21 U.S.C. § 356l Advanced Manufacturing Technologies Designation Program

• Library: United States Statutes
• Edition: prefLabel,label,title,shortLabel
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)
• Citation: 21 U.S.C. § 356l

(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