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.’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
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.
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
The Food and Drug
Administration (FDA) issued a final rule to deem products meeting
the statutory definition of “tobacco product” 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 Agency’s “tobacco product”
authorities to all other categories of products that meet the
statutory definition of “tobacco product” 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.
Form FDA 3742 Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)
0910-0650 Deeming Revision supporting statement Final 2016.docx
Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)