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  
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