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)