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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form 3911 Prescription Drug Marketing: Reporting Form
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.docx Supporting Statement A
Prescription Drug Marketing: Reporting Form
Prescription Drug Marketing: Recordkeeping

All Historical Document Collections

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 Approved without change	Extension without change of a currently approved collection	2021-06-25
201804-0910-016 Approved without change	Extension without change of a currently approved collection	2018-05-24
201503-0910-001 Approved without change	Extension without change of a currently approved collection	2015-03-06
201110-0910-002 Approved without change	Extension without change of a currently approved collection	2011-10-05
200908-0910-005 Approved without change	Extension without change of a currently approved collection	2009-08-31
200606-0910-003 Approved without change	Extension without change of a currently approved collection	2006-06-23
200305-0910-005 Approved with change	Extension without change of a currently approved collection	2003-05-30
199912-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	1999-12-07

OMB Details

Prescription Drug Marketing: Reporting

Federal Enterprise Architecture: Health - Public Health Monitoring

Form		www.fda.gov/about-fda/reports-manuals-forms/forms	Instruction
Form 3911	Drug Notification	www.fda.gov/about-fda/reports-manuals-forms/forms	Form

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