Sec. 2003. AUTHORITY TO ASSESS AND USE DEVICE FEES
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## SEC. 2003 AUTHORITY TO ASSESS AND USE DEVICE FEES ###
(a)Types of Fees Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended— ####
(1)in paragraph (1), by striking “fiscal year 2018” and inserting “fiscal year 2023”; and ####
(2)in paragraph (2)— #####
(A)in subparagraph (A)— ######
(i)in the matter preceding clause (i), by striking “October 1, 2017” and inserting “October 1, 2022”; ######
(ii)in clause (iii), by striking “75 percent” and inserting “80 percent”; and ######
(iii)in clause (viii), by striking “3.4 percent” and inserting “4.5 percent”; #####
(B)in subparagraph (B)(iii), by striking “or premarket notification submission” and inserting “premarket notification submission, or de novo classification request”; and #####
(C)in subparagraph (C), by striking “or periodic reporting concerning a class III device” and inserting “periodic reporting concerning a class III device, or de novo classification request”. ###
(b)Fee Amounts Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended— ####
(1)in paragraph (1), by striking “2018 through 2022” and inserting “2023 through 2027”; ####
(2)by amending paragraph
(2)to read as follows: > > #### “(2) Base fee amounts specified > > For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:“Fee TypeFiscal Year 2023Fiscal Year 2024Fiscal Year 2025Fiscal Year 2026Fiscal Year 2027Premarket Application$425,000$435,000$445,000$455,000$470,000Establishment Registration$6,250$6,875$7,100$7,575$8,465”; and > ####
(3)by amending paragraph
(3)to read as follows: > > #### “(3) Total revenue amounts specified > > For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows: > > > ##### “(A) > > $312,606,000 for fiscal year 2023. > > > ##### “(B) > > $335,750,000 for fiscal year 2024. > > > ##### “(C) > > $350,746,400 for fiscal year 2025. > > > ##### “(D) > > $366,486,300 for fiscal year 2026. > > > ##### “(E) > > $418,343,000 for fiscal year 2027.” > . ###
(c)Annual Fee Setting; Adjustments Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended— ####
(1)in paragraph (1), by striking “2017” and inserting “2022”; ####
(2)in paragraph (2)— #####
(A)in subparagraph (A), by striking “2018” and inserting “2023”; #####
(B)in subparagraph (B)— ######
(i)in the matter preceding clause (i), by striking “fiscal year 2018” and inserting “fiscal year 2023”; and ######
(ii)in clause (ii), by striking “fiscal year 2016” and inserting “fiscal year 2022”; #####
(C)in subparagraph (C), by striking “Washington-Baltimore, DC-MD-VA-WV” and inserting “Washington-Arlington-Alexandria, DC-VA-MD-WV”; and #####
(D)in subparagraph (D), in the matter preceding clause (i), by striking “fiscal years 2018 through 2022” and inserting “fiscal years 2023 through 2027”; ####
(3)in paragraph (3), by striking “2018 through 2022” and inserting “2023 through 2027”; ####
(4)by redesignating paragraphs
(4)and
(5)as paragraphs
(7)and (8), respectively; and ####
(5)by inserting after paragraph
(3)the following: > > #### “(4) Performance improvement adjustment > > > ##### “(A) In general > > For each of fiscal years 2025 through 2027, after the adjustments under paragraphs
(2)and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable: > > > ###### “(i) > > For fiscal year 2025, the product of— > > > ###### “(I) > > the amount determined under subparagraph (B)(i)(I); and > > > ###### “(II) > > the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. > > > ###### “(ii) > > For fiscal year 2026, the product of— > > > ###### “(I) > > the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and > > > ###### “(II) > > the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. > > > ###### “(iii) > > For fiscal year 2027, the product of— > > > ###### “(I) > > the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and > > > ###### “(II) > > the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. > > > ##### “(B) Amounts > > > ###### “(i) Presubmission amount > > For purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows: > > > ###### “(I) > > For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met. > > > ###### “(II) > > For fiscal year 2026: > > > ###### “(aa) > > $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met. > > > ###### “(bb) > > $36,792,200 if such goal for fiscal year 2024 is met. > > > ###### “(III) > > For fiscal year 2027: > > > ###### “(aa) > > $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met. > > > ###### “(bb) > > $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met. > > > ###### “(cc) > > $40,572,600 if such goal for fiscal year 2025 is met. > > > ###### “(ii) De novo classification request amount > > For purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows: > > > ###### “(I) > > For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met. > > > ###### “(II) > > For fiscal year 2027: > > > ###### “(aa) > > $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met. > > > ###### “(bb) > > $11,765,400 if such goal for fiscal year 2024 is met. > > > ###### “(iii) Premarket notification and premarket approval amount > > For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows: > > > ###### “(I) > > For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met. > > > ###### “(II) > > For fiscal year 2027: > > > ###### “(aa) > > $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met. > > > ###### “(bb) > > $3,906,000 