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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:
0910-0312
ICR Reference No:
201304-0910-003
Status:
Historical Active
Previous ICR Reference No:
201005-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
18658
Title:
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/16/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
04/10/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2016
36 Months From Approved
07/31/2013
Responses
302
0
25,032
Time Burden (Hours)
302
0
125,007
Cost Burden (Dollars)
0
0
3,000,000
Abstract:
This is a request for OMB renewal for FDA's regulations for cigarettes and smokeless tobacco containing nicotine. The codified regulations at 21 CFR Part 1140 are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This collection includes reporting information requirements for § 1140.30, which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the regulations. As the public is being advised through the FDA guidance entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco," the recordkeeping and disclosure requirements under section 1140.32 are not being enforced, and therefore, FDA is including 2 hours of burden as placeholders with this provision.
Authorizing Statute(s):
PL:
Pub.L. 111 - 31 102
Name of Law: Tobacco Control 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 59622
09/28/2012
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 20923
04/08/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Format and Content Requirements for labeling and advertising - 3rd party
Format and content requirements for labeling and advertising
Scope of permissible forms of labeling and advertising
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
302
25,032
0
-24,730
0
0
Annual Time Burden (Hours)
302
125,007
0
-124,705
0
0
Annual Cost Burden (Dollars)
0
3,000,000
0
-3,000,000
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
The estimated burden hours have been reduced from 125,007 hours to 302 hours. The reduction reflects: • FDA's is not enforcing § 1140.32 (for a reduction of 125,004 hours), and • The expected increase of 299 hours due to the expectation that 300 respondents will notify the FDA under § 1140.30 if they intend to use an advertising medium that is not listed in the regulation (Note that FDA has placed two 1-hour place holders for burden in § 1140.32 to reflect FDA enforcement discretion.)
Annual Cost to Federal Government:
$116,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
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:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
04/09/2013
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