Tobacco Products, User Fees, Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

Forms and Documents

Document Name	Status
Form FDA 3852 FDA 3852 Report of Tobacco Product Removals Subject to Tax Form and Instruction	Unchanged
0910-0749 user fee report 3Q update 06 25 15.docx Justification for No Material/Nonsubstantive Change	2015-06-25
0910-0749 user fee report Q2 Update 03 10 15-1.docx Justification for No Material/Nonsubstantive Change	2015-03-13
0910-0749 user fee report quarterly update 10 6 14.docx Justification for No Material/Nonsubstantive Change	2014-10-06
User Fees Final Rule Supporting Statement 6.23.doc Supporting Statement A	2014-06-23
Section 1150_15_d.doc Supplementary Document	2013-06-05
Section 1150_15_a.doc Supplementary Document	2013-06-05
Section 1150_13.doc Supplementary Document	2013-06-05
Section 1150_5_b_3.doc Supplementary Document	2013-06-05
Section 1150_5_a_b1_b2_FDA3852.doc Supplementary Document	2013-06-05

IC Document Collections

IC ID	Document Title	Status
207254	Submission of Requests for further review of disputes of User Fees	Unchanged
207253	Submission of User Fee Dispute	Unchanged
207252	Submission of User Fee Information with user fee payment	Unchanged
207251	Monthly certified copies	Unchanged
207250	FDA 3852 Report of Tobacco Product Removals Subject to Tax Form and Instruction	Unchanged

ICR Details

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
	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

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG81	Final or interim final rulemaking	79 FR 39302	07/10/2014

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Monthly certified copies
Submission of User Fee Information with user fee payment
Submission of User Fee Dispute
FDA 3852 Report of Tobacco Product Removals Subject to Tax	FDA 3852	Report of Tobacco Product Removals Subject to Tax
Submission of Requests for further review of disputes of User Fees

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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.

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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

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Common Form ICR:  No

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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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