82_FR_15417 82 FR 15359 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings

82 FR 15359 - Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Warning Statements for Cigarette Graphic Health Warnings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 58 (March 28, 2017)

Page Range15359-15361
FR Document2017-06078

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Experimental Study on Warning Statements for Cigarette Graphic Health Warnings that is being conducted in support of the graphic label statement provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).

Federal Register, Volume 82 Issue 58 (Tuesday, March 28, 2017)
[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15359-15361]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-06078]



[[Page 15359]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0932]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the Experimental Study on Warning 
Statements for Cigarette Graphic Health Warnings that is being 
conducted in support of the graphic label statement provision of the 
Family Smoking Prevention and Tobacco Control Act (the Tobacco Control 
Act).

DATES: Submit either electronic or written comments on the collection 
of information by May 30, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2017-N-0932 for ``Agency Information Collection Activities, 
Proposed Collection; Comment Request; Experimental Study on Warning 
Statements for Cigarette Graphic Health Warnings.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 15360]]

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 (Pub. L. 111-31), which amends the Federal Food, Drug, and 
Cosmetic Act (the FD&C 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 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 the 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 
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 (ages 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 
one of 17 conditions in a between-subjects 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 
(above) plus 1 statement that is a revised version of a statutory text 
warning. 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 raises blood sugar, which can cause type 2 
diabetes.
 WARNING: Smoking causes age-related 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. 
Following viewing all nine statements, participants will respond to a 
larger set of questions. Next, participants will view an additional 
nine revised warning statements, drawn from the revised statements 
listed above, and respond to an additional set of questions. Primary 
study outcomes include beliefs and knowledge of the negative health 
consequences of cigarette smoking. Prior to the main data collection, 
two pretests, each with 50 participants, will take place to ensure 
correct programming and to identify any issues with the proposed study 
design and implementation.
    Estimated Burden: FDA estimates the burden of this collection of 
information as follows:

[[Page 15361]]



                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
       Portion of study            Number of    responses  per   Total  annual   Average  burden    Total hours
                                  respondents      respondent      responses      per  response
----------------------------------------------------------------------------------------------------------------
Screening for pretest.........             762               1             762  .033 (2 minutes)              25
Pretest.......................             100               1             100  .25 (15 minutes)              25
Screening for main data                 19,082               1          19,082  .033 (2 minutes)             630
 collection.
Main data collection..........           2,500               1           2,500  .25 (15 minutes)             625
                               ------------------------------------------------                  ---------------
    Total.....................  ..............  ..............  ..............  ................           1,305
----------------------------------------------------------------------------------------------------------------
\1\ There 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: March 22, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-06078 Filed 3-27-17; 8:45 am]
 BILLING CODE 4164-01-P



                                                                              Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices                                            15359

