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FEDERAL FOOD, DRUG, AND COSMETIC ACT
CHAPTER VII - GENERAL AUTHORITY
SUBCHAPTER C - FEES
§ 736. [379h] AUTHORITY TO ASSESS AND USE DRUG FEES
(a)(1)(E): EXCEPTION FOR DESIGNATED ORPHAN DRUG OR INDICATION.-- A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 526 shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 526 as a drug for a rare disease or condition with regard to the indication proposed in such supplement.