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;

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

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.

data, analysis, and discussion of the changes in the number of individuals hired as agreed upon in the letters described in section 4001(b) of the Biosimilar 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–52 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 Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner;

for each of the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Office of Regulatory Affairs, and the Office of the Commissioner, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and

data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of biosimilar biological product application.

Relevant data to determine whether the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research have met the performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022 for the applicable fiscal year.

The most common causes and trends for external or other circumstances affecting the ability of the Secretary to meet review time and performance enhancement goals identified by the letters described in section 401(b) ¹ of the Biosimilar User Fee Amendments of 2022.

a justification for such determination and a description of the types of circumstances and trends, as applicable, under which biosimilar biological product applications missed the review goal times but were approved during the first cycle review, or review goals were missed; and

with respect to performance enhancement goals that were not achieved, a description of efforts the Food and Drug Administration has put in place for the fiscal year in which the report is submitted to improve the ability of such agency to meet each such goal for the such ² fiscal year.

the Committee on Energy and Commerce of the House of Representatives;

the Committee on Health, Education, Labor, and Pensions of the Senate;

scientific and academic experts;

health care professionals;

representatives of patient and consumer advocacy groups; and

the regulated industry.

publish a notice in the Federal Register requesting public input on the reauthorization;

hold a public meeting at which the public may present its views on the reauthorization;

provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes to this part; and

publish the comments on the Food and Drug Administration’s website.

present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

publish such recommendations in the Federal Register;

provide for a period of 30 days for the public to provide written comments on such recommendations;

hold a meeting at which the public may present its views on such recommendations; and

after consideration of such public views and comments, revise such recommendations as necessary.