Information Collection

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

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0938-0982 can be found here:

Documents and Forms

Documents and forms in this information collection
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

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	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 %

table that charts list of burden
	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

table that charts IC Documents
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.