21 U.S.C. 379h: Authority to assess and use drug fees

2022

• Pub. L. 117–180, §1003(a)(1)(A), substituted "fiscal year 2023" for "fiscal year 2018" in introductory provisions. (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(a)(1)(B), substituted "(c)(6)" for "(c)(5)" in cls. (i) and (ii). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(a)(1)(C), inserted "prior to approval" after "or was withdrawn". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(a)(1)(D), added subpar. (H). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(a)(2)(A), designated existing provisions as cl. (i) and inserted heading, substituted "subsection (c)(6)" for "subsection (c)(5)", and added cl. (ii). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(a)(2)(B), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug program fee shall not be assessed for a prescription drug product under subparagraph (A) if such product is— (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (a)
• Pub. L. 117–180, §1003(b)(1), amended par. (1) generally. Prior to amendment, par. (1) related to fees for fiscal years 2018 through 2022. (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (b)
• Pub. L. 117–180, §1003(b)(2), amended par. (3) generally. Prior to amendment, par. (3) related to annual base revenue for fiscal years 2018 through 2022. (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (b)
• Pub. L. 117–180, §1003(c)(1), substituted "Washington-Arlington-Alexandria, DC–VA–MD–WV" for "Washington-Baltimore, DC–MD–VA–WV". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(B), added par. (2). Former par. (2) redesignated (3). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(A), (3), redesignated par. (2) as (3) and amended it generally. Prior to amendment, par. related to establishment of a capacity planning methodology and interim methodology. Former par. (3) redesignated (4). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (3) as (4). Former par. (4) redesignated (5). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(4)(A), amended subpar. (A) generally. Prior to amendment, text read as follows: "For fiscal year 2018 and subsequent fiscal years, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees if su… (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(4)(B), substituted "paragraph (6)" for "paragraph (5)". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(A), (5), redesignated par. (4) as (5) and amended it generally. Prior to amendment, par. related to additional direct cost adjustment for fiscal years 2018, 2019, and subsequent fiscal years. Former par. (5) redesignated (6). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(A), (6), redesignated par. (5) as (6) and substituted "September 30, 2022" for "September 30, 2017" in introductory provisions. Former par. (6) redesignated (7). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–180, §1003(c)(2)(A), redesignated par. (6) as (7). (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (c)
• Pub. L. 117–328, §3625(a)(1), substituted "shall be available—" for "shall be available to defray", designated remainder of existing provisions as subcl. (I), inserted "for fiscal year 2023, to defray" before "increases in the costs", and added subcl. (II). (Consolidated Appropriations Act, 2023) Law text · (g)
• Pub. L. 117–328, §3625(a)(2), substituted "as described in subclause (I) or (II) of such subparagraph, as applicable" for "for the process for the review of human drug applications" in introductory provisions. (Consolidated Appropriations Act, 2023) Law text · (g)
• Pub. L. 117–180, §1003(d), substituted "fiscal years 2023 through 2027" for "fiscal years 2018 through 2022". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (g)
• Pub. L. 117–180, §1003(e), amended subsec. (i) generally. Prior to amendment, text read as follows: "To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secreta… (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (i)
• Pub. L. 117–180, §1003(f)(1), substituted "as determined under paragraph (2)" for "during the previous year". (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (k)
• Pub. L. 117–180, §1003(f)(2), amended par. (2) generally. Prior to amendment, text read as follows: "An exemption under paragraph (1) applies with respect to a drug only if the applicant involved submits a certification that its gross annual revenues did not exceed $50,000,000 for t… (Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023) Law text · (k)

