; and (E) after consideration of such public views and comments, revise such recommendations as necessary. (3) Transmittal of recommendations Not later than January 15, 2023, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments. . I Other Provisions 391. Protecting access to biological products Section 351(k)(7) of the Public Health Service Act ( 42 U.S.C. 262(k)(7) ) is amended by adding at the end the following: (D) Deemed licenses (i) No additional exclusivity through deeming An approved application that is deemed to be a license for a biological product under this section pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009 shall not be treated as having been first licensed under subsection (a) for purposes of subparagraphs (A) and (B). (ii) Application of limitations on exclusivity Subparagraph (C) shall apply with respect to a reference product referred to in such subparagraph that was the subject of an approved application that was deemed to be a license pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009. (iii) Applicability The exclusivity periods described in section 527, section 505A(b)(1)(A)(ii), and section 505A(c)(1)(A)(ii) of the Federal Food, Drug, and Cosmetic Act shall continue to apply to a biological product after an approved application for the biological product is deemed to be a license for the biological product under subsection (a) pursuant to section 7002(e)(4) of the Biologics Price Competition and Innovation Act of 2009. . 392. Orphan drug clarification Section 527(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360cc(c) ) is amended by adding at the end the following: (3) Applicability This subsection applies to any drug designated under section 526 for which an application was approved under section 505 of