re the sponsor of a drug that is otherwise the same drug as an already approved orphan drug seeks the designation for the drug for the same conditions, an explanation of why the proposed variation may be clinically superior to the first. 6. Where a drug is under the development for only a subset of people with a specific disease or condition, a demonstration that the subset is medically plausible. 7. A summary of the regulatory status and marketing history of the drug in the United States and in foreign countries. 8. Documentation, with appended authoritative references, to demonstrate that: The disease or condition for which the drug is intended affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug, or preventive drug, the people who the drug will be given to inn the United States are fewer than 200,000 people. 9. A statement to whether the sponsor submitting the request is the real party in interest of the development and the intended or actual production and sales of the product. ...
