Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Revision of a currently approved collection
No
Regular
10/05/2021
Requested
Previously Approved
36 Months From Approved
09/30/2022
4,479
1,570
282,330
278,637
0
0
The FD&C Act requires FDA to issue an order under section 910(c)(1)(A)(i) (order after review of a premarket application, see section 910(b) of the FD&C Act) before a new tobacco product may be commercially marketed. An order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits a report under section 905(j)(1)(A)(i) 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)(1)(A)(i) demonstrating that a new tobacco product is âsubstantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of this Actâ (section 905(j)(1)(A)(i) of the FD&C Act). The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. (In addition to the premarket application under section 910(b) and a report under 905(j)(1)(A)(i), certain new tobacco products may use the exemption premarket pathway, see 21 CFR 1107.1.)
The Food and Drug Administration (FDA) is now issuing a rule that establishes requirements for the content and format of SE Reports intended to establish the substantial equivalence of a tobacco product. The rule establishes the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the rule establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report.
This is a new final rule. FDA estimates that the burden for new requirements will increase this collection by 3,693 hours (1,338 reporting + 2,355 recordkeeping) and 2,909 responses. The burden for the submission of substantial equivalence information is estimated to total 282,330 hours (279,975 reporting and 2,355 recordkeeping). In this submission, the burden increased from the proposed rule ICR submission by 1,618 hours. This change was based on the increased burden per response for the associated forms.
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.
Form FDA 3964 Tobacco Amendment and General Correspondence Report
0673 final rule ss 9-15-2021.docx
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf
Recordkeeping SE Report under 1107.18-1107.58