Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Review; Experimental Study on the Public Display of Lists of Harmful and Potentially Harmful Tobacco Constituents, 26284-26287 [2012-10659]
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26284
Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
Fax written comments on the
collection of information by June 4,
2012.
DATES:
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 0910–0428. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400T, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Record Retention Requirements for the
Soy Protein and Risk of Coronary Heart
Disease Health Claim—21 CFR
101.82(c)(2)(ii)(B) (OMB Control
Number 0910–0428)—Extension
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health-related
condition only where that statement
meets the requirements of the
regulations promulgated by the
Secretary of Health and Human Services
to authorize the use of such a health
claim. Section 101.82 (21 CFR 101.82) of
FDA’s regulations authorizes a health
claim for food labels about soy protein
and the risk of coronary heart disease
(CHD). To bear the soy protein and CHD
health claim, foods must contain at least
6.25 grams of soy protein per reference
amount customarily consumed.
Analytical methods for measuring total
protein can be used to quantify the
amount of soy protein in foods that
contain soy as the sole source of protein.
However, at the present time there is no
validated analytical methodology
available to quantify the amount of soy
protein in foods that contain other
sources of protein. For these latter
foods, FDA must rely on information
known only to the manufacturer to
assess compliance with the requirement
that the food contain the qualifying
amount of soy protein. Thus, FDA
requires manufacturers to have and keep
records to substantiate the amount of
soy protein in a food that bears the
health claim and contains sources of
protein other than soy, and to make
such records available to appropriate
regulatory officials upon written
request. The information collected
includes nutrient databases or analyses,
recipes or formulations, purchase orders
for ingredients, or any other information
that reasonably substantiates the ratio of
soy protein to total protein.
In the Federal Register of November
16, 2011 (76 FR 71040), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
101.82(c)(2)(ii)(B) .................................................................
1 There
25
Total
annual
records
1
Average
burden per
recordkeeping
25
Total
hours
1
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the Agency’s experience
with the use of health claims, FDA
estimates that only about 25 firms
would be likely to market products
bearing a soy protein/coronary heart
disease health claim and that only,
perhaps, one of each firm’s products
might contain non-soy sources of
protein along with soy protein. The
records required to be retained by
§ 101.82(c)(2)(ii)(B) are the records, e.g.,
the formulation or recipe, that a
manufacturer has and maintains as a
normal course of its doing business.
Thus, the burden to the food
manufacturer is limited to assembling
and retaining the records, which FDA
estimates will take 1 hour annually.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Number of
records per
recordkeeper
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10647 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0867]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Review; Experimental Study
on the Public Display of Lists of
Harmful and Potentially Harmful
Tobacco Constituents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(the PRA).
SUMMARY:
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Fax written comments on the
collection of information by June 7,
2012.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Experimental Study on the Public
Display of Lists of Harmful and
Potentially Harmful Tobacco
Constituents.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
ADDRESSES:
E:\FR\FM\03MYN1.SGM
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Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
wreier-aviles on DSK7SPTVN1PROD with NOTICES
has submitted the following proposed
collection of information to OMB for
review and clearance.
Experimental Study on the Public
Display of Lists of Harmful and
Potentially Harmful Tobacco
Constituents—(OMB Control Number
0910–NEW)
The Tobacco Control Act (Pub. L.
111–31) 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 904(d)(1)
of the FD&C Act (21 U.S.C. 387d(d)(1))
states, ‘‘Not later than 3 years after the
date of enactment of the Family
Smoking Prevention and Tobacco
Control Act, and annually thereafter, the
Secretary shall publish in a format that
is understandable and not misleading to
a lay person, and place on public
display (in a manner determined by the
Secretary) the list [of harmful or
potentially harmful constituents]
established under [section 904(e)]’’ of
the FD&C Act. Section 904(e) of the
FD&C Act (21 U.S.C. 387d(e)) directs
FDA to establish ‘‘a list of harmful and
potentially harmful constituents,
including smoke constituents, to health
in each tobacco product by brand, and
by quantity in each brand and
subbrand.’’ On January 31, 2011, FDA
announced the availability of a final
guidance representing the Agency’s
current thinking on the meaning of the
term ‘‘harmful and potentially harmful
constituent’’ (see 76 FR 5387, January
31, 2011). On April 3, 2012, FDA
published a notice in the Federal
Register establishing a list of the
harmful and potentially harmful
constituents (HPHCs) in tobacco
products and tobacco smoke (see 77 FR
20034) as required by section 904(e) of
the FD&C Act.
