This new information collection is for 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 905 of the FFDCA requires this registration be completed by December 31 of each year. Section 904(c) of the act requires that a tobacco product manufacturer: 1) Provide all information required under section 904(a) "at least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment" of the Tobacco Control Act. 2) Advise the FDA in writing at least 90 days prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those additives that have been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use. 3) Advise the FDA in writing at least 60 days prior to eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.
FDA requests permission to use the emergency clearance process to obtain OMB approval of the tobacco product establishment registration requirements of FSPTCA. Section 905 of the 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 905 requires this registration be completed by December 31 of each year. To allow adequate time for establishment owners and operators to complete the registration process, FDA plans to begin accepting establishment registrations on November 9, 2009.
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 (Paper form 3742)