SPECIAL PROTOCOL ASSESSMENT.

SEC. 301. SPECIAL PROTOCOL ASSESSMENT. Section 505(b)(5)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(5)(B)) is amended by striking “size of clinical trials intended” and all that follows through “. The sponsor or applicant” and inserting the following: “size—“(i)(I) of clinical trials intended to form the primary basis of an effectiveness claim; or“(II) in the case where human efficacy studies are not ethical or feasible, of animal and any associated clinical trials which, in combination, are intended to form the primary basis of an effectiveness claim; or“(ii) with respect to an application for approval of a biological product under section 351(k) of the Public Health Service Act, of any necessary clinical study or studies.The sponsor or applicant”.