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Ex. AGY-FED-HEALTH-OTHER-039 Order Primary source read

Emergency Use Declaration (personal respiratory protective devices), 85 Fed. Reg. 13907 (Mar. 10, 2020)

Emergency Use Declaration

Alex M. Azar II, Secretary of Health and Human Services · United States (federal); Department of Health and Human Services, Office of the Secretary (Federal)

The COVID Project

The record

Jurisdiction
United States (federal); Department of Health and Human Services, Office of the Secretary
Level
Federal
Authority
FD&C Act s. 564(b)(1)(C)
Issued
2020-03-02 Mar. 2, 2020
Effective
2020-03-02
End
In force throughout 2020-2021 (read as 2021-09-30)
In force
Mar. 2, 2020 to Sept. 30, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Emergency declarationSupply chain
Addressees
  • FDA; respirator manufacturers, importers and users
Functions reached
  • SC supply chain (N95 respirators)
  • IC infection control
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

he also declared that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. DATES: The determination was effective February 4, 2020, and this declaration is effective March 2, 2020.

Enforcement

Predicate for the respirator EUAs