Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document Name	Status
Form FDA 3742 Tobacco Product Ingredient Listing (Paper form 3742) Form and Instruction	Modified
Form FDA 3742 Tobacco Product Ingredient Listing (electronic) Form and Instruction	Modified
Form FDA 3741 Tobacco Product Establishment Registration (Paper Form FDA 3741) Form and Instruction	Modified
905 final guidance 11-05-09.doc Supplementary Document	2009-11-05
905 final guidance 11-05-09.doc Supplementary Document	2009-11-05
0910-0650_ss_05-12-2010.doc Supporting Statement A	2010-05-28

IC Document Collections

IC ID	Document Title	Status
191384	Tobacco Product Ingredient Listing (Paper form 3742) Form and Instruction	Modified
191383	Obtaining a Dun and Bradstreet D-U-N-S Number Other-guidance document	Modified
191382	Tobacco Product Ingredient Listing (electronic) Form and Instruction	Modified
191228	Tobacco Product Establishment Registration (Paper Form FDA 3741) Form and Instruction	Modified
191227	Tobacco Product Establishment Registration (electronic) Instruction	Modified

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 201005-0910-019
Status: Historical Active	Previous ICR Reference No: 200912-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
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: 12/02/2010
	Date Received in OIRA: 05/28/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2012	36 Months From Approved	12/31/2010
Responses	112,650	0	112,650
Time Burden (Hours)	409,075	0	408,775
Cost Burden (Dollars)	488	0	484

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Abstract: This 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. Section 904(c) of the act requires that a tobacco product manufacturer: 1) Provide all information required under section 904(a) "at least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment" of the Tobacco Control Act. 2) Advise the FDA in writing at least 90 days prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those additives that have been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use. 3) Advise the FDA in writing at least 60 days prior to eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

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Authorizing Statute(s): US Code: 21 USC 905 Name of Law: FFDCA
   US Code: 21 USC 904 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 7269	02/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 25267	05/07/2010
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Tobacco Product Establishment Registration (electronic)	FDA 3741	Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
Tobacco Product Establishment Registration (Paper Form FDA 3741)	FDA 3741	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
Tobacco Product Ingredient Listing (electronic)	FDA 3742	LISTING OF INGREDIENTS IN TOBACCO PRODUCTS
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Ingredient Listing (Paper form 3742)	FDA 3742	Listing of Ingredients in Tobacco Products

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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	112,650	112,650	0	0	0	0
Annual Time Burden (Hours)	409,075	408,775	0	0	300	0
Annual Cost Burden (Dollars)	488	484	0	0	4	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: $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: 05/28/2010

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