The Food and Drug Administration (FDA) is classifying the prognostic test for assessment of chronic kidney disease progression 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 prognostic test for assessment of chronic kidney disease progression. We are taking this action because we have determined that classifying the device into class II will provide a reasonable

Original title: “Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Chronic Kidney Disease Progression”

The Food and Drug Administration (FDA) is classifying the diabetes digital behavioral therapeutic 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 diabetes digital behavioral therapeutic device. 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

Original title: “Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device”

The Food and Drug Administration (FDA) is classifying the intraoperative surgical angle measurement 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 classification of the intraoperative surgical angle measurement 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

Original title: “Medical Devices; Orthopedic Devices; Classification of the Intraoperative Surgical Angle Measurement Tool”

The Food and Drug Administration (FDA) is classifying the over-the-counter test to detect SARS-CoV-2 from 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 over-the-counter test to detect SARS-CoV-2 from clinical specimens. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assu

Original title: “Medical Devices; Immunology and Microbiology Devices; Classification of the Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens”

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 ethyl cellulose as a binder and coating on amino acids incorporated into food for ruminant animals.

Original title: “Evonik Corporation, Filing of Food Additive Petition (Animal Use)”

The National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is giving notice of the invention listed below, which is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies

Original title: “Government-Owned Inventions; Availability for Licensing”

The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Francis Esteban Matos for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Matos was convicted of a felony under Federal law. The factual basis supporting Mr. Matos's conviction, as described below, is conduct relating to the importation into the United States of a drug or

Original title: “Francis Esteban Matos: Final Debarment Order”

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is requesting a 3-year extension of the Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits. No changes are proposed to the data elements, but burden has been adjusted to reflect improved automation for processes.

Original title: “Proposed Information Collection Activity; Voluntary Acknowledgment of Paternity and Required Data Elements for Paternity Establishment Affidavits”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 9871: To name the Department of Veterans Affairs community-based outpatient clinic, Saint Thomas, United States Virgin Islands, as the "Sergeant First Class Floyd E. Lake Department of Veterans Affairs Community-Based Outpatient Clinic".”

Referred to the House Committee on Armed Services.

Original title: “HR 9865: To direct the Secretary of Defense to submit a report and establish standards on the timeliness of providing electronic health records to members of the Armed Forces separating from active duty, and for other purposes.”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: “HR 9844: To direct the Secretary of Health and Human Services to award grants to long-term care and post-acute care providers for purposes of developing and adopting health information technology.”

Referred to the Committee on Education and Workforce, and in addition to the Committee on 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: “HR 9839: To direct the Secretary of Health and Human Services to establish a grant program to, through subgrants to eligible entities, improve certain impacts of participation in programs related to physical activity or youth sports and increase access to youth sports, and for other purposes.”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 9862: To direct the Secretary of Veterans Affairs to seek to enter into an agreement with a federally funded research and development center for the conduct of an independent evaluation of artificial intelligence systems in use by the Veterans Health Administration, and for other purposes.”

Referred to the House Committee on Armed Services.

Original title: “HR 9863: To direct the Director of the Defense Health Agency to submit to Congress a report on the feasibility of establishing a pilot program that establishes a behavioral neurology fellowship program to provide training opportunities with respect to treating members of the Armed Forces and veterans with traumatic brain injuries.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 9866: C.A.R.E. for Mental Health Professionals Act”

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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: “HR 9891: To direct the Secretary of Health and Human Services to conduct a demonstration program to share savings with plans that invest in preventing the progression of kidney disease to end-stage renal disease.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 9842: To amend the Public Health Service Act to authorize grants to establish and maintain State offices of women's health, and for other purposes.”

Referred to the House Committee on Armed Services.

Original title: “HR 9864: To amend title 10, United States Code, to direct the Secretary of Defense to include on a website of the Department of Defense certain information with respect to a patient booking an appointment for health care provided under the TRICARE program at a military medical treatment facility, and for other purposes.”