This is a request for OMB renewal for
FDA's regulations for cigarettes and smokeless tobacco containing
nicotine. The codified regulations at 21 CFR Part 1140 are
authorized by section 102 of the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This
collection includes reporting information requirements for §
1140.30, which directs persons to notify FDA if they intend to use
a form of advertising that is not addressed in the regulations. As
the public is being advised through the FDA guidance entitled
"Enforcement Policy Concerning Certain Regulations Restricting the
Sale and Distribution of Cigarettes and Smokeless Tobacco"
We have adjusted our burden
estimate to approximately 25 notifications annually, which more
accurately reflects the current number of submissions under this
regulation. This is a decrease to the currently approved burden.
The decrease in notifications is not unexpected given that the
regulation applies to cigarettes and smokeless tobacco and many of
the alternative media notifications have been made in previous
years.
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.