Document ID: FDA-2010-N-0124-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Requirements Under the Comprehensive Smokeless Tobacco Health Education Act (1986) as Amended by the Family Smoking Prevention and Tobacco Control Act
Posted Date: 2010-07-09T04:00Z

[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]               
[Page 39543-39544]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy10-48]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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.

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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 (the PRA).

DATES: Fax written comments on the collection of information by August 
9, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Requirements Under the Comprehensive Smokeless Tobacco Health 
Education Act of 1986, as Amended by the Family Smoking Prevention and 
Tobacco Control Act.'' Also include the FDA 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: 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-NEW)

    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 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, because the requirements of the Smokeless Tobacco Act have 
been revised and because 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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    On August 7, 2007, FTC published a 30-day notice (72 FR 44138) 
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 six 
companies it represented would require 700-800 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, because 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.
    In the Federal Register of March 16, 2010 (75 FR 12552), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received on this 
information collection.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 39544]]

                                                     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 rotational plans for health warning                   20                     1                  20                 100               2,000
 label statements
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: July 2, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16805 Filed 7-8-10; 8:45 am]
BILLING CODE 4160-01-S