Healthcare updates for US practices

Notice · Nov 3, 2026

Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to he…

Notice · Nov 3, 2026

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request: Faculty Loan Repayment Program, OMB No. 0906-0082-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 pu…

Final rule · Nov 3, 2026

Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage

This final rule revises the Conditions for Coverage for Organ Procurement Organizations (OPOs) to clarify outstanding procedural questions and provide additional operational flexibility for OPOs to achieve high performa…

Final rule · Nov 3, 2026

Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance

The Department of Health and Human Services (HHS or Department) issues this rule to revise the regulation implementing section 504 of the Rehabilitation Act of 1973 (section 504) as it applies to recipients of HHS fundi…

Notice · Nov 3, 2026

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), federa…

Notice · Nov 3, 2026

Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus; Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus." The guidance document prov…

Notice · Nov 2, 2026

Prospective Grant of Exclusive Patent License: Catheter-Based Intramyocardial Ablation for Treating Ventricular Arrhythmia in a Human

The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to AntaraCore, Systems, Inc., locat…

Notice · Nov 2, 2026

Agency Forms Undergoing Paperwork Reduction Act Review

Notice · Nov 2, 2026

Agency Forms Undergoing Paperwork Reduction Act Review

Notice · Nov 2, 2026

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), federa…

Notice · Nov 2, 2026

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) provides notice of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal…

Notice · Nov 2, 2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Notice · Nov 2, 2026

Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

The Centers for Medicare & Medicaid Services (CMS) is requesting that an information collection request revision for the Review Choice Demonstration or Home Health Services (CMS-10599/0938- 1311) processed under the eme…

Notice · Nov 2, 2026

Proposed Information Collection Activity; Federal Fiscal Year (FFY) 2027 Child Care and Development Fund (CCDF) Quality Progress Report

The Administration for Children and Families (ACF) is requesting a 3-year reinstatement with changes to information collection: Child Care and Development Fund (CCDF) Quality Progress Report (QPR)--(Office of Management…

Proposed rule · Nov 2, 2026

Infant Formula Nutrient Requirements

The Food and Drug Administration (FDA or we) proposes to amend the regulations on nutrient specifications and labeling for infant formula as part of its phased, comprehensive review of infant formula nutrients. This act…

Notice · Oct 30, 2026

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: AIDS Drug Assistance Program-Transformation: Optimization and Best Practices in the Evolving Health Care Landscape, OMB No. 0906-XXXX-New

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), …

Notice · Oct 30, 2026

Notice of Amended Order Requirement for Attestation by All Persons Arriving in the United States From Any Foreign Country Via Transportation by Aircraft and Controlled Free Pratique for Airlines and Other Aircraft Operators Confirming That Such Persons Have Not Been in the Democratic Republic of the Congo in the Past 21 Days

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of an Amended Order under Sections 361, 365, 368, and 369 of the Public Heal…

Notice · Oct 30, 2026

Essential Drug Delivery Performance Characteristics for Devices Intended To Deliver Drugs and Biological Products; Revised Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drug…

Notice · Oct 30, 2026

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting

Notice · Oct 30, 2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Final rule · Oct 30, 2026

Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury (AKI) Dialysis Payment, and ESRD Quality Incentive Program

This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also includes updates to the payment rate for renal dialysis services furnished by an E…

Notice · Oct 30, 2026

Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances

The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of an "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." This documen…

Notice · Oct 30, 2026

Solicitation of Nominations for Appointment to the Advisory Committee on Immunization Practices

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the Advisor…

Final rule · Oct 30, 2026

Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea

The Food and Drug Administration (FDA) is classifying the over-the-counter device to assess risk of sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this…

Final rule · Oct 30, 2026

Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures

The Food and Drug Administration (FDA) is classifying the spinal imaging system for neuraxial procedures into class II (special controls). The special controls that apply to the device type are identified in this order …

Final rule · Oct 30, 2026

Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease

The Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II (special controls). The special controls that apply to the device type…

