HRSA published a notice in the Federal Register on February 2, 2024, concerning 2024 calendar year meetings of the Advisory Commission on Childhood Vaccines (ACCV). The notice contained incorrect dates. The notice originally stated the 2024 calendar year meetings will take place in ``2023'' and the meeting dates are being updated to say ``2024.''
Meeting of the National Advisory Committee on Rural Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at: https://www.hrsa.gov/advisory- committees/rural-health/.
Medicare and Medicaid Programs; Application From the Joint Commission for Continued CMS-Approval of Its Ambulatory Surgical Center Accreditation Program
This notice acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034-Extension
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. The initial notice was published on November 17, 2023, with a 60-day comment period. No comments were received. OMB will accept comments from the public during the 30-day comment period for this notice. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), through the National Institutes of Health (NIH), is rescinding a system of records titled ``Administration: Senior Staff, HHS/NIH/NIAID,'' system number 09-25-0087. The records are no longer needed for agency business, so are no longer retrieved by names or other personal identifiers. Because of this, the records no longer qualify as a Privacy Act system of records, and it is appropriate to rescind the system of records.
Adoption and Foster Care Analysis and Reporting System
ACF proposes to amend the Adoption and Foster Care Analysis and Reporting System (AFCARS) regulations that require title IV-E agencies to collect and report data to ACF on children who enter out- of-home care, their providers, and children who have a title IV-E adoption or guardianship assistance agreement to collect additional data related to Indian children.
Medicaid Program; Disproportionate Share Hospital Third-Party Payer Rule
This final rule primarily addresses recent legislative changes to the Social Security Act as a result of the Consolidated Appropriations Act, 2021 changes to the hospital-specific limit on Medicaid disproportionate share hospital (DSH) payments. This final rule affords States and hospitals more clarity on how the limit, the changes that took effect on October 1, 2021, will be calculated. Additionally, this final rule enhances administrative efficiency by making technical changes and clarifications to the DSH program.
Taylor McLaren: Final Debarment Order
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Taylor McLaren for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. McLaren was convicted of one felony count under Federal law for conspiracy to smuggle goods into the United States. The factual basis supporting Mr. McLaren's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. McLaren was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of January 8, 2024 (30 days after receipt of the notice), Mr. McLaren had not responded. Mr. McLaren's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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.
Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment.'' Although the public health emergency declared by the Department of Health and Human Services under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem with continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID- 19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.'' The guidance includes select updates to the guidance ``Medical Device User Fee Small Business Qualification and Certification'' which describe how FDA plans to determine if a small business is experiencing ``financial hardship'' which makes them eligible for a waiver of their registration fee. The guidance will detail what information FDA will review and consider in making this determination. This draft guidance is not final nor is it for implementation at this time.
Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee (the Committee) to the list of standing advisory committees.
Administration on Disabilities, The President's Committee for People With Intellectual Disabilities
The President's Committee for People with Intellectual Disabilities (PCPID) will host a virtual meeting for its members to address issues surrounding Home and Community Based Services (HCBS) to be examined in the Committee's Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format with committee members addressing the issues and recommendations identified by PCPID workgroups proposing to be incorporated in the PCPID Report to the President.
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.
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Health Professions Student Loan Program, Loans for Disadvantaged Students Program, Primary Care Loan Program, and Nursing Student Loan Program Administrative Requirements, OMB No. 0915-0047-Revision
In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
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.
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Members
The National Advisory Council for Healthcare Research and Quality (the Council) advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) with respect to activities proposed or undertaken to carry out AHRQ's statutory mission. AHRQ produces evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven new members will be appointed to replace seven current members whose terms will expire in November 2024.
Request for Nominations for Voting Members for the Genetic Metabolic Diseases Advisory Committee; Amendment of Notice
The Food and Drug Administration (FDA) is announcing an amendment to the notice of the request for nominations for voting members excluding consumer and industry representatives, to serve on the Genetic Metabolic Diseases Advisory Committee (the Committee) in the Center for Drug Evaluation and Research. This request for nominations was announced in the Federal Register of December 13, 2023. The amendment is being made to reflect a change in the DATES portion of the document. There are no other changes.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.
Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry; Extension of Comment Period
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that published in the Federal Register of December 22, 2023. In that notice, FDA requested comments on the draft guidance for industry entitled, ``Master Protocols for Drug and Biological Product Development.'' The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Agency Information Collection Activities: Proposed Collection; 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.
Submission for Office of Management and Budget Review; Healthy Marriage and Responsible Fatherhood Performance Measures and Additional Data Collection (Office of Management and Budget #0970-0566)
The Administration for Children and Families (ACF), Office of Family Assistance (OFA), is requesting an extension with changes to its approved collection and reporting of performance measures about program operations, services, and clients served through the Healthy Marriage (HM) and Responsible Fatherhood (RF) grant programs. In an effort to gain a great understanding of how HMRF programs influence program participants and staff at an individual level, ACF proposes to add one open field to the quarterly narrative reports to capture information about the experiences of HMRF participants and/or staff. ACF is requesting to extend approval, with the implementation of this change, for 3 years.
Confidentiality of Substance Use Disorder (SUD) Patient Records
The United States Department of Health and Human Services (HHS or ``Department'') is issuing this final rule to modify its regulations to implement section 3221 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Department is issuing this final rule after careful consideration of all public comments received in response to the notice of proposed rulemaking (NPRM) for the Confidentiality of Substance Use Disorder (SUD) Patient Records. This final rule also makes certain other modifications to increase alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule to improve workability and decrease burden on programs, covered entities, and business associates.
Submission for Office of Management and Budget Review; Administration for Children and Families Generic for Engagement Efforts (New Umbrella Generic)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services (HHS) intends to request approval from the Office of Management and Budget (OMB) to establish a new umbrella generic clearance to request information while engaging individuals and groups who could provide valuable information to inform ACF programs and work, including but not limited to those who are served or have been served by ACF, those with expertise in ACF program areas, and individuals invested in the outcomes of ACF research and evaluation. These engagement activities often need to be conducted quickly, to allow for sufficient time to inform project direction and decision-making. Additionally, planning for engagement activities is most often on a quick timeline and the standard timeline to comply with a full request under the Paperwork Reduction Act (PRA) often inhibits the ability to collect information to inform these activities. Therefore, an umbrella generic is necessary to allow for quick turnaround requests for similar information collections related to these activities.
Advisory Committee on Training in Primary Care Medicine and Dentistry Meeting Cancellation
This is to notify the public that the March 25-26, 2024, meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry is cancelled.
Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflict of Interest, and Related Provisions
This proposed rule would set forth a number of provisions to strengthen the oversight of accrediting organizations (AOs) by addressing conflicts of interest, establishing consistent standards, processes and definitions, and updating the validation and performance standards systems. Additionally, this proposed rule would revise the psychiatric hospital survey process, add a limitation on terminated deemed providers and suppliers when reentering the program, and provides technical corrections for End-Stage Renal Disease facilities and Kidney Transplant Programs. This proposed rule also solicits comments from stakeholders and AOs to refine and revise the AO oversight standards and processes. In addition, this proposed rule includes a request for information on the timeframes and expectations for the submission of AO applications.
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