Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
3rd PARTY DISCLOSURE: Dissemination of required information by EUA holder or authorized stakeholder Modified 420 2100 0 Other-Statutory Authority - Authorization for medical products for use in emergencies
Other-Statutory Authority - Emergency use of medical products
Other-Statutory Authority - Products held for emergency use
Pre-EUA submissions or amendments Modified 9 306 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
Other-Submission Template
Other-Submission Template - Surgical Masks EUA
Other-Submission Template
Other-Agency Template
Other-Submission Template
Other-Submission Tmeplate
Other-Submission Template
RECORDKEEPING: EUA holders Modified 444 11100 0 Other-Statutory Authority - Authorization for medical products for use in emergencies
Other-Statutory Authority - Emergency use of medical products
Other-Statutory Authority - Products held for emergency use
RECORDKEEPING: State and local Public Health Authorities Modified 1 3 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
Other-Statutory Authority - Authorization for medical products for use in emergencies
Other-Statutory Authority - Emergency use of medical products
Other-Statutory Authority - Products held for emergency use
Requests for an EUA and/or a substantive amendment to an existing EUA Modified 24 1080 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
State and local public health authority requests for Emergency Dispensing Order Modified 1 2 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
State and local public health authority requests for expiration date extension Modified 1 20 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
State and local public health authority submissions required under conditions of authorization for unapproved EUA product Modified 1 2 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
Submitting information required under conditions of aurhorization Modified 53 424 0 Other-Guidance; Emergency Use Authorization of Medical Products and Related Authorities
Total burden requested under this ICR: 954 15037 0  
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