An act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, 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, medical devices, generic drugs, and biosimilar biological products, and for other purposes.;FDA Reauthorization Act of 2017;Public Law 115-52; 115_cong_public_laws legislative 2017-12-08 H.R. 2430, 115th Congress H.R. 2430, 115th Congress S. 934, 115th Congress An act to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. FDA Reauthorization Act of 2017 Public Law 115-52 U.S. Government Publishing Office 2017-08-18 monographic deposited born digital 86 digital object pages AE 2.110: AE 2.110/3: AE 2.110:115-52 https://www.govinfo.gov/app/details/PLAW-115publ52 P0b002ee197b59636 001038311 f:publ052_115 DGPO 2017-12-08 2026-01-02 PLAW-115publ52 machine generated eng fdlp PUBLIC PLAW-115publ52 115 52 FDA Reauthorization Act of 2017 false LEGISLATIVE HISTORY--H.R. 2430 (S. 934): HOUSE REPORTS: No. 115-201 (Comm. on Energy and Commerce). CONGRESSIONAL RECORD, Vol. 163 (2017): July 12, considered and passed House. Aug. 3, considered and passed Senate. Committee on Energy and Commerce Energy and Commerce

U.S. Government Publishing Office 2017-08-18 monographic deposited born digital 86 p. AE 2.110: AE 2.110/3: AE 2.110:115-52 P0b002ee197b59636 https://www.govinfo.gov/app/details/PLAW-115publ52 f:publ052_115 Public Law 115-52 https://www.govinfo.gov/app/details/PLAW-115publ52 https://www.govinfo.gov/content/pkg/PLAW-115publ52/html/PLAW-115publ52.htm https://www.govinfo.gov/content/pkg/PLAW-115publ52/pdf/PLAW-115publ52.pdf https://www.govinfo.gov/content/pkg/PLAW-115publ52/uslm/PLAW-115publ52.xml fdlp DGPO 2017-12-08 2026-01-02 PLAW-115publ52 machine generated eng PUBLIC PLAW-115publ52 115 52 FDA Reauthorization Act of 2017 false LEGISLATIVE HISTORY--H.R. 2430 (S. 934): HOUSE REPORTS: No. 115-201 (Comm. on Energy and Commerce). CONGRESSIONAL RECORD, Vol. 163 (2017): July 12, considered and passed House. Aug. 3, considered and passed Senate. Committee on Energy and Commerce Energy and Commerce

United States House Bill 2430 (115th Congress) H.R. 2430 115 side note United States House Bill 2430 (115th Congress) H.R. 2430 115 legislative history United States Senate Bill 934 (115th Congress) S. 934 115 legislative history United States Code Title 5 Section 552a Title 5 Section 552 5 U.S.C. 552a 5 U.S.C. 552 United States Code Title 18 Section 1905 18 U.S.C. 1905 United States Code Title 21 Section 321 Title 21 Section 321(h) Title 21 Section 333 Title 21 Section 351 Title 21 Section 351et seq. Title 21 Section 355-1(e)(3) Title 21 Section 355a Title 21 Section 355a(d) Title 21 Section 355a(f) Title 21 Section 355a(o) Title 21 Section 355c-1(b) Title 21 Section 355c Title 21 Section 355c(a)(1) Title 21 Section 355c(a)(3) Title 21 Section 