Premarket Tobacco Product
Applications and Recordkeeping Requirements
New
collection (Request for a new OMB Control Number)
No
Regular
10/05/2021
Requested
Previously Approved
36 Months From Approved
72
0
13,592
0
0
0
The Tobacco Control Act was enacted on
June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and providing FDA with the authority to regulate
tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 910(a)
established requirements for premarket review of new tobacco
products. FDA is finalizing requirements for the content, format,
submission, and review of PMTAs, as well as other requirements
related to PMTAs, including recordkeeping requirements, and
postmarket reporting. FDA will also require recordkeeping regarding
the legal marketing of Pre-Existing Tobacco Products (i.e., those
products that were commercially marketed as of February 15, 2007)
and products that are exempt from the requirements of demonstrating
substantial equivalence.
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.