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OMB Control No: 0910-0673	ICR Reference No: 201609-0910-003
Status: Historical Active	Previous ICR Reference No: 201601-0910-019
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: 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: 09/28/2016
	Date Received in OIRA: 09/28/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	979	0	1,497
Time Burden (Hours)	171,878	0	196,224
Cost Burden (Dollars)	0	0	0

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."

Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG38	Final or interim final rulemaking	81 FR 28973	05/10/2016

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23141	04/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 28973	05/10/2016
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	979	1,497	-518
Annual Time Burden (Hours)	171,878	196,224	-24,346
Annual Cost Burden (Dollars)	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:

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

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

View ICR - OIRA Conclusion