; (II) all rapid-acting insulins; or (III) all long-acting insulins; or (ii) such other insulin categories, as the Secretary determines appropriate. (B) Increase The weighted averages under subparagraph (A) shall be increased in accordance with paragraph (2)(A)(ii), as applicable. (4) Application to authorized generic insulin In the case of an insulin that is classified as an authorized generic drug, as defined in section 505(t)(3) of the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. 355(t)(3) ), the manufacturer of such insulin may be certified under this section by submitting information under paragraph (1)(A) certifying that the list price of such authorized generic insulin is no greater than the list price, as of July 1, 2006, of the listed drug insulin product upon which the authorized generic drug was based under section 505(t) of the Federal Food, Drug and Cosmetic Act. The certification pursuant to this paragraph applies only to the authorized generic drug insulin, and does not apply with respect to the applicable listed drug insulin. (c) Audits and penalties The Inspector General of the Department of Health and Human Services may audit the financial records and other relevant records of any manufacturer submitting data under subsections (a) and (b), and any manufacturer or officer, director, agent, or managing employee of such manufacturer that knowingly submits false or incomplete data shall be subject to a civil penalty for each insulin for which false or incomplete data are submitted in an amount not to exceed the greater of— (1) an amount equal to 2 times the total amount of rebates paid by the manufacturer to State Medicaid plans for the insulin for rebate periods occurring in calendar year 2018 under section 1927 of the Social Security Act ( 42 U.S.C. 1396r–8 )