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Data / Federal rules / Health and Human Services Department

Health and Human Services Department: 642 rules and proposed rules since January 2024

440 final rules and 202 proposed rules since January 8, 2024, 144 of them marked significant. 13 are open for comment now. Common topics: reporting and recordkeeping requirements, medical devices, administrative practice and procedure, health facilities, medicare.

SpecStream is the live web data engine for teams and agents. It reads every rule and proposed rule in the Federal Register each morning, and this page is that reading. Name your industry once and new rules, comment deadlines and effective dates arrive in your sheet, CRM, Slack or agent as they are published.

Open for comment

DocumentTypeComments due
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
2026-19656
Final ruleOct 26
Reforming Federal Reporting and Assessments in Child Welfare
2026-20329
Proposed ruleNov 4
Further Reducing Bureaucracy and Burden From the Administration for Native Americans
2026-21004
Proposed ruleNov 13
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
2026-20979
Final ruleNov 13
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability
2026-20721
Proposed ruleNov 23
Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards
2026-19535
Proposed ruleNov 23
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
2026-20613
Proposed ruleDec 7
Nonclinical Testing Terminology
2026-19350
Final ruleDec 7
Nonclinical Testing Terminology
2026-19349
Proposed ruleDec 7
Substances Generally Recognized as Safe
2026-16296 · significant
Proposed ruleDec 9
Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026
2026-21420
Proposed ruleDec 15
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
2026-21670
Proposed ruleDec 22
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
2026-21669
Proposed ruleJan 21, 2027

The 500 newest documents

DocumentTypePublished
Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft Guidance for Industry; Availability
2026-21670
Proposed ruleOct 23
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability
2026-21669
Proposed ruleOct 23
Medicare Program; Implementation of Sections 6219, 6220, and 6224 of the Consolidated Appropriations Act, 2026
2026-21420
Proposed ruleOct 20
Further Reducing Bureaucracy and Burden From the Administration for Native Americans
2026-21004
Proposed ruleOct 14
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
2026-20979
Final ruleOct 14
Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
2026-20848 · significant
Final ruleOct 13
Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections Using Home-Collected Specimens
2026-20727
Final ruleOct 9
Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
2026-20726
Final ruleOct 9
Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit
2026-20725
Final ruleOct 9
Requirements for Additional Traceability Records for Certain Foods: Enforcement Policy for Certain Retail Food Establishments and Restaurants; Draft Guidance for Industry; Availability
2026-20721
Proposed ruleOct 9
Removal of Obsolete Portion of Regulation Relating to Care and Treatment of Ineligible Individuals
2026-20685
Final ruleOct 8
Removal of Obsolete/Suspended Regulations
2026-20684
Final ruleOct 8
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes
2026-20613
Proposed ruleOct 8
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems
2026-20448
Final ruleOct 6
Transparency in Coverage
2026-20447 · significant
Final ruleOct 6
Medical Devices; Immunology and Microbiology Devices; Classification of the High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System
2026-20443
Final ruleOct 6
Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry
2026-20441
Final ruleOct 6
Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound System for Non-Thermal, Mechanical Tissue Ablation
2026-20440
Final ruleOct 6
Reforming Federal Reporting and Assessments in Child Welfare
2026-20329
Proposed ruleOct 5
Global Benchmark for Efficient Drug Pricing (GLOBE) Model
2026-20281 · significant
Final ruleOct 2
Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction
2026-20134
Final ruleOct 1
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program; Correction
2026-20131
Final ruleOct 1
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
2026-20075
Final ruleSep 30
Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction
2026-20067
Final ruleSep 30
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027; Correction
2026-19959
Final ruleSep 30
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards; Correction
2026-19946 · significant
Final ruleSep 29
Filing of Color Additive Petition From Doehler GmbH; Request To Amend the Color Additive Regulations To Provide for the Safe Use of Calcium Sulfate in Various Foods at Levels Consistent With Good Manufacturing Practice
2026-19658
Proposed ruleSep 25
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Inactive Bakers Yeast
2026-19656
Final ruleSep 25
Request for Information; Medicare Part D Reasonable and Relevant Pharmacy Contracting Standards
2026-19535
Proposed ruleSep 24
Patient Protection and Affordable Care Act; Temporary Moratoria on Certain Agent and Broker Registration To Participate in the Exchanges
2026-19493
Final ruleSep 23
Nonclinical Testing Terminology
2026-19350
Final ruleSep 22
Nonclinical Testing Terminology
2026-19349
Proposed ruleSep 22
Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices
2026-19074
Final ruleSep 17
Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
2026-18612
Final ruleSep 11
Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)
2026-18469
Proposed ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
2026-18433
Final ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
2026-18432
Final ruleSep 10
Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
2026-18431
Final ruleSep 10
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease
2026-18430
Final ruleSep 10
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery
2026-18429
Final ruleSep 10
Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device
2026-18428
Final ruleSep 10
Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System
2026-18427
Final ruleSep 10
Medical Devices; General Hospital and Personal Use Devices; Classification of the Whole Room Microbial Reduction Device
2026-18426
Final ruleSep 10
Reducing Bureaucracy and Burden for the Repatriation of Mentally Ill Nationals
2026-18167
Proposed ruleSep 4
Federal Independent Dispute Resolution Operations; Correction
2026-17622 · significant
Final ruleAug 28
Gardenia Blue Interest Group; Filing of Color Additive Petition
2026-16944
Proposed ruleAug 19
International Association of Color Manufacturers; Filing of Color Additive Petition
2026-16943
Proposed ruleAug 19
Food Additives Permitted in Feed and Drinking Water of Animals; Chromium DL-methionine Chelate
2026-16942
Final ruleAug 19
GNT USA, LLC.; Filing of Color Additive Petition
2026-16939
Proposed ruleAug 19
Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments
2026-16729
Proposed ruleAug 17
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
2026-16728
Proposed ruleAug 17
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2026-16727
Final ruleAug 17
Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children
2026-16508
Final ruleAug 13
Guide To Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry; Availability
2026-16420
Final ruleAug 12
Adoption and Foster Care Analysis and Reporting System
