[Federal Register Volume 75, Number 50 (Tuesday, March 16, 2010)]
[Notices]
[Pages 12552-12553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5654]
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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, [email protected].
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