                                                DEPARTMENT OF HEALTH AND                                written/paper submission and in the                   the information at: http://www.fda.gov/
                                                HUMAN SERVICES                                          manner detailed (see ‘‘Written/Paper                  regulatoryinformation/dockets/
                                                                                                        Submissions’’ and ‘‘Instructions’’).                  default.htm.
                                                Food and Drug Administration
                                                                                                        Written/Paper Submissions                                Docket: For access to the docket to
                                                [Docket No. FDA–2017–N–0932]                                                                                  read background documents or the
                                                                                                           Submit written/paper submissions as
                                                                                                        follows:                                              electronic and written/paper comments
                                                Agency Information Collection
                                                Activities; Proposed Collection;                           • Mail/Hand delivery/Courier (for                  received, go to https://
                                                                                                        written/paper submissions): Division of               www.regulations.gov and insert the
                                                Comment Request; Experimental
                                                                                                        Dockets Management (HFA–305), Food                    docket number, found in brackets in the
                                                Study on Warning Statements for
                                                Cigarette Graphic Health Warnings                       and Drug Administration, 5630 Fishers                 heading of this document, into the
                                                                                                        Lane, Rm. 1061, Rockville, MD 20852.                  ‘‘Search’’ box and follow the prompts
                                                AGENCY:    Food and Drug Administration,                   • For written/paper comments                       and/or go to the Division of Dockets
                                                HHS.                                                    submitted to the Division of Dockets                  Management, 5630 Fishers Lane, Rm.
                                                ACTION:   Notice.                                       Management, FDA will post your                        1061, Rockville, MD 20852.
                                                                                                        comment, as well as any attachments,
                                                SUMMARY:  The Food and Drug                             except for information submitted,                     FOR FURTHER INFORMATION CONTACT:
                                                Administration (FDA) is announcing an                   marked and identified, as confidential,               JonnaLynn Capezzuto, Office of
                                                opportunity for public comment on the                   if submitted as detailed in                           Operations, Food and Drug
                                                proposed collection of certain                          ‘‘Instructions.’’                                     Administration, Three White Flint
                                                information by the Agency. Under the                       Instructions: All submissions received             North, 10A63, 11601 Landsdown St.,
                                                Paperwork Reduction Act of 1995 (the                    must include the Docket No. FDA–                      North Bethesda, MD 20852, 301–796–
                                                PRA), Federal Agencies are required to                  2017–N–0932 for ‘‘Agency Information                  3794.
                                                publish notice in the Federal Register                  Collection Activities, Proposed
                                                concerning each proposed collection of                  Collection; Comment Request;                          SUPPLEMENTARY INFORMATION:       Under the
                                                information and to allow 60 days for                    Experimental Study on Warning                         PRA (44 U.S.C. 3501–3520), Federal
                                                public comment in response to the                       Statements for Cigarette Graphic Health               Agencies must obtain approval from the
                                                notice. This notice solicits comments on                Warnings.’’ Received comments will be                 Office of Management and Budget
                                                the Experimental Study on Warning                       placed in the docket and, except for                  (OMB) for each collection of
                                                Statements for Cigarette Graphic Health                 those submitted as ‘‘Confidential                     information they conduct or sponsor.
                                                Warnings that is being conducted in                     Submissions,’’ publicly viewable at                   ‘‘Collection of information’’ is defined
                                                support of the graphic label statement                  https://www.regulations.gov or at the                 in 44 U.S.C. 3502(3) and 5 CFR
                                                provision of the Family Smoking                         Division of Dockets Management                        1320.3(c) and includes Agency requests
                                                Prevention and Tobacco Control Act                      between 9 a.m. and 4 p.m., Monday                     or requirements that members of the
                                                (the Tobacco Control Act).                              through Friday.                                       public submit reports, keep records, or
                                                DATES: Submit either electronic or                         • Confidential Submissions—To
                                                                                                                                                              provide information to a third party.
                                                written comments on the collection of                   submit a comment with confidential
                                                                                                        information that you do not wish to be                Section 3506(c)(2)(A) of the PRA (44
                                                information by May 30, 2017.                                                                                  U.S.C. 3506(c)(2)(A)) requires Federal
                                                ADDRESSES: You may submit comments                      made publicly available, submit your
                                                                                                        comments only as a written/paper                      Agencies to provide a 60-day notice in
                                                as follows:                                                                                                   the Federal Register concerning each
                                                                                                        submission. You should submit two
                                                Electronic Submissions                                  copies total. One copy will include the               proposed collection of information
                                                  Submit electronic comments in the                     information you claim to be confidential              before submitting the collection to OMB
                                                following way:                                          with a heading or cover note that states              for approval. To comply with this
                                                  • Federal eRulemaking Portal:                         ‘‘THIS DOCUMENT CONTAINS                              requirement, FDA is publishing notice
                                                https://www.regulations.gov. Follow the                 CONFIDENTIAL INFORMATION.’’ The                       of the proposed collection of
                                                instructions for submitting comments.                   Agency will review this copy, including               information set forth in this document.
                                                Comments submitted electronically,                      the claimed confidential information, in                 With respect to the following
                                                including attachments, to https://                      its consideration of comments. The                    collection of information, FDA invites
                                                www.regulations.gov will be posted to                   second copy, which will have the                      comments on these topics: (1) Whether
                                                the docket unchanged. Because your                      claimed confidential information                      the proposed collection of information
                                                comment will be made public, you are                    redacted/blacked out, will be available               is necessary for the proper performance
                                                solely responsible for ensuring that your               for public viewing and posted on
                                                                                                                                                              of FDA’s functions, including whether
                                                comment does not include any                            https://www.regulations.gov. Submit
                                                                                                                                                              the information will have practical
                                                confidential information that you or a                  both copies to the Division of Dockets
                                                                                                                                                              utility; (2) the accuracy of FDA’s
                                                third party may not wish to be posted,                  Management. If you do not wish your
                                                                                                        name and contact information to be                    estimate of the burden of the proposed
                                                such as medical information, your or
                                                                                                        made publicly available, you can                      collection of information, including the
                                                anyone else’s Social Security number, or
                                                confidential business information, such                 provide this information on the cover                 validity of the methodology and
                                                as a manufacturing process. Please note                 sheet and not in the body of your                     assumptions used; (3) ways to enhance
                                                that if you include your name, contact                  comments and you must identify this                   the quality, utility, and clarity of the
                                                                                                        information as ‘‘confidential.’’ Any                  information to be collected; and (4)
sradovich on DSK3GMQ082PROD with NOTICES




