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

(a) In general. Within 1 year of December 29, 2022, the Secretary had to start a program letting people request designation of an advanced manufacturing technology under subsection (b). (b) Designation process. The Secretary must establish a process for designating manufacturing methods for drugs (including biological products) and their active pharmaceutical ingredients as advanced manufacturing technologies. A method, or combination of methods, is eligible if it incorporates a novel technology — or uses an existing technique or technology in a novel way — that will substantially improve the drug's manufacturing process while keeping drug quality equivalent or better, including by (1) reducing development time, or (2) increasing or maintaining supply of a drug that is life-supporting, life-sustaining, or critically important to health care, or that is on the drug shortage list under section 356e. (c) Evaluation and designation. A person requesting designation must submit data or information showing the method meets subsection (b)'s criteria in a particular context of use. The Secretary may facilitate this by giving timely, interactive advice and involving senior managers and experienced FDA staff in a collaborative, cross-disciplinary review. Within 180 calendar days of the request, the Secretary must determine whether to designate the method as an advanced manufacturing technology, based on the submitted data and the subsection (b) criteria. (d) Review of advanced manufacturing technologies. If a method is designated, the Secretary must expedite development and review of applications (including supplements) for drugs manufactured using it, and must let the designation holder — or an authorized person — reference or rely on data about the technology in applications for drugs made using it in the same context. (e) Implementation and evaluation. Within 180 days of December 29, 2022, the Secretary had to publish notice of, and hold, a public meeting to get stakeholder input on the program's goals, scope, framework, and how the FDA will support advanced manufacturing approaches. The Secretary had to issue draft guidance within 180 days of that meeting, and final guidance within 2 years of December 29, 2022, covering: how to request a designation; what data to submit and how it's evaluated; how review is expedited; and the eligibility criteria. Starting 3 years after December 29, 2022, and annually after that, the Secretary must publish and submit to the Senate HELP Committee and House Energy and Commerce Committee a report describing and evaluating the program, including: the number of people who requested and who received designations; the number of manufacturing methods requested and designated; the average number of days to complete evaluations; an analysis of what factors led to designation or non-designation; and the number of applications that included a designated technology and how many were approved. (f) Sunset. The Secretary may not consider designation requests submitted after October 1, 2032, but may continue activities for technologies designated before that date, if the Secretary determines doing so serves the public health.