REAUTHORIZATION OF ORPHAN DRUG GRANTS.

SEC. 3107. REAUTHORIZATION OF ORPHAN DRUG GRANTS. Section 5 of the Orphan Drug Act (21 U.S.C. 360ee) is amended—(1) in subsection (a)—(A) by striking “and (3)” and inserting “(3)”; and (B) 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 (2) 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”.