disease, and the availability of other tests (such as confirmatory or adjunctive tests) or relevant material standards. (D) Whether such mitigating measures sufficiently mitigate the risk of harm such that the test or category of tests is moderate-risk or low-risk. (4) Process (A) In general For a test that is not first-of-a-kind, any action under paragraph (1) shall be made by publication of a notice of such proposed action on the website of the Food and Drug Administration, the consideration of comments to a public docket on such proposal, and publication of a final action on such website within 60 calendar days of the close of the comment period posted to such public docket, notwithstanding subchapter II of chapter 5 of title 5, United States Code. (B) Process for first-of-a-kind test In the case of an in vitro clinical test that is first-of-a-kind, the process is as follows: (i) Any determination that the test is subject to premarket approval or abbreviated premarket review under subparagraph (A) or (B) of paragraph (1) shall be published on the website of the Food and Drug Administration, notwithstanding subclause II of chapter 5 of title 5, United States Code, only after the in vitro clinical test is approved under section 587B. Until that time, the determination shall not be binding on other in vitro clinical tests. (ii) Any determination other than those made under clause (i) shall be made by publication of a notice of final action on the website of the Food and Drug Administration, notwithstanding subchapter II of chapter 5 of title 5, United States Code. (5) No effect on grandfathering determinations A determination under paragraph (1) shall have no effect on the applicability of section 587G to an in vitro clinical tests. (b) Transition period Upon a decision by the Secretary to change a regulatory pathway designation, or reclassifies an in vitro clinical test, or category of in vitro clinical tests, the Secretary shall provide an appropriate transition period with respect to any new requirements. (c)