On June 22, 2009, the President signed
the Family Smoking Prevention and Tobacco Control Act into law. The
Tobacco Control Act amended the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) by adding a chapter granting FDA important
authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect the public health generally and to
reduce tobacco use by minors. The FD&C Act requires FDA to
issue an order under section 910(c) before a new tobacco product
may be commercially marketed. An order under section 910(c) is not
required, however, if a manufacturer submits a report under section
905(j) for the new tobacco product and FDA issues an order finding
that the tobacco product is (1) substantially equivalent to a
tobacco product commercially marketed in the United States as of
February 15, 2007, and (2) in compliance with the requirements of
the FD&C Act. Manufacturers of these tobacco products may
submit a report under section 905(j) demonstrating that their new
tobacco product is substantially equivalent to a predicate tobacco
product. FDA has issued a guidance document containing
recommendations for preparing substantial equivalence reports under
section 905(j). For the purposes of substantial equivalence
reports, the new tobacco product is compared to a predicate tobacco
product in determining substantial equivalence. Additionally, under
the recently issued guidance entitled, "Demonstrating the
Substantial Equivalence of a New Tobacco Product: Responses to
Frequently Asked Questions," FDA is recommending that certain
modifications might be addressed in either a "Same Characteristics
SE Report" or "Product Quantity Change Report."
We have estimated an increase
of 106,759 hours and 591 respondents from the currently approved
burden. We attribute this adjustment to an increase in the number
of SE Reports we expect related to Deemed products (e.g., based on
the initial registration and listing information).
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.
0673 Supporting Statement 2019.docx
Product Quantity Change Bundled SE Report