AMENDMENTS TO THE ORPHAN DRUG GRANTS.

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.” .