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

Forms and Documents

Document Name	Status
emergency memo 12-21-2010.doc Supplementary Document	2010-12-21
Substantial Equivalence Guidance Doc ss 12-22-2010.doc Supporting Statement A	2010-12-23

IC Document Collections

IC ID	Document Title	Status
195793	Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a)) Other-guidance document	New

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 201012-0910-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 12/27/2010
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/30/2010
	Date Received in OIRA: 12/23/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2011	6 Months From Approved
Responses	150	0	0
Time Burden (Hours)	54,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 905(j) requires manufacturers who wish to demonstrate substantial equivalence for tobacco products commercially marketed after February 15, 2007 to include in their section 905(j) 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 also intends to include in the guidance recommendations on how to submit a section 905(j) report, and intends to issue the guidance as immediately in effect to ensure that manufacturers have the benefit of FDA's recommendations in time to prepare their 905(j) reports.

Emergency Justfication: Section 910 requires that FDA must review a premarket application and issue an order before a new tobacco product may be commercially marketed. An order under section 910 is not required, however, if a manufacturer submits a report under section 905(j) for the new tobacco product and FDA issues an order finding the tobacco product to be substantially equivalent to a predicate tobacco product. The FSPTCA contains a special provision for products placed on the market between February 15, 2007 and March 22, 2011. Section 905 requires that, for those products, a section 905(j) report must be submitted to FDA by March 22, 2011 in order for the product remain on the market. To ensure that this guidance is issued in enough time for manufacturers to use it to prepare their submissions and to satisfy the PRA requirements, FDA is requesting permission to use the emergency clearance procedures for the information collection requirements of the guidance. The Secretary of Health and Human Services has delegated to the Commissioner of the Food and Drug Administration the responsibility for administering the FD&C Act, including sections 905 and 910.

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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

Did the Agency receive public comments on this ICR? No

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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	150	0	0	150	0	0
Annual Time Burden (Hours)	54,000	0	0	54,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information

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Annual Cost to Federal Government: $696,000

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: 12/23/2010

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