The Food and Drug Administration (FDA) is classifying the Spinal Muscular Atrophy newborn screening 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 Spinal Muscular Atrophy newborn screening 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 effect

Original title: “Medical Devices; Immunology and Microbiology Devices; Classification of the Spinal Muscular Atrophy Newborn Screening Test System”

The Food and Drug Administration (FDA, the Agency, or we) is extending the comment period for the notice entitled "Drug Repurposing for Unmet Medical Needs; Request for Information" that appeared in the Federal Register of May 12, 2026 (91 FR 25897). In the notice, FDA requested comments to solicit input on FDA's efforts with respect to drug repurposing to address unmet medical needs. The Agency is taking this action to allow interested persons additional time to submit comments.

Original title: “Drug Repurposing for Unmet Medical Needs; Request for Information; Extension of Comment Period”

The Food and Drug Administration (FDA) is classifying the simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings 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 simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings. We are taking thi

Original title: “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”

The Office of the Assistant Secretary for Health (OASH) is seeking nominations for membership on the Presidential Advisory Council on HIV/AIDS (referred to as PACHA and/or the Council). The PACHA is a federal advisory committee within the U. S. Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the Office of the Assistant Secretary for Health (OASH). The qualified individuals will be nominated by the Secretary of the U.S.

Original title: “Solicitation of Nominations for Membership on the Presidential Advisory Council on HIV/AIDS”

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the request for information and comments that appeared in the Federal Register of March 3, 2026. In the notice, FDA requested comments on the Agency's series of guidances for industry on scale-up and postapproval changes for specific dosage forms. The Agency is taking this action to allow interested persons additional time to submit comments.

Original title: “Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments; Reopening of the Comment Period”

Referred to the House Committee on Education and Workforce.

Original title: “HR 9305: Juice for Healthy Families Act of 2026”

The Administration for Children, Youth and Families in the U.S. Department of Health and Human Services (HHS) is requesting a three-year extension of the National Child Abuse and Neglect Data System (NCANDS) collection (OMB#0970-0424, expiration 07/31/2026). There are no changes requested to this data collection.

Original title: “Submission for Office of Management and Budget Review; National Child Abuse and Neglect Data System”

Referred to the House Committee on Veterans' Affairs.

Original title: “HR 9212: To amend title 38, United States Code, to reimburse veterans for the cost of emergency medical transportation to a Federal facility, and for other purposes.”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 3260: Mental Health Improvement Act”

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Original title: “S 2121: SUPPORT for Patients and Communities Reauthorization Act of 2025”

This notice announces the application of the Commission on Laboratory Accreditation (COLA) for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program for the specialty of Histocompatibility. We have determined that COLA meets or exceeds the applicable CLIA requirements. Consequently, we are granting COLA deeming authority for the specialty of Histocompatibility for a period of 5 years.

Original title: “Announcement of the Approval of COLA as an Accreditation Organization for the Specialty of Histocompatibility Under the Clinical Laboratory Improvement Amendments of 1988”

The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus 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 combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device in

Original title: “Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus”

Thanks to President Trump's leadership, since 2017, the country has made significant progress in addressing mental health and substance use. However, President Trump and HHS Secretary Kennedy realize that the Department and country have more work to do. To facilitate this effort, HHS invites public comment in response to this RFI on the research, development, programs, and policies that have been most successful in improving availability of and access to effective prevention, treatment, and reco

Original title: “HHS Request for Comment on Chronic Disease of Addiction”

In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the final administrative order (final order) (OTC000039) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information." This final order amends "Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" (OTC Monograph M020) to add bemotriz

Original title: “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled 2026 Andes Hantavirus Cruise Passenger and Traveler Contact Monitoring. This informati

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled the National Death Index (NDI). The NDI allows NCHS to collect mortality data to sup

Original title: “Proposed Data Collection Submitted for Public Comment and Recommendations”

Original title: “Agency Forms Undergoing Paperwork Reduction Act Review”

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services intends to request approval from the Office of Management and Budget (OMB) for extension of an approved generic clearance to request information from potential participants at ACF gatherings, such as meetings or conferences. The current expiration date is September 30, 2026. Burden estimates have been updated to reflect agency plans over the next three years.

Original title: “Proposed Information Collection Activity; Administration for Children and Families Generic for Information Collections Related to Gatherings”

Referred to the House Committee on Energy and Commerce.

Original title: “HR 9190: To amend the Federal Food, Drug, and Cosmetic Act to authorize the use of investigational individualized medical treatments by patients diagnosed with a life-threatening disease or condition or severely debilitating illness, and for other purposes.”