Federal Regulations

Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices

The Food and Drug Administration (FDA) is issuing a final order reclassifying qualitative hepatitis B virus (HBV) antigen assays (product code LOM), HBV antibody assays (product code LOM), and quantitative HBV nucleic acid-based assays (product code MKT), all of which are postamendments class III devices, into class II (special controls), subject to premarket notification. FDA is also establishing the special controls that are necessary to provide a reasonable assurance of safety and effectiveness of these device types.

Radiological Health Regulations; Technical Amendments

The Food and Drug Administration (FDA) is making technical amendments to its radiological health regulations to correct an error. On January 20, 2023, FDA published a final rule entitled "Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products" that inadvertently deleted certain existing regulatory text from the Code of Federal Regulations. This action corrects the error by restoring the inadvertently deleted regulatory text. This action is editorial in nature and is intended to ensure accuracy and clarity in FDA's regulations by restoring inadvertently deleted regulatory text.

Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages

The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.

Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions; Correction

OS is correcting a final rule that was published in the Federal Register on August 22, 2025, with an effective date of October 21, 2025. The Standards of Conduct Final Rule revises, republishes, and renumbers, as needed, the sections of part 73 that have not been superseded and continue to be important to the efficient functioning of the Department to ensure they are consistent with current law and Department policy or procedures. It includes required provisions related to counter-trafficking in persons and removes all superseded and obsolete provisions, including parts 73a and 73b, in their entirety.

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

The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in yogurt and other cultured dairy products fermented with Lactobacillus delbrueckii, subspecies bulgaricus (L. delbrueckii, subsp. bulgaricus), and Streptococcus thermophilus (S. thermophilus) at a level higher than is currently permitted. We are taking this action in response to a food additive petition filed by General Mills, Inc. (General Mills or petitioner). We are also updating the reference for the vitamin D<INF>3</INF> specifications.

Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements; Correction

This document corrects typographical errors in the final rule that appeared in the August 5, 2025 Federal Register titled "Medicare Program; FY 2026 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Program Requirements" (hereinafter referred to as the "FY 2026 Hospice final rule"). The effective date of the FY 2026 Hospice final rule is October 1, 2025.

Biomin GmbH; Filing of Food Additive Petition (Animal Use)

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Biomin GmbH, proposing that we amend our food additive regulations to provide for the safe use of zearalenone hydrolase to degrade zearalenone in swine food at no less than 10 U/kg complete feed (U = the five-fold enzymatic activity that hydrolyzes 1 [micro]mol zearalenone per minute in a solution of 5 mg/L zearalenone).

Secondary Direct Food Additives Permitted in Food for Human Consumption; Hydrogen Peroxide

The Food and Drug Administration (FDA or we) is amending the food additive regulation to provide for the safe use of hydrogen peroxide in food as an antimicrobial agent, oxidizing and reducing agent, and bleaching agent, and to remove sulfur dioxide. We are taking this action in response to a food additive petition filed by Cargill, Inc. (Cargill or petitioner).

Advisory Committee; Arthritis Advisory Committee; Termination; Removal From List of Standing Committees

The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Arthritis Advisory Committee (Committee). Due to that termination, this final rule removes the Committee from the Agency's list of standing advisory committees in 21 CFR 14.100.

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

Terminating National Institutes of Health Minority Biomedical Research Support Program and Rescinding the Program's Related Regulation

The Department of Health and Human Services (HHS), in consultation with the National Institutes of Health (NIH), is repealing the regulation relating to the Minority Biomedical Research Support (MBRS) program in compliance with Executive Order (E.O.) 14173 (Ending Illegal Discrimination and Restoring Merit-Based Opportunity) and E.O. 14151 (Ending Radical and Wasteful Government DEI Programs and Preferencing), and to abide by Supreme Court precedent. HHS remains committed to ensuring equal treatment under the law throughout its grant programs.

New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2025. The animal drug regulations are also being amended to improve their accuracy and readability.

