OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Medication Guides for Prescription Drug Products: 21 CFR part 208

OMB 0910-0393 · HHS/FDA.

OMB 0910-0393

This information collection supports agency regulations pertaining to information communicated to patients through Patient Medication Guides found in 21 CFR part 208. Respondents to the information collection are sponsors of prescription drug products and authorized dispensers of prescription drug products who are required to provide the information upon dispensing the prescription drug product. FDA reviews the information as part of new drug marketing and biologic license applications submitted by product sponsors.

The latest form for Medication Guides for Prescription Drug Products: 21 CFR part 208 expires 2029-08-31 and is listed under ICR 202607-0910-001.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
E-D.pdf (document unavailable)Public Comments
E-C.pdf (document unavailable)Public Comments
E-A.pdf (document unavailable)Public Comments
PPLA Comment Letter FDA-2025-N-6869-Final 7-24-26.pdf (document unavailable)Public Comments
E-B.pdf (document unavailable)Public Comments
0393 Patient Medication Guides SSA 2026 - 30D response.docxSupporting Statement A
Content and Format of Medication Guide Information collection
Mfr. provides PMG or means to produce to distributers & authorized dispensers Information collection
Dispensing Medication Guide to patient Information collection
Distributor provides Medication Guide or means to produce to Dispenser Information collection
Exemptions and Deferrals Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202607-0910-001 Reinstatement with change of a previously approved collection 2026-07-01
202210-0910-010 Extension without change of a currently approved collection 2022-10-31 Approved with change
201908-0910-014 Extension without change of a currently approved collection 2019-09-10 Approved without change
201510-0910-012 Extension without change of a currently approved collection 2015-11-12 Approved with change
201204-0910-003 Extension without change of a currently approved collection 2012-04-30 Approved with change
200811-0910-007 Extension without change of a currently approved collection 2008-11-28 Approved with change
200506-0910-002 Extension without change of a currently approved collection 2005-06-07 Approved without change
200201-0910-004 Extension without change of a currently approved collection 2002-01-25 Approved without change
199812-0910-002 New collection (Request for a new OMB Control Number) 1998-12-03 Approved without change

OMB Details

Content and Format of Medication Guide

Federal Enterprise Architecture: Health - Consumer Health and Safety