financial hold

(A) means an order issued by the Secretary to prohibit the sponsor of a clinical investigation from continuing the investigation if the Secretary determines that the investigation is intended to support a biosimilar biological product application and the sponsor has failed to pay any fee for the product required under subparagraph (A), (B), or (D) of section 379j–52(a)(1) of this title; and

(B) does not mean that any of the bases for a “clinical hold” under section 355(i)(3) of this title have been determined by the Secretary to exist concerning the investigation.