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 user fee program described in this subsection shall take effect only if the Food and Drug Administration issues a regulation 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 chapter V of such Act. (5) User fee program definitions and resource requirements (A) In general The term process for the review of in vitro clinical test submissions and applications means the following activities of the Secretary with respect to the review of in vitro clinical test premarket and technology certification applications including supplements for such applications: (i) The activities necessary for the review of premarket applications, premarket reports, technology certification applications, and supplements to such applications. (ii) Actions related to submissions in connection with in vitro clinical test development, the issuance of action letters that allow the marketing of in vitro clinical tests or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to support the development of in vitro clinical tests. (iii) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, technology certifications, and supplements. (iv) Monitoring of research conducted in connection with the review of such applications,