Information Collection Request
Authorization of Medical Products for Use Emergencies
ICR 202504-0910-001 · OMB 0910-0595 · Active
Forms and Documents
IC Document Collections
| IC ID | Collection | Type | Status | Form |
|---|---|---|---|---|
| 43607 |  Requests for an EUA and/or a substantive amendment to an existing EUA |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 254792 | 3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder |
Other-Statutory Authority - Authorization for medical products f | Modified | |
| 254791 | RECORDKEEPING: EUA holders |
Other-Statutory Authority - Authorization for medical products f | Modified | |
| 236302 | RECORDKEEPING: State and local Public Health Authorities |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 191144 | State and local public health authority requests for expiration date extension |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 191143 | State and local public health authority requests for Emergency Dispensing Order |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 191142 | State and local public health authority submissions required under conditions of authorization for unapproved EUA product |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 191141 | Submitting information required under conditions of aurhorization |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified | |
| 191140 | Pre-EUA submissions or amendments |
Other-Guidance; Emergency Use Authorization of Medical Products | Modified |
ICR Details
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