An act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.

United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng PLAW Bills and Statutes An act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes.;Food and Drug Administration Safety and Innovation Act;Public Law 112-144; 112_cong_public_laws legislative 2012-08-22 S. 3187, 112th Congress S. 3187, 112th Congress An act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and medical devices, to establish user-fee programs for generic drugs and biosimilars, and for other purposes. Food and Drug Administration Safety and Innovation Act Public Law 112-144 U.S. Government Printing Office 2012-07-09 monographic deposited born digital 140 digital object pages AE 2.110: AE 2.110/3: AE 2.110:112-144 https://www.govinfo.gov/app/details/PLAW-112publ144 P0b002ee183442ded 000524864 f:publ144_112 DGPO 2012-08-22 2026-01-03 PLAW-112publ144 machine generated eng fdlp PUBLIC PLAW-112publ144 112 144 Food and Drug Administration Safety and Innovation Act true LEGISLATIVE HISTORY--S. 3187: CONGRESSIONAL RECORD, Vol. 158 (2012): May 23, 24, considered and passed Senate. June 20, considered and passed House, amended. June 21, 25, 26, Senate considered and concurred in House amendment.

U.S. Government Printing Office 2012-07-09 monographic deposited born digital 140 p. AE 2.110: AE 2.110/3: AE 2.110:112-144 P0b002ee183442ded https://www.govinfo.gov/app/details/PLAW-112publ144 f:publ144_112 Public Law 112-144 https://www.govinfo.gov/app/details/PLAW-112publ144 https://www.govinfo.gov/content/pkg/PLAW-112publ144/html/PLAW-112publ144.htm https://www.govinfo.gov/content/pkg/PLAW-112publ144/pdf/PLAW-112publ144.pdf fdlp DGPO 2012-08-22 2026-01-03 PLAW-112publ144 machine generated eng PUBLIC PLAW-112publ144 112 144 Food and Drug Administration Safety and Innovation Act true LEGISLATIVE HISTORY--S. 3187: CONGRESSIONAL RECORD, Vol. 158 (2012): May 23, 24, considered and passed Senate. June 20, considered and passed House, amended. June 21, 25, 26, Senate considered and concurred in House amendment.

United States Senate Bill 3187 (112th Congress) S. 3187 112 side note United States Senate Bill 3187 (112th Congress) S. 3187 112 legislative history United States Code Title 5 Section 552a Title 5 Section 552 Title 5 Section 552(b) Title 5 Section 552(b)(4) Title 5 Chapter 5 5 U.S.C. 552a 5 U.S.C. 552 5 U.S.C. 552(b) 5 U.S.C. 552(b)(4) 5 U.S.C. Chapter 5 United States Code Title 18 Section 1905 Title 18 Section 202 Title 18 Section 208 Title 18 Section 208(a) Title 18 Section 208(b)(1) Title 18 Section 2320 Title 18 Section 2320(a) Title 18 Section 2320(a)(4) Title 18 Section 2320(b)(3) Title 18 Section 2320(f) Title 18 Section 3553(a)(2) 18 U.S.C. 1905 18 U.S.C. 202 18 U.S.C. 208 18 U.S.C. 208(a) 18 U.S.C. 208(b)(1) 18 U.S.C. 2320 18 U.S.C. 2320(a) 18 U.S.C. 2320(a)(4) 18 U.S.C. 2320(b)(3) 