43764 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

manufacturer/processor to gather the 

information needed to be placed on a 

list or update its information is based on 

FDA’s experience with manufacturers/ 

processors submitting similar requests. 

FDA believes that the information to be 

submitted will be readily available to 

manufacturers/processors. We estimate 

that a firm will require 1 hour to read 

the guidance, gather the information 

needed, and prepare a communication 

to FDA that contains the information 

needed to request that the 

manufacturer/processor be placed on a 

list. 

To be placed on a list, manufacturers/ 

processors should provide FDA with 

evidence that they have obtained thirdparty certification from a CNCAacknowledged certifier that the 

manufacturer/processor complies with 

the standards, laws, and regulations of 

China according to relevant 

requirements specified in AQSIQ Decree 

145. Based on our experience with other 

certification programs, FDA estimates 

that it will take each new manufacturer/ 

processor about 21 hours to complete 

the third-party certification process for 

a total of 7,770 burden hours (370 

manufacturers/processors × 21 hours). 

Under the guidance, every 2 years 

each manufacturer/processor on the lists 

must provide updated information in 

order to remain on the lists. FDA 

estimates that each year approximately 

half of the manufacturers/processors on 

the lists, or 555 manufacturers/ 

processors (1,110 manufacturers/ 

processors × 0.5 = 555), will resubmit 

the information to remain on the lists. 

We estimate that a manufacturer/ 

processor already on the lists will 

require 1 hour to biennially update and 

resubmit the information to FDA, 

including time reviewing the 

information and corresponding with 

FDA, for a total of 555 hours. 

During the biennial update, 

manufacturers/processors also need to 

be recertified by a third-party certifier to 

remain on the lists. FDA estimates that 

each year approximately half of the 

manufacturers/processors on the lists, 

555 manufacturers/processors (1,110 

manufacturers/processors × 0.5 = 555), 

will get recertified. We estimate that it 

will take each manufacturer/processor 

about 21 hours to complete the 

certification process for a total of 11,655 

burden hours (555 manufacturers/ 

processors × 21 hours). 

FDA expects that, each year, 

approximately 100 manufacturers/ 

processors will need to submit an 

occasional update and each 

manufacturer/processor will require 0.5 

hours to prepare a communication to 

FDA reporting the change, for a total of 

50 hours. 

Dated: September 13, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19890 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–0932] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study on Warning Statements for 

Cigarette Graphic Health Warnings 

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 October 19, 

2017. 

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 on Warning 

Statements for Cigarette Graphic Health 

Warnings.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonalynn Capezzuto, Office of 

Operations, Food and Drug 

Administration, Three White Flint 

North, 10A63, 11601 Landsdown St., 

North Bethesda, MD 20852, 301–796– 

3794, PRAStaff@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 on Warning 

Statements for Cigarette Graphic Health 

Warnings 

OMB Control Number 0910–NEW 

The health risks associated with the 

use of cigarettes can be significant and 

far-reaching. In 2009, Congress enacted 

the Tobacco Control Act (TCA) (Pub. L. 

111–31), which amends the Federal 

Food, Drug, and Cosmetic Act to grant 

FDA authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health and to reduce 

tobacco use by minors. Section 201 of 

the Tobacco Control Act amends section 

4 of the Federal Cigarette Labeling and 

Advertising Act (FCLAA) (15 U.S.C. 

1333) to require 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).’’ Section 202(b) of the 

Tobacco Control Act further amends 

section 4 of the FCLAA by adding that 

the Secretary, through notice and 

comment rulemaking, may adjust the 

‘‘text of any of the label requirements 

. . . . if the Secretary finds that such a 

change would promote greater public 

understanding of the risks associated 

with the use of tobacco products.’’ 

In the Federal Register of June 22, 

2011 (76 FR 36628), FDA issued a final 

rule entitled ‘‘Required Warnings for 

Cigarette Packages and 

Advertisements,’’ which specified nine 

images to accompany new textual 

warning statements for cigarettes. 