Standards of Conduct; Revocation of Superseded Regulations; Revision of Residual Provisions

The Department of Health and Human Services (Department or HHS) is revising and reissuing the Standards of Conduct, a set of substantive and procedural rules relating to conduct and employee responsibilities that augment the Standards of Ethical Conduct for Employees of the Executive Branch, the Supplemental Standards of Ethical Conduct for Employees of the Department of Health and Human Services, the Supplemental Financial Disclosure Requirements for Employees of the Department of Health and Human Services, the Employee Responsibilities and Conduct Regulation, and the Executive Branch Financial Disclosure regulations. The Department is removing provisions that have been superseded by these regulations or are otherwise obsolete or unnecessary to efficient administration. This final rule addresses conduct on Federal Government (Government) property and the use of Government funds or official information; restates existing standards for workplace courtesy; specifies rules for acceptance of gifts, travel, and employment from foreign governments and other non- Federal entities; provides notice of disciplinary actions available to address violations and prescribes the continuing employee obligation to report violations of rules or law to appropriate authorities. This revision adds a new section addressing Counter-Trafficking in Persons requirements in response to the Trafficking Victims Prevention and Protection Reauthorization Act of 2022 (Pub. L. 117-348). The rule also continues and delineates restrictions on the political activity of commissioned officers of the United States Public Health Service, a category of employees not covered by the Hatch Act Reform Amendments of 1993, as amended.

Listing of Color Additives Exempt From Certification; Galdieria Extract Blue; Confirmation of Effective Date

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of galdieria extract blue as a color additive at levels consistent with good manufacturing practice (GMP) in: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing gum, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).

Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Non-Fusion Spinous Process Spacer Devices

The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of orthopedic manual surgical instrumentation for use with non-fusion spinous process spacer devices. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Orthopedic Devices; Classification of Orthopedic Manual Surgical Instrumentation for Use With Total Disc Replacement Devices

The Food and Drug Administration (FDA, the Agency, or we) is classifying orthopedic manual surgical instrumentation for use with total disc replacement devices into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of orthopedic manual surgical instrumentation for use with total disc replacement devices. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Listing of Color Additives Exempt From Certification; Calcium Phosphate; Confirmation of Effective Date

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.

Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms

The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the mutation detection test for myeloproliferative neoplasms. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Laparoscopic Gastrointestinal Sizing Tool

The Food and Drug Administration (FDA, the Agency, or we) is classifying the laparoscopic gastrointestinal sizing tool into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the laparoscopic gastrointestinal sizing tool. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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

This document updates compliance and other dates presented in the final rule that appeared in the December 13, 2024 Federal Register titled "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" to conform with the subsequent final rule that appeared in the February 11, 2025 Federal Register.

Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date

The Food and Drug Administration (FDA or we) is confirming the effective date of June 26, 2025, for the final order that appeared in the Federal Register of May 12, 2025. The final order amends the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive at levels consistent with good manufacturing practice (GMP) in: ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips.

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

The Food and Drug Administration (FDA, the Agency, or we) is classifying the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the multiplex respiratory panel to detect and identify emerging respiratory pathogen(s) and common respiratory pathogens in human clinical specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Cancer Predisposition Risk Assessment System

The Food and Drug Administration (FDA, the Agency, or we) is classifying the cancer predisposition risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the cancer predisposition risk assessment system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Radiology Devices; Classification of the Liver Iron Concentration Imaging Companion Diagnostic for Deferasirox

The Food and Drug Administration (FDA, the Agency, or we) is classifying the liver iron concentration imaging companion diagnostic for deferasirox into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the liver iron concentration imaging companion diagnostic for deferasirox. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Menopause Test System

The Food and Drug Administration (FDA, Agency, or we) is classifying the menopause test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the menopause test system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Device That Detects Nucleic Acid Sequences From Microorganisms Associated With Vaginitis and Bacterial Vaginosis

The Food and Drug Administration (FDA, the Agency, or we) is classifying the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device that detects nucleic acid sequences from microorganisms associated with vaginitis and bacterial vaginosis's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System

The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the postnatal chromosomal copy number variation detection system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Anti-Phospholipase A2 Receptor Immunological Test System

The Food and Drug Administration (FDA, the Agency, or we) is classifying the anti-phospholipase A2 receptor immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the anti-phospholipase A2 receptor immunological test system's classification. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System

The Food and Drug Administration (FDA, the Agency, or we) is classifying the pharmacogenetic assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the pharmacogenetic assessment system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Evonik Corporation; Filing of Food Additive Petition (Animal Use)

The Food and Drug Administration (FDA or we) is announcing that we have filed a food additive petition, submitted by Evonik Corporation, proposing that we amend our food additive regulations to provide for the safe use of Bacillus velezensis as a source of viable microorganism in animal food for all species.