Department of Health and Human Services 2023 – Federal Register Recent Federal Regulation Documents
Results 351 - 400 of 3,523
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.
Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments
The Food and Drug Administration (FDA, Agency, or we) is publishing this request for information to better understand the status of trading partners' interoperable systems and processes for enhanced drug distribution security as required by the Food, Drug and Cosmetic Act (FD&C Act).
Proposed Information Collection Activity; Financing for Early Care and Education: Quality and Access for All (New Collection)
The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval to collect information to explore the role of Head Start in the early care and education (ECE) financing landscape, as well as how the use of multiple funding sources within a single Head Start program may be associated with the provision of Head Start's comprehensive services and with state-level differences in ECE funding. Survey data will be collected from Head Start program directors and state government administrators.
Supporting the Head Start Workforce and Consistent Quality Programming
We propose to add new requirements to the Head Start Program Performance Standards (HSPPS) to support and stabilize the Head Start workforce, including requirements for wages and benefits, breaks for staff, and enhanced supports for staff health and wellness. We also propose to enhance several existing requirements and add new requirements to promote consistent quality of services across Head Start programs. This includes proposed enhancements to requirements for mental health services to better integrate these services into every aspect of programs as well as elevate the role of mental health consultation to support the well-being of children, families, and staff. Enhancements are also proposed in the areas of family service, worker family assignments, identifying and meeting community needs, ensuring child safety, services for pregnant women and people, and alignment with State early childhood systems. Finally, we propose minor clarifications to existing standards to promote better transparency and clarity of understanding for grant recipients.
Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy (Duke-Margolis) in collaboration with FDA and supported by a cooperative agreement between FDA and Duke-Margolis, the workshop will focus on how best to understand patients' experiences living with a rare disease and how to incorporate those experiences, as well as patients' priorities for treatment goals, throughout the drug development process.
Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
The U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a virtual meeting. The meeting will be open to the public via webcast. The committee will discuss and vote on recommendations related to surge capacity for blood and blood products.
Announcement of Intent To Establish Federal Advisory Committee on Long COVID
The Department of Health and Human Services announces the intent to establish an Advisory Committee on Long COVID and invites nominations for the Committee.
Determination of Regulatory Review Period for Purposes of Patent Extension; ROZLYTREK INJECTION; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 8, 2022. The document announced the determination of the regulatory review period for ROZLYTREK INJECTION (entrectinib) for purposes of patent extension. The document was published with an incorrect dosage form. This notice corrects the dosage form of the drug product.
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.
Medicare and Medicaid Programs; Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers' and Suppliers' Disclosure of Private Equity Companies and Real Estate Investment Trusts
This final rule will implement portions of section 6101 of the Patient Protection and Affordable Care Act (Affordable Care Act), which require the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities. It will also finalize definitions of private equity company and real estate investment trust for Medicare provider enrollment purposes.
Notice of Meeting; Correction
The Substance Abuse and Mental Health Services Administration (SAMHSA) published a document in the Federal Register of October 17, 2023, in FR Doc. 2023-22797 announcing the meeting of the SAMHSA Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) on December 5, 2023, and to request comments on editing the Authorized Drug Testing Panels for federally regulated testing. The document was revised to reflect new information under the Supplementary Section.
Advisory Board on Radiation and Worker Health, National Institute for Occupational Safety and Health
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (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.
General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-506J Device List
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Notifying the Food and Drug Administration of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the Federal Food, Drug, and Cosmetic Act; Final Guidance for Industry and Food and Drug Administration Staff; and Select Updates for the 506J Guidance: 506J Device List and Additional Notifications; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance entitled ``Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act'' and the draft guidance entitled ``Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.'' The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires manufacturers to notify FDA of a permanent discontinuance or an interruption in the manufacture of certain devices that is likely to lead to a meaningful disruption in supply of that device in the United States during or in advance of a public health emergency (PHE). This final guidance is intended to assist manufacturers in providing timely, informative notifications about changes in the production of certain medical device products that will help prevent or mitigate shortages of such devices. FDA is concurrently issuing a draft guidance to propose select updates to the final guidance ``Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.'' This draft guidance proposes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the FD&C Act (hereafter referred to as the ``506J Device List'') and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. This draft guidance is not final nor is it for implementation at this time.
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Pulse Oximeters
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The Committee will discuss an approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient's skin pigmentation, and patient-reported race and ethnicity. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.'' Computational modeling and simulation (CM&S) can be used in a variety of ways in medical device applications, including to perform ``in silico'' device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of CM&S used in medical device regulatory submissions. The guidance is intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S credibility evidence submitted in regulatory submissions.
Board of Scientific Counselors, National Center for Injury Prevention and Control
In accordance with regulatory provisions, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC or Board). This meeting is partially open to the public.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation, OMB No. 0906-0034-Extension
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.
Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) and the Medical Devices Advisory Committee (MDAC) device panels in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary of Health and Human Services (the Secretary) to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; of the ACL Generic Clearance for the Collection of Routine Customer Feedback OMB 0985-NEW
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 Information Collection (IC) solicits comments on the IC requirements relating to the ACL Generic Clearance for the Collection of Routine Customer Feedback, a generic mechanism for Collecting Service Delivery Feedback under the Paperwork Reduction Act.
Agency Information Collection Activities: Proposed Collection; Public Comment Request; of the Independent Living Services (ILS) Program Performance Report (PPR) 0985-0043
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a 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 Proposed Extension of a Currently Approved Information Collection (IC Ext) solicits comments on the information collection requirements relating to the Administration on Disabilities' Independent Living Services Program Performance Report.
Proposed Information Collection Activity; Community-Based Child Abuse Prevention Program (Office of Management and Budget #: 0970-0155)
The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the Program Instruction (PI) for the Community-Based Child Abuse Prevention (CBCAP) program (Office of Management and Budget #:0970-0155, expiration June 30, 2024), which outlines information collection requirements pursuant to receiving a grant award. There are no changes requested to the information collection process.
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 (the 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.
Advisory Committee; Nonprescription Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until the August 27, 2025, expiration date.
Medicare Program; Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Health Information Technology Standards and Implementation Specifications
This proposed rule would revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This proposed rule also includes proposals to codify existing sub-regulatory guidance in the Part C and Part D programs.
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 National Notifiable Diseases Surveillance System. This data collection provides the official source of statistics in the United States for nationally notifiable disease conditions.
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 OD2ALOCAL Linkage to and Retention in Care Surveillance. This project is designed to help standardize data processes that drive data-to-action decision-making and improve intra- jurisdictional comparisons over time.
Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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 (the 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.
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.
National Rural Health Information Clearinghouse Program
HRSA provided supplemental award funds to the National Rural Health Information Clearinghouse Program recipient to develop toolkits and other resources that address strategies to promote rural community health.
Submission for OMB Review; Multistate Financial Institution Data Match With Federally Assisted State Transmitted Levy (OMB No.: 0970-0169)
The Office of Child Support Services (OCSE), Administration for Children and Families (ACF), is requesting the federal Office of Management and Budget (OMB) to extend approval of the Multistate Financial Institution (MSFIDM) Data Match with Federally Assisted State Transmitted (FAST) Levy, without changes, for an additional three years. The current OMB approval expires January 31, 2024.
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