Information Collection

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

IC 43675 under ICR 202403-0938-002 · OMB 0938-0982.

Documents and Forms

Document Name Document Type
PDEGuidance_PRA Disclosure Statement.pdf Instruction
PDEGuidance_PRA Disclosure Statement.pdf Instruction
PDE-Inbound-File-Layout-Final-20250101_Q4-2023.xlsx Instruction
PDE-Inbound-File-Layout-Final-20250101_Q4-2023.xlsx Instruction
PDE-Outbound-File-Layout-Final-20250101_Q4-2023.xlsx Instruction
PDE-Outbound-File-Layout-Final-20250101_Q4-2023.xlsx Instruction
Proposed Updates to the Prescription Drug Event (PDE) File Layout_508.pdf Proposed Updates to the Prescription Drug Event (PDE) File Layout IC Document
Proposed Updates to the Prescription Drug Event (PDE) File Layout_508.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
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
IRASA PDE Guidance_508.pdf IRASA PDE Guideline IC Document
ERPOSA Memo_508.pdf Reporting Estimated Remuneration Applied to the Point-of-Sale Price MEMO IC Document
ERPOSA Memo_508.pdf Reporting Estimated Remuneration Applied to the Point-of-Sale Price MEMO 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:

Document Type	Instrument File	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction	PDEGuidance_PRA Disclosure Statement.pdf	Yes	No	Printable Only
Instruction	PDE-Inbound-File-Layout-Final-20250101_Q4-2023.xlsx	Yes	Yes	Printable Only
Instruction	PDE-Outbound-File-Layout-Final-20250101_Q4-2023.xlsx	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 856	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 %

	Approved	Previously Approved
Annual Number of Responses for this IC	1,499,064,780	1,499,064,780
Annual IC Time Burden (Hours)	2,998	2,998
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Proposed Updates to the Prescription Drug Event (PDE) File Layout	Proposed Updates to the Prescription Drug Event (PDE) File Layout_508.pdf	03/01/2024
Timely Submission of Prescription Drug Event (PDE) Records and Resolution of Rejected PDEs	HPMS_memo_PDE_timeliness_clarification.pdf	03/01/2024
IRASA PDE Guideline	IRASA PDE Guidance_508.pdf	03/01/2024
Reporting Estimated Remuneration Applied to the Point-of-Sale Price MEMO	ERPOSA Memo_508.pdf	03/01/2024

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