Document ID: FDA-2010-N-0124-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, etc.
Posted Date: 2010-03-16T04:00Z

[Federal Register: March 16, 2010 (Volume 75, Number 50)]
[Notices]               
[Page 12552-12553]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr10-63]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0124]

 
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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the collection of information pertaining to 
the submission of smokeless tobacco rotational warning plans under the 
Comprehensive Smokeless Tobacco Health Education Act of 1986 (the 
Smokeless Tobacco Act), as amended by the Family Smoking Prevention and 
Tobacco Control Act (the Tobacco Control Act).

DATES:  Submit written or electronic comments on the collection of 
information by May 17, 2010.

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: Jonna Capezzuto, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-3794, Jonnalynn.Capezzuto@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 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

    On June 22, 2009, the President signed the Tobacco Control Act 
(Public Law 111-31) into law. The Smokeless Tobacco Act (15 U.S.C. 
4402), as amended by section 204 of the Tobacco Control Act, requires 
that manufacturers, packagers, importers, distributors, and retailers 
(in limited circumstances) of smokeless tobacco products include one of 
four specified health warning label statements on product packages and 
in advertisements.\1\ The Smokeless Tobacco Act, as amended, also 
requires smokeless tobacco product manufacturers, importers, 
distributors, and certain retailers to submit a plan to FDA specifying 
the method to rotate, display, and distribute the specified health 
warning label statements

[[Page 12553]]

required to appear in advertising and packaging. FDA is required to 
review each plan submitted and approve the plan if it provides for 
rotation, display, and distribution of warnings in compliance with the 
requirements of the Smokeless Tobacco Act. To the best of FDA's 
knowledge, all of the affected companies have previously submitted 
similar plans to the Federal Trade Commission (FTC), which had 
authority to implement the requirements of the Smokeless Tobacco Act 
prior to the Tobacco Control Act's amendments. However, since the 
requirements of the Smokeless Tobacco Act have been revised and since 
FDA now has authority to implement the Smokeless Tobacco Act, each 
affected company will be required to submit a new plan to FDA instead 
of FTC. The Tobacco Control Act's amendments to the Smokeless Tobacco 
Act are effective on June 22, 2010.
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    \1\ The warnings themselves disclose information completely 
supplied by the Federal Government. As such, the disclosure does not 
constitute a ``collection of information'' as it is defined in the 
regulations implementing the PRA, nor, by extension, do the 
financial resources expended in relation to it constitute paperwork 
``burden.'' See 5 CFR 1320.3(c)(2).
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    In the Federal Register of August 7, 2007 (72 FR 44138), FTC 
published a 30-day notice announcing an opportunity for public comment 
and that the information collection would be sent to OMB for review. 
Based on FTC's previous experience with the submission of rotational 
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), FDA estimates that there are 14 companies affected by this 
information collection. To account for the entry of new smokeless 
tobacco companies who may be affected by this information collection, 
FDA is estimating the total number of respondents to be 20.
    When FTC originally implemented the rotational plan requirements in 
1986, the Smokeless Tobacco Council, Inc. indicated that the 6 
companies it represented would require 700 to 800 hours in total (133 
hours each) to complete an initial rotational plan, involving multiple 
brands, multiple brand varieties, and multiple forms of both packaging 
and advertising. When FTC requested an extension of their PRA clearance 
in 2007, FTC decreased the estimate for submitting an initial plan from 
143 hours to 60 hours, accounting for increased computerization and 
improvements in electronic communication over the subsequent 20 years 
since the Smokeless Tobacco Act was enacted. FDA believes the estimate 
of 60 hours to complete an initial rotational plan continues to be 
reasonable. However, since the requirements of the new Smokeless 
Tobacco Act are unfamiliar to industry, FDA is increasing the time 
estimate for submitting initial plans to 100 hours.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
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                        No. of        Annual Frequency     Total Annual          Hours per
    Activity         Respondents        per Response         Responses           Response          Total Hours
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Submission of                    20                  1                  20                 100             2,000
 rotational
 plans for
 health warning
 label
 statements
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: March 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5654 Filed 3-15-10; 8:45 am]
BILLING CODE 4160-01-S