2026-16414 · significant
Proposed ruleAug 12
Substances Generally Recognized as Safe
2026-16296 · significant
Proposed ruleAug 11
Radiology Devices; Reclassification of Digital Breast Tomosynthesis System
2026-16209
Proposed ruleAug 10
Reducing Federal Burden for Head Start Programs
2026-16134
Proposed ruleAug 7
Medical Devices; Radiology Devices; Classification of the Fludeoxyglucose F18-Guided Radiation Therapy System
2026-15963
Final ruleAug 6
Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing
2026-15920
Final ruleAug 5
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; Other Policy Changes; and Adoption of Updated Versions of Certain Health Information Technology Standards
2026-15833
Final ruleAug 4
Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
2026-15686
Final ruleAug 3
Reducing Bureaucracy and Burden in Family Violence and Prevention Services
2026-15681
Final ruleAug 3
Modification of Certain Terminology in Title 21; Reopening of the Comment Period
2026-15671
Proposed ruleAug 3
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-15652
Final ruleAug 3
Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
2026-15588
Final ruleJul 31
Reducing Bureaucracy and Burden for Family Assistance Programs
2026-15567
Final ruleJul 31
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027
2026-15562
Final ruleJul 31
Medicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List
2026-15446
Final ruleJul 30
Administrative Costs for Children in Title IV-E Foster Care
2026-15403 · significant
Proposed ruleJul 30
Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy
2026-15303
Final ruleJul 29
Medical Devices; General Hospital and Personal Use Devices; Classification of the Active Noise Attenuation System for Infant Incubators
2026-15075
Final ruleJul 27
Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Medicated Topical Formulation for Treatment of Erectile Dysfunction
2026-15074
Final ruleJul 27
Evonik Corporation, Filing of Food Additive Petition (Animal Use)
2026-15021
Proposed ruleJul 24
Rescinding Portions of the U.S. Department of Health and Human Services Title VI Regulations To Align With the Statutory Text and Conform to Executive Order 14281
2026-15000
Final ruleJul 24
Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool
2026-14987
Final ruleJul 24
Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
2026-14986
Final ruleJul 24
Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens
2026-14985
Final ruleJul 24
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression
2026-14984
Final ruleJul 24
Revocation of the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2026-14910
Final ruleJul 23
Proposal To Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
2026-14909
Proposed ruleJul 23
Medicaid Program; Amending the Indirect Hold Harmless Threshold of Health Care-Related Taxes
2026-14897
Proposed ruleJul 23
Rescinding Guidelines for Eliminating Discrimination and Denial of Services on the Basis of Race, Color, National Origin, Sex, and Handicap in Vocational Education Programs
2026-14893
Final ruleJul 23
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
2026-14709 · significant
Final ruleJul 21
Food Standards of Identity Modernization; Pasteurized Orange Juice
2026-14573
Final ruleJul 20
Request for Information; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Regulations
2026-14358
Proposed ruleJul 16
Medicare and Medicaid Programs; CY 2027 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2026-14327
Proposed ruleJul 16
Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission
2026-14131
Final ruleJul 14
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
2026-14073 · significant
Proposed ruleJul 13
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
2026-13716
Final ruleJul 7
Recission of the National Cancer Institute Clinical Cancer Education Program Regulation
2026-13711
Proposed ruleJul 7
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; and Quality Reporting Programs; Including the Hospital Outpatient Quality Reporting Program and Ambulatory Surgical Center Quality Program; Request for Information on Strengthening the Standardization and Comparability of Hospital Price Transparency (HPT) Data; Prior Authorization; Accrediting Organization (AO) Deeming for Emergency Medical Treatment and Labor Act (EMTALA); and Notices of Closure of Teaching Hospitals and Opportunities To Apply for Available Slots
2026-13656
Proposed ruleJul 7
Calendar Year 2027 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the Expanded HH Value-Based Purchasing Model; Medicare Provider Enrollment, Durable Medical Equipment (DME), and DME, Prosthetics, Orthotics, and Supplies (DMEPOS) Policies
2026-13602
Proposed ruleJul 6
Reducing Bureaucracy and Burden for Children, Youth, and Family Programs
2026-13451
Final ruleJul 2
Medical Devices; Anesthesiology Devices; Classification of the Monitor for Opioid Induced Impairment of Oxygenation
2026-13140
Final ruleJun 30
Medical Devices; General and Plastic Surgery Devices; Classification of the Skin Patch for Treatment of Hyperhidrosis
2026-13139
Final ruleJun 30
Medicaid Program; Community Engagement Requirement for Certain Individuals
C1-2026-11094
Final ruleJun 29
Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber
2026-13101
Final ruleJun 29
Establishment Registration and Product Listing for Tobacco Products
2026-13047 · significant
Proposed ruleJun 29
Unaccompanied Children Program Foundational Rule; Sponsor Assessment Update To Include Proof of Identity, Background Check, Placement, and Income Verification Standards
2026-12946
Proposed ruleJun 26
Medicare Program; CY 2027 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Acute Kidney Injury Dialysis (AKI) Payment, and ESRD Quality Incentive Program
2026-12925
Proposed ruleJun 26
Medical Devices; General Hospital and Personal Use Devices; Classification of the Infant Supine Sleep System
2026-12905
Final ruleJun 26
Medical Devices; Neurological Devices; Classification of the External Lower Extremity Nerve Stimulator for Restless Legs Syndrome
2026-12904
Final ruleJun 26
Medical Devices; General and Plastic Surgery Devices; Classification of the Breast Implant Suction Retrieval System
2026-12903
Final ruleJun 26
Medical Devices; Immunology and Microbiology Devices; Classification of the SARS-CoV-2 Serology Test
2026-12902
Final ruleJun 26
Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for the Treatment of Fibromyalgia Symptoms
2026-12901
Final ruleJun 26
Medical Devices; Clinical Chemistry and Toxicology Devices; Classification of the Prognostic Test for Development or Progression of Preeclampsia
2026-12900
Final ruleJun 26
Medical Devices; General Hospital and Personal Use Devices; Classification of the Foam or Gel Chemical Sterilant/High Level Disinfectant
2026-12899
Final ruleJun 26
Sterigenics U.S., LLC; Filing of Food Additive Petition
2026-12855
Proposed ruleJun 25
Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
2026-12676
Proposed ruleJun 24
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device
2026-12445
Final ruleJun 22
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
2026-12444
Final ruleJun 22
Medical Devices; Immunology and Microbiology Devices; Classification of the Simple In Vitro Diagnostic Device for the Detection of Secreted Proteins From Bacillus Species (spp.) in Human Clinical Samples
2026-12443
Final ruleJun 22
Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection
2026-12344
Proposed ruleJun 18
Reducing Bureaucracy and Burden for Native American Programs
