Department of Health and Human Services November 22, 2024 – Federal Register Recent Federal Regulation Documents
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Orthopedic Non-Spinal Bone Plates, Screws, and Washers-Premarket Notification (510(k)) Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Orthopedic Non-Spinal Bone Plates, Screws, and WashersPremarket Notification (510(k)) Submissions." This guidance document provides recommendations for information to include in 510(k) submissions for non-resorbable bone plate, screw, and washer devices. The scope of this guidance includes devices that are indicated for orthopedic bone fixation but does not include devices indicated for spinal, mandibular, maxillofacial, cranial, and orbital fracture fixation.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Health Resources and Services Administration Uniform Data System
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.
Agency Information Collection Activities: Submission for OMB Review; 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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.
Agency Information Collection Activities: Proposed Collection; 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.
Notice of Purchased/Referred Care Delivery Area Redesignation for the Pokagon Band of Potawatomi Indians of Michigan and Indiana
Notice is hereby given that the Indian Health Service (IHS) has decided to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Pokagon Band of Potawatomi Indians of Michigan and Indiana ("Pokagon Band") to include the counties of Kalamazoo, Kent, and Ottawa in the State of Michigan. The final PRCDA for the Pokagon Band now includes the Michigan counties of Allegan, Berrien, Cass, Kalamazoo, Kent, Ottawa, and Van Buren, and the Indiana counties of Elkhart, Kosciusko, La Porte, Marshall, St. Joseph, and Starke. The sole purpose of this expansion is to authorize additional Pokagon Band members and beneficiaries to receive Purchased/ Referred Care (PRC) services.
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