52352 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 

TABLE 1—ESTIMATES OF ANNUAL BURDEN HOURS

Type of respondents Survey instrument Number of 

respondents 

Frequency of 

response 

Average time 

per response 

(minutes/hour) 

Annual burden 

hours 

Adults (40–79 years old) Telephone Screener (Attachment 16) ................. 1700 1 10/60 (0.17) 283 

Main Questionnaire (Attachment 6) ..................... 225 1 60/60 (1) 225 

Prostate Supplemental Questionnaire (Attachment 7).125 1 30/60 (0.5) 63 

Liver Supplement (Attachment 8) ........................ 225 1 30/60 (0.5) 113 

Refusal Questionnaire Form (Attachment 21) ..... 225 1 2/60 (0.03) 8 

Totals ..................... .............................................................................. 2500 ........................ ........................ 692 

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 

Glenwood E. Trivers or Elise Bowman, 

Center for Cancer Research, NCI, NIH, 

37 Convent Drive Room 3060–C or 

3060–A, Building 37, Bethesda, 

Maryland 30893–4258 or call non-tollfree number 301–496–2094 or 301–496– 

2090 or e-mail your request, including 

your address to triversg@mail.nih.gov or 

bowmane@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: August 18, 2010. 

Vivian Horovitch-Kelley 

NCI Project Clearance Liaison, National 

Institutes of Health. 

[FR Doc. 2010–21098 Filed 8–24–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0079] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study of Graphic Cigarette Warning 

Labels 

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 September 

24, 2010. 

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 emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–NEW and 

title ‘‘Experimental Study of Graphic 

Cigarette Warning Labels.’’ Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3794, 

Jonnalynn.capezzuto@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. 

Experimental Study of Graphic 

Cigarette Warning Labels—(OMB 

Control Number 0910–NEW) 

Tobacco products are responsible for 

more than 440,000 deaths each year. 

The Centers for Disease Control and 

Prevention report that approximately 46 

million U.S. adults smoke cigarettes in 

the United States, even though this 

behavior will result in death or 

disability for half of all regular users. 

Paralleling this enormous health burden 

is the economic burden of tobacco use, 

which is estimated to total $193 billion 

annually in medical expenditures and 

lost productivity. Curbing the 

significant adverse consequences of 

tobacco use is one of the most important 

public health goals of our time. One way 

to do this is through health warnings 

that describe and graphically depict the 

harm caused by cigarette use. 

On June 22, 2009, the President 

signed the Family Smoking Prevention 

and Tobacco Control Act (Tobacco 

Control Act) (Public Law 111–31) into 

law. The Tobacco Control Act granted 

FDA important new authority to 

regulate the manufacture, marketing, 

and distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Section 201 of the Tobacco Control Act, 

which amends section 4 of the Federal 

Cigarette Labeling and Advertising Act 

(15 U.S.C. 1333), requires FDA to issue 

‘‘regulations that require color graphics 

depicting the negative health 

consequences of smoking to accompany 

the label statements specified in 

subsection (a)(1).’’ FDA conducts 

research relating to tobacco products 

under its statutory authority in section 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 52353 

1103(d)(2)(C) of the Federal Food, Drug, 

and Cosmetic Act, as amended by the 

Tobacco Control Act, to conduct 

research ‘‘relating to foods, drugs, 

cosmetics, devices, and tobacco 

products in carrying out the act.’’ The 

study proposed here is an effort by FDA 

to collect data concerning graphic 

warnings on cigarette packages and their 

impact on consumer perceptions, 

attitudes, and behavior with respect to 

smoking. 