2026-12324
Final ruleJun 18
Reducing Bureaucracy and Burden for Child Support Enforcement Programs
2026-12295
Proposed ruleJun 18
Reducing Bureaucracy and Burden for Human Services and Emergency Response Programs-Repatriation Program
2026-12189
Final ruleJun 17
Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
2026-12166
Final ruleJun 17
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
2026-12165
Final ruleJun 17
Medicare Program; Strengthening Oversight of Accrediting Organizations (AOs) and Preventing AO Conflicts of Interest, and Related Provisions
2026-12069 · significant
Final ruleJun 16
Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program
2026-12059
Proposed ruleJun 16
Amendment and Revocation of Organizational Information Regulations
2026-11998
Final ruleJun 15
Request for Information; Comprehensive Review of the Essential Health Benefits Framework and Typical Employer Plan Standard
2026-11994
Proposed ruleJun 15
Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System
2026-11740
Final ruleJun 11
Medical Devices; Immunology and Microbiology Devices; Classification of the Simple Point-of-Care Device to Directly Detect SARS-CoV-2 Viral Targets From Clinical Specimens in Near-Patient Settings
2026-11739
Final ruleJun 11
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
2026-11589
Final ruleJun 10
Reducing Bureaucracy and Burden for Community Services Programs
2026-11531
Final ruleJun 9
Employment and Training Services for Noncustodial Parents in the Child Support Program; Rescission
2026-11530 · significant
Proposed ruleJun 9
Medical Devices; Orthopedic Devices; Classification of the Resorbable Calcium Salt Bone Void Filler Containing a Single Approved Aminoglycoside Antibacterial
2026-11308
Final ruleJun 5
Medical Devices; Orthopedic Devices; Classification of the Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented or Uncemented Prosthesis
2026-11306
Final ruleJun 5
Medical Devices; Orthopedic Devices; Classification of the Absorbable Metallic Bone Fixation Fastener
2026-11302
Final ruleJun 5
Federal Independent Dispute Resolution Operations
2026-11140 · significant
Final ruleJun 4
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
2026-11104
Final ruleJun 3
Medicaid Program; Community Engagement Requirement for Certain Individuals
2026-11094
Final ruleJun 3
Notice of Vacatur Regarding Certain Provisions of the 2024 Nondiscrimination in Health Programs and Activities Final Rule
2026-11015
Final ruleJun 2
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
2026-10908
Final ruleJun 1
Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
2026-10907
Final ruleJun 1
Medical Devices; Anesthesiology Devices; Classification of the Adjunctive Pain Measurement Device for Anesthesiology
2026-10905
Final ruleJun 1
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
2026-10904
Final ruleJun 1
Medical Devices; Dental Devices; Classification of the Intraoral Cooling Device
2026-10899
Final ruleJun 1
Medical Devices; Hematology and Pathology Devices; Classification of the Von Willebrand Factor Assay
2026-10898
Final ruleJun 1
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
2026-10894
Final ruleJun 1
Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
2026-10890 · significant
Final ruleJun 1
Regulation for Federal Financial Assistance
2026-10817
Proposed ruleMay 29
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms
2026-10675
Final ruleMay 29
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
2026-10621
Final ruleMay 28
Food Additive Petition From Environmental Defense Fund, et al.; Request To Amend the Food Additive Regulations To Remove the Solvents Benzene, Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period
2026-10615
Proposed ruleMay 28
Color Additive Petition from Environmental Defense Fund, et al.; Request To Amend the Color Additive Regulations To Remove the Solvents Ethylene Dichloride, Methylene Chloride, and Trichloroethylene; Reopening of the Comment Period
2026-10614
Proposed ruleMay 28
Control of Communicable Diseases; Foreign Quarantine
2026-10543
Final ruleMay 27
Reducing Bureaucracy and Burden for Family Assistance Programs
2026-10401
Proposed ruleMay 26
Medicaid Program; Medicaid Managed Care State Directed Payments and Medicaid Fee-for-Service Targeted Medicaid Practitioner Payments
2026-10292 · significant
Proposed ruleMay 22
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes; Correction
2026-10276
Proposed ruleMay 22
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program
2026-10050 · significant
Final ruleMay 20
Excepted Fertility Benefits
2026-09479
Proposed ruleMay 13
Restoring Flexibility To Support Head Start Program Access
2026-09383 · significant
Proposed ruleMay 12
Restoring Flexibility in the Child Care and Development Fund (CCDF)
2026-09382 · significant
Final ruleMay 12
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganism Nucleic Acids and Resistance Markers From Patients With Suspected Orthopedic Infection
2026-09335
Final ruleMay 12
Extension of Compliance Dates for Nondiscrimination on the Basis of Disability; Accessibility of Web Content and Mobile Applications of Recipients of Departmental Financial Assistance
2026-09266
Final ruleMay 11
Medical Devices; Obstetrical and Gynecological Devices; Classification of the External Condom for Anal Intercourse or Vaginal Intercourse
2026-09152
Final ruleMay 8
Modification of Certain Terminology in Title 21
2026-08826
Proposed ruleMay 6
Medical Devices; Ophthalmic Devices; Classification of the Corneal Storage Medium With Preservatives Including Antifungals
2026-08813
Final ruleMay 6
Medical Devices; Immunology and Microbiology Devices; Classification of the Circulating Tumor Cell Enrichment Device
2026-08812
Final ruleMay 6
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Preserve and Stabilize Relative Abundances of Microbial Nucleic Acids in Clinical Samples
2026-08811
Final ruleMay 6
Medical Devices; General and Plastic Surgery Devices; Classification of the Phototherapy Device for Reducing the Appearance of Acute Post-Surgical Incisions
2026-08497
Final ruleMay 1
Medical Devices; Cardiovascular Devices; Classification of the Laser-Powered Inferior Vena Cava Filter Retrieval Catheter
2026-08426
Final ruleApr 30
Medical Devices; Neurological Devices; Classification of the Brain Temperature Measurement System
2026-08425
Final ruleApr 30
Medical Devices; Radiology Devices; Classification of the Radiation Therapy Marking Device
2026-08424
Final ruleApr 30
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System
2026-07863
Final ruleApr 22
Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement
2026-07862
Final ruleApr 22
Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia
2026-07861
Final ruleApr 22
Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test
2026-07860
Final ruleApr 22
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
2026-07500
Final ruleApr 16
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes; Correction
2026-07470
Proposed ruleApr 16
Medical Devices; Orthopedic Devices; Classification of the Manual Surgical Instrument for Appropriate Patient Selection for Orthopedic Implant
2026-07367
Final ruleApr 16
Physical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
2026-07366
Final ruleApr 16
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion
2026-07365
Final ruleApr 16
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability Standards and Prior Authorization for Drugs for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, and Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges
