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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:
0910-0749
ICR Reference No:
201506-0910-024
Status:
Historical Active
Previous ICR Reference No:
201503-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/24/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
06/25/2015
Terms of Clearance:
Prior terms remain in effect: The data to be collected under this ICR overlaps with collections of excise tax and import information by Alcohol and Tobacco Tax and Trade Bureau (TTB) and Customs and Border Protection (CBP). However, the TTB and CBP data cannot currently be used by FDA for calculating user fees due to both logistical reasons and restrictions on the use of excise tax information that could be provided to FDA directly by TTB. FDA has had meetings with TTB about establishing a memorandum of understanding (MOU) with TTB to receive information directly from TTB regarding tobacco permit holders and excise tax payments. FDA will work with TTB and CBP to further develop means for the sharing of information that FDA could use to calculate and assess tobacco product user fees. This purpose of FDA’s collaboration with TTB and CBP is to explore whether it would be possible, in light of current legal restrictions on the use of individual taxpayer information, for FDA to rely solely on data received from TTB and CBP and thus eliminate the need for this information collection. FDA will report to OIRA on a quarterly basis beginning October 1, 2014, regarding the progress of these meetings until a resolution is reached, which shall be accomplished no later than July 1, 2016.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2017
07/31/2017
07/31/2017
Responses
5,215
0
5,215
Time Burden (Hours)
10,150
0
10,150
Cost Burden (Dollars)
0
0
0
Abstract:
The Food and Drug Administration (FDA) is issuing a proposed rule that would require domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The United States Department of Agriculture (USDA) has been collecting this information and providing FDA with the data FDA needs to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA intends to cease collecting this information in fiscal year 2015 (October 2014). Consistent with the requirements of the FD&C Act, FDA is proposing to require the submission of this information to FDA instead of USDA. FDA is taking this action to ensure that FDA continues to have the information FDA needs to calculate, assess, and collect user fees.
Authorizing Statute(s):
PL:
Pub.L. 111 - 31 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG81
Final or interim final rulemaking
79 FR 39302
07/10/2014
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
FDA 3852 Report of Tobacco Product Removals Subject to Tax
FDA 3852
Report of Tobacco Product Removals Subject to Tax
Monthly certified copies
Submission of Requests for further review of disputes of User Fees
Submission of User Fee Dispute
Submission of User Fee Information with user fee payment
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
5,215
5,215
0
0
0
0
Annual Time Burden (Hours)
10,150
10,150
0
0
0
0
Annual Cost Burden (Dollars)
0
0
0
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:
$232,000
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:
Amber Sanford 301 796-8867 amber.sanford@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:
06/25/2015
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