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Ex. FED-182 Order Primary source read

Emergency Use Declaration: personal respiratory protective devices

Emergency Use Declaration, 85 Fed. Reg. 13907 (Mar. 10, 2020)

Secretary of Health and Human Services · United States (Federal)

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The record

Jurisdiction
United States
Level
Federal
Authority
FD&C Act § 564
Issued
2020-03-02 Mar. 2, 2020
Effective
2020-03-02 ('this declaration is effective March 2, 2020') (read as 2020-03-02)
End
through the § 564 emergency (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; manufacturers and importers of respirators; health care employers
Functions reached
  • context for SC (respirator supply) in every health care and industrial sector
Collection
Federal health, safety and transport layer FED-A

Operative words

On the basis of this determination, 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

Framework for the NIOSH-respirator, imported-respirator and decontamination EUAs

Notes

CONTEXT ONLY; the federal finding of March 2, 2020 that respirator supply required emergency measures precedes the DPA orders (FED-070 to FED-075) by two to five weeks.

Retrieval note

context.