Sec. 2201. Applicability of the targeted liability protections for pandemic and epidemic products and security countermeasures with respect to covid–19

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Section 319F–3(i)(1) of the Public Health Service Act (42 U.S.C. 247d–6d(i)(1)) is amended— in subparagraph (C), by striking ; or and inserting a semicolon; in subparagraph (D), by striking the period and inserting ; or ; and by adding at the end the following: a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act), biological product (including a vaccine) (as such term is defined in section 351(i)), or device (as such term is defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act) that— is the subject of a notice of use of enforcement discretion issued by the Secretary if such drug, biological product, or device is used— when such notice is in effect; within the scope of such notice; and in compliance with other applicable requirements of the Federal Food, Drug, and Cosmetic Act that are not the subject of such notice; in the case of a device, is exempt from the requirement under section 510(k) of the Federal Food, Drug, and Cosmetic Act; or in the case of a drug— meets the requirements for marketing under a final administrative order under section 505G of the Federal Food, Drug, and Cosmetic Act; or is marketed in accordance with section 505G(a)(3) of such Act. .

Section 319F–3(a)(5) of the Public Health Service Act (42 U.S.C. 247d–6d(a)(5)) is amended by inserting by, or in partnership with, Federal, State, or local public health officials or the private sector after distribution the first place it appears. Section 319F–3 of the Public Health Service Act ( 42 U.S.C. 247d–6d ) is amended by adding at the end the following: Nothing in this section shall be construed— to require use of procedures described in section 553 of title 5, United States Code, for a notice of use of enforcement discretion for which such procedures are not otherwise required; or to affect whether such notice constitutes final agency action within the meaning of section 704 of title 5, United States Code. .

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42 USC 247d–6d(i)(1)
42 USC 247d–6d(a)(5)
42 USC 247d–6d

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Sec. 2201

Applicability of the targeted liability protections for pandemic and epidemic products and security countermeasures with respect to covid–19

Cite42 USC 247d–6d(i)(1)

Cite42 USC 247d–6d(a)(5)

Cite42 USC 247d–6d

Cites 3Cited by 0 across 0 sources