Sec. 503. Accelerating countermeasure development and review

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Section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ) is amended by adding at the end the following: The Secretary may, at the request of the sponsor of a countermeasure, during a domestic, military, or public health emergency or material threat described in section 564A(a)(1)(C), expedite the development and review of countermeasures that are intended to address such domestic, military, or public health emergency or material threat for approval, licensure, clearance, or authorization under this title or section 351 of the Public Health Service Act. The actions to expedite the development and review of a countermeasure under paragraph

(1)may include the following: Expedited review of submissions made by sponsors of countermeasures to the Food and Drug Administration, including rolling submissions of countermeasure applications and other submissions. Expedited and increased engagement with sponsors regarding countermeasure development and manufacturing, including— holding meetings with the sponsor and the review team and providing timely advice to, and interactive communication with, the sponsor regarding the development of the countermeasure to ensure that the development program to gather the nonclinical and clinical data necessary for approval, licensure, clearance, or authorization is as efficient as practicable; involving senior managers and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review; assigning a cross-disciplinary project lead for the review team to facilitate; taking steps to ensure that the design of the clinical trials is as efficient as practicable, when scientifically appropriate, such as by minimizing the number of patients exposed to a potentially less efficacious treatment; and streamlining the review of approved, licensed, cleared, or authorized countermeasures to treat or prevent new or emerging threats, including the review of any changes to such countermeasures. Expedited issuance of guidance documents and publication of other regulatory information regarding countermeasure development and manufacturing. Other steps to expedite the development and review of a countermeasure application submitted for approval, licensure, clearance, or authorization, as the Secretary determines appropriate. Nothing in this subsection shall be construed to require the Secretary to grant, or take any other action related to, a request of a sponsor to expedite the development and review of a countermeasure for approval, licensure, clearance, or authorization under paragraph (1). .

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21 USC 360bbb–4

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Sec. 503

Accelerating countermeasure development and review

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