70268 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

(Response 11) CSPI suggested 

extensive changes to the Nutrition Facts 

label that affect many parts of the label. 

In this research, the Agency is focused 

on how consumers use labels for 

products that are customarily consumed 

at one eating occasion but may contain 

more than one serving per container as 

well as on how consumers react to 

different ways that calorie information 

is declared on the label. FDA believes 

these changes have the potential to be 

among the most useful changes to help 

consumers make informed choices. 

Therefore, FDA identified and chose the 

proposed formats, such as dual column 

formats and prominence of calorie 

formats, for this study. The variety of 

different experimental conditions for 

just these changes requires a very large 

number of respondents. It is not feasible 

to test the additional extensive changes 

such as those suggested by CSPI in this 

study because the number of 

respondents needed would become 

unmanageable. 

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 ...... 96 1 96 0 .083 8 

Cognitive interview ..................... 12 1 12 1 12 

Pretest invitation ........................ 1,000 1 1,000 0 .033 33 

Pretest ........................................ 150 1 150 0 .25 38 

Experiment invitation .................. 50,000 1 50,000 0 .033 1,650 

Experiment ................................. 10,000 1 10,000 0 .25 2,500 

Total .................................... ................................ ................................ ................................ .................................. 4,241 

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

In the 60-day notice that published in 

the Federal Register of November 18, 

2009, we estimated a total burden of 

1,595 hours for the study. In this 

document, table 1 has been modified to 

reflect our re-evaluation of the original 

study design. The new total estimated 

burden is 4,241 hours. 

To help design and refine the 

questionnaire to be used for the 

experimental study, we plan to conduct 

cognitive interviews by screening 96 

adult consumers in order to obtain 12 

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 20 hours (8 hours + 12 

hours). Subsequently, we plan to 

conduct pretests of the questionnaire 

before it is administered in the study. 

We expect that 1,000 invitations, each 

taking 2 minutes (0.033 hours), will 

need to be sent to adult members of an 

online consumer panel to have 150 of 

them complete a 15-minute (0.25 hours) 

pretest. The total for the pretest 

activities is 71 hours (33 hours + 38 

hours). For the experiment, we estimate 

that 50,000 invitations, each taking 2 

minutes (0.033 hours), will need to be 

sent to adult members of an online 

consumer panel to have 10,000 of them 

complete a 15-minute (0.25 hours) 

questionnaire. The total for the 

experiment activities is 4,150 hours 

(1,650 hours + 2,500 hours). Thus, the 

total estimated burden is 4,241 hours. 

FDA’s burden estimate is based on prior 

experience with research that is similar 

to this proposed study. 

II. References 

1. Levy A., S. Fein, and R. Schucker, 

‘‘Nutrition Labeling Formats: 

Performance and Preference,’’ Food 

Technology 45: 116–121, 1991. 

2. Levy A., S. Fein, and R. Schucker, 

‘‘More Effective Nutrition Label 

Formats Are Not Necessarily 

Preferred,’’ Journal of the American 

Dietetic Association 92: 1230–1234, 

1992. 

3. Levy A., S. Fein, and R. Schucker, 

‘‘Performance Characteristics of 

Seven Nutrition Label Formats,’’ 

Journal of Public Policy and 

Marketing 15: 1–15, 1996. 

4. Lando A. and J. Labiner-Wolfe, 

‘‘Helping Consumers to Make More 

Healthful Food Choices: Consumer 

Views on Modifying Food Labels 

and Providing Point-of-Purchase 

Nutrition Information at QuickService Restaurants,’’ Journal of 

Nutrition Education and Behavior 

39: 157–163, 2007. 

5. U.S. Food and Drug Administration, 

Calories Count: Report of the 

Working Group on Obesity, 2004, 

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

LabelingNutrition/ReportsResearch/ 

ucm081696.htm). 

6. 70 FR 17008, April 4 2005. 

7. 70 FR 17010, April 4 2005. 

8. 72 FR 62149, November 2 2007. 

9. Schnieder Chafer, J.J., S.J. Newbery, 

M.A. Riedl, et al., ‘‘Diagnosing and 

Managing Common Food Allergies: 

A Systematic Review,’’ Journal of 

the American Medical Association 

303(18): 1848–1856. 

10. Silverglade, B and I.R. Heller, ‘‘Food 

Labeling Chaos: The Case for 

Reform,’’ Center for Science in the 

Public Interest, March 2010, 

available at: http:// 

www.cspinet.org/new/pdf/ 

food_labeling_chaos_report.pdf. 

