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Ex. AGY-FED-HEALTH-OTHER-131 Order Primary source read

Notice, Process for Making Available Guidance Documents Related to Coronavirus Disease 2019, 85 Fed. Reg. 16949 (Mar. 25, 2020)

Process for Making Available Guidance Documents Related to Coronavirus Disease 2019

Food and Drug Administration, HHS · United States (federal); Food and Drug Administration (Federal)

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The COVID Project

The record

Jurisdiction
United States (federal); Food and Drug Administration
Level
Federal
Authority
FD&C Act s. 701(h); 21 C.F.R. 10.115(g)(2), (g)(4)
Issued
2020-03-25 Mar. 25, 2020
Effective
2020-03-25
End
Through the public health emergency (read as 2021-09-30)
In force
Mar. 25, 2020 to Sept. 30, 2021
Quarters
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
Limitation types
Other
Addressees
  • regulated industry
Functions reached
  • SC supply chain
Collection
Other federal health agencies AGY-FED-HEALTH-OTHER

Operative words

The Food and Drug Administration (FDA or Agency) is announcing the process for making available FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA believes that this process will allow the Agency to

Enforcement

Procedural; authorizes immediately-in-effect guidance without prior comment

Notes

The procedural predicate under which every FDA COVID-19 temporary policy in this cluster issued without notice and comment and took effect immediately.

A record of The COVID Project. The instrument's text is the source's; the summary fields are The COVID Project's reading of it. Not legal advice.