
[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Page 34107]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13448]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0190]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements Under 
the Comprehensive Smokeless Tobacco Health Education Act of 1986, as 
Amended by the Family Smoking Prevention and Tobacco Control Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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.

DATES: Fax written comments on the collection of information by July 8, 
2013.

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 0910-0671. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@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.

Requirements Under the Comprehensive Smokeless Tobacco Health Education 
Act of 1986, as Amended by the Family Smoking Prevention and Tobacco 
Control Act--(OMB Control Number 0910-0671)--Extension

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. L. 
111-31) into law. Section 3 of the Comprehensive Smokeless Tobacco 
Health Education Act of 1986 (the Smokeless Tobacco Act) (15 U.S.C. 
4402), as amended by section 204 of the Tobacco Control Act, requires, 
among other things, that all smokeless tobacco product packages and 
advertisements bear one of four required warning statements. Section 
3(b)(3)(A) of the Smokeless Tobacco Act requires that the warnings be 
displayed on packaging and advertising for each brand of smokeless 
tobacco ``in accordance with a plan submitted by the tobacco product 
manufacturer, importer, distributor, or retailer'' to, and approved by, 
FDA.
    This information collection--the submission to FDA of warning plans 
for smokeless tobacco products--is statutorily mandated. The warning 
plans will be reviewed by FDA, as required by the Smokeless Tobacco 
Act, to determine whether the companies' plans for the equal 
distribution and display of warning statements on packaging and the 
quarterly rotation of warning statements in advertising for each brand 
of smokeless tobacco products comply with section 3 of the Smokeless 
Tobacco Act, as amended.
    Based on the Federal Trade Commission's (FTC's) previous experience 
with the submission of warning plans and FDA's experience with 
smokeless tobacco companies (e.g., correspondence associated with user 
fees under section 919 of the Federal Food, Drug, and Cosmetic Act, as 
amended by the Tobacco Control Act (21 U.S.C. 387s)), FDA estimates 
that there are 36 companies affected by this information collection. To 
account for the entry of new smokeless tobacco companies that may be 
affected by this information collection, FDA is estimating the total 
number of respondents to be 100.
    When the FTC requested an extension of their approved information 
collection in 2007, based on over 20 years implementing the warning 
plan requirements and taking into account increased computerization and 
improvements in electronic communication, the FTC estimated submitting 
an initial plan would take 60 hours. Based on FDA's experience over the 
past several years, FDA believes the estimate of 60 hours to complete 
an initial rotational plan continues to be reasonable.
    In the Federal Register of March 18, 2013 (78 FR 16678), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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     Total capital
                                                      respondents       respondent       responses      per  response                         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of rotational plans for health warning              100                1              100               60            6,000           $1,200
 label statements.................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.

    FDA estimates a total of 100 respondents at 1 response each and 60 
burden hours per response for a total of 6,000 burden hours (100 
respondents x 1 response x 60 burden hours = 6,000 total burden hours). 
In addition, capital costs are based on all 100 respondents mailing in 
their submission at a postage rate of $12 for a 5-pound parcel 
(business parcel post mail delivered from the farthest delivery zone). 
Therefore, FDA estimates that the total postage cost for mailing the 
rotational warning plans to be $1,200.

    Dated: June 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13448 Filed 6-5-13; 8:45 am]
BILLING CODE 4160-01-P


