Sec. 3107. Reauthorization of orphan drug grants

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Section 5 of the Orphan Drug Act ( 21 U.S.C. 360ee ) is amended— in subsection (a)— by striking and

(3)and inserting

(3); and by inserting before the period at the end the following: , and

(4)developing regulatory science pertaining to the chemistry, manufacturing, and controls of individualized medical products to treat individuals with rare diseases or conditions ; and in subsection (c), by striking $6,328,767 for the period beginning on October 1, 2022, and ending on December 23, 2022 and inserting $30,000,000 for each of fiscal years 2023 through 2027 .

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U.S. Code

Grants and contracts for development of drugs for rare diseases and conditions
§ 360ee

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Sec. 3107

Reauthorization of orphan drug grants

U.S.C.§ 360ee

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