United States Government Publishing Office publisher pbl distributor dst United States Congress House of Representatives author aut Government Organization text government publication eng CRPT Congressional Committee Materials 117_cong_reports legislative 2022-06-15 U.S. Government Publishing Office 2022-06-07 monographic deposited born digital 384 digital object pages Y 1.1/8: https://www.govinfo.gov/app/details/CRPT-117hrpt348 P0b002ee1b5b14901 001181450 f:hr348.117.txt DGPO 2022-06-15 2024-11-08 CRPT-117hrpt348 machine generated eng fdlp Report of the COMMITTEE ON ENERGY AND COMMERCE to accompany H.R. 7667 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT, June 7, 2022.--Committed to the Committee of the Whole House on the State of the Union and ordered to be printed . FOOD AND DRUG AMENDMENTS OF 2022 117th Congress } { Report HOUSE OF REPRESENTATIVES 2d Session } { 117-348 _______________________________________________________________________ . FOOD AND DRUG AMENDMENTS OF 2022 __________ R E P O R T of the COMMITTEE ON ENERGY AND COMMERCE to accompany H.R. 7667 GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT, June 7, 2022.--Committed to the Committee of the Whole House on the State of the Union and ordered to be printed __________ U.S. GOVERNMENT PUBLISHING OFFICE 29-006 WASHINGTON : 2022 117th Congress } { Report HOUSE OF REPRESENTATIVES 2d Session } { 117-348 ====================================================================== . FOOD AND DRUG AMENDMENTS OF 2022 _______ June 7, 2022.--Committed to the Committee of the Whole House on the State of the Union and ordered to be printed _______ Mr. Pallone, from the Committee on Energy and Commerce, submitted the following R E P O R T to accompany H.R. 7667 HRPT CRPT-117hrpt348 HOUSE 117 348 2 false true https://www.govinfo.gov/app/details/CRPT-117hrpt348 https://www.govinfo.gov/content/pkg/CRPT-117hrpt348/html/CRPT-117hrpt348.htm https://www.govinfo.gov/content/pkg/CRPT-117hrpt348/pdf/CRPT-117hrpt348.pdf H. Rept. 117-348 The Committee on Energy and Commerce, to whom was referred the bill (H.R. 7667) 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, having considered the same, reports favorably thereon with an amendment and recommends that the bill as amended do pass. FOOD AND DRUG AMENDMENTS OF 2022;H. Rept. 117-348 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed FIRSTPART CRPT-117hrpt348 Committed to the Committee of the Whole House on the State of the Union and ordered to be printed 2 21st Century Cures Act Food and Drug Amendments of 2022 The Committee on Energy and Commerce, to whom was referred the bill (H.R. 7667) 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, having considered the same, reports favorably thereon with an amendment and recommends that the bill as amended do pass. Mr. Pallone, from the Committee on Energy and Commerce, submitted the following Committee on Energy and Commerce Energy and Commerce Mr. Pallone Frank Pallone, Jr. Pallone, Frank Mr. Frank Pallone Jr.

