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OMB Control No: 0910-0673	ICR Reference No: 202402-0910-004
Status: Active	Previous ICR Reference No: 202101-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Substantial Equivalence Reports for Tobacco Products
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: 04/28/2025
	Date Received in OIRA: 11/26/2024
Terms of Clearance: Previous terms continue: 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	04/30/2028	36 Months From Approved	04/30/2025
Responses	7,384	0	4,479
Time Burden (Hours)	351,340	0	282,330
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 regulations contain requirements for the content and format of SE Reports intended to establish the substantial equivalence of a tobacco product. The regulations establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the regulation contain 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. FDA will have three forms (Form FDA 3965; Form FDA 3965a; and new Form FDA 3965b) required for use (once this revision is approved) under section 21 CFR 1107.18(a)) when submitting an SE Report to the Agency. Forms FDA 3965 and 3965b are required when submitting single and bundled SE submissions. Form FDA 3965a is for use when firms are submitting amendments and other general correspondence. Form FDA 3965b is a new form that assists industry and FDA in identifying the products that are the subject of a submission. CTP is planning a significant upgrade to the submission process for SEs, known as the CTP Portal Next Generation (CTP Portal NG), streamlining the application process for the tobacco industry.

Authorizing Statute(s): US Code: 21 USC 321(rr) Name of Law: Federal Food, Drug and Cosmetic Act
   PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387e(j) and 387j(a) 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:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 57903	07/16/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 93305	11/26/2024
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion	Change Due to Adjustment in Estimate
Annual Number of Responses	7,384	4,479	3,140	-235
Annual Time Burden (Hours)	351,340	282,330	1,696	67,314
Annual Cost Burden (Dollars)	0	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: Program Change Burden The content in Form FDA 3965 and 3965a have not significantly changed and we do not attribute program change burden related to the form revisions. :There is a program change increase in reporting burden hours related to use of the addition of Form FDA 3965b and the validator tool. Adjustment Burden The burden adjustment is related to an increase in respondents reporting information. There is an increase in the average response time associated with SE Report--1107.18 due to the consolidation of SE Report--1107.18 and Bundled SE--1107.18. Bundled SE--1107.18 previously had a lower estimated average response time. There is a decrease in the number of responses associated with waiver requests, as well as a decrease in the average response time associated with the SE Report where applicant provides certification for identical characteristics--1107.18(g) and 1107.18(l)(2). Total Burden Our estimated burden for the information collection reflects an overall increase of 69,010 hours and a corresponding increase of 2,905 responses/records. We attribute this to adding a new form, providing the validator tool, and reevaluating our current estimates.

Annual Cost to Federal Government: $8,174,817

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: Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov

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