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

ICR 201506-0910-027

OMB: 0910-0673

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-07-14
ICR Details
0910-0673 201506-0910-027
Historical Active 201503-0910-003
HHS/FDA CTP
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Extension without change of a currently approved collection   No
Regular
Approved without change 01/07/2016
Retrieve Notice of Action (NOA) 07/16/2015
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
01/31/2019 36 Months From Approved 01/31/2016
300 0 300
38,075 0 38,075
0 0 0

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."

PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 11989 03/03/2015
80 FR 40071 07/13/2015
Yes

  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
No
No

$2,320,000
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/16/2015


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