Dated: November 10, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–28966 Filed 11–16–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; NIH NCI Central 

Institutional Review Board (CIRB) 

Initiative (NCI) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Cancer Institute (NCI), the National 

Institutes of Health (NIH), has submitted 

to the Office of Management and Budget 

(OMB) a request to review and approve 

the information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on August 16, 2010 (75 FR 

49938) and allowed 60-days for public 

comment. No public comments were 

received. The purpose of this notice is 

to allow 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 70269 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: NIH NCI 

Central Institutional Review Board 

(CIRB). Type of Information Collection 

Request: Existing Collection in Use 

Without an OMB Number. Need and 

Use of Information Collection: The CIRB 

was created to reduce the administrative 

burden on local IRBs and investigators 

while protecting human research 

participants. To accomplish this, the 

CIRB uses several information collection 

tools to ensure that CIRB operations 

occur with high level of reviewer and 

board member satisfaction and is absent 

of conflicts of interest with the protocols 

under review. Tools utilized to 

accomplish this include the new 

member packets which are completed 

once a new member joins the CIRB to 

provide background information on 

workflow and processes of CIRB 

operations as well as a non-disclosure 

agreement. A conflict of interest form is 

completed occasionally or each time the 

reviewer is requested to serve as a 

reviewer for a study. CIRB helpdesk 

surveys measure satisfaction of 

helpdesk users and is conducted 

occasionally or each time the person 

contacts the helpdesk. Frequency of 

Response: Once, except for the SAE 

Reviewer Worksheet. Affected Public: 

Includes the Federal Government, 

business or other for-profits and not-forprofit institutions. Type of Respondents: 

Respondents include any customer who 

contacts the CIRB Helpdesk, 

institutional review board members and 

CIRB review participants. The annual 

reporting burden is estimated at 2209 

hours (see Table 1 below for the 

estimated time burden). The total 

burden has decreased slightly as a result 

of corrected calculations from what was 

published in the 60-Day Federal 

Register Notice. The average annual cost 

to the government over a 12-month 

period is approximately $153,574 per 

year for a six year contract. This 

includes total annualized capital/start 

up costs of $25,108 and operating costs 

of $150,637. 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of 

respondents Survey instrument Number of respondents 

Frequency of 

response 

Average time per 

response 

(min/hr) 

Annual burden 

hours 

Participants/Board 

Members.

CIRB Helpdesk Survey (Attachment 1) ....... 1,500 1 10/60 (.17 hour) ........ 250 

Participants ................ NCI CIRB Institution Enrollment Worksheet 

(Attachment 2A).

30 1 3.5 hours ................... 105 

Participants ................ IRB Staff at Signatory Institution’s IRB (Attachment 2B).65 1 10/60 (.17 hour) ........ 11 

Participants ................ Investigator at Signatory Institution (Attachment 2C).65 1 10/60 (.17 hour) ........ 11 

Participants ................ Research Staff at Signatory Institution (Attachment 2D).65 1 10/60 (.17 hour) ........ 11 

Participants ................ Investigator at Affiliate Institution (Attachment 2E).65 1 10/60 (.17 hour) ........ 11 

Participants ................ Research Staff at Affiliate Institution (Attachment 2F).65 1 10/60 (.17 hour) ........ 11 

Participants ................ IRB at Signatory Institution (Attachment 2G) 65 1 10/60 (.17 hour) ........ 11 

Participants ................ Component Institution at Signatory Institution (Attachment 2H).65 1 10/60 (.17 hour) ........ 11 

Participants ................ IRB at Affiliate Institution (Attachment 2I) .... 65 1 10/60 (.17 hour) ........ 11 

Participants ................ Institution Affiliate Institution without an IRB 

(Attachment 2J).

65 1 10/60 (.17 hour) ........ 11 

Participants ................ Request for 30–Day Access Form (Attachment 2K).50 1 10/60 (.17 hour) ........ 8 

Participants ................ Facilitated Review (FR) Acceptance Form 

(Attachment 2L).

1,450 1 10/60 (.17 hour) ........ 242 

Participants ................ Study Review Responsibility Transfer Form 

(Attachment 2M).

120 1 10/60 (.17 hour) ........ 20 

Board Members ......... CIRB New Board Member Biographical 

Sketch Form (Attachment 3B).