355c(d)(1) Title 21 Section 355c(e) Title 21 Section 355c(e)(2)(C) Title 21 Section 355c(k) Title 21 Section 355d Title 21 Section 355 Title 21 Section 355(b)(1) Title 21 Section 355(j) Title 21 Section 355(j)(2)(C) Title 21 Section 355(j)(5) Title 21 Section 355(u)(4) Title 21 Section 355g(b) Title 21 Section 355g(d) Title 21 Section 356e Title 21 Section 356g(b)(1)(A) Title 21 Section 360bbb-0 Title 21 Section 360bbb-0(f) Title 21 Section 360bbb-5(f) Title 21 Section 360bbb-8c(c)(2)(A) Title 21 Section 360bbb Title 21 Section 360bbb(b) Title 21 Section 360bb Title 21 Section 360cc Title 21 Section 360c Title 21 Section 360c(b) Title 21 Section 360c(b)(5)(D) Title 21 Section 360d Title 21 Section 360(h) Title 21 Section 360(h)(6) Title 21 Section 360(k) Title 21 Section 360(m) Title 21 Section 360e-1(a)(3) Title 21 Section 360e-1(b) Title 21 Section 360e-3 Title 21 Section 360e-3(f)(2) Title 21 Section 360e Title 21 Section 360e(c)(4)(A) Title 21 Section 360ee(c) Title 21 Section 360i Title 21 Section 360j Title 21 Section 360j(m) Title 21 Section 360m Title 21 Section 360n(a)(4) Title 21 Section 374 Title 21 Section 374(b) Title 21 Section 374(g)(11) Title 21 Section 379d-3(b)(1) Title 21 Section 379fet seq. Title 21 Section 379g Title 21 Section 379h-2 Title 21 Section 379h-2(a) Title 21 Section 379h Title 21 Section 379h(a) Title 21 Section 379h(d) Title 21 Section 379h(e) Title 21 Section 379h(f) Title 21 Section 379h(f)(2) Title 21 Section 379h(g) Title 21 Section 379h(k) Title 21 Section 379i Title 21 Section 379iet seq. Title 21 Section 379j-12(a)(3) Title 21 Section 379j-1(a) Title 21 Section 379j-1(a)(1)(A) Title 21 Section 379j-1(b) Title 21 Section 379j-41 Title 21 Section 379j-42 Title 21 Section 379j-42(a) Title 21 Section 379j-42(b) Title 21 Section 379j-42(c) Title 21 Section 379j-42(d) Title 21 Section 379j-42(e) Title 21 Section 379j-42(f) Title 21 Section 379j-42(g) Title 21 Section 379j-42(h)(2) Title 21 Section 379j-42(i) Title 21 Section 379j-43 Title 21 Section 379j-43(a) Title 21 Section 379j-51(1) Title 21 Section 379j-51(3) Title 21 Section 379j-52 Title 21 Section 379j-52(a) Title 21 Section 379j-52(e)(2)(B) Title 21 Section 379j-53 Title 21 Section 379j-53(a) Title 21 Section 379j Title 21 Section 379j(a) Title 21 Section 379j(b) Title 21 Section 379j(c) Title 21 Section 379j(d) Title 21 Section 379j(e)(2)(C) Title 21 Section 379j(h) Title 21 Section 379k-1(b) Title 21 Section 381(d) Title 21 Section 381(e)(4) Title 21 Section 384e(a)(1) Title 21 Section 393a(d) Title 21 Section 739i Title 21 Section 739j-1 21 U.S.C. 321 21 U.S.C. 321(h) 21 U.S.C. 333 21 U.S.C. 351 21 U.S.C. 351et seq. 21 U.S.C. 355-1(e)(3) 21 U.S.C. 355a 21 U.S.C. 355a(d) 21 U.S.C. 355a(f) 21 U.S.C. 355a(o) 21 U.S.C. 355c-1(b) 21 U.S.C. 355c 21 