Sec. 3015. AMENDMENTS TO THE ORPHAN DRUG GRANTS
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## SEC. 3015 AMENDMENTS TO THE ORPHAN DRUG GRANTS Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended— ####
(1)in subsection (a), by striking paragraph
(1)and inserting the following: “(1) defraying the costs of developing drugs for rare diseases or conditions, including qualified testing expenses,”; and ####
(2)in subsection (b)(1)— #####
(A)in subparagraph (A)(ii), by striking “and” after the semicolon; #####
(B)in subparagraph (B), by striking the period and inserting “; and”; and #####
(C)by adding at the end the following: > > ##### “(C) > > prospectively planned and designed observational studies and other analyses conducted to assist in the understanding of the natural history of a rare disease or condition and in the development of a therapy, including studies and analyses to— > > > ###### “(i) > > develop or validate a drug development tool related to a rare disease or condition; or > > > ###### “(ii) > > understand the full spectrum of the disease manifestations, including describing genotypic and phenotypic variability and identifying and defining distinct subpopulations affected by a rare disease or condition.” > .
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Sec. 3015
AMENDMENTS TO THE ORPHAN DRUG GRANTS
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