Information Collection Request

Prescription Drug Product Labeling; Medication Guide Requirements

ICR 202210-0910-010 · OMB 0910-0393 · Received in OIRA

Forms and Documents

Document Name	Status
0393 Patient Medication Guides SSA 2022 EXT.docx Supporting Statement A	2022-10-31
PDUFA User Fee Schedule 87 FR 61063 Oct 7 2022.pdf Supplementary Document	2022-10-24

IC Document Collections

IC ID	Document Title	Status
6050	Content and Format of a Medication Guide	Modified
205325	Distributing and Dispensing a Medication Guide to Patients	Modified
188594	Distributor Provides Medication Guide to Dispenser	Unchanged
187331	Exemptions and Deferrals	Unchanged
187330	Supplements and Other Changes to an Approved Application	Removed

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0393
Type of Information Collection	Extension without change of a currently approved collection
Previous ICR Reference No	201908-0910-014
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31