Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA research in obtaining information from medical specialty groups and/or medical experts regarding compounded drug products that contain certain bulk drug substances to support establishment of a list of bulk drug substances under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).