Sec. 2. Advanced manufacturing technologies 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 adding at the end the following: Not later than 1 year after the date of enactment of the Securing America’s Medicine Cabinet Act of 2020 , the Secretary shall continue in effect the program to evaluate and approve new drug manufacturing technologies that are included in an application, or supplement to an application, for a drug under subsection
(b)or
(j)of section 505 of this Act or for a biological product submitted under subsection
(a)or
(k)of section 351 of the Public Health Service Act. The Secretary shall designate a method of manufacturing a drug as an advanced manufacturing technology under this section if the drug manufacturer demonstrates that such technology is likely to— prevent or resolve a drug shortage; maintain an adequate supply of critical medications for national emergencies; or promote the adoption of innovative approaches to drug product design and manufacturing. If the Secretary designates a method of manufacturing as an advanced manufacturing technology under this section, the Secretary shall take actions to expedite the development and implementation of such method of manufacture for purposes of approval of the application under subsection
(c)or
(j)of section 505 of this Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act, which may include, as appropriate— holding meetings between the sponsor of the application and appropriate Food and Drug Administration staff throughout the development of the technology; providing timely advice to, and interactive communication with, the sponsor regarding the development of the technology; 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. A sponsor who receives designation of an advanced manufacturing technology under this section shall provide the Secretary with a package of scientific evidence supporting the implementation of the advanced manufacturing technology in a particular context-of-use. Within 90 days of receiving the package, the Secretary shall determine whether a designated advanced manufacturing technology is validated for the proposed context of use based on the scientific merit the supporting evidence provided by the sponsor. Upon approval, the same sponsor may rely upon the advanced manufacturing technology for use across multiple manufacturing product lines within the same context-of-use without having to re-submit data to the Secretary validating the underlying technology. The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than 1 year after the date of enactment of the Securing America’s Medicine Cabinet Act of 2020 to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the program under this section. The Secretary shall— not later than 1 year after the date of enactment of the Securing America’s Medicine Cabinet Act of 2020 , issue draft guidance regarding the goals and implementation of the program under this section; and not later than 2 years after the date of enactment of the Securing America’s Medicine Cabinet Act of 2020 , issue final guidance with respect to the implementation of such program. The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this section. .
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Sec. 2
Advanced manufacturing technologies program
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