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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Annual Updates of Registration Information (including expedited updates)
Unchanged
10000
5000
0
CARES 3112(e); reporting drug manufacture amounts and exemption from reporting - drug shortage determinations
Unchanged
288000
72000
0
Initial establishment registration
Unchanged
2960
2960
0
Initial listing (including NDC) information
Unchanged
12470
18705
0
June and December review and updates (or certifications) of listing (including NDC) information
Unchanged
106000
79500
0
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Recordkeeping; developing and updating plan)
New
70
17500
0
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation)
New
2
32
0
RECORDKEEPING: One-Time Preparation of SOP
Unchanged
1000
40000
0
Reporting and Mitigating Animal Drug Shortages
New
60
60
0
Requests for exemptions from public disclosures under 207.81
Unchanged
100
100
0
Waiver requests
Unchanged
1
1
0
Total burden requested under this ICR:
420663
235858
0
To view an IC, click on IC Title