H.R. 7667, 117th Frank Pallone, Jr. United States House of Representatives sponsor spn United States Congress Member United States Congress House of Representatives Committee on Energy and Commerce associated name asn Government Organization H.R. 7667 117 OTHER H.R. 7667 117 PRIMARY Title 3 Section 102 3 U.S.C. 102 Title 5 Section 552 Title 5 Section 552(b) Title 5 Section 552(b)(4) Title 5 Section 5703 Title 5 Chapter 5 Title 5 Chapter 53 5 U.S.C. 552 5 U.S.C. 552(b) 5 U.S.C. 552(b)(4) 5 U.S.C. 5703 5 U.S.C. Chapter 5 5 U.S.C. Chapter 53 Title 15 Section 12 Title 15 Section 45 Title 15 Section 52-57 Title 15 Section 52 15 U.S.C. 12 15 U.S.C. 45 15 U.S.C. 52-57 15 U.S.C. 52 Title 18 Section 1001 Title 18 Section 1905 Title 18 Section 202 18 U.S.C. 1001 18 U.S.C. 1905 18 U.S.C. 202 Title 21 Section 1(h) Title 21 Section 201et seq. Title 21 Section 301et seq. Title 21 Section 321 Title 21 Section 321(h) Title 21 Section 331(q) Title 21 Section 351 Title 21 Section 351(a)(2)(B) Title 21 Section 351(g) Title 21 Section 351et seq. Title 21 Section 352 Title 21 Section 352(t) Title 21 Section 353 Title 21 Section 355-1 Title 21 Section 355-1(h) Title 21 Section 355c Title 21 Section 355c(a) Title 21 Section 355c(a)(1) Title 21 Section 355c(a)(3) Title 21 Section 355c(e)(1) Title 21 Section 355 Title 21 Section 355(i) Title 21 Section 355(j) Title 21 Section 355(j)(10)(A) Title 21 Section 355(j)(11)(A)(i) Title 21 Section 355(j)(3) Title 21 Section 355(j)(5)(A) Title 21 Section 355(p) Title 21 Section 355(u)(4) Title 21 Section 355note Title 21 Section 355f Title 21 Section 356b(a) Title 21 Section 356c-1(a)(2) Title 21 Section 356c(a) Title 21 Section 356d Title 21 Section 356(c) Title 21 Section 356(c)(2)(A) Title 21 Section 356(c)(3)(B) Title 21 Section 356e Title 21 Section 356i Title 21 Section 356i(e) Title 21 Section 356j Title 21 Section 360bbb-3 Title 21 Section 360bbb-5 Title 21 Section 360bbb-5(f) Title 21 Section 360bbb-8c Title 21 Section 360bbb-8cnote Title 21 Section 360bbb-8(a)(2) Title 21 Section 360bbb Title 21 Section 360bb Title 21 Section 360bb(a)(2) Title 21 Section 360cc Title 21 Section 360c Title 21 Section 360c(f)(2) Title 21 Section 360d(d) Title 21 Section 360 Title 21 Section 360(h)(4) Title 21 Section 360(i) Title 21 Section 360(k) Title 21 Section 360e Title 21 Section 360ee Title 21 Section 360f Title 21 Section 360f(a) Title 21 Section 360j(g) Title 21 Section 360j(m) Title 21 Section 360j(m)(6)(A)(iv) Title 21 Section 360m Title 21 Section 360m(b)(2)(C) Title 21 Section 360m(c) Title 21 Section 360n-1(a) Title 21 Section 373 Title 21 Section 374(a) Title 21 Section 374(a)(1) Title 21 Section 374(a)(4) Title 21 Section 374(a)(4)(A) Title 21 Section 374(b) Title 21 Section 374(g)(11) Title 21 Section 379d-3a Title 21 Section 379g Title 21 Section 379g(1) Title 21 Section 379g(3) Title 21 Section 379get seq. Title 21 Section 379h-2 Title 21 Section 379h(a) Title 21 Section 379h(a)(2) Title 21 Section 379h(b) Title 21 Section 379h(c) Title 21 Section 379h(c)(1)(B)(ii) Title 21 Section 379h(g)(3) Title 21 Section 379h(i) Title 21 Section 379h(k) 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-41 Title 21 Section 379j-41et seq. Title 21 Section 379j-42(a) Title 21 Section 379j-42(b) Title 21 Section 379j-42(c) Title 21 Section 379j-42(d)(1) Title 21 Section 379j-42(g) Title 21 Section 379j-42(i)(3) Title 21 Section 379j-43 Title 21 Section 379j-51 Title 21 Section 379j-51(1) Title 21 Section 379j-51(4)(B)(iii) Title 21 Section 379j-51et seq. Title 21 Section 379j-52 Title 21 Section 379j-52(a) Title 21 Section 379j-52(a)(1)(B) Title 21 Section 379j-52(a)(1)(D) Title 21 Section 379j-52(a)(2)(D) Title 21 Section 379j-52(a)(3) Title 21 Section 379j-52(c) Title 21 Section 379j-52(h) Title 21 Section 379j-53 Title 21 Section 379j Title 21 Section 379j(a) Title 21 Section 379j(b) Title 21 Section 379j(c) Title 21 Section 379j(g) Title 21 Section 379j(h)(3) Title 21 Section 384e Title 21 Section 393(b) Title 21 Section 396 Title 21 