11788 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

Dated: February 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4741 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0098] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Infant Formula 

Label Statements Experimental Study 

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 ‘‘Infant Formula Label 

Statements Experimental Study.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 2, 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. 

Infant Formula Label Statements 

Experimental Study—(OMB Control 

Number 0910–NEW) 

FDA is planning to conduct an 

experimental study about certain types 

of label statements on infant formula, 

such as those that are either structure 

function claims or similar to such 

claims. An example of the type of 

statements that are of interest is: 

‘‘Supports brain and eye development.’’ 

The Infant Formula Label Statements 

Experimental Study will collect 

information from four groups: Pregnant 

women, mothers of infants less than 12 

months old, mothers of children older 

than 1 year but younger than 5 years 

old, and women of childbearing age 

who do not have a child younger than 

5 years. The purpose of the study is to 

assess women’s understanding of and 

response to various statements on infant 

formula labels. The study results will be 

used to help the Agency to understand 

the role that certain types of statements 

on infant formula labels have in 

influencing formula choice. 

The data will be collected over the 

Internet from a sample of 5,000 adult 

women selected from an online 

consumer panel. Participants will be 

randomly assigned to an experimental 

condition. The study will show 

participants one of five explanations of 

the regulatory, scientific, or marketing 

context (or none of these) of infant 

formula marketing in the United States 

and will ask them to compare two sets 

of two experimental infant formula 

labels. One label will always be a 

control label with no statement similar 

to a structure function claim. The other 

label will include one of the statements 

of interest to the study. The study will 

focus on purchase choice, perceived 

similarity of the formula to breast milk, 

and perceived likelihood that the 

formula has certain health benefits. In 

addition, information about certain 

covariates will be collected, depending 

on the group the participant is in. 

Covariate information will include, as 

appropriate, month of pregnancy, plans 

for feeding the infant, number of 

children, age of youngest child, whether 

the youngest child was fed infant 

formula, whether the youngest child 

was ever breast fed, whether the mother 

bought infant formula for her youngest 

child, priorities used to select the 

formula purchased, and attitudes about 

the differences between breast milk and 

formula. Participation in the study is 

voluntary. 

Approximately 10,000 women will be 

screened. We estimate that it will take 

a respondent 20 seconds (0.0055 hours) 

to complete the screening questions, for 

a total of 55 hours. A pretest will be 

conducted with 150 participants. We 

estimate that it will take a respondent 

15 minutes (0.25 hours) to complete the 

experiment and 10 minutes (0.167 

hours) to complete debriefing questions 

for the pretest, for a total of 25 minutes 

(0.42 hours) per respondent and a total 

of 63 hours for the pretest. Five 

thousand (5,000) adult women will 

complete the experiment. We estimate 

that it will take a respondent 15 minutes 

(0.25 hours) to complete the entire 

experiment, for a total of 1,250 hours. 

Thus, the total estimated burden is 

1,368 hours. FDA’s burden estimate is 

based on prior experience with 

consumer experiments that are similar 

to this proposed experiment. 

FDA estimates the burden of this 

collection of information as follows: 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11789 

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 

Screener ............................................................................... 10,000 1 10,000 0 .0055 55 

Pretest .................................................................................. 150 1 150 0 .42 63 

Experiment ........................................................................... 5,000 1 5,000 0 .25 1,250 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,368 

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

Dated: February 25, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4740 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0344] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Testing Communications on Medical 

Devices and Radiation-Emitting 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Testing Communications on Medical 

Devices and Radiation-Emitting 

Products’’ has been approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of October 18, 2010 (75 

FR 63838), the Agency announced that 

the proposed information collection had 

been submitted to OMB for review and 

clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0678. The 

approval expires on January 31, 2014. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.reginfo.gov/ 

public/do/PRAMain. 

Dated: February 16, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4738 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2006–N–0238] (formerly 

2006N–0062) 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Expanded Access to Investigational 

Drugs for Treatment Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Expanded Access to Investigational 

Drugs for Treatment Use’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of December 14, 2006 

(71 FR 75147), the Agency announced 

that the proposed information collection 

had been submitted to OMB for review 

and clearance under 44 U.S.C. 3507. An 

Agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0653. The 

approval expires on December 31, 2011. 

A copy of the supporting statement for 

this information collection is available 

on the Internet at http:// 

www.reginfo.gov/public/do/PRAMain. 

Dated: February 23, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–4739 Filed 3–2–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0478] 

Albert Poet: Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) 

permanently debarring Albert Poet, MD 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. We 

base this order on a finding that Dr. Poet 

was convicted of felonies under Federal 

law for conduct relating to the 

regulation of a drug product under the 

FD&C Act. Dr. Poet was given notice of 

the proposed permanent debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. Dr. Poet failed to respond. 

Dr. Poet’s failure to respond constitutes 

a waiver of his right to a hearing 

concerning this action. 

DATES: This order is effective March 3, 

2011. 

ADDRESSES: Submit applications for 

special termination of debarment to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Kenny Shade, Division of Compliance 

Policy (HFC–230), Office of 

Enforcement, Office of Regulatory 


srobinson on DSKHWCL6B1PROD with NOTICES