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

ICR 202603-0910-008

OMB: 0910-0045

Federal Form Document

IC Document Collections

IC ID	Document Title	Status
5696	Initial establishment registration Other-Agency Guidance	Unchanged
279482	RULE: One-Time Declaration of Label Update in Annual Report	New
279481	RULE: One-Time Declaration of Label Update in Annual Report	New
279478	RULE: One-Time Declaration of Label Update in Annual Report	New
279474	RULE: One-Time Update to Label (Barcode and NDC)	New
257653	Reporting and Mitigating Animal Drug Shortages Other-Reporting and Mitigating Animal Drug Shortages - Agency Gu	Unchanged
257646	Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (Reporting; Notify FDA of Plan Activation and Deactivation) Other-Planning for the Effects of Absenteeism - Agency Guidance	Unchanged
250057	Manufacture amounts and exemption from reporting - drug shortage determinations Other-Public Law: CARES Act	Unchanged
187820	Waiver requests	Unchanged
183175	June and December review and updates (or certifications) of listing (including NDC) information Other-Agency Guidance	Unchanged
183174	Requests for exemptions from public disclosures Other-Agency Guidance	Unchanged
183173	Initial listing (including NDC) information Other-Agency Guidance	Unchanged
183172	Annual Updates of Registration Information (including expedited updates) Other-Agency Guidance	Unchanged