This bill amends the Federal Food, Drug, and Cosmetic Act to modify the exclusive approval or licensure period for drugs designated for rare diseases or conditions. Currently, orphan drug exclusivity prevents other drugs from being approved for the same rare disease or condition for a period of seven years. The proposed changes narrow this exclusivity to apply only to the specific approved use or indication within that rare disease or condition. This means that a drug would only have exclusive marketing rights for the particular use it was approved for, rather than blocking other drugs for different uses within the same rare disease. These amendments are intended to apply retroactively to all designated and approved orphan drugs, potentially fostering greater competition and access to treatments for various indications of rare diseases.