OMB is
withholding approval at this time. Prior to publication of the
final rule, the agency should provide a summary of any comments
related to the information collection and their response, including
any changes made to the ICR as a result of comments. In addition,
the agency must enter the correct burden estimates.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
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The Food and Drug Administration (FDA)
is issuing a proposed rule that would establish basic requirements
for premarket tobacco product applications (PMTAs) and would
require manufacturers to maintain records establishing that their
tobacco products are legally marketed. The proposed rule would
allow for the submission of PMTAs in alternative formats in certain
instances to reduce the burden of submitting a PMTA for
modifications to a product that previously received a PMTA
marketing order or resubmitting a PMTA to address deficiencies
specified in a no marketing order.
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.