The study, the Experimental Study of 

Graphic Cigarette Warning Labels, is a 

voluntary experimental survey of 

consumers. The purpose of the study is 

to assess the effectiveness of various 

graphic warnings on cigarette packs for 

achieving three communication goals: 

(1) Conveying information about various 

health risks of smoking, (2) encouraging 

cessation of smoking among current 

smokers, and (3) discouraging initiation 

of smoking among youth and former 

smokers. The study will collect data 

from various groups of consumers, 

including current smokers aged 13 years 

and older, former smokers aged 13 years 

and older, and non-smokers aged 

between 13 and 25 years who may be 

susceptible to initiation of smoking. The 

study goals are to: (1) Measure 

consumer attitudes, beliefs, and 

intended behaviors related to cigarette 

smoking in response to graphic warning 

labels; (2) determine whether consumer 

responses to graphic warning labels 

differ across various groups based on 

smoking status, age, or other 

demographic variables; and (3) evaluate 

the relative effectiveness of various 

graphic images associated with each of 

the nine warning statements specified in 

the Tobacco Control Act for achieving 

each of the communication goals. The 

information collected from the study is 

necessary to inform the agency’s efforts 

to implement the mandatory graphic 

warnings required by the Tobacco 

Control Act. 

The experimental study data will be 

collected from participants of an 

Internet panel. Participation in the 

experimental study is voluntary. 

In the Federal Register of February 

22, 2010 (75 FR 7604), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received five 

comments in response to the notice. 

All five comments supported FDA’s 

proposal to sponsor consumer research 

to provide a scientific basis for 

regulations requiring color graphics to 

accompany the new statutory health 

warnings set forth in the Federal 

Cigarette Labeling and Advertising Act, 

as amended by the Tobacco Control Act. 

One comment recommended that the 

FDA consider conducting followup 

assessments to determine whether the 

warnings are having their intended 

effects and, if not, to determine what 

revisions are needed. 

FDA agrees that appropriate 

surveillance is important, and that the 

comment makes an excellent suggestion 

for future research. 

Two comments recommended that 

FDA include information about 

cessation resources in the tested graphic 

warnings. 

FDA will be testing a variety of 

different graphics that will vary in style 

and intensity. Some of the tested images 

will include information about cessation 

resources. Decisions about whether to 

include specific graphics containing 

cessation information in final 

regulations will be made after the 

results of the experimental study are 

available and these data will be a 

primary factor in the selection of images 

for final regulations. 

One comment recommended that 

FDA use images that are medically 

accurate to avert claims that the 

graphics are deceptive to consumers and 

ensure that smokers are confident in the 

accuracy of the health information 

provided. 

FDA agrees that it is important to 

ensure that the graphic health warnings 

convey accurate information about 

smoking risks to consumers. The data 

collected from the proposed research 

will provide important information to 

ensure that the graphic health warnings 

being tested do not elicit unintended 

responses from consumers. 

One comment urged that FDA ensure 

that the questionnaire ask questions in 

an objective and unbiased manner. 

FDA agrees with this recommendation 

and has designed a survey instrument 

that includes validated measures used 

in other research. Thus the questions are 

objective, unbiased, and reliably 

understood by respondents. In addition, 

FDA plans to conduct cognitive 

interviews prior to the experimental 

survey. These interviews will help 

identify any unanticipated problems 

consumers may have in understanding 

or responding to the questions in the 

survey. 

One comment questioned the basic 

premise of requiring graphic health 

warnings, stating that international 

experience shows that graphic health 

warnings have not reduced smoking 

rates. 

The purpose of this study is not to 

determine whether FDA should require 

graphic health warnings. Congress has 

already made that determination. 

Similarly, the purpose of this study is 

not to determine the absolute 

effectiveness of graphic health warnings 

in terms of changing smoking behavior. 

Instead, the purpose of this study is to 

determine the relative efficacy of 

various graphic health warnings for 

conveying risk information to 

consumers and provide a scientific basis 

for FDA’s regulations for graphic health 

warnings as required by the Federal 

Cigarette Labeling and Advertising Act, 

as amended by the Tobacco Control Act. 

One comment sought assurance that 

FDA will obtain appropriate parental 

consent and Institutional Review Board 

(IRB) approvals, especially with respect 

to the collection of information from 

adolescents. 

FDA strongly agrees that appropriate 

parental consent and IRB approval is 

important and necessary. Such consent 

and approval will be obtained as part of 

the standard regulatory research process 

and before any collection of 

information. 

