Tobacco Products, Exemptions From Substantial Equivalence Requirements

ICR 202204-0910-015

OMB: 0910-0684

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0684 202204-0910-015
Received in OIRA 201903-0910-012
Tobacco Products, Exemptions From Substantial Equivalence Requirements
Revision of a currently approved collection   No
Regular 08/16/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
2,179 2,273
22,372 23,871
0 0

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 If the manufacturer fails to respond within the timeframe requested, FDA will consider the exemption request withdrawn.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

PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 387e Name of Law: Federal Food, Drug and Cosmetics Act

Not associated with rulemaking

  87 FR 10797 02/25/2022
87 FR 48669 08/10/2022

  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 2,179 2,273 0 -94 0 0
Annual Time Burden (Hours) 22,372 23,871 0 0 -1,499 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Our estimated burden for the information collection reflects an overall decrease of 1,499 hours and 94 respondents. The estimates reflect a decrease of 1,217 hours to account for a reduction in average response time for preparing an abbreviated report. The estimates also reflect a decrease of 94 responses for submissions requiring additional information in support of the initial exemption request, which resulted in a decrease of 282 hours.

Rachel Showalter 202 693-2146 [email protected]


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:
    (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;
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.

© 2022 | Privacy Policy