V of the Federal Food, Drug, and Cosmetic Act, as added by this Act. Fees under such program shall be assessed and collected only if the requirements under paragraph (4) are met. (3) Audit (A) In general On the date that is 2 years after first receiving a user fee applicable to submission of an in vitro clinical test application submitted under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and on a biennial basis thereafter until October 1, 2027, the Secretary shall perform an audit of the costs of reviewing such applications under such subchapter J. Such an audit shall compare the costs of reviewing such applications under such subchapter J to the amount of the user fee applicable to such applications. (B) Alteration of user fee If the audit performed under subparagraph (A) indicates that the user fees applicable to applications submitted under such subchapter J exceed 30 percent of the costs of reviewing such applications, 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. (4) Conditions The user fee program described in this subsection shall take effect only if the Food and Drug Administration issues draft guidance related to the review requirements for in vitro diagnostic tests that would be subject to premarket review under section 587B of the Federal Food, Drug, and Cosmetic Act, as added by section 3, the review requirements for test categories eligible for technology certification under section 587D of such Act, as added by section 3, and the parameters for the test categories that would be exempt from any review under subchapter J of