A sponsor seeking orphan designation for a drug must submit a request for designation to OOPD with the information required in 21 CFR 316.20 and 316.21. Each designation request must stand on its own merit.afety and effectiveness of a drug must be established through adequate and well-controlled studies. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (âdrugâ) to treat a rare disease or condition upon request of a sponsor.
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Sponsored Topics. Ozark, incorporated in 1890, is a city in Christian County, Missouri, United States. The population was 9,665 at the 2000 census. As of 2009 the population has grown 18,458. It is the county seat of Christian County. Ozark is part of the Springfield, Missouri Metropolitan Statistical Area.