Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document Name	Status
0910_0650_83C_for_Use_of_FURLs[1].doc Justification for No Material/Nonsubstantive Change	2013-04-23
Update Registration Package Screenshots.pdf Supplementary Document	2013-04-15
New Registration and Product Listing Package Screenshots.pdf Supplementary Document	2013-04-15
905 final guidance 11-05-09.doc Supplementary Document	2009-11-05

IC Document Collections

IC ID	Document Title	Status
191383	Obtaining a Dun and Bradstreet D-U-N-S Number Other-guidance document	Modified
191382	Tobacco Product Ingredient Listing Instruction	Modified
191227	Tobacco Product Establishment Registration Instruction	Modified

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 201304-0910-006
Status: Historical Active	Previous ICR Reference No: 201208-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: 19272
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/23/2013
	Date Received in OIRA: 04/25/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2015	10/31/2015	10/31/2015
Responses	408	0	408
Time Burden (Hours)	1,092	0	1,354
Cost Burden (Dollars)	2	0	2

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Abstract: The FDA's Center for Tobacco Products is requesting that OMB approve the use of a more streamlined electronic submission system named FURLs to submit tobacco product registration and listing information in a more streamlined electronic way. The information collected will be the same as approved and collected on FDA Form 3741, and the FURLs system allows the users to log in instantly and begin data entry, saving weeks of submission time. FURLs also allows users to review and revise existing files, and is projected to reduce burden for Registration and Listing electronic entries by 35%.

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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:
	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	Registration and Listing for Tobacco Product Establishments
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

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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	408	0	0	0	0
Annual Time Burden (Hours)	1,092	1,354	0	-262	0	0
Annual Cost Burden (Dollars)	2	2	0	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: Yes

Burden Reduction Due to: Using Information Technology

Short Statement: The Food and Drug Administration (FDA) Center for Tobacco Products (CTP) is submitting this nonmaterial/non-substantive change request (83-C) for changes to an OMB No. 0910-0650, "Tobacco Product Establishment Registration and Listing." CTP is requesting this change due to a switch from the current electronic registration and listing submissions system, known as eSubmitter, to a more robust and more efficient electronic registration and listing system known as FURLs. The information elements in eSubmitter and FURLS are identical, and FURLS offers the user an easier interface to enter that information. FDA thinks that the use of FURLs will reduce the overall burden on industry when submitting their registration and product listing submissions by approximately 35%. The current eSubmitter system requires industry to download eSubmitter software onto their computer and register for an Electronic Submissions Gateway (ESG) account, which can be a multi-week process, before they are able to submit information on the electronic FDA Form 3741. FURLs users may log in online instantly and begin their data entry immediately, as no software download is required, eliminating long wait times. The burden for entering new registration and product listing information under FURLs will likely be similar to that for eSubmitter, but time to complete updates to this information will be greatly reduced. Currently CTP reviewers estimate that 75% of labeling, advertising, and consumer information submitted during biannual product listing updates is duplicative, and CTP has learned that the largest firms will often resubmit all labeling, advertising, and consumer information for up to 2 years in an effort to provide the most current snapshot of their marketing materials that may still be in distribution. Companies using eSubmitter often resubmit their entire packages twice a year, but with FURLs, industry can simply log in and delete any files that they believe are no longer current. FURLs removes the need to resubmit files every reporting period (June and December). A search of FDA's database shows that to date, 5,366 product listing s have been resubmitted when there was no change, and the use of FURLs will eliminate most of this duplicative resubmission of data. Because FURLs will make it much easier to complete the biannual product listing changes without the need to resubmit any files, FURLs should substantially reduce the burden on industry when filing these reports twice a year. The burden hours for the Tobacco Product Establishment Registration (collected under FDA form 3741) will be reduced from 750 to 488 hours for a reduction of 262 burden hours. The total burden for this ICR is now estimated to be 1,092. All other IC's remain unchanged

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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: 04/25/2013

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