DEFINITIONS.

SEC. 4002. DEFINITIONS. (a) Adjustment Factor.—Section 744G(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is amended to read as follows: “(1) The term ‘adjustment factor’ applicable to a fiscal year is the Consumer Price Index for urban consumers (Washington-Arlington-Alexandria, DC-VA-MD-WV; Not Seasonally Adjusted; All items) for September of the preceding fiscal year divided by such Index for September 2011.” . (b) Biosimilar Biological Product Application.—Section 744G(4)(B)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(4)(B)(iii)) is amended— (1) by striking subclause (II) (relating to an allergenic extract product); and (2) by redesignating subclauses (III) and (IV) as subclauses (II) and (III), respectively.