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 applications means the following activities of the Secretary with respect to the review of premarket applications under section 587B of the Federal Food, Drug, and Cosmetic Act (as added by section 3), technology certification applications under section 587D of such Act (as added by section 3), and supplements for such applications: (i) The activities necessary for the review of premarket applications, premarket reports, and supplements to such applications. (ii) 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 place them in condition for approval. (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, supplements, and submissions. (v) Review of in vitro clinical test applications subject to section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), investigational new drug applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) ), or investigational test exemptions under section 587A(m) of the Federal Food, Drug, and Cosmetic Act (as added by section 3), and activities conducted in anticipation of the submission of such applications under section 505(i) of the Federal Food, Drug, and Cosmetic Act or investigational use under section 587R of the