Department of Health and Human Services – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting
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 revision 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 collections associated with requirements for medical device reporting for user facilities, manufacturers, importers, and distributors of medical devices.
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-2025-2026 Formula for COVID-19 Vaccines for Use in the United States
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will meet in an open session to discuss and make recommendations on the selection of the 2025-2026 Formula for COVID-19 vaccines for use in the United States. FDA is establishing a docket for public comment on this document.
Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Supplemental Biologics License Application 761309/S-001, for COLUMVI (glofitamab) Injection; Supplemental Biologics License Application 761145/S-029, for DARZALEX FASPRO (daratumumab and hyaluronidase) Injection; New Drug Application 215793, for (mitomycin) Intravesical Solution; Supplemental New Drug Application 211651/S-013, for TALZENNA (talazoparib) Capsules
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs 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.
Medicare Program; Public Meeting for New Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding
This notice announces the first Healthcare Common Procedure Coding System (HCPCS) public meeting of 2025 to discuss the Centers for Medicare & Medicaid Services preliminary coding, Medicare benefit category, and Medicare payment determinations, if applicable, for new revisions to the HCPCS Level II code set for non-drug and non- biological items and services, as well as how to register for the meeting.
Submission for Office of Management and Budget Review; Current Population Survey-Child Support Supplement
The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF) is requesting that the Office of Management and Budget (OMB) approve a revision to an approved information collection: Current Population SurveyChild Support Supplement. Information collected through the survey pertains to child support programs. Analysis of survey data helps OCSE fulfill the mandate to oversee the national child support program and will help legislators and policymakers determine the efficacy of various child support legislation. The current OMB approval expires August 31, 2025.
Proposed Information Collection Activity; Head Start Program Information Report
The Administration for Children and Families (ACF) Office of Head Start (OHS) is requesting a 3-year extension of the Head Start Program Information Report (PIR), Monthly Enrollment reporting instrument, and Center Locations and Contacts instrument (Office of Management and Budget (OMB) #0970-0427, expiration June 30, 2025). OHS has not made any updates to these instruments.
Proposed Information Collection Activity; Plan for Foster Care and Adoption Assistance-Title IV-E
The Administration for Children and Families (ACF) is requesting a 3-year extension and revisions to the Plan for Foster Care and Adoption AssistanceTitle IV-E, (OMB#: 0970-0433, expiration July 31, 2025). This plan also incorporates the plan requirements for the optional guardianship assistance, Title IV-E prevention services and the Title IV-E kinship navigator programs.
Proposed Information Collection Activity; National Directory of New Hires
The Office of Child Support Services (OCSS), Administration for Children and Families (ACF), is requesting the Office of Management and Budget (OMB) to approve the National Directory of New Hires (NDNH), with minor changes to the Multistate Employer Registration form, for an additional three years. The current OMB approval expires July 31, 2025.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Drug User Fee Program
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.
Recommendations To Reduce the Risk of Transmission of Disease Agents Associated With Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis by Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidances for Industry; Availability
The Food and Drug Administration (FDA or the Agency) is withdrawing two final guidances entitled "Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and "Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" and reissuing them as draft guidances.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Microbiological Testing and Corrective Measures for Bottled Water
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.
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export Notification and Recordkeeping Requirements
The Food and Drug Administration (FDA, Agency, or we) 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 notifications and records required for human drug, biological product, device, animal drug, food, cosmetic, and tobacco product exports.
Agency Information Collection Activities; Proposed Collection; Comment Request; Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
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 of FDA's Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.
Agency Information Collection Activities; Proposed Collection; Comment Request; Establishing and Maintaining Lists of United States Establishments With Interest in Exporting Human Food Program-Regulated Products
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 information collection associated with export lists for products regulated by the Human Food Program (HFP).
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
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 information collection associated with Agency guidance on reagents for detection of specific novel influenza A viruses.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tropical Disease Priority Review Vouchers
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 Tropical Disease Priority Review Vouchers.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additives Intended for Use in Animal Food, Food Additive Petitions, Investigational Food Additive Files Exemptions, and Declaration on Animal Food Labels
The Food and Drug Administration (FDA, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antimicrobial Animal Drug Sales and Distribution
The Food and Drug Administration (FDA, 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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
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 "Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products."
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medicated Feed Mill License Application
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Compounding Animal Drugs From Bulk Drug Substances
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 recordkeeping provisions set forth in Guidance for Industry, GFI #256Compounding Animal Drugs from Bulk Substances.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
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; Prescription Drug User Fee Program
The Food and Drug Administration (FDA, 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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
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 (PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Distribution Supply Chain; Drug Supply Chain Security
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
The Food and Drug Administration (FDA, Agency, or we) 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 this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled "PHS Guideline on Infectious Disease Issues in Xenotransplantation" dated January 19, 2001.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Obtaining Information To Understand Challenges and Opportunities Encountered by Compounding Outsourcing Facilities
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.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026
This proposed rule would change and update policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for FY 2026. This rulemaking also proposes to update the requirements for the SNF Quality Reporting Program and the SNF Value-Based Purchasing Program.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program
This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2026. As required by statute, this proposed rule includes the proposed classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2026. It also continues the second year of the 3-year phaseout of the rural adjustment, which began in FY 2025. Additionally, the proposed rule includes updates to the IRF Quality Reporting Program (QRP).
Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
This proposed rule would update the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2026. This rule also proposes changes to the admission to hospice regulations and the hospice face-to-face attestation requirements under the certification of terminal illness regulations. This proposed rule also includes a technical correction to the regulatory text and provides updates to the Hospice Quality Reporting Program requirements. Finally, this proposed rule solicits comments regarding requests for information surrounding future measure concepts for Hospice Quality Reporting Program.
Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
This rulemaking proposes to update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rulemaking also proposes to revise the payment adjustment factors for teaching status and for IPFs located in rural areas. These proposed changes would be effective for IPF discharges occurring during the fiscal year beginning October 1, 2025 through September 30, 2026. We are proposing to make changes to measures used in the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program, to update and codify the Extraordinary Circumstances Exception policy, and to solicit feedback through requests for information on future changes to the IPFQR Program.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2026 Rates; Requirements for Quality Programs; and Other Policy Changes
This proposed rule would revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital- related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); update and make changes to requirements for certain quality programs; and make other policy-related changes.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the revision of the currently approved information collection project "Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP)," OMB # 0935-0206.
Proposed Collection; 60-Day Comment Request; Generic Clearance for National Cancer Institute (NCI) Resources, Software and Data Sharing Forms
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an 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.
Proposed Collection; 60-Day Comment Request; National Cancer Institute (NCI) Generic Clearance for Application Information From Fellows, Interns, and Trainees
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an 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.
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