Information Collection

Tobacco Health Document Submission

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

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

CTP

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of instruments
Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3743				Yes	Yes	Fillable Fileable
Other-Health Document Submission Requirements for Tobacco Products				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 %

table that charts list of burden
	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

table that charts IC Documents
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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