Although the rule was scheduled to 

become effective 15 months after it 

issued, a panel of the U.S. Court of 

Appeals of the District of Columbia 

held, on August 24, 2012, that the rule 

in its current form violated the First 

Amendment. In a letter to Congress on 

March 15, 2013, the Attorney General 

reported FDA’s intention to undertake 

research to support a new rulemaking 

consistent with the Tobacco Control 

Act. Preliminary research has been 

underway since 2013. Informed by the 

previous court decisions on this matter, 

including on the First Amendment, the 

next phase of the research includes the 

study proposed here, which is an effort 

by FDA to collect data concerning 

revised textual warning statements for 

use with new images as part of cigarette 

graphic health warnings, and their 

potential impact on public 

understanding of the risks associated 

with the use of cigarettes. 

As currently proposed, this 

Experimental Study on Warning 

Statements for Cigarette Graphic Health 

Warnings is a voluntary online 


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Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43765 

experiment conducted with consumers. 

The purpose of the proposed study is to 

assess whether potential textual 

warnings statements, which have been 

revised from those enumerated in 

section 4 of FCLAA, promote greater 

public understanding of the negative 

health consequences of cigarette 

smoking. The study will collect data 

from various groups of consumers, 

including adolescent (under age 18) 

current cigarette smokers, adolescents 

who are susceptible to initiation of 

cigarette smoking, young adult (ages 18 

to 24) current cigarette smokers, and 

older adult (age 25 and above) current 

cigarette smokers. The results will 

inform the Agency’s development of 

cigarette graphic health warnings to be 

tested in future studies with the goal of 

implementing the mandatory graphic 

warning label statement consistent with 

section 4(d) of FCLAA and the First 

Amendment. 

Proposed Study Overview: In this 

study, adolescent current cigarette 

smokers, adolescents who are 

susceptible to initiation of cigarette 

smoking, young adult current cigarette 

smokers, and older adult current 

smokers will be recruited from an 

Internet panel of more than 1.2 million 

people and screened for inclusion into 

the study. Participants who meet the 

inclusion criteria will be randomized 

into 1 of 17 conditions in a betweensubjects design. In each condition, 

participants will be exposed to a series 

of nine warning statements, presented 

sequentially. Participants randomized to 

the control condition will view all nine 

of the warning statements listed in 

section 4(a)(1) of FCLAA: 

• WARNING: Cigarettes are addictive. 

• WARNING: Tobacco smoke can 

harm your children. 

• WARNING: Cigarettes cause fatal 

lung disease. 

• WARNING: Cigarettes cause cancer. 

• WARNING: Cigarettes cause strokes 

and heart disease. 

• WARNING: Smoking during 

pregnancy can harm your baby. 

• WARNING: Smoking can kill you. 

• WARNING: Tobacco smoke causes 

fatal lung disease in nonsmokers. 

• WARNING: Quitting smoking now 

greatly reduces serious risks to your 

health. 

Participants randomized to 1 of the 16 

experimental conditions will view 8 of 

the warning statements listed in section 

4(a)(1) of FCLAA (first bulleted list in 

this document) plus 1 revised warning 

statement. The revised warning 

statements being tested in this proposed 

study are: 

• WARNING: Smoking causes mouth 

and throat cancer. 

• WARNING: Smoking causes head 

and neck cancer. 

• WARNING: Smoking causes 

bladder cancer, which can lead to 

bloody urine. 

• WARNING: Smoking during 

pregnancy causes premature birth. 

• WARNING: Smoking during 

pregnancy stunts fetal growth. 

• WARNING: Smoking during 

pregnancy causes premature birth and 

low birth weight. 

• WARNING: Secondhand smoke 

causes respiratory illnesses in children, 

like pneumonia. 

• WARNING: Smoking can cause 

heart disease and strokes by clogging 

arteries. 

• WARNING: Smoking causes COPD, 

a lung disease that can be fatal. 

• WARNING: Smoking causes serious 

lung diseases like emphysema and 

chronic bronchitis. 

• WARNING: Smoking reduces blood 

flow, which can cause erectile 

dysfunction. 

• WARNING: Smoking reduces blood 

flow to the limbs, which can require 

amputation. 

• WARNING: Smoking causes type 2 

diabetes, which raises blood sugar. 

• WARNING: Smoking causes agerelated macular degeneration, which 

can lead to blindness. 

• WARNING: Smoking causes 

cataracts, which can lead to blindness. 