One comment questioned FDA’s 

decision to use an Internet survey, 

especially with respect to the collection 

of information from adolescents, and 

recommended that FDA sponsor an inperson survey instead. 

As indicated previously in this 

document, the purpose of this study is 

to assess the relative efficacy of various 

graphic health warnings. The use of an 

Internet-based panel to collect our 

experimental data is appropriate for this 

purpose. FDA believes that the Internetbased panel will provide the most 

efficient and practical methodology for 

collecting the data. 

One comment also indicated that an 

Internet-based survey is not well-suited 

to analyzing health warnings because 

the health warnings under real world 

conditions appear on three-dimensional 

packages rather than on twodimensional images on a computer 

screen. The comment recommended 

that FDA consider a prior mailing of 

realistic mockups of cigarette packages, 

which the participants could examine 

while taking the survey. 

FDA agrees that it is important that 

survey participants view realistic 

images of the tested graphic health 

warnings on product packaging. The 

study is designed so that participants 

will view a three-dimensional 

animation of mockups of various 

graphic warnings on product packaging. 

Participants will be able to manipulate 

the animation during the survey to see 

the front, back, and sides of the package. 

We believe that this animation is 

sufficient to ensure that study 

participants view the tested graphic 

warnings under realistic conditions. 


srobinson on DSKHWCL6B1PROD with NOTICES
52354 Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 

One comment recommended that 

FDA include a meaningful pretesting of 

the survey instrument, including the use 

of cognitive interviews. 

FDA agrees that meaningful pretesting 

of the survey instrument is important, 

and plans both cognitive interviews and 

pretests. The cognitive interviews will 

help FDA evaluate and refine the draft 

questionnaire, and help to identify areas 

where the instrument is ambiguous, 

burdensome, or confusing. FDA will 

also conduct pretests of the algorithms 

and programs for respondent sampling, 

survey administration, and data 

collection. 

One comment raised a number of 

individual concerns that the planned 

cross-sectional design of the proposed 

survey is not capable of providing 

information from which causal 

conclusions about the relationship 

between exposure to the graphic images 

and smoking behavior can be based. The 

comment also raised the concern that 

questions regarding intended actions 

about smoking cessation or smoking 

initiation are inadequate to demonstrate 

actual behavioral changes. To address 

these concerns, the comment 

recommended the use of a longitudinal 

design that monitors actual behavior 

over time. 

The purpose of this study is not to 

determine the absolute effectiveness of 

graphic health warnings in terms of 

changing smoking behavior. Instead, as 

indicated previously in this document, 

the purpose of the study is to determine 

the relative efficacy of various graphic 

health warnings for purposes of 

providing a scientific basis for FDA’s 

regulations for graphic health warnings 

as required by the Federal Cigarette 

Labeling and Advertising Act, as 

amended by the Tobacco Control Act. A 

cross-sectional design is appropriate for 

this purpose. 

In addition, FDA disagrees that 

questions concerning intentions to quit 

smoking or to not begin smoking are 

inappropriate. The more recent 

scientific literature shows that 

statements by smokers concerning their 

intentions to quit smoking are 

predictive of their making subsequent 

quit attempts (Ref. 1). Similarly, the 

scientific literature demonstrates that 

statements by children and adolescents 

concerning their intentions to smoke or 

not smoke are reliable predictors of 

subsequent smoking and precedes 

smoking initiation (Ref. 2). 

One comment noted that it is 

important that the study be conducted 

in a manner that avoids question order 

bias. 

FDA agrees that efforts must be taken 

to avoid any potential bias, and is 

confident that the study will be 

conducted in a manner that yields 

objective and reliable results. The 

planned cognitive interviews and 

pretests should help identify potential 

problems with question order and allow 

FDA to address those concerns prior to 

the experimental survey. 

One comment recommended that 

FDA use a research design that tests 

across subjects, rather than within 

subjects. The comment states that 

failure to use an across-subjects design 

will lead to an overestimate of the 

effects of bolder warnings. 

FDA’s proposed study employs a 

between-subjects design that will test 

across subjects. 

One comment recommends that care 

be taken to avoid information overload, 

given the number of warning statements 

and images. 

