Department of Health and Human Services May 24, 2023 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; ENSPRYNG; Correction
The Food and Drug Administration (FDA or the Agency) is correcting a notice that appeared in the Federal Register of July 13, 2022. The document determined the regulatory review period for ENSPRYNG. After review of a timely request for reconsideration by the applicant of the calculation of the applicable regulatory review period of the biologic product ENSPRYNG in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments; Correction
The Food and Drug Administration is correcting a final rule entitled ``Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments'' that appeared in the Federal Register of March 24, 2023. The final rule corrected typographical errors, corrected errors in sample labels, restored inadvertent omissions, and updated office and organization names, addresses, and other references. The document was published with an incorrect abbreviation to ``Potassium'' in the codified language. This document corrects that error.
Health Information Technology Advisory Committee 2023 Schedule of Meetings
The Health Information Technology Advisory Committee (HITAC) was established in accordance with the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2023. See list of public meetings below.
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