2026-07205 · significant
Proposed ruleApr 14
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates; Requirements for Quality Programs; and Other Policy Changes
2026-07203
Proposed ruleApr 14
Reducing Bureaucracy and Burden for Community Services Programs
2026-06760
Proposed ruleApr 8
Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
2026-06675
Proposed ruleApr 7
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2027
2026-06674
Proposed ruleApr 7
Reducing Bureaucracy and Burden for Children, Youth, and Family Programs
2026-06646
Proposed ruleApr 6
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2027 and Updates to the IRF Quality Reporting Program
2026-06642
Proposed ruleApr 6
Reducing Bureaucracy and Burden in Family Violence and Prevention Services
2026-06633
Proposed ruleApr 6
Work Participation Rate Calculation Changes: Recalibration of the Caseload Reduction Credit and Prohibition of Small Checks in Work Participation Rate Calculation
2026-06632 · significant
Proposed ruleApr 6
Medicare Program; FY 2027 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
2026-06604
Proposed ruleApr 6
Medicare Program; Contract Year 2027 and Certain Contract Year 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
2026-06600 · significant
Final ruleApr 6
Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride
2026-06295
Proposed ruleApr 1
Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests
2026-06064
Proposed ruleMar 30
Reducing Bureaucracy and Burden for Refugee Resettlement Programs
2026-06027
Final ruleMar 27
Reducing Bureaucracy and Burden for Human Services and Emergency Response Programs-Repatriation Program
2026-05997
Proposed ruleMar 27
Reducing Bureaucracy and Burden for Native American Programs
2026-05994
Proposed ruleMar 27
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Software-Aided Adjunctive Diagnostic Devices for Use on Skin Lesions by Physicians Trained in the Diagnosis and Management of Skin Cancer
2026-05772
Final ruleMar 25
Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date
2026-05733
Final ruleMar 24
Listing of Color Additive Exempt From Certification; Beetroot Red; Delay of Effective Date
2026-05732
Final ruleMar 24
Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures
2026-05676 · significant
Final ruleMar 24
Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended To Prevent Metastasis
2026-05322
Proposed ruleMar 18
Medical Devices; Radiology Devices; Classification of Blood Irradiators
2026-05320
Proposed ruleMar 18
General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule
2026-05103
Proposed ruleMar 16
Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels
2026-04981
Final ruleMar 13
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction
2026-04797 · significant
Final ruleMar 12
Designated Placement Requirements Under Titles IV-E and IV-B for LGBTQI+ Children; Rescission
2026-04515
Proposed ruleMar 6
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program; Correction
2026-04467 · significant
Proposed ruleMar 6
Revising the National Drug Code Format and Drug Label Barcode Requirements
2026-04368
Final ruleMar 5
Ecoflora Cares; Filing of Color Additive Petition
2026-04288
Proposed ruleMar 4
Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
2026-04284
Proposed ruleMar 4
Request for Information (RFI) Related to Comprehensive Regulations To Uncover Suspicious Healthcare (CRUSH)
2026-03968
Proposed ruleFeb 27
Private Health Insurance; Transparency in Coverage; Extension of Comment Period
2026-03798 · significant
Proposed ruleFeb 25
Managed Care
2026-03779
Final ruleFeb 25
Medicare Program; Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots; Correction
2026-03578 · significant
Final ruleFeb 23
Medications for the Treatment of Opioid Use Disorder; Correction
2026-03577 · significant
Final ruleFeb 23
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and the European Community
2026-03286
Final ruleFeb 19
Revocation of Methods of Analysis Regulation
2026-03285
Final ruleFeb 19
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2027; and Basic Health Program
2026-02769 · significant
Proposed ruleFeb 11
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
2026-02331
Final ruleFeb 6
Listing of Color Additives Exempt From Certification; Spirulina Extract
2026-02314
Final ruleFeb 6
Listing of Color Additives Exempt From Certification; Beetroot Red
2026-02313
Final ruleFeb 6
Medicaid Program; Preserving Medicaid Funding for Vulnerable Populations-Closing a Health Care-Related Tax Loophole
2026-02040 · significant
Final ruleFeb 2
Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance
2026-02038
Proposed ruleFeb 2
Request for Information: Diagnostic Imaging Interoperability Standards and Certification
2026-01866
Proposed ruleJan 30
Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Conditions for Coverage
2026-01833 · significant
Proposed ruleJan 30
Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Federal Anti-Kickback Statute and Beneficiary Inducements CMP
2026-01817
Proposed ruleJan 29
Medicare Program; Ensuring Safety Through Domestic Security With Made in America Personal Protective Equipment (PPE) and Essential Medicine Procurement by Medicare Participating Hospitals
2026-01730 · significant
Proposed ruleJan 29
Annual Civil Monetary Penalties Inflation Adjustment
2026-01688
Final ruleJan 28
Tribal Consultation on Proposed Modifications to the HIPAA Privacy Rule
2026-00561
Proposed ruleJan 14
Medicare Program; Updates to the Master List of Items Potentially Subject to Face to Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face Encounter and Written Order Prior to Delivery List; and Updates to the Required Prior Authorization List
2026-00487
Final ruleJan 13
Restoring Flexibility in the Child Care and Development Fund (CCDF)
2025-24272 · significant
Proposed ruleJan 5
Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
2025-24123 · significant
Final ruleDec 31, 2025
Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity
2025-23896 · significant
Proposed ruleDec 29, 2025
Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability; Withdrawal
2025-23890 · significant
Proposed ruleDec 29, 2025
Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model
2025-23705
Proposed ruleDec 23, 2025
Global Benchmark for Efficient Drug Pricing (GLOBE) Model
2025-23702 · significant
Proposed ruleDec 23, 2025
Transparency in Coverage
2025-23693 · significant
Proposed ruleDec 23, 2025
Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance
2025-23484
Proposed ruleDec 19, 2025
Medicare and Medicaid Programs; Hospital Condition of Participation: Prohibiting Sex-Rejecting Procedures for Children
2025-23465
Proposed ruleDec 19, 2025
Medicaid Program; Prohibition on Federal Medicaid and Children's Health Insurance Program Funding for Sex-Rejecting Procedures Furnished to Children
2025-23464
Proposed ruleDec 19, 2025
COVID-19 Mitigation Policy Requirement in Head Start Programs; Recission
2025-23452 · significant
Final ruleDec 19, 2025
Medical Devices; Neurological Devices; Classification of the Electrical Tongue Nerve Stimulator To Treat Motor Deficits
2025-23413
Final ruleDec 19, 2025
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program; Correction
2025-23081 · significant
Final ruleDec 17, 2025
Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
2025-22543 · significant
Proposed ruleDec 11, 2025
Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts
2025-22327
Proposed ruleDec 9, 2025
