Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20675 

Services announces OHS Tribal 

Consultations for leaders of Tribal 

Governments operating Head Start and 

Early Head Start programs in Regions I, 

II, IV, and VI. The Consultation Session 

for Region VI will take place Friday, 

April 29, 2011, at the Indian Pueblo 

Cultural Center in Albuquerque, New 

Mexico, immediately following the 

Department of Health and Human 

Services Regional Consultations session. 

The Consultation Session for Regions I, 

II, and IV will take place Thursday, May 

19, 2011, at the Paragon Casino Resort 

in Marksville, Louisiana, immediately 

following the United South and Eastern 

Tribes, Inc. 2011 Semi-annual Meeting. 

We are convening the OHS Tribal 

Consultations in conjunction with other 

Tribal Leader events in order to 

minimize the financial and travel 

burden for participants. 

The agendas for both scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of American Indian 

and Alaska Native children and 

families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2010 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for the Albuquerque or 

Marksville Consultation Sessions 

should contact Camille Loya at 

Camille.Loya@acf.hhs.gov at least three 

days in advance of the Session. 

Proposals should include a brief 

description of the topic area along with 

the name and contact information of the 

suggested presenter. 

The Consultation Sessions will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives [42 

U.S.C.9835, Section 640(l)(4)(A)]. 

Designees must have a letter from the 

Tribal Government authorizing them to 

represent the Tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Camille 

Loya at (202) 205–9721 (fax). Other 

representatives of Tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of each Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Camille Loya at 

Camille.Loya@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in the report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for all 

Consultation Sessions has been sent to 

Tribal leaders via e-mail and posted on 

the Head Start Resource Center Web site 

at http:// 

www.headstartresourcecenter.org. 

Dated: April 6, 2011. 

Ann Linehan, 

Deputy Director, Office of Head Start. 

[FR Doc. 2011–8999 Filed 4–12–11; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0221] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study on Consumer Responses to 

Labeling Statements on Food 

Packages 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

a study entitled ‘‘Experimental Study on 

Consumer Responses to Labeling 

Statements on Food Packages.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by June 13, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

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: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Experimental Study on Consumer 

Responses to Labeling Statements on 

Food Packages; 21 U.S.C. 393(d)(2)(C)— 

(OMB 0910–NEW) 

I. Background 

The Nutrition Labeling and Education 

Act requires almost all packaged foods 

to bear nutrition labeling in the form of 

the Nutrition Facts label. The law also 

allows manufacturers to provide other 

nutrition information on labels in the 

form of various types of statements, 

including claims, as long as such 

statements comply with the regulatory 

limits that govern the use of each type 

of statement. There are three types of 

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20676 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 

claims that the food industry can 

voluntarily use on food labels: (1) 

Health claims, (2) nutrient content 

claims (e.g., ‘‘Low fat’’), and (3) 

structure/function claims (e.g., ‘‘Calcium 

builds strong bones.’’). There are three 

types of health claims: (1) Those that 

meet the Significant Scientific Standard 

(e.g., ‘‘Adequate calcium and Vitamin D 

throughout life, as part of a wellbalanced diet, may reduce the risk of 

osteoporosis.’’), (2) those that are based 

on authoritative statements from a 

recognized scientific body of the U.S. 

government or the National Academy of 

Sciences (e.g., ‘‘Diets containing foods 

that are a good source of potassium and 

that are low in sodium may reduce the 

risk of high blood pressure and stroke.’’), 

and (3) qualified health claims that are 

granted under enforcement discretion 

(e.g., ‘‘Supportive but not conclusive 

research shows that consumption of 

EPA and DHA omega-3 fatty acids may 

reduce the risk of coronary heart 

disease. One serving of [Name of the 

food] provides [ ] grams of EPA and 

DHA omega-3 fatty acids. [See nutrition 

information for total fat, saturated fat, 

and cholesterol content.]’’). Although 

the different types of claims are 

regulated differently, they all must be 

truthful and not misleading (Ref. 1). 

