View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-0338
ICR Reference No:
201212-0920-007
Status:
Historical Active
Previous ICR Reference No:
201102-0920-006
Agency/Subagency:
HHS/CDC
Agency Tracking No:
Title:
Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S.
Type of Information Collection:
Reinstatement without change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
02/04/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/03/2013
Terms of Clearance:
Approved without change for 1 year consistent with the understanding that CDC will work with FDA¿s Center for Tobacco Products to identify duplication of tobacco product ingredient collections. Within this year, CDC will work with FDA, OMB, and HHS to eliminate duplication and reduce burden on respondents. As part of this effort, HHS, including CDC and FDA, should determine why the existing collection of information by the Center for Tobacco Products (OMB Control Number 0910-0650, and a pending ICR titled Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act) would not eliminate the need for and the practical utility of CDC¿s annual collection of this information. HHS should also consider whether the authority delegated to CDC for this collection should be delegated to the Center for Tobacco Products.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
02/28/2014
36 Months From Approved
Responses
13
0
0
Time Burden (Hours)
22,269
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
This is a legislatively mandated information collection. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq. or Pub.L. 99-252) requires each person who manufactures, packages, or imports smokeless tobacco products to provide the Secretary of HHS with an annual list of ingredients added to tobacco in the manufacture of smokeless tobacco products, as well as a specification of quantity of nicotine contained in each product. Responsibility for collecting the information has been delegated to CDC's Office on Smoking and Health.
Authorizing Statute(s):
US Code:
15 USC 4401
Name of Law: Comprehensive Smokeless Tobacco Education Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
77 FR 12595
03/01/2012
30-day Notice:
Federal Register Citation:
Citation Date:
77 FR 40362
07/09/2012
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
List of Ingredients Added in the Manufacture of Smokeless Tobacco Products
ICR Summary of Burden
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
13
0
0
13
0
0
Annual Time Burden (Hours)
22,269
0
0
22,269
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a request for reinstatement without change of a previous approved collection. There are no changes to data collection procedures or the estimated burden per response.
Annual Cost to Federal Government:
$140,000
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
Yes
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Thelma Sims 4046394771
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/21/2012
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