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Code · BILL · 117th Congress · H.R. 7667 (Engrossed in House) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 404

Sec. 404. Reauthorization; reporting requirements

243 words·~1 min read·/bill/117/hr/7667/eh/section-404·

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Section 744I of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–53 ) is amended— in subsection (a)(1), by striking Beginning with fiscal year 2018, not and inserting Not ; by striking Biosimilar User Fee Amendments of 2017 each place it appears and inserting ; Biosimilar User Fee Amendments of 2022 in subsection (a)(2), by striking Beginning with fiscal year 2018, the and inserting The ; in subsection (a)(3)(A), by striking Not later than 30 calendar days after the end of the second quarter of fiscal year 2018, and not later than 30 calendar days after the end of each quarter of each fiscal year thereafter and inserting Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this part ; in subsection (b), by striking Not later than 120 days after the end of fiscal year 2018 and each subsequent fiscal year for which fees are collected under this part and inserting Not later than 120 days after the end of each fiscal year for which fees are collected under this part ; in subsection (c), by striking Beginning with fiscal year 2018, and for and inserting For ; and in subsection (f)— in paragraph (1), in the matter preceding subparagraph (A), by striking fiscal year 2022 and inserting fiscal year 2027 ; and in paragraph (3), by striking January 15, 2022 and inserting January 15, 2027 .
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  • 21 USC 379j–53
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Sec. 404
Reauthorization; reporting requirements
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