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 FDAâs Center for Tobacco Products (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.âs: 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
Inventory as of this Action
Requested
Previously Approved
01/31/2019
36 Months From Approved
01/31/2016
818
0
408
1,084
0
1,092
2
0
2
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.
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.
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.
Form FDA 3741 Tobacco Product Establishment Renewal Registration and Listing
0910-0650_supporting statement.doc
Tobacco Product Ingredient Listing electronic and paper submission