Information Request Regarding pH of Smokeless Tobacco Products

ICR 201406-0910-020

OMB: 0910-0781

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2014-10-23
Supporting Statement A
2014-10-23
ICR Details
0910-0781 201406-0910-020
Historical Active
HHS/FDA CTP
Information Request Regarding pH of Smokeless Tobacco Products
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 01/26/2015
Retrieve Notice of Action (NOA) 11/10/2014
  Inventory as of this Action Requested Previously Approved
01/31/2018 36 Months From Approved
125 0 0
1,615 0 0
0 0 0

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is proposing to collect information from tobacco manufacturers and/or their agents via a letter to become better informed about the impact of the use and public health effects of tobacco products. This proposed ICR will collect information regarding the effects of smokeless tobacco product pH on the public health under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). The information collected will include information that industry is required to provide under the FD&C Act, as well as voluntary information requests beyond the inquiries described in the FD&C Act. FDA will use the information collected to assess the effects of product pH of smokeless tobacco products on consumers and the public health.

PL: Pub.L. 111 - 31 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  79 FR 42797 07/23/2014
79 FR 64394 10/29/2014
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 125 0 0 125 0 0
Annual Time Burden (Hours) 1,615 0 0 1,615 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new collection of information.

$387,000
No
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.
11/10/2014


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