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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	12/31/2025
Responses	1,018	2,179
Time Burden (Hours)	17,190	22,372
Cost Burden (Dollars)	0	0

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 If the manufacturer fails to respond within the timeframe requested, FDA will consider the exemption request withdrawn.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.

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

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:
	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

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	1,018	2,179	-1,161
Annual Time Burden (Hours)	17,190	22,372	-5,182
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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