Section 739i Title 21 Section 739j-1 21 U.S.C. 1(h) 21 U.S.C. 201et seq. 21 U.S.C. 301et seq. 21 U.S.C. 321 21 U.S.C. 321(h) 21 U.S.C. 331(q) 21 U.S.C. 351 21 U.S.C. 351(a)(2)(B) 21 U.S.C. 351(g) 21 U.S.C. 351et seq. 21 U.S.C. 352 21 U.S.C. 352(t) 21 U.S.C. 353 21 U.S.C. 355-1 21 U.S.C. 355-1(h) 21 U.S.C. 355c 21 U.S.C. 355c(a) 21 U.S.C. 355c(a)(1) 21 U.S.C. 355c(a)(3) 21 U.S.C. 355c(e)(1) 21 U.S.C. 355 21 U.S.C. 355(i) 21 U.S.C. 355(j) 21 U.S.C. 355(j)(10)(A) 21 U.S.C. 355(j)(11)(A)(i) 21 U.S.C. 355(j)(3) 21 U.S.C. 355(j)(5)(A) 21 U.S.C. 355(p) 21 U.S.C. 355(u)(4) 21 U.S.C. 355note 21 U.S.C. 355f 21 U.S.C. 356b(a) 21 U.S.C. 356c-1(a)(2) 21 U.S.C. 356c(a) 21 U.S.C. 356d 21 U.S.C. 356(c) 21 U.S.C. 356(c)(2)(A) 21 U.S.C. 356(c)(3)(B) 21 U.S.C. 356e 21 U.S.C. 356i 21 U.S.C. 356i(e) 21 U.S.C. 356j 21 U.S.C. 360bbb-3 21 U.S.C. 360bbb-5 21 U.S.C. 360bbb-5(f) 21 U.S.C. 360bbb-8c 21 U.S.C. 360bbb-8cnote 21 U.S.C. 360bbb-8(a)(2) 21 U.S.C. 360bbb 21 U.S.C. 360bb 21 U.S.C. 360bb(a)(2) 21 U.S.C. 360cc 21 U.S.C. 360c 21 U.S.C. 360c(f)(2) 21 U.S.C. 360d(d) 21 U.S.C. 360 21 U.S.C. 360(h)(4) 21 U.S.C. 360(i) 21 U.S.C. 360(k) 21 U.S.C. 360e 21 U.S.C. 360ee 21 U.S.C. 360f 21 U.S.C. 360f(a) 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. 360m 21 U.S.C. 360m(b)(2)(C) 21 U.S.C. 360m(c) 21 U.S.C. 360n-1(a) 21 U.S.C. 373 21 U.S.C. 374(a) 21 U.S.C. 374(a)(1) 21 U.S.C. 374(a)(4) 21 U.S.C. 374(a)(4)(A) 21 U.S.C. 374(b) 21 U.S.C. 374(g)(11) 21 U.S.C. 379d-3a 21 U.S.C. 379g 21 U.S.C. 379g(1) 21 U.S.C. 379g(3) 21 U.S.C. 379get seq. 21 U.S.C. 379h-2 21 U.S.C. 379h(a) 21 U.S.C. 379h(a)(2) 21 U.S.C. 379h(b) 21 U.S.C. 379h(c) 21 U.S.C. 379h(c)(1)(B)(ii) 21 U.S.C. 379h(g)(3) 21 U.S.C. 379h(i) 21 U.S.C. 379h(k) 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-41 21 U.S.C. 379j-41et seq. 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)(1) 21 U.S.C. 379j-42(g) 21 U.S.C. 379j-42(i)(3) 21 U.S.C. 379j-43 21 U.S.C. 379j-51 21 U.S.C. 379j-51(1) 21 U.S.C. 379j-51(4)(B)(iii) 21 U.S.C. 379j-51et seq. 21 U.S.C. 379j-52 21 U.S.C. 379j-52(a) 21 U.S.C. 379j-52(a)(1)(B) 21 U.S.C. 379j-52(a)(1)(D) 21 U.S.C. 379j-52(a)(2)(D) 21 U.S.C. 379j-52(a)(3) 21 U.S.C. 379j-52(c) 21 U.S.C. 379j-52(h) 21 U.S.C. 379j-53 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(g) 21 U.S.C. 379j(h)(3) 21 U.S.C. 384e 21 U.S.C. 393(b) 21 U.S.C. 396 21 U.S.C. 739i 21 U.S.C. 739j-1 Title 26 Section 3220 Title 26 Section 3238(b) 26 U.S.C. 3220 26 U.S.C. 3238(b) Title 28 Section 1254 Title 28 Section 2112 Title 28 Section 2201 28 U.S.C. 1254 28 U.S.C. 2112 28 U.S.C. 2201 Title 31 Section 529 Title 31 Chapter 37 31 U.S.C. 529 31 U.S.C. Chapter 37 Title 35 Section 156 Title 35 Section 271(e)(2)(A) Title 35 Section 271(e)(4)(A) 35 U.S.C. 156 35 U.S.C. 271(e)(2)(A) 35 U.S.C. 271(e)(4)(A) Title 41 Section 5 41 U.S.C. 5 Title 42 Section 1320b-5(g)(1)(B) Title 42 Section 201et seq. Title 42 Section 262 Title 42 Section 262(a) Title 42 Section 262(i) Title 42 Section 263a(d)(3) Title 42 Section 284m(d)(1) 42 U.S.C. 1320b-5(g)(1)(B) 42 U.S.C. 201et seq. 42 U.S.C. 262 42 U.S.C. 262(a) 42 U.S.C. 262(i) 42 U.S.C. 263a(d)(3) 42 U.S.C. 284m(d)(1) Title 44 Chapter 35 44 U.S.C. Chapter 35 Public Law 107-109 Public Law No 107-109 Public Law 107-250 Public Law No 107-250 Public Law 110-85 Public Law No 110-85 Public Law 111-139 Public Law No 111-139 Public Law 112-114 Public Law No 112-114 Public Law 112-144 Public Law No 112-144 Public Law 114-255 Public Law No 114-255 Public Law 115-52 Public Law No 115-52 Title 21 Part 316 21 CFR Part 316