The COVID Project
The record
- Jurisdiction
- United States (federal); Food and Drug Administration
- Level
- Federal
- Authority
- FD&C Act s. 564(g)(2), (h)(1)
- Issued
- 2021-08-31 Aug. 31, 2021
- Effective
- Decontamination and bioburden-reduction EUAs revoked June 30, 2021; imported FFR and China FFR umbrella EUAs revoked July 6, 2021 (read as 2021-06-30)
- End
- Revocations effective as stated (read as 2021-09-30)
- In force
- June 30, 2021 to Sept. 30, 2021
- Quarters
- 2021 Q3
2020 Q22020 Q32020 Q42021 Q12021 Q22021 Q3
- Limitation types
- Health care ordersSupply chain
- Addressees
- holders of the fifteen revoked EUAs; health care facilities using decontaminated or imported respirators
- Functions reached
- SC supply chain (PPE)
- IC infection control
- WH warehouse (inventory of imported respirators)
- Collection
- Other federal health agencies AGY-FED-HEALTH-OTHER
Operative words
The Food and Drug Administration (FDA) is announcing the revocation of 15 Emergency Use Authorizations (EUAs) (the Authorizations), including 12 Authorizations for decontamination systems for personal protective equipment, 1 Authorization for a bioburden reduction system for personal protective equipment, and 2 umbrella Authorizations for certain imported, non-NIOSH... approved disposable respirators.... DATES: The Authorizations for the decontamination and bioburden reduction systems are revoked as of June 30, 2021. The Authorizations for the China FFR Authorization and Imports FFR Authorization are revoked as of July 6, 2021.
Enforcement
Interstate commerce in the formerly authorized products again subject to 21 U.S.C. 331
Notes
A Q3 2021 federal instrument that changed the PPE supply chain of every health-care employer and of the importers, distributors and decontamination contractors that had operated under the revoked EUAs.
Retrieval note86, No. 166 / Tuesday, August 31, 2021 / Notices'; no page 48491 appears in the file (25 FR pages, 48712-48736)).