20990 Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices 

Desk Officer for the Administration for 

Children and Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–9079 Filed 4–13–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB review; comment 

request 

Title: IRS Project 1099. 

OMB No.: 0970–0183. 

Description: A voluntary program 

which provides State Child Support 

Enforcement agencies, upon their 

request, access to the earned and 

unearned income information reported 

to IRS by employers and financial 

institutions. The IRS 1099 information 

is used to locate noncustodial parents 

and to verify income and employment. 

Respondents: 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

1099 Record Specifications ............................................................................. 54 12 1.96 1,270.08 

IRS Safeguarding Certification Letter .............................................................. 54 1 0.48 25.92 

Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 1,296 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–9054 Filed 4–13–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0267] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Survey on 

Consumers’ Emotional and Cognitive 

Reactions to Food Recalls 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 16, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–new and 

‘‘Survey on Consumers’ Emotional and 

Cognitive Reactions to Food Recalls.’’ 

Also include the FDA docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Survey on Consumers’ Emotional and 

Cognitive Reactions to Food Recalls— 

21 U.S.C. 393(d)(2)(C) (OMB Control 

Number 0910–NEW) 

I. Background 

The proposed ‘‘Survey on Consumers’ 

Emotional and Cognitive Reactions to 

Food Recalls’’ will be conducted under 

a cooperative agreement between the 

Joint Institute for Food Safety and 

Applied Nutrition (JIFSAN) and the 

Center for Risk Communication 

Research at the University of Maryland. 

JIFSAN was established in 1996 and is 

a public and private partnership 

between FDA and the University of 

Maryland. The Center for Risk 

Communication Research will design 

and administer the study. 

The proposed study will assess 

consumers’ emotional and cognitive 

recollection of certain food recalls and 

gauge how these recollections affect 

their current perceptions about food 

recalls and their inclination to adhere to 

future recommended food recall 

behaviors. Existing data show that many 

consumers do not take appropriate 

protective actions during a foodborne 

illness outbreak or food recall (Refs. 1 

and 2). For example, 41 percent of U.S. 

consumers say they have never looked 

for any recalled product in their home 

(Ref. 2). Conversely, some consumers 

overreact to the announcement of a 

foodborne illness outbreak or food 

recall. In response to the 2006 fresh, 

bagged spinach recall which followed a 

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Federal Register / Vol. 76, No. 72 / Thursday, April 14, 2011 / Notices 20991 

multistate outbreak of Escherichia coli 

O157: H7 infections (Ref. 3), 18 percent 

of consumers said they stopped buying 

other bagged, fresh produce because of 

the spinach recall (Ref. 1). 

Research shows that emotion plays a 

large role in decisionmaking, and that 

individuals may not be conscious of its 

effects on their behavior (Ref. 4). For 

example, when people are angry they 

are likely to place blame, take action, 

and want justice to be served (Ref. 5). 

If a particular food recall engenders 

widespread anger and the anger is 

coupled with behavior that is less than 

desirable from a food safety or 

nutritional standpoint, it is possible that 

anger will be the lens through which 

future food recall situations are viewed, 

thus resulting in similar undesirable 

behaviors. Findings from this study will 

help FDA understand the emotional 

response to food recalls. This will help 

FDA to design more effective consumer 

food recall messages during and after a 

recall. 

FDA conducts research and 

educational and public information 

programs relating to food safety under 

its broad statutory authority, set forth in 

section 903(b)(2) of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 393(b)(2)), to protect the 

public health by ensuring that foods are 

‘‘safe, wholesome, sanitary, and properly 

labeled,’’ and in section 903(d)(2)(C), to 

conduct research relating to foods, 

drugs, cosmetics, and devices in 

carrying out the FD&C Act. 

