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MedWatch: The FDA Medical Products Reporting Program
MedWatch: The FDA Medical Products Reporting Program
OMB: 0910-0291
IC ID: 5858
OMB.report
HHS/FDA
OMB 0910-0291
ICR 200508-0910-004
IC 5858
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0291 can be found here:
2023-06-21 - No material or nonsubstantive change to a currently approved collection
2022-05-23 - Revision of a currently 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:
MedWatch: The FDA Medical Products Reporting Program
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-3500
Yes
Yes
Form
3500A
Yes
Yes
Federal Enterprise Architecture Business Reference Module
Line of Business:
Subfunction:
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
30,617
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
20 %
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
488,403
0
0
115,416
0
372,987
Annual IC Time Burden (Hours)
523,118
0
0
166,749
0
356,369
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.