Final rule · Oct 30, 2026

Medical Devices; General and Plastic Surgery Devices; Classification of the Software-Aided Adjunctive Diagnostic Device for Use by Physicians on Lesions Suspicious for Skin Cancer

The Food and Drug Administration (FDA) is classifying the software-aided adjunctive diagnostic device for use by physicians on lesions suspicious for skin cancer into class II (special controls). The special controls th…

Notice · Oct 30, 2026

Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-Androgen Fixed-Combination Drug Products; Third Extension of Effective Date of Final Resolution of Drug Efficacy Study Implementation 7661

The Food and Drug Administration (FDA or Agency) is extending the effective date of the notice published in the Federal Register on May 27, 2026, titled Drugs for Human Use; Drug Efficacy Study Implementation: Estrogen-…

Proposed rule · Oct 29, 2026

Reducing Bureaucracy and Burden for Block Grants

ACF proposes to amend its block grant regulations to modernize requirements, reduce administrative burden on States and Tribal grantees, and improve the clarity and efficiency of program administration. The current regu…

Proposed rule · Oct 29, 2026

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG)

The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), published in the Federal Register on Oc…

Proposed rule · Oct 29, 2026

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG)

The Department of Health and Human Services ("HHS" or "Department") is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) published on October 12, 2023.

Notice · Oct 29, 2026

Office of the Director, National Institutes of Health; Notice of Meeting

Notice · Oct 29, 2026

Office of the Director, National Institutes of Health; Notice of Meeting

Notice · Oct 29, 2026

Office of the Director, National Institutes of Health; Notice of Meeting

Final rule · Oct 29, 2026

Reducing Bureaucracy and Burden for Child Support Enforcement Programs

This final rule amends the Child Support regulations that were unnecessary or obsolete in the following sections: State Plan Approval and Grant Procedures, State Plan Requirements, Standards for Program Operations, Fede…

Notice · Oct 29, 2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Notice · Oct 29, 2026

Fogarty International Center; Notice of Meeting

Notice · Oct 29, 2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

Notice · Oct 29, 2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Notice · Oct 29, 2026

Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting

Notice · Oct 29, 2026

Fogarty International Center; Notice of Meeting

Notice · Oct 29, 2026

National Institute on Aging; Notice of Meeting

Notice · Oct 29, 2026

National Institute on Aging; Notice of Meeting

Notice · Oct 29, 2026

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), federa…

Notice · Oct 29, 2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

Notice · Oct 29, 2026

Agency Information Collection Request. 60-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 (HHS), the Assistant Secretary for Planning and Evaluation (ASPE) is i…

Notice · Oct 29, 2026

Privacy Act of 1974; Matching Program

In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is providing notice of a computer matching…

Notice · Oct 28, 2026

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 extension without change of the currently approved infor…

Notice · Oct 28, 2026

National Institute on Aging; Notice of Meeting

Notice · Oct 28, 2026

National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting

Notice · Oct 28, 2026

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

Notice · Oct 28, 2026

Center for Scientific Review; Notice of Closed Meeting

Notice · Oct 28, 2026

Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management." T…

Notice · Oct 28, 2026

Electronic Submission Template for Investigational Device Exemption (IDE) Applications; Draft Guidance for Sponsors and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Electronic Submission Template for Investigational Device Exemption (IDE) Applications." FDA is issuing this …

Final rule · Oct 28, 2026

Health Data, Technology, and Interoperability: ONC Deregulatory Actions To Unleash Prosperity

This final rule focuses on deregulatory actions identified in HHS regulations regarding health information technology standards, implementation specifications, and certification criteria and regarding certification prog…

Notice · Oct 28, 2026

Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs

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), Fed…

Notice · Oct 28, 2026

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification

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 o…

Notice · Oct 28, 2026

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys

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 …

Notice · Oct 28, 2026

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol)

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) authoriz…

Notice · Oct 28, 2026

Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ATEBRIOZ (Zilurgisertib)

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) authoriz…