Tobacco Health Document Submission

Forms and Documents

Document Name	Status
Form FDA 3743 Tobacco Health Document Submission (Form FDA 3743) Form and Instruction	Modified
904(a)(4) draft guidance 12 22 2009.pdf Supplementary Document	2009-12-23
0654 ss 7-7-2010.doc Supporting Statement A	2010-07-07

IC Document Collections

IC ID	Document Title	Status
191699	Tobacco Health Document Submission (Form FDA 3743) Form and Instruction	Modified
191698	Tobacco Health Document Submission Other-screenshots	Modified

ICR Details

OMB Control No: 0910-0654	ICR Reference No: 201007-0910-005
Status: Historical Active	Previous ICR Reference No: 201001-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Health Document Submission
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/11/2010
	Date Received in OIRA: 07/26/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2013	36 Months From Approved	10/31/2010
Responses	832	0	72
Time Burden (Hours)	8,000	0	400
Cost Burden (Dollars)	828	0	828

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Abstract: Section 904(a)(4) of the act requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009 "that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives" (herein referred to as "tobacco health documents"). Information required under section 904(a)(4) must be submitted to FDA beginning December 22, 2009. FDA is collecting the information submitted pursuant to section 904(a)(4) through an electronic portal and through a paper form (Form FDA 3743) for those individuals who choose not to use the electronic portal.

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Authorizing Statute(s): US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 20603	04/20/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 41210	07/15/2010
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Tobacco Health Document Submission
Tobacco Health Document Submission (Form FDA 3743)	FDA 3743	Tobacco Health Document Submission

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	832	72	0	0	760	0
Annual Time Burden (Hours)	8,000	400	0	0	7,600	0
Annual Cost Burden (Dollars)	828	828	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $5,696,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 07/26/2010

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