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 FDA’s Center for Tobacco
Products (OMB Control No. 0910-0650) and Center for Disease Control
(OMB Control No.’s: 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.
US Code:
21
USC 905 Name of Law: FFDCA
PL:
Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and
Tobacco Control Act
US Code: 21
USC 904 Name of Law: FFDCA
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