FDA intends to conduct research with
consumers to help inform decisions
about how to implement section
904(d)(1) of the FD&C Act and to
provide information about how
consumers understand information
about HPHCs. The primary research goal
is to evaluate the impact of different list
formats on the public’s ability to
understand HPHC information. The
impact of different list formats will be
measured by evaluating respondents’
understanding of certain
communication objectives addressed in
this document. Secondary outcomes of
interest include measuring effects of
different list formats upon respondents’
susceptibility to initiation of tobacco
use, motivation and confidence to quit
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tobacco use, and risk perceptions about
tobacco use.
FDA proposes to conduct an
experimental study with current
smokers aged 13 years and older,
smokeless tobacco users aged 18 years
and older, and nonsmokers aged
between 13 and 17 years who may be
susceptible to initiation of smoking.
Data will be collected from members of
an Internet panel. Participation in the
experimental study is voluntary. The
information collected from the study is
necessary to inform the Agency’s efforts
to implement the requirement of the
FD&C Act to place on public display a
list of HPHCs in tobacco products and
tobacco smoke in a format that is
understandable and not misleading to a
lay person, and is expected to provide
information that may inform Agency
communications about HPHCs. The data
obtained from this study is one factor
that will be used to inform FDA’s
decisionmaking regarding the public
display of the list of HPHCs required
under section 904(d)(1). By evaluating
respondents’ understanding of the
concepts listed in this document we do
not intend to imply that consumer
understanding of all concepts is needed
to comply with these requirements.
In the Federal Register of December
14, 2011 (76 FR 77837), FDA published
a 60-day notice requesting public
comment on its proposed collection of
information. FDA received eight
comments that were PRA related, which
required a total of 10 responses.
(Comment 1) One comment
recommended that the study examine
the effects of HPHC lists for smokeless
tobacco products as well as for
cigarettes.
(Response) FDA agrees. The proposed
study will assess the impact of different
HPHC list formats for three classes of
tobacco products (cigarettes, smokeless
tobacco products, and roll-your-own
tobacco) on consumer comprehension,
beliefs, perceptions, and other
precursors to behavior.
(Comment 2) One comment
encouraged FDA to recruit participants
from multiple demographic groups.
(Response) FDA agrees that it is
important to include a diverse group of
individuals in the study and plans to
include a demographically diverse
sample of respondents drawn from four
primary groups: Adult smoker, young
adult smoker, youth smoker, and youth
at risk for tobacco initiation.
(Comment 3) One comment
recommended that FDA compare
consumer responses to the HPHC lists
against those that do not view an HPHC
list. This would facilitate an evaluation
of what consumers may understand,
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26285
believe, perceive, or do in the absence
of the HPHC list.
(Response) FDA agrees. Within each
sample group, respondents will be
randomly assigned to one of the
treatment groups that view an HPHC list
format or to a control group that does
not view a list. Some of the formats will
include additional information to
provide context for the HPHC lists to the
consumer. The effects of each list will
be determined during analysis through
a comparison of responses between
treatment and control groups.
(Comment 4) One comment cautioned
FDA to consider the utility of including
underage nonsmokers in the
experimental study.
