OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

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

ICR 201403-0910-002 · OMB 0910-0768 · Historical Inactive

Forms and Documents
DocumentTypeStatusAvailability
Deeming NPRM SS-041814.doc Supporting Statement A Uploaded 2014-04-19 Available
IC Document Collections
IC IDCollectionTypeStatusForm
210603 Exemptions From the Required Warning Statement Requirement New
210602 Environmental Assessments Applications for Premarket Review of New Tobacco Products New
210600 Request for meeting with CTP's Office of Science to discuss Investigational Plan New
210599 Obtaining an FDA order authorizing marketing of tobacco product (the application) New
210598 Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 New
210597 Cigars 2 largest manufacturers Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007 New
210594 Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products New
210593 Importation of Tobacco Products New
210592 Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product New
210591 Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product New
210590 Exemption from SE Report to demonstrate tobacco product modified under section 905(j)(3) New
210589 Preparation of an Environmental Assessment New
210588 Preparation of Additional Information for Tobacco Product Exemption from Substantial Equivalence Request New
210587 Preparation of Tobacco Product Exemption from Substantial Equivalence Request New
210570 Health Document Submission New
210569 Tobacco Product Ingredient Listing New
210568 Obtaining a Dun and Bradstreet D-U-N-S Number New
210567 Tobacco Product Listing New
210566 Tobacco Product Establishment Registration New
ICR Details
0910-0768 201403-0910-002
Historical Inactive
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
Comment filed on proposed rule 07/08/2014
Retrieve Notice of Action (NOA) 04/28/2014
OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is not approving the collection at this time. Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0
The Food and Drug Administration (FDA) is issuing a proposed 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 proposed rule would extend 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. This proposed rule also would prohibit the sale of tobacco products covered under the rule to individuals under the age of 18 and would require the display of health warnings on tobacco product packages and in advertisements for tobacco products covered under the rule. FDA is taking this action to address the public health concerns associated with the use of 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
0910-AG38 Proposed rulemaking 79 FR 23141 04/25/2014
  79 FR 23141 04/25/2014
No
Yes
Miscellaneous Actions
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.
04/28/2014