Platform technologies

The Secretary shall establish a program for the designation of platform technologies that meet the criteria described in subsection (b). A platform technology incorporated within or utilized by a drug or biological product is eligible for designation as a designated platform technology under this section if— A person may request the Secretary designate a platform technology as a designated platform technology concurrently with, or at any time after, submission under section 355(i) of this title or section 351(a)(3) of the Public Health Service Act [42 U.S.C. 262(a)(3)] for the investigation of a drug that incorporates or utilizes the platform technology that is the subject of the request. Not later than 90 calendar days after the receipt of a request under subsection (c), the Secretary shall determine whether the platform technology that is the subject of the request meets the criteria described in subsection (b). If the Secretary determines that the platform technology meets the criteria described in subsection (b), the Secretary shall designate the platform technology as a designated platform technology and may expedite the development and review of any subsequent application submitted under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for a drug that uses or incorporates the platform technology pursuant to subsection (e), as appropriate. If the Secretary determines that the platform technology does not meet the criteria under subsection (b), the Secretary shall include with the determination not to designate the technology a written description of the rationale for such determination. The Secretary may revoke a designation made under paragraph (2), if the Secretary determines that the designated platform technology no longer meets the criteria described in subsection (b). The Secretary shall communicate the determination to revoke a designation to the requesting sponsor in writing, including a description of the rationale for such determination. Nothing in this section shall prevent a product that uses or incorporates a designated platform technology from being eligible for expedited approval pathways if it is otherwise eligible under this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.]. The Secretary may take actions to expedite the development and review of an application for a drug that incorporates or utilizes a designated platform technology, including— The Secretary shall, consistent with applicable standards for approval, authorization, or licensure under this chapter and section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)], allow the sponsor of an application under section 355(b) of this title or section 351(a) of the Public Health Service Act or a request for emergency use authorization under section 360bbb–3 of this title, in order to support approval, licensure, or authorization, to reference or rely upon data and information within an application or request for a drug or biological product that incorporates or utilizes the same platform technology designated under subsection (d), provided that— A sponsor of more than one application approved under section 355(b) of this title or section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] for drugs that incorporate or utilize a designated platform technology may submit a single supplemental application for proposed changes to the designated platform technology that may be applicable to more than one such drug that incorporates or utilizes the same designated platform technology. Such supplemental application may cross-reference data and information submitted in other applications and may include one or more comparability protocols regarding how such changes to the platform technology would be made for each applicable drug or biological product. For purposes of this section: The term “platform technology” means a well-understood and reproducible technology, which may include a nucleic acid sequence, molecular structure, mechanism of action, delivery method, vector, or a combination of any such technologies that the Secretary determines to be appropriate, that the sponsor demonstrates— Nothing in this section shall be construed to—