21 U.S.C. § 356l: Advanced manufacturing technologies designation program

Not later than 1 year after December 29, 2022 , the Secretary shall initiate a program under which persons may request designation of an advanced manufacturing technology as described in subsection (b). reducing development time for a drug using the designated manufacturing method; or a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or a drug that is on the drug shortage list under section 356e of this title . providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and involving senior managers and experienced staff of the Food and Drug Administration, as appropriate, in a collaborative, cross-disciplinary review of the method of manufacturing, as applicable. Not later than 180 calendar days after the receipt of a request under paragraph (1), the Secretary shall determine whether to designate such method of manufacturing as an advanced manufacturing technology, in a particular context of use, based on the data and information submitted under paragraph (1) and the criteria described in subsection (b). expedite the development and review of an application submitted under section 355 of this title or section 262 of title 42 , including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology; and allow the holder of an advanced technology designation, or a person authorized by the advanced manufacturing technology designation holder, to reference or rely upon, in an application submitted under section 355 of this title or section 262 of title 42 , including a supplemental application, data and information about the designated advanced manufacturing technology for use in manufacturing drugs in the same context of use for which the designation was granted. the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs. not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the program under this section; and not later than 2 years after December 29, 2022 , issue final guidance regarding the implementation of such program. the process by which a person may request a designation under subsection (b); the data and information that a person requesting such a designation is required to submit under subsection (c), and how the Secretary intends to evaluate such submissions; the process to expedite the development and review of applications under subsection (d); and the criteria described in subsection (b) for eligibility for such a designation. The number of persons that have requested designations and that have been granted designations. The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations. The average number of calendar days for completion of evaluations under subsection (c)(2). An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2). The number of applications received under section 355 of this title or section 262 of title 42 , including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved. may not consider any requests for designation submitted under subsection (c) after October 1, 2032 ; and may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection (b) prior to such date, if the Secretary determines such activities are in the interest of the public health.