(Response) FDA has considered the
utility of including under age
nonsmokers in the study. FDA believes
it is important to consider the risks and
benefits of the HPHC lists to the
population as a whole, including users
and nonusers of the tobacco product,
and taking into account the increased or
decreased likelihood that existing users
of tobacco products will stop using such
products, and the increased or
decreased likelihood that those who do
not use tobacco products will start using
such products. Although FDA does not
believe that there is any information on
the HPHC list that would encourage
nonusers to initiate tobacco use, one of
the secondary outcomes it is to assess
the effects of the provision of HPHC lists
on youth that do not currently use
tobacco products but who may be at risk
of initiating the use of tobacco products.
(Comment 5) One comment
recommended that the data collected
from the users of smokeless tobacco
products be analyzed separately from
cigarette smokers.
(Response) FDA agrees. FDA will
collect data on the use of tobacco
products. The study now includes a
sample of adult smokeless tobacco users
aged 18 years and older. The data from
those who use smokeless products will
be analyzed separately.
(Comment 6) Three comments
provided recommendations on
pretesting the information provided in
the lists with target audiences prior to
implementation. One of these comments
suggested that FDA use open-ended
questions to allow respondents to say/
type what they understand each
statement to mean.
(Response) FDA agrees. FDA intends
to conduct cognitive interviews with
individuals to assess comprehension of
the test instrument and certain aspects
of the list formats prior to conducting
the study. Individuals will be asked
open-ended questions during the
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Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
cognitive testing of the list formats and
the survey questions.
(Comment 7) Two comments
encouraged FDA to provide additional
information for public comment during
the development of the study including
the list formats, study design, and
measurement plans for the listed
unintended consequences.
(Response) The study protocol, list
formats, and the survey questionnaire
are available for review and public
comment upon request. To request this
information see the FOR FURTHER
INFORMATION CONTACT section of this
document.
(Comment 8) One commenter stated
that the HPHC list could not fully
inform consumers because the list is not
complete, and the consumer would not
understand that the listed quantity of
the chemicals were based on machine
testing and therefore are not necessarily
a reflection of human use. Other
comments argued there was a high
likelihood that consumers will conclude
that lower numbers or fewer
constituents means a product is less
risky. They also suggested the need to
have disclaimers that provide
information to counter potential
misunderstandings.
(Response) FDA agrees that the list
format may have the potential to
mislead consumers, which is why FDA
plans to conduct an experiment with
consumers to assess the impact of
various formats of the HPHC lists on
consumer comprehension and
precursors to behavior, such as beliefs,
attitudes, and intentions. Some of the
list formats to be included in the study
will contain additional text and
graphics to convey other information to
consumers that may not be evident from
a list of chemicals and numerical
values. The study will assess various
formats for conveying the
communication goals enumerated in
this document, such as uncertainty
about the information contained in the
list; that other relationships between the
constituents in tobacco products and
health problems may be discovered in
the future; that the values are the results
of machine testing; and that exposure to
the chemicals also depends on other
factors, such as the variability of human
use.
FDA’s proposed study will also assess
each list’s potential for increasing the
likelihood that consumers will conclude
that lower numbers or fewer
constituents imply that a tobacco
product is less risky. To evaluate
whether the lists encourage consumers
to compare the relative risks of
products, the study will include
measures, such as whether consumers
comprehend that the amount of a
chemical listed for a specific tobacco
product does not necessarily indicate
the likelihood of experiencing a health
problem, and the number of chemicals
listed for a specific tobacco product
does not necessarily indicate the
likelihood of experiencing a health
problem.
(Comment 9) Two comments stressed
the importance of using clear language
with one suggesting that information be
written at a fifth grade reading level.
They also recommended FDA consider
the impact of color, font type, and font
size on consumer comprehension.
(Response) FDA intends to use plain
language, where additional information
is provided, and to select colors, font
type, and font size that are likely to
improve consumer comprehension.
(Comment 10) One commenter
suggested FDA prioritize the
communication objectives to facilitate
evaluation of study results.
