; (B) is a clinical laboratory service performed in a laboratory (including a public health laboratory) certified to conduct high-complexity testing pursuant to section 353 of the Public Health Service Act ( 42 U.S.C. 253a ) for which the developer has requested, or intends to request, emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), unless and until the emergency use authorization request under such section 564 has been denied or the developer of such test does not submit a request under such section within a reasonable timeframe