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Agenda
Reg Review
ICR
View Information Collection (IC)
View Information Collection (IC)
IC Title:
Expansion of the PDE File Layout and Addition of New PDE Fields (New)
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Instruction
New_2025_Prescription_Drug_Event_File_Layouts_FINAL_G.pdf
Yes
No
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:
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
Program Change Due to New Statute
Program Change Due to Agency Discretion
Change Due to Adjustment in Agency Estimate
Change Due to Potential Violation of the PRA
Previously Approved
Annual Number of Responses for this IC
856
0
0
0
0
856
Annual IC Time Burden (Hours)
59,920
0
0
0
0
59,920
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
New 2025 Prescription Drug Event (PDE) Final File Layouts Field Updates
New 2025 Prescription Drug Event (PDE) Final File Layouts_Field Updates_Q4-2023_508.pdf
03/01/2024
New 2025 Prescription Drug Event (PDE) Final File Layouts_Seeking Feedback
New 2025 Prescription Drug Event (PDE) File Layouts (Draft)_508.pdf
03/01/2024
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.