Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007

ICR 202509-0910-002

OMB: 0910-0775

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2025-09-29
ICR Details
0910-0775 202509-0910-002
Received in OIRA 202410-0910-006
HHS/FDA CTP
Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007
Extension without change of a currently approved collection   No
Regular 09/30/2025
  Requested Previously Approved
36 Months From Approved 09/30/2025
500 1,000
2,500 5,000
0 0

The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. A "Pre-Existing" tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A Pre-Existing tobacco product may also serve as the predicate tobacco product in a section 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act( 21 U.S.C. 387e(j)(1)(A)(i))). FDA interprets the phrase "as of February 15, 2007," as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007. The guidance associated with this collection of information recommends that the manufacturer submit information adequate to demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007. Examples of such information may include, but are not limited to, the following: dated copies of advertisements, dated catalog pages, dated promotional material, and dated bills of lading.

US Code: 21 USC 387 Name of Law: Federal Food, Drug and Cosmetic Act
   PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  90 FR 27632 06/27/2025
90 FR 46609 09/29/2025
No

1
IC Title Form No. Form Name
Submit evidence of commercial marketing in the United States as of February 15, 2007

  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 500 1,000 0 0 -500 0
Annual Time Burden (Hours) 2,500 5,000 0 0 -2,500 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden adjustment is related to and overall decrease in the expected number of respondents. The number of hours per response has remained the same. As a result of this adjustment, we recorded a decrease to the currently approved burden. Our estimated burden for the information collection reflects an overall decrease of 2,500 hours and a corresponding decrease of 500 responses. The number of submissions FDA received to establish marketing as of February 15, 2007 has decreased and we have therefore revised the number of respondents to the information collection based on this data.

$663,190
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

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.
09/30/2025


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