21 U.S.C. § 356l (FOOD AND DRUGS)
§ 356l. Advanced manufacturing technologies designation program
(a) In general
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).
(b) Designation process
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 while maintaining equivalent, or providing superior, drug quality, including by—
(1) reducing development time for a drug using the designated manufacturing method; or
(2) increasing or maintaining the supply of—
(A) a drug that is life-supporting, life-sustaining, or of critical importance to providing health care; or
(B) a drug that is on the drug shortage list under section 356e of this title.
(c) Evaluation and designation of an advanced manufacturing technology
(1) Submission
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—
(A) providing timely advice to, and interactive communication with, such person regarding the development of the method of manufacturing; and
(B) 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.
(2) Evaluation and designation
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).
(d) Review of advanced manufacturing technologies
If the Secretary designates a method of manufacturing as an advanced manufacturing technology, the Secretary shall—
(1) 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
(2) 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.
(e) Implementation and evaluation of advanced manufacturing technologies program
(1) Public meeting
The Secretary shall publish in the Federal Register a notice of a public meeting, to be held not later than 180 days after December 29, 2022, to discuss, and obtain input and recommendations from relevant stakeholders regarding—
(A) the goals and scope of the program under this section, and the framework, procedures, and requirements suitable for such program; and
(B) ways in which the Food and Drug Administration will support the use of advanced manufacturing technologies and other innovative manufacturing approaches for drugs.
(2) Program guidance
(A) In general
The Secretary shall—
(i) 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
(ii) not later than 2 years after December 29, 2022, issue final guidance regarding the implementation of such program.
(B) Content
The guidance described in subparagraph (A) shall address—
(i) the process by which a person may request a designation under subsection (b);
(ii) 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;
(iii) the process to expedite the development and review of applications under subsection (d); and
(iv) the criteria described in subsection (b) for eligibility for such a designation.
(3) Report
Not later than 3 years after December 29, 2022, 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 program being conducted under this section, including the types of innovative manufacturing approaches supported under the program. Such report shall include the following:
(A) The number of persons that have requested designations and that have been granted designations.
(B) The number of methods of manufacturing that have been the subject of designation requests and that have been granted designations.
(C) The average number of calendar days for completion of evaluations under subsection (c)(2).
(D) An analysis of the factors in data submissions that result in determinations to designate and not to designate after evaluation under subsection (c)(2).
(E) 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.
(f) Sunset
The Secretary—
(1) may not consider any requests for designation submitted under subsection (c) after October 1, 2032; and
(2) 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.
(June 25, 1938, ch. 675, § 506L, as added Pub. L. 117–328, div. FF, title III, § 3213, Dec. 29, 2022, 136 Stat. 5826.)