PRA IC List
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Agenda
Reg Review
ICR
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
Unchanged
1270
6350
0
Other-Statutory Authority
Other-Statutory Authority
Other-Statutory Authority
Pre-EUA submissions or amendments
Unchanged
2001
68034
0
Other-Guidance
Other-Submission Template
Other-Submission Template
Other-Submission Template
Other-Agency Template
Other-Submission Template
Other-Submission Tmeplate
Other-Submission Template
Public Health Authorities; request for EUA dispensing order
Unchanged
1
2
0
Other-Guidance
Public Health Authorities; request for extension of expiration date
Unchanged
1
20
0
Other-Guidance
Public Health Authorities; unapproved EUA product
Unchanged
1
2
0
Other-Guidance
RECORDKEEPING: EUA holders
Unchanged
1296
32400
0
Other-Statutory Authority
Other-Statutory Authority
Other-Statutory Authority
RECORDKEEPING: Public Health Authorities
Unchanged
1
2
0
Other-Guidance
Other-Statutory Authority
Other-Statutory Authority
Other-Statutory Authority
Requests for substantive amendment to an existing EUA
Unchanged
5448
245160
0
Other-Guidance
Submitting information required under conditions of aurhorization
Unchanged
108
864
0
Other-Guidance
Total burden requested under this ICR:
10127
352834
0
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