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%.
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
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:
(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;
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.
0910_0650_83C_for_Use_of_FURLs[1].doc
Update Registration Package Screenshots.pdf
Obtaining a Dun and Bradstreet D-U-N-S Number