(Response) FDA agrees that a
prioritization of the communication
objectives may facilitate the evaluation
of the results. At this time, FDA
proposes a study to test the impact of
various HPHC list formats on consumer
comprehension of the communication
objectives, although it is unlikely that a
single format will be completely
successful at meeting all of those
objectives.
Based on comments received and
preliminary qualitative research,1 FDA
has refined the communication
objectives listed in the Federal Register
of December 14, 2011 (76 FR 77837) to
the following: (1) The chemicals come
from the tobacco leaf itself and different
parts of a tobacco product, such as the
tobacco smoke, glues, inks, paper, and
additives; (2) for smokeless products,
many of the chemicals come from the
tobacco leaf itself; for smoked products,
many of the chemicals come from
burning the tobacco leaf; (3) tobacco
companies are required to test their
tobacco products and smoke for the
chemicals on the list and report the
amounts to FDA; (4) science has linked
the chemicals on these lists to health
problems or potential health problems;
(5) these lists do not necessarily identify
all of the health problems that may be
caused by the tobacco product; (6) these
lists do not necessarily include all of the
chemicals in the tobacco product that
may be harmful; (7) the amount of a
chemical listed for a specific tobacco
product does not necessarily indicate
the likelihood of experiencing a health
problem; (8) the number of chemicals
listed for a specific tobacco product
does not necessarily indicate the
likelihood of experiencing a health
problem; and (9) when a chemical is
listed without a quantity it may mean
that the chemical was not detected or
the information is not currently
available.
The remaining comments were
unresponsive to the 60-day Federal
Register notice. These comments were
related to the development of an
accompanying education campaign; the
development of a Web site for
consumers to get additional
information; the provision of HPHC
information on the packages of tobacco
products; the use of claims by tobacco
manufacturers, such as ‘‘all natural’’ or
‘‘no additives’’; and the conformance of
tobacco manufacturers and retailers to
section 911 of the FD&C Act (21 U.S.C.
387k) regarding modified risk claims.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
wreier-aviles on DSK7SPTVN1PROD with NOTICES
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
responses
Average burden
per response
Total hours
Pretest ............................................................
Screener .........................................................
Experimental Survey ......................................
60
10,000
3,150
1
1
1
60
10,000
3,150
0.5
0.0167
0.5
30
167
1,575
Total ........................................................
............................
............................
............................
..............................
1,772
1 There
1 OMB
are no capital costs or operating and maintenance costs associated with this collection of information.
control number 0910–0674.
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Federal Register / Vol. 77, No. 86 / Thursday, May 3, 2012 / Notices
FDA’s burden estimate is based on
prior experience with Internet panel
experiments similar to the study
proposed here. Sixty panel members
will take part in a pretest of the study,
estimated to last 30 minutes (0.5 hours),
for a total of 30 hours. Approximately
10,000 respondents will complete a
screener to determine eligibility for
participation in the study, estimated to
take 1 minute (0.0167 hours), for a total
of 167 hours. Three thousand one
hundred and fifty respondents will
complete the full study, estimated to
last 30 minutes (0.5 hours), for a total
of 1,575 hours. The total estimated
burden is 1,772 hours.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–10659 Filed 5–2–12; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2012–N–0009]
Cooperative Agreement To Support the
Joint Institute for Food Safety and
Applied Nutrition, JIFSAN (U01)
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of grant funds for the
support of the Joint Institute for Food
Safety and Applied Nutrition (JIFSAN).
FDA believes that University of
Maryland, College Park (UMCP)–JIFSAN
is a sound investment to protect and
promote public health. FDA faces an
increasing number of critical and
complex food safety and public health
issues associated with the products that
FDA regulates. These complex issues
can be addressed most efficiently by
expanding the scientific base through
the development of collaborative
partnerships. FDA believes that
partnering with UMCP–JIFSAN will
enhance FDA’s ability to address safety
and other public health issues related to
foods, cosmetics, and animal health and
continue to stimulate the integration of
applied research, education, and
outreach programs.
DATES: Important dates are as follows:
1. The application due date is June 1,
2012.
