Biocompatibles UK Ltd.; Filing of Color Additive Petition, 13556 [2010-6177]
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Federal Register / Vol. 75, No. 54 / Monday, March 22, 2010 / Notices
Fishery Products — Decomposition,
which is available on the Internet at
https://www.fda.gov/ICECI/Compliance
Manuals/CompliancePolicyGuidance
Manual/ucm123201.htm.
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
Dated: March 9, 2010.
Michael A. Chappell,
Acting Associate Commissioner for
Regulatory Affairs.
[FR Doc. 2010–6209 Filed 3–19–10; 8:45 am]
Dated: March 5, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
BILLING CODE 4160–01–S
[FR Doc. 2010–6177 Filed 3–19–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2010–C–0077]
[Docket No. FDA–2010–N–0123]
Biocompatibles UK Ltd.; Filing of Color
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
ACTION:
The Food and Drug
Administration (FDA) is announcing
that Biocompatibles UK Ltd., has filed a
petition proposing that the color
additive regulations be amended to
provide for the safe use of C.I. Reactive
Blue No. 4 [2-anthracenesulfonic acid,
1-amino-4-(3-((4,6-dichloro-s-triazin-2yl)amino)-4-sulfoanilino)-9,10-dihydro9,10-dioxo, disodium salt] (CAS Reg.
No. 4499–01–8) reacted with polyvinyl
alcohol as a color additive in vascular
embolization devices.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1071.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(sec. 721(d)(1) (21 U.S.C. 379e(d)(1))),
notice is given that a color additive
petition (CAP 0C0288) has been filed by
Biocompatibles UK Ltd., c/o John
Greenbaum, Generic Devices
Consulting, Inc., 20310 SW. 48th St,
Southwest Ranches, FL 33332. The
petition proposes to amend the color
additive regulations in 21 CFR part 73,
subpart D, Medical Devices, to provide
for the safe use of C.I. Reactive Blue No.
4 [2-anthracenesulfonic acid, 1-amino-4(3-((4,6-dichloro-s-triazin-2-yl)amino)-4sulfoanilino)-9,10-dihydro-9,10-dioxo,
disodium salt] (CAS Reg. No. 4499–01–
8) reacted with polyvinyl alcohol as a
color additive in vascular embolization
devices.
The agency has determined under 21
CFR 25.32(l) that this action is of a type
that does not individually or
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SUMMARY:
16:41 Mar 19, 2010
AGENCY:
Food and Drug Administration,
HHS.
Notice.
VerDate Nov<24>2008
Impact of Dissolvable Tobacco Use on
Public Health; Request for Comments
Jkt 220001
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is establishing a
public docket to provide an opportunity
for interested parties to share
information, research, and ideas on how
use of dissolvable tobacco products may
impact public health, including such
use among children. This information
will be used to support the work of the
Tobacco Products Scientific Advisory
Committee, which is charged with
evaluating this issue.
DATES: Submit written or electronic
comments by [insert date 180 days from
date of publication in the Federal
Register].
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.
FOR FURTHER INFORMATION CONTACT:
Kathleen K. Quinn, Center for Tobacco
Products, Food and Drug
Administration, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 240–276–
1717, Kathleen.Quinn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
Tobacco products are responsible for
more than 440,000 deaths each year.
The Centers for Disease Control and
Prevention report that every day in the
United States, approximately 3,900
young people between these ages of 12
and 17 smoke their first cigarette and
approximately 1,000 adolescents
become daily smokers. Multiple studies
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
have shown that adolescents who use
smokeless tobacco products are more
likely to become smokers than those
who do not.
Dissolvable tobacco products are a
novel class of smokeless tobacco
products, which are sold as thin strips,
tablets, and sticks resembling
toothpicks. Because some of these
products look like candy, are highly
flavored, and can be easily concealed,
public health officials have raised
concerns that dissolvable tobacco
products may be particularly appealing
to children and adolescents. These
products also contain up to 4.0
milligrams of nicotine per unit, which
could facilitate initiation of tobacco use
and the development of nicotine
dependence in adolescents, or even
serve as a mechanism for inadvertent
toxicity in children.
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) into law. The Tobacco
Control Act granted FDA important new
authority to regulate the manufacture,
marketing, and distribution of tobacco
products to protect the public health
generally and to reduce tobacco use by
minors. Among its many provisions, the
Tobacco Control Act added section
907(f) to the Federal Food, Drug, and
Cosmetic Act (the act). This section
requires FDA to refer the issue of ‘‘the
nature and impact of the use of
dissolvable tobacco products on the
public health, including such use
among children’’ to a Tobacco Products
Scientific Advisory Committee, which
will be charged with providing FDA a
report and recommendations.
We are requesting comments that will
support the work of the Tobacco
Products Scientific Advisory Committee
in evaluating the public health impact
of dissolvable tobacco products. A copy
of the Tobacco Control Act is available
at https://www.fda.gov/tobacco.
II. Request for Comments and
Information
Data around the nature, impact, and
use of dissolvables tobacco products
will be critical to the Tobacco Products
Scientific Advisory Committee in
studying and reporting on their public
health impact. We are therefore
requesting comment, research, and data
on ways in which these products might
be used by individuals, including
children and adolescents, how the risks
of using these products are perceived by
smokers and non-smokers, and how use
of these products affects health. Such
research may address:
E:\FR\FM\22MRN1.SGM
22MRN1
]]>Agencies
[Federal Register Volume 75, Number 54 (Monday, March 22, 2010)]
[Notices]
[Page 13556]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-C-0077]
Biocompatibles UK Ltd.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
Biocompatibles UK Ltd., has filed a petition proposing that the color
additive regulations be amended to provide for the safe use of C.I.
Reactive Blue No. 4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-
dichloro-s-triazin-2-yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo,
disodium salt] (CAS Reg. No. 4499-01-8) reacted with polyvinyl alcohol
as a color additive in vascular embolization devices.
FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1071.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a
color additive petition (CAP 0C0288) has been filed by Biocompatibles
UK Ltd., c/o John Greenbaum, Generic Devices Consulting, Inc., 20310
SW. 48th St, Southwest Ranches, FL 33332. The petition proposes to
amend the color additive regulations in 21 CFR part 73, subpart D,
Medical Devices, to provide for the safe use of C.I. Reactive Blue No.
4 [2-anthracenesulfonic acid, 1-amino-4-(3-((4,6-dichloro-s-triazin-2-
yl)amino)-4-sulfoanilino)-9,10-dihydro-9,10-dioxo, disodium salt] (CAS
Reg. No. 4499-01-8) reacted with polyvinyl alcohol as a color additive
in vascular embolization devices.
The agency has determined under 21 CFR 25.32(l) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
Dated: March 5, 2010.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2010-6177 Filed 3-19-10; 8:45 am]
BILLING CODE 4160-01-S