2017

• Pub. L. 115–52, §102(a)(1)(A), substituted "fiscal year 2018" for "fiscal year 2013" in introductory provisions. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(B), (C), struck out "and supplement" before "fee" in heading and struck out "or a supplement" and "or supplement" wherever appearing in text. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(D)(i), substituted "(c)(5)" for "(c)(4)". (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(C), (D)(ii), substituted "A fee established under subsection (c)(5) for a human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are not required for approval." f… (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(E), struck out "or supplement" after "application" in heading. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(F), struck out "or indication" after "drug" in heading and "A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designa… (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(G)–(I), redesignated par. (3) as (2), substituted "Prescription drug program fee" for "Prescription drug product fee" in heading, and struck out former par. (2) which related to prescription drug establishment fee. (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(J), substituted "Except as provided in subparagraphs (B) and (C), each person who is named as the applicant in a human drug application, and who, after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall pay… (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(K), inserted "for certain prescription drug products" after "Exception" in heading and substituted "A prescription drug program fee shall not be assessed for a prescription drug product" for "A prescription drug product shall not be assessed a fee" in i… (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(L), added subpar. (C). (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(a)(1)(H), redesignated par. (3) as (2). (FDA Reauthorization Act of 2017) Law text · (a)
• Pub. L. 115–52, §102(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee revenue amounts for fiscal years 2013 through 2017. (FDA Reauthorization Act of 2017) Law text · (b)
• Pub. L. 115–52, §102(c), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to adjustment of revenues for inflation and changes in workload, final year adjustment, setting of annual fee, and limit on total amount of fees charged. (FDA Reauthorization Act of 2017) Law text · (c)
• Pub. L. 115–52, §102(d)(1), redesignated subpar. (D) as (C) and struck out former subpar. (C) which read as follows: "the fees to be paid by such person will exceed the anticipated present and future costs incurred by the Secretary in conducting the process for the review of… (FDA Reauthorization Act of 2017) Law text · (d), (D)
• Pub. L. 115–52, §102(d)(2), (3), redesignated par. (4) as (3) and struck out former par. (3). Text read as follows: "In making the finding in paragraph (1)(C), the Secretary may use standard costs." (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §102(d)(4)(A), substituted "paragraph (1)(C)" for "paragraph (1)(D)". (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §102(d)(4), substituted "paragraph (1)(C)" for "paragraph (1)(D)", struck out cl. (i) designation before "application fees", substituted a period for "; and" after "qualify as a small business", and struck out cl. (ii), which read as follows: "all supplement fees … (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §102(d)(3), redesignated par. (4) as (3). (FDA Reauthorization Act of 2017) Law text · (d)
• Pub. L. 115–52, §102(e), substituted "all such fees" for "all fees". (FDA Reauthorization Act of 2017) Law text · (e)
• Pub. L. 115–52, §102(f), substituted "prescription drug program fees" for "supplements, prescription drug establishments, and prescription drug products". (FDA Reauthorization Act of 2017) Law text · (f)
• Pub. L. 115–52, §905(b)(1), added par. (3). (FDA Reauthorization Act of 2017) Law text · (f)
• Pub. L. 115–52, §102(g)(1), substituted "2018 through 2022" for "2013 through 2017" and struck out "and paragraph (4) of this subsection" after "subsection (c)". (FDA Reauthorization Act of 2017) Law text · (g)
• Pub. L. 115–52, §102(g)(2), struck out par. (4). Prior to amendment, text read as follows: "If the sum of the cumulative amount of fees collected under this section for the fiscal years 2013 through 2015 and the amount of fees estimated to be collected under this section for fiscal … (FDA Reauthorization Act of 2017) Law text · (g)
• Pub. L. 115–52, §102(h), substituted "prescription drug program fees" for "product and establishment fees" in two places. (FDA Reauthorization Act of 2017) Law text · (k)