18 U.S.C. 2320(f) 18 U.S.C. 3553(a)(2) United States Code Title 19 Section 1498(a)(1) 19 U.S.C. 1498(a)(1) United States Code Title 21 Section 301et seq. Title 21 Section 321 Title 21 Section 321(g) Title 21 Section 321(h) Title 21 Section 331 Title 21 Section 331et seq. Title 21 Section 333(b) Title 21 Section 334 Title 21 Section 335a(g) Title 21 Section 351 Title 21 Section 351(f) Title 21 Section 351(k)(3) Title 21 Section 351et seq. Title 21 Section 352 Title 21 Section 352(o) Title 21 Section 353(b)(1) Title 21 Section 355-1(g) Title 21 Section 355-1(h)(2)(A) Title 21 Section 355a Title 21 Section 355a(k) Title 21 Section 355a(l)(1) Title 21 Section 355c Title 21 Section 355c(f)(6) Title 21 Section 355c(f)(6)(D) Title 21 Section 355d Title 21 Section 355 Title 21 Section 355(b) Title 21 Section 355(c) Title 21 Section 355(d) Title 21 Section 355(j) Title 21 Section 355(j)(5)(D)(i)(IV) Title 21 Section 355(j)(7)(A)(iii) Title 21 Section 355(q) Title 21 Section 355(q)(1)(G) Title 21 Section 355(u)(1)(A)(ii)(II) Title 21 Section 355(u)(4) Title 21 Section 356b Title 21 Section 356c Title 21 Section 356 Title 21 Section 356(a) Title 21 Section 356(a)(1) Title 21 Section 360aaet seq. Title 21 Section 360bbb-5 Title 21 Section 360bbb Title 21 Section 360bbbet seq. Title 21 Section 360bb Title 21 Section 360b Title 21 Section 360c(a)(3)(D) Title 21 Section 360c(e)(1) Title 21 Section 360c(e)(2) Title 21 Section 360c(f) Title 21 Section 360c(f)(2) Title 21 Section 360c(i)(1)(D) Title 21 Section 360d(a)(1) Title 21 Section 360 Title 21 Section 360(h) Title 21 Section 360(j) Title 21 Section 360(n) Title 21 Section 360(p) Title 21 Section 360e-1(a)(2) Title 21 Section 360e Title 21 Section 360e(c)(4)(A) Title 21 Section 360ee(b)(1)(A)(ii) Title 21 Section 360ee(c) Title 21 Section 360g Title 21 Section 360g(a)(1) Title 21 Section 360h Title 21 Section 360i Title 21 Section 360i(f) Title 21 Section 360j(b) Title 21 Section 360j(g) Title 21 Section 360j(m) Title 21 Section 360j(m)(6)(A)(iv) Title 21 Section 360l Title 21 Section 360m(b)(2) Title 21 Section 360m(c) Title 21 Section 371(h)(1) Title 21 Section 371et seq. Title 21 Section 374(a) Title 21 Section 374(g)(11) Title 21 Section 379d-1 Title 21 Section 379 Title 21 Section 379fet seq. Title 21 Section 379g Title 21 Section 379g(1)(B) Title 21 Section 379h-2 Title 21 Section 379h Title 21 Section 379i Title 21 Section 379iet seq. Title 21 Section 379j-1(a) Title 21 Section 379j-1(b) Title 21 Section 379j Title 21 Section 379j(a) Title 21 Section 379j(b) Title 21 Section 379j(c) Title 21 Section 379j(h)(1)(A) Title 21 Section 379j(i) Title 21 Section 379ket seq. Title 21 Section 381 Title 21 Section 381(a) Title 21 Section 381et seq. Title 21 Section 383(c) Title 21 Section 393a Title 21 Section 739i Title 21 Section 739j-1 Title 21 Section 811(h)(2) Title 21 