2. The anticipated start date is August
1, 2012.
3. The opening date is May 3, 2012.
wreier-aviles on DSK7SPTVN1PROD with NOTICES
SUMMARY:
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Elizabeth M. Calvey, Center for Food
Safety and Applied Nutrition (HFS–
560), Food and Drug Administration,
CPK1, Rm. 4A007 (HFS–006), 5100
Paint Branch Pkwy., College Park, MD
20740, 240–402–1981,
elizabeth.calvey@fda.hhs.gov.
Gladys Melendez, Office of Acquisition
& Grants Services (HFA–500), Food
and Drug Administration, 5630
Fishers Lane, Rm. 1078, Rockville,
MD 20857, 301–827–7175,
gladys.bohler@fda.hhs.gov.
For more information on this funding
opportunity announcement (FOA) and
to obtain detailed requirements, please
refer to the full FOA located at https://
www.fda.gov/food/newsevents/
default.htm.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
Funding Opportunity Number: RFA–
12–016.
Catalog of Federal Domestic
Assistance Number: 93.103.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
4. The expiration date is June 2, 2012.
FOR FURTHER INFORMATION AND
ADDITIONAL REQUIREMENTS CONTACT:
A. Background
FDA is announcing its intention to
receive and consider a single source
application for the award of a
cooperative agreement in fiscal year
2012 (FY12) to UMCP to support
JIFSAN.
FDA believes that the UMCP–JIFSAN
collaboration is a sound investment.
The last 15 years of FDA’s partnership
with UMCP–JIFSAN have been
successful in developing multiple
programs to support public health
policy. The goal of JIFSAN is to advance
sound strategies that improve public
health, nutrition, and food/feed safety
through three broad program areas:
research, education, and outreach.
With an increasingly diverse domestic
and global food supply, FDA continues
to face complex food safety issues
associated with products that it
regulates (i.e., conventional foods; food
ingredients; dietary supplements;
cosmetics; animal feed, feed additives,
and animal drugs). FDA believes that
some of these complex issues can be
effectively addressed by further
strengthening the available sciencebased programs established through
JIFSAN. FDA also believes that
innovative capacity-building
partnerships with various sectors of
stakeholders in conjunction with
JIFSAN’s research and training
programs can further support the
development of proactive approaches to
the prevention of problems before they
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26287
occur. A proposal is being solicited for
meeting this need as well as FDA’s
strategic goals to protect and promote
public health.
B. Research Objectives
This cooperative agreement will
provide continued support so that
UMCP–JIFSAN can meet the following
objectives:
• Establish multi-institutional,
multidisciplinary applied research
projects to address complex food/feed
safety and public health issues
associated with products that FDA
regulates. Applied research includes not
only traditional laboratory and field
research, but also epidemiological,
educational, social and behavioral
science.
• Continue the development of
mechanisms for the exchange of
technical information and scientific
concepts between FDA and other sectors
of the international and domestic
community, through workshops, short
courses and symposia, and online
resources that focus on existing and
emerging complex food/feed safety and
public health issues.
• Continue the development and
refinement of programs based on the
application of the principles of risk
analysis to address food/feed defense
and safety issues.
• Continue the design and
improvement of domestic and
international collaborations, which
foster greater implementation of
effective food safety practices.
• Continue developing innovative
education and outreach programs that
will provide opportunities to leverage
resources among various sectors of
stakeholders to address complex safety
issues associated with an increasingly
diverse global food supply.
C. Eligibility Information
Competition is limited to UMCP–
JIFSAN because UMCP–JIFSAN is
uniquely qualified to fulfill the
objectives of the proposed cooperative
agreement. The administrative structure
and policies of UMCP–JIFSAN offer the
flexibility needed to create and operate
strategic alliances involving multiple
partners. They also allow effective
utilization of resources to plan and run
multidisciplinary and multiinstitutional research programs and
internationally-recognized food safety
training and risk analysis programs.