Expiration of Interim Final Rule: Control of Communicable Diseases; Foreign Quarantine
2025-21962 · significant
Final ruleDec 4, 2025
Medical Devices; Quality Management System Regulation Technical Amendments
2025-21955
Final ruleDec 4, 2025
Medicare and Medicaid Programs; Repeal of Minimum Staffing Standards for Long-Term Care Facilities
2025-21792
Final ruleDec 3, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
2025-21767 · significant
Final ruleDec 2, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction
2025-21458 · significant
Final ruleNov 28, 2025
Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
2025-21456 · significant
Proposed ruleNov 28, 2025
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products; Withdrawal
2025-21407 · significant
Proposed ruleNov 28, 2025
Green Innovation GmbH; Filing of Food Additive Petition (Animal Use)
2025-21226
Proposed ruleNov 26, 2025
Medical Devices; Neurological Devices; Classification of Field Generator Positioning Device
2025-21218
Final ruleNov 26, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Anchored Esophageal Sheath
2025-21217
Final ruleNov 26, 2025
Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product; Proposed Amendment; Proposed Order; Request for Comments
2025-21071
Proposed ruleNov 25, 2025
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Rating; Hospital Price Transparency; and Notice of Closure of a Teaching Hospital and Opportunity To Apply for Available Slots
2025-20907 · significant
Final ruleNov 25, 2025
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
2025-20681 · significant
Final ruleNov 24, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2025-19787 · significant
Final ruleNov 5, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Confirmation of Effective Date
2025-19166
Final ruleOct 1, 2025
Revocation of Food Standards for 11 Products Not Currently Sold; Confirmation of Effective Date
2025-18730
Final ruleSep 26, 2025
Prior Notice: Adding Requirement To Submit Mail Tracking Number for Articles of Food Arriving by International Mail and Timeframe for Post-Refusal and Post-Hold Submissions
2025-18655
Final ruleSep 25, 2025
Regulation Identification Number 0910-AJ05 Medical Devices; Laboratory Developed Tests; Implementation of Vacatur
2025-18239
Final ruleSep 19, 2025
Medicare and Medicaid Programs; Contract Year 2026 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 (PACE)-Finalization of Format Provider Directories for Medicare Plan Finder
2025-18236 · significant
Final ruleSep 19, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
2025-18217
Final ruleSep 19, 2025
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
2025-18082
Final ruleSep 18, 2025
Radiological Health Regulations; Technical Amendments
2025-18080
Final ruleSep 18, 2025
Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
2025-18023
Proposed ruleSep 17, 2025
Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions; Correction
2025-17237
Final ruleSep 8, 2025
Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction
2025-16960 · significant
Final ruleSep 4, 2025
Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 in Yogurt and Other Cultured Dairy Products Fermented With Lactobacillus delbrueckii, Subspecies bulgaricus, and Streptococcus thermophilus
2025-16946
Final ruleSep 4, 2025
Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide
2025-16898
Final ruleSep 3, 2025
Biomin GmbH; Filing of Food Additive Petition (Animal Use)
2025-16859
Proposed ruleSep 3, 2025
Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees
2025-16629
Final ruleAug 29, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
C3-2025-12347 · significant
Proposed ruleAug 28, 2025
Terminating National Institutes of Health Minority Biomedical Research Support Program and Rescinding the Program's Related Regulation
2025-16321
Final ruleAug 26, 2025
Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions
2025-16129
Final ruleAug 22, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2025-16079
Final ruleAug 22, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date
2025-16047
Final ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date
2025-16046
Final ruleAug 21, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
2025-16045
Final ruleAug 21, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool
2025-16041
Final ruleAug 21, 2025
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices
2025-16040
Final ruleAug 21, 2025
Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices
2025-16039
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
2025-16038
Final ruleAug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
2025-16037
Final ruleAug 21, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System
2025-16036
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System
2025-16035
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of A Multiplex Respiratory Panel To Detect and Identify Emerging Respiratory Pathogen(s) and Common Respiratory Pathogens in Human Clinical Specimens
2025-16034
Final ruleAug 21, 2025
Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox
2025-16033
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
2025-16032
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System
2025-16031
Final ruleAug 21, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis
2025-16030
Final ruleAug 21, 2025
Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA), National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Updates to Compliance and Other Related Dates
2025-15958
Final ruleAug 21, 2025
Evonik Corporation; Filing of Food Additive Petition (Animal Use)
2025-15792
Proposed ruleAug 19, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction
2025-15492 · significant
Proposed ruleAug 14, 2025
Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule; Correction
2025-15473
Proposed ruleAug 14, 2025
Requirements for Additional Traceability Records for Certain Foods: Compliance Date Extension
2025-14967
Proposed ruleAug 7, 2025
Food Standards of Identity Modernization; Pasteurized Orange Juice
2025-14949
Proposed ruleAug 6, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue; Correction
2025-14905
Final ruleAug 6, 2025
Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
2025-14782 · significant
Final ruleAug 5, 2025
Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
2025-14781 · significant
Final ruleAug 5, 2025
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program
2025-14780 · significant
Final ruleAug 5, 2025
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2026 Rates; Changes to the FY 2025 IPPS Rates Due to Court Decision; Requirements for Quality Programs; and Other Policy Changes; Health Data, Technology, and Interoperability: Electronic Prescribing, Real-Time Prescription Benefit and Electronic Prior Authorization
2025-14681
Final ruleAug 4, 2025
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026
2025-14679 · significant
Final ruleAug 4, 2025
Spoonbill Foundation; Filing of Food Additive Petition
2025-14339
Proposed ruleJul 29, 2025
APIX Biosciences US LLC; Filing of Food Additive Petition (Animal Use)
2025-14335
Proposed ruleJul 29, 2025
Regulatory Hearing Before the Food and Drug Administration
2025-14203
Final ruleJul 28, 2025
Proposal To Revoke 18 Standards of Identity for Dairy Products
2025-13424
Proposed ruleJul 17, 2025
Revocation of Food Standards for 11 Products Not Currently Sold
2025-13423
Proposed ruleJul 17, 2025
Revocation of Food Standards for 11 Products Not Currently Sold
2025-13421
Final ruleJul 17, 2025
