Department of Health and Human Services

CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits

Medical Devices; Orthopedic Devices; Classification of the Medial Knee Implanted Shock Absorber

Health and Human Services Department, Food and Drug Administration | Rule | The Food and Drug Administration (FDA) is classifying the medial knee implanted shock absorber 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 medial knee implanted shock absorber. 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 device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

CW Claire Walsh

Jun 29 · 1 min

CABI U.S. Government Accountability Office · Audits audits

Innovation in Action: Bringing New Ideas to Life

This Scroll-Driven Narrative tells the story of how pharmaceutical companies and the federal government work together to turn ideas into innovative medical treatments. It is a companion to GAO’s report Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property, GAO-21-52. This product highlights key themes from GAO’s prior work—particularly the lack of publicly available information on licensing of intellectual property developed through National Institutes of Health (NIH) research. It also highlights recommendations from GAO’s prior work and NIH efforts to implement them. For more information, contact Candice N. Wright at [email protected].

EM Elena Martinez

Jun 26 · 1 min

CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits

Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection

Health and Human Services Department, Centers for Medicare & Medicaid Services | Proposed Rule | This request for information (RFI) solicits technical input on the services and business practices of pharmacy benefit managers ("PBMs") and their affiliates to inform implementation of recent legislation. It specifically focuses on gathering information to inform two specific legislative requirements that are effective beginning calendar year 2028: restrictions on the remuneration that PBMs and their affiliates may receive for services in connection with the utilization of covered Part D drugs; and data reporting requirements.

CW Claire Walsh

Jun 18 · 1 min

CABI Office of the Federal Register / National Archives and Records Administration · Rulemaking audits

Agency Information Collection Activities: Proposed Collection; Comment Request

Health and Human Services Department, Centers for Medicare & Medicaid Services | Notice | 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 collecti.

CW Claire Walsh

Jun 10 · 1 min

NIH National Institutes of Health · Healthcare healthcare

Center for Scientific Review; Amended Notice of Meeting

National Institutes of Health published a notice titled "Center for Scientific Review; Amended Notice of Meeting." TeamCog summarizes the official filing and links to the source record.

EM Elena Martinez

Jun 4 · 1 min