UMCP and FDA, through their
collaboration in JIFSAN, developed
FoodRisk.org, which is an extensive
Web-based information resource
addressing many aspects of food safety
risk analysis, as well as providing tools
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]]>Agencies
[Federal Register Volume 77, Number 86 (Thursday, May 3, 2012)]
[Notices]
[Pages 26284-26287]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0867]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Review; Experimental Study on
the Public Display of Lists of Harmful and Potentially Harmful Tobacco
Constituents
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 (the PRA).
DATES: Fax written comments on the collection of information by June 7,
2012.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-NEW and
title ``Experimental Study on the Public Display of Lists of Harmful
and Potentially Harmful Tobacco Constituents.'' Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
[[Page 26285]]
has submitted the following proposed collection of information to OMB
for review and clearance.
Experimental Study on the Public Display of Lists of Harmful and
Potentially Harmful Tobacco Constituents--(OMB Control Number 0910-NEW)
The Tobacco Control Act (Pub. L. 111-31) 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 904(d)(1) of the FD&C Act (21 U.S.C. 387d(d)(1))
states, ``Not later than 3 years after the date of enactment of the
Family Smoking Prevention and Tobacco Control Act, and annually
thereafter, the Secretary shall publish in a format that is
understandable and not misleading to a lay person, and place on public
display (in a manner determined by the Secretary) the list [of harmful
or potentially harmful constituents] established under [section
904(e)]'' of the FD&C Act. Section 904(e) of the FD&C Act (21 U.S.C.
387d(e)) directs FDA to establish ``a list of harmful and potentially
harmful constituents, including smoke constituents, to health in each
tobacco product by brand, and by quantity in each brand and subbrand.''
On January 31, 2011, FDA announced the availability of a final guidance
representing the Agency's current thinking on the meaning of the term
``harmful and potentially harmful constituent'' (see 76 FR 5387,
January 31, 2011). On April 3, 2012, FDA published a notice in the
Federal Register establishing a list of the harmful and potentially
harmful constituents (HPHCs) in tobacco products and tobacco smoke (see
77 FR 20034) as required by section 904(e) of the FD&C Act.
FDA intends to conduct research with consumers to help inform
decisions about how to implement section 904(d)(1) of the FD&C Act and
to provide information about how consumers understand information about
HPHCs. The primary research goal is to evaluate the impact of different
list formats on the public's ability to understand HPHC information.
The impact of different list formats will be measured by evaluating
respondents' understanding of certain communication objectives
addressed in this document. Secondary outcomes of interest include
measuring effects of different list formats upon respondents'
susceptibility to initiation of tobacco use, motivation and confidence
to quit tobacco use, and risk perceptions about tobacco use.
FDA proposes to conduct an experimental study with current smokers
aged 13 years and older, smokeless tobacco users aged 18 years and
older, and nonsmokers aged between 13 and 17 years who may be
susceptible to initiation of smoking. Data will be collected from
members of an Internet panel. Participation in the experimental study
is voluntary. The information collected from the study is necessary to
inform the Agency's efforts to implement the requirement of the FD&C
Act to place on public display a list of HPHCs in tobacco products and
tobacco smoke in a format that is understandable and not misleading to
a lay person, and is expected to provide information that may inform
Agency communications about HPHCs. The data obtained from this study is
one factor that will be used to inform FDA's decisionmaking regarding
the public display of the list of HPHCs required under section
904(d)(1). By evaluating respondents' understanding of the concepts
listed in this document we do not intend to imply that consumer
understanding of all concepts is needed to comply with these
requirements.
In the Federal Register of December 14, 2011 (76 FR 77837), FDA
published a 60-day notice requesting public comment on its proposed
collection of information. FDA received eight comments that were PRA
related, which required a total of 10 responses.
(Comment 1) One comment recommended that the study examine the
effects of HPHC lists for smokeless tobacco products as well as for
cigarettes.
