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Product Quantity Change SE Report
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
OMB: 0910-0673
IC ID: 215515
OMB.report
HHS/FDA
OMB 0910-0673
ICR 201904-0910-003
IC 215515
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0673 can be found here:
2024-11-26 - Revision of a currently approved collection
2021-10-05 - Revision of a currently approved collection
Documents and Forms
Document Name
Document Type
SE FAQ guidance.pdf
Other-Guidance
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
Product Quantity Change SE Report
Agency IC Tracking Number:
CTP
Is this a Common Form?
No
IC Status:
Modified
Obligation to Respond:
Mandatory
CFR Citation:
Information Collection Instruments:
Document Type
Form No.
Form Name
Instrument File
URL
Available Electronically?
Can Be Submitted Electronically?
Electronic Capability
Other-Guidance
SE FAQ guidance.pdf
Yes
No
Printable Only
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:
239
Number of Respondents for Small Entity:
0
Affected Public:
Private Sector
Private Sector:
Businesses or other for-profits
Percentage of Respondents Reporting Electronically:
99 %
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
239
0
0
-25
0
264
Annual IC Time Burden (Hours)
20,793
0
0
-2,175
0
22,968
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.