Information Collection

Tobacco Health Document Submission

IC 191698 under ICR 202508-0910-003 · OMB 0910-0654.

Documents and Forms

Document Name Document Type
Form FDA 3743 Tobacco Health Document Submission Form and Instruction
Form FDA 3743 Tobacco Health Document Submission Tobacco Health Document Submission Form and Instruction
Guidance; Health Document Submission Requirements for Tobacco Products (Revised).pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission-revised Other-Health Document Submission Req
Guidance; Health Document Submission Requirements for Tobacco Products (Revised).pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission-revised Other-Health Document Submission Req
FDA 3743 Tobacco Health Document Submission Form FDA 3743; Tobacco Health Document Submission Document.pdf Form and Instruction
FDA 3743 Tobacco Health Document Submission Form FDA 3743; Tobacco Health Document Submission Document.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Tobacco Health Document Submission	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
Form and Instruction	FDA 3743	Tobacco Health Document Submission	Form FDA 3743; Tobacco Health Document Submission Document.pdf		Yes	Yes	Fillable Fileable
Other-Health Document Submission Requirements for Tobacco Products			Guidance; Health Document Submission Requirements for Tobacco Products (Revised).pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/tobacco-health-document-submission-revised	Yes	No	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 1

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

Percentage of Respondents Reporting Electronically: 33 %

	Approved	Previously Approved
Annual Number of Responses for this IC	32	32
Annual IC Time Burden (Hours)	1,600	1,600
Annual IC Cost Burden (Dollars)	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.

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