OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements

OMB 0910-0435 · HHS/FDA.

OMB 0910-0435

This information collection supports implementation of the Prescription Drug Marketing Act and FDA regulations. The regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.

The latest form for Prescription Drug Marketing: Administrative Procedures, Policies, and Requirements expires 2028-02-29 and is listed under ICR 202502-0910-009.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 3911 Drug NotificationForm
Form 3911 Prescription Drug Marketing: ReportingForm
0435 PDMA 83-C to use Form FDA 3911 FEB 2025.docxJustification for No Material/Nonsubstantive Change
0435 PDMA 83-C to use Form FDA 3911 FEB 2025.docx Justification for No Material/Nonsubstantive Change
0435 PDMA SSA Ext 2024 FDA amended 1-17-25.docxSupporting Statement A
0435 PDMA SSA Ext 2024 FDA amended 1-17-25.docxSupporting Statement A
Prescription Drug Marketing: Reporting Form
Prescription Drug Marketing: Reporting Form
Prescription Drug Marketing: Reporting Instruction
Prescription Drug Marketing: Recordkeeping Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202502-0910-009 No material or nonsubstantive change to a currently approved collection 2025-03-31
202403-0910-010 Extension without change of a currently approved collection 2024-06-06
202105-0910-006 Extension without change of a currently approved collection 2021-06-25 Approved without change
201804-0910-016 Extension without change of a currently approved collection 2018-05-24 Approved without change
201503-0910-001 Extension without change of a currently approved collection 2015-03-06 Approved without change
201110-0910-002 Extension without change of a currently approved collection 2011-10-05 Approved without change
200908-0910-005 Extension without change of a currently approved collection 2009-08-31 Approved without change
200606-0910-003 Extension without change of a currently approved collection 2006-06-23 Approved without change
200305-0910-005 Extension without change of a currently approved collection 2003-05-30 Approved with change
199912-0910-002 New collection (Request for a new OMB Control Number) 1999-12-07 Approved without change

OMB Details

Prescription Drug Marketing: Reporting

Federal Enterprise Architecture: Health - Public Health Monitoring

Information collection instruments
FormNameElectronic accessType
Form www.fda.gov/about-fda/reports-manuals-forms/formsInstruction
Form 3911Drug Notificationwww.fda.gov/about-fda/reports-manuals-forms/formsForm

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.