2012

• Pub. L. 112–144, §103(1)(A), substituted "fiscal year 2013" for "fiscal year 2008" in introductory provisions. (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §103(1)(B), substituted "(c)(4)" for "(c)(5)" in cls. (i) and (ii). (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §103(1)(C), substituted "(c)(4)" for "(c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for … (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §103(1)(D)(i), substituted "subsection (c)(4)" for "subsection (c)(5)" and "due on the later of the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection an… (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §103(1)(D)(ii), amended subpar. (B) generally. Prior to amendment, text read as follows: "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title wi… (Food and Drug Administration Safety and Innovation Act) Law text · (a)
• Pub. L. 112–144, §103(2)(A)(i), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012" in introductory provisions. (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §103(2)(A)(ii), substituted "$693,099,000;" for "$392,783,000; and". (Food and Drug Administration Safety and Innovation Act) Law text · (b)
• Pub. L. 112–144, §103(2)(A)(iii), added subpars. (B) and (C) and struck out former subpar. (B) which read as follows: "an amount equal to the modified workload adjustment factor for fiscal year 2007 (as determined under paragraph (3))." (Food and Drug Administration Safety and Innovation Act) Law text · (b), (C)
• Pub. L. 112–144, §103(2)(B), added par. (3) and struck out former pars. (3) and (4) which related to the modified workload adjustment factor for fiscal year 2007 and additional fee revenues for drug safety for fiscal years 2008 through 2012, respectively. (Food and Drug Administration Safety and Innovation Act) Law text · (b), (4)
• Pub. L. 112–144, §103(3), added subsec. (c) and struck out former subsec. (c) which related to inflation adjustment for fiscal year 2009 and subsequent fiscal years, workload adjustment for fiscal year 2009 and subsequent fiscal years, rent and rent-related cost adjustment for fiscal y… (Food and Drug Administration Safety and Innovation Act) Law text · (c)
• Pub. L. 112–144, §103(4)(A), substituted "Subject to paragraph (2)(C), fees authorized" for "Fees authorized". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §103(4)(B)(i), substituted "subject to subparagraph (C), shall be collected and available" for "shall be retained". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §103(4)(B)(ii), substituted "shall be available" for "shall only be collected and available". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §103(4)(B)(iii), added subpar. (C). (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §103(4)(C), substituted "fiscal years 2013 through 2017" for "fiscal years 2008 through 2012". (Food and Drug Administration Safety and Innovation Act) Law text · (g)
• Pub. L. 112–144, §103(4)(D), substituted "fiscal years 2013 through 2015" for "fiscal years 2008 through 2010", "fiscal year 2016" for "fiscal year 2011", "fiscal years 2013 through 2016" for "fiscal years 2008 through 2011", and "fiscal year 2017" for "fiscal year 2012". (Food and Drug Administration Safety and Innovation Act) Law text · (g)

2007

• Pub. L. 110–85, §103(a)(1), substituted "2008" for "2003" in introductory provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)" in cls. (i) and (ii). (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(a)(2)(A), inserted "or withdrawn before filing" after "refused for filing" in heading and "or withdrawn without a waiver before filing" before period at end of text. (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(a)(2)(B), (C), added subpar. (E) and redesignated former subpars. (E) and (F) as (F) and (G), respectively. (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(a)(3)(A), (g), substituted "subparagraphs (B) and (C)" for "subparagraph (B)" in introductory provisions and "(c)(5)" for "(c)(4)" in concluding provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(a)(3)(B), added subpar. (C). (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(g), substituted "(c)(5)" for "(c)(4)". (Food and Drug Administration Amendments Act of 2007) Law text · (a)
• Pub. L. 110–85, §103(b), amended subsec. (b) generally, substituting provisions contained in pars. (1) to (4) relating to fee revenue amounts for fiscal years 2008 through 2012 for undesignated provisions relating to fee schedules for fiscal years 2003 to 2007. (Food and Drug Administration Amendments Act of 2007) Law text · (b)
• Pub. L. 110–85, §103(c)(1), amended par. (1) by substituting "For fiscal year 2009 and subsequent fiscal years, the revenues established in subsection (b)" for "The revenues established in subsection (b)" in introductory provisions, adding subpar. (C), and substituting "fiscal year … (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(2)(A), substituted "For fiscal year 2009 and subsequent fiscal years," for "Beginning with fiscal year 2004," in introductory provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(2)(B), substituted "human drug applications (adjusted for changes in review activities, as described in the notice that the Secretary is required to publish in the Federal Register under this subparagraph), efficacy supplements, and manufacturing supplemen… (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(2)(C), inserted at end "Any adjustment for changes in review activities made in setting fees and revenue amounts for fiscal year 2009 may not result in the total workload adjustment being more than 2 percentage points higher than it would have been in the … (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(2)(D), added subpar. (C). (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(3), added par. (3). Former par. (3) redesignated (4). (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(3)(A), (4), redesignated par. (3) as (4) and amended it generally. Prior to amendment, text read as follows: "For fiscal year 2007, the Secretary may, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenues and fees establis… (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(3)(A), (5), redesignated par. (4) as (5) and substituted "2007" for "2002". Former par. (5) redesignated (6). (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(c)(3)(A), redesignated par. (5) as (6). (Food and Drug Administration Amendments Act of 2007) Law text · (c)
• Pub. L. 110–85, §103(d)(1), inserted "to a person who is named as the applicant in a human drug application" after "The Secretary shall grant" and "to that person" after "one or more fees assessed" in introductory provisions. (Food and Drug Administration Amendments Act of 2007) Law text · (d)
• Pub. L. 110–85, §103(d)(2), (3), added par. (2) and redesignated former par. (2) as (3). Former par. (3) redesignated (4). (Food and Drug Administration Amendments Act of 2007) Law text · (d), (3)
• Pub. L. 110–85, §103(d)(2), redesignated par. (3) as (4). (Food and Drug Administration Amendments Act of 2007) Law text · (d)
• Pub. L. 110–85, §103(d)(4), inserted before period at end ", and that does not have a drug product that has been approved under a human drug application and introduced or delivered for introduction into interstate commerce". (Food and Drug Administration Amendments Act of 2007) Law text · (d)
• Pub. L. 110–85, §103(h)(1), substituted "Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended." for "Fees coll… (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §103(e)(1), amended par. (3) generally. Prior to amendment, par. (3) authorized appropriations for fiscal years 2003 to 2007. (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §103(e)(2), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year … (Food and Drug Administration Amendments Act of 2007) Law text · (g)
• Pub. L. 110–85, §103(f), added subsec. (k). (Food and Drug Administration Amendments Act of 2007) Law text · (k)

