definiens: means ( i ) a disease or condition for which the in tended drug affects fewer than 200,000 people in th eUnited States or, if the drug is a vaccine, diagnos tic drug, or preventive drug, the persons to whom t he drug will beadministered in the United States are fewer than 20 0,000 per year as specified in Sec . 316.21(b ) of th e Federal Food, Drug and Cosmetic Act ( the ), or ( ii ) a diseases or conditions affecting 200, 000 or more people, or for a vaccine, 95 diagnostic drug, or preventive drug to be administe red to 200,000 or more persons per year in the Unit ed States, thereis no reasonable expectation that costs of research and development of the drug for the indication can be recoveredby sales of the drug in the United States as specif ied in Sec . 316.21(c ) of the Act