; and (B) include any other information required by the Secretary. (2) Exception The annual reporting requirement in paragraph (1) shall not apply to in vitro clinical tests that are deemed to have a premarket approval based on a prior approval under section 515(c), clearance under section 510(k), or authorization under section 513(f). (l) Service of orders Orders of the Secretary under this section with respect to applications under subsection (c) or (d) or supplements under subsection (h) shall be served— (1) in person by any officer or employee of the Department of Health and Human Services designated by the Secretary; or (2) by mailing the order by registered mail or certified mail or electronic equivalent addressed to the applicant at the last known address in the records of the Secretary. 587C. Breakthrough in vitro clinical tests (a) In General The purpose of this section is to encourage the Secretary and provide the Secretary with sufficient authority to apply efficient and flexible approaches to expedite the development of, and prioritize the review of, in vitro clinical tests that represent breakthrough technologies. (b) Establishment of program The Secretary shall establish a program to expedite the development of, and provide for the priority review of, in vitro clinical tests. (c) Eligibility The program developed under subsection (b) shall be available for any in vitro clinical test that— (1) provides or enables more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions compared to existing approved or precertified alternatives; and (2) is a test— (A) that represents a breakthrough technology; (B) for which no approved or precertified alternative exists