Department of Health and Human Services February 6, 2023 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
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.
Fiscal Year 2023 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2023 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2024 Generic Drug User Fee Amendments (GDUFA) science and research initiatives.
Determination of Regulatory Review Period for Purposes of Patent Extension; XIIDRA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XIIDRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Micro-Tracers, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Micro-Tracers, Inc., proposing that the food additive regulations be amended to permit the use of ethyl cellulose as a matrix scaffolding in tracers for use in feeds at no more than 0.09 grams per ton of feed (0.1 ppm).
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the recordkeeping requirements for manufacturers of medicated animal feeds.
Submission for OMB Review; 30-Day Comment Request; Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine)
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Determination of Regulatory Review Period for Purposes of Patent Extension; DOPTELET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DOPTELET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review; Public Workshop
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review.'' Convened by the Duke-Robert J. Margolis, MD Center for Health Policy and supported by a cooperative agreement between FDA and Duke-Margolis, the purpose of the public workshop is to understand the priorities for the development of Digital Health Technologies (DHTs) to support clinical drug trials, including accessibility, diversity, and clinical outcome measures using DHTs. Additionally, this public workshop meets a Prescription Drug User Fee Amendments (PDUFA VII) commitment to convene the first of a series of public workshops by the end of the second quarter (Q2), fiscal year (FY) 2023.
Determination That TRIAMCINOLONE ACETONIDE (Triamcinolone Acetonide) Topical Cream, 0.025% and 0.1%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Determination of Regulatory Review Period for Purposes of Patent Extension; OLUMIANT
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OLUMIANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. This Generic Clearance is designed to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Administration's commitment to improving service delivery.
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