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OMB Control No: 0910-0673	ICR Reference No: 202101-0910-003
Status: Historical Active	Previous ICR Reference No: 201904-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/12/2021
	Date Received in OIRA: 10/05/2021
Terms of Clearance: FDA will continue to evaluate the burden associated with submission, in response to commenters' concerns about its accuracy, and update this package as appropriate.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2024	36 Months From Approved	09/30/2022
Responses	4,479	0	1,570
Time Burden (Hours)	282,330	0	278,637
Cost Burden (Dollars)	0	0	0

Abstract: 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 “substantially 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 Act” (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.

Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG89	Final or interim final rulemaking	86 FR 55224	10/05/2021

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	4,479	1,570	2,909
Annual Time Burden (Hours)	282,330	278,637	3,693
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

Annual Cost to Federal Government: $2,320,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

View ICR - OIRA Conclusion