🏥Extension of Expiration Dates for Disability Listings by SSA
We are extending the expiration dates of the following body systems in the Listing of Impairments (listings) in our regulations: Low Birth Weight and Failure to Thrive, Musculoskeletal Disorders, Special Senses and Speech, Respiratory Disorders, Cardiovascular System, Genitourinary Disorders, Hematological Disorders, Endocrine Disorders, Congenital Disorders That Affect Multiple Body Systems, Neurological Disorders, Mental Disorders, Cancer (Malignant Neoplastic Diseases), and Immune System Disorders. We are making no other revisions to these body systems in this final rule. This extension ensures that we will continue to have the criteria we need to evaluate impairments in the affected body systems at step three of the sequential evaluation processes for initial claims and continuing disability reviews.
Learn More💉National Vaccine Injury Compensation Program Petitions Notice
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.
Learn More🏥Medicare Town Hall Meeting for FY 2027 New Technology Payments
This notice announces a town hall meeting in accordance with section 1886(d)(5)(K)(viii)(III) of the Social Security Act (the Act) to discuss fiscal year (FY) 2027 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this virtual meeting to present their comments, recommendations, and data regarding whether the FY 2027 applications for new technology add- on payments meet the substantial clinical improvement criterion.
Learn More📊Proposed HCUP Data Collection Notice and Business Implications
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the reinstatement with change of the currently approved information collection project "Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP)," OMB #0935-0206. This information collection was previously published in the Federal Register on April 30, 2025 and allowed 60 days for public comment. AHRQ received no comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.
Learn More💉FDA Guidance on Therapeutic Protein Biosimilars
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." This guidance describes the Agency's recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance "Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product" issued on April 30, 2015.
Learn More🧪CDC Requests Comments on Drug Susceptibility Testing Program
The CDC has submitted an information collection request for the Model Performance Evaluation Program related to Mycobacterium tuberculosis drug susceptibility testing. This initiative aims to enhance the quality of testing practices among U.S. laboratories. The program is designed to provide evaluations that help optimize laboratory capabilities in identifying drug-resistant tuberculosis strains, thereby informing continuous program improvement.
Learn More🏥NIH Clinical Center Meeting Notice
The Department of Health and Human Services has announced a hybrid meeting of the NIH Clinical Center Research Hospital Board. This event will cover leadership announcements and updates from the Clinical Center, focusing on its strategic activities and priority areas, and is open to public participation to foster stakeholder engagement.
Learn More🏥CDC Seeks Input on CAUTI Surveillance for SCI-NB Patients
The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (HHS), is seeking information regarding Catheter-associated Urinary Tract Infections (CAUTIs) among patients with Spinal Cord Injury-associated Neurogenic Bladder (SCI- NB). We want to understand better the burden of CAUTIs among this patient population and any implications related to reporting within the CDC National Healthcare Safety Network (NHSN) device-associated urinary tract infection (UTI) event module. This docket provides an opportunity for professionals who work with this patient population, as well as those who conduct NHSN UTI surveillance, to offer feedback related to our approach.
Learn More🏥Regulatory Update
This notice extends the comment period for a 60-day notice request for proposed information collection request associated with the notice [Document Identifier: CMS-855S] entitled "Medicare Enrollment Application: Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Suppliers." and published in the August 18, 2025 (90 FR 40073) Federal Register. The comment period for the information collection request, which would have ended on June 20, 2025, is extended to Monday, July 7, 2025.
Learn More🩺Medicaid and CHIP Information Collection Proposed Comments - 2025
On May 28, 2010, the Office of Management and Budget (OMB) issued Paperwork Reduction Act (PRA) guidance related to the "generic" clearance process. Generally, this is an expedited process by which agencies may obtain OMB's approval of collection of information requests that are "usually voluntary, low-burden, and uncontroversial collections," do not raise any substantive or policy issues, and do not require policy or methodological review. The process requires the submission of an overarching plan that defines the scope of the individual collections that would fall under its umbrella. This Federal Register notice seeks public comment on one or more of our collection of information requests that we believe are generic and fall within the scope of the umbrella. Interested persons are invited to submit comments regarding our burden estimates or any other aspect of this collection of information, including: the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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