11786 Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 

canned food, processors of acidified 

food, and processors of both types of 

food. Thus, we estimate the number of 

processors keeping records under parts 

113 and 114 to be 9,500, as shown in 

table 2, row 1 of this document. In the 

final rule, we estimated that there are 

approximately 8,450 foreign and 

domestic low-acid canned food 

processing establishments. This 

estimate, which does not encompass 

establishments that process only 

acidified foods (because such processors 

are not affected by the final rule), was 

based on data in the LACF database as 

of September 2009. As discussed in the 

explanation of the recordkeeping 

estimate for the final rule in the 

following paragraphs, our estimate 

assumes that half of the LACF industry 

currently does not record all of the 

device accuracy testing information that 

the final rule requires. Thus, as shown 

in table 2, row 2 of this document, we 

estimate that 4,225 low-acid canned 

food manufacturers that are not 

currently keeping the records that are 

required under the final rule will begin 

to keep such records to comply with the 

final rule when it becomes effective. 

FDA bases its estimates of the number 

of recordkeepers and the hours per 

record on its experience and on 

information from industry. FDA 

estimates that it takes 250 hours per 

respondent to comply with the 

recordkeeping requirements in parts 113 

and 114. In table 2, row 1 of this 

document, FDA estimates the total 

burden of recordkeeping under parts 

113 and 114 before the effective date of 

the final rule to be 2,375,000 hours 

(9,500 respondents × 250 hours = 

2,375,000 hours). Table 2, row 2 reports 

the average annual recordkeeping 

burden of the final rule. The burden of 

the recordkeeping requirement of the 

final rule consists of the set-up time 

required to design and establish a form 

for recording the required information, 

and the additional hours of labor 

needed to record the information. The 

set-up time required for designing a new 

recordkeeping form is assumed to be 

minimal because we estimate that only 

a few data elements required in the final 

rule are currently unreported by some 

processors and that only small 

modifications to a processor’s 

recordkeeping form would be required 

to accommodate the additional data 

elements. 

We estimate that the amount of time 

needed to comply with the 

recordkeeping requirements of the final 

rule will be small because current 

industry practice is to keep track of 

most, if not all, of this information. 

Because current incentives to track 

accuracy of mercury-in-glass 

thermometers may vary across the 

industry, however, some information 

that is currently generated during 

accuracy tests may not be recorded as 

required under the final rule. Thus, we 

assume there will be a burden incurred 

from the final rule to record information 

that is currently generated, but not 

recorded. 

We assume that half of the industry 

currently does not record all of the 

device accuracy testing information that 

the final rule requires. We further 

assume that current practice by these 

firms is to leave unrecorded 1 to 4 

separate pieces of information required 

under the final rule, and that each piece 

of information takes between 10 and 15 

seconds to record. Consequently, we 

estimate that half of all low-acid canned 

food manufacturers will spend between 

10 seconds and 1 minute (i.e., 1 × 10 

seconds and 4 × 15 seconds) per device 

to record information required in the 

final rule. 

Based on a survey conducted by FDA 

between 1992 and 1993 of mercury-inglass thermometer calibration in the 

low-acid canned food industry, we 

estimate that low-acid food firms use an 

average of 10 temperature-indicating 

devices, including reference devices. 

We estimate that 4,225 low-acid canned 

food manufacturers (half of the 

industry) currently do not fully record 

the accuracy test results required by the 

final rule. Because the regulations 

specify that each device must be tested 

upon installation and at least once per 

year thereafter, or more frequently if 

necessary to ensure accuracy, we 

estimate that each device requires 1 to 

2 tests per year (midpoint of 1.5 tests 

per year). We therefore estimate the 

annual frequency per recordkeeping to 

be 15 (i.e., 10 devices × 1.5 tests per 

year). We estimate the burden for 

recording the additional information to 

be between 10 and 60 seconds per 

device (midpoint of 35 seconds or 

0.0097 hours per device). Therefore, the 

estimated total annual burden in hours 

for the recordkeeping requirements of 

the final rule is approximately 615 

hours (63,375 × 0.0097 = 614.7 hours, 

rounded to 615 hours). Thus, the final 

rule increases the total burden of this 

information collection by approximately 

0.3 percent, from 2,375,000 hours to 

2,375,615 hours. 

