Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65685 

Based on a review of the information 

collection since our last request for 

OMB approval, we have made no 

adjustments to our burden estimate. 

Dated: December 17, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27655 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3552] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Experimental 

Study of Cigarette 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 January 22, 

2019. 

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 Cigarette 

Warnings.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, 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 of Cigarette 

Warnings 

OMB Control Number 0910–NEW 

The Tobacco Control Act (Pub. L. 

111–31) 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 4(a)(1) of the 

FCLAA. Section 202(b) of the Tobacco 

Control Act further amends section 4 of 

the FCLAA by adding that the Secretary 

of Health and Human Services 

(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. Various phases of research have 

been underway since 2013. The next 

phase of the research includes the study 

proposed here, which is an effort by 

FDA to collect data concerning 

responses to health warnings placed on 

cigarette packages and advertisements 

for cigarettes. 

The health risks associated with the 

use of cigarettes are significant and farreaching. Cigarette smoking is the 

leading cause of preventable disease and 

death in the United States and is 

responsible for more than 480,000 

deaths per year. Smoking causes more 

deaths each year than human 

immunodeficiency virus, illegal drug 

use, alcohol use, motor vehicle injuries, 

and firearm-related incidents combined 

(Ref. 1). In addition to lung cancer, heart 

disease, and chronic obstructive 

pulmonary disease, smoking also causes 

numerous other serious health 

conditions including several types of 

cancer, premature birth, low birth 

weight, respiratory illnesses, clogged 

arteries, reduced blood flow, diabetes, 

and vision conditions such as agerelated macular degeneration and 

cataracts (Ref. 2). 

Approximately 37.8 million U.S. 

adults smoke cigarettes (Ref. 3) and 8.6 

million Americans have at least one 

serious illness caused by smoking 

cigarettes (Ref. 4). Results from the 2016 

National Survey on Drug Use and 

Health demonstrate that, each day in the 

United States, more than 2,300 youth 

under age 18 smoke their first cigarette, 

and nearly 400 youth become daily 

cigarette smokers (Ref. 5). If the current 

trajectory of smoking rates continues, 

5.6 million children alive today will die 

prematurely as a result of smoking (Ref. 

2). Providing the public with accurate 

information regarding the health 

consequences of cigarette use is critical 

in achieving FDA’s mission to protect 

the public health. 

This Experimental Study of Cigarette 

Warnings is a voluntary online 

experiment. The purpose of the study is 

to assess whether new cigarette health 

warnings increase public understanding 

of the negative health consequences of 

cigarette smoking. The study will collect 

data from various groups of consumers, 

including adolescent current cigarette 

smokers aged 13 to 17 years, adolescent 

non-smokers who are susceptible to 

initiation of cigarette smoking aged 13 

to 17 years, young adult current 

cigarette smokers and non-smokers aged 

18 to 24 years, and older adult current 

cigarette smokers and non-smokers aged 

25 years and older. The results will 

inform the Agency’s efforts to 

implement the mandatory color 

graphics to accompany health warning 

label statements as required by section 

4 of FCLAA. 

Study Overview: In this study, 

adolescent current cigarette smokers, 

adolescent non-smokers who are 

susceptible to initiation of cigarette 

smoking, young adult current cigarette 

smokers and non-smokers, and older 

adult current cigarette smokers and nonsmokers will be recruited from an 

existing 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 

each condition, respondents will view 

one cigarette warning. In the 16 

treatment conditions, participants will 

view 1 cigarette health warning, 

containing a textual warning statement 


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65686 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

accompanied by a concordant color 

graphic depicting the negative health 

consequences of smoking described in 

the statement. In the control condition, 

participants will be randomized to view 

one of the four current Surgeon 

General’s warnings, representing the 

current state of cigarette warnings in the 

United States. In all conditions, 

participants will view their assigned 

warnings both on a mock cigarette 

package and in a mock cigarette 

advertisement, presented in a 

randomized order. 

There will be three sessions. During 

Session 1, participants will complete a 

baseline assessment about their beliefs 

about the negative health consequences 

of cigarette smoking. Next, they will be 

exposed to the stimuli (i.e., the warning 

based on condition assignment) and 

complete a set of items assessing (a) if 

the information presented in the 

warning was new; (b) self-reported 

learning from the warning; (c) if the 

warning was easy to understand; (d) if 

the warning was perceived to be a fact 

or an opinion; (e) if the warning was 

informative; (f) if the warning grabbed 

their attention; and (g) if the warning 

made them think about the health risks 

of cigarette smoking. During Session 2 

(1 to 2 days after Session 1), participants 

will be exposed to the same stimuli 

again (i.e., the warning based on 

condition assignment from Session 1) 

and complete a set of items assessing 

beliefs about the negative health 

consequences caused by cigarette 

smoking. During Session 3 

(approximately 14 days after Session 2), 

participants will complete a delayed 

post-test on beliefs about the negative 

health consequences caused by cigarette 

smoking and items assessing recall of 

the warning. 

