Sec. 105.
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Section 319F–2(c)(1)(B) of the Public Health Service Act (42 U.S.C. 247d–6b(c)(1)(B)) is amended— in clause (i)(III)(bb), by striking ; or and inserting a semicolon; in clause (ii), by striking the period and inserting ; or ; and by adding the following new clause: the Secretary determines to be a necessary countermeasure to diagnose, mitigate, prevent, or treat harm from any infectious disease that may pose a threat to the public health; and is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act, or licensed under section 351 of this Act; or is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under subclause (I). .
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- 42 USC 247d–6b(c)(1)(B)
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Sec. 105
Cite42 USC 247d–6b(c)(1)(B)
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