(Response) FDA agrees. The proposed study will assess the impact of
different HPHC list formats for three classes of tobacco products
(cigarettes, smokeless tobacco products, and roll-your-own tobacco) on
consumer comprehension, beliefs, perceptions, and other precursors to
behavior.
(Comment 2) One comment encouraged FDA to recruit participants from
multiple demographic groups.
(Response) FDA agrees that it is important to include a diverse
group of individuals in the study and plans to include a
demographically diverse sample of respondents drawn from four primary
groups: Adult smoker, young adult smoker, youth smoker, and youth at
risk for tobacco initiation.
(Comment 3) One comment recommended that FDA compare consumer
responses to the HPHC lists against those that do not view an HPHC
list. This would facilitate an evaluation of what consumers may
understand, believe, perceive, or do in the absence of the HPHC list.
(Response) FDA agrees. Within each sample group, respondents will
be randomly assigned to one of the treatment groups that view an HPHC
list format or to a control group that does not view a list. Some of
the formats will include additional information to provide context for
the HPHC lists to the consumer. The effects of each list will be
determined during analysis through a comparison of responses between
treatment and control groups.
(Comment 4) One comment cautioned FDA to consider the utility of
including underage nonsmokers in the experimental study.
(Response) FDA has considered the utility of including under age
nonsmokers in the study. FDA believes it is important to consider the
risks and benefits of the HPHC lists to the population as a whole,
including users and nonusers of the tobacco product, and taking into
account the increased or decreased likelihood that existing users of
tobacco products will stop using such products, and the increased or
decreased likelihood that those who do not use tobacco products will
start using such products. Although FDA does not believe that there is
any information on the HPHC list that would encourage nonusers to
initiate tobacco use, one of the secondary outcomes it is to assess the
effects of the provision of HPHC lists on youth that do not currently
use tobacco products but who may be at risk of initiating the use of
tobacco products.
(Comment 5) One comment recommended that the data collected from
the users of smokeless tobacco products be analyzed separately from
cigarette smokers.
(Response) FDA agrees. FDA will collect data on the use of tobacco
products. The study now includes a sample of adult smokeless tobacco
users aged 18 years and older. The data from those who use smokeless
products will be analyzed separately.
(Comment 6) Three comments provided recommendations on pretesting
the information provided in the lists with target audiences prior to
implementation. One of these comments suggested that FDA use open-ended
questions to allow respondents to say/type what they understand each
statement to mean.
(Response) FDA agrees. FDA intends to conduct cognitive interviews
with individuals to assess comprehension of the test instrument and
certain aspects of the list formats prior to conducting the study.
Individuals will be asked open-ended questions during the
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cognitive testing of the list formats and the survey questions.
(Comment 7) Two comments encouraged FDA to provide additional
information for public comment during the development of the study
including the list formats, study design, and measurement plans for the
listed unintended consequences.
(Response) The study protocol, list formats, and the survey
questionnaire are available for review and public comment upon request.
To request this information see the FOR FURTHER INFORMATION CONTACT
section of this document.
(Comment 8) One commenter stated that the HPHC list could not fully
inform consumers because the list is not complete, and the consumer
would not understand that the listed quantity of the chemicals were
based on machine testing and therefore are not necessarily a reflection
of human use. Other comments argued there was a high likelihood that
consumers will conclude that lower numbers or fewer constituents means
a product is less risky. They also suggested the need to have
disclaimers that provide information to counter potential
misunderstandings.
(Response) FDA agrees that the list format may have the potential
to mislead consumers, which is why FDA plans to conduct an experiment
with consumers to assess the impact of various formats of the HPHC
lists on consumer comprehension and precursors to behavior, such as
beliefs, attitudes, and intentions. Some of the list formats to be
included in the study will contain additional text and graphics to
convey other information to consumers that may not be evident from a
list of chemicals and numerical values. The study will assess various
formats for conveying the communication goals enumerated in this
document, such as uncertainty about the information contained in the
list; that other relationships between the constituents in tobacco
products and health problems may be discovered in the future; that the
values are the results of machine testing; and that exposure to the
chemicals also depends on other factors, such as the variability of
human use.
