View Information Collection Request (ICR) Package

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
Retrieve Notice of Action (NOA)	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

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%.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	408	408	0
Annual Time Burden (Hours)	1,092	1,354	-262
Annual Cost Burden (Dollars)	2	2	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

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

Agency Contact: Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

View ICR - OIRA Conclusion