Document ID: FDA-2011-D-0125-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Guidance for
Industry on Establishing That a Tobacco Product Was Commercially
Marketed in the United States as of February 15, 2007
Posted Date: 2014-07-11T04:00Z

[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40107-40108]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16252]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0125]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance for Industry 
on Establishing That a Tobacco Product Was Commercially Marketed in the 
United States as of February 15, 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 40108]]

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by August 
11, 2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-New and 
title ``Guidance for Industry on Establishing That a Tobacco Product 
Was Commercially Marketed in the United States as of February 15, 
2007.'' Also include the FDA docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry on Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007--
(OMB Control Number 0910-New)

    This guidance provides information on how a manufacturer may 
establish that a tobacco product was commercially marketed in the 
United States as of February 15, 2007. Grandfathered tobacco products 
are not considered new tobacco products and thus are not subject to 
premarket review. A grandfathered tobacco product may also serve as the 
predicate tobacco product in a Section 905(j) Report: Demonstrating 
Substantial Equivalence for Tobacco Products (intended to be used 
toward demonstrating substantial equivalence) for a new tobacco product 
(section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 387e(j)(1)(A)(i))).
    The guidance recommends that the manufacturer submit information 
adequate to demonstrate that the tobacco product was commercially 
marketed in the United States as of February 15, 2007. Examples of such 
information may include, but are not limited to, the following: dated 
copies of advertisements, dated catalog pages, dated promotional 
material, and dated bills of lading.
    FDA's estimate of the number of respondents is based on the fact 
that requesting an Agency determination of the grandfathered status of 
a tobacco product under the guidance is not required and also on 
indications of interest of making such request. The number of hours to 
gather the evidence is FDA's estimate of how long it might take one to 
review, gather, and submit dated information if making a request for 
Agency determination. After further consideration of these estimates, 
FDA has reduced the number of hours to submit this information from 10 
to 5 hours.
    In the Federal Register of April 25, 2011 (76 FR 22903), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were submitted on FDA's 
estimates of the number of respondents or burden. FDA received three 
comments that generally addressed topics related to the recommendations 
of the guidance, including questions about the status of tobacco 
products that were in test markets in the United States as of February 
15, 2007, and how much evidence should be submitted.
    FDA estimates the burden of this collection of information as 
follows:

                                                      Table 1--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submit evidence of commercial marketing in the United States as of              150                1              150                5              750
 February 15, 2007.................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based the estimates on information it received from 
interactions with the industry that 3 large manufacturers might submit 
as many as 25 packages of evidence annually, and other manufacturers 
might submit as many as 125 packages of evidence indicating that their 
tobacco product was commercially marketed in the United States as of 
February 15, 2007, for a total of 150 responses annually. FDA further 
estimates it would take a manufacturer approximately 5 hours to put 
together this collection of evidence and to submit the package to FDA 
for review. This is a reduction from FDA's original estimate of 10 
hours per response. FDA estimates that it should take approximately 750 
hours annually (150 responses times 5 hours for each response) to 
respond to this collection of information.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16252 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P