; and (2) the number of such petitions pending a substantive response for more than 180 days from the date of receipt. 204. Inspections Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ), as amended by section 101, is further amended by adding at the end the following: (14) If the Secretary issues feedback pursuant to section 704(b)(2) with respect to information submitted in response to a report under section 704(b)(1), and a report that was issued under section 704(b)(1) is the only obstacle to approval of an application under this subsection or the Secretary determines that the public health benefit of approving an application under this subsection outweighs any risk to public health, the Secretary shall, within 45 days of notification by the applicant that necessary changes have been made to the establishment to address any findings or deficiencies identified previously by the Secretary— (A) re-inspect the establishment with respect to which the report was issued; or (B) make a determination regarding the response to such report and review of such application. .