Tobacco Product Establishment Registration and Submission of Certain Health Information

ICR 201612-0910-004

OMB: 0910-0650

Federal Form Document

ICR Details
0910-0650 201612-0910-004
Historical Active 201607-0910-001
HHS/FDA CTP
Tobacco Product Establishment Registration and Submission of Certain Health Information
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 12/20/2016
Retrieve Notice of Action (NOA) 12/14/2016
Previous terms continue: The data to be collected by CTP in this ICR (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents
  Inventory as of this Action Requested Previously Approved
06/30/2019 06/30/2019 06/30/2019
85,494 0 85,494
96,063 0 96,063
44 0 44

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.

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

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

  79 FR 23141 04/25/2014
81 FR 28973 05/10/2016
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 85,494 85,494 0 0 0 0
Annual Time Burden (Hours) 96,063 96,063 0 0 0 0
Annual Cost Burden (Dollars) 44 44 0 0 0 0
No
No
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.

$928,000
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.
12/14/2016


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