With the increased public interest in 

identifying healthier foods, U.S. food 

processors have been adding nutritional 

information in the form of nutrition 

symbols to food labels in addition to 

claims. Examples of nutrition symbols 

that have been or are planned to be used 

on food labels include nutrient-specific 

disclosure (e.g., ‘‘Guideline Daily 

Amounts’’) (Ref. 2), calorie declaration 

(Ref. 3), summary product rating (e.g., 

‘‘Smart Spot’’) (Ref. 4), and a hybrid 

summary indicator with nutrientspecific disclosure (e.g., ‘‘Sensible 

Solution: Good Source of Calcium, Good 

Sources of 8 Vitamins and Minerals’’) 

(Ref. 5). Claims related to nonnutritional product characteristics are 

also used in food labeling. The claims 

may feature, among other things, 

statements about how foods are grown 

or made (e.g., ‘‘Organic’’ and ‘‘All 

Natural’’) or absence of a substance (e.g., 

‘‘Gluten-free’’). 

Many consumers use claims and the 

Nutrition Facts label in food choice 

decisions (Refs. 6 through 8). While 

some products carry only a single 

labeling statement (e.g., either one claim 

or one symbol) on their packages, many 

products carry two or more labeling 

statements. In addition, on the same 

package the attributes of one statement 

may differ from those of other 

statements in terms of featured nutrient, 

type of claim, framing of statement, 

nature of statement, and presentation of 

statement. For example, a package may 

display one or more statements such as 

symbols relating to nutrition content, 

statements in words relating to the 

presence of certain nutrients, statements 

in words relating to the absence of other 

nutrients, statements in words relating 

the health benefits of consuming foods 

containing or not containing certain 

other nutrients, and statements in words 

describing how the product was 

produced. Moreover, all of those 

symbols and statements are distributed 

in various places on the package in 

different font sizes and colors. 

There exists a large body of literature 

on the impacts of different types of 

labeling statements on consumer 

perceptions and choices of products 

(Refs. 9 and 10). The majority of the 

research, including the consumer 

research that the Agency has previously 

conducted (Refs. 11 and 12), has 

focused on single labeling statements by 

eliciting study participants’ reactions to 

variants of a given statement. An 

advantage of this research approach is 

that it helps isolate the effects of 

individual statements and avoid 

potential confounding effects caused by 

the presence of other statements. A 

disadvantage of this research approach, 

however, is that it does not necessarily 

reflect the labels consumers see in the 

marketplace. In particular, the existing 

literature provides little information 

about how the coexistence of two or 

more different labeling statements 

affects product perceptions and choices. 

This information, however, is critical for 

understanding the roles played by 

labeling statements in dietary decisions. 

Research suggests consumer product 

perceptions and purchase decisions can 

be influenced by labeling statements 

and different labeling statements may 

have different influences (Refs. 9 

through 12). Therefore, the FDA, as part 

of its effort to promote public health, 

proposes to use this study to explore 

consumer responses to food labels that 

bear multiple labeling statements. 

Specifically, the study plans to examine: 

(1) Consumer responses to food labels 

that exhibit various combinations of the 

characteristics of labeling statements 

(i.e., nutrients, types of claim, framing of 

statement, nature of statement, and 

presentation of statement), (2) whether 

and how consumer responses to one of 

the characteristics may be affected by 

other characteristics (i.e., the 

interactions between different 

characteristics of labeling statements), 

and (3) whether and how labeling 

statements affect the use of the Nutrition 

Facts label. 

The proposed collection of 

information is a controlled randomized 

experimental study. The study will use 

a 15-minute Web-based survey to collect 

information from 4,000 Englishspeaking adult members of an online 

consumer panel maintained by a 

contractor. The study will aim to 

produce a sample that reflects the U.S. 

Census on gender, education, age, and 

ethnicity/race. 

