; application of excise tax (a) Definitions In this section: (1) Applicable entity The term applicable entity means the holder of an application approved under subsection (c) or (j) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ), or of a license issued under subsection (a) or (k) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), for an insulin product. (2) Commerce The term commerce has the meaning given such term in section 4 of the Federal Trade Commission Act ( 15 U.S.C. 44 ). (3) Inspector General The term Inspector General means the Inspector General of the Department of Health and Human Services. (4) Price spike (A) In general The term price spike means an increase in the wholesale acquisition cost in commerce of an insulin product for which the price spike percentage is equal to or greater than the applicable price increase allowance. (B) Price spike percentage The term price spike percentage means the percentage (if any) by which— (i) the wholesale acquisition cost of an insulin product in commerce for the calendar year; exceeds (ii) the wholesale acquisition cost of such insulin product in commerce for the calendar year preceding such year. (C) Applicable price increase allowance The term applicable price increase allowance , with respect to a calendar year, means the percentage (rounded to the nearest one-tenth of 1 percent) by which the C–CPI–U (as defined in section 1(f)(6) of the Internal Revenue Code of 1986) for that year exceeds the C–CPI–U (as so defined) for the preceding calendar year. (5) Price spike revenue (A) In general The term price spike revenue , with respect to a calendar year, means an amount equal to— (i) the gross price spike revenue, minus (ii) the adjustment amount. (B) Gross price spike revenue The term gross price spike revenue , with respect to a calendar year, means an amount equal to the product of— (i) an amount equal to the difference between clause (i) of paragraph (4)(B) and clause (ii) of such paragraph