; or (ii) as provided under section 587F. (D) Process for establishment, change, or withdrawal Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may, upon the initiative of the Secretary or upon petition of an interested person, establish, change, or withdraw mitigating measures for an in vitro clinical test or category of in vitro clinical tests by— (i) publishing a proposed order in the Federal Register; (ii) providing an opportunity for public comment for a period of not less than 30 60 calendar days; and (iii) after consideration of any comments submitted, publishing a final order in the Federal Register that responds to the comments submitted, and which shall include a reasonable transition period. (E) Effect of mitigating measures on grandfathered tests A mitigating measure shall not be required by the Secretary for an in vitro clinical test subject to section 587G(a). (2) In vitro clinical tests previously cleared or exempt as devices with special controls (A) In general Any special controls applicable to an in vitro clinical test previously cleared or exempt under section 510(k), or classified under section 513(f)(2) prior to date of enactment of the VALID Act of 2023 , including any such special controls established during the period beginning on the date of enactment of the VALID Act of 2023 and ending on the effective date of such Act (as described in section 5(b) of such Act)— (i) shall continue to apply to such in vitro clinical test after such effective date