The study will randomly assign each 

of its participants to view two label 

images from a set of food labels that will 

be created for the study and 

systematically varied in the (1) number 

of statements (none, one, or two); (2) 

featured nutrient and substance (e.g., 

fat, sodium, sugars, fiber, whole grain, 

calories, antioxidant vitamins, or 

allergen); (3) type of statement (text or 

graphic, specifically the Guideline Daily 

Amounts nutrition symbol); (4) framing 

of statement (‘‘good source of,’’ ‘‘low,’’ or 

‘‘free’’); (5) nature of statement (nutrition 

or method of production such as 

‘‘natural’’); (6) type size of statement 

(large or small); and (7) featured product 

(e.g., snacks, breakfast cereals, breads, 

soups, or frozen meals). With regard to 

claims, the study will focus on 

examples of nutrient content claims and 

structure/function claims, which can be 

found on many food packages (Ref. 13). 

All label images will be mock-ups 

resembling food labels that may be 

found in the marketplace. Images will 

show product identity (e.g., potato 

chips), but not any real or fictitious 

brand name. The study will provide 

interested participants access to the 

Nutrition Facts label, but not together 

with a product image. 

The survey will ask its participants to 

view label images and answer questions 

about their perceptions and reactions 

related to the viewed product and label. 

Product perceptions (e.g., healthiness, 

potential health benefits, levels of 

nutrients and substances, taste, and 

safety) and label perceptions (e.g., 

helpfulness and credibility) will 

constitute the measures of responses in 

the experiment. To help understand the 

data, the survey will also collect 

information about participants’ 

background, such as consumption, 

purchase, perception, and familiarity 

with a category of food; awareness and 

knowledge of nutrients and substances; 

dietary interests; motivation regarding 

label use and health literacy; and health 

status and demographic characteristics. 

The study is part of the Agency’s 

continuing effort to enable consumers to 

make informed dietary choices and 

construct healthful diets. Results of the 

study will be used primarily to enrich 

the Agency’s understanding of how 

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Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices 20677 

multiple claims and other labeling 

statements on food packages may affect 

how consumers perceive a product or a 

label, which may in turn affect their 

dietary choices. Results of the study will 

not be used to develop population 

estimates. 

To help design and refine the 

questionnaire, FDA plans to conduct 

cognitive interviews by screening 72 

panelists in order to obtain 9 

participants in the interviews. Each 

screening is expected to take 5 minutes 

(0.083 hour) and each cognitive 

interview is expected to take 1 hour. 

The total for cognitive interview 

activities is 15 hours (6 hours + 9 

hours). Subsequently, we plan to 

conduct pretests of the questionnaire 

before it is administered in the study. 

We expect that 1,600 invitations, each 

taking 2 minutes (0.033 hour), will need 

to be sent to panelists to have 200 of 

them complete a 15-minute (0.25 hour) 

pretest. The total for the pretest 

activities is 106 hours (53 hours + 50 

hours). For the survey, we estimate that 

32,000 invitations, each taking 2 

minutes (0.033 hour) to complete, will 

need to be sent to the consumer panel 

to have 3,000 of its members complete 

a 15-minute (0.25 hour) questionnaire. 

The total for the survey activities is 

2,056 hours (1,056 hours + 1,000 hours). 

Thus, the total estimated burden is 

2,174 hours. FDA’s burden estimate is 

based on prior experience with research 

that is similar to this proposed study. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Cognitive interview screener ................................................ 72 1 72 5/60 6 

Cognitive interview ............................................................... 9 1 9 1 9 

Pretest invitation .................................................................. 1,600 1 1,600 2/60 53 

Pretest .................................................................................. 200 1 200 15/60 50 

Survey invitation ................................................................... 32,000 1 32,000 2/60 1,056 

Survey .................................................................................. 4,000 1 4,000 15/60 1,000 

Total .............................................................................. ........................ ........................ ........................ ........................ 2,174 

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. (FDA has verified the 

Web site addresses, but we are not 

responsible for any subsequent changes 

to the Web site after this document 

publishes in the Federal Register.) 

