Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

ICR 202212-0910-014

OMB: 0910-0045

Federal Form Document

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