Dated: February 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–4474 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–0583] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Radioactive Drug 

Research Committees 

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 April 4, 

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 0910–0053. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

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 

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

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Radioactive Drug Research 

Committees—(OMB Control Number 

0910–0053)—Extension 

Under sections 201, 505, and 701 of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 321, 355, and 371), FDA 

has the authority to issue regulations 

governing the use of radioactive drugs 

for basic scientific research. Section 

361.1 (21 CFR 361.1) sets forth specific 

regulations regarding the establishment 

and composition of Radioactive Drug 

Research Committees and their role in 

approving and monitoring basic 

research studies utilizing 

radiopharmaceuticals. No basic research 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 42 / Thursday, March 3, 2011 / Notices 11787 

study involving any administration of a 

radioactive drug to research subjects is 

permitted without the authorization of 

an FDA-approved Radioactive Drug 

Research Committee (§ 361.1(d)(7)). The 

type of research that may be undertaken 

with a radiopharmaceutical drug must 

be intended to obtain basic information 

and not to carry out a clinical trial for 

safety or efficacy. The types of basic 

research permitted are specified in the 

regulation, and include studies of 

metabolism, human physiology, 

pathophysiology, or biochemistry. 

Section 361.1(c)(2) requires that each 

Radioactive Drug Research Committee 

shall select a chairman, who shall sign 

all applications, minutes, and reports of 

the committee. Each committee shall 

meet at least once each quarter in which 

research activity has been authorized or 

conducted. Minutes shall be kept and 

shall include the numerical results of 

votes on protocols involving use in 

human subjects. Under § 361.1(c)(3), 

each Radioactive Drug Research 

Committee shall submit an annual 

report to FDA. The annual report shall 

include the names and qualifications of 

the members of, and of any consultants 

used by, the Radioactive Drug Research 

Committee, using FDA Form 2914, and 

a summary of each study conducted 

during the proceeding year, using FDA 

Form 2915. 

Under § 361.1(d)(5), each investigator 

shall obtain the proper consent required 

under the regulations. Each female 

research subject of childbearing 

potential must state in writing that she 

is not pregnant, or on the basis of a 

pregnancy test be confirmed as not 

pregnant. 

Under § 361.1(d)(8), the investigator 

shall immediately report to the 

Radioactive Drug Research Committee 

all adverse effects associated with use of 

the drug, and the committee shall then 

report to FDA all adverse reactions 

probably attributed to the use of the 

radioactive drug. 

Section 361.1(f) sets forth labeling 

requirements for radioactive drugs. 

These requirements are not in the 

reporting burden estimate because they 

are information supplied by the Federal 

Government to the recipient for the 

purposes of disclosure to the public (5 

CFR 1320.3(c)(2)). 

Types of research studies not 

permitted under this regulation are also 

specified, and include those intended 

for immediate therapeutic, diagnostic, 

or similar purposes or to determine the 

safety or effectiveness of the drug in 

humans for such purposes (i.e., to carry 

out a clinical trial for safety or efficacy). 

These studies require filing of an 

investigational new drug application 

(IND) under 21 CFR part 312, and the 

associated information collections are 

covered in OMB control number 0910– 

0014. 

The primary purpose of this 

collection of information is to determine 

whether the research studies are being 

conducted in accordance with required 

regulations and that human subject 

safety is assured. If these studies were 

not reviewed, human subjects could be 

subjected to inappropriate radiation or 

pharmacologic risks. 

Respondents to this information 

collection are the chairperson(s) of each 

individual Radioactive Drug Research 

Committee, investigators, and 

participants in the studies. 

The burden estimates are based on 

FDA’s experience with these reporting 

and recordkeeping requirements over 

the past few years and the number of 

submissions received by FDA under the 

regulations. 

In the Federal Register of November 

30, 2010 (75 FR 74059), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Forms Number of 

respondents 

Annual frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

361.1(c)(3) and (4) ............................ FDA 2914 ..................... 80 1 80 1 80 

361.1(c)(3) ........................................ FDA 2915 ..................... 50 6 .8 340 3 .5 1,190 

361.1(d)(8) ........................................ ....................................... 50 6 .8 340 0 .1 34 

Total ........................................... ....................................... ........................ .................... ........................ .................... 1,304 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Annual frequency per 

recordkeeping 

Total annual 

records 

Hours 

per 

records 

Total hours 

361.1(c)(2) ........................................................................................ 80 4 320 10 3,200 

361.1(d)(5) ....................................................................................... 50 6 .8 340 0 .75 255 

Total .......................................................................................... ........................ ........................ ........................ ............ 3,455 

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


srobinson on DSKHWCL6B1PROD with NOTICES
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