In all conditions, after viewing each 

statement, participants will respond to a 

small number of questions about that 

specific statement (Section A in the 

questionnaire). After viewing the nine 

statements per their condition, 

participants will respond to a larger set 

of questions (Section B in the 

questionnaire). Next, participants in the 

experimental conditions will view an 

additional nine revised warning 

statements, drawn from the revised 

statements listed in this document, and 

respond to an additional set of questions 

(Section C in the questionnaire). 

Primary study outcomes include 

knowledge of the negative health 

consequences of cigarette smoking. Prior 

to the main data collection, 2 pretests, 

each with 50 participants, will take 

place to ensure correct programming 

and to identify any issues with the 

proposed study design and 

implementation. 

In the Federal Register of March 28, 

2017 (82 FR 15359), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received 13 comment 

submissions. Eight submissions were 

PRA related, and some included 

multiple comments. 

(Comment) Three comments 

suggested that the textual warning 

statements should be evaluated together 

with accompanying images because the 

impact of the final cigarette graphic 

warning labels will be a combination of 

the effects of both the text and images. 

(Response) FDA declines to make this 

change at this time. This current phase 

of the research, which includes the 

study proposed here, is an effort by FDA 

to collect data concerning revised 

textual warning statements that may 

later be used with new images as part 

of cigarette graphic health warnings. In 

the future, FDA will conduct research 

pairing warning statements with images. 

(Comment) One comment suggested 

using a longitudinal study design to 

understand the long-term effects of the 

warning statements. 

(Response) FDA declines to make this 

change. A longitudinal study, while 

providing useful data, is beyond the 

scope of the research questions being 

addressed in the present study. 

(Comment) One comment 

recommended FDA use a baseline 

assessment of understanding of risks 

associated with cigarette smoking in the 

form of a pre-exposure assessment of 

current awareness of negative health 

outcomes associated with cigarette 

smoking to evaluate respondents’ 

baseline knowledge. 

(Response) FDA declines to make this 

change. The measurement of baseline 

level of understanding of risk should be 

evenly distributed throughout the 

conditions due to the randomized 

nature of the experiment. 

(Comment) One comment suggested 

that FDA implement prescreening 

measures and collect information about 

the study respondents. 

(Response) Prior to randomization to 

condition, FDA will implement a 

screener to collect information about 

potential study participants to confirm 

eligibility. A copy of the screener is part 

of the overall package submitted to 

OMB for review through the public Web 

site https://www.reginfo.gov. Participant 

demographics will be assessed in the 

questionnaire and additional 

demographics will be provided by the 

Internet panel for all participants. 

(Comment) Two comments suggested 

that FDA change the control group of 

warning statements to which the revised 

textual warning statements would be 

compared in this study. 

(Response) FDA declines to make this 

change. The purpose of the proposed 

study is to test if the revised textual 

warning statements promote greater 

public understanding of the negative 

health consequences of cigarette 

smoking compared to the warnings 

enumerated in the TCA. Therefore, the 


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43766 Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 

TCA warning statements are the 

appropriate comparison group. 

(Comment) One comment questioned 

whether the use of an Internet panel is 

the most appropriate method for 

obtaining the desired information in this 

study, as compared to in-person 

interviews. 

(Response) With respect to the 

sample, the large heterogeneous sample 

that can be obtained through the 

Internet panel will allow FDA to test 

outcomes across a range of individuals, 

thus strengthening the conclusions and 

generalizability of the study. 

(Comment) Two comments suggested 

that the timing of the administration of 

Section B of the questionnaire 

(administered after viewing eight TCA 

warnings with one revised warning, but 

before viewing a second set of nine 

revised warnings) could introduce bias. 

One of those comments also suggested 

FDA remove Section B. 

(Response) FDA declines to make 

such a change at this time. Section B 

includes the primary outcome measures 

necessary to assess participants’ 

understanding of the negative health 

consequences of cigarette smoking as 

described in the revised warning 

statements compared to the TCA 

statements. Further, knowledge gained 

from exposure to questions in Section B 

is expected to be minimal and 

consistent across conditions. Therefore, 

any such knowledge gained from 

exposure to Section B would suggest 

that any differences found between 

conditions are robust. 

(Comment) One comment 

recommended that FDA conduct a 

power analysis to ensure the sample 

size is adequate for detecting the 

expected effect size. 

