Department of Health and Human Services – Federal Register Recent Federal Regulation Documents

The Administration for Children and Families (ACF), Office of Early Childhood Development (ECD) is requesting revisions to the Tribal Maternal, Infant, and Early Childhood Home Visiting Program Community Needs and Readiness Assessment Guidance and Implementation Plan Guidance (Office of Management and Budget (OMB) #: 0970-0611; expiration June 30, 2026) and a 3-year extension of approval.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Primary Hypofractionated Radiation Therapy for Localized Prostate Cancer: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

This notice announces the 2025 meetings of the Physician- Focused Payment Model Technical Advisory Committee (PTAC). These meetings include deliberation and voting on proposals for physician- focused payment models (PFPMs) submitted by individuals and stakeholder entities and may include discussions on topics related to current or previously submitted PFPMs. All meetings are open to the public.

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.

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 information collection associated with our generic drug user fee program.

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.

This document corrects technical and typographical errors in the final rule with comment period that appeared in the November 27, 2024 Federal Register titled "Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs, including the Hospital Inpatient Quality Reporting Program; Health and Safety Standards for Obstetrical Services in Hospitals and Critical Access Hospitals; Prior Authorization; Requests for Information; Medicaid and CHIP Continuous Eligibility; Medicaid Clinic Services Four Walls Exceptions; Individuals Currently or Formerly in Custody of Penal Authorities; Revision to Medicare Special Enrollment Period for Formerly Incarcerated Individuals; and All-Inclusive Rate Add-On Payment for High-Cost Drugs Provided by Indian Health Service and Tribal Facilities".

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Administration for Native Americans Project Outcome Assessment Survey (OMB #: 0970-0379, expiration 6/30/2025). The survey was revised based on a review by the Administration for Native Americans (ANA) and feedback from grantees, which identified some data elements that could be eliminated and areas that could be clarified.

This notice provides an update to the organizational structure for the Department of Health and Human Services (HHS), Office of the Secretary (OS), Office of Minority Health (OMH). OMH has changed the name of the Division of Information and Education (DIE acronym), as noted in an April 11, 1995 Federal Register Notice, to the Division of Strategic Communication and Community Engagement (DCE acronym). This name change better aligns with the functions of the division and provides for a more socially acceptable acronym. The functions of the division are unchanged from the April 11, 1995 Federal Register Notice.

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) has scheduled a public meeting. Information about ACCV and the agenda for this meeting can be found on the ACCV website at https:// www.hrsa.gov/advisory-committees/vaccines/.

This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace[supreg],\1\ Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Food and Drug Administration (FDA, we, or Agency) is soliciting comments from the public regarding the National Antimicrobial Resistance Monitoring System (NARMS) 2026-2030 Strategic Plan. Comments received will help inform the development of a draft 2026-2030 Strategic Plan, to be discussed at a public meeting in spring 2025. Specific questions and information requests are included in this notice to help guide input from interested parties.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRENESSITY (crinecerfont), approved on December 13, 2024, manufactured by Neurocrine Biosciences, Inc., meets the criteria for a priority review voucher.