receiving a user fee applicable to submission of an in vitro clinical test application described under subparagraph (A) indicates that the user fees collected for purposes of such subchapter J exceed 40 percent of the costs of reviewing such applications, and carrying out activities included in recommendations transmitted to Congress pursuant to this subsection, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. (iii) If the audit performed 12 years after first receiving a user fee applicable to submission of an in vitro clinical test application described under subparagraph (A), and any audit performed after such date, indicates that the user fees collected for purposes of such subchapter J exceed 49 percent of the costs of reviewing such applications, and carrying out activities included in recommendations transmitted to Congress pursuant to this subsection, the Secretary shall alter the user fees applicable to applications submitted under such subchapter J such that the user fees do not exceed such percentage. (C) Accounting standards The Secretary shall perform an audit under subparagraph (A) in conformance with the accounting principles, standards, and requirements prescribed by the Comptroller General of the United States under section 3511 of title 31, United States Code, to ensure the validity of any potential variability. (D) Implementation requirements In the event that the Secretary fails to promulgate the regulations described in section 587B(a)(4), 587D(j), or 587S(b)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 3, by the applicable deadline for each such regulations as described in section 5(a)(2)(A)(ii), the Secretary shall provide that the user fees applicable to applications submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by section 3, do not exceed 30 percent of the costs of reviewing such applications. (4) Conditions The