Prior to the main data collection, 2 

sequential pretests, each with 50 

participants, will take place to ensure 

correct programming of Session 1 and to 

identify any issues with the study 

design and implementation. 

Study outcomes include comparisons 

to assess the extent to which exposure 

to new cigarette health warnings, 

relative to the text-only Surgeon 

General’s warnings, provide new 

information, increase self-reported 

learning, change beliefs about the 

negative health consequences of 

cigarette smoking, increase thinking 

about the risks of smoking, and the 

extent to which the warnings are 

informative, easy to understand, factual, 

attention grabbing, and recalled. 

In the Federal Register of September 

26, 2018 (83 FR 48625), FDA published 

a 60-day notice requesting public 

comment on the proposed collection of 

information. FDA received six unique 

comment submissions. Four 

submissions were PRA related, and 

some included multiple comments. 

(Comment) One commenter stated 

that it’s important to educate and 

reinforce the facts surrounding the 

dangers of smoking. 

(Response) FDA agrees that it is 

important to provide the public with 

accurate information about the risks 

associated with the use of tobacco 

products. The purpose of this study is 

to assess whether new cigarette 

warnings increase public understanding 

of the negative health consequences of 

smoking. 

(Comment) One comment urged FDA 

to move forward to complete the 

proposed consumer research study as 

soon as possible to facilitate the prompt 

promulgation of a rule to require new 

warnings on cigarette packages and in 

cigarette advertisements. The comment 

also stated that FDA must take every 

available opportunity to minimize 

delays that may be attributable to the 

Paperwork Reduction Act. 

(Response) FDA agrees that it is 

important to complete this study and 

promulgate a rule in accordance with 

the statutory mandate laid out by 

Congress. FDA is following the 

requirements of the Paperwork 

Reduction Act and its associated 

timelines. 

(Comment) One comment stated that, 

as designed, the proposed study does 

not help FDA satisfy the requirements of 

the First Amendment because FDA has 

failed to consider less-burdensome 

alternatives and because FDA has not 

identified a ‘‘substantial’’ interest that 

this current iteration of a cigarette 

health warnings rule serves. 

(Response) As stated previously, the 

purpose of the proposed study is to 

assess whether new cigarette health 

warnings increase public understanding 

of the negative health consequences of 

smoking. FDA further notes that this 

notice is respecting a proposed study, 

the results of which, if used in a future 

rulemaking, would be provided along 

with other evidence in a future notice of 

proposed rulemaking and subject to 

public comment at that time. 

(Comment) FDA received two 

comments that asked FDA to provide 

more detail about the design of the 

proposed study to allow for meaningful 

public comments. One commenter also 

stated that FDA must provide additional 

information for public comment, 

including details of the protocol, 

inclusion criteria for screening study 

participants, questionnaire, and the text 

and color graphics the agency proposes 

to test. 

(Response) FDA notes in response to 

this comment that the proposed study 

and copies of the instruments used to 

collect this information are described in 

detail as part of the overall information 

collection request submitted to OMB for 

review. 

(Comment) One comment provided a 

published scientific study and suggested 

that focusing on the presence of certain 

features of the warnings might provide 

more robust evidence about the 

effectiveness of warning labels rather 

than a comparison of a single pictorial 

message to a text-only message. 

(Response) FDA appreciates the 

submission of the published study; 

however, it focuses on outcomes not 

relevant to the study FDA proposes 

here. The proposed study examines how 

new cigarette health warnings provide 

new information, increase self-reported 

learning, change beliefs about the 

negative health consequences of 

cigarette smoking, and increase thinking 

about the risks of smoking. 

(Comment) One comment stated that 

the cigarette health warnings should be 

compared relative to the new text-only 

warning statements rather than the 

current, familiar text-only Surgeon 

General’s warnings. 

(Response) FDA disagrees. First, 

Section 201 of the Tobacco Control Act 

amends section 4 of FCLAA to require 

FDA to issue regulations that require 

color graphics depicting the negative 

health consequences of smoking to 

accompany the textual label statements. 

Second, FDA believes that the 

comparison to the current Surgeon 

General’s warnings is the most 

appropriate comparison for the 

purposes of this proposed study. This 

comparison will allow for investigation 

of the potential effect of implementing 

new cigarette health warnings compared 

to the current state of warnings for 

cigarette packages and advertisements, 

which the commenter recognizes are 

‘‘familiar.’’ 

