Previous terms
continue: The data to be collected by CTP in this ICR (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
09/30/2022
36 Months From Approved
09/30/2019
3,858
0
85,494
830
0
93,916
21
0
44
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.
PL:
Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and
Tobacco Control Act
US Code: 21
USC 905 Name of Law: FFDCA
US Code: 21
USC 904 Name of Law: FFDCA
FDA estimates the total burden
for this collection is 830 hours. We have adjusted our burden
estimate, which has resulted in a decrease of 93,086 hours and
81,636 annual responses to the currently approved burden. The IC
referencing vape shops was deleted as these numbers have been
incorporated into the appropriate places. Additionally, the IC
titled Tobacco Product Ingredient Listing electronic and paper
submission was deleted as it was a duplicate item intended to be
removed previously. Based on data we reviewed from the past 3 years
and projecting the number of remaining establishments that have not
registered and submitted product ingredient listings, we revised
the number of respondents and burden hours in this information
collection.
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 3742 Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)
0650_Supporting Statement 2019 Final.docx
Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)