if the 4 goals for fiscal year 2024 are met. > > > ##### “(C) Performance calculation > > For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows: > > > ###### “(i) > > The performance of the Presubmission Written Feedback goal shall be based on data available as of— > > > ###### “(I) > > for fiscal year 2023, March 31, 2024; > > > ###### “(II) > > for fiscal year 2024, March 31, 2025; and > > > ###### “(III) > > for fiscal year 2025, March 31, 2026. > > > ###### “(ii) > > The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of— > > > ###### “(I) > > for fiscal year 2023, March 31, 2025; and > > > ###### “(II) > > for fiscal year 2024, March 31, 2026. > > > ##### “(D) Goals defined > > For purposes of this paragraph, the terms ‘Presubmission Written Feedback goal’, ‘De Novo Decision goal’, ‘510(k) decision goal’, ‘510(k) Shared Outcome Total Time to Decision goal’, ‘PMA decision goal’, and ‘PMA Shared Outcome Total Time to Decision goal’ refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022. > > > #### “(5) Hiring adjustment > > > ##### “(A) In general > > For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph
(B)for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C). > > > ##### “(B) Thresholds > > The thresholds specified in this subparagraph are as follows: > > > ###### “(i) > > For fiscal year 2025, the threshold is 123 hires for fiscal year 2023. > > > ###### “(ii) > > For fiscal year 2026, the threshold is 38 hires for fiscal year 2024. > > > ###### “(iii) > > For fiscal year 2027, the threshold is— > > > ###### “(I) > > 22 hires for fiscal year 2025 if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i); or > > > ###### “(II) > > 75 hires for fiscal year 2025 if such fees are so increased. > > > ##### “(C) Hiring adjustment amount > > The hiring adjustment amount for fiscal year 2025 and each subsequent fiscal year is the product of— > > > ###### “(i) > > the number of hires by which the hiring goal specified in subparagraph
(D)for the fiscal year before the prior fiscal year was not met; > > > ###### “(ii) > > $72,877; and > > > ###### “(iii) > > the applicable inflation adjustment under paragraph (2)(B) for the fiscal year for which the hiring goal was not met. > > > ##### “(D) Hiring goals > > The hiring goals for each of fiscal years 2023 through 2025 are as follows: > > > ###### “(i) > > For fiscal year 2023, 144 hires. > > > ###### “(ii) > > For fiscal year 2024, 42 hires. > > > ###### “(iii) > > For fiscal year 2025: > > > ###### “(I) > > 24 hires if the base establishment registration fees are not increased by the amount determined under paragraph (4)(A)(i). > > > ###### “(II) > > 83 hires if the base establishment registration fees are increased by the amount determined under paragraph (4)(A)(i). > > > ##### “(E) Number of hires > > For purposes of this paragraph, the number of hires for a fiscal year shall be determined by the Secretary as set forth in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022. > > > #### “(6) Operating reserve adjustment > > > ##### “(A) In general > > For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves. > > > ##### “(B) Designated amount > > Subject to subparagraph (C), for each fiscal year, the designated amount in this subparagraph is equal to the sum of— > > > ###### “(i) > > 13 weeks of operating reserves of carryover user fees; and > > > ###### “(ii) > > 1 month of operating reserves maintained pursuant to paragraph (8). > > > ##### “(C) Excluded amount > > For the period of fiscal years 2023 through 2026, a total amount equal to $118,000,000 shall not be considered part of the designated amount under subparagraph
(B)and shall not be subject to the decrease under subparagraph (A).” > . ###
(d)Conditions Section 738(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(g)) is amended— ####
(1)in paragraph (1)(A), by striking “$320,825,000” and inserting “$398,566,000”; and ####
(2)in paragraph (2), by inserting “de novo classification requests,” after “class III device,”. ###
(e)Crediting and Availability of Fees Section 738(h)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(h)(3)) is amended to read as follows: > > #### “(3) Authorization of appropriations > > > ##### “(A) In general > > For each of fiscal years 2023 through 2027, there is authorized to be appropriated for fees under this section an amount equal to the revenue amount determined under subparagraph (B), less the amount of reductions determined under subparagraph (C). > > > ##### “(B) Revenue amount > > For purposes of this paragraph, the revenue amount for each fiscal year is the sum of— > > > ###### “(i) > > the total revenue amount under subsection (b)(3) for the fiscal year, as adjusted under paragraphs
(2)and
(3)of subsection (c); and > > > ###### “(ii) > > the performance improvement adjustment amount for the fiscal year under subsection (c)(4), if applicable. > > > ##### “(C) Amount of reductions > > For purposes of this paragraph, the amount of reductions for each fiscal year is the sum of— > > > ###### “(i) > > the hiring adjustment amount for the fiscal year under subsection (c)(5), if applicable; and > > > ###### “(ii) > > the operating reserve adjustment amount for the fiscal year under subsection (c)(6), if applicable.” > .
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Sec. 2003
AUTHORITY TO ASSESS AND USE DEVICE FEES
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