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Electronic Submissions via ESG - Mandatory Reports
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based)
OMB: 0910-0291
IC ID: 253750
OMB.report
HHS/FDA
OMB 0910-0291
ICR 202306-0910-006
IC 253750
( )
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:
Electronic Submissions via ESG - Mandatory Reports
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR Parts 1-1299 as applicable (To search for a specific CFR, visit the
Code of Federal Regulations.
)
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
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:
956
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
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
1,836
0
0
0
0
1,836
Annual IC Time Burden (Hours)
1,486
0
0
0
0
1,486
Annual IC Cost Burden (Dollars)
0
0
0
0
0
0
Documents for IC
Title
Document
Date Uploaded
No associated records found
Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.