; (B) describe additional types of regulatory processes that will become subject to such initiatives; (C) specify the countries and geographic regions where such initiatives will be established or expanded; and (D) identify additional opportunities and challenges for expanding mutual recognition agreements in drug and biologic regulation. (d) Annual reporting (1) In general Not later than the end of calendar year 2020 and annually thereafter, the Secretary shall publish a report on the public website of the Food and Drug Administration on the utilization of agreements described in subsection (c)(1) in the previous fiscal year. (2) Contents The report under paragraph (1) shall include each of the following: (A) The total number of establishments that are registered under section 510(i) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360 ) and located outside of the United States, and of these establishments, the number in each region of interest. (B) The total number of inspections conducted at establishments described in subparagraph (A). (C) Of the inspections described in subparagraph (B), the total number of inspections in each of region of interest. (D) Of the inspections in each region of interest reported pursuant to subparagraph (C), the number of inspections in each FDA inspection category. (E) Of the number of inspections reported under each of subparagraphs (B), (C), and (D)— (i) the number of inspections which have been conducted pursuant to an agreement described in subsection (c)(1)