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Code · BILL · 117th Congress · S. 4535 (Introduced in Senate) — To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs,... · Sec. 204

Sec. 204. Reauthorization; reporting requirement

148 words·~1 min read·/bill/117/s/4535/is/section-204·

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Section 738A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(a) ) is amended— by striking fiscal year 2018 each place it appears and inserting fiscal year 2023 ; by striking Medical Device User Fee Amendments of 2017 each place it appears and inserting Medical Device User Fee Amendments of 2022 ; in paragraph (1)— in subparagraph (A), by redesignating the second clause
(iv)(relating to analysis) as clause (v); and in subparagraph (A)(iv) (relating to rationale for MDUFA program changes), by striking fiscal year 2020 and inserting fiscal year 2023 ; and in paragraph (4), by striking 2018 through 2022 and inserting 2023 through 2027 . Section 738A(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379j–1(b) ) is amended— in paragraph (1), by striking 2022 and inserting 2027 ; and in paragraph (5), by striking 2022 and inserting 2027 .
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  • 21 USC 379j–1(a)
  • 21 USC 379j–1(b)
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Sec. 204
Reauthorization; reporting requirement
Cite21 USC 379j–1(a)
Cite21 USC 379j–1(b)
Cites 2Cited by 0 across 0 sources
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