                                                information, or other information that
                                                identifies you in the body of your                      information marked as ‘‘confidential’’                ways to minimize the burden of the
                                                comments, that information will be                      will not be disclosed except in                       collection of information on
                                                posted on https://www.regulations.gov.                  accordance with 21 CFR 10.20 and other                respondents, including through the use
                                                  • If you want to submit a comment                     applicable disclosure law. For more                   of automated collection techniques,
                                                with confidential information that you                  information about FDA’s posting of                    when appropriate, and other forms of
                                                do not wish to be made available to the                 comments to public dockets, see 80 FR                 information technology.
                                                public, submit the comment as a                         56469, September 18, 2015, or access


                                           VerDate Sep<11>2014   17:14 Mar 27, 2017   Jkt 241001   PO 00000   Frm 00046   Fmt 4703   Sfmt 4703   E:\FR\FM\28MRN1.SGM   28MRN1


                                                15360                         Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices

                                                Experimental Study on Warning                           Statements for Cigarette Graphic Health               statutory text warning. The revised
                                                Statements for Cigarette Graphic Health                 Warnings is a voluntary online                        warning statements being tested in this
                                                Warnings                                                experiment conducted with consumers.                  proposed study are:
                                                OMB Control Number—0910–New                             The purpose of the proposed study is to               • WARNING: Smoking causes mouth
                                                                                                        assess whether potential textual                         and throat cancer.
                                                   The health risks associated with the                 warnings statements, which have been
                                                use of cigarettes can be significant and                                                                      • WARNING: Smoking causes head and
                                                                                                        revised from those enumerated in                         neck cancer.
                                                far-reaching. In 2009, Congress enacted                 section 4 of FCLAA, promote greater
                                                the Tobacco Control Act (Pub. L. 111–                                                                         • WARNING: Smoking causes bladder
                                                                                                        public understanding of the negative                     cancer, which can lead to bloody
                                                31), which amends the Federal Food,                     health consequences of cigarette
                                                Drug, and Cosmetic Act (the FD&C Act)                                                                            urine.
                                                                                                        smoking. The study will collect data                  • WARNING: Smoking during
                                                to grant FDA authority to regulate the                  from various groups of consumers,
                                                manufacture, marketing, and                                                                                      pregnancy causes premature birth.
                                                                                                        including adolescent (under age 18)                   • WARNING: Smoking during
                                                distribution of tobacco products to                     current cigarette smokers, adolescents
                                                protect the public health and to reduce                                                                          pregnancy stunts fetal growth.
                                                                                                        who are susceptible to initiation of
                                                tobacco use by minors. Section 201 of                                                                         • WARNING: Smoking during
                                                                                                        cigarette smoking, young adult (ages 18-
                                                the Tobacco Control Act amends section                                                                           pregnancy causes premature birth and
                                                                                                        to 24) current cigarette smokers, and
                                                4 of the Federal Cigarette Labeling and                                                                          low birth weight.
                                                                                                        older adult (ages 25 and above) current
                                                Advertising Act (FCLAA) (15 U.S.C.                                                                            • WARNING: Secondhand smoke
                                                                                                        cigarette smokers. The results will
                                                1333) to require FDA to issue                                                                                    causes respiratory illnesses in
                                                                                                        inform the Agency’s development of
                                                ‘‘regulations that require color graphics                                                                        children, like pneumonia.
                                                                                                        cigarette graphic health warnings to be
                                                depicting the negative health
                                                                                                        tested in future studies with the goal of             • WARNING: Smoking can cause heart
                                                consequences of smoking to accompany                                                                             disease and strokes by clogging
                                                                                                        implementing the mandatory graphic
                                                the label statements specified in                                                                                arteries.
                                                                                                        warning label statement consistent with
                                                subsection (a)(1).’’ Section 202(b) of the
                                                                                                        section 4(d) of FCLAA and the First                   • WARNING: Smoking causes COPD, a
                                                Tobacco Control Act further amends                                                                               lung disease that can be fatal.
                                                                                                        Amendment.
                                                section 4 the FCLAA by adding that the
                                                                                                          Proposed Study Overview: In this                    • WARNING: Smoking causes serious
