Sec. 5. Grants and contracts for development of drugs for rare diseases and conditions
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Section 5(a) of the Orphan Drug Act ( 21 U.S.C. 360ee(a) ) is amended— in paragraph (2), by striking and at the end; and by inserting before the period at the end , and
(4)developing practices pertaining to the chemistry, manufacturing, regulatory approval of, and controls of individualized therapies or therapies to treat very small populations . In supporting grants and contracts under section 5(a)(4) of the Orphan Drug Act, as added by subsection (a), the Secretary of Health and Human Services shall consult with the Director of the Intercenter Institute on Rare Diseases and Conditions regarding the Accelerating Lifesavings Therapies in Treating Ultra-rare Disease Entities Program established under section 529B(b) of the Federal Food, Drug, and Cosmetic Act, as added by section 3(c) of this Act, to— identify the regulatory science and related challenges and needs associated with developing individualized therapies or therapies to treat very small patient populations; and support research to address such challenges.
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Sec. 5
Grants and contracts for development of drugs for rare diseases and conditions
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