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(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))
Substantial Equivalence Applications for Tobacco Products
OMB: 0910-0673
IC ID: 195793
OMB.report
HHS/FDA
OMB 0910-0673
ICR 201701-0910-004
IC 195793
( )
⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0673 can be found here:
2021-10-05 - Revision of a currently approved collection
2019-06-05 - Extension without change of a currently approved collection
Documents and Forms
Document Name
Document Type
Section 905j Reports Demo Substantial Equivalence Guidance Document .pdf
Instruction
Information Collection (IC) Details
View Information Collection (IC)
IC Title:
(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))
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
Instruction
Section 905j Reports Demo Substantial Equivalence Guidance Document .pdf
No
Printable Only
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:
683
Number of Respondents for Small Entity:
75
Affected Public:
Individuals or Households
Percentage of Respondents Reporting Electronically:
99 %
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
683
0
273
0
0
410
Annual IC Time Burden (Hours)
204,900
0
81,900
0
0
123,000
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.