Information Collection

Collection of Drug Event Data from Contracted Part D Providers For Payments

IC 43675 under ICR 202609-0938-018 · OMB 0938-0982.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Requirements for Submitting Prescription Drug Event Data (PDE) .pdf	Instruction
PDE-Inbound-File-Layout-Final-20250101_Q4-2023.xlsx	Instruction
PDE-Outbound-File-Layout-Final-20250101_Q4-2023.xlsx	Instruction
September 30, 2025 - 2026 Prescription Drug Event (PDE) File Layout Updates_ pde_outbound_file_layout_effective_01012026 [XLSX].	Instruction
pdeparticipantguide.pdf	Instruction
September 30, 2025 - 2026 Prescription Drug Event (PDE) File Layout Updates_ 2026_prescription_drug_event_file_layout_updates [PDF].pdf Proposed Updates to the Prescription Drug Event (PDE) File Layout	IC Document
HPMS_memo_PDE_timeliness_clarification.pdf Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs	IC Document
IRASA PDE Guidance_508.pdf IRASA PDE Guideline	IC Document
ERPOSA Memo_508.pdf Reporting Estimated Remuneration Applied to the Point-of-Sale Price	IC Document
November 22, 2024 - End of Year Prescription Drug Event Submission Instructions to Facilitate Transition to 1000-byte File Layout [PDF].pdf End of Year Prescription Drug Event Submission Instructions to Facilitate Transition to 1000-byte File Layout	IC Document
May 10, 2024 - May 2024 Updates to the Drug Data Processing System (DDPS) [PDF].pdf Updates to the Drug Data Processing System (DDPS)	IC Document
May 10, 2024 - Prescription Drug Event Submission Certification Requirements for 2025 [PDF].pdf Prescription Drug Event Submission Certification Requirements for 2025	IC Document
June 28, 2024 - Additional Information Regarding Prescription Drug Event Submission Certification for 2025 [PDF].pdf Additional Information Regarding Prescription Drug Event Submission Certification for 2025 - June 2024	IC Document
July 12, 2024 - Prescription Drug Event Submission Certification Requirements for 2025 for PACE Organizations [PDF].pdf Additional Information Regarding Prescription Drug Event Submission Certification for 2025 - July 2024	IC Document

Information Collection (IC) Details

View Information Collection (IC)

IC Title:

Collection of Drug Event Data from Contracted Part D Providers For Payments

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	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction	Yes	No	Printable Only
Instruction	Yes	Yes	Printable Only
Instruction	Yes	Yes	Printable Only
Instruction	Yes	Yes	Printable Only
Instruction	Yes	Yes	Printable Only

Federal Enterprise Architecture Business Reference Module

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,627,798,686	128,733,906	1,499,064,780
Annual IC Time Burden (Hours)	3,256	258	2,998
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

table that charts IC Documents
Title	Document	Date Uploaded
Proposed Updates to the Prescription Drug Event (PDE) File Layout		09/30/2026
Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs		03/01/2024
IRASA PDE Guideline		03/01/2024
Reporting Estimated Remuneration Applied to the Point-of-Sale Price		10/01/2026
End of Year Prescription Drug Event Submission Instructions to Facilitate Transition to 1000-byte File Layout		10/01/2026
Updates to the Drug Data Processing System (DDPS)		10/01/2026
Prescription Drug Event Submission Certification Requirements for 2025		10/01/2026
Additional Information Regarding Prescription Drug Event Submission Certification for 2025 - June 2024		10/01/2026
Additional Information Regarding Prescription Drug Event Submission Certification for 2025 - July 2024		10/01/2026

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

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