Department of Health and Human Services January 27, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) is announcing the following virtual public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The purpose of the virtual public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Revising ANDA Labeling Following Revision of the RLD Labeling.'' This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This draft guidance revises the guidance for industry entitled ``Revising ANDA Labeling Following Revision of the RLD Labeling'' issued in April 2000.

The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (DDC Feb. 2, 2021), has postponed the effectiveness of portions of the final rulemaking amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021. Those provisions are now effective April 18, 2022.

The Food and Drug Administration (FDA, the Agency or we) is evaluating substances that have been nominated for inclusion on a list of bulk drug substances (i.e., active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B Bulks List can qualify for certain exemptions from the Federal Food, Drug, and Cosmetic Act (FD&C Act) provided certain conditions are met. This notice identifies four bulk drug substances that FDA has considered and is including on the list at this time: Diphenylcyclopropenone (DPCP) for topical use only, glycolic acid for topical use only in concentrations up to 70 percent, squaric acid dibutyl ester (SADBE) for topical use only, and trichloroacetic acid (TCA) for topical use only. This notice also identifies eight bulk drug substances that FDA has considered and is not including on the list at this time: diazepam, dipyridamole, dobutamine hydrochloride (HCl), dopamine HCl, edetate calcium disodium, folic acid, glycopyrrolate, and sodium thiosulfate (except for topical administration). Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future notices.