; (B) provide a template for requests under subsection (b); (C) identify the criteria the Secretary will use in evaluating a request for designation under this section; and (D) identify the criteria and processes the Secretary will use to expedite the development and review of products designated under this section. (2) Process Prior to finalizing the guidance under paragraph (1), the Secretary shall seek public comment on a draft version of that guidance. (e) Generic complex drug product defined In this section, the term generic complex drug product means a product that represents a complex therapy that consists of or includes a drug for approval under section 505(j) and that— (1) (A) contains complex active ingredients (such as peptides, polymeric compounds, complex mixtures of active ingredients, and naturally sourced ingredients); (B) is composed of complex formulations (such as liposomes or colloids); (C) requires a complex route of delivery (such as locally acting drugs such as dermatological products and complex ophthalmological products and otic dosage forms that are formulated as suspensions, emulsions, or gels); or (D) involves a complex dosage form (such as transdermals, metered dose inhalers, or extended release injectables); (2) presents as a complex drug-device combination product (such as auto injectors or metered dose inhalers); or (3) is a product that would benefit from early scientific engagement due to complexity or uncertainty concerning the approval pathway under section 505(j). . 342. Preventing blocking of generic drugs (a) In general Section 505(j)(5)(B)(iv)(I) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j)(5)(B)(iv)(I) ) is amended— (1) by striking 180 days after the date and inserting “180 days after the earlier of the following: (aa) The date