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:
0910-0650
ICR Reference No:
200911-0910-002
Status:
Historical Active
Previous ICR Reference No:
200911-0910-001
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Emergency
Approval Requested By:
11/25/2009
OIRA Conclusion Action:
Approved with change
Conclusion Date:
11/24/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
11/24/2009
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2010
6 Months From Approved
05/31/2010
Responses
112,650
0
100,000
Time Burden (Hours)
408,775
0
375,000
Cost Burden (Dollars)
484
0
440
Abstract:
This new information collection is for 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 905 of the FFDCA requires this registration be completed by December 31 of each year. Section 904(c) of the act requires that a tobacco product manufacturer: 1) Provide all information required under section 904(a) "at least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product not on the market on the date of enactment" of the Tobacco Control Act. 2) Advise the FDA in writing at least 90 days prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those additives that have been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use. 3) Advise the FDA in writing at least 60 days prior to eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by the FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.
Emergency Justfication:
FDA requests permission to use the emergency clearance process to obtain OMB approval of the tobacco product establishment registration requirements of FSPTCA. Section 905 of the 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 905 requires this registration be completed by December 31 of each year. To allow adequate time for establishment owners and operators to complete the registration process, FDA plans to begin accepting establishment registrations on November 9, 2009.
Authorizing Statute(s):
US Code:
21 USC 904
Name of Law: FFDCA
US Code:
21 USC 905
Name of Law: FFDCA
Citations for New Statutory Requirements:
US Code: 21 USC 905 Name of Law: FFDCA
US Code: 21 USC 904 Name of Law: FFDCA
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Other Documents for OIRA Review
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Establishment Registration
FDA 3741
Tobacco Product Establishment Registration (Paper Form FDA 3741)
FDA 3741
Tobacco Product Ingredient Listing
FDA 3742
Tobacco Product Ingredient Listing (Paper form 3742)
FDA 3742
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
112,650
100,000
12,650
0
0
0
Annual Time Burden (Hours)
408,775
375,000
33,775
0
0
0
Annual Cost Burden (Dollars)
484
440
44
0
0
0
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:
This is a new information collection.
Annual Cost to Federal Government:
$996,000
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]?
Uncollected
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:
11/24/2009
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