Department of Health and Human Services March 14, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Hoffmann-La Roche, Inc., et al.; Withdrawal of Approval of Two New Drug Applications; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 18, 2023. The document announced the withdrawal of approval of two new drug applications (NDA), withdrawn as of January 17, 2024. The document indicated that FDA was withdrawing approval of NDA 022424, FLOWTUSS (guaifenesin 200 milligrams (mg)/5 milliliters (mL) and hydrocodone bitartrate 2.5 mg/5 mL) Oral Solution held by Chartwell RX Sciences, LLC, 77 Brenner Dr., Congers, NY 10920. Before FDA withdrew the approval of this NDA, Chartwell RX Sciences, LLC informed FDA that it did not want the approval of the NDA withdrawn. Because Chartwell RX Sciences, LLC timely requested that approval of NDA 022424 not be withdrawn, the approval is still in effect. This notice corrects that error.
Determination of Regulatory Review Period for Purposes of Patent Extension; CIBINQO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CIBINQO 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.
Agency Information Collection Request. 30-Day Public Comment Request
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment, Improving Customer Experience (OMB Circular A-11, Section 280 Implementation).
National Institute for Occupational Safety and Health; Outdoor Workers Exposed to Wildland Fire Smoke; Request for Information
The Centers for Disease Control and Prevention's (CDC) National Institute for Occupational Safety and Health (NIOSH), in the Department of Health and Human Services, announces an opportunity for the public to provide information about approaches to assess and control the hazards of wildland fire smoke to outdoor workers. Wildland fire smoke is a complex mixture of potentially toxic gases and particles that can vary depending on factors in the wildland or wildland urban interface environment, such as weather, fire behavior, and the type of materials or vegetation burning. Because of this, outdoor workers may be exposed to varying types and amounts of compounds in wildland fire smoke throughout their work shift or during different fire events and job tasks. NIOSH is seeking information to develop a hazard review document that summarizes the scientific literature about the health effects from exposures to wildland fire smoke and provides recommendations to protect outdoor workers.
Determination of Regulatory Review Period for Purposes of Patent Extension; VTAMA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VTAMA 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; PYRUKYND
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PYRUKYND 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 patents which claim that human drug product.
Proposed Collection; 60-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development)
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institutes of Health will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
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. The information collection activities provide a means to garner qualitative customer and stakeholder feedback in an efficient, timely manner, in accordance with the Federal Government's commitment to improving service delivery.
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the existing E2D guidance entitled ``E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,'' published in 2003. The draft guidance is intended is to clarify the use of new or increasingly used data sources (e.g., social media, market research programs, patient support programs) and update terminology and standards for postmarket adverse event reporting.
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