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 http://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. 

[FR Doc. 2011–8936 Filed 4–13–11; 8:45 am] 

BILLING CODE 4160–01–P 

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 ‘‘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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0189] 

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Low Level Laser System for Aesthetic 

Use; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Class II Special Controls Guidance 

Document: Low Level Laser System for 

Aesthetic Use.’’ This guidance document 

describes a means by which low level 

laser systems for aesthetic use may 

comply with the requirement of special 

controls for class II devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a final rule to classify 

low level laser systems for aesthetic use 

into class II (special controls). This 

guidance document is being 

immediately implemented as the special 

control for low level laser systems for 

aesthetic use, but it remains subject to 

comment in accordance with the 

Agency’s good guidance practices. 

DATES: Submit either electronic or 

written comments on the guidance at 

any time. General comments on Agency 

guidances are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Class II Special Controls 

Guidance Document: Low Level Laser 

System for Aesthetic Use’’ to the 

Division of Small Manufacturers, 

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 http://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 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 360c(f)(2)). 

This guidance document will serve as 

the special control for low level laser 

systems for aesthetic use. Section 

513(f)(2) of the FD&C Act provides that 

any person who submits a premarket 

notification under section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) for a device 

that has not previously been classified 

may, within 30 days after receiving an 

order classifying the device in class III 

under section 513(f)(1) of the FD&C Act, 

request FDA to classify the device under 

the criteria set forth in section 513(a)(1) 

of the FD&C Act. FDA shall, within 60 

days of receiving such a request, classify 

the device by written order. This 

classification shall be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing such classification. Because 

of the timeframes established by section 

513(f)(2) of the FD&C Act, FDA has 

determined, under § 10.115(g)(2) (21 

CFR 10.115(g)(2)), that it is not feasible 

to allow for public participation before 

issuing this guidance as a final guidance 

document. Thus, FDA is issuing this 

guidance document as a level 1 

guidance document that is immediately 

in effect. FDA will consider any 

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