CooperVision, Inc.; Filing of Color Additive Petitions, 37690 [2011-16089]
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37690
Federal Register / Vol. 76, No. 124 / Tuesday, June 28, 2011 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket Nos. FDA–2011–C–0344 and FDA–
2011–C–0463]
CooperVision, Inc.; Filing of Color
Additive Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that CooperVision, Inc., has filed two
petitions proposing that the color
additive regulations be amended to
provide for the safe use of 1,4-bis[4-(2methacryloxyethyl)phenlyamino]
anthraquinone (C.I. Reactive Blue 246)
and 1,4-bis[(2-hydroxyethyl)amino]9,10-anthracenedione bis(2-methyl-2propenoic)ester (C.I. Reactive Blue 247).
The color additives are intended to be
copolymerized with various monomers
for use as colored contact lens materials.
FOR FURTHER INFORMATION CONTACT:
Regarding CAP 1C0291: Judith Kidwell,
Center for Food Safety and Applied
Nutrition (HFS–265), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
240–402–1071.
Regarding CAP 1C0292: Teresa Croce,
Center for Food Safety and Applied
Nutrition (HFS–265), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740–3835,
240–402–1281.
SUPPLEMENTARY INFORMATION: Under the
Federal Food, Drug, and Cosmetic Act
(section 721(d)(1) (21 U.S.C.
379e(d)(1))), notice is given that two
color additive petitions (CAP 1C0291,
Docket No. FDA–2011–C–0344 and CAP
1C0292, Docket No. FDA–2011–C–0463)
have been filed by CooperVision, Inc.,
6150 Stoneridge Mall Rd., Suite 370,
Pleasanton, CA 94588. The petitions
propose to amend the color additive
regulations in 21 CFR part 73, subpart
D, Medical Devices, to provide for the
safe use of 1,4-bis[4-(2methacryloxyethyl)phenstylamino]
anthraquinone (C.I. Reactive Blue 246;
CAS Reg. No. 121888–69–5) (CAP
1C0291) and 1,4-bis[(2hydroxyethyl)amino]-9,10anthracenedione bis(2-methyl-2propenoic)ester (C.I. Reactive Blue 247;
CAS Reg. No. 109561–07–1) (CAP
1C0292). The color additives are
intended to be copolymerized with
various monomers for use as colored
contact lens materials.
emcdonald on DSK2BSOYB1PROD with PROPOSALS
SUMMARY:
16:26 Jun 27, 2011
Dated: June 20, 2011.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[FR Doc. 2011–16089 Filed 6–27–11; 8:45 am]
Notice of petitions.
VerDate Mar<15>2010
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.
Jkt 223001
BILLING CODE 4160–01–P
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
Federal holidays. The telephone number
is 202–366–9329.
To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
Comments’’ portion of the
SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
If
you have questions on this proposed
rule, call or e-mail Petty Officer (PO)
David Labadie of the Waterways
Management Division, U.S. Coast Guard
Sector Boston; telephone 617–223–3010,
e-mail David.J.Labadie@uscg.mil. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 100 and 165
[Docket No. USCG–2011–0109]
RIN 1625–AA08; AA00
Special Local Regulations and Safety
Zones; Recurring Events in Captain of
the Port Boston Zone
Coast Guard, DHS.
Notice of proposed rulemaking.
AGENCY:
ACTION:
The Coast Guard proposes to
amend special local regulations (SLR)
and to establish permanent safety zones
in the Coast Guard Sector Boston
Captain of the Port (COTP) Zone for
annual recurring marine events. When
these SLRs or safety zones are activated,
and thus subject to enforcement, this
rule would restrict persons and vessels
from portions of waterway during
annual events listed in TABLES 1 and
2 that pose a hazard to public safety.
The revised SLRs and safety zones are
proposed to reduce administrative
overhead, expedite public notification
of events, and to ensure the protection
of the maritime public and event
participants from the hazards associated
with firework displays, boat races, and
other marine events.
DATES: Comments and related material
must be received by the Coast Guard on
or before July 28, 2011.
Requests for public meetings must be
received by the Coast Guard on or before
July 5, 2011.
ADDRESSES: You may submit comments
identified by docket number USCG–
2011–0109 using any one of the
following methods:
(1) Federal e-Rulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
SUMMARY:
PO 00000
Frm 00013
Fmt 4702
Sfmt 4702
Public Participation and Request for
Comments
We encourage you to participate in
this rulemaking by submitting
comments and related materials. All
comments received will be posted
without change to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting Comments
If you submit a comment, please
include the docket number for this
rulemaking (USCG–2011–0109),
indicate the specific section of this
document to which each comment
applies, and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online (via https://
www.regulations.gov) or by fax, mail, or
hand delivery, but please use only one
of these means. If you submit a
comment online via https://
www.regulations.gov, it will be
considered received by the Coast Guard
when you successfully transmit the
comment. If you fax, hand deliver, or
mail your comment, it will be
considered as having been received by
the Coast Guard when it is received at
the Docket Management Facility. We
recommend that you include your name
and a mailing address, an e-mail
address, or a telephone number in the
body of your document so that we can
contact you if we have questions
regarding your submission.
E:\FR\FM\28JNP1.SGM
28JNP1
]]>Agencies
[Federal Register Volume 76, Number 124 (Tuesday, June 28, 2011)]
[Proposed Rules]
[Page 37690]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16089]
[[Page 37690]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket Nos. FDA-2011-C-0344 and FDA-2011-C-0463]
CooperVision, Inc.; Filing of Color Additive Petitions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petitions.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that
CooperVision, Inc., has filed two petitions proposing that the color
additive regulations be amended to provide for the safe use of 1,4-
bis[4-(2-methacryloxyethyl)phenlyamino] anthraquinone (C.I. Reactive
Blue 246) and 1,4-bis[(2-hydroxyethyl)amino]-9,10-anthracenedione
bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color
additives are intended to be copolymerized with various monomers for
use as colored contact lens materials.
FOR FURTHER INFORMATION CONTACT: Regarding CAP 1C0291: Judith Kidwell,
Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835,
240-402-1071.
Regarding CAP 1C0292: Teresa Croce, Center for Food Safety and
Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740-3835, 240-402-1281.
SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that
two color additive petitions (CAP 1C0291, Docket No. FDA-2011-C-0344
and CAP 1C0292, Docket No. FDA-2011-C-0463) have been filed by
CooperVision, Inc., 6150 Stoneridge Mall Rd., Suite 370, Pleasanton, CA
94588. The petitions propose to amend the color additive regulations in
21 CFR part 73, subpart D, Medical Devices, to provide for the safe use
of 1,4-bis[4-(2-methacryloxyethyl)phenstylamino]anthraquinone (C.I.
Reactive Blue 246; CAS Reg. No. 121888-69-5) (CAP 1C0291) and 1,4-
bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-
propenoic)ester (C.I. Reactive Blue 247; CAS Reg. No. 109561-07-1) (CAP
1C0292). The color additives are intended to be copolymerized with
various monomers for use as colored contact lens materials.
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: June 20, 2011.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2011-16089 Filed 6-27-11; 8:45 am]
BILLING CODE 4160-01-P
