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

ICR 201904-0910-007

OMB: 0910-0775

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-06-04
ICR Details
0910-0775 201904-0910-007
Active 201601-0910-018
HHS/FDA CTP
Guidance for Industry on 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
Approved without change 08/29/2019
Retrieve Notice of Action (NOA) 06/05/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 08/31/2019
1,000 0 153
5,000 0 765
0 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 grandfathered tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A grandfathered 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.

PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  83 FR 52488 10/17/2018
84 FR 26120 06/05/2019
No

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

  Total Approved 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 1,000 153 0 0 847 0
Annual Time Burden (Hours) 5,000 765 0 0 4,235 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The burden for this collection of information is expected to increase by 4,235 reporting hours. We attribute this adjustment to an updated number of submissions received through this approval and the number of submissions expected in the next 3 years. The estimated number of respondents and annual responses will increase by 847 (from 153 to 1,000).

$812,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  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.
06/05/2019


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