each request in the form and containing the information required in paragraph (B) of this section. A sponsor may request orphan drug designation of a previously unapproved drug, or of a new orphan indication for an already marketed drug. In addition, a sponsor of a drug that is otherwise the same drug as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent for the same rare disease or condition if it can be present or plausible hypothesis that its drug may be clinically superior to the first drug. More than one sponsor may receive orphan drug designation of the same drug for the same rare disease or condition, but each sponsor seeking orphan drug designation must file a complete request for the designation as provided in paragraph (B). B. A sponsor shall submit 2 copies of a completed, dated, and signed request for a designation that contains the following:1. A statement that the sponsor requests orphan drug designation for a rare disease or condition, which shall be identified with specifically.2. The name and address of the sponsor; the name of the sponsor’s primary contact person and/or resident agent including title, address, and telephone number; the generic and trade name, if any, of the drug or drug product; and the name and address of the source of the drug if it is not manufactured by the sponsor.3. A description of the rare disease or condition for which the drug is being or will be investigated, the proposed indication/s for use of the drug, and the reasons why such therapy is needed. 4. A description of the drug and a discussion of the scientific rationale for the use of the drug for the rare disease or condition, including all data from non-clinical laboratory studies, clinical investigations, and other relevant data that are available to the sponsor, whether positive, negative, or inconclusive. Copies of the pertinent unpublished and published papers are also required. 5. Whe...