FDA's proposed study will also assess each list's potential for
increasing the likelihood that consumers will conclude that lower
numbers or fewer constituents imply that a tobacco product is less
risky. To evaluate whether the lists encourage consumers to compare the
relative risks of products, the study will include measures, such as
whether consumers comprehend that the amount of a chemical listed for a
specific tobacco product does not necessarily indicate the likelihood
of experiencing a health problem, and the number of chemicals listed
for a specific tobacco product does not necessarily indicate the
likelihood of experiencing a health problem.
(Comment 9) Two comments stressed the importance of using clear
language with one suggesting that information be written at a fifth
grade reading level. They also recommended FDA consider the impact of
color, font type, and font size on consumer comprehension.
(Response) FDA intends to use plain language, where additional
information is provided, and to select colors, font type, and font size
that are likely to improve consumer comprehension.
(Comment 10) One commenter suggested FDA prioritize the
communication objectives to facilitate evaluation of study results.
(Response) FDA agrees that a prioritization of the communication
objectives may facilitate the evaluation of the results. At this time,
FDA proposes a study to test the impact of various HPHC list formats on
consumer comprehension of the communication objectives, although it is
unlikely that a single format will be completely successful at meeting
all of those objectives.
Based on comments received and preliminary qualitative research,\1\
FDA has refined the communication objectives listed in the Federal
Register of December 14, 2011 (76 FR 77837) to the following: (1) The
chemicals come from the tobacco leaf itself and different parts of a
tobacco product, such as the tobacco smoke, glues, inks, paper, and
additives; (2) for smokeless products, many of the chemicals come from
the tobacco leaf itself; for smoked products, many of the chemicals
come from burning the tobacco leaf; (3) tobacco companies are required
to test their tobacco products and smoke for the chemicals on the list
and report the amounts to FDA; (4) science has linked the chemicals on
these lists to health problems or potential health problems; (5) these
lists do not necessarily identify all of the health problems that may
be caused by the tobacco product; (6) these lists do not necessarily
include all of the chemicals in the tobacco product that may be
harmful; (7) the amount of a chemical listed for a specific tobacco
product does not necessarily indicate the likelihood of experiencing a
health problem; (8) the number of chemicals listed for a specific
tobacco product does not necessarily indicate the likelihood of
experiencing a health problem; and (9) when a chemical is listed
without a quantity it may mean that the chemical was not detected or
the information is not currently available.
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\1\ OMB control number 0910-0674.
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The remaining comments were unresponsive to the 60-day Federal
Register notice. These comments were related to the development of an
accompanying education campaign; the development of a Web site for
consumers to get additional information; the provision of HPHC
information on the packages of tobacco products; the use of claims by
tobacco manufacturers, such as ``all natural'' or ``no additives''; and
the conformance of tobacco manufacturers and retailers to section 911
of the FD&C Act (21 U.S.C. 387k) regarding modified risk claims.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Pretest....................................................... 60 1 60 0.5 30
Screener...................................................... 10,000 1 10,000 0.0167 167
Experimental Survey........................................... 3,150 1 3,150 0.5 1,575
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Total..................................................... ................ ................ ................ ................ 1,772
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
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FDA's burden estimate is based on prior experience with Internet
panel experiments similar to the study proposed here. Sixty panel
members will take part in a pretest of the study, estimated to last 30
minutes (0.5 hours), for a total of 30 hours. Approximately 10,000
respondents will complete a screener to determine eligibility for
participation in the study, estimated to take 1 minute (0.0167 hours),
for a total of 167 hours. Three thousand one hundred and fifty
respondents will complete the full study, estimated to last 30 minutes
(0.5 hours), for a total of 1,575 hours. The total estimated burden is
1,772 hours.
Dated: April 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-10659 Filed 5-2-12; 8:45 am]
BILLING CODE 4160-01-P
