Substantial Equivalence Reports for Tobacco Products

Forms and Documents

Document Name	Status
Form Form FDA 3965b Reporting; Form FDA 3659b - SE Unique Identification for New Tobacco Products Form and Instruction	New
Form Form FDA 3965a Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a) Form and Instruction	Modified
Form Form FDA 3965 Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965) Form and Instruction	Modified
FDA CTP Electronic Submissions (eSub) PIA 1.15.2021.pdf Supplementary Document	2024-11-21
Guidance-Demonstrating-the-SE-of-a-New-Tobacco-Product-Responses-to-FAQs (Oct 2023).pdf Supplementary Document	2024-11-20
0910-0673 SS 11-19-24.docx Supporting Statement A	2024-11-21

IC Document Collections

IC ID	Document Title	Status
265906	Reporting; SE Grouping Spreadsheet Validator Other-Validation Tool	New
265904	Reporting; Form FDA 3659b - SE Unique Identification for New Tobacco Products Form and Instruction	New
245290	Recordkeeping; SE Report	Modified
245289	Reporting; Waiver from electronic submission	Modified
245288	Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a) Form and Instruction	Modified
245286	Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965) Form and Instruction	Modified
221154	Identical Characteristics (Bundled) Other-Guidance	Removed
221153	Bundled Reports	Removed
215515	Reporting; SE Report - certification for identical characteristics	Modified
195793	Reporting; Substantial Equivalence (SE) Report	Modified

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 202402-0910-004
Status: Received in OIRA	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	Date Submitted to OIRA: 11/26/2024

	Requested	Previously Approved
Expiration Date	36 Months From Approved	11/30/2024
Responses	7,384	4,479
Time Burden (Hours)	351,340	282,330
Cost Burden (Dollars)	0	0

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Bundled Reports
Identical Characteristics (Bundled)
Recordkeeping; SE Report
Reporting; Form FDA 3659b - SE Unique Identification for New Tobacco Products	Form FDA 3965b	Unique Identifying Information for New Tobacco Products
Reporting; SE Grouping Spreadsheet Validator
Reporting; SE Report - certification for identical characteristics
Reporting; Substantial Equivalence (SE) Report
Reporting; Tobacco Substantial Equivalence Report Amendment and General Correspondence Report (Form FDA 3965a)	Form FDA 3965a, FDA Web Form 3965a	Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission ,   Tobacco Substantial Equivalence Report Amendment
Reporting; Tobacco Substantial Equivalence Report Submission (Form FDA 3965)	Form FDA 3965, FDA Web Form 3965	Tobacco Substantial Equivalence Report Submission ,   Tobacco Substantial Equivalence Report
Reporting; Waiver from electronic submission

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	7,384	4,479	0	3,140	-235	0
Annual Time Burden (Hours)	351,340	282,330	0	1,696	67,314	0
Annual Cost Burden (Dollars)	0	0	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.

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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

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/26/2024

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