Section 812(c) Title 21 Section 826 21 U.S.C. 301et seq. 21 U.S.C. 321 21 U.S.C. 321(g) 21 U.S.C. 321(h) 21 U.S.C. 331 21 U.S.C. 331et seq. 21 U.S.C. 333(b) 21 U.S.C. 334 21 U.S.C. 335a(g) 21 U.S.C. 351 21 U.S.C. 351(f) 21 U.S.C. 351(k)(3) 21 U.S.C. 351et seq. 21 U.S.C. 352 21 U.S.C. 352(o) 21 U.S.C. 353(b)(1) 21 U.S.C. 355-1(g) 21 U.S.C. 355-1(h)(2)(A) 21 U.S.C. 355a 21 U.S.C. 355a(k) 21 U.S.C. 355a(l)(1) 21 U.S.C. 355c 21 U.S.C. 355c(f)(6) 21 U.S.C. 355c(f)(6)(D) 21 U.S.C. 355d 21 U.S.C. 355 21 U.S.C. 355(b) 21 U.S.C. 355(c) 21 U.S.C. 355(d) 21 U.S.C. 355(j) 21 U.S.C. 355(j)(5)(D)(i)(IV) 21 U.S.C. 355(j)(7)(A)(iii) 21 U.S.C. 355(q) 21 U.S.C. 355(q)(1)(G) 21 U.S.C. 355(u)(1)(A)(ii)(II) 21 U.S.C. 355(u)(4) 21 U.S.C. 356b 21 U.S.C. 356c 21 U.S.C. 356 21 U.S.C. 356(a) 21 U.S.C. 356(a)(1) 21 U.S.C. 360aaet seq. 21 U.S.C. 360bbb-5 21 U.S.C. 360bbb 21 U.S.C. 360bbbet seq. 21 U.S.C. 360bb 21 U.S.C. 360b 21 U.S.C. 360c(a)(3)(D) 21 U.S.C. 360c(e)(1) 21 U.S.C. 360c(e)(2) 21 U.S.C. 360c(f) 21 U.S.C. 360c(f)(2) 21 U.S.C. 360c(i)(1)(D) 21 U.S.C. 360d(a)(1) 21 U.S.C. 360 21 U.S.C. 360(h) 21 U.S.C. 360(j) 21 U.S.C. 360(n) 21 U.S.C. 360(p) 21 U.S.C. 360e-1(a)(2) 21 U.S.C. 360e 21 U.S.C. 360e(c)(4)(A) 21 U.S.C. 360ee(b)(1)(A)(ii) 21 U.S.C. 360ee(c) 21 U.S.C. 360g 21 U.S.C. 360g(a)(1) 21 U.S.C. 360h 21 U.S.C. 360i 21 U.S.C. 360i(f) 21 U.S.C. 360j(b) 21 U.S.C. 360j(g) 21 U.S.C. 360j(m) 21 U.S.C. 360j(m)(6)(A)(iv) 21 U.S.C. 360l 21 U.S.C. 360m(b)(2) 21 U.S.C. 360m(c) 21 U.S.C. 371(h)(1) 21 U.S.C. 371et seq. 21 U.S.C. 374(a) 21 U.S.C. 374(g)(11) 21 U.S.C. 379d-1 21 U.S.C. 379 21 U.S.C. 379fet seq. 21 U.S.C. 379g 21 U.S.C. 379g(1)(B) 21 U.S.C. 379h-2 21 U.S.C. 379h 21 U.S.C. 379i 21 U.S.C. 379iet seq. 21 U.S.C. 379j-1(a) 21 U.S.C. 379j-1(b) 21 U.S.C. 379j 21 U.S.C. 379j(a) 21 U.S.C. 379j(b) 21 U.S.C. 379j(c) 21 U.S.C. 379j(h)(1)(A) 21 U.S.C. 379j(i) 21 U.S.C. 379ket seq. 21 U.S.C. 381 21 U.S.C. 381(a) 21 U.S.C. 381et seq. 21 U.S.C. 383(c) 21 U.S.C. 393a 21 U.S.C. 739i 21 U.S.C. 739j-1 21 U.S.C. 811(h)(2) 21 U.S.C. 812(c) 21 U.S.C. 826 United States Code Title 28 Section 994(p) 28 U.S.C. 994(p) United States Code Title 31 Chapter 37 31 U.S.C. Chapter 37 United States Code Title 42 Section 12101et seq. Title 42 Section 213a(a) Title 42 Section 213a(b) Title 42 Section 262 Title 42 Section 262(i) Title 42 Section 262(m)(1) Title 42 Section 280g-3 Title 42 Section 282note Title 42 Section 284m Title 42 Section 284m(c) Title 42 Section 284m(e)(1) Title 42 Section 284mnote Title 42 Section 290b(c)(1)(C) 42 U.S.C. 12101et seq. 42 U.S.C. 213a(a) 42 U.S.C. 213a(b) 42 U.S.C. 262 42 U.S.C. 262(i) 42 U.S.C. 262(m)(1) 42 U.S.C. 280g-3 42 U.S.C. 282note 42 U.S.C. 284m 42 U.S.C. 284m(c) 42 U.S.C. 284m(e)(1) 42 U.S.C. 284mnote 42 U.S.C. 290b(c)(1)(C) United States Code Title 44 Chapter 35 44 U.S.C. 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