(Comment) One comment 

recommended that certain demographic 

(e.g., age, socioeconomic status) and 

other (e.g., nicotine dependence among 

smokers) factors should be evaluated 

during the course of this study. 

(Response) FDA disagrees. The 

purpose of this proposed study is to 

assess whether new cigarette health 

warnings increase public understanding 

of the negative health consequences of 

smoking, not the mechanisms for such 

changes. Some basic sub-group analyses 

will be performed by age group; 

however, the primary analyses will 

focus on whether new cigarette health 

warnings increase public understanding 


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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65687 

of the negative health consequences of 

smoking in the sample overall. 

(Comment) One comment urged FDA 

to consider previous research that has 

shown that use of ‘‘graphical’’ warnings 

can produce an opposite effect to the 

desired outcome. 

(Response) In our research to develop, 

test, and revise the content of new 

cigarette health warnings, we 

considered communication best 

practices, including minimizing 

unintended consequences and potential 

reactance to the warnings. Additionally, 

given the purpose and design of the 

proposed study, unintended 

consequences would be evident if the 

control warnings showed greater gains 

on outcomes compared to the warnings 

in the treatment conditions. 

(Comment) One comment 

recommended that the study design 

include pre/post measures of risk 

perceptions to evaluate whether the 

cigarette health warnings meaningfully 

increase likely pre-existing high levels 

of incoming risk perceptions. 

(Response) FDA declines to make 

such a change. The purpose of this 

proposed study is to assess whether new 

cigarette warnings increase public 

understanding of the negative health 

consequences of smoking, not whether 

such warnings increase risk perceptions. 

The focus of the study is on the specific 

health conditions that are the focus of 

the warning statements and their 

accompanying color graphics depicting 

the negative health consequences of 

smoking, not on the perception of 

overall risks of smoking. 

(Comment) One comment indicated 

that the sample size for each condition 

appears to be small. 

(Response) FDA disagrees. The 

sample size for this study was 

determined by a comprehensive 

statistical power analysis, taking into 

account the study design, planned 

analyses to be conducted, and potential 

study attrition. Based on its statistical 

power analysis, FDA is confident that 

the study will have sufficient sample 

sizes to detect meaningful effects. 

(Comment) One comment stated that 

the proposed study’s methodology 

suffers from selection bias. Specifically, 

the commenter stated that the proposed 

study is a voluntary online experiment, 

uses sampling methodology that may 

limit generalizability of outcomes to the 

broader U.S. population, and appears to 

lack corrective measures such as the 

ability to identify factors that contribute 

to participant drop out. 

(Response) Although the large sample 

for this study is not truly nationally 

representative, FDA has made efforts to 

ensure that the demographics of 

participants in the study population 

closely mirror those of national 

estimates to ensure a better 

representation. Additionally, the sample 

size calculation and study analysis 

account for the potential of attrition 

over the multiple time points (i.e., study 

sessions). 

(Comment) One comment asserted 

that the study questions create a serious 

risk of bias. Specifically, the commenter 

stated that FDA’s broad description of 

the questions to be asked in the study 

suggests that they are deliberately 

crafted to support a ‘‘pre-ordained’’ 

result, namely, that the warnings would 

increase public understanding of the 

negative health consequences of 

cigarette smoking. 

(Response) FDA disagrees. There is no 

pre-ordained result. The questions used 

in this study were selected from prior 

studies on similar topics, including 

cigarette warnings. Some questions have 

been slightly edited to fit the specific 

content of the warnings to be tested, but 

the question instructions and question 

stems have not changed. The study 

questions are face valid (i.e., it is clear 

they measure what they are intended to 

measure). Additionally, the study 

questions have previously been shown 

to produce a range of responses, 

indicating that they do not produce 

demand characteristics (i.e., study 

participants do not respond to the items 

with what they think the researchers 

want to hear). 

(Comment) One comment stated that 

FDA will need to avoid question-order 

bias. 

(Response) FDA agrees that it is 

important to avoid question-order bias 

in this proposed study. In many sections 

of the study instrument, the order of 

questions is randomized specifically to 

avoid question-order bias. In other 

sections of the study instrument, the 

order was determined by starting with 

more general and then moving on to 

more specific items to avoid bias. In 

designing the survey, FDA ensured that 

the item order follows established 

models of information processing and 

attention. 