FDA plans to survey U.S. consumers 

using a web-based panel of U.S. 

households to collect information on 

consumers’ cognitive and emotional 

reaction to food recalls. The survey will 

query consumers on their recollection of 

food recalls within the past 5 years; 

attitude toward recalled foods; 

knowledge about particular food recalls; 

behavior during the food recall; and 

assessment and appraisals of 

susceptibility, severity, satisfaction, and 

self-efficacy. 

The data will be collected using an 

online survey. A pool of 10,000 

consumers from a Web-based consumer 

panel will be screened for eligibility 

based on age (18+ years) and familiarity 

with recent food recalls. One thousand 

of eligible consumers will be randomly 

selected to participate in the survey. 

The results of the survey will not be 

used to generate population estimates. 

The estimated total hour burden of 

the collection of information is 354 

hours (table 1 of this document). To 

help design and refine the 

questionnaire, the Center for Risk 

Communication Research will conduct 

cognitive interviews by screening 25 

adult consumers in order to obtain 8 

respondents for the cognitive 

interviews. Each screening is expected 

to take 5 minutes (0.083 hours) and each 

cognitive interview is expected to take 

1 hour. The total for cognitive interview 

activities is 10 hours (2 hours + 8 

hours). Subsequently, we will conduct 

pretests of the study questionnaire 

before it is administered. We expect that 

100 invitations, each taking 2 minutes 

(0.033 hours), will need to be sent to 

adult members of the online consumer 

panel to have 40 of them complete a 10 

minute (0.167 hours) pretest. The total 

for the pretest activities is 10 hours (3 

hours + 7 hours). We estimate sending 

10,000 survey screeners, each taking 1 

minute (0.017 hours), to adult members 

of the online consumer panel to have 

1,000 of them complete a 10 minute 

(0.167 hours) survey. The total for the 

survey activities is 337 hours (170 hours 

+ 167 hours). 

The burden estimate for this study 

published in the Federal Register of 

June 18, 2010 (75 FR 34745), has 

increased from 234 hours to 357 hours. 

The increase in burden hours represents 

the addition of cognitive interviews to 

the study design and correction of a 

math error. 

In the Federal Register of June 18, 

2010 (75 FR 34745), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received two letters 

containing multiple comments in 

response to the notice. One letter 

contained comments outside the scope 

of the four collection of information 

topics on which the notice solicits 

comments and, thus, will not be 

addressed here. 

(Comment) One comment suggested 

that the survey should include 

consumers whose pets were sickened or 

had died because of mycotoxins in pet 

food that resulted in the 2004 pet food 

recall. 

(Response) FDA agrees that 

consumers who were affected by the 

2004 pet food recall should be included 

as survey respondents. These consumers 

will be included if they are members of 

the online consumer panel from which 

the survey sample will be drawn and 

they are randomly selected from the 

panel. FDA does not believe that the 

affected population should be targetsampled because the study focuses on 

human food recalls rather than pet food 

recalls. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response 

Total 

hours 

Cognitive interview screener ................................................................ 25 1 25 5/60 2 

Cognitive interview ............................................................................... 8 1 8 1/60 8 

Pretest screener ................................................................................... 100 1 100 2/60 3 

Pretest .................................................................................................. 40 1 40 10/60 7 

Screener ............................................................................................... 10,000 1 10,000 1/60 170

Survey .................................................................................................. 1,000 1 1,000 10/60 167

Total .......................................................................................... ........................ ........................ ........................ .................... 357 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

II. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

1. Cuite, C., Condry, S., Nucci, M., 

and Hallman, W., ‘‘Public Response to 

the Contaminated Spinach Recall of 

2006,’’ Publication number RR–0107– 

013. New Brunswick, New Jersey: 

Rutgers, the State University of New 

Jersey, Food Policy Institute, 2007. 

2. Hallman, W., Cuite, C., and Hooker, 

N., ‘‘Consumer Responses to Food 

Recalls: 2009 National Survey Report,’’ 

Publication number RR–0109–018. New 

Brunswick, New Jersey: Rutgers, the 

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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 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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