Document ID: FDA-2013-N-0190-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements under Comprehensive Smokeless Tobacco Health Education Act of 1986 as Amended
Posted Date: 2013-03-18T04:00Z

[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16678-16679]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06127]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on submission of rotational plans 
for health warning label statements for smokeless tobacco products.

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 16679]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Numbers of
                     Activity                          Numbers of     responses  per   Total  annual   Average  burden    Total  hours    Total  capital
                                                      respondents       respondent       responses       per  response                        costs
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Submission of rotational plans for health warning              100                1              100               60            6,000           $1,200
 label statements.................................
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\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 furthest delivery zone). 
Therefore, FDA estimates that the total postage cost for mailing the 
rotational warning plans to be $1,200.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06127 Filed 3-15-13; 8:45 am]
BILLING CODE 4160-01-P