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Drug Product Problem Reporting System
DRUG PRODUCT PROBLEM REPORTING SYSTEM
OMB: 0910-0024
IC ID: 109371
OMB.report
HHS/FDA
OMB 0910-0024
ICR 198412-0910-006
IC 109371
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0024 can be found here:
1992-07-09 - Reinstatement with change of a previously approved collection
1988-12-07 - Reinstatement with change of a previously approved collection
Documents and Forms
Document Name
Document Type
no available documents/forms check other ICs listed under this ICR
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
DRUG PRODUCT PROBLEM REPORTING SYSTEM
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Migrated
Obligation to Respond:
Voluntary
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Form
FDA 2519
No
No
Federal Enterprise Architecture Business Reference Module
Line of Business:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
5,500
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
0 %
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
6,325
0
0
205
0
6,120
Annual IC Time Burden (Hours)
632
0
0
-388
0
1,020
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.