Sec. 707. Advanced manufacturing technologies designation pilot program
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Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by inserting after section 506J ( 21 U.S.C. 356j ) the following: Not later than 1 year after the date of enactment of this section, the Secretary shall initiate a pilot program under which persons may request designation of an advanced manufacturing technology as described in subsection (b). The Secretary shall establish a process for the designation under this section of methods of manufacturing drugs, including biological products, and active pharmaceutical ingredients of such drugs, as advanced manufacturing technologies.
A method of manufacturing, or a combination of manufacturing methods, is eligible for designation as an advanced manufacturing technology if such method or combination of methods incorporates a novel technology, or uses an established technique or technology in a novel way, that will substantially improve the manufacturing process for a drug and maintain equivalent or provide superior drug quality, including by— reducing development time for a drug using the designated manufacturing method; or increasing or maintaining the supply of— a drug that is described in section 506C(a) and is intended to treat a serious or life-threatening condition; or a drug that is on the drug shortage list under section 506E.
A person who requests designation of a method of manufacturing as an advanced manufacturing technology under this section shall submit to the Secretary data or information demonstrating that the method of manufacturing meets the criteria described in subsection
(b)in a particular context of use. The Secretary may facilitate the development and review of such data or information by— 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). If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall— expedite the development and review of an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, for drugs that are manufactured using a designated advanced manufacturing technology and could help mitigate or prevent a shortage or substantially improve manufacturing processes for a drug and maintain equivalent or provide superior drug quality, as described in subsection (b); 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 505 of this Act or section 351 of the Public Health Service Act, 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 Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after the date of enactment of this section, to discuss and obtain input and recommendations from relevant stakeholders regarding— the goals and scope of the pilot program, and a suitable framework, procedures, and requirements 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. The Secretary shall— not later than 180 days after the public meeting under paragraph (1), issue draft guidance regarding the goals and implementation of the pilot program under this section; and not later than 2 years after the date of enactment of this section, issue final guidance regarding the implementation of such program. The guidance described in subparagraph
(A)shall address— 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. Not later than 3 years after the date of enactment of this section and annually thereafter, the Secretary shall publish on the website of the Food and Drug Administration and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report containing a description and evaluation of the pilot program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following: 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 are relevant to determinations to designate and not to designate after evaluation under subsection (c)(2). The number of applications received under section 505 of this Act or section 351 of the Public Health Service Act, including supplemental applications, that have included an advanced manufacturing technology designated under this section, and the number of such applications approved. The Secretary— may not consider any requests for designation submitted under subsection
(c)after October 1, 2029; and may continue all activities under this section with respect to advanced manufacturing technologies that were designated pursuant to subsection
(d)prior to such date, if the Secretary determines such activities are in the interest of the public health. .
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