(Response) FDA agrees that it is 

important to conduct a power analysis; 

the Agency did conduct a power 

analysis to ensure the sample size is 

appropriate for the proposed study. 

(Comment) One comment expressed a 

desire to see the questionnaire to be 

used in the study as well as an 

explanation of the study design. 

(Response) FDA notes that the 

questionnaire and supporting 

statements outlining the study design 

and methods were available as 

supporting documents in the docket for 

public review during the public 

comment period. Additionally, the 

study is described in detail as part of the 

overall package submitted to OMB for 

review through the public Web site 

https://www.reginfo.gov, and copies of 

the instrument used to collect this 

information are also included in that 

package. 

(Comment) Many comments focused 

on the content of the revised textual 

warning statements in the proposed 

study, and provided suggestions for 

changes to the wording of the warning 

statements and additional topics on 

which they should focus. 

(Response) The topics being tested in 

this proposed study include a wide 

range of health conditions caused by 

cigarette smoking and are presented 

with as much information as 

practicable. The revised warning 

statements were developed based on 

opportunities to promote greater public 

understanding about the negative health 

consequences of cigarette smoking. In 

addition, prior to the proposed study, 

the warning statements have been tested 

with consumers; vetted by medical and 

other scientific experts; and revised to 

ensure that they clearly and 

understandably convey factual 

information about the negative health 

consequences associated with the use of 

cigarettes. Based on comments about the 

content of the revised textual warning 

statements and FDA’s ongoing 

preparation for the proposed study, FDA 

is changing the warning statement 

‘‘WARNING: Smoking raises blood 

sugar, which can cause type 2 diabetes’’ 

to ‘‘WARNING: Smoking causes type 2 

diabetes, which raises blood sugar.’’ 

This change was made to better reflect 

the causal link between cigarette 

smoking and diabetes and to clarify that 

higher blood sugar is a result, not a 

cause, of diabetes. FDA has updated the 

questionnaire accordingly. 

(Comment) One comment suggested 

that FDA conduct a ‘‘meaningful 

pretest’’ for the questionnaire. 

(Response) As explained in the draft 

supporting statements included in the 

docket, the purpose of the pretests is to 

help ensure understandability of the 

questionnaire, to reduce participant 

burden, and to enhance interview 

administration. The questionnaire uses 

slightly modified versions of scales and 

instruments that have already been 

thoroughly tested and used in previous 

research. 

(Comment) Many comments 

suggested changes to or addition of 

specific constructs as study outcomes or 

suggested how FDA should use the 

outcomes already included in the study. 

Measures suggested for FDA 

consideration included the following: 

How much the warning statements 

attract attention; how novel they are; 

personal identification with the 

statements; levels of emotion evoked/ 

emotional appeal or emotional reaction; 

perceived risk or likelihood of the 

outcome occurring; and perceived 

effectiveness of the revised warning 

statements. 

(Response) FDA declines to make 

such changes to the outcome measures, 

although FDA notes that the 

questionnaire already includes items 

assessing perceived effectiveness of the 

warnings. The purpose of this study is 

to assess whether potential textual 

warning statements, which have been 

revised from those enumerated in 

section 4 of FCLAA, promote greater 

understanding of the negative health 

consequences of cigarette smoking, and 

the proposed outcome measures focus 

on just such an evaluation. Therefore, 

the suggested outcome measures do not 

contribute to the evaluation of whether 

the revised warning statements improve 

public understanding of the negative 

health consequences of cigarette 

smoking. 

(Comment) One comment noted that 

the study does not include information 

that would assist in the design of the 

graphic images. 

(Response) FDA agrees that the 

proposed study does not include these 

outcomes, and the Agency declines to 

make such a change. The focus of this 

study is on the textual warning 

statements only to assess whether they 

promote greater understanding of the 

negative health consequences of 

cigarette smoking and not the design of 

the graphic images. 

(Comment) Two comments stated that 

FDA was including measures of risk 

perception and suggested that FDA 

include additional risk perception 

measures, such as likelihood of the 

outcome; measures of absolute and 

comparative perceived risk; and 

perceptions of these risks over and 

above any ‘‘background’’ risk and other 

similar outcomes. 

