Section 905(j) requires manufacturers who wish to demonstrate substantial equivalence for tobacco products commercially marketed after February 15, 2007 to include in their section 905(j) reports recommendations for providing information comparing the characteristics of the new and predicate tobacco product, including:
1) materials, 2) ingredients, 3) design, 4) composition, 5) heating source, or 6) other features. FDA also intends to include in the guidance recommendations on how to submit a section 905(j) report, and intends to issue the guidance as immediately in effect to ensure that manufacturers have the benefit of FDA's recommendations in time to prepare their 905(j) reports.
Section 910 requires that FDA must review a premarket application and issue an order before a new tobacco product may be commercially marketed. An order under section 910 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 the tobacco product to be substantially equivalent to a predicate tobacco product. The FSPTCA contains a special provision for products placed on the market between February 15, 2007 and March 22, 2011. Section 905 requires that, for those products, a section 905(j) report must be submitted to FDA by March 22, 2011 in order for the product remain on the market. To ensure that this guidance is issued in enough time for manufacturers to use it to prepare their submissions and to satisfy the PRA requirements, FDA is requesting permission to use the emergency clearance procedures for the information collection requirements of the guidance. The Secretary of Health and Human Services has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the FD&C Act, including sections 905 and 910.
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.
emergency memo 12-21-2010.doc
Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))