SUITABILITY PETITIONS.

SEC. 805. SUITABILITY PETITIONS. (a) In general.—It is the sense of Congress that the Food and Drug Administration shall meet the requirement under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)) and section 314.93(e) of title 21, Code of Federal Regulations, of responding to suitability petitions within 90 days of submission. (b) Report.—The Secretary of Health and Human Services shall include in the annual reports under section 807— (1) the number of pending petitions under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(2)(C)); and (2) the number of such petitions pending a substantive response for more than 180 days from the date of receipt.