26244 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Public Sector Groups ....................................................................................... 332 0.33 0.2 22 

Health Professionals ........................................................................................ 711 0.33 0.2 47 

Totals ........................................................................................................ 2,450 ........................ ........................ 162 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Dr. Ann 

M. Taubenheim, Principal Investigator, 

National Heart, Lung, and Blood 

Institute, Office of Communications and 

Legislative Activities, NIH, 31 Center 

Drive, Building 31, Room 4A10, 

Bethesda, MD 21045, or call non-tollfree number 301–496–4236 or e-mail 

your request, including your address, to 

taubenha@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: May 22, 2009. 

Ann M. Taubenheim, 

Principal Investigator, NHLBI, National 

Institutes of Health. 

[FR Doc. E9–12604 Filed 5–29–09; 8:45 am] 

BILLING CODE 4140–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0220] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Experimental 

Study of Nutrition Symbols 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 

the Experimental Study of Nutrition 

Symbols on Food Packages. 

DATES: Submit written or electronic 

comments on the collection of 

information by July 31, 2009. 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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 of Nutrition 

Symbols on Food Packages 

FDA has been following the 

emergence of front-of-package nutrition 

symbols in the marketplace. These 

symbols are associated with programs 

from sources including food 

manufacturers, retailers, and third party 

organizations (e.g., trade and health 

organizations). The symbols are 

intended to assist consumer choice by 

providing simplified and easilyaccessible information on the 

nutritional attributes of a food product. 

Relevant and nonproprietary 

information about the effects of 

nutrition symbols on consumers, 

however, is limited (see, for example, 

Feunekes et al., 2008; ‘‘FDA Comments 

on Symbols Public Hearing and Current 

Plans for Addressing Issues,’’ Docket 

Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 26245 

1Feunekes, G. I. J., I. A. Gortemaker, A. A. 

Willems, and R. Lion, Front-of-pack Nutrition 

Labeling: Testing Effectiveness of Different 

Nutrition Labeling Formats Front-of-pack in Four 

European Countries, Appetite 50(1): 57-70, 2008. 

2http://www.cfsan.fda.gov/~dms/cfsup196.html. 

No. FDA–2007–N–0198).1 2 Therefore, 

FDA is proposing to conduct an 

experimental study to assess 

quantitative consumer reactions to 

front-of-package nutrition symbols. 

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 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) (21 

U.S.C. 393 (d)(2)(C)), to conduct 

research relating to foods, drugs, 

cosmetics and devices in carrying out 

the act. 

The purpose of the study is to help 

enhance FDA’s understanding of 

consumer understanding and use of a 

selected sample of nutrition symbols in 

the domestic marketplace. The study is 

part of the agency’s continuing effort to 

enable consumers to make informed 

dietary choices and construct healthful 

diets. 

The proposed experimental study will 

use a Web-based survey to collect 

information from a sample of adult 

members in an online consumer panel 

established by a contractor. The study 

plans to randomly assign each of 2,400 

participants to view a label from a set 

of food labels that vary in the presence 

and type of symbol, the type of food 

product, and the quality of nutritional 

attributes of the product. The study 

plans to make the mandatory Nutrition 

Facts label available to all participants. 

The study will focus on the following 

types of consumer reaction: (1) 

Judgments about a food product in 

terms of its nutritional attributes, overall 

healthfulness, health benefits, and other 

characteristics such as taste; (2) 

judgments about a label in terms of its 

credibility in conveying the product’s 

nutritional attributes and helpfulness in 

product choices; (3) identification of the 

more nutritious product in a pair of 

products; and (4) impact of the symbol 

on the use of the Nutrition Facts label. 

To help understand consumer reactions, 

the study will also collect information 

on participants’ background, including 

but not limited to consumption and 

perceptions of food products, nutrition 

attitudes and practice, food label use, 

health literacy, and health status. 

In addition, the study will conduct a 

separate face-to-face eye-tracking 

examination using a separate sample of 

30 adult consumers to explore their 

label viewing patterns when they are 

asked to judge product attributes and to 

compare products. Participants will be 

selected from a commercial database of 

consumers. 

The study results will be used to help 

the agency in its continuing evaluation 

of issues related to the use of nutrition 

symbols in food labeling. The results of 

the experimental study will not be used 

to develop population estimates. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Portion of Study No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Cognitive interview screener 144 1 144 0.083 12 

