Information Collection List

IC Title Status Responses Hours Dollars Document Type Form No. Form Name
Annual Updates of Registration Information (including expedited updates) Modified 31440 15720 0 Other-Agency Guidance
Initial establishment registration Modified 1186 1186 0 Other-Agency Guidance
Initial listing (including NDC) information Modified 22130 33197 0 Other-Agency Guidance
June and December review and updates (or certifications) of listing (including NDC) information Modified 103060 77295 0 Other-Agency Guidance
Manufacture amounts and exemption from reporting - drug shortage determinations Modified 195750 195750 0 Other-Public Law: CARES Act
Other-Procedural Guidance
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Recordkeeping; developing and updating plan) Removed 0 0 0 Other-Planning for the Effects of Absenteeism Guidance
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation) Unchanged 2 32 0 Other-Planning for the Effects of Absenteeism - Agency Guidance
RECORDKEEPING: One-Time Preparation of SOP Removed 0 0 0
Reporting and Mitigating Animal Drug Shortages Unchanged 60 60 0 Other-Reporting and Mitigating Animal Drug Shortages - Agency Guidance
Requests for exemptions from public disclosures Modified 30 30 0 Other-Agency Guidance
Waiver requests Unchanged 1 1 0
Total burden requested under this ICR: 353659 323271 0  
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