(Response) FDA declines to make 

such changes because this study does 

not aim to measure risk perceptions. 

The measures included in this proposed 

study assess knowledge and 

understanding of a negative health 

outcome caused by cigarette smoking. 

The goal of these measures is not to 

assess the absolute or relative level of 

perception of such risks, but rather to 

investigate the effect that viewing the 

warning statements has on increasing 

the understanding of the negative health 

consequences of cigarette smoking. 

(Comment) Two comments suggested 

that, in order to minimize the burden of 

the proposed collection, FDA should 

use best practice methods for survey 

and focus group research, including 

developing a statistical analysis plan 

and involving a private consultant with 

experience in conducting such research 

efficiently. 


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Federal Register / Vol. 82, No. 180 / Tuesday, September 19, 2017 / Notices 43767 

(Response) As stated in the 

supporting statements included in the 

docket, FDA is working with a skilled 

and experienced research contractor to 

conduct the proposed study. In 

addition, FDA scientific experts possess 

skill and expertise in conducting such 

research. Survey and focus group best 

practices will be used, including 

avoiding bias in questions due to 

wording and question order and 

developing a statistical analysis plan. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Portion of study Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Screening for pretest .............................................. 762 1 762 0.033 (2 minutes) ........ 25 

Pretest .................................................................... 100 1 100 0.25 (15 minutes) ........ 25 

Screening for main data collection ........................ 19,082 1 19,082 0.033 (2 minutes) ........ 630 

Main data collection ............................................... 2,500 1 2,500 0.25 (15 minutes) ........ 625 

Total ................................................................ ........................ ........................ ........................ ..................................... 1,305 

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 research that is 

similar to this proposed study. 

Screening potential participants for the 

2 pretests will occur with 762 

respondents (487 adults and 275 

adolescents) identified and recruited 

through the Internet panel. This brief 

screening will take an average of 2 

minutes (0.033 hours) per respondent. 

Each of the 2 pretests will consist of 50 

respondents (34 adults and 16 

adolescents) conducted during a single 

session and take an average of 15 

minutes (0.25 hours) per respondent. 

Screening potential participants for the 

main data collection will occur with 

19,082 respondents (11,925 adults and 

7,157 adolescents) identified and 

recruited through the same Internet 

panel as used for the pretests. This brief 

screening will take an average of 2 

minutes (0.033 hours) per respondent. 

Recent national estimates of the 

numbers of adolescent current cigarette 

smokers, adolescents who are 

susceptible to initiation of cigarette 

smoking, young adult current cigarette 

smokers, and older adult current 

cigarette smokers informed the 

estimates of 13.9 percent qualification 

rate for adults and 11.6 percent 

qualification rate for adolescents. 

Applying these estimates and other 

assumptions from previous experience 

conducting similar studies to the 

number of adolescents and adults to be 

screened results in the desired sample 

size for the main data collection of 2,500 

participants, of which 1,667 will be 

adults and 833 will be adolescents. The 

main data collection will occur with 

those 2,500 respondents during a single 

session. The main data collection will 

take an average of 15 minutes (0.25 

hours) per respondent. The total 

estimated burden is 1,305 hours (25 

hours + 25 hours + 630 hours + 625 

hours). 

Dated: September 14, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–19901 Filed 9–18–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–3615] 

Administering the Hatch-Waxman 

Amendments: Ensuring a Balance 

Between Innovation and Access; 

Public Meeting; Request for 

Comments; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

extending the comment period for the 

public meeting on ‘‘Administering the 

Hatch-Waxman Amendments: Ensuring 

a Balance Between Innovation and 

Access’’ for which the notice of public 

meeting appeared in the Federal 

Register of June 22, 2017. In the notice 

of public meeting, FDA requested 

comments concerning administration of 

the Hatch-Waxman Amendments to the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) to help ensure that the 

intended balance between encouraging 

innovation in drug development and 

accelerating the availability to the 

public of lower cost alternatives to 

innovator drugs is maintained. The 

Agency is taking this action in response 

to a request for an extension to allow 

interested persons additional time to 

submit comments. 

DATES: FDA is extending the comment 

period on the notice of public meeting 

published June 22, 2017 (82 FR 28493). 

Submit either electronic or written 

comments by November 17, 2017. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before November 17, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of November 17, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 


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