Tobacco Products, Exemptions From Substantial Equivalence Requirements

Forms and Documents

Document Name	Status
0684_Supporting Statement_2025.docx Supporting Statement A	2025-09-16

IC Document Collections

IC ID	Document Title	Status
197951	Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3) Other-Recommended Format for Abbreviated Report	Modified
196723	21 CFR 1107.1(c)-- Preparation of additional information for tobacco product exemption from substantial equivalence request	Modified
196722	21 CFR 1107.1(b)-- Preparation of tobacco product exemption from substantial equivalence request and 21 CFR 25.40-- Preparation of an environmental assessment	Modified

ICR Details

OMB Control No: 0910-0684	ICR Reference No: 202507-0910-008
Status: Received in OIRA	Previous ICR Reference No: 202410-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Products, Exemptions From Substantial Equivalence Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/22/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2025
Responses	1,018	2,179
Time Burden (Hours)	17,190	22,372
Cost Burden (Dollars)	0	0

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Abstract: FDA has established in its regulations a pathway for manufacturers to request exemptions from the substantial equivalence requirements of the FD&C Act. An exemption request must be submitted with supporting documentation, the manufacturer's contact information, and a detailed explanation of the modification and its purpose. This information is submitted to FDA so FDA can determine whether an exemption from substantial equivalence to the predicate product is appropriate for the protection of the public health. FDA determines whether to grant or deny the request for an exemption based on whether the criteria in the statute have been satisfied. If FDA determines that the information is insufficient, FDA may request additional information from the manufacturer. If the manufacturer fails to respond within the timeframe requested, FDA will consider the exemption request withdrawn. FDA may rescind an exemption where necessary to protect the public health. FDA may exempt tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, from the requirement of demonstrating substantial equivalence if the Agency determines that (1) the modification would be a minor modification of a tobacco product, (2) a report demonstrating substantial equivalence is not necessary for the protection of public health, and (3) an exemption is otherwise appropriate.

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Authorizing Statute(s): US Code: 21 USC 387e Name of Law: Federal Food, Drug and Cosmetics Act
   PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control 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:
	90 FR 27623	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45221	09/19/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
21 CFR 1107.1(b)-- Preparation of tobacco product exemption from substantial equivalence request and 21 CFR 25.40-- Preparation of an environmental assessment
21 CFR 1107.1(c)-- Preparation of additional information for tobacco product exemption from substantial equivalence request
Report Demonstrating Tobacco Product Mod under 905(j)(3), Commercially Mkted and Compliant, and Modifications covered under 905(j)(3)

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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	1,018	2,179	0	0	-1,161	0
Annual Time Burden (Hours)	17,190	22,372	0	0	-5,182	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: FDA has adjusted its burden estimates based on updated respondent numbers. Specifically, we have reduced the annual number of respondents submitting exemption requests from 812 to 682 based on the average number of exemption requests received during the past 3 years. We have reduced the number of respondents who will submit Abbreviated Reports, as required by section 905(j)(1)(A)(ii) of the FD&C Act, from 1,217 to 186 annually based on the average number of exemptions issued during the past 3 years. Our estimated burden for the information collection reflects an overall decrease of 5,182 hours and 1,161 total respondents. We attribute this adjustment to the number of submissions we received over the last 3 years. Therefore, FDA now estimates the respondent burden associated with Exemptions for Substantial Equivalence Requirement is 17,190 hours.

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Annual Cost to Federal Government: $663,190

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: 09/22/2025

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