under subchapter J of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this Act, and any other activities or goals included in recommendations transmitted to Congress pursuant to this subsection. Fees under such program shall be assessed and collected only if the requirements under paragraph (4) are met. (3) Audit (A) In general Beginning 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, the Secretary shall, on a biennial basis, perform an audit of the costs of reviewing such applications and any other activities under such subchapter J included in recommendations transmitted to Congress pursuant to this subsection. Such an audit shall compare the costs of reviewing such applications and other activities under such subchapter J to the amount of the user fee applicable to such applications and make any necessary adjustments as described in subparagraph (B). (B) Alteration of user fee The following adjustments shall apply with respect to audits performed under subparagraph (A): (i) If the audit performed 2 years after first 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 33 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. (ii) If the audit performed 6 years after first 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,