FDA agrees with the comment. The 

between-subjects design of the study 

will reduce the potential for information 

overload. Each treatment group of 

respondents will view and respond to 

one graphic warning label. 

One comment also included 

comments on a separate Federal 

Register notice that sought public 

comment on a proposed FDA collection 

of information concerning the pretesting 

of tobacco communications, Docket No. 

FDA–2010–N–0084. That notice is not 

related to the information collection 

concerning graphic health warnings. 

Accordingly, those comments are not 

addressed in this document. 

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 

Pre-test 60 1 60 0 .25 15 

Screener 36,000 1 36,000 0 .016 600 

Experimental Survey 23,400 1 23,400 0 .25 5,850 

Total 6,465 

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

FDA’s burden estimate is based on 

prior experience with Internet panel 

experiments similar to the study 

proposed here. Sixty panel members 

will take part in a pre-test of the study, 

estimated to last 15 minutes (0.25 

hours), for a total of 15 hours. 

Approximately 36,000 respondents will 

complete a screener to determine 

eligibility for participation in the study, 

estimated to take 1 minute (0.016 

hours), for a total of 600 hours. Eighteen 

thousand (18,000) respondents will 

complete the full study, estimated to 

last 15 minutes (0.25 hours) and 

approximately 5,400 of those 

respondents will complete an additional 

survey 1 to 2 weeks following the 

original survey, estimated to last 15 

minutes (0.25 hours), for a total of 5,850 

hours. The total estimated burden is 

6,465 hours. Burden hours exceed 

FDA’s previous estimates published in 

the 60-day notice of this study. 

Additional hours are the result of an 

increase in respondent sample size. A 

larger sample size is required to ensure 

sufficient statistical power for analysis 

of the data. 

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. 

1. Zhou, X et al. ‘‘Attempts to quit smoking 

and relapse: Factors associated with success 

or failure from the ATTEMPT cohort study,’’ 

Addictive Behaviors, 2009; 34: 365–373; 

Hyland A et al. (2006), ‘‘Individual-level 

predictors of cessation behaviours among 

participants in the International Tobacco 

Control (ITC) Four Country Survey,’’ Tobacco 

Control, 15: iii83–iii94. 

2. Hampson SE et al., ‘‘Predictors of the 

Development of Elementary-School 

Children’s Intentions to Smoke Cigarettes: 

Hostility, Prototypes, and Subjective Norms,’’ 

Nicotine and Tobacco Research, 2007 July; 

9(7): 751–760; Wakefield, M. et al., ‘‘The role 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 164 / Wednesday, August 25, 2010 / Notices 52355 

of smoking intentions in predicting future 

smoking among youth: findings from the 

Monitoring the Future data,’’ Addiction 2004 

Jul; 99(7): 914–22; Pierce J, et al., ‘‘Validation 

of susceptibility as a predictor of which 

adolescents take up smoking in the United 

States,’’ Health Psychology, 1996(Sept): 355– 

61. 

Dated: August 20, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–21123 Filed 8–24–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[Docket Number NIOSH–210] 

A Review of Information Published 

Since 1995 on Coal Mine Dust 

Exposures and Associated Health 

Outcomes 

AGENCY: National Institute for 

Occupational Safety and Health 

(NIOSH) of the Centers for Disease 

Control and Prevention (CDC), 

Department of Health and Human 

Services (HHS). 

ACTION: Notice of draft document 

available for public comment. 

SUMMARY: The National Institute for 

Occupational Safety and Health of the 

Centers for Disease Control and 

Prevention announces the availability of 

a draft Current Intelligence Bulletin 

entitled ‘‘A Review of Information 

Published Since 1995 on Coal Mine 

Dust Exposures and Associated Health 

Outcomes’’ now available for public 

comment. The draft document and 

instructions for submitting comments 

can be found at: http://www.cdc.gov/ 

niosh/docket/review/docket210/ 

default.html. This document updates 

and supports the coal mine dust 

Recommended Exposure Limit (REL) of 

1 mg/m3 that was recommended in the 

1995 document, ‘‘Criteria for a 

Recommended Standard: Occupational 

Exposure to Respirable Coal Mine Dust, 

(1995–106)’’ which can be viewed at: 

http://www.cdc.gov/niosh/95-106.html. 

