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Federal forms, ICRs, and supporting documents

Information Collection Request

Deeming Tobacco Products To Be Subject to the FD&C Act

ICR 201907-0910-004 · OMB 0910-0768 · Active

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-07-25
IC Document Collections
IC ID
Document
Title
Status
210603
Modified
210600
Modified
210599
Modified
210598
Modified
210597
Modified
ICR Details
0910-0768 201907-0910-004
Active 201602-0910-002
HHS/FDA CTP
Deeming Tobacco Products To Be Subject to the FD&C Act
Extension without change of a currently approved collection   No
Regular
Approved without change 10/22/2019
Retrieve Notice of Action (NOA) 07/25/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
1,040 0 1,355
1,287,800 0 1,326,000
0 0 0
The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. The rule also provides that manufacturers, distributors, importers, and retailers are responsible for ensuring that the covered tobacco products (in addition to cigarettes and smokeless tobacco) they manufacture, label, advertise, package, distribute, import, sell, or otherwise hold for sale comply with all applicable requirements. FDA is taking this action to reduce the death and disease from tobacco products.
US Code: 21 USC 301 et seq Name of Law: The Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 111 - 31 101 Name of Law: The Family Smoking Prevention and Tobacco Control Act
  
None
Not associated with rulemaking
  84 FR 16673 04/22/2019
84 FR 35875 07/25/2019
Yes
  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 1,040 1,355 0 0 -315 0
Annual Time Burden (Hours) 1,287,800 1,326,000 0 0 -38,200 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The total estimated burden for this information collection is 1,286,950 reporting hours, and 1,040 annual responses. Our estimated burden for the information collection reflects an overall decrease of 39,050 hours and a corresponding decrease of 315 responses. We attribute this adjustment to updated information in the number of submissions we received over the last few years.
$6,380,000
No
    Yes
    No
No
No
No
Uncollected
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.
07/25/2019