Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3742 Listing of Ingredients in Tobacco Products	Form	New	Available
Form FDA 3742 Listing of Ingredients in Tobacco Products	Form	New	Repair queued
Form FDA 3741 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments	Form	New	Available
Form FDA 3742 Listing of Ingredients in Tobacco Products	Form	Modified	Available
Form FDA 3741 Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments	Form	Modified	Available
0910-0650_supporting statement.doc	Supporting Statement A	Uploaded 2015-07-20	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
217657	Tobacco Product Ingredient Listing electronic and paper submission	Form	New	Listing of Ingredients in Tobacco Products
217657	Tobacco Product Ingredient Listing electronic and paper submission	Other-Screenshot - Main Menu	New
217656	Tobacco Product Renewal Ingredient Listing	Form	New	Listing of Ingredients in Tobacco Products
217656	Tobacco Product Renewal Ingredient Listing	Other-Screenshot - Main Menu	New
217655	Tobacco Product Establishment Renewal Registration and Listing	Form	New	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
217655	Tobacco Product Establishment Renewal Registration and Listing	Other-Screenshot - Main Menu	New
191383	Obtaining a Dun and Bradstreet D-U-N-S Number	Instruction	Modified
191382	Tobacco Product Initial Ingredient Listing	Form	Modified	Listing of Ingredients in Tobacco Products
191382	Tobacco Product Initial Ingredient Listing	Other-Screenshot - Main Menu	Modified
191227	Tobacco Product Establishment Initial Registration and Listing and Product Listing	Form	Modified	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
191227	Tobacco Product Establishment Initial Registration and Listing and Product Listing	Other-Screenshot - Main Menu	Modified

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 201507-0910-007
Status: Historical Active	Previous ICR Reference No: 201304-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
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: 01/07/2016
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/29/2015
Terms of Clearance: This ICR Extension is approved to continue this ongoing collection. However, upon publication of the Tobacco Deeming Final Rule(RIN 0910-AG38) an ICR Revision request will be submitted to adjust the requested burden hours to account for the anticipated increase in applications submitted post effective date of the rule. In addition, the data to be collected by the FDA’s Center for Tobacco Products (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved	01/31/2016
Responses	818	0	408
Time Burden (Hours)	1,084	0	1,092
Cost Burden (Dollars)	2	0	2

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Abstract: The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C 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 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA 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
   PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   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:
	80 FR 22202	04/21/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 44971	07/28/2015
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

table that charts list of burden

IC Title	Form No.	Form Name
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Establishment Initial Registration and Listing and Product Listing	FDA 3741	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
Tobacco Product Establishment Renewal Registration and Listing	FDA 3741	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
Tobacco Product Ingredient Listing electronic and paper submission	FDA 3742	Listing of Ingredients in Tobacco Products
Tobacco Product Initial Ingredient Listing	FDA 3742	Listing of Ingredients in Tobacco Products
Tobacco Product Renewal Ingredient Listing	FDA 3742	Listing of Ingredients in Tobacco Products

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ICR Summary of Burden

table that charts list 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	818	408	0	410	0	0
Annual Time Burden (Hours)	1,084	1,092	0	-8	0	0
Annual Cost Burden (Dollars)	2	2	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: After an internal review of this collection's burden hours, FDA realized that the number of respondents had been understated, based on data received from another federal agency, and has been revised from 125 to 135 respondents. The breakdown in information being collected has been split into specific categories under sections 904 and 905 of the Tobacco Control Act from the last approved collection to specifically identify what information under each section is being collected. • The burden for responding to this collection of information has been adjusted to fully incorporate the use of FDA's new electronic system known as FURLS for submitting registration and product listing information to FDA. The FURLS system allows companies to enter information quickly and easily, resulting in a slight decrease in hours through its use when entering Registration and Listing information. FURLS is a relatively new system for FDA and allows companies an easier way to enter, review, and revise previously entered information, and also allows registrants the ability to easily submit electronic labels, ads, and other information more accurately and quickly.

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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: 07/29/2015

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