; and (E) in subparagraph (C), as so redesignated by subparagraph (C) of this paragraph, by redesignating subclauses (I) through (III) as clauses (i) through (iii), respectively, and by adjusting the margins accordingly; (3) by amending paragraph (4) to read as follows: (4) Interchangeability (A) In general A biological product licensed under this subsection shall be deemed to be interchangeable with the reference product. (B) Congressional briefing prior to certain study requirements The Secretary may require the sponsor of an application submitted under this section to conduct a study to evaluate the risk, in terms of safety, purity, or potency, of alternating or switching between the use of the biological product that is the subject of the application and the reference product, if, before requiring such a study, the Secretary first holds a private briefing with the chair and ranking member of the Committee on Health, Education, Labor, and Pensions of the Senate and the chair and the ranking member of the Committee on Energy and Commerce of the House of Representatives, to explain why such a study is necessary for the biological product, what information the Secretary expects such a study to reveal, what alternatives to such study have been considered, and why those alternatives are not sufficient. ; (4) by striking paragraph (6); and (5) in paragraph (8)(D)— (A) in clause (i), by striking class; and and inserting class. ; (B) by striking clause (ii)