This guidance does not have the force 

and effect of the law. 

Public Comment Period: Comments 

must be received by September 24, 

2010. 

ADDRESSES: Written comments may be 

submitted to the NIOSH Docket Office, 

identified by Docket Number NIOSH– 

210, by any of the following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Room 111, Cincinnati, Ohio 45226. A 

complete electronic docket containing 

all comments submitted will be 

available on the NIOSH Web page at 

http://www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. All electronic 

comments should be formatted as 

Microsoft Word. Please make reference 

to Docket Number NIOSH- 210. 

FOR FUTHER INFORMATION CONTACT: 

Michael D. Attfield, Ph.D., telephone 

(304) 285–5737, e-mail mda1@cdc.gov 

or Eileen Storey, M.D., telephone (304) 

285–6382, e-mail eps4@cdc.gov, NIOSH, 

1095 Willowdale Road, Morgantown, 

WV 26505. 

Dated: August 17, 2010. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–21187 Filed 8–24–10; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Draft National Conversation on Public 

Health and Chemical Exposures Work 

Group Reports; Opportunity for Public 

Comment 

AGENCY: Centers for Disease Control and 

Prevention and Agency for Toxic 

Substances and Disease Registry (CDC/ 

ATSDR), Department of Health and 

Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The National Conversation on 

Public Health and Chemical Exposures 

is a collaborative initiative through 

which many organizations and 

individuals are helping develop an 

action agenda for strengthening the 

nation’s approach to protecting the 

public’s health from harmful chemical 

exposures. This notice announces the 

availability of draft National 

Conversation work group reports for 

public review and comment. CDC/ 

ATSDR has partnered with RESOLVE, a 

non-profit independent consensusbuilding organization, to manage 

aspects of the National Conversation 

project. RESOLVE is convening the 

National Conversation Leadership 

Council and facilitating the work group 

process. 

DATES: Draft work group reports will be 

available on or about September 7, 2010. 

In order to be considered, comments 

must be received within 14 days of the 

reports being posted. The public 

comment period is anticipated to close 

September 20, 2010. Comments received 

after the close of the comment period 

will be considered to the fullest extent 

possible. 

ADDRESSES: Draft work group reports 

will be available on RESOLVE’s Web 

site at http://www.resolv.org/ 

nationalconversation. Those interested 

in submitting comments are encouraged 

to submit them through that Web site. 

Comments can also be submitted by email to nccomments@resolv.org. Please 

indicate in the e-mail subject line the 

name of the work group report that your 

comments address (e.g. ‘‘Comments on 

Monitoring Work Group Report’’). 

Comments can be submitted by mail to 

National Conversation c/o RESOLVE, 

Inc. 1255 23rd Street, NW., Suite 875, 

Washington, DC 20037 or by fax 

attention to Jason Gershowitz at 

202–338–1264. 

FOR FURTHER INFORMATION CONTACT: 

Please direct questions about the 

National Conversation project to CDC/ 

ATSDR by e-mail at 

nationalconversation@cdc.gov, phone at 

770–488–0604, or mail at National 

Conversation, CDC/ATSDR, 4770 

Buford Hwy, NE., MS F–61, Atlanta, GA 

30341. 

SUPPLEMENTARY INFORMATION: The 

National Conversation project includes 

a Leadership Council, which will author 

the action agenda, and six work groups, 

formed to research and make 

recommendations on the following 

cross-cutting public health and 

chemical exposures issues: 

• Monitoring 

• Scientific Understanding 

• Policies and Practices 

• Chemical Emergencies 

• Serving Communities 

• Education and Communication 

Following the public comment 

period, National Conversation work 

groups will finalize their reports during 

the fall of 2010. The National 

Conversation Leadership Council will 

draw on work group reports and the 

results of public input received through 

Web dialogues, community 

conversations, and stakeholder forums 


srobinson on DSKHWCL6B1PROD with NOTICES