Proposal To Revoke 23 Standards of Identity for Foods
2025-13420
Proposed ruleJul 17, 2025
Medicare and Medicaid Programs: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Overall Hospital Quality Star Ratings; and Hospital Price Transparency
2025-13360 · significant
Proposed ruleJul 17, 2025
Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program
2025-13271 · significant
Proposed ruleJul 16, 2025
Listing of Color Additives Exempt From Certification; Gardenia (Genipin) Blue
2025-13175
Final ruleJul 15, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
C2-2025-12347 · significant
Proposed ruleJul 11, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
C1-2025-12347 · significant
Proposed ruleJul 9, 2025
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
2025-12368 · significant
Proposed ruleJul 2, 2025
Medicare and Medicaid Programs; Calendar Year 2026 Home Health Prospective Payment System (HH PPS) Rate Update; Requirements for the HH Quality Reporting Program and the HH Value-Based Purchasing Expanded Model; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Updates; DMEPOS Accreditation Requirements; Provider Enrollment; and Other Medicare and Medicaid Policies
2025-12347 · significant
Proposed ruleJul 2, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Muscular Dystrophy Newborn Screening Test
2025-11796
Final ruleJun 26, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Simplex Virus Nucleic Acid-Based Assay for Central Nervous System Infections
2025-11794
Final ruleJun 26, 2025
Medical Devices; Hematology and Pathology Devices; Classification of the Fluorescence In Situ Hybridization-Based Detection of Chromosomal Abnormalities From Patients With Hematologic Malignancies
2025-11793
Final ruleJun 26, 2025
Medical Devices; Radiology Devices; Classification of the Cream for X-Ray Attenuation
2025-11791
Final ruleJun 26, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Lysosomal Storage Disorder Newborn Screening Test System
2025-11781
Final ruleJun 26, 2025
Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability
2025-11606
Final ruleJun 25, 2025
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Clinical Electronic Thermometers
2025-11207
Final ruleJun 18, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software
2025-10789
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Clinical Mass Spectrometry Microorganism Identification and Differentiation System
2025-10788
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
2025-10787
Final ruleJun 13, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Fungal Nucleic Acids Directly in Respiratory Specimens
2025-10786
Final ruleJun 13, 2025
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
2025-10549
Proposed ruleJun 11, 2025
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; Correction
2025-10261 · significant
Proposed ruleJun 5, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Bacterial Protease Activity in Chronic Wound Fluid
2025-09883
Final ruleJun 2, 2025
Request for Information Regarding the Prescription Drug Machine-Readable File Requirement in the Transparency in Coverage Final Rule
2025-09858 · significant
Proposed ruleJun 2, 2025
Medical Devices; Radiology Devices; Classification of the Radiological Acquisition and/or Optimization Guidance System
2025-09837
Final ruleJun 2, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Mullerian Hormone Test System
2025-09776
Final ruleMay 30, 2025
Medicare and Medicaid Programs; Contract Year 2026 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; Correction
2025-09695 · significant
Final ruleMay 29, 2025
Listing of Color Additives; Myoglobin; Confirmation of Effective Date
2025-09680
Final ruleMay 29, 2025
Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Draft Guidance for Industry; Reopening of Comment Period
2025-09653
Proposed ruleMay 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Inherited Nucleotide Repeat Disorder Deoxyribonucleic Acid Test
2025-09641
Final ruleMay 29, 2025
Medical Devices; Gastroenterology-Urology Devices; Classification of the Temporarily-Placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
2025-09640
Final ruleMay 29, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Zika Virus Serological Reagents
2025-09639
Final ruleMay 29, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Plazomicin Test System
2025-09638
Final ruleMay 29, 2025
World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders
2025-09411
Final ruleMay 27, 2025
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026
C1-2025-06348 · significant
Proposed ruleMay 21, 2025
Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
C1-2025-06317 · significant
Proposed ruleMay 21, 2025
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium
2025-08864
Final ruleMay 19, 2025
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments; and Appeal Rights for Certain Changes in Patient Status; Corrections and Correcting Amendment
2025-08676
Final ruleMay 16, 2025
Medicaid Program; Preserving Medicaid Funding for Vulnerable Populations-Closing a Health Care-Related Tax Loophole Proposed Rule
2025-08566 · significant
Proposed ruleMay 15, 2025
Notification of HHS Documents Identified for Rescission
2025-08393
Final ruleMay 14, 2025
Listing of Color Additives Exempt From Certification; Galdieria Extract Blue
2025-08250
Final ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Calcium Phosphate
2025-08249
Final ruleMay 12, 2025
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
2025-08248
Final ruleMay 12, 2025
Food Labeling: Front-of-Package Nutrition Information; Extension of Comment Period
2025-08204 · significant
Proposed ruleMay 9, 2025
Medical Devices; Hematology and Pathology Devices; Classification of the Coagulation System for the Measurement of Whole Blood Viscoelastic Properties in Perioperative Patients
2025-08151
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Nucleic Acids by Fluorescence In Situ Hybridization in Clinical Specimens
2025-08150
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect Nucleic Acids From Non-Viral Microorganism(s) Causing Sexually Transmitted Infections and Associated Resistance Marker(s)
2025-08149
Final ruleMay 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Voriconazole Test System
2025-08148
Final ruleMay 9, 2025
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Breast Milk Macronutrients Test System
2025-08147
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
2025-08146
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Microbial Nucleic Acid Storage and Stabilization Device
2025-08145
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections
2025-08144
Final ruleMay 9, 2025
Medical Devices; Immunology and Microbiology Devices; Classification of the DNA-Based Test To Measure Minimal Residual Disease in Hematological Malignancies
2025-08143
Final ruleMay 9, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
2025-08137
Final ruleMay 9, 2025
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program for Federal Fiscal Year 2026
2025-06348 · significant
Proposed ruleApr 30, 2025
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2026 and Updates to the IRF Quality Reporting Program
2025-06336 · significant
Proposed ruleApr 30, 2025
Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements
2025-06317 · significant
Proposed ruleApr 30, 2025
Medicare Program; FY 2026 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
2025-06298 · significant
Proposed ruleApr 30, 2025
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