2002

• Pub. L. 107–188, §504(a)(1), substituted "fiscal year 2003" for "fiscal year 1998" in introductory provisions. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §504(a)(2)(A), substituted "under subsection (c)(4)" for "in subsection (b)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §504(a)(2), substituted "under subsection (c)(4)" for "in subsection (b)" and inserted "Such fee shall be half of the amount of the fee established under clause (i)." at end. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–109 redesignated subpar. (G) as (F) and struck out heading and text of former subpar. (F). Text read as follows: "A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under sub… (Best Pharmaceuticals for Children Act) Law text · (a), (G)
• Pub. L. 107–188, §504(a)(3), in concluding provisions, substituted "under subsection (c)(4)" for "in subsection (b)" and "payable on or before October 1" for "payable on or before January 31". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §504(a)(4)(A), amended heading and text of subpar. (A) generally. Prior to amendment, text read as follows: "Except as provided in subparagraph (B), each person— (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §504(a)(4)(B), substituted "A prescription drug product shall not be assessed a fee under subparagraph (A) if such product is identified on the list compiled under section 355(j)(7)(A) of this title with a potency described in terms of per 100 mL, or if such prod… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
• Pub. L. 107–188, §504(b), amended heading and text of subsec. (b) generally, substituting "Fee revenue amounts" for "Fee amounts" in heading and substituting fee schedules for fiscal years 2003 to 2007 for fee provisions relating to fiscal years 1998 to 2002. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b)
• Pub. L. 107–188, §504(c)(1)(A), (D), substituted "revenues" for "fees and total fee revenues" in introductory provisions and "fiscal year 2003" for "fiscal year 1997" in concluding provisions. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (c)
• Pub. L. 107–188, §504(c)(1)(B), struck out "during the preceding fiscal year" before "in the Consumer Price Index" and substituted "for the 12 month period ending June 30 preceding the fiscal year for which fees are being established, or" for ", or". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (c)
• Pub. L. 107–188, §504(c)(1)(C), substituted "for the previous fiscal year" for "for such fiscal year". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (c)
• Pub. L. 107–188, §504(c)(2)–(4), added pars. (2) and (3), redesignated former pars. (2) and (3) as (4) and (5), respectively, and amended heading and text of par. (4) generally. Prior to amendment, text of par. (4) read as follows: "Subject to the amount appropriated for a fi… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (c)
• Pub. L. 107–188, §504(d)(1), inserted "or" at end of subpar. (C), redesignated subpar. (E) as (D), and struck out former subpar. (D) which read as follows: "assessment of the fee for an application or a supplement filed under section 355(b)(1) of this title pertaining to a… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
• Pub. L. 107–188, §504(d)(2), substituted "paragraph (1)(D)" for "paragraph (1)(E)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d), (B)
• Pub. L. 107–188, §504(e)(1), substituted "Limitations" for "Assessment of fees" in heading. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (f)
• Pub. L. 107–188, §504(e)(2), substituted "In general" for "Limitation" in heading and "Fees under subsection (a) shall be refunded for a fiscal year beginning" for "Fees may not be assessed under subsection (a) for a fiscal year beginning" in text. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (f)
• Pub. L. 107–188, §504(f)(1), which directed the amendment of par. (1) by striking "Fees collected for a fiscal year" and all that follows through "fiscal year limitation." and inserting "Fees authorized under subsection (a) shall be collected and available for obligation only to the… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (g)
• Pub. L. 107–188, §504(f)(2), amended par. (2) by designating existing provisions as subpar. (A), inserting subpar. (A) heading, adding subpar. (B), redesignating former subpars. (A) and (B) as cls. (i) and (ii), respectively, of subpar. (A), substituting "shall be retained in each f… (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (g)
• Pub. L. 107–188, §504(f)(3), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which read as follows: (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (g)

