Tobacco Product Establishment Registration and Submission of Certain Health Information

ICR 202112-0910-010

OMB: 0910-0650

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-07-15
ICR Details
0910-0650 202112-0910-010
Received in OIRA 201904-0910-005
HHS/FDA CTP
Tobacco Product Establishment Registration and Submission of Certain Health Information
Extension without change of a currently approved collection   No
Regular 08/12/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
3,258 3,858
962 830
0 21

The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 905 Name of Law: FFDCA
   US Code: 21 USC 904 Name of Law: FFDCA
  
None

Not associated with rulemaking

  87 FR 4622 01/28/2022
87 FR 49593 08/11/2022
No

  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 3,258 3,858 0 0 -600 0
Annual Time Burden (Hours) 962 830 0 0 132 0
Annual Cost Burden (Dollars) 0 21 0 0 -21 0
No
No
We have adjusted our burden estimate, which has resulted in an increase of 132 hours to the currently approved burden. FDA now estimates the total burden for this collection to be 962 hours. The Consolidated Appropriations Act of 2022 (the Appropriations Act), enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) of the FD&C Act to include products that contain nicotine from any source. As a result, non-tobacco nicotine (NTN) products that were not previously subject to the FD&C Act (e.g., products containing synthetic nicotine) are now subject to all of the tobacco product provisions in the FD&C Act beginning on April 14, 2022. Based on this new authority the owners and operators of establishments engaged in the manufacture, preparation, compounding, or processing of tobacco products containing non-tobacco nicotine (NTN) must register with the FDA and list all these tobacco products that they manufacture, prepare, compound, or process for commercial distribution. As such we have revised the estimates in the burden chart to account for products containing non-tobacco nicotine (NTN). We have therefore revised the number of respondents and burden hours in this information collection.

$940,040
No
    Yes
    No
No
No
No
No
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.
08/12/2022


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