The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures 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 mechanical deviation device for esophageal protection during cardiac ablation procedures. We are taking this action because we have determined that classifying the device

Original title: “Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures”

The Food and Drug Administration (FDA) is classifying the anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease 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 anti-tumor necrosis factor alpha monoclonal antibody test system for inflammatory bowel disease. We are taking this action because we have determined that classifyi

Original title: “Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease”

The Food and Drug Administration (FDA) is classifying the implanted tibial electrical urinary continence device 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 implanted tibial electrical urinary continence device. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and ef

Original title: “Medical Devices; Gastroenterology-Urology Devices; Classification of the Implanted Tibial Electrical Urinary Continence Device”

The Food and Drug Administration (FDA) is classifying the vaginal hydrogel packing 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 vaginal hydrogel packing system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this a

Original title: “Medical Devices; Radiology Devices; Classification of the Vaginal Hydrogel Packing System”

The Food and Drug Administration (FDA) is classifying the cooperative powered surgical assist device for ear, nose, and throat (ENT) surgery 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 cooperative powered surgical assist device for ENT surgery. We are taking this action because we have determined that classifying the device into class II will provide a reasona

Original title: “Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery”

Referred to the House Committee on Foreign Affairs.

Original title: “HR 10345: To require continued participation by the United States in the World Health Organization, and for other purposes.”

The Food and Drug Administration (FDA or the Agency) is announcing the fee rate for using a priority review voucher for fiscal year (FY) 2027. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, authorizes FDA to determine and collect priority review user fees for certain applications for review of human drug or biological products when those applications use a tropical disease, rare pediatric disease, or material threat medical countermeasure (MCM) priority review voucher. These vo

Original title: “Fee Rate for Using a Priority Review Voucher in Fiscal Year 2027”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 10349: To amend the Public Health Service Act to direct the Secretary of Health and Human Services to establish a Public Safety Mental Health Fellowship Program, and for other purposes.”

The Food and Drug Administration (FDA or we) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 2323) proposing that the food additive regulations be amended to provide for the safe use of hydrolyzed lignin as a source of neutral detergent soluble fiber in food for broiler chickens, laying hens, turkeys, growing swine, sows, lactating dairy cows, beef cattle, sheep, goats, salmonids, and adult dogs at no more than 1% of the food on a weight basis

Original title: “Green Innovation GmbH; Withdrawal of Food Additive Petition (Animal Use)”

The National Center for Advancing Translational Sciences (NCATS) will host a public online roundtable to share the latest updates on how NCATS is advancing translational science research and provide an opportunity for an interactive discussion with NCATS director Dr. Joni Rutter.

Original title: “National Center for Advancing Translational Sciences; Notice of Public Online Roundtable”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 1521: Honoring the 100th anniversary of the American Cleaning Institute and recognizing the contributions of the cleaning products industry to the health, safety, and economic vitality of the United States.”

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA

Original title: “Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANKTIVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ANKTIVA”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANZUPGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ANZUPGO”

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

Original title: “National Vaccine Injury Compensation Program; List of Petitions Received”

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ANDEMBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

Original title: “Determination of Regulatory Review Period for Purposes of Patent Extension; ANDEMBRY”

CDC has modified its structure. This notice announces the reorganization of the National Center for Immunization and Respiratory Diseases (NCIRD). NCIRD has consolidated offices, retitled divisions and branches, and modified mission and function statements.

Original title: “Reorganization of the National Center for Immunization and Respiratory Diseases”

Referred to the House Committee on Energy and Commerce.

Original title: “HRES 1514: Recognizing suicide as a serious public health problem, expressing support for the designation of September 8, 2026, as "988 Day" and the role of the 988 Suicide and Crisis Lifeline, and for other purposes.”

Referred to the Committee on Transportation and Infrastructure, and in addition to the Committees on the Judiciary, and Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Original title: “HRES 1515: Recognizing New Jersey's first responders, including its law enforcement officers, firefighters, and emergency medical personnel, who responded to the September 11, 2001, attacks at the World Trade Center and who carried out the rescue, recovery, and medical relief efforts in the days and months that followed.”