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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:
201005-0910-009
Status:
Historical Active
Previous ICR Reference No:
199608-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
06/25/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/19/2010
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2013
36 Months From Approved
Responses
25,032
0
0
Time Burden (Hours)
125,007
0
0
Cost Burden (Dollars)
3,000,000
0
0
Abstract:
The regulations, which are codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897), are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). Section 102 of the Tobacco Control Act requires FDA to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996) with certain specified exceptions including that subpart C (which included ? 897.24) and ? 897.32(c) be removed from the reissued rule (? 102(a)(2)(B)). In accordance with the statutory mandate, the rule includes section 1140.30 (formerly ? 897.30) which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the rule. Section 1140.32 (formerly ? 897.32) states that the advertising must use black text on a white background, but that this particular requirement does not apply to adult newspapers, magazines, periodicals, or other publications. The rule indicates that competent and reliable survey evidence is required to determine whether a particular publication is an "adult" publication.
Authorizing Statute(s):
PL:
Pub.L. 111 - 31 102
Name of Law: Tobacco Control Act
Citations for New Statutory Requirements:
PL: Pub.L. 111 - 31 102 Name of Law: Tobacco Control Act
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG33
Final or interim final rulemaking
75 FR 13225
03/19/2010
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Format and content requirements for labeling and advertising
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
25,032
0
-2,019
0
0
27,051
Annual Time Burden (Hours)
125,007
0
-80,394
0
0
205,401
Annual Cost Burden (Dollars)
3,000,000
0
-17,301,000
0
0
20,301,000
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
The estimated burden hours have been reduced from 205,001 hours to 125,007. The reduction reflects the removal of 21 CFR 897.24, which were part of the 1999 information collection request for this rule, from this 2010 information collection request. The Tobacco Control Act struck these provisions from the reissued final rule.
Annual Cost to Federal Government:
$257,785
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]?
Uncollected
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:
Jonnalynn Capezzuto 3018274659
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:
05/19/2010
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