; or (2) notify the Secretary that the holder of the approved application does not believe that the requested labeling changes are warranted and submit a statement detailing the reasons why such changes are not warranted. (f) Review of application holder’s response (1) In general Upon receipt of the application holder’s response, the Secretary shall promptly review each statement received under subsection (e)(2) and determine which labeling changes pursuant to the Secretary’s notice under subsection (d) are appropriate, if any. If the Secretary disagrees with the reasons why such labeling changes are not warranted, the Secretary shall provide opportunity for discussions with the application holders to reach agreement on whether the labeling for the covered drug should be updated to reflect available scientific evidence, and if so, the content of such labeling changes. (2) Changes to labeling After considering all responses from the holder of an approved application under paragraph (1) or (2) of subsection (e), and any discussion under paragraph (1), the Secretary may order such holder to make the labeling changes the Secretary determines are appropriate and meet the standards under section 505 for adding or modifying information or providing supplemental information to such labeling. Such holder of an approved application shall— (A) update its paper labeling for the drug at the next printing of that labeling; (B) update any electronic labeling for the drug within 30 days of such order; and (C) submit the revised labeling through the form, Supplement—Changes Being Effected . (g) Violation If the holder of an approved application for the generic version of the selected drug does not comply with the requirements of subsection (f)(2), such generic version of the selected drug shall be deemed to be misbranded under section 502. (h) Limitations