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Reporting; Substantial Equivalence (SE) Report
Substantial Equivalence Reports for Tobacco Products
OMB: 0910-0673
IC ID: 195793
OMB.report
HHS/FDA
OMB 0910-0673
ICR 202402-0910-004
IC 195793
( )
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:
Reporting; Substantial Equivalence (SE) Report
Agency IC Tracking Number:
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Voluntary
CFR Citation:
21 CFR 1107.18
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:
1,139
Number of Respondents for Small Entity:
126
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
83 %
Requested
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
1,139
0
0
456
0
683
Annual IC Time Burden (Hours)
341,700
0
0
136,800
0
204,900
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.