                                                Secretary, through notice and comment                                                                            lung diseases like emphysema and
                                                                                                        study, adolescent current cigarette
                                                rulemaking, may adjust the ‘‘text of any                                                                         chronic bronchitis.
                                                                                                        smokers, adolescents who are
                                                of the label requirements . . . if the                                                                        • WARNING: Smoking reduces blood
                                                                                                        susceptible to initiation of cigarette
                                                Secretary finds that such a change                                                                               flow, which can cause erectile
                                                                                                        smoking, young adult current cigarette
                                                would promote greater public                                                                                     dysfunction.
                                                                                                        smokers, and older adult current
                                                understanding of the risks associated                                                                         • WARNING: Smoking reduces blood
                                                with the use of tobacco products.’’                     smokers will be recruited from an
                                                                                                        Internet panel of more than 1.2 million                  flow to the limbs, which can require
                                                   In the Federal Register of June 22,
                                                                                                        people and screened for inclusion into                   amputation.
                                                2011 (76 FR 36628), FDA issued a final
                                                                                                        the study. Participants who meet the                  • WARNING: Smoking raises blood
                                                rule entitled ‘‘Required Warnings for
                                                                                                        inclusion criteria will be randomized                    sugar, which can cause type 2
                                                Cigarette Packages and
                                                Advertisements,’’ which specified nine                  into one of 17 conditions in a between-                  diabetes.
                                                images to accompany the new textual                     subjects design. In each condition,                   • WARNING: Smoking causes age-
                                                warning statements for cigarettes.                      participants will be exposed to a series                 related macular degeneration, which
                                                Although the rule was scheduled to                      of nine warning statements, presented                    can lead to blindness.
                                                become effective 15 months after it                     sequentially. Participants randomized to              • WARNING: Smoking causes cataracts,
                                                issued, a panel of the U.S. Court of                    the control condition will view all nine                 which can lead to blindness.
                                                Appeals of the District of Columbia                     of the warning statements listed in                      In all conditions, after viewing each
                                                held, on August 24, 2012, that the rule                 section 4(a)(1) of FCLAA:                             statement, participants will respond to a
                                                in its current form violated the First                  • WARNING: Cigarettes are addictive.                  small number of questions about that
                                                Amendment. In a letter to Congress on                   • WARNING: Tobacco smoke can harm                     specific statement. Following viewing
                                                March 15, 2013, the Attorney General                      your children.                                      all nine statements, participants will
                                                reported FDA’s intention to undertake                   • WARNING: Cigarettes cause fatal lung                respond to a larger set of questions.
                                                research to support a new rulemaking                      disease.                                            Next, participants will view an
                                                consistent with the Tobacco Control                     • WARNING: Cigarettes cause cancer.                   additional nine revised warning
                                                Act. Preliminary research has been                      • WARNING: Cigarettes cause strokes                   statements, drawn from the revised
                                                underway since 2013. Informed by the                      and heart disease.                                  statements listed above, and respond to
                                                previous court decisions on this matter,                • WARNING: Smoking during                             an additional set of questions. Primary
                                                including on the First Amendment, the                     pregnancy can harm your baby.                       study outcomes include beliefs and
                                                next phase of the research includes the                 • WARNING: Smoking can kill you.                      knowledge of the negative health
                                                study proposed here, which is an effort                 • WARNING: Tobacco smoke causes                       consequences of cigarette smoking. Prior
                                                by FDA to collect data concerning                         fatal lung disease in nonsmokers.                   to the main data collection, two pretests,
                                                                                                        • WARNING: Quitting smoking now                       each with 50 participants, will take
                                                revised textual warning statements for
                                                                                                          greatly reduces serious risks to your               place to ensure correct programming
                                                use with new images as part of cigarette
                                                                                                          health.                                             and to identify any issues with the
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                                                graphic health warnings, and their
                                                potential impact on public                                Participants randomized to 1 of the 16              proposed study design and
                                                understanding of the risks associated                   experimental conditions will view 8 of                implementation.
                                                with the use of cigarettes.                             the warning statements listed in section                 Estimated Burden: FDA estimates the
                                                   As currently proposed, this                          4(a)(1) of FCLAA (above) plus 1                       burden of this collection of information
                                                Experimental Study on Warning                           statement that is a revised version of a              as follows:




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                                                                                         Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices                                                                                              15361

                                                                                                              TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
                                                                                                                                                   Number of                      Total                                Average
                                                                                                                        Number of                   responses
                                                                     Portion of study                                                                                            annual                              burden per                          Total hours
                                                                                                                       respondents                     per                     responses                              response
                                                                                                                                                   respondent

                                                Screening for pretest ....................................                           762                              1                     762        .033 (2     minutes)        ...................             25
                                                Pretest ...........................................................                  100                              1                     100        .25 (15     minutes)        ...................             25
                                                Screening for main data collection ...............                                19,082                              1                  19,082        .033 (2     minutes)        ...................            630
                                                Main data collection ......................................                        2,500                              1                   2,500        .25 (15     minutes)        ...................            625

                                                      Total .......................................................   ........................   ........................   ........................   ...............................................          1,305
                                                   1 There     are no capital costs or operating and maintenance costs associated with this collection of information.


                                                  FDA’s burden estimate is based on                                        Dated: March 22, 2017.                                                      ADDRESSES:    The meeting will be held
                                                prior experience with research that is                                   Leslie Kux,                                                                   online via webinar. To register to attend
                                                similar to this proposed study.                                          Associate Commissioner for Policy.                                            the meeting, please visit the Healthy
                                                Screening potential participants for the                                 [FR Doc. 2017–06078 Filed 3–27–17; 8:45 am]                                   People Web site at http://
                                                2 pretests will occur with 762                                           BILLING CODE 4164–01–P
                                                                                                                                                                                                       www.healthypeople.gov.
                                                respondents (487 adults and 275                                                                                                                        FOR FURTHER INFORMATION CONTACT:
                                                adolescents) identified and recruited                                                                                                                  Emmeline Ochiai, Designated Federal
                                                through the Internet panel. This brief                                   DEPARTMENT OF HEALTH AND                                                      Officer, Secretary’s Advisory Committee
                                                screening will take an average of 2                                      HUMAN SERVICES                                                                on National Health Promotion and
                                                minutes (0.033 hours) per respondent.                                                                                                                  Disease Prevention Objectives for 2030,
                                                                                                                         Announcement of Meeting of the                                                U.S. Department of Health and Human
                                                Each of the 2 pretests will consist of 50
                                                                                                                         Secretary’s Advisory Committee on                                             Services, Office of the Assistant
                                                respondents (34 adults and 16
                                                                                                                         National Health Promotion and Disease                                         Secretary for Health, Office of Disease
                                                adolescents) conducted during a single                                   Prevention Objectives for 2030
                                                session and take an average of 15                                                                                                                      Prevention and Health Promotion, 1101
                                                minutes (0.25 hours) per respondent.                                                                                                                   Wootton Parkway, Room LL–100,
                                                                                                                         AGENCY:  Office of Disease Prevention
                                                Screening potential participants for the                                                                                                               Rockville, MD 20852, (240) 453–8280
                                                                                                                         and Health Promotion, Office of the
                                                main data collection will occur with                                                                                                                   (telephone), (240) 453–8281 (fax).
                                                                                                                         Assistant Secretary for Health, Office of
                                                19,082 respondents (11,925 adults and                                                                                                                  Additional information is available on
                                                                                                                         the Secretary, Department of Health and
                                                                                                                                                                                                       the Healthy People Web site at http://
                                                7,157 adolescents) identified and                                        Human Services.
                                                                                                                                                                                                       www.healthypeople.gov.
                                                recruited through the same Internet                                      ACTION:        Notice.
                                                panel as used for the pretests. This brief                                                                                                             SUPPLEMENTARY INFORMATION: The
                                                screening will take an average of 2                                                                                                                    names and biographies of the
                                                                                                                         SUMMARY:   The U.S. Department of
                                                minutes (0.033 hours) per respondent.                                                                                                                  Committee members are available at
                                                                                                                         Health and Human Services (HHS)
                                                Recent national estimates of the                                                                                                                       https://www.healthypeople.gov/2020/
                                                                                                                         announces the next federal advisory
                                                numbers of adolescent current cigarette                                                                                                                about/history-development/healthy-
                                                                                                                         committee meeting regarding the
