; (B) by striking safety information and inserting new safety information or new effectiveness information such ; and (C) by striking believes should be and inserting believes changes should be made to ; (2) in subparagraph (B)(i)— (A) by striking new safety information and by inserting new safety information or new effectiveness information ; and (B) by inserting indications, after boxed warnings, ; (3) in subparagraph (C), by inserting or new effectiveness information after safety information ; and (4) in subparagraph (E), by inserting or new effectiveness information after safety information . (f) Rule of construction Nothing in the amendments made by this section shall be construed to alter, in any manner, the meaning or application of the provisions of paragraph (3) of section 505(o) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o) ) with respect to the authority of the Secretary of Health and Human Services to require a postapproval study or clinical trial for a purpose specified in clauses (i) through (iii) of subparagraph (B) of such paragraph (3) or paragraph (4) of such section 505(o) with respect to the Secretary’s authority to require safety labeling changes.