16 1 30/60 (.5 hour) .......... 8 

Board Members ......... CIRB New Board Member Contact Information Form (Attachment 3C).16 1 15/60 (.25 hour) ........ 4 

Board Members ......... CIRB New Board Member W–9 (Attachment 3D).16 1 15/60 (.25 hour) ........ 4 

Board Members ......... CIRB New Board Member Non-Disclosure 

Agreement (NDA) (Attachment 3E).

16 1 15/60 (.25 hour) ........ 4 

Board Members ......... Direct Deposit Form (Attachment 4) ............ 16 1 15/60 (.25 hour) ........ 4 

Participants ................ NCI Adult CIRB Application (Attachment 

5A).

150 1 2 hours ...................... 300 

Participants ................ NCI Pediatric CIRB Application (Attachment 

5B).

62 1 2 hours ...................... 124 

Participants ................ Adult/Pediatric CIRB Application—Ancillary 

Studies (Attachment 5C).

10 1 2 hours ...................... 20 

Participants ................ Summary of CIRB Application Revisions 

(Attachment 5D).

20 1 30/60 (.5 hour) .......... 10 

Participants ................ Adult/Pediatric CIRB Application for Continuing Review (Attachment 5E).230 1 1 hour ........................ 230 

Board Members ......... Adult CIRB Reviewer Findings—Initial Review of Cooperative Group Protocol (Attachment 6A).20 1 4 hours ...................... 80 

mstockstill on DSKH9S0YB1PROD with NOTICES

70270 Federal Register / Vol. 75, No. 221 / Wednesday, November 17, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS—Continued 

Type of 

respondents Survey instrument Number of respondents 

Frequency of 

response 

Average time per 

response 

(min/hr) 

Annual burden 

hours 

Board Members ......... Pediatric CIRB Reviewer Findings—Initial 

Review of Cooperative Group Protocol 

(Attachment 6B).

12 1 4 hours ...................... 48 

Board Members ......... Adult CIRB Reviewer Findings Cooperative 

Group Response to CIRB Review (Attachment 6C).

25 1 1 hour ........................ 25 

Board Members ......... Pediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review 

(Attachment 6D).

70 1 1 hour ........................ 70 

Board Members ......... Adult CIRB Reviewer Findings Amendment 

Cooperative Group Protocol (Attachment 

6E).

130 1 1.5 hours ................... 195 

Board Members ......... Pediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attachment 6F).50 1 1.5 hours ................... 75 

Board Members ......... Adult CIRB Reviewer Findings Continuing 

Review of Cooperative Group Protocol 

(Attachment 6G).

150 1 .5 hour ....................... 75 

Board Members ......... Pediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6H).110 1 .5 hour ....................... 55 

Board Members ......... CIRB Reviewer Form (Attachment 6I) ......... 20 1 2 hours ...................... 40 

Board Members ......... CIRB Statistical Reviewer Form (Attachment 6J).20 1 2 hours ...................... 40 

Board Members ......... CIRB SAE Reviewer Worksheet (Attachment 6K).10 15 30/60 (.5 hour) .......... 75 

Total ................... ....................................................................... 4,904 ........................ ................................... 2,209 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate 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) Evaluate 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) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) 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 

Attention: NIH Desk Officer, Office of 

Management and Budget, at 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact Jeanne 

Adler, Division of Cancer Treatment and 

Diagnosis or call non-toll-free number 

301–594–0083 or e-mail your request, 

including your address to: 

adlerj@mail.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: November 10, 2010. 

Vivian Horovitch-Kelley, 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–28883 Filed 11–16–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Pretesting of 

NIAID’s Biomedical HIV Prevention 

Research Communication Messages 

SUMMARY: 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 

National Institute of Allergy and 

Infectious Diseases (NIAID), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Pretesting 

of NIAID’s Biomedical HIV Prevention 

Research Communication Messages. 

Type of Information Collection Request: 

Revision of a previously approved 

collection. Need and Use of Information 

Collection: This is a request for 

clearance to pretest messages, materials 

and program activities about biomedical 

HIV prevention research. The primary 

objectives of the pretests are to (1) 

Assess audience knowledge, attitudes, 

behaviors and other characteristics for 

the planning/development of health 

messages, education products, 

communication strategies, and public 

information programs; and (2) pretest 

these health messages, products, 

strategies, and program components 

while they are in developmental form to 

assess audience comprehension, 

reactions, and perceptions. The 

information obtained from audience 

research and pretesting results in more 

effective messages, materials, and 

programmatic strategies. By maximizing 

the effectiveness of these messages and 

strategies for reaching targeted 

audiences, the frequency with which 

publications, products, and programs 

mstockstill on DSKH9S0YB1PROD with NOTICES