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
- 2020-03-27 Mar. 27, 2020
- Effective
- 2020-03-27 (determination effective Feb. 4, 2020) (read as 2020-03-27)
- End
- In force throughout 2020-2021 (read as 2021-09-30)
- In force
- Mar. 27, 2020 to Sept. 30, 2021
- Quarters
- 2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Emergency declarationSupply chain
- Addressees
- FDA; drug and biologic manufacturers
- Functions reached
- SC supply chain
- IC infection control (therapeutics, vaccines)
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
he also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, 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 27, 2020.
Enforcement
Predicate for FDA drug and vaccine EUAs
Notes
Predicate for every COVID-19 vaccine and therapeutic EUA of 2020-2021, and therefore for the vaccination mandates of Q3 2021.
Retrieval noteFile slug misdescribes the subject: this Apr. 1, 2020 publication (85 Fed. Reg. 18250) is the DRUGS AND BIOLOGICS declaration of Mar. 27, 2020. Cite by the text, not the slug.