                                                smokers, adolescents who are                                                                                                                           people-2030-advisory-committee.
                                                                                                                         development of national health
                                                                                                                                                                                                          Purpose of Meeting: Through the
                                                susceptible to initiation of cigarette                                   promotion and disease prevention
                                                                                                                                                                                                       Healthy People initiative, HHS leverages
                                                smoking, young adult current cigarette                                   objectives for 2030. This meeting will be
                                                                                                                                                                                                       scientific insights and lessons from the
                                                smokers, and older adult current                                         held online via webinar and is open to
                                                                                                                                                                                                       past decade, along with new knowledge
                                                cigarette smokers informed the                                           the public. The Committee will discuss
                                                                                                                                                                                                       of current data, trends, and innovations,
                                                estimates of 13.9 percent qualification                                  the nation’s health promotion and
                                                                                                                                                                                                       to develop the next iteration of national
                                                rate for adults and 11.6 percent                                         disease prevention objectives and will
                                                                                                                                                                                                       health promotion and disease
                                                qualification rate for adolescents.                                      provide recommendations to improve
                                                                                                                                                                                                       prevention objectives. Healthy People
                                                Applying these estimates and other                                       health status and reduce health risks for
                                                                                                                                                                                                       provides science-based, 10-year national
                                                assumptions from previous experience                                     the nation by the year 2030. The
                                                                                                                                                                                                       objectives for promoting health and
                                                conducting similar studies to the                                        Committee will advise the Secretary on
                                                                                                                                                                                                       preventing disease. Since 1979, Healthy
                                                number of adolescents and adults to be                                   the Healthy People 2030 mission,
                                                                                                                                                                                                       People has set and monitored national
                                                                                                                         vision, framework, and organizational
                                                screened results in the desired sample                                                                                                                 health objectives that meet a broad
                                                                                                                         structure. The Committee will provide
                                                size for the main data collection of 2,500                                                                                                             range of health needs, encourage
                                                                                                                         advice regarding criteria for identifying
                                                participants, of which 1,667 will be                                                                                                                   collaboration across sectors, guide
                                                                                                                         a more focused set of measurable,
                                                adults and 833 will be adolescents. The                                                                                                                individuals toward making informed
                                                                                                                         nationally representative objectives. The
                                                main data collection will occur with                                                                                                                   health decisions, and measure the
                                                                                                                         Committee’s advice must assist the
                                                those 2,500 respondents during a single                                                                                                                impact of our prevention and health
                                                                                                                         Secretary in reducing the number of
                                                session. The main data collection will                                                                                                                 promotion activities. Healthy People
                                                                                                                         objectives while ensuring that the
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                                                take an average of 15 minutes (0.25                                                                                                                    2030 health objectives will reflect
                                                                                                                         selection criteria identifies the most
                                                hours) per respondent. The total                                                                                                                       assessments of major risks to health and
                                                                                                                         critical public health issues that are
                                                estimated burden is 1,305 hours (25                                                                                                                    wellness, changing public health
                                                                                                                         high-impact priorities supported by
                                                hours + 25 hours + 630 hours + 625                                                                                                                     priorities, and emerging technologies
                                                                                                                         current national data.
                                                hours).                                                                                                                                                related to our nation’s health
                                                                                                                         DATES: The Committee will meet on                                             preparedness and prevention.
                                                                                                                         April 27, 2017, from 12:00 p.m. to 2:00                                          Public Participation at Meeting:
                                                                                                                         p.m. Eastern Time (ET).                                                       Members of the public are invited to


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Document Created: 2017-03-28 00:31:59
Document Modified: 2017-03-28 00:31:59
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on the collection of information by May 30, 2017.
ContactJonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
FR Citation82 FR 15359 

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