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Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
ICR 202212-0910-014
OMB: 0910-0045
Federal Form Document
OMB.report
HHS/FDA
OMB 0910-0045
ICR 202212-0910-014
( )
Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check
IC Document Collections
.
IC Document Collections
IC ID
Document
Title
Status
5696
Initial establishment registration
Unchanged
257653
Reporting and Mitigating Animal Drug Shortages
New
257647
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Recordkeeping; developing and updating plan)
New
257646
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation)
New
250057
CARES 3112(e); reporting drug manufacture amounts and exemption from reporting - drug shortage determinations
Unchanged
187821
RECORDKEEPING: One-Time Preparation of SOP
Unchanged
187820
Waiver requests
Unchanged
183175
June and December review and updates (or certifications) of listing (including NDC) information
Unchanged
183174
Requests for exemptions from public disclosures under 207.81
Unchanged
183173
Initial listing (including NDC) information
Unchanged
183172
Annual Updates of Registration Information (including expedited updates)
Unchanged
ICR Details
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