; (II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of in vitro clinical test submissions and applications, including identifying— (aa) drivers of such changes; and (bb) changes in the average total cost per full-time equivalent in the in vitro clinical test review program; (III) for each of 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, the number of employees for whom time reporting is required and the number of employees for whom time reporting is not required; and (IV) data, analysis, and discussion of the changes in the average full-time equivalent hours required to complete review of each type of in vitro clinical test application. (v) Analysis For each fiscal year, the Secretary shall include in the report under clause (i) an analysis of the following: (I) The difference between the aggregate number of premarket applications filed under section 587B or section 587D of the Federal Food, Drug, and Cosmetic Act and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for— (aa) the number of applications filed under each of sections 587B and 587D of the Federal Food, Drug, and Cosmetic Act during one fiscal year for which a decision is not scheduled to be made until the following fiscal year