Premarket Tobacco Product Applications and Recordkeeping Requirements

ICR 202101-0910-001

OMB: 0910-0879

Federal Form Document

ICR Details
0910-0879 202101-0910-001
Received in OIRA 202003-0910-008
Premarket Tobacco Product Applications and Recordkeeping Requirements
New collection (Request for a new OMB Control Number)   No
Regular 10/05/2021
  Requested Previously Approved
36 Months From Approved
72 0
13,592 0
0 0

The Tobacco Control Act was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing FDA with the authority to regulate tobacco products (Pub. L. 111-31; 123 Stat. 1776). Section 910(a) established requirements for premarket review of new tobacco products. FDA is finalizing requirements for the content, format, submission, and review of PMTAs, as well as other requirements related to PMTAs, including recordkeeping requirements, and postmarket reporting. FDA will also require recordkeeping regarding the legal marketing of Pre-Existing Tobacco Products (i.e., those products that were commercially marketed as of February 15, 2007) and products that are exempt from the requirements of demonstrating substantial equivalence.

US Code: 21 USC 387j Name of Law: FFDCA

0910-AH44 Final or interim final rulemaking 86 FR 55300 10/05/2021


  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 72 0 0 72 0 0
Annual Time Burden (Hours) 13,592 0 0 13,592 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Changing Regulations
This is a new information collection. There are no changes in burden from the proposed rule.

Jonna Capezzuto 301 796-3794 [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.

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