1. U.S. Food and Drug Administration. 

Claims That Can Be Made for 

Conventional Foods and Dietary 

Supplements. September 2003. Available 

at http://www.fda.gov/Food/ 

LabelingNutrition/LabelClaims/ 

ucm111447.htm. 

2. Kellogg’s. Nutrition at a Glance. 2010. 

Available at http:// 

www.kelloggnutrition.com/learn-aboutlabels/nutrition-at-a-glance.html. 

3. PepsiCo. Nutrition Labeling. 2010. 

Available at http://www.pepsico.com/ 

Purpose/Human-Sustainability/ 

Nutrition-Labeling.html. 

4. Schmit, J. ‘‘PepsiCo Labels Some of Its 

Products ‘Smart,’’’ USA Today, 

September 2, 2004. Available at http:// 

www.usatoday.com/money/industries/ 

food/2004–09–02-smart-spot_x.htm. 

5. Kraft Foods. Sensible Solution. 2010. 

Available at http:// 

www.kraftrecipes.com/kf/HealthyLiving/ 

SensibleSolution/ 

SensibleSolution_Landing.aspx. 

6. Centers for Disease Control and 

Prevention. 2005–2006 National Health 

and Examination Survey questionnaire, 

Diet Behavior and Nutrition section. 

Unpublished results of questions 

DBQ.750 and DBQ.780. Questionnaire is 

available at http://www.cdc.gov/nchs/ 

data/nhanes/nhanes_05_06/ 

sp_dbq_d.pdf. 

7. U.S. Food and Drug Administration. 2008 

Health and Diet Survey. March 20, 2010. 

Available at http://www.fda.gov/Food/ 

ScienceResearch/ResearchAreas/ 

ConsumerResearch/ucm193895.htm. 

8. Food Marketing Institute. 2009 U.S. 

Grocery Shopper Trends Survey. 

Washington, DC 2009. 

9. Drichoutis, A.C., Lazaridis, P. and Nayga, 

R.M., ‘‘Consumers’ Use of Nutritional 

Labels: a Review of Research Studies and 

Issues,’’ Academy of Marketing Science 

Review, 2006(9), 2006. Available at 

http://www.amsreview.org/articles/ 

drichoutis09-2006.pdf. 

10. La ̈hteenma ̈ki, L., Lampila, P.. Grunert, K., 

Boztug, Y., Ueland, ;., A ̊ stro ̈m, A. and 

Martinsdo ́ttir, E., ‘‘Impact of HealthRelated Claims on the Perception of 

Other Product Attributes,’’ Food Policy, 

23: 230–9. 2010. 

11. Labiner-Wolfe, J., Lin, C.-T. J. and Verrill 

L., ‘‘Effect of Low Carbohydrate Claims 

on Consumer Perceptions about Food 

Products’ Healthfulness and Helpfulness 

for Weight Management,’’ Journal of 

Nutrition Education and Behavior, 42(5): 

315–320, 2010. 

12. Roe, B., Levy, A.S., and Derby, B.M., ‘‘The 

Impact of Health Claims on Consumer 

Search and Product Evaluation 

Outcomes: Evidence from FDA 

Experimental Data,’’ Journal of Public 

Policy and Marketing, 18(1): 89–105, 

1999. 

13. LeGault, L., Brandt, M.B., McCabe, N., 

Adler, C., Brown, A.-M., and Brecher, S., 

‘‘2000–2001 Food Label and Package 

Survey: An Update on Prevalence of 

Nutrition Labeling and Claims on 

Processed, Packaged Foods,’’ Journal of 

the American Dietetic Association, 

104(6): 952–8, 2004. 

Dated: April 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8908 Filed 4–12–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0237] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Applications for 

Food and Drug Administration 

Approval To Market a New Drug; 

Postmarketing Reports; Reporting 

Information About Authorized Generic 

Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

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