2025-06271 · significant
Proposed ruleApr 30, 2025
Name Change From Office of Child Support Enforcement to Office of Child Support Services; Withdrawal
2025-06958
Final ruleApr 23, 2025
Medicare and Medicaid Programs; Contract Year 2026 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
2025-06008 · significant
Final ruleApr 15, 2025
Nondiscrimination on the Basis of Disability in Programs or Activities Receiving Federal Financial Assistance; Clarification
2025-06127
Final ruleApr 11, 2025
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2025-04978 · significant
Final ruleMar 25, 2025
Unaccompanied Children Program Foundational Rule; Update To Accord With Statutory Requirements
2025-04971
Final ruleMar 25, 2025
Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
2025-05007 · significant
Final ruleMar 24, 2025
Privacy Act; Implementation; Further Delay of Effective Date
2025-04979
Final ruleMar 24, 2025
Patient Protection and Affordable Care Act; Marketplace Integrity and Affordability
2025-04083
Proposed ruleMar 19, 2025
Impossible Foods, Inc.; Filing of Color Additive Petition
2025-04034
Proposed ruleMar 14, 2025
Policy on Adhering to the Text of the Administrative Procedure Act
2025-03300
Final ruleMar 3, 2025
Name Change From Office of Child Support Enforcement to Office of Child Support Services; Reopening of Comment Period and Delaying Effective Date
2025-03147
Final ruleFeb 27, 2025
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
2025-03118
Final ruleFeb 25, 2025
Privacy Act; Implementation
2025-02810
Final ruleFeb 19, 2025
Expansion of Buprenorphine Treatment via Telemedicine Encounter and Continuity of Care via Telemedicine for Veterans Affairs Patients
2025-02793 · significant
Final ruleFeb 19, 2025
Exchange Establishment Standards and Other Related Standards Under the Affordable Care Act
2025-02715
Final ruleFeb 14, 2025
Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard; Delay of Effective Date
2025-02511
Final ruleFeb 11, 2025
Privacy Act; Implementation
2025-02158
Final ruleFeb 3, 2025
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2025-01840 · significant
Final ruleJan 27, 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2025-01226
Final ruleJan 21, 2025
Listing of Color Additives Exempt From Certification; Myoglobin
2025-01239
Final ruleJan 17, 2025
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Withdrawal
2025-01145
Final ruleJan 17, 2025
Expansion of Buprenorphine Treatment via Telemedicine Encounter
2025-01049 · significant
Final ruleJan 17, 2025
Continuity of Care via Telemedicine for Veterans Affairs Patients
2025-01044 · significant
Final ruleJan 17, 2025
Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
2025-00830
Final ruleJan 16, 2025
Food Labeling: Front-of-Package Nutrition Information
2025-00778 · significant
Proposed ruleJan 16, 2025
Privacy Act; Implementation
2025-00670
Final ruleJan 16, 2025
Mandatory Guidelines for Federal Workplace Drug Testing Programs-Authorized Testing Panels
2025-00425
Final ruleJan 16, 2025
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
2025-00397
Proposed ruleJan 16, 2025
Enhancing Coverage of Preventive Services Under the Affordable Care Act
2025-00774
Proposed ruleJan 15, 2025
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program
2025-00640
Final ruleJan 15, 2025
Parentage Establishment in the Child Support Services Program; Withdrawal
2025-00638 · significant
Proposed ruleJan 15, 2025
Strengthening Temporary Assistance for Needy Families (TANF) as a Safety Net and Work Program; Withdrawal
2025-00537
Proposed ruleJan 14, 2025
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; Correcting Amendment
2025-00081
Final ruleJan 13, 2025
Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event; Draft Guidance for Industry; Availability
2024-31528
Proposed ruleJan 7, 2025
Considerations for Complying With 21 CFR 211.110; Draft Guidance for Industry; Availability
2024-31356
Final ruleJan 6, 2025
HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information
2024-30983 · significant
Proposed ruleJan 6, 2025
Uniform Compliance Date for Food Labeling Regulations
2024-31419
Final ruleDec 31, 2024
Name Change From Office of Child Support Enforcement to Office of Child Support Services
2024-30987
Final ruleDec 31, 2024
Coverage of Certain Preventive Services Under the Affordable Care Act
2024-31239 · significant
Proposed ruleDec 30, 2024
Adoption and Foster Care Analysis and Reporting System; Correction
2024-31238 · significant
Final ruleDec 30, 2024
Medicare Program: Appeal Rights for Certain Changes in Patient Status and Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures; Correcting Amendment
2024-31146
Final ruleDec 30, 2024
Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products
2024-30544 · significant
Proposed ruleDec 27, 2024
Food Labeling: Nutrient Content Claims; Definition of Term “Healthy”
2024-29957
Final ruleDec 27, 2024
Investigations of Child Abuse and Neglect Rule; Correction
2024-30755 · significant
Final ruleDec 26, 2024
Select Agent: Modified Junín Virus Vaccine Strain
2024-30568
Final ruleDec 26, 2024
Monterey Mushrooms, LLC; Filing of Food Additive Petition
2024-30362
Proposed ruleDec 26, 2024
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
2024-30261 · significant
Final ruleDec 26, 2024
Privacy Act; Implementation
2024-30311
Final ruleDec 23, 2024
Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies; Correction
2024-30169
Final ruleDec 20, 2024
Health Data, Technology, and Interoperability: Protecting Care Access
2024-29683 · significant
Final ruleDec 17, 2024
Possession, Use, and Transfer of Select Agents and Toxins; Biennial Review of the List of Select Agents and Toxins
2024-29583 · significant
Final ruleDec 17, 2024
Health Data, Technology, and Interoperability: Trusted Exchange Framework and Common Agreement (TEFCA)
2024-29163
Final ruleDec 16, 2024
Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Modification of the Medicaid Pharmacy Subrogation Standard
2024-29138
Final ruleDec 13, 2024
Employment and Training Services for Noncustodial Parents in the Child Support Program
2024-29081 · significant
Final ruleDec 13, 2024
Leprino Nutrition; Filing of Food Additive Petition
2024-29248
Proposed ruleDec 12, 2024
Medicare and Medicaid Programs; Contract Year 2026 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
2024-27939 · significant
Proposed ruleDec 10, 2024
Clinical Trials Registration and Results Information Submission
2024-28475
Final ruleDec 9, 2024
Medicare and Medicaid Programs; CY 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program; and Medicare Overpayments
2024-25382 · significant
Final ruleDec 9, 2024
Adoption and Foster Care Analysis and Reporting System
2024-28072 · significant
Final ruleDec 5, 2024
National Institute on Minority Health and Health Disparities Research Endowment Programs
2024-28082
Final ruleDec 4, 2024
Medicare Program; Alternative Payment Model Updates and the Increasing Organ Transplant Access (IOTA) Model
2024-27841 · significant
Final ruleDec 4, 2024
Final Scientific Integrity Policy; Withdrawal
2024-28128
Final ruleDec 2, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
2024-28061
Final ruleDec 2, 2024
Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities
2024-26804
Proposed ruleDec 2, 2024
Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts
2024-27710
Proposed ruleNov 27, 2024
Investigations of Child Abuse and Neglect Rule
2024-27626 · significant
Final ruleNov 27, 2024
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act
