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21 U.S. Code § 379j-53. Reauthorization; reporting requirements
(a) Performance report
(1) General requirements
Not later than 120 days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) [1] of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals. The report for a fiscal year shall include information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort.
(2) Additional informationThe report under this subsection shall include the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—
(A)
information on all previous cohorts for which the Secretary has not given a complete response on all biosimilar biological product applications and supplements in the cohort;
(B)
the number of original biosimilar biological product applications filed per fiscal year, and the number of approvals issued by the agency for such applications; and
(C)
the number of resubmitted original biosimilar biological product applications filed per fiscal year and the number of approvals [2] letters issued by the agency for such applications.
(3) Real time reporting
(A) In general
Not later than 30 calendar days after the end of each quarter of each fiscal year for which fees are collected under this subpart, the Secretary shall post the data described in subparagraph (B) for such quarter and on a cumulative basis for the fiscal year on the internet website of the Food and Drug Administration, and may remove duplicative data from the annual report under this subsection.
(B) DataThe Secretary shall post the following data in accordance with subparagraph (A):
(i)
The number and titles of draft and final guidance on topics related to the process for the review of biosimilars, and whether such guidances were required by statute or pursuant to a commitment under the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022.
(ii)
The number and titles of public meetings held on topics related to the process for the review of biosimilars, and whether such meetings were required by statute or pursuant to a commitment under the letters described in section 401(b) 1 of the Biosimilar User Fee Amendments of 2022.