(Comment) One comment raised a 

number of concerns that the study 

protocols do not appear to adequately 

mimic real-world conditions because 

cigarette smokers would not be exposed 

to only a single warning (but rather they 

would be exposed to all of them over 

time); the study asks participants to 

specifically focus on the warnings, 

which will likely overestimate their 

effects; in the real world, consumers 

would rarely view both cigarette 

packaging and advertisements at the 

same time; the study does not measure 

whether consumers would get used to 

the warnings after viewing them 

repeatedly over a long period of time; 

and the study’s 14-day gap between 

Sessions 2 and 3 gives participants time 

to do their own research about the risks 

of cigarettes, which could overstate any 

effects that cigarette health warnings 

might have. 

(Response) FDA disagrees with these 

assertions. The procedures proposed for 

the current study provide a greater 

number of exposures (and thus closer to 

real-world conditions) and use a longer 

follow-up time than many similar 

studies (Ref. 6). 

The Tobacco Control Act requires that 

the cigarette health warning label 

statements with accompanying color 

graphics be displayed both on cigarette 

packages and in cigarette 

advertisements; therefore, exposure to 

the warnings on both formats provides 

an appropriate assessment of the impact 

of the warnings. 

Finally, if warnings in certain 

conditions prompt study participants to 

seek health information in the 14-day 

follow-up period, thus resulting in 

greater understanding of the negative 

health consequences of cigarette 

smoking, such an effect would only 

strengthen findings that the warnings 

are working as intended and provide 

further evidence that the study mimics 

real world conditions in which 

consumers could seek additional 

information about the negative health 

consequences of smoking. Participants’ 

health beliefs will be assessed at all 

three study sessions, thus allowing for 

comparison of the effect both 

immediately after exposure as well as 

after a delay. 

(Comment) One comment 

recommended that FDA consider 

assessing comprehension of the new 

warnings objectively (i.e., evaluating 

recall of specific content, evaluating 

comprehension of disease risk) rather 

than participants indicating only that 

they learned (i.e., ‘‘self-reported 

learning from the warning’’). 

(Response) FDA agrees that it is 

important to assess comprehension of 

the new warnings objectively. The 

proposed study contains these items, in 

addition to other measures. 

(Comment) One comment stated that 

FDA should prioritize measuring the 

impact of the warnings on behavior 

(e.g., quit intentions among cigarette 

smokers, initiation intentions among 

non-users) over concepts such as 

whether the warning is informative or 

grabs attention. 

(Response) The purpose of the 

proposed study is to assess whether new 

cigarette health warnings increase 


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65688 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 

public understanding of the negative 

health consequences of cigarette 

smoking. The study does not focus on 

behavior. 

(Comment) One comment stated that 

the study does not appear to include 

meaningful pretesting. 

(Response) FDA disagrees with this 

assertion. As explained previously, the 

items in this proposed study were 

selected from prior studies on similar 

topics, including cigarette warnings. 

Additionally, the specific language used 

in the warning statements has been 

extensively tested in multiple 

qualitative studies and a large 

quantitative study conducted by FDA. 

The findings from those studies 

informed the development of warning 

statements, revisions to those 

statements, and the questions used to 

assess participant reactions (e.g., beliefs) 

about the warnings. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 2

Total hours 

Adult—Screener for pretest .............. 456 1 456 0.03 hours (2 minutes) ..................... 14 

Adult—Pretest ................................... 68 1 68 0.20 hours (12 minutes) ................... 14 

Adult—Screener for main data collection.51,054 1 51,054 0.03 hours (2 minutes) ..................... 1,532 

Adult—Main data collection (3 sessions).7,460 1 7,460 0.42 hours (25 minutes) ................... 3,133 

Total Adult Hours ....................... ........................ ........................ ........................ ........................................................... 4,693 

Adolescent—Screener for pretest ..... 410 1 410 0.03 hours (2 minutes) ..................... 12 

Adolescent—Pretest ......................... 32 1 32 0.20 hours ........................................

(12 minutes) .....................................

6 

Adolescent—Screener for main data 

collection.

29,487 1 29,487 0.03 hours (2 minutes) ..................... 885 

Adolescent—Main data collection .....

(3 sessions) .......................................

2,300 1 2,300 0.42 hours (25 minutes) ................... 966 

Total Adolescent Hours .................... ........................ ........................ ........................ ........................................................... 1,869 

Total Burden Hours ................... ........................ ........................ ........................ ........................................................... 6,562 

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

2The hours per response are rounded to two decimal places. 

