Information Collection

Expansion of the PDE File Layout and Addition of New PDE Fields (New)

IC 261111 under ICR 202609-0938-018 · OMB 0938-0982.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
New_2025_Prescription_Drug_Event_File_Layouts_FINAL_G.pdf	Instruction
New 2025 Prescription Drug Event (PDE) Final File Layouts_Field Updates_Q4-2023_508.pdf New 2025 Prescription Drug Event (PDE) Final File Layouts Field Updates	IC Document
New 2025 Prescription Drug Event (PDE) File Layouts (Draft)_508.pdf New 2025 Prescription Drug Event (PDE) Final File Layouts_Seeking Feedback	IC Document
May 01, 2026 - Clarification of Prescription Drug Event (PDE) Reporting Requirements for 340B Identification [PDF].pdf Clarification of Prescription Drug Event (PDE) Reporting Requirements for 340B Identification	IC Document

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction					Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 994

Number of Respondents for Small Entity: 149

Affected Public: Private Sector

Private Sector: Businesses or other for-profits, Not-for-profit institutions

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	994	138	856
Annual IC Time Burden (Hours)	7,952	-51,968	59,920
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
New 2025 Prescription Drug Event (PDE) Final File Layouts Field Updates		03/01/2024
New 2025 Prescription Drug Event (PDE) Final File Layouts_Seeking Feedback		03/01/2024
Clarification of Prescription Drug Event (PDE) Reporting Requirements for 340B Identification		09/30/2026

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.

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