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

ICR 201602-0910-002

OMB: 0910-0768

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-05-05
IC Document Collections
ICR Details
0910-0768 201602-0910-002
Historical Active 201403-0910-002
HHS/FDA CTP
Deeming Tobacco Products To Be Subject to the FD&C Act
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/04/2016
Retrieve Notice of Action (NOA) 05/10/2016
  Inventory as of this Action Requested Previously Approved
08/31/2019 36 Months From Approved
1,355 0 0
1,326,000 0 0
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.

PL: Pub.L. 111 - 31 101 Name of Law: The Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 301 et seq Name of Law: The Federal Food, Drug, and Cosmetic Act
  
None

0910-AG38 Final or interim final rulemaking 81 FR 28973 05/10/2016

No

  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 1,355 0 0 1,355 0 0
Annual Time Burden (Hours) 1,326,000 0 0 1,326,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new information collection.

$6,380,000
No
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [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.
05/10/2016


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