Cognitive interview 18 1 18 1 18 

Pretest invitation 1,600 1 1,600 0.033 53 

Pretest 200 1 200 0.25 50 

Survey invitation 19,200 1 19,200 0.033 634 

Survey 2,400 1 2,400 0.25 600 

Eye-tracking screener 240 1 240 0.083 20 

Eye-tracking 30 1 30 1 30 

Total 1,417 

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

To help design and refine the 

questionnaire to be used for the 

experimental study, we plan to conduct 

cognitive interviews by screening 144 

adult consumers in order to obtain 18 

participants in the 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 30 hours (12 hours + 18 

hours). Subsequently, we plan to 

conduct pretests of the survey 

questionnaire before it is administered 

in the study. We expect that 1,600 

invitations, each taking 2 minutes (0.033 

hours), will need to be sent to adult 

members of an online consumer panel 

to have 200 of them complete a 15– 

minute (0.025 hours) pretest. The total 

for the pretest activities is 103 hours (53 

hours + 50 hours). For the survey, we 

estimate that 19,200 invitations, each 

taking 2 minutes (0.033 hours), will 

need to be sent to adult members of an 

online consumer panel to have 2,400 of 

them complete a 15–minute (0.025 

hours) questionnaire. The total for the 

survey activities is 1,234 hours (634 

hours + 600 hours). To conduct the eyetracking study, we expect to screen 240 

adult consumers, each taking 5 minutes 

(0.083 hours), to have 30 of them 

participate in an 1-hour interview. The 

total for the eye-tracking activities is 50 

hours (20 hours + 30 hours). Thus, the 

total estimated burden is 1,417 hours. 

FDA’s burden estimate is based on prior 

experience with research that is similar 

to this proposed study. 

26246 Federal Register / Vol. 74, No. 103 / Monday, June 1, 2009 / Notices 

Dated: May 26, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12669 Filed 5–29–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–09–0743] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

The Centers for Disease Control and 

Prevention (CDC) publishes a list of 

information collection requests under 

review by the Office of Management and 

Budget (OMB) in compliance with the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35). To request a copy of these 

requests, call the CDC Reports Clearance 

Officer at (404) 639–5960 or send an email to omb@cdc.gov. Send written 

comments to CDC Desk Officer, Office of 

Management and Budget, Washington, 

DC or by fax to (202) 395–6974. Written 

comments should be received within 30 

days of this notice. 

Proposed Project 

Assessment and Monitoring of 

Breastfeeding-Related Maternity Care 

Practices in Intra-partum Care Facilities 

in the United States and Territories 

(OMB Control No. 0920–0743, Exp. 7/ 

31/2009)–Revision–National Center for 

Chronic Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

Substantial evidence demonstrates the 

health benefits of breastfeeding. 

Breastfeeding mothers have lower risks 

of breast and ovarian cancers and type 

2 diabetes, and breastfeeding better 

protects infants against infections, 

chronic diseases like diabetes and 

obesity, and even childhood leukemia 

and sudden infant death syndrome 

(SIDS). However, the groups that are at 

higher risk for diabetes, obesity, and 

poor health overall persistently have the 

lowest breastfeeding rates. Public health 

priorities for the U.S. include increasing 

the overall rate of breastfeeding, and 

reducing variation in breastfeeding rates 

across population subgroups. 

The health care system is one of the 

most important and effective settings to 

improve breastfeeding. In 2007, CDC 

conducted the first national survey of 

Maternity Practices in Infant Nutrition 

and Care (known as the mPINC Survey) 

in health care facilities (hospitals and 

free-standing childbirth centers). The 

survey was designed to provide baseline 

information and to be repeated again in 

2009. It inquired about patient 

education and support for breastfeeding 

throughout the maternity stay as well as 

staff training and maternity care 

policies. Each responding organization 

received a customized Benchmark 

Report as well as other feedback to use 

in self-assessment and quality 

improvement activities. 

CDC proposes to repeat the mPINC in 

2009 using previously fielded questions 

and methodology. In addition to all 

facilities that participated in 2007, the 

2009 survey will include those that 

were invited but did not participate in 

2007 and any that are new since then. 

All birth centers and hospitals with ≥ 1 

registered maternity beds will be 

screened via a brief phone call to assess 

their eligibility, identify additional 

locations, and identify the appropriate 

point of contact. 

A major goal of the 2009 survey is to 

be fully responsive to respondents’ 

needs for information and technical 

assistance. CDC will again provide 

customized benchmark reports to 

respondents and document progress 

since 2007 on their quality 

improvement efforts. National and state 

reports will use de-identified data to 

describe incremental changes in 

practices and care processes over time at 

the facility, state, and national levels. 

Participation in the survey is 

voluntary, and responses may be 

submitted by mail or through a webbased system. There are no costs to 

respondents other than their time. The 

total estimated annualized burden hours 

are 1,686. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Hospitals ................................. Telephone Screening Interview for Hospitals ........................ 3,897 1 5/60 

2009 mPINC Survey for Hospitals ......................................... 2,568 1 30/60 

Birth Centers ........................... Telephone Screening Interview for Birth Centers .................. 192 1 5/60 

2009 mPINC Survey for Birth Centers ................................... 122 1 30/60 

Dated: May 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–12631 Filed 5–29–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day-0920–09BS] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

In compliance with the requirement 

of Section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995 for 

opportunity for public comment on 

proposed data collection projects, the 

Centers for Disease Control and 

Prevention (CDC) will publish periodic 

summaries of proposed projects. To 

request more information on the 

proposed projects or to obtain a copy of 

the data collection plans and 

instruments, call 404–639–5960 and 

send comments to Maryam I. Daneshvar, 

CDC Acting Reports Clearance Officer, 

1600 Clifton Road, MS–D74, Atlanta, 

GA 30333 or send an e-mail to 

omb@cdc.gov. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the