Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document	Type	Status	Availability
Form FDA 3742 Tobacco Product Ingredient Listing (Paper form 3742)	Form and Instruction	Removed	Repair queued
Form FDA 3741 Tobacco Product Establishment Registration (Paper Form FDA 3741)	Form and Instruction	Removed	Available
905 final guidance 11-05-09.doc	Supplementary Document	Uploaded 2009-11-05	Available
0910-0650_ss_8.6.12.doc	Supporting Statement A	Uploaded 2012-08-06	Available

IC Document Collections

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

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 201208-0910-004
Status: Historical Active	Previous ICR Reference No: 201005-0910-019
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: 10/15/2012
	Date Received in OIRA: 08/09/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	36 Months From Approved	12/31/2012
Responses	408	0	112,650
Time Burden (Hours)	1,354	0	409,075
Cost Burden (Dollars)	2	0	488

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Abstract: Section 905 of the Family Smoking Prevention and Tobacco Control Act requires annual registration of any tobacco product manufacturer, preparer, compounder, or processor by December 31 annually via an electronic portal or paper form FDA 3741. Section 904(a)(1) of the act requires each tobacco product manufacturer or importer to submit a listing of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or other part of each tobacco product.

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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
   PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  

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:
	77 FR 26281	05/03/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 46441	08/03/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Tobacco Product Establishment Registration	FDA 3741, FDA 3741 and 3742 eSubmitter form	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments ,   FDA 3741 & 3742
Tobacco Product Ingredient Listing	FDA Form 3742, FDA Form 3742 (e-submitter version)	Listing of Ingredients in Tobacco Products ,   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
Tobacco Product Establishment Registration (Paper Form FDA 3741)	FDA 3741	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments

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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	408	112,650	0	0	-112,242	0
Annual Time Burden (Hours)	1,354	409,075	0	0	-407,721	0
Annual Cost Burden (Dollars)	2	488	0	0	-486	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: $928,000

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: 08/09/2012

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