Department of Health and Human Services December 29, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities: Proposed Collection: Public Comment Request SHIP COVID-19 Testing and Mitigation Program Data Collection
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.
Most Favored Nation (MFN) Model
This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Transcutaneous Electrical Continence Device
The Food and Drug Administration (FDA or we) is classifying the transcutaneous electrical continence device 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 the transcutaneous electrical continence device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Lallemand Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Lallemand Inc., proposing that the food additive regulations be amended to provide for the safe use of vitamin D2 heat-killed (``inactive'') baker's yeast as a source of vitamin D2 in specific food categories.
Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
The Food and Drug Administration (FDA or we) is classifying the diagnostic neurosurgical microscope filter 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 the diagnostic neurosurgical microscope filter's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of October 5, 2021, for the final rule that appeared in the Federal Register of September 2, 2021, and that amended the color additive regulations to provide for the safe use of butterfly pea flower extract in various food categories at levels consistent with good manufacturing practice.
Listing of Color Additives Exempt From Certification; Silver Nitrate; Confirmation of Effective Date
The Food and Drug Administration (FDA or we) is confirming the effective date of November 8, 2021, for the final rule that appeared in the Federal Register of October 6, 2021, and that amended the color additive regulations to provide for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes.
Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
The Food and Drug Administration (FDA or we) is classifying the cerebrospinal fluid shunt 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 the cerebrospinal fluid shunt system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
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