1997

• Pub. L. 105–115, §103(a)(1), substituted "Beginning in fiscal year 1998" for "Beginning in fiscal year 1993" in introductory provisions. (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(2)(A), amended heading and text of subpar. (B) generally. Prior to amendment, text read as follows: (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(2)(B), substituted "refused" for "not accepted" in heading and "75 percent" for "50 percent", "subparagraph (B)" for "subparagraph (B)(i)", and "refused" for "not accepted" in text. (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(2)(C), added subpars. (E) to (G). (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(3), reenacted heading without change and amended text generally. Prior to amendment, text read as follows: "Each person that— (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(4)(A), substituted, in cl. (i), "has been submitted for listing" for "is listed" and, in closing provisions, "Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 360 of this title, or is submitte… (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(a)(4)(B), substituted "355(j) of this title, under an abbreviated application filed under section 357 of this title (as in effect on the day before November 21, 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to th… (Food and Drug Administration Modernization Act of 1997) Law text · (a)
• Pub. L. 105–115, §103(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to fee amounts, including a schedule of fees in par. (1) and fee exceptions for certain small businesses in par. (2). (Food and Drug Administration Modernization Act of 1997) Law text · (b)
• Pub. L. 105–115, §103(c)(1), substituted "Adjustments" for "Increases and adjustments" in heading. (Food and Drug Administration Modernization Act of 1997) Law text · (c)
• Pub. L. 105–115, §103(c)(2), substituted "Inflation adjustment" for "Revenue increase" in heading, "The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary" for "The total fee revenues established by the schedule in subsection (b)(1) shall be… (Food and Drug Administration Modernization Act of 1997) Law text · (c)
• Pub. L. 105–115, §103(c)(3), substituted "September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (… (Food and Drug Administration Modernization Act of 1997) Law text · (c)
• Pub. L. 105–115, §103(c)(4), substituted "this subsection" for "paragraph (2)". (Food and Drug Administration Modernization Act of 1997) Law text · (c)
• Pub. L. 105–115, §103(d), struck out introductory provisions which read "The Secretary shall grant a waiver from or a reduction of 1 or more fees under subsection (a) of this section where the Secretary finds that—" and closing provisions which read "In making the finding in paragraph … (Food and Drug Administration Modernization Act of 1997) Law text · (d)
• Pub. L. 105–115, §103(e), substituted "fiscal year 1997" for "fiscal year 1993" and "fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)" for "fiscal year 1992". (Food and Drug Administration Modernization Act of 1997) Law text · (f)
• Pub. L. 105–115, §103(f)(1), inserted at end "Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal ye… (Food and Drug Administration Modernization Act of 1997) Law text · (g)
• Pub. L. 105–115, §103(f)(2)(A), substituted "Acts, or otherwise made available for obligation," for "Acts". (Food and Drug Administration Modernization Act of 1997) Law text · (g)
• Pub. L. 105–115, §103(f)(2)(B), substituted "over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997" for "over such costs for fiscal year 1992". (Food and Drug Administration Modernization Act of 1997) Law text · (g)
• Pub. L. 105–115, §103(f)(3), added pars. (3) and (4) and struck out heading and text of former par. (3). Text read as follows: "There are authorized to be appropriated for fees under this section— (Food and Drug Administration Modernization Act of 1997) Law text · (g), (4)
• Pub. L. 105–115, §103(g), added subsec. (i) and redesignated former subsec. (i) as (j). (Food and Drug Administration Modernization Act of 1997) Law text · (i), (j)