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