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."
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.
0910-0673 Non substantive change request 9 23 16.docx
Product Quantity Change Bundled SE Report