Department of Health and Human Services March 1, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) (jointly, we) are announcing the withdrawal of the proposed rule entitled ``General Principles and Food Standards Modernization,'' which published in the Federal Register of May 20, 2005. FDA and FSIS are taking this action in response to comments received in 2005 and in 2020 after FDA reopened the comment period for the proposed rule.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug Products.'' The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and life-cycle management of CM. The guidance replaces the draft guidance entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug Products'' issued on October 14, 2021. This guidance also replaces the draft guidance entitled ``Quality Considerations for Continuous Manufacturing'' issued on February 27, 2019.

The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for upcoming vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYZULTA 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.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is announcing publication of a discussion paper providing information for stakeholders and soliciting public comments on a specific area of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including CDER and the Center for Biologics Evaluation and Research (CBER) stakeholders.