( 21 U.S.C. 379j–1(a)(1)(A) ), as amended by section 2(b), is further amended by adding at the end the following: (iv) Analysis For each fiscal year, the Secretary shall include in the report an analysis of the following: (I) The difference between the number of premarket applications filed under section 515 and applications filed under section 510(k) and the number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for— (aa) such applications filed during one fiscal year for which a decision is not scheduled to be made until the following fiscal year