Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document Name	Status

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

IC Document Collections

IC ID	Document Title	Status
191228	Tobacco Product Establishment Registration (Paper Form FDA 3741)	New
191227	Tobacco Product Establishment Registration	New

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 200911-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 11/06/2009
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/06/2009
	Date Received in OIRA: 11/05/2009
Terms of Clearance: If FDA updates any of the documents associated with this collection, they must be approved by OIRA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2010	6 Months From Approved
Responses	100,000	0	0
Time Burden (Hours)	375,000	0	0
Cost Burden (Dollars)	440	0	0

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Abstract: This new information collection is for the annual registration of any "establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products." Section 905 of the FFDCA requires this registration be completed by December 31 of each year.

Emergency Justfication: FDA requests permission to use the emergency clearance process to obtain OMB approval of the tobacco product establishment registration requirements of FSPTCA. Section 905 of the act requires the annual registration of any "establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products." Section 905 requires this registration be completed by December 31 of each year. To allow adequate time for establishment owners and operators to complete the registration process, FDA plans to begin accepting establishment registrations on November 9, 2009.

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Authorizing Statute(s): US Code: 21 USC 905 Name of Law: FFDCA
  

Citations for New Statutory Requirements: US Code: 21 USC 905 Name of Law: FFDCA

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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 Product Establishment Registration	FDA 3741
Tobacco Product Establishment Registration (Paper Form FDA 3741)	FDA 3741

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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	100,000	0	100,000	0	0	0
Annual Time Burden (Hours)	375,000	0	375,000	0	0	0
Annual Cost Burden (Dollars)	440	0	440	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: This is a new information collection that requires the annual registration of any "establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products and requires this registration be completed by December 31 of each year.

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Annual Cost to Federal Government: $996,000

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: 11/05/2009

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