Tobacco Product Establishment Registration and Submission of Certain Health Information
Revision of a currently approved collection
No
Regular
Approved without change
06/27/2016
05/12/2016
This revision request satisfies the previous terms of clearance by accounting for the increase in burden due to inclusion of additioanl respondents as a result of the Tobacco Deeming Rule. The data to be collected by CTP in this ICR (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
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
06/30/2019
36 Months From Approved
01/31/2019
85,694
0
818
96,507
0
1,084
44
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.
The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of âtobacco productâ to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agencyâs âtobacco productâ authorities to all other categories of products that meet the statutory definition of âtobacco productâ in the FD&C Act, except accessories of such newly deemed tobacco products.
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.
Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)