Sun Chemical Corp.; Filing of Color Additive Petition, 20992 [2011-8575]
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20992
Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices
State University of New Jersey, Food
Policy Institute, 2009.
3. Acheson, D., ‘‘Outbreak of
Escherichia coli 0157 Infections
Associated with Fresh Spinach—United
States, August–September 2006,’’ 2007.
Available at https://first.fda.gov/cafdas/
documents/Acheson_Spinach_Outbreak
_2006_FDA_pres.ppt.
4. Han, S., Lerner, J.S., and Keltner,
D., ‘‘Feelings and Consumer Decision
Making: The Appraisal-Tendency
Framework,’’ Journal of Consumer
Psychology, 17(3), 158–168, 2007.
5. Lazurus, R.S., Emotion and
Adaptation. New York: Oxford
University Press, 1991.
Dated: April 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
for the recently identified impurity 1[(4-methylphenyl)azo]-2-naphthalenol
and by removing Appendix A in 21 CFR
part 74, which pertains to the ‘‘Ethersoluble matter’’ specification.
The Agency has determined under 21
CFR 25.30(i) 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: April 4, 2011.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive
Safety, Center for Food Safety and Applied
Nutrition.
[FR Doc. 2011–8575 Filed 4–13–11; 8:45 am]
BILLING CODE 4160–01–P
[FR Doc. 2011–8936 Filed 4–13–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2011–D–0189]
[Docket No. FDA–2011–C–0050]
Guidance for Industry and Food and
Drug Administration Staff; Class II
Special Controls Guidance Document:
Low Level Laser System for Aesthetic
Use; Availability
Sun Chemical Corp.; Filing of Color
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that Sun Chemical Corp. has filed a
petition proposing that the color
additive regulations for D&C Red No. 6
and D&C Red No. 7 be amended by
replacing the current specification for
‘‘Ether-soluble matter’’ with a maximum
limit of 0.015 percent for the recently
identified impurity 1-[(4methylphenyl)azo]-2-naphthalenol.
FOR FURTHER INFORMATION CONTACT:
Teresa A. Croce, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 301–436–1281.
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 a color
additive petition (CAP 1C0290) has been
filed by Sun Chemical Corp., 5020
Spring Grove Ave., Cincinnati, OH
45232. The petition proposes to amend
the color additive regulations for D&C
Red No. 6 (21 CFR 74.1306 and 74.2306)
and D&C Red No. 7 (21 CFR 74.1307 and
74.2307) by replacing the current
specification for ‘‘Ether-soluble matter’’
with a maximum limit of 0.015 percent
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SUMMARY:
VerDate Mar<15>2010
18:34 Apr 13, 2011
Jkt 223001
International, and Consumer Assistance,
Office of Communication, Education
and Radiation Programs, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
rm. 4613, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to 301–
847–8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance 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:
Richard Felten, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1436, Silver Spring,
MD 20993–0002, 301–796–6392.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal
Register, FDA is publishing a final rule
classifying low level laser systems for
aesthetic use into class II (special
controls) under section 513(f)(2) of the
AGENCY: Food and Drug Administration, Federal Food, Drug, and Cosmetic Act
HHS.
(the FD&C Act) (21 U.S.C. 360c(f)(2)).
This guidance document will serve as
ACTION: Notice.
the special control for low level laser
SUMMARY: The Food and Drug
systems for aesthetic use. Section
Administration (FDA) is announcing the 513(f)(2) of the FD&C Act provides that
availability of the guidance entitled
any person who submits a premarket
‘‘Class II Special Controls Guidance
notification under section 510(k) of the
Document: Low Level Laser System for
FD&C Act (21 U.S.C. 360(k)) for a device
Aesthetic Use.’’ This guidance document that has not previously been classified
describes a means by which low level
may, within 30 days after receiving an
laser systems for aesthetic use may
order classifying the device in class III
comply with the requirement of special
under section 513(f)(1) of the FD&C Act,
controls for class II devices. Elsewhere
request FDA to classify the device under
in this issue of the Federal Register,
the criteria set forth in section 513(a)(1)
FDA is publishing a final rule to classify of the FD&C Act. FDA shall, within 60
low level laser systems for aesthetic use days of receiving such a request, classify
into class II (special controls). This
the device by written order. This
guidance document is being
classification shall be the initial
immediately implemented as the special classification of the device. Within 30
control for low level laser systems for
days after the issuance of an order
aesthetic use, but it remains subject to
classifying the device, FDA must
comment in accordance with the
publish a notice in the Federal Register
Agency’s good guidance practices.
announcing such classification. Because
DATES: Submit either electronic or
of the timeframes established by section
written comments on the guidance at
513(f)(2) of the FD&C Act, FDA has
any time. General comments on Agency determined, under § 10.115(g)(2) (21
guidances are welcome at any time.
CFR 10.115(g)(2)), that it is not feasible
to allow for public participation before
ADDRESSES: Submit written requests for
issuing this guidance as a final guidance
single copies of the guidance document
document. Thus, FDA is issuing this
entitled ‘‘Class II Special Controls
guidance document as a level 1
Guidance Document: Low Level Laser
guidance document that is immediately
System for Aesthetic Use’’ to the
in effect. FDA will consider any
Division of Small Manufacturers,
PO 00000
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[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Notices]
[Page 20992]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8575]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-C-0050]
Sun Chemical Corp.; Filing of Color Additive Petition
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that Sun
Chemical Corp. has filed a petition proposing that the color additive
regulations for D&C Red No. 6 and D&C Red No. 7 be amended by replacing
the current specification for ``Ether-soluble matter'' with a maximum
limit of 0.015 percent for the recently identified impurity 1-[(4-
methylphenyl)azo]-2-naphthalenol.
FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1281.
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 a
color additive petition (CAP 1C0290) has been filed by Sun Chemical
Corp., 5020 Spring Grove Ave., Cincinnati, OH 45232. The petition
proposes to amend the color additive regulations for D&C Red No. 6 (21
CFR 74.1306 and 74.2306) and D&C Red No. 7 (21 CFR 74.1307 and 74.2307)
by replacing the current specification for ``Ether-soluble matter''
with a maximum limit of 0.015 percent for the recently identified
impurity 1-[(4-methylphenyl)azo]-2-naphthalenol and by removing
Appendix A in 21 CFR part 74, which pertains to the ``Ether-soluble
matter'' specification.
The Agency has determined under 21 CFR 25.30(i) 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: April 4, 2011.
Mitchell A. Cheeseman,
Acting Director, Office of Food Additive Safety, Center for Food Safety
and Applied Nutrition.
[FR Doc. 2011-8575 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P
