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