Tobacco Health Document Submission

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
191699	Tobacco Health Document Submission (Form FDA 3743)		New
191698	Tobacco Health Document Submission		New

ICR Details

OMB Control No: 0910-0654	ICR Reference No: 201001-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Health Document Submission
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 01/07/2010
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/07/2010
	Date Received in OIRA: 01/05/2010
Terms of Clearance: Any other changes to these forms must be submitted to OMB for approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2010	6 Months From Approved
Responses	72	0	0
Time Burden (Hours)	400	0	0
Cost Burden (Dollars)	828	0	0

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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." Information required under section 904(a)(4) must be submitted to FDA beginning December 22, 2009.

Emergency Justfication: In order to provide respondents with adequate time to prepare information for submission, FDA will need to launch the electronic portal and associated paper form for the collection of this information on December 22, 2009. In accordance with 5 CFR 1320.13, the use of normal clearance procedures will impede FDA's ability to collect information required under the act.

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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
	Other Documents for OIRA Review

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Federal Register Notices & Comments
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 52495	10/13/2009
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

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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	72	0	0	0	0	72
Annual Time Burden (Hours)	400	0	0	0	0	400
Annual Cost Burden (Dollars)	828	0	0	0	0	828

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 01/05/2010

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