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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. 1

Sec. 1. Short title; table of contents

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

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This Act may be cited as the or the Food and Drug Administration Simple Reauthorization Act of 2022 . FDASRA Act of 2022 The table of contents for this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—Fees relating to drugs Sec. 101. Short title; finding. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Reauthorization; reporting requirement. Sec. 105. Sunset dates. Sec. 106. Effective date. Sec. 107. Savings clause. TITLE II—Fees relating to devices Sec. 201.
Short title; finding. Sec. 202. Definitions. Sec. 203. Authority to assess and use device fees. Sec. 204. Reauthorization; reporting requirement. Sec. 205. Accreditation programs. Sec. 206. Sunset dates. Sec. 207. Effective date. Sec. 208. Savings clause. TITLE III—Fees relating to generic drugs Sec. 301. Short title; finding. Sec. 302. Authority to assess and use human generic drug fees. Sec. 303. Reauthorization; reporting requirements. Sec. 304. Sunset dates. Sec. 305. Effective date.
Sec. 306. Savings clause. TITLE IV—Fees relating to biosimilar biological products Sec. 401. Short title; finding. Sec. 402. Definitions. Sec. 403. Authority to assess and use biosimilar biological product fees. Sec. 404. Reauthorization; reporting requirements. Sec. 405. Sunset dates. Sec. 406. Effective date. Sec. 407. Savings clause. TITLE V—Other reauthorizations Sec. 501. Reauthorization of the critical path public-private partnership. Sec. 502. Reauthorization of the best pharmaceuticals for children program.
Sec. 503. Reauthorization of the humanitarian device exemption incentive. Sec. 504. Reauthorization of the pediatric device consortia program. Sec. 505. Reauthorization of provision pertaining to drugs containing single enantiomers. Sec. 506. Reauthorization of orphan drug grants. Sec. 507. Reauthorization of certain device inspections.
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