FDA’s burden estimate is based on 

prior experience with research that is 

similar to this proposed study (OMB 

control number 0910–0848). Screening 

potential participants for the 2 pretests 

will occur with 866 respondents (456 

adults and 410 adolescents) identified 

and recruited through the internet 

panel. Participants will complete the 

screening questionnaire through an 

email invitation. This brief screening 

will take an average of 2 minutes (0.03 

hours) per respondent. If, based on this 

screening, participants qualify for the 

study, they will be automatically 

directed to begin the pretest. As 

previously mentioned, each of the 2 

pretests conducted will consist of 50 

respondents (34 adults and 16 

adolescents in each) (100 total) during a 

single session and, we estimate an 

average of 12 minutes (0.20 hours) per 

respondent. 

Screening potential participants for 

the main data collection will occur with 

80,541 respondents (51,054 adults and 

29,487 adolescents) identified and 

recruited through the same internet 

panel as used for the pretests. 

Participants will complete the screener 

questionnaire through an email 

invitation. This brief screening will take 

an average of 2 minutes (0.03 hours) per 

respondent. If, based on this screening, 

participants qualify for the study, they 

will be directed to begin Session 1. 

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 14.6 percent qualification 

rate for adults and 7.8 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 9,760 

participants, of which 7,460 will be 

adults and 2,300 will be adolescents. 

The three sessions of the main data 

collection will take an average of 12 

minutes (0.20 hours) for Session 1, 8 

minutes (0.13 hours) for Session 2, and 

5 minutes (0.08 hours) for Session 3, for 

a total of an estimated 25 minutes (0.42 

hours) per respondent. The total 

estimated burden for the data collection 

is 6,561 hours (4,692 hours for adults + 

1,869 hours for adolescents). 

I. References 

The following references are on 

display at the Dockets Management Staff 

(see ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the website addresses, as of the date this 

document publishes in the Federal 

Register, but websites are subject to 

change over time. 

1. Murphy, S.L., J. Xu, K.D. Kochanek. 

‘‘Deaths: Final Data for 2010’’. National Vital 

Statistics Reports, 61(4):37–41, 2013. 

2. U.S. Department of Health and Human 

Services. ‘‘The Health Consequences of 

Smoking: 50 Years of Progress. A Report of 

the Surgeon General.’’ Atlanta, GA: U.S. 

Department of Health and Human Services, 

Centers for Disease Control and Prevention, 

National Center for Chronic Disease 

Prevention and Health Promotion, Office on 

Smoking and Health; 2014. 

3. Jamal, A., E. Phillips, A.S. Gentzke, et 

al. ‘‘Current Cigarette Smoking Among 

Adults—United States, 2016’’. MMWR 

Morbidity and Mortality Weekly Report, 

67:53–59, 2018. 

4. Centers for Disease Control and 

Prevention. ‘‘Cigarette Smoking-Attributable 

Morbidity—United States, 2000’’. MMWR 

Morbidity and Mortality Weekly Report, 

52(35):842–844, 2003 

5. Substance Abuse and Mental Health 

Services Administration (SAMHSA). See 

Table 4.10A in ‘‘2016 National Survey on 

Drug Use and Health: Detailed Tables.’’ 


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Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Notices 65689 

Rockville, MD: U.S. Department of Health 

and Human Services, SAMHSA, Center for 

Behavioral Health Statistics and Quality; 

2017. 

6. Noar, S.M., Hall, M.G., Francis, D.B., et 

al. ‘‘Pictorial Cigarette Pack Warnings: A 

Meta-Analysis of Experimental Studies’’. 

Tobacco Control, 25:341–354, 2016. 

Dated: December 18, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–27658 Filed 12–20–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–4308] 

Labeling of Red Blood Cell Units With 

Historical Antigen Typing Results; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a final 

guidance entitled ‘‘Labeling of Red 

Blood Cell Units with Historical 

Antigen Typing Results; Guidance for 

Industry.’’ The guidance document 

provides establishments that collect 

blood and blood components for 

transfusion with recommendations for 

labeling Red Blood Cell (RBC) units 

with non-ABO/Rh(D) antigen typing 

results obtained from previous 

donations (historical antigen typing 

results). The guidance provides 

recommendations to transfusion 

services for managing RBC units labeled 

with historical antigen typing results. 

The guidance also provides licensed 

blood establishments that choose to 

implement labeling of RBC units with 

historical antigen typing results 

instructions regarding how to report the 

manufacturing and labeling changes 

under the biologics regulations. The 

guidance does not apply to test results 

for ABO and Rh(D) antigens. The 

guidance announced in this notice 

finalizes the draft guidance of the same 

title dated January 2017. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 21, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA 2016– 

D–4308 for ‘‘Labeling of Red Blood Cell 

Units with Historical Antigen Typing 

Results; Guidance for Industry.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Segal, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 


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