such change. . (b) Administration (1) Implementation Notwithstanding any other provision of law, the Secretary of Health and Human Services may implement the amendment made by subsection (a) by subregulatory guidance, program instruction, or otherwise. (2) Non-application of the Paperwork Reduction Act Chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act of 1995 ), shall not apply to the implementation of the amendment made by subsection (a). 303. Expediting competitive biosimilar competition (a) In general Section 351(k) of the Public Health Service Act ( 42 U.S.C. 262(k) ) is amended by adding at the end the following: (10) Expediting competitive biosimilar competition (A) In general The Secretary may, at the request of the sponsor of an application under this subsection for a biosimilar biological product that is designated as a competitive biosimilar therapy pursuant to subsection (b), expedite the development and review of such application under this subsection. (B) Designation process (i) Request The sponsor of an application under this subsection may request the Secretary to designate the drug as a competitive biosimilar therapy. A request for such designation may be made concurrently with, or at any time prior to, the submission of a biosimilar biological product license application under this subsection. (ii) Criteria A biological product is eligible for designation as a competitive biosimilar therapy under this paragraph if the Secretary determines that there is inadequate biosimilar competition. (iii) Designation Not later than 60 calendar days after the receipt of a request under clause (i), the Secretary may— (I) determine whether the biosimilar biological product that is the subject of the request meets the criteria described in clause (ii)