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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Work . Rock Valley is a city of over 3,500 people located in extreme Northwest Iowa. It is a progressive, clean community in a rural setting. Our hardworking, well-educated, and friendly people make our community a special place to live and work. Rock Valley is located between two larger cities; Sioux City, Iowa and Sioux Falls, South Dakota. Our location offers residents the security and friendliness of small town living with big city attractions nearby. Rock Valley is located on U.S. Highway 18 with Interstate 29 and 90 nearby, offering easy transportation access to the surrounding areas.