Product Quantity Change Bundled SE Report

Substantial Equivalence Applications for Tobacco Products

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0673 can be found here:

Documents and Forms

Document Name Document Type
Guidance SE of a New Tobacco Product - Responses to FAQs (Ed 2).pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Product Quantity Change Bundled SE Report	Agency IC Tracking Number:	CTP

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

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
Other-Guidance			Guidance SE of a New Tobacco Product - Responses to FAQs (Ed 2).pdf		Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 192	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	192	137	55
Annual IC Time Burden (Hours)	11,904	8,494	3,410
Annual IC Cost Burden (Dollars)	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.