Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product

Forms and Documents

Document Name	Status
SE Guidance Supporting Statement-062711.doc Supporting Statement A	2011-06-29

IC Document Collections

IC ID	Document Title	Status
195793	Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a)) Instruction	Modified

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 201105-0910-001
Status: Historical Active	Previous ICR Reference No: 201012-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 07/08/2011
	Date Received in OIRA: 05/10/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved	07/31/2011
Responses	1,000	0	150
Time Burden (Hours)	360,000	0	54,000
Cost Burden (Dollars)	0	0	0

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Abstract: The FD&C Act requires FDA to issue an order after review of a premarket application before a new tobacco product may be commercially marketed. An order is not required, however, if a manufacturer submits a section 905(j)(1)(A)(i) report for the new tobacco product and FDA issues an order finding that the tobacco product is substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and in compliance with the Act. Manufacturers of these tobacco products may submit a report under section 905(j)(1)(A)(i) demonstrating that their new tobacco product is substantially equivalent to a predicate tobacco product. FDA issued a guidance document with recommendations on preparing substantial equivalence reports in which a tobacco manufacturer must show that a new tobacco product is substantially equivalent within the meaning of section 910 to a tobacco product commercially marketed in the U.S. as of February 15, 2007, or to a tobacco product that the Secretary has previously determined is substantially equivalent and in compliance with the Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product. For 905(j)(1)(A)(i) reporting, the new tobacco product is compared to a single predicate tobacco product to determine substantial equivalence. Section 905(j)(1)(A)(i) requires manufacturers who wish to demonstrate substantial equivalence for tobacco products commercially marketed after February 15, 2007 to include in their reports recommendations for providing information comparing the characteristics of the new and predicate tobacco product, including: 1) materials, 2) ingredients, 3) design, 4) composition, 5) heating source, or 6) other features. FDA recommends how to submit a section 905(j)(1)(A)(i) report in the issued guidance to ensure that manufacturers have time to prepare their 905(j) reports.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Tobacco Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 4116	01/24/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 24888	05/03/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))

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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	1,000	150	0	0	850	0
Annual Time Burden (Hours)	360,000	54,000	0	0	306,000	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:

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Annual Cost to Federal Government: $2,320,000

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: 05/10/2011

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