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

Forms and Documents

Document Name	Status
0910_0673 SE Supporting Statement Final.docx Supporting Statement A	2015-07-14

IC Document Collections

IC ID	Document Title	Status
215516	Same characteristics SE Report Other-Guidance	Unchanged
215515	Product Quantity Change SE Report Other-Guidance	Unchanged
195793	Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a)) Instruction	Unchanged

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 201506-0910-027
Status: Historical Active	Previous ICR Reference No: 201503-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
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 without change	Conclusion Date: 01/07/2016
	Date Received in OIRA: 07/16/2015
Terms of Clearance: This ICR Extension is approved to continue this ongoing collection. However, upon publication of the Tobacco Deeming Final Rule(RIN 0910-AG38) an ICR Revision request will be submitted to adjust the requested burden hours to account for the anticipated increase in applications submitted post effective date of the rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2019	36 Months From Approved	01/31/2016
Responses	300	0	300
Time Burden (Hours)	38,075	0	38,075
Cost Burden (Dollars)	0	0	0

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Abstract: On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a chapter granting FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The FD&C Act requires FDA to issue an order under section 910(c) before a new tobacco product may be commercially marketed. An order under section 910(c) 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 that the tobacco product is (1) substantially equivalent to a tobacco product commercially marketed in the United States as of February 15, 2007, and (2) in compliance with the requirements of the FD&C Act. Manufacturers of these tobacco products may submit a report under section 905(j) demonstrating that their new tobacco product is substantially equivalent to a predicate tobacco product. FDA has issued a guidance document containing recommendations for preparing substantial equivalence reports under section 905(j). For the purposes of substantial equivalence reports, the new tobacco product is compared to a predicate tobacco product in determining substantial equivalence. Additionally, under the recently issued guidance entitled, "Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions," FDA is recommending that certain modifications might be addressed in either a "Same Characteristics SE Report" or "Product Quantity Change Report."

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Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic 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:
	80 FR 11989	03/03/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 40071	07/13/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Product Quantity Change SE Report
Same characteristics SE Report
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	300	300	0	0	0	0
Annual Time Burden (Hours)	38,075	38,075	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:

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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: 07/16/2015

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