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

ICR 201503-0910-003

OMB: 0910-0673

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2015-03-03
Supporting Statement A
2014-05-14
ICR Details
0910-0673 201503-0910-003
Historical Active 201405-0910-002
HHS/FDA CTP
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 03/16/2015
Retrieve Notice of Action (NOA) 03/06/2015
  Inventory as of this Action Requested Previously Approved
08/31/2015 08/31/2015 08/31/2015
300 0 1,000
38,075 0 360,000
0 0 0

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires FDA to issue an order under section 910(c)(1)(A)(i) (order after review of a premarket application) before a new tobacco product may be commercially marketed in the United States. An order under section 910(c)(1)(A)(i) is not required, however, if a manufacturer submits under section 905(j)(1)(A)(i) a 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 FD&C Act. This ICR requests information from manufacturers of tobacco products who submit a report to FDA under section 905(j)(1)(A)(i) demonstrating that their new tobacco product is substantially equivalent to a predicate tobacco product. FDA has 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 to a tobacco product commercially marketed in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined is substantially equivalent and in compliance with the FD&C Act. For tobacco product substantial equivalence reporting, the new tobacco product is compared to a single predicate tobacco product to determine substantial equivalence.

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

Not associated with rulemaking

  78 FR 78974 12/27/2013
79 FR 33196 06/10/2014
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 1,000 0 -700 0 0
Annual Time Burden (Hours) 38,075 360,000 0 -321,925 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The Food and Drug Administration is submitting this nonmaterial/non-substantive change request to reduce the burden based on new guidance document recommendations which will reduce the time for a manufacturer to submit a Substantial Equivalence (SE) report.

$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.
03/06/2015


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