INSPECTIONS.

SEC. 806. [21 U.S.C. 374 note] INSPECTIONS. Within 6 months of the date of enactment of this Act, the Secretary of Health and Human Services shall develop and implement a protocol for expediting review of timely responses to reports of observations from an inspection under section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374). Such protocol shall— (1) apply to responses to such reports pertaining to applications submitted under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355)— (A) for which the approval is dependent upon remediation of conditions identified in the report; (B) for which concerns related to observations from an inspection under such section 704 are the only barrier to approval; and (C) where the drug that is the subject of the application is a drug— (i) for which there are not more than 3 other approved applications under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) that reference the same listed drug and for which there are less than 6 abbreviated new drug applications tentatively approved; or (ii) that is included on the list under section 506E of such Act (21 U.S.C. 356e); (2) address expedited re-inspection of facilities, as appropriate; and (3) establish a 6-month timeline for completion of review of such responses to such reports.