; and (C) in clause (i)(II), by inserting after discontinued) the following: by such person ; (10) in the heading of paragraph (1)(E), by striking biosimilar development program ; (11) in the heading of subparagraph (F) of paragraph (1), by striking biosimilar development program fees and inserting biosimilar biological product development fees ; (12) in paragraph (1)(F)— (A) in the heading of subparagraph (F), by striking biosimilar development program before fees ; and (B) by amending clause (i) to read as follows: (i) Refunds Except as provided in subparagraph (B)(iv), the Secretary shall not refund any initial or annual biosimilar biological product development fee paid under subparagraph (A) or (B), or any reactivation fee paid under subparagraph (D). ; (13) in paragraph (2)— (A) in the heading of paragraph (2), by striking and supplement ; (B) by amending subparagraphs (A) and (B) to read as follows: (A) In general Each person that submits, on or after October 1, 2017, a biosimilar biological product application shall be subject to the following fees: (i) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are required for approval. (ii) A fee established under subsection (c)(5) for a biosimilar biological product application for which clinical data (other than comparative bioavailability studies) with respect to safety or effectiveness are not required for approval. Such fee shall be equal to half of the amount of the fee described in clause (i). (B) Rule of applicability