; (3) in paragraph (1)(A)(i), by striking (b)(1)(A) and inserting (c)(5) ; (4) in paragraph (1)(B)(i), by striking (b)(1)(B) for biosimilar biological product development and inserting (c)(5) for the biosimilar biological product development program ; (5) in paragraph (1)(B)(ii), by striking annual biosimilar biological product development program fee and inserting annual biosimilar biological product development fee ; (6) in paragraph (1)(B)(iii), by striking annual biosimilar development program fee and inserting annual biosimilar biological product development fee ; (7) in paragraph (1)(B), by adding at the end the following: (iv) Refund If a person submits a marketing application for a biosimilar biological product before October 1 of a fiscal year and such application is accepted for filing on or after October 1 of such fiscal year, the person may request a refund equal to the annual biosimilar development fee paid by the person for the product for such fiscal year. To qualify for consideration for a refund under this clause, a person shall submit to the Secretary a written request for such refund not later than 180 days after the marketing application is accepted for filing. ; (8) in paragraph (1)(C), by striking for a product effective October 1 of a fiscal year by, and inserting for a product, effective October 1 of a fiscal year, by, ; (9) in paragraph (1)(D)— (A) in clause (i) in the matter preceding subclause (I), by inserting , if the person seeks to resume participation in such program, before pay a fee ; (B) in clause (i)(I), by inserting after grants a request the following: by such person ; 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