2024-27410
Final ruleNov 27, 2024
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
2024-25521
Final ruleNov 27, 2024
Final Scientific Integrity Policy
2024-25810
Final ruleNov 25, 2024
Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
2024-27018 · significant
Final ruleNov 19, 2024
Increase Flexibility for Tribes in Child Care and Development Fund (CCDF) Eligibility
2024-26909 · significant
Final ruleNov 18, 2024
Use of Federal Real Property To Assist the Homeless
2024-25722 · significant
Final ruleNov 13, 2024
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, Conditions for Coverage for End-Stage Renal Disease Facilities, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
2024-25486
Final ruleNov 12, 2024
Color Additive Certification; Increase in Fees for Certification Services
2024-25974 · significant
Final ruleNov 8, 2024
Medicare Program; Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin (IVIG) Items and Services Rate Update; and Other Medicare Policies
2024-25441
Final ruleNov 7, 2024
Head Start Program CLASS Implementation Date Delay
2024-25440
Final ruleNov 6, 2024
Supporting the Head Start Workforce and Consistent Quality Programming; Announcement and Correction
2024-23032
Final ruleOct 31, 2024
Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
2024-25122
Final ruleOct 30, 2024
Environmental Defense Fund, et al.; Response to Objections and Requests for a Public Hearing
2024-25120
Proposed ruleOct 30, 2024
Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program; Correcting Amendment
2024-24910
Final ruleOct 28, 2024
New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
2024-24820
Final ruleOct 28, 2024
Enhancing Coverage of Preventive Services Under the Affordable Care Act
2024-24675
Proposed ruleOct 28, 2024
Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally- Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program; Correcting Amendment
2024-24801 · significant
Final ruleOct 25, 2024
Improving Child Care Access, Affordability, and Stability in the Child Care and Development Fund (CCDF); Corrections
2024-24781
Final ruleOct 25, 2024
Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability
2024-24715
Final ruleOct 24, 2024
Department of Health and Human Services Policy for the Protection of Human Research Subjects: Update to the Additional Protections for Specific Populations
2024-24399 · significant
Final ruleOct 24, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction
2024-24100
Final ruleOct 18, 2024
Medical Devices; Quality System Regulation Amendments; Correction
2024-23701
Final ruleOct 15, 2024
Medicare Program: Appeal Rights for Certain Changes in Patient Status
2024-23195 · significant
Final ruleOct 15, 2024
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program
2024-23103
Proposed ruleOct 10, 2024
Medicare Program; Changes to the Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Rates Due to Court Decision
2024-22765
Final ruleOct 3, 2024
HHS Acquisition Regulation: Regulatory Review
2024-17095
Proposed ruleOct 3, 2024
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025; Correction
2024-22504
Final ruleOct 2, 2024
Medicare and Medicaid Programs and the Children's Health Insurance 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 2025 Rates; Quality Programs Requirements; and Other Policy Changes; Correction
2024-22501
Final ruleOct 2, 2024
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program; Correction
2024-22497
Final ruleOct 2, 2024
Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction
2024-22496 · significant
Final ruleOct 2, 2024
Health and Human Services Adoption of the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
2024-21984
Final ruleOct 2, 2024
Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements; Correction
2024-22495
Final ruleOct 1, 2024
Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and 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 (PACE); Correcting Amendment
2024-22203 · significant
Final ruleSep 30, 2024
Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023
2024-22054
Final ruleSep 27, 2024
PHM Brands; Withdrawal of Food Additive Petition
2024-21934
Proposed ruleSep 26, 2024
Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program
2024-21254
Final ruleSep 26, 2024
Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices
2024-21932
Proposed ruleSep 25, 2024
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
2024-21840
Final ruleSep 24, 2024
DSM Biomedical; Filing of Color Additive Petition
2024-21684
Proposed ruleSep 23, 2024
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
2024-21616
Final ruleSep 23, 2024
Requirements Related to the Mental Health Parity and Addiction Equity Act
2024-20612
Final ruleSep 23, 2024
Revocation of Regulations Regarding the Mutual Recognition of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, and Certain Medical Device Product Evaluation Reports: United States and The European Community
2024-21559
Proposed ruleSep 20, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
2024-21232
Proposed ruleSep 20, 2024
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
2024-21231
Final ruleSep 20, 2024
Performance Standards for Medicaid Fraud Control Units
2024-20416
Final ruleSep 18, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
2024-21086
Final ruleSep 17, 2024
Public Health Service Policies on Research Misconduct
2024-20814
Final ruleSep 17, 2024
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
2024-20999
Final ruleSep 16, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
2024-20896
Final ruleSep 16, 2024
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
2024-20895
Final ruleSep 16, 2024
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability
2024-20850
Final ruleSep 13, 2024
Organ Procurement and Transplantation: Implementation of the HIV Organ Policy Equity (HOPE) Act
2024-20643
Proposed ruleSep 12, 2024
Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
2024-20550
Final ruleSep 11, 2024
World Trade Center (WTC) Health Program; Expanded Eligibility for Pentagon and Shanksville, Pennsylvania Responders
2024-20540
Final ruleSep 11, 2024
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
2024-20254
Final ruleSep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device
2024-20248
Final ruleSep 9, 2024
Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications; Correction
2024-20174
Final ruleSep 9, 2024
Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
2024-20081
Final ruleSep 6, 2024
Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution
2024-19882
Final ruleSep 5, 2024
Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
2024-19868
Final ruleSep 5, 2024
Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast
2024-19856
Final ruleSep 5, 2024
Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
2024-19824
Final ruleSep 5, 2024
Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender
2024-19736
Final ruleSep 5, 2024
Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
2024-19726
Final ruleSep 3, 2024
Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
2024-19725
Final ruleSep 3, 2024
Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
2024-19722
Final ruleSep 3, 2024
Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
2024-19720
Final ruleSep 3, 2024
Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
2024-19481 · significant
Final ruleAug 30, 2024
Catastrophic Health Emergency Fund
2024-19421
Final ruleAug 30, 2024

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