Smokeless Tobacco Product Warning Statements; Request for Comments and Scientific Evidence, 6056 [2013-01626]
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Federal Register / Vol. 78, No. 19 / Tuesday, January 29, 2013 / Proposed Rules
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Dated: January 17, 2013.
Edward J. DeMarco,
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[FR Doc. 2013–01428 Filed 1–28–13; 8:45 am]
BILLING CODE 8070–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1142
[Docket No. FDA–2012–N–1032]
Smokeless Tobacco Product Warning
Statements; Request for Comments
and Scientific Evidence
AGENCY:
Food and Drug Administration,
HHS.
Notification; request for
comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to obtain comments,
supported by scientific evidence,
regarding what changes to the smokeless
tobacco product warnings, if any, would
promote greater public understanding of
the risks associated with the use of
smokeless tobacco products.
DATES: Submit electronic or written
comments by April 1, 2013.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Gail
Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 1–877–287–
1373, gail.schmerfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
sroberts on DSK5SPTVN1PROD with
SUMMARY:
I. Background
On June 22, 2009, the President
signed the Family Smoking Prevention
VerDate Mar<15>2010
17:08 Jan 28, 2013
Jkt 229001
and Tobacco Control Act (Pub. L. 111–
31) (Tobacco Control Act) into law. The
Tobacco Control Act grants FDA
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect public health
generally and to reduce tobacco use by
minors.
Section 204 of the Tobacco Control
Act amended section 3 of the
Comprehensive Smokeless Tobacco
Health Education Act (Smokeless
Tobacco Act) (15 U.S.C. 4402) to
prescribe new requirements for health
warnings that must appear on smokeless
tobacco product packages and
advertising. The Smokeless Tobacco Act
(15 U.S.C. 4402(a)(1) and (b)(1)),
requires that smokeless tobacco product
packages and advertising must bear one
of four required warning statements.
The four required warning statements
are:
‘‘WARNING: This product can cause
mouth cancer.’’
‘‘WARNING: This product can cause
gum disease and tooth loss.’’
‘‘WARNING: This product is not a
safe alternative to cigarettes.’’
‘‘WARNING: Smokeless tobacco is
addictive.’’ (15 U.S.C. 4402(a)(1))
One of the four required warning
statements must be located on each of
the two principal display panels of the
package and comprise at least 30
percent of each such display panel (15
U.S.C. 4402(a)(2)(A)). The Smokeless
Tobacco Act (15 U.S.C. 4402(a)(2) and
(b)(2)), also sets forth requirements for
the placement, type, size, and color of
warnings on packaging and
advertisements, respectively.
Section 205(a) of the Tobacco Control
Act further amended section 3 of the
Smokeless Tobacco Act to give FDA the
authority to ‘‘adjust the format, type size
and text of any of the label
requirements, require color graphics to
accompany the text, increase the
required label area from 30 up to 50
percent of the front and rear panels of
the package, or establish the format,
type size, and text of any other
disclosures required under the Federal
Food, Drug, and Cosmetic Act’’ through
rulemaking conducted under the
Administrative Procedures Act (5 U.S.C.
552, et seq.) if FDA ‘‘finds that such a
change would promote greater public
understanding of the risks associated
with the use of smokeless tobacco
products’’ (15 U.S.C. 4402(d)).
II. Request for Scientific Evidence and
Information
We are interested in comments,
supported by scientific evidence,
regarding what changes, if any, to the
smokeless tobacco product warnings
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
would promote greater public
understanding of the risks associated
with the use of smokeless tobacco
products. The ‘‘public’’ includes both
tobacco users and nonusers (i.e., never
users and former users). Comments and
supporting evidence should address
how any changes in the warnings would
affect both users’ and nonusers’
understanding of the risks associated
with the use of smokeless tobacco
products.
III. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. It is only
necessary to send one set of comments.
Identify comments with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: January 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–01626 Filed 1–28–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 31
[REG–102966–10]
RIN 1545–BJ31
Designation of Payor as Agent To
Perform Acts Required of an Employer
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking.
AGENCY:
This document contains
proposed regulations under section
3504 of the Internal Revenue Code
(Code) providing circumstances under
which a person (payor) is designated as
an agent to perform the acts required of
an employer and is liable for
employment taxes with respect to wages
or compensation paid by the payor to
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payor’s client pursuant to a service
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SUMMARY:
Written or electronic comments
must be received by April 29, 2013.
DATES:
E:\FR\FM\29JAP1.SGM
29JAP1
]]>Agencies
[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Proposed Rules]
[Page 6056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01626]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1142
[Docket No. FDA-2012-N-1032]
Smokeless Tobacco Product Warning Statements; Request for
Comments and Scientific Evidence
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is establishing a
public docket to obtain comments, supported by scientific evidence,
regarding what changes to the smokeless tobacco product warnings, if
any, would promote greater public understanding of the risks associated
with the use of smokeless tobacco products.
DATES: Submit electronic or written comments by April 1, 2013.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Gail Schmerfeld, Center for Tobacco
Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 1-877-287-
1373, gail.schmerfeld@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control
Act) into law. The Tobacco Control Act grants FDA authority to regulate
the manufacture, marketing, and distribution of tobacco products to
protect public health generally and to reduce tobacco use by minors.
Section 204 of the Tobacco Control Act amended section 3 of the
Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco
Act) (15 U.S.C. 4402) to prescribe new requirements for health warnings
that must appear on smokeless tobacco product packages and advertising.
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(1) and (b)(1)), requires
that smokeless tobacco product packages and advertising must bear one
of four required warning statements. The four required warning
statements are:
``WARNING: This product can cause mouth cancer.''
``WARNING: This product can cause gum disease and tooth loss.''
``WARNING: This product is not a safe alternative to cigarettes.''
``WARNING: Smokeless tobacco is addictive.'' (15 U.S.C. 4402(a)(1))
One of the four required warning statements must be located on each
of the two principal display panels of the package and comprise at
least 30 percent of each such display panel (15 U.S.C. 4402(a)(2)(A)).
The Smokeless Tobacco Act (15 U.S.C. 4402(a)(2) and (b)(2)), also sets
forth requirements for the placement, type, size, and color of warnings
on packaging and advertisements, respectively.
Section 205(a) of the Tobacco Control Act further amended section 3
of the Smokeless Tobacco Act to give FDA the authority to ``adjust the
format, type size and text of any of the label requirements, require
color graphics to accompany the text, increase the required label area
from 30 up to 50 percent of the front and rear panels of the package,
or establish the format, type size, and text of any other disclosures
required under the Federal Food, Drug, and Cosmetic Act'' through
rulemaking conducted under the Administrative Procedures Act (5 U.S.C.
552, et seq.) if FDA ``finds that such a change would promote greater
public understanding of the risks associated with the use of smokeless
tobacco products'' (15 U.S.C. 4402(d)).
II. Request for Scientific Evidence and Information
We are interested in comments, supported by scientific evidence,
regarding what changes, if any, to the smokeless tobacco product
warnings would promote greater public understanding of the risks
associated with the use of smokeless tobacco products. The ``public''
includes both tobacco users and nonusers (i.e., never users and former
users). Comments and supporting evidence should address how any changes
in the warnings would affect both users' and nonusers' understanding of
the risks associated with the use of smokeless tobacco products.
III. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to https://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: January 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01626 Filed 1-28-13; 8:45 am]
BILLING CODE 4160-01-P
