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Mandatory and voluntary RFR (human and animal) via SRP
FDA Adverse Event and Products Experience Reports; Electronic Submissions
OMB: 0910-0645
IC ID: 192363
OMB.report
HHS/FDA
OMB 0910-0645
ICR 202109-0910-006
IC 192363
( )
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:
Mandatory and voluntary RFR (human and animal) via SRP
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Unchanged
Obligation to Respond:
Mandatory
CFR Citation:
21 CFR 514.80(b)(1)
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:
Consumer Health and Safety
Privacy Act System of Records
Title:
FR Citation:
Number of Respondents:
1,260
Number of Respondents for Small Entity:
0
Affected Public:
Individuals or Households
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
1,260
0
0
0
0
1,260
Annual IC Time Burden (Hours)
756
0
0
0
0
756
Annual IC Cost Burden (Dollars)
59,118
0
0
0
0
59,118
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.