🏥Proposed CMS Information Collection Activities - Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send 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.
Learn More🏥HHS Modifies OASIS System of Records Requirements for Home Health Agencies
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), titled "Home Health Agency (HHA) Outcome and Assessment Information Set (OASIS)," System No. 09-70-0522. This system of records covers information about patients receiving home health services from a Medicare and/or Medicaid approved HHA. Home health agencies required to comply with Medicare Conditions of Participation (CoP) are now mandated to collect OASIS on patients with any payer source, instead of just patients with Medicare/Medicaid pay sources. The amended System of Records Notice (SORN) includes other modifications which are explained in the Supplementary Information section, below.
Learn More📄NIH Notice on Certificates of Confidentiality Information Collection
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Office of Extramural Research (OER), in the Office of the Director (OD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Learn More💰NIH Notice on Closed Meetings and Grant Evaluation Opportunities
The Department of Health and Human Services announces closed meetings by the Center for Scientific Review to evaluate grant applications across various health and scientific disciplines. These virtual meetings aim to review proposals focusing on critical topics such as population health sciences and Alzheimer’s research, emphasizing confidentiality in the evaluation process.
Learn More💰Proposed Updates to ESRD Payment System Impacting Business
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2026. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update requirements for the ESRD Quality Incentive Program and to terminate and modify requirements for the ESRD Treatment Choices Model.
Learn More📉Proposed Rule to Remove COVID-19 Recordkeeping in Healthcare
OSHA is proposing to remove OSHA's COVID-19 Emergency Temporary Standard and its associated recordkeeping and reporting provisions from the Code of Federal Regulations.
Learn More🏥HRSA Data Collection Notice for Organ Procurement and Transplantation
In compliance with of the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.
Learn More💊FDA Seeks Input on Generic Drug User Fees for 2028-2032
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that interested parties, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for Fiscal Years (FYs) 2028-2032. At the end of September 2027, new legislation will be required for FDA to continue collecting generic drug user fees for subsequent fiscal years for the generic drug program. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA consult with a range of interested parties in developing recommendations for the next GDUFA program. The FD&C Act also requires that FDA hold continued discussions with patient and consumer advocacy groups at least monthly during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent representation by interested parties.
Learn More💵Overview of COVID-19 Provider Relief Fund Reporting Requirements
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Learn More⚕️FDA Modifications to Recognized Standards on Medical Devices
The Food and Drug Administration (FDA or the Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled "Modifications to the List of Recognized Standards, Recognition List Number: 064" (Recognition List Number: 064), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
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