§2001. Designation of United States Anti-Doping Agency — Inbound Citations

Citations to §2001(b)

• 21 U.S.C. § 379j(c)(4)(A)

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  (A) 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.

• 21 U.S.C. § 379j(c)(4)(C)

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  (C) 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.

• 21 U.S.C. § 379j(c)(4)(D)

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  (D) 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.

• 21 U.S.C. § 379j(c)(5)(E)

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  (E) 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.

• 21 U.S.C. § 379j–1(a)(1)(A)(iv)(I)

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  (I) data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and the number of remaining vacancies, the number of full-time equivalents funded by fees collected pursuant to section 379j of this title, and the number of full time equivalents funded by budget authority at the Food and Drug Administration by each division within the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;