U.S.C. 355c(a)(1) 21 U.S.C. 355c(a)(3) 21 U.S.C. 355c(d)(1) 21 U.S.C. 355c(e) 21 U.S.C. 355c(e)(2)(C) 21 U.S.C. 355c(k) 21 U.S.C. 355d 21 U.S.C. 355 21 U.S.C. 355(b)(1) 21 U.S.C. 355(j) 21 U.S.C. 355(j)(2)(C) 21 U.S.C. 355(j)(5) 21 U.S.C. 355(u)(4) 21 U.S.C. 355g(b) 21 U.S.C. 355g(d) 21 U.S.C. 356e 21 U.S.C. 356g(b)(1)(A) 21 U.S.C. 360bbb-0 21 U.S.C. 360bbb-0(f) 21 U.S.C. 360bbb-5(f) 21 U.S.C. 360bbb-8c(c)(2)(A) 21 U.S.C. 360bbb 21 U.S.C. 360bbb(b) 21 U.S.C. 360bb 21 U.S.C. 360cc 21 U.S.C. 360c 21 U.S.C. 360c(b) 21 U.S.C. 360c(b)(5)(D) 21 U.S.C. 360d 21 U.S.C. 360(h) 21 U.S.C. 360(h)(6) 21 U.S.C. 360(k) 21 U.S.C. 360(m) 21 U.S.C. 360e-1(a)(3) 21 U.S.C. 360e-1(b) 21 U.S.C. 360e-3 21 U.S.C. 360e-3(f)(2) 21 U.S.C. 360e 21 U.S.C. 360e(c)(4)(A) 21 U.S.C. 360ee(c) 21 U.S.C. 360i 21 U.S.C. 360j 21 U.S.C. 360j(m) 21 U.S.C. 360m 21 U.S.C. 360n(a)(4) 21 U.S.C. 374 21 U.S.C. 374(b) 21 U.S.C. 374(g)(11) 21 U.S.C. 379d-3(b)(1) 21 U.S.C. 379fet seq. 21 U.S.C. 379g 21 U.S.C. 379h-2 21 U.S.C. 379h-2(a) 21 U.S.C. 379h 21 U.S.C. 379h(a) 21 U.S.C. 379h(d) 21 U.S.C. 379h(e) 21 U.S.C. 379h(f) 21 U.S.C. 379h(f)(2) 21 U.S.C. 379h(g) 21 U.S.C. 379h(k) 21 U.S.C. 379i 21 U.S.C. 379iet seq. 21 U.S.C. 379j-12(a)(3) 21 U.S.C. 379j-1(a) 21 U.S.C. 379j-1(a)(1)(A) 21 U.S.C. 379j-1(b) 21 U.S.C. 379j-41 21 U.S.C. 379j-42 21 U.S.C. 379j-42(a) 21 U.S.C. 379j-42(b) 21 U.S.C. 379j-42(c) 21 U.S.C. 379j-42(d) 21 U.S.C. 379j-42(e) 21 U.S.C. 379j-42(f) 21 U.S.C. 379j-42(g) 21 U.S.C. 379j-42(h)(2) 21 U.S.C. 379j-42(i) 21 U.S.C. 379j-43 21 U.S.C. 379j-43(a) 21 U.S.C. 379j-51(1) 21 U.S.C. 379j-51(3) 21 U.S.C. 379j-52 21 U.S.C. 379j-52(a) 21 U.S.C. 379j-52(e)(2)(B) 21 U.S.C. 379j-53 21 U.S.C. 379j-53(a) 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(d) 21 U.S.C. 379j(e)(2)(C) 21 U.S.C. 379j(h) 21 U.S.C. 379k-1(b) 21 U.S.C. 381(d) 21 U.S.C. 381(e)(4) 21 U.S.C. 384e(a)(1) 21 U.S.C. 393a(d) 21 U.S.C. 739i 21 U.S.C. 739j-1 United States Code Title 42 Section 1320d-2note Title 42 Section 262(a) Title 42 Section 262(m) Title 42 Section 282note Title 42 Section 284m Title 42 Section 360j 42 U.S.C. 1320d-2note 42 U.S.C. 262(a) 42 U.S.C. 262(m) 42 U.S.C. 282note 42 U.S.C. 284m 42 U.S.C. 360j United States Statutes at Large Volume 131 Page 1005 Volume 131 Page 1006 Volume 131 Page 1007 Volume 131 Page 1008 Volume 131 Page 1009 Volume 131 Page 1010 Volume 131 Page 1011 Volume 131 Page 1012 Volume 131 Page 1013 Volume 131 Page 1014 Volume 131 Page 1015 Volume 131 Page 1016 Volume 131 Page 1017 Volume 131 Page 1018 Volume 131 Page 1019 Volume 131 Page 1020 Volume 131 Page 1021 Volume 131 Page 1022 Volume 131 Page 1023 Volume 131 Page 1024 Volume 131 Page 1025 Volume 131 Page 1026 Volume 131 Page 1027 Volume 131 Page 1028 Volume 131 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Rept. 115-201