; (II) standards for allocating fixed expenditures across multiple years of an applicable drug clinical trial; (III) a standard format for the submission and posting of cost data under this paragraph; (IV) procedures, standards, and requirements for the reporting documentation and methodology required under subparagraph (C)(ii)(IV); and (V) any other procedures, standards, or requirements necessary to ensure public transparency of cost data as required by this paragraph. (ii) Initial regulations The Secretary shall— (I) not later than one year after the date of enactment of the Pharmaceutical Research Transparency Act of 2023 , propose initial regulations under clause (i); and (II) not later than 2 years after such date of enactment, finalize such regulations. (F) Applicability The requirements of this paragraph apply only to applicable drug clinical trials with a start date on or after the date of enactment of the Pharmaceutical Research Transparency Act of 2023 . . (b) Conforming changes Section 402(j) of the Public Health Service Act ( 42 U.S.C. 282(j) ), as amended by subsection (a), is further amended— (1) in paragraph (1)(A)(iv), by striking paragraph (2) or under paragraph (3) and inserting paragraph (2), (3), or (7) ; (2) in paragraph (4)— (A) in subparagraph (A), by striking paragraph (2) or paragraph (3) and inserting paragraph (2), (3), or (7) ; and (B) in subparagraph (B)(i), by striking paragraphs (2) and (3) each place it appears and inserting paragraphs (2), (3), and (7) ; and (3) in paragraph (5)— (A) in subparagraph (A), by striking paragraphs (2) and (3) each place it appears and inserting paragraphs (2), (3), and (7)